Patent Office Releases Role of AI in Inventorship Determinations

In February, the PTO released “Inventorship Guidance for AI-assisted Inventions (89 CFR 10043) and noted that the Office will issue examples to assist in the examination of applications in accord with this Guidance. I recently finished reading and annotating the Guidance and the Examples, that amounts to a short course on inventorship in all its fact-driven glory. The Guidance goes beyond factors involving the determination of inventorship, and tackles the duties of disclosed in Rule 56 and the duty of reasonable inquiry and the requirements for information. The latter can be made by the examiner “or other USPTO employee” (37 CFR s. 1.105). This can include an inquiry into inventorship and the role of AI in making the invention. Remember, the application cannot name an AI inventor, since AI is not a natural person, but the role that AI played in making the claimed invention may well be relevant to the role(s) played by the named inventors, and that role may not meet the “significant contribution” required by the Pannu standard.(Pannu v. Iolab Corp., 155 F.3d 1344 (Fed. Cir.  1998)). Put another way, “[A] new inventor cannot be named if no natural person made a significant contribution to an AI assisted invention” (89 C.F.R. 10048). So AI can “invent”, just not be named as an inventor on any claim when the application is filed.

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Is the Patent Eligibility Act a Panacea for Claims to Diagnostics?

On January 23, the Subcommittee on Intellectual Property held a hearing in which the members of the committee heard testimony about the Patent Eligibility Restoration Act (PERA) introduced by Senators Coons and Tillis. I have considered case law directed to s. 101 of 25 U.S.C. for more than a decade, and was hopeful that PERA could achieve its subtitled goal of “Restoring Clarity, Certainty, and Predictability to the U.S. Patent System”. The eight panelists had submitted comments that preceded the hearing, and the hearing was live streamed. The panelists were a blue ribbon group of patent attorneys who testified before the Senators, and took questions.

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Federal March-In Rights Meet Clawbacks – The Future of 35 USC ss. 200-212

This post could have been “The Revival of the March-In Rights of the Bayh-Dole Act.”

The passage of the Bayh-Dole Act in 1980 permitted universities to take title to inventions made with federal funding and grant licenses to commercial entities. These licenses were notably to “small business concerns” such as start-ups in the pharma and biotech ventures running on capital attracted by professors and their IP rights. Sections 200-212 covered the “who, how, what and were” requirements for universities to obtain title to inventions made with government funding and occupy pages 93-107 of the Act as presented by J. M. Samuels’ “Patent Trademark and Copyright Laws.” The requirements that must be met include the now-universal notice clause on resultant patents, “The invention was made with Government Support [usually naming the agency and the grant number] and that the Government has certain rights in the invention.”

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The Tyranny Of Large Numbers: Their Grip on s. 102 Inquiries

So that I don’t have to explain the claims and the arguments presented by the parties, please read my posts on the Supreme Court’s opinion on Amgen v. Sanofi on May 22, 2023 and the Fed. Cir.’s opinion on February 13, 2021. In Amgen the Supreme Court affirmed the Fed. Cir.’s opinion, ruling that the disclosure of 26 antibodies did not enable the functional claims that encompassed millions of antibodies, because the effort to identify the other members of the genus would amount to undue experimentation. Earlier I wrote that “While Lourie tries to cabin the undue effort holding by writing ‘We do not hold that the effort required to exhaust a genus is dispositive’, he contradicts himself in the same paragraph by concluding that ‘no reasonable jury could conclude under these facts that anything but ‘substantial time and effort’ would be required to reach the full scope of the claimer embodiments.” The Supreme Court quoted the first sentence I quoted but ignored the second and wrote, “Instead the court stressed, the problem it saw was the same problem we see: Amgen offers persons skilled in the art little more than advice to engage in ‘trial and error.’” So Sanofi succeeded in being found not-guilty of infringement of their antibody-based therapeutic simply by waiving the “at least millions of candidates” that would have to be screened for the recited bioactivity, and this effort involves “undue experimentation.”

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