US 12102368

Here's a concise summary of US Patent 12102368:

US Patent 12102368

• Title: Bone positioning guide
• Assignee: Treace Medical Concepts Inc
• Inventors: W. Bret Smith, Paul Dayton, Sean F. Scanlan, F. Barry Bays, Carlos Eduardo Gil, John T. Treace, Robert D. Santrock, Daniel J. Hatch, Joe W. Ferguson
• Filing Date: April 5, 2024 (for application US18/627,609)
• Issue Date: October 1, 2024
• Abstract: A bone positioning guide may include a main body member, a shaft, and a bone engagement member. The shaft is movably connected to the main body member and has the bone engagement member rotatably coupled to its distal end. The bone engagement member has a surface configured to engage a bone. The main body member also includes a tip opposite the bone engagement member for engaging a second bone. In use, the bone engagement member may be positioned in contact with a medial side of a first metatarsal while the tip is positioned in contact with a lateral side of a different metatarsal, such as a second metatarsal. The shaft can then be moved to advance the bone engagement member toward the tip, causing realignment of the first metatarsal.

Independent Claims Overview:
The full text of the independent claims for US12102368B2 was not provided in the authoritative source. Therefore, a plain-language overview of each independent claim cannot be given at this time.

Litigation Status:
US Patent 12102368 is currently involved in litigation. A PTAB (Patent Trial and Appeal Board) case, IPR2026-00194, was filed and is pending. Additionally, a US case related to this patent family has been filed in the Delaware District Court (case 1:25-cv-00592).

Known litigation involving US patent 12102368 includes the following:

1. PTAB Case

   • Plaintiff(s): Unified Patents
   • Defendant(s): Treace Medical Concepts Inc. (Patent Owner)
   • Jurisdiction: Patent Trial and Appeal Board (PTAB)
   • Case Number: IPR2026-00194
   • Filing Date: 2026 (year inferred from case number)
   • Outcome or Current Status: Pending

2. US District Court Case

   • Plaintiff(s): Not explicitly specified in the provided information.
   • Defendant(s): Not explicitly specified in the provided information.
   • Jurisdiction: Delaware District Court
   • Case Number: 1:25-cv-00592
   • Filing Date: 2025 (year inferred from case number)
   • Outcome or Current Status: Ongoing (status not explicitly detailed beyond "case filed")

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.

Inventors

• W. Bret Smith (Treace Medical Concepts Inc)
• Paul Dayton (Treace Medical Concepts Inc)
• Sean F. Scanlan (Treace Medical Concepts Inc)
• F. Barry Bays (Treace Medical Concepts Inc)
• Carlos Eduardo Gil (Treace Medical Concepts Inc)
• John T. Treace (Treace Medical Concepts Inc)
• Robert D. Santrock (Treace Medical Concepts Inc)
• Daniel J. Hatch (Treace Medical Concepts Inc)
• Joe W. Ferguson (Treace Medical Concepts Inc)

Original assignee

The original assignee, Treace Medical Concepts Inc, is a publicly traded medical device company (NASDAQ: TMCI) that develops and commercializes products for the surgical treatment of bunions and related foot and ankle deformities. They ship products embodying the claims, specifically their Lapiplasty® 3D Bunion Correction™ System, which includes bone positioning and preparation guides. The company is currently operating.

Assignment timeline

The USPTO Assignment Center search page (https://assignmentcenter.uspto.gov/patent/index.html) was checked using patent number 12102368. As of 2026-05-28, there are no recorded assignments for US Patent 12102368 in the USPTO Assignment Center.

The Google Patents legal events section for US12102368B2 indicates a "reassignment" on 2024-09-23 to "Treace Medical Concepts, Inc.". This entry specifies "ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS)" and lists the inventors as assignors. However, without a corresponding record in the USPTO Assignment Center with a reel/frame number, full details of this specific transaction (e.g., correspondent information) cannot be independently verified or included as a formal assignment record in this timeline. Based on the Google Patents data, this appears to be a formal assignment from the individual inventors to the corporate entity.

Timeline diagram

timeline
    title Ownership of US 12102368
    2024 : Filed by Treace Medical Concepts Inc
         : Assigned to Treace Medical Concepts Inc from inventors
         : Issued to Treace Medical Concepts Inc

NPE / troll-pattern signals

1. Shell-entity transfer — not present. The patent remains with the original operating company, Treace Medical Concepts Inc.
2. Known asserter in the chain — not present. Treace Medical Concepts Inc is an operating company, not a known NPE.
3. Repeat correspondent across the chain — unclear. While Google Patents indicates an assignment from inventors to the assignee, without the USPTO Assignment Center record details, the correspondent cannot be identified or checked for recurrence.
4. Cascading transfers — not present. There are no recorded transfers in the USPTO Assignment Center.
5. Pre-litigation transfer — unclear. The patent was issued on October 1, 2024, and litigation (IPR2026-00194, 1:25-cv-00592) was filed subsequently. While the Google Patents record shows an assignment from inventors to the assignee on September 23, 2024, the exact date of the first infringement suit is not precisely given beyond the year "2025" for the Delaware case, making it difficult to definitively assess if this transfer was "pre-litigation" (i.e., within 6 months of a suit).
6. Bankruptcy fire-sale — not present. Treace Medical Concepts Inc is an active, operating company.
7. Privateering — not present. The patent remains with the operating company.
8. Defensive aggregator (anti-NPE) — not present. The patent is held by an operating company and is involved in litigation.

Verdict

Operating-company assertion. The patent is currently assigned to Treace Medical Concepts Inc, an operating company that commercializes products embodying the claims. While litigation is pending (IPR2026-00194 and 1:25-cv-00592), there is no evidence of a transfer to a shell entity or known NPE.

The full text of the independent claims for US12102368B2 was not provided in the authoritative source within the prompt. To identify the most relevant prior art, the full claims would be necessary to assess potential anticipation under 35 U.S.C. § 102.

However, based on the provided patent text, US12102368B2 is a continuation of several earlier patent applications, which are highly relevant prior art. The "Related Applications" section explicitly states this patent's lineage.

Here are the prior art references from the "Related Applications" section of US12102368B2:

• U.S. patent application Ser. No. 18/182,995

  • Full Citation: U.S. patent application Ser. No. 18/182,995, filed Mar. 13, 2023.
  • Publication/Filing Date: March 13, 2023.
  • Brief Description: This is a direct parent continuation of the current patent. As a continuation, it likely shares a very similar specification and claims.
  • Potential Anticipation: Given it's a direct continuation, it potentially anticipates all claims of US12102368B2 under 35 U.S.C. § 102, as it would disclose the same invention.

• U.S. patent application Ser. No. 17/537,183 (now U.S. Pat. No. 11,602,386)

  • Full Citation: U.S. patent application Ser. No. 17/537,183, filed Nov. 29, 2021, now U.S. Pat. No. 11,602,386, issued Mar. 14, 2023.
  • Publication/Filing Date: November 29, 2021 (application), March 14, 2023 (patent issue).
  • Brief Description: This is a grandparent continuation of the current patent, and was issued as U.S. Pat. No. 11,602,386. It would disclose subject matter highly relevant to the bone positioning guide.
  • Potential Anticipation: Potentially anticipates claims of US12102368B2 that cover the bone positioning guide and its method of use, particularly those aspects described as common throughout the lineage.

• U.S. patent application Ser. No. 16/422,557 (now U.S. Pat. No. 11,185,359)

  • Full Citation: U.S. patent application Ser. No. 16/422,557, filed May 24, 2019, now U.S. Pat. No. 11,185,359, issued Nov. 30, 2021.
  • Publication/Filing Date: May 24, 2019 (application), November 30, 2021 (patent issue).
  • Brief Description: This is a great-grandparent continuation, issued as U.S. Pat. No. 11,185,359. It would further detail the development of the bone positioning guide.
  • Potential Anticipation: Potentially anticipates claims of US12102368B2 related to the core features of the bone positioning guide, its components, and methods.

• U.S. patent application Ser. No. 15/910,428 (now U.S. Pat. No. 10,335,220)

  • Full Citation: U.S. patent application Ser. No. 15/910,428, filed Mar. 2, 2018, now U.S. Pat. No. 10,335,220, issued Jul. 2, 2019.
  • Publication/Filing Date: March 2, 2018 (application), July 2, 2019 (patent issue).
  • Brief Description: This is an even earlier continuation, issued as U.S. Pat. No. 10,335,220.
  • Potential Anticipation: Potentially anticipates claims of US12102368B2 concerning the fundamental design and operation of the bone positioning guide.

• U.S. patent application Ser. No. 15/210,426 (now U.S. Pat. No. 9,936,994)

  • Full Citation: U.S. patent application Ser. No. 15/210,426, filed Jul. 14, 2016, now U.S. Pat. No. 9,936,994, issued Apr. 10, 2018.
  • Publication/Filing Date: July 14, 2016 (application), April 10, 2018 (patent issue).
  • Brief Description: This is an earlier continuation, issued as U.S. Pat. No. 9,936,994.
  • Potential Anticipation: Potentially anticipates claims of US12102368B2 related to the core elements and method of the bone positioning guide.

• U.S. patent application Ser. No. 14/981,335 (now U.S. Pat. No. 9,622,805)

  • Full Citation: U.S. patent application Ser. No. 14/981,335, filed Dec. 28, 2015, now U.S. Pat. No. 9,622,805, issued Apr. 18, 2017.
  • Publication/Filing Date: December 28, 2015 (application), April 18, 2017 (patent issue).
  • Brief Description: This is an earlier continuation, issued as U.S. Pat. No. 9,622,805.
  • Potential Anticipation: Potentially anticipates claims of US12102368B2 covering the basic features of the bone positioning guide.

• U.S. Provisional Application No. 62/205,338

  • Full Citation: U.S. Provisional Application No. 62/205,338, filed Aug. 14, 2015.
  • Publication/Filing Date: August 14, 2015.
  • Brief Description: This provisional application is an early filing that would describe the foundational concepts of the bone positioning guide.
  • Potential Anticipation: Provisional applications establish an early priority date for the subject matter disclosed within them. Therefore, this provisional application potentially anticipates any claims in US12102368B2 that are directly supported by its disclosure.

• U.S. Provisional Application No. 62/192,319

  • Full Citation: U.S. Provisional Application No. 62/192,319, filed Jul. 14, 2015.
  • Publication/Filing Date: July 14, 2015.
  • Brief Description: This provisional application is the earliest filing cited, predating all others, and would likely introduce the initial concepts of the bone positioning guide.
  • Potential Anticipation: As the earliest provisional application, it would anticipate any claims in US12102368B2 that are fully enabled and described within its content, establishing the earliest priority date for those aspects.

Without the full text of the claims for US12102368B2, it is not possible to specify which individual claims are potentially anticipated by each reference. However, as continuation applications and their issued patents generally build upon the same inventive concept, it is highly probable that the claims of US12102368B2 are closely related to, and thus potentially anticipated by, the disclosures of these earlier applications and patents, especially regarding the core elements of the bone positioning guide and its method of use for bone realignment in the foot.

An analysis of the obviousness of US patent 12102368 under 35 U.S.C. § 103 cannot be fully performed with the information provided. To conduct a proper obviousness analysis, the following are required:

1. Full Text of the Claims of US12102368: The independent claims, in their entirety, are necessary to determine the scope of the invention and compare them against prior art. Only an abstract summary of the claims is available in the provided "Patent summary" section.
2. Specific Prior Art References (Documents): The "Prior art" section of the provided patent text lists "metatarsal," "bone," "guide," "fixation," and "positioning guide" as "Prior art keywords" and "2015-07-14" as a "Prior art date." These are keywords and a date, not specific patent or non-patent literature documents that can be combined for an obviousness argument.

While the "Legal status" section mentions that US12102368B2 claims priority from U.S. patent application Ser. No. 14/981,335, which issued as U.S. Pat. No. 9,622,805 (US9622805B2), this earlier application/patent is typically considered a parent or continuity application. Subject matter disclosed in a parent application that supports the claims of a continuation application generally does not serve as prior art against the continuation application for obviousness purposes under 35 U.S.C. § 103, provided the claims of US12102368 are fully supported by the disclosure of US9622805B2. Without additional specific prior art documents, identifying combinations and motivations for a person having ordinary skill in the art to combine them is not possible.

Therefore, without the complete claims of US12102368 and a list of specific prior art documents (e.g., patents or publications cited during prosecution, or other relevant prior art), a comprehensive obviousness analysis under 35 U.S.C. § 103, including identifying combinations of references and motivations to combine them, cannot be completed.