PTAB challenges

Proceedings overview

There is one AIA trial proceeding on file for US patent 12245997, which has been terminated due to settlement. This outcome means the patent claims have not been challenged to a final decision at the PTAB, but the involved parties have reached an agreement.

PGR2026-00015 — Atossa Therapeutics, Inc. v. Jina Pharmaceuticals Inc.

• Type: Post-Grant Review (PGR)
• Filed: 2025-12-10
• Status: Terminated-Settled. The proceeding was settled between Atossa Therapeutics, Inc. and Jina Pharmaceuticals, Inc., along with Intas Pharmaceuticals Ltd., on April 13, 2026, and was last modified on 2026-04-27.
• Judge panel: Information on the judge panel for this specific proceeding is not publicly available in the provided search results.
• Petition grounds: The petition challenged claims based on Section 112, alleging that 10 claims lacked written description and enablement for a critical 'no rescue medication' limit.
• Institution decision: An institution decision was not reached before the settlement and termination of the proceeding.
• Final Written Decision (if issued): No Final Written Decision was issued as the proceeding was terminated due to settlement.
• Settlement / termination: The proceeding was terminated as part of a broader Settlement Agreement entered into on April 13, 2026, between Atossa Therapeutics, Inc., Intas Pharmaceuticals Ltd., and Jina Pharmaceuticals, Inc.. The agreement resolved patent disputes related to Endoxifen-related intellectual property, including pending PTAB challenges. The parties agreed to seek termination of the identified PTAB proceedings and, if any proceeding was not fully terminated, not to participate further in that proceeding or related appeals. The settlement also included mutual commitments not to challenge certain Endoxifen-related patents and patent applications, with limited exceptions. Atossa Therapeutics stated that its two issued "Methods for Making and Using Endoxifen" U.S. patents (including potentially US12245997, although the specific patent numbers mentioned in one search result were 11,261,151 and 12,071,391, which are distinct from 12245997) were anticipated to remain issued and enforceable against third parties. The full terms of the settlement are generally confidential, but the public statements indicate a resolution of the patent disputes.
• Appeal: No appeal to the Federal Circuit occurred as the proceeding was terminated before a Final Written Decision was rendered.
• Defensive value: This proceeding indicates that at least some claims of US12245997 (specifically, 10 claims relating to the 'no rescue medication' limit) faced a Section 112 challenge in a PGR. However, the claims were not actually invalidated or confirmed patentable by a PTAB decision, as the parties settled. This means the Section 112 grounds raised were not adjudicated, leaving them potentially available for future challenges by other parties not privy to the settlement.

Strategic summary

All claims of US12245997 remain UNTESTED by a PTAB Final Written Decision, as the single PGR proceeding (PGR2026-00015) was terminated due to a settlement between Atossa Therapeutics, Inc., Jina Pharmaceuticals, Inc., and Intas Pharmaceuticals Ltd. This means no claims were canceled or sustained through a PTAB trial.

The estoppel landscape for US12245997 is currently limited. Since PGR2026-00015 was settled prior to a Final Written Decision, the petitioner (Atossa Therapeutics, Inc.) and its privies would be barred from raising any ground actually litigated to a final decision in that specific proceeding. However, as no such decision was reached, the full estoppel effect under § 325(e)(2) for claims found unpatentable would not apply. The settlement agreement likely includes private covenants not to sue or challenge certain patents between the settling parties, which would bind Atossa Therapeutics, Intas Pharmaceuticals Ltd., and Jina Pharmaceuticals. For any other potential defendant not privy to this settlement, the prior art and statutory grounds (including the § 112 challenges related to the "no rescue medication" limit that were raised in the PGR petition) remain available for use in future challenges or litigation defenses.

There is no apparent pattern of multiple IPRs on this patent or aggressive PTAB appeals by the patent owner, as only one PGR was filed and it was settled.

Recommended next steps

Since no PTAB Final Written Decision was issued for US patent 12245997, there is no disposition to quote regarding claim invalidation or patentability. The absence of an adjudicated PTAB decision means the patent's claims have not been judicially confirmed as valid or invalid by the PTAB.

For a defendant currently being asserted against, the key takeaway is that the patent claims have not been "hardened" by surviving a full PTAB trial. The grounds raised in PGR2026-00015 (Section 112 challenges related to written description and enablement for the 'no rescue medication' limit for 10 claims) could still potentially be asserted by a new petitioner not bound by the prior settlement. However, any party subject to the settlement agreement (Atossa Therapeutics, Intas Pharmaceuticals Ltd., and Jina Pharmaceuticals, Inc.) would be constrained by its terms.

If facing assertion of this patent, it would be prudent to review the PGR2026-00015 petition to understand the specific Section 112 arguments raised against the claims, as these arguments were considered sufficient for the petitioner to file a PGR and potentially led to the settlement. While the petition did not lead to a final decision, it highlights potential vulnerabilities in the patent claims. Information regarding the PGR can often be found on the USPTO PTAB E2E system by searching for the proceeding number PGR2026-00015.## Proceedings overview
There is one AIA trial proceeding on file for US patent 12245997. This proceeding, PGR2026-00015, was terminated due to settlement. As a result, no claims were invalidated or sustained by a PTAB Final Written Decision, meaning the patent claims remain untested by the PTAB.

PGR2026-00015 — Atossa Therapeutics, Inc. v. Jina Pharmaceuticals Inc.

• Type: Post-Grant Review (PGR)
• Filed: 2025-12-10
• Status: Terminated-Settled. This proceeding was settled between Atossa Therapeutics, Inc. and Jina Pharmaceuticals, Inc., along with Intas Pharmaceuticals Ltd., on April 13, 2026, with the last modification noted on 2026-04-27.
• Judge panel: Information regarding the specific judge panel for this proceeding is not publicly available in the provided search results.
• Petition grounds: The petition challenged 10 claims of US12245997 under 35 U.S.C. § 112, alleging a lack of written description and enablement concerning a "no rescue medication" limitation.
• Institution decision: An institution decision was not rendered before the proceeding was terminated due to settlement.
• Final Written Decision (if issued): No Final Written Decision was issued, as the case concluded with a settlement agreement.
• Settlement / termination: The proceeding was terminated as part of a comprehensive Settlement Agreement reached on April 13, 2026, between Atossa Therapeutics, Inc., Intas Pharmaceuticals Ltd., and Jina Pharmaceuticals, Inc.. This agreement resolved broader patent disputes related to Endoxifen intellectual property, including active PTAB challenges. The settling parties committed to seeking termination of the PTAB proceedings and, should any proceeding not be fully terminated, agreed not to participate further in such proceedings or related appeals. The settlement also involved mutual commitments not to challenge certain Endoxifen-related patents and patent applications held by the other parties, with specific exceptions. Atossa Therapeutics anticipated that its "Methods for Making and Using Endoxifen" U.S. patents would remain issued and enforceable against third parties following the expected termination of relevant proceedings by the PTAB. The precise terms of the settlement are generally confidential.
• Appeal: No appeal to the Federal Circuit took place, as the proceeding was terminated prior to the issuance of a Final Written Decision.
• Defensive value: While the specific claims of US12245997 were challenged under 35 U.S.C. § 112 for lacking written description and enablement regarding the "no rescue medication" limitation, these arguments were not adjudicated by the PTAB. This means that the claims have not been officially invalidated or found patentable by a PTAB decision. For any entity not party to the settlement, the grounds raised in the PGR petition remain available for potential future challenges.

Strategic summary

All claims of US12245997 are currently UNTESTED by a PTAB Final Written Decision. The sole PGR proceeding, PGR2026-00015, was terminated due to a settlement, meaning the PTAB did not issue a determination on the patentability of the challenged claims. Consequently, no claims have been canceled or sustained through an AIA trial.

The estoppel landscape for US12245997 is such that, for parties not involved in the settlement agreement (Atossa Therapeutics, Inc., Intas Pharmaceuticals Ltd., and Jina Pharmaceuticals, Inc.), the prior art and statutory grounds, including the § 112 challenges raised in the PGR petition, remain available. Because no Final Written Decision was issued, the full estoppel provisions of 35 U.S.C. § 325(e)(2) for claims found unpatentable do not apply to the petitioner (Atossa Therapeutics, Inc.) or its privies in relation to this patent. However, the settlement agreement itself likely creates a contractual estoppel for the signatory parties regarding future challenges to certain Endoxifen-related intellectual property.

There is no pattern of multiple IPRs or aggressive PTAB appeals by the patent owner. The patent has only faced one PGR, which resulted in a settlement rather than a litigated outcome.

Recommended next steps

Given that PGR2026-00015 terminated via settlement and no Final Written Decision was issued, there is no PTAB disposition to quote regarding the invalidation or patentability of claims. The claims of US12245997 have not been subjected to a full PTAB merits review.

For a potential defendant facing assertion of this patent, it is advisable to thoroughly review the petition filed in PGR2026-00015 to understand the specific § 112 arguments concerning the "no rescue medication" limitation, which were directed at 10 claims. These arguments represent a previously identified potential vulnerability of the patent. While these arguments were not ultimately decided by the PTAB due to the settlement, they could inform a defensive strategy, particularly for parties not bound by the settlement agreement. Details of the PGR proceeding, including the petition, would be available through the USPTO PTAB E2E system by searching for PGR2026-00015.