Source: https://patentlyo.com/patent/enablement
Timestamp: 2019-04-21 18:08:17+00:00

Document:
[t]hereby reducing the wind and storm surge of the eye wall or raising the pressure in the eye or center of lowest pressure and converting it back to a tropical rainstorm.
[The patent must disclose] 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.
The breadth of the claims.
And perhaps most significantly, the very efficacy of the method itself is subject to considerable doubt in the scientific community.
In other words, the enablement burden is more difficult to meet when the invention is surprising or when it goes against conventional wisdom. Of course, those same inventions will more easily surpass the central patentability test of non-obviousness. My point here, though, is that patentees with clearly groundbreaking inventions should take extra pause to ensure that the surprising result has been properly enabled.
Summary: In a 6-2-1 en banc decision, the Federal Circuit has reversed its prior precedent and held that a patent applicant must be allowed to introduce new evidence in a Section 145 civil action filed to challenge a USPTO refusal to grant patent rights and that the issues implicated by the new facts must be considered de novo.
[W]e hold that the only limitations on the admissibility of evidence applicable to a § 145 proceeding are the limitations imposed by the Federal Rules of Evidence and Federal Rules of Civil Procedure. Therefore, we hold that the district court applied the wrong legal standard for the admissibility of evidence in a § 145 proceeding and abused its discretion when it excluded Mr. Hyatt's declaration. . . .
The particular significance of a § 145 civil action is that it affords an applicant the opportunity to introduce new evidence after the close of the administra-tive proceedings—and once an applicant introduces new evidence on an issue, the district court reviews that issue de novo.
However, the Court also wrote that an applicant may still be barred from presenting new "issues" in the civil action and that, when no new evidence is presented, that BPAI findings and rulings should be given deference under the Administrative Procedures Act.
Impact: This decision could be seen as relieving some pressure on applicants to ensure that their cases for patentability are exhaustively presented to the USPTO's internal Board of Patent Appeals and Interferences (BPAI). The decision is especially important in light of the growing role of BPAI appeals in the ordinary course of patent prosecution. In its argument, the USPTO suggests that a strategic applicant may now choose hold-back some evidence from the BPAI appeal in order to overcome the APA deference if the case goes to the District Court.
Statute in Question: 35 U.S.C. § 145 creates a right to a "civil action" in Federal District Court against the USPTO Director whenever an applicant is "dissatisfied with the decision of the Board of Patent Appeals and Interferences in an appeal under section 134(a)." In the alternative, an applicant may appeal directly to the Court of Appeals for the Federal Circuit.
Background: Gil Hyatt is a well-known inventor and successful patentee. Hyatt filed a civil action in 2003 after the BPAI sustained written description and enablement rejections for seventy-nine of Hyatt's claims. The examiner had issued "2546 separate rejections of Mr. Hyatt's 117 claims" based on the doctrines of inadequate "written description, lack of enablement, double patenting, anticipation, and obviousness." The Board reversed all of the examiner rejections except for the § 112 p1 arguments. Complicating this case is the fact that the application's claimed priority date is 1975. Hyatt has aggressively pushed the bounds of USPTO practice. This decision is one of more than a dozen Federal Circuit decisions focusing on Hyatt's patent rights. When California pursued Hyatt for tax revenue for his patent licenses, Hyatt took the case to the Supreme Court and eventually won a $388 million judgment against the state of California for invasion of privacy.
After the Board affirmed a set of written description and enablement rejections, Hyatt filed a Section 145 civil action and included a declaration offering new evidence of enablement and written description. The district court excluded that inventor-declaration from evidence based on Hyatt's "negligence" in failing to previously submit the information to the PTO. In a 2009 panel decision, the Federal Circuit held that the district court had properly excluded the new evidence – holding that the district court may properly exclude evidence that Hyatt should have produced to the PTO. That opinion was penned by former Chief Judge Michel and Joined by Judge Dyk. Judge Moore wrote a vigorous dissent that supported a patent applicant's right to a full civil action including the right to submit additional evidence when challenging a PTO decision.
Judge Moore wrote the en banc decision that was joined by Chief Judge Rader and Judges Lourie, Bryson, Linn, and Prost. Judge Dyk dissented and was joined by Judge Gajarsa. Judge Newman Concurred-in-Part – arguing that the civil action should not give deference to PTO factual determinations.
A key to the majority decision is the notion that a Section 145 civil action is not an appeal, but rather a new, separate lawsuit filed to force the PTO to act. In its analysis, the court began with a focus on the 150-year history of the civil action right (and its predecessor Bill in Equity) and the reality that new evidence has always a part of those remedies. See, e.g., Gandy v. Marble, 122 U.S. 432 (1887) (explaining that the [predecessor] § 4915 suit in equity was "not a technical appeal from the Patent Office, nor confined to the case as made in the record on that office"). The court then reviewed the current text of the statute, implications of the APA, and various policy arguments before reaching its conclusions.
In a 37-page dissent, Judge Dyk argued that the majority made an improper leap from (1) the correct premise that new evidence should be admissible in the civil action to (2) the incorrect conclusion that the law provides no meaningful limits on the introduction of new evidence regardless of what was presented at the BPAI.
Appellate specialist Aaron Panner argued the case on behalf of Hyatt. The USPTO's case was argued by Beth Brinkman of the DOJ. In the original panel, the late Ken Bass has argued for Hyatt and Bill Jenks for the Government. Michael L. Martinez represented Hyatt in the civil action.
The district court rejected LMA’s patent on summary judgment — holding that the claims covering a laryngeal mask device were invalid for lack of written description.
The written description issues here are similar to those presented in Liebel-Flarsheim and Lizard Tech. The patented invention included both (1) a “cuff” with a “thicker and stiffer” region and (2) a “backplate.” The described embodiments all showed the thick-stiff region of the cuff connected to the backplate, but the accused device’s cuff-backplate connection was in a different location. The claims themselves did not expressly limit the connection-site with reference to the thick-stiff region and therefore arguably covered the accused device. Given that broad construction of the claims (as requested by the patentee), the district court held the patent invalid on written description grounds because the patent document failed to describe or show possession of the invention as embodied by the accused device.
On appeal, the Federal Circuit panel of Chief Judge Rader, Judge Lourie, and Judge Moore rejected the district court’s findings — holding instead that the factual question of written description should be left for the jury in this case.
Rather than focusing on affirmative evidence of possession, the Federal Circuit highlighted that nothing in the specification suggested that that design of the connection between the cuff and backplate was important or necessary to the invention.
Because those factual conclusions raised issues of material fact, the appellate panel reversed the summary judgment holding and remanded.
The Court’s approach implicitly presumes that the asserted patent satisfies the written description requirement and then looks to see whether the evidence is sufficient to overcome that presumption. That method of analysis makes sense based on the procedural setup of the case: Namely, (1) clear and convincing evidence is required to prove that the patent lacks written description; (2) the decision being reviewed was one of summary judgment; and (3) written description is a question of fact.
The court also reversed a claim construction holding that had led to summary judgment of non-infringement.
The asserted claims were all added during prosecution. The original claims required that the backplate be “hermetically bonded to a periphery of the main-cuff” and the new claims have a seemingly broader requirement that the backplate be “attached” to the cuff. The original claim appears broad enough to cover the link as embodied in the accused device.
Transocean brought suit against Maersk for infringement of three patents relating to an improved apparatus for offshore drilling. Offshore drilling involves lowering a variety of equipment, including the drill bit, a series of long pipes, and a blow-out-preventor, to the ocean floor in order to drill and stabilize a borehole that reaches a subterranean oil reservoir. These components are moved by a derrick (the tower on the picture to the right), which is equipped with a station that raises and lowers them to the ocean floor. To begin the drilling process, the rig lowers the drill bit to the ocean floor, adding sections of pipe until the bit reaches the floor. Periodically as the drill descends into the seabed, it must be brought back up to the surface so that casings can be inserted into the borehole. Conventional rigs utilized a derrick with only a single station for performing these steps, thus requiring that they be performed sequentially – a time consuming process.
The patents-in-suit describe a derrick that includes two stations – a main advancing station and an auxiliary advancing station – that can each assemble the strings of drilling materials and lower them to the ocean floor. According to the patent, this "dual-activity" rig can significantly decrease the time required to complete a borehole. The accused infringer, Maersk, contracted with a U.S. company to build a rig with two stations for use in the Gulf of Mexico. However, prior to delivery of the rig, Maersk implemented a modification that, it argued, precluded Transocean from claiming infringement. It also argued that the claims were invalid.
The district court granted summary judgment in favor of Maersk, holding that the asserted claims were obvious and not enabled. The court further ruled that Maersk's activities did not constitute either an offer for sale or a sale within the United States. Transocean appealed these rulings, along with the district court's grant of summary judgment of collateral estoppel and no willful infringement.
The Federal Circuit's obviousness ruling is notable because, although it found that the references cited by Maersk created a prima facie case of obviousness, it concluded that the district court had erred by ignoring Transocean's significant objective evidence of nonobviousness. This included evidence of industry skepticism about a dual drill string approach, industry praise for its dual activity rig, copying, and commercial success, in that its dual activity rigs commanded a higher licensing premium then standard rigs. Although Maersk presented counter evidence, the Federal Circuit concluded that it was improper to resolve these disputes on summary judgment.
The Federal Circuit also reversed the grant of summary judgment of lack of enablement, finding that factual issues precluded such a ruling. In particular, it noted that while the patent must enable one of ordinary skill in the art to practice the claimed invention without undue experimentation, it does not need to enable the most optimized configuration (unless it is an explicit part of the claims).
The district court's noninfringement ruling did not rest on a comparison of the accused device to the claim, but rather on a conclusion that there was no offer for sale or sale within the United States. Although the contract at issue was between two U.S. companies, and specified an "Operating Area" for the rig that was in U.S. territorial waters, it was negotiated and signed outside of the United States.
The Federal Circuit disagreed that these activities fell outside the scope of 35 U.S.C. 271(a). With respect to the "offer for sale" provision, after reviewing the legislative history of this language, analyzing its literal text, and considering the policy implications, the court concluded that it covered a contract between two U.S. companies for performance in the U.S., regardless of whether it was negotiated or signed within the U.S. Likewise, the court concluded that, because the contract was for the sale of a patented invention with delivery and performance in the U.S., it constituted a sale for purposes of 271(a) as a matter of law.
Note: Although the court used the term "patented invention," it was careful to note that there remained a dispute over whether the rig described in the contract actually infringed the patents-in-suit.
The Federal Circuit did, however, affirm the district court's ruling that Transocean was collaterally estopped from arguing that the rig Maersk ultimately delivered infringed the patents. In another litigation, Transocean had obtained by an injunction requiring the defendant GlobalStantaFe Corp. ("GSF") to make a particular modification to its rig in order to avoid infringing the patents-in-suit. Prior to delivering the rig to the United States, Maersk had learned about this injunction and made the relevant modification. The Federal Circuit concluded that the ruling in the GSF litigation estopped Transocean from arguing that rigs with the modification infringed its patents.
The panel also affirmed the district court's ruling of no willful infringement, concluding that Maersk's activities were insufficient to create an objectively high risk of infringement.
Essay Overview: In the pending case of Ariad v. Eli Lilly, an en banc Federal Circuit is considering whether Section 112 of the Patent Act as properly interpreted includes a written description requirement that is separate and distinct from the enablement requirement. Although the USPTO has no direct role in the infringement dispute, the government submitted an amicus curiae brief arguing that a separate written description requirement is “necessary to permit the USPTO to perform its basic examination function.” However, when pressed during oral arguments the government could not point to any direct evidence supporting its contention.
Although there may be valid reasons for retaining a separate written description requirement, this study safely leads to the conclusion that the government’s conclusory statements regarding the doctrine’s critical importance for patent examination lack a factual basis.
These results fit well with those of UMKC professor Christopher Holman that he reported in his 2007 article, Is Lilly Written Description a Paper Tiger?: A Comprehensive Assessment of the Impact of Eli Lilly and its Progeny in the Courts and PTO , 17 ALB. L.J. SCI. & TECH. 1, 62 (2007).
Board of Patent Appeals: Numbers are in for FY2009 (ending September 30, 2009). 15,349 appeals docketed; 6,757 appeals completed; 12,489 appeals pending at the end of the FY. The Board took heroic efforts to increase its throughput by over 35% in FY2009. However, the Board was already operating in a deficit and the number of cases received in FY2009 is more than double that of FY2008.
Board of Patent Appeals II: Despite the backlog, the Board reports an average pendency of only 7.7 months (calculated from assignment of appeal number to decision date).
Vestas is looking to hire an experienced in-house patent attorney in Houston.
Covidien is looking to hire an experienced in-house patent and trademark attorney in Boulder, Colorado.
Metabolix is looking to hire an experienced intellectual property manager in Lowell, Massachusetts with a focus on polymer science.
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.
(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.).
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.
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.
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.
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.
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.
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.
The essential element and omitted element test are largely interchangeable, although some logical distinction could perhaps be made.
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 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.
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.
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.
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.
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).
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)).
This appeal focuses on the question of when a prior art disclosure is sufficiently enabled.
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.
Holding: Affirmed. Validity challenge defeated because prior art was not enabled.
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.
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.
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.
“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.).
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.
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).
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.
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.
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.

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