April 6, 2019
For the second time in two years, the Federal Circuit has held claims in Cleveland Clinic’s patents invalid for claiming ineligible subject matter. The patents at issue in Cleveland Clinic Found. v. True Health Diagnostics LLC, 2019 U.S. App. LEXIS 9451 (Fed. Cir. Apr. 1, 2019) (“Cleveland Clinic II”), were linked to the same natural law as the three patents at issue in Cleveland Clinic Found. v. True Health Diagnostics LLC, 859 F.3d 1352 (Fed. Cir. 2017) (“Cleveland Clinic I”): the correlation between cardiovascular disease and levels of the heme protein myeloperoxidase (“MPO”) in a subject’s blood.
The claims in Cleveland Clinic I were held ineligible because they were directed to “assessing a test subject’s risk of having atherosclerotic cardiovascular disease” by comparing levels of MPO in a subject’s blood sample to MPO levels in normal subjects. The Federal Circuit found that the claims were based on observing a naturally occurring phenomenon, and reflected no new technique for measuring MPO.
The claims in Cleveland Clinic II differed slightly. One patent claimed “a method for identifying an elevated [MPO] concentration in a plasma sample” by (a) contacting the sample with an anti-MPO antibody, (b) detecting the sample’s MPO level and MPO concentration, and (c) comparing that concentration to a control. Another patent claimed a “method of detecting elevated MPO” in a sample by (a) obtaining a plasma sample, (b) contacting the sample with anti-MPO antibodies, and (c) detecting elevated levels of MPO by detecting binding between the sample and the antibodies.
Cleveland Clinic argued that these claims in the second case warranted a different result because they focused on the blood, not on a higher-level “assess[ment] [of] a test subject’s risk of having [cardiovascular disease].” The Federal Circuit called this distinction “overly superficial.” Just like the claims in Cleveland Clinic I, the claims in Cleveland Clinic II were “not directed to new techniques for performing an immunoassay to detect a patient’s blood MPO levels.” The claims still rested on “reaching [the] conclusion[ ] that the patient’s blood MPO levels are elevated in comparison to a control group.” The “rephrasing of the claims does not make them less directed to a natural law.”
One wrinkle in Cleveland Clinic II has generated significant attention. Cleveland Clinic contended that the PTO’s May 2016 eligibility guidance contained an example claim that paralleled the claims in suit, and that the PTO guidance stated was patent-eligible. The Federal Circuit did not reach a conclusion as to whether Cleveland Clinic’s claims were in fact analogous to the PTO’s example claim. But the court held that the district court correctly declined to follow the PTO guidance.
While the Federal Circuit expressed “great[ ] respect [for] the PTO’s expertise on all matters relating to patentability, including patent eligibility,” the court concluded that it is “not bound by [the PTO’s] guidance.” The PTO’s example claim was “strikingly similar” to a claim the Federal Circuit had held invalid in its prior Ariosa decision and, regardless of the PTO’s eligibility guidance, “Ariosa must control.”
The Federal Circuit’s jurisprudence on the extent of deference afforded to PTO guidance is evolving. A couple of weeks earlier, the Federal Circuit confronted the PTO’s guidance in Natural Alternatives Int’l, Inc. v. Creative Compounds, LLC, 918 F.3d 1338 (Fed. Cir. March 15, 2019). The court there held method of treatment claims eligible. In a footnote, the court remarked that it need not resolve “[t]he parties[’] dispute [regarding] the persuasiveness of this [guidance] and the weight we should afford it under Skidmore v. Swift & Co., 323 U.S. 134, 65 S. Ct. 161, 89 L. Ed. 124 (1944).” Because “the result [wa]s clear” for the claims at issue, the court held that “Skidmore deference would [not] affect the outcome.”
Litigants should consider the Federal Circuit’s comments in Cleveland Clinic II and Natural Alternatives when deciding how to frame the PTO guidelines, and example claims from them, in court.
Author: Marc J. Pernick