US 12268428

Here's a concise summary of US Patent 12,268,428 B2:

Title: Tarsal-metatarsal joint procedure utilizing fulcrum

Assignee: Treace Medical Concepts Inc.

Inventors: F. Barry Bays, Robert D. Santrock, Paul Dayton, Daniel J. Hatch, W. Bret Smith, Carlos Eduardo Gil, Sean F. Scanlan, Joe William Ferguson, John T. Treace.

Filing Date: April 25, 2024.

Issue Date: April 8, 2025.

Abstract: A technique for correcting a bone deformity, such as a bunion, may be performed using an instrument. In some examples, the technique involves inserting the instrument between a first metatarsal and a second metatarsal. The technique further includes preparing an end of the first metatarsal and preparing an end of a medial cuneiform opposing the end of the first metatarsal.

Plain-Language Overview of Independent Claims:

Independent Claim 1:
This claim describes a method for correcting a bunion deformity. It involves these key steps:

1. Inserting a fulcrum: A fulcrum is placed between the first and second metatarsal bones, where the first metatarsal is incorrectly aligned with the second metatarsal.
2. Preparing bone ends: The end of the first metatarsal and the end of the medial cuneiform bone (which faces the first metatarsal) are prepared.
3. Moving the first metatarsal: A part of the first metatarsal further from the body (distal portion) is moved towards the second metatarsal in a horizontal plane (transverse plane). This action causes the part of the first metatarsal closer to the body (proximal portion) to pivot around the fulcrum. This pivoting reduces the angle between the first and second metatarsal bones.

Independent Claim 12:
This claim describes a fulcrum device designed for use in a bone realignment procedure. The fulcrum includes:

1. A body: This part of the fulcrum is shaped to be inserted into the space between two adjacent metatarsal bones.
2. A handle: This handle is connected to the body and extends from it at an angle greater than zero degrees. This angled design creates a space between the handle and the body, which can be used to retract (pull back) soft tissue during surgery.

Independent Claim 15:
This claim describes a multidimensional fulcrum, detailing its physical characteristics:

1. A fulcrum body: This body has a specific length, width, and thickness.
2. Two distinct ends:
   • A first end with a first thickness, designed to be inserted into an intermetatarsal space of a particular size.
   • A second end with a second thickness, designed for an intermetatarsal space of a different size.
3. Thickness difference: The second thickness is explicitly greater than the first thickness. This allows the same instrument to be used in intermetatarsal spaces of different sizes by simply flipping it.

Uncertainty Note Regarding CAFC 2026 Dockets:
While the patent document itself indicates that there is "Family has litigation," including a "PTAB case PGR2026-00020 filed (Pending)" and a "US case filed in Delaware District Court", direct access to the CAFC dockets for a specific patent number without a case name or number is generally not provided by a simple search of the public portal. The provided search results confirmed the existence of the USPTO's search tools but did not yield specific CAFC docket entries for patent 12268428 directly. Therefore, while litigation is noted in the patent's metadata, detailed information from CAFC dockets would require more specific search parameters than just the patent number.

As of April 26, 2026, known litigation involving US patent 12268428 includes one Post-Grant Review (PGR) case before the Patent Trial and Appeal Board (PTAB).

Details of the known litigation:

1. PTAB Case (Post-Grant Review)
   • Plaintiff(s): Unified Patents [cite: The provided patent text snippet notes the petitioner as being from "Unified Patents PTAB Data".]
   • Defendant(s): Treace Medical Concepts Inc. (the current assignee of US12268428) [cite: The provided patent text lists Treace Medical Concepts Inc. as the current assignee.]
   • Jurisdiction: Patent Trial and Appeal Board (PTAB)
   • Case Number: PGR2026-00020 [cite: The provided patent text explicitly lists this case number.]
   • Filing Date: 2026 (exact date not specified in available information, but implied by the case number and current status) [cite: The case number PGR2026-00020 implies a filing year of 2026.]
   • Outcome or Current Status: Pending [cite: The provided patent text states the case is "(Pending)".]

Please note that while the Google Patents page for US12268428 also references a "US case filed in Delaware District Court" with case number 1:25-cv-00592, a review of publicly available court documents for this case number indicates that it involves parties and subject matter unrelated to US patent 122684428. The case 1:25-cv-00592 in the Delaware District Court pertains to solar portfolios and distributed generation resources, with plaintiffs such as Catalyze Pyrite 2023 Solar Portfolio, LLC, and not the medical device field of patent US12268428. Therefore, this district court case is not considered litigation involving US patent 12268428.

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

Inventors

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

(All inventors appear to be associated with Treace Medical Concepts Inc., the original assignee, at the time of filing based on the patent's information).

Original assignee

The original assignee is Treace Medical Concepts Inc. They ship products embodying the claims, specifically surgical devices and methods for bunion correction, such as the Lapiplasty® 3D Bunion Correction™ System. Their primary line of business is the design, manufacture, and marketing of medical devices for foot and ankle pathologies. Treace Medical Concepts Inc. is currently an operating company.

Assignment timeline

The USPTO Patent Assignment Search was consulted. As of the current date, May 27, 2026, there are no recorded assignments for US Patent 12268428 beyond the original assignment to Treace Medical Concepts Inc. at the time of publication.

Timeline diagram

timeline
    title Ownership of US 12268428
    2024 : Filed by Treace Medical Concepts Inc
    2025 : Issued

NPE / troll-pattern signals

1. Shell-entity transfer — not present. The patent remains with the original operating company, Treace Medical Concepts Inc., which actively markets products.
2. Known asserter in the chain — not present. The sole assignee is Treace Medical Concepts Inc., which is not identified as a known NPE.
3. Repeat correspondent across the chain — not present. There is only one recorded assignment (the original grant), so no chain exists to show recurrence.
4. Cascading transfers — not present. There is only one recorded assignment (the original grant).
5. Pre-litigation transfer — not present. There are no recorded assignments that would precede litigation.
6. Bankruptcy fire-sale — not present. Treace Medical Concepts Inc. is an active, operating company.
7. Privateering — not present. No evidence of transfer to an NPE for assertion on behalf of an operating company.
8. Defensive aggregator (anti-NPE) — not present. The patent is held by an operating company, not a defensive aggregator.

Verdict

Insufficient data. There are no recorded post-issuance assignments for US Patent 12268428. The patent is currently held by the original operating assignee, Treace Medical Concepts Inc., which manufactures and sells products related to the patented technology. Without any subsequent transfers, it is not possible to identify any NPE or troll patterns. The USPTO Assignment Center can be searched for verification at https://assignmentcenter.uspto.gov/.

Prior Art Analysis for US Patent 12268428

To identify the most relevant prior art for US patent 12268428, I will examine the patent's cited references.

Cited Patent References:

1. US 9,622,805 B2

   • Full Citation: US 9,622,805 B2, titled “Bone positioning and preparing guide systems and methods.”
   • Publication/Filing Date: Publication date: April 18, 2017. Filing date: December 28, 2015.
   • Brief Description: This patent describes bone positioning and cutting guide systems and methods, particularly for use in correcting anatomically misaligned bones, such as in the foot or hand. It covers devices and methods for positioning a bone from an anatomically misaligned position to an anatomically aligned position, and preparing the ends of bones, potentially in more than one plane.
   • Potential Anticipation (35 U.S.C. § 102): US 9,622,805 B2 potentially anticipates elements of Independent Claim 1 (method of correcting bunion deformity) as it describes methods for positioning and preparing bones to correct anatomical misalignments. Specifically, it details moving a bone from a misaligned to an aligned position and preparing bone ends, which are core components of Claim 1. The concept of correcting alignment in multiple planes by applying force at a single location, leading to both translation and rotation, is also present.
     It also potentially anticipates aspects of Independent Claim 12 and Claim 15 in a broader sense, by disclosing general "systems and methods" for bone positioning. While it may not explicitly detail the specific fulcrum structures of Claims 12 and 15, the underlying principles of bone manipulation and correction using instruments are highly relevant.

2. US 10,342,590 B2

   • Full Citation: US 10,342,590 B2, titled "Tarsal-metatarsal joint procedure utilizing fulcrum."
   • Publication/Filing Date: Publication date: July 9, 2019. Filing date: August 14, 2016.
   • Brief Description: This patent describes methods and devices for positioning and/or preparing bones, specifically focusing on tarsal-metatarsal joint procedures. It explicitly mentions methods for correcting bunion deformities, including inserting a fulcrum between metatarsals, preparing bone ends, and moving a distal portion of the first metatarsal to pivot the proximal portion about the fulcrum, reducing the intermetatarsal angle.
   • Potential Anticipation (35 U.S.C. § 102): US 10,342,590 B2 is a direct antecedent to US 12268428 B2, being a parent application in the continuation chain. Therefore, it directly anticipates almost all aspects of Independent Claim 1 as it describes the identical method of correcting a bunion deformity using a fulcrum, including the steps of inserting the fulcrum, preparing bone ends, and moving the metatarsal to pivot around the fulcrum and reduce the intermetatarsal angle. It also explicitly discusses the use of a fulcrum in a bone realignment procedure, making it highly relevant to Independent Claims 12 and 15 by disclosing the fundamental concept and context for such a fulcrum.

3. US 2016/0192970 A1

   • Full Citation: US 2016/0192970 A1, titled “Bone Plating System and Method.”
   • Publication/Filing Date: Publication date: July 7, 2016. Filing date: January 7, 2016.
   • Brief Description: This publication describes a bone plating system and method for fracture fixation. It includes bone plates with both locking and non-locking holes, and corresponding screws, designed to compress the bone plate against the bone and hold fracture reduction. It specifically mentions that example bone plates described in this publication can be used as first bone plate 310 and/or second bone plate 320 in US12268428.
   • Potential Anticipation (35 U.S.C. § 102): US 2016/0192970 A1 primarily focuses on bone plating systems for fixation. While US 12268428 B2 mentions the use of bone plates for permanent fixation after the bone realignment procedure (e.g., in the steps following the fulcrum use), the core inventive claims (Claims 1, 12, and 15) of US 12268428 B2 are directed to the method of correcting the bunion using a fulcrum and the fulcrum device itself. Therefore, US 2016/0192970 A1 does not directly anticipate the methods or the fulcrum device of Claims 1, 12, or 15. It may be relevant as prior art for the overall surgical technique in a broader sense, particularly for the final fixation step, but not for the specific fulcrum-utilizing steps or the fulcrum device itself described in the independent claims.

Note: The patent 12268428 B2 is a continuation of application Ser. No. 18/323,138, which is a continuation of Ser. No. 17/888,272 (now US Pat. No. 11,690,659), which is a continuation of Ser. No. 16/448,357 (now US Pat. No. 11,413,081), which is a divisional of Ser. No. 15/236,464 (now US Pat. No. 10,342,590), which claims the benefit of US Provisional Application No. 62/293,189 and is a continuation-in-part of Ser. No. 14/981,335 (now US Pat. No. 9,622,805), which claims the benefit of US Provisional Application No. 62/205,338. This complex lineage highlights that US 10,342,590 B2 and US 9,622,805 B2 are closely related and share significant overlap in subject matter with US 12268428 B2.

An analysis of obviousness under 35 U.S.C. § 103 for US Patent 12268428 requires identifying combinations of prior art references that would render the claims obvious and explaining the motivation a person having ordinary skill in the art (POSA) would have to combine them.

However, the provided patent text for US12268428, specifically the "Prior Art section" (which consists of "Prior art keywords" and a "Prior art date"), does not include specific prior art documents or references, other than a single reference for bone plates (US2016/0192970) that is distinct from the core method and fulcrum claims. While "metatarsal," "bone," "surgical technique," "instrument," and "fulcrum" are listed as prior art keywords, these are broad terms and not specific documents that can be combined. The listed related applications (e.g., US9622805B2, US10342590B2) are ancestral family members, and while they disclose related subject matter, their claims would need to be specifically examined to determine their relevance as §103 prior art against the current claims.

Therefore, without specific prior art references that teach or suggest the claimed elements of US12268428, it is not possible to confidently identify combinations of references or articulate the specific motivations a POSA would have had to combine them to achieve the claimed inventions. I cannot fabricate such combinations or motivations.

A proper obviousness analysis would typically proceed as follows for each independent claim:

Independent Claim 1: Method of Correcting a Bunion Deformity

Key features:

1. Inserting a fulcrum between the first and second metatarsals.
2. Preparing the end of the first metatarsal and the opposing end of the medial cuneiform.
3. Moving a distal portion of the first metatarsal toward the second metatarsal in a transverse plane, pivoting a proximal portion of the first metatarsal about the fulcrum, and reducing the intermetatarsal angle.

Hypothetical Prior Art & Motivation (General, without specific references):
To render this claim obvious, one would typically need prior art references that individually or in combination teach or suggest:

• A first reference: A surgical method for correcting bunion deformities, possibly involving osteotomy or fusion of the tarsal-metatarsal joint, and techniques for preparing bone ends. The patent mentions the Lapidus procedure as an example, which involves tarsal-metatarsal fusion.
• A second reference: The use of a fulcrum or spacer in foot surgery, specifically in the intermetatarsal space, to facilitate bone movement or maintain spacing during realignment. The prior art keywords explicitly mention "fulcrum".
• Motivation to Combine: A POSA might be motivated to combine these references to improve existing bunion correction techniques. For example, if a prior art method for bunion correction lacked precise control over the pivot point or resulted in undesirable bone impingement, a POSA would be motivated to introduce a fulcrum (from a second reference) to provide a controlled pivot, minimize base shift, or maintain intermetatarsal spacing during the repositioning and reduction of the intermetatarsal angle. This could be driven by known problems such as uncontrolled rotation or translation of the metatarsals during realignment procedures.

Independent Claim 12: Fulcrum Device

Key features:

1. A fulcrum for bone realignment.
2. Includes a body configured for insertion into an intermetatarsal space.
3. Includes a handle operatively connected to the body.
4. The handle projects at a non-zero degree angle from the body to define a tissue retraction space between the handle and the body.

Hypothetical Prior Art & Motivation (General, without specific references):
To render this claim obvious, one would typically need prior art references that individually or in combination teach or suggest:

• A first reference: A fulcrum or similar instrument designed for insertion into narrow anatomical spaces, such as between bones, for surgical manipulation or spacing.
• A second reference: A surgical instrument with a handle designed for tissue retraction. The patent describes the handle of fulcrum 356 as pushing skin away from the surgical incision line to provide access.
• Motivation to Combine: A POSA would be motivated to combine these elements to create a more versatile or user-friendly fulcrum. For instance, if existing fulcrums were difficult to manipulate or obscured the surgical field, a POSA would consider adding an angled handle (from a second reference) to provide both a mechanical advantage for manipulation and a tissue retraction function, thereby improving surgical access and efficiency. The ergonomic benefits of an angled handle are well-known in surgical instrument design.

Independent Claim 15: Multidimensional Fulcrum

Key features:

1. A fulcrum body with length, width, and thickness.
2. A first end with a first thickness for a first size intermetatarsal space.
3. A second end with a second thickness for a second size intermetatarsal space.
4. The second thickness is greater than the first thickness.

Hypothetical Prior Art & Motivation (General, without specific references):
To render this claim obvious, one would typically need prior art references that individually or in combination teach or suggest:

• A first reference: A fulcrum or spacer instrument used in orthopedic surgery that is designed for insertion between bones.
• A second reference: Surgical instruments or shims that are reversible or multi-ended, offering different dimensions (e.g., thicknesses) to accommodate varying anatomical sizes or surgical requirements. The patent explicitly states that different thicknesses can be useful for different sized intermetatarsal spaces and that a clinician might flip the instrument.
• Motivation to Combine: A POSA would be motivated to combine these features to create a single instrument capable of serving multiple functions or accommodating a range of patient anatomies, thereby reducing the need for multiple instruments and improving surgical workflow. The ability to select different thicknesses from a single instrument (e.g., by flipping it) for "different sized intermetatarsal spaces" would be an obvious design choice for a POSA seeking efficiency and adaptability, especially in procedures where anatomical variations are common.

In summary, while the conceptual framework for obviousness can be outlined based on the claim elements, specific conclusions regarding US12268428 cannot be drawn without the actual prior art documents that were considered during its prosecution, or those that would otherwise be relevant under 35 U.S.C. § 103.