On March 4, 2014, Andrew Hirschfield, the Deputy Commissioner For Patent Examination Policy, released a “Memorandum” entitled “Guidance for Subject Matter Eligibility Analysis Of Claims Reciting Or Involving Laws of Nature/Natural Principles, Natural Phenomena, And/Or Natural Products” in view of the Myriad and Mayo (“Prometheus”) Decisions. (A copy is available at the end of this post.) The Guidance is intended to “assist examiners in determining whether a claim reflects a significant difference from what exists in nature and thus is  eligible, or whether a claim is effectively drawn to something that is naturally occurring, like the claims found ineligible by the Supreme Court in Myriad.” The Guidelines include a number of examples, including the analysis that is to be followed in deciding if they meet or do not meet the exceptions to s. 101.
The Guidelines do not apply to the examination of claims reciting an abstract idea, which are to be analyzed using MPEP c. 2106(I). However, the examples in these Guidelines include the analysis that Judge Lourie applied to conclude that claim 1 of the Myriad ‘857 patent was patent-ineligible as an abstract idea. Interestingly, these Guidelines do not include an analysis of claim 2 of the ‘857 patent which was directed to a method for diagnosing a predisposition to develop cancer by comparing the sequence of a subject’s BRACA1 DNA to a reference sequence and determining if there were alterations in the subject’s DNA sequence. The Office seems to want to ignore not only that “comparing and concluding claim” but also do not provide an analysis of any simple “If marker A, the disorder B” claim, such as the claim analyzed, and found wanting by Justice Breyer in the “Metabolite Dissent.” (Judge Rader’s criticism of that “dissent” is reproduced in my recent post noting the 5th birthday of this blog.)