As previously reported, on March 20, 2012, the U.S. Supreme Court decided Mayo Collaborative Services v. Prometheus Laboratories, Inc. [enhanced version available to lexis.com subscribers], a seminal decision on patentability of claims that involve a so-called "law of nature." On July 3, 2012, the USPTO released a memorandum titled "2012 Interim Procedure for Subject Matter Eligibility Analysis of Process Claim Involving Laws of Nature" ("2012 Interim Procedure") to the patent examiners. This memorandum provides guidance to attorneys and applicants particularly in the medical and chemical arts.
Under the 2012 Interim Procedure, examiners are required to establish the broadest reasonable interpretation of the claimed invention as a whole, as is consistent with normal examination. Subsequently, examiners must apply a tripartite analysis to determine whether the claim is drafted to patent-eligible subject matter under 35 U.S.C. § 101.
The first inquiry is whether "the claimed invention is directed to a process, defined as an act, or a series of acts or steps." If not, no further analysis under the 2012 Interim Procedure is required.
If the claim is directed to a process, the second inquiry is "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)?" If not, then no further analysis under the 2012 Interim Procedure is required, but the examiner should determine whether the applicant is claiming an abstract idea
The third inquiry is the crux: "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?" In other words, "Is it more than a law of nature + the general instruction to simply 'apply it'?" If the answer is no, the examiners are instructed to reject the claim for lack of patent eligibility. If the answer is yes, the examiners should conclude the claim is patent-eligible and substantive examination should proceed.
The 2012 Interim Procedure provides a number of sample claim analyses. In one example, it explains that a method claim directed to administering a man-made drug without reciting other steps or elements directed to natural principles "would be directed to [patent-] eligible subject matter," as would be "a claim that recites a novel drug or a new use of an existing drug, in combination with a natural principle, ... because the claim would amount to significantly more than the natural principle itself." Several additional sample claims involving different scenarios are also described.
The USPTO is expected to provide further guidance once the Federal Circuit reconsiders Assn. for Molecular Pathology v. Myriad Genetics [enhanced version available to lexis.com subscribers] and WildTangent v. Ultramerical [enhanced version available to lexis.com subscribers], which were both remanded from the U.S. Supreme Court in view of the Mayo decision. In the meantime, the 2012 Interim Procedure should be carefully reviewed by those who are in the process of drafting applications involving laws of nature.
We will report on further developments. For more information, please contact Fitch Even partner Kendrew H. Colton.
© Copyright 2006-2012 Fitch, Even, Tabin & Flannery LLP - All Rights Reserved
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