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The Cleveland Clinic Foundation v. True Health Diagnostics, LLC

United States District Court, E.D. Virginia, Alexandria Division

August 4, 2017

THE CLEVELAND CLINIC FOUNDATION, et al. Plaintiffs
v.
TRUE HEALTH DIAGNOSTICS, LLC, Defendant.

          MEMORANDUM OPINION

          Leonie M. Brinkema United States District Judge

         Plaintiffs The Cleveland Clinic Foundation ("CCF") and Cleveland Heartlab, Inc. ("CH") (collectively, "plaintiffs"), have filed a three-count complaint for patent infringement against defendant True Health Diagnostics, LCC ("True Health" or "defendant"), alleging that the defendant's procedures for diagnosing atherosclerotic cardiovascular disease ("CVD")[1] infringe three patents owned by the plaintiffs: U.S. Patent 9, 575, 065 ("the '065 patent") (Count 1); U.S. Patent 9, 581, 597 ("the '597 patent") (Count 2); and U.S. Patent 9, 612, 242 ("the '242 patent") (Count 3). Defendant moved to dismiss all three counts, arguing that the patents asserted in the first two counts are directed to an unpatentable natural law, and that plaintiffs did not adequately plead that defendants infringe the patent asserted in the third count. On June 9, 2017, the Court denied that motion without prejudice for two reasons. First, an appeal was still pending before the Federal Circuit in a related civil action in which the Northern District of Ohio held the parent patent of the '065, '597, and '242 patents to be invalid. As a matter of prudence and judicial economy, it made sense to wait for the Federal Circuit's disposition rather than attempt to predict what it was going to do. Second, in the absence of a ruling from the Federal Circuit, the Court concluded that additional factual discovery would likely be necessary to determine whether certain steps claimed in the patents were conventional.

         The Federal Circuit has now resolved that appeal, affirming the conclusion that the parent patent was invalid because it was directed toward subject matter that falls within a judicial exception to 35 U.S.C. § 101, which sets the outer limit of what is eligible for patent protection. Cleveland Clinic Found, v. True Health Diagnostics. LLC. 859 F.3d 1352 (2017) ("Cleveland Clinic I"). In light of that ruling, True Health has filed a motion to reconsider the decision as to Counts 1 and 2, arguing that the Federal Circuit's opinion renders additional factual discovery unnecessary and that those counts should now be dismissed.[2] For the reasons that follow, the Court is persuaded that the Federal Circuit's opinion in Cleveland Clinic I fully resolved all relevant factual issues as to Counts 1 and 2 and defendant's Motion to Reconsider will be granted.

         I. BACKGROUND

         A. The Patents at Issue

         All three of the patents at issue in this civil action are children of the now-invalidated U.S. Patent 7, 223, 552 ("the '552 patent"), and all involve identifying the levels of a particular enzyme-myeloperoxidase ("MPO")-in the blood stream of a person suffering from atherosclerotic CVD. The '552 patent contains 23 total claims, most of which are minor variations on Claim 1, which describes:

         1. A method for characterizing the test subject's risk of having atherosclerotic cardiovascular disease, comprising:

determining levels of [MPO] activity, [MPO] mass, or both in a bodily sample from the test subject, said bodily sample being blood, serum, plasma, blood leukocytes selected from the group consisting of neutrophils and monocytes, or any combination thereof,
wherein elevated levels of MPO activity or MPO mass or both in the bodily sample of the test subject as compared to at least one predetermined value based on levels of MPO activity, MPO mass or both, respectively, in comparable bodily samples obtained from control subjects diagnosed as not having the disease indicates that the test subject is at risk of having atherosclerotic cardiovascular disease.

[Dkt. 38-2] at 52.

         As for the patents in this civil action, the '065 patent recites one claim:

         1. A method of detecting elevated MPO mass in a patient sample comprising:

a) obtaining a plasma sample from a human patient having atherosclerotic cardiovascular disease (CVD); and
b) detecting elevated MPO mass in said plasma sample, as compared to a control MPO mass level from the general population or apparently healthy subjects, by contacting said plasma sample with anti-MPO antibodies and detecting binding between MPO in said plasma sample and said anti-MPO antibodies.

[Dkt.35-l]atC0000332.

         The '597 patent recites two 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.
2. The method of claim 1, further comprising, prior to step a), centrifuging an anti-coagulated blood sample from said human subject to generate said plasma sample.

[Dkt. 35-2] at C0000659.

         The specifications for both the '065 and '597 patents provide that the inventions "relate[] to a diagnostic test which can be used to determine whether an individual or test subject is at a lower risk or higher risk of developing or having cardiovascular disease than other individuals in a given population of human subjects." [Dkt. 35-1] at C0000318; [Dkt. 35-2] at C0000645. In the "Summary of the Invention" section, both specifications provide that the "present invention provides new diagnostic tests for characterizing an individual's risk of developing or having cardiovascular disease .... based on the discovery that patients with coronary artery disease (CAD) have significantly greater levels of leukocyte and blood [MPO] levels than patients without angiographically significant CAD." Id. Both specifications state that "[MPO] activity may be determined by any of a variety of standard methods known in the art. [Dkt. 35-1 ] at C0000321; [Dkt. 35-2] at C0000648.

         B. Prosecution History of The '065 and '597 Patents

         The patent examiner initially rejected the '065 patent on § 101 grounds, concluding that it was directed toward an unpatentable abstract idea. Plaintiffs successfully challenged that decision, citing Example 29 from the U.S. Patent and Trademark Office's ("USPTO") Subject Matter Eligibility Examples in the guidelines that the USTPO ...


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