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Federal Circuit Declines to Follow Patent Office's Subject Matter Eligibility Guidance In Affirming Trial Court's Decision That Claims Are Directed to Patent-Ineligible Subject Matter
On April 1, 2019, a Federal Circuit panel consisting of Judge Lourie, Judge Moore and Judge Wallach issued a unanimous, nonprecedential opinion, authored by Judge Lourie, in Cleveland Clinic Found. v. True Health Diagnostics LLC, 2019 U.S. App. LEXIS 9451 (Fed. Cir. 2019). Cleveland Clinic Foundation and Cleveland Heartlab, Inc. (together, Cleveland) appealed the United States District Court for the Eastern District of Virginia's decision that the claims at issue were directed to patent-ineligible subject matter. Because the district court correctly concluded that the claims are directed to a natural law and recite no other inventive concept, the panel affirmed.
Cleveland sued True Health Diagnostics LLC (True Health) for infringement of two related patents, asserting claims that are directed to methods of detecting an elevated myeloperoxidase (MPO) concentration in a plasma sample from a human subject with atherosclerotic cardiovascular disease (ACVD). Slip Op. at 6-7. In granting True Health's Rule 12(b)(6) motion, the district court found the asserted claims patent-ineligible as directed to a natural law under 35 U.S.C. §101 and dismissed Cleveland's complaint for failure to state a claim. Slip Op. at 7.
The panel first addressed whether the district court correctly found the asserted claims directed to a natural law, and concluded that it did. Cleveland argued that the asserted claims are not directed to a natural law because they recite the technique of using immunoassay to measure the blood MPO levels of patients with ACVD. Slip Op. at 9. Cleveland attempted to distinguish the asserted claims from claims of a parent patent that recite methods of assessing a subject's risk of having ACVD by comparing the subject's MPO level to a control group. Slip Op. at 9-10. In a prior decision, the Federal Circuit had found the claims of that parent patent invalid as directed to the natural law that blood MPO levels correlate with ACVD. Slip Op. at 5. Here, the panel found the distinction overly superficial and determined that the claims in all three patents are just different articulations of the same natural law. Slip Op. at 10. Cleveland next argued that the correlation between blood MPO levels and ACVD is not a natural law because it can only be detected using certain techniques. Slip Op. at 9. The panel rejected this argument, noting that these laws of nature exist regardless of the methods used by humans to observe them, and inadequate measures of detection do not render a natural law any less natural. Slip Op. at 10.
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