USPTO Formalizes Role of Rule 132 Subject-Matter Eligibility Declarations (SMEDs)
Memos: Evidence Over Abstraction
The United States Patent and Trademark Office (USPTO) under Director John A. Squires has moved quickly to address one of the most persistent sources of friction in the U.S. patent system: subject matter eligibility under 35 U.S.C. § 101. Following the recent designation of In re Desjardins as precedential—a decision that vacated a rejection of machine learning claims—the Office has released two significant memoranda regarding Subject Matter Eligibility Declarations (SMEDs).
These documents, one directed to the Patent Examining Corps and the other to applicants and practitioners, do not alter the substantive law of Alice Corp. v. CLS Bank Int’l. Instead, they emphasize a procedural pathway that has apparently long existed but remained underutilized: the submission of factual evidence under 37 C.F.R. § 1.132 to traverse eligibility rejections.
For IP stakeholders, particularly those in software and biotechnology, this guidance signals a shift toward evidence-based prosecution strategies. However, this approach introduces new strategic decisions and potential risks that require careful management.
The Context: A Focus on Technological Improvement
The release of these memoranda aligns with the Director’s early administrative actions. Upon confirmation, as stated in the announcement, Director Squires immediately signed patents in distributed ledger technology and medical diagnostics, signaling an intent to ensure that “applied technologies, including those in rapidly developing fields, remain eligible for patent protection when they satisfy the statutory requirements” (Announcement, p. 1).
The Desjardins decision further reinforced this by clarifying that improvements to the functioning of machine learning models can constitute practical applications. The new memoranda build upon this foundation by providing the procedural mechanics for proving such improvements.
As the Director noted in the memo to the Examining Corps, “Especially with new and emerging technologies, the ‘something more’ may be particularly challenging to divine so we need to evaluate, for example, how the invention is applied, how it operates and/or what it accomplished” (Corps, p. 1).
Guidance to the Examining Corps: Weighing the Evidence
The memorandum to the Patent Examining Corps serves as both a reminder and an instruction manual for handling evidentiary submissions. It explicitly states that applicants may “voluntarily... submit SMEDs pursuant to existing Rule 132” (Corps, p. 1). The central directive to examiners is that they must evaluate these declarations on their merits.
The Standard of Review
The guidance instructs that examiners “must carefully consider all of the applicant’s arguments and the evidence rebutting the subject matter eligibility rejection” (Corps, p. 3). Importantly, the memo reinforces the standard of proof required during prosecution. Evidence provided in a SMED must be weighed alongside other record evidence to determine eligibility “based on the preponderance of the evidence (i.e., more likely than not) standard” (Corps, p. 4).
This instruction is significant. In many prosecution histories, § 101 rejections are treated as pure questions of law, often leading to stalemates where an examiner asserts an abstract idea and an applicant asserts a technological improvement. By emphasizing the preponderance standard, the Office suggests that a well-supported SMED can tip the scale where the legal conclusion is otherwise close.
The Nexus Requirement
The memo clarifies that not all declarations will be persuasive. There must be a “nexus between the invention as claimed and the evidence provided in the declaration” (Corps, p. 3). A SMED is not a vehicle to import entirely new concepts into the record; rather, it “may demonstrate how one of ordinary skill in the art would interpret a specification that describes a technological improvement” (Corps, p. 1).
The Office warns that a declaration “cannot be used to supply information that was required to be present in the original disclosure upon filing” (Corps, p. 3). This limitation is critical for drafters. The specification must contain the seeds of the technological improvement; the SMED essentially waters them with expert testimony. The memo notes that while an “opinion as to the legal conclusion itself... is not entitled to any weight, the underlying factual basis for the opinion may be persuasive” (Corps, p. 3).
Illustrative Examples
To assist examiners, the Corps memo provides hypothetical scenarios demonstrating how SMEDs can overcome rejections. These examples offer a roadmap for drafting effective declarations.
1. Mental Processes and Distributed Computing
In a scenario involving network packet analysis, an examiner rejects claims as a “mental process.” The applicant submits a SMED showing that the “distributed processes” spanning multiple machines “cannot practically be performed in the human mind” (Corps, p. 4). The declaration provides “objective evidence showing that these teachings cannot be practically performed in the human mind” (Corps, p. 4). This example is particularly relevant for AI and software inventions, where the “mental steps” doctrine is frequently applied overly broadly.
2. Improvement to Computer Functioning
The memo describes a “self-referential table for a computer database” rejected as an abstract idea. A SMED provides testimony on “how one of ordinary skill in the art would interpret the disclosed invention as improving the functioning of a computer” (Corps, p. 5). The evidence links the improvement to the “way the computer stores and retrieves data in memory” (Corps, p. 5). This underscores the value of technical details regarding memory, storage, and processing efficiency in eligibility arguments.
3. Particular Treatment or Prophylaxis
Addressing the life sciences, the memo uses a “heartworm disease booster” example. A claim involves analyzing data (alleged mental process) to determine a dosing schedule. The applicant argues the additional element of administering the shot integrates the exception. A SMED supports this by showing that “adjusting the prophylactic schedule as disclosed would lower the susceptibility” of the animals to disease (Corps, p. 7). Here, the SMED provides the scientific data necessary to prove the practical application.
Guidance to Applicants and Practitioners: Separation of Issues
The companion memorandum addressed to applicants and practitioners focuses on “Best Practices.” The primary recommendation is procedural but carries substantive weight: “SMEDs should be submitted as separate documents and not combined with declarations or testimony addressing other issues, such as obviousness” (Applicant, p. 1).
The Risk of Intertwining Issues
The USPTO advises against the “kitchen sink” approach to declarations. While Rule 132 permits addressing multiple issues, the Office warns that “combining these can lead to confusion regarding the evidentiary weight and relevance of the testimony” (Applicant, p. 2).
The concern is that arguments made to support non-obviousness under § 103 might inadvertently weaken a § 101 position, or vice versa. The memo notes that by separating the submissions, “the applicant may avoid the risk of intertwining issues of enablement, written description, novelty and nonobviousness with those of subject matter eligibility” (Applicant, p. 2).
For instance, secondary considerations of non-obviousness (like commercial success) might not directly support a “technological improvement” argument required for Alice Step 1 or Step 2. As the memo states, “Declarations for obviousness may address secondary considerations and motivation to combine, which are distinct from SME issues” (Applicant, p. 2).
Supporting Authority
The memo cites Federal Circuit jurisprudence to bolster this separation. It references In re Oetiker, noting that “The burden of proof shifts depending on the rejection, and evidence must be relevant to the specific issue” (Applicant, p. 3).
It also cites In re Sullivan for the proposition that the Board must consider all evidence, but implies that distinct declarations make this task easier for the adjudicator (Applicant, p. 3).
Private practice guidance is also referenced, including the AIPLA Practice Guide, which suggests declarations “should be responsive to the specific grounds of rejection they seek to overcome” (Applicant, p. 3).
The USPTO’s clear preference is for a clean record: “This approach improves clarity, avoids confusion, and ensures that each declaration is focused on the specific rejection being traversed” (Applicant, p. 4).
Analysis: Benefits, Challenges, and Risks
The formalization of SMED practice represents a maturation of post-Alice prosecution. Moving the debate from attorney argument to evidentiary submissions allows for a more rigorous, objective inquiry.
However, this shift is not without peril. Patent owners and practitioners must weigh the advantages against significant risks.
Benefits: Crystallizing the Improvement
The primary benefit of a SMED is the ability to bridge the gap between a sparse specification and the understanding of a person of ordinary skill in the art (POSITA). Specifications are often drafted before the full scope of the eligibility challenge is understood.
A SMED allows an inventor or expert to explain why a specific data structure or reaction condition represents a technical leap, rather than a mere conventional activity.
Furthermore, a separate SMED creates a clean appellate record. If a case proceeds to the Patent Trial and Appeal Board (PTAB) or the Federal Circuit, having a dedicated document that outlines the technological improvement—unencumbered by arguments regarding prior art references—allows the judges to focus exclusively on the eligibility question.
Challenges: Cost and Timing
Drafting a declaration is significantly more time-consuming and expensive than standard attorney remarks. It requires identifying a declarant, drafting testimony, verifying technical accuracy, and executing the document.
For startups and individual inventors, this added cost may be prohibitive, potentially creating a two-tiered system where only well-resourced applicants can afford the evidence necessary to secure eligibility.
Timing is also a factor. The Corps memo emphasizes that the declaration “must be timely filed” (Corps, p. 3). Introducing a SMED late in prosecution (e.g., after a final rejection) may require a Request for Continued Examination (RCE), further increasing costs.
Risks: Estoppel, Admissions, and AI Concerns
The most substantial risks involve prosecution history estoppel and the potential for creating intervening rights or narrowing claim scope.
1. Creating a Narrowing Record
By submitting a declaration that explicitly defines what the invention “is” and “does” to survive § 101, an applicant may inadvertently disclaim broader interpretations of the claims. If a SMED argues that the “improvement” relies on a specific hardware configuration to escape the “abstract idea” label, the patentee may be stuck with that limitation during litigation, even if the claims technically read broader.
2. The “Admission” of Abstractness
Submitting a SMED that focuses heavily on Alice Step 2 (Inventive Concept) could be viewed as a tacit admission that the claims fail Alice Step 1 (Abstract Idea). While the legal framework allows arguing in the alternative, a forceful Step 2 declaration might signal to an examiner that the applicant lacks confidence in the statutory category of the invention.
3. The “New Matter” and Section 112 Trap
The guidance explicitly warns that SMEDs cannot “supply information that was required to be present in the original disclosure” (Corps, p. 3). This creates a delicate tightrope for practitioners attempting to bolster a thin specification.
Triggering New Rejections: A robust SMED might successfully overcome a § 101 rejection by detailing complex technical operations or specific improvements, only to inadvertently trigger a § 112(a) rejection for lack of written description or enablement. If the “technological improvement” described in the declaration is not clearly supported by the original filing, the examiner may conclude the applicant is attempting to add new matter.
The “Missing” Disclosure: If a SMED is required to explain the “technological improvement” because the specification is largely silent on the mechanism, an examiner may view this as an implicit admission that the original disclosure was insufficient to support the claims.
The Corps memo specifically warns that “To be of probative value, any objective evidence should be supported by actual proof” (Corps, p. 3).
Generative AI outputs are not “actual proof” and should never be treated as a substitute for verified technical data.
Conclusion
The USPTO’s new guidance on Subject Matter Eligibility Declarations offers a structured mechanism for applicants to defend their innovations against § 101 rejections. This is (a piece of) what Director Squires has been talking about for weeks.
By encouraging the separation of eligibility evidence from other prosecution issues, the Office aims to create a clearer, more robust record. For practitioners, the “Best Practices” memo serves as a strong recommendation to isolate § 101 inquiries from the factual entanglements of § 103.
However, the decision to file a SMED should not be automatic. It requires a strategic calculation regarding the value of the patent, the strength of the eligibility rejection, and the long-term risks of prosecution history estoppel.
As the industry integrates these new-but-old evidentiary tools, legal professionals should view them as a welcome opportunity to advocate for innovation with precision. Yet, this optimism must be tempered with vigilance.
Disclaimer: This is provided for informational purposes only and does not constitute legal or financial advice. To the extent there are any opinions in this article, they are the author’s alone and do not represent the beliefs of his firm or clients. The strategies expressed are purely speculation based on publicly available information. The information expressed is subject to change at any time and should be checked for completeness, accuracy and current applicability. For advice, consult a suitably licensed attorney and/or patent professional.