Patent Law Blog (Patently-O)

Ariad v. Lilly: Federal Circuit Grants En Banc Request to Challenge Written Description Requirement

Ariad Pharmaceuticals, MIT, and Harvard v. Eli Lilly (Fed. Cir. 2009) (en banc)

The Federal Circuit has granted Ariad's motion for an en banc rehearing of its case. The motion boldly asks whether the written description requirement should be eliminated as a doctrine that is separate and distinct from enablement. The questions:

a. Whether 35 U.S.C. � 112, paragraph 1, contains a written description requirement separate from an enablement requirement? and

b. If a separate written description requirement is set forth in the statute, what is the scope and purpose of the requirement?

Ariad's brief is due within 45 days, and Lilly's brief is then due within thirty days of that.

Briefs of amici curiae will be entertained, and any such amicus briefs may be filed without leave of court but otherwise must comply with Federal Rule of Appellate Procedure 29 and Federal Circuit Rule 29. The United States is invited to submit an amicus brief.

Value of Amicus Briefs: In its recent Cardiac Pacemaker decision, the Federal Circuit expressly indicated that it was "appreciative of these [amicus] contributions." To make one particular point in the decision, the court emphasized that Cardiac's extreme position was "not even supported by the lone amicus brief we have received in favor of including method patents within Section 271(f)'s reach."

Although the written description requirement is primarily raised in pharmaceutical and biotechnology cases, it is an increasing aspect of software patent litigation. This decision could have a significant impact both on how patents are litigated and on how they are prosecuted. The inventors here discovered an important biochemical pathway and broadly claimed uses of that pathway.

Notes:

• Written Description: Araid Petitions en banc Federal Circuit to Eliminate Separate Written Description Requirement
• Written Description: Pioneering Claims Require More Expansive Written Description
• See Chris Holman's blog for more [Link]
• Other News: Today the court also lifted its stay of en banc proceedings in the Tafas v. Dudas case. Briefs are due in October. However, it is widely expected that PTO Director Kappos will end the litigation by giving up on implementation of the proposed rules.

Written Description: Araid Petitions en banc Federal Circuit to Eliminate Separate Written Description Requirement

Ariad v. Eli Lilly (en banc suggestion 2009)

Ariad has petitioned the Federal Circuit for an en banc rehearing - boldly asking the court to eliminate the written description test as a distinct requirement of patentability under 35 USC Section 112, paragraph 1. The petition - drafted by Professors Duffy and Whealan - is essentially a well-formed collage of quotations from Federal Circuit dissents and 19th Century Supreme Court decisions.

The petition raises the following two questions:

(1) Whether this Court has erred by "engrafting . . . a separate written description requirement onto section 112, paragraph 1 .... " Ariad Pharms., Inc. v. Eli Lilly & Co., 560 F.3d 1366, 1380 (Fed. Cir. 2009) (Linn, J., concurring).

(2) What is the proper test to satisfy the requirement in Section 112, paragraph 1, that a patent specification contain "a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same"?

Apart from the merits of this case, the brief notes that half of the Federal Circuit judges "have either voted to grant en banc review of this Court’s written description jurisprudence (Newman, Rader, Bryson, Gajarsa, and Linn, JJ.), or have expressly noted that future en banc review may be appropriate because this Court’s written description standards are unsatisfactory. (Dyk, J.).

Notes:

• Ariad Brief: ariadrehearingpetition.pdf
• Federal Circuit Decision
• The original opinion was written by Judge Moore and joined by Judge Prost. Judge Linn wrote a concurring opinion as a reminder of his belief that the written description requirement should be eliminated and enablement be allowed to do its job.
• Patent Docs has more.

Pointing Out the Problem to be Solved or Objects of the Invention

Revolution Eyewear v. Aspex Eyewear (Fed. Cir. 2009) 08-1267.pdf [UPDATED 5/7/09 – To correct a mix-up of parties]

The patents at issue in this litigation focus on eyeglasses configured to be fitted with a second set of sunglass lenses using magnets. Magnetic auxiliary frames were already in the prior art, but the apparent advance is that the magnets are located in projections rather than embedded in the frames -- thus allowing for a stronger magnetic bond. The patent also identified a second deficiency in the prior art: insufficient "stability support."

The district court held that Revolution infringes claim 22 of Patent No. RE37,545.

On appeal, Revolution argued that that the claim was invalid -- raising three separate arguments: (1) failure of written description under Section 112 ¶ 1 because the apparatus as claimed does not address both deficiencies in the prior art; (2) failure to claim the "original" invention in the reissued patent under Section 251; and (3) improper expansion of claim scope in the reissue application under the recapture rule. The Federal Circuit rejected each of these invalidity arguments.

Written Description: The written description requirement is often raised when the issued claims are different than those originally filed. New claims must find support in the original specification in a way that "convey[s] with reasonable clarity to those skilled in the art that, as of the filing date sought, [the inventor] was in possession of the [claimed] invention."

Revolution admits that all of the claimed elements are found in the original drawings. Of course, that is not conclusive for written description. Rather, in cases such as LizardTech and Liebel-Flarsheim, the Federal Circuit found claims invalid even though all the explicitly claimed limitations and arrangements were originally disclosed. The problem with the claims in those cases was that they did not include enough limits.

The invalidity argument in this case is actually more akin to Gentry Gallery. Here, Revolution argues that the patent is invalid because the claimed apparatus does not address both of the stated functions of the invention. The Federal Circuit found that argument lacked legal grounding: "when the specification sets out two different problems present in the prior art, it is unnecessary for each and every claim in the patent to address both problems." Of course, the negative implication of the court's statement is that the claim must address at least one of the stated problems. "Inventors can frame their claims to address one problem or several, and the written description requirement will be satisfied as to each claim as long as the description conveys that the inventor was in possession of the invention recited in that claim." In this case, the claim addressed the magnetic strength problem - and thus satisfied the written description requirement.

Claiming the Same Invention: 35 USC Section 251 focuses on requirements of reissue applications. Under the statute, a reissued patent must be for the same "invention disclosed in the original patent." Here, the Federal CIrcuit found that this requirement is "analogous to the written description requirement." "Because we have held that the written description requirement is satisfied, we similarly hold that claim 22 complies with § 251."

Recapture Rule in Reissue Patents: Reissue patents are intended to correct errors in the originally issued patents. Courts have created the recapture doctrine which would exclude certain intentional acts from the list of correctable 'errors.' In particular, under the recapture rule, an intentional and deliberate act of narrowing claims or disclaimer of claim scope in order move the patent application toward issuance will not be considered an "error" under Section 251. Akin to prosecution history estoppel, "the recapture rule is aimed at ensuring that the public can rely on a patentee's admission during prosecution of an original patent." On appeal, the Federal Circuit could find no admission or disclaimer being recaptured.

Affirmed.

Notes:

• Pointing out deficiencies in the prior art: Most patent attorneys no longer discuss the prior art in the patent application because of the potential problems raised by this and other cases. Almost as an aside, this case also notes that by "pointing out the two deficiencies in the prior art, [the inventor] disclaimed an auxiliary frame that is not stably supported in top-mounting configuration and a primary frame that has embedded magnetic members."

The Essential Element Test and ICU Medical

In discussing the recent ICU Medical case, I noted that Judge Moore's decision did not rely on the "essential element" test or even cite Gentry Gallery. In Gentry Gallery, the patent covered a sectional recliner. During prosecution, the patentee had amended its claims to drop any reference to the location of the recliner controls. The Federal Circuit held those later-drafted claims invalid because the location of the controls was an "essential element" of the invention that must be included in the claims – otherwise, the claim scope would be unduly broad. Following Gentry Gallery, however, the Federal Circuit stepped-back from the essential element language– instead narrowing the case holding to the well trod notion that claims should be limited to the supporting disclosure. In both Johnson Worldwide, and Cooper Cameron, for instance, the Federal Circuit explicitly denied that Gentry Gallery created any new requirement.

"[W]e did not announce a new 'essential element' test mandating an inquiry into what an inventor considers to be essential to his invention and requiring that the claims incorporate those elements." Cooper Cameron, 291 F.3d 1317 (Fed. Cir. 2002)

In parallel fashion to Gentry Gallery, ICU had included a "spike" in every embodiment and each original claim. During prosecution, and apparently after seeing competing products, ICU amended its claims to drop the "spike" limitation. This was important because the market had moved to a spikeless version of IV valves. This district court in ICU discussed Gentry Gallery and the essential element test, but found no need to base its ruling on that "disfavored" theory. Rather, the court based its analysis on the traditional notion that claims must be described in the specification.

"[T]he Court's analysis employs the accepted rule that the claims may be no broader than the supporting disclosure, or, conversely, that claims are invalid when the entirety of the specification clearly indicates that the invention is of a much narrower scope. By focusing on the language of the Common Specification in a manner that highlights the function of the "spike" element, and the frequency and ubiquity with which it is referenced, the Court is only attempting to discern the breadth and substance of the invention ICU actually disclosed in the original 1992 Application."

Although the district court denied its application of any "essential element" test, it went on to hold that any valid claims must include a spike:

"The pervasiveness of the "spike" element in the invention description clearly informs the Court, and would inform any reasonable juror, that what was disclosed and claimed as the invention in the 1992 Application was a needleless medical valve with at a minimum, a "body," a "seal" and a "spike.""

Likewise, the Federal Circuit's version denies an omitted element test, but held that any valid claim must include a spike limitation because "a person of skill in the art would not understand the inventor ... to have invented a spikeless medical valve."

Notes:

• ICU Medical Part I
• ICU Medical Part II
• ICU Medical Part III
• The essential element and omitted element test are largely interchangeable, although some logical distinction could perhaps be made.

Written Description: Federal Circuit Again Invalidates Broadened Claims

ICU Medical v. Alaris Medical System (Fed. Cir. 2009)

This is the second post on the ICU case. Part I discusses the $4.6 million award of attorney fees to the accused infringer based on the patentee's litigation misconduct.

The district court found several of ICU's claims invalid for lack of written description under 35 U.S.C. § 112, ¶ 1. On appeal, the Federal Circuit affirmed. (Judges Michel (CJ), Prost, and Moore; Opinion by Moore). Although similar to enablement, the written description requirement pushes an applicant to "convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention." Most often, written description arises in cases where new matter is added to the claims during prosecution. That is also the case here - during prosecution ICU amended its claims to include "spikeless" claims -- directed to a valve mechanism for adding drugs to an IV without using needles.

To be clear - the original claims included the "spike." That element was removed during prosecution - seemingly broadening the claims. As the court stated "we refer to these claims as spikeless not because they exclude the preferred embodiment of a valve with a spike but rather because these claims do not include a spike limitation—i.e., they do not require a spike." It is that failure to include any discussion of a spike in the claim that lead to the claim being held invalid for lack of written description.

The Federal Circuit does not cite Gentry Gallery or the infamous "omitted element" or "essential element" theories. However, the court does rely heavily on LizardTech. In that case, the court did not point to any claim limitation that was not sufficiently described. Rather, the court found the claim invalid because an embodiment arguably covered by the claim was not sufficiently disclosed.

We addressed a similar issue in LizardTech . . . We explained that "the specification provides only one method for creating a seamless DWT, which is to 'maintain updated sums' of DWT coefficients. That is the procedure recited by claim 1. Yet claim 21 is broader than claim 1 because it lacks the 'maintain updated sums' limitation." We determined, however, that "[a]fter reading the patent, a person of skill in the art would not understand how to make a seamless DWT generically and would not understand LizardTech to have invented a method for making a seamless DWT, except by 'maintaining updat[ed] sums of DWT coefficients.'" We therefore concluded that claim 21 was invalid under the written description requirement of § 112, ¶ 1.

In LizardTech, the court explicitly rejected the argument that the written description requirement "requires only that each individual step in a claimed process be described adequately."

In this case, ICU's original disclosure focused on spiked embodiments, but the more generic claims are not so limited.

ICU's asserted spikeless claims are broader than its asserted spike claims because they do not include a spike limitation; these spikeless claims thus refer to medical valves generically—covering those valves that operate with a spike and those that operate without a spike. But the specification describes only medical valves with spikes.

Since all the embodiments included the "spike," the court concluded that "Based on this disclosure, a person of skill in the art would not understand the inventor ... to have invented a spikeless medical valve."

Invalidity affirmed

Notes:

• This case also includes an important discussion of claim differentiation that will be dissected in a later post.  
• Of course, this case suggests the best patent drafting practice of providing multiple embodiments of each claim element, and considering whether each and every limitation in the broadest original claims are necessary.
• ICU broadened its claim by dropping a limitation -- did ICU introduce new matter?
• In a powerful rhetorical approach, Judge Moore chose to refer to the broad claims as "spikeless claims." As mentioned, those claims do not include a "spikeless" limitation. Rather, they simply omit a "spike" element. As it turns out more than 99.9% all patent claims issued in 2008 are silent about "spikes," and under the traditional interpretation of the "comprising" transition - all those claims would literally cover embodiments without spikes. The holding here cannot be that all those claims are invalid. I believe that the holding here is largely a result of the fact that the accused device was in-fact spikeless. Unfortunately, this decision does not provide helpful guidance as to when it will apply. Rather, it appears to simply be an additional vague tool available to defense attorneys.
• The court did not mention enablement - since it was easy to remove the needle from a syringe and the disclosure includes a preslit seal that could arguably work with a spikeless syringe. That modification would have been enabled based on the original disclosure.

Written Description: Single Embodiment Insufficient

This decision is nothing new. Broad claims must either be supported by multiple embodiments or some general principles describing how the single embodiment is applicable to other configurations. Failing that, a broad claim may fail the enablement prong. As seen here, even when enabled, a broad claim without sufficient support will be invalid under the written description requirement.

In re Alonso (Fed. Cir. 2008)

The PTO Board of Appeals (BPAI) rejected claim 92 of Kenneth Alonso's for failing the written description requirement of Section 112. "To satisfy this requirement, the specification must describe the invention in sufficient detail so that one skilled in the art can clearly conclude that the inventor invented the claimed invention as of the filing date sought." (quoting case). In an opinion written by Judge Stearns (D.M.A.) sitting by designation, the Federal Circuit affirmed.

Claim 92 of the Alonso patent application claims a "method of treating neurofibrosarcoma in a human by administering an effective amount" of an idiotypic monoclonal antibody (mAb) secreted in a human-human cell hybridoma.

In his application, Alonso only described the preparation of a single mAb, but claimed essentially all Mab's that bind to neurofibrosarcoma, and the PTO found that a "skilled artisan would reasonably conclude that applicant was clearly not in possession of the claimed genus of compounds. Applicant should direct the claim language toward the only described embodiment (e.g., a mAb produced by hybridoma HB983)."

Standard of Review: The PTO's factual determinations are reviewed for "substantial evidence." Thus, the Federal Circuit will affirm when "a reasonable mind might accept [the evidence] as adequate to support a conclusion." Even if the Federal Circuit might ultimately have seen the facts differently, it will affirm if the PTO's position is reasonable.

Predictability: The Federal Circuit acknowledged that disclosure of a single embodiment can be sufficient for a broader genus claim. However, more disclosure is necessary when the composition and effectiveness of members of the genus is heterogeneous or unpredictable.

We have previously held in a similar context that "a patentee of a biotechnological invention cannot necessarily claim a genus after only describing a limited number of species because there may be unpredictability in the results obtained from species other than those specifically enumerated." Noelle v. Lederman, 355 F.3d 1343, 1350 (Fed. Cir. 2004).

Alonso argued that his single embodiment should be given more weight because he had actually reduced it to practice (unlike the Rochester COX-2 case). The Federal Circuit rejected that argument because Alonso had not provided the necessary predictive information – "nothing about the structure, epitope characterization, binding affinity, specificity, or pharmacological properties common to the large family of antibodies implicated by the method."

Notes:

• The court gives the following justification for the written description requirement: "The requirement 'serves a teaching function, as a quid pro quo in which the public is given meaningful disclosure in exchange for being excluded from practicing the invention for a limited period of time.'" quoting Univ. of Rochester, 358 F.3d 916 (Fed. Cir. 2004) (in turn quoting Enzo Biochem, 323 F.3d 956 (Fed. Cir. 2002)).
• In his 2005 book on Electronic and Software Patents, Steve Lundberg, et al. include the understatement: "The purpose of the written description requirement has been in flux recently."

Prior Art Must Enable a Skilled Artisan to Make the Invention without Undue Experimentation

Impax Labs v. Aventis Pharmaceuticals (Fed. Cir. 2008)

This appeal focuses on the question of when a prior art disclosure is sufficiently enabled.

An Aventis patent covers the use of RILUTEK (riluzole) to treat ALS. Impax filed an ANDA with the FDA (seeking to market a generic version of the drug). In subsequent litigation, Impax also alleged, inter alia, that the listed patent should be held invalid. In particular, Impax argued that an earlier Aventis patent (the '940 patent) anticipates the asserted Aventis patent (the '814 patent) by suggesting a class of compounds may be used to treat ALS. The district court, however found that the '940 patent "does not enable a person of ordinary skill in the art to treat ALS with riluzole and therefore does not anticipate claims 1-5 of the '814 patent."

Burden particularly heavy: A defendant who hopes to use previously considered art to invalidate a patent has a "particularly heavy" burden.

Thus, a party challenging patent validity has the burden to prove its case with clear and convincing evidence. When the examiner considered the asserted prior art and basis for the validity challenge during patent prosecution, that burden becomes particularly heavy. See Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1467 (Fed. Cir. 1990).

In this case, the '940 patent had been considered by the examiner during prosecution of the asserted patent.

Enabled Prior Art: To anticipate, the prior art must be enabling – i.e., it must "enable one of ordinary skill in the art to make the invention without undue experimentation."  This enablement standard is different from the applicant's 112 enablement requirement which requires enablement of both making and using the invention.  That distinction becomes lost in cases like this, however, where the patent covers a method of treatment.  Here, the Federal Circuit appears to require anticipatory prior art to enable practicing the claimed method.

Enablement of prior art is a question of law, but is based on underlying factual findings. In close cases, the important factual finding is the amount of experimentation that would have been necessary. Applying Wands factors, the Federal Circuit agreed that the prior reference was not enabling.

As shown by the trial court, the [prior art] '940 patent's dosage guidelines are broad and general without sufficient direction or guidance to prescribe a treatment regimen. The alleged prior art also contains no working examples. Finally, nothing in the '940 patent would have led one of skill in the art to identify riluzole as a treatment for ALS. In sum, each component of the claimed invention—identifying riluzole as a treatment for ALS and devising dosage parameters—would require undue experimentation based on the teachings of the '940 patent.

Burden of Proving Enabled Prior Art: In judging anticipation, courts generally presume that prior art is enabled. That presumption may be overcome by a patentee by providing "persuasive evidence" of nonenablement. At that point, the ultimate burden of proof (with clear and convincing evidence) lies with the accused infringer. In this case, the district court did not explicitly follow this burden shifting framework. On appeal, the Federal Circuit held that articulation of the rule was not necessary. The burden was properly shifted because Aventis presented "sufficient evidence to overcome the presumption of enablement."

Holding: Affirmed. Validity challenge defeated because prior art was not enabled.

Notes:

• The opinion did not focus on timing: As technology develops more and more prior art references become enabled. Thus, it is important to consider at what point in time the reference must be enabling.

Disclosure: My former colleagues at MBHB represent Aventis in this case. The district court case was ongoing while I was there.

CAFC Applies Lilly to Invalidate Carnegie Mellon’s Plasmid Claims

Carnegie Mellon University v. Hoffman-La Roche (Fed. Cir. 2008)

Carnegie Mellon's patents cover recombinant plasmids used to enhance expression of an DNA polymerase. On appeal, the CAFC affirmed the lower court holding that the patent claims fail to meet the written description requirement under Lilly.

35 U.S.C. §112 requires that the patent document "contain a written description of the invention and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.

The written description requirement is used to make sure that the patentee only claims what has been invented. The public gets a "meaningful disclosure in exchange for being excluded from practicing the invention for a limited period of time." Quoting Enzo Biochem (Fed. Cir. 2002).

A common written description argument is that the claims have not been disclosed to their full scope. In the Lilly case, for instance, the CAFC found that a generic claim directed to "any vertebrate and mammalian cDNA" were not supported by a specification that only discussed one species – rat cDNA.

To be clear, written description is not about enablement. Patent claims may well be enabled based on PHOSITA's knowledge of the art, but still fail the written description requirement because the patentee did not disclose the entire scope of its invention.

A representative claim from Carnegie's patents reads as follows:

1. A recombinant plasmid containing a cloned complete structural gene coding region isolated from a bacterial source for the expression of DNA polymerase I, under operable control of a conditionally controllable foreign promoter functionally linked to said structural gene coding region, said foreign promoter being functional to express said DNA polymerase I in a suitable bacterial or yeast host system.

In reviewing the claim, the CAFC noted that the DNA coding sequence is "broadly defined … only by its function of encoding DNA polymerase I" and that the claims are not limited to any particular bacterial or yeast species.

The specification only discloses one operative gene – the E. coli polA gene. And at the time of the patent, only three polA genes had been cloned (out of thousands of bacteria strains). "[W]ith regard to the promoter, the patents fail to disclose the nucleotide sequence or other descriptive features for a polA gene (including the promoter sequence) from any bacterial source other than E. coli."

"To satisfy the written description requirement in the case of a chemical or biotechnological genus, more than a statement of the genus is normally required. One must show that one has possession, as described in the application, of sufficient species to show that he or she invented and disclosed the totality of the genus. . . . [W]e conclude that that requirement was not met here.

Gentry Gallery: The district court also applied Gentry Gallery to invalidate other claims. In Gentry, the CAFC found a patent claim invalid because the claim failed to recite an "essential element" of the invention. Here, Roche argued that the patents were directed to avoiding the problem of lethality to host cells, but that the claims did not include that limitation. As it has done repeatedly, the CAFC rejected the idea that Gentry Gallery created an essential element test. (The claims remain invalid under the Lilly analysis.).

CAFC Continues to Expand Doctrine of Full Scope Enablement

Sitrick v. Dreamworks (Fed. Cir. 2008)

Sitrick’s patented invention involves a method for a integrating user-generated audio and visual effects into a video game or movie. The solo-inventor sued Dreamworks and other defendants who use the “ReVoice Studio” software to allow users to add their own voice to the imagery.  The issue on appeal is whether the asserted claims are enabled under 35 U.S.C. 112 ¶ 1.

Full Scope Enablement: Although loosely tied to the patent statute — the enablement requirement continues to grow and develop through Federal Circuit panel opinions.  Generally, the “requirement is satisfied when one skilled in the art, after reading the specification, could practice the claimed invention without undue experimentation."

When analyzing enablement, the court looks to ensure that the “full scope of the invention” is enabled — and thus looking beyond whether the particular accused design is enabled. The “full scope” doctrine has recently been applied by the Federal Circuit to invalidate several patents. (See below)

Broad Claim Narrow Disclosure: It is easy to criticize patentees who attempt to enforce broad claims supported only by a narrow disclosure. This is especially true in cases such as Liebel’s where the claim scope had been expanded well after filing the original application. (i.e., “late claiming”).

However, the “full scope” doctrine has serious deficiencies. The most notable are the potentially chaotic results from applying the doctrine to claims that include the comprising transition language.  The problem arises because the comprising transition allows a claim to implicitly encompass a wide variety of add on limitations that might be found in an infringing device. See, for example Automotive Technologies Int’l v. BMW (Fed. Cir. 2007) (claim scope that implicitly covered both mechanical and electrical sensor was not enabled by description of mechanical sensor); Liebel-Flarsheim v. Medrad (Fed. Cir. 2007) (claim scope that implicitly covered both jacketed and jacket-free needle holders was not enabled by description of jacketed needle holders).

Here, the asserted claims were construed as covering both movies and video games. Thus, the patent must enable both types of applications. Here, the CAFC confirmed that Sitrick had failed to enable its use in movies — and thus that the claims are not fully enabled.

• Buyer Beware: As with other recent enablement cases, this one may be best seen through the lens of the claim construction process. In each case, the patentee requested (or at least did not challenge) broad claim construction.  Consequently, the court was not sympathetic to enablement arguments that could have been avoided by a narrower construction of the claims. This line of thinking was spelled out by Judge Laurie in the Liebel case: “The irony of this situation is that Liebel successfully pressed to have its claims include a jacketless system, but, having won that battle, it then had to show that such a claim was fully enabled, a challenge it could not meet. The motto, “beware of what one asks for,” might be applicable here.”  This buyer beware theory is also useful to break the potential analytical morass of full scope enablement of claims drafted with comprising transitions. 
• Don’t Begin with the Specification: One aspect of enablement that is continually bothersome. In the opinion, the court noted that “enablement analysis begins with the disclosure in the specification.”  That approach unduly confuses enablement with written description. Rather, I would contend that enablement should begin with the knowledge of one skilled in the art and move forward from there.
• Johnson v. M’Intosh: In my property law class, we recently discussed Johnson v. M’Intosh and the doctrine of of sovereign authorized discovery of land. In those empire building years, we also saw over-zealous claiming.
• David Sitrick: The inventor, David Sitrick, is a Skokie based patent attorney registered with the firm of Sitrick & Sitrick. (Reg. No. 29349).  Mr. Sitrick prosecuted the patent himself. His son, Greg Sitrick, is an associate at the Bell Boyd firm in Chicago. (Reg. No. 57195).

Enablement: Claimed "surfactant" not enabled by three working examples

Par Pharmaceuticals v. Roxane Labs (Fed. Cir. 2007) (Nonprecedential)

Par’s megestrol acetate suspension is prescribed to people who lose their appetites — often during treatment for cancer or AIDS. Interestingly, the company created this popular drug while attempting to design around a megestrol patent owned by BMS.

After obtaining patent protection, Par sued Roxane for infringement. The district court, however, granted summary judgment of invalidity under 35 USC 112 ¶ 1 — finding that “Par is not entitled to the broad claims it asserts.”

Enablement analysis begins with the presumptions that an issued claim is enabled and that a challenge to enablement requires clear and convincing evidence.  Unlike its close analog written description, enablement is reviewed by the CAFC on a de novo basis.

A claim is enabled when a PHOSITA can make and use the claim without undue experimentation. Broader claims, of course, require broader disclosure to ensure that their “full scope” is enabled. The unpredictable nature of an area of technology often serves patentees well as they argue non-obviousness. (It cannot be obvious if the results could not have been predicted). However, the enablement requirement demands more disclosure for unpredictable arts.

Broad Claims: Here, Par’s claim includes the following elements: “(a) megestrol acetate; … and (c) a surfactant.”  The CAFC finds this claim very broad because it would “allow the choice of any surfactant in any concentration.” (emphasis in original). In its disclosure, Par described three working examples and only one new surfactant. As a matter of law, the CAFC found that “these three working examples do not provide an enabling disclosure commensurate with the entire scope of the claims.”

Notes:

• This opinion, drafted by Judge Moore may begin to provide some indication of her style.
• Does this make sense: Because the applicant broadly claimed “a surfactant,” the specification must enable various types of surfactants. If, the claim had been written even more broadly — by eliminating that limitation — there would have been no need to include a description of various types of surfactants.

Extending Liebel-Flarsheim: "distinctly different" embodiment of claim elements must be enabled

Automotive Technologies International v. BMW, et al. (Fed. Cir. 2007).

ATI’s patent claims are directed to an automotive side impact crash sensor used to trigger an airbag and include the following means-plus-function limitation:

“means responsive to the motion of said mass upon acceleration of said housing in excess of a predetermined threshold value, for initiating an occupant protection apparatus”

Following ATI’s suggestion, the district court construed the means limitation to include both mechanical and electronic sensor structures. Then, based on this interpretation, the district court ruled the patent invalid for lack of enablement. (summary judgment).  

On appeal, the CAFC affirmed the ruling — finding that the specification did not enable the full scope of the claimed invention.

The specification describes the mechanical sensor in detail with multiple figures. The electronic sensor, however, is only shown in a sparse “conceptual” Figure 11 (see image at right) and described in broad terms as potentially operating “through variety of technologies using, for example, optics, resistance change, capacitance change or magnetic reluctance change.”

Enabling One Embodiment Is Insufficient: Following on the heels of Liebel-Flarsheim v. Medrad, this case reaffirms the principle that the full scope of a claim must be enabled. Enablement of a single embodiment is not sufficient. Thus, the patent’s enablement of one mode of practicing the invention (the mechanical sensor) was not sufficient to satisfy the enablement requirement.

Looking back, Liebel-Flarsheim discussed “full scope” enablement as being “at least reasonable enablement of the scope of the [claim] range.” Here, the CAFC further defines that principle by noting that electronic sensors must be particularly enabled because they are “distinctly different” from the enabled mechanical sensor.

Novel Aspects Must Be Enabled: ATI also argued that Figure 11 and its accompanying text were enabling — especially when coupled with the knowledge of one having ordinary skill in the art. This argument was rejected based on the CAFC’s combined measure of law and fact. As a matter of law, enablement of the novel aspects of an invention must be enabled by the specification even if implementation would have been within the PHOSITA’s skill level. As a matter of fact, the CAFC concluded that sensor mechanism must be a novel aspect based on statements in the specification that side impact sensing is a “new field” and that the only available side-impact switch was a crush sensor.

Notes:

• Its unclear how the enablement doctrine will work in conjunction with the doctrine of equivalents.
• The summary judgment was reviewed de novo for clear and convincing evidence of non-enablement sufficient to overcome the patent’s presumption of validity.
• Disclaimer: My former firm, McDonnell Boehnen Hulbert & Berghoff LLP, handled this appeal on behalf of the plaintiff. Although I have not worked on the case, MBHB took-over the case while I was of counsel last year.

The New Law of Enablement

Liebel-Flarsheim v. Medrad (Fed. Cir. 2007).

This case raises an interesting enablement issue. The issue involves how we should interpret patent claims that extend coverege over material that is not enabled.  This is an important question because most patent claims are written to literally cover embodiments that are not fully enabled. 

Facts: Liebel-Flarsheim's patent describes a preferred embodiment of a needle holder that includes an associated pressure jacket but do not enable a jacket-free embodiment.  The patent claims did not claim (or even mention) the pressure jacket and thus, based on comprising language, were construed to cover injectors regardless of whether they have an associated pressure jacket.  Medrad's accused products do not have the pressure jacket.

Lower Court: The lower court found the patent invalid as not enabled -- holding that it would have taken undue experimentation to practice the claimed invention without the pressure jacket.

Argument on Appeal: Liebel argues that "the asserted claims do not recite or require the absence of a pressure jacket and the court improperly focused on such an embodiment."  In particular, the question of creating an embodiment without a pressure jacket is not one of "experimentation" but rather additional follow-on innovation.

Appellate Decision: On appeal, CAFC panel found the patent invalid as not enabled.

We have previously construed the claims ... such that they are not limited to an injector with a pressure jacket, and therefore the full scope of the claimed inventions includes injectors with and without a pressure jacket. That full scope must be enabled, and the district court was correct that it was not enabled.

...

There must be “reasonable enablement of the scope of the range” which, in this case, includes both injector systems with and without a pressure jacket.

...

The irony of this situation is that Liebel successfully pressed to have its claims include a jacketless system, but, having won that battle, it then had to show that such a claim was fully enabled, a challenge it could not meet. The motto, “beware of what one asks for,” might be applicable here.

Invalidity affirmed.

Notes:

• "During the prosecution of the front-loading patents, Liebel removed all references in the claims to a pressure jacket."