The Cleveland Clinic Foundation, et al. v. True Health Diagnostics LLC

In Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66 (2012), the inventors identified an element existing in nature and claimed known methods to detect that element for a purpose already known in the art. This Court held that patent invalid for claiming ineligible subject matter, but cautioned that “too broad an interpretation of this exclusionary principle could eviscerate patent law.” Id. at 71. This Court further noted, for example, that “a new drug or a new way of using an existing drug” could be patent-eligible under 35 U.S.C. § 101 (“Section 101”). Id. at 87. In this case, the patents were fully examined by the United States Patent and Trademark Office (“PTO”) and found to be novel and not obvious, including for one of the patents, confirmation after two ex parte reexaminations. The PTO further found that the prior art taught away from the claimed inventions. Notwithstanding that the inventions were groundbreaking and a significant advancement over the prior art, the district court declared them invalid at the pleading stage. It gave the patents a cursory review, and refused to construe any claim terms. It took 55 separate claims—each claiming a distinct invention with many different limitations— and analyzed them as if all of the claimed inventions were a single method with two simplistic steps. The court did not permit evidentiary submissions or development of the record, and while the district court purported to take judicial notice of the prosecution history, it ignored the PTO record in its analysis. The Federal Circuit affirmed the lower court, invalidating valuable patent rights in a new