PTAB challenges

Proceedings overview

There is one active AIA trial proceeding on US Patent 12268428, specifically a Post-Grant Review (PGR). The proceeding is currently pending, meaning no final decision on patentability has been issued. This indicates that the patent has not yet been hardened or narrowed by PTAB, and all claims currently remain asserted. For a defendant, this means the patent is currently under review, but no claims have been invalidated, so any infringement theories built on the patent's claims are still valid from a PTAB perspective.

PGR2026-00020 — Paragon 28, Inc. v. Treace Medical Concepts Inc.

• Type: Post-Grant Review
• Filed: 2025-12-23
• Status: Pending – the proceeding is ongoing, and no final decision on patentability has been issued yet.
• Judge panel: Information regarding the specific judge panel for this pending PGR is not publicly available at this stage.
• Petition grounds: The petition was filed by Paragon 28, Inc. challenging the patentability of claims 1-17 of U.S. Patent 12,268,428. The challenge is based on anticipation under 35 U.S.C. § 102 and obviousness under 35 U.S.C. § 103, citing various prior art references including U.S. Patent No. 9,622,805 (Bays), U.S. Patent No. 10,342,590 (Bays), and published PCT application WO 2017/027429 A1 (Bays).
• Institution decision: As of today's date (2026-05-27), an institution decision for PGR2026-00020 has not yet been publicly issued by the PTAB. The statutory deadline for an institution decision in a PGR is typically within 6 months of the petition filing date, or three months after the Patent Owner's preliminary response. Given the filing date of 2025-12-23, the institution decision is expected around June 2026.
• Final Written Decision: Not yet issued due to the pending status of the proceeding.
• Settlement / termination: No information regarding settlement or termination is available.
• Appeal: Not applicable, as no Final Written Decision has been issued.
• Defensive value: This pending PGR indicates that claims 1-17 of US12268428 are currently under challenge for patentability. If institution is granted, it means the PTAB has found a reasonable likelihood that at least one of the challenged claims is unpatentable, posing a significant risk to the patent's validity. Until then, the claims are presumed valid, but a defendant should closely monitor the outcome of the institution decision.

Strategic summary

Currently, all claims (1-17) of US Patent 12268428 are being challenged in a single Post-Grant Review, PGR2026-00020, filed by Paragon 28, Inc. No claims have been officially canceled or sustained by the PTAB, as the proceeding is still in the institution phase. Therefore, all claims of the patent are presently untested by a final PTAB decision and remain potentially asserted.

The estoppel landscape has not yet been formed, as no Final Written Decision has been issued. If PGR2026-00020 proceeds to a Final Written Decision, any grounds raised or that reasonably could have been raised by Paragon 28, Inc. (and their privies) would be barred in future proceedings under 35 U.S.C. § 315(e)(2). Until then, all prior-art grounds, including those currently asserted by Paragon 28, Inc. in the petition, remain available to other potential defendants not in privy with Paragon 28, Inc. There is no pattern of multiple IPRs or aggressive appeals from the patent owner to observe at this early stage of litigation, nor is there any indication of a defensive aggregator like Unified Patents in this specific chain for this patent.

Recommended next steps

For a defendant currently facing assertion of US12268428, the immediate focus should be on monitoring the institution decision in PGR2026-00020. The decision is expected around June 2026 (approximately six months from the petition filing date). If institution is denied, the patent owner would have prevailed at this stage, making an IPR/PGR-based defense against the asserted claims harder on the same grounds. If institution is granted (either fully or partially), it signals that the PTAB believes claims are likely unpatentable, which would be a significant development for any defense strategy.

Since the proceeding is pending, the patent is currently subject to the PTAB's one-year trial deadline from the date of institution. If instituted, the Final Written Decision would typically be due approximately one year after the institution date.

Link to the PTAB proceeding:

• PGR2026-00020 information on Unified Patents: https://portal.unifiedpatents.com/ptab/case/PGR2026-00020