USPTO Urges Separate Filing of Subject Matter Eligibility Declarations

The United States Patent and Trademark Office (USPTO) has issued new guidance reminding patent applicants and patent examiners of best practices for submission and evaluation of subject matter eligibility declarations (SMEDs) under Rule 132. According to two memoranda — one addressed to applicants and one to examiners — applicants should submit Rule 132 declarations addressing subject matter eligibility separately from those addressing other grounds of rejection (i.e., §§ 102, 103, and 112). The memos note that, while applicants are permitted under Rule 132 to address multiple grounds of rejection in a single declaration, doing so can diminish the probative value of the evidence contained therein and complicate the examiner’s analysis of the applicant’s record.

Key point

• The USPTO is advising patent applicants to submit SMEDs under Rule 132 separately from declarations addressing other grounds of rejection.

Digging deeper

In response to a rejection, an applicant may submit evidence traversing the rejection in the form of a declaration according to the procedures set forth at 37 CFR 1.132. Declarations pertaining to subject matter eligibility rejections (known as “SMEDs”) are intended to clarify the record and provide objective evidence relevant to the eligibility of a claimed invention under 35 U.S.C. § 101. For a SMED or any other evidentiary declaration to be relevant, there must be a nexus between the invention as claimed and the evidence provided in the declaration.

Rule 132 declarations are voluntary but can be helpful in demonstrating patent eligibility that may not be readily apparent. Many applicants use SMEDs to provide clarifying information, such as facts that describe the state of the art at the time of filing, objective evidence as to how the invention improved upon the state of the art, or a factual basis for determining how one of ordinary skill in the art would have concluded that the invention improved the underlying technology. However, SMEDs cannot be used to supply information that was required to be present in the original disclosure upon filing.

While Rule 132 allows applicants to address multiple grounds of rejection in a single declaration, the Office now strongly urges applicants not to do so and instead file separate declarations addressing each rejection ground independently. The Office notes that separate declarations are particularly helpful for § 101 rejections, as patent eligibility determinations can be especially challenging. The presence of non-§ 101 evidence in SMEDs can risk the intertwining of issues of enablement, written description, novelty, and nonobviousness with those of subject matter eligibility.

As support for its position on the advantages of submitting Rule 132 SMEDs as distinct documents, the Office cites a variety sources, including USPTO training materials, Federal Circuit case law, and practitioner guidance.

Takeaways

Applicants faced with § 101 rejections who intend to respond with Rule 132 SMEDs should file those declarations separately from declarations addressing other grounds of rejection.

Applicants should also note that filing declarations is not without risk. A declaration is an affirmative act intended to be relied upon by the Office and so is treated, for purposes of inequitable conduct, as inherently material to patentability. See Therasense, Inc. v. Becton, Dickson & Co., 649 F.3d 1276, 1292 (Fed. Cir. 2011) (en banc). A declaration likely will receive heightened scrutiny in any future litigation involving the resulting patent even if the error or misstatement does not affect patentability. Applicants should thus undertake Rule 132 declarations, including SMEDs, with care.