Cleveland Clinic Foundation v. True Health Diagnostics: District Court Finds Diagnostic Claims Patent-Ineligible

On February 23, 2016, a judge in the Northern District of Ohio found three patents invalid for ineligible subject matter on a Rule 12(b)(6) motion to dismiss (see opinion and order).  The patents, U.S. Patents Numbers 7,223,552, 7,459,286, and 8,349,581, are generally directed towards Myeloperoxidase (“MPO”) testing, which analyzes inflammation of the blood vessels to assess a patient’s risk for cardiovascular disease.  MPO is an enzyme released by white blood cells when inflammation occurs in the body, and thus MPO is an early symptom of many types of cardiovascular disease.

The claims recite limitations such as “comparing levels of [MPO] in a bodily sample from the test subject with levels of [MPO] in comparable bodily samples from control subjects diagnoses not having the disease” and “determining levels of [MPO] activity… in a bodily sample of the test subject.”  They also contain “wherein” clauses, e.g., “wherein elevated levels of [MPO] in the bodily sample from the test subject relative to the levels of [MPO] in the comparable bodily sample from control subjects is indicated of the extent of the test subject’s risk of having atherosclerotic cardiovascular disease.”

For those familiar with patent eligibility case law, it should come as no surprise that the District Court found these claims to be patent ineligible under the Mayo/Alice test for patent eligibility (named after the Alice and Mayo Supreme Court decisions].  The court found that the relationship between MPO levels in the bloodstream and the risk of having or developing cardiovascular disease is a natural phenomenon (first prong of the Alice test) and that the “determining” and “comparing” steps are insufficiently inventive (second prong of the Alice test).  The court found that at the time of invention a “myriad of methods well-known in the arts existed” for “determining” MPO levels, and that a “comparing” step involves a mental process, “which does not add an inventive step.”

The patent owner might have been able to help itself by arguing for a narrower interpretation of claim terms such as “comparing levels” and “determining levels.”  Unfortunately, in connection with its motion for temporary restraining order and preliminary injunction, plaintiff argued to the Court that “[e]xcept for “MPO Activity and “MPO Mass,” all of the claim terms should simply be afforded their plain and ordinary meaning.”  Later, in its brief opposing the Rule 12(b)(6) motion to dismiss, the plaintiff indicated “that it is now apparent that additional terms new construction,” including “immunological technique,” “comparing levels,” and “determining levels,” and argued that the Court could not address the issue of patent eligibility  prior to claim construction.  The judge rejected this argument, noting that the defendant had stipulated to plaintiff’s proposed claim construction, and that the plaintiff had failed to offer its own proposed construction for these terms.

The court stated that “Plaintiff’s failure [offer its proposed construction of the claim terms] will not serve to block the Court from considering defendant’s motion.  Otherwise, a plaintiff could prevent dismissal before claim construction simply by noting without explanation that claim construction is ‘necessary.’  The Court rejects any such rule.”