DCT

1:22-cv-01632

Moskowitz Family LLC v. ZimVie Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:22-cv-01632, D. Del., 12/23/2022
  • Venue Allegations: Venue is based on Defendant’s incorporation in the State of Delaware.
  • Core Dispute: Plaintiff alleges that Defendant’s spinal fusion and artificial disc products infringe six patents related to intervertebral implants and surgical devices.
  • Technical Context: The technology concerns medical devices designed to replace or fuse spinal discs to treat degenerative disc disease and other spinal conditions, a significant segment of the orthopedic device market.
  • Key Procedural History: The complaint alleges a lengthy pre-suit history, beginning in 2005, in which the inventors disclosed patented and patent-pending technologies, including CAD drawings, to Defendant’s predecessors-in-interest (Zimmer, Biomet, and LDR Medical) under confidentiality agreements. Plaintiff alleges that after these disclosures and years of communications, Defendant’s predecessors launched the accused products without a license.

Case Timeline

Date Event
2004-05-12 Earliest Priority Date for ’371, ’591, ’072 Patents
2005-02-XX Meeting between Dr. Moskowitz and Zimmer Spine representatives
2005-04-12 Earliest Priority Date for ’875, ’383, ’723 Patents
2013-08-XX Accused Mobi-C product receives FDA clearance
2014-04-XX Accused Optio-C product launched
2017-04-18 ’875 Patent Issues
2019-03-26 ’383 Patent Issues
2020-XX-XX Accused TrellOss C SA product launched
2020-04-07 ’371 Patent Issues
2021-03-23 ’723 Patent Issues
2021-08-10 ’591 Patent Issues
2021-10-05 ’072 Patent Issues
2022-12-23 Complaint Filing Date

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

U.S. Patent No. 9,622,875 - “Bi-Directional Fixating/Locking Transvertebral Body Screw/Intervertebral Cage Stand-Alone Constructs Having a Central Screw Locking Lever, and Pliers and Devices for Spinal Fusion”

The Invention Explained

  • Problem Addressed: The patent describes complications with conventional spinal fusion plating, such as plate and screw dislodgement, screw back-out or breakage, and potential for esophageal or vascular injury due to the "high profile" of plates placed on the exterior of the spine (’875 Patent, col. 3:1-6).
  • The Patented Solution: The invention is a self-contained, or "stand-alone," intervertebral cage that maintains disc height and also provides fixation without an external plate (’875 Patent, col. 4:47-52). It contains two internal screw guides that direct screws bi-directionally into the adjacent vertebral bodies. A central locking lever is then rotated to cover the screw heads, preventing them from backing out (’875 Patent, col. 8:12-20). This creates a "zero-profile" construct, as the fixation and locking mechanisms are contained within the normal dimensions of the intervertebral space (’875 Patent, col. 4:12-16).
  • Technical Importance: This "zero-profile" approach sought to provide the stability of a traditional plate-and-cage system while reducing the risk of injury to surrounding tissues associated with externally mounted hardware.

Key Claims at a Glance

  • The complaint asserts at least independent Claim 1 (Compl. ¶54).
  • Essential elements of Claim 1 include:
    • An intervertebral cage with a top wall, bottom wall, and sidewalls defining an open space for bone fusion material.
    • A first and second internal screw guide, each angled to orient screws "bi-directionally in opposite directions."
    • The entry opening for each screw guide is "formed only in a top surface of the top wall."
    • A "central screw locking lever" coupled to the cage that "prevents the first screw member and the second screw member from pulling-out."

U.S. Patent No. 10,238,383 - “Bi-Directional Fixating Transvertebral Body Screws, Zero-Profile Horizontal Intervertebral Miniplates, Expansile Intervertebral Body Fusion Devices, and Posterior Motion-Calibrating Interarticulating Joint Stapling Device for Spinal Fusion”

The Invention Explained

  • Problem Addressed: The patent addresses complications from existing spinal fusion techniques, including the need for supplemental fixation with pedicle screws, which can lead to significant tissue dissection, muscle retraction, nerve injury, and excessive rigidity that stresses adjacent spinal segments (’383 Patent, col. 1:50-2:1).
  • The Patented Solution: The invention is an artificial intervertebral implant, or fusion cage, with specific geometric features designed to match the anatomy of the disc space (’383 Patent, col. 14:15-32). It features a "substantially flat" top surface and curved bottom and sidewalls that form a "U-shape" when viewed from the front. The device includes two extendable, curved anchors with "outwardly-extending bone engagement ridges" that are sequentially deployed from the cage to secure it to the vertebral bodies (’383 Patent, col. 14:56-65).
  • Technical Importance: This design aims to provide secure fixation through integrated anchors, potentially reducing the need for supplemental posterior fixation like pedicle screws, and is shaped to conform to the vertebral endplates.

Key Claims at a Glance

  • The complaint asserts at least independent Claim 14 (Compl. ¶79).
  • Essential elements of Claim 14 include:
    • A fusion cage with a top wall, bottom wall, and two sidewalls.
    • The top wall comprises a top surface that is "substantially flat."
    • The bottom wall and sidewalls are "at least partially curved" to "substantially form a U-shape when viewed from a direction facing the first vertebral body facing surface."
    • A first anchor and a second anchor, each having a body that is "curved along the... anchor body" and has a "plurality of outwardly-extending bone engagement ridges."
    • The anchors are configured to be "sequentially extended out of the fusion cage in opposite directions."

U.S. Patent No. 10,952,723 - “Artificial Intervertebral Implant”

  • Technology Synopsis: This patent is directed to a fusion cage with a specific cross-sectional geometry and integrated, extendable anchors. The technology is similar to the ’383 Patent but claims a cage that forms a "D-shape" when viewed from the front, with the top wall forming the straight portion and the bottom/sidewalls forming the curved portion (’723 Patent, col. 11:15-24).
  • Asserted Claims: At least independent Claim 1 (Compl. ¶123).
  • Accused Features: The complaint alleges that the ROI-C, ROI-C Ti Coated, ROI-A, and ROI-A Oblique products infringe the ’723 patent (Compl. ¶121).

U.S. Patent No. 10,610,371 - “Artificial Cervical and Lumbar Discs, Disc Plate Insertion Gun for Performing Sequential Single Plate Intervertebral Implantation Enabling Symmetric Bi-Disc Plate Alignment For Interplate Mobile Core Placement”

  • Technology Synopsis: This patent describes a three-piece artificial disc replacement system, comprising two endplates that attach to the vertebrae and a "mobile core" positioned between them to permit motion (’371 Patent, Abstract). The endplates feature specific anchor configurations, with groups of anchors on the left and right sides and no anchors in the middle portion to facilitate fixation while preserving the endplate structure (’371 Patent, col. 9:10-21).
  • Asserted Claims: At least independent Claim 1 (Compl. ¶103).
  • Accused Features: The complaint alleges that the Mobi-C Cervical Disc product infringes the ’371 patent (Compl. ¶101).

U.S. Patent No. 11,083,591 - “Artificial Cervical and Lumbar Disc System”

  • Technology Synopsis: This patent also relates to a three-piece artificial disc system with two endplates and a mobile core. The claims focus on specific geometric features of the endplates, including defined groups of anchors (e.g., "a first group of three anchors") on the left and right sides and flat surfaces on the peripheral edge of the plates (’591 Patent, col. 10:1-25). It also claims a surgical tool for inserting the disc.
  • Asserted Claims: At least independent Claims 1, 17, and 18 (Compl. ¶147, 148, 149).
  • Accused Features: The complaint alleges that the Mobi-C product and its associated surgical tool infringe the ’591 patent (Compl. ¶145).

U.S. Patent No. 11,135,072 - “Artificial Disc System”

  • Technology Synopsis: This patent is also directed to a three-piece artificial disc system. Its claims are distinguished by requirements for the positioning of the anchors on the endplates; for example, anchors on the first plate are positioned adjacent to the perimeter surface, while anchors on the second plate are "entirely offset from the second perimeter surface" (’072 Patent, col. 9:18-47). The claims also recite "raised barriers or protrusions" to limit the motion of the mobile core.
  • Asserted Claims: At least independent Claims 1 and 10 (Compl. ¶173, 174).
  • Accused Features: The complaint alleges that the Mobi-C product and its associated surgical tool infringe the ’072 patent (Compl. ¶171).

III. The Accused Instrumentality

Product Identification

  • The accused instrumentalities are grouped into three product families: (1) the Optio-C and TrellOss-C SA devices; (2) the ROI-C and ROI-A family of devices; and (3) the Mobi-C Cervical Disc system (Compl. ¶¶53, 77, 101).

Functionality and Market Context

  • The Optio-C and TrellOss-C SA devices are described as interbody fusion systems for anterior cervical procedures (Compl. ¶55, p. 17). The image provided in the complaint shows a cage with two screws angled outward and a central locking mechanism. (Compl. p. 17).
  • The ROI-C and ROI-A devices are identified as cervical and anterior lumbar interbody fusion (ALIF) cages, respectively (Compl. ¶¶79, 123). The complaint's visuals depict cage-like structures with deployable, blade-like anchors that extend from the cage to engage the vertebrae. (Compl. p. 26).
  • The Mobi-C is an artificial cervical disc replacement system designed to preserve motion rather than fuse the vertebrae (Compl. ¶103). The complaint's image shows two endplates with anchoring fins and a mobile core between them, implanted in a spine. (Compl. p. 36).
  • The complaint alleges that these products are commercially significant and were launched by Defendant’s predecessors after being informed of Plaintiff’s patented inventions (Compl. ¶¶46-47).

IV. Analysis of Infringement Allegations

U.S. Patent No. 9,622,875 - Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
an intervertebral cage for maintaining disc height, wherein the intervertebral cage includes: a top wall, a bottom wall, and two sidewalls defining an open space capable of receiving bone filling for the biological bone fusion The Optio-C and TrellOss-C SA products are intervertebral cages with a top wall, bottom wall, and sidewalls defining an open space for bone graft. ¶55 col. 8:1-4
a first internal screw guide and a second internal screw guide, wherein the first internal screw guide and the second internal screw guide each have an internal bore with an entry opening and an exit opening The accused products include internal guides that direct two screws. ¶55 col. 8:5-7
the entry opening of the internal bore formed only in a top surface of the top wall The entry points for the screws in the accused products are located on the top surface of the cage. ¶55 col. 8:7-9
each of the first internal screw guide and the second internal screw guide are angled to orient the first screw member and the second screw member bi-directionally in opposite directions The screw guides in the accused products are angled to direct the screws in opposite, divergent paths into the adjacent vertebrae. ¶55 col. 8:12-15
a central screw locking lever coupled to the intervertebral cage, wherein the central screw locking lever prevents the first screw member and the second screw member from pulling-out The accused products include a central mechanism that locks the screws to prevent them from backing out. ¶55 col. 8:17-20

Identified Points of Contention

  • Scope Questions: A central question may be the scope of the term "central screw locking lever." The complaint alleges the accused products have such a feature, but litigation may focus on whether the accused locking mechanism is structurally and functionally equivalent to the "lever" described and claimed in the patent, which is depicted as a rotating T-shaped component (’875 Patent, FIG. 1E).
  • Technical Questions: The analysis may turn on the precise geometry of the screw guide openings. The claim requires the entry opening to be "formed only in a top surface of the top wall." Evidence regarding the exact location and formation of the screw entry points in the accused Optio-C and TrellOss-C SA products will be relevant.

U.S. Patent No. 10,238,383 - Infringement Allegations

Claim Element (from Independent Claim 14) Alleged Infringing Functionality Complaint Citation Patent Citation
a fusion cage comprising a top wall, a bottom wall, a first sidewall, and a second sidewall The ROI-C and ROI-A products are fusion cages with four walls. ¶79 col. 14:15-18
wherein the top surface is a substantially flat surface The accused products allegedly have a substantially flat top surface. ¶79 col. 14:23-27
wherein each of the bottom wall and the first and second sidewalls are at least partially curved ... such that the bottom wall along with the first and second sidewalls together substantially form a U-shape when viewed from a direction facing the first vertebral body facing surface The accused products are alleged to have curved bottom and side surfaces that form a U-shape from a frontal view. ¶79 col. 14:27-35
a first anchor having a first anchor body ... [with] a first plurality of outwardly-extending bone engagement ridges, wherein the first anchor body is curved along the first anchor body The accused products have a first extendable anchor with bone-engaging ridges on a curved body. ¶79 col. 14:56-62
a second anchor having a second anchor body... [with] a second plurality of outwardly-extending bone engagement ridges, wherein the second anchor body is curved along the second anchor body The accused products have a second extendable anchor with bone-engaging ridges on a curved body. ¶79 col. 15:1-7
wherein the first and second anchors are configured to be sequentially extended out of the fusion cage in opposite directions The anchors of the accused products are allegedly deployed sequentially in opposite directions. ¶79 col. 15:9-12

Identified Points of Contention

  • Scope Questions: The construction of highly specific geometric terms like "substantially flat," "partially curved," and "substantially form a U-shape" will be critical. The phrase "when viewed from a direction facing the first vertebral body facing surface" introduces a specific condition that may be a point of dispute. Practitioners may focus on whether this requires a perfectly orthogonal view or allows for some tolerance.
  • Technical Questions: A key factual question will be whether the accused ROI products, as manufactured and used, actually possess the specific U-shape geometry required by the claim when viewed from the specified direction. This may require expert testimony and analysis of the physical products or their design files.

V. Key Claim Terms for Construction

U.S. Patent No. 9,622,875

  • The Term: "central screw locking lever"
  • Context and Importance: This term defines the mechanism that prevents screw back-out, a core feature of the invention. The definition of "central" and "lever" will determine whether the accused products' locking mechanisms, which may operate differently, fall within the claim's scope.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The claim language itself is functional, stating the lever "prevents the first screw member and the second screw member from pulling-out." A party might argue this functional language covers any centrally-located mechanism that achieves this result.
    • Evidence for a Narrower Interpretation: The specification repeatedly depicts the lever as a singular, T-shaped component that rotates into position over the screw heads (’875 Patent, FIGS. 1A-1E, 2A-2G). A party might argue that "lever" should be limited to such a rotating structure, as opposed to, for example, a sliding or snap-fit bracket.

U.S. Patent No. 10,238,383

  • The Term: "substantially form a U-shape when viewed from a direction facing the first vertebral body facing surface"
  • Context and Importance: This term is a primary structural limitation defining the shape of the claimed cage. Infringement will depend heavily on whether the accused ROI-C and ROI-A products meet this specific geometric constraint. Practitioners may focus on this term because it is a potential point of non-infringement if the accused device has a different shape, such as a D-shape or a more rectangular profile.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The use of the word "substantially" suggests the shape does not need to be a perfect "U" and allows for some deviation. The specification describes various implant shapes, which may support an argument that the claim is not limited to the exact embodiment shown.
    • Evidence for a Narrower Interpretation: The claim is highly specific about the viewing direction and which walls contribute to the "U-shape" (the bottom wall and sidewalls, while the top wall is "substantially straight"). A party could argue that this detailed description limits the claim to implants that precisely match this profile, distinguishing it from, for example, D-shaped implants where the top wall forms part of the overall shape, which are described elsewhere in the patent family (e.g., ’723 Patent).

VI. Other Allegations

  • Indirect Infringement: The complaint alleges inducement of infringement against doctors and medical institutions. The basis for this allegation is Defendant’s provision of "product manuals, surgical technique guides, brochures, videos, demonstrations, and website materials" that instruct and encourage the use of the accused products in an infringing manner (Compl. ¶¶56, 80, 104, 124, 150, 175).
  • Willful Infringement: The willfulness allegations are based on extensive alleged pre-suit knowledge by Defendant’s predecessors-in-interest. The complaint details communications, meetings, and sharing of confidential information, including CAD drawings and patent applications, beginning as early as 2005 (Compl. ¶¶25-45). The complaint alleges that Defendant either had actual knowledge of the patents shortly after they issued or was willfully blind to their existence, and made no attempt to design around the claims (Compl. ¶¶69-71, 93-95).

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

  • A central issue will be one of pre-suit conduct and knowledge: given the extensive history of alleged disclosures under confidentiality agreements, a court will examine whether Defendant's predecessors-in-interest had pre-suit knowledge of the inventions, which could significantly influence a finding of willfulness if infringement is found.
  • A key question of definitional scope will concern the geometric limitations in the '383 and '723 patents. The case may turn on whether the accused ROI products "substantially form a U-shape" as claimed in the '383 patent, or a "D-shape" as claimed in the '723 patent, and whether these terms can be interpreted to cover the same accused structures.
  • Another key question will be one of claim construction and technical operation: the dispute over the '875 patent may focus on whether the accused Optio-C product's locking mechanism is a "central screw locking lever" as claimed, raising questions about both the structural meaning of the term and the functional equivalence of the accused mechanism.