Attorney:
Derek Lightner, Ph.D.
December 30, 2024
In the matter Ex parte MICHAEL J. WEST, in Technology Center 1700 (USSN 16/078,845; Appeal 2023-003903) rejections for an alleged lack of patentable subject matter, a lack of enablement, indefiniteness, and obviousness by a primary examiner, Lore Jarrett, were reversed by a panel of the Patent Trial and Appeal Board (PTAB) made up of Jeffrey R. Snay, Whitney Wilson, and Jane E. Inglese. The first appealed claim recited (with the underlined portions added after the first rejection): <... Read more
Attorney:
Derek Lightner, Ph.D.
October 7, 2024
On September 25, 2024, in Ex parte Sim, the Patent Trial and Appeal Board (PTAB) overturned the obviousness position of primary examiner, John Chu, supported by Supervisory Patent Examiners Mark Huff and Christine Tierney, in US Appl. No. 16/176,245 (Appeal 2023-003254, Technology Center 1700). Ex parte Sim involved a disagreement on the meaning of recitation regarding a copolymer structure.<... Read more
Attorney:
Richard D. Kelly
October 2, 2024
In Astellas Pharma Inc. v. Sandoz Inc,, et al, following a five-day patent claims bench trial the court found asserted claims 5, 20, and 25 invalid under 35 U.S.C. § 101 even though Sandoz had not asserted 101 as defense at any time during the case. The parties had agreed to limit the issue to claims 5, 20, and 25 and the defense to invalidity under 35 U.S.C. § 112. Neither party had notice that patent eligibility was an issue. In making his ruling Judge Bataillon relied upon a statement in Astellas post-trial brief that the “inventive concept of the ’780 Patent was discovering the dissolution rate that would address the food effect and achieving it using previously known formulation technology.” Thus, because the claimed invention “reflects merely the discovery of the food-effect-resolving dissolution profile,” the district court deemed the asserted claims invalid as patent ineligible. Not only had the issue of patent eligibility not been raised by the defendant, but the claims were also to a specific composition. Recognizing the district court had gone on astray Sandoz moved the court to make additional findings of fact advising the court that the § 101 defense had not been raised as a defense and that the decision must be based on the language in the claims. The motion was denied.<... Read more
Attorney:
Nicholas Rosa, Ph.D.
September 17, 2024
The Patent Trial and Appeal Board (PTAB) recently reversed a final rejection based on § 101 by finding that a method for selecting individuals for a breeding program that recited the steps of “growing, selecting, and crossing” did integrate an “optimized [genome] estimation data set” judicial exception into practical application. These actionable steps and the distinct advantages the method represented over conventional breeding methods involving other types of genomic prediction described in the specification were instrumental in the PTAB’s findings. The inclusion of such actionable steps and description of the advantages of the subject matter of the application may be useful to support amendments that may be necessary to overcome § 101 rejections.<... Read more
Attorney:
Cristina Lai
July 5, 2024
The Patent Trial and Appeal Board (PTAB) issued a final written decision on IPR2023-00442 determining that claims 1, 3-11, 13, 14, 16-24, and 26 of U.S. Patent No. 10,130,681 (“the ‘681 patent”) were unpatentable. The ‘681 patent is owned by Regeneron Pharmaceuticals, Inc., and was challenged in an IPR by Samsung Bioepis Co., Ltd. The ‘681 patent claims priority to a number of patents that were invalidated in previous IPR proceedings.<... Read more
Attorney:
Derek Lightner, Ph.D.
June 11, 2024
In Ex parte Freeman (USSN 16/270,259; TC 1600; Appeal 2023-000512, the underlying application being referred to herein as the “Freeman application”), a finding of obviousness and obviousness-type double patenting (ODP) was reversed on May 24, 2024. Freeman’s application was examined by Devang Thakor initially, but the case was taken over by another primary examiner, Nicole Babson, whose position was supported by Supervisor Patent Examiners, David Blanchard and Bethany Barham.<... Read more
Attorney:
Sara Pistilli, PharmD.
May 21, 2024
On May 17, 2024, the Patent Trial and Appeal Board (PTAB) affirmed a rejection of a claim directed to a purification method using single-domain antigen-binding proteins that bind mammalian IgG as lacking adequate written description (Appeal 2023-000567). The claim at issue in U.S. Application No. 16/282,082 (the ‘082 Application) recites:<... Read more
Attorney:
Sara Pistilli, PharmD.
April 30, 2024
On May 2, 2023, the Patent Trial and Appeal Board (PTAB) overturned a rejection of a claim directed to microparticles containing leuprolide and a biodegradable polymer, and a method for producing the same as anticipated and obvious (Appeal 2024-000508). The claim at issue of the application US 17/832,229 (the ‘229 Application) is directed towards:<... Read more
April 1, 2024
In Medtronic, Inc. v. Teleflex Life Sciences Ltd. the Federal Circuit upheld the Patent Trial and Appeal Board (PTAB) decision that U.S. Patent No. 8,142,413 (“the ’413 patent”), owned by Teleflex, was not shown to be unpatentable over the asserted prior art. This post will focus on how the Federal Circuit affirmed the PTAB’s claim interpretation to find ’413 patent claims 1, 2, 4, 5, and 7–14 non-obvious.<... Read more
Attorney:
Cristina Lai
March 18, 2024
In Pfizer Inc. vs. Sanofi Pasteur Inc., the Federal Circuit upheld the Patent Trial and Appeal Board (PTAB) decision to invalidate portions of Pfizer’s pneumococcal vaccine patent on the grounds of obviousness. My colleague’s post discusses the Federal Circuit’s decision to vacate and remand to the PTAB to further consider Pfizer’s motions to amend with regards to proposed claims 48 and 49, holding that the PTAB has not actually addressed the additional limitations for these claims. This post will focus on the patentability of Claims 1-45, and specifically how the Federal Circuit affirmed the PTAB’s application of the result-effective variable doctrine and reasonable expectation of success in order to arrive at a finding of obviousness of Claims 1-45 of U.S. Patent No. 9,492,599 (“the ‘559 patent”).<... Read more