In Patent Eligibility It's the Claim That Is the Name of the Game*

Attorney: Richard D. Kelly
December 18, 2023

Recently Judge Connolly, Chief Judge of the District Court of Delaware had an opportunity of deciding three motions for summary judgment filed by CareDX in its litigation with Natera, Natera, Inc. v. CareDX, Inc, Dist. DE, CA 20-38, that one patent was invalid as being directed to patent ineligible subject matter. The patents are U.S. Patent Nos. 10,597,724 (‘724), 10,655,180 (‘180), and 11,111,544 (‘544). The ‘724 and ‘180 patents are directed to methods of observing DNA in samples taken from patients. The ‘544 patent is directed to a method of “preparing a preparation of amplified DNA” from the sample of an individual to observe the DNA of a second individual in the sample. The Court found that one claim in each patent was representative of all claims in the respective patent. These representative claims are:<... Read more

In Re Cellect – ODP Defense Does Not Impact The Expiration Date of A Patent With Both PTA and PTE In The Absence of A Terminal Disclaimer

Attorney: Richard D. Kelly
September 15, 2023

The Federal Circuit in In re Cellect, Appeals Nos. 2022-1293, 2022-1294, 2022-1295, 2022-1296 held that the earliest patent to expire in a series of patents subject to obviousness-type double patenting (ODP) controls, i.e., the PTA in the later to expire patents is lost and all patents are invalid for double patenting. In Cellect the relation between the patents is shown below:

<... Read more

American Axle Part 2 – Not an Abstract Idea

Attorney: Richard D. Kelly
August 4, 2023

On July 28, 2023, Judge Williams of the Delaware District unsealed his decision on remand from the Federal Circuit addressing competing summary judgment motions regarding the patent eligibility of remanded claim 1. The Federal Circuit remanded the case to the district court to determine if claim 1 was directed to an abstract idea argued by Neapco on appeal for invalidity.  Claim 1 provided:<... Read more

No Motivation to Modify Product-Specific Method with Method Features for Different Products

Attorney: Derek Lightner, Ph.D.
July 14, 2023

On July 10, 2023, the Patent Trial and Appeal Board (PTAB) reversed an examiner’s finding of obvious on the basis of a failure to show a motivation to modify the prior art and a lack of a reasonable expectation of success. The appeal (No. 2023-002080, USSN 15/558,153, Technology Center 1700) of Ex parte MARK HETHERINGTON began with the filing of a Notice of Appeal on May 13, 2022, after filing the national stage application on September 13, 2017. The main appealed claim recited:<... Read more

The CareDx Petition For Certiorari, Maybe This Is The One

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

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