Applying Standard Techniques in a Standard Way to Observe Natural Phenomena Is Not Patent-Eligible

In CareDx, Inc. v. Natera, Inc., No. 2022-1027 (Fed. Cir. July 18, 2022), the Federal Circuit Court of Appeals affirmed that CareDx’s three patents were invalid for claiming patent-ineligible subject matter.

In 2019, CareDx sued Natera and Eurofin in the District Court for the District of Delaware for infringing its three patents entitled “Non-Invasive Diagnosis of Graft Rejection in Organ Transplant Patients.” The district court granted summary judgment finding the patents invalid as directed to patent-ineligible subject matter. The Federal Circuit affirmed.

First, under Alice Step one, the Federal Circuit found that the asserted claims are directed to natural phenomena. The claims recite collecting a bodily sample, analyzing the cfDNA, identifying naturally occurring DNA from the donor organ, and then using the natural correlation between heightened cfDNA levels and transplant health to identify a potential rejection, none of which the Court found to be inventive in this particular case. CareDx also conceded that it did not invent or discover the relationship between the donor cfDNA and the likelihood of organ transplant rejection. Second, under Alice step two, the Federal Circuit found that the asserted claims add nothing inventive because they merely recite well-known techniques in a logical combination. The specification also admitted that each step in the purported invention requires only conventional and commercially available technology.