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January 14, 2022 - United States, Digital Health, Biotech, Pharma, Intellectual Property, Bioinformatics

USPTO Launches Program to Defer Subject Matter Eligibility Responses

USPTO Launches Program to Defer Subject Matter Eligibility Responses

Starting February 1, 2022, the U.S. Patent and Trademark Office (USPTO) will begin inviting selected applicants to participate in a pilot program to defer subject matter eligibility examination until final disposition of the application or all other rejections have been addressed. The theory behind the program appears to be that satisfaction of other patentability conditions (e.g., novelty, non-obviousness, and written description) may resolve subject matter eligibility issues as well. Continuation and divisional applications, reissue applications, and applications accorded special status (such as Fast- Track applications) are not eligible for the program. Applications must raise both subject matter eligibility rejections and non-subject matter eligibility rejections to be eligible. 

Participating examiners may invite the applicant of a prospective pilot application to participate in the pilot program by including a form paragraph in the first Office action on the merits. An applicant can then elect to accept the invitation and participate in the program or decline. To accept the invitation, the applicant must file form PTO/SB/456. Once in the program, the Examiner will assess all bases of patentability, including subject matter eligibility, in each office action. In response, the applicant is able to defer presenting arguments, evidence, or amendments in response to the subject matter eligibility rejection(s) until the earlier of final disposition of the application or the withdrawal or obviation of all other outstanding rejections. “Final disposition” of the application is the first of (1) mailing of a notice of allowance, (2) mailing of a final Office action, (3) filing of a notice of appeal, (4) filing of a request for continued examination (RCE), or (5) abandonment of the application.

It will be interesting to see how many applicants elect to enter the program and whether it meaningfully impacts patent quality or time to issuance. The program still requires examiners to evaluate subject matter eligibility early on in prosecution. However, applicants may benefit from the program by avoiding wasted time and effort wading into arguments in the sometimes murky area of subject matter eligibility. Instead, applicants can focus their prosecution efforts on more straightforward novelty and non-obviousness analyses, which may also resolve the subject matter eligibility issue.

Read more about the program here.