Category: Uncategorized

By Kevin E. Noonan – Over several years and two administrations (see “FTC Announces Efforts to Police Pharmaceutical Companies’ Patent Behavior“; “FTC Warns Pharma Companies It Means Business with Its Orange Book Listing Policy“; “Federal Trade Commission Continues Efforts to Delist Drug Device Administration Patents in Orange Book“), the Federal Trade Commission has maintained a…

By Mike Borella – Late last week, the U.S. Patent and Trademark Office (USPTO) published three memos addressing its latest policies regarding subject matter eligibility.  These included “Subject Matter Eligibility Declarations” from Director Squires to the patent examining corps, “Best Practices for Submission of Rule 132 Subject Matter Eligibility Declarations (SMEDs)” from Director Squires to…

By Joshua Rich and Mike Borella – On February 13, 2024, then-USPTO Director Vidal issued inventorship guidance for AI-assisted inventions;[1] on November 28, 2025, new USPTO Director Squires revoked and replaced it. But both the earlier guidance and current Revised Inventorship Guidance are based on previously decided Federal Circuit precedent. That is, the change in…

By Michael S. Borella – Once upon a time, patent eligibility was not controversial or difficult to understand. Then along came Alice Corp. v. CLS Bank, and with it the Supreme Court’s bright idea to replace statutory clarity with metaphysical hand-waving about so-called abstract ideas. The result has been a decade of improvisation, where examiners…

By Manav Das – We added some tariffs with pride,Hoping that’ll keep rivals outside.But inventors soon foundThere was less cash aroundAnd our own breakthroughs quietly died. With all the talk about tariffs, and the recent Oral Hearing at the Supreme Court, I started wondering as to how this impacts intellectual property (IP). Tariffs are defined…

By Kevin E. Noonan – The new Director of the Patent and Trademark Office, Undersecretary of Commerce for Intellectual Property John A. Squires has spent the last few weeks making serious policy changes in the Office (see “New Director Overturns PTAB Procedural Precedents: Part I“; “USPTO Proposed New Rules Limiting the Availability of Inter Partes…

By Kevin E. Noonan – In a seemingly otherwise run-of-the-mill, albeit precedential, decision, the Federal Circuit affirmed a stipulated judgment of non-infringement in Aortic Innovations LLC v. Edwards Lifesciences Corp. The case arose in litigation over the claims of Aortic’s U.S. Patent Nos. 10,881,538, 10,966,846, 10,987,236, and 11,129,735 directed towards devices for transcatheter aortic valve…

By Michael S. Borella – From a technical standpoint, everything a computer does involves reading, manipulating, and storing information through microcode instructions that move around 0’s and 1’s. Each operation performed by a processor, such as addition, comparison, and data transfer, can be manually simulated as a series of these instructions. Undergraduate students in computer…

By Michael S. Borella – It has been over a decade since the Supreme Court blessed us with the two-step framework for patent eligibility under 35 U.S.C. § 101 in Alice Corp. v. CLS Bank. First, one must determine whether the claim at issue is “directed to” a judicial exception, and if so, one must…

By Kevin E. Noonan – It is fair to say (no matter what else can be said) that the current administration is outcome- rather than process-driven. This general inclination is true of the Department of Health and Human Services and the agencies contained thereinunder, and the Food and Drug Administration exhibited this tendency in a…