Cleveland Clinic - Another Black Eye for the Federal Circuit and Dissing the USPTO

April 3, 2019 – Article

            In the April 1 Cleveland Clinic Foundation v. True Health Diagnostics LLC decision, the Federal Circuit has once again given itself a black eye in finding a new diagnostic procedure to be patent ineligible and with the same punch dissed the USPTO.

            The Federal Circuit performed its fete by deciding once again that where, one discovers a new disease marker its use to diagnose the disease is patent ineligible because the steps to analysis for the marker are conventional. Briefly the invention involved the discovery by the Clinic that elevated levels of myeloperoxidase (MPO) were an excellent marker for cardiovascular disease. (CVD). The clinic has filed minerals patent on this invention in an attempt to find a claim the Federal Circuit would find to be patent ineligible. Previously the Federal Circuit had found the claims drawn to this technology in U.S.P. 7,223,552 to be patent ineligible. In this appeal the Federal Circuit torpedoed two more patents, U.S.P. 9,575,065 and 9,581,597. Claim 1 of the ‘552 patent is exemplary of the claims:

1. A method for identifying an elevated myeloperoxidase (MPO) concentration in a plasma sample from a human subject with atherosclerotic cardiovascular disease comprising:

a) contacting a sample with an anti-MPO antibody, wherein said sample is a plasma sample from a human subject having atherosclerotic cardiovascular disease;

b) spectrophotometrically detecting MPO levels in said plasma sample;

c) comparing said MPO levels in said plasma sample to a standard curve generated with known amounts of MPO to determine the MPO concentration in said sample; and

d) comparing said MPO concentration in said plasma sample from said human subject to a control MPO concentration from apparently healthy human subjects and identifying said MPO concentration in said plasma sample from said human subject as being elevated compared to said control MPO concentration.

            The district court found the claims to be drawn to a law of nature. There is no question but that the relationship between the MPO level and CVD is a law of nature. But until the Clinic discovered the relationship it was not possible to put the law into practical use. The Court looked to see if the claims involved any inventive step, that is, was the claimed method apart from the natural law patentable. The Clinic had conceded during prosecution that the steps were conventional.

            The Court dismissed the USPTO’s guidance relied upon by Clinic because it considered its Ariosa decision to control. (Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371 (Fed. Cir. 2015)). In particular, the Court found that the USPTO guidance example 29 to be analogous to claim in Ariosa and declined to apply the USPTO guidance but instead followed Ariosa without analyzing properly the claims at issue or controlling Supreme Court law.

            In Eibel Process Co. V. Minnesota & Ontario Paper Co., 261 U.S. 45, 68 (1923) the Supreme Court found patentable claims to a paper making machine which used gravity to solve a problem which had vexed the paper making industry. The Supreme Court noted that:

The invention was not the mere use of a high or substantial pitch to remedy a known source of trouble. It was the discovery of the source not before known, and the application of the remedy [gravity], for which Eibel was entitled to be rewarded in his patent.

            Here Clinic discovered a relationship between CVD and MPO and used that relationship to diagnose CVD. The natural law remains available for others to use for other purposes such as treating the patient with a drug to inhibit the formation of MPO. In Eibel the natural law, gravity, was used to solve a problem which everyone agreed was solvable by gravity but not until the source of the problem was discovered. In Clinic the law is being used to solve the problem of diagnosing CVD. While in Eibel a machine was modified to take advantage of gravity, the modification was obvious, what made Eibel patentable was finding the source of the problem and Eibel was entitled to his patent on the solution – using gravity to solve the problem. Here Clinic

            The Federal Circuit continues to wear blinders to the fact that in Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 87 (2012)) the Supreme Court specifically stated that its decision was limited to the unique fact pattern at issue:

We need not, and do not, now decide whether were the steps at issue here less conventional, these features of the claims would prove sufficient to invalidate them. For here, as we have said, the steps add nothing of significance to the natural laws themselves. Unlike, say, a typical patent on a new drug or a new way of using an existing drug, the patent claims do not confine their reach to particular applications of those laws.

            Here, the claims are limited to a particular use of the natural law – to diagnose heart disease. The Federal Circuit needs to consider what acts would infringe Clinic’s claims. The only act is one where the MPO level is used to detect CVD. All other are free to use. Further, in  Mayo doctors had already identified the metabolite as important and routinely measured its level:

Indeed, scientists routinely measured metabolites as part of their investigations into the relationships between metabolite levels and efficacy and toxicity of thiopurine compounds. '623 patent, col. 8, ll. 37-40, id., at 10. Thus, this step tells doctors to engage in well-understood, routine, conventional activity previously engaged in by scientists who work in the field.

            What was routine in Mayo was analyzing for the thiopurine metabolite not simply the general laboratory procedures as noted by the Court at 566 U.S. 79:

Indeed, scientists routinely measured metabolites as part of their investigations into the relationships between metabolite levels and efficacy and
toxicity of thiopurine compounds. ‘623 patent, col.8, ll.37–40, id., at 10. Thus, this step tells doctors to engage in well understood, routine, conventional activitypreviously engaged in by scientists who work in the field. Purely "conventional or obvious “[pre]-solution activity” is normally not sufficient to transform an unpatentable law of nature into a patent-eligible application of such a law. [Emphasis added]

            At the time Clinic filed for its patents there was nothing routine about measuring MPO levels as no one understood the relevance of the level to CVD.