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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On April 1, 2019, a Federal Circuit panel consisting of Judge Lourie, Judge Moore and Judge Wallach issued a unanimous, nonprecedential opinion, authored by Judge Lourie, in Cleveland Clinic Found.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.
The panel then turned to Cleveland's argument that using immunoassay to detect the correlation between blood MPO levels and ACVD supplies an inventive concept, and found it lacking. The panel noted that the claims simply recite a known immunoassay technique in a standard way to observe a natural law, which does not confer an inventive concept. Slip Op. at 11. In the panel's view, the patents' failure to disclose any technical impediment to carry out the standard immunoassay further demonstrates a lack of an inventive concept. Slip Op. at 11.
Finally, the panel addressed whether the district court failed to give appropriate deference to the subject matter eligibility guidance published by the United States Patent and Trademark Office (USPTO), and found no error in the district court's consideration of the same. Example 29 of the guidance recites a method of detecting a protein in a plasma sample using standard immunoassay and spectroscopic techniques. Slip Op. at 13. In the guidance, the USPTO advises that Example 29 is not directed to a natural law and is patent-eligible. Slip Op. at 13. While expressing its respect to the USPTO's expertise on all matters relating to patentability, including patent eligibility, the panel declared itself not bound by the guidance. Slip Op. at 13. The panel found Example 29 to be strikingly similar to a claim that recites a method for detecting a paternally inherited DNA of fetal origin in a maternal sample, which the Federal Circuit found to be directed to patent-ineligible subject matter in its decision in Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371 (Fed. Cir. 2015). Slip Op. at 13-14. Finding that Ariosa, not the guidance, must control, the panel concluded that the district court did not err in refusing to follow the guidance. Slip Op. at 14.
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Jeffrey S. Ginsberg is the Assistant Editor of this newsletter and a partner with Patterson Belknap Webb & Tyler LLP. Zhiqiang Liu is an associate at the firm.
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