Attorney:
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
Attorney:
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
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:
Richard D. Kelly
May 30, 2023
On May 16, the Supreme Court distributed the CareDX cert petition for consideration at the June 1 conference since the Respondents waived filing a reply. The CareDX family of three patents, licensed from Stanford University, U.S.Ps. 8,703,652, 9,845,497 and 10,329,607, are directed to the noninvasive diagnosis of the state of a transplanted organ. The test provides the doctor with information on whether everything is okay, or that the organ is showing signs of being rejected. Both the district court and the Federal Circuit held the patent to be patent ineligible based primarily on admissions appearing in the specification of all three patents which are identical. Given the low success rate (recently zero) of requests for certiorari in the diagnostic/biomarker area, this raises the question as to the possibility the petition will be granted. The CareDx petition’s chances seem better than recent certiorari petitions. <... Read more
Attorney:
Marina I. Miller, Ph.D.
February 22, 2023
CareDx is the exclusive licensee of U.S. Patents 8,703,652, 9,845,497, and 10,329,607 entitled “Non-Invasive Diagnosis of Graft Rejection in Organ Transplant Patients” owned by Stanford. The patents describe diagnosing or predicting organ transplant status by using methods to detect a donor’s cell-free DNA (“cfDNA”). When an organ transplant is rejected, the recipient’s body, through its natural immune response, destroys the donor cells, thus releasing cfDNA from the donated organ’s dying cells into the blood. The increased levels of donor cfDNA, which occur naturally as the organ’s condition deteriorates, can be detected and used to diagnose the likelihood of an organ transplant rejection. Claim 1 of the ’652 patent reads (simplified):<... Read more
Attorney:
Grace Kim
December 13, 2022
Update by Grace Kim and Sara Pistilli, PharmD.
On December 6, 2022, the Patent Trial and Appeal Board (PTAB) overturned a rejection of a claim to a plant extract based on patent ineligible subject matter (Appeal 2022-001062). Claim 1 of the application US 15/521,212 (the 212 Application) is directed towards:<... Read more
Attorney:
Marina I. Miller, Ph.D.
August 23, 2021
Plaintiff Zyrcuits IP LLC has sued Defendants Acuity Brands, Inc. and Universal Electronics Inc. for infringement of claim 4 of U.S. Patent No. 6,671,307 (the ‘307 patent). Defendants argued that Zyrcuits's complaints should be dismissed because the ‘307 patent is invalid under 35 U.S.C. § 101 for failing to claim patentable subject matter. Applying the two-step framework from Alice, the court found that the ‘307 patent was invalid under § 101, as the claims of the ‘307 patent are directed to the abstract idea of grouping data together with a single code and do not contain any inventive concept.... Read more
Attorney:
Marina I. Miller, Ph.D.
July 6, 2021
Yu sued Apple for infringement of the claims of U.S. Patent 6,611,289. The district court granted Defendants’ motion to dismiss on the basis that the asserted claims were invalid under 35 U.S.C. § 101. Yu appealed. The Federal Circuit (“the Court”) found no error and affirmed.<... Read more
Attorney:
Marina I. Miller, Ph.D.
April 6, 2021
The Board of Trustees of the Leland Stanford Junior University (“Stanford”) appeals the final rejection of patent claims in its patent Application No. 13/486,982. The patent examiner rejected the claims as involving patent ineligible subject matter. The PTAB affirmed the examiner’s rejection. On appeal, the Federal Circuit affirmed the decision of the PTAB that the rejected claims were drawn to abstract mathematical calculations and statistical modeling, and similar subject matter that is not patent eligible.<... Read more
February 4, 2021
For practitioners at the USPTO, the reversal of a 101 rejection in Ex parte Patil (PTAB January 7, 2021), APJs Grimes, Scneider and Valek, in Appeal 2020-002775 should be interesting if not provide some light on the dance floor for doing the two-step with the USPTO.
The invention focused on assessing genetic variability with a system including databases and processors and as recited in Claim 27 U.S. 15/169,498:<... Read more