DCT

1:25-cv-00592

Treace Medical Concepts Inc v. Zimmer Biomet Holdings Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:25-cv-00592, D. Del., 05/12/2025
  • Venue Allegations: Venue is alleged to be proper in the District of Delaware because both defendants are Delaware corporations, maintain registered agents for service of process in the state, and are alleged to be conducting business within the district.
  • Core Dispute: Plaintiff alleges that Defendants’ Bun-Yo-Matic™ System for surgical bunion correction infringes patents related to surgical instruments, systems, and methods for correcting three-dimensional foot deformities.
  • Technical Context: The technology pertains to orthopedic surgical systems for treating hallux valgus (bunions), a condition where an unstable joint causes the metatarsal bone to rotate out of alignment in three anatomical planes.
  • Key Procedural History: The complaint alleges that Plaintiff pioneered the "instrumented TMT bunion correction market" and protected its technology through an extensive patent portfolio, virtual marking, and public announcements. It also notes Defendant Zimmer Biomet acquired Defendant Paragon 28 on April 21, 2025, after the launch of the accused product.

Case Timeline

Date Event
2014-07-15 Plaintiff files first provisional patent applications
2015-01-07 Priority Date for ’397 Patent
2015-07-14 Priority Date for ’368 Patent
2015-08-14 Priority Date for ’428 and ’481 Patents
2015-01-01 Plaintiff launches first Lapiplasty® System (approx. date)
2021-01-01 Plaintiff launches Lapiplasty Mini-Incision® System (approx. date)
2024-01-01 Defendant Paragon 28 launches accused Bun-Yo-Matic™ System (approx. date)
2024-01-01 Plaintiff launches Micro-Lapiplasty® System (approx. date)
2024-10-01 ’368 Patent Issued
2025-04-08 ’397 Patent Issued
2025-04-08 ’428 Patent Issued
2025-04-15 ’481 Patent Issued
2025-04-21 Defendant Zimmer Biomet acquires Defendant Paragon 28
2025-05-12 Complaint Filed

II. Technology and Patent(s)-in-Suit Analysis

U.S. Patent No. 12,102,368 - "Bone Positioning Guide," Issued October 1, 2024

The Invention Explained

  • Problem Addressed: The patent background describes that traditional surgical bone realignment procedures often rely on surgeons manually realigning bones, which can lead to inconsistent treatment results (U.S. Pat. No. 12,102,368, col. 1:36-43).
  • The Patented Solution: The invention is a surgical guide system that allows a clinician to accurately and reproducibly correct the multi-planar misalignment of a bunion deformity (Compl. ¶¶ 21, 25-26). The system includes a "bone positioning guide," which is an instrument that engages two different metatarsal bones simultaneously and, when actuated, realigns the first metatarsal relative to the second in the transverse, sagittal, and frontal planes to restore the foot's natural anatomy (U.S. Pat. No. 12,102,368, col. 2:15-26). The complaint includes a diagram illustrating how a bunion represents a "Complex 3D Deformity" across these three distinct anatomical planes (Compl. ¶21, p. 6).
  • Technical Importance: This instrumented approach was designed to provide reproducible, three-dimensional correction of the root cause of the bunion deformity, a capability the complaint alleges was lacking in prior surgical techniques (Compl. ¶¶ 18-21).

Key Claims at a Glance

  • The complaint asserts infringement of at least independent claim 1 (Compl. ¶70).
  • Claim 1 of the ’368 patent is directed to a "metatarsal bunion correction system" comprising three essential elements:
    • A bone preparation guide with a guide surface for guiding a cutting instrument.
    • A bone positioning guide configured to move the first metatarsal in both a transverse plane (to reduce the intermetatarsal angle) and a frontal plane (to correct rotation).
    • At least one fixation device (e.g., screws, plates) to fixate the corrected bone position for fusion.
  • The complaint does not explicitly reserve the right to assert dependent claims for this patent.

U.S. Patent No. 12,268,397 - "Bone Cutting Guide Systems and Methods," Issued April 8, 2025

The Invention Explained

  • Problem Addressed: The patent addresses the need for systems and techniques to accurately cut bones during orthopedic procedures (U.S. Pat. No. 12,268,397, col. 1:40-42). In the context of a bunion correction, achieving precise, parallel cuts on the joint surfaces of the metatarsal and cuneiform bones is critical for ensuring proper fusion after realignment (Compl. ¶29).
  • The Patented Solution: The invention is a method for bunion correction that uses a sequence of steps involving bone cutting guides. The method involves attaching a first guide to the metatarsal, cutting the bone, adjusting the bone's alignment, and then positioning a second guide to cut the cuneiform, thereby preparing the joint for fusion in its corrected orientation (U.S. Pat. No. 12,268,397, Claim 1). The complaint includes an illustration showing the distinct "Cut" and "Compress" steps of the procedure, which rely on such precise preparation of the joint surfaces (Compl. ¶29, p. 11).
  • Technical Importance: This methodical, guide-based approach to bone preparation aims to create optimal bone-to-bone contact for fusion, which is essential for the long-term stability of the surgical correction (Compl. ¶29).

Key Claims at a Glance

  • The complaint asserts infringement of at least independent claim 1 (Compl. ¶102).
  • Claim 1 of the ’397 patent is directed to a "bunion correction method" comprising the essential steps of:
    • Positioning a first bone cutting guide slot over a metatarsal.
    • Attaching the guide slot to the metatarsal using first and second fixation pins.
    • Inserting a cutting member through the slot to cut the metatarsal.
    • Adjusting the alignment of the metatarsal relative to a cuneiform.
    • Positioning a second bone cutting guide slot over the cuneiform.
    • Inserting the cutting member through the second slot to cut the cuneiform.
    • Causing the metatarsal to fuse to the cuneiform in its moved position.
  • The complaint does not explicitly reserve the right to assert dependent claims for this patent.

U.S. Patent No. 12,268,428 - "Tarsal-Metatarsal Joint Procedure Utilizing Fulcrum," Issued April 8, 2025

  • Technology Synopsis: The ’428 patent claims an instrumented surgical technique that utilizes a "fulcrum" placed between the first and second metatarsals. This fulcrum provides a controlled pivot point during realignment, which is intended to prevent undesirable shifting at the base of the metatarsal bone while correcting the deformity at the other end (U.S. Pat. No. 12,268,428, Abstract; col. 15:58-67).
  • Asserted Claims: At least Claim 1 (Compl. ¶137).
  • Accused Features: The complaint alleges that the surgical technique performed with the Bun-Yo-Matic™ System constitutes the claimed instrumented technique for treating a bunion deformity (Compl. ¶¶ 133, 136).

U.S. Patent No. 12,274,481 - "Bone Positioning and Preparing Guide Systems and Methods," Issued April 15, 2025

  • Technology Synopsis: The ’481 patent is directed to an instrumented surgical technique that combines the steps of repositioning a first metatarsal to correct a bunion deformity and preparing the tarsal-metatarsal joint for fusion (U.S. Pat. No. 12,274,481, Abstract). The technique involves using guide systems for both positioning the bones and preparing them for fixation.
  • Asserted Claims: At least Claim 1 (Compl. ¶172).
  • Accused Features: The complaint alleges that the use of the Bun-Yo-Matic™ System to perform a bunion correction constitutes the claimed instrumented surgical technique (Compl. ¶¶ 168, 171).

III. The Accused Instrumentality

  • Product Identification: The accused instrumentality is the "Bun-Yo-Matic™ Lapidus Clamp System" and the associated surgical technique for its use (Compl. ¶¶ 39, 50).
  • Functionality and Market Context: The complaint alleges the Bun-Yo-Matic™ System is marketed as an "instrument to aid in correcting bunion deformities in a more reproducible and controlled manner" (Compl. ¶52). Its stated purpose is to assist with "de-rotation, IM angle reduction, and joint closure," and it is equipped with "cutting guides designed to remove minimal bone...to prepare the joint for fusion" (Compl. ¶¶ 52-53). The complaint characterizes the system as a "copycat" of Plaintiff's Lapiplasty® System, launched by Paragon 28 in January 2024 and acquired by Zimmer Biomet in April 2025 (Compl. ¶¶ 39, 51, 59). A promotional image of Plaintiff's "Lapiplasty Positioner" is provided in the complaint, which illustrates the type of instrument central to the dispute (Compl. ¶28, p. 10).

IV. Analysis of Infringement Allegations

The complaint references claim chart exhibits that were not provided. The narrative infringement theories are summarized below.

’368 Patent Infringement Allegations

The complaint alleges that the Bun-Yo-Matic™ System directly infringes the ’368 patent because the combination of its components—including the clamp and cutting guides—constitutes the claimed "metatarsal bunion correction system" (Compl. ¶¶ 45, 68-70). The theory is that the accused system provides the same three core elements recited in claim 1: a bone positioning guide (the Bun-Yo-Matic clamp), a bone preparation guide (the Bun-Yo-Matic cutting guides), and is used with fixation devices to complete the procedure (Compl. ¶¶ 52-53).

’397 Patent Infringement Allegations

The complaint alleges that infringement of the ’397 method patent occurs when surgeons use the Bun-Yo-Matic™ System according to Defendants' instructions (Compl. ¶103). The infringement theory is that the steps detailed in Defendants' "Bun-Yo-Matic Guide and Bun-Yo-Matic Videos" direct users to perform the sequence of actions claimed in the patent: positioning and attaching guides, cutting the respective bones, realigning the joint, and securing it for fusion (Compl. ¶¶ 47, 101, 109).

  • Identified Points of Contention:
    • Scope Questions: A central question for the '368 patent may be whether the accused "Bun-Yo-Matic™ Lapidus Clamp" falls within the scope of the claimed "bone positioning guide." The infringement analysis may turn on the structural and functional equivalence between the accused product and the specific elements recited in the patent's system claims.
    • Technical Questions: For the '397 method patent, a key question will be whether the surgical technique actually taught and performed with the Bun-Yo-Matic™ System includes every step of the claimed method in the recited order. The analysis may focus on whether there are material differences between the claimed sequence of "attaching," "cutting," and "adjusting," and the steps instructed by the Defendants' surgical guide.

V. Key Claim Terms for Construction

  • The Term: "bone positioning guide" (from ’368 Patent, Claim 1)

    • Context and Importance: The determination of infringement of the '368 system patent may depend entirely on whether the accused "Bun-Yo-Matic™ Lapidus Clamp" is construed as a "bone positioning guide." Practitioners may focus on this term because Defendants will likely argue their clamp is structurally and functionally distinct from the device claimed in the patent.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The specification describes the guide's function as being "useful for positioning a bone (e.g., orientating and/or translating) during a medical procedure" and capable of correcting an alignment "in more than one plane," including a rotational correction in the frontal plane (U.S. Pat. No. 12,102,368, col. 5:22-35). This functional language may support a broader construction that is not limited to a specific physical structure.
      • Evidence for a Narrower Interpretation: The patent's figures consistently depict a specific "generally C-shaped" embodiment with a threaded shaft and actuator knob (U.S. Pat. No. 12,102,368, Fig. 1; col. 6:42-45). This consistent depiction of a single embodiment could be used to argue for a narrower construction limited to devices with a similar C-clamp structure.

  • The Term: "attaching the first bone cutting guide slot to the metatarsal with a first fixation pin...and a second fixation pin" (from ’397 Patent, Claim 1)

    • Context and Importance: This term recites a specific, multi-part step for securing the cutting guide. The infringement analysis for the '397 method patent may hinge on whether the accused surgical technique requires this exact two-pin attachment method.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The patent's detailed description may discuss other ways to secure a guide, potentially framing the two-pin method as an exemplary, rather than exclusive, embodiment. The summary describes a guide that is "fixated to a bone" without specifying the number of pins, which may support a broader reading (U.S. Pat. No. 12,268,397, col. 1:52-53).
      • Evidence for a Narrower Interpretation: The plain language of the claim explicitly requires attachment with "a first fixation pin...and a second fixation pin." Parties arguing for a narrower construction may assert that this language is unambiguous and requires two distinct pins, and that any method using one pin, or a different fixation mechanism, would not infringe.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges both induced and contributory infringement for all asserted patents. Inducement is based on allegations that Defendants provide instructional materials, such as the "Bun-Yo-Matic Guide and Bun-Yo-Matic Videos," that actively instruct and encourage surgeons to perform the patented methods and assemble the patented system (Compl. ¶¶ 73, 109, 144, 179). Contributory infringement is based on allegations that Defendants sell components of the Bun-Yo-Matic™ System that are material to the inventions, not staple articles of commerce, and are especially made for infringing use (Compl. ¶¶ 81, 116, 151, 186).
  • Willful Infringement: Willfulness is alleged based on Defendants' purported knowledge of Treace's patent rights prior to and during the infringing conduct (Compl. ¶¶ 91, 126, 161, 196). This alleged knowledge is based on Treace's virtual patent marking, public announcements of its patent portfolio, and Defendants' alleged awareness of Treace's technology from industry conferences (Compl. ¶¶ 59-64).

VII. Analyst’s Conclusion: Key Questions for the Case

  • A core issue will be one of structural and functional equivalence: does the accused Bun-Yo-Matic™ "clamp" system perform substantially the same function in substantially the same way to achieve the same result as the "bone positioning guide" system claimed in the '368 patent, or are there fundamental differences in its components and operation that place it outside the scope of the claims?
  • A second central question will be one of methodological identity: does the surgical procedure taught by Defendants for the Bun-Yo-Matic™ System contain, step-for-step, every element of the methods claimed in the '397, '428, and '481 patents? The outcome may depend on whether minor variations in surgical technique are sufficient to avoid the specific sequence of steps recited in the claims.
  • Finally, a key evidentiary question will concern knowledge and intent: what evidence can be presented to establish that Defendants knew of the asserted patents and their likely infringement, yet proceeded with the launch and sale of the accused system? The answer will be critical to the allegations of indirect and willful infringement.