The United States Patent and Trademark Office (USPTO) issued the 2014 Interim Guidance on Patent Subject Matter Eligibility on 16-12-2014 and it will be open for comments from the public till March 16, 2015. It had issued Preliminary Instructions in June 2014 which are now superseded.
The Interim Guidance sets out the Office’s interpretation of the subject matter eligibility requirements of 35 U.S.C. 101 in view of recent decisions by the Supreme Court and the U.S. Court of Appeals for the Federal Circuit (Federal Circuit) notably Alice Corporation, Myriad and Mayo. An illustrative flowchart for a two-part analysis, indicating the various steps to decide patent eligibility in terms of whether the claim as a whole is directed to a judicial exception and whether the claim recites a patent-eligible application of the exception, is provided.
A claim which is directed to a law of nature, natural phenomenon, or abstract idea will be subjected to what is called the Part 2 Mayo test as to whether the claim recites additional elements that amount to significantly more than the judicial exception. If the claim amounts to something significantly more it will be patent eligible. The example of the isolated DNA coding for a BRCA1 polypeptide (Myriad), having the amino acid sequence which is not markedly different from its naturally occurring counterpart (BRCA 1 gene), and thus does not pass the Part 2 test is provided. A number of other examples from decided cases form part of the guidance material along with analysis of eligibility as per the new guidelines. It however states that mere presence of an exception does not necessarily render a claim ineligible.