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Cleveland Clinic Foundation v. True Health Diagnostics LLC

Claims for Correlating Enzyme Level to Cardiovascular Disease Not Patent Eligible

Cleveland Clinic Foundation v. True Health Diagnostics LLC, (Fed. Cir. June 16, 2017) (Lourie, REYNA, Wallach) (N.D. Ohio: Gaughan) (3 of 5 stars)

Fed Cir affirms determination of patent ineligibility. The Cleveland Clinic’s patents related to methods for detecting myeloperoxidase (“MPO”) in the body, and correlating the results to cardiovascular risk. As procedural matter, the district court did not err in addressing only certain claims from Cleveland Clinic’s three patents. Per Content Extraction, 776 F.3d 1343 (Fed. Cir. 2014), it is appropriate to review only representative claims where the claims are substantially similar and linked to the same law of nature. The district court also did not err in rejecting the claims at the motion to dismiss stage, per Genetic Technologies, 818 F.3d 1369 (Fed. Cir. 2016), and other cases.

At step one of Alice, 134 S. Ct. 2347 (2014), Cleveland Clinic’s claims were directed to the natural law correlating presence of MPO to cardiovascular disease. As in Ariosa, 788 F.3d 1371 (Fed. Cir. 2015), “the method starts and ends with naturally occurring phenomena with no meaningful non-routine steps in between.” Op. at 14. The opinion rejects Cleveland Clinic’s citation to CellzDirect, 827 F.3d 1042 (Fed. Cir. 2016), because Cleveland Technique did not create a new laboratory technique, but was only using well-known techniques to execute the claimed method. At Alice step two, Cleveland Clinic’s claims lacked an inventive concept sufficient to confer patentability. Citing Ariosa and Mayo, 566 U.S. 66 (2012), the opinion concludes that Cleveland Clinic’s claims were merely applying a law of nature. The techniques used to assess MPO levels were well-known, as were the statistical techniques for making the required comparison to control levels. CellzDirect was distinguishable because in that case, there was an improvement to existing methods of cell preservation that applied a new discovered natural law; here, the patents “do not extend their discovery” of a correlation between MPO and cardiovascular disease. Op. at 17.

The district court also did not err in dismissing Cleveland Clinic’s claims under a separate patent, which related to methods of treating cardiovascular disease by prescribing lipid lowering drugs. The district court did not abuse its discretion in denying Cleveland Clinic’s request for leave to amend its complaint to correct some of the issues herein; the request was “buried” in Cleveland Clinic’s opposition to True Health’s motion to dismiss. The opinion described how True Health’s sale of lab reports documenting various testing services could not support contributory infringement liability because they were not a “material or apparatus” used for infringement. Nor could the sale of such reports support inducement due to Cleveland Clinic’s failure to allege a connection between True Health’s reports and any subsequent prescription of lipid lowering drugs by physicians.

KEYWORDS: SUBJECT MATTER ELIGIBILITY (NO); LAWS OF NATURE; CONTRIBUTORY INFRINGEMENT (NO); INDUCEMENT (NO); MOTION TO DISMISS (YES)