Spinelogik Inc v. Choice Spine LLC

I. Executive Summary and Procedural Information

• Parties & Counsel:
  • Plaintiff: Spinelogik, Inc. (Oregon)
  • Defendant: Choice Spine, LLC (Delaware)
  • Plaintiff’s Counsel: Garteiser Honea, PLLC
• Case Identification: Spinelogik, Inc. v. Choice Spine, LLC, 2:23-cv-00296, E.D. Tex., 06/22/2023
• 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, in part through its relationship with an authorized distributor, Voyage Medical Solutions, which is located in Longview, Texas.
• Core Dispute: Plaintiff alleges that Defendant’s Blackhawk Ti Cervical Spacer System infringes a patent related to spinal fusion implants that feature channels for guiding anchoring members into adjacent vertebrae.
• Technical Context: The technology pertains to interbody spinal fusion devices, which are implants used to stabilize vertebral segments and promote bone growth to treat conditions like degenerative disc disease.
• Key Procedural History: Plaintiff alleges Defendant had actual notice of the patent-in-suit as early as May 2016, due to the patent being cited during the prosecution of Defendant’s own patent applications, which may form the basis for a willfulness claim.

Case Timeline

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

U.S. Patent No. 8,460,385 - "Fusion Member for Insertion Between Vertebral Bodies"

• Patent Identification: U.S. Patent No. 8,460,385, issued June 11, 2013.

The Invention Explained

• Problem Addressed: The patent addresses the "unacceptably high" failure rates of prior art spinal fusion surgeries, which were often caused by inadequate structural integrity of the implants used to stabilize vertebral segments (’385 Patent, col. 2:8-15). The background notes a need for an improved method to achieve a "more rapid, reliable fusion" (’385 Patent, col. 2:11-13).
• The Patented Solution: The invention is an apparatus that delivers and affixes a fusion member (an implant or "shaped block") into the space between two vertebrae (’385 Patent, Abstract). The fusion member contains one or more curved channels that guide separate "anchoring members" (such as needles or screws) through the implant and into the adjacent vertebral bone, thereby locking the implant in place (’385 Patent, col. 2:40-46; Fig. 4). This approach is designed to provide immediate, solid mechanical fixation.
• Technical Importance: The patent describes a method for providing immediate, robust fixation of an interbody spacer by actively anchoring it into the bone of the adjacent vertebrae, aiming to improve stability over prior art devices that relied primarily on a press-fit or surface texturing (’385 Patent, col. 2:16-24).

Key Claims at a Glance

• The complaint asserts independent claim 1 of the ’385 Patent.
• The essential elements of independent claim 1 are:
  • A fusion member configured to be positioned between first and second vertebral bodies, comprising a first curved channel and a second curved channel.
  • A first anchoring member configured to insert through the first curved channel and partially into the first vertebral body.
  • A second anchoring member configured to insert through the second curved channel and partially into the second vertebral body.
  • Wherein the first curved channel has a first cross-sectional plane along its path and the second curved channel has a second cross-sectional plane along its path, and these first and second cross-sectional planes are parallel to each other.
• Plaintiff reserves the right to assert additional claims (Compl. ¶ 31).

III. The Accused Instrumentality

Product Identification

• The ChoiceSpine – Blackhawk Ti Cervical Spacer System ("Accused Instrumentalities") (Compl. ¶29).

Functionality and Market Context

• The complaint describes the Accused Instrumentalities as a cervical spacer system for anterior cervical spinal fusion (Compl. ¶29, p. 10). The system includes a 3D-printed implant made with "BioBond™" technology and features "integrated anchors" (Compl. ¶29, p. 10). A provided screenshot from Defendant's marketing materials describes a "single-step anchor deployment" designed to reduce surgical steps (Compl. ¶29, p. 10). This screenshot shows the Blackhawk Ti implant, illustrating its porous body and the internal mechanism for deploying anchors.
• The system is alleged to include a fusion member with curved channels through which anchoring members are inserted to affix the implant to the vertebrae (Compl. ¶29, pp. 10, 13-14).

IV. Analysis of Infringement Allegations

'385 Patent Infringement Allegations

• Identified Points of Contention:
  • Scope Questions: A central question may be whether the "integrated anchors" of the accused product meet the claim limitation of an "anchoring member configured to insert through" the channel. The patent often depicts the anchoring member as a separate component (like a needle) that is pushed through the fusion member, which may create a distinction from a pre-loaded, integrated anchor mechanism.
  • Technical Questions: The infringement analysis will depend on the precise geometry of the accused device. A key factual question is whether the "first and second cross-sectional planes" of the channels in the Blackhawk Ti system are, in fact, "parallel to each other" as required by the final limitation of claim 1.

V. Key Claim Terms for Construction

• The Term: "cross-sectional planes are parallel to each other"
• Context and Importance: This geometric limitation appears in the independent claim and is a potentially significant point of distinction. The definition of how these "planes" are determined and what constitutes "parallel" in the context of the device's complex 3D geometry will be critical for infringement. Practitioners may focus on this term because it is a precise technical constraint that could be difficult to prove or could be used by the defendant to argue non-infringement.
• Intrinsic Evidence for Interpretation:
  • Evidence for a Broader Interpretation: The claim language does not provide a specific definition for "cross-sectional plane" or "parallel," which may support an argument that the terms should be given their plain and ordinary meaning as understood by a person of ordinary skill in the art of mechanical engineering or medical device design.
  • Evidence for a Narrower Interpretation: The specification, in describing Figure 4, states that "the cross-sectional planes of the fusion member channels 410 and 440 are parallel to each other, but are not parallel to the right and left face of the fusion member 120" (’385 Patent, col. 10:1-5). A party could argue that this specific embodiment, which distinguishes the channel planes from the device's external faces, informs or limits the scope of the claim term.

VI. Other Allegations

• Indirect Infringement: The complaint alleges active inducement under 35 U.S.C. § 271(b), asserting that Defendant provides "videos of use..., brochures, manuals, [and] instructional documents" that instruct others (e.g., surgeons) to use the Accused Instrumentalities in an infringing manner (Compl. ¶35).
• Willful Infringement: The complaint alleges willful infringement based on pre-suit knowledge. The basis for this allegation is that Defendant had actual notice of the ’385 Patent "at least as early as May 2016, as it was cited it in Defendant's own patent file histories" (Compl. ¶37).

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

This case will likely center on two primary questions:

1. A core issue will be one of claim construction and scope: can the claim requirement that the "first and second cross-sectional planes are parallel to each other" be met by the specific geometry of the accused Blackhawk Ti system? The resolution will depend on how the court defines the "cross-sectional plane" of a curved channel and the standard for parallelism.

2. A key evidentiary question will be one of technical operation: does the accused product’s "integrated anchor" system, which features a "single-step anchor deployment," function in a manner equivalent to the claimed "anchoring member configured to insert through" a channel, which the patent specification often describes as a distinct, separate component?