Missing Feature Overcomes Obviousness but Cautions Succinct Claiming and Argument

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

Myrbetriq® Patent Invalidated On Grounds Not Asserted by Any Party Violating Party Presentation Principle

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

PTAB Finds Method Involving "Growing, Selecting, and Crossing" Sufficient for Integrating Genome Estimation Data Set Into Practical Application

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

Finally, an ODP Decision in Favor of the Patentee

Attorney: Richard D. Kelly
August 28, 2024

In Allergan USA, Inc v Sun Pharmaceutical Indus. Ltd, Appeal No. 2024-1061, August 13, 2024, the Federal Circuit reversed the district court’s holding that Allergan patent, U.S.P. 7,741,356 (‘356) was invalid for obviousness-type double patenting over USPs 11,007,179, 11,090,291, and 11,311,516. The relationship between the patents is shown below:


The ‘356 patent was entitled to significant PTA but because of the PTE it received, Allergan effectively disclaimed all but 487 days of the PTA. The total extension PTE plus PTA resulted in an expiration date of May 27, 2029, 15 years from the ‘356 issue date -- the maximum extension possible.<... Read more

USPTO Seeks Public Feedback on The Experimental Use Exception to Patent Infringement

Attorney: Evan Smith
July 26, 2024

On June 27, 2024, the United States Patent and Trade Office (“USPTO”) published a request for comments (“RFC”) in the Federal Register inquiring about the current state of the experimental use defense to patent infringement and to determine the potential value of legislative action on the issue.  This RFC both supports the President’s 2021 Executive Order on Promoting Competition in the American Economy and furthers the United States Department of Agriculture and the USPTO’s joint commitment to evaluate “New proposals for incentivizing and protecting innovation in the seed and agricultural-related space, including the addition of research or breeders' exemptions for U.S. utility patents.”[1]<... Read more

PTAB Invalidates Regeneron Claims on Method of Treatment

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

PTAB Reverses Examiners on Unexpected Results

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

IOEngine v. Ingenico: Printed Matter Doctrine and Forfeiture of Claim Construction

Attorney: Xiaohua (Joyce) Guo, Ph.D.
May 30, 2024

In a precedential decision, the US Court of Appeals for the Federal Circuit partially reversed and partially affirmed the Final Written Decisions made by the Patent Trial and Appeals Board (“Board”) during a series of inter partes review (IPR) proceedings.<... Read more

PTAB Reaffirms Written Description Threshold When Claiming a Genus

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

Anything You (are Required to) Say May be Used Against You (as Prior Art): Federal Circuit Upholds Invalidity Based on Mandatory Publication of Clinical Trial Protocol

Attorney: Nicholas Rosa, Ph.D.
May 16, 2024

Clinical trials are a critical part of the development and approval process for drugs, biologics, and medical devices. The lengthy and public nature of clinical trials, however, can create challenges for protecting relevant IP.  A clinical trial is a study or investigation in humans to “evaluate the effect(s) of intervention(s) on biomedical or health-related outcomes.”  42 C.F.R. 11.  Interventions can take many forms that benefit from patent protection including drugs/small molecules/compounds; biologics; devices; procedures (e.g., surgical techniques); treatment strategies; prevention strategies; and diagnostic strategies. Id. <... Read more