DCT

1:25-cv-00637

Stryker European Operations Holdings LLC v. Treace Medical Concepts Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:25-cv-00637, D. Del., 05/22/2025
  • Venue Allegations: Venue is asserted on the basis that Defendant is a Delaware corporation and thus resides in the district.
  • Core Dispute: Plaintiffs allege that Defendant’s Hammertoe PEEK Fixation System infringes four patents related to intramedullary implants for surgical bone fixation.
  • Technical Context: The technology lies in the field of orthopaedic medical devices, specifically bio-resorbable or biocompatible implants used to correct toe deformities such as hammertoe, claw toe, and mallet toe.
  • Key Procedural History: The complaint notes that the U.S. Patent and Trademark Office previously denied institution of an inter partes review (IPR) proceeding against the ’074 Patent (IPR2022-00486), finding the petitioner had not established a reasonable likelihood of success. The asserted patents are all members of the same family, descending from a common priority application.

Case Timeline

Date Event
2008-09-09 Earliest Priority Date for all Asserted Patents
2013-04-09 U.S. Patent 8,414,583 Issued
2015-10-27 U.S. Patent 9,168,074 Issued
2019-08-20 U.S. Patent 10,383,671 Issued
2022-08-12 PTAB denies institution of IPR on '074 Patent
2023-09-11 Press release regarding market release of Accused Product
2024-08-13 U.S. Patent 12,059,186 Issued
2025-05-22 Complaint Filed

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

U.S. Patent 8,414,583

  • Patent Identification: U.S. Patent No. 8,414,583, “Resorptive Intramedullary Implant Between Two Bones or Two Bone Fragments,” issued April 9, 2013. (Compl. ¶16).

The Invention Explained

  • Problem Addressed: The patent family addresses the challenge of creating stable and reliable bone fixation using intramedullary implants made from bio-resorbable materials, which may have different mechanical properties than traditional metal implants. ('583 Patent, col. 1:45-50).
  • The Patented Solution: The invention is a single-piece implant with two distinct anchoring zones designed for different functions. A first, proximal end has a cylindrical shape with external threads for screwing into a first bone, providing rotational stability. A second, distal end has a flat cross-section with at least two elastically deformable anchor arms equipped with teeth, designed to spread and grip the interior of a second bone, resisting pull-out forces. ('583 Patent, col. 2:54-col. 3:17; FIG. 1, FIG. 7).
  • Technical Importance: This hybrid design combines two different fixation modalities—a screw and an expanding anchor—into a single implant, aiming to provide robust, multi-axial stability in bone fusion procedures. ('583 Patent, col. 2:7-14).

Key Claims at a Glance

  • The complaint asserts independent claim 1. (Compl. ¶36).
  • Essential elements of claim 1 include:
    • A one-piece intramedullary implant body with opposing first and second ends.
    • The first end's anchor zone is threaded and has a generally cylindrical shape.
    • The second end's anchor zone has a flat cross-section.
    • The second end has a plurality of outwardly projecting teeth, with teeth spaced along the longitudinal axis.
    • A first tooth faces in a direction opposite a third tooth, and a second tooth faces in a direction opposite a fourth tooth.
  • The complaint reserves the right to assert additional claims. (Compl. ¶36).

U.S. Patent 9,168,074

  • Patent Identification: U.S. Patent No. 9,168,074, “Resorptive Intramedullary Implant Between Two Bones or Two Bone Fragments,” issued October 27, 2015. (Compl. ¶20).

The Invention Explained

  • Problem Addressed: As a continuation of the '583 Patent, the '074 Patent addresses the same problem of achieving stable fixation with a resorptive intramedullary implant. ('074 Patent, col. 1:36-41).
  • The Patented Solution: The patent describes a similar dual-zone implant, but the claims focus on a different characterization of the anchoring teeth. The claims describe the relative directions of the teeth, requiring that some teeth extend from the body in a "same direction" while at least one extends in a "different direction" than another, capturing a specific geometric arrangement for anchoring. ('074 Patent, col. 3:25-39; FIG. 2, FIG. 4).
  • Technical Importance: This patent refines the claims around the specific geometry of the anchoring teeth, potentially capturing embodiments with specific anti-rotation or anti-pullout features derived from the directional orientation of the teeth. ('074 Patent, col. 3:9-19).

Key Claims at a Glance

  • The complaint asserts independent claim 1. (Compl. ¶49).
  • Essential elements of claim 1 include:
    • An intramedullary implant with a first threaded end and a second end.
    • The second end has a body portion and a plurality of teeth projecting from it.
    • At least a first and second tooth are spaced from each other and extend from the body portion in a "same direction."
    • At least the first tooth extends from the body portion in a "different direction" than a third tooth.
  • The complaint reserves the right to assert additional claims. (Compl. ¶49).

Multi-Patent Capsule: U.S. Patent 10,383,671

  • Patent Identification: U.S. Patent No. 10,383,671, “Resorptive Intramedullary Implant Between Two Bones or Two Bone Fragments,” issued August 20, 2019. (Compl. ¶24).
  • Technology Synopsis: This patent claims methods for performing arthrodesis or osteosynthesis. The claimed method involves using an implant with a threaded first end and a second end having spreadable arms with teeth, and sequentially inserting the ends into two bone parts, where the arms spread by elasticity to engage the second bone part. ('671 Patent, Abstract; col. 4:38-54).
  • Asserted Claims: The complaint asserts independent claim 9. (Compl. ¶62).
  • Accused Features: The complaint accuses the surgical procedures for using the Treace Hammertoe PEEK Fixation System, as detailed in Treace's instructional materials, which allegedly direct surgeons to perform the claimed method steps. (Compl. ¶62-¶64).

Multi-Patent Capsule: U.S. Patent 12,059,186

  • Patent Identification: U.S. Patent No. 12,059,186, “Resorptive Intramedullary Implant Between Two Bones or Two Bone Fragments,” issued August 13, 2024. (Compl. ¶27).
  • Technology Synopsis: This patent claims an implant device with specific structural features. The claims describe an implant with a threaded first end and a second end that includes a body portion defining an opening, with pluralities of projections extending from opposing sides of the body portion. ('186 Patent, Abstract; col. 4:46-64).
  • Asserted Claims: The complaint asserts independent claim 10. (Compl. ¶82).
  • Accused Features: The Treace Hammertoe PEEK Fixation System implant is accused of infringing, based on its alleged structure comprising a threaded end and a second end with a body defining an opening and projections (barbs) extending from it. (Compl. ¶32, ¶82).

III. The Accused Instrumentality

  • Product Identification: The accused instrumentality is the "Hammertoe PEEK Fixation System," which includes intramedullary implants made of polyetheretherketone (PEEK). (Compl. ¶30, ¶31).
  • Functionality and Market Context:
    • The system is indicated for the fixation of osteotomies and reconstruction of lesser toes following correction for hammertoe, claw toe, and mallet toe. (Compl. ¶31).
    • The implant's design features a "threaded segment" on one end and a "barbed segment" on the other. (Compl. ¶32). An annotated image from Treace's "Key Steps Guide" illustrates these two distinct ends. (Compl. p. 13). The surgical technique involves threading the first end into the middle phalanx and then inserting the barbed end into the proximal phalanx via axial compression. (Compl. ¶34, ¶12).
    • The complaint alleges Treace actively markets the system to surgeons through its website, instructional guides, video demonstrations, and presentations at industry conferences. (Compl. ¶33, ¶41).

IV. Analysis of Infringement Allegations

’583 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
an anchor zone of the first end is threaded and has a generally cylindrical shape The accused implant has a "Threaded segment" for insertion into a first bone part. ¶32 col. 3:1-3
the anchor zone of the second end has a flat cross-section in a direction perpendicular to the longitudinal axis thereof The accused implant’s "Barbed segment" is alleged to have a flat cross-section, from which two arms with barbs extend. ¶32 col. 3:3-6
the anchor zone of the second end has a plurality of outwardly projecting teeth The accused implant’s "Barbed segment" has multiple barbs, which the complaint equates to "teeth." An annotated image from Treace's literature explicitly labels the "Barbed segment (second end with barbs (i.e., teeth))." ¶32, p. 13 col. 3:6-8
at least the first tooth facing in a direction opposite a third tooth The complaint alleges infringement of this element but provides no specific textual explanation. It relies on images of the accused implant, which show barbs on two opposing arms of the barbed segment. ¶37, p. 13 col. 3:50-54
  • Identified Points of Contention:
    • Scope Questions: A primary point of dispute may be the construction of "flat cross-section." Defendant could argue that its PEEK implant, which may have a more three-dimensional or rounded profile, does not meet the "flat" limitation as depicted in the patent's embodiments.
    • Technical Questions: The infringement analysis may turn on whether the accused implant's barbs meet the limitation of a "first tooth facing in a direction opposite a third tooth." The patent figures show teeth on opposing arms pointing away from each other to create an expansion force. The complaint relies on images where the accused barbs appear angled to resist pull-out, and it raises the question of whether this configuration constitutes "opposite" directions as required by the claim.

’074 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
a first threaded end for anchoring to the first bone part The accused implant includes a "Threaded segment" at one end. ¶32, p. 13 col. 3:26-27
a second end... having a longitudinal axis, a body portion, and a plurality of teeth projecting from the body portion The accused implant has a second "Barbed segment" with multiple barbs (equated to teeth) extending from a body. ¶32, p. 13 col. 3:28-30
the first and second teeth extending from the body portion in a same direction The complaint relies on visual evidence showing multiple barbs on a single arm of the accused implant are oriented in the same general direction to resist pull-out. ¶50, p. 13 col. 3:31-33
at least the first tooth extending from the body portion in a different direction than a direction a third tooth... extends The complaint relies on visual evidence of the accused implant, which has two distinct arms with barbs. An image from a Treace "Key Steps Guide" shows the surgical procedure, including insertion of the two-armed barbed segment. ¶50, p. 25 col. 3:33-38
  • Identified Points of Contention:
    • Scope Questions: The case may hinge on the construction of "same direction" and "different direction." Plaintiff may argue that teeth on opposing arms inherently extend in different directions relative to the implant's central axis. Defendant may argue that all its barbs are functionally oriented in the same direction (i.e., to resist pull-out) and do not meet the claimed directional differentiation.
    • Technical Questions: Does the complaint provide sufficient evidence that the arrangement of barbs on the accused product creates the specific directional relationships required by claim 1? The court will need to compare the accused product's geometry to the claim language, as informed by the patent's specification and figures.

V. Key Claim Terms for Construction

  • The Term: "flat cross-section" (’583 Patent, claim 1)

    • Context and Importance: The determination of literal infringement of the '583 patent depends on whether the accused implant's barbed end, made of PEEK, is properly characterized as having a "flat cross-section." Practitioners may focus on this term because the patent contrasts it with the "cylindrical" shape of the other end, suggesting a key structural distinction.
    • Intrinsic Evidence for a Broader Interpretation: The specification describes the second anchor zone (A2) as "flat" in a way that enables it to have deformable anchor arms. A party could argue "flat" does not require a perfectly planar shape but rather a non-cylindrical geometry that facilitates the claimed anchoring function. ('583 Patent, col. 2:5-7).
    • Intrinsic Evidence for a Narrower Interpretation: The patent's figures, particularly the side view in Figure 3, depict the second anchor zone as having a distinctly thin, rectangular profile. A party could argue that "flat" is limited to this specific, ribbon-like geometry shown in the preferred embodiments. ('583 Patent, FIG. 3).

  • The Term: "extending... in a different direction" (’074 Patent, claim 1)

    • Context and Importance: This term is central to the infringement analysis for the '074 Patent. Whether the accused implant's barbs meet this limitation is a primary technical question. Practitioners may focus on this term because its ambiguity creates a clear point of contention regarding the scope of the claim.
    • Intrinsic Evidence for a Broader Interpretation: The patent’s figures show teeth on opposing anchor arms that point away from one another. A party could argue that any angular or vectorial difference, such as the mirrored placement of barbs on opposing arms, satisfies the "different direction" limitation. (’074 Patent, FIG. 4).
    • Intrinsic Evidence for a Narrower Interpretation: A party could argue the term requires a more substantial difference in orientation or function than simply being on opposite sides of the implant. The specification's goal is to provide stability and resist rotational movement, suggesting "different direction" could be interpreted to require teeth that are oriented to counter different force vectors (e.g., one for pull-out, one for rotation). (’074 Patent, col. 1:36-41).

VI. Other Allegations

  • Indirect Infringement: The complaint alleges induced infringement for all four patents. The allegations are based on Defendant's distribution of promotional and instructional materials, including a "Surgical Technique" guide, a "Key Steps Guide," and online demonstration videos, which allegedly instruct and encourage surgeons to use the Hammertoe PEEK Fixation System in an infringing manner. (Compl. ¶40, ¶53, ¶69, ¶86). For the '671 method patent, the complaint also alleges contributory infringement, asserting that the accused implant is a material component especially made for the infringing surgical use and is not a staple article of commerce. (Compl. ¶75).
  • Willful Infringement: Willfulness is alleged for all four patents. The complaint pleads pre-suit knowledge based on constructive notice via Plaintiffs' patent marking website and alleges willful blindness based on Defendant's status as a direct competitor, its alleged monitoring of Plaintiffs' products, prior litigation between the companies, and its own SEC filings acknowledging the risk of infringing third-party patents. (Compl. ¶39, ¶52, ¶68, ¶85).

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

  • A core issue will be one of definitional scope: can the claim terms "flat cross-section" ('583 patent) and teeth "extending... in a different direction" ('074 patent), which are described in the context of the patents' specific drawn embodiments, be construed to cover the geometry and features of the accused PEEK implant?
  • A key evidentiary question will be one of technical correspondence: does the accused implant’s dual-ended design (threaded segment and barbed segment) function in substantially the same way as the patented invention, particularly with respect to how the barbed anchor arms are alleged to elastically engage bone, or is there a fundamental mismatch in their mode of operation?
  • A third central question will concern willfulness: what specific evidence will Plaintiffs be able to present to elevate the willfulness allegation from general industry awareness to a showing of subjective, pre-suit knowledge of the asserted patents and a deliberate or reckless disregard of Plaintiffs' patent rights?