USPTO Announces Deferred Subject Matter Eligibility Response Pilot Program

10 January 2022 PharmaPatents Blog
Author(s): Courtenay C. Brinckerhoff

In a Federal Register Notice published January 6, 2022, the USPTO announced a new pilot program that will permit certain applicants to temporarily defer responding to subject matter eligibility (“SME”) rejections. The program is responsive to the March 22, 2021 letter from Senators Tillis and Cotton suggesting that the USPTO modify its compact prosecution paradigm with respect to SME issues, but will this program address the Senators’ concerns?


The Pilot Program – Are You Invited?

As explained on the Deferred Subject Matter Eligibility Response (“DSMER”) webpage, unlike most USPTO pilot programs that applicants opt-in to, participation in the DSMER pilot program is “by invitation only.”

According to the Federal Register Notice, to qualify for an invitation:

  • the application must be an original (not reissue) nonprovisional utility application or national stage of an international application
  • the application must not claim the benefit of the earlier filing date of any prior nonprovisional application (i.e., continuation and divisional applications are excluded)
  • the application must not have been accorded special status (but can request to participate in the Fast-Track Appeals Pilot Program or file an RCE with a request for Track I expedited examination after participating in the DSMER pilot program)
  • the application must be assigned to a participating primary examiner
  • the first Office Action on the merits must include both SME and non-SME rejections

The invitation will be made in a form paragraph in the first Office Action on the merits. To accept the invitation, the applicant must file completed form PTO/SB/456 with a timely response to the Office Action. No special action is required to decline the invitation.

The Pilot Program – Why Participate?

Applicants who participate in the DSMER pilot program are excused from having to address the SME rejection(s) raised in the first Office Action “until the earlier of final disposition of the participating application or the withdrawal or obviation of all other outstanding rejections.”

As usual in USPTO lingo, “final disposition” means the earliest of:

  • mailing of a Notice of Allowance
  • mailing of a final Office Action
  • filing of a Notice of Appeal
  • filing of an RCE
  • abandonment of the application.

As explained in the Federal Register Notice, “‘withdrawal or obviation of all other outstanding rejections’ refers to the situation in which a second or subsequent non-final Office action containing only the SME rejection(s) is mailed … because the applicant has overcome, or the examiner has withdrawn, all the non-SME rejections that were previously made.” After such a non-final Office Action has been issued, the Applicant is required to address the SME rejection(s). However, the second Office action is usually going to be a “final” Office action.

Thus, an applicant who participates in the DSMER pilot program is excused from having to address the SME rejection(s) when responding to the first Office Action. If the next Office Action(s) also happens to be non-final, the applicant also is excused from having to address the SME rejection(s) when responding to the subsequent non-final Office Action(s). However, the next Office action is usually going to be a “final” Office action.

The real potential benefit of the DSMER pilot program is the possibility that the arguments/amendments made to address the non-SME rejections overcome the SME rejections. On this point, the Federal Register Notice emphasizes that even though the applicant does not have to address the SME rejection(s) directly, “the examiner will consider whether the applicant's responses to other rejections (e.g., amendments made in response to an obviousness or indefiniteness rejection) overcome the SME rejection(s) of record.”

The Pilot Program – Why Decline The Invitation?

Applicants considering whether to participate in the DSMER pilot program should be aware of the consequences of coming to a “final disposition” without having addressed the SME rejection(s). The Federal Register Notice explains that once a final Office Action is issued, the waiver of the pilot program ends. Thus, any after-final response or appeal has to address the SME rejection(s) on the existing record. The Federal Register Notice expressly warns:

Applicants are cautioned that participation in this program is not, in itself, a good and sufficient reason why an amendment or evidence was not earlier presented under 37 CFR 1.116 or 41.33. See, e.g., MPEP 714.12 and MPEP 1206 regarding amendments and other replies after final rejection or appeal.

This means applicants who have participated in the DSMER pilot program may have to file an RCE to address the deferred SME rejection(s), even if they would be ready to appeal the non-SME rejections. In other words, applicants opting into the DSMER program bear the risk that the response to the non-SME rejections will not overcome the SME rejections, in which case they may be under the constraints of 37 CFR 1.116 when they first address the SME rejections. As such, this program will be most attractive when the SME rejections are plainly tied to non-SME rejections an applicant expects to overcome in a first response. 

The Pilot Program – Does It Address The Concerns Raised In The Tillis-Cotton Letter?

In their letter to the Commissioner, Senators Tillis and Cotton expressly asked the USPTO to change the examiner’s approach to examination:

[W] e ask that you initiate a pilot program directing examiners to apply a sequenced approach to patent examination. This pilot program would require selected examiners—and applicants who voluntarily elect to participate—to engage in a full examination of the grounds of patentability and then, once that process is complete, a full examination of the grounds of eligibility. Such a pilot program should conduct a thorough and reasonable number of examinations using this method and measure whether this approach is more effective, and produces higher quality patents, than the traditional compact examination approach.

Instead, the DSMER pilot program requires examiners to continue the current practice of reviewing eligibility under § 101 at the same time they are assessing patentability under §§ 102, 103, and 112, which is the very process the Senators were concerned about. For example, the Senators raised concerns that the current process may lead examiners to “issue Section 101 rejections without the benefit of addressing prior art, clarity and enablement issues that may well inform the examiner that the claim is eligible under Section 101,” and may cause examiners to “spend[] inordinate time on Section 101 at a time when it is difficult or impossible to conduct a meaningful examination under Section 101.”

The DSMER pilot program does not offer the advantages of the sequenced approach the Senators had suggested. It would not “focus[] initial examination on the objective areas of patentability as opposed to the abstract, vague, and subjective questions of eligibility.” It would not “improve[] efficiency by avoiding the waste of valuable examination … time on vague questions of patent eligibility as a threshold matter.” It is not clear it would “lead[] to stronger, more reliable, and higher quality patents by focusing first on the more rigorous and easy to identify standards of patentability.”

The USPTO may argue that the DSMER pilot program could have these effects because examiners will consider whether arguments/amendments made to address the non-SME rejections overcome the SME rejections, even if applicants do not address the SME rejections directly. But examiners still will have spent time formulating the SME rejections, and may be less likely to withdraw them without the applicant’s explanation of how the arguments/amendments establish eligibility.

The USPTO will start issuing invitations to participate in the DSMER pilot program beginning February 1, 2022, continuing through July 30, 2022. The USPTO will consider comments on the pilot program submitted through the Federal eRulemaking Portal received by March 7, 2022.

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