Contributed by: Lee Kim, Esq.


In a unanimous decision, the US Supreme Court held that the claims in Mayo Collaborative Services v. Prometheus Laboratories, Inc. (Docket No. 10-1150) effectively claim a law of nature and are therefore not patent eligible under 35 U.S.C. 101.  The claims in the Mayo decision were directed to a process of medical treatment, specifically, a method of optimizing therapeutic efficacy for treatment of an immune-mediated gastrointestinal disorder (as recited in Claim 1).  Because the laws of nature were recited by the patent claims (i.e., the relationships between concentrations of certain metabolites in the blood and the likelihood that a thiopurine drug dosage would prove ineffective or cause harm) are not themselves patent eligible. 

The claims inform a relevant audience about certain laws of nature and any additional steps consisted of well-understood, routine, conventional activity already engaged in by the scientific community.  Those steps, when viewed as a whole, added nothing significant beyond the sum of their parts taken separately.  To transform an unpatentable law of nature into a patent-eligible application of such a law, one must do more than simply state a the law of nature while adding the words "apply it."  Appending conventional steps, specified at a high level of generality, to the laws of nature, natural phenomena, and abstract ideas cannot make those laws, phenomena, and ideas patent-eligible.

More complete examination guidelines will be developed by the United States Patent and Trademark Office, but, the USPTO has issued a memorandum which states that examiners must continue to ensure that claims, particularly process claims are not directed to an exception to eligibility which claim the amounts to a monopoly on the law of nature, natural phenomenon, or the abstract idea itself.  A claim that includes an exception should include other elements or combination of elements such that the claimed product or process amounts to significantly more than a law of nature, a natural phenomenon, or an abstract idea with conventional steps specified at a high level of generality appended thereto.

Link to the US Supreme Court Opinion:

Link to the USPTO guidance in view of the Mayo decision: