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The USPTO has rescinded its prior guidance on AI assisted inventions which relied on the Pannu factors when determining if a human sufficiently contributed to an AI-assisted invention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The guidance issued on February 13, 2024, titled “Inventorship Guidance for AI-Assisted Inventions” is rescinded in its entirety.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approach set forth in that guidance, which relied on the application of the Pannu factors to AI-assisted inventions, is withdrawn.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. 

USPTO Stands Firm for Strong Patent Remedies

USPTO states that strong remedies for patent infringement are necessary to protect the public interest.  The Press Release states:

The United States Patent and Trademark Office (USPTO) today submitted a Joint Public Interest Comment to the U.S. International Trade Commission in Inv. No. 337-TA-3854, emphasizing that the public interest is best served when valid U.S. patent rights are fully and effectively enforced.

The USPTO’s filing explains that patents are constitutional property rights that have powered America’s leadership in technologies “from Morse’s telegraph to modern semiconductors, biologics, and artificial intelligence.” Strong patent protection encourages the investment-based risk taking needed to create and bring to market new technologies.

The Joint Comment with the Department of Justice cautions against approaches that would transform public-interest considerations into preliminary hurdles or de facto barriers to enforcement. Congress designed patent remedies—including injunctions and exclusion orders—to operate as reliable tools for protecting innovation and fueling economic growth.

The USPTO noted that weakening remedies undermines America’s innovation ecosystem, which depends on predictable, enforceable patent rights. The Office recently expressed similar views in its June 2025 Joint Statement of Interest filing with the Department of Justice in Radian Memory Systems v. Samsung, highlighting that patents are unique assets whose value is often not captured through monetary damages alone.

USPTO Director Reclaims Authority to Institute IPRs

The new Under Secretary of Commerce for Intellectual Property and Director of the United States Patent and Trademark Office, John Squires, has reclaimed authority to institute IPRs. Here is his letter regarding the subject:

An Open Letter From America’s Innovation Agency

Bringing the USPTO Back to the Future: Return of Institution Authority under 35 U.S.C. §§ 314 and 324 to the Director

Dear Colleagues, Inventors, and Americans,

Under the America Invents Act (AIA), Congress entrusted the United States Patent and Trademark Office with several mandates to ensure the timely and fair adjudication of patent validity challenges through post-grant review (PGR) or inter partes review (IPR) mechanisms and priority contests via derivation proceedings. As to IPRs specifically, under 35 U.S.C. § 314(a), Congress made plain that: The Director may not authorize an inter partes review to be instituted unless the Director determines that the information presented in the petition … shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition. This statutory language expressly vests the authority to institute IPRs and PGRs in the USPTO Director. While 35 U.S.C. § 3(b)(3)(B) permits delegation of that authority, such delegation is non-exclusive. Statutorily, the Director retains full and concurrent authority over whether an IPR or PGR shall proceed. Since the AIA’s enactment, initial operational choices led to the delegation of institution decisions to the Patent Trial and Appeal Board, where panels then adjudicated the merits once instituted. Although this delegation was initially practical, experience has raised structural, perceptual, and procedural concerns inconsistent with the AIA’s design, clear language, and intent affecting, among other things, the public’s rightful expectation of impartiality. Given the statutory charge, my aim as Director is to address these concerns. Under oath in my confirmation hearing before the Senate Judiciary Committee and thereafter in my submitted Questions for the Record responses, I expressed discomfort that data seemed to be “skewed” in favor of certain provisions (namely IPRs over PGRs and a very high invalidation rate). To me, this raised questions about both the administration of IPR proceedings and their institution in particular. I vowed to administer the AIA as the statute provides and as Congress intended.

Today, in keeping with my vow and having now taken the Oath of Office as USPTO Director, I have ordered changes pursuant to my memo to the Board (attached). Below, I describe the reasons for my action today. Over the past several years, the delegated-institution model has given rise to the following difficulties: 1. Perception of Self-Incentivization – While the Board has done an admirable job, performance metrics and workload structures have created the appearance that institution decisions affect docket size, credit, and resource allocation—inviting concern that the Board may be “filling its own docket.” – This may be unfounded, but nevertheless such a perception undermines public confidence in the integrity of our Office’s adjudicatory functions with respect to IPRs. 2. Bifurcated Procedures for Discretionary Considerations – The evolution of the bifurcated processes, which were smart and necessary, was never intended to be permanent. Under those processes, a preliminary review precedes Board referral. However, this appears to have inadvertently produced extraordinarily high institution rates (at one point exceeding 95 percent) for referred cases. 3. Statutory Adherence and Administrative Clarity – Congress expressly charges the Director—not the Board as delegees —to make institution determinations. Returning this function to the Director re aligns our Office’s procedures with the clear language and intent of the statute and returns accountability for such decisions to the Director just as the framework of the AIA provides. In sum, reclaiming the Director’s statutory role is intended to: • Eliminate the appearance of self-interest by separating the power to institute from the body that conducts the trial; • Remove a perceived referral-signal bias by centralizing the decision point; • Enhance transparency and public trust through a single line of authority; and • Re-align the duties and responsibilities of the Director, as a Presidentially appointed and Senate-confirmed officer, to be accountable for this threshold determination and properly effectuate the clear language of the AIA and thus Congress’s intent.

This action aligns the USPTO’s administration of IPRs with both the letter and the spirit of 35 U.S.C. § 314 and strengthens the integrity of the Office’s adjudicatory processes. In closing, the mission of America’s Innovation Agency is to lead the world in intellectual property protection. We can do so and serve the public interest only by maintaining a patent system that is fair, predictable, and respected. Returning institution authority to the Director bolsters our mission because it restores the statutory framework mandated by Congress in the America Invents Act.

UK intervention on SEPs including rate setting swims against the tide

The UK Intellectual Property Office’s 2025 consultation on standard essential patents proposes measures to improve licensing transparency and efficiency. These include searchable SEP databases, essentiality checking services, and mechanisms for aggregate rate setting to facilitate top-down approach FRAND licensing rate apportionments. While these initiatives aim to support UK innovation – particularly for SMEs – they risk undermining a licensing system that has successfully evolved through decades of commercial practice and judicial developments.

The UK’s Prime Minister and Chancellor have recently pledged to promote economic growth by slashing red tape and taking out regulators. The IPO’s proposals fly in the face of that.

In my response submission to the IPO’s consultation, I focus on interventions that could do more harm than good: essentiality checking and essentiality rate estimating, aggregate royalty setting and top-down rate apportionment. My concerns are similar to those previously raised in response to the EU SEP consultation in 2023 and 2024.

Checking essentiality – along with infringement and validity – are important and are economically achieved on handfuls of patents to reliably establish that licensing is required. Comparable licences are then the generally preferred method of determining FRAND rates. Where these do not yet exist or are unavailable, parties are best placed to determine rates through discussion and negotiation.

Estimating essentiality rates of entire patent portfolios and for all patents reading on a standard is a far more demanding and costly endeavour, even when only random samples of patents are checked. Results are inaccurate and unreliable.

Setting aggregate royalties and then apportioning them based on counts of declared essential or checked essential patents is also very problematic.

My consultation submission can be downloaded here.

U.S. NIST Report on DeepSeek

The U.S. National Institute of Standards and Technology has recently released a 69 page report concerning DeepSeek and the risks associated with utilizing it.  The Press Release states:

WASHINGTON — The Center for AI Standards and Innovation (CAISI) at the Department of Commerce’s National Institute of Standards and Technology (NIST) evaluated AI models from the People’s Republic of China (PRC) developer DeepSeek and found they lag behind U.S. models in performance, cost, security and adoption.

“Thanks to President Trump’s AI Action Plan, the Department of Commerce and NIST’s Center for AI Standards and Innovation have released a groundbreaking evaluation of American vs. adversary AI,” said Secretary of Commerce Howard Lutnick. “The report is clear that American AI dominates, with DeepSeek trailing far behind. This weakness isn’t just technical. It shows why relying on foreign AI is dangerous and shortsighted. By setting the standards, driving innovation, and keeping America secure, the Department of Commerce will ensure continued U.S. leadership in AI.”

The CAISI evaluation also notes that the DeepSeek models’ shortcomings related to security and censorship of model responses may pose a risk to application developers, consumers and U.S. national security. Despite these risks, DeepSeek is a leading developer and has contributed to a rapid increase in the global use of models from the PRC.

CAISI’s experts evaluated three DeepSeek models (R1, R1-0528 and V3.1) and four U.S. models (OpenAI’s GPT-5, GPT-5-mini and gpt-oss and Anthropic’s Opus 4) across 19 benchmarks spanning a range of domains. These evaluations include state-of-the-art public benchmarks as well as private benchmarks built by CAISI in partnership with academic institutions and other federal agencies.

The evaluation from CAISI responds to President Donald Trump’s America’s AI Action Plan, which directs CAISI to conduct research and publish evaluations of frontier models from the PRC. CAISI is also tasked with assessing: the capabilities of U.S. and adversary AI systems; the adoption of foreign AI systems; the state of international AI competition; and potential security vulnerabilities and malign foreign influence arising from the use of adversaries’ AI systems.

CAISI serves as industry’s primary point of contact within the U.S. government to facilitate testing, collaborative research, and best practice development related to commercial AI systems, and is a key element in NIST’s efforts to secure and advance American leadership in AI.

Key Findings

DeepSeek performance lags behind the best U.S. reference models.
The best U.S. model outperforms the best DeepSeek model (DeepSeek V3.1) across almost every benchmark. The gap is largest for software engineering and cyber tasks, where the best U.S. model evaluated solves over 20% more tasks than the best DeepSeek model.

DeepSeek models cost more to use than comparable U.S. models.
One U.S. reference model costs 35% less on average than the best DeepSeek model to perform at a similar level across all 13 performance benchmarks tested.

DeepSeek models are far more susceptible to agent hijacking attacks than frontier U.S. models.
Agents based on DeepSeek’s most secure model (R1-0528) were, on average, 12 times more likely than evaluated U.S. frontier models to follow malicious instructions designed to derail them from user tasks. Hijacked agents sent phishing emails, downloaded and ran malware, and exfiltrated user login credentials, all in a simulated environment.

DeepSeek models are far more susceptible to jailbreaking attacks than U.S. models.
DeepSeek’s most secure model (R1-0528) responded to 94% of overtly malicious requests when a common jailbreaking technique was used, compared with 8% of requests for U.S. reference models.

DeepSeek models advance Chinese Communist Party (CCP) narratives.
DeepSeek models echoed four times as many inaccurate and misleading CCP narratives as U.S. reference models did.

Adoption of PRC models has greatly increased since DeepSeek R1 was released.
The release of DeepSeek R1 has driven adoption of PRC models across the AI ecosystem. Downloads of DeepSeek models on model-sharing platforms have increased nearly 1,000% since January 2025.

A Good Idea to Cut Public Funding for R&D? Doesn't Look Like It.

David Rotman has authored an excellent article titled, “How to Measure the Returns on R&D Spending: Forget the Glorious Successes of Past Breakthroughs—the Real Justification for Research Investment is What We Get for Our Money. Here’s What Economists Say” in the MIT Technology Review.  The article does a nice job explaining recent research concerning public funding of R&D and the return on investment to the public.  The article notes that many questions are not answered.  The article is available, here. 

Medicaid to Receive Most Favored Nation Pricing on Pfizer Drugs

The White House has announced that President Trump has made a deal with Pfizer for state Medicaid to receive most favored nation pricing on Pfizer pharmaceuticals.  This is welcome news; however, I do wonder if the rest of the world’s pharmaceutical prices will rise.  The White House has released a fact sheet that states:

ADVANCING MOST-FAVORED-NATION PRICING: Today, President Donald J. Trump announced the first agreement with a major pharmaceutical company, Pfizer, to bring American drug prices in line with the lowest paid by other developed nations (known as the most-favored-nation, or MFN, price).

• The agreement will provide every State Medicaid program in the country access to MFN drug prices on Pfizer products, resulting in many millions of dollars in savings and continuing President Trump’s historic efforts to strengthen the program for the most vulnerable.
• The agreement ensures foreign nations can no longer use price controls to freeride on American innovation by guaranteeing MFN prices on all new innovative medicines Pfizer brings to market. 
• The agreement requires Pfizer to repatriate increased foreign revenue on existing products that Pfizer realizes as a result of the President’s strong America First U.S. trade policies for the benefit of American patients. 
• The agreement requires Pfizer to offer medicines at a deep discount off the list price when selling directly to American patients.

 
DELIVERING REDUCED COSTS: Today’s actions will result in tangible cost savings to American patients and the healthcare system as a whole. Taken together, more than 100 million patients are impacted by the diseases Pfizer’s medicines treat, and many of those will benefit from the President’s successful negotiation of lower prices for Americans. Examples include:

• Eucrisa, a topical ointment for atopic dermatitis, will be made available at an 80% discount to patients purchasing directly.
• Xeljanz, a widely used oral medication for rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis, will be available at a 40% discount to patients purchasing directly.
•  Zavzpret, a commonly utilized treatment for migraines, will be sold directly to patients at a 50% discount.

 
ENDING GLOBAL FREELOADING ON AMERICAN PHARMACEUTICAL INNOVATION:  President Trump is taking decisive action to rebalance a system that allows pharmaceutical manufacturers to offer low prices to other wealthy nations while charging Americans significantly higher prices.  

• According to recent data, the prices Americans pay for brand-name drugs are more than three times the price other Organization for Economic Cooperation and Development nations pay, even after accounting for discounts manufacturers provide in the U.S. 
• The United States has less than five percent of the world’s population, yet roughly 75% of global pharmaceutical profits come from American taxpayers.
• Drug manufacturers benefit from generous research subsidies and enormous healthcare spending by the U.S. Government. Instead of passing that benefit through to American consumers, drug manufacturers then discount their products abroad to gain access to foreign markets and subsidize those discounts through high prices charged in America. Americans are subsidizing drug-manufacturer profits and foreign health systems, both in development and once the drugs are sold. 

 
DELIVERING ON PROMISES TO PUT AMERICAN PATIENTS FIRST: President Trump is delivering on promises for American patients that the political establishment did not believe were possible.

• On May 12, 2025, President Trump signed an Executive Order titled: “Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients” directing the Administration to take numerous actions to bring American drug prices in line with those paid by similar nations.
• On July 31, 2025, President Trump sent letters to leading pharmaceutical manufacturers outlining the steps they must take to bring down the prices of prescription drugs in the United States to match the lowest price offered in other developed nations 
• President Trump has been relentless in his effort to address the unfair and outrageous prices Americans pay for prescription drugs:

o   President Trump: “In case after case, our citizens pay massively higher prices than other nations pay for the same exact pill, from the same factory, effectively subsidizing socialism aboard [abroad] with skyrocketing prices at home. So we would spend tremendous amounts of money in order to provide inexpensive drugs to another country. And when I say the price is different, you can see some examples where the price is beyond anything — four times, five times different.”