Clevland Clinic Foundation v. True Health Diagnostics (Fed. Cir 2017) applies the two-step Alice framework to several patents of Cleveland Clinic and finds each patent invalid under the framework. US Patent No. 7,223,552 is directed to a method of assessing a test subject’s risk of having atherosclerotic cardiovascular disease by comparing levels of MPO in a bodily sample wherein the levels of MPO relative to that form a control is indicative of the exent of the test subject’s risk of having atherosclerotic cardiovascular disease. US Patent No. 7,459,286 and 8,349,581 further calim ways of detecting MPO.
In holding the patents met step one as to whether the claims are directed to ineligible subject matter, such as a law of nature, the Court found that the testing patents are directed to multistep methods for observing the law of nature that MPO correlates to cardiovascular disease. The case was similar to Ariosa where the ineligible claims were directed to a method of detecting paternally inherited cell free fetal DNA, which is naturally occurring in maternal blood. Thus, just like Ariosa, the method starts and ends with naturally occurring phenomena with no meaningful non-routine steps in between –the presence of MPO in a boidly sample is correlated to its relationship to cardiovascular disease.
Step two which examines the elements of the claims to determine whether they contain an inventive concept sufficient to transform the claimed naturally occurring phenomena into a patent eligible concept did not save Cleveland Clinic. As with Ariosa, the claims involved a method that was a general instruction to doctors to apply routine, conventional techniques when seeking to detect paternally inherited cell free DNA in the blood serum of a pregnant woman.
Cleveland Clinic did not purport to have invented color-imetric-based assay, flow cytometry, or ELISA or any of the claimed methods to “see” MPO and its derivatives in bodily samples.
The Court did not get to a fourth patent, US Patent 9,170,260 which further requires “adminsitering a lipd lowering agent to the selected human patient” after a prior step of “selecting a patient who has elevated levels of MPO” because Cleveland was denied its motion to amend its complaint for direct infringement and the Court found no contributory or induced infringement under the facts alledged in the complaint.
