IP UPDATE
Exploring the Latest in Intellectual Property Law
IP UPDATE
Exploring the Latest in Intellectual Property Law
Patent & Trademark Office/PTO
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AI Takeover: PTO Issues More Patent Eligibility Guidance for AI Inventions

by | Jul 25, 2024 | ,

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

by | Jul 18, 2024 |

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

by | Jun 20, 2024 |

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

by | Jun 13, 2024 |

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

by | Jun 13, 2024 |

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

by | Jun 6, 2024 |

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

by | May 23, 2024 |

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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Clean Up on Aisle PTAB: Clarification of Discretionary Denial Practice

by | May 2, 2024 |

The US Patent & Trademark Office (PTO) issued a Notice of Proposed Rulemaking (NPRM) for inter partes review (IPR) and post-grant review (PGR) proceedings before the Patent Trial & Appeal Board, seeking to codify existing precedent and guidance regarding the Board’s discretionary considerations in denying IPR or PGR petitions. 89 Fed. Reg. 28693 (Apr. 19, 2024).

The NPRM follows a 2020 request for comments and an April 2023 Advance Notice of Proposed Rulemaking (ANPR) that the PTO had hoped to finalize in terms of rulemaking by fall 2023. However, proposals in the ANPR hit a snag following criticism from Congress and more than 14,500 comments from stakeholders and the public, including charges that the PTO Director was overstepping her authority.

The newly proposed rules address:

  • Briefing on motions for discretionary denial
  • Factors for discretionary denial
  • Termination and settlement agreements

Briefing on Motions for Discretionary Denial

A significant aspect of the proposal provides for a separate briefing schedule between a patent owner’s preliminary response (POPR) and a request for discretionary denial, which must be filed no later than one month prior to the deadline for the POPR for briefing on its merits. Under the proposal, the discretionary denial arguments would be excluded from the preliminary response unless otherwise authorized by the Board and are intended to avoid encroaching on the wordcount limits for briefing on the merits. Under the proposed briefing process, there would be a 10-page limit for a patent owner’s request for discretionary denial and for the petitioner opposition, and a five-page limit for the patent owner’s sur-reply.

Factors for Discretionary Denial

The proposed rules address denial of institution for “parallel petitions” or “serial petitions” to provide a framework for considering whether previously presented art or arguments provide grounds for denial. The proposed rules also address treatment of joinder petitions, particularly in relation to already instituted petitions. Parallel petitions are defined in the proposed rule as two or more petitions by the same petitioner challenging the same patent that are filed on or before the filing of a POPR to any of the petitions or on or before the due date for filing a POPR to the first petition. Serial petitions are defined as challenged claims of the same patent overlapping with those in a previously filed petition for IPR, PGR or covered business method patent review.

According to the proposed rules, a parallel petition would not be instituted without a good cause showing of why more than one petition is necessary. Factors for a good cause showing include:

  • A petitioner’s ranking of desired petitions for consideration
  • An explanation of differences and materiality between the petitions
  • The number of challenged patent claims, including those asserted by the patent owner in district court litigation
  • A priority date dispute
  • Alternative claim constructions requiring different prior art references on mutually exclusive grounds
  • Knowledge of asserted claims at the time of filing a petition
  • Complexity of the technology

Similar considerations would also apply to joinder petitions.

[...]

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PTO Proposes New Guidelines for Director Review in Board Proceedings

by | Apr 25, 2024 | ,

The US Patent & Trademark Office (PTO) proposed new rules governing the process for Director review of Patent Trial & Appeal Board decisions in America Invents Act (AIA) proceedings. Rules Governing Director Review of Patent Trial and Appeal Board Decisions, 89 Fed. Reg. 26,807 (proposed Apr. 16, 2024) (to be codified at 37 C.F.R. pt. 42).

The Notice of Proposed Rulemaking (NPRM) proposes adding 37 C.F.R. § 42.75, which includes rules addressing the following issues:

Limited Availability of Director Review. The NPRM proposes that Director review in AIA proceedings would only be available to a party from institution decisions, final written decisions or panel decisions granting rehearing of a decision on institution or a final written decision. However, the Director would have authority to review any interlocutory decisions rendered in reaching such decisions. The NPRM also proposes that the Director may sua sponte review institution decisions, final written decisions or decisions granting rehearing.

Timing, Format and Content of Requests for Director Review. The NPRM proposes that requests for Director review would have to be sought within the time period set forth by 37 C.F.R. § 42.71(d), comply with the formatting and length requirements of 37 C.F.R. §§ 42.6(a) and 42.24(a)(1)(v), and would not be allowed to introduce new evidence. Any sua sponte Director review would have to be initiated within 21 days after the deadline to seek rehearing.

Effect of Director Review. The NPRM proposes that a decision on institution, a final written decision or a decision granting rehearing would become final agency action unless Director review was timely sought or timely initiated sua sponte or a request for Director review was denied.

Director Review Process. The NPRM proposes that Director review would not stay the underlying proceeding, but if the Director grants review, the review would conclude with the issuance of a decision or order that provides the reasons for the Director’s disposition of the case. A party would be permitted to appeal a Director review decision of either a final written decision or a decision granting rehearing of a final written decision (not institution decisions or decisions granting rehearing of institution decisions) to the Federal Circuit in accordance with the procedures set forth in 35 U.S.C. §§ 141(c) and 319. A request for Director review would be treated as a request for rehearing and would reset the time for appeal until Director review was resolved.

Delegation. The NPRM proposes that delegation of Director review would be permitted, subject to conditions set forth by the Director.

Communications With the PTO. The NPRM proposes that communications from a party concerning a specific Director review request or proceeding would have to copy counsel for all parties. Other than authorized amicus briefings, communications from third parties would not be allowed.

Comments are due by June 17, 2024, and can be submitted through the federal eRulemaking portal here.



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New Guidance Addresses Use of AI Systems, Tools in Practice Before the PTO

by | Apr 18, 2024 |

The US Patent & Trademark Office (PTO) issued new guidance on the use of artificial intelligence (AI) tools in practice before the PTO. The new guidance is designed to promote responsible use of AI tools and provide suggestions for protecting practitioners and clients from misuse or harm resulting from their use. This guidance comes on the heels of a recent memorandum to both the trademark and patent trial and appeal boards concerning the applicability of existing regulations addressing potential misuse of AI  and recent guidance addressing the use of AI in the context of inventorship.

Patent practitioners are increasingly using AI-based systems and tools to research prior art, automate the patent application review process, assist with claim charting, document reviews and gain insight into examiner behavior. The PTO’s support for AI use is reflected in patent examiners’ utilization of several different AI-enabled tools for conducting prior art searches. However, because AI tools are not perfect, patent practitioners are potentially vulnerable to misuse or misconduct. Therefore, the PTO’s new guidance discusses the legal and ethical implications of AI use in the patent system and provides guidelines for mitigating the risks presented by AI tools.

The guidance discusses the PTO’s existing rules and policies for consideration when applying AI tools, including duty of candor, signature requirement and corresponding certifications, confidentiality of information, foreign filing licenses and export regulations, electronic systems’ policies and duties owed to clients. The guidance also discusses the applicability of these rules and policies with respect to the use of AI tools in the context of document drafting, submissions, and correspondence with the PTO; filing documents with the PTO; accessing PTO IT systems; confidentiality and national security; and fraud and intentional misconduct.

AI tools have been developed for the intellectual property industry to facilitate drafting technical specifications, generating responses to PTO office actions, writing and responding to briefs, and drafting patent claims. While the use of these tools is not prohibited, nor is there any obligation to disclose their use unless specifically requested, the guidance emphasizes the need for patent practitioners to carefully review any AI outputs generated before signing off on any documents or statements made to the PTO. For example, when using AI tools, practitioners should make a reasonable inquiry to confirm that all facts presented have evidentiary support, that all citations to case law and other references are accurately presented, and that all arguments are legally warranted. Any errors or omissions generated by AI in the document must be corrected. Likewise, trademark and Board submissions generated or assisted by AI must be reviewed to ensure that all facts and statements are accurate and have evidentiary support.

While AI tools can be used to assist or automate the preparation and filing of documents with the PTO, care must be taken to ensure that no PTO rules or policies are violated and that documents are reviewed and signed by a person, not an AI tool or non-natural person. AI [...]

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