Written Description Archives

Written Description

Enablement: Skilled artisan’s knowledge no substitute for adequate written description

by Jolie B. Schenerman | Oct 30, 2025 | Patents

The US Court of Appeals for the Federal Circuit affirmed the US International Trade Commission’s (Commission) decision that a water filtration patent was invalid for lack of written description and enablement because the scope of the asserted claim was not enabled by the patent’s specification. Brita LP v. International Trade Commission, Case No. 24-1098 (Fed. Cir. Oct. 15, 2025) (Prost, Reyna, Chen, JJ.)

Brita filed a complaint at the Commission alleging that Vestergaard Frandsen and Helen of Troy infringed its water filtering patent. The main dispute focused on the patent’s only independent claim, which in part recites a “gravity-fed water filter, comprising filter media including at least activated carbon and a lead scavenger” that achieves a “Filter Rate and Performance (FRAP) factor of about 350 or less.” The patent identifies several types of filter media, including carbon filters.

The administrative law judge (ALJ) construed the term “filter usage lifetime claimed by a manufacturer or seller of the filter” to mean “the total number of gallons of water that a manufacturer or seller has validated can be filtered before the filter is replaced.” Based on this construction, the ALJ issued an initial determination finding that the asserted claims met the written description and enablement requirements.

Brita sought review of the initial determination before the full Commission. On review, the Commission reversed the ALJ’s finding of a violation, concluding that the “filter usage” term was indefinite, the asserted claims lacked adequate written description, and the claims were not enabled with respect to non-carbon block filters. Brita appealed.

To satisfy the written description requirement, a patent must demonstrate that the inventor was in possession of the claimed invention at the time of filing. This means the specification must adequately support each claim. In this case, the Federal Circuit found that the specification only supported carbon block filters meeting the claimed FRAP factor, not the broader category of “filter media” as claimed. As a result, the Court found that the asserted claims failed the written description requirement.

The Federal Circuit emphasized that the patent specification failed to support the broad claim language because of its narrow focus on carbon block filters. Specifically, the specification:

Described only carbon blocks, with other filter media mentioned solely as tested examples for FRAP factor
Provided specific formulations for carbon blocks only
Illustrated only carbon block filters in the figures
Made clear distinctions between carbon blocks and other filter types.

The Federal Circuit found persuasive the inventor’s testimony that only carbon block filters were created to meet the FRAP factor.

The Federal Circuit also affirmed the Commission’s finding that the claims were invalid for lack of enablement. Under the Federal Circuit’s 1988 In re Wands decision, enablement requires that a person of ordinary skill in the art be able to make and use the invention without undue experimentation. The Court found no reversible error in the Commission’s conclusion that undue experimentation would be required for filters other than carbon blocks to meet the claimed FRAP factor. The [...]

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Specification controls: Written description must be clear

by Taylor MacDonald | Aug 21, 2025 | Patents

The US Court of Appeals for the Federal Circuit reversed a district court’s decision upholding patent validity, finding that the subject patent’s specification clearly established that the written description failed to adequately support the full scope of the asserted claims (35 U.S.C. § 112). Mondis Technology Ltd. v. LG Electronics Inc., Case Nos. 23-2117; -2116 (Fed. Cir. Aug. 8, 2025) (Taranto, Clevenger, Hughes, JJ.)

Mondis sued LG for alleged infringement of a patent related to computer display technology. During prosecution, Mondis amended the claims to overcome prior art, changing a limitation from identifying a particular display unit to identifying a type of display unit (the type limitation). A jury found in favor of Mondis and awarded $45 million in damages. LG moved for judgment as a matter of law (JMOL), arguing that the patent was invalid due to a lack of written description supporting the type limitation. The district court denied the motion but granted a retrial on damages. The second jury awarded more than $14 million. LG appealed.

The Federal Circuit applied regional law standard (here, Third Circuit law) to review the district court’s denial of JMOL (i.e., assessing whether a reasonable jury could have reached the verdict). In evaluating patent validity under the written description requirement of § 112, the Court focused on whether the specification sufficiently demonstrated that the inventor possessed the claimed invention, including any amendments made during prosecution.

The Federal Circuit examined whether substantial evidence supported the jury’s finding of validity and concluded that LG did not need extrinsic evidence to challenge the patent’s validity but properly relied on the specification. The Court found that Mondis’ attempt to piece together fragments of testimony (primarily related to infringement) to argue for implicit support in the specification was insufficient because the specification’s plain language supported only the original unamended claim limitation, not the amended type limitation.

The Federal Circuit acknowledged that both parties presented expert testimony at trial. However, the Court found that even Mondis’ expert testimony, when considered alongside the specification’s plain meaning, failed to provide adequate support for the jury’s finding. While a jury may infer implicit support, Mondis did not present enough particularized testimony to justify such an inference.

Mondis also argued that the examiner’s allowance of the amended claim indicated sufficient support in the specification, and that the presumption of validity of an issued patent supported its position. The Federal Circuit rejected this argument, noting that the examiner’s focus was on overcoming prior art, not on evaluating written descriptions. Accepting Mondis’ position would effectively shield most patents from later invalidation, a result the Court deemed impractical.

Accordingly, the Federal Circuit reversed the district court’s ruling and found the asserted claims invalid for lack of written description.

Take That Conception Out of the Oven – It’s CRISPR Even If the Cook Doesn’t Know

by Connor M. Larson | May 22, 2025 | America Invents Act, Patents

Addressing the distinction between conception and reduction to practice and the requirement for written description in the unpredictable arts, the US Court of Appeals for the Federal Circuit explained that proof of conception of an invention does not require that the inventor appreciated the invention at the time of conception. Knowledge that an invention is successful is only part of the case for reduction to practice. Regents of the Univ. of Cal. et al. v. Broad Inst. et al., Case No. 22-1594 (Fed. Cir. May 12, 2025) (Reyna, Hughes, Cunningham, JJ.)

The Regents of the University of California, the University of Vienna, and Emmanuelle Charpentier (collectively, Regents) and the Broad Institute, Massachusetts Institute of Technology, and the President and Fellows of Harvard College (collectively, Broad) were each separately involved in research concerning CRISPR systems that “are immune defense systems in prokaryotic cells that naturally edit DNA.” At issue was the invention of the use of CRISPR systems to modify the DNA in eukaryotic cells. Regents and Broad filed competing patent applications resulting in an interference proceeding under pre-AIA law at the US Patent & Trademark Office Board of Patent Appeals & Interferences to determine which applicant had priority to the invention.

The main issue before the Board was a priority dispute over who first conceived of the invention and sufficiently reduced it to practice under pre-AIA patent law. Regents submitted three provisional patent applications dated May 2012, October 2012, and January 2013 and moved to be accorded the benefit of the earliest filing date, May 2012, for the purpose of determining priority. Alternatively, Reagents sought to be accorded either October 2012 or January 2013 as its priority date. The Board found that Regents’ first and second provisional applications (filed in May and October 2012, respectively) were not a constructive reduction to practice because neither satisfied the written description requirement of 35 U.S.C. § 112. The third provisional application, filed in January 2013, was the first to amount to a constructive reduction to practice of the counts in interference. The Board then ruled that Broad was the senior party for the purposes of priority in the interference proceeding because Broad reduced the invention to practice by October 5, 2012, when a scientist submitted a manuscript to a journal publisher. The Board ruled that Regents failed to prove conception of the invention prior to Broad’s actual reduction to practice. Regents appealed.

Regents argued that in assessing conception, the Board “legally erred by requiring Regents’ scientist to know that their invention would work.” The Federal Circuit agreed and vacated the Board’s decision. As the Court explained, there are three stages to the inventive process: conception, reasonable diligence, and reduction to practice. At the conception stage, “an inventor need not know that his invention will work for conception to be complete.” Rather, knowledge that the invention will work, “necessarily, can rest only on an actual reduction to practice.” The Board therefore legally erred by requiring Regents to know its invention would work to prove [...]

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“Payment Handler”: A Nonce Term Without Instructions

by Jodi Benassi | May 8, 2025 | Patents

The US Court of Appeals for the Federal Circuit affirmed a district court’s ruling that a software term was a “nonce” term that invoked 35 U.S.C. § 112, sixth paragraph (i.e., a means-plus-function claim element). The Court further found that the patent specification did not recite sufficient corresponding structure, rendering the claim element indefinite. Fintiv, Inc. v. PayPal Holdings, Inc., Case No. 23-2312 (Fed. Cir. Apr. 30, 2025) (Prost, Taranto, Stark JJ.)

Fintiv sued PayPal for infringing four patents related to cloud-based transaction systems, also known as “mobile wallet platforms,” “mobile financial services platforms,” or “electronic payment systems.” During claim construction, the district court ruled that the terms “payment handler” and “payment handler service” were indefinite. The court concluded that both terms were means-plus-function limitations governed by § 112, sixth paragraph. Although the claims did not use the word “means,” the district court found that PayPal had demonstrated that the terms were drafted in a format consistent with traditional means-plus-function language, effectively substituting “payment handler” for the word “means.” The court also found that the patent specifications failed to disclose corresponding structure capable of performing the claimed functions. As a result, the court held the claims invalid for indefiniteness and entered final judgment. Fintiv appealed.

Fintiv argued that the district court erred in concluding that the payment handler terms invoked § 112(f) and that the specifications failed to disclose the structure for the claimed functions. The Federal Circuit disagreed.

The Federal Circuit analyzed the “payment-handler” terms, which did not explicitly use the word “means.” Under § 112(f), there is a rebuttable presumption that a claim term does not invoke means-plus-function treatment unless the challenger can show that the term is a nonce term that lacks “sufficiently definite structure” or only recites a function without providing enough structure to perform that function. Fintiv contended that the payment handler terms, both individually and collectively, identified the required structure. However, the Court found that PayPal had successfully rebutted the presumption since the payment handler terms recited functions without reciting sufficient structure to perform those functions. The Court agreed with the district court that the term “handler” did not convey sufficient structure to a person of ordinary skill in the art.

Having determined that the payment handler terms invoked § 112(f), the Federal Circuit sought to identify the corresponding structure described in the specifications for performing the payment handler function but found none. The Court concluded that “without an algorithm to achieve these functionalities – and, more generally, given the specifications’ failure to disclose adequate corresponding structure – we hold the payment-handler terms indefinite.”

Detour Ahead: New Approach to Assessing Prior Art Rejections Under § 102(e)

by Benjamin Ediger, Ph.D. | Apr 3, 2025 | America Invents Act, Patents

The US Court of Appeals for the Federal Circuit established a more demanding test for determining whether a published patent application claiming priority to a provisional application is considered prior art under pre-America Invents Act (AIA) 35 U.S.C. § 102(e) as of the provisional filing date, explaining that all portions of the published patent application that are relied upon by the US Patent & Trademark Office (PTO) to reject the claims must be sufficiently supported in the provisional application. In re Riggs, Case No. 22-1945 (Fed. Cir. Mar. 24, 2025) (Moore, Stoll, Cunningham, JJ.)

Several inventors who work for Odyssey Logistics filed a patent application directed to logistics systems and methods for the transportation of goods from various shippers by various carriers across different modes of transport (e.g., by rail, truck, ship, or air). PTO rejected the application under § 102(e) in view of Lettich, which claimed the benefit of a provisional application (Lettich provisional), and as obvious in view of Lettich in combination with the Rojek reference.

The inventors appealed the Lettich rejections to the Patent Trial & Appeal Board, arguing that Lettich did not qualify as prior art under § 102(e). The Board initially agreed with the inventors, but the Examiner assigned to the application requested a rehearing, asserting that the Board applied the incorrect standard for § 102(e) prior art. The Board ultimately issued its decision on the Request for Rehearing, stating that it had jurisdiction over the Examiner’s request and that the Examiner’s arguments regarding Lettich’s status as prior art under § 102(e) “[we]re well taken.” The Board amended its original decision “to determine that Lettich is proper prior art against the instant claims.” The Board then reviewed and affirmed the Examiner’s anticipation and obviousness rejections. The inventors appealed.

The Federal Circuit vacated and remanded the Board’s decision. With respect to whether Lettich qualified as § 102(e) prior art, the Court found that the Board’s analysis was incomplete. The Court concluded that the Board correctly applied the test set forth in the Federal Circuit’s 2015 decision in Dynamic Drinkware v. National Graphics by determining that the Lettich provisional supported at least one of Lettich’s as-published claims. However, the Court found that this test was insufficient because all portions of the disclosure that are relied upon by the PTO to reject the claims must also be sufficiently supported in the priority document. Although the PTO asserted that the Board had conducted this additional analysis, the Federal Circuit disagreed and vacated and remanded for the Board to determine whether the Lettich provisional supported the entirety of the Lettich disclosure that the Examiner relied on in rejecting the claims.

Even Jepson Preambles Require Written Description Support

by Tessa Kroll | Mar 27, 2025 | Patents

The US Court of Appeals for the Federal Circuit found a Jepson claim unpatentable where the specification did not provide adequate written description for the portion of the claim purporting to recite what was already well known in the prior art. In re Xencor, Inc., Case No. 24-1870 (Fed. Cir. Mar. 13, 2025) (Hughes, Stark, Schroeder, JJ.)

Xencor filed a patent application claiming a modified anti-C5 antibody treatment with certain amino acid substitutions that provide for longer serum half-lives and reduce the need for more frequent treatment. The application included:

A Jepson claim reciting, “[i]n a method of treating a patient by administering an anti-C5 antibody with an Fc domain, the improvement comprising” certain amino acid substitutions, wherein the modified antibody has “increased in vivo half-life.”
A non-Jepson claim directed to “a method of treating a patient by administering an anti-C5 antibody comprising” certain amino acid substitutions, wherein the modified antibody “has increased in vivo half-life.”

The specification provided one example of an anti-C5 antibody, 5G1.1, and three high-level examples of potential uses for anti-C5 antibodies. The examiner rejected the claims for lack of written description. Xencor unsuccessfully appealed the rejection to the Patent Trial & Appeal Board. Xencor then unsuccessfully petitioned the Board for reconsideration. Xencor appealed to the Federal Circuit, which resulted in a remand to the Board’s Appeals Review Panel (ARP).

The ARP concluded that Jepson claim preambles require written description support and that the preamble language of “treating a patient” was limiting – even without the Jepson claim format – because it gave life and meaning to the claim recitations “increased in vivo half-life” and “administering.” Because the specification did not provide a representative number of species to support the broad genus of anti-C5 antibodies, a description of conditions that can successfully be treated with an anti-C5 antibody, or even a single working example describing treatment with an anti-C5 antibody with the claimed modifications, the ARP found that the claims lacked written description and that Xencor had not shown that anti-C5 antibodies were well known. Xencor again appealed, arguing that “treating a patient” was not limiting and that Jepson preambles do not require written description support.

With respect to the preamble of the method claim, the Federal Circuit noted that Xencor agreed that the “administering” portion was limiting but nonetheless argued that “treating a patient” was not. Although a preamble can be split into limiting and non-limiting parts, the Court reasoned that the preamble here could not be neatly packaged into separate portions because the phrase “treating a patient” was directly connected through the word “by” to the phrase “administering an anti-C5 antibody,” and each phrase gave meaning to the other. The Court further explained that the entire preamble provided the raison d’être of the claimed method: When a patient is treated with the modified anti-C5 antibody, the treatment lasts longer, reducing the frequency of treatments. Accordingly, the Court agreed with the ARP that the recitation “treating a patient” was limiting.

The Federal Circuit [...]

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Eye-Catching: Biosimilars Injunction Prevails

by Courtney Seams | Feb 6, 2025 | Patents

Addressing a preliminary injunction in patent litigation related to the Biologics Price Competition and Innovation Act (BPCIA), the US Court of Appeals for the Federal Circuit upheld the district court’s grant of a preliminary injunction, finding that there was a proper exercise of personal jurisdiction and that no substantial question of invalidity had been raised for the patents at issue that would prevent the injunction from issuing. Regeneron Pharmaceuticals, Inc. v. Mylan Pharmaceuticals Inc., Case No. 24-1965 (Fed. Cir. Jan. 29, 2025) (Moore, C.J.; Reyna, Taranto, JJ.)

Regeneron holds a Biologics License Application for Eylea®, a therapeutic product containing aflibercept (a VEGF antagonist used in various treatments for eye diseases). Regeneron owns multiple patents related to its Eylea® product, including a patent directed to intravitreal injections using VEGF formulations. Mylan, Samsung Bioepis (SB), and other companies filed abbreviated Biologics License Applications (aBLAs) with the US Food and Drug Administration (FDA) seeking approval to market Eylea® biosimilars. Regeneron brought suit against these parties asserting infringement of its patent and filed a motion for a preliminary injunction.

The district court granted the preliminary injunction against SB, enjoining it from offering for sale or selling the subject of its aBLA without a license from Regeneron. SB appealed, arguing that:

The exercise of personal jurisdiction over it was improper.
There was a substantial question of invalidity of the patent under either obviousness-type double patenting or lack of adequate written description.
There was no causal nexus established.

The Federal Circuit upheld the exercise of personal jurisdiction on SB, finding that SB had minimum contacts with the state of West Virginia. SB is headquartered in South Korea and entered into a development and commercialization agreement with Biogen for a biosimilar to Eylea®, SB15, that gives SB continuing rights and responsibilities as the agreement is implemented. The Court found that SB did not have to distribute the product itself under the agreement for it to be subject to personal jurisdiction. Further, the Court found that SB’s aBLA and internal documentation indicated an intent to distribute SB15 US-wide, which was sufficient to establish intent to distribute the product in West Virginia.

The Federal Circuit also upheld the district court’s grant of the preliminary injunction. SB invoked another patent in the same family as the asserted patent that was directed to an intravitreal injection containing a VEGF trap as the reference patent for an obviousness-type double patenting theory. The Federal Circuit upheld the district court’s findings that the stability requirement, the “glycosylated” requirement, and the “vial” limitations in the claims of the asserted patent were all patentably distinct from the reference patent. The Court found that the stability requirement recited in the asserted patent was more specific than, and not inherent within, the reference patent. The Court further agreed that the reference patent embraced both non-glycosylated and glycosylated aflibercept, not only the glycosylated aflibercept contained in the asserted patent claims.

The Federal Circuit then addressed SB’s arguments that the specification lacked sufficient written description for the claimed [...]

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Complex or Not Written Description Is Evaluated Against Claims

by Connor M. Larson | Jan 23, 2025 | Patents

The US Court of Appeals for the Federal Circuit reversed a district court’s ruling of invalidity for lack of written description, finding that the district court erred in its analysis of written description because patents must be evaluated based on the claims themselves, not on their construction. In re Entresto, Case No. 23-2218 (Fed. Cir. Jan. 10, 2025) (Lourie, Prost, Reyna, JJ.)

Novartis owns an approved new drug application (NDA) for a combination therapy of valsartan and sacubitril that Novartis markets under the brand name Entresto®. The term “combination therapy” is used to describe pharmaceuticals where two or more active pharmaceutical ingredients are combined in a single method of treatment. Entresto® is protected by several patents, including the patent at issue. Several generic pharmaceutical manufacturers, including MSN, filed abbreviated new drug applications (ANDAs) seeking to market generic versions of Entresto® prior to the expiration of Novartis’ patent. Novartis sued for infringement.

A unique property of Entresto® is the specific form taken by the active pharmaceutical ingredients, valsartan and sacubitril. The valsartan and sacubitril in Entresto® are present in what is known as a “complex,” meaning the two drugs are bonded together by weak, noncovalent bonds. At issue before the district court was the construction of the claim term “wherein said [valsartan and sacubitril] are administered in combination.” The inquiry focused on whether “in combination” required the valsartan and sacubitril to be chemically separated molecules (not in the form of a complex). The district court adopted Novartis’ proposal to give the term its plain and ordinary meaning because the intrinsic record was silent as to whether the molecules must be separate and not complexed. The complexed form of valsartan and sacubitril was not developed until four years after the priority date of the patent.

After the district court declined to adopt MSN’s “complexed” claim construction, MSN stipulated to infringement. The case proceeded to a bench trial on the issue of validity. The district court found the patent not invalid for obviousness, lack of enablement, and indefiniteness. However, the district court ruled that because the patent did not disclose the complexed form of valsartan and sacubitril, it was invalid for lack of written description. Novartis appealed.

Novartis argued that a complex of valsartan and sacubitril was an after-arising invention that need not have been enabled or described. The Federal Circuit agreed, finding that because the patent did not claim the complexed form of valsartan and sacubitril, those complexes need not have been described. The Court cited its “long-recognized” rule that “the invention is, for purposes of the written description inquiry, whatever is now claimed.” All that was required to meet the written description requirement was a disclosure sufficient to show that the inventors possessed a pharmaceutical composition comprising valsartan and sacubitril administered in combination. The Federal Circuit found that by considering what the claims were “construed to cover,” the district court improperly conflated the distinct issues of patentability and infringement. The Federal Circuit reversed the district court’s finding of invalidity for lack [...]

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Later-Filed, Earlier-Expiring Patent Not an ODP Reference

by Alexander P. Ott | Aug 29, 2024 | Patents

Addressing invalidity due to obvious-type double patenting (ODP) based on later-filed-related patents, the US Court of Appeals for the Federal Circuit reversed a district court’s application of In re Cellect (Fed. Cir. 2023) and held that the later-filed, earlier-expiring continuation patents were not available as ODP references against the earlier-filed, later-expiring patent. Allergan USA, Inc. v. MSN Labs Private Ltd., Case No. 24-1061 (Fed. Cir. Aug. 13, 2024) (Lourie, Dyk, Reyna JJ.)

In 2015, the US Food and Drug Administration approved a new drug application for a drug sold by Allergan to treat the symptoms of irritable bowel syndrome. In 2019, Sun Pharma filed an abbreviated new drug application (ANDA) seeking to market a generic version of the drug. Allergan then sued Sun Pharma and MSN Labs for infringement of four patents related to the drug. One of the patents, which claims a compound of the drug, had been granted almost three years of patent term adjustment (PTA) and was followed by two more patents from continuation applications in the same patent family. The other three patents all claimed tablet forms of the drug. The claims of one of the patents recited that a glidant was optional while the claims of the other two patents did not require a glidant at all.

The US District Court for the District of Delaware held a three-day bench trial and concluded that the asserted claim of the compound patent was invalid under the ODP doctrine and that the claims of the three tablet patents were invalid for lack of written description. On the issue of ODP, the district court found Allergan’s “first-filed, first-issued” distinction “immaterial.” The district court stated that “[w]hen analyzing ODP, a court compares patent expiration dates, rather than filing or issuance dates.” Allergan appealed.

The Federal Circuit reversed on both issues. The Court held that the claims of the later-filed, earlier-expiring continuation patents were not available as ODP references against the first patent because the purpose of the ODP doctrine is to prevent patentees from obtaining a second patent to effectively extend the life of the first patent. The Federal Circuit explained that the district court misread Cellect as binding it to solely consider expiration dates in the ODP analysis. The Court explained that Cellect only controls to the extent that it requires a court to consider the later-filed patent’s expiration date (i.e., the expiration date after the addition of PTA) in its ODP analysis, not the expiration date that it would have shared with the reference patents in the absence of a PTA award. The panel majority emphasized that it does not follow that the later-filed patent must be invalidated by the earlier-filed reference patents simply because it expires later. The majority noted that “Cellect does not address, let alone resolve, any variation of the question presented here – namely, under what circumstances can a claim properly serve as an ODP reference – and therefore has little to say on the precise issue before us.”

The Federal Circuit also [...]

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For Statutory Equivalents, Even One Means May Be Enough

by Ian J. Howard | Jun 6, 2024 | Patents

A US Patent & Trademark Office (PTO) appeals review panel decided that a means-plus-function (M+F) claim element supported by the disclosure of only a single species is not invalid for indefiniteness or lack of written description, even if the specification lacks other disclosed statutory corresponding equivalents. Ex parte Chamberlain, Appeal No. 22-001944 (App. Review Panel, May 21, 2024) (Vidal, Dir.; Udupa, Boalick, APJs) (per curiam).

The independent claims of the patent application at issue involved methods of treating patients with “anti-C5 antibod[ies]” that include amino acid substitutions devised to increase the in vivo half-life of the antibody. Each claim involved similar preambles: “A method of treating a patient by administering an anti-C5 antibody comprising . . . .” One of the independent claims was in Jepson form, whereas the other included a M+F limitation.

Following rejections by the examiner and the applicant’s appeal to the Patent Trial & Appeal Board, the Board entered new grounds of rejection finding both claims invalid under 35 U.S.C. § 112, ¶1 (written description) and affirmed the examiner’s rejection of the claims for obviousness-type double patenting. The Board also entered a new ground of rejection finding the claim including the M+F claim element indefinite under 35 U.S.C. § 112, ¶2. Following the applicant’s appeal to the Federal Circuit, the PTO took the unusual step of petitioning the Federal Circuit to “administratively remand [the case] to the Office in order to convene an Appeals Review Panel to clarify the Office’s position on the proper analysis of ‘Jepson-format and means-plus-function claims in the field of biotechnology, and particularly in the antibody art’ and ‘to issue a revised decision.’”

On remand, the panel affirmed the Board’s determinations that written description was lacking but overturned the Board’s finding of indefiniteness for the claim including the M+F element. In doing so, the panel offered useful commentary on the invalidity standard for M+F claim elements as well as the implications that a limiting preamble may have on invalidity.

The panel found the “treating a patient” preamble recitation limiting in both claims. For the Jepson claim, the preamble was per se limiting. However, the panel went on to find that, even independent of the Jepson claim format, the “treating a patient” phrase would be limiting. Outside the Jepson context, the panel characterized the inquiry of determining whether a preamble limits the body of the claim as a highly contextual one. According to the panel, the “treating a patient” term did not merely provide “circumstances in which the method may be useful” but instead constituted “the raison d’être of the claimed method itself.” The “treating a patient” language was necessary to “give life, meaning, and vitality” to limitations in the body of the claim involving increasing the in vivo half-life of the antibodies and administering the antibodies.

Having determined that the “treating a patient” recitation was limiting, the panel found that the limitation was overbroad compared to the scope of the patent’s disclosure, and thus the Jepson format claim lacked adequate written description. Read in light of [...]

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