Patent Law Blog (Patently-O)

Post Grant and Inter Partes Reviews Now Being Filed

by Dennis Crouch

48–hours after opening its doors, the Patent Trial & Appeal Board has new business.  According to the USPTO, ten new requests for inter partes reviews have been filed in the first two days as well as three post-grant review requests of financial business method patents (“covered business methods”).  Interestingly, four of the requests were filed by the non-practising entity Intellectual Ventures against patents owned by Xilinix. U.S. Patent Nos. 7,566,960, 7994609, 8,058,897, and 8,062,968.  Patrick Anderson has more history regarding the IV versus Xilinix fight at his GametimeIP blog.

On September 16, 2012, the USPTO's new inter partes reviews system became effective.  These reviews involve a complete redesign of inter partes reexaminations that can no longer be filed.  The new post-grant review system allows for an expanded scope of challenges.  Generally, PGR will only be available to challenge patents issued under the new first-to-file rules of the AIA. However, under the AIA, the PGR system can currently be used to challenge financial business method patents that fit the description provided by the statute.

The three business method reviews each focus on subject matter eligibility of the business method claims. Liberty Mutual challenged two such patents, including the following claim from U.S. Patent No. 6,553,350.

17. A method for determining a price of a product offered to a purchasing organization comprising:

arranging a hierarchy of organizational groups comprising a plurality of branches such that an organizational group below a higher organizational group in each of the branches is a subset of the higher organizational group;

arranging a hierarchy of product groups comprising a plurality of branches such that a product group below a higher product group in each of the branches in a subset of the higher product group;

storing pricing information in a data source, wherein the pricing information is associated, with (i) a pricing type, (ii) the organizational groups, and (iii) the product groups;

retrieving applicable pricing information corresponding to the product, the purchasing organization, each product group above the product group in each branch of the hierarchy of product groups in which the product is a member, and each organizational group above the purchasing organization in each branch of the hierarchy of organizational groups in which the purchasing organization is a member;

sorting the pricing information according to the pricing types, the product, the purchasing organization, the hierarchy of product groups, and the hierarchy of organizational groups;

eliminating any of the pricing information that is less restrictive; and determining the product price using the sorted pricing information.

Most of the challenged patents are in the electronic, software, and business method market areas.  However, three patents stem from USPTO Technology Center 1600 (biochemistry and organic chemistry).

• Patent No. 6,258,540 (non-invasive prenatal diagnosis using maternal plasma owned by Oxford University (UK) Isis Innovation) challenged by Ariosa Diagnostic.
• Patent Nos. 7,713,698 and 7,790,869 (Columbia University patents on “massive parallel methods for decoding DNA and RNA”) challenged by Ilumina.

Other filers include Garmin Int'l (6,258,540); Nichia Corp. (6,653,215); and Macauto USA (6,422,291).

You can search the PTO post grant submissions here: https://ptabtrials.uspto.gov

 

Patentable Subject Matter: Relying on Benson; Construing Claims for Eligibility

By Dennis Crouch

FuzzySharp Tech. Inc. v. 3DLabs Inc. (Fed. Cir. 2011)

In a per curiam opinion marked nonprecedential, the Federal Circuit has vacated and remanded the subject matter invalidity finding of a N.D. California District Court and instead ordered the court to rework its decision in light of Bilski v. Kappos, 130 S. Ct. 3218 (2010) and subsequent Federal Circuit decisions on point. As discussed below, FuzzySharp's invention relates to compression software for computer graphics. U.S. Patent Nos. 6,172,679 and 6,618,047. The main idea of the invention is to avoid calculations associated with always hidden surfaces. Although the specification explains that its implementation uses "fuzzy" math to calculate always hidden surfaces. However, "fuzzy" limitations are not found in the asserted patent claims. The application was filed in 1997, but claims priority to a 1991 Australian patent application.

FuzzySharp's appeal was filed after the district court determined that the claimed method failed to pass the machine-or-transformation and therefore, under the prevailing law at the time, the method did not constitute patentable subject matter. In re Bilski, 545 F.3d 943 (2008). In its 2010 Bislki decision, the Supreme Court rejected the notion that the machine-or-transformation test could serve as the exclusive test of the patentable subject matter of a newly invented process. In the new rubric, the machine-or-transformation test offers only an important clue.

In its opinion, the Federal Circuit largely agreed with the lower court's conclusion that the FuzzySharp claims fail the machine-or-transformation test, but, following the new Bilski rubric, remanded for a determination on the ultimate question of patentable subject matter.

Meaningful Limitations: FuzzySharp's asserted claims involve two elements that are potentially linked to a machine – computation and computer storage. However, the appellate panel found those elements lacked "meaningful limits" on claim scope in the same way that the recitation of a general-purpose-computer is not a meaningful limitation of a software process that will only be performed on a computer. (Citing Gottshalk v. Benson, 409 U.S. 64 (1972)).

Claim Construction: An important and arising issue is the interplay between claim construction and patentable subject matter. Under Federal Circuit precedent, claim construction appears to be a necessary precursor. However, the Supreme Court has regularly ignored details of claim language in making its determinations – focusing instead on what it saw as the invention.

Here, the court held that some claim construction is necessary: "[W]e conclude that … the patent eligibility of at least one of the asserted claims turns on questions of claim construction that the district court did not have the opportunity to address." It will be interesting to watch how the parties argue on remand for claim construction results that favor their hoped-for subject matter eligibility outcome.

Notes:

• The per curiam panel included Judges Bryson, O'Malley, and Reyna.
• The U.S. application was prosecuted by Carl Oppedahl's Colorado-based firm.
• The patentee is represented by Matthew McAndrews from the Niro firm on appeal; Jonathan Baker from Skadden Arps is handling the appellate defense.
• Here is Claim 12 of the '047 patent that the Federal Circuit analyzed:

  12. A method of reducing a step of visibility computations in 3-D computer graphics from a perspective of a viewpoint, the method comprising:

  computing, before said step and from said perspective, the visibility of at least one entity selected from 3-D surfaces and sub-elements of said 3-D surfaces, wherein said computing step comprises:

  employing at least one projection plane for generating projections with said selected set of 3-D surfaces and said sub-elements with respect to said perspective;

  identifying regions on said at least one projection plane, wherein said regions are related to the projections associated with said selected 3-D surfaces, said sub-elements, or bounding volumes of said 3-D surfaces or said sub-elements;

  updating data related to said regions in computer storage; and

  deriving the visibility of at least one of said 3-D surfaces or said sub-elements from the stored data in said computer storage; and

  skipping, at said step of visibility computations, at least an occlusion relationship calculation for at least one entity that has been determined to be invisible in said computing step.

 

 

Ongoing Battles over Patentable Subject Matter

By Dennis Crouch

In Ultramercial v. Hulu, the Federal Circuit held that Ultramercial's asserted Patent No. 7,346,545 fit within the subject matter eligibility guidelines of 35 U.S.C. § 101 and was not merely an unpatentable abstract idea. The patent claims a method of distributing copyrighted products (such as a movie) over the internet. The novel idea is that the copyrighted product be both (1) offered for sale and (2) delivered for free if the consumer agrees to view an advertisement. The district court held the patent invalid under section 101. On appeal, however, the Federal Circuit reversed – holding that the patent claims a "practical application" of the idea that "advertising can serve as a currency." An important element of the decision was the finding that "[v]iewing the subject matter as a whole, the invention involves an extensive computer interface."

Now, WildTangent (one of the accused infringers) has petitioned for a rehearing en banc. The public interest organization Electronic Frontier Foundation (EFF) has filed a brief in support of the rehearing – arguing that an en banc determination is necessary in light of (1) the court's failure to follow Bilski v. Kappos; (2) inconsistencies in application of the law apparent from the court's recent decisions in Ultramercial, Classen Immunotherapies v. Biogen IDEC, and CyberSource Corp. v. Retail Decisions, Inc.; and (3) a growing intra-circuit division regarding patentable subject matter jurisprudence. This filing ties-in closely with the pending Supreme Court case of Mayo v. Prometheus, which questions the patentability of a method of personalizing the dosage of a pharmaceutical and the pending case of AMP v. Myriad, which questions the patentability of isolated human DNA. Other pending Section 101 cases include DealerTrack, Inc. v. Huber (App. No. 2010-1544) (Claims 1, 3, and 4 of U.S. Patent No. 7,181,427); FuzzySharp Tech., Inc. v. 3DLabs Inc. (App. No. 2010-1160) (U.S. Patent Nos. 6,172,679 and 6,618,047); CLS Bank Int'l. v. Alice Corp (App. No. 2011-1301) (Patent No. 7,725,375); Cognex v. ITC (App. No. 2011-1098) (Patent Nos. 7,016,539 and 7,065,262); and Fort Properties, Inc. v. American Master Lease LLC (App. No. 2009-1242) (Patent No. 6,292,788).

Operating Efficiently Post-Bilski by Ordering Patent Doctrine Decision-Making

Last year, Professor Merges and I co-authored this short article on the administration of Bilski. In light of the pending Section 101 cases and Judge Rader's opinion in Classen Immunotherapies v. Biogen, I thought I would post it here again. Download the twenty-page essay from SSRN.

Here is the introduction:

Now that the Supreme Court has decided Bilski v. Kappos, there is an enormous amount of speculation about the case's impact on patent applicants, litigants, and other participants in the patent system. Most of the commentary is concerned with the holding in Bilski, how this holding will be applied by courts and the Patent Office, and ultimately, the effect of the holding on inventors, and those who hold and seek patents.

We take a different approach; rather than try to cut through the complexity of Bilski, or predict how it will be applied, we talk about how to avoid it. We are interested in how to minimize the cost and confusion that accompany a review of patents for § 101 subject-matter eligibility. To be specific, we propose that the § 101 issue of Bilski be considered only when doing so is absolutely necessary to determine the validity of a claim or claims in a patent. We believe any claim that can be invalidated under one of the less controversial and less complex requirements for patentability—§§ 102, 103, and 112, for instance—ought to be disposed of without considering subject matter patentability. In other words, the Bilski issue should be avoided wherever it is not strictly necessary. To support this conclusion, we present a set of empirical data that indicates that the vast majority of patent claims challenged on subject matter eligibility grounds were also challenged on other patentability issues.

We set the stage for our proposal in Part II, which briefly reviews the history behind Bilski and explains its open-ended holding and individualized approach. The difficulty of applying the Bilski ruling to different types of patent claims leads us to Part III, in which we call into question an accepted (if largely implicit) principle of patent law—that the lexical priority of statutory provisions in the 1952 Patent Act dictates a necessary logical sequence of invalidity tests. We reject this widespread assumption. There is nothing in the statute that requires this.

Indeed, in Part III we argue that in many ways the very idea of a sequence of discrete patentability requirements is conceptually misleading. Claims can be and often are rejected by the Patent Office for multiple reasons, suggesting that at least certain claims suffer from defects that transcend specific statutory validity requirements. We argue further that the policy underpinnings of various requirements overlap in complex ways, so that in reality patentability doctrine does not test for a series of discrete and independent qualities that are distinct from and mutually exclusive of each other. In the same way, transcendent qualities of an invention can influence multiple doctrines simultaneously, with pioneering inventions (due to both a liberal treatment under enablement, and a broad reach under infringement doctrines) being a prime example. This demonstrates again that there is not and should not be a strong separation between various patent law doctrines. Another argument along these lines recognizes that while patentability doctrines are not discrete entities, neither is "the invention" whose validity is being considered. Patent applicants routinely present multiple, overlapping claims, all of which cover fine-grained variations on a central inventive insight or advance. So it is inaccurate to visualize patentability as a stepwise series of tests applied to a single "invention." It is not true for example that "invention X" passes § 101 and should thus proceed in logical sequence to be tested under § 102. One claim growing out of inventive insight X might present no § 101 problems at all, yet another claim in the same patent application might raise a difficult issue under this provision. Each claim, being a unique slice of the overall inventive insight, ought to be considered on its own terms, and in whatever order makes the most sense. Put another way, the mental model of a stepwise sequence of patentability determinations overlooks the highly granular nature in which different slices of the inventive concept are presented for validity testing.

This analysis is further developed in Section III.A. When a claim fails to pass muster under any single test of validity, that claim should be invalidated. No further tests should be applied. We describe this as "chain" theory of validity: once one link in the chain is broken, the claim fails, and there is no reason to proceed further. Beyond that point, any expenditure of resources on validity questions is inefficient. Pragmatic considerations enter at this point. Issues of cost, justiciability, and spillover effects are perfectly appropriate in determining the actual sequence in which validity tests are applied with respect to any particular patent claim. The non-linearity of patent validity tests, together with the principle of efficient administration, yields a simple rule: start with chain links that are, in general, easiest and cheapest to test, and when the chain fails, stop the process. That way, the costliest and most complex doctrines—the trickiest "links in the chain"— are often avoided, and in any event are put off until later. Therefore, § 101 should often be avoided, both at the Patent Office and in the courts. We justify this not only on efficiency grounds, but also by analogy to the Supreme Court rules of avoidance.

In Part IV, we apply this simple principle. It leads to several recommendations. First, though the PTO has good reasons for its longstanding practice of rejecting claims for multiple reasons, we recommend that §101 be used only as an exception or last resort even at the PTO. Next, we contend that the courts should proceed in a stepwise fashion, beginning with §§ 102, and 103, and 112, changing the order of doctrines as dictated by pragmatic considerations, and stopping as soon as a claim is conclusively invalidated. In all cases, the complex and costly process of deciding whether a claim presents patentable subject matter under § 101 should be deferred until very late in the process. Therefore, we recommend, courts should in effect hold off on the difficult task of evaluating claims under § 101—ideally deploying the full § 101 analysis only when that is essential, i.e., when a claim passes muster under the other validity doctrines.

http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1953512. Thanks!

Mayo v. Prometheus: the Patentee’s Section 101 Argument

Mayo Collaborative Services v. Prometheus Labs., Inc. (Supreme Court 2011)

The briefing continues in this patentable subject matter case pending before the US Supreme Court. (Read Professor Golden's discussion of the first round of merits briefs).  In its newly filed merits brief, Prometheus attempts to refocus attention on the "concreteness" of its patented method of personalizing the dosage of a particular drug treatment. The refocus begins with the statement of the question presented.  Download 2011-10-31_Prometheus Merits Brief. 

Mayo, the petitioner challenging the patent, opened briefing with a question of whether a patent that "covers observed correlations between blood test results and patient health, so that the patent effectively preempts use of the naturally occurring correlations, simply because well-known methods used to administer prescription drugs and test blood may involve "transformations" of body chemistry."  This language of Mayo's question is directly suggestive of the decisions of Benson and Flook — both of which held claimed methods to be unpatentable.

In its brief, Prometheus restates the question in a way that instead highlights the concrete and practical application language found in Diehr and Brenner v. Manson. Prometheus asks: "Whether the Federal Circuit correctly held that concrete methods for improving the treatment of patients suffering from autoimmune diseases by using individualized metabolite measurements to inform the calibration of the patient's dosages of synthetic thiopurines are patentable processes under 35 U.S.C. §101."

Prometheus describes its challenged invention as follows:

First, most of the claims begin with the administration of a thiopurine compound to a patient with an autoimmune disorder. As noted, the thiopurine converts within the body into metabolites that do not otherwise exist in nature.

Second, the patient's metabolite levels are determined. Because "metabolite levels are not detectable in raw human tissue," all methods for measuring their concentration require "significant chemical and physical alteration of blood or human tissue" and sophisticated laboratory equipment and machines. Some of the dependant claims, for example, specify the use of high pressure liquid chromatography (HPLC), which entails an intricate series of operations on the blood (including heating, centrifuging, separating, and adding various reagents), running the resulting solution through a computer-controlled chromatography instrument, calculating the peak height or peak area, and feeding those figures into an equation, which finally outputs the metabolite levels.

Third, the metabolite measurements are compared to the patents' reference levels, "warning" the physician about the potential efficacy or toxicity of the patient's dosage.

Several important points are hidden by the patentee's statement of its invention: First, although most of the patented claims do require administration of thiopurine some claims do not include that particular step.  Second, although current technological methods of measuring metabolite levels apparently require the extraction of human tissue and the use of "sophisticated laboratory equipment," the broadest claims only require "determining" of the metabolite levels.  Finally, it is likely important to recognize that the claimed method is about tweaking the dosage of thiopurine and at the time of the invention most of the individual elements of the claim were already well known: It was well known that thiopurine could be used to treat IBD; it was well known that that the body converted thiopurine to the claimed metabolite; it was known that individuals had varying responses to thiopurine; and it was known that dosage should be adjusted so that it would be both effective and nontoxic.

Summary of the Prometheus argument:

First, to be patent-eligible, a process must really be a process—a series of steps that involve physical action in the real world, as opposed to merely an idea or principle stated in the abstract. Second, that process must be described at a narrow and specific enough level of generality that it does not preempt abstract ideas or basic building blocks of science that go far beyond what the patentee actually invented: A process for using a telegraph is patentable; the basic idea that information might be transmitted at a distance by exploiting laws of electromagnetism is not.

A. Prometheus's patented methods describe concrete methods for improving treatment of seriously ill patients with specific synthetic drugs. These patents do not claim the "correlations" they employ in the abstract, but as part of specific physical processes employing drugs and machines. . . . As the Federal Circuit recognized, the patents-in-suit pass [the machine-or-transformation] test with flying colors and easily satisfy the requirements of §101. Mayo attempts to avoid that conclusion in three ways, none of which has merit. First, Mayo invites this Court to discard the two initial steps (administering the thiopurines and determining the resulting metabolite levels) because they were "well known" in the art. But this Court rejected that "point-of-novelty" approach over 30 years ago in Diehr and again recently in Bilski. Second, Mayo argues that those same two initial steps should be disregarded because, according to Mayo, they are not "central" to the patents' purpose. Mayo does this only by ignoring the Federal Circuit's settled construction that the claims are limited to patient treatment (a question not presented here) and that those two steps are essential to that purpose. Third, Mayo invites this Court to invent, out of whole cloth, a categorical rule that processes ending with the provision of useful information cannot be patentable—even if preceding steps involve machines and physical transformations. That argument also is inconsistent with Bilski, and it would impose an arbitrary and (in the information age) absurd limitation on patentability.

B. The patents-in-suit do not preempt natural phenomena in any relevant sense. Their "correlations" concern certain properties attending certain uses of non-natural thiopurine compounds, which would not exist but for the handiwork of man. A patent system that recognizes thiopurine compounds themselves as potentially patentable subject matter, allowing preemption of all uses of these compounds, cannot be concerned that a process patent may preempt some of their uses. . . .

C. Prometheus agrees with the United States that the Patent Act's express statutory criteria for patentability—under 35 U.S.C. §§102, 103, and 112—make expansive judicial lawmaking under §101, of the sort invited by Mayo's arguments, unnecessary. But the application of those provisions is not before the Court in this case, and presents difficult and fact-bound questions that the lower courts should address in the first instance on remand.

II. Mayo proposes to transform §101 into an invitation for ad hoc, case-by-case evaluation of whether granting a particular patent will promote or retard the progress of the useful arts. That would create an unadministrable morass for courts and patent examiners, doom any hope for consistent administration of the patent laws, and usurp Congress's authority to determine the appropriate scope of the patent laws.

III. Any change in the Court's §101 jurisprudence that permitted a ruling in Mayo's favor, on whatever grounds, would have drastic and unfortunate consequences. It would upend settled expectations by invalidating thousands of diagnostic and personalized treatment patents. And it would stifle investment and innovation in the nascent field of personalized medicine. Contrary to Mayo's understanding, government funding does not translate pure academic research into practical products that benefit patients, and doctors themselves cannot bring to bear the resources necessary to fuel innovation and commercialize inventions on a large scale. Mayo's contention that patents like these hinder medical care is also unpersuasive. The United States is the world leader in biotechnology and personalized medicine, in part because investors have committed billions of dollars in capital in reliance on the prospect of patents like these. Thousands have been issued, including many to Mayo itself. Mayo's short-sighted view would exchange long-term innovation (including cost reductions) for ephemeral savings. In any event, Congress already considered Mayo's invitation to broadly restrict patent protection for medical diagnostic and treatment methods—and chose to adopt a limited personal immunity for doctors instead.

VS Tech v. Twitter: Patentable Subject Matter

VS Tech v. Twitter, 11–cv-0043 (E.D. Virginia 2011)

Trial is set for this week in the patent infringement lawsuit between VS Tech and Twitter.  VS’s asserted U.S. Patent No. 6,408,309 claims a “method of creating an interactive virtual community of people in a field of endeavor” and has a February 2000 filing date.  The inventor is Dinesh Agarwal who has also been a patent attorney since 1985.  VS Tech was formed to pursue the lawsuit and is headquartered in Mr. Agarwal’s law office address. The first two claims of the patent are reproduced below:

What is claimed is:

1. A method of creating an interactive virtual community of people in a field of endeavor, comprising the steps of:
a) selecting a field of endeavor;
b) compiling a list of members in the selected field;
c) selecting a member from the compiled list of members based on a preselected factor;
d) obtaining biographical information about the selected member;
e) processing the biographical information in a preselected format to create a personal profile of the selected member;
f) publishing the profile of the selected member on a machine readable media; and
g) allowing the selected member to interact with the profile.

2. The method of claim 1, wherein the step (f) comprises publishing the profile of the selected member on a network of computers.

In his most recent judgment in the case, Judge Morgan denied Twitter’s motion for summary judgment of invalidity under 35 U.S.C. 101, 102 & 103 and non-infringement.

The section 101 decision is interesting in that the judge treated the machine-or-transformation test as a question of fact to be determined by the jury.  “In light of all of the foregoing considerations, the Court finds that the evidence is sufficient for a reasonable juror to conclude that the '309 patent is linked to a particular machine or apparatus.”  Like claim construction and obviousness, patentable subject matter is treated by the courts as a question of law. However, unlike claim construction, the appellate courts have never held that it must be the judge who decides section 101 issues.

• File Attachment: Denial of Summary Judgment (1542 KB)
• File Attachment: Twitter Motion for Summary Judgment (2814 KB)
• File Attachment: VS Tech Opposition Brief (2481 KB)

When the case was filed in January, Patent Law reporter Joe Mullin wrote “The central role of patent lawyers in suits like this raises questions about the health of the U.S. patent system. Patent lawyers are insiders in this system, and an increasing number of them aren’t satisfied just with being very-expensive service providers to patent owners. They’re seeing the millions made by so-called patent trolls and are eager to get into the game themselves. The patent office simply isn’t set up to say no to a persistent applicant, and the patent lawyers know that as well as anybody.  Mike Masnick filed his story under the “bang-head-slowly dept.”

The following is the text of Twitter’s proposed jury instructions on what it terms “unpatentable subject matter”:

Even if an invention is both new and not obvious, a patent claim may be invalid if its subject matter is not patentable. The law establishes three categories that are not eligible for patents: laws of nature, physical phenomena, and abstract ideas.

Twitter contends that the asserted claims of the ‘309 patent claim an unpatentable abstract idea. Methods which can be performed mentally, or which are the equivalent of human mental work, are abstract ideas which cannot be patented. An abstract idea is unpatentable even if the patent claim limits the idea’s use to a particular technological environment, or adds insignificant post-solution activity. Systems that depend for their operation on human intelligence alone cannot be patented.

A useful and important clue for determining whether a patent claims unpatentable subject matter is whether the claim is tied to a particular machine or apparatus, or transforms a particular article into a different state or thing. This is called the “machine or transformation test.” To satisfy the machine prong of this test, the use of the machine must also impose meaningful limits on the claim’s scope. If the claim does not satisfy the machine-or-transformation test, this indicates that the claim may be invalid because it claims unpatentable subject matter.

 

 

Guest Posts: Preparing for Mayo v. Prometheus Labs

By Professor John Golden, Professor in Law, The University of Texas at Austin

Mayo Collaborative Services v. Prometheus Laboratories, Inc., No. 10-1150 (S. Ct.)

Scheduled for oral argument on Wednesday, December 7, 2011

In Mayo Collaborative Services v. Prometheus Laboratories, Inc., the U.S. Supreme Court looks to address questions of whether and when certain types of medical methods are patentable subject matter. Prometheus specifically involves methods for optimizing patient treatment in which the level of a drug metabolite is measured and a measured level above or below a recited amount "indicates a need" to decrease or increase dosage levels. In 2005, the Court granted certiorari on related issues in Laboratory Corp. of America v. Metabolite Laboratories, Inc., but the Court later dismissed LabCorp as improvidently granted. In 2010, the Court reaffirmed the existence of meaningful limitations on patentable subject matter in Bilski v. Kappos, but the Court but did little to clarify the scope of those limitations.

Will Prometheus bring light where Bilski failed? Arguments to the Court invite it to further clarify the status of the machine-or-transformation test for process claims. Bilski indicated that this test is relevant but not necessarily decisive, and the Federal Circuit relied heavily on the test in upholding the subject-matter eligibility of Prometheus's claims. In the circuit's view, "asserted claims are in effect claims to methods of treatment, which are always transformative when one of a defined group of drugs is administered to the body to ameliorate the effects of an undesired condition." Likewise, a metabolite-level measurement step was found to "necessarily involv[e] a transformation." Although Prometheus's claims include "mental steps," the circuit emphasized that the inclusion of such steps "does not, by itself, negate the transformative nature of prior steps."

Prior posts provide additional background on the Prometheus case. The first wave of merits briefs have been filed. These include the opening brief for the petitioners, briefs in support of the petitioners, and briefs in support of neither party. The respondent-patentee's brief as well as supporting amicus briefs will be due in the upcoming weeks.

BRIEF FOR PETITIONERS (Stephen Shapiro, Mayer Brown): Prometheus's patent claims violate Supreme Court precedent forbidding claims that "preemp[t] all practical use of an abstract idea, natural phenomenon, or mathematical formula." Prometheus's claims "recite a natural phenomenon—the biological correlation between metabolite levels and health—without describing what is to be done with that phenomenon beyond considering whether a dosage adjustment may be necessary." The claims' drug-administration and metabolite-measurement steps are merely "'token' and 'conventional' data-gathering steps" that cannot establish subject-matter eligibility. Patent protection is unnecessary to promote the development of diagnostic methods like those claimed and will in fact interfere with both their development and actual medical practice.

AMICUS BRIEFS SUPPORTING PETITIONERS

AARP & PUBLIC PATENT FOUNDATION (Daniel Ravicher, Public Patent & Cardozo School of Law): "Allowing patents on pure medical correlations … threatens doctors with claims of patent infringement" and "burdens the public with excessive health care costs, and dulls incentives for real innovation." "The Federal Circuit has latched on to trivial steps beyond mental processes, such as the 'administering' step in this case, to uphold patents that effectively preempt all uses of laws of nature." Prometheus's recitation of an "administering" step stands "in stark contrast to most pharmaceutical patents that require a 'therapeutically effective amount' of a drug be administered."

ACLU (Sandra Park, ACLU): In assessing subject matter eligibility, the Supreme Court "has focused on the essence of the claim," using a "pragmatic approach [that] allows the Court to see through clever drafting." Prometheus's insertion of drug-administration and/or measurement steps into a claim "does not alter the fact that the essence of the claim is the correlation between thiopurine drugs and metabolite levels in the blood." Further, the First Amendment bars Prometheus's claims. "What Prometheus seeks to monopolize … is the right to think about the correlation between thiopurine drugs and metabolite levels, and the therapeutic consequences of that correlation."

AMERICAN COLLEGE OF MEDICAL GENETICS ET AL. (Katherine Strandburg, NYU School of Law): The patents at issue "grant exclusive rights over the mere observation of natural, statistical correlations." They "convert routine, sound medical practice into prohibited infringement" and generate burdens and conflicts for patient care and follow-on innovation. "The machine or transformation test is inapposite … to determining whether a claim preempts a natural phenomenon." It can be too trivially satisfied without shedding sufficient light on whether claims "reflect inventive activity" or "improperly preempt downstream uses of the phenomenon."

ARUP & LABCORP (Kathleen Sullivan, Quinn Emanuel): "The patents assert exclusive rights over the process of administering a drug and observing the results…. This not only blocks the mental work of doctors advising patients, but also impedes the progress of research by seeking to own a basic law of nature concerning the human body's reaction to drugs." "Patents on measurements of nature" raise constitutional concerns by removing factual information from the public domain, thereby conflicting with patents' constitutional purpose to "promote the Progress of Science and useful Arts" and threatening to chill "scientific and commercial publication."

CATO INSTITUTE ET AL. (Ilya Shapiro, Cato Institute): This case provides the Supreme Court with an opportunity to strike a blow against the "thousands of abstract process patents which have been improvidently granted since the 1990s" and that are already adversely affecting software and financial innovation. Historically, patentable "processes" "aimed to produce an effect on matter, and these patents do not." The "indicat[ing] a need" clauses in Prometheus's claims do not even form part of a process because they do "not describe an action." Patent claims such as these, "whose final step is mental," impermissibly tread on the public domain and "freedom of thought."

NINE LAW PROFESSORS (Joshua Sarnoff, DePaul College of Law): The Supreme Court "should expressly recognize" that the Constitution requires that "laws of nature, physical phenomena, and abstract ideas" be treated as prior art for purposes of determining patentability. "Allowing patents for uncreative applications would effectively provide exclusive rights in and impermissibly reward the ineligible discovery itself." Barring claims like Prometheus's under section 101, as opposed to relying on patentability requirements such as novelty and nonobviousness, promotes "efficient gate-keeping" and "sends important signals."

VERIZON & HP (Michael Kellogg, Kellogg Huber): "It is longstanding law that a claim is non-patentable if it recites a prior art process and adds only the mental recognition of a newly discovered property of that process." See Gen. Elec. Co. v. Jewel Incandescent Lamp Co., 326 U.S. 242 (1945). "This principle is soundly based on Section 101's limitation to processes and products that are not only 'useful' but 'new.'" "[A]dding to the old process in Prometheus's patent claims nothing more than a mental step of recognizing the possible health (toxicity or efficacy) significance of the result of the process does not define a 'new and useful process.'"

AMICUS BRIEFS SUPPORTING NEITHER PARTY

UNITED STATES (Solicitor General Donald Verrilli, Jr.): The claimed methods recite "patent-eligible subject matter," and petitioners' objections to patentability are properly understood as challenges to the claimed methods' novelty and nonobviousness. By analogy with "patent law's 'printed matter' doctrine," the claims should ultimately be found invalid because, as construed by the district court, they "merely … appen[d] a purely mental step or inference to a process that is otherwise known in (or obvious in light of) the prior art." But the Supreme Court should affirm the Federal Circuit's holding on subject matter eligibility.

AIPPI (Peter Schechter, Edwards Wildman): AIPPI "encourages all member countries to allow medical personnel the freedom to provide medical treatment of patients without the authorization of any patentee." Unlike the U.S. and Australia, most countries "exclud[e] methods of medical treatment of patients from patent eligibility." When the medical-practitioner exemption of 35 U.S.C. § 287(c)(1) applies, "the courts lack subject matter jurisdiction." The exemption applies to the defendants, who "are plainly 'related health care entities.'" Thus, "the case should be dismissed for lack of federal subject matter jurisdiction."

MICROSOFT (Matthew McGill, Gibson Dunn): Subject-matter eligibility tests should not involve "pars[ing] the claimed invention into the 'underlying invention' and those aspects that are 'conventional' or 'obvious' or insignificant 'extra- or post-solution activity.'" Such parsing lacks any guiding principle that can make its application predictable. Petitioners seek an improperly "expansive application of the mental steps doctrine." "[I]f every step of a process claim can be performed in the human mind, that process is unpatentable." But the Federal Circuit has improperly "extended th[is] principle to apply to machines or manufactures that replicate mental steps."

NYIPLA (Ronald Daignault, Robins Kaplan): Innovation's "bewildering pace" argues against "rigid categorization of patent-eligible subject matter." "[T]here is no basis for excluding processes directed to analyzing the chemicals in a patient's body from patent eligibility." When satisfied, the machine-or-transformation test should decisively establish eligibility. But failure of the test should not necessarily establish ineligibility. Preemption analysis "must incorporate a critical assessment of whether the claim at issue actually claims a fundamental principle as a fundamental principle in contrast to an application of that principle."

ROCHE & ABBOTT (Seth Waxman, WilmerHale): Patents are crucial for innovation in personalized medicine and more particularly for the continued development diagnostic tests that can enable such medicine's practice. Arguments "that patents on diagnostic tests stifle innovation and basic scientific research" are "largely based on speculation, rather than sound evidence." Generally speaking, "market-driven business practices and self-enforcing market norms correct for any perceived limitations on the accessibility of patented diagnostic technologies." Congress should be trusted to provide appropriate patent-law exemptions for medical practice and research.

Survey on Willful Infringement

Prof. David C. Berry (Cooley) is researching how In re Seagate Technology, LLC, 497 F.3d 1360 (Fed. Cir. 2007)(en banc) has altered the practical landscape of willful patent infringement. One goal of the project is to collect data from persons with recent experience evaluating whether an organization's activities create a risk of patent infringement, and deciding how to respond to that risk. Current or recent in-house counsel interested in participating in the research project are invited to complete a confidential, on-line survey at: http://www.novisystems.com/NoviSurvey/n/risksurvey.aspx.

The survey was developed in conjunction with the ABA Section of Intellectual Property Law, Special Committee on Patent Analysis and Opinions of Counsel Post-Seagate. It has approximately 30 questions, and can be completed in less than 15 minutes. The survey link will be open for responses until February 15, 2011.

Tracing the Quote: Everything that can be Invented has been Invented

Charles H. Duell was the Commissioner of US patent office in 1899. Mr. Deull's most famous attributed utterance is that "everything that can be invented has been invented." Most patent attorneys have also heard that the quote is apocryphal.

In his 1989 article, Samuel Sass traced the quote back to 1981 book titled "The Book of Facts and Fallacies" by Chris Morgan and David Langford. Sass did his work well before Gore created the Internets, so I decided to take a fresh look at the research using Google. The following chart was created based on Google's electronic compilation of 12 million books. The chart shows the frequency that the phrase "everything that can be invented" shows up in the corpus, grouped by the year of publication of each book. The chart shows that Mr. Sass is largely correct in his assessment. Google has no reference to the quote prior to 1980 in its ngram database.

However, with a bit more searching, I came across an 1899 edition of Punch Magazine that had been donated to Harvard University by the Pulitzer family. In that edition, the comedy magazine offered a look at the "coming century." In colloquy, a genius asked "isn't there a clerk who can examine patents?" A boy replied "Quite unnecessary, Sir. Everything that can be invented has been invented."

I suspect that 1899 joke is the origin of the expression. Of course, there is still Ecclesiastes.

Prometheus Laboratories v. Mayo: The Broad Scope of Statutory Subject Matter

By Jason Rantanen

Prometheus Laboratories, Inc. v. Mayo Collaborative Services (Fed. Cir. 2010)
Panel: Rader, Lourie (author), Bryson

Last Friday, the Federal Circuit released its second noteworthy post-Bilski decision (the first being Research Corp v. Microsoft).  The opinion, Prometheus v. Mayo, issued following a grant-vacate-remand order from the Supreme Court instructing the CAFC to revisit its original decision in light of Bilski.  Despite this procedural posture, however, the new opinion is quite similar to the old, arriving at the same conclusion through essentially the same reasoning.   

Prometheus initially came to the Federal Circuit following a district court grant of summary judgment of invalidity under § 101 (lack of patentable subject matter).  After the CAFC reversed the ruling of invalidity using its "machine-or-transformation" test, Mayo sought review by the Supreme Court.  The Court granted certiorari, vacated the CAFC decision, and remanded for consideration in light of its Bilski opinion.  Earlier Patently-O commentary includes a summary of the original Federal Circuit opinion and a discussion of the remand.

The patents-in-suit claim a method for determining whether a patient has received a therapeutically efficacious amount of drugs such as 6-mercaptopurine ("6-MP") and azthiopurine ("AZA"), which are used to treat inflammatory bowel diseases but can produce toxic side effects.  In the human body, these drugs metabolize into 6-MP metabolites, including 6-methylmercaptopurine ("6-MMP") and 6-thioguanine ("6-TG").  By administering the drug, measuring the subject's levels of 6-MMP and 6-TG and comparing them to pre-determined levels, toxicity can be minimized and efficacy maximized. 

Claim 1 of Patent No. 6,355,623 is representative:

1. A method of optimizing therapeutic efficacy for treatment of an immune-mediated gastrointestinal disorder, comprising:
    (a) administering a drug providing 6-thioguanine to a subject having said im-mune-mediated gastrointestinal disorder; and
    (b) determining the level of 6-thioguanine in said subject having said immune-mediated gastrointestinal disorder,
    wherein the level of 6-thioguanine less than about 230 pmol per 8x108 red blood cells indicates a need to increase the amount of said drug subsequently administered to said subject and
    wherein the level of 6-thioguanine greater than about 400 pmol per 8x108 red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject.

Although similar in most respects, some claims of the second patent-in-suit, No. 6,680,302, dispense with the "administering" step.

The Patents Do Not Claim a Physical Phenomena
On remand, the CAFC again rejected Mayo's argument that the '623 and '302 patents claim a "natural phenomenon."  In seeking a judgment of invalidity under Section 101, Mayo contended (and the district court agreed) that the "administering" and "determining" steps are merely necessary data-gathering steps for the use of the correlations between 6-TG and 6-MMP and therapeutic efficacy or toxicity in patients.  Because these correlations are simply natural phenomena, Mayo reasoned, they were unpatentable.

As before, the Federal Circuit disagreed, noting that Bilski provides a broad - although not unlimited - scope for patent protection, and “an application of a law of nature or mathematical formula to a known structure or process may well be deserving of patent protection.”  Slip. Op. at 12, quoting Bilski, 130 S.Ct. at 3230.  Furthermore, the court stated, neither the Supreme Court's order to vacate and remand the original Prometheus decision nor Bilski dictates a wholly different analysis or different result.  

The crux of the CAFC's determination that the asserted claims recite a patent-eligible application of naturally occurring correlations between metabolite levels and efficacy or toxicity as opposed to the natural correlation itself rests on the specific treatment steps recited by the claims: the "administering" step and the "determining" step.  "The inventive nature of the claimed methods stems not from preemption of all use of these natural processes, but from the application of a natural phenomenon in a series of steps comprising particular methods of treatment." Slip. Op. at 15-16.

In support of its conclusion, the court reiterated its earlier determination that the treatment methods in Prometheus's patents satisfy the "machine-or-transformation test.  Although this is not the exclusive test, post-Bilski, it nevertheless provides important clues to subject matter patentabilty.  In applying the machine-or-transformation framework, the court specifically rejected Mayo's argument that the disputed claims simply claim natural correlations and the associated data-gathering steps, broadly stating that the asserted claims are "claims to methods of treatment, which are always transformative when one of a defined group of drugs is administered to the body to ameliorate the effects of an undesired condition."  Slip Op. at 17.  Even leaving out the administration step does not make the claims unpatentable, as the CAFC also found the "determining" step to be transformative because it involves "[s]ome form of manipulation, such as the high pressure liquid chromatography method specified in several of the asserted dependent claims or some other modification of the substances to be measured, [which] is necessary to extract the metabolites from a bodily sample and determine their concentration."  Id. at 18.

In reaching this conclusion, however, the court was forced to distinguish its earlier decision In re Grams, 888 F.2d 835 (Fed. Cir. 1989), which similarly claimed a process that involved "(1) performing a clinical test on individuals and (2) based on the data from that test, determining if an abnormality existed and determining possible causes of any abnormality by using an algorithm."  Id. at 20.   Unlike the claims in Grams - which the CAFC found unpatentable "because the tests were just to 'obtain data'" (Slip Op. at 20) - the claims of the Prometheus patents "require the performing of clinical tests on individuals that were transformative." 

Mental Steps
In addition to its overarching analysis of the subject matter issue, the opinion also includes an interesting discussion of the use of mental steps in patent claims.  Although the CAFC agreed that the final "wherein" clauses are mental steps, "A subsequent mental step does not, by itself, negate the transformative nature of prior steps. Thus, when viewed in the proper context, the final step of providing a warning based on the results of the prior steps does not detract from the patentability of Prometheus’s claimed methods as a whole." Slip Op. at 21. Because no claim in the Prometheus patents claims only mental steps, "contrary to Mayo’s assertions, a physician who only evaluates the result of the claimed methods, without carrying out the administering and/or determining steps that are present in all the claims, cannot infringe any claim that requires such steps." Id.

Additional Commentary
In addition to an extensive discussion about the decision in response to Dennis's post on Sunday, other sites commenting on the decision include:

• Patent Docs
• patents4life
• IP Watchdog
• Chris Holman's IP Blog
• Hal Weger of Foley has suggested that another grant of certiorari may be down the road, given the opinion's refusal to discuss a three-Justice dissent from the dismissal of certiorari in Lab. Corp., 548 U.S. 124, that was cited with approval by five Justices in two concurrences in Bilski.

Research Corp. v. Microsoft: Section 101 and Process Claims

By Jason Rantanen

There are three articulated exceptions to the scope of patentable subject matter under 35 U.S.C. § 101: laws of nature, physical phenomena, and abstract ideas.  Research Corp. v. Microsoft places a high hurdle in front of challengers who seek to invalidate process patents on the third ground. 

Research Corp. Technologies v. Microsoft Corp. (Fed. Cir. 2010)
Panel: Rader (author), Newman, and Plager

Research Corporation ("RCT") owns several patents relating to digital image halftoning, which is the process of generating electronic display and print images using only a small number of pixel colors (ex.: red, blue and green in the case of color displays) while appearing to present many more colors and shades than were actually used.  Four related patents are relevant to this summary: Nos. 5,111,310, 5,341,228, 5,477,305, and 5,726,772.  The applications for the '310 and '228 patents (a continuation-in-part of the '310 patent) were filed before December 4, 1991; the remaining patents are continuations of the '228 patent and claim priority to the earlier filing dates. 

RCT brought an infringement action against Microsoft based on these patents; in response, Microsoft asserted, and the district court initially concluded, that the patents were unenforceable due to inequitable conduct, invalid and not infringed.  The Federal Circuit reversed that determination in 2008.  Microsoft subsequently sought summary judgment against the '310 and '228 patents on Section 101 patentable subject matter grounds, and asserted that the claims of the '772 patent were not entitled to the earlier priority date, thus rendering them anticipated.  The district court granted Microsoft's motions, and subsequently held that the only remaining claim, claim 29 of the '305 patent, also lacked entitlement to the earlier priority date.  Based on these ruling, the parties stipulated to a dismissal of the suit and RCT appealed.

Section 101 and Process Claims
In reversing the district court's ruling that the '310 and '228 patents failed to satisfy Section 101, the Federal Circuit identified a set of considerations that can be applied when assessing the question of abstractness.  Drawing upon the Supreme Court's precedent in this area, including its recent decision In re Bilski, the opinion first reiterates that there are only three articulated exceptions to subject matter eligibility: "laws of nature, physical phenomena, and abstract ideas." 

Focusing on the category of abstract ideas, the court noted the Supreme Court's admonition in Bilski not to provide a rigid formula or definition for abstractness.  Rather, "the Supreme Court invited this court to develop 'other limiting criteria that further the purpose of the Patent Act and are not inconsistent with its text.'" Slip Op. at 14.  With that guidance, the panel concluded that it perceived nothing abstract in the subject matter of the processes claimed in the '310 and '228 patents.  Specifically, the court observed that:

• "The invention presents functional and palpable applications in the field of computer technology";
• Some claims in the patents require physical components;
• "[I]nventions with specific applications or improvements to technologies in the marketplace are not likely to be so abstract that they override the statutory language and framework of the Patent Act"; and
• The incorporation of algorithms and formulas does not prevent patent eligibility.

Nevertheless, while finding these factors met in the instant case, the panel further noted that its analysis was limited to the context of Section 101, which provides only a coarse filter.  Abstractness challenges can also be brought against specific claims under Section 112 even if the requirements of Section 101 are met.

Comment: The court's discussion of Section 101 suggests that the issue of patentable subject matter should be analyzed with respect to the patent as a whole; in contrast, Section 112 challenges are analyzed on a per-claim basis.

Burden of Proof for Establishing Priority
In addressing the district court's ruling that the asserted claims of the '772 and '305 patents were not entitled to claim priority to the '310 and '228 filing dates, the opinion reinforced the court's prior ruling that the patent holder bears the burden of establishing priority.  As the court held, although a patent challenger has the burden of going forward with invalidating prior art, once it has done so the burden shifts to the patent holder.  Thus, in an instance where the patent holder attempts to defeat the assertion of invalidity by claiming priority to an earlier application, the patent holder bears the burden of proving the entitlement to priority - including that the claims of the earlier patent are supported by the written description of the earlier specification.

Note: The '772 and '305 patents shared the same specification as the earlier '305 and '228 patents.  If the relevant claims had been contained in the '305 or '228 patents, Microsoft would have had the burden of proving lack of written description, as opposed to the burden resting with RCT.  Thus, the fact that the claims were part of a continuation was highly significant with respect to the allocation of the burden.

Comment: A related issue is who bears the burden of proof in the context of claims to a pre-filing conception or reduction to practice date. Although not mandated by the text of the opinion, which specifically refers to the burden to establish "an earlier filing date," the court's analysis could be read to support the conclusion that the patent holder bears the burden of proof in this situation as well.

After dispensing with RCT's challenge to the district court's allocation of burden, the panel proceeded to address the priority claims on the merits.  With respect to the '772 claims, the panel agreed with the district court, concluding that they were unsupported by the prior disclosure.  The panel did reverse on the '305 claim, however, ruling that to satisfy the written description requirement for apparatus claims, the patent need not disclose every method of making the apparatus. 

Guest Post: What Ultimately Matters In Deciding the “Gene Patenting” Issue?

By Jacqueline Wright Bonilla, PhD, JD. Ms. Bonilla is a partner at Foley & Lardner and filed an amicus brief supporting Myriad's position.

In entering the fray of this discussion, I note that I, along with two of my colleagues at Foley & Lardner LLP, submitted an amicus brief in the AMP v. PTO (a/k/a ACLU v. Myriad) "gene patenting" case on behalf of our clients Rosetta Genomics and George Mason University. In addition to our brief, other colleagues at our firm submitted a different amicus brief on behalf of a different client, Alnylam Pharmaceuticals. Both briefs, along with Myriad's brief and a number of other amicus briefs filed last week, support a reversal of the district court opinion as it pertains to "isolated DNA" composition claims. These briefs agree that such claims are patent eligible under current law, and should continue to meet the threshold of 35 U.S.C. § 101 as a matter of policy and social considerations. We are sensitive to dire consequence to biotech innovation in the face of a possible alternative outcome.

As it turns out, however, while such briefs agree on patent eligibility of "isolated DNA" claims, a number of briefs differ in viewpoints regarding applicable law, and even which cases are relevant versus not. As such, a reading of just the briefs filed with the Federal Circuit so far—even without considering the ACLU brief yet to be filed, much less amicus briefs filed in support of the ACLU's position—underscores a point worth mentioning.

The point is this: reasonable minds can differ on an interpretation of what constitutes relevant case law and how it should be interpreted in this case. This point is often missed in the hubbub we see in the press. For instance, many have commented on the amicus brief filed by the Department of Justice last week. Some have accused the DOJ of misreading the law entirely and attempting to eviscerate biotechnology innovation altogether. Such viewpoints misread the point of the DOJ brief, in my opinion.

Look what the DOJ brief actually says. It argues that the district court got it wrong in certain important respects. As stated in the DOJ brief:

… the district court erroneously cast doubt on the patent-eligibility of a broad range of manmade compositions of matter whose value derives from the information encoding capacity of DNA. Such compositions—e.g., cDNAs, vectors, recombinant plasmids, and chimeric proteins, as well as countless industrial products, such as vaccines and genetically modified crops, created with the aid of such molecules—are in every meaningful sense the fruits of human ingenuity and thus qualify as "'human-made inventions'" eligible for patent protection under section 101. [] The district court therefore erred in invalidating the challenged composition claims, such as claim 2 of the '282 patent, that are directed solely to cDNAs.

DOJ brief, pages 9-10 (citations omitted). As part of this discussion, the DOJ likewise agrees with our position that claims directed to recombinant vectors comprising any isolated DNA—even DNA having a sequence exactly as it exists in nature—constitutes patentable subject matter. See DOJ brief, page 16, discussing claim 8 of the '282 patent. Thus, unlike the district court opinion, the DOJ proposal does not throw the entire biotech baby out with the bath water.

That said, it appears that the DOJ may cut off a hand of the biotech baby. It argues that "isolated DNA" comprising a sequence from genomic DNA as it exists in a body does not constitute patentable subject matter. The DOJ brief (pages 10-11) argues that the "chemical structure of native human genes is a product of nature," even "when that structure is 'isolated' from its natural environment."

This position presents a slippery slope of considerable concern to those affiliated with biotech innovators responsible for actually getting medical products to patients. For example, the DOJ sidesteps an important scientific fact: all isolated nucleotide compositions—regardless of sequence—are, in fact, engineered DNA molecules. Such DNA molecules are necessarily, by definition of their existence in an isolated form, "human made" inventions. These products simply do not exist without human intervention. Thus, how does one successfully distinguish what is really "human made"? Moreover, human involvement is needed to identify valuable isolated nucleic acid molecules, such as DNA vaccines, PCR probes, interfering or micro RNA, etc., and then isolate them. When exactly is the human involvement sufficient to meet § 101? An additional slippery slope in the DOJ position is that many non-nucleotide compositions also exist as "products of nature" in a human body or other natural physical state. These compositions include many valuable small molecule pharmaceuticals, proteins, antibodies, just to name a few. Such compositions could likewise be subject to the same legal reasoning propagated in the DOJ brief. In other words, the fallout of the DOJ's position has wide-sweeping implications, even if not as flabbergastingly debilitating as the district court opinion.

This all said, I propose that it does no good to simply assert that the DOJ (or any party or judge for that matter) incorrectly reads relevant case law and/or misunderstands the science wholesale. As mentioned already, reasonable minds can differ on case law interpretation in this case, and how to apply scientific facts to the law. The sheer number of briefs and differences in positions—see DOJ versus USPTO as just one example—indicates this phenomenon in vivid color.

Thus, at the end of the day, the Federal Circuit and/or Supreme Court may ultimately decide the outcome of this case based on policy and social/economic considerations. The courts will consider case law, of course, but in reality may only apply it after the fact. I also believe that any precedential decision issued here, either way, will necessarily have at least some negative fallout. In fact, the patent system itself intends negative fallout to some people by virtue of granting a right to exclude others for a limited time. Thus, keeping the ideals of patent law in mind, it will be critical for courts to choose a course of action that provides the most amount of good, while causing the least amount of collateral damage. In other words, forget all the clever legal mumbo-jumbo—what do we want to happen here for the better collective good?

My understanding of the patent system is that it exists for the very purpose of stimulating innovation, as well as public disclosure of that innovation. As discussed at length in our amicus brief (and by others), abolishing patent eligibility of genetic inventions—not to mention inventions in other areas of health and medicine potentially impacted by a decision here—will have more of a dampening effect on research, development and innovation than any patent right could ever have.

My hope is that courts will remain ever conscious of slippery slopes created by any one interpretation of the law and application of science. No one wins if we inappropriately dampen incentives for innovators to discover, apply and provide innovation to the benefit of humans.

Documents:

• File Attachment: Myriad.CAFC.Amicus.RosettaGenetics.pdf (3443 KB)
• USG Brief

US Government Argues in Court that Isolated Genes are Unpatentable

AMP v. Myriad (Fed. Cir. 2010)

In March, 2010, District Court Judge Robert Sweet held Myriad's gene patent claims invalid for failing to satisfy the subject matter eligibility requirements of 35 U.S.C. 101.  The ruling was directed toward claims that cover particular isolated DNA molecules (genes) and processes of detecting and screening for those genes, but was written broadly enough to essentially invalidate all patents covering genes that were isolated from an organism. 

Last month, I heard a rumor that Obama administration science and legal advisors outside of the USPTO supported Judge Sweet's ruling.  At the time I disregarded that suggestion as unlikely. I was wrong. [Andy Pollack at the NYTimes has the scoop]

The US Department of Justice (DOJ) has now filed an amicus brief supporting the lower court decision — arguing that isolated genes are unpatentable because they improperly claim a product of naturer [Link to Brief]:

The district court correctly held . . . that genomic DNA that has merely been isolated from the human body, without further alteration or manipulation, is not patent-eligible. Unlike the genetically engineered microorganism in Chakrabarty, the unique chain of chemical base pairs that induces a human cell to express a BRCA protein is not a “human-made invention.” Nor is the fact that particular natural mutations in that unique chain increase a woman’s chance of contracting breast or ovarian cancer. Indeed, the relationship between a naturally occurring nucleotide sequence and the molecule it expresses in a human cell — that is, the relationship between genotype and phenotype — is simply a law of nature. The chemical structure of native human genes is a product of nature, and it is no less a product of nature when that structure is “isolated” from its natural environment than are cotton fibers that have been separated from cotton seeds or coal that has been extracted from the earth.

. . . .

Thus, the patent laws embrace gene replacement therapies, engineered biologic drugs, methods of modifying the properties of plants or generating biofuels, and similar advanced applications of biotechnology. Crossing the threshold of section 101, however, requires something more than identifying and isolating what has always existed in nature, no matter how difficult or useful that discovery may be.

. . . .

A product of nature is unpatentable because it is not the inventive work of humankind. That essential rule cannot be circumvented by drafting claims for the same natural product removed from its natural environment and proclaiming the result “pure.”

Several other amici have filed briefs:

• USA. Myriad.CAFC.Amicus.USA.pdf (191 KB)
• Intellectual Property Owners Association. Myriad.CAFC.Amicus.IPO.pdf (423 KB). The IPO brief was written by Paul Berghoff, Kevin Noonan, and their team at the MBHB law firm.
• Alnylam Phamaceuticals. Myriad.CAFC.Amicus.Alnylam.pdf (273 KB).  The Alnylam brief was drafted by Hal Wegner and his Foley partners.
• AIPLA. Myriad.CAFC.Amicus.AIPLA.pdf (2136 KB). The AIPLA brief was filed by Erika Arner and her team at Finnegan.

Federal Circuit: Patentability of Isolated Genes

Association for Molecular Pathology v. USPTO and Myriad Genetics (Fed. Cir. 2010)

In a landmark 2010 declaratory judgment decision, a Southern District of New York court invalidated claims from seven Myriad patents associated with the BRCA1/2 breast and ovarian cancer genes.  The patents include both composition claims covering isolated DNA molecules and method claims covering the processes of detecting and screening for BRCA mutations.  The lower court held that these claims all fail the patentable subject matter eligibility test of 35 U.S.C. §101.  A typical invalidated claim includes Claim 1 of Patent No. 5,747,282 which reads “1.  An isolated DNA coding for a BRCA1 polypeptide, said polypeptide having the amino acid sequence set forth in SEQ ID NO:2.” (The amino acid sequence No. 2 was provided as a part of the patent filing).

Myriad has now filed its Federal Circuit appeal brief on the merits and argues two main points: (1) that the declaratory judgment plaintiffs had no standing to sue because there was no actual case or controversy between them and Myriad and (2) that Myriad's patents cover inventions that fit well within the broad scope of Section 101 subject matter eligibility. As I wrote earlier, I believe that the Federal Circuit will reverse.

Standing: A general rule of appellate advocacy is to lead with your best argument. One caveat involves standing — when standing is argued, it is invariably argued first. Although the weaker of its two primary arguments, Myriad led with its case for no standing.

It is important to remember how this case arose — with twenty plaintiffs joining together to sue Myriad and to ask the Federal Court to declare Myriad's patents invalid.

Declaratory Judgment Jurisdiction is governed by Article III of the US Constitution, the Declaratory Judgment Act of 1934, and most recently, the 2007 Supreme Court case of MedImmune v. Genentech which eliminated the reasonable-apprehension-of-suit test that had been previously followed by the Federal Circuit. 

The basic question for this case is whether sufficient controversy and adversity exists between the parties or, as Myriad argues, did the lower court improperly provide an advisory opinion.  The Supreme Court restated its standing test in MedImmune — asking “whether the facts alleged, under all the circumstances, show that there is a substantial controversy, between parties having adverse legal interests, of sufficient immediacy and reality to warrant the issuance of a declaratory judgment.” Myriad argues that there is no controversy between the parties because Myriad has not taken any (recent) action toward the plaintiffs and that any controversy between the parties lacks “sufficient immediacy.”

Here, neither plaintiffs’ complaint nor the district court’s opinion identifies any “affirmative act” by Myriad within the past ten years putting plaintiffs at risk of an infringement suit. There is no allegation, much less evidence, that Myriad ever identified the patents-in-suit (or any claim thereof) to any plaintiff, or identified any plaintiff’s product or conduct as infringing. In fact, there is no allegation that Myriad was even aware of any plaintiff’s “ability and desire” to infringe (A1034-64), let alone that Myriad evaluated any product or conduct to determine infringement. Accordingly, plaintiffs have no basis for declaratory judgment jurisdiction because “the totality of the circumstances analysis in the instant case is that which has not occurred.”

The district court disagreed with these arguments — holding that a controversy existed based on Myriad's activity against researchers along with an understanding “within the research community . . . [that] Myriad has taken the position that any BRCA1/2 related activity infringes its patents and that Myriad will assert its patent rights against parties engaged in such activity.” 

Discovering the Importance of a Mutation: The important scientific discovery in this case is the knowledge that BRCA mutations predict breast and ovarian cancer.  Of course, that informational discovery by-itself cannot be patented because it represents an abstract idea rather than a useful implementation.  The mutation itself occurs in nature and therefore is not sufficiently new to be patentable. The patents therefore were drafted to cover “isolated” forms of the mutated gene and methods of isolating the gene.  As with many software algorithm patents that are “tied” to a computer, the core of the Myriad invention rests in the unpatentable information/algorithm but the claims are drafted to include technical features that ground the invention in a specific, practical use of the information discovered.  Here, once the information regarding BRCA mutations was known, the actual isolation of the genes arguably did not take any further inventing because the generic isolation process was already well known.

With this setup, the Federal Circuit will be asked to determine whether tying the informational discovery to the isolated compound or method of isolation is sufficient to move the patent outside of the scope of abstract ideas and natural phenomena.  The question may be whether the Court should follow Diehr or instead follow Flook and Benson. The Bilski decision does not help in analyzing the claim here other than by revitalizing the precedential value of Flook and Benson.

Amicus briefs supporting Myriad will be filed shortly.

• File Attachment: Myriad Brief of Appellant.pdf (5512 KB)

Business Method Patenting in Canada

Amazon.com v. Canada (Canada Fed. Ct. 2010).

The Canadian Commissioner of Patents rejected Amazon's one-click patent application — pejoratively calling the invention a “business method.”  The Commissioner's legal hook for rejection was that business methods do not fit within the legal definition of “invention” required by s. 2 of the Canadian Patent Act. The text that provision was derived from United States law and closely follows the language of the 35 U.S.C. 101.

“[I]nvention” means any new and useful art, process, machine, manufacture or composition of matter, or any new and useful improvement in any art, process, machine, manufacture or composition of matter.

On appeal, the Federal Court of Canada (J. Phelan) reversed — holding that business methods “can be patented in appropriate circumstances.” Namely, the court indicated that a “mere business scheme” or “disembodied idea” are not patentable because they have no “practical embodiment.” Although the court rejected a “technology” test, it went on to hold that Amazon’s invention qualified under s. 2 because (1) the system claims require a machine as an essential element of the invention and (2) the method claims are “put the into action through the use of cookies, computers, the internet and the customer’s own action” and results in a “physical effect” on those elements.

Although the Court had the power to grant the patent, it decided instead to remand the decision for “expedited re-examination” – noting that the Patent Office’s decisions on other patentability doctrines may have been tainted by the Office’s desire for this to serve as a test case on patentable subject matter eligibility.

Comparative International Law: Canadian courts often welcome a comparative analysis of the laws of its neighbors – especially the laws of the United Kingdom and United States. In the patent realm, the European Patent Convention (EPC) is also influential.  While those laws often help the courts in making policy decisions, the Canadian decision “must correspond to Canadian law. . . . International jurisprudence, and certainly the policies advocated therein, is not determinative, but at most a potential guide when applied correctly and mindfully.”  Here, the Court appears to have closely followed the US Supreme Court’s recent decision in Bilski v. Kappos, 130 U.S. 3218 (2010).

 

Patentable Subject Matter at the Board of Patent Appeals

The work of the Board must go on . . . . In several recent decisions, the Board of Patent Appeals (BPAI or Board) has continued to affirm rejections of claims on patentable subject matter eligibility grounds under 35 U.S.C. § 101.

In Ex parte Kelkar, App. No. 2009–004635 (BPAI, September 24 ,2010), the applicant had claimed a method of determining the similarity between two genetic profiles and a computer program stored on a recordable medium for accomplishing the method. The method involves the broad steps of iteratively matching gene expression profile pairs in clusters until a best match is found. Because the method neither recites any particular machinery nor transforms an article into a different state or thing, the Board held that it failed the machine-or-transformation test. Citing Flook (1978), the Board then held that the claim was improperly directed to an abstract algorithm because the underlying innovation was the unpatentable mathematical algorithm. Some of the method claims included a preamble statement that the method occurred “in a computer.” The Board found that limitation at most a “a field-of-use limitation that is insufficient to render the otherwise ineligible process . . . patent eligible.”

The Board went on to affirm the rejection of the computer program claims that were “stored on a recordable medium.”  The Board agreed with the examiner that those the storage medium limitation was broad enough to encompass unpatentable “carrier wave storage.” (See Nuijten (Fed. Cir. 2007)). The Board wrote:

When the broadest reasonable interpretation of a claim covers a signal per se, the claim must be rejected under 35 U.S.C. § 101 as covering nonstatutory subject matter. See In re Nuijten, 500 F.3d 1346, 1356-57 (Fed. Cir. 2007) (transitory embodiments are not directed to statutory subject matter). See also, Subject Matter Eligibility of Computer Readable Media, 1351 Off. Gaz. Pat. Office 212 (Feb. 23, 2010).

In Ex parte MacKenzie, App. No. 2009–-7332 (BPAI, October 4, 2010), the Board issued a new grounds of rejection under Section 101 because the claimed method was directed to an abstract process under Bilski. MacKenzie's rejected claim 1 reads as follows:

1. A method for use in a device associated with a first party for performing a signature operation on a message substantially based on the digital signature algorithm (DSA), the method comprising the steps of:

generating in the first party device a first component associated with the signature operation based on assistance from a device associated with a second party, wherein the assistance from the second party device is received as a first message from the second party device;

transmitting the first component to the second party device;

generating in the first party device a second component associated with the signature operation based on further assistance from the second party device, wherein the further assistance from the second party device is received as a second message from the second party device, wherein the second message comprises results generated using the transmitted first component; and

outputting a form of the first component and the second component as a result of the DSA signature operation.

Although MacKenzie's claim does recite various devices, the Board saw these as “nominal” limitations to “generic devices.” The Board wrote:

As the unpatentability of abstract ideas was reaffirmed by the U.S. Supreme Court in Bilski (2010), clever claim drafting involving the nominal addition of generic structures cannot circumvent the principles articulated by the Court. That is, even when a claim appears to apply an idea or concept in combination with a nominal claim to generic structure(s), one must ensure that it does not in reality seek patent protection for that idea in the abstract.

In Ex parte Venkata, App. No. 2009–007302 (BPAI, October 5, 2010), the Board held that “the claim’s body recites nothing more than software [and therefore] lacks statutory subject matter.” Venkata's claim was directed to a “system” that included two “discovery agents” that operate either via a local network or via an Internet host.

Kelkar's patent application is owned by IBM and prosecuted by its in-house patent department. MacKenzie's patent application is owned by Lucent and prosecuted by the small firm of Ryan, Mason & Lewis. Venkata's patent application is owned by Nokia and prosecuted by the small firm of Hollingsworth & Funk.

Notes:

The USPTO's January 2010 guidance on the Subject Matter Eligibility of Computer Readable Media is repeated as follows. I would argue that the Nuijten decision – if read to categorically exclude transitory embodiments, is no longer good law post-Bilski.

The United States Patent and Trademark Office (USPTO) is obliged to give claims their broadest reasonable interpretation consistent with the specification during proceedings before the USPTO. See In re Zletz, 893 F.2d 319 (Fed. Cir. 1989) (during patent examination the pending claims must be interpreted as broadly as their terms reasonably allow). The broadest reasonable interpretation of a claim drawn to a computer readable medium (also called machine readable medium and other such variations) typically covers forms of non-transitory tangible media and transitory propagating signals per se in view of the ordinary and customary meaning of computer readable media, particularly when the specification is silent. See MPEP 2111.01. When the broadest reasonable interpretation of a claim covers a signal per se, the claim must be rejected under 35 U.S.C. § 101 as covering non-statutory subject matter. See In re Nuijten, 500 F.3d 1346, 1356-57 (Fed. Cir. 2007) (transitory embodiments are not directed to
statutory subject matter) and Interim Examination Instructions for Evaluating Subject Matter Eligibility Under 35 U.S.C. § 101, Aug. 24, 2009; p. 2.

The USPTO recognizes that applicants may have claims directed to computer readable media that cover signals per se, which the USPTO must reject under 35 U.S.C. § 101 as covering both non-statutory subject matter and statutory subject matter. In an effort to assist the patent community in overcoming a rejection or potential rejection under 35 U.S.C. § 101 in this situation, the USPTO suggests the following approach. A claim drawn to such a computer readable medium that covers both transitory and non-transitory embodiments may be amended to narrow the claim to cover only statutory embodiments to avoid a rejection under 35 U.S.C. § 101 by adding the limitation "non-transitory" to the claim. Cf. Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (suggesting that applicants add the limitation "non-human" to a claim covering a multi-cellular organism to avoid a rejection under 35 U.S.C. § 101). Such an amendment would typically not raise the issue of new matter, even when the specification is silent because the broadest reasonable interpretation relies on the ordinary and customary meaning that includes signals per se. The limited situations in which such an amendment could raise issues of new matter occur, for example, when the specification does not support a non-transitory embodiment because a signal per se is the only viable embodiment such that the amended claim is impermissibly broadened beyond the supporting disclosure. See, e.g., Gentry Gallery, Inc. v. Berkline Corp., 134 F.3d 1473 (Fed. Cir. 1998).

DAVID J. KAPPOS
Under Secretary of Commerce for Intellectual Property and
Director of the United States Patent and Trademark Office

Citations to Supreme Court Patentable Subject Matter Jurisprudence

The chart above shows the cumulative law review citation count for the Supreme Court's leading pre-Bilski patentable subject matter decisions.  The data is based on a westlaw keycite search, each law review article is counted only once per case. Thus, if an article that cites Diehr twenty times only adds one to the tally. 

Prometheus v. Mayo: Patenting Medical Methods

Prometheus Labs. v. Mayo Collaborative Services (Mayo Clinic) (Fed. Cir. 2010)

This case is one of several pending Federal Circuit appeals that are questioning whether medical diagnostic and treatment methods are the proper subject of patent protection.

The claims asserted by Prometheus are directed toward a method of “optimizing therapeutic efficacy” by first administering an active drug (6-thioguanine) to a subject and then using the subject's metabolite blood-level to adjust future doses of the drug.  (U.S. Patents 6,355,623 and 6,680,302). Thus, most of the claims are centered around three ordered-steps of:

1. administering the drug to the subject;
2. determining the amount of drug in the subject’s blood; and
3. re-calibrating the drug dosage based on step-2.

A broader claim (claim 46 of the ‘632 patent) eliminates the administering step of claim 1 above.

The district court found the claims invalid as lacking patentable subject matter under 35 U.S.C. 101.  On appeal, the Federal Circuit reversed — holding that the steps of “administering a drug” and “determining the level of 6-thioguanine” were both sufficiently transformative of “a particular article into a different state or thing.”  That Federal Circut decision was based on the court's machine-or-transformation test that was subsequently discredited by the Supreme Court in Bilski v. Kappos (2010).  In the wake of its Bilski decision, the Supreme Court vacated the Federal Circuit's Prometheus decision and remanded for a new opinion.  Seeing this as a potential watershed case, Mayo immediately requested that the Federal Circuit hear the case en banc.

Briefing by October 1: The Federal Circuit has apparently denied the en banc request and has moved-forward with a rapid briefing schedule: By October 1, 2010, both parties are scheduled to submit 20–page briefs “addressing the effect of the Supreme Court’s Bilski decision on the disposition of this case. No additional briefing or oral argument is contemplated at this time.”  The scheduling order was signed by the court clerk Jan Horbaly.

Judges in Charge: The scheduling order suggests that the remand will be taken as a supplement to the original decision. A quirk of that original decision is that the three-member panel included two judges who are not on the Federal Circuit (Chief Judge Paul Michel (Ret.) and E.D. Texas District Court Judge Ron Clark). The third member of the panel is Judge Lourie.  Federal Circuit rules indicate that Judge Clark can retain on the panel on remand, but would not be part of any en banc hearing.

Related cases include Classen Immunotherapies Inc. v. Biogen Idec (method of determining an immunization schedule) and Association for Molecular Pathology v. Myriad Genetics (gene patents). 

IN DEFENSE OF SOFTWARE PATENTS - PART 2

Guest Post by Martin Goetz

 

Back on November 30, 2009, Patently-O published my article “In Defense of Software Patents” in response to the editorial “Abandoning Software Patents” by Ciaran O’Riordan, Director of End Software Patents (posted on Patently-O on November 6, 2009) which had as its premise that software companies are trying to protect “software ideas”.

 

In this article I comment on the Bilski Opinion as well as give some concrete examples of software-only patents as well as hardware/software patents. Also, my previous article received hundreds of comments, many being negative, and part of this new post is in response to those negative comments.

 

Since the June 28^th Supreme Court Bilski decision there have been many articles[1] on what the Opinion stated and inferred about the patentability of software.

 

The Opinion restated what previous Supreme Courts concluded: that laws of nature, physical phenomena, mathematics, mathematical formulas (by themselves), algorithms (by themselves), and abstract ideas (which would include software ideas) are not eligible for patent protection.

 

While the Bilski Opinion never directly questioned the patentability of software, the Justices wrote extensively about the meaning of Section 101, the meaning of the term “process” and why the test for patent eligibility should not exclusively be “the machine-or –transformation test”. Justice Kennedy, with the concurrence of all other Supreme Court members, wrote that the Information Age puts innovation in the hands of more people and raises new difficulties for the patent law (and the Patent Office) to determine who should or should not receive patent protection.[2]

 

My November 2009 Patently-O article “In Defense of Software Patents” produced hundreds of comments. Many wrote that they were against the patenting of software because software was an “algorithm” or “mathematics”. In that article my primary argument was that a computer software invention is as patentable as a computer hardware invention and the only difference is the mode of implementation. My thesis was that Software Product companies in the Software Industry are looking to patent a machine process and not a computer program, which is protected by the copyright law. I showed why software product companies can be viewed as high technology manufacturing entities and should be just as eligible for patent protection as computer hardware companies.   

 

In this article I give examples of patents where the preferred implementation of an inventive machine process is in software (via a computer program[3]), hardware (via circuitry), or a combination of both software and hardware.

 

There is little argument that “processes” and “machine processes” are patentable subject matter[4] The question has always been about the nature of software and what one is trying to patent. For over 40 years I have been involved in that argument since I received the first software patent in 1968 for an innovative way to sort large amounts data on a computer that had tape drives that could only read and write data in a forward direction (See Patent # 3,380,029, Sorting System, Issued April 23, 1968).

 

The Sorting System patent was dubbed a software patent but it could also have been a computer hardware patent. It was dubbed a software patent solely because the preferred implementation (the disclosure) was a logic chart (which is recognized by the patent office as a proper disclosure). My Sorting System patent would not have been controversial if the disclosure had been hardware circuitry since there were many hardware patents for sorting data on special-purpose computers and special apparatus. In my patent application I referenced six of those patents which all had unique hardware circuitry in their patent disclosure. Three of them are available online, courtesy of Google Patent Search[5].

 

From 1968 through 1980 my previous company, Applied Data Research filed Amicus briefs in the Prater & Wei, Benson, Johnson, Flook, and Diehr cases in which we argued that a machine process patentable in hardware is equally patentable in software. Here is exactly how we posed a “Question of Law” “in our 1980 Diehr brief:

Whether a computerized machine or industrial process that is patentable subject matter under 35 USC 101 when constructed with a hardware program (wired circuits) would also be patentable subject matter when constructed with a stored computer program (i.e., firmware or software)?

The USPTO is currently in agreement with that “Question of Law” when in 1996 it published its Examination Guidelines for Computer-Related Inventions (Final Version).  The Guidelines stated in its Introduction the following: “The Guidelines alter the procedure office personnel will follow when examining applications drawn to computer-related inventions and are equally applicable to claimed inventions implemented in hardware or software.”

 

In that 1980 Diehr brief we also posed the following argument to the Supreme Court:

An inventor demonstrates his new invention to his patent attorney with great pride; he has developed a cabinet for reading books out loud to the blind. The cabinet contains both a reading and talking computer. After the demonstration, the patent attorney responds:

 

What's inside the cabinet? Did you build it with software or hardware (a stored program or hardware circuitry)? If built with a hardware program, your machine would be patentable. But if you built it with a stored program, the Patent Office would say it was merely mathematics and, therefore, unpatentable.”

The example above of a hypothetical “cabinet for the blind” invention was back in 1980 in our Diehr Amicus brief.

 

Twenty years later, in 2000, a renowned inventor, Ray Kurzweil received a patent named Reading System which Reads Aloud From An Image Representation Of A Document. The patent disclosure shows a diagram of a monitor, scanner, speakers, and a PC computer composed of a processor, storage and a keyboard. The essence of the disclosure and the invention is a logic chart describing a machine system which interacts with a speech synchronizer and the various devices.  

 

The first sentence of the abstract in the patent stated “a reading system includes a computer and a mass storage device including software comprising instructions for causing a computer to accept an image file generated from optically scanning an image of a document.”

 

At that time, Ray Kurzweil’s company, Kurzweil Educational Systems marketed a special purpose hardware/software system called the Kurzweil 3000 Reading Machine which was marketed to the blind and poor readers. Their 2000 year patent protected this product from imitators. Today the company sells a software only system called Kurzweil 3000 and continues to have the protection of the patent system thru his original 2000 patent and with additional patents e.g., Reducing processing latency in optical character recognition for portable reading machine (which is a software-only patent).

 

Few would argue that the Kurzweil 3000 Reading Machine was not an invention and not deserving of a patent.

 

While I am a strong advocate for software-related patents I have always been opposed to the patenting of Business Method Patents (BMPs). In my 2006 article Patents: Where's the Invention? I stated that the Patent Office should do what the European Patent Convention did when it  ruled that anything that consists of "schemes, rules and methods for performing mental acts, playing games or doing business, and programs for computers" is not an invention and therefore not patentable.” Justice Stevens, in his Opinion[6] also wanted to ban BMP’s from being patentable subject matter when he concluded that a method of doing business is not a “process” under 101.

 

Although the Bilski Opinion disallowed the Bilski application they stated that under certain conditions business methods could still be patentable subject matter. On July 27^th the USPTO set up more stringent rules for the issuance of BMPs in their Interim Guidance for Determining Subject Matter Eligibility for Process Claims in View of Bilski v. Kappos. In many ways those guidelines are similar to the way computer software and hardware patents are currently being treated under the 1996 Guidelines for Computer-Related Inventions.    

 

One of the greatest challenges facing the Patent office today for BMPs, software or hardware patent applications is in discovering prior art and determining if there is an invention. The USPTO “Peer to Patent” pilot project” which  allows the public (including professionals in their respective fields) to comment on patent applications is still in its infancy, but offers the potential to assist the Patent Office in rejecting the large number of applications that are filed each year. The stated goal of the pilot project was to “connect the USPTO to an open network of experts online.”   Also, private companies e.g., the Article One Partners, a patent research firm, have the potential to significantly reduce the large number of patent litigation cases.

 

In conclusion, while I am a strong proponent of software patents I am very aware, and agree with, many of the arguments against patents because of patent trolls, frivolous patents, e.g. Amazon’s one-click patent, and frivolous patent litigation that can put companies out of business. And I support changes in the Patent Law to reduce those problems. But if one believes in the how the Patent System has fostered innovation and helped the US grow and prosper, then there is no rational reason to eliminate technology inventions that use software as its implementation.

 

In my previous article there were many comments from die-hards that continued to believe that software companies are trying to patent a computer program,  Whether those die-hards still  believe that a computer program is mathematics, or a mathematical formula, or an algorithm, or an abstract idea, so be it. Computer software programs are not what software companies are trying to patent. A software patent invention is on a unique machine process ---- nothing more and nothing less. And the criteria should be 1. Innovation 2. A proper disclosure and 3. Usefulness --- the same requirement that is the criteria for all patentable subject matter.

---

[1] Click below for a sample of many of these articles. Reading the Bilski Tea Leaves For What The Supreme Court Thinks Of Software Patents Comments on Bilski and Software Patents; Here's Bilski: It's Affirmed, But . . .No Decision on Software Patentability; Supreme Court Decision Raises Software Patent Questions; Supreme Court 'Bilski' ruling doesn't rule out software, business-method patents; Software patent debate rages on; Software, pharmaceutical, and business method patents survive; Patent Office Says No to Supreme Court and Software Patents; Death Knell For Software Patents; Software Is Not Necessarily Business Method; Software Patents and Business Method Patents Still Possible after Bilski Supreme Court Decision.

 

[2](Underlining and bold added) (pages 9 & 10) “The machine-or-transformation test may well provide a sufficient basis for evaluating processes similar to those in the Industrial Age—for example, inventions grounded in a physical or other tangible form. But there are reasons to doubt whether the test should be the sole criterion for determining the patentability of inventions in the Information Age. As numerous amicus briefs argue, the machine-or-transformation test would create uncertainty as to the patentability of software, advanced diagnostic medicine techniques, and inventions based on linear programming, data compression, and the manipulation of digital signals. See, e.g., Brief for Business Software Alliance 24– 25; Brief for Biotechnology Industry Organization et al. 14–27; Brief for Boston Patent Law Association 8–15; Brief for Houston Intellectual Property Law Association 17–22; Brief for Dolby Labs., Inc., et al.”

 

The Opinion went on to state:

It is important to emphasize that the Court today is not commenting on the patentability of any particular invention, let alone holding that any of the above-mentioned technologies from the Information Age should or should not receive patent protection. This Age puts the possibility of innovation in the hands of more people and raises new difficulties for the patent law. With ever more people trying to innovate and thus seeking patent protections for their inventions, the patent law faces a great challenge in striking the balance between protecting inventors and not granting monopolies over procedures that others would discover by independent, creative application of general principles. Nothing in this opinion should be read to take a position on where that balance ought to be struck.

[3] While the implementation is in a computer program, the disclosure for one skilled in the art, are thru flow charts (also called logic charts) and thru block diagrams.

[4]. The Bilski Opinion closely examined the meaning and the words of 35 U.S.C 101. From 35 U.S.C. 101: Inventions patentable: Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent there for, subject to the conditions and requirements of this title.

[5] The Sorting Patents below were described thru and/or gates, and as methods and apparatus for sorting data. Sorting Device, Fillebrown, 5/1961 #2,985,864; Sorting Apparatus, Guerber, 5/1960 #2,935,732; Apparatus for sorting of Recorded Digital data, Dirks 3/1966 #3,242,466.

 

[6] (page 15) Because the text of §101 does not on its face convey the scope of patentable processes, it is necessary, in my view, to review the history of our patent law in some detail. This approach yields a much more straightforward answer to this case than the Court’s. As I read the history, it strongly supports the conclusion that a method of doing business is not a “process” under §101.

 

Genus-Species; Doctrine of Equivalents; and Patentable Subject Matter

By Dennis Crouch

For many, the most interesting aspect of this case comes at the end in Judge Dyk’s dissent. Dyk makes the case that genes should not be patentable. 

* * * *

Intervet Inc. v. Merial Limited (Fed. Cir. 2010)

In 2006, Intervet filed a complaint against Merial — asking the DC District Court for a declaratory judgment that Intervet’s Porcine Circovirus vaccine (PCV-2) did not infringe Merial’s gene patent.  Merial’s patent claims both the isolated DNA molecule of PCV-2 and a vector that contains the DNA.  The application includes a listing of several different sequences that all fall within the PCV-2 category. 

Although Intervet also uses a PCV-2 vector. The DJ plaintiff argues that its DNA molecule is different from the one described and deposited by Merial. The district court agreed — holding that the Intervet product was only 99.7% homologous to the closest deposited sequence and therefore outside of the literal claim scope. The district court also applied prosecution history estoppel to rejected Merial’s claims of infringement under the doctrine of equivalents (DOE). On appeal, the Federal Circuit reversed on both claim construction and DOE.

Genus Not Limited to Examples: The asserted claim includes a limitation of a “PCV-2” DNA molecule. The District Court limited that term to cover only the DNA sequences that were deposited with the PTO. On appeal, the Federal Circuit rejected that construction as overly limiting. Rather, the appellate panel held that the deposited sequences serve as a representative sample of PCV-2 DNA sequences. “Sequences are representative of the scope of broader genus claims if they indicate that the patentee has invented species sufficient to constitute the genera. Here, the deposited strains are representative species of the larger ‘type II’ genus, where the genus is identified and claimed as the invention.” In describing its invention, the specification noted that the PCV-2 desposited sequences had a 96% homology and that the invention did not cover PCV-1 sequences that at most shared 76% homology with the deposited sequences.  Taking those quantitative limits from the specification, the Federal Circuit ruled that the claimed PCV-2 molecule should be construed as being “about 96% or more homologous with the … sequences disclosed in the present specification, and about 76% or less homologous with the [disclosed PCV-1] sequence.”

What is Equivalents are Surrendered by a Narrowing Amendment: An accused infringer may still be liable even though its product does not literally infringe every element of an asserted patent claim.  Under the doctrine of equivalents (DOE), a patentee may be able to provie infringement by showing that one or more elements of the accused product are equivalent to elements in the claim.  Under the limiting doctrine of prosecution history estoppel (PHE), a patentee will ordinarly be estopped from claiming DOE over a claim element that was narrowed during prosecution. (A narrowing amendment made for purposes related to patentability creates a rebuttable presumption that estoppel applies.)

Here, one of Merial’s original claims was directed to a markush group of open reading frames (ORFs) that had been described in the specification as “ORFs 1–13.”  In an initial rejection, the examiner suggested that the limitation could refer to ORFs of non-PCV-2 molecules. Although the patentee argued that the claim was clear, it still added the limitation that the claimed ORFs were PCV-2 ORFs.  The Federal Circuit held that this was a narrowing amendment substantially related to patentability. That narrowing amendment therefore created a presumption that the patentee had surrendered all equivalents that relate to non-PCV-2 ORFs. The district court erred, however, in holding that this narrowing amendment would estopp the the patentee from asserting that the claims cover a non-claimed PCV-2 ORF as an equivalent. “Such a draconian preclusion would be beyond a fair interpretation of what was surrendered. The rationale for the amendment was to narrow the claimed universe of ORFs down to those of PCV-2, and bore only a tangential relation to the question of which DNA sequences are and are not properly characterized as PCV-2.”

Dissenting-in-part, Judge Dyk discussed his argument that the claims directed toward the isolated form of a naturally occurring gene are likely unpatentable under 35 U.S.C. § 101.

[T]he isolated DNA claim raises “substantial issues of patentable subject matter under 35 U.S.C. § 101. . . . Neither the Supreme Court nor this court has directly decided the issue of the patentability of isolated DNA molecules. Although we have upheld the validity of several gene patents, none of our cases directly addresses the question of whether such patents encompass patentable subject matter under 35 U.S.C. § 101. . . .

I think that such patents do in fact raise serious questions of patentable subject matter. The Supreme Court’s recent decision in Bilski v. Kappos has reaffirmed that “laws of nature, physical phenomena, and abstract ideas” are not patentable. No. 08-964, slip op. at 5 (U.S. June 28, 2010) (quoting Diamond v. Chakrabarty, 447 U.S. 303, 309 (1980)); Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 130 (1948). Just as the patentability of abstract ideas would preempt others from using ideas that are in the public domain, see Bilski, slip op. at 13, so too would allowing the patenting of naturally occurring substances preempt the use by others of substances that should be freely available to the public. Thus, “a new mineral discovered in the earth or a new plant found in the wild is not patentable subject matter. Likewise, Einstein could not patent his celebrated law that E=mc2; nor could Newton have patented the law of gravity.” Chakrabarty, 447 U.S. at 309. These aspects are properly conceptualized as representing a public domain, “free toall men and reserved exclusively to none.” Id. (quoting Funk Bros., 333 U.S. at 130) (quotation mark omitted).

In Funk Brothers, the Court considered the patentability of a mixture of several naturally-occurring species of bacteria. 333 U.S. at 128-31. The patented product was a mixture of bacteria used in agricultural processes, enabling plants to draw nitrogen from the air and convert it for usage. The inventor discovered that certain strains of the bacteria were effective in combination with one another, and contrary to existing assump-tions, did not exert mutually inhibitive effects on each other. The Court held that the invention was not pat-entable subject matter. Id. at 131. The inventor “did not create a state of inhibition or of non-inhibition in the bacteria. Their qualities are the work of nature. Those qualities are of course not patentable.” Id. at 130. The Court furthermore noted:

The qualities of these bacteria, like the heat of the sun, electricity, or the qualities of metals, are part of the storehouse of knowledge of all men. They are manifestations of laws of nature, free to all men and reserved exclusively to none. He who discovers a hitherto unknown phenomenon of na-ture has no claim to a monopoly of it which the law recognizes. If there is to be invention from such a discovery, it must come from the applica-tion of the law of nature to a new and useful end.

Id.

In Chakrabarty, the Court considered whether a human-made microorganism is patentable subject matter under section 101. 447 U.S. at 305. The microorganism in question was a bacterium that had been genetically engineered to break down crude oil. In concluding that the man-made bacteria was patentable, the Court observed that the claim “is not to a hitherto unknown natural phenomenon, but to a nonnaturally occurring manufacture or composition of matter.” Id. at 309. The Court went on to distinguish Funk Brothers on the ground that the Chakrabarty bacterium possessed “markedly different characteristics from any found in nature. . . . His discovery is not nature’s handiwork, but his own; accordingly it is patentable subject matter under § 101.” Id. at 310 (em-phasis added).

Thus, it appears that in order for a product of nature to satisfy section 101, it must be qualitatively different from the product occurring in nature, with “markedly different characteristics from any found in nature.” It is far from clear that an “isolated” DNA sequence is qualita-tively different from the product occurring in nature such that it would pass the test laid out in Funk Brothers and Chakrabarty. The mere fact that such a DNA molecule does not occur in isolated form in nature does not, by itself, answer the question. It would be difficult to argue, for instance, that one could patent the leaves of a plant merely because the leaves do not occur in nature in their isolated form.

 

 

Gene Patents on Appeal: ACLU's Recusal Motion

Association for Molecular Pathology (AMP) and the American Civil Liberties Union (ACLU) v. United States Patent and Trademark Office (USPTO) and Myriad Genetics (Myriad) (Fed. Cir. 2010)

In a May 2010 decision, Judge Sweet of the Southern District of New York issued an opinion that would render most gene patents invalid for failing to claim patentable subject matter under 35 U.S.C. 101.  That high-profile case is now on an appeal, and has the potential of shifting US patent law both by its in-court and out-of-court impact.

Even before filing a substantive brief on the merits, the declaratory judgment plaintiffs (AMP & ACLU) filed a motion asking that Chief Judge Rader recuse himself from potentially hearing the decision. AMP argues that the Chief’s public statements regarding this case “have created an appearance of partiality that calls into question his ability to engage in impartial legal analysis.”

Notably, while attending a BIO meeting, Judge Rader reportedly responded to a comment by Professor Whealan (and former Rader clerk) that there are no real “legal standards for making [a Section 101] decision. . . [U]sing Section 101 to say that the subject matter is unpatentable is so blunt a tool that there is no neutral step to [draw] a line here [between what is and is not patentable].”  In Judge Rader’s construct, the lack of a clear legal standard means that the decision will then be based on “politics. It’s what you believe in your soul, but it isn’t the law.”  In another conference (this time at Fordham Law School), AMP’s attorney Dan Ravicher was speaking and Chief Judge Rader asked Ravicher a question “hinting at disagreement” with Ravicher’s position.  In particular, the Ravicher-Rader colloquy was quoted as follows:

Ravicher (pointing to a bottle of water): "Was that [purification] sufficient intervention between what God gave us ... and what man created to merit a patent?"

Chief Judge Rader: "How many people have died of water pollution over the course of human events? Probably billions."

Two responses to the ACLU motion have been filed. 

First, Myriad responded that the cited statements by Chief Judge Rader “do not even suggest how Chief Judge Rader might vote, were he a member of the panel assigned to decide this case.”

The second filing is by the Federal Circuit Bar Association (FCBA) as amicus. The FCBA argues strongly that Judges should be encouraged to participate in educational conferences such as the BIO meeting and Fordham Law School.  The FCBA makes the important point that “Just as it is important that judges recuse themselves when the rules require it, it is equally important that judges refuse to recuse themselves where the rules do not require it.”  Granting recusal on the thin-evidence presented here would have the two primary effects of (1) discouraging sitting Federal Circuit judges from participating in public conversations and (2) encourage more strategic recusal motions.  The FCBA motion was a joint effort by former Deputy Solicitor General Thomas Hungar (Gibson Dunn) and the oft-paired team of Ed Reines & Amber Rovner (Weil Gotshal).

This particular motion may never be decided. Since the panel has not yet been assigned for this appeal, the CAFC has refrained from deciding the motion. In a letter to AMP, the court indicated that “[i]n the event that Judge Rader is assigned, the motion will be transmitted to him.” 

Documents:

• File Attachment: RecusalMotion.pdf (449 KB)
• File Attachment: RecusalResponse.pdf (566 KB)
• File Attachment: Recusal.FCBA.pdf (888 KB)

Ignoring Non-Patentable Elements While Judging Novelty

By Dennis Crouch

The Federal Circuit offers some clues to its post-Bilski patentable-subject-matter jurisprudence, but leaves that fight for another day.  Instead, the court held the claims anticipated by explicitly ignoring novel claim elements.

* * * * *

King Pharmaceuticals, Inc. v. Eon Labs, Inc. and Elan Pharmaceuticals, Inc. (Fed. Cir. 2010)

King’s patent claims a method of increasing oral bioavailability of the muscle relaxant metaxalone by putting metaxalone in food eaten by the patient. Claim 21 includes a step of “informing the patient that the administration [of the drug with food] results in an increase [in absorption].  This step likely has two benefits: (1) increasing patient compliance with the drug regimen and (2) taking advantage of any placebo effect that may exist.  The drug metaxalone itself was already a known muscle relaxant well prior to King’s 2001 application date.

Patenting Methods of Treatment: The district court held claim 21 invalid under 35 U.S.C. 101 based on the Federal Circuit’s machine-or-transformation test from Bilski. On appeal, the Federal Circuit rejected the lower court analysis — noting that when examined “as a whole”, the claim requires treatment and “methods of treatments ‘are always transformative when a defined group of drugs is administered to the body to ameliorate the effects of an undesired condition.’” (quoting Prometheus Labs., Inc. v. Mayo Collaborative Serv., 581 F.3d 1336, 1346 (Fed. Cir. 2009), cert. granted and vacated, 78 U.S.L.W. 3254 (U.S. June 29, 2010)).

Although the appellate panel rejected the lower court’s Section 101 analysis, it stopped short of providing any positive position on the patentability of medical treatment methods — presumably saving that battle for the pending remands of Prometheus and Classen. 

Instead, the appellate court held that a Section 101 decision was not necessary because the claims of interest are anticipated under Section 102.

Ignoring Non-Patentable Elements: Here, the novelty question is interesting because the “informing” step was not specifically identified in the prior art. On appeal, the Federal Circuit held that claiming a step of “informing someone about the existence of an inherent property” of a method cannot render the claim patentable. “[I]n light of our holding that the method of taking metaxalone with food to increase the drug’s bioavailability, as recited in claim 1, is not patentable, it readily follows that claim 21, which recites the same method with the sole additional step of informing the patient about this increase in bioavailability, is not patentable.” 

In its decision, the court ties its case to the precedential foundation of “printed matter” cases that have barred the patentability of known products by the inclusion of printed matter describing the product.

In some ways, this decision may be seen as reviving the suggestion found in the now vacated 2007 In re Comiskey decision. There, the court suggested that, during nonobviousness analysis, any portion of an invention that constitutes nonstatutory subject matter will be considered de facto obvious.

Panel: Judges Bryson, Gajarsa, and Prost. Authored by Judge Gajarsa. 

 

 

Guest Post: USPTO Must Amend Examiner Guidelines On Bilski

by Paul Craane of Marshall Gerstein & Borun

In the wake of Bilski, the United States Patent and Trademark Office has provided unclear, and potentially incorrect, guidance to the Examining Corps regarding the application of 35 U.S.C. 101. The guidance instructs examiners to reject claims if the claims fail to meet the machine-or-transformation (MoT) test, absent some "clear indication that the method is not directed to an abstract idea." This application of Bilski effectively ignores the guidance provided by the opinion to the effect that the MoT test is not the sole test for patent-eligible processes under Section 101.

According to existing precedent, the examiner has the burden to make out a prima facie case before the burden shifts to the applicant. Given that the examiner has the burden and given that the MoT test is not the sole test, a failure to meet the MoT test should not automatically result in rejection of a claim. In fact, if failure to meet the MoT test did necessarily result in the rejection of a claim, then the USPTO would be using the MoT test as the sole test for patent-eligibility, contrary to Bilski.

Of course, the guidance does not suggest a rejection based solely on the MoT test, in that the examiner must still look for a clear indication that the method is not directed to an abstract idea. Even though there is an additional step, this procedure would appear to shift the burden from the examiner to show patent-ineligibility to the applicant to affirmatively show patent-eligibility before the examiner has made out a prima facie case of patent-ineligibility. According to Bilski, there are only three exceptions to patent-eligibility: laws of nature, physical phenomena, and abstract ideas. In accordance with Bilski, unless one of these exceptions is shown, the examiner can hardly be said to have made out a prima facie case of patent-ineligibility, such that the burden should shift to the applicant.

Consequently, the USPTO should amend its guidance to clarify that the examiner has an obligation to show that the claim recites an abstract idea (or law of nature or physical phenomena) to reject the claim, rather than simply indicating that if they should reject after applying the MoT test if they fail to find a clear indication that it does not recite an abstract idea.

Note: As per our usual rule, this post does not necessarily reflect opinions of Mr. Craane's firm or its clients.

The Business Method Patent Art Units

By Dennis Crouch

In prior posts, I noted that the USPTO is issuing patents at an all-time-high-rate.  This increase is perhaps most dramatic in the art units that examine applications classified by the USPTO as "business methods."  This post explores the history and the numbers.

* * * * * 

The USPTO patent examiner corps is organized into small technology-specific groups known as art units.  Each art unit has a manager that reports to a technology center director.  About twenty art units have been classified as generally dealing with “business method” patents. (See list of art units).  I’ll call these art units “business method art units” for lack of a better term.  All of the patents issued from these art units are classified in class 705. And, these are the patents and applications that are most likely to be affected by the decision in Bilski v. Kappos (2010).

Under former PTO Director Jon Dudas, the business method art units received special attention.  Individual examiners were given free power to reject pending applications as unpatentable, but claims could not be allowed as patentable until being reviewed by at least a “second pair of eyes.”  Under Director Kappos and Commissioner Stoll, the second pair of eyes regime has been eliminated and, as might be expected, the number of patents being allowed in these art units has risen dramatically. Perhaps coincidentally, this rise also correlates with the Federal Circuit’s October 2008 decision in Bilski.

The following two charts respectively show the number and percentage of patents that issue from the business method art units for each quarter (three-month period) going back to January 2005.  (2010 Q3 only includes two-weeks worth of data). As a bit of perspective, since January 2005, more than 900,000 utility patents have issued. Fewer than 9,000 are associated with these business method art units.

As the charts show, the number of patents issued by the business method art units is on the rise — both in terms of absolute numbers and as a percentage of patents being issued. 

Most of the patents issuing from the business method art units are directed toward some type of computer software that helps solve a business problem. Newly issued U.S. Patent No. 7,747,465 is a typical example. The ‘465 patent claims a method and apparatus for determining the effectiveness of internet advertising. The claimed method does not explicitly recite any hardware except for a “manager console”, “dynamic sampling engine”, and “logic module.”  In response to a Section 101 rejection, the applicant amended its claims and then — without explanation — provided the conclusory argument that the application was “directed to statutory subject matter because the claims are either directed to statutory processes tied to a particular machine or directed to statutory apparatuses.”

One problem with studies of business method patents is that there is no accepted definition the term.  The 1998 State Street decision that jump-started business method patenting did not actually involve any method claims.  On the technology front, inventions that look like business methods are often examined in other art units. Rand Warsaw (Bernard Bilski's co-inventor) was issued a patent in 2004 on a method for providing energy efficiency changes based upon historic consumption and weather data.  That patent looks was examined by a non business method art unit in an entirely different technology center. (Patent No. 6,785,620).

Explaining Patentable Subject Matter: The First Bilski Test Cases

RESEARCH CORPORATION TECHNOLOGIES v. MICROSOFT (Fed. Cir. 2010)

One of the first cases that may address the Supreme Court's ruling in Bilski v. Kappos involves RCT's claimed method of halftoning color images. The district court held the asserted claims invalid for failing to satisfy Section 101 of the patent act. The following two claims are representative:

1. A method for the halftoning of gray scale images by utilizing a pixel-by-pixel comparison of the image against a blue noise mask in which the blue noise mask is comprised of a random non-deterministic, non-white noise single valued function which is designed to produce visually pleasing dot profiles when thresholded at any level of said gray scale images.

11. A method for the halftoning of color images, comprising the steps of utilizing, in turn, a pixel-by-pixel comparison of each of the plurality of color planes of said color image against a blue noise mask in which the blue noise mask is comprised of a random non-deterministic, non-white noise single valued function which is designed to provide visually pleasing dot profiles when thresholded at any level of said color images, wherein a plurality of blue noise masks are separately utilized to perform said pixel-by-pixel comparison and in which at least one of said blue noise masks is independent and uncorrected with the other blue noise masks.

Microsoft argues that the inventive portion of the claims are directed to the unpatentable mathematical operation of halftoning and the remaining portions use well known technology to preempt use of the mathematical operation.

* * * * *

IN RE BONNSTETTER (Fed. Cir. 2010)

A second pending Section 101 case involves Bonstetter's claimed "method of benchmarking a job." The specification reports that the invention can be implemented "using pencil and paper" and the claim involves a simple four step process:

Claim 1. A method of benchmarking a job comprising:
identifying subject matter experts (SMEs) for the job;
facilitating discussion with the SMEs to identify and prioritize key accountabilities of the job;
giving a survey to SMEs to determine soft skills necessary for superior performance in the job, the survey incorporating the key accountabilities;
combining responses to the survey from multiple subject matter experts into a composite report identifying and prioritizing skills for superior performance for the job; and
interviewing a job candidate relative to said prioritized skills.

Neither the examiner nor the BPAI suggested that the claim would fail under Section 101. However, in its brief to the Federal Circuit, the USPTO indicated that the claim certainly failed the machine or transformation test (as well as being obvious). The USPTO explained the delayed Section 101 analysis based on internal USPTO delay -- the examiner's rejection was entered in July 2007, before the Federal Circuit's Bilski decision. The USPTO brief only mentions the patentable subject matter issue in a footnote (FN7). However, the issue will likely arise -- especially if the obviousness rejection is reversed.

* * * * *

Accenture Global Servs. GmbH v. Guidewire Software, 2010 U.S. Dist. LEXIS 65193 (D. Del. 2010)

In the Accenture case, district court Judge Sue Robinson has requested briefing on whether Accenture's asserted patents are invalid based on Bilski v. Kappos. The court had previously delayed its ruling on Section 101 pending outcome of that case.

Accenture's claim 1 reads as follows:

Claim 1. A method for generating a file note for an insurance claim, comprising the steps of, executed in a data processing system, of:
prefilling a first set of fields with information identifying a file note, said information comprising at least one suffix indicating a type of insurance coverage for a participant in a claim and identification of the participant, wherein the at least one suffix is preselected from one or more types of insurance coverage applicable to the claim;
obtaining a selection of fields of a first set of fields from a user, the selection identifying information for a second set of fields;
displaying in the second set of fields, the information identified by selection of field of the first set of fields;
permitting the user to add data to a predefined text area related to each field of the second set of fields based on the selected fields;
generating a file note that contains the first set of fields, the second set of fields, and the data in the predefined text area;
identifying a level of significance of the file note; and
storing the file note with the identified level of significance in a claim database including file notes associated with the claim.

Ongoing Commentary on Bilski v. Kappos

• Bilski v. Kappos: A Preliminary Analysis of the Opinion
• Bilski v. Kappos and the Anti-State-Street-Majority
• Mayo v. Prometheus Labs: Bilski and Medical Methods (Discussing the Post-Bilski GVR by the Supreme Court in this case)
• Ted Sichelman Guest Post: Why Bilski Benefits Startup Companies
• Shubha Ghosh Guest Post: Throwing Back the Gauntlet
• Don Chisum provides Notes on Bilski
• Tax Prof on The Impact of Bilski on Tax Strategy Patents
• Bilski v. Kappos: Read the Opinion 

Guest Post on Bilski: Throwing Back the Gauntlet

Guest Post by Shubha Ghosh, Vilas Research Professor & Professor of Law at the University of Wisconsin Law School

A year and a half ago, the Federal Circuit threw down a gauntlet in its Bilski opinion, extensively citing Supreme Court precedent to come up with the “machine or transformation test” to determine when a process constitutes patentable subject matter. Now the Supreme Court has rejected the Federal Circuit’s conclusion that “machine or transformation” is the only test to use and provided an additional basis for why Bilski’s patent for a method of hedging risk is not patentable. In doing so, the Supreme Court has thrown back the gauntlet, leaving scholars and the Patent Bar to speculate on where the USPTO and the Federal Circuit might go with using patentable subject matter as a limit on patentability. When the smoke clears, the Bilski opinion will appear a lot like the KSR decision from 2007 and that should not be surprising since Justice Kennedy authored both.

Here are the highlights of Bilski v. Kappos.Justice Kennedy‘s opinion of the court unanimously affirmed the Federal Circuit’s ruling that Bilski’s patent should be rejected. Where the nine justices agree is that the Federal Circuit erred in distilling from precedents the “machine or transformation” test as the sole one to determine when a process is patentable subject matter. The Court based this ruling on the definition of process in Section 100 of the Patent Act and its own precedents (from the 1970’s and 1981) in Gottschalk v Benson, Parker v Flook, and Diamond v Diehr. There also was agreement that patentable subject matter is broad with limits that are finite and discernible, rather than open ended.   One of these limits is no patents for abstract ideas, and there is unanimity that Bilski’s claims for methods of hedging were too abstract, describing a general process well established in the field. In short, there was unanimity in rejecting the “machine or transformation” test as the sole test for identifying a patentable process and affirming the well known exceptions from patentable subject matter: laws of nature, physical phenomenon, and abstract ideas.

In terms of method, Bilski v. Kappos reminds me of the Canadian Supreme Court’s 2002 decision in Harvard College v. Canada (Commissioner of Patents), which rejected a patent on a multicellular living organism.   Both decisions relied heavily on a strict reading of the statute with the Canadian Supreme Court ruling that the word “invention” in the Canadian patent statute did not include living organisms. The Canadian Supreme Court decision, however, seemed to be sending a clear message to the Canadian Parliament to amend the statute if necessary. By contrast, it is not clear what the U.S. Supreme Court’s message is in Bilski. The opinion was a response to the Federal Circuit’s mischaracterization of Supreme Court precedent as a “machine or transformation” test. But at a deeper level, one is left wondering what guidance the Supreme Court is providing for practitioners, scholars, and policymakers. The Court throws the gauntlet back to the Federal Circuit, and presumably they will now take the new precedent and use it to mold patent practice.

The lack of clarity is reflected in part in the Justice Breyer concurrence, joined by Justice Scalia, providing four guiding principles for how to determine whether a process is patentable subject matter. The four principles are: (i) there are limits on patentable subject matter; (ii) transformation is an important “clue” to when a process is patentable subject matter: (iii) machine or transformation is not the sole test for determining when a process is patentable subject matter; and (iv) the “useful, concrete, tangible” test does not describe the full scope of what constitutes patentable subject matter.   These four distill down to the principle that limits on patentable subject matter have something to do with transformation to a physical state, but that usefulness, concreteness, and tangibility do not describe the extent of patentable subject matter. Justice Breyer’s principles imply that there are limitations on “dubious” patents, such as those for “exercising a cat with a laser pointer” that have nothing to do with machine or transformation. The problem is we have no sense of what those additional limitations are.

Undoubtedly, more litigation is on the way, and perhaps the Court will hear another case involving either a medical diagnostic patent or a “dubious” patent. But the Bilski case will have immediate impact on how patents are prosecuted.   After the Supreme Court’s 2007 KSR decision, patent examiners latched onto the Supreme Court’s language about “common sense” to issue obviousness rejections because a claimed combination was deemed “common sensical.” We can predict similar responses post-Bilski. The Court did not kill machine or transformation; it is now just one test. Patent examiners can still use the test as a basis for rejection. In addition, the Court’s emphasis on abstract ideas creates another basis for rejecting patents for lack of patentable subject matter.

Specifically, the Court has now revived the Gottschalk-Parker-Diehr line of cases, which were established before the creation of the Federal Circuit and which the Federal Circuit had distilled over time into the expansive “useful-concrete-tangible” approach to patentable subject matter and then into the “machine or transformation test.” In effect, the Supreme Court by reviving its precedent has negated over twenty-five years of the Federal Circuit’s attempts at doctrine. This revival opens up possibilities for examiners to rethink the relationships among process, machine, and the physical world. “Dubious” patents may be rejected because the physical phenomenon is trivial or too preemptive of the field. Patent claims might require closer connection to a machine embodiment as opposed to an abstracted, disembodied form.   An interesting question to ask is whether the patent at issue in State Street would survive the analysis proposed by Bilski.   On the one hand, the asset allocation method at issue is arguably as abstract as the hedging method. On the other hand, the method seems closely tied to a machine to give the process some specific limits.  

Ultimately, Bilski v Kappos says more about how patent law is made in the United States than about patentable subject matter. By setting the clock back to 1982, the Supreme Court is telling the Federal Circuit to try again in devising workable rules for patent law. The Federal Circuit wrote an opinion that was goading the Supreme Court to address the issue of patentable subject matter after nearly three decades. The resulting opinion raises some fundamental and unsettled questions and, unfortunately, gives us the same, old answers.

Mayo v. Prometheus Labs: Bilski and Medical Methods

Mayo v. Prometheus Labs (On Remand to the Federal Circuit 2010)

The Federal Circuit’s first full post-Bilski decision may come in the case of Mayo v. Prometheus Labs. That case had been pending on a petition for a writ of certiorari to the Supreme Court. In a June 29 order, the Court granted the petition and then summarily vacated the decision with a remand to the Federal Circuit to reconsider the case “in light of Bilski v. Kappos, 561 U.S. ___ (2010).”  The Supreme Court regularly uses this grant-vacate-remand (“GVR”) proceeding for pending cases are impacted by a decision.

In the case, the Mayo Clinic has challenging the validity of two Prometheus patents based upon suspect patentable subject matter. (U.S. Patents 6,355,623 and 6,680,302). 

The Prometheus patents claims an iterative approach to dosing that involves three steps: (1) first administer a drug to a subject; (2) then determine the level of drug in the subject; and (3) finally decide whether the next dose should be the same, higher, or lower. The decision on the next dose is made by comparing the the level of the drug in the subject against predetermined thresholds. Claim 1 of the '302 patent adds additional detail including identifying the active ingredient (6-thioguanine), the diagnosis (a GI disorder), and the predetermined thresholds (e.g., 230 pmol of drug per 8108 red blood cells). Claim 46 of the '623 is a broad claim in that it does not not require the administration step (step 1 from above).

The Federal Circuit held the method patentable under its Bilski test by finding that the required administration of the drug transformed an article into a different state or thing -- essentially creating a per se rule that a method requiring administration of a drug will be deemed patentable subject matter under Section 101. The court also held that the "determining the level" step was necessarily transformative since "those levels cannot be determined by mere inspection." 

On remand, the focus will shift from the machine-or-transformation test to the broader question of whether the claims are directed to a statutory “process” and/or whether the claim scope is impermissibly abstract. Of course, the machine-or-transformation test may still be instructive in answering these question.

Abstract Idea and Broad Functional Language: The claims are written in broad functional language without tying the the claimed methods to any particular technology. Thus, the "administering" step could potentially be accomplished by any effective method (that has or will be invented) of getting the drug into the subject. Likewise, the patent offers potential methods of "determining the level" of drug in the body (e.g., liquid chromatography) but the claim is broadly written to seemingly cover any mechanism that fulfills that method. 

Novelty Involves the Mental Step: Of course, the general iterative process is well known, what makes the Prometheus claims novel is that they identify the particular thresholds that are important (e.g., 230 pmol). In practice, the process of comparing the thresholds to the subject's drug level is done in the mind of a physician. As Mayo explains, this merely involves the physician's mental recognition of a natural correlation between metabolite levels and patient condition.

The case also represents a growing trend of pitting patient advocates (who want cheaper access to medicine) against innovators (who create better treatments).

Note: In the same Post-Bilski order, the Supreme Court also issued a GVR in the case of Classen Immunotherapies, Inc. v. Biogen IDEC.  On remand, the Federal Circuit will be asked to decide whether the following claim fits within the scope of 35 USC 101:

Claim: A method of determining whether an immunization schedule affects the incidence or severity of a chronic immune-mediated disorder in a treatment group of mammals, relative to a control group of mammals, which comprises immunizing mammals in the treatment group of mammals with one or more doses of one or more immunogens, according to said immunization schedule, and comparing the incidence, prevalence, frequency or severity of said chronic immune-mediated disorder or the level of a marker of such a disorder, in the treatment group, with that in the control group.

Guest Post: Why Bilski Benefits Startup Companies

I asked Professor Ted Sichelman to provide his thoughts on how the Bilski decision impacts start-up companies and their incentive to innovate. DC

By Ted Sichelman, University of San Diego School of Law

Before practicing law and becoming a professor, I founded and ran a small software company that sells speech recognition software to taxicab companies. After my company designed its technology, we filed for patents. Later on, when raising financing from angel and venture capital investors, they reviewed our pending applications carefully and considered them a way to stop potential competition. Indeed, in a recent survey of startup firms, the Berkeley Patent Survey—which I conducted with Robert Merges and Pamela Samuelson of UC Berkeley School of Law and Stuart Graham (now Chief Economist at the PTO)—startup executives reported that nearly 70% of venture capital firms and 50% of angel investors said that patents were important to their investment decisions. Relatively broad patentable subject matter assists startups in raising needed funds. As I have argued elsewhere, another reason for broad subject matter is that startups engage in substantial amounts of post-invention—but pre-commercialization—innovation that is not always technological in nature. For instance, many startups generate marketing, financial, legal, and other types of non-technological innovations during the costly commercialization process. Providing IP protection for these innovations not only can produce more of them, but also can help drive technology commercialization.

Assuming the Federal Circuit and the PTO do not go astray in implementing Bilski—which admittedly leaves many doors open to do so—the opinion will allow startups to continue to use patents to garner financing and will, hopefully, set an appropriate balance on the patentability of non-technological inventions. In particular, as I urged in an amicus brief with Professors Mark Lemley, Michael Risch, and Polk Wagner—Bilski rightly adheres to the 150-year old tradition that as long as the claimed invention is a machine, manufacture, composition of matter, or a process, only natural phenomena, laws of nature, and abstract ideas should be excluded from eligible subject matter.

One might contend that by allowing business methods—as well as software and other “intangible” innovations—to be patented, startup firms will encounter a greater “thicket” of patents, making it more difficult for them to enter particular markets. For example, an amicus brief in Bilski filed on behalf of “entrepreneurial and consumer advocates” argued that “if the PTO is permitted to grant broad business and service process patents, small start-up businesses would face an entirely new regime of business regulation - essentially requiring businesses to request private permits to operate from their competitors who have patents, independent of whatever technology the new business uses to compete.” Justice Stevens’ echoed this view by writing in his concurrence that business methods patents “can take a particular toll on small and upstart businesses.”

In actuality, under the Federal Circuit’s previous State Street Bank opinion, in operation for a decade prior to Bilski, the PTO regularly granted “broad business and service process patents” and there is little evidence that these patent-holders required startups to license them in any significant numbers. The Berkeley Patent Survey found that only 8% of the population of respondent software companies and 12% of venture-backed software companies had licensed-in even one patent. In sum total, a relatively low percentage, 0.6% and 3%, respectively, reported licensing a patent solely to avoid a lawsuit. And while Bilski ultimately holds that business methods are not per se unpatentable, the practical effect of the outcome will be to place unapplied business methods into the precluded “abstract idea” category. If implemented properly, such an approach will ensure that startups—and, indeed, larger and more established companies—are not unnecessarily subject to overly broad patents while maintaining robust incentives to innovate.

Ted Sichelman is an Assistant Professor at the University of San Diego School of Law, where he teaches patent law and other intellectual property courses.

Bilski v. Kappos and the Anti-State-Street-Majority

The 1998 Federal Circuit decision in State Street Bank opened the door to patent protection on a wider variety of innovations — especially in the fields of business methods and software. State Street held that an invention should be patent eligible under 35 U.S.C. §101 if it involves some practical application and “it produces a useful, concrete and tangible result.”

Although not rejected by the majority opinion, it is clear that the broad “useful, concrete, and tangible result” test is dead. That test is conclusively rejected by what I term the Anti-State-Street Majority — a majority created by the combining the two concurring opinions in Bilski and their five-justice majority. The result is that the scope of patentable subject matter is certainly narrowed from its 1998 high-water-mark.

* * * * *

In Bilski v. Kappos (2010), the majority opinion neither endorses nor rejects State Street — writing instead that “nothing in today’s opinion should be read as endorsing interpretations of §101 that the Court of Appeals for the Federal Circuit has used in the past. See, e.g., State Street, 149 F. 3d, at 1373; AT&T Corp., 172 F. 3d, at 1357.”

The two concurring opinions in Bilski (2010) both explicitly reject the Useful-Concrete-And-Tangible-Result test of State Street. Justice Stevens writes that “it would be a grave mistake to assume that anything with a ‘useful, concrete and tangible result,’ may be patented. (Justice Stevens concurrence at FN 1). Justice Breyer reiterated his prior statement that “if taken literally, the statement [that anything which produces a useful, concrete, and tangible result, is patentable] would cover instances where this court has held the contrary.” (Justice Breyer concurrence). The two concurrences are in agreement on this point and are signed by five Supreme Court Justices — leading to a second majority on that particular point.

Of course, in its In re Bilksi decision, the Federal Circuit already repudiated State Street as inadequate and "insufficient to determine whether a claim is patent-eligible under § 101."

Cumulatively, this means that the broadest notion of patentable subject matter as represented by State Street is not the law. Although not "the test" it appears that the USPTO will continue to use the machine-or-transformation test as a "tool" for determining whether particular process claims fit within Section 101. A recent Post-Bilski notice to examiners indicated as much:

Examiners should continue to examine patent applications for compliance with section 101 using the existing guidance concerning the machine-or-transformation test as a tool for determining whether the claimed invention is a process under section 101. If a claimed method meets the machine-or-transformation test, the method is likely patent eligible under section 101 unless there is a clear indication that the method is directed to an abstract idea. If a claimed method does not meet the machine-or-transformation test, the examiner should reject the claim under section 101 unless there is a clear indication that the method is not directed to an abstract idea. If a claim is rejected under section 101 on the basis that it is drawn to an abstract idea, the applicant then has the opportunity to explain why the claimed method is not drawn to an abstract idea.

I'm sure that our notion of the law will continue to develop as the Bilski decision makes its way into daily practice.

• Bilski v. Kappos: A Preliminary Analysis of the Opinion
• Bilski v. Kappos: Read the Opinion

Bilski v. Kappos

Although Bilski's claims were held unpatentably abstract, the Supreme Court has re-affirmed that the door to patent eligibility should remain broad and open.

Bilski v. Kappos (Supreme Court 2010)(08-964)

The Supreme Court has issued its opinion in Bilski v. Kappos. In the decision, the Supreme Court affirmed that Bilski’s risk-management method was not the type of innovation that may be patented. However, rather than using the Federal Circuit's "machine-or-transformation test", the court simply relied on prior precedent to find the claimed method unpatentably abstract. Justice Kennedy authored the majority opinion. Justices Breyer and Stevens both wrote concurring opinions.

Business as Usual: In general, the opinion offers no clarity or aid for those tasked with determining whether a particular innovation falls within Section 101. The opinion provides no new lines to be avoided. Rather, the outcome from the decision might be best stated as "business as usual."

Today, the Court once again declines to impose limitations on the Patent Act that are inconsistent with the Act’s text. The patent application here can be rejected under our precedents on the unpatentability of abstract ideas. The Court, therefore, need not define further what constitutes a patentable “process,” beyond pointing to the definition of that term provided in §100(b) and looking to the guideposts in Benson, Flook, and Diehr.

By refusing to state any particular rule or categorical exclusion, the Court has almost certainly pushed Section 101 patent eligibility to the background in most patent prosecution and litigation.

Business Methods: Section 101 does not categorically exclude business methods from patentability. Rather, the court noted that the prior-use defense found in Section 273(b)(1) of the Patent Act "explicitly contemplates the existence of at least some business method patents. . . . [B]y allowing this defense the statute itself acknowledges that there may be business method patents."

Software: Although the court expressly refused to rule on the patentability of software, it appears that software will largely remain patentable. At minimum, the decision would bar any categorical exclusion of software patents. The court neither endorsed nor rejected the Federal Circuit's past interpretations of Section 101 -- Noting that "nothing in today’s opinion should be read as endorsing interpretations of §101 that the Court of Appeals for the Federal Circuit has used in the past. See, e.g., State Street, 149 F. 3d, at 1373; AT&T Corp., 172 F. 3d, at 1357."

Abstract Idea: The one thing that all nine justices agreed upon is that Bilski's method of hedging risk was not patentable because it is an abstract idea "just like the algorithms at issue in Benson and Flook."

 

The concept of hedging, described in claim 1 and reduced to a mathematical formula in claim 4, is an unpatentable abstract idea, just like the algorithms at issue in Benson and Flook. Allowing petitioners to patent risk hedging would preempt use of this approach in all fields, and would effectively grant a monopoly over an abstract idea.

Petitioners’ remaining claims are broad examples of how hedging can be used in commodities and energy markets. Flook established that limiting an abstract idea to one field of use or adding token postsolution components did not make the concept patentable. That is exactly what the remaining claims in petitioners’ application do. These claims attempt to patent the use of the abstract idea of hedging risk in the energy market and then instruct the use of well-known random analysis techniques to help establish some of the inputs into the equation. Indeed, these claims add even less to the underlying abstract principle than the invention in Flook did, for the Flook invention was at least directed to the narrower domain of signaling dangers in operating a catalytic converter.

It is unclear to me how patent office examiners will be able to apply the test for abstract ideas in any meaningful way. I suspect that they will not. Rather, the best advice for the USPTO is to focus on Section II-A of Justice Kennedy's opinion. There, the opinion recognizes that Section 101 patent eligibility is "only a threshold test." To be patentable, the invention must also "be novel, see §102, nonobvious, see §103, and fully and particularly described, see §112."

What is the test?: 35 USC 101 offers patent protection for "any new and useful process, machine, manufacture, or composition of matter." Here, the focus was on the definition of a "process" because Bilski's patent application was written to claim a method of hedging risk. Although the majority opinion refused to define the term process, it did write that the machine-or-transformation test developed by the Federal Circuit does not define what is (and is not) a patentable process. Rather, the Court held that the machine-or-transformation offers "a useful and important clue, an investigative tool, for determining whether some claimed inventions are processes under §101. The machine-or-transformation test is not the sole test for deciding whether an invention is a patent-eligible process." As a "clue," the machine-or-transformation test likely correlates with the existence of patentable subject matter. However, some patent claims that fail the test will still be patentable and other patent claims that pass the test will still be ineligible.   

Read the Opinion

Bilski v. Kappos

90% chance that Bilski will be decided this morning.

Bilski, Kenny Rogers and Supreme Court Rule 46

by Professor John F. Duffy, George Washington University Law School

You got to know when to hold 'em, know when to fold 'em
Know when to walk away, know when to run                       
                                                       -- Kenny Rogers in The Gambler
_____________________________

Kenny Rogers’ hit song The Gambler provides some wise strategic advice, valid not only in cards and but also in law and perhaps in life generally:   If “fold ’em” is an option, sometimes it is the best one. Supreme Court Rule 46 on “Dismissing Cases” provides petitioners in Supreme Court cases the opportunity to “fold ’em,” and in the days remaining before the Supreme Court delivers an opinion in its Bilski v. Kappos case, the most puzzling question in the case has become this: Why won’t the petititoners in Bilski fold?

From the perspective of the petitioners, the case for seeking dismissal seems overwhelmingly strong. In the months since the oral argument in Bilski, every Justice save Justice Stevens has delivered an opinion from the set of cases argued in the November sitting. Bilski remains the only case not decided from that sitting. Because only one case remains undecided and only one Justice has yet to deliver an opinion from that month, there is widespread agreement among those familiar with Supreme Court practice that Justice Stevens is writing the Court’s opinion in Bilski. Thus, the petitioners are now reduced to hoping that Justice Stevens, who once argued in dissent that all software should be outside patentable subject matter, will author an opinion that will be more pro-patent than the positions taken by all but one of the Federal Circuit judges.

But there’s more. Not only do petitioners have no realistic hope of winning anything in the case, they also have much to lose by persisting in the appeal. Petitioners—the named inventors in the application, Bernard Bilski and Rand Warsaw—and their firm WeatherWise have other patent claims, some issued and some pending, that pass the machine-or-transformation test but that may not pass whatever test Justice Stevens is busy constructing.

That’s a quick summary of the case for the petitioners seeking dismissal of Bilski. The details only make the case stronger. Then again, there is also a distinct possibility that petitioners’ side of the case may want to lose.

The Petitioners’ Chances for Victory: Nil.

Any rational consideration of persisting in a legal case should begin with a frank assessment of the chances for gain and loss.   I’ll begin with the chances for gain, for they are as close to zero as can be imagined.

Good poker players learn to read other players’ “tells,” subtle clues which give hints about the likely outcomes if the hand is played to completion. In Bilski, the Supreme Court has also given some awfully clear “tells” that do not bode well for the petitioners.

Most importantly, the assignment pattern of the Court’s opinions strongly suggests that Justice Stevens is writing the opinion. The assignment of opinions in the Court is typically done with two goals in mind: (1) to give each Justice the chance to author at least one majority opinion from each sitting; and (2) to average out the number of majority opinions written by each Justice. Twelve separate cases were argued in the November sitting, including Bilski. (This counts two cases—Graham v. Florida and Sullivan v. Florida—as effectively one case, as the two cases involved the same issue and were eventually decided the same day.) Every Justice has delivered a majority opinion from that month, with the exception of the Justice Stevens. Thus, most Supreme Court watchers would predict that the one remaining opinion from the month—Bilski—was assigned to Justice Stevens.

There is some uncertainty about this result, however. Pursuant to Supreme Court Rule 46, one of those twelve cases (Pottawattamie County v. McGhee) was dismissed two months after the oral argument, so the Justice assigned to write the opinion in that case is not publicly known. Still, Stevens still remains the most likely candidate to have been assigned the Bilski opinion because of the larger pattern of assignments from the Court’s first three sittings (September, October and November). During those three months, 26 cases were argued. If the Court were trying to average out the workload among the Justices, then every Justice save one should have been assigned three majority opinions to write.

By now, all Justices have delivered three majority opinions from those first sittings with the exception of Justices Stevens and Sotomayor. Justice Stevens has delivered only one majority opinion (a case argued in October); Justice Sotomayor has delivered two majority opinions (one each from October and November). It seems highly likely that Justice Stevens was assigned only two majority opinions to write from the first three sittings because Stevens was also writing the principal dissent in Citizens United v. FEC, the hugely important campaign finance case to which the Court gave expedited consideration.   (If, however, Justice Stevens was originally assigned three majority opinions, then he would have definitely been assigned Bilski.) Assuming Justice Stevens was assigned only two majority opinions, then the assignments to write majority opinions in Bilski and the now-dismissed Pottawattamie County case would have been distributed to Stevens and Sotomayor. Sotomayor would seem like the natural for Pottawattamie County, which involved the immunity of state prosecutors from civil liability, because Sotomayor served as a state criminal prosecutor under New York City’s Robert Morgenthau. Stevens, by contrast, was an antitrust lawyer before becoming a judge, and he has shown significant interest in patentable subject matter.

Another clue to the authorship of Bilski comes from the lengthy delay in announcing the opinion. As previously mentioned, Justice Stevens wrote the principal dissent in the Citizens United case, which was heard and decided on an expedited basis by the Court because of the case’s importance to the spring primary season. Stevens’ impassioned dissent in that case ran for 90 pages, and that opinion seems to have delayed the release Stevens’ other majority opinions. Indeed, for two months after the January decision in the Citizens United case, Justice Stevens was the only Justice on the Court not to have delivered any majority opinion during the entire Term.

If, as seems likely, Justice Stevens is writing the majority opinion in Bilski, that is an awful omen for the petitioners. Justice Stevens wrote the majority opinion for the Court in Parker v. Flook (1978), which created the enigmatic rule that certain forms of “post-solution activity” cannot transform an unpatentable principle into a patentable process. Justice Stevens is also one of the few Justices ever to attempt to draw bright-line rules for excluding whole fields from the patent system. His dissent in Diamond v. Diehr, 450 U.S. 175, 193 (1981), sought to promulgate “an unequivocal holding that no program-related invention is a patentable process under § 101 unless it makes a contribution to the art that is not dependent entirely on the utilization of a computer.” 450 U.S. at 219.

In addition to the Court’s fairly clear “tell” that Justice Stevens will deliver the opinion of the Court, there are other signs that the petitioners’ chances for ultimate success are nil. The oral argument did not go well at all for petitioners’ counsel (to put it mildly), and a significant portion of the government’s argument was devoted to arguing that the Court should not impose a more restrictive rule than that sought by the PTO (e.g., a complete ban on business method patents, whether machine implemented or not). See Transcript of Argument at 40-50. In addition, at the Federal Circuit, even Judge Rader—one of the two judges willing to take a more comprehensive view of patentable subject matter—stated explicitly that he would agree the petitioners’ claims were unpatentable as abstract ideas.

Finally, if more evidence were needed, there is the PTO’s extraordinary record of success at the Supreme Court in patent cases. Two recent articles, one by Colleen Chien of Santa Clara University and one of my own, have independently noted that, since the creation of the Federal Circuit, the government’s substantive positions on patent law have always prevailed at the Supreme Court. See Colleen Chien, Patent Amicus Briefs: What the Courts’ Friends Can Teach Us About the Patent System (2010); John F. Duffy, The Federal Circuit in the Shadow of the Solicitor General, 78 G.W.U. L. Rev. 518 (2010).   The petitioners in Bilski must hope that the Supreme Court will finally rule against the government, and in an opinion by Justice Stevens, stake out a much more pro-patent position than every judge on the Federal Circuit save one.

The Value of Dismissal.

The impossibly slim odds of winning would not matter to the petitioners if they had nothing to lose from persisting in the appeal. But petitioners Bilski and Warsaw have at least two pending patent applications on business methods for hedging risk. See U.S. Pat. App. 200030233323 A1 (Dec. 18, 2003); U.S. Pat. App. 20040122764 A1 (June 24, 2004). Furthermore, Petitioner Warsaw also is the named inventor on several issued claims in a patent assigned to the firm WeatherWise.   See U.S. Pat. No. 6,785,620 (2004). Many of the claims in that patent would seem to pass the machine-or-transformation test, as the claims cover “system[s]” that include various modules for storing and manipulating data. Some claims are also directed to a “computer-readable medium having stored thereon instructions,” which is a form of claim for covering business software that the government currently views as permissible but that could be jeopardized by an unfavorable Supreme Court opinion in Bilski.   

If the Bilski case were dismissed, a decision about patentable subject matter would be left for the future. From the standpoint of petitioners, the future would better for two reason. First, Justice Stevens would be replaced by a new Justice, likely Elana Kagan. That change has to favor those on the side of the petitioners since Justice Stevens takes a more restrictive view of patentable subject matter than many of the other Justices on the Court. By contrast, the Solicitor General’s Office under Kagan expressly endorsed the position (stated during the Bilski oral argument) that the Federal Circuit had correctly decided State Street Bank v. Signature Financial. See Transcript of Oral Argument at 44. The future also presents the possibility of a different case, with perhaps more attractive facts.

Dismissal: Still Time?

Supreme Court Rule 46.1 allows any case to be dismissed, even after the oral argument, by agreement of the parties. The Rule directs that, upon filing of such an agreement, the Clerk of the Court, “without further reference to the Court, will enter an order of dismissal.” Furthermore, Rule 46.2 allows petitioners unilaterally to seek dismissal by agreeing to pay all the court costs and fees due. (Such costs and fees are not attorneys’ fees but merely the minor costs associated with the appeal that are paid by the losing party in any case.) The grounds on which respondents may object to such a filing are strictly “limited to the amount of damages and costs in this Court alleged to be payable or to showing that the moving party does not represent all petitioners or appellants.” The Clerk of the Court is directed “not [to] file any objection not so limited.”

The Rule reflects a very clear policy that the Court will not plunge ahead to decide a case if the petitioners have decided to “fold ’em,” and that policy makes perfect sense from the Court’s perspective. The Supreme Court has plenty of cases to decide, and important issues eventually percolate back up to the Court if they really need to be decided. Indeed, in the November sitting alone, the Pottawattamie County case was dismissed even though argument had been heard two months earlier and the case involved an important issue about the scope of prosecutors’ immunity.

True, if the Solicitor General’s Office were unwilling to agree to the dismissal, it is unclear what would happen. At oral argument, however, the advocate for the Solicitor General’s Office emphasized that the government thought the Court should never have taken the case because it was an “unsuitable vehicle” to decide questions of patentable subject matter. Transcript of Argument at 48. Moreover, the Solicitor General’s Office is very much a repeat player at the Supreme Court, and thus the Office tends to be willing to follow not just the letter but also the spirit of the Court’s rules. Since those rules reflect a fairly clear policy that petitioners’ dismissals should not be opposed unless the petitioner either is not willing to pay costs or does not represent all petitioners, the Solicitor General’s Office seems unlikely to attempt to thwart dismissal where the petitioners comply with the conditions of Rule 46.

A Final Point: A Desired Defeat?

All of the above makes the crucial assumption that the petitioners in Biski want to sustain the patentability of business method patents such as their own. But that assumption may be wrong. The patent application at issue is no longer owned by Bernard Bilski, Rand Warsaw or even WeatherWise, the small start-up company that holds similar patent claims on hedging energy consumption risks and is merely a licensee of the patent application at issue in the case (see Paul Schaafsma news article noting the licensing relationship). As the petitioners’ briefs in the Supreme Court disclose, the real party in interest in the case is Equitable Resources Inc., renamed EQT Inc. during the pendency of the case. See Petitioners’ Reply Brief at (i). That corporation has market capitalization of $5.4 billion (see EQT Financial Report). A quick search of the PTO’s database does not show any issued patents owned by this corporation, and the company’s most recent annual report filed with the SEC makes no mention of patents or intellectual property. It is not at all clear that such a company really wants to have patent protection for innovative ways to manage energy costs or risks, or for any other form of business method. Large companies are often the targets of patent infringement litigation, and start-ups often see patents as a means to compete against established firms. Indeed, the Warsaw patent on hedging risk—which is assigned to WeatherWise, not EQT—could itself provide a reason why the petitioners’ side of the case would welcome defeat.

It remains a puzzle why the petitioners in this case are persisting in an appeal that seems not only doomed but also capable of establishing new and unpredictable restrictions to the scope of patentable subject matter. I had previously thought that “irrational exuberance” provided the best answer—that the Bilski petitioners were likely to remain unrealistically optimistic about their chances for success right up to the end. But the presence of a multibillion-dollar corporation controlling the litigation decreases the chances that the strategy is due to simple inventor over-optimism. Perhaps the entity controlling the petitioners’ side of the case is really quite wily, for there would be no cause to “fold ’em,” if the petitioners’ side would view thorough defeat as victory. That would explain much.  

Business Method Patents: Insurance Companies Fighting over Patented Annuity Plans

Lincoln National Life Insurance Co. v. Transamerica Life Insurance Co. (Fed. Cir. 2010)

It is not unusual to see insurance companies in litigation. What is unusual here is that the context is patent infringement. Lincoln is pursuing Transamerica and others for infringement of its patents covering a method of administering a variable annuity plan with a guaranteed minimum payment that continues even after an account had been exhausted. Although clearly a business method, the asserted claims do recite (in the preambles) that the method is "computerized."  U.S. Patent No. 7,089,201.

A jury found the claims valid and infringed and awarded $13 million in damages. On appeal, Transamerica asked for reversal of the infringement verdict and for an opportunity to present its case on patentable subject matter. The Federal Circuit reversed on infringement.

Non-Infringement: The asserted claims require that scheduled payments be made "even if the account value is exhausted before all payments have been made." Transamerica argued that it could not infringe because (1) none of its subscribers had ever "exhausted" their accounts and (2) that its computer system has not been configured to automatically pay on an exhausted account.

On appeal, the Federal Circuit agreed with the patentee that the claim did not require that any accounts actually be exhausted. Rather, the claim only requires a particular action if the accounts are exhausted.

On the second point, however, the Federal Circuit agreed with the accused infringer — finding that "nothing in the record" shows that Transamerica uses a computer system to make scheduled payments once an account has been exhausted.

Legal Obligation to Infringe: As an interesting tid-bit, Transamerica's contracts apparently do required the company to continue making scheduled payments even after its accounts had been exhausted.  The Federal Circuit rejected the legal obligation as proof of infringement — holding instead that the claims require computer implementation of the method. Furthermore, a contractual obligation to perform a method does not constitute infringement. Rather, infringement requires performance: "A contractual obligation to perform an act is not performance; indeed, a party could avoid infringement simply by breaching its contract."

Non-Patentable Subject Matter: Based on its non-infringement holding, the Federal Circuit left the Section 101 question undecided as moot.

    

Federal Circuit Affirms Summary Judgment of Obviousness for Bulk EMail Patent

Perfect Web Technologies v. InfoUSA (Fed. Cir. 2009)

Perfect Web's asserted patent covers a method of managing bulk e-mail distribution. Claim 1 of the application (filed in 2000) reads as follows:

1. A method for managing bulk e-mail distribution comprising the steps:

(A) matching a target recipient profile with a group of target recipients;

(B) transmitting a set of bulk e-mails to said target recipients in said matched group;

(C) calculating a quantity of e-mails in said set of bulk e-mails which have been successfully received by said target recipients; and,

(D) if said calculated quantity does not exceed a prescribed minimum quantity of successfully received e-mails, repeating steps (A)-(C) until said calculated quantity exceeds said prescribed minimum quantity. (Pat. No. 6,431,400).

The district court held the claims invalid as anticipated and obvious as well as for failing to claim statutory subject matter under Section 101. On appeal, the Federal Circuit upheld the obviousness finding and left the alternative reasons undecided.

Of course, in 2000, targeted bulk e-mail was already around, and the defendants provided prior art evidence of steps (A)-(C). That is, marketers were already identifying target recipients, sending out e-mails, and calculating the percent received. Missing from the prior art was step (D) - iteratively repeating steps (A)-(C) until the number of recipients reaches the a prescribed quantity.

Evidence of Common Sense: The district court held on summary judgment that KSR style "common sense" would lead one of ordinary skill in the art to perform the iterative step (D). On appeal, the Federal Circuit affirmed that finding - holding particularly that the finding of common sense does not require "explication in any reference or expert opinion."

Although a court need not have documentary support of its common sense analysis, a court (or patent examiner) must at least clearly explain its reasoning.

We reiterate that, on summary judgment, to invoke “common sense” or any other basis for extrapolating from prior art to a conclusion of obviousness, a district court must articulate its reasoning with sufficient clarity for review.

In this case, the appellate panel agreed that the idea of repeating already known steps until a threshold is met was simply a common sense extension:

Thus, this last step, and the claim as a whole, simply recites repetition of a known procedure until success is achieved. Recognizing this, the district court explained: “If 100 e-mail deliveries were ordered, and the first transmission delivered only 95, common sense dictates that one should try again. One could do little else.”

The court added an interesting caveat regarding expert testimony and the level of one of skill in the art -- noting that expert testimony may well be necessary for "complex" technology.

If the relevant technology were complex, the court might require expert opinions. Here, however, the parties agreed that ordinary skill in the relevant art required only a high school education and limited marketing and computer experience. No expert opinion is required to appreciate the potential value to persons of such skill in this art of repeating steps (A)-(C).

Obvious to Try: As a corollary to its common sense holding, the appellate court also held that the additional step (D) would have been "obvious to try" under KSR. "[S]imple logic suggests that sending messages to new addresses is more likely to produce successful deliveries than re-sending messages to addresses that have already failed. . . . [I]ndeed, the predictable and actual result of performing step (D) is that more e-mail messages reach more recipients."

Long-felt Need: The patentee argued that a nonobviousness conclusion was supported by evidence of the secondary consideration of long-felt need. Particularly, the method helps solve the recognized competing problems of reaching customers without "burning up" the mailing list by oversending.

The Federal Circuit rejected these arguments because the patentee had failed to provide any evidence of improved efficiency beyond "bare assertion." In addition, the court suggested that any proof of long-felt need would be insufficient to "overcome [the] strong prima facie showing of obviousness." (quoting Asyst Techs (2008))

Claim Construction: Interestingly, the court issued its summary judgment order prior to claim construction. The Federal Circuit found no error because construction of the disputed claim terms would not have changed the obviousness outcome.

Notes: The patent was originally titled "Statement regarding federally sponsored research or development." That is apparently a typographical error fixed in a subsequent certificate of correction.   

Bilski Briefs: Supporting the Government (In Name)

UPDATE: More briefs added Oct 5, 2009, 11:30 am

The final round of amicus briefs have been filed in the pending Supreme Court case of Bilski v. Kappos. Mr. Bilski is appealing the Federal Circuit's en banc rejection of his patent application. In that decision, the court held that Bilski's claimed method of hedging risk did not qualify as patentable subject matter under 35 U.S.C. 101 because the method was neither tied to a particular machine nor transformative of any physical article. Bilski challenges this "machine-or-transformation" test as unduly narrow. Bilski's legal position was supported in a large set of amicus briefs including a strong textualist argument made by Professor John Duffy.

Briefs supporting the government position have been filed. As summarized below, the vast majority of briefs also reject the Federal Circuit's machine-or-transformation test as the sole test of patentable subject matter for a claimed process. In my summaries, I have attempted to capture what I learned from each brief, of course the briefs and arguments are much more extensive and nuanced than my squibs suggest.

Electronic Frontier Foundation (EFF) and the Kauffman Foundation: Business method patents are harmful and should not be allowed. The long history of US patentable subject matter indicate that a patentable process must provide a technological advance. Likewise the mere fact that a process uses a machine or computer does not immediately render the process patentable subject matter. Rather to be patentable, the advance must be a technological advance. EFF etc amicus brief.pdf.

Red Hat: Software methods do not become patentable simply because they are tied to a computer. Benson. Download 08-964bsacRedHatInc.

William Mitchell College of Law IP Institute: This case does not properly present the issue of patentability of claims that include a mix of statutory and non-statutory subject matter. The court should wait for an appropriate case to decide that issue. Parsing Section 101 provides few real answers as to patentable subject matter. Download 08-964 William Mitchell College of Law Intellectual Property Institute.

SFLC (Moglen and Ravicher): Standing alone, software is not patentable. This result is derived from the Supreme Court's decision in Microsoft v. AT&T that “[a]bstract software code [uninstalled in a machine] is an idea without physical embodiment.” 550 U.S. 437, 449 (2007). Download 08-964 Software Freedom Law Center.

SIIA: The patent eligibility of software is well established and should not be disturbed. Download 08-964 Software & Information Industry Association.

Knowledge Ecology Int'l: The goal of the system is to encourage progress, not to reward inventors. Further, patent protection is not a "necessary policy intervention to reward successful investment in new medical technologies. . . . [M]any of the greatest medical advances have benefited significantly, and in some cases exclusively, from mechanisms that exist completely outside of the patent system." Download 08-964 Knowledge Ecology International.

Mark Landesmann: The evidence of the negative social impact of business method and software patenting is properly directed at the PTO's allowance of patents that were not substantially novel and that were not properly disclosed or claimed. There is no evidence that patents on novel, non-obvious and properly disclosed business-method process inventions create any harm. Download 08-964 Mark Landesmann.

Nevada State Bar Ass'n: The machine-or-transformation test harms emerging Nevada businesses - especially in the growing areas of solar energy, gaming, and digital communications. Download 08-964bsacintellectualpropertysectionnevadastatebar.

American Bar Ass'n: The court should use an incremental approach to excluding claims to subject matter where patenting does not make sense and creates a problem. Categorical limits such as the machine-or-transformation test may limit innovation. That said, the "[p]atent law should not interfere with the exercise of human intellect by granting a monopoly on processes in which thinking is central." A specific target of the ABA is to eliminate patents covering tax planning methods. Download 08-964 American Bar Association.

American Insurance Ass'n: Regardless of their novelty, insurance policies should not be the subject of patent protection - even when combined with a computer. Download 08-964 American Insurance Association.

Bank of America, Google, et al.: The patent laws should bar patentability of "accounting methods, tax mitigation techniques, financial instruments, and other means of organizing human behavior—or software used to implement those methods." Download 08-964 Bank of America et al..

Bloomberg: Limiting a method to use on a general purpose computer should not render the method patentable. Download 08-964 Bloomberg.

CCIA: It is important that the Federal Circuit eliminated the overbroad State Street test. The current tension in the patent system can largely be traced to that unprecedented over-expansion of the system. Tight limits on patentable subject matter are important because (inter alia) of the strict liability nature of patent infringement. "Tying patentability to physical subject matter is not a perfect solution. However, it limits the reach of patents in important ways that can significantly reduce the risks of inadvertent infringement and the scope of potential liability."Download 08-964 Computer & Communications Industry Association.

FFII: Patents on business methods have been considered and were rejected by the Statute of Monopolies in 1623. Patents greatly harm the Free & Open Source Software (FOSS) movement. Download 08-964 Foundation for a Free Information Infrastructure.

Professors Menell and Meurer: The Constitution creates a real limit on patentable subject matter - i.e., the subject matter of the patent must be within the "useful Arts." Economic evidence indicates that business method patents (especially internet related business methods) are harmful. 08-964 bsac Menell.pdf.

Law Professors and the AARP (Including Josh Sarnoff): Patents should only cover "inventions in the application." Patents can not cover "non-inventive applications of public domain science, nature, and ideas." The right interpretation of the statute requires that the invention "reside in the application, rather than in a discovery preceding or employed by it. This is because the science, nature, or ideas must be treated as if they are already in the prior art, i.e., are publicly known and free for all to use. Absent invention in applying such discoveries, there is simply no invention to patent." 08-964 bsac Brief of Eleven Law Professors and AARP.pdf.

Microsoft, Philips, and Symantec: Nobody (except Bilski) believes that his claims deserve patent rights. The machine-or-transformation test should not be seen as the exclusive test of patentable subject matter of a process claim - in part because the test has already "proven overly difficult to implement in practice." Like Professor Hollaar, Microsoft would simplify the test by requiring that the invention "involve one or more disclosed physical things." Today's computers - although complex - are not fundamentally different from Babbage's 1836 mechanical computer. Process claims that use computers should be patentable. Am Brief.pdf.

Professor Hollaar and the IEEE: Just restating the general principles of patentable subject matter is unhelpful. Rather, clear rules are needed - especially because the subject matter question is most frequently addressed by patent examiners who have little legal training and little time to ponder abstractions. A clear and time-tested rule would be: A process is patentable subject matter when it involves making or using a machine, manufacture, or composition of matter. This means that software method patents that require a computer would be patentable, but Bilski's method of hedging would not be patentable. bilski-sc-amicus.pdf.

American Medical Association: The machine-or-transformation test should not supplant the requirement that a patent claim "address a technology." A patent should not be allowed to cover "every possible application of a scientific observation." Rather, claims should be limited to "a particular new and useful application or use of the observation. The Supreme Court should use this case to make a statement especially directed to "overreaching claims in the life sciences. . . . Such patents chill research, and patents such as those in Labcorp and Prometheus chill talking and thinking of ideas by making talking and thinking into a tort." 08-964 bsac The American Medical Association.pdf.

Adamas Pharma and Tethys: Section 101 should be interpreted in a way that is objective, predictable, and not duplicative of the other patentability requirements. The machine-or-transformation (MoT) test does not meet any of these requirements. The Federal Circuit test also violates US treaty obligations under TRIPS and NAFTA and potentially subject the US to trade disputes adjudicated at the World Trade Organization (WTO). Under these US-initiated treaties member countries agreed to offer patent rights "in all fields of technologies." A major purpose of the agreements was to ensure that countries offered a full scope of patent rights, and by limiting the scope of rights, the US "will no longer be able to credibly argue in Special 301 trade disputes that failure to protect healthcare inventions made by cutting-edge U.S. companies constitutes inadequate protection of intellectual property rights." Some Congressional intent can be gleaned from the legislative history of Section 287(c) of the patent act. As originally proposed, that provision would have limited the subject matter eligibility of medical and diagnostic methods. After some debate, a compromise was reached to continue to allow their patenting, but to limit the remedies available. 08-964 bsac Adamas Pharmaceuticals.pdf.

Robert Sachs and Daniel Brownstone: Software should be patentable and has been for a long time. The Federal Circuit test greatly confuses the issue. Although software is an abstraction from the physical world, it is not "abstract." SF-5270929-v1-Bilski_v_Doll_Amicus_Brief_of_R_Sachs_and_D_Brownstone_as_amici_curiae_2009-08-06.PDF.

Big Internet Retailers, including Crutchfield, Overstock, and LL Bean: Patent Trolls are hurting online retailers and one way to stop them is to eliminate business method patents (including software business method patents). In effect, business method patents amount to a tax on Internet commerce. (The companies don't mention - unlike offline retailers - internet companies are often exempt from paying sales tax...) Internet Retailer Amicus Brief.pdf.

Brief of CASRIP (U. Washington): The US Constitution sets a bound on the scope of patentable subject matter - limiting them to the Constitutionally proscribed "useful Arts" as that term was understood at ratification. For new methods, one key is to consider the purpose of the method. Methods of entertaining a cat using a laser and telling a joke into a microphone should not be patentable regardless of their tie to particular machines because neither of those functions have ever "been considered a useful Art, and surely . . . is not the kind of discovery that the Patent Clause contemplates." Some methods also exist that should be patentable even though they fail the machine-or-transformation test. Despite its problems, the machine-or-transformation test is "superior to its competitors in filtering out preemptive claims to basic principles." However, it should not be the sole test of eligibility. Bilski's claim is unpatentable because hedging against price inflation (the purpose of the method) is not within the useful Arts. CASRIP am cur brf.pdf.

Interim Guidelines on Examining Statutory Subject Matter

The USPTO has issued a set of interim examination guidelines for determining whether a claim is properly directed to patentable subject matter under 35 U.S.C. � 101, relevant Supreme Court precedent, and Bilski. The instructions begin with a realization that the area is in flux and that more permanent guidelines will be established once the Supreme Court rules on Bilski v. Kappos. In addition, these are guidelines rather than rules or laws. Thus, an examiner's failure to follow the guidelines is "neither appealable nor petitionable."

Download 101 Memo to Directors | Download 101 Examiner Instructions 8 24 09 | Download FLOWCHARTMORT 8 24 09 | Download FLOWCHARTPROD 8 24 09

The guidelines appear to do a good job of synthesizing the highly confusing area of law into a straightforward algorithm. The problem is that next spring the Supreme Court is almost sure to reject the Federal Circuit's Machine-or-Transformation test. At that point, all of the examiner time and applicant money focusing on this "threshold issue" will have been wasted. I understand that the business of the PTO must continue even in the face of potential policy shifts. However, I would have suggested that examination of Section 101 eligibility be put on a back-burner - especially in light of the fact that most questionable subject matter cases will also fail the tests of obviousness, enablement, and indefiniteness.

The guidelines bear the signature of Drew Hirshfeld, Acting Deputy Commissioner for Patent Examination Policy. The PTO recently posted a notice looking to permanently fill this extremely important position.

Bilski v. Doll: Reconsidering Patentable Subject Matter

Bilski v. Doll (Supreme Court 2009)

The Supreme Court has granted certiorari in an important case challenging the scope of patentable subject matter. [Order]

Questions Presented:

Whether the Federal Circuit erred by holding that a “process” must be tied to a particular machine or apparatus, or transform a particular article into a different state or thing (“machine-or-transformation” test), to be eligible for patenting under 35 U.S.C. § 101, despite this Court’s precedent declining to limit the broad statutory grant of patent eligibility for “any” new and useful process beyond excluding patents for “laws of nature, physical phenomena, and abstract ideas.”

Whether the Federal Circuit’s “machine-or-transformation” test for patent eligibility, which effectively forecloses meaningful patent protection to many business methods, contradicts the clear Congressional intent that patents protect “method[s] of doing or conducting business.” 35 U.S.C. § 273.

Prior Coverage of the Case:

• Supreme Court Docket
• Mar 5, 2009: Bilski v. Doll: Round I of Amicus Briefs  
• Mar 1, 2009: Patentable Subject Matter Redux: Bilski 2009
• Jan 30, 2009: BPAI Again Rejects System Claims under Bilski  
• Jan 28, 2009: Bilski Petitions Supreme Court to Decide Issues of Patentable Subject Matter
• Jan 27, 2009: Should Patent Attorneys Support Bilski?
• Nov 18, 2008: Software Method Claims: Bilski in light of Benson  
• Nov 13, 2008: Post-Bilski BPAI Approves of Beauregard Claims
• Nov 10, 2008: Applying Bilski to Metabolite’s Diagnosis Claim   
• Nov 4, 2008: Holman: Applying Bilski to Biotechnology and the Life Sciences
• Nov 2, 2008: Collins: In re Bilski: Tangibility Gone “Meta”
• Oct 30, 2008: In re Bilski: Patentable Process Must Either (1) be Tied to a particular machine or (2) Transform a Particular Article
• May 8, 2008: CAFC Hears En Banc Bilski Case (oral arguments)
• Apr 10, 2008: Ex Parte Bilski: On the Briefs
• Mar 28, 2008: Ex Parte Bilski: Once Again Rethinking the Scope of Patentable Subject Matter   
• Feb 15, 2008: Bilski: Full CAFC to Reexamine the Scope of Subject Matter Patentability

Documents:

• Supreme Court: Bilski Petition for Certiorari
• Supreme Court: Government Opposition to Certiorari, Bilski Government Opposition to Certiorari
• Supreme Court: Bilski Reply in Support of Certiorari, Bilski.reply.pdf
• Supreme Court: Nine Amicus Briefs In Support of Certiorari.
• Federal Circuit: En Banc Decision: 07-1130.pdf
• Federal Circuit: Dozens of Amicus Briefs
• PTO Board of Patent Appeals & Interferences Bilski Decision: BPAI.Bilski.pdf

Amicus Support:

• According to the Supreme Court rule, the petitioner (here Bilski) now has 45 days to file its opening brief on the merits. The respondent's brief is ordinarily due within thirty days of that date. Any amicus brief would be due 7 days after the filing of the brief for the party being supported. This pushes the deadline for the first round of amicus briefs to the week of July 20.

In re Ferguson: Patentable Subject Matter

In re Ferguson (Fed. Cir. 2009)

Scott Harris has been discussed several times on Patently-O. Harris is a former Fish & Richardson partner. Fish handles the most patent litigation of any firm in the country. In addition to being a patent attorney, Harris is an inventor. He has contracted with the plaintiffs firm Niro Scavone in several actions to enforce patents against Google and other companies. Harris is one of the named inventors of the Ferguson application and he handled the [futile] appeal.

The claimed invention focuses on a "method of marketing a product" and a "paradigm for marketing software." These claims focus on methods and structures for operating a business.

Methods Under Bilski: Claim 1 reads as follows:

A method of marketing a product, comprising:

developing a shared marketing force, said shared marketing force including at least marketing channels, which enable marketing a number of related products;

using said shared marketing force to market a plurality of different products that are made by a plurality of different autonomous producing company, so that different autonomous companies, having different ownerships, respectively produce said related products;

obtaining a share of total profits from each of said plurality of different autonomous producing companies in return for said using; and

obtaining an exclusive right to market each of said plurality of products in return for said using.

Under Bilski, this case is open and shut. The claim is not even arguably tied to a machine -- especially under the Nuijten construction of machine to be a "concrete thing, consisting of parts, or of certain devices and combination of devices [including] every mechanical device or combination of mechanical powers and devices to perform some function and produce a certain effect or result." (Quoting Burr v. Duryee, 68 U.S. (1 Wall.) 531, 570 (1863)). Thus, the 1863 touchability definition of machine appears to hold weight. On the second Bilski prong, the claim does not require transformation of any article into a different state or thing. The only transformation is that of legal rights and organizational relationships that were explicitly excluded in the Bilski decision: "transformations or manipulations simply of public or private legal obligations or relationships, business risks, or other such abstractions cannot meet the test because they are not physical objects or substances, and they are not representative of physical objects or substances.”

Harris asked the court to consider a different test of patentable subject matter: “Does the claimed subject matter require that the product or process has more than a scintilla of interaction with the real world in a specific way?” The CAFC panel rejected that proposal primarily based on the precedential value of Bilski: "In light of this court’s clear statements that the “sole,” “definitive,” “applicable,” “governing,” and “proper” test for a process claim under § 101 is the Supreme Court’s machine-or-transformation test, see Bilski, passim, we are reluctant to consider Applicants’ proposed test." The court went on to determine that the "scintilla" test would create too much ambiguity as well.

Non Method Claims: The application also included claims directed to a "paradigm for marketing software" made up of a marketing company that markets software in return for a contingent share of income. Although "instructive," the Federal Circuit did not directly follow Bilski. Rather, the court looked to determine whether the claimed paradigm fit within one of the four statutory classes listed in Section 101:

Inventions Patentable: "... any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof..."

In a gentle Koan, the Court stated that it "need not resolve the particular class of statutory subject matter into which Applicants' paradigm claims fall, [however], the claims must satisfy at least one category." In fact, the court did attempt to resolve the particular class, but was unable to fit the paradigm claim into any of the four.

Applicants’ paradigm claims are not directed to processes, as “no act or series of acts” is required. Nuijten, 500 F.3d at 1355. Applicants do not argue otherwise. Applicants’ marketing company paradigm is also not a manufacture, because although a marketing company may own or produce tangible articles or commodities, it clearly cannot itself be an “‘article[]’ resulting from the process of manufacture.” Nuijten, 500 F.3d at 1356. Again, Applicants do not argue otherwise. And Applicants’ marketing company paradigm is certainly not a composition of matter. Applicants do not argue otherwise.  

Again applying the touchability notion of machine, the Court also rejected the notion that the company paradigm could be a machine:

Applicants do assert, however, that “[a] company is a physical thing, and as such analogous to a machine.” But the paradigm claims do not recite “a concrete thing, consisting of parts, or of certain devices and combination of devices,” Nuijtent, and as Applicants conceded during oral argument, “you cannot touch the company.”

Ending in a flourish, the court found that in fact, the Ferguson paradigm claims are "drawn quite literally to the paradigmatic abstract idea." (quoting Warmerdam).

Judge Newman offers a poignant concurring opinion.  

Bilski v. Doll: Round I of Amicus Briefs

Bilski v. Doll (on petition for writ of certiorari 2009)

In a 2008 en banc decision, the Federal Circuit affirmed a Patent Office ruling that Bernard Bilski’s claimed method of hedging the risk of bad weather through commodities trading was not patent eligible under Section 101 of the patent act. The Court applied a “machine-or-transformation test” as the only test to be used in determining whether a claimed process is eligible for patenting under § 101. The decision holds that a claimed process either (1) be tied to a particular machine or apparatus or (2) transform a particular article into a different state or thing. Although the Court identified the Bilski test as the only test, it added two corollaries: (1) the addition of a mere field-of-use limitation without other meaningful limits on claim scope will not render a method claim patent eligible; and (2) insignificant extra-solution limitations will not render a method claim patent eligible.

Bilski has petitioned the Supreme Court to hear its appeal and look at the question of patentable subject matter for the first time in a generation. Diamond v. Chakrabarty and Diamond v. Diehr together opened the door for broader patent eligible subject matter. Notably, Justice Stevens – author of the Diehr dissent – is the only justice still on the bench. Bilski’s petition asks two questions:

1.       Whether the Federal Circuit erred by holding that a “process” must be tied to a particular machine or apparatus, or transform a particular article into a different state or thing … despite this Court’s precedent declining to limit the broad statutory grant of patent eligibility for “any” new and useful process beyond excluding patents for “laws of nature, physical phenomena, and abstract ideas.”

2.       Whether the Federal Circuit’s “machine-or-transformation” test for patent eligibility, which effectively forecloses meaningful patent protection to many business methods, contradicts the clear Congressional intent that patents protect “method[s] of doing or conducting business.” 35 U.S.C. § 273.

The first round of Amicus briefs – those supporting the petition – have now been filed. The PTO’s briefs and briefs in opposition to the petition are due in early April.

Amicus Briefs Supporting the Petition (I have not reviewed all of these, but wanted to post them for public consumption):

• AIPLA: “There is no support in this Court’s precedent for the Federal Circuit majority’s conclusion that this Court enunciated a definitive ‘machine or transformation’ test for determining the patent eligibility of a claimed process under § 101.” The statute should be interpreted to promote new areas of technology.   File Attachment: aiplaamicus.pdf (148 KB)

• Boston IPLA: The “machine-or-transformation test” conflicts with Supreme Court precedent. File Attachment: bostonamicus.pdf (142 KB)

• Borland Software: File Attachment: borlandamicus.pdf (158 KB)

• Koninklijke Philips Electronics: File Attachment: philipsamicus.pdf (162 KB)

• Anne Barschall: The Supreme Court appears to have some “prejudice against electronic devices [as evidenced by] both Benson and Morse.” Its not magic, it is engineering. You can’t see electricity or quantum particles but that does not make them abstract ideas. File Attachment: barschallamicus.pdf (217 KB)

• Medistem: Bilski has considerable bleed-through to non-business method patents. File Attachment: medistemamicus.pdf (109 KB)

• Accenture and Pitney Bowes: The Federal Circuit's "only one test" rule is too rigid and goes against the Supreme Court's precedent that demonstrated flexibility in the Section 101 inquiry. [DDC Comment: The flexibility theme is strongly present in the past several years of Supreme Court patent cases. In eBay, MedImmune, and KSR, the Supreme Court saw a rigid Federal Circuit rule and made it more flexible.] File Attachment: accentureamicus.pdf (122 KB)

• Franklin Pierce Law Center: File Attachment: fplcamicus.pdf (128 KB)

• John Sutton: File Attachment: suttonamicus.pdf (120 KB)

PTO’s Current Examination Standards for Applying Bilski

DATE: January 7,2009
TO: Technology Center Directors Patent Examining Corps
FROM: John J. Love
SUBJECT: Guidance for Examining Process Claims in view of In re Bilski

Recently, the Court of Appeals for the Federal Circuit issued an opinion affirming a final decision by the Board of Patent Appeals and Interferences sustaining a rejection of claims because they were not directed to patent-eligible subject matter under 35 U.S.C. § 101. See In re Bilski, 545 F.3d 943, 88 USPQ2d 1385 (Fed. Cir. 2008). The court's opinion clarified the standards applicable in determining whether a claimed method constitutes a statutory "process" under § 101. Office policy is consistent with the court's opinion in Bilski.

We are presently studying the full ramifications of the court's clarification and other recent developments in the law. In view of the Bilski decision, the guidelines are being redrafted to reflect the most current standards for subject matter eligibility. Until the guidelines are completed, examiners should continue to follow the current patent subject matter eligibility guidelines appearing in MPEP 2106, with the following modification.

As explained in a memorandum dated May 15, 2008, entitled "Clarification of 'Processes' under 35 USC § 101", a method claim must meet a specialized, limited meaning to qualify as a patent-eligible process claim. As clarified in Bilski, the test for a method claim is whether the claimed method is (1) tied to a particular machine or apparatus, or (2) transforms a particular article to a different state or thing. This is called the "machine-or-transformation test". It should be noted that the machine-or-transformation test from Bilski is slightly different from the test explained in the May 15 Clarification memo, which was based on the Office's interpretation of the law prior to Bilski.

There are two corollaries to the machine-or-transformation test. First, a mere field-of-use limitation is generally insufficient to render an otherwise ineligible method claim patent- eligible. This means the machine or transformation must impose meaningful limits on the method claim's scope to pass the test. Second, insignificant extra-solution activity will not transform an unpatentable principle into a patentable process. This means reciting a specific machine or a particular transformation of a specific article in an insignificant step, such a data gathering or outputting, is not sufficient to pass the test.

For guidance, examiners are encouraged to consult their managers and to consult additional training materials as they are developed.

[Read the memo]

Obviousness; Scope and Content of the Prior Art; Secondary Considerations

Süd-Chemie v. Multisorb Technologies (Fed. Cir. 2009)

Süd-Chemie holds a patent covering a desiccant container for keeping products dry in shipment. In an infringement action, the Kentucky district court found the patent invalid as obvious. On appeal, the Federal Circuit vacated - holding that the lower court had erred in its analysis of the scope and content of the prior art. There are two primary take-away points from Sud-Chemie. First, obviousness jurisprudence continues to require detailed analysis of the claims and the prior art. I.e., KSR did not suddenly allow handwaving as a substitute for evidence and clear argument. Second, well presented secondary indicia of nonobviousness continue to be important in rebutting obviousness allegations.

Here, the claimed patent required the use of "compatible polymeric materials" used in a laminate seal. The prior art disclosed the use of laminate materials taken from the same general class of materials. However, the Federal Circuit recognized that the prior art did not specify that the selected materials be "compatible" in a way to allow for a proper laminate seal.

This is a case where a definition of the claim term in the specification greatly aided the patentee. The specification defined "compatible" materials as those that "mix on a molecular scale and will crystallize homogeneously." The prior art reference did not teach this form of compatibility. In fact, the prior art appeared to teach "incompatible" materials.  

Multisorb ignores the fact that while the ’942 patent requires the inner surfaces of the laminate and microporous films to have similar softening points, Komatsu [the prior art] requires the films to have dissimilar softening points. Komatsu thus does not teach the use of a microporous film that is compatible with the inner surface of the laminate film.

Looking at secondary considerations, the Federal Circuit instructed district courts to "attend carefully to any evidence of ... secondary considerations of nonobviousness." Here, the focus is on the surprising and unexpected result that compatible materials formed stronger bonds even without adhesive.

The Federal Circuit did not apply these findings to form a conclusion on the issue of obviousness. Rather, the court remanded for further development of the facts.

[NOTE- This decision is from January 2009]

Orion and Taurus: NPEs at the Federal Circuit

Erich Spangenberg has at least two pending appeals at the Federal Circuit: Taurus IP v. Daimlerchrysler (and Hyundai) and Orion IP v. Hyundai Motor. In the Taurus case, the Wisconsin District Court found the asserted patent (6,141,658) invalid and also asserted jurisdiction over Spangenberg and Orion IP via a veil-piercing theory. In a recent order, the Federal Circuit properly refused to allow Chrysler and Mercedes to present argument and documents "in camera" in that case. [Link] In the Orion case, a Texas court found Hyundai liable for infringement of the asserted patent (5,367,627) and awarded $34 million in damages. Hyundai has posted $25 million bond to stay the full payment until the appeal is concluded. [LINK ]. The general rule is that money damages will be stayed pending appeals if bond is posted, and that injunctive relief might be stayed.

The '627 patent is patent reformer's poster child for damages reform. The patent covers a method that helps a sales clerk properly order the parts that match a customer's needs. It is hard to know what the value of the incremental invention as compared with the prior art back in 1989 when the original application was filed. I will note that the $34 million patent has only 15 claims and includes means-plus-function language in the claims. Claim 1 of the patent is reproduced below:

1. A computerized method of selling parts for particular equipment specified by a customer, comprising the steps of: a) receiving information identifying a customer's parts requirements for the equipment, comprising the step of receiving equipment application information, comprising an identification of the equipment with which one or more parts are to be used; b) electronically specifying information identifying a plurality of parts and specifications for the parts; c) gathering parts-related information for one or more parts within the plurality of parts which meets the customer's requirements, comprising the step of electronically associating at least one of the parts within the plurality of parts with the received equipment application information; and d) receiving the gathered parts-related information and compiling the parts-related information into a proposal meeting the customer's requirements.

Although the '658 patent does not claim priority to the earlier '627 patent, it does have one overlapping inventor and a large amount of overlapping scope.

Classen v. Biogen: Request for Rehearing

In Classen v. Biogen, the Federal Circuit issued a one paragraph non-precedential opinion rejecting Dr. Classen's claimed method for evaluating a vaccine immunization schedule. The problem with the claims stems from the Bilsmane or transformation test. The appellate panel found that "the claims are invalid under 35 U.S.C. § 101. Dr. Classen's claims are neither "tied to a particular machine or apparatus" nor do they "transform[] a particular article into a different state or thing." Bilski, 545 F.3d at 954."

Now, Classen has filed its request for a rehearing en banc and is looking for further amicus support. The brief cites only one case -- Bilski -- and argues the facts: that at least the claim limitation of "immunizing mammals" is a qualifying transformation of matter.

Notes:

• Patently-O Discusses Classen v. Biogen
• classenrehearing.pdf
• Prometheus
• Prof. Holman

BPAI Again Rejects System Claims under Bilski

Ex parte Atkins (BPAI 2009)

The BPAI has again raised the issue of Post-Bilski patentable subject matter sua sponte. Like most claims challenged under Section101, Atkins claims also have serious nonobvousness and indefiniteness problems.

Atkins claims a method of "converting a unidirectional domain name to a bidirectional domain name." In reviewing the claim under Bilski, the BPAI noted that the claims do not "recite any machine or apparatus or call for transforming an article into a different state or thing. A domain name is simply a series of characters representing the address of a resource, such as a server, on the World Wide Web. All of the steps are data manipulation steps."

Atkins also claims a parallel "system" for converting the domain name. The BPAI rejected the system claims under Bilski since "those claims encompass any and all structures for performing the recited functions. As a result, [the system claims] are at least as broad as method claims ... which we have determined recite patent ineligible subject matter under Bilski."

• Ex parte Atkin.pdf

Bilski Petitions the Supreme Court to Decide Issues of Patentable Subject Matter

Bilski v. Doll (on petition for certiorari)

In Bilski, the Court of Appeals for the Federal Circuit applied the “machine-or-transformation test” as the only test to be used in determining whether a claimed process is eligible for patenting under § 101. The decision holds that a claimed process either (1) be tied to a particular machine or apparatus or (2) transform a particular article into a different state or thing.

Bilski’s claimed method of hedging the risk of bad weather through commodities trading had been rejected by the USPTO as lacking patentable subject matter. On appeal, the Federal Circuit affirmed – finding that the method failed the machine-or-transformation test.

Now, Bilski has petitioned the Supreme Court for a writ of certiorari — asking the high court to determine whether the new test of patentable subject matter is the correct test.

The petition asks two questions:

Whether the Federal Circuit erred by holding that a “process” must be tied to a particular machine or apparatus, or transform a particular article into a different state or thing … despite this Court’s precedent declining to limit the broad statutory grant of patent eligibility for “any” new and useful process beyond excluding patents for “laws of nature, physical phenomena, and abstract ideas.”

Whether the Federal Circuit’s “machine-or-transformation” test for patent eligibility, which effectively forecloses meaningful patent protection to many business methods, contradicts the clear Congressional intent that patents protect “method[s] of doing or conducting business.” 35 U.S.C. § 273.

Under Supreme Court rules, any amici brief in support of the petitioner (Bilski) would be due within thirty days (Feb 27). Those in support of the respondent (PTO) would be due the dame day, but the PTO will likely seek an extension.

Notes

• File Attachment: Bilski Petition for Certiorari (665 KB)
• Federal Circuit Decision in Bilski
• The BPAI and the Machine or Transformation test of Bilski
• Should Patent Practitioners Support the Bilski Petition?
• Prometheus v. Mayo: Limits of Patentable Subject Matter in Medical Treatment and Diagnosis
• Drafting Software Patents Under Bilski
• Professor Collins: In re Bilski: Tangibility Gone “Meta”

Bilski at the Supreme Court

Bernard Bilski's petition for certiorari is due within days (unless an extension is granted). I think that there is a real question of whether (and how) the patent community should react to presentation of the case. Should the patent community support this case for Supreme Court review, wait for a better situated case, or sit content with the machine-or-transformation test outlined by the Federal Circuit in the en banc Bilski decision? Each position has its merits.

The case is well developed, parties and amici have already invested time standing behind the case. Yet, the underlying invention is not compelling (a method of hedging the risk of bad weather by using commodities trading) and issues of obviousness would almost certainly cloud the issues. There are many other potential cases in the pipeline, and the Supreme Court may properly wait to see how the new Bilski rule develops before weighing-in.

Federal Circuit Revises (Muzzles) Comiskey

In re Comiskey (Fed. Cir. 2009) (Revised Panel Opinion)(En Banc Order)

After a request for en banc rehearing, the original Federal Circuit panel has revised its decision in Comsikey – erasing the "misunderstood" phrases of the original opinion linking Sections 101 (subject matter) and 103 (nonobviousness). The original opinion implicitly held that any portion of an invention that would constitute nonstatutory subject matter would be considered de facto obvious. [Link]

The new opinion finds that Comiskey's method claims do not present patentable subject matter and remanded the case to the PTO to determine the subject matter eligibility of the system claims. The Federal Circuit refused to consider nonobviousness issues – even though nonobviousness was the sole issue presented in the original appeal. Subject matter eligibility had been raised sua sponte by the panel.

Judges Moore and Newman each dissented from the en banc order. Judge Moore argued that the decision violates the court's "well established precedent that this court will not consider new grounds of rejecting patent claims on appeal."

Bilski: Adding Obvious but Meaningful Limitations

Paul Gardner is PRG's Academic Director. In an e-mail, I asked him whether claim drafting techniques and strategies can be effectively tailored to satisfy Bilski's requirements without sacrificing valuable claim scope. Mr. Gardner says yes it can be done most of the time (and PRG is developing the CLE to tell you how). For Gardner, an important consideration in Bilski is between "meaningful limits" versus "nonobvious limits."

While Bilski requires that process claims recite machine or transformation limitations that "impose meaningful limits on the claim's scope," such limitations need not themselves be new or nonobvious. In other words, "meaningful limits" is not to be equated with "nonobvious limits," and the "meaningful limits" requirement may be satisfied – insofar as Section 101 patent-eligibility is concerned – by machine or transformation limitations which, standing alone, are old or obvious. Once Section 101 patent-eligibility is found to be present, novelty and nonobviousness of the claim as a whole may be satisfied by a novel and nonobvious algorithm in combination with the structural machine or transformation recitations.

This difference is seen in the Federal Circuit's discussion of Abele.

As Chief Judge Michel points out in Bilski, in Abele the CCPA found a broad method claim reciting only data manipulation steps (calculating the difference between two values and displaying the value of the difference) to be patent-ineligible, but found a dependent claim adding only that the data is "X-ray attenuation data produced in a two dimensional field by a computed tomography scanner" to be patent-eligible, because the data represented physical and tangible objects.

My own caution comes from the CAFC's nonobviousness analysis in the 2007 Comiskey decision. In describing that case, I led with the headline "35 USC 101 Finds its Teeth (Biting into Nonobviousness)" because Comiskey could be read to indicate that any portion of an invention that constitutes nonstatutory subject matter will be considered de facto obvious. Under this reading of Comiskey, obvious but meaningful limitations may overcome §101, but leave the claim extremely vulnerable under §103(a). The Supreme Court's 1978 Parker v. Flook decision follows this same line of thinking – treating a non-statutory (but previously unknown) algorithm "as though it were a familiar part of the prior art."

   

     

     

   

Professor Collins: In re Bilski: Tangibility Gone “Meta”

By Professor Kevin Emerson Collins (Indiana University Law School – Bloomington) [PDF Version]

In its recently issued en banc majority opinion in In re Bilski, the Federal Circuit articulates a "machine-or-transformation" test for patent-eligible subject matter under § 101 of the Patent Act. Although they are both legitimate questions, this short comment addresses neither whether there is a legitimate statutory basis for this test nor whether Supreme Court precedent should be interpreted so as to mandate (or even support) this test. Rather, it focuses solely on the criteria that the court offers to draw the line between patentable and unpatentable transformations. The Federal Circuit has added a new twist to the tangibility test that has for many years played a role in determining patent-eligibility: the tangibility test has gone "meta." The tangibility of the formal data that is actually transformed by a method of processing information is not relevant to patent-eligibility, but the tangibility of the things that the data is about—the tangibility of the informational content of the data or the things to which the data refers—now appears to be dispositive.

Bilski sets out a disjunctive two-prong "machine-or-transformation" test for patent-eligible subject matter: "A claimed process is surely patent-eligible subject matter under § 101 if: (1) it is tied to a particular machine or apparatus, or (2) it transforms a particular article into a different state or thing." Slip op. at 10. The opinion declines to elaborate on the implications of the particular-machine prong of the test because the applicants conceded that their claim did not satisfy this prong. Id. at 24. It addresses only the transformation prong. It puts forward a conjunctive, two-prong test that must be satisfied for a method to "transform[] a particular article into a different state or thing" and thus to qualify as patent-eligible subject matter. First, the transformation implicated "must be central to the purpose of the claimed process." Id. In other words, it must also "impose meaningful limits on the claim's scope" and not "be insignificant extra-solution activity." Id. Second, the transformation only qualifies as patent-eligible if it transforms a certain type of "article." "[T]he main aspect of the transformation test that requires clarification here is what sorts of things constitute 'articles' such that their transformation is sufficient to impart patent-eligibility under § 101." Id. at 24–25. This is the distinction—the distinction between the "articles" that, if transformed, constitute patent-eligible subject matter and the other "articles" that, if transformed, do not constitute patent-eligible subject matter—on which the opinion elaborates at length, id. at 25–32, and on which this comment focuses.

Most importantly for the point addressed here, the Federal Circuit implies in Bilski that there are two different categories of "electronically-manipulated data," id. at 25, and that the data in each category is a different type of "article" insofar as patent-eligibility is concerned. The data in the first category is an "article" that, if transformed by a method claim, constitutes patent-eligible subject matter, but a method that transforms the data in the second category is not a patent-eligible method.

The first category is comprised of data that represents a "physical object or substance." Id. at 28. For example, citing In re Abele, 684 F.2d 902 (C.C.P.A. 1982), the Federal Circuit stated that a method that transforms data that "clearly represent[s] the physical and tangible objects, namely the structure of bones, organs, and other body tissues" is a patent-eligible method. Slip. op. at 26.

The second category of data seems to have two distinct subsets. The first subset is data that, as claimed, does not represent anything (or, alternatively, that can represent anything). This data is semantically empty; it is a variable without any specified informational content. Bilski again uses Abele—but this time the claims that the court rejected under § 101—as an example. Id. The fact that methods reciting the transformation of this meaningless (or infinitely meaningful) data are not patent-eligible should come as no surprise to those familiar with the history of patent-eligibility in the last several decades: methods that recite the manipulation of variables without semantic meaning are nothing more than methods that recite mathematical algorithms in the abstract.

The second subset of the second category, however, is likely to raise some eyebrows: it contains data that represents something specific or something in particular, but that something represented is itself intangible. Here, the informational content of the data—the thing in the world to which the data refers—is intangible. The Federal Circuit holds that the method at issue in Bilski is not patent-eligible because it "transform[s]" or "manipulat[es]" data representing "public or private legal obligations or relationships, business risks, or other such abstractions," which critically is not data "representative of physical objects or substances." Id. at 28.

The idea that the meaning that the user attributes to the data transformed or manipulated by an information processing method is relevant to patent-eligibility is not a novel feature of the "machine-or-transformation" test announced in Bilski. For example, the "concrete, useful and tangible result" test of State Street Bank required the courts to examine the meaning of the data, variables or "numbers" in the course of determining patent-eligibility. State St. Bank & Trust Co. v. Signature Fin. Group, 149 F.3d 1368, 1373–75 (Fed. Cir. 1998). However, what is new in Bilski is the importance now placed on the physicality of the thing to which the data refers. Thus, the tangibility test has gone "meta": it is no longer the tangibility of jostling electrons that is of concern (as it was in the early days of patents on computer-executed information processing methods), but the tangibility of the stuff represented by those electrons-as-symbols. In the language of semiotics, the tangibility analysis has shifted from a concern about the tangibility of the signifier—the physical configuration of matter that forms a symbol—to a concern about the tangibility of the signified—the informational content of or the thing represented by the symbol.

There is in my opinion much that needs to be said about this move in Bilski that takes the long-standing concern about tangibility in the patent-eligibility analysis "meta," transforming it from a concern about a signifier to a concern about a signified. Here, however, I limit myself to raising two initial, narrow questions.

First, the move raises a normative question: Why should we treat information about tangible things in a manner that is categorically different from the manner in which we treat information about intangible things? Having taken its cue from the Supreme Court, the Federal Circuit clearly wants to prevent patent-eligible method claims from pre-empting mathematical "fundamental principles." Slip op. at 26. However, the most appropriate means to achieve this end would seem to be a focus on the specificity, not the intangibility, of what is meant. Why should the manipulation of data that represents my height (a presumptively physical property of my body) be patentable, yet the manipulation of data that represents my expected longevity (a property that is difficult to classify as a physical one) be unpatentable?

Second, the move raises concerns about administrability. Is data about my expected longevity about something physical, namely my body? If it is, then why isn't the data at issue in Bilski also about something tangible? The data is after all about a property of lumps of coal, namely their expected future rate of consumption or the legal rights that individuals have with respect to them. Or, to formulate the administrability problem in a recursive manner, what about data that is about the structural qualities of electronic signals? To determine whether a method that manipulates such data is patent-eligible, it would seem again to be necessary to confront the tangibility of an electronic signal—the very question that patent doctrine has been trying to render irrelevant for several decades—but this time with the signal as a signified rather than as a signifier.