DCT
2:23-cv-00529
Spinelogik Inc v. Globus Medical Inc
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Spinelogik Inc (Oregon)
- Defendant: Globus Medical Inc (Delaware)
- Plaintiff’s Counsel: Garteiser Honea PLLC
- Case Identification: 2:23-cv-00529, E.D. Tex., 02/23/2024
- Venue Allegations: Plaintiff alleges venue is proper in the Eastern District of Texas because Defendant maintains regular and established places of business within the district through its employees (e.g., Spine Territory Managers, Associate Spine Specialists) and authorized sales agents who conduct sales, training, and support activities from locations in Tyler, Whitehouse, Bullard, McKinney, and Plano.
- Core Dispute: Plaintiff alleges that Defendant’s spinal fusion implant systems infringe two patents related to an apparatus for delivering and anchoring an intervertebral fusion member.
- Technical Context: The technology pertains to medical devices used in spinal fusion surgery, a common procedure to treat degenerative disc disease and other spinal conditions by fusing adjacent vertebrae.
- Key Procedural History: The complaint alleges that Defendant had pre-suit knowledge of the asserted patents, asserting that Defendant cited the patent family of both the ’385 and ’805 patents as relevant prior art in its own patent applications as early as 2016. This allegation forms the basis for Plaintiff's claim of willful infringement.
Case Timeline
| Date | Event |
|---|---|
| 2008-03-27 | Earliest Priority Date for ’385 and ’805 Patents |
| 2013-06-11 | ’385 Patent Issued |
| 2016-09-01 | Alleged Notice of Asserted Patents to Defendant (approx.) |
| 2017-08-15 | ’805 Patent Issued |
| 2024-02-23 | First Amended Complaint Filed |
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, "Fusion Member for Insertion Between Vertebral Bodies," issued June 11, 2013.
The Invention Explained
- Problem Addressed: The patent background identifies unacceptably high failure rates for spinal fusion surgeries and notes "a need in the art for an improved method to effect a more rapid, reliable fusion between unstable vertebral segments" (’385 Patent, col. 2:10-15).
- The Patented Solution: The invention provides an apparatus that delivers a fusion member (an implant block) into the space between two vertebrae and then affixes it using anchoring members (’385 Patent, Abstract). The key concept involves passing these anchoring members through pre-formed, curved channels within the fusion member itself, allowing them to extend into the bone of the adjacent vertebrae to secure the implant (’385 Patent, Fig. 4; col. 10:41-49). The specific geometry of these curved channels is designed to allow the anchoring members to enter from one face of the implant and exit on different faces (e.g., superior and inferior) to anchor into opposite vertebrae.
- Technical Importance: This approach provided a method for securing an interbody fusion device without requiring separate, externally applied screws or plates, potentially simplifying the surgical procedure. (Compl. ¶32).
Key Claims at a Glance
- The complaint asserts independent claim 1 (Compl. ¶38).
- Essential elements of claim 1 include:
- A fusion member configured to position between first and second vertebral bodies.
- The fusion member 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, with a portion remaining within the fusion member.
- A second anchoring member configured to insert through the second curved channel and partially into the second vertebral body, with a portion remaining within the fusion member.
- A geometric constraint 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 two planes are parallel to each other.
- The complaint reserves the right to assert additional claims (Compl. ¶35).
U.S. Patent No. 9,730,805 - "Intervertebral Fusion Device and Method or Use"
- Patent Identification: U.S. Patent No. 9,730,805, "Intervertebral Fusion Device and Method or Use," issued August 15, 2017.
The Invention Explained
- Problem Addressed: The ’805 patent, part of the same family as the ’385 patent, addresses the same need for a more rapid and reliable method for spinal fusion to avoid the economic and medical impact of failed surgeries (’805 Patent, col. 2:1-5).
- The Patented Solution: This patent claims an apparatus that includes not only the fusion member but also the delivery mechanism used by the surgeon. The claimed apparatus comprises the fusion member with its channels, the external delivery mechanism that aligns with those channels, and a plurality of "independent anchoring members" for securing the device (’805 Patent, Abstract; col. 2:12-18). The claims focus on the combination of these components as a complete system for implanting and securing the fusion device.
- Technical Importance: The invention as claimed integrates the implant with its specific delivery and fixation tooling, presenting them as a cohesive surgical system (Compl. ¶32).
Key Claims at a Glance
- The complaint asserts independent claim 1 (Compl. ¶47).
- Essential elements of claim 1 include:
- An apparatus comprising a fusion member for positioning between two vertebral bodies, with a first plurality of channels.
- A delivery mechanism for delivering the fusion member, which extends outside the patient's body and is coupled to the fusion member.
- The delivery mechanism having a second plurality of channels, which are configured to align with the channels of the fusion member.
- A plurality of independent anchoring members configured to secure the fusion member to the vertebral bodies.
- Each anchoring member is for traversing through a channel, penetrating a vertebral body, coupling the fusion member to the bone, and preventing decoupling.
- The complaint reserves the right to assert additional claims (Compl. p. 15).
III. The Accused Instrumentality
- Product Identification: The complaint identifies the COALITION MIS spacer, the CORBEL spacer, the HEDRON IA ALIF spacer, and the INDEPENDENCE MIS spacer as the "Accused Instrumentalities" (Compl. ¶34).
- Functionality and Market Context: The accused products are described as interbody spacers used in spinal fusion surgery (Compl. ¶34). The complaint provides visual evidence from Defendant's marketing materials for the HEDRON IA ALIF spacer, identifying it as a "3D Printed Interbody Spacer" (Compl. p. 12). A screenshot from an instructional video shows the HEDRON spacer being surgically inserted into the disc space between two vertebrae (Compl. p. 13). The complaint alleges these products function by being positioned between vertebral bodies and then secured using anchoring members that pass through channels within the spacer itself (Compl. ¶34).
IV. Analysis of Infringement Allegations
'385 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| a fusion member configured to position between first and second vertebral bodies, the fusion member comprising a first curved channel and a second curved channel | The accused spacers are fusion members designed for placement between vertebrae and allegedly contain a first and second curved channel. (Compl. p. 17). | ¶34 | col. 10:41-45 |
| a first anchoring member configured to insert through the first curved channel and partially into the first vertebral body while a portion of the first anchoring member remains within the fusion member, in order to couple the fusion member with the first vertebral body | The accused systems allegedly use a first anchoring member (e.g., a screw) inserted through the first channel to partially enter the first vertebra while a portion remains in the spacer. | ¶34 | col. 7:1-5 |
| a second anchoring member configured to insert through the second curved channel and partially into the second vertebral body while a portion of the second anchoring member remains within the fusion member, in order to couple the fusion member with the second vertebral body | The accused systems allegedly use a second anchoring member inserted through the second channel to partially enter the second vertebra while a portion remains in the spacer. | ¶34 | col. 7:1-5 |
| wherein the first curved channel has a first cross-sectional plane along a first path that is traversed by the first curved channel...and the second curved channel has a second cross-sectional plane along a second path...wherein the first and second cross-sectional planes are parallel to each other | The complaint alleges the accused spacers contain channels with this specific parallel plane geometry. | ¶34 | col. 10:1-14 |
'805 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| a fusion member for positioning between two vertebral bodies, the fusion member having a first plurality of channels, each channel of the first plurality of channels having an opening on a same side of the fusion member | The accused spacers are fusion members with multiple channels that allegedly open on the same side of the device to receive anchoring members. | ¶34 | col. 9:49-55 |
| a delivery mechanism for delivering the fusion member between the two vertebral bodies, the delivery mechanism extending outside a patient's body...the delivery mechanism having a second plurality of channels, wherein each channel of the first plurality of channels is configured to be aligned with a different channel... | The accused systems allegedly include a surgical delivery tool that couples to the spacer, extends outside the patient, and has channels that align with the spacer's channels to guide the anchoring members. | ¶34 | col. 11:46-64 |
| a plurality of independent anchoring members configured to secure the fusion member to the vertebral bodies, each independent anchoring member for (i) traversing through a different channel of the fusion member, (ii) penetrating into one of the vertebral bodies, (iii) coupling... and (iv) preventing decoupling... | The accused systems use multiple, separate anchoring members (e.g., screws) that are passed through the aligned channels of the delivery mechanism and spacer to penetrate the bone, thereby locking the spacer in place and preventing it from backing out. A video shows this implantation. (Compl. p. 20) | ¶34 | col. 7:1-5 |
- Identified Points of Contention:
- Scope Questions: The infringement analysis may focus on whether the fixation elements of the accused products meet the definition of an "anchoring member" as described in the patents, particularly the limitation that a portion "remains within the fusion member" after partial insertion into the vertebra. A central question for the ’385 Patent will be whether the accused devices meet the specific geometric limitation requiring the cross-sectional planes of the two curved channels to be "parallel to each other."
- Technical Questions: A factual dispute may arise over the precise path of the fixation elements within the accused spacers. The case may require expert testimony to determine if the channels in the accused products are technically "curved" and if their paths conform to the "parallel planes" geometry required by claim 1 of the ’385 patent.
V. Key Claim Terms for Construction
The Term: "anchoring member" (’385 Patent, cl. 1; ’805 Patent, cl. 1)
Context and Importance: This term is central to the infringement analysis for both patents. Its construction will determine whether the screws or other fixation elements used in the accused products fall within the scope of the claims. Practitioners may focus on the requirement that a portion "remains within the fusion member," as this could distinguish the claimed invention from a simple screw passed through a hole.
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The claims themselves do not limit the "anchoring member" to a specific structure, such as a needle, suggesting it could encompass various fasteners. The specification refers to them as "one or more open-tipped or close-tipped needles" but presents this as an example ("e.g.") rather than a limitation (’385 Patent, col. 2:41-43).
- Evidence for a Narrower Interpretation: The specification repeatedly describes embodiments where the anchoring members are hollow needles used to inject polymer cement (PMMA) to form a hardened "cloud" for fixation (’385 Patent, col. 3:25-34; Fig. 27A). A defendant may argue that the term should be limited to structures capable of this function, which may not include the solid screws potentially used in the accused products.
The Term: "curved channel" (’385 Patent, cl. 1)
Context and Importance: The "curved" nature of the channels is a specific limitation in the ’385 Patent. Whether the channels in the accused products are sufficiently "curved" to meet this limitation will be a key factual question.
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The term itself is not explicitly defined, which may support giving it its plain and ordinary meaning, potentially covering any non-linear path.
- Evidence for a Narrower Interpretation: The figures consistently depict channels with a distinct and significant arc or radius of curvature (e.g., ’385 Patent, Figs. 4, 16, 30). A defendant could argue these embodiments define the scope of "curved" and that a channel with only a slight angle or deviation from a straight line would not infringe.
VI. Other Allegations
- Indirect Infringement: The complaint alleges induced infringement based on Defendant providing instructional materials to surgeons and other end-users. It specifically references "videos of use," "brochures," and "manuals" that allegedly instruct on the infringing use of the Accused Instrumentalities (Compl. ¶39, ¶48). The complaint includes a screenshot from a video titled "HEDRON® 3D Printed Interbody Spacers" that allegedly instructs on the implantation of the device (Compl. p. 17).
- Willful Infringement: The complaint alleges willful infringement based on pre-suit knowledge. The primary basis for this allegation is that Defendant cited the patent family of both asserted patents as prior art in its own patent applications, with the earliest citation occurring in 2016 (Compl. ¶41, ¶50). The complaint includes screenshots from Google Patents showing these "Family to Family Citations" (Compl. p. 16, p. 19).
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of geometric conformance: Can Plaintiff prove, as a matter of fact, that the internal channels of the accused spacers embody the precise geometric constraints of the claims, particularly the requirement in the ’385 patent that the "cross-sectional planes" of the two separate channels are "parallel to each other"?
- A second key question will be one of definitional scope: Will the term "anchoring member," as used in the claims and described in a specification that emphasizes hollow needles for polymer injection, be construed broadly enough to read on the solid fixation screws or other fasteners allegedly used in Defendant’s products?
- The case will also present a critical question of willfulness: Does a defendant's citation to a patent's family in its own patent prosecution, years before litigation is filed, constitute knowledge of the specific asserted patents sufficient to support a finding of willful infringement if liability is found?