USPTO

Subscribe to USPTO via RSS

Patent eligibility under 35 U.S.C. § 101 remains one of the most hotly contested and unpredictable areas of U.S. patent law. In the years following the Supreme Court’s landmark decisions in Alice Corp. v. CLS Bank Int’l (2014) and Mayo Collaborative Services v. Prometheus Laboratories, Inc. (2012), lower courts, the USPTO, and the Federal Circuit have wrestled with the proper application of the two-step framework for determining whether an invention is directed to an abstract idea, law of nature, or natural phenomenon—and, if so, whether it includes an inventive concept sufficient to transform it into patent-eligible subject matter.

patent denial

On the heels of the rescission of the Fintiv guidance memorandum, the U.S. Patent and Trademark Office has again reshaped the PTAB’s approach to discretionary denials. On March 26, 2025, the Acting Director issued a new memorandum that fundamentally changes how the PTAB will handle inter partes review and post grant review petitions

On February 28, 2025, the U.S. Patent and Trademark Office announced that it was rescinding a 2022 memorandum that provided guidance regarding the application of the Apple v. Fintiv decision to the Patent Trial and Appeal Board’s discretion to deny patent challenges with pending parallel district court litigation. The PTO has referred parties back to precedent for guidance including Apple Inc. v. Fintiv, Inc. Rescinding the 2022 memorandum also has the effect of effectively removing the proposed rules related to discretionary denial that were under consideration as recently as last year.

As generative artificial intelligence (AI) continues to transform industries, its impact on patent law is raising critical legal questions. From the recognition of AI as an inventor and potential infringement risks posed by the AI-generated outputs to the use of AI in patent validity challenges, the legal landscape is rapidly evolving. This article explores how generative AI is reshaping patent litigation, including the legal implications for inventorship, infringement and validity.

In an unprecedented PTAB decision involving Spectrum Solutions LLC and Longhorn Vaccines & Diagnostics, the Board found all five challenged patents invalid and imposed sanction against patent owner Longhorn for failure to meet the duty of candor and fair dealing. The board determined that Longhorn selectively disclosed testing results to…

The U.S. Supreme Court on May 18, 2023 delivered its decision on the scope of the patent enablement requirement, set forth in 35 U.S.C. § 112, in the antibody dispute Amgen, Inc. v. Sanofi. While the parties obtained finality, many in the pharmaceutical and biotechnology industries received the opinion under a cloud of uncertainty and concern for exclusivity rights broad enough to both protect clinical candidates and deter competitors. While the patent bar may remain apprehensive, the Supreme Court kept the door open to genus claims.  The impact of the decision may not be as far-reaching as feared.

In three previous blog posts, we have discussed recent inventorship issues surrounding Artificial Intelligence (“AI”) and its implications for life sciences innovations – focusing specifically on scientist Stephen Thaler’s attempt to obtain a patent for an invention created by his AI system called DABUS (“Device for Autonomus Bootstrapping of Unified Sentence). Most recently, we considered Thaler’s appeal of the September 3, 2021 decision out of the Eastern District of Virginia, which ruled that under the Patent Act, an AI machine cannot qualify as an “inventor.” Continuing this series, we now consider the USPTO’s recently filed opposition to Thaler’s appeal.

Our previous blog posts, Artificial Intelligence as the Inventor of Life Sciences Patents? and Update on Artificial Intelligence: Court Rules that AI Cannot Qualify As “Inventor,” discuss recent inventorship issues surrounding AI and its implications for life sciences innovations. Continuing our series, we now look at the appeal recently filed by Stephen Thaler (“Thaler”) in his quest to obtain a patent for an invention created by AI in the absence of a traditional human inventor. 

Confronting a life sciences patentee with its statements to regulatory bodies (such as the FDA) is a textbook defense strategy in patent litigation.  After all, communications with regulatory bodies are often performed by non-attorneys who may not appreciate the consequences of their statements in future litigation. And while in ideal circumstances the patentee’s attorneys will ensure accurate and consistent communications and try to put potentially inconsistent statements in context, it is not always possible to do so once the genie is out of the bottle. Belcher Pharmaceuticals, LLC v. Hospira, Inc., exemplifies the dire consequences that can result from inconsistent communications with regulators—particularly if a defendant can point to a single source for those communications.