The U.S. Patent and Trademark Office (USPTO) has issued a memorandum to its patent examining corps to communicate the agency’s 2012 interim procedure for a subject-matter eligibility-analysis of process claims involving laws of nature, in light of Mayo Collaborative Services v. Prometheus Laboratories, Inc., 132 S. Ct. 1289 (2012).
Simply stated, the new guidance provides that “process claims having a natural principle as a limiting element or step should be evaluated by determining whether the claim includes additional elements/steps or a combination of elements/steps that integrate the natural principle into the claimed invention such that the natural principle is practically applied, and are sufficient to ensure that the claim amounts to significantly more than the natural principle itself. If the claim as a whole satisfies this inquiry, the claim is directed to patent-eligible subject matter. If the claim as a whole does not satisfy this inquiry, it should be rejected under 35 U.S.C. § 101 as being directed to non-statutory subject matter.”
The new interim procedure took effect July 2, 2012, and supersedes a March 21, 2012, memorandum issued the day after the U.S. Supreme Court decided that patent claims for a diagnostic procedure involving “administering,” “determining” and “wherein” steps failed to transform un-patentable natural laws into patent-eligible applications of those laws. In the Court’s words, “the claims inform a relevant audience about certain laws of nature; any additional steps consist of well-understood, routine, conventional activity already engaged in by the scientific community; and those steps, when viewed as a whole, add nothing significant beyond the sum of their parts taken separately.” USPTO will issue comprehensive updated guidance after the Federal Circuit Court of Appeals has had an opportunity to rehear cases pending when Mayo v. Prometheus Labs was decided. Among the cases from which USPTO expects to learn more about the patentability of process claims involving laws of nature are Association for Molecular Pathology v. Myriad Genetics and WildTangent v. Ultramercial.