USPTO Issues Interim Guidance Regarding Patent Subject Matter Eligibility

On 16 December 2014, the USPTO issued its much anticipated Interim Guidance Regarding Patent Subject Matter Eligibility and provided new explanatory training examples relating to nature-based products.  The December 16 guidance supersedes the USPTO’s 4 March 2014 guidance and issued in view of the Supreme Court decisions in Myriad and Mayo and supplements the 25 June 2014, Preliminary Examination Instructions in view of the Supreme Court decision in Alice Corp.


In summarizing differences between the March 2014 guidance and the new interim guidance, the USPTO explains that:

1)      The test for determining whether a claim is directed to a “product of nature” exception is separated from the analysis of whether the claim includes significantly more than the exception.

2)      The application of the overall analysis is based on claims directed to judicial exceptions (defined as claims reciting the exception, i.e., set forth or described), rather than claims merely “involving” an exception.

3)      The markedly different analysis focuses on characteristics that can include a product’s structure, function, and/or other properties as compared to its naturally occurring counterpart in its natural state.

The interim guidance clarifies the USPTO’s position regarding the subject matter eligibility of natural products but does not provide much further insight regarding natural phenomena/natural principles and their application to diagnostic methods.


According to the USPTO, “[i]mplementation of examination guidance on eligibility will be an iterative process continuing with periodic supplements based on developments in patent subject matter eligibility jurisprudence and public feedback.”  Therefore, further clarity regarding subject matter eligibility, including the eligibility of diagnostic method claims, will hopefully be forthcoming as the USPTO considers further public feedback and new court decisions relevant to this issue.