PTAB challenges

Proceedings overview

There is one AIA trial proceeding on file for US Patent 12102368. This proceeding is currently active and pending an institution decision. Given the early stage of the proceeding, no claims have been invalidated or sustained, and the patent's claims remain untested by a final written decision. The defensive posture for a defendant is that one IPR has been filed and is in its early stages, meaning the patent's validity is currently being challenged, but no determination has yet been made.

IPR2026-00194 — Paragon 28, Inc. v. Treace Medical Concepts Inc.

• Type: Inter Partes Review
• Filed: 2026-01-05
• Status: Pending. The proceeding is ongoing and awaiting an institution decision from the PTAB.
• Judge panel: Information regarding the specific Administrative Patent Judges (APJ) assigned to this panel is not publicly available at this early stage of the proceeding.
• Petition grounds: The specific claims challenged, the prior art cited, and the statutory bases (§ 102 for anticipation / § 103 for obviousness) for the petition are not publicly detailed in the provided data. This information would typically be found in the filed petition.
• Institution decision: Not yet issued. As of 2026-05-28, the PTAB has not yet decided whether to institute an IPR. The statutory deadline for an institution decision is typically six months from the filing date of the petition, which would be around 2026-07-05.
• Final Written Decision: Not applicable; a Final Written Decision has not been issued as the case is still pending institution.
• Settlement / termination: Not applicable; the proceeding is active and has not been settled or terminated.
• Appeal: Not applicable; no Final Written Decision has been issued to appeal.
• Defensive value: This proceeding indicates that at least one competitor, Paragon 28, Inc., believes there are valid grounds to challenge the patentability of claims in US12102368. While the IPR is still pending, it represents an active challenge to the patent's validity. Should institution be granted, it will highlight specific claims and prior art that the PTAB believes have a reasonable likelihood of success.

Strategic summary

US Patent 12102368 is currently subject to a single Inter Partes Review, IPR2026-00194, filed by Paragon 28, Inc. on 2026-01-05. As of today, 2026-05-28, this proceeding is in its early stages and is awaiting a decision on institution. This means that currently, all claims of US12102368 are legally considered valid and have not been canceled or sustained by the PTAB. The specific claims being challenged and the prior art asserted by Paragon 28, Inc. are not detailed in the provided information, but would typically target claims related to the "bone positioning guide" described in the patent (e.g., claims outlining the main body member, shaft, bone engagement member, and tip, or the methods of positioning bones).

The estoppel landscape under § 315(e)(2) is not yet applicable as no Final Written Decision has been rendered. If the IPR is instituted and proceeds to a Final Written Decision, Paragon 28, Inc. (and its privies) would be estopped from raising invalidity grounds that were raised or reasonably could have been raised during the IPR with respect to claims found patentable. However, until then, all prior-art grounds remain available to other potential challengers or defendants. The filing of this IPR by Paragon 28, Inc. suggests that this patent may be part of an ongoing competitive landscape or litigation, and the petitioner is a direct market player.

Recommended next steps

For a defendant facing assertion of US patent 12102368:

• Monitor IPR2026-00194 closely: The institution decision for IPR2026-00194 is expected around 2026-07-05. This decision will be a critical milestone. If institution is denied, it suggests the PTAB found the petition grounds unconvincing, which strengthens the patent. If instituted, the specific claims challenged and the PTAB's reasoning will provide valuable insight into potential weaknesses of the patent. You can monitor the progress of this case on the USPTO PTAB E2E portal.
• Review the petition: Obtain and review the petition filed by Paragon 28, Inc. to understand the specific claims being challenged, the prior art cited, and the invalidity arguments presented. This information is crucial for assessing the strength of the challenge and informing your own defensive strategy.
• Anticipate trial stages: If IPR2026-00194 is instituted, be aware of upcoming trial stages, including potential discovery, expert testimony, and the oral hearing. A Final Written Decision would then be due within one year of institution.
• Consider your own PTAB strategy: Depending on the strength of your own prior art and invalidity arguments, you may consider filing your own IPR. The outcome of IPR2026-00194 could influence the scope and strategy of any subsequent petition you might file.