More patents directed to diagnostic methods were found to be invalid as directed to the ineligible subject matter in Cleveland Clinic Foundation v. True Health Diagnostics, LLC, Case No. 2018-1218 (Fed. Cir. April 1, 2018). The Court of Appeals for the Federal Circuit applied the “Alice two-step” test and found the claims in U.S. Patent Nos. 9,575,065 and 9,581,597 invalid under § 101. This holding may come as a surprise to some because Cleveland Clinic argued, among other things, that the claims at issue mirrored Example 29-Claim 1 in the USPTO guidance published on May 4, 2016 (“referred to as Guidance”). Claim 1 in Example 29 of the Guidance was deemed patent eligible by the USPTO. Although the Court noted the similarities between the claims at issue and the claims in Example 29 of the Guidance, the Court declined to give deference to the USPTO. The message here is that sheer reliance on the Guidance without more does not shield claims involving laws of nature or abstract ideas against claims of invalidity under § 101.  A closer look at the claim language is instructive.

Claim 1 of the ‘065 patent (which is a continuation of US Patent No. 7,223,552 also found to be invalid as directed to patent ineligible subject matter) is generally directed to a method for detecting elevated MPO mass in a patient sample by detecting binding between MPO in the sample with anti-MPO antibodies and comparing the detected MPO mass with a control MPO mass. The Court held that this claim and the other claims at issue “are directed to the natural law that blood MPO levels correlate with atherosclerotic CVD.” Importantly, the Court noted that “the specification and prosecution history plainly concede that each of the process steps was well-known in the art.”  Citing Mayo, the Court reiterated that ” a claim directed to a natural law may nevertheless be patent-eligible if it “contain[s] other elements or a combination of elements, sometimes referred to as an ‘inventive concept,’ sufficient to ensure that the patent in practice amounts to significantly more than a patent upon the natural law itself.” Mayo, 566 U.S. at 72–73 (citing Flook, 437 U.S. at 594). Applying Mayo, the Court went on to conclude that the claims at issue do not contain an additional inventive concept, and were, therefore, directed to the patent-ineligible subject matter.

It is noteworthy that the Court clarified that process claims using a known technique in a standard way to observe a natural law have been consistently rejected as directed to patent ineligible subject matter.  To survive § 101 scrutiny, a process claim that is directed to a law of nature must contain other elements or a combination of elements, sometimes referred to as an ‘inventive concept,’ sufficient to ensure that the patent in practice amounts to significantly more than a patent upon the natural law itself. If the claim contains a new method for detecting a known analyte or employs a new technique for detecting a known analyte, the claim should survive § 101 scrutiny.  Although many commentators have argued that the test for patent-eligible subject matter articulated by the courts conflates the novelty and non-obviousness statutory requirements with subject matter eligibility requirements, the existing framework for evaluating subject matter eligibility appears to be consistently applied.  It seems that any change in the analysis for patent subject matter eligibility for diagnostic claims will require an act of Congress.