On March 4, the USPTO issued its Guidance for Determining Subject Matter Eligibility of Claims Reciting or Involving Law of Nature, Natural Phenomena, & Natural Products, for use in assisting patent examiners in assessing whether claims cover subject matter that is eligible for patentability. Over the last couple of years the Supreme Court has addressed this issue in a number of cases including Myriad (natural products exception) and Prometheus (laws of nature exception). The guidance provides a three question test, which culminates in the query of whether, if the subject matter of the claim falls into one of the four judicial exceptions to patentability (abstract ideas, laws of nature/natural principles, natural phenomena, and natural products), the subject matter is nonetheless “significantly different” and therefore patent eligible. The guidance goes on to provide some guidelines as to how “significantly different” should be determined, and sets forth a series of factors which must be assessed and balanced to make that determination. The USPTO also provides a series of examples to illustrate how the balancing test should be applied.

We expect that implementation of these guidelines will result in an increase in section 101 rejections, some of which may not otherwise have been raised. For example, in assessing whether the subject matter of a claim covers a product of nature, the USPTO appears to consider each claimed element by itself, and the presence of a product of nature as only one of the claimed elements could be the basis for a rejection if the examiner considers that the factors overall weigh in favor of ineligibility. We recommend that patent prosecution going forward, in particular drafting of new applications, take these guidelines into account, and while circumventing such rejections where possible also be aggressive in rebutting section 101 rejections where the case law does not support them.