In another setback for diagnostic method patents, the Federal Circuit rejected efforts by patent owner/appellant Cleveland Clinic[1] to avoid 35 U.S.C. § 101 by restyling diagnostic method claims as “techniques” for detecting a correlation between protein levels and a disease state. Cleveland Clinic Found. v. True Health Diagnostics LLC, No. 2018-1218, 2019 WL 1452697, at *4 (Fed. Cir. Apr. 1, 2019) (“Cleveland Clinic”). The court’s unwillingness to accept the patent eligibility of diagnostic method claims – even those claims that are rephrased as a process of detection rather than the product or natural correlation per se – directly contradicts the position taken by the United States Patent and Trademark Office (USPTO) in the agency’s May 2016 Subject Matter Eligibility Guidelines (USPTO Guidelines). Cleveland Clinic, although designated as a non-precedential opinion, deepens the growing divide between administrative and judicial interpretations of 35 U.S.C. § 101 and is sure to be an unwelcome development for practitioners who have been modeling diagnostic method claims on the USPTO Guidelines since 2016.
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