Federal Circuit Reiterates: Isolated Natural Products Alone Are Not Patent Eligible Without A Markedly Different Characteristic

March 3, 2023

co-authored by Sara Pistilli, PharmD. and Richard D. Kelly<... Read more

Claims Directed to Detecting Natural Phenomena Using Conventional Techniques Are Patent Ineligible

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

PTAB Reverses §101 and §103 Rejections for Plant Extract

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

Failure to Identify the Invention and to Explain How you Do It May Lead to Invalidity under Section 101

Attorney: Marina I. Miller, Ph.D.
October 5, 2022

Integrated Technology Solutions, LLC (“ITS”) alleged that products manufactured and distributed by iRacing.com Motorsport Simulations, LLC ("iRacing") infringed on U.S. Patent 10,046,241. iRacing moved to dismiss, arguing that the ‘241 patent was invalid under 35 U.S.C Section 101, as construed by Alice Corp. Pty. Ltd. v. CLS Bank Int'l., 573 U.S. 208 (2014), and its progeny, because the asserted claims were directed to an abstract idea and were patent-ineligible. The U.S. District Court, D. Massachusetts (“the Court”) found that the claims at issue were directed at patent-ineligible concepts, and that the elements of each claim did not transform the claim into patent-eligible application, and granted the motion to dismiss. <... Read more

Federal Circuit Reverses Novartis Gilyena Negative Limitation Decision

Attorney: Richard D. Kelly
June 22, 2022

On June 21, 2022, the Federal Circuit acting on a request for panel rehearing in the decision by the Federal Circuit in Novartis v. Accord Health Care, Inc., 21 F.4th 1362 (Fed. Cir. 2022), affirming the district court’s decision of infringement and validity of the Novartis patent on Gilenya, U.S.P. 9,187,405, granted the request and proceeded to reverse the original decision and hold the asserted claim invalid for failing to comply with the written description of 35 U.S.C. § 112(a).<... Read more

Claims to a Spread-Spectrum Method For Sending Data Over a Communications Channel Are Patent Ineligible under Section 101

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

A Digital Camera (A Mechanical/Electronic Device) is Patent Ineligible

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

In re Rudy and the PTO 101 Guidance

Attorney: Richard D. Kelly
April 22, 2021

The USPTO 101 Guidance document has been under a cloud when Judge Brinkema refused to follow the guidance in Cleveland Clinic Found. V. True Health Diagnostics LLC., affirmed at 760 F. App'x. 1013, 1020 (Fed. Cir. 2019). Cleveland Clinic relied on Guidance example 29, claim 1 to assert that its claims were patent eligible since they were drafted in the same manner. The Federal Circuit in rejecting the argument found the 101 Guidance example 29, claim 1 to be "strikingly" similar to claim 1, see760 F. App'x. at 1020, which the Federal Circuit held was patent ineligible. The guidance teaches that example 29, claim 1 is patent eligible. The USPTO has not responded to the Court's criticism and example 29 continues to appear in the Guidance unchanged.... Read more

Claims Directed to Computerized Statistical Methods for Determining Haplotype Phase Are Patent Ineligible

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

Two-Step Eligibility for Genomic Analysis Systems

Attorney: Daniel J. Pereira, Ph.D.
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