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No Need to Call for Backup at the PTAB (Sometimes)

The US Patent & Trademark Office (PTO) published a final rule entitled, Expanding Opportunities to Appear Before the Patent Trial & Appeal Board; 89 Fed. Reg. 82172 (Oct. 10, 2024).

The new rule, set to take effect on November 12, 2024, will apply to America Invents Act (AIA) proceedings, which, until now, have required that a party designate lead counsel and backup counsel. Lead counsel was required to be a registered practitioner, and non-registered practitioners could be backup counsel upon a showing of good cause.

The PTO filed a notice of proposed rulemaking on February 21, 2024, in which it proposed amending the regulations to allow the Board to permit a party to proceed without separate backup counsel as long as lead counsel is a registered practitioner. The PTO also proposed to allow a non-registered practitioner admitted pro hac vice to serve as either lead or backup counsel for a party as long as a registered practitioner was also counsel of record for that party, and to allow a non-registered practitioner who was previously recognized pro hac vice in an AIA proceeding to be considered a Board-recognized practitioner and eligible for automatic pro hac vice admission in subsequent proceedings via a simplified and expedited process.

Citing the benefits of flexibility where good cause is shown while ensuring parties are well represented, the PTO has now issued a final rule that will allow parties to proceed without backup counsel. The PTO noted that a party may demonstrate good cause, for example, by demonstrating lack of financial resources to retain both lead and backup counsel. However, the Board will question any claim of lack of financial resources where a party has also elected to pursue litigation involving the challenged patents in other forums. As a result, this rule is more likely to benefit patentees than patent challengers. The PTO also explained that the good cause analysis will center on the party, not on the counsel’s preferences. For example, the PTO is unlikely to find good cause where the lead counsel is a solo practitioner who prefers to work alone.

The PTO also issued a final rule simplifying the process for attorneys who were previously admitted to practice before the Board pro hac vice to gain admission for subsequent matters and to do so without a fee. Any attorney seeking subsequent pro hac vice admission must file a declaration or affidavit stating that all the requirements set out by the Board are met. Opposing counsel also has the opportunity to object.

Finally, the PTO rejected an amendment that would allow non-registered attorneys to serve as lead counsel.




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End of an Era: PTO Terminates AFCP 2.0 Amid Fee Concerns

The US Patent & Trademark Office (PTO) announced the termination of the After Final Consideration Pilot Program (AFCP) 2.0, effective December 15, 2024. 89 Fed. Reg. 79899 (Oct. 1, 2024).

Launched in 2013, AFCP 2.0 aimed to streamline the patent examination process following a final rejection by allowing applicants to submit amendments without incurring additional fees. The program provided examiners with extra time to review these amendments, conduct additional searches, and potentially schedule interviews with applicants to discuss the results.

Since 2016, applicants have filed more than 60,000 AFCP 2.0 requests annually. The PTO noted that the high usage was due in part to the program’s benefits being provided at no direct cost to participants. However, the PTO estimated that it has incurred more than $15 million in costs due to the program. Consequently, on April 3, 2024, the PTO proposed a new fee to recuperate costs affiliated with AFCP 2.0 requests. This proposal sparked concerns among commenters about AFCP 2.0.

In light of these concerns, the PTO has decided to allow the AFCP 2.0 program to expire. Although the program was initially set to end on September 30, 2024, the PTO extended it to accommodate those currently participating or preparing to use the program. The final date to submit a request under the program is December 14, 2024.




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Got Pillaged? Not If You Didn’t Follow the APA and FTCA

The US Court of Appeals for the Federal Circuit affirmed a district court decision dismissing claims under the Administrative Procedure Act (APA) and Federal Tort Claims Act (FTCA) against the US Patent & Trademark Office (PTO) relating to “pillaged patents.” The Federal Circuit found that dismissal was appropriate because the plaintiff failed to exhaust administrative remedies and the claims were barred under collateral estoppel. Winfrey v. Dep’t of Com., Case No. 24-1260 (Fed. Cir. Sept. 25, 2024) (Prost, Hughes, Cunningham, JJ.) (per curiam).

Eula Winfrey filed a pro se complaint in district court seeking “relief for the issue of two pillaged patents,” one of which was directed to a “step-up diaper” and the other to a “stroller buddy.” Winfrey claimed that the PTO “improperly denied her two patent applications and wrongfully deemed the applications to be abandoned,” and that she was the true inventor of Huggies Pull-Ups diapers. Interpreting Winfrey’s requests for relief as claims under the FTCA and the APA, the district court dismissed the claims related to the step-up diaper patent application for failure to exhaust administrative remedies. The district court found that Winfrey never presented an administrative claim to the PTO as required by the FTCA and that she did not file a petition to revive the application after the PTO deemed it abandoned. The district court also dismissed Winfrey’s APA claim related to the stroller buddy patent application based on collateral estoppel because Winfrey had previously litigated that claim. Winfrey appealed.

Applying Eleventh Circuit law, the Federal Circuit affirmed the district court’s dismissal of all of Winfrey’s claims. Addressing the FTCA claim first, the Court noted that “nowhere in any of her extensive filings before this court do we find evidence that Ms. Winfrey filed the requisite administrative claim to bring a claim for money damages against the USPTO.” The Federal Circuit also affirmed the district court’s dismissal of claims related to the stroller buddy application based on collateral estoppel, finding that Winfrey had brought the claim unsuccessfully three times. Finally, with respect to the APA claim for the step-up diaper patent application, the Court affirmed the district court’s dismissal for failure to exhaust administrative remedies after finding that Winfrey failed to “present any evidence that she filed a petition with the USPTO to revive her application or challenge its abandonment determination.”




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AI Takeover: PTO Issues More Patent Eligibility Guidance for AI Inventions

The US Patent & Trademark Office (PTO) issued a 2024 Guidance Update on Patent Subject Matter Eligibility, Including on Artificial Intelligence, which focuses on subject matter eligibility for artificial intelligence (AI)-based inventions. 89 Fed. Reg. 58128 (July 17, 2024).

The new guidance is part of the PTO’s ongoing efforts since 2019 to provide clarity on the issue of subject matter eligibility under 35 U.S.C. § 101 and to promote responsible innovation, competition and collaboration in AI technology development as espoused in the Biden administration’s Executive Order 14110, “Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence.” The guidance follows on the heels of the PTO’s recently issued Guidance on Use of AI-Based Tools in Practice Before the PTO and Inventorship Guidance for AI-Assisted Inventions.

The new guidance aims to assist PTO examiners, patent practitioners and stakeholders in evaluating the subject matter eligibility of patent claims involving AI technology. The guidance includes three main sections:

  • Section I provides background on issues concerning patentability of AI inventions.
  • Section II provides a general overview of the PTO’s patent subject matter eligibility guidance developed over the past five years.
  • Section III provides an update to certain areas of the guidance applicable to AI inventions.

As in the prior subject matter eligibility updates and discussions, the guidance document’s analysis of subject matter eligibility focuses on the Alice two-step analysis: an evaluation of whether a claim is directed to a judicial exception (i.e., abstract ideas, natural phenomena, laws of nature), and if so, an evaluation of whether the claim as a whole integrates the judicial exception into a practical application of that exception and/or an analysis of whether the claim recites additional elements that amount to significantly more than the recited judicial exception itself. The guidance highlights a number of relevant recent Federal Circuit cases and is further accompanied by three new examples with hypothetical patent claims for assisting PTO examiners in applying the guidance to an analysis of patent claim eligibility under 35 U.S.C. § 101.

The PTO requests written comments to the guidance through the Federal eRulemaking Portal by September 16, 2024. If there is anything to be gleaned from the guidance or the current state of patentability for AI inventions, the topic will remain highly controversial and heavily debated.




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PTO Asks Whether Legislative Action for Experimental Use Exception Is Warranted

The US Patent & Trademark Office (PTO) issued a request for comments concerning the public’s views on the common law experimental use exception and whether Congress should enact a statutory experimental use exception. 89 Fed. Reg. 53963 (June 28, 2024).

The experimental use defense for alleged patent infringement has been part of US jurisprudence for more than 200 years. The current state of experimental use exception jurisprudence in the United States is set forth in Madey v. Duke University, 307 F.3d 1351 (Fed. Cir. 2002). In that case, the Federal Circuit proffered a “very narrow and strictly limited experimental use defense” prohibiting an alleged infringer from invoking such a defense for “use that is in any way commercial in nature” or “any conduct that is in keeping with the alleged infringer’s legitimate business, regardless of commercial implications.”

The Madey decision has been met with a mix of opinions, some arguing that the Federal Circuit’s construction encourages innovation and others arguing that it impedes innovation. Limited exemptions have been carved out in the US. For example, 35 U.S.C. § 271(e)(1) established a safe harbor (the Bolar exemption) allowing for the experimental use of a patented invention by parties to collect regulatory approval data for medical devices or drugs. The Plant Variety Protection Act also provides for exemptions allowing the use of protected plant varieties for research and breeding of new varieties.

While many European and Asian nations have statutory experimental use exceptions in place, legislative efforts for codifying a statutory experimental use exception in the US have thus far failed. With the intent to promote fair competition and innovation, the PTO seeks to revisit this issue by collecting the public’s views on the impact of the experimental use exception in all technology areas. Of particular interest, the PTO seeks comments on one or more topics, including:

  • How current US experimental use exception jurisprudence impacts investment and/or research and development in any field of technology.
  • Whether certain technologies are negatively affected by the current experimental use exception jurisprudence.
  • The impact that a statutory experimental use exception would have on the innovation and commercialization of new technologies with respect to research and development, ability to obtain funding, investment strategy, licensing of patents and patent applications, product development, sales (including downstream and upstream sales), competition, and patent enforcement and litigation.
  • The impact of current experimental use exception jurisprudence on decisions made with respect to filing, purchasing, licensing, selling or maintaining patent applications and patents in the US.
  • Reasons for adopting a statutory experimental use exception or maintaining the status quo.
  • How a statutory experimental use exception should be defined to ensure that patent rights are preserved.
  • Recommendations for enhancing and facilitating experimental research on patent inventions in the US.

When responding to the questions, commenters are further asked to identify whether they represent, for example:

  • An inventor, patent owner or investor.
  • A licensee or user of patented technology.
  • An entity representing inventors or patent owners (g., law firms).
  • A recipient of [...]

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PTO Finalizes Rules Promoting Independence in PTAB Decision-Making

The US Patent & Trademark Office (PTO) announced a final rule concerning pre-issuance internal circulation and review of decisions within the Patent Trial & Appeal Board. The new rules are designed to bolster the independence of administrative patent judge (APJ) panels when issuing decisions and increase transparency regarding Board processes. 89 Fed. Reg. 49808 (June 12, 2024).

The new rules amend and codify Title 37 of the Code of Federal Regulations (37 C.F.R. §§ 43.1 – 43.6) by adding Section 43 relating to Board proceedings pending under 37 C.F.R. §§ 41 and 42. The final rule was developed in response to a July 2022 request for comments concerning interim processes and standards in place since May 2022, and an October 2023 notice of proposed rulemaking and request for comments. The final rule codifies the interim processes set forth in Standard Operating Procedure 4 (SOP4), which replaced the standards in place since May 2022.

Under the new rules codified in §§ 43.3 and 43.4, prior to issuance of a panel decision, senior PTO management and non-management APJs (as defined in § 43.2) are barred from communicating, directly or through intermediaries, with any panel member (unless they were themselves panel members) regarding panel decisions. Limited communications are permitted for procedural status and generally applicable paneling guidance that doesn’t directly or otherwise influence the paneling or repaneling of any specific proceeding. The rules do not forbid a panel member from requesting input on a decision prior to issuance from non-panel senior APJs, however. The rules further stipulate that it is within the panel’s sole discretion to adopt any edits, suggestions or feedback from non-panel APJs.

The rule is effective July 12, 2024.




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PTO Collaborates With UK Counterpart to Address Standard-Essential Patents

On June 3, 2024, Under Secretary of Commerce for Intellectual Property and US Patent & Trademark Office (PTO) Director Kathi Vidal and Chief Executive Officer of the UK Intellectual Property Office (IPO) Adam Williams signed a memorandum of understanding (MOU) designed to tackle various issues related to standard-essential patents (SEPs).

SEPs are patents that have been declared essential to a particular technical standard. Common examples of technical standards with active SEP bases include cellular communication and other wireless standards, such as LTE, 5G and Wi-Fi. Standards are typically adopted by Standard Setting Organizations (SSOs). To have input on standard adoption, many SSOs require participants agree to license any patents that result from discussions with potential licensees on Fair, Reasonable and Non-Discriminatory (FRAND) terms (See e.g., ETSI Intellectual Property Rights Policy).

But what are FRAND terms, and who gets to decide whether they issue? While individual patents are territorial (e.g., a US-issued patent is only enforceable in the United States), patent owners often obtain patent coverage in multiple jurisdictions. This can lead to challenges wherein a court in one jurisdiction may determine FRAND terms for a patent in that jurisdiction, which may then set or significantly influence the FRAND rate for the patent owner’s corresponding patents in other jurisdictions.

While the MOU is not public at this time, the PTO indicated that the MOU sets forth a framework for the following action items:

  • Cooperate on activities to facilitate collaboration and exchange of information on policy matters concerning SEPs to better ensure a balanced standards ecosystem.
  • Explore means to educate small- and medium-sized enterprises seeking to implement or contribute to the development of technical interoperability standards on FRAND terms.
  • Examine ways of improving transparency in the FRAND licensing of technical interoperability standards.
  • Engage in outreach to stakeholders to raise awareness of issues related to SEPs.
  • Discuss means to incorporate additional jurisdictions into the PTO and IPO’s activities concerning SEPs, including exploring a venue for broader discussions.

The agreement remains in place through June 3, 2029. PTO Director Vidal emphasized that “[t]his important collaboration with UKIPO will help us work together toward a fair and balanced international standard essential patent ecosystem that benefits all businesses in our two countries, including small and medium-sized enterprises and new market entrants.”




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PTO Reopens Comment Period for AI Inventorship Guidance

The US Patent & Trademark Office (PTO) reopened and extended until June 20, 2024, the period for public comment on the guidance regarding inventorship in applications involving artificial intelligence (AI) assisted inventions. The guidance was published on February 13, 2024, at 89 FR 10043. The PTO will also treat as timely any comments received between May 13, 2024, and the notice’s June 6, 2024, publication date.

Comments on the inventorship guidance must be submitted via the Federal Rulemaking Portal.

For more information, see our previous report on the February 13 PTO notice and related examination guidance.




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For Statutory Equivalents, Even One Means May Be Enough

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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Patent Thicket Avoidance: PTO Proposes Changes to Terminal Disclaimer Practice

On May 10, 2024, the US Patent & Trademark Office (PTO) issued a notice of proposed rulemaking (Notice) concerning major changes to the terminal disclaimer (TD) practice, which may lead to a sea change in patent prosecution strategies. The proposed change would require a TD to include an agreement from the patent owner that the patent will be unenforceable if it’s tied directly or indirectly to another patent having any patent claim invalidated or canceled based on prior art. 89 Fed. Reg. 40439 (May 10, 2024).

The rule change is a potential boon for patent challengers and is intended to promote innovation and competition by allowing a competitor to avoid enforcement of patents tied by TDs to patents with claims finally held unpatentable or invalid. Under current practice, invalidation of a patent tied to another patent by a TD does not directly affect the patentability of the other patent. Under the new rule, a competitor could target a single patent in a validity dispute in a post-grant challenge without the need to seek review and invalidation of other related patents. As a result, invalidating one claim in a patent tied to other patents by TDs would render all other tied patents unenforceable.

According to the Notice, the proposed change aligns with the US government’s intent to reduce drug costs and promote competition by reducing barriers to market entry in accordance with President Biden’s Executive Order 14036 on “Promoting Competition in the American Economy.” Part of the reduced costs are said to come from bringing down the cost of challenging large “patent thickets” of multiple patents covering a single product or minor variations of the product tied by TDs.

The proposed rule change would represent a paradigm shift for TD practice. Current TD practice under 37 CFR 1.321(c) or (d) allows applicants to file multiple patents with claims varying in only minor ways from one another by filing TDs to obviate obviousness-type double patenting (ODP) rejections over closely related patent claims issued or pending in applications commonly owned or commonly owned on the basis of a joint research agreement. In filing a TD, the applicant agrees to disclaim any patent term extending beyond the term of the prior patent having similar patent claims.

The proposed rule seeks “to revise 37 CFR 1.321 (c) and (d) to require that a terminal disclaimer filed to obviate nonstatutory double patenting include an agreement by the disclaimant that the subject patent or any patent granted on the subject application shall be enforceable only if the patent is not tied and has never been tied directly or indirectly to a patent by one or more terminal disclaimers filed to obviate nonstatutory double patenting in which:

(1) any claim has been finally held unpatentable or invalid under 35 U.S.C. 102 or 103 . . . by a Federal court in a civil action or by the PTO, and all appeal rights have been exhausted; or

(2) a [...]

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