On July 3, 2012, the United States Patent and Trademark Office (“USPTO”) issued a 13-page memorandum (hereinafter referred to as “the Memorandum”) providing interim guidance to patent examiners in view of the U.S. Supreme Court’s decision in Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. ___, 132 S. Ct. 1289, 101 USPQ2d 1961 (2012) (“Prometheus”). The interim guidance, entitled 2012 Interim Procedure for Subject Matter Eligibility Analysis of Process Claims Involving Laws of Nature (the “Interim Procedure”), provides specific guidance with illustrative examples on how patent examiners should determine whether a process claim involving laws of nature or natural correlations is patent eligible. The Memorandum supersedes the three-page memorandum issued the day after the Supreme Court’s decision on Prometheus, and is intended to serve as an interim measure while two other cases are being reheard at the Federal Circuit in view of Prometheus. A more comprehensive and updated guidance is expected to issue once those cases are resolved, but meanwhile, the Memorandum sheds light on how the Prometheus ruling is to be applied at the USPTO.
35 U.S.C. §101 states that “[w]hoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefore….” In a series of cases dating back into the nineteenth century, the Supreme Court has long held that this section of the Patent Act contains an important exception – that “laws of nature, natural phenomena, and abstract ideas” are not patent eligible. On March 20, 2012, in a unanimous decision, the Supreme Court held that a claim that involves correlating the blood level of a drug metabolite with the drug’s efficacy or toxicity is not patent eligible because of the law of nature exception. Although the claim at issue recites specific steps of administering the drug and determining the level of the metabolite, those steps were found to be insufficient to render the claim patent eligible. According to the Supreme Court, “to transform an unpatentable law of nature into a patent-eligible application of such a law, one must do more than simply state the law of nature while adding the words ‘apply it.’” The Court, however, provided little guidance on what would constitute a meaningful application of the law of nature that renders the claim patent eligible.
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