Tuesday, the United States Supreme Court issued a unanimous (9-0) decision in Mayo Collaborative Servs. v. Prometheus Labs., Inc. In holding that Prometheus’s claims were not eligible for patenting, the Court stated that the claims sought to protect “the underlying laws of nature themselves” (Slip Op., p. 24), rather than a specific application of those laws of nature. The Court further emphasized that, although a claim may recite a law of nature, the novel and nonobvious aspects of the claim must be separate from the law of nature. That is, in evaluating claim elements that are separate from the law of nature recitation, the §101 patent-eligibility inquiry and inquiries under §§102, 103, and 112 may overlap. (Id. at p. 21.) Although this Opinion was issued in the context of a diagnostic method, the positions taken by the Court affect other technologies as well.

The Claim -

A method of optimizing therapeutic efficacy for treatment of an immune mediated gastrointestinal disorder, comprising:

(a) administering a drug providing 6-thioguanine to a subject having said immune-mediated gastrointestinal disorder; and

(b) determining the level of 6-thioguanine in said subject having said immune mediated gastrointestinal disorder, wherein the level of 6-thioguanine less than about 230 pmol per 8x108 red blood cells indicates a need to increase the amount of said drug subsequently administered to said subject and wherein the level of 6-thioguanine greater than about 400 pmol per 8x108 red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject.

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