Cleveland Clinic Foundation v. True Health Diagnostics LLC

            On April 1, 2019, the U.S. Court of Appeals for the Federal Circuit (“Federal Circuit”) issue a non-precedential decision in Cleveland Clinic Foundation v. True Health Diagnostics LLC, holding that Cleveland Clinic Foundation”™s (“Cleveland Clinic”) U.S. Patent. Nos. 9,575,065 and 9,581,597 (collectively, “the disputed patents”) were invalid under 35 U.S.C. § 101 (“§ 101”). More importantly, however, the Federal Circuit stated it was not bound by the U.S. Patent and Trademark Office (“USPTO”) guidance.

            In 2017, the U.S. District Court for the Eastern District of Virginia (“district court”) held that the disputed patents were invalid under § 101 for being directed to an ineligible natural law. Subsequently, Cleveland Clinic appealed to the Federal Circuit.

            On appeal, Cleveland Clinic argued that the disputed patents were not directed to an abstract idea. Cleveland Clinic furthered its argument by alleging the district court failed to give proper weight to the USPTO”™s decision to allow the disputed patent applications to issue. Specifically, according to Cleveland Clinic, the district court did not give the proper weight to the examiner”™s decision to allow the disputed patent claims under the USPTO”™s 2016 subject matter eligibility guideline”™s Example 29.

            In its opinion, the Federal Circuit first determined whether the disputed patent claims were directed to a natural law. Citing to its decision in Ariosa Diagnostics, Inc. v. Sequenom, Inc., the Federal Circuit explained that it previously determined Example 29 was invalid under § 101 as being directed to an ineligible natural law. Therefore, the Federal Circuit reasoned the examiner”™s reliance on Example 29 rendered the disputed patents invalid.  Furthermore, the Federal Circuit concluded that the disputed patent claims did not recite an inventive concept which would render the claims patent eligible. Finally, the Federal Circuit turned to Cleveland Clinic”™s argument regarding the district court”™s failure to give proper weight to the examiner”™s decision.

            The Federal Circuit stated, “[w]hile we greatly respect the [USPTO”™s] expertise on all matters relating to patentability, including patent eligibility, we are not bound by its guidance. And, especially regarding the issue of patent eligibility and the efforts of the courts to determine the distinction between claims directed to natural laws and those directed to patent-eligible applications of those laws, we are mindful of the need for consistent application of our case law.” Accordingly, in view of Ariosa, the Federal Circuit held the disputed patents were invalid.

            Although this case revolved around the USPTO”™s 2016 subject matter eligibility guidelines, this case may indicate the Federal Circuit”™s unwillingness to follow the newly revised § 101 test provided by the USPTO”™s 2019 subject matter eligibility guidelines. However, as stated in our firm”™s 2019 Winter Newsletter, the 2019 subject matter eligibility guidelines essentially reduce Supreme Court and Federal Circuit precedent into the new § 101 test. Therefore, the Federal Circuit””when consistently applying its own case law””is likely to reach the same outcome as the USPTO when determining validity under § 101 for patents allowed under the new guidance.