The US Patent and Trademark Office (USPTO) has updated its Subject Matter Eligibility Guidance to address artificial intelligence (AI) and other emerging technologies.

This is in response to President Biden’s Executive Order 14110, from November, 2023, on the Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence. That order states that:

Promoting responsible innovation, competition, and collaboration will allow the United States to lead in AI and unlock the technology’s potential to solve some of society’s most difficult challenges. This effort requires investments in AI-related education, training, development, research, and capacity, while simultaneously tackling novel intellectual property (IP) questions and other problems to protect inventors and creators.

The new Guidance includes three new detailed hypothetical examples involving:

• An application-specific integrated circuit (ASIC) for an artificial neural network; 
• A system for monitoring health and activity in a herd of dairy livestock animals; and
• A treatment method comprising administering rapamycin to a patient identified as having Nephritic Autoimmune Syndrome Type 3 (NAS-3).

The USPTO had previously issued 46 examples involving various fact patterns relevant to subject matter eligibility in the fields of “AI, biotechnology, business methods, diagnostic and treatment methods, pharmaceutical treatments, precision medicine, and software.”

As the USPTO explains in the new Guidance,

Claims directed to nothing more than a judicial exception (i.e., abstract ideas, natural phenomena, and laws of nature) are not eligible for patent protection. The Supreme Court has explained that the judicial exceptions reflect the Court’s view that abstract ideas, laws of nature, and natural phenomena are “the basic tools of scientific and technological work,” and are thus excluded from patentability because “monopolization of those tools through the grant of a patent might tend to impede innovation more than it would tend to promote it.”  Even if the judicial exception is narrow (e.g., a particular mathematical formula or detailed mental process), the Court has held that a claim may not preempt that judicial exception.

The USPTO further explains that

While it is common for claims to AI inventions to involve abstract ideas, USPTO personnel must draw a distinction between a claim that “recites” an abstract idea (and thus requires further eligibility analysis) and one that merely involves, or is based on, an abstract idea.

The three hypotheticals listed above (described in more detail in the Federal Register) do not recite an abstract idea according to the USPTO. 

The last time the USPTO issued similar eligibility guidance was in 2019, in the wake of the (enduring) confusion over the Alice/Mayo test for patentability. 

In February of 2024, the USPTO issued guidance on inventorship in the wake of attempts to get AI tools listed as “inventors” on patent applications. 

As the USPTO explains in the latest Guidance,

The guidance explains that current statutes (e.g.,35 U.S.C. 101 and 115) do not provide for recognizing contributions by tools such as AI systems (or other advanced systems) for inventorship purposes, even if those AI systems were instrumental in the creation of the invention. However, AI-assisted inventions are not categorically unpatentable. Patent protection may be sought for AI-assisted inventions where one or more persons made a significant contribution to the claimed invention.

Other recent AI-related releases from the USPTO include:

• On February 13, 2024, “Inventorship Guidance for AI-Assisted Inventions,” explaining the level of human contribution necessary for the USPTO to issue a patent on AI-assisted inventions.
  
• On April 11, 2024, “Guidance on Use of Artificial Intelligence-Based Tools in Practice Before the United States Patent and Trademark Office,” informing practitioners and the public of the important issues that patent and trademark professionals, innovators, and entrepreneurs must navigate while using AI in matters before the USPTO.
  
• On April 30, 2024 “Request for Comments Regarding the Impact of the Proliferation of Artificial Intelligence on Prior Art, the Knowledge of a Person Having Ordinary Skill in the Art, and Determinations of Patentability Made in View of the Foregoing.” 

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