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Drawing Can Teach Claim Limitations If “Clear on Its Face”

by Connor M. Larson | Apr 18, 2024 | Patents

Addressing when a drawing in a prior art reference includes a teaching that is “clear on its face,” the Director of the US Patent & Trademark Office vacated and remanded a Patent Trial & Appeal Board decision denying institution of an inter partes review (IPR) petition. MAHLE Behr Charleston Inc. v. Catalano, IPR2023-00861 (PTAB Decision Review, Apr. 5, 2024) (Vidal, PTO Dir.)

MAHLE Behr filed a petition requesting institution of an IPR, challenging claims of a patent owned by Catalano. The patent is directed to a device known as a sacrificial anode that prevents corrosion in motor vehicle radiators caused by electrolysis. One of the claim terms at issue requires the anode to be “within 10 inches” of another element. MAHLE argued that a figure in a prior art reference anticipated or rendered obvious several challenged claims.

The Board denied the institution after determining that MAHLE did not establish a reasonable likelihood that it would prevail with respect to at least one of the challenged claims. The Board cited the Federal Circuit’s 2000 decision in Hockerson-Halberstadt v. Avia Group International to explain that “[p]atent drawings do not define the precise proportions of the elements and may not be relied on to show particular sizes if the specification is completely silent on the issue.” The Board concluded that the figure relied on by MAHLE did not provide exact dimensions and thus could not be sufficient to render the claims invalid.

MAHLE filed a request for Director Review, which was granted. In its request, MAHLE argued that the Board erred in its application of Federal Circuit case law on the use of patent drawings as prior art teachings. The Director agreed, explaining that “the Board did not adequately address [MAHLE’s] arguments regarding what [the figure in the prior art] clearly shows or would have reasonably suggested to a person of ordinary skill in the art.” Federal Circuit case law established that a claim may be anticipated or rendered obvious by a figure in the prior art if the drawing clearly discloses the claim limitation. If “a person of skill in the art could derive the claimed dimensions from the patent’s disclosure, there is no additional requirement that the specification must explicitly disclose the precise proportions or particular sizes.”

The Director further explained that “the Board did not adequately address MAHLE’s arguments regarding what [the prior art figure] clearly shows or would have reasonably suggested to a person of ordinary skill in the art.” While the prior art figure did not disclose the precise proportions or measured quantity specified in the challenged claims, the figure showed the elements being located as claimed (necessarily within the 10 inches recited). The Director explained that the Board should have considered whether a person of ordinary skill in the art would have understood the figure to disclose the claimed elements being within 10 inches of each other.

The Director vacated the Board’s decision and remanded the petition with instructions to consider both what the prior art figure [...]

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Heightened Written Description Standard for Negative Limitations?

by Mandy H. Kim | Jun 30, 2022 | Patents

Addressing the issue of negative claim limitations, the US Court of Appeals for the Federal Circuit granted a petition for panel rehearing, vacated its prior decision (authored by now-retired Judge O’Malley) and reversed the district court’s finding that the patent was not invalid for inadequate written description. Novartis Pharms. v. Accord Healthcare Inc., Case No. 21-1070 (Fed. Cir. June 21, 2022) (Moore, C.J.; Hughes, J.) (Linn, J., dissenting).

This is the second time this Hatch-Waxman case has been before the Federal Circuit. Novartis sued HEC, alleging that HEC’s abbreviated new drug application infringed a patent directed to methods of treating remitting multiple sclerosis (RRMS) with fingolimod or a fingolimod salt at a daily dose of 0.5 mg without an immediately preceding loading dose. The district court found sufficient written description for the claimed 0.5 mg daily dose and no-loading dose negative limitation. In January 2022, the Federal Circuit affirmed the district court’s decision finding adequate written description.

HEC petitioned for panel rehearing. The Federal Circuit granted the petition, vacated its January 2022 decision and reversed the district court’s judgment finding adequate written description for the no-loading dose negative limitation. The majority explained that “silence is generally not disclosure” because “[i]f it were, then every later-added negative limitation would be supported so long as the patent makes no mention of it.” The majority also explained that implicit disclosure cannot satisfy the written description requirement if it would render the limitation obvious to a skilled artisan. The majority emphasized that while a negative limitation need not be recited in the specification in haec verba, there generally must be something in the specification that conveys to a skilled artisan that the inventor intended the exclusion—for example, a description of a reason to exclude the relevant element. Here, the majority found that the specification made no mention of the presence or absence of a loading dose. This silence cannot support a later-added claim limitation that precludes loading doses, particularly where there was no evidence that the patentee precluded the use of a loading dose and skilled artisans agreed that loading doses are sometimes given to RRMS patients.

Judge Linn (a member of the majority in the January 2022 opinion) dissented, arguing that the majority applied a heightened written description standard requiring not only a “reason to exclude” but a showing that the negative limitation was also “necessarily excluded.” He stated that the question was not whether the patentee precluded the use of a loading dose, but whether the claim limitation that precluded a loading dose was supported by the specification’s written description that disclosed only a daily dose. Judge Linn argued that disclosure along with the testimony of Novartis’s experts implied an absence of a loading dose to a skilled artisan, and that is all that is required for adequate written description. Citing precedent and the US Patent & Trademark Office’s guidance in the Manual of Patent Examining Procedure, he argued that newly added claims or claim limitations may be supported [...]

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This .SUCKS: Trademark Applications for Identical Characters Is a No-Go

by Jodi Benassi | Feb 10, 2022 | Trademarks

The US Court of Appeals for the Federal Circuit affirmed a Trademark Trial and Appeal Board (Board) decision affirming the US Patent and Trademark Office’s (PTO) refusal to register two trademark applications for “.SUCKS.” In Re: Vox Populi Registry Ltd., Case No. 21-1496 (Fed. Cir. Feb. 2, 2022) (Lourie, Dyk, Stoll, JJ.)

Vox is a domain registry operator that maintains the master database of all domain names registered in each top-level domain. Vox filed two trademark applications for identical characters, one as a standard character and the other as a stylized form of .SUCKS, as shown below.

The PTO refused Vox’s applications on the grounds that, when used in connection with the domain services, each failed to function as a trademark. Vox appealed to the Board. The Board concluded that .SUCKS, whether as a standard mark or in the stylized form, would not be perceived as a source identifier. Vox appealed the Board’s decision only with respect to the stylized form of .SUCKS.

On appeal, the Federal Circuit noted that although Vox did not appeal the rejection of the standard character application, it spent much of its opening brief arguing that the standard character functions as a mark. As such, the Court reviewed the Board’s decision with respect to the standard character mark .SUCKS under the substantial evidence standard. Substantial evidence “means only such relevant evidence as a reasonable mind might accept as adequate to support a conclusion.” The Court found that substantial evidence supported the Board’s finding that consumers will view .SUCKS as only a non-source identifying part of a domain name, rather than as a trademark. The Court cited evidence reviewed by the Board, including Vox’s website, online articles and advertisements showing that .SUCKS refers to a product rather than as an identifiable provider or service. Ultimately, the Court found that the Board reasonably weighed the evidence.

The Federal Circuit next addressed the question of whether the stylized design of .SUCKS is registerable. The Court found no error in the Board’s analysis of whether the stylized form creates a separate commercial impression, where “all of the characters in the mark are the same height and width and are merely displayed in a font style that was once mandated by the technological limitations of computer screens.” Because the stylized design was not inherently distinctive, the Court rejected Vox’s application, thus affirming the Board’s decision in full.

Silence May Be Sufficient Written Description Disclosure for Negative Limitation

by Mandy H. Kim | Jan 13, 2022 | Patents

Addressing the issue of written description in a Hatch-Waxman litigation, the US Court of Appeals for the Federal Circuit affirmed the district court’s finding that the patent adequately described the claimed daily dose and no-loading dose negative limitation. Novartis Pharms. v. Accord Healthcare Inc., Case No. 21-1070 (Fed. Cir. Jan. 3, 2022) (Linn, O’Malley, JJ.) (Moore, CJ, dissenting).

Novartis’s Gilenya is a 0.5 mg daily dose of fingolimod hydrochloride medication used to treat relapsing remitting multiple sclerosis (RRMS). HEC filed an abbreviated new drug application (ANDA) seeking approval to market a generic version of Gilenya. Novartis sued, alleging that HEC’s ANDA infringed a patent directed to methods of treating RRMS with fingolimod or a fingolimod salt at a daily dosage of 0.5 mg without an immediately preceding loading dose.

The specification described the results of an Experimental Autoimmune Encephalomyelitis (EAE) experiment induced in Lewis rats showing that fingolimod hydrochloride inhibited disease relapse when administered daily at a dose of 0.3 mg/kg or administered orally at 0.3 mg/kg every second or third day or once a week, and a prophetic human clinical trial in which RRMS patients would receive 0.5, 1.25 or 2.5 mg of fingolimod hydrochloride per day for two to six months. The specification did not mention a loading dose associated with either the EAE experiment or the prophetic trial. It was undisputed that loading doses were well known in the prior art and used in some medications for the treatment of multiple sclerosis.

The district court found that HEC had not shown that the patent was invalid for insufficient written description for the claimed 0.5 mg daily dose or the no-loading dose negative limitation. The district court also found sufficient written description in the EAE experiment and/or prophetic trial and credited the testimony of two of Novartis’s expert witnesses. HEC appealed.

The Federal Circuit affirmed the district court’s decision. Turning first to the daily dose limitation, the majority held that the prophetic trial described daily dosages of 0.5, 1.25 or 2.5 mg and found no clear error by the district court in crediting expert testimony converting the lowest daily rat dose described in the EAE experiment to arrive at the claimed 0.5 mg daily human dose. Reciting Ariad, the Court explained that a “disclosure need not recite the claimed invention in haec verba” and further, that “[b]laze marks” are not necessary where the claimed species is expressly described in the specification, as the 0.5 mg daily dose was here.

Turning to the no-loading dose negative limitation, the majority disagreed with HEC’s arguments that there was no written description because the specification contained zero recitation of a loading dose or its potential benefits or disadvantages, and because the district court inconsistently found that a prior art abstract (Kappos 2006) did not anticipate the claims because it was silent as to loading doses. The Court explained that there is no “new and heightened standard for negative claim limitations.” The majority acknowledged that silence alone is insufficient disclosure but emphasized that [...]

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Injunctive Relief Available Even Where Laches Bars Trademark Infringement, Unfair Competition Damage Claims

by Paul Devinsky | Aug 12, 2021 | Trademarks

The US Court of Appeals for the 11th Circuit affirmed a district court’s conclusion that laches barred an advertising and marketing company’s claims for monetary damages for trademark infringement and unfair competition, but remanded the case for assessment of injunctive relief to protect the public’s interest in avoiding confusion between two similarly named companies operating in the advertising sector. Pinnacle Advertising and Marketing Group, Inc. v. Pinnacle Advertising and Marketing Group, LLC, Case No. 19-15167 (11th Cir. Aug. 2, 2021) (Branch, J.)

Pinnacle Advertising and Marketing Group (Pinnacle Illinois) is an Illinois-based company and owner of two registered trademarks including the name “Pinnacle.” Pinnacle Illinois learned of a Florida-based company operating under almost the same name that was also in the advertising and marketing space—Pinnacle Advertising and Marketing Group (Pinnacle Florida) —through potential clients and a magazine’s accidental conflation of the two unrelated companies. Several years later, Pinnacle Illinois sued Pinnacle Florida for trademark infringement, unfair competition and cybersquatting. Pinnacle Florida filed a counterclaim seeking to cancel Pinnacle Illinois’s trademark registrations and also alleged that Pinnacle Illinois’s claims were barred by the doctrine of laches.

Following a jury trial, the district court granted Pinnacle Florida’s motion for judgment as a matter of law on Pinnacle Illinois’s cybersquatting claim. The jury returned a verdict in favor of Pinnacle Illinois on its claims for trademark infringement and unfair competition, awarding Pinnacle Illinois $550,000 in damages. The district court then granted Pinnacle Florida’s motion for judgment as a matter of law on its laches defense, concluding that Pinnacle Illinois’s trademark infringement and unfair competition claims were barred by laches because it waited more than four years to bring suit after it should have known that it had a potential infringement claim against Pinnacle Florida. The district court also cancelled Pinnacle Illinois’s registrations because it concluded that Pinnacle Illinois’s marks were merely descriptive and lacked secondary meaning. Pinnacle Illinois appealed.

Pinnacle Illinois argued that the district court abused its discretion in finding that Pinnacle Illinois’s claims were barred by laches, and that even if laches did bar Pinnacle Illinois’s claims for money damages, the district court should have considered whether injunctive relief was proper to protect the public’s interest in avoiding confusion between the two companies. Pinnacle Illinois also argued that the district court erred when it cancelled its registrations without regard to the jury’s findings of distinctiveness and protectability or the presumption of distinctiveness afforded to its registered marks.

The 11th Circuit found that the district court did not abuse its discretion in determining that laches barred Pinnacle Illinois from bringing its trademark infringement and unfair competition claims for monetary damages. Pinnacle Illinois sued after the Florida four-year statute of limitations had passed, and the Court found that the company was not excused for its delay because it did not communicate with Pinnacle Florida about the infringement until it filed suit. Pinnacle Florida also suffered economic prejudice because it invested significant time and money, including around $2 million, in developing its business under [...]

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PTO to Patent Examiners: Make Interpretation of Means-Plus-Function Claims Clear in the Record

by Peter Brunovskis, PhD | Mar 28, 2024 | Patents

On March 18, 2024, the US Patent & Trademark Office (PTO) issued a memorandum to patent examiners addressing means-plus-function and step-plus-function claim limitations and how to clearly articulate, in the prosecution record, the PTO’s interpretation of such claim limitations. The goal of the memorandum is to ensure consistency in connection with the examination of such limitations, provide both the applicant and the public with notice regarding the claim interpretation used by the patent examiner, and provide the applicant an opportunity to advance a different claim interpretation early in the prosecution.

As stated in 35 U.S.C. §112(f), “[a]n element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.” The memorandum does not suggest any changes in interpretation of the statute.

One aspect of the memorandum is to remind examiners of the resources and guidance available when examining means-plus-function and step-plus-function claim limitations, specifically MPEP §§ 2181-2187 and refresh training. In accordance with the guidance, the primary steps when examining such claim elements include:

Determining whether a claim limitation invokes § 112(f)
Ensuring the record is clear with respect to invoking § 112(f)
Evaluating the description necessary to support a § 112(f) claim limitation under §§ 112(a) and (b).

To determine whether a claim limitation invokes §112(f), the guidance instructs examiners to employ the three-prong analysis set forth in MPEP § 2181, subsection I. Using this analysis, recitation of the terms “means” or “step” in association with functional language, rather than structure, material or acts for performing that function, should be interpreted as claim limitations invoking § 112(f). However, where these terms are accompanied by structure, materials or acts for performing the function, § 112(f) is not invoked. On the other hand, a limitation reciting functional language along with a generic placeholder term instead of “means,” which fails to recite sufficiently definite structure for performing the function, would nonetheless invoke § 112(f), according to a proper analysis. Examples of such generic placeholders include “mechanism for,” “module for,” “device for,” “unit for,” “component for,” “element for,” “member for,” “apparatus for,” “machine for” and “system for.”

An important caveat in the memorandum states that “[e]stablishing the interpretation of § 112(f) limitations in writing during prosecution is critical in supporting the agency goal of establishing a clear prosecution record.” The guidance advises examiners that form paragraphs are available in support of meeting this objective, which serve to inform “the applicant, the public, and the courts . . . as to the claim construction the examiner used during prosecution. This further informs the applicant, the public, and the courts (and the PTO for any post-grant review procedures) as to how the examiner searched and applied prior art based on the examiner’s interpretation of the claim.”

The memorandum further emphasizes the need to [...]

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New PTAB Claim Construction? Give the Parties Review Opportunity

by Benjamin Ediger, Ph.D. | Mar 28, 2024 | Patents

The US Patent & Trademark Office (PTO) Director vacated Final Written Decisions issued by the Patent Trial & Appeal Board that presented a sua sponte construction of a claim term in dispute, holding that the parties were not provided adequate notice of the Board’s new construction. Assa Abloy AB v. CPC Patent Technologies Pty., Ltd., IPR2022-01006, -01045, -01089 (PTAB Decision Review Mar. 15, 2024) (Vidal, PTO Dir.)

The Board issued Final Written Decisions in three inter partes reviews (IPRs), holding that the petitioner failed to demonstrate that any of the challenged claims were unpatentable. The petitioner requested Director Review, raising three issues concerning the Final Written Decisions’ treatment of the claim term “biometric signal”:

The Board’s construction newly added a limitation that neither the petitioner nor the patent owner proposed
The Board’s construction was erroneous
The Board inconsistently addressed this claim limitation among the IPRs at issue.

The Director decided that review was appropriate.

The Director explained that in view of the petitioner’s and patent owner’s divergent post-institution positions regarding this limitation, the Board had authority to construe “biometric signal” even though its institution decisions indicated that the Board would give this claim term its plain and ordinary meaning. The petitioner argued that the term meant “the input and output of the biometric sensor,” and the patent owner argued that the term meant a “physical attribute of the user” (i.e., a fingerprint, facial pattern, iris, retina or voice). The Board held that it meant “a physical or behavioral biometric attribute that provides secure access to a controlled item.”

The Director vacated and remanded the Final Written Decisions, explaining that the Board failed to provide the petitioner and the patent owner reasonable notice of its new construction or the opportunity to present arguments concerning it, as required under the Administrative Procedure Act (APA). The Director noted that neither party requested the Board’s inclusion of a construction that required an attribute of the claimed signal to “provide[] secure access to a controlled item” and concluded this was the sort of “difficult to imagine” sua sponte construction that the US Court of Appeals for the Federal Circuit held (in its 2021 decision in Qualcomm v. Intel) lacked sufficient notice if appearing for the first time in a Final Written Decision.

The Director instructed that on remand the Board should authorize the petitioner to file a supplemental briefing that addresses the Board’s construction and its application to the asserted prior art and authorize the patent owner to respond to the petitioner’s supplemental briefing.

The Director also noted that the patent owner’s proposed claim construction in the IPRs was similar to the construction that the Board adopted in its institution decisions in other IPRs challenging two of the patents at issue. In recognition of this situation, the Director also invited the petitioner, in its supplemental briefing, to address the perceived inconsistencies in these claim constructions.

Be Cool: Don’t Construe the Construction

by Keval Amin | Mar 21, 2024 | Patents

The US Court of Appeals for the Federal Circuit vacated and remanded a Patent Trial & Appeal Board decision after concluding that the patent owner’s proposed construction would require the parties to construe the construction. CoolIT Systems, Inc. v. Katherine Vidal, Director of the United States Patent & Trademark Office, Case No. 22-1221 (Fed. Cir. March 7, 2024) (Lourie, Bryson, Stark, JJ.) (nonprecedential).

CoolIT Systems owns a patent directed to a system for fluid heat transfer to cool electronic devices. The patent focuses on a heat exchange system comprising various components including a heat sink, a housing member and a compliant member. The patent claims priority from two provisional applications. Asetek Danmark petitioned for inter partes review (IPR) of the patent based on anticipation and obviousness. During the IPR proceeding, the parties disputed the meaning of the term “matingly engaged,” a term introduced in the later provisional application. To preserve validity, CoolIT argued that the term should be construed narrowly to mean “mechanically joined or fitted together to interlock.” Asetek sought a broader construction of “joined or fitted together to make contact,” which would encompass all methods of joining two surfaces.

The Board found both interpretations extreme and partially construed the term as being satisfied when at least a portion of the compliant member fits within the recessed region of the housing member. Despite agreement on the term “mate” to mean “join or fit together,” there was disagreement on the term “engage.” However, the Board did not determine whether “matingly engaged” could encompass forms of engagement beyond fitting.

The Board found that the cited prior art suggested a compliant member fitting the housing, thus rendering the claims obvious. CoolIT appealed. The US Patent & Trademark Office (PTO) intervened after Asetek withdrew from the appeal based on settlement.

CoolIT argued that the Board’s interpretation was flawed, and that the prior art did not meet the requirements of the “matingly engaged” limitation irrespective of the interpretation adopted. CoolIT contended that its proposed construction aligned with the invention’s purpose and properly distinguished between the 2007 and 2011 provisional applications. CoolIT also argued that the compliant member must partition features to control coolant flow, necessitating a specific type of joining or fitting.

In response, the PTO argued that CoolIT’s proposed construction read limitations from the specification into the claim. The PTO contended that neither the claims nor the specification required “interlock” and disputed CoolIT’s interpretation of the 2007 provisional application. The PTO did not propose an alternative construction, however.

The Federal Circuit concluded that “matingly engaged” should properly be construed as “mechanically joined or fitted together,” as that construction accurately reflected the term’s meaning and aligned with arguments presented by both parties. The Court rejected CoolIT’s proposal to add the word “interlock” because it would cause more confusion than clarity, noting that even CoolIT and the PTO still disagreed over what the term “interlock” meant and thus adding that term to the construction would provide little guidance.

The Federal Circuit found that the Board [...]

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New PTO Guidance: Use KSR Flexible Approach to Obviousness

by Peter Brunovskis, PhD | Mar 7, 2024 | Uncategorized

On February 27, 2024, the US Patent & Trademark Office (PTO) published updated guidance for examiners on how to make a proper determination of obviousness. The guidance expands upon and reinforces the legal framework for obviousness determinations discussed by the Supreme Court in KSR Int’l. v. Teleflex (2007) and Graham v. John Deere Co. (1966) through the lens of post-KSR precedential Federal Circuit cases. The guidance does not have the force and effect of law and is not intended by the PTO to convey any new practice or procedure.

Drawing from more than 30 Federal Circuit cases, the guidance addresses several themes. An overriding theme concerns the implementation of a flexible approach to obviousness and the need for a reasoned explanation when concluding that a claimed invention would have been obvious. In its discussion, the PTO characterizes the flexibility expressed by the KSR court and reiterated by subsequent Federal Circuit cases as mandating a proper understanding of the scope of the prior art and providing appropriate reasons to modify the prior art.

Regarding the scope and content of the prior art, the guidance draws attention to understanding the prior art and all that it may reasonably suggest to a person of ordinary skill in the art (POSITA) who would naturally apply common sense and glean suggestions from the art – even where such suggestions are not explicitly stated. Thus, the obviousness inquiry need not seek out precise teachings regarding a solution to a technological problem but can take account of the inferences, creative steps and common knowledge that a POSITA would employ. In one precedential example, the Federal Circuit held that a POSITA would have combined certain prior art elements based on common knowledge of an industry’s concern for rider stability when using water recreational devices. (Zup v. Nash Mfg. (2018).) The guidance also affirms the need for an evaluation of analogous prior art, which must be evaluated using a flexible approach when considering the “same field of endeavor” and “reasonably pertinent” tests in combination with evidence concerning the knowledge and perspective of a POSITA.

According to the guidance, a flexible approach to obviousness should provide a reasoned explanation with evidentiary support for modifying the prior art. To facilitate compact prosecution, the examiner should clearly articulate this explanation early in the prosecution. The PTO also cautions that wholesale use of “common sense” as a rationale is no substitute for reasoned analysis and evidentiary support. There should be an explanation of why common sense would have compelled a finding of obviousness, especially where limitations are not expressly disclosed in the prior art.

The guidance further emphasizes that decision-makers are not free to ignore relevant evidence before them, including Graham’s secondary considerations or other objective indicia of obviousness, to establish prima facie obviousness. At the same time, conclusory opinions by an expert in a declaration or attorney argument alone should not be accorded weight in the absence of factual support. The guidance notes that in keeping with the flexible approach to obviousness [...]

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PTO Continues to Wave Wands in Assessing Enablement

by Christopher M. Bruno | Jan 18, 2024 | Patents

In light of the 2023 Supreme Court of the United States decision in Amgen Inc. v. Sanofi, the US Patent & Trademark Office (PTO) published guidelines for PTO employees to use, regardless of technology, to ascertain compliance with the enablement requirement under 35 U.S.C. § 112. (89 Fed. Reg. 1563 (Jan. 10, 2024).) Unsurprising to those familiar with the Amgen decision, the PTO hewed closely to existing practice.

The PTO collected the Supreme Court’s clarifications regarding the relationship between the enablement requirement and an amount of experimentation, namely that although particular disclosure of all embodiments is not required, claims are not enabled if they require more than reasonable experimentation. Regarding the “reasonable experimentation” requirement, the PTO explained that consistent with several post-Amgen US Court of Appeals for the Federal Circuit opinions, it would continue to apply the factors that the Federal Circuit announced in its 1988 In re Wands decision.

Although the PTO intends to continue to rely on pre-Amgen Federal Circuit Wands analyses as instructive, it found particular persuasive force since the Federal Circuit’s decision was affirmed by the Supreme Court in Amgen. There, according to the guidance, the Federal Circuit concluded that the genus claims were not enabled because of the amount of experimentation required to test whether antibodies satisfied certain functional limitations. Thus, because “the scope of the claims was far broader in functional diversity than the disclosed examples, … [and] the invention was in an unpredictable field of science with respect to satisfying the full scope of the functional limitations, … there was not adequate guidance in the specification.”

The PTO also noted that the Federal Circuit’s 2023 Baxalta v. Genentech decision, like Amgen, found claims directed to antibodies that contained certain functional limitations to be invalid. There, the Court, like the PTO, detected no appreciable difference between the reasonable experimentation standard as articulated in Wands and the standard as set forth in Amgen. The guidance canvassed other post-Amgen enablement decisions, all of which the PTO read to support continued reliance on Wands.

Practice Note: Although the PTO says that it will continue to apply the Wands factors as it has before, the Amgen decision may, as a practical matter, make establishing enablement of functional limitations more difficult. Whether examiners—especially those in life sciences technology areas—change the course of their review post-Amgen remains to be seen.

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