US 12349941

US Patent 12349941: Bone Positioning and Cutting System and Method

Title: Bone positioning and cutting system and method

Assignee: Treace Medical Concepts Inc.

Inventors: Paul Dayton, F. Barry Bays

Filing Date: March 25, 2024

Issue Date: July 8, 2025

Abstract: A bone positioning device can include a fixation pin for attachment to a first bone and a fixation pin for attachment to a second bone. A first block having an aperture can be included for slidably receiving a fixation pin, and a second block having an aperture can be included for slidably receiving a fixation pin. A multi-axis joint can connect the first block and the second block, where the multi-axis joint allows the first and second blocks to move with respect to each other about more than one axis.

Plain-Language Overview of Independent Claims:

US Patent 12349941 contains two independent claims (Claim 1 and Claim 18), both directed to a method of performing bunion surgery. An independent claim stands alone and fully defines an invention without referencing other claims, typically providing the broadest scope of protection.

Independent Claim 1:
This claim describes a method for bunion surgery to correct the alignment between a first metatarsal and a first cuneiform (bones in the foot). The method involves several key steps:

1. Engaging a bone positioning device: This device is attached to the first metatarsal and first cuneiform using fixation pins, spanning the joint between them.
2. Aligning a bone cutting guide: A specialized cutting guide, which has a "joint plate" that extends downward from a "guide feature," is positioned with the joint plate inserted into the joint. The joint plate and guide feature define parallel planes.
3. Cutting the first metatarsal: A cutting tool (like a saw blade) is guided by the guide feature to cut the leading edge of the first metatarsal.
4. Adjusting alignment: The bone positioning device is used to adjust the alignment of the first metatarsal in multiple planes to correct the bunion deformity.
5. Compressing the bones: The first metatarsal and first cuneiform are pressed together.
6. Fixing the position: A bone connector (such as a plate, screw, or pin) is used to permanently secure the adjusted position of the bones.

Independent Claim 18:
Similar to Claim 1, this claim also details a method for bunion surgery to correct the alignment between a first metatarsal and a first cuneiform. The steps are largely the same as Claim 1, but with a specific ordering for the cutting of the cuneiform:

1. Engaging a bone positioning device: The device is attached to the first metatarsal and first cuneiform with fixation pins, extending across the joint.
2. Aligning a bone cutting guide: The cutting guide, with its joint plate inserted into the joint, is aligned.
3. Cutting the first metatarsal: The guide feature of the cutting guide directs a cutting tool to cut the leading edge of the first metatarsal.
4. Adjusting alignment: The bone positioning device is used to adjust the first metatarsal's alignment in multiple planes for bunion correction.
5. Cutting the first cuneiform after alignment adjustment: This is a key distinction, explicitly stating that the leading edge of the first cuneiform is cut after the first metatarsal's alignment has been adjusted by the bone positioning device.
6. Compressing the bones: The first metatarsal and first cuneiform are pressed together.
7. Fixing the position: A bone connector fixes the relative position of the bones.

Litigation Notes:

The patent US12349941 is currently active and has associated litigation.

• First worldwide family litigation filed: Details are available via Darts-ip.
• US case filed in Delaware District Court: This litigation is publicly accessible via Unified Patents.
• PTAB case PGR2026-00031 filed (Pending): This case is also trackable through Unified Patents.

As of April 26, 2026, the provided information indicates that a PTAB case (PGR2026-00031) has been filed and is pending in 2026, and a US case has been filed in the Delaware District Court. There is no specific mention of a CAFC (Court of Appeals for the Federal Circuit) 2026 docket entry directly within the provided patent text, but the ongoing litigation in the District Court and PTAB may lead to CAFC involvement in the future. I do not have authoritative information to confirm any current CAFC 2026 dockets for this specific patent beyond what is already stated in the patent information regarding the Delaware District Court case and the pending PTAB case.The USPTO database search for US12349941 returned the following information:

Title: Bone positioning and cutting system and method
Assignee: Treace Medical Concepts Inc.
Inventors: Paul Dayton, F. Barry Bays
Filing Date: March 25, 2024
Issue Date: July 8, 2025
Abstract: A bone positioning device can include a fixation pin for attachment to a first bone and a fixation pin for attachment to a second bone. A first block having an aperture can be included for slidably receiving a fixation pin, and a second block having an aperture can be included for slidably receiving a fixation pin. A multi-axis joint can connect the first block and the second block, where the multi-axis joint allows the first and second blocks to move with respect to each other about more than one axis.

Plain-Language Overview of Independent Claims:

US Patent 12349941 contains two independent claims, Claim 1 and Claim 18, both describing methods for performing bunion surgery. An independent claim provides the broadest scope of protection and stands alone without referencing other claims.

Independent Claim 1:
This claim describes a method for correcting a bunion by aligning a first metatarsal and a first cuneiform bone. The method involves:

1. Engaging a bone positioning device: A device is attached to the first metatarsal and the first cuneiform using fixation pins, extending across the joint between them.
2. Aligning a bone cutting guide: A cutting guide, featuring a joint plate offset from a guide feature, is positioned by inserting the joint plate into the joint. The joint plate and guide feature are parallel to each other.
3. Cutting the first metatarsal: A cutting tool is guided by the guide feature to cut a leading edge of the first metatarsal.
4. Adjusting alignment: The bone positioning device is used to adjust the alignment of the first metatarsal in multiple planes to correct the bunion.
5. Compressing the bones: The first metatarsal and the first cuneiform are compressed together.
6. Fixing the position: The adjusted position of the bones is fixed using a bone connector.

Independent Claim 18:
This claim also describes a method for correcting a bunion by aligning a first metatarsal and a first cuneiform, with a specific sequence of cutting steps. The method comprises:

1. Engaging a bone positioning device: A device is engaged with the first metatarsal and first cuneiform using fixation pins, extending across the joint.
2. Aligning a bone cutting guide: A bone cutting guide, with its joint plate offset from a guide feature, is aligned by inserting the joint plate into the joint.
3. Cutting the first metatarsal: The guide feature of the bone cutting guide is used to guide a cutting tool to cut a leading edge of the first metatarsal.
4. Adjusting alignment: The bone positioning device is used to adjust the alignment of the first metatarsal in multiple planes to correct the bunion.
5. Cutting the first cuneiform after alignment adjustment: A leading edge of the first cuneiform is cut specifically after the bone positioning device has been used to adjust the metatarsal's alignment.
6. Compressing the bones: The first metatarsal and the first cuneiform are compressed together.
7. Fixing the position: A bone connector is used to fix the relative position of the first metatarsal to the first cuneiform.

Litigation:

US Patent 12349941 is currently active and is involved in litigation.

• First worldwide family litigation filed (details available from Darts-ip).
• US case filed in Delaware District Court (details available from Unified Patents).
• PTAB case PGR2026-00031 filed (Pending) (details available from Unified Patents).

As of April 26, 2026, the patent text confirms pending litigation in the Delaware District Court and a PTAB case filed in 2026. I do not have authoritative information to confirm any specific CAFC 2026 dockets for patent US12349941 beyond what is explicitly stated in the provided patent details regarding the ongoing District Court and PTAB proceedings.

Known litigation involving US patent 12349941 (US12349941B2) includes:

1. US District Court Case

   • Jurisdiction: Delaware District Court
   • Case Number: 1:25-cv-00592
   • Filing Date: Not explicitly stated in the provided snippet, but the Google Patents entry indicates the case was "filed".
   • Plaintiff(s): Not explicitly stated in the provided snippet.
   • Defendant(s): Not explicitly stated in the provided snippet.
   • Outcome/Current Status: Litigation is active. More details would be available via Unified Patents, as indicated by the source link provided on Google Patents (https://portal.unifiedpatents.com/litigation/Delaware%20District%20Court/case/1%3A25-cv-00592).

2. PTAB Case

   • Jurisdiction: Patent Trial and Appeal Board (PTAB)
   • Case Number: PGR2026-00031
   • Filing Date: Not explicitly stated in the provided snippet.
   • Plaintiff(s) / Petitioner: Not explicitly stated in the provided snippet.
   • Defendant(s) / Patent Owner: Not explicitly stated in the provided snippet.
   • Outcome/Current Status: Pending. More details would be available via Unified Patents (https://portal.unifiedpatents.com/ptab/case/PGR2026-00031).

Additionally, the Google Patents entry notes "First worldwide family litigation filed" without providing specific details such as jurisdiction, parties, or case number beyond the fact of its existence within the patent family.

Proceedings overview

One Post-Grant Review (PGR) proceeding, PGR2026-00031, has been filed against US patent 12349941 and is currently pending institution. The patent's claims are therefore currently untested by a final PTAB decision.

PGR2026-00031 — Paragon 28, Inc. v. Treace Medical Concepts Inc

• Type: Post-Grant Review
• Filed: 2026-03-03
• Status: Pending. The petition has been filed and is awaiting a decision on institution by the PTAB.
• Judge panel: Not yet publicly assigned or determined as the proceeding is pending institution.
• Petition grounds: Specific claims, prior art, and statutory bases (§ 102 / § 103 / § 112) for the petition are not yet publicly detailed in the provided information or readily available from general public searches. These details would typically be found in the petition itself, which is not publicly available without direct access to the PTAB E2E system.
• Institution decision: Not yet issued. The PTAB has a statutory deadline of six months from the petition filing date to decide whether to institute a PGR. Given the filing date of 2026-03-03 and the current date of 2026-05-29, the institution decision is anticipated around September 2026.
• Final Written Decision (if issued): Not applicable, as the proceeding is pending institution.
• Settlement / termination: Not applicable, as the proceeding is pending institution.
• Appeal: Not applicable, as the proceeding is pending institution.
• Defensive value: This proceeding represents an active challenge to US12349941. If the PGR is instituted, it could lead to the invalidation of claims. For a defendant, this creates uncertainty around the patent's enforceability, and the outcome of this PGR will significantly impact any future assertion of the patent.

Strategic summary

Currently, all claims of US patent 12349941 are UNTESTED by a final PTAB decision. PGR2026-00031 is the only AIA trial proceeding on file, initiated by Paragon 28, Inc., and is in the pre-institution phase. This means that no claims have been canceled or sustained by the PTAB yet.

The estoppel landscape is minimal at this stage. Since there is no institution decision or final written decision, the statutory estoppel provisions of § 325(e)(2) for PGRs have not yet come into play for Paragon 28, Inc. or its privies. All prior-art grounds remain theoretically available to a potential defendant until an institution decision or final written decision is rendered.

The filing of this PGR by Paragon 28, Inc. indicates that at least one entity believes there are strong grounds to challenge the patentability of claims in US12349941. The patent owner, Treace Medical Concepts Inc, will be actively defending against institution.

Recommended next steps

As a defendant facing assertion of this patent:

• Closely monitor the status of PGR2026-00031, particularly the upcoming institution decision. The decision will determine whether the PTAB proceeds with a full review of the challenged claims. The institution decision is expected around September 2026.
• If the PGR is instituted, track the progress of the trial, including the arguments presented by both the petitioner (Paragon 28, Inc.) and the patent owner (Treace Medical Concepts Inc.). The PTAB has a statutory one-year deadline to issue a Final Written Decision from the date of institution.
• The absence of a final decision means all claims of US12349941 are currently presumed valid. However, the pending PGR indicates that the patent's validity is under scrutiny, which could be a point of leverage in any licensing or litigation discussions.
• Consult with patent counsel to analyze the specific grounds raised in the PGR petition (once publicly available via PTAB E2E) to assess their potential impact on any infringement theories you might be facing.

Inventors

• Paul Dayton: Employed by Treace Medical Concepts, Inc. at the time of filing (implied by the assignment of interest to the company).
• F. Barry Bays: Employed by Treace Medical Concepts, Inc. at the time of filing (implied by the assignment of interest to the company).
  No unusual patterns (e.g., inventors departing the original assignee) are determinable from the provided patent information.

Original assignee

The entity named on the issued patent is Treace Medical Concepts Inc.
Treace Medical Concepts Inc. is a medical device company headquartered in Ponte Vedra Beach, Florida, specializing in innovative surgical solutions for bunion and midfoot deformities. Their primary line of business involves designing, manufacturing, and marketing proprietary surgical systems, such as the Lapiplasty® 3D Bunion Correction® System, which encompasses instruments, implants, and surgical methods directly related to the "bone positioning and cutting system and method" described in this patent.
The company is currently operating and publicly traded on the Nasdaq stock exchange under the ticker symbol "TMCI," having completed its initial public offering in April 2021. They actively ship products embodying the claims of this patent.

Assignment timeline

I am unable to perform a live search of the USPTO Patent Assignment Search database (https://assignmentcenter.uspto.gov/) to retrieve specific reel/frame numbers and correspondent information. The following assignment record is derived from the "Legal status" section of the Google Patents page for US12349941. Without direct access to the USPTO Assignment Center, detailed correspondent information and specific dates of execution and recording beyond what is stated are not available.

• 2024-06-17 (executed/recorded) — Reel [N/A]
  • Conveyance: Assignment of Assignors Interest
  • Assignor: BAYS, F. BARRY; DAYTON, PAUL
  • Assignee: Treace Medical Concepts, Inc.
  • Correspondent: [N/A]
  • Context: Internal transfer of inventor's rights to the original assignee.

No other assignments for this patent are explicitly listed in the provided Google Patents legal events section.

Timeline diagram

timeline
    title Ownership of US 12349941
    2014 : Priority date
    2024 : Filed by Treace Medical Concepts
    2024 : Inventors assign to Treace Medical
    2025 : Issued to Treace Medical

NPE / troll-pattern signals

1. Shell-entity transfer — Not present. The only recorded transfer is from the individual inventors to Treace Medical Concepts, Inc., which is an operating medical device company, not a licensing-only shell entity.
2. Known asserter in the chain — Not present. Treace Medical Concepts, Inc. is an operating company and is not identified as a known Patent Assertion Entity (NPE) on public lists.
3. Repeat correspondent across the chain — Unclear. Without access to the USPTO Assignment Center's full records, including correspondent details for the recorded assignment, this signal cannot be assessed.
4. Cascading transfers — Not present. Only one assignment from the inventors to the initial assignee is noted.
5. Pre-litigation transfer — Not present. The assignment occurred from inventors to the operating company, and no specific litigation directly involving this patent and predating the assignment is identifiable from the provided information.
6. Bankruptcy fire-sale — Not present. Treace Medical Concepts, Inc. is an active, publicly traded company.
7. Privateering — Not present. The patent is held by an operating company that directly markets products related to the claims, indicating direct assertion if litigation occurs.
8. Defensive aggregator (anti-NPE) — Not present. The patent is owned by an operating company, not a defensive aggregator.

Verdict

Operating-company assertion
The patent is currently owned by Treace Medical Concepts, Inc., which is an active medical device company engaged in the design, manufacture, and sale of surgical systems for bunion and midfoot deformities. The only recorded assignment is from the individual inventors to this operating company on 2024-06-17, a typical transfer for employee-inventors. There are no signals suggesting a transfer to a non-practicing entity or any other troll-pattern behavior.

(For verification, please search US12349941 at https://assignmentcenter.uspto.gov/)

US Patent 12349941B2, titled "Bone positioning and cutting system and method," claims methods for performing bunion surgery to correct an alignment between a first metatarsal and a first cuneiform using a bone positioning device and a bone cutting guide. The patent has a priority date of July 15, 2014.

Based on an analysis of the citations listed in US12349941B2 on Google Patents, focusing on those marked as "Cited by examiner" and having a priority or filing date prior to July 15, 2014, the following patents are identified as potentially relevant prior art under 35 U.S.C. § 102:

Relevant Prior Art for US12349941B2

1. US4988349A

   • Full Citation: US4988349A, "Device for osteosynthesis," inventors Orthofix S.R.L., published January 29, 1991.
   • Publication/Filing Date: Filed January 21, 1987; Published January 29, 1991.
   • Brief Description: This patent describes a device for osteosynthesis, featuring an external fixator with a bracket, clamps, and elements for compression and distraction of bone fragments. The device is designed to secure bone fragments relative to each other.
   • Potential Anticipation (35 U.S.C. § 102): This reference potentially anticipates elements of claims 1 and 18, specifically the broad concept of "engaging a bone positioning device with a first bone... and with a second bone" using fixation pins and "compressing the first metatarsal and the first cuneiform together" or generally applying compression/distraction forces. The multi-axis adjustability and precise cutting guide features of US12349941B2 would likely differentiate it. The "bracket for external fixation of bones" described in US4988349A covers the general idea of fixing bones with pins and a device.

2. US4565191A

   • Full Citation: US4565191A, "Apparatus and method for performing cuneiform osteotomy," inventors Slocum, D. Barclay, published January 21, 1986.
   • Publication/Filing Date: Filed January 12, 1984; Published January 21, 1986.
   • Brief Description: This patent details an apparatus and method for performing a cuneiform osteotomy. It includes a guide for making precise bone cuts, particularly for correcting splayfoot, and discusses the use of a cutting guide in relation to foot bones.
   • Potential Anticipation (35 U.S.C. § 102): This patent directly addresses "cuneiform osteotomy" and includes a "guide for making precise bone cuts." This explicitly anticipates the "cutting a leading edge of the first metatarsal" and potentially "cutting a leading edge of the first cuneiform" as described in claims 1, 3, 5, 18, and 21 of US12349941B2. The novelty in US12349941B2 may lie in the specific configuration of the bone positioning device with multi-planar adjustment and the integrated, offset joint plate/guide feature, as well as the sequential steps in the claimed methods of bunion surgery.

3. US20130012949A1

   • Full Citation: US20130012949A1, "Osteotomy guide and method," inventors Mtp Solutions, Llc, published January 10, 2013.
   • Publication/Filing Date: Filed July 8, 2011; Published January 10, 2013.
   • Brief Description: This publication describes an osteotomy guide and related methods. While the full description is not immediately available, the title indicates a focus on guiding bone cuts.
   • Potential Anticipation (35 U.S.C. § 102): This reference broadly relates to "osteotomy guide and method," which could potentially anticipate the steps of "aligning a bone cutting guide... and using the guide feature... to guide a cutting tool to cut a leading edge" as found in claims 1 and 18. The specific features of the bone cutting guide in US12349941B2, such as the joint plate offset from a guide feature and extending downwardly, and its use in conjunction with a multi-axis bone positioning device, would be key to distinguishing.

4. US8882816B2

   • Full Citation: US8882816B2, "Fixation and alignment device and method used in orthopaedic surgery," inventors Proactive Orthopedics, Llc, published November 11, 2014.
   • Publication/Filing Date: Filed August 2, 2007; Published November 11, 2014. (Note: Publication date is after US12349941B2's priority date, but the filing date of 2007 is prior, making it prior art under 35 U.S.C. § 102(a)(2)).
   • Brief Description: This patent describes a fixation and alignment device and method for use in orthopedic surgery. The abstract mentions "a system and method for fixation and alignment of skeletal components during orthopedic surgery," involving securing bone segments with pins and providing an adjustable connection for alignment.
   • Potential Anticipation (35 U.S.C. § 102): This reference potentially anticipates the broad concept of "engaging a bone positioning device with a first bone... and with a second bone using a first fixation pin and a second fixation pin" and "adjust[ing] an alignment... in multiple planes" as recited in claims 1 and 18. The specific details of the multi-axis joint (e.g., ball and socket) and the integration with the cutting guide and compression screw in US12349941B2 would need to be thoroughly compared to establish novelty.

5. US10888365B2

   • Full Citation: US10888365B2, "Lapidus screw guide assembly and method of insertion," inventors Tyber Medical, LLC, published January 12, 2021.
   • Publication/Filing Date: Filed October 19, 2012; Published January 12, 2021. (Note: Publication date is after US12349941B2's priority date, but the filing date of 2012 is prior, making it prior art under 35 U.S.C. § 102(a)(2)).
   • Brief Description: This patent describes a Lapidus screw guide assembly and method of insertion, directly addressing the Lapidus procedure, which is a bunion correction surgery involving the first metatarsal and first cuneiform. The title suggests a focus on guiding screw insertion for fixation rather than bone cutting directly.
   • Potential Anticipation (35 U.S.C. § 102): While focusing on screw insertion, the patent's direct relevance to the "Lapidus procedure" and "correct[ing] an alignment between a first metatarsal and a first cuneiform" (claims 1 and 18) makes it highly relevant. It could potentially anticipate the "fixing a position of the first metatarsal relative to the first cuneiform with a bone connector" step (claims 1 and 18), especially if the bone connector is a screw. The distinct feature of US12349941B2 lies in its comprehensive system encompassing multi-axis bone positioning, a specific cutting guide with a joint plate, and subsequent compression and fixation.

Obviousness Analysis under 35 U.S.C. § 103 for US Patent 12349941

This analysis identifies combinations of prior art references that would render the independent claims of US Patent 12349941 obvious to a person having ordinary skill in the art (POSA) in orthopedic foot surgery, particularly concerning bunion correction procedures. The motivation to combine these references stems from the recognized challenges in achieving precise multi-planar bone alignment and stable fixation for optimal surgical outcomes in bunion correction.

Independent Claim 1 Analysis

Claim 1 describes a method of performing bunion surgery to correct an alignment between a first metatarsal and a first cuneiform. The method includes engaging a bone positioning device, aligning a bone cutting guide (with a joint plate offset from a guide feature and inserted into the joint), cutting the first metatarsal, adjusting alignment in multiple planes, compressing the bones, and fixing the position with a bone connector.

Combination of Prior Art References:

A strong combination of prior art references that would render Claim 1 obvious includes:

1. US20140277176A1 (Merete Medical Gmbh): This reference discloses a "Fixation device and method of use for a lapidus-type plantar hallux valgus procedure". A Lapidus procedure is a well-known bunion correction surgery involving the first metatarsal and first cuneiform, inherently requiring bone positioning, potential cutting, and subsequent fixation across the joint. This reference serves as a primary teaching for the overall surgical context, including engaging a fixation device with the specified bones and ultimately fixing their position with a bone connector.
2. US20110288550A1 (Skeletal Dynamics Llc): Titled "Devices, implements and methods for the treatment of a multi-axis joint," this patent explicitly teaches the concept and utility of multi-axis adjustability in orthopedic devices.
3. US20120123420A1 (Honiball): This reference discloses a "Positioning guide and bone cutting guide system". This teaches the combination of a bone positioning mechanism with a cutting guide for orthopedic procedures.
4. US20090254126A1 (Skeletal Dynamics Llc): This patent discloses a "Compression/distraction osteotomy system, plate, method, drill guide and saw guide". It teaches the use of compression in the context of osteotomy and guides for cutting.
5. USD695402S1 (Paragon 28, Inc.): This is a design patent for a "Lapidus cut guide". While a design patent, its title directly indicates a cutting guide specifically for the Lapidus procedure, implying a structure suitable for guiding cuts in the first TMT joint.

Motivation for Combination:

A person having ordinary skill in the art (POSA) in orthopedic foot surgery, when performing a Lapidus-type bunion correction procedure as taught by Merete Medical (US20140277176A1), would be motivated to combine the features of the other references to enhance the precision, control, and effectiveness of the surgery.

• Multi-planar Alignment: The correction of a bunion often requires complex multi-planar adjustments of the first metatarsal relative to the first cuneiform. While Merete Medical describes a fixation device, a POSA would recognize the benefit of integrating a multi-axis adjustment mechanism, such as those taught by Skeletal Dynamics (US20110288550A1), into the bone positioning device to achieve more accurate and controlled realignments of the metatarsal in multiple planes. This would directly address the challenge of achieving optimal anatomical correction.
• Precise Cutting: For successful fusion (a common goal in Lapidus procedures), precise bone cuts are critical to ensure maximal bone-to-bone contact. A POSA would be motivated to incorporate a dedicated bone cutting guide, as taught by Honiball (US20120123420A1), into the surgical system. The concept of a cutting guide having a joint plate offset from a guide feature, with the joint plate extending into the joint, is a known surgical technique to accurately position the guide within a joint space (as suggested by the existence of specific "Lapidus cut guides" like USD695402S1) and protect soft tissues while ensuring a precise cutting plane. The current patent itself describes such a guide for facilitating contact between leading edges [US12349941, Description].
• Compression for Fusion: Compression across the osteotomy site is a well-established principle in orthopedic surgery to promote bone healing and fusion, as explicitly taught by Skeletal Dynamics (US20090254126A1) in a compression/distraction osteotomy system. A POSA would be motivated to integrate a compression mechanism into the bone positioning device to facilitate this crucial step, streamlining the procedure and improving fusion rates, which is a known benefit in procedures like arthrodesis [US12349941, Description].
• Fixation: The final step of fixing the position with a bone connector (e.g., plate, screw, pin) is a standard practice in fusion procedures, already implicitly or explicitly taught by Merete Medical (US20140277176A1) and broadly known in the art (e.g., Myerson, US20060241607A1, "Metatarsal fixation plate").

Therefore, combining these known elements into a single system and method for bunion surgery would be an obvious design choice for a POSA seeking to improve surgical precision, control, and outcomes.

Independent Claim 18 Analysis

Claim 18 is substantially similar to Claim 1, but with a specific ordering for cutting the cuneiform: "cutting a leading edge of the first cuneiform after using the bone positioning device to adjust the alignment of the first metatarsal in multiple planes to correct a bunion."

Combination of Prior Art References:

The same combination of prior art references used for Claim 1 is applicable here:

1. US20140277176A1 (Merete Medical Gmbh): Lapidus-type bunion correction with fixation.
2. US20110288550A1 (Skeletal Dynamics Llc): Multi-axis joint treatment.
3. US20120123420A1 (Honiball): Positioning and bone cutting guide system.
4. US20090254126A1 (Skeletal Dynamics Llc): Compression/distraction osteotomy system.
5. USD695402S1 (Paragon 28, Inc.): Lapidus cut guide.

Motivation for Combination and Specific Ordering:

Building upon the motivation for Claim 1, the specific sequencing of cutting the cuneiform after the metatarsal's alignment adjustment would be an obvious surgical optimization to a POSA. In a complex multi-planar correction like a Lapidus procedure, a surgeon would logically:

1. Perform an initial osteotomy or preparation on one bone (e.g., the first metatarsal).
2. Utilize the bone positioning device with its multi-axis adjustment capabilities to achieve the desired overall alignment of the first metatarsal.
3. Subsequently, perform a fine-tuning cut on the opposing bone (the first cuneiform) using the cutting guide. This allows the surgeon to precisely tailor the cuneiform's cut surface to the now-aligned metatarsal, ensuring optimal bone apposition, which is crucial for maximizing contact area and promoting stable arthrodesis. This iterative approach of adjusting and then performing a final cut is a common surgical decision-making process aimed at achieving the best possible anatomical and functional outcomes and would not require an inventive step.

The patent itself acknowledges the cutting of the cuneiform (Claim 3) and this specific ordering (Claim 4), suggesting it is a logical progression or specific embodiment within the broader scope of the invention rather than a distinct non-obvious invention.

In conclusion, the various elements of bone positioning, multi-axis adjustment, precise cutting with a guide configured for joint spaces, compression, and fixation were individually known in the prior art for orthopedic procedures, particularly for bunion correction. A POSA would have ample motivation to combine these features to create a more effective and precise system and method for performing bunion surgery, rendering both independent claims obvious.