ARTICLE
8 April 2026

The Rise Of Ex Parte Reexamination And The Director’s New Gatekeeping Role

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Over the past year, the USPTO has made a series of significant changes to inter partes review and post‑grant review practice that have reduced institution rates...
United States Intellectual Property
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Over the past year, the USPTO has made a series of significant changes to inter partes review and post‑grant review practice that have reduced institution rates, expanded discretionary denials, and made outcomes harder to predict for parties challenging patents at the Office. Because institution decisions in IPR and PGR proceedings are discretionary, made by the Director and not appealable, many accused infringers have responded by reverting to an older mechanism that sits outside those proceedings: ex parte reexamination. The filing numbers reflect that shift. Ex parte reexamination requests are now up sharply and, in recent periods, have exceeded the number of IPR and PGR petitions filed. Against that backdrop, the USPTO has turned renewed attention to ex parte reexaminations. In an April 1, 2026 notice, the Director announced a material change to how the Office will decide whether a reexamination request raises a substantial new question of patentability. The new guidance appears aimed at addressing the surge in ex parte filings by giving the Director more ammunition, and a more developed record, to deny requests through a decision that, like institution decisions in IPR and PGR proceedings, is final and not appealable.

A New Opportunity for Early Patent Owner Briefing

Under the new guidance, a patent owner may file a pre‑order paper addressing whether the reexamination request raises a substantial new question of patentability. The paper must be no more than 30 pages and must be filed as soon as possible, but no later than 30 days from service of the request on the patent owner. The procedure applies to reexamination requests filed on or after April 5, 2026.

The Director anticipates that the requester ordinarily will not respond, though limited exceptions may arise. If permitted, any response must be filed within 15 days. As before, a determination that no substantial new question has been raised is final and nonappealable. See 35 U.S.C. § 303(c).

How the Substantial New Question Determination Traditionally Worked

The ex parte reexamination process has long followed a familiar sequence. A requester files a request explaining the pertinency and manner of applying cited prior art to the claims. If the requester does not own the patent, the request is served on the patent owner. Within three months, the Director determines whether the request raises a substantial new question of patentability affecting any claim. That determination is placed in the patent file and is final and nonappealable. See 35 U.S.C. §§ 302 and 303.

When a substantial new question is found, the patent owner may file a statement and amend or add claims, after which the requester may reply. See 35 U.S.C. § 304. In practice, patent owners rarely use this post‑institution opportunity, choosing instead to respond to formal rejections once examination resumes.

What the New Guidance Changes and Why

Historically, the substantial new question determination was made by reviewing the reexamination request itself without input from the patent owner. Ordering reexamination required little explanation. Denying a request, however, required the Office to explain why the cited art failed to raise a substantial new question, typically by engaging directly with the requester’s arguments and doing so without any adversarial counterpoint.

The new procedure changes that dynamic. By inviting focused patent owner briefing before the threshold decision is made, the Director ensures that the Office has a developed explanation on the record for why a request may not warrant reexamination. That explanation can then be credited or relied upon in a final, nonappealable decision declining to order reexamination.

Viewed in context, the timing of the change is telling. As ex parte reexamination filings have increased, so too has the burden on the Office to process them. Allowing early patent owner input may make it easier for the Director to deny requests that do not truly raise a substantial new question, without having to develop that reasoning independently. In that sense, the new procedure functions as a gatekeeping mechanism designed to manage volume while remaining within the statutory framework.

A Procedural Shift Without Rulemaking

The guidance is notable because it conflicts with existing regulations. Under 37 C.F.R. § 1.530, patent owner submissions before the threshold determination were prohibited. Similarly, 37 C.F.R. § 1.540 limited the Director’s consideration to the papers identified in 35 U.S.C. § 304. The guidance expressly waives those provisions for timely filed pre‑order papers, reshaping long‑standing practice through Director guidance rather than formal rulemaking.

Limits on Early Briefing

The Director’s notice draws clear boundaries around what patent owners may argue. Patent owners are instructed not to raise discretionary denial arguments under 35 U.S.C. § 325(d). Instead, the focus remains on whether the request presents a new, noncumulative technical teaching or a new light that escaped earlier review. Existing MPEP guidance remains in effect.

A Familiar Gatekeeping Structure

There is a familiar pattern here. In IPR and PGR proceedings, institution decisions are discretionary, Director‑driven, and insulated from appellate review. Ex parte reexamination historically has been different, with a more mechanical threshold inquiry and no express discretionary denial regime.

But the common thread remains the same. In all three contexts, the threshold decision is made by the Director and is final and unreviewable. By introducing adversarial briefing at the front end of ex parte reexamination, the Office is strengthening that gatekeeping role. Whether this leads to more denials remains to be seen, but the structure now looks familiar: a front‑loaded decision, informed by briefing, controlled by the Director, and shielded from appeal.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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