On March 4, 2014 the USPTO issued new patent subject matter eligibility guidelines in an attempt to provide examiners and patent practitioners with some guidance on which claims improperly encompass laws of nature, natural principles, natural phenomena, or products of nature in the wake of the U.S. Supreme Court ruling in Association for Molecular Pathology v. Myriad Genetics, Inc., 133 S. Ct. 2107.

In Myriad, the U.S. Supreme Court addressed the issue of whether subject matter improperly recites or involves a law of nature, natural principles, natural phenomena, and/or natural products.  The U.S. Supreme Court ruled that naturally occurring things, such as the nucleic acids are not patent-eligible subject matter if the product is merely “isolated” or “not altered”.  This decision did not provide any guidance to practitioners regarding what subject matter improperly encompass laws of nature, natural principles, natural phenomena, or products of nature.

The newly issued guidelines include a general framework for analyzing claims encompassing laws of nature, natural principles, natural phenomena, or products of nature.  The basic analysis involves a set of three questions for determining patent eligible subject under 35 U.S.C. § 101.  The third question is the most important in determining the outcome of the analysis: “Does the claim as a whole recite something significantly different than the judicial exception(s)^[1]?”  The analysis further provides a list of twelve factors, six that weigh toward subject matter eligibility, and six that weigh against subject matter eligibility.

One of the factors that weigh toward patent eligibility is whether “[a] claim is a product claim reciting something that initially appears to be a natural product, but after analysis is determined to be non-naturally occurring and markedly different in structure from naturally occurring products”.  The other factors relate to the addition of extra elements or steps that would distinguish a claim from a fundamental principle.

The guidelines also provide a number of examples that apply the factors.  Example B, relates to a natural product and recites 3 claims.  Claim 1 is directed to a purified amazonic acid and claim 2 involves a purified 5-methyl amazonic acid.  While claim 3 recites “[a] method of treating colon cancer, comprising: administering a daily dose of purified amazonic acid to a patient suffering from colon cancer for a period of time from 10 days to 20 days, wherein said daily dose comprises about 0.75 to about 1.25 teaspoons of amazonic acid.”

In the analysis of claim 1, the guidelines state that the answers to question 3 is “no”, because the claim does not recite something significantly different than the natural product.  While an analysis of claims 2 and 3, reveals that the answers to question 3 is “yes”, because claims 2 and 3 as a whole recites something significantly different than the natural product and include elements in addition to the judicial exception.  In claim 2 this something different is the purified 5-methyl amazonic acid, which is different than the purified amazonic acid found in nature.  While claim 3, uses the purified amazonic acid found in nature, but includes elements and steps in addition to the judicial exception.  Thus, Example B demonstrates how the USPTO will examine claims directed to products of nature.

Overall, the guidelines provide some help to practitioners in understanding how to apply theMyriad decision.  Specifically, they provide applicants and practitioners insight on how examiners will view patent applications involving natural phenomena going forward.  The guidelines further provide a framework in which to draft applications and claims to highlight the factors the USPTO believes weigh in favor of subject matter eligibility.  However, applicants and practitioners should be aware that the guidelines are potentially a moving target, as the guidelines will be litigated and the courts will have the final say on whether the USPTO correctly interpreted the U.S. Supreme Court’s Myriad decision.

_{[1] Judicial exceptions means laws of nature, natural principles, natural phenomena, or products of nature.}