A weekly summary of the precedential patent-related opinions issued by the Court of Appeals for the Federal Circuit and the opinions designated precedential or informative by the Patent Trial and Appeal Board.
CareDx, Inc., et al. v. Natera, Inc., Nos. 2022-1027, -1028 (Fed. Cir. (D. Del.) July 18, 2022). Opinion by Lourie, joined by Bryson and Hughes.
CareDx sued Natera for infringement of three patents relating to diagnosing or predicting organ transplant status by using methods to detect a donor’s cell-free DNA (cfDNA). Natera moved for summary judgment of ineligibility under 35 U.S.C. § 101. The district court granted the motion, ruling that the claims were directed to “the detection of natural phenomena, specifically, the presence of donor cfDNA in a transplant recipient and the correlation between donor cfDNA and transplant rejection.” The court also concluded that, based on the specification’s numerous admissions, the claims recited only conventional techniques. CareDx appealed.
The Federal Circuit affirmed the ineligibility of the claims. Applying the Supreme Court’s two-step Alice/Mayo test for eligibility, the Federal Circuit ruled at step one that the claims “apply conventional measurement techniques to detect a natural phenomenon—the level of donor cfDNA and the likelihood of organ transplant rejection.” The Federal Circuit emphasized that the patents’ written description expressly stated that the disclosed techniques “are, unless otherwise indicated, conventional.” And the court determined that “the written description is replete with characterizations of the claimed techniques in terms that confirm their conventionality.”
In so ruling, the Federal Circuit rejected CareDx’s argument that the court’s precedent limits the conventionality inquiry to step two. The court stated that it has “repeatedly analyzed conventionality at step one as well.”
Turning to step two, the Federal Circuit held that “the asserted claims add nothing inventive because they merely recite standard, well-known techniques in a logical combination to detect natural phenomena.” In particular, “the specification admits that each step in the purported invention requires only conventional techniques and commercially available technology.” Further, there was no genuine dispute that the claimed techniques add nothing inventive to the natural phenomena being detected. Therefore, because “applying standard techniques in a standard way to observe natural phenomena does not provide an inventive concept,” the Federal Circuit affirmed the ineligibility under § 101.