- Filed
- Jan 13, 2026
- Last modified
- Jun 23, 2026
- Petitioner
- Paragon 28, Inc.
- Patent owner
- TREACE MEDICAL CONCEPTS, INC.
- Outcome
- Institution Denied
Invalidity dossier
US 12274481
Bone positioning and preparing guide systems and methods
Current assignee: Treace Medical Concepts Inc
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Patent summary
Title, assignee, inventors, filing/issue dates, abstract, and a plain-language overview of the claims.
Here's a concise summary of US Patent 12274481:
US Patent Number: 12274481B2
- Title: Bone positioning and preparing guide systems and methods
- Assignee: Treace Medical Concepts Inc [cite: Original Assignee]
- Inventors: Robert D. Santrock, Paul Dayton, Daniel J. Hatch, W. Bret Smith, F. Barry Bays, Carlos Eduardo Gil, Sean F. Scanlan, Joe W. Ferguson, John T. Treace [cite: Inventor]
- Filing Date: 2024-02-26 [cite: Filing date]
- Issue Date: 2025-04-15 [cite: Publication date]
- Abstract: The patent describes methods for temporarily fixing the orientation of one or more bones, particularly for correcting bunion deformities. It also covers bone positioning devices, methods for using these devices, bone preparation guides, and methods for using these guides. [cite: Abstract]
Plain-Language Overview of Independent Claims:
Claim 1: This claim outlines an instrumented surgical technique for preparing a tarsal-metatarsal joint for fusion and correcting a bunion deformity by repositioning the first metatarsal. The technique involves making an incision, engaging the first metatarsal with a bone engagement member of a bone positioning guide, and engaging the guide with the second metatarsal. It then specifies cutting the end of the first metatarsal, rotating a knob on the guide's threaded shaft to push the first metatarsal laterally (reducing the intermetatarsal angle), and applying force to a pin in the first metatarsal to adjust its alignment in the frontal plane. The technique further includes cutting the end of the medial cuneiform, compressing the first metatarsal and medial cuneiform, and then fixating their new position with at least one bone fixation device for fusion.
Claim 14: This claim details another instrumented surgical technique for tarsal-metatarsal joint fusion and bunion deformity correction, building upon Claim 1 with more specific sequencing and additional steps. After making an incision and engaging the first and second metatarsals with the bone positioning guide, it mandates cutting and removing a portion of the first metatarsal before rotating the knob to reduce the intermetatarsal angle and imparting force to a pin for frontal plane alignment. Subsequently, after these alignment steps, the medial cuneiform end is cut, and its cut portion is removed. The technique then includes fenestrating (perforating) the cut ends of both the first metatarsal and medial cuneiform, compressing them, fixating their moved position with at least one bone fixation device, and finally removing the bone positioning guide.
Claim 27: This claim describes an instrumented surgical technique specifically for correcting a bunion deformity. It includes making an incision, engaging the first metatarsal with a bone engagement member and the bone positioning guide with the second metatarsal, and preparing the end of the first metatarsal for fusion. Similar to previous claims, it involves rotating a knob on a threaded shaft to push the first metatarsal laterally, reducing the intermetatarsal angle, and imparting force to a pin to adjust frontal plane alignment. The technique also requires preparing an end of the medial cuneiform for fusion and installing at least one fixation device through the incision to fixate the repositioned first metatarsal relative to the medial cuneiform.
Claim 30: This claim provides a further instrumented surgical technique for tarsal-metatarsal joint fusion and bunion correction, emphasizing the timing of cutting steps relative to alignment. It includes making two incisions (one for the tarsal-metatarsal joint, one for the second metatarsal), engaging the first metatarsal with the bone engagement member, and positioning a bone contact surface of the guide on the second metatarsal. The end of the first metatarsal is cut. The key distinction is that the knob is rotated to reduce the intermetatarsal angle, and force is imparted to a pin to adjust frontal plane alignment, before or during which one or both of the first metatarsal and medial cuneiform are cut. Finally, the first metatarsal and medial cuneiform are compressed, fixated, and the bone positioning guide is removed.
Litigation/Docket Information (as of April 26, 2026):
The patent family of US12274481 has active litigation. Specifically, there is a PTAB (Patent Trial and Appeal Board) case, PGR2026-00022, that was filed in 2026 and is currently pending. [cite: PTAB case PGR2026-00022 filed (Pending)] Additionally, a US case was filed in the Delaware District Court (1:25-cv-00592) in 2025. [cite: US case filed in Delaware District Court]
Generated 5/28/2026, 6:47:50 AM
Cases on file (1)
Group view →Specific litigation cases in our database that name US patent 12274481. The free-form analysis below may also discuss cases beyond this list.
- Untitled casefiled Jan 17, 20251:25-cv-00592Delaware District Courtactive
Litigation summary
Past and pending lawsuits — plaintiffs, defendants, jurisdictions, outcomes, and notable rulings.
Known litigation involving US Patent 12274481 includes the following:
Delaware District Court Case
- Jurisdiction: Delaware District Court
- Case Number: 1:25-cv-00592
- Filing Date: January 17, 2025
- Plaintiff(s): Not explicitly identified in the provided patent text or search results in relation to US12274481.
- Defendant(s): Not explicitly identified in the provided patent text or search results in relation to US12274481.
- Outcome or Current Status: The patent document lists this as an active "litigation".
PTAB Post Grant Review (PGR) Case
- Jurisdiction: PTAB (Patent Trial and Appeal Board)
- Case Number: PGR2026-00022
- Filing Date: Implied to be in 2026, based on the case number "PGR2026-00022".
- Plaintiff(s) (Petitioner): Not explicitly identified in the provided patent text or search results.
- Defendant(s) (Patent Owner): Not explicitly identified in the provided patent text or search results (likely Treace Medical Concepts Inc., the current assignee, but not confirmed).
- Outcome or Current Status: Filed (Pending).
Generated 5/28/2026, 6:48:06 AM
Proceedings on file (1)
All PTAB activity →AIA trial proceedings (IPR / PGR / CBM) filed at the USPTO Patent Trial and Appeal Board against this patent. Sourced from the USPTO Open Data Portal and refreshed every six hours; each proceeding number deep-links to the PTAB E2E docket.
Current assignee: TREACE MEDICAL CONCEPTS, INC.
PTAB challenges
AIA trial proceedings at the USPTO Patent Trial and Appeal Board — IPR, PGR, and CBM. Petitioners, judge panels, claim-level invalidation outcomes from Final Written Decisions, and Federal Circuit appeals. The single most important defensive datapoint after litigation history.
Proceedings overview
There is one active AIA trial proceeding on file for US patent 12274481. This Post-Grant Review (PGR) is currently pending institution, meaning the patent owner's claims have not yet been tested by the PTAB. Consequently, the patent is not yet hardened, nor have any claims been invalidated, leaving all claims of US12274481 available for assertion.
PGR2026-00022 — Paragon 28, Inc. v. Treace Medical Concepts Inc.
- Type: Post-Grant Review
- Filed: 2026-01-13
- Status: Pending – The PTAB is currently reviewing the petition to determine whether to institute a trial. The last modification was on 2026-05-15, which indicates ongoing administrative activity.
- Judge panel: Not yet publicly available, as the institution decision is pending.
- Petition grounds: The petition was filed by Paragon 28, Inc.. PGRs can challenge claims under 35 U.S.C. §§ 101, 102, 103, and 112 (except for best mode). Specific claims and prior art asserted are not yet publicly detailed in the provided structured data, nor are they typically available in a summary fashion before institution.
- Institution decision: Pending. The statutory deadline for the PTAB to issue an institution decision is typically six months from the filing date of the petition. For PGR2026-00022, filed on 2026-01-13, the institution decision is expected around July 13, 2026.
- Final Written Decision: Not yet issued, as the proceeding is pending institution.
- Settlement / termination: Not applicable, as the proceeding is active and pending institution.
- Appeal: Not applicable.
- Defensive value: This active PGR presents an opportunity to challenge the patentability of US12274481's claims. If instituted and successful, it could lead to claim cancellation, weakening the patent's enforceability. Conversely, if institution is denied or the patent owner prevails, the patent will gain strength.
Strategic summary
All claims of US12274481 are currently UNTESTED by the PTAB, as the sole proceeding, PGR2026-00022, is pending an institution decision. There are no claims that have been canceled or sustained by a PTAB Final Written Decision. The patent owner is Treace Medical Concepts Inc., and the petitioner is Paragon 28, Inc..
Regarding the estoppel landscape, since no trial has been instituted, no estoppel has yet attached under 35 U.S.C. § 325(e)(2). If PGR2026-00022 is instituted, the petitioner, Paragon 28, Inc., and its privies would be estopped from asserting invalidity grounds that were raised or reasonably could have been raised in the PGR against claims that result in a Final Written Decision. For a defendant currently facing assertion of this patent, all prior-art grounds remain available until an institution decision is made and, if instituted, until a Final Written Decision is issued.
There is no discernible pattern yet, as only one proceeding has been filed. The involvement of Paragon 28, Inc. as a petitioner suggests a potential competitive interest in challenging the patent.
Recommended next steps
For a defendant facing assertion of US12274481:
- Monitor the status of PGR2026-00022 closely. The institution decision is a critical upcoming milestone, expected around 2026-07-13.
- Review the PGR petition (once publicly available in the PTAB E2E system if not already) to understand the specific claims being challenged and the grounds asserted by Paragon 28, Inc. This information can help assess the strength of the challenges and inform your own invalidity analyses.
- Consider filing your own petition or joining the existing one, depending on your relationship with Paragon 28, Inc. and the specific legal strategy.## Proceedings overview
There is one active AIA trial proceeding on file for US patent 12274481. This Post-Grant Review (PGR) is currently pending an institution decision. Consequently, the patent has not yet been challenged through a final written decision, nor have any claims been invalidated or sustained, leaving all claims of US12274481 available for assertion.
PGR2026-00022 — Paragon 28, Inc. v. Treace Medical Concepts Inc.
- Type: Post-Grant Review
- Filed: 2026-01-13
- Status: Pending – The Patent Trial and Appeal Board (PTAB) is currently reviewing the petition to determine whether to institute a trial. The last modification was on 2026-05-15, indicating ongoing administrative activity.
- Judge panel: Not yet publicly available, as the institution decision is pending.
- Petition grounds: Specific claims and prior art asserted are not publicly detailed in the provided structured data or general search results at this stage. However, PGRs can challenge claims under 35 U.S.C. §§ 101, 102, 103, and 112 (excluding the best mode requirement).
- Institution decision: Pending. The statutory deadline for the PTAB to issue an institution decision for a PGR is typically six months from the filing date of the petition. For PGR2026-00022, filed on 2026-01-13, the institution decision is expected around 2026-07-13.
- Final Written Decision: Not yet issued, as the proceeding is pending institution.
- Settlement / termination: Not applicable, as the proceeding is active and pending institution.
- Appeal: Not applicable.
- Defensive value: This active PGR presents a potential avenue for challenging the patentability of US12274481's claims. If the PTAB institutes the trial and ultimately issues a Final Written Decision unfavorable to the patent owner, it could lead to claim cancellation, weakening the patent's enforceability. Conversely, if institution is denied or the patent owner prevails, the patent will gain strength.
Strategic summary
All claims of US12274481 are currently UNTESTED by the PTAB. The sole proceeding, PGR2026-00022, is in the pre-institution phase, meaning no claims have been canceled or sustained by a PTAB Final Written Decision. The patent owner is Treace Medical Concepts Inc., and the petitioner is Paragon 28, Inc.
Regarding the estoppel landscape, since no trial has been instituted, no estoppel has yet attached under 35 U.S.C. § 325(e)(2). If PGR2026-00022 is instituted, the petitioner, Paragon 28, Inc., and its privies would be estopped from asserting invalidity grounds that were raised or reasonably could have been raised in the PGR against claims that are subject to a Final Written Decision. For a defendant currently facing assertion of this patent, all prior-art grounds for invalidity remain available until an institution decision is made and, if instituted, until a Final Written Decision is issued.
There is no discernible pattern yet, as only one proceeding has been filed. The involvement of Paragon 28, Inc. as a petitioner suggests a potential competitive or defensive interest in challenging the patent.
Recommended next steps
For a defendant facing assertion of US12274481:
- Monitor PGR2026-00022 closely: The institution decision for PGR2026-00022 is the next critical milestone and is expected around 2026-07-13.
- Review the PGR petition: Once publicly available in the USPTO's Patent Trial and Appeal Case Tracking System (P-TACTS), review the petition to understand the specific claims being challenged and the grounds asserted by Paragon 28, Inc. This information is crucial for assessing the strength of the challenges and can inform your own invalidity analyses.
- Evaluate intervention or parallel filing: Depending on your specific situation and strategic goals, consider whether intervening in the ongoing PGR or filing your own petition is appropriate.
Generated 5/28/2026, 6:48:01 AM
Ownership chain (1)
Asserters network →Structured records extracted from the assignment-history narrative below. Each entity links to its full ownership-network profile.
? · recorded 2024-10-08 · ASSIGNMENT OF ASSIGNORS INTEREST
Robert D. Santrock; Paul Dayton; Daniel J. Hatch; W. Bret Smith; F. Barry Bays; Carlos Eduardo Gil; Sean F. Scanlan; Joe W. Ferguson; John T. TreaceTREACE MEDICAL CONCEPTS, INC.
internal reorg
Assignment history
Inventors, original assignee, and the chain of ownership recorded with the USPTO — including the correspondent attorney who recorded each assignment, since shell-LLC chains often share one repeat-player attorney even when the entity names look unrelated. Surfaces NPE / patent-troll patterns: shell-entity transfers, known asserters in the chain, repeat correspondent fingerprints, pre-litigation assignments, and bankruptcy fire-sales.
Inventors
- 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)
- F. Barry Bays (Treace Medical Concepts Inc)
- Carlos Eduardo Gil (Treace Medical Concepts Inc)
- Sean F. Scanlan (Treace Medical Concepts Inc)
- Joe W. Ferguson (Treace Medical Concepts Inc)
- John T. Treace (Treace Medical Concepts Inc)
Original assignee
The original assignee is Treace Medical Concepts Inc. They ship products embodying the claims, specifically surgical systems and instruments for the foot and ankle, including those for bunion correction, as described in the patent. Their primary line of business is orthopedic medical devices. Treace Medical Concepts Inc. is currently operating.
Assignment timeline
I performed a search on the USPTO Assignment Center for US patent 12274481. As of May 28, 2026, there are no recorded assignments for US Patent 12274481 beyond the original assignment to Treace Medical Concepts Inc. The patent information on Google Patents also indicates "Assigned to Treace Medical Concepts, Inc." on 2024-10-08 with a conveyance type of "ASSIGNMENT OF ASSIGNORS INTEREST". This suggests that the initial assignment from the inventors to Treace Medical Concepts Inc. was recorded, but no subsequent transfers have been publicly filed with the USPTO.
Timeline diagram
timeline
title Ownership of US 12274481
2015 : Priority date
2024 : Filed by Treace Medical Concepts Inc
2024 : Assigned to Treace Medical Concepts Inc
2025 : Issued
2025 : US case filed in Delaware District Court
2026 : PTAB case PGR2026-00022 filed
NPE / troll-pattern signals
- Shell-entity transfer — not present. The current assignee, Treace Medical Concepts Inc., is an operating company that manufactures and sells medical devices, which is inconsistent with a shell entity.
- Known asserter in the chain — not present. Treace Medical Concepts Inc. is not identified as a known NPE on public lists.
- Repeat correspondent across the chain — not present. No subsequent assignments are recorded, so there is no chain to observe for repeat correspondents.
- Cascading transfers — not present. No subsequent assignments are recorded.
- Pre-litigation transfer — unclear. The patent was issued in April 2025 and a US case was filed in the Delaware District Court in 2025. While the litigation started relatively soon after issuance, there are no recorded assignments immediately preceding the litigation to suggest a pre-litigation transfer to an asserting entity distinct from the original assignee.
- Bankruptcy fire-sale — not present. There is no indication that Treace Medical Concepts Inc. has filed for bankruptcy.
- Privateering — unclear. There is no publicly available information in SEC filings or from third-party coverage to suggest that Treace Medical Concepts Inc. has transferred this patent to an NPE to assert on their behalf.
- Defensive aggregator (anti-NPE) — not present. The patent is currently assigned to an operating company and there are active litigations, which is contrary to being held by a defensive aggregator.
Verdict
Operating-company assertion
This verdict is based on the fact that the patent remains with its original assignee, Treace Medical Concepts Inc., which is an operating company that develops and sells products in the medical device field. The ongoing litigation, including the US case filed in the Delaware District Court in 2025, suggests that Treace Medical Concepts Inc. is asserting its patent rights, likely against competitors. The lack of any recorded assignments to shell entities or known NPEs further supports this conclusion.
For verification, see the USPTO Assignment Center: https://assignmentcenter.uspto.gov/ and search for patent number 12274481.
Generated 5/28/2026, 6:48:02 AM
Prior art
Earlier patents, publications, and products that may anticipate or render the claims unpatentable.
To identify the most relevant prior art for US Patent 12274481, I will examine the "Prior art references" section as listed on Google Patents for US12274481B2 [cite: https://patents.google.com/patent/[US12274481](/patent/US12274481)/en]. It is important to note that a definitive determination of anticipation under 35 U.S.C. § 102 requires a detailed claim-by-claim analysis against the full text of each prior art document. The following analysis provides potential anticipations based on the titles and general understanding of these prior art documents.
Here are the prior art patent citations for US12274481:
1. US20130072922A1
- Full Citation: US20130072922A1, "Bunionectomy Guide and Method" [cite: https://patents.google.com/patent/US12274481/en]
- Publication Date: 2013-03-21 [cite: https://patents.google.com/patent/US12274481/en]
- Brief Description: This patent application describes a guide and method specifically for bunionectomy procedures, which likely involves instruments to assist in the surgical correction of bunions, potentially including bone cuts and alignment steps.
- Potential Anticipation (35 U.S.C. § 102):
- Claim 1, 14, 27, 30 (Instrumented surgical technique for correcting a bunion deformity): The title "Bunionectomy Guide and Method" strongly suggests this reference could anticipate the general concept of an instrumented surgical technique for bunion correction, including making incisions, using guides, and performing bone modifications.
- Claims 1, 14, 27, 30 (Steps involving cutting/preparing bone): References to "guide" and "method" in a bunionectomy context imply preparation of bone ends, potentially using cutting instruments.
- Claims 1, 14, 27, 30 (Use of a guide for bunion correction): The core idea of using a guide during a bunionectomy procedure is directly covered.
2. US9078652B2
- Full Citation: US9078652B2, "Devices and methods for correcting bunion deformities" [cite: https://patents.google.com/patent/US12274481/en]
- Publication Date: 2015-07-14 [cite: https://patents.google.com/patent/US12274481/en]
- Brief Description: This patent focuses on devices and associated methods designed for the correction of bunion deformities, implying surgical tools and procedures aimed at realigning affected foot bones.
- Potential Anticipation (35 U.S.C. § 102):
- Claim 1, 14, 27, 30 (Instrumented surgical technique for correcting a bunion deformity): The title explicitly mentions "Devices and methods for correcting bunion deformities," indicating that this patent likely discloses a surgical technique for bunion correction, which could anticipate the broader procedural steps of US12274481.
- Claims 1, 14, 27, 30 (General bone positioning and realignment in bunion surgery): The goal of "correcting bunion deformities" inherently involves repositioning bones, making it relevant to the positioning aspects of US12274481's claims.
3. US20150112347A1
- Full Citation: US20150112347A1, "Devices and methods for correcting bunion deformities" [cite: https://patents.google.com/patent/US12274481/en]
- Publication Date: 2015-04-23 [cite: https://patents.google.com/patent/US12274481/en]
- Brief Description: This patent application, with a title identical to US9078652B2 and a close publication date, is likely a related application or an earlier publication of similar subject matter. It would describe instruments and techniques for addressing bunion deformities.
- Potential Anticipation (35 U.S.C. § 102): Given the identical title and close publication to US9078652B2, it is highly probable to anticipate similar aspects:
- Claim 1, 14, 27, 30 (Instrumented surgical technique for correcting a bunion deformity): This application would likely disclose a surgical method for bunion correction.
- Claims 1, 14, 27, 30 (General bone positioning and realignment in bunion surgery): The subject matter would involve devices and methods for repositioning bones to correct bunion deformities.
4. US9072551B2
- Full Citation: US9072551B2, "Bone positioning and preparation guides" [cite: https://patents.google.com/patent/US12274481/en]
- Publication Date: 2015-07-07 [cite: https://patents.google.com/patent/US12274481/en]
- Brief Description: This patent specifically pertains to guides used for both positioning and preparing bones during surgical procedures, which are key components and methods described in US12274481.
- Potential Anticipation (35 U.S.C. § 102): This reference is highly relevant due to its explicit mention of "Bone positioning and preparation guides."
- Claim 1, 14, 27, 30 (Engaging first metatarsal with bone engagement member of bone positioning guide and engaging guide with second metatarsal): The concept of a "bone positioning guide" directly addresses the initial engagement and positioning steps.
- Claim 1, 9, 14, 17, 30 (Cutting/preparing bone using a bone preparation guide and cutting slots): The term "preparation guides" strongly suggests instruments with guide surfaces or slots for tissue removal, directly relevant to the cutting steps.
- Claims 1, 14, 27, 30 (Overall methods of using positioning and preparation guides): The combination of both positioning and preparation guides aligns very closely with the systems and methods claimed in US122774481.
5. US20150190135A1
- Full Citation: US20150190135A1, "Bone positioning and preparation guides" [cite: https://patents.google.com/patent/US12274481/en]
- Publication Date: 2015-07-09 [cite: https://patents.google.com/patent/US12274481/en]
- Brief Description: Similar to US9072551B2, this patent application likely describes devices and methods for positioning and preparing bones using specialized guides in a surgical context.
- Potential Anticipation (35 U.S.C. § 102): Given the identical title and close publication date to US9072551B2, it is expected to anticipate similar aspects:
- Claim 1, 14, 27, 30 (Engaging first metatarsal with bone engagement member of bone positioning guide and engaging guide with second metatarsal): Likely discloses a "bone positioning guide."
- Claim 1, 9, 14, 17, 30 (Cutting/preparing bone using a bone preparation guide and cutting slots): Likely discloses "preparation guides" with means for cutting or preparing bone.
- Claims 1, 14, 27, 30 (Overall methods of using positioning and preparation guides): The combined use of positioning and preparation guides for surgical procedures would be anticipated.
It is noteworthy that the filing date of US12274481 is 2024-02-26, but it claims priority back to a provisional application filed on 2015-08-14 [cite: Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.) 2015-08-14]. All the cited prior art documents (US20130072922A1, US9078652B2, US20150112347A1, US9072551B2, US20150190135A1) have publication dates prior to this priority date of 2015-08-14, making them valid prior art under 35 U.S.C. § 102.
Generated 5/28/2026, 6:48:14 AM
Obviousness
Combinations of prior art that suggest the claimed invention would have been obvious under 35 U.S.C. § 103.
Based on the provided patent text and its metadata, specific prior art references (e.g., U.S. patents, publications) that were cited by the examiner or are otherwise publicly available for a direct combination analysis under 35 U.S.C. § 103 are not present. The "Prior art keywords" (metatarsal, bone, positioning guide, guide, surgical technique) and "Prior art date" (2015-08-14) indicate the general field of the invention but do not provide specific documents to combine. Without named prior art documents, a detailed obviousness analysis combining specific disclosures cannot be performed.
However, a hypothetical obviousness analysis can be considered, assuming a person having ordinary skill in the art (PHOSITA) in orthopedic foot and ankle surgery would possess general knowledge consistent with the provided keywords by the priority date of August 14, 2015.
The independent claims (1, 14, 27, 30) of US12274481 primarily describe an instrumented surgical technique for correcting bunion deformities and preparing the tarsal-metatarsal joint for fusion. Key features include:
- A bone positioning guide: This guide has a bone engagement member and a bone contact surface (tip), a threaded shaft with a knob for actuation, and is used to push a first metatarsal laterally towards a second metatarsal to reduce the intermetatarsal angle (transverse plane correction).
- Multi-planar correction: The technique involves adjusting the first metatarsal's alignment in a frontal plane using a pin, in addition to the lateral push. Some embodiments also mention sagittal plane movement. [cite: FIG. 9 B, FIG. 10 B, FIG. 11 A-C, FIG. 14 B, FIG. 30 B]
- Bone preparation: Cutting the ends of the first metatarsal and medial cuneiform using a tissue removing instrument, often guided by bone preparation guide cutting slots.
- Sequential steps: Various sequences of cutting, positioning, and aligning are claimed.
- Compression and fixation: Compressing the bones together and fixating them for fusion using bone fixation devices (e.g., screws, plates).
Hypothetical Combination of General Prior Art Elements (as known to a PHOSITA by 2015-08-14):
A PHOSITA would have been aware of the following general types of devices and techniques, as implied by the "Prior art keywords" and the patent's background description:
1. Existing Bunion Correction Surgical Techniques:
* PHOSITAs are familiar with procedures like the Lapidus procedure and basilar metatarsal osteotomies for bunion correction, which involve repositioning the first metatarsal relative to the medial cuneiform and second metatarsal. [cite: an example of such a procedure is a Lapidus procedure, An example of such a procedure is a basilar metatarsal osteotomy procedure]
* It was known that bunion deformities often present in multiple planes, including transverse (intermetatarsal angle deviation) and frontal (axial rotation). [cite: anatomical misalignment, a normal first metatarsal]
* Correction techniques often involve both translating and rotating the metatarsal. [cite: the bone is anatomically aligned in more than one plane such that the bone both translates and rotates in response to a moving force]
2. Generic Bone Positioning and Reduction Tools:
* Instruments for holding, reducing, and approximating bones (generic "bone positioning guide" or similar tools like clamps, tenaculums, or distractors) would have been known in general orthopedic surgery. Such tools often employ threaded shafts and knobs for precise, controlled movement (e.g., linear translation). [cite: bone positioning guide, the bone positioning guide includes a bone engagement member, a tip, a mechanism to urge the bone engagement member and the tip towards each other, and an actuator to actuate the mechanism]
3. Surgical Cutting Guides:
* Guides for precisely cutting bone (generic "guide" or "bone preparation guide" with cutting slots) using instruments like saw blades or burs were well-established in orthopedic surgery for osteotomies and arthrodesis (fusion) procedures. [cite: bone preparing guide, the bone preparation guide includes a body defining a first guide surface to define a first preparing plane and a second guide surface to define a second preparing plane]
4. Bone Fixation Devices:
* Various internal fixation devices (e.g., bone plates, screws, staples, intramedullary nails) were standard for stabilizing bones after repositioning and preparation for fusion. [cite: bone fixation devices]
Motivation for a PHOSITA to Combine these Elements:
A PHOSITA, faced with the known challenge of multi-planar bunion correction and tarsal-metatarsal fusion, would have strong motivation to combine and adapt these existing technologies to improve surgical outcomes and efficiency:
Addressing Multi-planar Deformity: The recognition that bunions involve both transverse and frontal plane deformities would motivate a PHOSITA to develop a single instrument or technique capable of correcting both simultaneously or sequentially with precision. Combining a translational bone positioning mechanism (e.g., threaded shaft/knob for lateral shift and IMA reduction) with a means to achieve frontal plane rotation (e.g., using an auxiliary pin as a lever or fulcrum) within a single operative sequence would be a logical and desirable improvement over separate, less integrated approaches. The patent itself highlights the issue of "base compression" [cite: FIG. 30 B] and "unwanted spring-back" [cite: first metatarsal 210 and medial cuneiform 220] as problems in existing techniques, further motivating integrated solutions for stable, multi-planar correction.
Integrated Positioning and Preparation: Once a precise multi-planar bone position is achieved and temporarily maintained, the next critical step for fusion is preparing the bone ends. It would be obvious to integrate the use of a bone preparation guide with precise cutting slots to make accurate cuts at the newly aligned joint surfaces. This ensures optimal bone apposition for fusion. Placing such a guide in relation to or after the bone positioning guide, and potentially using a joint spacer to define resection thickness, directly addresses the known need for accuracy in fusion procedures. [cite: a bone preparation guide can be placed over the joint spacer and engaged with the joint spacer to set a position and orientation of the bone preparation guide relative to the joint]
Optimized Surgical Flow: The various claimed sequences of cutting and alignment (e.g., cutting the first metatarsal before or after alignment, then cutting the cuneiform) would be considered routine surgical variations for a PHOSITA. Depending on the extent of deformity, soft tissue release, or the need to minimize spring-back, a surgeon might choose to perform initial bone preparation before final alignment, or vice versa. Experimenting with such sequences to achieve the best functional outcome and reduce complications would be an obvious clinical decision, not a non-obvious inventive step in itself, when combining known tools and techniques.
Therefore, while specific prior art documents are not provided, the features claimed in US122744481, when viewed through the lens of a PHOSITA with knowledge of general bone positioning tools, multi-planar bunion correction principles, surgical cutting guides, and bone fixation techniques (all generally known by the 2015 priority date), would likely be considered obvious combinations or adaptations to solve existing problems in bunion surgery.
Generated 5/28/2026, 6:48:21 AM
Extensions
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This patent in court (1)
1 tracked lawsuit name US 12274481.