Strategic Use of Rule 132 Declarations and SMEDs in Patent Prosecution

This article was developed by Chris Emerson, Patrick Torre and the Kentucky Bar Association (KBA) Intellectual Property (IP) Section.

Declarations have long been a tool available to patent practitioners to make evidence of record in a patent application prosecution history. Declaration evidence from third-party experts having no stake in the patent application at issue is often most persuasive to a patent examiner. One example use of declarations is to provide post-filing data to support arguments in favor of enablement of claimed subject matter. Declarations may also include expert opinions from third-party experts or inventors to support arguments such as unexpected results, commercial success, long-felt need or prior art inoperability when responding to obviousness rejections.

It is important to note that declarations may include both factual and opinion evidence but cannot be used to provide opinion evidence regarding the ultimate legal conclusion at issue.

Considerations of Using Declarations

For many practitioners, declarations are considered a tool of last resort and are avoided unless absolutely necessary to obtain allowance of claims. This reluctance stems from the risk of placing statements on the record in a patent application file history that may later be used against a patent owner in subsequent proceedings such as litigation, post-grant review (PGR) and inter partes review (IPR). Practitioners must exercise care to avoid statements placed on record that might later be used against a patent owner.

However, the benefit of strengthening the prosecution file history of a patent application through objective evidence submitted in declaration form likewise cannot be denied. It is well established in patent practice that even legitimate and scientifically sound attorney arguments cannot take the place of evidence in the record (see 37 C.F.R. § 1.132 and Manual of Patent Examining Procedure [MPEP] § 716.01). Well-crafted declarations submitted under 37 C.F.R. § 1.132 (Rule 132 Declarations) are often more persuasive to patent examiners and administrative judges of the Patent Trial and Appeal Board (PTAB) than legal or scientific arguments made by a patent attorney or agent.

U.S. Patent and Trademark Office (USPTO) training materials instruct examiners that when a Rule 132 Declaration has been submitted, the examiner must make the ultimate determination of patentability based on a fresh consideration of the entire record using a preponderance of the evidence standard. In other words, an examiner should not reject a claim if it is more likely than not that the claim is patentable in view of the evidence presented.

Rule 132 Declarations: Timing and Use Cases

As stated in MPEP § 716, Rule 132 Declarations may be filed prior to a final rejection of claims, before appeal in an application without a final rejection, after a final rejection but before appeal with a persuasive showing of good and sufficient reasons for not presenting the declaration earlier or after the close of prosecution when filed concurrently with a request for continued examination (RCE).

A common use of Rule 132 Declarations is to rebut obviousness rejections by providing persuasive evidence of unexpected results resulting from, commercial success of and/or long-felt need for the claimed invention, or to rebut allegations of inherency of a claim limitation in a prior art reference(s). Declarations may also be used to provide evidence supporting arguments that an asserted prior art combination is inoperable. In addition, Rule 132 Declarations are frequently used to rebut enablement rejections by supporting arguments that the disclosure satisfies the enablement or written description requirements of 35 U.S.C. § 112 for the claimed subject matter.

For example, a Rule 132 Declaration submitted to rebut an obviousness rejection based on unexpected results must include a full description of the testing performed and comparisons between the claimed invention and the closest prior art. The declaration must also describe test conditions to ensure they are commensurate in scope with the claims and should include actual test results and analysis.  

USPTO training materials emphasize that conclusory statements such as assertions that prior art did not perform well are insufficient without showing actual test results for both the prior art and the claimed invention.

The declaration must further establish a nexus between any purported unexpected results to claimed features rather than to unclaimed features. Evidence must also be commensurate in scope with the claim limitations.

Subject Matter Eligibility Declarations (SMEDs)

In an effort to clarify the rules for analysis of patent-eligible subject matter, the USPTO has issued several memoranda to the patent examining corps. Two of these memoranda address the use of Subject Matter Eligibility Declarations (SMEDs) submitted under Rule 132. These memoranda remind patent examiners that patent applicants are entitled to submit SMEDs to provide evidence of statutory eligibility and outline best practices for their use.

Applicants may use SMEDs to provide evidence establishing subject matter eligibility (SME) of the claimed invention. For example, a SMED may demonstrate how a person having ordinary skill in the art (a PHOSITA) would interpret a specification that describes a technological improvement or may demonstrate why claims are not directed to judicial exceptions of patentable subject matter. A SMED may therefore be used to show that a claimed invention is directed to patent-eligible subject matter – which is useful for addressing rejections under 35 U.S.C. 101 (regarding patentability). SMEDs are particularly relevant in software and chemical inventions where subject matter eligibility rejections are relatively more common.

To carry probative value, a SMED should be supported by actual proof such as technical facts or expert explanation, as opposed to bare assertions or hypotheticals untethered to real-world practice.

A SMED should be supported by one or more industry documents, comparisons of alleged prior-art systems and claimed systems, empirical data or corroborative expert testimony. Presentation of a legal conclusion in and of itself via a SMED (e.g., “This invention is patentable”) is not entitled to any weight, unless supported by persuasive underlying factual evidence.

A SMED may not supply information that was required to be present in the original disclosure at the time of filing. For example, a SMED should not introduce new problems addressed by the invention or add structural components, steps or relationships necessary to perform the claimed invention if such information was absent from the original disclosure.

Examiners must consider a properly submitted SMED on its merits when formal requirements are met (e.g., timeliness, proper signature, etc.). However, the SMED evidence alone does not necessarily control the eligibility determination. For example, a SMED may not control eligibility if the SMED addresses the wrong legal questions, draws unsupported legal conclusions or conflicts with the intrinsic record. Further, an examiner may rebut a SMED with official notice or record evidence by relying on the filed specification, citing prior art or general knowledge or pointing out inconsistencies between the SMED and the claims.

If the SME rejection is maintained in an Office Action (after a SMED has been properly filed), the examiner must explain, based on all evidence of record, why the SME rejection has not been overcome. If the rejection is withdrawn, the examiner must explain, based on all evidence of record including the declaration, why it has been overcome. 

As mentioned above, the practical concern regarding declarations – including declarations directed to subject matter eligibility (SMEDs) – is that they act as a double-edged sword. While SMEDs may be beneficial in moving a case forward during prosecution and potentially securing a patent from a pending application, they will also put statements in the application file history that may be used against the applicant in subsequent proceedings. SMEDs may intentionally or unintentionally represent what an invention is, what an invention is not and how claim features should be construed – which could lead to a later accused infringer of a patent arguing that applicant disclaimed a broader interpretation of a claim limitation via a filed SMED.

Practical Drafting Considerations for SMEDs

Strategic considerations for a SMED may include:

• Framing language from the perspective of a PHOSITA – as opposed to a perspective of the inventor’s intent.

• Avoiding characterizations regarding what “the invention” is or is not.

• Leveraging a SMED to address specific claim features as opposed to broad assertions which could unintentionally arguably apply to other claimed features in later proceedings.

• Contemplating how definitions provided in a SMED may impact claim scope.

• Coordinating SMED statements with future continuation filings or foreign filings. Prosecution history estoppel may dictate that SMED statements filed with a patent application may impact other filings.

It is important to consult with a licensed and registered USPTO representative when considering whether a SMED is appropriate for your circumstances. Nothing herein constitutes legal advice.