June 19, 2017

Missed opportunity: Federal Circuit Again Offers No Clarifying Insight on Alice’s Two-Step Framework

By Jewell N. Briggs, Associate

On June 16, the Federal Circuit upheld the District Court’s decision in The Cleveland Clinic Found. V. True Health Diagnostics.

Plaintiffs brought suit alleging Defendant infringed three patents (U.S. Patent Nos. 7,223,552; 7,459,286; 8,349,581) (the “testing patents”) claiming methods for testing for myeloperoxidase in a bodily sample and a fourth patent (U.S. Patent No. 9,170,260) claiming a method for treating a patient that has cardiovascular disease.  Defendant moved to dismiss arguing (i) the testing patents were directed to patent-ineligible subject matter and (ii) Plaintiffs failed to state a claim for indirect infringement of the ‘260 patent.

The body releases enzyme myeloperoxidase (“MPO”) when an artery is damaged or inflamed. Consequently, MPO can be used as an indicator of a person’s risk of cardiovascular disease.  In the present instance, the inventors collected data from a pre-selected population to formulate a control value that could be compared with collected MPO data to determine a patient’s risk of cardiovascular disease.  For example, see Claim 11 of the ‘552 Patent:

11. A method of assessing a test subject’s risk of having atherosclerotic cardiovascular disease, comprising comparing levels of myeloperoxidase in a bodily sample from the test subject with levels of myeloperoxidase in comparable bodily samples from control subjects diagnosed as not having the disease, said bodily sample being blood, serum, plasma, blood leukocytes selected from the group consisting of neutrophils, monocytes, subpopulations of neutrophils, and sub-populations of monocytes, or any combination thereo[f];

wherein the levels of myeloperoxidase in the bodily from the test subject relative to the levels of [m]yeloperoxidase in the comparable bodily samples from control subjects is indicative of the extent of the test subject’s risk of having atherosclerotic cardiovascular disease.

The District Court, applying the two-step framework of Alice, concluded the testing patents employed well-known methods to detect MPO and that comparing collected data with a control was “a bare mental process.”  With regard to the ‘260 Patent, the District Court concluded that Defendant’s testing service was not a “material or apparatus” forming an explicit basis for contributory infringement, nor did the Plaintiffs allege sufficient facts to show that Defendant had the specific intent to induce third party infringement.

In a fairly short opinion, the Federal Circuit, taking the issues in turn, affirmed the District Court’s holdings.

In particular, the Federal Circuit, in review of Alice Prong One, concluded that the testing patents merely call for the use of well-known techniques to “see” MPO already present in a bodily sample and to correlate the measured or seen MPO to a risk of cardiovascular disease.  Relying on Mayo and Ariosa, the Federal Circuit, considering in Alice Prong Two, concluded that the steps merely called for the use of known methods to make a reasonably foreseeable comparison.  Thus, the Federal Circuit, adding little additional analysis or insight, affirmed the determination that the testing patents were directed to patent-ineligible subject matter.

Addressing the allegations of contributory and induced infringement, the Federal Circuit confirmed that lab reports reflect only the manner in which results are reported and are not themselves a material or apparatus so to constitute contributory infringement under 35 U.S.C. §271(c).  Finally, the Federal Circuit agreed that the Plaintiffs failed to provide a showing of specific intent to establish a claim for induced infringement.