Patent Law Blog (Patently-O)

In re Nature's Remedies: Foreign Regulatory Submission Invalidates Patent Under 102(b)

In re Natures Remedies (Fed. Cir. 2009) (nonprecedential)

In October of 2005, a third party (Jemo-Pharm) submitted a request for ex parte re-examination of Natures Remedies patented claim covering an herbal composition of guarana, damiana, and yerbe-mate claimed to cause weight loss. More than one year before Remedies' filing date, an anticipating composition had been submitted to a Danish regulatory organization as part of a request for approval for clinical testing. (The decision is unclear, but implies that the submission was done by Remedies).

A Danish official provided testimony that the submission was a public record and was open for inspection since its date of submission. Remedies' expert, however, argued that a Danish trade-secrecy law would have prevented such inspection. The BPAI accepted the open-access line of argument and found the submission invalidating prior art under 35 USC 102(b). The patentee appealed - arguing that the official submission was not sufficiently publicly accessible to be considered 102(b) prior art.

On appeal, the Federal Circuit affirmed - finding that the regulatory submission was publicly available more than one year before Remedies filed its application. The court began by recognizing that the official's testimony created a prima facie case that the submission was publicly accessible - shifting the burden to the patentee. Of course, BPAI factual findings such as this will be affirmed with a finding of "substantial evidence."

Because [the Danish Official's] declaration established a prima facie case of public availability, the onus was on Remedies to demonstrate that the [regulatory submission] was not accessible to interested members of the public. Remedies, however, failed to carry its burden.

Under the Danish trade-secrecy law, the regulatory submissions are kept secret when they are of "material importance" to a company's "economy." It appears that Remedies could have proven its case but failed to provide evidence to the Board.

Attorney argument, however, cannot take the place of record evidence. See In re Geisler, 116 F.3d 1465, 1470 (Fed. Cir. 1997); Johnston v. IVAC Corp., 885 F.2d 1574, 1581 (Fed. Cir. 1989). Here, the evidence of record does not establish that Remedies intended to keep the formulation of the Medi-Tab capsule confidential until after the study had been completed and a patent application had been filed.

Rejection affirmed

Notes:

• 102(b) looks at prior art that was "described in a printed publication" more than one year prior to the date of application for the US patent. Implicit within 'publication' is a notion that the material is publicly accessible. Notably, however, there is generally no need to prove that the material was actually accessed. Thus, in this case, there is no discussion of whether the regulatory submission was ever seen by anyone.
• Read the case
• Reexam No. 90/007,785 (look it up in PAIR).
• In some ways, this case is simply an extension of the Pivonka v. Axelrod case where the Federal Circuit held that the applicant has waived arguments by failing to present them at the Board of Patent Appeals.

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."

   

     

     

   

BPAI: Under §102(e), Provisional Application Considered Prior Art as of its Filing Date.

Ex parte Yamaguchi (BPAI 2008)(Precedential Opinion)

In prosecution, the Examiner cited the Narayanan reference against a Texas Instruments patent application filed by Yamaguchi. The rejection identified Narayanan as prior art under 35 U.S.C. § 102(e). The issue on appeal to the BPAI was whether the Narayanan reference can be considered 102(e) prior art as of the filing date of its provisional application.

Section 102(e) allows for submarine prior art – these are typically pending US patent applications that, when published or patented, suddenly become prior art as of their filing date. The statute allows that "[a] person shall be entitled to a patent unless . . .the invention was described in . . .a patent granted on an application for patent by another filed in the United States before the invention by the applicant for patent.. . ." 35 U.S.C. § 102(e).

102(e) Provisional: The issue here is whether Narayanan's provisional application can be used in 102(e) analysis. The expanded BPAI panel agreed with the examiner that the 102(e) prior art date does reach-back to the date of provisional filing. This result is based on their analysis of 35 U.S.C. § 111(b). Section 111(b) requires that "provisions of this title relating to applications for patent shall apply to provisional applications for patent."

"Based on this express intent to apply the provisions of Title 35 relating to "applications for patent" to provisional applications (except for four enumerated sections noted in §111(b)(8)), a provisional application can therefore be reasonably considered an "application for patent" within the meaning of §102(e). The plain meaning of these provisions of Title 35 as noted above is outlined in MPEP 2136.03(111) for establishing the critical reference date under §102(e) of a U.S. patent or U.S. application publication that is entitled to the benefit of the filing date of a provisional application under §119(e). Based on the statutory scheme of Title 35, we hold that Appellants have not shown harmful error in the rejections on appeal."

This holding is in tension with the controlling precedent of In re Wertheim, 646 F.2d 527 (CCPA 1981). In Wertheim, the CCPA held that for a continuation-in-part application, the parent's filing date may serve as a §102(e) date, but only if the parent contains full §§120 and 112 support for the disclosure.

In this case the Examiner found that the Narayanan provisional application fully supported the eventual publication – and thus that the 102(e) date for narayanan was the filing date of the provisional. The applicant was unable to disprove these findings and the BPAI affirmed the rejection.

Anticipation Requires More Than Disclosing All the Elements

Net MoneyIn v. Verisign (Fed. Cir. 2008)

NMI sued Verisign and others for infringing its credit card processing patent. One of NMI's claims was found anticipated by a single prior art reference. That reference taught each element in the invalidated claim. However, there was no single example that taught all the elements together.

On appeal, the Federal Circuit reversed – holding that anticipation takes more than simply locating each element within the four corners of a single document.

In its rebuttal, the appellate panel focused on the concept anticipating the invention. To anticipate, the prior art must teach all the claim elements and the claimed arrangement.

Section 102 embodies the concept of novelty—if a device or process has been previously invented (and disclosed to the public), then it is not new, and therefore the claimed invention is "anticipated" by the prior invention. . . . Because the hallmark of anticipation is prior invention, the prior art reference—in order to anticipate under 35 U.S.C. § 102—must not only disclose all elements of the claim within the four corners of the document, but must also disclose those elements "arranged as in the claim."

Focusing for a moment on arrangement – to anticipate, the reference must teach "all of the limitations arranged or combined in the same way as recited in the claim."

Applying the rule to this case, the appellate panel found that the prior art reference was not anticipating. The reference disclosed two transaction protocols, but neither protocol contained all of the elements combined in the manner claimed. "Thus, although the iKP reference might anticipate a claim directed to either of the two protocols disclosed, it cannot anticipate the system of claim 23. The district court was wrong to conclude otherwise."

Means Plus Function: After claim construction, the district court also found NMI's means-plus-function claims invalid because they lacked any corresponding structure in the specification. On appeal, the Federal Circuit affirmed.

The patent statute allows patentees to draft claims in more generic 'means plus function' language. That language allows a patentee claim various elements based on their function. However, means plus function claims are only valid if the specification describes some structure to carry out the proposed function. According to the courts, this structure requirement is separate from any enablement requirement. Thus, some structure must be provided in the specification even if one skilled in the art would not need that disclosure to make the invention.

Here, NMI claimed a "[a bank computer including] means for generating an authorization indicia" but did not provide any corresponding structure in the specification to perform that structure.

On appeal, NMI incredibly argued that the claim was not a means-plus-function claim. The Federal Circuit disagreed – finding that the claim lacks structure.

Searching for structure in the specification, NMI pointed to its recitation of a "bank computer." Of course that recitation is insufficient.

'To avoid purely functional claiming in cases involving computer-implemented inventions, we have "consistently required that the structure disclosed in the specification be more than simply a general purpose computer or microprocessor." Quoting Aristocrat … Consequently, a means-plus-function claim element for which the only disclosed structure is a general purpose computer is invalid if the specification fails to disclose an algorithm for performing the claimed function.

Holding of MPF claim invalidity affirmed.

Anticipated yet Nonobvious

Cohesive Tech v. Water Corp (Fed. Cir. 2008)

Perhaps the most important portion of this case relates to the notion that novelty and nonobviousness are separate and distinct inquiries. And, that a patent may be found anticipated yet nonobvious.

On summary judgment, the district court Cohesive’s HPLC patent might be obvious, but certainly was not anticipated.  Water appealed — arguing that the judgment was logically incorrect if anticipation truly is the “epitome of obviousness.”  On appeal, however, the Federal Circuit confirmed that novelty and obviousness are separate and distinct — one does not necessarily follow the other.

“While it is commonly understood that prior art references that anticipate a claim will usually render that claim obvious, it is not necessarily true that a verdict of nonobviousness forecloses anticipation. The tests for anticipation and obviousness are different.

The court suggested two circumstances where an anticipated claim might still be nonobvious.  First, secondary considerations of nonobviousness may exist that are not relevant in an anticipation claim. Second, although inherent elements apply in an anticipation, inherency is generally not applicable to nonobviousness. 

“[O]bviousness requires analysis of secondary considerations of nonobviousness, while secondary considerations are not an element of a claim of anticipation. And although anticipation can be proven inherently, proof of inherent anticipation is not the same as proof of obviousness.”

The court also gives an example —

“Consider, for example, a claim directed toward a particular alloy of metal. The claimed metal alloy may have all the hallmarks of a nonobvious invention—there was a long felt but resolved need for an alloy with the properties of the claimed alloy, others may have tried and failed to produce such an alloy, and, once disclosed, the claimed alloy may have received high praise and seen commercial success. Nevertheless, there may be a centuries-old alchemy textbook that, while not describing any metal alloys, describes a method that, if practiced precisely, actually produces the claimed alloy. While the prior art alchemy textbook inherently anticipates the claim under § 102, the claim may not be said to be obvious under § 103.”

Judge Mayer dissented — arguing that anticipation is a subset of nonobviousness. “Although a claimed invention can be obvious but not anticipated, it ‘cannot have been anticipated and not have been obvious.’ In re Fracalossi, 681 F.2d 792, 794 (CCPA 1982).”

“The majority’s assertion that a claim can be anticipated but not obvious, flies in the face of a long line of precedent to the contrary. Not surprisingly, it is unable to cite a case remanding to the district court for consideration of anticipation, while at the same time sustaining a determination that claims at issue are not obvious.”

The practical impact of this case:

1. Anticipation still gets to a jury even when the defense has a credible obviousness argument.
2. The Majority’s example might be seen to narrow the scope of documents available for obviousness arguments along a temporal axis. (References from a long time ago shouldn’t be combined with more recent references.)
3. In some ways, the ‘common sense’ approach of KSR encourages this decision. While anticipation may still be a formal construct, obviousness should focus on what really would have been obvious at the time of the invention.
4. Professor Ochoa (Santa Clara) reminded me about the European rule that does not allow “secret” prior art to be used in obviousness (inventive step) analysis.  If the US so modified its rules, perhaps the distinction between obviousness and anticipation would begin to ring true.

Combining References in Novelty; Slack in New Matter; No Decision on Injunction for NPE

CSIRO v. Buffalo Technology (Fed. Cir. 2008)

CSIRO is a nonpractising patent holder. It is also an arm of the Australian government. After winning an infringement suit against Buffalo Tech, CSIRO was awarded permanent injunctive relief to protect its spread spectrum WLAN technology.

On appeal, more than a half-dozen amici filed briefs arguing for and against injunctive relief in this situation. On appeal, however, the Federal Circuit vacated the infringement holding – leaving the discussion of injunctive relief for another day. The vacatur came from the district court’s pre-KSR strict requirement for a motivation to combine references.

Combining References For Novelty: On novelty, Buffalo asked the court to combine two references in its analysis because one of the reference cites the other in a footnote. The Federal Circuit rejected that argument — finding that the footnote discussion was insufficient to concatenate the two references. “In particular, the reference to Bingham does not ‘identify with detailed particularity what specific material it incorporates and clearly indicate where that material is found in the various documents.’ Advanced Display Systems, (Fed. Cir. 2000).”

New Matter: 35 USC 132 bars an applicant from presenting new matter once a patent application has been filed.  In litigation, the written description requirement of Section 112 serves as the basis for invalidating patents with added new matter.  The new matter limitation is not strict. Rather, when the claims are amended, the patent will only be invalidated if the original specification is not “sufficient to allow persons of ordinary skill in the art to recognize that the inventor invented the subject matter that is claimed in the asserted claims.”  Further, the PTO’s decision to allow an amendment provides a patent with “an especially weighty presumption of correctness.”

Here, CSIRO changed its claim limitation from “frequencies in excess of 10 GHz” to simply “radio frequencies.”  On appeal, the Federal Circuit affirmed the lower court’s factual finding that the amendment did not impermissibly add new matter. (No clear error). In particular, neither party suggested a technical distinction between handling lower frequencies. Further, the court found that the original specification was not limited to frequencies in excess of 10 GHz.

On remand, the lower court will reevaluate obviousness.

Zyprexa Patent Upheld on Appeal

Eli Lilly v. Zenith Goldline (Fed. Cir. 2006)

Lilly’s patent covers olanzapine (Zyprexa®) and its use for the treatment of schizophrenia. Three generic manufacturers (Zenith (IVAX), Dr. Reddy’s, and Teva) filed an ANDA and Lilly responded with a complaint in the Southern District of Indiana.  After a bench trial, the district court agreed with Lilly that the patent was valid, infringed, and enforceable.  The defendants appealed to the Court of Appeals of the Federal Circuit.

Anticipation: To anticipate the invention, a prior art reference “must disclose each and every feature of the claimed invention, either explicitly or inherently.”  However, in both Petering and Schaumann, prior art references that disclosed the family of the claimed compound were found to anticipate the claimed compound — even though the claimed compounds were not specifically discussed.

Here, the CAFC found that those cases were not applicable because the closest reference to olanzapine did not spell out “a definite and limited class of compounds that enabled a person of ordinary skill in the art to at once envisage each member in this limited class.”

Obviousness: The CAFC agreed that the prior art references did not suggest a the compound. In addition, Lilly provided strong evidence of secondary considerations, including: “(1) a long-felt and unmet need; (2) failure of others; (3) industry acclaim; and (4) unexpected results.”

The record shows a long-felt need for a safer, less toxic, and more effective clozapine-like drug; a decade (or more) of failure to find a replacement for clozapine; a reasonable amount of commercial success for olanzapine; and a number of awards for olanzapine as indicators of industry acclaim.

Public Use: Prior to filing the patent application, Lilly conducted Phase I clinical safety trials. The court found, however, that the trials were well within the experimental use exception:

In this case, Lilly tailored its tests to their experimental drug safety and efficacy purpose, adequately monitored for results, and maintained confidentiality throughout the duration of the study. The trial court did not err in finding no public use.