August 13, 2025

Shortly after the Federal Circuit issued Shockwave Medical, Inc. v. Cardiovascular Sys., Inc., 142 F.4th 1371 (Fed. Cir. 2025) (see NV July 30-2025 Post on Shockwave), Acting Director Stewart on July 31, 2025, issued a Memorandum titled “Enforcement and Non-Waiver of 37 C.F.R. § 104(b)(4) and Permissible Uses of General Knowledge in Inter Partes Reviews.”  As stated therein, the USPTO will enforce and no longer waive the requirement of § 104(b)(4) that an IPR petition “specify where each element of the claim is found in the prior art patents or printed publications relied upon.” Memo. at 1.  Importantly, “applicant admitted prior art (AAPA), expert testimony, common sense, and other evidence that is not ‘prior art consisting of patents or printed publications’ (collectively, ‘general knowledge’) may not be used to supply a missing claim limitation.” Id. (confirming that “[g]eneral knowledge may still be used in an IPR to support a motivation to combine or to demonstrate the knowledge of a person having ordinary skill in the art”).  The expressed rationale for this action is that past efforts by the USPTO to permit limited use of “general knowledge” to satisfy a missing claim limitation are inconsistent with Federal Circuit precedent. Id. at 2-3 (citing exemplary decisions).  Enforcement of § 104(b)(4), rather than trying to navigate the limited uses and risk further litigation on the issue at the Federal Circuit, was determined to be “the best course of action to provide certainty to the parties, the Board, and the public, and to allow for the efficient administration of the Office.” Id.  The Memorandum applies to IPR petitions filed on or after September 1, 2025. Id. at 3.