The CareDx Petition For Certiorari, Maybe This Is The One

• Jurisdiction: United States,Federal
• Law Firm: Oblon, McClelland, Maier & Neustadt, L.L.P
• Subject Matter: Intellectual Property, Patent
• Author: Mr Richard D. Kelly
• Published date: 05 June 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.

First, the petition begins with the claims demonstrating that the claims do not preempt the use of cell free DNA (cfDNA) to determine the state of an organ transplant. It explains, as do the patent specifications, the problems with the previous approaches, one of which predates the patent by over a decade.

The oldest of the prior techniques would work reliably only in women who received the organ from of male donor since it relied upon detecting and quantifying the amount of Y chromosome in the recipient's blood. Only about 25% of all organ recipients fall into this group and the group is further reduced since the technique is of questionable accuracy in women who have received a blood transfusion where the donor was a male. The second technique, the detection of donor-specific human leukocyte antigen (HLA) alleles in circulating DNA, has been considered as a signal for organ rejection in kidney and pancreas transplant patients. However, this strategy is limited by the inability to distinguish HLA alleles between all donors and recipients, particularly for common HLA types, and the potential complication of microchimerism such as from blood transfusions.

The claims of the CareDx patents as represented by claim 1 of the '607 claim are to a multi-step process:

1. A method of quantifying kidney transplant-derived circulating cell-free deoxyribonucleic acids in a human kidney transplant recipient, said method comprising:

(a) providing a plasma sample from said human kidney transplant recipient, wherein said human kidney transplant recipient has...