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Cleveland Clinic Found. v. True Health Diagnostics LLC

United States Court of Appeals for the Federal Circuit

April 1, 2019, Decided

2018-1218

Opinion

 [*1014]  Lourie, Circuit Judge.

The Cleveland Clinic Foundation and Cleveland HeartLab, Inc., (collectively, "Cleveland Clinic") appeal from a decision of the United States District Court for the Eastern District of Virginia, dismissing their complaint for patent infringement under Rule 12(b)(6) and holding claim 1 of U.S. Patent 9,575,065 (the "'065 patent") and claims 1 and 2 of U.S. Patent 9,581,597 (the "'597 patent") invalid under [**2]  35 U.S.C. § 101 as directed to an ineligible natural law. Cleveland Clinic Foundation v. True Health Diagnostics LLC, No. 1:17-cv-00198-LMB-IDD, 2017 U.S. Dist. LEXIS 123745, 2017 WL 3381976 (E.D.  [*1015]  Va. Aug. 4, 2017) ("Decision"). Because the district court correctly concluded that the claims are directed to a natural law and recite no other inventive concept, we affirm.

Background

The patents at issue1 disclose "diagnostic test[s] which can be used to determine whether an individual . . . is at a lower risk or higher risk of developing or having cardiovascular disease." '065 patent col. 1 ll. 21-25. These diagnostic tests are "based on the discovery that patients with coronary artery disease (CAD) have significantly greater levels of leukocyte and blood myeloperoxidase (MPO) levels." Id. col. 2 ll. 36-39.

At the time of the invention, cardiovascular disease ("CVD") was understood to be multifactorial, '065 patent col. 1 l. 51-col. 2 l. 26, and scientists and physicians were developing predictive algorithms based on genetic, environmental, and lifestyle factors. Id. col. 1 l. 53-60. However, these factors alone did not fully predict an individual's risk of developing CVD; in particular, "a large number of cardiovascular disorders occur[red] in individuals with apparently low to moderate risk profiles." [**3]  Appellant Br. 6 (citation omitted). Thus, the patents disclose a need in the art for "[d]iagnostic tests which employ risk factors that are independent of traditional CVD risk factors such as LDL levels." '065 patent col. 2 ll. 24-26.

Myeloperoxidase ("MPO") is a naturally-occurring heme protein associated with some types of white blood cells. '065 patent col. 6 ll. 60-65. It functions as an oxidant, converting inert substrates to reactive oxygen species toxic to pathogens, to aid in phagocytosis, an important process in the body's immune system. Id. col. 7 ll. 4-22. Atherosclerosis (the major cause of coronary artery disease) was known to be "a chronic inflammatory disorder," and high blood levels of other metabolites had been correlated to CVD. Id. col. 2 ll. 12-21 (disclosing the then-recent discovery that plasma concentrations of C-reactive protein could predict an individual's risk of developing some types of CVD). But these metabolites are imperfect markers of CVD because they are not specific to cardiovascular inflammation. While MPO had been found to be present at elevated levels in atherosclerotic lesions, it had not been shown that MPO was present at elevated levels in blood samples from patients [**4]  with atherosclerotic CVD. Id. col. 6 l. 66-col. 7 l. 3.

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760 Fed. Appx. 1013 *; 2019 U.S. App. LEXIS 9451 **; 2019 U.S.P.Q.2D (BNA) 113930

CLEVELAND CLINIC FOUNDATION, CLEVELAND HEARTLAB, INC., Plaintiffs-Appellants v. TRUE HEALTH DIAGNOSTICS LLC, Defendant-Appellee

Notice: THIS DECISION WAS ISSUED AS UNPUBLISHED OR NONPRECEDENTIAL AND MAY NOT BE CITED AS PRECEDENT. PLEASE REFER TO FEDERAL RULES OF APPELLATE PROCEDURE RULE 32.1 GOVERNING THE CITATION TO UNPUBLISHED OPINIONS.

Prior History:  [**1] Appeal from the United States District Court for the Eastern District of Virginia in No. 1:17-cv-00198-LMB-IDD, Judge Leonie M. Brinkema.

Cleveland Clinic Found. v. True Health Diagnostics, LLC, 2017 U.S. Dist. LEXIS 123745 (E.D. Va., Aug. 4, 2017)

Disposition: AFFIRMED.

CORE TERMS

levels, blood, natural law, patent, detecting, plasma, atherosclerotic, patients, district court, inventive, correlate, disclose, eligibility, antibody, protein, myeloperoxidase, concentration, comparing, elevated, cardiovascular disease, immunoassay, ineligible, samples, deference, discovery, observe, argues, recite, coronary artery disease, subject matter

Civil Procedure, Appeals, Standards of Review, De Novo Review, Defenses, Demurrers & Objections, Motions to Dismiss, Failure to State Claim, Constitutional Law, Congressional Duties & Powers, Copyright & Patent Clause, Patent Law, Subject Matter, Responses, Motions to Dismiss, Evidence, Judicial Notice, Subject Matter, Utility Patents, Process Patents, Administrative Law, Judicial Review, Deference to Agency Statutory Interpretation, Agency Adjudication, Informal Agency Action