On April 1, 2026, the United States Patent and Trademark Office (USPTO) issued new guidance establishing "pre-institution procedures for the determination of substantial new questions of patentability in ex parte reexamination proceedings," marking a further adjustment to the Office's long-standing practice of correcting errors in granted patents.

Guidance Overview

The guidance adds a new written statement option, allowing patent owners to submit comments in response to a reexamination request filed by a third party before the Office makes a decision to grant or deny the request (i.e., the pre-institution stage). According to the notice, this pre-institution written statement will enable the USPTO to reference the patent owner's opinions when making a "Substantial New Question (SNQ)" determination. Relevant materials must be submitted within 30 days from the date of service of the reexamination request and must not exceed 30 pages in length. Patent owners are also prohibited from using the materials to argue that the relevant content overlaps with previous analyses made by the USPTO pursuant to Section 325(d); such issues will be considered separately in subsequent proceedings.

Third-party requesters have no right to respond to the pre-institution materials submitted by the patent owner and may only file an appeal based on extraordinary circumstances. For example, if a third party believes the patent owner has made a misrepresentation of fact or law, and such misrepresentation would materially impede the determination of a "substantial new question."

Impact on Patent Owners and Third Parties

This guidance has significant practical implications for both parties:

For Patent Owners

· The 30-day window to address all substantial new questions in the pre-institution written statement and optional declarations is time-sensitive and costly.

· Patent owners involved in parallel litigation will be reluctant to prematurely disclose potential claim constructions and claim mapping in the USPTO’s optional submission, whereas the statutory deadline for such official filings is at least six months later than the pre-institution stage.

· If there is a pending or anticipated motion to stay in parallel litigation, establishing a substantive reexamination record—and demonstrating active engagement with the USPTO—may tip the scales in favor of the motion to stay.

· The practical value of this option may be relatively limited. Statistical data over more than 40 years shows that the rate of third-party challengers successfully raising a substantial new question exceeds 92%, and this guidance cannot change the statutory standard for determining a substantial new question—a standard with a lower threshold than that applied for rejecting claims based on the prima facie evidence rule in subsequent reexamination proceedings.

· Requesters are likely to file a response to any statement submitted by the patent owner during the pre-institution stage, asserting that it contains factual misdescriptions; if the patent owner waits until after the reexamination process is initiated to act, no such right of response exists.

For Third Parties

· If pre-institution written statements become routine, the overall cost of reexamination proceedings will increase for all parties. Meanwhile, if the standard for determining a substantial new question is disguisedly raised, third parties may need to file reexamination requests multiple times until support is obtained.

· There is currently a strategic motivation to block or increase the patent owner's pre-institution submission workload by adding more substantial new questions, thereby further increasing costs for the requester.

· If the USPTO deviates from the statutory standard for determining a substantial new question and directly adopts the patent owner's assertions, the fairness of the reexamination proceedings will be compromised, similar to issues that have arisen previously at the Patent Trial and Appeal Board (PTAB).