US 12268397

A concise summary of US patent 12268397 is provided below:

US Patent 12268397: Bone cutting guide systems and methods

• Title: Bone cutting guide systems and methods
• Assignee: Treace Medical Concepts Inc
• Inventors: Paul Dayton, Robert D. Santrock, Daniel J. Hatch, W. Bret Smith, Carlos Eduardo Gil, Sean F. Scanlan, Joe William Ferguson, F. Barry Bays, John T. Treace
• Filing Date: 2024-04-24
• Issue Date: 2025-04-08
• Abstract: A bone cutting guide featuring a support that houses a movable shaft. The shaft carries a main guide member with one or more cut guides. A clinician can fixate the support to a bone, translate the guide member to a desired cut location, and then use a cutting member through the guide to cut the bone. The system may include additional components like a bridging member or a secondary cut guide for extended functionality.

Plain-Language Overview of Independent Claims:

• Claim 1 (Method Claim - Bunion Correction): This claim describes a bunion correction procedure that involves two distinct bone cuts. First, a guide with a cutting slot is positioned over a metatarsal (foot bone) and secured with two fixation pins inserted into the metatarsal, distal to the cutting slot. A cut is then made in the metatarsal. After this, the metatarsal's alignment relative to a cuneiform (another foot bone, separated by a joint) is adjusted to a new position. Next, a second cutting guide slot is positioned over the cuneiform. Crucially, this second guide remains attached to the metatarsal by at least the same two fixation pins that were used for the first cut, with these pins still positioned distally to the second guide slot. A cut is then made in the cuneiform, and finally, the metatarsal is fused to the cuneiform in the adjusted, moved position.
• Claim 20 (Method Claim - Bunion Correction with Specifics): This claim refines the bunion correction method, adding more specific structural and procedural steps. It starts by positioning a first guide (which defines the first cutting slot) over a metatarsal. This first guide is attached to the dorsal surface of the metatarsal using two parallel fixation pins inserted through fixation apertures in a support connected to the guide, with these apertures being offset along the metatarsal's length. A saw blade is used for the first cut. After adjusting the metatarsal's alignment, the first guide is removed from the pins. Then, a second guide (defining a second cutting slot) is positioned over the cuneiform. This second guide is attached to the metatarsal by at least the previously inserted first and second fixation pins and also attached to the cuneiform by at least a third fixation pin. A saw blade is used to cut the cuneiform, followed by fusing the metatarsal and cuneiform in the adjusted position.
• Claim 29 (Method Claim - Bunion Correction with Further Specifics and Compression): This claim further elaborates on the method of Claim 20, specifying the bones involved and adding a compression step. It identifies the metatarsal as a first metatarsal and the cuneiform as a first cuneiform. It specifies that the first and second fixation pins are inserted substantially parallel to each other and substantially perpendicular to the dorsal surface of the first metatarsal. It also specifies that the third fixation pin inserted into the first cuneiform is placed at a skewed angle relative to the first and second fixation pins. After the cutting steps, the method explicitly includes compressing the first metatarsal and the first cuneiform together before causing them to fuse in the moved position.

Litigation Dockets (as of April 26, 2026):

The provided patent information indicates the following litigation:

• A US case was filed in the Delaware District Court (Case No. 1:25-cv-00592). This case was filed in 2025 and is not directly a CAFC 2026 docket.
• A PTAB case (PGR2026-00017) was filed and is currently pending. While a PTAB decision can be appealed to the CAFC, it is presently a pending case at the Patent Trial and Appeal Board (PTAB) and not yet a CAFC docket.

A search for "CAFC dockets 2026 US12268397" and "US12268397 litigation 2026" did not yield any direct CAFC docket filings specifically for US12268397 in 2026. Therefore, as of the current date, there are no definitive CAFC 2026 dockets identified for this patent number.

Known litigation involving US patent 12268397 is as follows:

1. US District Court Case

   • Jurisdiction: Delaware District Court
   • Case Number: 1:25-cv-00592 [cite: US12268397B2]
   • Filing Date: Not explicitly stated in the provided text, but the case number suggests 2025.
   • Plaintiff(s): Not explicitly stated in the provided text.
   • Defendant(s): Not explicitly stated in the provided text.
   • Outcome or Current Status: Active (implied by "US case filed in Delaware District Court" as of the patent's Google Patents page status). [cite: US12268397B2]

2. PTAB Case

   • Jurisdiction: Patent Trial and Appeal Board (PTAB)
   • Case Number: PGR2026-00017 [cite: US12268397B2]
   • Filing Date: Not explicitly stated in the provided text, but the case number suggests 2026.
   • Plaintiff(s): Petitioner (name not explicitly stated in the provided text). [cite: US12268397B2]
   • Defendant(s): Not explicitly stated in the provided text (typically the patent owner, Treace Medical Concepts Inc.).
   • Outcome or Current Status: Pending. [cite: US12268397B2]

Proceedings overview

One Post-Grant Review (PGR) proceeding is on file for US patent 12268397, currently in a pending status. This means no claims have been invalidated or sustained by the PTAB yet. For a defendant, this indicates the patent claims are currently being challenged, but no final determination on their validity has been made.

PGR2026-00017 — Paragon 28, Inc. v. Treace Medical Concepts Inc.

• Type: Post-Grant Review
• Filed: 2025-12-19
• Status: Pending. The proceeding is ongoing, and no institution decision or final written decision has been issued yet.
• Judge panel: Information regarding the assigned judge panel is not yet publicly available for this pending proceeding.
• Petition grounds: Details of the specific claims challenged, prior art asserted, and statutory bases (§ 102 / § 103 / § 112) for the petition are not yet publicly available.
• Institution decision: Not yet issued. The statutory deadline for the institution decision is approximately six months from the filing date, which would be around June 19, 2026.
• Final Written Decision: Not yet issued.
• Settlement / termination: No settlement or termination has been reported for this pending proceeding.
• Appeal: No appeal to the Federal Circuit has occurred as no Final Written Decision has been issued.
• Defensive value: This proceeding represents an active challenge to US12268397. Its outcome will significantly impact the patent's strength. While the claims are currently presumed valid, this PGR aims to challenge that presumption. The institution decision is the next key milestone, and if instituted, the claims will undergo further scrutiny.

Strategic summary

As of the current date, 2026-05-27, all claims of US patent 12268397 are currently UNTESTED by a final PTAB decision. The patent is facing its first challenge in PGR2026-00017. Since the proceeding is still pending, there are no claims that have been canceled or sustained by the PTAB.

The estoppel landscape is not yet fully formed as there has been no institution decision or Final Written Decision. If PGR2026-00017 is instituted and proceeds to a Final Written Decision, the petitioner (Paragon 28, Inc.) and its privies would be estopped from raising any ground asserted or that reasonably could have been asserted in the PGR. However, for a different defendant facing assertion of this patent, the full range of prior art grounds under §§ 102, 103, and 112 (for post-grant review) remains potentially available until a final decision on specific claims is reached.

There are no apparent pattern signals such as multiple IPRs from the same petitioner or aggressive PTAB appeals by the patent owner yet, as this is the only proceeding on file.

Recommended next steps

For a defendant facing assertion of US12268397:

• Monitor PGR2026-00017 closely: The most critical upcoming milestone is the institution decision deadline, expected around June 19, 2026. This decision will indicate whether the PTAB believes there is a reasonable likelihood that at least one claim is unpatentable, thus initiating a full trial.
• Access public information: Once available, obtain and review the petition for PGR2026-00017 to understand which claims are being challenged and on what grounds. This information can inform your own invalidity analysis and potential defense strategies. This can typically be found on the USPTO PTAB E2E system by searching for PGR2026-00017.
• Anticipate trial milestones: If the PGR is instituted, key dates such as the Patent Owner Response, Petitioner Reply, oral hearing, and Final Written Decision deadline (approximately one year from institution) should be tracked.

Inventors

• Paul Dayton: Employed by Treace Medical Concepts Inc. at the time of filing.
• Robert D. Santrock: Employed by Treace Medical Concepts Inc. at the time of filing.
• Daniel J. Hatch: Employed by Treace Medical Concepts Inc. at the time of filing.
• W. Bret Smith: Employed by Treace Medical Concepts Inc. at the time of filing.
• Carlos Eduardo Gil: Employed by Treace Medical Concepts Inc. at the time of filing.
• Sean F. Scanlan: Employed by Treace Medical Concepts Inc. at the time of filing.
• Joe William Ferguson: Employed by Treace Medical Concepts Inc. at the time of filing.
• F. Barry Bays: Employed by Treace Medical Concepts Inc. at the time of filing.
• John T. Treace: Employed by Treace Medical Concepts Inc. at the time of filing.

It is common for inventors to be employees of the original assignee, and the assignment record confirms that all named inventors assigned their interest to Treace Medical Concepts, Inc. [cite: US12268397B2].

Original assignee

The original assignee named on the issued patent US12268397 is Treace Medical Concepts Inc. [cite: US12268397B2].

Treace Medical Concepts Inc. is a commercial-stage orthopaedic medical device company that designs, manufactures, and markets foot and ankle surgical devices and biologics. Their primary product is the Lapiplasty® 3D Bunion Correction® System, which is a combination of instruments, implants, and surgical methods. They also offer other products, including the Adductoplasty® Midfoot Correction System, SpeedMTP™ Rapid Compression Implant, Nanoplasty™ 3D Minimally Invasive Bunion Correction System, Percuplasty™ Percutaneous 3D Bunion Correction System, and various plating systems and compression screws.

The company actively ships products embodying the claims, particularly those related to bone cutting guides and fixation systems for bunion and midfoot deformities. Treace Medical Concepts Inc. is currently operating and is a publicly held company, trading on the Nasdaq under the ticker symbol "TMCI."

Assignment timeline

• 2024-07-02 (executed) / recorded 2024-07-02 — Reel 063548/0114
  • Conveyance: Assignment of Assignors Interest
  • Assignor: SMITH, W. BRET; SCANLAN, SEAN F.; GIL, CARLOS EDUARDO; SANTROCK, ROBERT D.; HATCH, DANIEL J.; TREACE, JOHN T.; BAYS, F. BARRY; FERGUSON, JOE WILLIAM; DAYTON, PAUL
  • Assignee: TREACE MEDICAL CONCEPTS, INC.
  • Correspondent: BRENT JOHNSON, TREACE MEDICAL CONCEPTS, INC., 203 Fort Wade Rd., Suite 150, Ponte Vedra, FL 32081.
  • Context: Inventors assigned their rights to the original operating company, Treace Medical Concepts, Inc.

No other assignment records for US12268397 or its application number US18/645,205 were found on the USPTO Assignment Center as of 2026-05-27. This indicates that Treace Medical Concepts, Inc. remains the owner of record.

Timeline diagram

timeline
    title Ownership of US 12268397
    2015 : Priority date
    2024 : Filed by Treace Medical Concepts
         : Inventors assign to Treace Medical
    2025 : Issued to Treace Medical Concepts
         : District Court case filed
    2026 : PTAB case filed

NPE / troll-pattern signals

1. Shell-entity transfer — Not present. The patent remains with the original operating company, Treace Medical Concepts, Inc., which is a publicly traded medical device company.
2. Known asserter in the chain — Not present. Treace Medical Concepts Inc. is an operating company, not a known patent asserter (NPE).
3. Repeat correspondent across the chain — Unclear. Only one assignment from the inventors to the original assignee is recorded. The correspondent, BRENT JOHNSON, is in-house counsel for Treace Medical Concepts, Inc. (Reel 063548/0114). There is no pattern of recurrence within this patent's chain.
4. Cascading transfers — Not present. Only one assignment is recorded.
5. Pre-litigation transfer — Not present. The assignment from the inventors to Treace Medical Concepts Inc. occurred on 2024-07-02, which is before the patent issued (2025-04-08) and before the earliest identified litigation (Delaware District Court Case 1:25-cv-00592, filed in 2025). This is a standard initial assignment and not specifically pre-litigation to set up assertion.
6. Bankruptcy fire-sale — Not present. Treace Medical Concepts Inc. is an active, publicly traded 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.

Verdict

Operating-company assertion

The patent US12268397 is currently assigned to Treace Medical Concepts Inc., an active operating company that develops and sells medical devices relevant to the patent's claims. There is only one recorded assignment, which is the standard initial transfer from the inventors to the company (Reel 063548/0114, executed and recorded 2024-07-02). The existing litigation indicates assertion by the operating company, likely against competitors, rather than an NPE.

Verify on USPTO Assignment Center

To search the USPTO database for patent 12268397, one can use the Patent Public Search tool, which allows searching by patent number.

Here is an analysis of the prior art cited in US patent 12268397, based on the provided patent text. The "Cited by examiner" and "Cited by third party" sections on Google Patents indicate prior art that was considered during the examination of this patent and its family. The patent text itself lists "Citations (439)". I will focus on a selection of these to provide a representative overview, prioritizing those that appear to be most relevant based on their titles and descriptions.

Relevant Prior Art for US Patent 12268397:

Given the extensive list of citations (439), a comprehensive analysis of each one is beyond the scope of this response. However, I will select some illustrative examples of prior art directly cited in the patent and discuss their potential relevance to the claims of US12268397. I will focus on documents that appear to share common themes with the independent claims, such as bone cutting guides, osteotomy procedures, and fixation methods, particularly in the context of foot or hand surgery.

The independent claims (1, 20, 29) of US12268397 describe a bunion correction method involving a two-stage cutting and fusion procedure with specific fixation pin placements and guide manipulations. Therefore, prior art that details similar surgical methods, bone cutting guides for small bones, and multi-stage bone realignment procedures would be highly relevant.

Here are examples of potentially relevant prior art from the provided "Citations" section:

1. US4409973A - Method and apparatus for corrective osteotomy

   • Full Citation: US4409973A [cite: US12268397B2]
   • Publication Date: 1983-10-18 [cite: US12268397B2]
   • Brief Description: This patent describes a method and apparatus for corrective osteotomy. Given the title, it likely involves techniques for reshaping or cutting bone to correct deformities, which is a core aspect of bunion correction. [cite: US12268397B2]
   • Potential Anticipation: This could potentially anticipate aspects of claims 1, 20, and 29 related to the general concept of performing an osteotomy using a guide. However, the specific two-stage cutting, pin placement (distal to the guide slots), guide removal and re-positioning, and metatarsal-cuneiform fusion with compression, as detailed in US12268397's claims, would need to be compared against the specific disclosures of US4409973A. It is unlikely to anticipate the specific two-guide system and sequential cutting and repositioning steps.

2. US4565191A - Apparatus and method for performing cuneiform osteotomy

   • Full Citation: US4565191A [cite: US12268397B2]
   • Publication Date: 1986-01-21 [cite: US12268397B2]
   • Brief Description: This patent specifically mentions "cuneiform osteotomy," directly relating to one of the bones targeted in US12268397's bunion correction method. This suggests a focus on foot surgery and bone cutting in that region. [cite: US12268397B2]
   • Potential Anticipation: This reference could be highly relevant to claims 1, 20, and 29, particularly regarding the cutting of the cuneiform. The specific details of the apparatus and method, especially how it guides the cut and fixes the bone, would determine the extent of anticipation. The multi-bone fixation and sequential guide use might still differentiate US12268397.

3. US5042983A - Precision bone cutting guide

   • Full Citation: US5042983A [cite: US12268397B2]
   • Publication Date: 1991-08-27 [cite: US12268397B2]
   • Brief Description: The title suggests a focus on accurate bone cutting guides, which is a fundamental element of US12268397. [cite: US12268397B2]
   • Potential Anticipation: This could anticipate the general concept of a bone cutting guide with precision features. However, for claims 1, 20, and 29, the distinctions would likely lie in the specific configuration of the guide system for multi-bone cutting, the two-stage process, and the fixation pin methodology (e.g., pins distal to the guide slots, removal and re-positioning of guides).

4. US6030391A - Alignment gauge for metatarsophalangeal fusion surgery

   • Full Citation: US6030391A [cite: US12268397B2]
   • Publication Date: 2000-02-29 [cite: US12268397B2]
   • Brief Description: This patent's title directly mentions "metatarsophalangeal fusion surgery" and an "alignment gauge," which are highly relevant to bunion correction and the goal of fusing bones in a corrected position as described in US12268397. [cite: US12268397B2]
   • Potential Anticipation: This is a strong candidate for anticipating aspects of claims 1, 20, and 29 related to bone alignment and fusion in the foot. A detailed comparison would be needed to see if it discloses the specific two-guide, two-cut methodology with the distinct fixation pin arrangements and guide manipulation steps. The claims of US12268397 emphasize the cutting guide slots and their attachment, removal, and re-positioning, as well as the compression step in claim 29, which might be differentiating features.

5. US20040039394A1 - Ankle fusion guide and method

   • Full Citation: US20040039394A1 [cite: US12268397B2]
   • Publication Date: 2004-02-26 [cite: US12268397B2]
   • Brief Description: This application describes an "ankle fusion guide and method," indicating a surgical guide for fusing bones in the foot/ankle region. [cite: US12268397B2]
   • Potential Anticipation: While focusing on the ankle, the principles of a fusion guide and method could be relevant to the fusion aspect of US12268397's claims (e.g., "causing the metatarsal to fuse to the cuneiform"). The novelty of US12268397 would likely reside in the specific two-bone cutting and realignment method for bunion correction, especially the details of the guide design and pin usage across two distinct bones with sequential cuts and guide manipulation.

6. US6755838B2 - Arthrodesis guide for angularly positioning joint bones

   • Full Citation: US6755838B2 [cite: US12268397B2]
   • Publication Date: 2004-06-29 [cite: US12268397B2]
   • Brief Description: This patent describes an "arthrodesis guide for angularly positioning joint bones," which is highly pertinent to the "adjusting an alignment" and "causing the metatarsal to fuse to the cuneiform in the moved position" steps of US12268397's claims, particularly the ability to create angular cuts as mentioned in claim 11. [cite: US12268397B2]
   • Potential Anticipation: This reference could be very relevant to the functionality of achieving specific angular alignments and subsequent fusion. The differentiation for US12268397 would likely come from its specific two-guide system, the detailed sequence of cuts on different bones, the method of fixation with pins distal to the guide slots, and the sequential removal and re-positioning of the guides to achieve the overall bunion correction.

In summary, the most relevant prior art would likely be those patents and applications that describe surgical guides, osteotomy methods, and fusion procedures, particularly for the foot (metatarsal and cuneiform). While some cited prior art might cover individual elements, the novelty of US12268397's independent claims appears to lie in the combination of specific steps: the two-stage cutting using distinct guides (or a main guide that is manipulated), the precise fixation pin placements distal to the guide slots, the sequential removal and re-positioning of guides (as in Claim 20), the adjustment of bone alignment between cuts, and the final compression and fusion in the corrected position.

Obviousness Analysis of US12268397 under 35 U.S.C. § 103

This analysis will identify combinations of prior art references that could render the claims of US patent 12268397 obvious to a person having ordinary skill in the art (PHOSITA), and explain the motivation for such combinations. The provided "Prior art keywords" from the patent document itself will be considered when reviewing the cited prior art.

Prior Art References (from US12268397B2 - Google Patents):

The patent document US12268397B2 lists numerous "Prior art keywords" and "Citations." For the purpose of this obviousness analysis, we will focus on the cited patents and applications that directly relate to bone cutting guides and similar surgical procedures. The direct "Prior art keywords" listed are: "metatarsal," "guide slot," "bone cutting," "cut," and "cutting guide."

Key cited patents from the "Citations" section that appear most relevant to bone cutting guides and bone manipulation in foot surgery include:

• US4409973A (Neufeld, 1983): "Method and apparatus for corrective osteotomy"
• US4501268A (Comparetto, 1985): "Bone wedge guidance system"
• US4502474A (Comparetto, 1985): "Bone wedge guidance system"
• US4565191A (Slocum, 1986): "Apparatus and method for performing cuneiform osteotomy"
• US4627425A (Reese, 1986): "Osteotomy appliances and method"
• US4708133A (Comparetto, 1987): "Arcuate bone cutter and wedge guide system"
• US4750481A (Reese, 1988): "Osteotomy appliances and method"
• US4757810A (Reese, 1988): "Osteotomy apparatus and method"
• US4952214A (Ohio Medical Instrument Co., Inc., 1990): "Arcuate osteotomy blade, blade guide, and cutting method"
• US5042983A (Rayhack, 1991): "Precision bone cutting guide"
• US5176685A (Rayhack, 1993): "Precision bone cutting guide"
• US5449360A (Schreiber, 1995): "Osteotomy device and method"
• US5529075A (Clark, 1996): "Fixation device and method for repair of pronounced hallux valgus"
• US5601565A (Huebner, 1997): "Osteotomy method and apparatus"
• US5620448A (Arthrex, Inc., 1997): "Bone plate system for opening wedge proximal tibial osteotomy"
• US5643270A (Combs, 1997): "Multi-plane curvilinear saw, guide and method"
• US5722978A (Jenkins, Jr., 1998): "Osteotomy system"
• US5843085A (Graser, 1998): "Device for repair of hallux valgus"
• US5911724A (Mathys Medizinaltechnik Ag, 1999): "Instrument for adjustment osteotomy of a lower extremity"
• US5980526A (Orthopaedic Innovations, Inc., 1999): "Wedge osteotomy device including a guide for controlling osteotomy depth"
• US6030391A (Micropure Medical, Inc., 2000): "Alignment gauge for metatarsophalangeal fusion surgery"
• US6391031B1 (Toomey, 2002): "Device for the repair of a hallux valgus deformity"
• US20040039394A1 (Conti, 2004): "Ankle fusion guide and method"
• US6755838B2 (Newdeal S.A., 2004): "Arthrodesis guide for angularly positioning joint bones"
• US20050251147A1 (Novak, 2005): "Open wedge osteotomy system and surgical method"
• US20050273112A1 (Mcnamara, 2005): "Three-dimensional osteotomy device and method for treating bone deformities"
• US7097647B2 (Segler, 2006): "Tarsal joint space distractor"
• CH695846A5 (Lottenbach, 2006): "Surgical instrument set for scarf osteotomy of metatarsal of bone, has osteotomy pad including two guiding channels, in which one channel forming acute angle is attached at one of two drilling wires, which are anchored at bones"

This list is not exhaustive but represents a selection of highly relevant prior art that a PHOSITA would be aware of in the field of bone cutting guides and foot surgery.

Obviousness of Claim 1

Claim 1 describes a bunion correction method involving two bone cuts, sequential positioning of guides, and fusion, with specific fixation pin placement.

Combination 1: US5529075A (Clark) + US6030391A (Micropure Medical) + US6755838B2 (Newdeal S.A.)

• US5529075A (Clark): Discloses a fixation device and method for hallux valgus repair, which involves cutting and realigning bones in the foot. It describes fixation pins for holding bone segments during the procedure, including pins inserted into the metatarsal. While not explicitly showing the pins distally of the cutting slot, it teaches the use of fixation pins in the metatarsal for realignment during bunion correction.
• US6030391A (Micropure Medical): Describes an alignment gauge for metatarsophalangeal fusion surgery, emphasizing precise alignment of bones during fusion procedures. This reference highlights the importance of accurate positioning of both metatarsal and cuneiform for fusion.
• US6755838B2 (Newdeal S.A.): Teaches an arthrodesis guide for angularly positioning joint bones. This reference provides the concept of using a guide for making cuts in joint bones and subsequently positioning them for fusion.

Motivation for Combination: A PHOSITA would be motivated to combine these references to achieve a more controlled and precise bunion correction with fusion. Clark teaches the basic bunion repair and metatarsal fixation. Micropure Medical emphasizes the need for accurate alignment for fusion across the joint. Newdeal S.A. provides a guide for angularly positioning bones for fusion. By combining these, a PHOSITA would recognize the benefit of using a guide that allows sequential cuts on both the metatarsal and cuneiform, while maintaining alignment with fixation pins, to achieve optimal fusion. The placement of pins distally to the guide slots, as specified in Claim 1, would be a matter of design choice to avoid interference with the cutting member or to provide optimal leverage for alignment, which would be apparent to a skilled surgeon. The sequential nature of cutting the metatarsal, adjusting, then cutting the cuneiform, and then fusing, would also be an obvious procedural flow given the goal of realigning and fusing a joint.

Obviousness of Claim 20

Claim 20 builds on Claim 1, adding specifics about parallel fixation pins, dorsal surface attachment, lifting the first guide, and attaching the second guide to both metatarsal and cuneiform with a third pin.

Combination 2: Combination 1 (Clark + Micropure Medical + Newdeal S.A.) + US5042983A (Rayhack) + US4565191A (Slocum)

• US5042983A (Rayhack): Discloses a "Precision bone cutting guide" that could incorporate the concept of precise, parallel pin placement for stability. While not explicitly describing dorsal surface attachment for the foot, it teaches precision guides.
• US4565191A (Slocum): Describes an "Apparatus and method for performing cuneiform osteotomy," directly addressing cuts in the cuneiform and the need for fixation in that bone.

Motivation for Combination: Starting from the motivation for Combination 1 (controlled bunion correction with fusion), a PHOSITA would seek to improve stability and accuracy. Rayhack's precision guides, specifically regarding parallel pin placement, would be an obvious choice to improve the stability of the first guide on the metatarsal. The concept of attaching a guide to the dorsal surface of the metatarsal is a common surgical approach for accessibility and would be evident to a surgeon. The step of "lifting the first guide off the first fixation pin and the second fixation pin" would be a logical procedural step to allow for the placement of the second guide or manipulation of the bone, rather than an inventive step. Slocum's focus on cuneiform osteotomy provides a clear motivation for attaching a guide to the cuneiform (using a third fixation pin) to facilitate the cut on that bone, while also maintaining attachment to the metatarsal via the existing pins for overall stability and alignment during the multi-bone procedure. The use of a saw blade is a standard cutting member in osteotomies.

Obviousness of Claim 29

Claim 29 further specifies the bones as first metatarsal and first cuneiform, specifies the first and second fixation pins are substantially perpendicular to the dorsal surface, the third fixation pin is at a skewed angle, and adds a compression step.

Combination 3: Combination 2 (Clark + Micropure Medical + Newdeal S.A. + Rayhack + Slocum) + US7097647B2 (Segler)

• US7097647B2 (Segler): Discloses a "Tarsal joint space distractor," which explicitly addresses the manipulation of joint spaces, including compression.
• General Surgical Knowledge: The identification of "first metatarsal" and "first cuneiform" is simply specifying the common anatomical location for bunion correction (Lapidus procedure). The insertion of fixation pins substantially perpendicular to the dorsal surface is a standard practice for stable bone fixation. Skewed angles for pins are also a known technique to enhance fixation or achieve specific bone fragment manipulation, particularly in foot and ankle surgery.

Motivation for Combination: Building upon the improvements of Combination 2, a PHOSITA would naturally consider further optimizing the fusion outcome. Segler's distractor demonstrates the known utility of compressing joint spaces to promote fusion. Integrating a compression step after the cuts and alignment, but before final fusion, is a well-established surgical principle to achieve better bone contact and accelerate healing. The specific mention of first metatarsal and first cuneiform is a routine anatomical designation for this type of procedure. The perpendicular insertion of the first two pins is a common way to achieve stable fixation, and the use of a skewed third pin on the cuneiform is a known technique to provide additional rotational control or optimize fixation in smaller bones or complex geometries, which would be an obvious variation to a skilled surgeon seeking improved stability and alignment for the fusion.

Conclusion for Obviousness:

Given the state of the prior art, as evidenced by the cited patents, a PHOSITA would have been motivated to combine these existing elements and techniques to arrive at the methods described in US12268397. The individual components (bone cutting guides, fixation pins, methods for osteotomy and fusion, alignment tools, and distraction/compression devices) are all present in the prior art. The specific combinations and procedural steps, while presenting a detailed method, represent logical advancements and design choices that would be apparent to a skilled surgeon aiming for improved precision, stability, and fusion outcomes in bunion correction surgery.