USPTO Introduces Pilot Program to Defer Response to Subject Matter Eligibility Rejections

Morgan Lewis

Morgan Lewis

The US Patent and Trademark Office is implementing a pilot program to allow participating applicants to defer responding to subject matter eligibility rejections until the earlier of a final disposition of the application, or a withdrawal or obviation of all other outstanding rejections.

Under the Deferred Subject Matter Eligibility Response Pilot program (the Pilot), certain applicants that have received a rejection on subject matter eligibility (SME) and other patentability-related rejections, may receive invitations to participate in the Pilot. Applicants who accept the invitation may defer responding to the SME rejections until all other issues have been resolved. Some reasons for accepting (or not accepting) such an invitation are discussed below.

By introducing this Pilot, the US Patent and Trademark Office (USPTO) is ostensibly seeking to evaluate whether deferred application responses to SME rejections affect examination efficiency and patent quality. The rationale is that satisfying non-SME conditions for patentability may resolve the SME issues.


An application must meet all of the following criteria to be eligible for the Pilot[1]:

  1. The application is assigned to a participating examiner. (While the Pilot is open to all primary examiners, examiner participation is not mandatory.)
  2. The application is an original nonprovisional utility application or a national stage application. Continuation and divisional application, as well as applications with special status (e.g., fast track examination) are not eligible for the Pilot.
  3. The first Office Action includes both SME and non-SME rejections.

For the purposes of the Pilot, an SME rejection is a rejection under 35 USC § 101 that includes, under the USPTO’s patent eligibility guidelines, both step 1 rejections, where the claim as a whole does not fall within a statutory category, and step 2B rejections, where the claim as a whole is directed to a judicial exception without also including additional limitations amounting to significantly more than the exception.

Under the provisions of the Pilot, participating examiners may invite an applicant of an eligible application to participate in the Pilot. If an applicant wishes to participate in the Pilot, a timely response must be accompanied by a duly completed request form. Failure to file the form will exclude the application from the Pilot. Additionally, once entered into the Pilot, there is no provision to withdraw from the Pilot.

While the Pilot allows a participating applicant to defer responding to the SME rejections in certain circumstances, not availing such benefit and voluntarily responding to such rejections does not withdraw or remove the application from the Pilot.

The Notice indicates that any comments relating to this Pilot must be received by March 7, 2022 to ensure consideration. The Pilot will run from February 1, 2022 through July 30, 2022.


Applicants electing to participate in the Pilot must file a reply to every Office Action mailed in the participating applications. Participation in the Pilot, however, provides a limited waiver permitting the applicants to defer presenting arguments, evidence, or amendments in response to the SME rejection(s) until the earlier of final disposition of the participating application or the withdrawal or obviation of all other outstanding rejections. The limited waiver terminates upon the mailing of a second or subsequent non-final Office Action containing only the SME rejection(s) because the applicant has overcome or the examiner has withdrawn all the non-SME rejections.

As an example, under the Pilot, if an Office Action includes a step 1 SME rejection, a step 2B SME rejection, and a prior art rejection, the applicant may: (1) respond only to the prior art rejection; (2) respond to the prior art rejection and one of the SME rejections; or (3) respond to all three rejections, for the response to be considered a bona fide response.

The examiner, in turn, is required to consider whether the applicant’s responses to the non-SME rejections overcome the SME rejection(s) of record. Further, if the examiner deems that the applicant’s responses—despite the deferral of a response to the SME rejection(s)—overcomes all rejections, the examiner must issue a Notice of Allowance, and include the reasons for allowance as needed. On the other hand, if the examiner deems that the responses do not overcome all outstanding rejections, and issues a final Office Action, the limited waiver under the Pilot is terminated.

It should be noted that because the issuance of a final Office Action is considered a final disposition resulting in termination of the limited waiver under the Pilot, there are no changes to after-final practice under this Pilot.


Overcoming prior art (i.e., non-SME) rejections may obviate, or render moot, Step 2B SME rejections, as if the invention is found to be novel and non-obvious it may overcome the “substantially more” requirement of Step 2B analysis of a 101 rejection. In such instances, it is worthwhile, in terms of time and cost efficiency, to use the Pilot program to first focus arguments on overcoming the prior art rejections. Such a situation may occur when, for example, the SME rejection focuses solely on the conventionality or routineness of the additional elements, and the arguments against the prior art rejections make it plain that the additional elements are novel and non-obvious.

The MPEP clarifies that the Step 2A of the SME analysis “specifically excludes consideration of whether the additional elements represent well-understood, routine, conventional activity ...  Additional elements that represent well-understood, routine, conventional activity may integrate a recited judicial exception into a practical application.”[2] Thus, the specific exclusion of applications with Step 2A (but not Step 2B) rejections from this Pilot program appears to indicate a belief on part of the PTO that overcoming prior art rejections would logically result in the conclusion that the inventive concept in the claim is, in fact, not conventional and amounts to more than what is disclosed in the prior art.

Consequently, in situations where an applicant believes that Step 2B SME rejections are improper because the examiner improperly deems inventive concept as being conventional or as not amounting to significantly more, the applicant may want to focus their efforts on overcoming prior art rejections and in the process render the Step 2B SME rejections moot.

In addition, if all the non-SME issues are resolved during prosecution, and only SME rejections—in particular Step 2B rejections—are maintained, practitioners may decide to appeal only the SME question, thereby simplifying the appeal process.

Moreover, many practitioners, at least anecdotally, appear to already be focusing on overcoming prior art rejections, as overcoming all prior art rejections may soften examiners’ stance on the SME issues.

In summary, while practitioners will have to decide whether it is worthwhile accepting an invitation to participate in the Pilot on a case-by-case basis, claims where it is relatively easier to argue that the additional elements are not conventional or routine may be better suited for this Pilot.

[1] 87 Fed. Reg. 776-780 (January 6, 2022).

[2] MPEP 2106.04(d)(I)

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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