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NO FAKES Act Would Create Individual Property Right to Control Digital Replicas

by Sarah Bro | Aug 8, 2024 | Technology

On July 31, 2024, a bipartisan group of US senators introduced the Nurture Originals, Foster Art, and Keep Entertainment Safe (NO FAKES) Act of 2024 to protect the voice and visual likeness rights of individuals from unauthorized use in the form of digital replicas, including digital replicas created by generative artificial intelligence (AI). The bill was introduced by Senators Chris Coons (D-DE), Marsha Blackburn (R-TN), Amy Klobuchar (D-MN) and Thom Tillis (R-NC) and follows a discussion draft released in October 2023. The press release from Senator Coons’ office makes note of the many organizations that support the proposed legislation and includes quotes from representatives of SAG-AFTRA, the Recording Industry Association of America, the Motion Picture Association, OpenAI, IBM and Creative Artists Agency.

Designed to protect all individuals (not just celebrities), the bill defines a digital replica as a newly created, computer-generated, highly realistic electronic representation that is readily identifiable as the voice or visual likeness of an individual and that is embodied in a sound recording, image, audiovisual work or transmission in which the actual individual did not perform or appear, or a version of such work in which the fundamental character of the performance or appearance has been materially altered. The bill would grant each individual or right holder the right to authorize the use of their voice or visual likeness in a digital replica, which the bill states is a property right. The bill also would establish the characteristics, requirements and duration of the license rights that can be granted in a digital replica. The right to authorize the use of an individual’s voice or visual likeness in a digital replica would not expire upon the death of the individual and would be transferable and licensable (subject to certain time limitations on the post-mortem right and registration requirements with the Register of Copyrights).

The bill would create a civil cause of action for a rights holder against any person that produces or makes available to the public an unauthorized digital replica and would provide for injunctive relief, actual or statutory damages, punitive damages and attorneys’ fees. There would be a limitations period, however, and any civil action would have to be commenced no later than three years after the date on which a rights holder discovered – or with due diligence should have discovered – the violation at issue. The bill provides certain exceptions and safe harbors for the production or use of digital replicas in news, public affairs, sports, documentaries, commentary, criticism, scholarship, satire or parody, or for online services that remove or disable access to unauthorized digital replicas upon receiving a notification from the rights holder.

The bill would preempt any cause of action under state law for the protection of voice and visual likeness rights in connection with a digital replica in an expressive work, except for certain existing state statutes or common law or state statutes regulating sexually explicit or election-related digital replicas.

On August 5, 2024, the US Patent & Trademark Office hosted [...]

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It’s an Old Tune: Third-Party-Use Evidence From Long Ago Can Support Genericness

by Joshua Revilla | Jul 18, 2024 | Trademarks

The US Court of Appeals for the Fifth Circuit found that the district court abused its discretion in wholesale exclusion of evidence on the issue of genericness. The evidence was offered to show prior use of a trade dress from more than five years prior to an alleged infringer’s first use of a mark. Gibson Inc. v. Armadillo Distribution Enterprises, Inc., Case No. 22-40587 (5th Cir. July 8, 2024) (Stewart, Clement, Ho, JJ.)

Gibson filed trademark infringement and counterfeiting claims against Armadillo Distribution Enterprises in 2019, alleging that Armadillo infringed four of Gibson’s trademarked guitar body shapes, one guitar headstock shape and two word marks. Just before trial, the district court made several evidentiary rulings on the parties’ motions in limine, including one in which Gibson sought to exclude all arguments and evidence related to advertisements or sales of third-party guitars before 1992, arguing they had limited probative value and were unduly prejudicial. Gibson argued that any third-party-use evidence should be restricted to a five-year period from 1992 to 1997. In its first exclusion order, the district court found that evidence of third-party use was relevant to determining whether a mark was generic or unprotectable but concluded that the probative value of the evidence from before the 1990s was low and found that the five-year cutoff date was reasonable. Armadillo objected to that ruling, leading to oral argument and a second exclusion order upholding the first order. The district court relied on Federal Rule of Evidence (FRE) 403 and the 2018 Federal Circuit ruling in Converse v. International Trade Commission to support this wholesale exclusion of evidence prior to 1992.

The parties proceeded to trial in mid-2022. A jury found that Armadillo infringed all of the trademarks other than one word mark and found that Armadillo marketed counterfeits. Armadillo appealed based on the district court’s exclusion of decades of third-party-use evidence. Armadillo asserted that this evidence was central to Armadillo’s counterclaim seeking cancellation of the marks and its main defense of genericness.

The Fifth Circuit first considered the district court’s reliance on Converse and determined that the district court abused its discretion in excluding the third-party evidence predating 1992. Armadillo argued that reliance on Converse was error because that case concerned secondary meaning and not genericness. Gibson countered that genericness and secondary meaning are closely related issues and that the five-year period predating infringement is the most logical measuring line. Alternatively, Gibson argued that 15 U.S.C. § 1064 would bar evidence predating 1992 because it provides that a petition to cancel a mark’s registration must be filed within five years from the date of registration of the mark.

The Fifth Circuit found that Converse did not rule that third-party-use evidence from more than five years prior to the alleged infringer’s first use was irrelevant to the issue of genericness and did not compel a strict five-year limitation of third-party-use evidence. The Court further reasoned that under Converse, evidence of prior use is relevant if such use was likely to have [...]

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Family Feud: Counterclaims Too Little, Too Late

by Kathleen Lynch | Jun 27, 2024 | Copyrights

The US Court of Appeals for the Seventh Circuit affirmed a district court’s ruling that aggrieved family members’ counterclaims for various intellectual property matters were long overdue and subject to a laches defense. Sumrall v. LeSEA, Inc., Case No. 23-2833 (7th Cir. June 12, 2024) (Scudder, Pryor, St. Eve, JJ.)

During Lester Frank Sumrall’s life, he created a legacy that began as a church, later blossoming into the Lester Sumrall Evangelical Association (LeSEA). Through LeSEA, Sumrall delivered his ministry from Indiana to the rest of the world via television, travel, writings and media productions. These works, including books and films (many of which Sumrall registered for copyrights in his or LeSEA’s name) are the subject of dispute. Particularly in dispute was the ownership of the “Traveler Photo,” a picture that Sumrall’s grandson Lester took during a ministry trip to China while Lester worked for LeSEA.

Sumrall’s death raised issues regarding succession. After his death, Sumrall’s sons, Peter, Stephen and Frank, took over LeSEA. Peter and Stephen relayed to Frank and others that Sumrall left all his assets to the ministry. Eight years later, Lester researched Indiana’s intestate succession law. Believing that Sumrall died without a will, Lester thought Frank should have inherited one-third of Sumrall’s estate. Under this belief, Frank granted Lester power of attorney to legally pursue his interest in the estate. For 12 years, Lester took no further legal action.

After learning that Sumrall did indeed have a will, Lester petitioned an Indiana probate court to open an estate for Sumrall in 2017. One of Lester’s cousins produced the will that granted some personal items to Sumrall’s grandchildren, with the remainder of his estate divided among his sons equally. The probate court denied the petition, reasoning that the estate was devoid of assets.

This case began with LeSEA’s trademark infringement claims against Lester and a competitor Lester created, the LeSEA Broadcasting Corporation. Those claims were resolved after Lester stopped using LeSEA’s name and therefore were not on appeal.

At issue in the appeal were counterclaims brought by the Lester Sumrall Family Trust against LeSEA, LeSEA’s affiliate corporations, and Lester’s uncles and cousins who are currently involved in the ministry (collectively, LeSEA). Lester and the trust asserted that:

LeSEA unrightfully took ownership of Sumrall’s copyrights.
LeSEA unlawfully used the Traveler Photo in its materials.
The trust was entitled to damages for its state law claims.
LeSEA unlawfully continued to use Sumrall’s right of publicity.

The Seventh Circuit rejected the appellants’ assertion that they owned Sumrall’s copyrighted works. The Court ruled that the appellants’ copyright claim arose under the Copyright Act, which bars suits three years after they accrue. The Court explained that an ownership claim accrues “when plain and express repudiation of co-ownership is communicated to the claimant.” Here, repudiation occurred when Sumrall died 28 years prior to the counterclaim and Stephen and Peter declared in “plain and express” terms that LeSEA owned the copyrights and the remainder of the estate.

As for the Traveler Photo, the [...]

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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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A Lesson in Laches: You Waited Too Long to Start Your Kar

by Sarah Bro | May 2, 2024 | Trademarks

After the district court, on remand, held that laches did not bar relief, the US Court of Appeals for the Third Circuit again determined that the district court abused its discretion by not properly applying the presumption in favor of laches and issued an order to vacate and remand with instructions to dismiss a charity’s trademark infringement claims with prejudice. Kars 4 Kids Inc. v. America Can!, Case Nos. 23-1273; -1281 (3rd Cir. Apr. 17, 2024) (Bibas, Porter, Fisher, JJ.)

Kars 4 Kids and America Can! Cars for Kids are charities that sell donated vehicles to fund children’s education programs and have been engaged in a trademark dispute since 2003. Both parties have alleged federal and state trademark infringement, unfair competition and trademark dilution over their respective KARS 4 KIDS and CARS FOR KIDS trademarks. The parties were last before the Third Circuit in 2021, when the Court held that America Can was first to use its CARS FOR KIDS trademark in Texas, and Kars 4 Kids waived any challenge to the validity of America Can’s marks. In that 2021 decision, the Third Circuit also vacated the district court judgment in part and remanded the case for the district court to reexamine its laches and disgorgement conclusions, which had been decided in favor of America Can.

The Lanham Act does not contain a statute of limitations. Instead, it subjects all claims to the principles of equity. To determine whether laches bars a claim, a court considers two elements: whether the plaintiff inexcusably delayed in bringing suit, and whether the defendant was prejudiced as a result of the delay. With respect to the burden of proof for the laches claim at issue, America Can and Kars 4 Kids agreed that their Lanham Act claims were properly analogous to New Jersey’s six-year fraud statute. Therefore, because America Can first discovered the Kars 4 Kids trademark in Texas in 2003 and did not bring counterclaims until 2015, America Can was subject to a presumption that its claims were barred by laches unless it was able to prove both that its delay in filing suit was excusable and that it did not prejudice Kars 4 Kids.

On the issue of delay, the Third Circuit found that the district court erred because it did not find that America Can met its burden of establishing that its delay in bringing suit was excusable and that a reasonable person in its shoes would have waited to file suit. Instead, the district court improperly placed the burden on Kars 4 Kids to establish whether its advertisements in Texas were viewed by a sufficient number of Texans so as to put America Can on notice. As the Third Circuit explained, this was error. The district court should have held America Can to the burden of persuasion to show that it was not sufficiently aware of Kars 4 Kids’s use of its mark in Texas and to show what it did to identify and stop any potentially [...]

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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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