On July 31, the U.S. Patent and Trademark Office (PTOPatent and Trademark Office, informally used interchangeably with USPTO.) issued a memorandum that, while framed as a clarification of existing rules, carries significant implications for inter partes review (IPRIntellectual Property Rights. Usually associated with formal legal rights such as patent, trademark, and copyright. Intellectual property is a broader term that encompasses knowledge, information, and data considered proprietary whether or not it is formally protected.) processes and the ability for members of the public to successfully challenge low-quality patents. The guidance declared that beginning September 1, the PTOPatent and Trademark Office, informally used interchangeably with USPTO. will begin enforcing 37 C.F.R. § 42.104(b)(4), which requires petitioners to “specify where each element of the claim is found in the prior artPrior art is the knowledge in the field of a patent that was publicly available before the patent was filed. patents or printed publications relied upon.”
In practice, this means petitioners can no longer rely on any form of general knowledge—including expert declarations, common sense, or applicant-admitted prior artPrior art is the knowledge in the field of a patent that was publicly available before the patent was filed. (AAPA)—to fill in gaps in the prior artPrior art is the knowledge in the field of a patent that was publicly available before the patent was filed.. If a limitation isn’t disclosed in a prior artPrior art is the knowledge in the field of a patent that was publicly available before the patent was filed. patent or printed publicationThe term applied when a patent application or issued patent is made public. Normally required 18 months after filing. A feature unique to the U.S. patent system allows patent applicants who limit their application solely to the United States to delay publication until the patent is issued by the USPTO., the petition must fail. This reverses years of PTOPatent and Trademark Office, informally used interchangeably with USPTO. practice and supersedes prior agency guidance in 2020 and 2022 that explicitly permitted the use of general knowledge and AAPA to satisfy missing claim limitations.
Most notably, this change is a direct contradiction to the Federal Circuit’s ruling just two weeks earlier in Shockwave Medical, Inc. v. Cardiovascular Systems, Inc., decided on July 14th. In Shockwave, the court ruled that “[g]eneral knowledge can be used to supply a missing claim limitation,” and that AAPA may be used as evidence of that knowledge. This reflects a common understanding dating back to prior Federal CircuitSee CAFC rulings, commonly known as Qualcomm I and Qualcomm II, which recognized that while IPRs must be based on patents or printed publications, general knowledge remains a legitimate evidentiary tool.
Further worth noting is that, while patentees are legally required to support every element of their claims in their written description under 35 U.S.C. § 112, the USPTOUnited States Patent and Trademark Office. See also PTO. does not impose a similar requirement during the application process. Patent applicants are under no obligation to map claims back to the specificationThe section of a patent that provides a description of the invention and the manner and process of making and using it. It must enable the "person having ordinary skill in the art" to reproduce and use the invention without undue experimentation. A patent's claims are interpreted in light of the specification..
Although Acting Director Stewart has insisted this shift was not prompted by the Shockwave decision, the close timing and the substance of the memorandum suggest otherwise. At a webinar in early August, Stewart acknowledged that Shockwave is “a little bit more clear than the past decisions” on AAPA, but said it was still “not clear enough for us to continue to go down this road, which I consider to be a risky path, when there’s a very simple path laid out by our rules.”
In effect, the PTOPatent and Trademark Office, informally used interchangeably with USPTO. has chosen to abandon a well-established line of Federal CircuitSee CAFC precedent in favor of a stricter reading of its own regulations, one that sharply limits the evidentiary tools available to petitioners. Beginning September 1st, every claim element must be explicitly found in a prior artPrior art is the knowledge in the field of a patent that was publicly available before the patent was filed. patent or printed publicationThe term applied when a patent application or issued patent is made public. Normally required 18 months after filing. A feature unique to the U.S. patent system allows patent applicants who limit their application solely to the United States to delay publication until the patent is issued by the USPTO., even if a missing limitation reflects widely known or uncontested knowledge in the field.
Some observers have characterized this change as “policy whiplash” and it even drew public criticism from former USPTOUnited States Patent and Trademark Office. See also PTO. Director Kathi Vidal, in a LinkedIn post that has now been removed. And of course, Director Stewart doesn’t seem interested in clarity when it comes to the morass of discretionary denial rationales she continues to make up in order to deny institutions.
This narrowing raises the bar for invalidating weak patents, especially those which are cloaked in the kind of complex and technical jargon that is easiest invalidated with appeals to general knowledge. As with Stewart’s other recent moves to expand discretionary denials, this change undercuts the very purpose of the IPRIntellectual Property Rights. Usually associated with formal legal rights such as patent, trademark, and copyright. Intellectual property is a broader term that encompasses knowledge, information, and data considered proprietary whether or not it is formally protected. process: to provide a fast, reliable, accessible, and expert check on questionable patents.
