In CareDx (Stanford U.) v. Natera Civ. Action No. 19-0567-CFC-CJB Consolidated (Sept. 28, 2021, D. Delaware), Judge Connolly ruled that the diagnostic method claimed in U. S. Pat. No. 8,703,652 and two others was a patent-ineligible natural phenomenon. The method is based upon the known correlation between the presence of donor-specific cell-free DNA (cfDNA) in a transplant recipient’s tissue and transplant rejection. Since the correlation was known, CareDx was left to argue that the improvement in sensitivity provided by the combination of known steps—which improvement was even recited in claim 1—was sufficient to satisfy the Mayo/Alice test for patent eligibility. However, by now we know that even discovery of a natural correlation and the discovery of its utility as a diagnostic is not enough to satisfy the requirement for the further “inventive concept” required by Step 2 of the Mayo/Alice test.
[The USPTO’s] webpage houses useful information regarding the implementation of an interim Director review process in Patent Trial and Appeal Board (PTAB) proceedings following Arthrex.
On June 21, 2021, the U.S. Supreme Court issued a decision in United States v. Arthrex, Inc., Nos. 19-1434, 19-1452, 19-1458, 2021 WL 2519433, addressing the Constitution’s appointments clause as it relates to PTAB administrative patent judges (APJs). The court considered whether APJs are “principal officers” who must be appointed by the President with the Senate’s advice and consent, or, as the United States Patent and Trademark Office (USPTO) and the U.S. government argued, whether they are “inferior officers” who can be appointed by the Secretary of Commerce.