USPTO Issues New Guidance on AI Assisted Inventions

The USPTO has rescinded its prior guidance on AI assisted inventions which relied on the Pannu factors when determining if a human sufficiently contributed to an AI-assisted invention to be considered an inventor.  The USPTO will continue to look to the Pannu factors in cases involving multiple humans to determine joint inventorship.  The USPTO will now focus on conception as the main test to determine whether a human is an inventor when using AI.  I understand why the USPTO is following this approach, but I did find the Pannu test helpful for ascertaining inventorship with AI assisted inventions.  My belief is that the USPTO’s new approach will result in more AI assisted inventions resulting in patentability.  The guidance applies to utility, design and plant patents.  Here is the updated guidance:

Revised Inventorship Guidance for AI-Assisted Inventions

AGENCY: United States Patent and Trademark Office, Department of Commerce. ACTION: Examination guidance.

SUMMARY: The United States Patent and Trademark Office (USPTO) had issued inventorship guidance for AI-assisted inventions on February 13, 2024.1 The USPTO hereby rescinds the previously published Inventorship Guidance for AI-Assisted Inventions and replaces it with the guidance below. . . .

I. Purpose

This notice provides further guidance on the proper legal standard for determining inventorship in patent applications for AI-assisted inventions.

II. Recission of Prior Guidance

The guidance issued on February 13, 2024, titled “Inventorship Guidance for AI-Assisted Inventions” is rescinded in its entirety. The approach set forth in that guidance, which relied on the application of the Pannu factors to AI-assisted inventions, is withdrawn. The Pannu factors only apply when determining whether multiple natural persons qualify as joint inventors. Pannu is inapplicable when only one natural person is involved in developing an invention with AI assistance because AI systems are not persons and therefore cannot be “joint inventors” so there is no joint inventorship question to analyze.

III. Governing Legal Standards

The same legal standard for determining inventorship applies to all inventions, regardless of whether AI systems were used in the inventive process. There is no separate or modified standard for AI-assisted inventions.

The Federal Circuit has held that AI cannot be named as an inventor on a patent application (or issued patent) and that only natural persons can be inventors. Artificial intelligence systems, regardless of their sophistication, cannot be named as inventors or joint inventors on a patent application as they are not natural persons.

The Federal Circuit has centered its inventorship inquiry around “conception,” characterizing conception as “the touchstone of inventorship.” Conception is “the formation in the mind of the inventor, of a definite and permanent idea of the complete and operative invention, as it is hereafter to be applied in practice.” Conception is complete when “the inventor has a specific, settled idea, a particular solution to the problem at hand, not just a general goal or research plan.”

Determining inventorship is highly fact intensive. The question is whether the natural person possessed knowledge of all the limitations of the claimed invention such that it is so “clearly defined in the inventor’s mind that only ordinary skill would be necessary to reduce the invention to practice, without extensive research or experimentation.” Analysis of conception turns on the ability of an inventor to describe an invention with particularity. Absent such a description, an inventor cannot objectively prove possession of a complete mental picture of the invention at a later time.

IV. Inventorship Guidance for AI-Assisted Inventions

Generally, the USPTO presumes those inventors named on the application data sheet or oath/declaration are the actual inventor or joint inventors of the application. A rejection under 35 U.S.C. 101 and 115, or other appropriate action, should be made for all claims in any application that lists an AI system or other non-natural person as an inventor or joint inventor.

AI systems, including generative AI and other computational models, are instruments used by human inventors. They are analogous to laboratory equipment, computer software, research databases, or any other tool that assists in the inventive process. As the case law establishes, inventors may “use the services, ideas, and aid of others” without those sources becoming co-inventors. The same principle applies to AI systems: they may provide services and generate ideas, but they remain tools used by the human inventor who conceived the claimed invention. When one natural person is involved in creating an invention with the assistance of AI, the inquiry is whether that person conceived the invention under the traditional conception standard set forth above in Section III.

When multiple natural persons are involved in creating an invention with AI assistance, the traditional joint inventorship principles apply, including the Pannu factors to determine whether each person qualifies as a joint inventor. Each purported inventor must “(1) contribute in some significant manner to the conception or reduction to practice of the invention, (2) make a contribution to the claimed invention that is not insignificant in quality, when that contribution is measured against the dimension of the full invention, and (3) do more than merely explain to the real inventors well-known concepts and/or the current state of the art.” The fact that AI tools were used in the development process does not change the joint inventorship analysis among the human contributors. . . .

Teva Pharmaceuticals will remove over 200 improper patent listings from the Orange Book

On December 10, 2025, the FTC announced that Teva Pharmaceuticals will “[r]emove. . .  Over 200 Improper Patent Listings” to improve generic competition.  The Press Release states:

FTC investigation prompts Teva request for removal of patents from Orange Book, paving the way for generic competition

After a challenge from the Federal Trade Commission, Teva Pharmaceuticals has requested that the Food and Drug Administration (FDA) remove more than 200 improper patent listings from the FDA’s Orange Book. The FTC sent a series of warning letters in May 2025 to Teva and several other pharmaceutical companies, which have also withdrawn most of the disputed listings.

These challenges are part of the FTC’s broader efforts to promote competition and lower drug prices in keeping with President Trump’s Executive Order on Lowering Drug Prices. Improper patent listings can limit competition by preventing generic alternatives from entering the market. This can keep drug prices artificially high and prevent patients from accessing lower-cost alternatives. The removals of more than 200 improper listings will pave the way for greater competition for generic alternatives for more than 30 asthma, diabetes, and COPD drugs and epinephrine autoinjectors.

“President Trump has promised Americans access to prescription drugs at lower costs. The FTC is fighting to help deliver on that promise,” said FTC Chairman Andrew N. Ferguson. “When improper patent listings limit competition from generic alternatives, it hurts Americans’ bank accounts and more importantly, it can endanger their health. The Trump-Vance FTC is working hard to ensure that Americans have access to the affordable prescription drugs they need.”

The FTC’s 2025 challenges followed a decision from the U.S. Court of Appeals for the Federal Circuit decision that affirmed that Teva’s patents were improperly listed, consistent with an amicus brief filed by the FTC. The FTC will continue to monitor the pharmaceutical industry for other improper listings and anticompetitive conduct.

The Federal Trade Commission works to promote competition, and to protect and educate consumers. The FTC will never demand money, make threats, tell you to transfer money, or promise you a prize. You can learn more about how competition benefits consumers, file an antitrust complaint, or comment on a proposed merger. For the latest news and resources, follow the FTC on social media, subscribe to press releases, and read our blog.

The AI Genesis Mission Launched by Trump Administration

On November 24, the Trump Administration announced the Genesis Mission to improve scientific research.  The Press Release states:

USHERING IN A NEW ERA OF DISCOVERY: Today, President Donald J. Trump signed an Executive Order launching the Genesis Mission, a new national effort to use artificial intelligence (AI) to transform how scientific research is conducted and accelerate the speed of scientific discovery.

• The Genesis Mission charges the Secretary of Energy with leveraging our National Laboratories to unite America’s brightest minds, most powerful computers, and vast scientific data into one cooperative system for research.
• The Order directs the Department of Energy to create a closed-loop AI experimentation platform that integrates our Nation’s world-class supercomputers and unique data assets to generate scientific foundation models and power robotic laboratories.
• The Order instructs the Assistant to the President for Science and Technology (APST) to coordinate the national initiative and the integration of data and infrastructure from across the Federal government.
• The Secretary of Energy, APST, and the Special Advisor for AI & Crypto will collaborate with academia and private-sector innovators to support and enhance the Genesis Mission.
• Priority areas of focus include the greatest scientific challenges of our time that can dramatically improve our Nation’s national, economic, and health security, including biotechnology, critical materials, nuclear fission and fusion energy, space exploration, quantum information science, and semiconductors and microelectronics.

HARNESSING AI FOR OUR NATIONAL SECURITY AND ECONOMIC DEVELOPMENT: With the Genesis Mission, the Trump Administration intends to dramatically expand the productivity and impact of Federal research and development within a decade.

• Despite research budgets soaring since the 1990s, scientific progress has stalled—new drug approvals have declined, and more researchers are needed to achieve the same outputs.
• Harnessing AI as a scientific tool will revolutionize the way scientific research is conducted.

o   For example, AI technologies can generate models of protein structures and novel materials, design and analyze experiments, and aggregate and generate new data faster and more effectively. Research that once took years could now take weeks or months.

• To do this, AI needs large amounts of organized and high-quality data and significant computing power. These datasets and computing technology already exist within DOE’s National Laboratories. With the Genesis Mission, the Trump Administration is bringing the power of AI to bear on our already expansive data infrastructure and creating a platform for multiple Federal research agencies and the private sector to collaborate to achieve breakthroughs currently thought impossible, and to win and stay ahead in the AI race.

STRENGTHENING AMERICA’S AI DOMINANCE: President Trump continues to prioritize America’s global dominance in AI to usher in a new golden age of human flourishing, economic competitiveness, and national security. 

• In January, President Trump signed an Executive Order to reverse harmful Biden Administration AI policies and enhance America’s global AI dominance.
• In April, President Trump signed an Executive Order to advance AI education for America’s youth.
• In July, President Trump signed Executive Orders to prevent woke AI in the Federal government and promote the export of full-stack American AI technologies.
• In July, President Trump issued America’s AI Action Plan, a policy agenda identifying nearly a hundred Federal actions to accelerate American AI innovation, build AI infrastructure at home, and lead in international diplomacy and security.

o   The AI Action Plan includes recommended policies for investing in AI-enabled science, including the direction to build world-class data sets.

• In September, the President signed an Executive Order on harnessing AI innovation to unlock cures for pediatric cancer, using the Childhood Cancer Data Initiative, which President Trump initially established in 2019 to collect, generate, and analyze childhood cancer data.