Interim USPTO Guidance on Patent Subject Matter Eligibility
On 16th December 2014 the USPTO published its Interim Guidance on Patent Subject Matter Eligibility for use by its Examiners in determining subject matter eligibility under 35 U.S.C. 101. This Guidance supplements the Preliminary Examination Instructions of 25th June 2014 issued following the Supreme Court’s decision in Alice Corp. and supersedes the Procedure for Subject Matter Eligibility Analysis of Claims Reciting or Involving Laws of Nature/Natural Principles, Natural Phenomena, and/or Natural Products of 4th March 2014 issued following the Supreme Court’s decisions in Myriad and Mayo.
This Guidance is effective from 16th December 2014 and applies to all applications filed before, on or after 16th December 2014.
The following flowchart, provided by the USPTO, is to be used during examination to help its Examiners determine whether a claim is drawn to patent eligible subject matter. Prior to evaluating a claim for patentability, the Examiner is required to establish the broadest reasonable interpretation of the claim as a whole.
The notable changes in this Guidance from the prior Guidance are:
• The same steps apply to all claims which contain any type of judicial exception; and
• In Step 2A a nature-based product in a claim is compared to its naturally occurring counterpart to identify markedly different characteristics based on structure, function, and/ or properties to determine whether the nature-based product is a ‘‘product of nature’’ exception. The Guidance states that when the nature-based product is produced by combining multiple components, the markedly different characteristics analysis should be applied to the resultant nature-based combination, rather than its component parts. The example given in the Guidance is the mixture of Lactobacillus and milk which should be analyzed for markedly different characteristics, rather than the Lactobacillus separately and the milk separately. The analysis proceeds to Step 2B only when the claim is directed to an exception (i.e. when no markedly different characteristics are shown).
Regardless of whether a rejection under 35 U.S.C. 101 is made, a complete examination should be made for every claim under each of the other patentability requirements.
The full Guidance Note can be found here.
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