The Alice Analysis Finds Patent-Ineligible Subject Matter
{2:50 minutes to read} In a recent case, Cleveland Clinic Foundation v. True Health Diagnostics LLC, the court affirmed the invalidity of claims related to method for diagnosing atherosclerotic cardiovascular disease with a blood test.
The diagnostic patents at issue were U.S. Patent No. 7,223,552, U.S. Patent No. 7,459,286, and U.S. Patent No. 8,349,581.
Claim 14 of the ‘552 patent illustrates the claimed methods:
14. A method of assessing a test subject’s risk of developing a complication of atherosclerotic cardiovascular disease comprising:
Determining levels of myeloperoxidase (MPO) activity, myeloperoxidase (MPO) mass, or both in a bodily sample of the test subject, said bodily sample being blood … ;
wherein elevated levels of MPO activity or MPO mass or both in the test subject’s bodily sample as compared to 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 developing a complication of atherosclerotic cardiovascular disease.
The Federal Circuit upheld the district court’s findings that the patents were directed to non-patentable subject matter by applying the Alice analysis:
Step 1: Are the claims directed to a natural law: Answer: yes.
Since the presence of MPO in a bodily sample is correlated to its relationship to cardiovascular disease, the claims are directed to a natural law.
Step 2: Do the claims recite something more? Answer: no.
According to the court, the claims do not recite the use of any new detection or analytical techniques.
The steps here merely tell those “interested in the subject about the correlations that the researchers discovered.”
Thus, the court held that the patents are directed to “patent-ineligible subject matter.”
Please contact me with questions or comments regarding this case.
Silvia Salvadori, PhD
(212) 897-1938