DCT

2:25-cv-00911

Zehnder Consulting Lnhaber DR Thomas Zehnder v. Globus Medical Inc

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:25-cv-00911, E.D. Tex., 08/28/2025
  • Venue Allegations: Plaintiff alleges venue is proper in the Eastern District of Texas because Defendant maintains a regular and established place of business in the district through the physical presence of its employees and authorized sales agents located in cities such as Tyler, Whitehouse, and Bullard.
  • Core Dispute: Plaintiff alleges that Defendant’s REFLECT™ Scoliosis Correction System infringes a patent related to elastic stabilization systems for the vertebral column.
  • Technical Context: The technology pertains to medical devices for spinal surgery, specifically non-fusion implants that use flexible elements to correct deformities while preserving patient motion.
  • Key Procedural History: The complaint alleges that Defendant had pre-suit knowledge of the patent-in-suit, citing it during the prosecution of its own patents as early as 2004. This allegation forms the basis for Plaintiff's claim of willful infringement.

Case Timeline

Date Event
2002-05-21 ’618 Patent Priority Date
2004-04-19 Date of Defendant's patent application that cited the ’618 Patent family
2013-04-09 ’618 Patent Issue Date
2021-06-01 Issue date of Defendant's patent that cited the ’618 Patent
2025-08-28 Complaint Filing Date

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

U.S. Patent No. 8,414,618 - "Elastic stabilization system for vertebral columns"

The Invention Explained

  • Problem Addressed: The patent’s background section describes prior art spinal stabilization systems as often being too rigid (aiming for bone fusion), or, if elastic, having drawbacks such as an inability to transmit both tension and compression forces, being difficult to implant across multiple vertebral segments, or requiring complex components. (’618 Patent, col. 1:16-51).
  • The Patented Solution: The invention is a vertebral implant system featuring an "elastically bendable connecting element" designed to be passed through "seats" in the heads of multiple bone screws anchored to the vertebrae. (’618 Patent, Abstract). A key feature is that the connecting element is flexible enough to be threaded through screw heads that are not perfectly aligned, which accommodates the natural curvature of the spine and surgical realities. This element is designed to elastically stabilize the spine by handling both tensile and compressive forces between the vertebrae. (’618 Patent, col. 2:20-25; Fig. 2).
  • Technical Importance: This design enables dynamic, non-fusion stabilization of the spine, which can preserve motion in the treated segments—an advantage over traditional spinal fusion. (’618 Patent, col. 3:26-34).

Key Claims at a Glance

  • The complaint asserts independent claim 1 and reserves the right to assert additional claims (Compl. ¶¶31, 32, 35).
  • Claim 1 of the ’618 Patent recites:
    • A vertebral column implant comprising a connecting element and a plurality of bone screws.
    • Each bone screw has a seat in a screwhead for fixing the connecting element.
    • Segments of the connecting element between adjacent seats have bending elasticity for flexible stabilization.
    • The connecting element is made of an elastic material, "bendable elastically about every axis of its cross-section," allowing it to be passed through non-aligned screwheads.
    • The connecting element stabilizes the vertebral column by elastic adjustment of both "tensile and compressive forces between successive bone screws."

III. The Accused Instrumentality

Product Identification

The REFLECT™ Scoliosis Correction System, including all augmentations (Compl. ¶30).

Functionality and Market Context

The complaint alleges the REFLECT™ system is a "non-fusion fixation" device for correcting spinal deformities (Compl. ¶31, p. 10).

Its central component is described as a "flexible, durable cord" that is applied to the convex side of a scoliotic spine. The system allegedly works by harnessing the patient's natural growth to correct the deformity, limiting growth on the convex side while allowing more growth on the concave side, all while "preserving motion." (Compl. ¶31, p. 10). The complaint includes a product overview from Defendant's website illustrating the system implanted along a curved spine. (Compl. p. 10). It also includes a still image from a promotional video showing a close-up of the cord passing through the screw heads. (Compl. p. 13).

IV. Analysis of Infringement Allegations

’618 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A vertebral column implant comprising a connecting element and a plurality of bone screws... The REFLECT™ Scoliosis Correction System is a vertebral implant that includes a "flexible, durable cord" and associated bone screws. ¶30, 31 col. 5:62 - col. 6:2
...each bone screw having a seat in a screwhead for the connecting element... The system includes bone screws that receive and hold the flexible cord. ¶30, 31 col. 5:64-65
...the connecting element being made of an elastic material, bendable elastically about every axis of its cross-section... The system's "flexible, durable cord" is alleged to be an elastic and flexible connecting element. ¶31 col. 6:9-12
...in such a way that the connecting element is passed longitudinally through, or inserted in, the seats of the screwheads, one behind the other, even when the seats are not situated on one and the same axis... The REFLECT™ system is shown in marketing materials being applied along the curve of a scoliotic spine, suggesting the cord passes through non-aligned screwheads. ¶31 col. 6:12-18
...and the connecting element elastically stabilizing a vertebral column...by elastic adjustment of the connecting element of both tensile and compressive forces between successive bone screws. The REFLECT™ system is alleged to provide "non-fusion fixation" to correct spinal deformities while preserving motion, which Plaintiff alleges satisfies this limitation. ¶31 col. 6:18-24
  • Identified Points of Contention:
    • Scope Questions: A primary question may be whether the REFLECT™ system’s "flexible, durable cord" is designed to handle both "tensile and compressive forces" as required by the claim. The complaint’s description of the accused product focuses on a tension-based mechanism for scoliosis correction ("limit growth on the convex side"), which raises the question of whether it also provides the claimed compressive force transmission. (Compl. ¶31, p. 10).
    • Technical Questions: The complaint does not specify the material composition of the accused "flexible, durable cord." The analysis may turn on whether that material meets the definition of an "elastic material" as contemplated by the patent. Further, the specific structure of the "seat" in the accused screws and how it "fix[es]" the cord will be compared to the structures disclosed in the patent, such as the C-shaped seats with interlocking grooves. (’618 Patent, Figs. 4, 4a; col. 3:4-8).

V. Key Claim Terms for Construction

  • The Term: "connecting element... [capable of] elastic adjustment of... both tensile and compressive forces"

  • Context and Importance: This term is central to the invention's purported improvement over prior art that could only handle tension. The infringement case may depend on whether the accused REFLECT™ cord, used primarily for tensioning, also transmits compressive forces in a manner covered by the claim.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The claims require the element to adjust both forces, but do not specify the degree or mechanism. Plaintiff may argue that any non-trivial transmission of compressive force satisfies the limitation. The patent broadly states the invention's task is "to transmit both tensile and compressive forces between adjacent vertebrae by means of one and the same connecting element." (’618 Patent, col. 2:20-23).
    • Evidence for a Narrower Interpretation: The background criticizes prior art where stabilization is "produced by means of at least two individual, mutually offset textile loops," which primarily handle tension. (’618 Patent, col. 1:31-36). A defendant may argue that the term requires a single element specifically designed and structured to robustly handle both forces, distinguishing it from flexible tethers that may incidentally resist some compression.
  • The Term: "seat in a screwhead for... fixing the connecting element"

  • Context and Importance: The interaction between the screw's "seat" and the connecting element is critical to how the system is assembled and functions. Whether the accused product's screw design falls within the scope of this term will be a key point of dispute.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The claim language is functional, requiring a "seat" that "fix[es]" the element. Plaintiff may argue this covers any structure in the screw head that secures the cord.
    • Evidence for a Narrower Interpretation: The specification discloses specific embodiments of the seat, such as a C-shaped head with an "interlocking-surface structure" like grooves that provide a "form-engagement" with the connecting element. (’618 Patent, col. 3:4-14; Figs. 3, 4a, 12b). Defendant may argue that the term should be limited to these or structurally similar designs.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges inducement of infringement, stating that Defendant provides "manuals, instructional documents, and/or similar materials with instructions" to surgeons and other end users on how to assemble and implement the accused system (Compl. ¶36, 39).
  • Willful Infringement: The willfulness allegation is based on pre-suit knowledge. The complaint asserts that Defendant cited the ’618 patent during the prosecution of its own U.S. patents, with the earliest citation dating to an application filed in 2004. (Compl. ¶38). This is presented as evidence that Defendant knew of the patent and the patented technology long before the suit was filed.

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

  • A core issue will be one of functional capability: Does the accused REFLECT™ system's "flexible, durable cord," which is described as correcting scoliosis via a tension-based mechanism, also perform the claimed function of elastically adjusting "compressive forces" in a manner that infringes Claim 1, or is there a fundamental mismatch in its technical operation?
  • The case will also involve a critical question of claim scope: Will the term "seat in a screwhead," as used in the patent, be construed broadly to cover any screw head that secures the flexible cord, or will it be narrowed to the specific C-shaped, grooved, interlocking structures detailed in the patent’s preferred embodiments?
  • A key evidentiary question will concern willfulness: Does Defendant's citation of the ’618 patent during its own patent prosecution establish the level of pre-suit knowledge and egregious conduct required to support a finding of willful infringement, or will it be characterized as routine patent examination practice?