Last week, the United States Court of Appeals for the Federal Circuit issued an opinion in Cleveland Clinic Foundation v. True Health Diagnostics LLC, 2018-1218 (April 1, 2019). Cleveland Clinic sued True Health for infringing patents relating to tests to determine whether an individual has increased risk of cardiovascular disease (“CVD”). Specifically, the patents related to evaluating CVD risk by measuring the concentration of myeloperoxidase (“MPO”) in the blood using an immunoassay and comparing the MPO concentration to those of healthy control subjects. According to the patents, this was more accurate than prior methods. In granting a Rule 12(b)(6) motion brought by True Health, the district court found the asserted claims directed to ineligible subject matter under 35 U.S.C. § 101. Cleveland Clinic appealed.
The patents in suit matured from continuation applications claiming priority from a parent patent, the validity of which had already been adjudicated by the Federal Circuit. In Cleveland Clinic Foundation v. True Health Diagnostics LLC, 859 F.3d 1352 (Fed. Cir. 2017), the Court held the parent patent was directed to the ineligible natural law that blood MPO levels correlate with CVD risk. Cleveland Clinic argued the newly asserted claims were different, and valid, because using an immunoassay to detect the correlation between blood MPO levels and CVD risk supplied an inventive concept sufficient to transform the asserted claims into patent-eligible subject matter. True Health responded that the correlation of CVD risk and blood MPO levels is a natural law that exists apart from human intervention regardless of the technique to observe it. The Federal Circuit agreed with True Health. Cleveland Clinic raised a number of additional arguments, each of which the Court rejected in affirming the district court’s dismissal. In one such argument, Cleveland Clinic asserted the district court failed to give appropriate deference, under Skidmore v. Swift & Co., to subject matter eligibility guidance published by the USPTO. Skidmore requires courts to give some deference to informal agency interpretations of “ambiguous statutory dictates.” According to Cleveland Clinic, Example 29 of the USPTO Guidance confirmed Cleveland Clinic’s patents were directed to patent eligible subject matter, and the district court erred in concluding otherwise. The Federal Circuit disagreed, explaining it is “not bound by [the USPTO’s] guidance” on issues related to subject matter eligibility. The Court further held Example 29 contradicted its own case law, which “must control.”
