United States: USPTO Released 2014 Interim Guidance On Patent Subject Matter Eligibility

On December 15, 2014, the U.S. Patent and Trademark Office (USPTO) released its much awaited revised guidelines regarding patent subject matter eligibility. The "2014 Interim Guidance on Patent Subject Matter Eligibility" ("Interim Eligibility Guidance") was published in the December 16, 2014, Federal Register.

Effective December 16, 2014, the Interim Eligibility Guidance supplements the June 25, 2014, Preliminary Examination Instructions in view of the Supreme Court decision in Alice Corp. ("June 2014 Preliminary Instructions") and supersedes the March 4, 2014, Procedure for Subject Matter Eligibility Analysis of Claims Reciting or Involving Laws of Nature/Natural Principles, Natural Phenomena, and/or Natural Products ("March 2014 Procedure") issued in view of the Supreme Court decisions in Myriad and Mayo.  

Like the March 2014 Procedure, the Interim Eligibility Guidance provides a two-part/three-inquiry framework for determining patent subject matter eligibility. Under this framework, a patent examiner determines whether a claim as a whole satisfies the requirement of patent subject matter eligibility under 35 U.S.C. § 101, and whether to raise a rejection under this section by finding answers to the following three questions:

However, unlike the March 2014 Procedure, the last two inquiries of the Interim Eligibility Guidance determine whether a claim is "directed to" an exception and recites "elements that amount to significantly more," while the counterparts in the March 2014 Procedure ask whether a claim "recite[s] or involve[s]" an exception and "recite[s] something significantly different than" a judicial exception. To that end, the Interim Eligibility Guidance provides detailed guidelines and examples. Notably, the Interim Eligibility Guidance does not have the "12-factor test" set forth in the March 2014 Procedure. 

Since its issuance, the March 2014 Procedure has been criticized by the public, in particular the life science community. One of the defects criticized is that it focuses too much on structural differences and ignores functional differences between a claimed product and a natural product in the "significantly different" inquiry. In view of public feedback, the Interim Eligibility Guidance has now made it clear that "changes in functional characteristics and other non-structural properties can evidence markedly different characteristics." Additionally, 10 groups of 37 examples have been made available at the USPTO website for use in conjunction with the 2014 Interim Eligibility Guidance.

The Interim Eligibility Guidance is less harsh than the March 2014 Procedure, and should be a welcome change for patent applicants. The USPTO is seeking public comments on the Interim Eligibility Guidance along with additional suggestions on claim examples for explanatory example sets. To ensure consideration, written comments must be received by the USPTO on or before March 16, 2015.

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