The U.S. Patent and Trademark Office has issued interim guidance for use in subject matter eligibility determinations during examination of process claims that involve laws of nature/natural correlations. The guidelines come in the wake of the Supreme Court’s decision in Mayo Collaborative Services v. Prometheus Laboratories, Inc. (Mayo) and supersedes an earlier memorandum issued in March 2012.
According to the USPTO, “The Office is issuing this guidance as an interim measure to provide instruction to examiners in technology areas impacted by the Mayo decision while pending cases at the Federal Circuit are reheard in view of Mayo. While Mayo has provided additional details for the eligibility analysis…, the Office believes that the prudent course of action is to wait for resolution of these cases before issuing comprehensive updated guidance.”
The patent examination procedure set forth in the guidance consists of three “essential” inquiries:
1. Is the claimed invention directed to a process, defined as an act, or a series of acts or steps? If no, this analysis is not applicable. For product claims, see the Interim Examination Instructions for Evaluating Subject Matter Eligibility Under 35 U.S.C. § 101 issued August 24, 2009. If yes, proceed to Inquiry 2.
2. Does the claim focus on use of a law of nature, a natural phenomenon, or naturally occurring relation or correlation (collectively referred to as a natural principle herein)? (Is the natural principle a limiting feature of the claim?) If no, this analysis is complete, and the claim should be analyzed to determine if an abstract idea is claimed. If yes, proceed to Inquiry 3.
3. Does the claim include 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? (Is it more than a law of nature + the general instruction to simply “apply it”?) If no, the claim is not patent-eligible and should be rejected. If yes, the claim is patent eligible, and the analysis is complete.
While the guidance offers useful insight into how patent examiners will analyze claims in light of the Mayo decision, this area of law is expected to continue to develop. I encourage my readers to stay tuned for updates and contact me with any questions you may have.