Cleveland clinic diagnostic’s or “testing patent” at an issue dealt with a process by which an enzyme was measured and correlated against known level of enzymes in a patient who are healthy or who have a cardiovascular disease. The court applied a twostep ALICE analysis. First, the court found that the patents were directed to “multistep method for observing the law of nature that the enzymes correlates to cardiovascular disease.” Second the claim were not transformative and “merely tell those interested in the subject about the correlation that researchers undermined.”
The Federal Circuit affirmed a finding of section 101 ineligibility and a failure by plaintiff to state a claim of contributory or induced infringements.

Cleveland Clinics vs. True Health Diagnostic

When an artery is damaged or inflammated, the body releases an enzyme myeloperoxidase (MPO). Prior art taught that MPO could be detected in an atherosclerotic plaque or lesion that required a surgically invasive method; could be indirectly detected in blood; or could be detected in blood with results that were not predictive of cardiovascular disease. Cleveland Clinic purportedly discovered how to “see” MPO in blood and correlate that to the risk of cardiovascular disease. True Health, a diagnostic laboratory, purchased the assets of Diagnostics, which had contracted with Cleveland Clinic to perform MPO testing. Rather than continue that relationship, True Health performed its own MPO testing. Cleveland Clinic sued, asserting infringement of the patents. The district court found all the claims patent-ineligible under 35 U.S.C. 101; dismissed the contributory and induced infringement claims of the 260 patent; denied leave to amend; and held that it was proper to consider section 101 at the motion to dismiss stage.. The court found that the claims were directed to a law of nature, with no saving inventive concept. The Federal Circuit affirmed.

Method of Treatment: Patent

The court held that the method of treatment and induced infringement were poorely dismissed for a “method of treatment” patent. It was not an abuse for discretion to deny the patentee leave to amend the complaint. On the fact of the records, True health does not provide, “material or apparatus”, which is required for the contributory infringement. Cleveland Clinics also did not show that there was “specific intent and action”, between True Health and doctors that may prescribe drugs based on the patented method and could not show induced infringement.


Observed statistical correlations between healthy and diseased population, such as correlating level of an enzyme to a cardiovascular disease is not a patentable subject matter. A defendant does not “contribute”, to infringing a method of treatment when no material or apparatus is involved. A defendant does not “induce” infringement by knowing others might infringe, there must be an evidence showing “specific intent and action”, to encourage infringing conduct. Absent such fact and records it is not an abuse of discretion to deny amending a complaint to add allegations of contributory or induced infringement.