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

• Jurisdiction: United States,Federal
• Law Firm: Oblon, McClelland, Maier & Neustadt, L.L.P
• Subject Matter: Intellectual Property, Patent
• Author: Ms Marina I. Miller
• Published date: 28 February 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):

1. A method for detecting transplant rejection, graft dysfunction, or organ failure, the method comprising:

(a) providing a sample comprising [cfDNA] from a subject who has received a transplant from a donor;

(b) obtaining a genotype of donor-specific polymorphisms to establish a polymorphism profile for detecting donor [cfDNA];

(c) multiplex sequencing of the [cfDNA] in the sample followed by analysis of the sequencing results using the polymorphism profile to detect donor [cfDNA] and subject [cfDNA]; and

(d) diagnosing, predicting, or monitoring a transplant status or outcome of the subject who has received the transplant by determining a quantity of the donor [cfDNA] based on the detection of the donor [cfDNA] and subject [cfDNA] by the multiplexed sequencing, wherein an increase in the quantity of the donor [cfDNA] over time is indicative of transplant rejection, graft dysfunction or organ failure, and wherein sensitivity of the method is greater than 56% compared to sensitivity of current surveillance methods for cardiac allograft vasculopathy (CAV).

Claim 1 of the '497 patent is similar, except that it recites high-throughput sequencing or digital PCR instead of multiplex sequencing for 'determining' the amount of donor cfDNA. Claim 1 of the '607 patent is also similar, except that it recites selective amplification of the cfDNA by PCR before high-throughput sequencing.

A two-step analysis under Alice/Mayo is used to determine whether a patent claim is directed to patent eligible subject matter. In Step 1, the question is whether the claims are directed to a law of nature, natural phenomenon, or/and abstract idea. If yes, in Step 2 the question is whether the claim elements individually and as a whole contain additional elements that amount to significantly more than the judicial exception (i.e., transform the claim into patent-eligible subject...