Author:
Richard D. Kelly
March 19, 2026
In our January Newsletter (here) we reported on the non-precedential Federal Circuit decision in Daiichi Sankyo Co. v. Seagen Inc., Fed. Cir. Dec 02, 2025, appeal 2023-2424, holding that Seagen’s U.S. Patent 10,808,039 (‘039) was invalid for lack of written description and enablement, over turning a jury verdict and JMOL to the contrary. This was the second time in a two-week period that the Court had overturned jury verdicts in favor of the patentee on written description. As the Court recognized in the earlier decision Duke Univ. et al. v Sandoz, Inc., 160 F.4th 1305 (2025) “a district court’s refusal to grant judgment as a matter of law may be reversed only if the evidence is such that without weighing the credibility of the witnesses the only reasonable conclusion is in the moving party’s favor.” This is a high burden to meet.<... Read more
Author:
Yan Cong, Ph.D.
March 12, 2026
In In re Blue Buffalo Enterprises, Inc., No. 2024-1611 (Fed. Cir. Jan. 14, 2026), the Federal Circuit affirmed the PTAB’s decision affirming the Examiner’s obviousness rejection after rejecting Blue Buffalo’s narrow construction of the claim term “configured for”.<... Read more
Author:
David Inglefield
March 11, 2026
On February 20, 2026, the U.S. Court of Appeals for the Federal Circuit (CAFC) issued a decision regarding recombinant DNA subject-matter eligibility, reversing a decision by the United States District Court for the District of Delaware in REGENXBIO, Inc. v. Sarepta Therapeutics. The district court had previously ruled claims of U.S. Patent No. 10,526,617 (the ‘617 patent) covering a cultured host cell containing a recombinant nucleic acid molecule patent ineligible under 35 U.S.C. § 101 during a patent infringement suit in which both parties moved for summary judgment of patent eligibility under 35 U.S.C. § 101. The district court agreed with Sarepta and held the claims ineligible under § 101 as directed to a natural phenomenon. The CAFC held the claims as not being directed to a natural phenomenon and reversed the district court’s decision, remanding the case for further proceedings.<... Read more
Author:
Derek Lightner, Ph.D.
December 19, 2025
An obviousness rejection was recently reversed by the Patent Trial and Appeal Board (PTAB) by the panel of Administrative Patent Judges (APJs) authored by Debra L. Dennett, and further including Jeffrey W. Abraham and Avelyn M. Ross in U.S. Appl. No. 17/395,422 (the 422 Application). The PTAB reversed the obviousness finding of examiner Justin Fischer, supported by Supervisory Patent Examiner (SPE) Katelyn W. Smith, and Quality Assurance Specialist (TQAS) Colleen P. Dunn, on the alleged obviousness of the claims over a combination of three to five references, three of which were the applicant-appellant’s own prior art. The main claim on appeal recited<... Read more
Author:
David Inglefield
July 23, 2025
On June 30, the U.S. Court of Appeals for the Federal Circuit (CAFC) issued a precedential decision regarding transitional phrase claim construction, reversing the decision of the Patent Trial and Appeal Board (PTAB) in Eye Therapies, LLC. v. Slayback Pharma, LLC. The PTAB had previously ruled the claims of U.S. Patent No. 8,293,742 (the ‘742 patent) unpatentable as obvious in a inter partes review brought by Slayback. During the inter partes review, the parties had disagreed on the construction of the transitional phrase “consisting essentially of” in the ‘742 patent. The Court found that the Board had incorrectly applied the conventional open construction of the transitional phrase, which was at odds with the prosecution record. This demonstrates how prosecution history can alter a phrase’s typical meaning.<... Read more
Author:
Lucas Koziol, Ph.D.
April 7, 2025
Restem, LLC, v. Jadi Cell, LLC (see the Resources link below for a copy of the Opinion)<... Read more
Author:
Richard D. Kelly
March 27, 2025
In Maquet Cardiovascular LLC. v. Abiomed Inc., Appeal No. 2023-2045, March 21, 2025, the Federal Circuit provided guidance as to when the prosecution history of one member of a patent family may act as an estoppel in the claim construction of another member of the family. At issue was the construction of claims 1 and 24 of U.S.P. 10,238,783 (‘783) in view of the prosecution histories of its parent application, U.S.P. 9,789,238 (‘238) and great-great-grandparent application U.S.P. 8,888,728 (‘728). The ‘783 patent was directed to blood pumps which could be placed in a patient’s vascular system without using a supplemental guide means. The guide was integrated into the apparatus.<... Read more
Author:
David Inglefield
March 10, 2025
On February 13, the U.S. Court of Appeals for the Federal Circuit (CAFC) reversed the decision of the International Trade Commission (ITC) in US Synthetic Corp. v. International Trade Commission, issuing a precedential decision regarding subject matter eligibility important to the pharmaceutical and other life science industries. The ITC had previously ruled that US Synthetic’s composition of matter claims reciting measured properties of a composition were directed to a patent-ineligible abstract idea under 35 U.S.C. § 101. The CAFC found that the claims were indeed related to concrete structures, not patent-ineligible abstract ideas, and affirmed the lower court’s finding regarding enablement.<... Read more
Author:
Xiaohua (Joyce) Guo, Ph.D.
February 18, 2025
In a precedential opinion issued on January 10, 2025, the United States Court of Appeals for the Federal Circuit reversed a district court’s ruling that had invalidated claims 1-4 of U.S. Patent No. 8,101,659 (“the ’659 patent”) for lack of written description.<... Read more
Author:
Robert W. Downs
February 7, 2025
Personalized medicine is especially intriguing, as a problem with most drugs are the potential side effects. From a naive perspective, administering drugs may appear to be a trial and error process: take this for two weeks and come back with a follow up visit. If you have any side effects, contact me immediately. Wouldn’t it be nice if a drug had the effect it was meant to have without the possibility of side effects?<... Read more