DCT

1:25-cv-00711

Moskowitz Family LLC v. NuVasive LLC

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:25-cv-00711, D. Del., 06/06/2025
  • Venue Allegations: Venue is alleged to be proper in the District of Delaware because Defendant NuVasive is incorporated in the State of Delaware and therefore resides in the district.
  • Core Dispute: Plaintiff alleges that Defendant’s spinal surgery systems, including interbody fusion devices and artificial discs, infringe ten patents related to spinal implants and fixation technologies.
  • Technical Context: The technology concerns medical devices for spinal fusion surgery, a market segment focused on providing stability to the spine to treat degenerative conditions and injuries.
  • Key Procedural History: The complaint alleges extensive pre-suit history, including discussions between the inventor, Dr. Moskowitz, and NuVasive executives from 2010 to 2011, where technical details and patent applications were allegedly disclosed. A formal notice letter was allegedly sent to NuVasive in 2015 identifying several of the asserted patents and related applications. The complaint also alleges that NuVasive has cited patents from the asserted families during its own patent prosecution activities.

Case Timeline

Date Event
2005-04-12 Earliest Priority Date for ’363, ’293, ’854, ’940, ’753, ’743 Patents
2006-04-04 Earliest Priority Date for ’567 Patent
2010-01-01 Alleged pre-suit discussions between Dr. Moskowitz and NuVasive begin
2011-07-05 U.S. Patent No. 7,972,363 Issues
2012-10-25 Earliest Priority Date for ’284, ’633, ’136 Patents
2015-04-14 U.S. Patent No. 9,005,293 Issues
2015-06-01 Plaintiff allegedly sends formal notice letter to NuVasive
2016-04-05 U.S. Patent No. 9,301,854 Issues
2018-03-27 U.S. Patent No. 9,924,940 Issues
2018-07-10 U.S. Patent No. 10,016,284 Issues
2019-10-01 U.S. Patent No. 10,426,633 Issues
2021-02-23 U.S. Patent No. 10,925,753 Issues
2022-07-05 U.S. Patent No. 11,376,136 Issues
2023-10-03 U.S. Patent No. 11,771,567 Issues
2024-11-19 U.S. Patent No. 12,144,743 Issues
2025-06-06 Complaint Filing Date

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

U.S. Patent No. 7,972,363

  • Patent Identification: U.S. Patent No. 7,972,363, titled “Bi-directional fixating/locking transvertebral body screw/intervertebral cage stand-alone constructs and posterior cervical and lumbar interarticulating joint stapling guns and devices for spinal fusion,” issued July 5, 2011.
  • The Invention Explained:
    • Problem Addressed: The patent’s background section describes complications associated with traditional spinal fusion techniques, which often require supplemental fixation such as posterior pedicle screws or anterior plates. These methods can lead to significant tissue dissection, misplaced screws, vascular injury, and excess rigidity, causing further complications for patients (Compl. ¶9; ’363 Patent, col. 1:11-30).
    • The Patented Solution: The invention is a stand-alone intervertebral cage that incorporates its own fixation mechanism. It features internal screw guides that direct screws in opposing directions (bi-directionally) into the adjacent vertebral bodies, providing stability without the need for an external plate (’363 Patent, Abstract; col. 2:44-53). This "zero-profile" design is intended to minimize disruption to surrounding tissues and reduce the risk of complications associated with traditional plates and screws (Compl. ¶10, ¶31).
    • Technical Importance: This stand-alone approach aimed to simplify spinal fusion procedures, reduce surgical time and morbidity, and provide stable fixation while minimizing the implant's profile.
  • Key Claims at a Glance:
    • The complaint asserts at least independent claim 1 (Compl. ¶50).
    • The essential elements of Claim 1 include:
      • An intervertebral cage for maintaining disc height, including a first and second internal screw guide.
      • A first screw member with a tapered end and a threaded body disposed within the cage.
      • A second screw member with a tapered end and a threaded body disposed within the cage.
      • A first screw locking mechanism that prevents the screw members from pulling out.
    • The complaint does not explicitly reserve the right to assert dependent claims for this patent.

U.S. Patent No. 9,005,293

  • Patent Identification: U.S. Patent No. 9,005,293, titled “Bi-directional fixating transvertebral body screws and posterior cervical and lumbar interarticulating joint calibrated stapling devices for spinal fusion,” issued April 14, 2015.
  • The Invention Explained:
    • Problem Addressed: The patent addresses the same technical problems as the related ’363 Patent, namely the complications and risks associated with traditional spinal fusion hardware like pedicle screws and anterior plates (’293 Patent, col. 1:45-67).
    • The Patented Solution: The invention discloses an intervertebral cage with integrated bi-directional screws. A key feature of the claimed invention is a specific screw locking mechanism consisting of a "leaf spring" that interacts with "ratchet teeth" on the screw heads. This mechanism is designed to allow the screws to be advanced into the bone but prevents them from backing out, thereby locking them in their final position (’293 Patent, Abstract; col. 4:1-17).
    • Technical Importance: This design provides an integrated, low-profile locking mechanism intended to enhance the security of the fixation without adding bulk or requiring separate locking components.
  • Key Claims at a Glance:
    • The complaint asserts at least independent claim 43 (Compl. ¶73).
    • The essential elements of Claim 43 include:
      • An intervertebral cage with first and second internal screw guides.
      • First and second screw members, each having a screw head with ratchet teeth.
      • A screw locking mechanism which consists of a leaf spring that allows rotation of the screw head in only one direction.
    • The complaint does not explicitly reserve the right to assert dependent claims for this patent.

Multi-Patent Capsules

  • U.S. Patent No. 9,301,854

    • Patent Identification: ’854 Patent, “Bi-directional fixating transvertebral body screws and posterior cervical and lumbar interarticulating joint calibrated stapling devices for spinal fusion,” issued April 5, 2016.
    • Technology Synopsis: This patent relates to intervertebral implants that provide fixation via bi-directionally oriented screws, similar to the ’363 and ’293 patents. The technology aims to create a stand-alone construct for spinal fusion, reducing the need for supplemental fixation hardware (Compl. ¶9-10).
    • Asserted Claims: At least independent claim 1 (Compl. ¶93).
    • Accused Features: The Brigade and CoRoent systems are accused of infringing the ’854 patent (Compl. ¶92).

  • U.S. Patent No. 9,924,940

    • Patent Identification: ’940 Patent, “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,” issued March 27, 2018.
    • Technology Synopsis: The patent describes expandable intervertebral body fusion devices. These devices can be inserted in a compressed state and then expanded in situ to restore disc height, providing a customized fit and minimizing the challenges of insertion (Compl. ¶10).
    • Asserted Claims: At least independent claim 22 (Compl. ¶116).
    • Accused Features: The X-Core systems are accused of infringing the ’940 patent (Compl. ¶115).

  • U.S. Patent No. 10,016,284

    • Patent Identification: ’284 Patent, “Zero-profile expandable intervertebral spacer devices for distraction and spinal fusion and a universal tool for their placement and expansion,” issued July 10, 2018.
    • Technology Synopsis: This patent covers zero-profile, expandable intervertebral spacers. The technology focuses on devices that can be inserted in a single step and then expanded to a desired height, with locking mechanisms to provide a customized and stable fit for spinal fusion procedures (Compl. ¶10).
    • Asserted Claims: At least independent claim 1 (Compl. ¶139).
    • Accused Features: The TLX systems and instrumentation are accused of infringing the ’284 patent (Compl. ¶138).

  • U.S. Patent No. 10,426,633

    • Patent Identification: ’633 Patent, “Zero-profile expandable intervertebral spacer devices for distraction and spinal fusion and a universal tool for their placement and expansion,” issued October 1, 2019.
    • Technology Synopsis: Continuing the technology of the related ’284 patent, this patent concerns expandable, zero-profile intervertebral spacers. These devices are designed for minimally invasive insertion and controlled expansion to restore disc height and facilitate spinal fusion (Compl. ¶10).
    • Asserted Claims: At least independent claim 1 (Compl. ¶159).
    • Accused Features: The TLX systems and instrumentation are accused of infringing the ’633 patent (Compl. ¶158).

  • U.S. Patent No. 10,925,753

    • Patent Identification: ’753 Patent, “Bi-directional fixating/locking transvertebral body screw/intervertebral cage stand-alone constructs,” issued February 23, 2021.
    • Technology Synopsis: This patent relates to stand-alone intervertebral cages with integrated bi-directional screw fixation, continuing the technology family of the ’363 patent. The invention provides fixation to adjacent vertebrae without requiring external plates, aiming to reduce surgical complexity and potential complications (Compl. ¶10).
    • Asserted Claims: At least independent claim 31 (Compl. ¶179).
    • Accused Features: The Base and CoRoent systems are accused of infringing the ’753 patent (Compl. ¶178).

  • U.S. Patent No. 11,376,136

    • Patent Identification: ’136 Patent, “Expandable spinal implant and tool system,” issued July 5, 2022.
    • Technology Synopsis: The patent describes expandable spinal implants and the tool systems used for their placement and expansion. The technology is directed at providing a custom-fit implant that can be adjusted in situ to match patient anatomy and achieve desired vertebral distraction (Compl. ¶10).
    • Asserted Claims: At least independent claim 1 (Compl. ¶202).
    • Accused Features: The TLX and Mod-Ex PL systems are accused of infringing the ’136 patent (Compl. ¶201).

  • U.S. Patent No. 11,771,567

    • Patent Identification: ’567 Patent, “Artificial disc system,” issued October 3, 2023.
    • Technology Synopsis: This patent relates to an artificial disc system, which is a motion-preserving alternative to spinal fusion. The invention likely concerns the mechanical structure of the artificial disc, including its endplates and core, designed to replicate the natural movement of a spinal segment.
    • Asserted Claims: At least independent claim 1 (Compl. ¶225).
    • Accused Features: The Simplify systems and instrumentation are accused of infringing the ’567 patent (Compl. ¶224).

  • U.S. Patent No. 12,144,743

    • Patent Identification: ’743 Patent, “Intervertebral implant,” issued November 19, 2024.
    • Technology Synopsis: This patent pertains to intervertebral implants, likely stand-alone fusion devices with integrated fixation similar to others in the portfolio. The technology aims to provide spinal stability while minimizing the implant profile and avoiding the need for supplemental plating (Compl. ¶10).
    • Asserted Claims: At least independent claim 1 (Compl. ¶245).
    • Accused Features: The Base, Brigade, and CoRoent systems are accused of infringing the ’743 patent (Compl. ¶244).

III. The Accused Instrumentality

  • Product Identification: The complaint names seven product families as the Accused Instrumentalities: the BASETM Interfixated System ("Base"), BrigadeTM System (“Brigade”), CoRoentTM Small Interlock System (“CoRoent”), MOD-EX PLTM Interbody System (“MOD-EX PL”), Simplify® Cervical Disc (“Simplify”), TLXTM Interbody System (“TLX”), and X-CORE® Expandable Vertebral Body Replacement (VBR) System (“X-Core”) (Compl. ¶13).
  • Functionality and Market Context: The Accused Instrumentalities are spinal surgery products used for interbody fusion and disc replacement procedures (Compl. ¶13). Based on the infringement allegations, these products fall into several categories:
    • Interbody fusion devices with integrated fixation (Base, Brigade, CoRoent), which are alleged to function as stand-alone cages with screws (Compl. ¶49, ¶72, ¶92, ¶178, ¶244).
    • Expandable interbody spacers (TLX, Mod-Ex PL, X-Core), which are alleged to be expandable in situ to restore disc height (Compl. ¶115, ¶138, ¶158, ¶201).
    • An artificial cervical disc (Simplify), which is a motion-preserving implant (Compl. ¶224).
      The complaint alleges that prior to its acquisition by Globus Medical in 2023, NuVasive was the third-largest player in the global spine market (Compl. ¶13).

No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The complaint references, but does not include, claim chart exhibits detailing its infringement theories. The following summarizes the narrative infringement allegations for the lead patents.

  • ’363 Patent Infringement Allegations
    The complaint alleges that Defendant’s Base and CoRoent systems directly infringe at least Claim 1 of the ’363 Patent (Compl. ¶49). It states that representative charts attached as Exhibits A2 and A3 describe how the elements of this claim are met by the accused products (Compl. ¶50). The core of this allegation appears to be that the Base and CoRoent systems are "stand-alone intervertebral cage constructs" that contain internal guides for directing "transvertebral body screws" into adjacent vertebrae, thereby meeting the limitations of the claim.

  • ’293 Patent Infringement Allegations
    The complaint alleges that the Base, Brigade, and CoRoent systems directly infringe at least Claim 43 of the ’293 Patent (Compl. ¶72). It refers to Exhibits B2-B4 for a detailed element-by-element mapping (Compl. ¶73). The infringement theory for this patent appears to center on the specific screw locking mechanism recited in the claim, alleging that the accused products contain a "screw locking mechanism which consists of a leaf spring" that interacts with "ratchet teeth" on the screw heads to prevent screw backout.

  • Identified Points of Contention:

    • Scope Questions: A central question for the ’363 Patent and its relatives may be the scope of the term “stand-alone.” The litigation may explore whether this term implies that the device must be used without any supplemental fixation, or if it simply refers to a device that does not require an integrated anterior plate. For the ’293 Patent, a key question will be whether the locking mechanisms in the accused products operate in the same way as the claimed "leaf spring" and "ratchet teeth," or if there are material differences in their structure and function.
    • Technical Questions: A factual dispute may arise regarding how the accused products actually achieve fixation. What evidence does the complaint provide that the accused products’ fixation features perform the specific functions of the "internal screw guides" and "screw locking mechanism" as required by the respective claims? The analysis will depend on the detailed mechanical operation of the accused products, which is not described in the complaint itself.

V. Key Claim Terms for Construction

  • The Term: "stand-alone intervertebral cage" (from Claim 1 of the ’363 Patent)

  • Context and Importance: This term is central to the patent's asserted novelty, distinguishing the invention from prior art systems that required separate plates or pedicle screws. The definition of "stand-alone" will be critical to determining the scope of infringement, as Defendant may argue its products are designed for or frequently used with supplemental fixation, potentially placing them outside a narrow construction of the term.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The specification describes that the ZP-EIS embodiments "can be used as stand-alone intervertebral devices" and that they "may obviate the need for supplemental pedicle screw fixation in many situations," which may support an interpretation that the device is capable of stand-alone use, even if sometimes used with other fixation (’284 Patent, col. 2:20-21, 31-33).
    • Evidence for a Narrower Interpretation: The description of the invention as combining "the dual functions of intervertebral calibrated expandable distraction, and segmental vertebral body spinal fusion" in a single device could be argued to limit the term to devices that achieve final, complete fixation without any other hardware (’284 Patent, col. 2:23-25).

  • The Term: "a screw locking mechanism which consists of a leaf spring" (from Claim 43 of the ’293 Patent)

  • Context and Importance: This term defines the specific anti-backout feature of the claimed invention. The dispute will likely focus on whether the locking features of the accused products meet the structural and functional requirements of a "leaf spring" as disclosed in the patent. Practitioners may focus on this term because a narrow definition could allow Defendant to design around the claim, while a broad one could capture a wider range of anti-rotation mechanisms.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The patent does not appear to provide an explicit definition of "leaf spring," which might allow Plaintiff to argue for its plain and ordinary meaning, potentially encompassing any flexible metal tab that provides a spring-like force.
    • Evidence for a Narrower Interpretation: The figures and corresponding description show a specific cantilevered spring element that interacts with ratchet teeth (’293 Patent, Fig. 1F; col. 4:20-31). Defendant may argue that the term should be limited to this disclosed embodiment, excluding other types of locking mechanisms that may be present in the accused products.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges induced infringement under 35 U.S.C. § 271(b), stating that NuVasive provides instructions, manuals, brochures, videos, and technical support that instruct and encourage third parties like surgeons to use the accused products in a manner that directly infringes the asserted patents (Compl. ¶52-53, ¶75-76). The complaint also pleads contributory infringement under § 271(c) for certain patents, alleging the components sold by NuVasive are not staple articles of commerce and are a material part of the invention (Compl. ¶62, ¶105).
  • Willful Infringement: The complaint makes extensive allegations to support willfulness. It alleges that NuVasive had pre-suit knowledge of the patents and technology based on: (1) direct communications and disclosure of technology and patent applications by the inventor to NuVasive executives between 2010 and 2011 (Compl. ¶31-34); (2) a formal notice letter sent in 2015 that identified the ’363 and ’293 patents by number and attached a copy of the ’293 patent (Compl. ¶35, ¶39); and (3) NuVasive’s own alleged citation of the asserted patents and their family members in Information Disclosure Statements submitted to the USPTO during its own patent prosecutions (Compl. ¶41, ¶46, ¶60).

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

  • A core issue will be one of claim construction and technical scope: How will the court define key claim limitations such as "stand-alone intervertebral cage" and the specific mechanical elements of the various locking and expansion mechanisms? The outcome will depend on whether the functional and structural details of the accused products fall within the construed scope of these terms.
  • A key evidentiary question will be one of knowledge and intent: Given the extensive and detailed allegations of pre-suit interactions, disclosures, and formal notice, a central focus of the litigation will be NuVasive’s state of mind. The facts surrounding these alleged events will be critical to determining whether its conduct, if found to be infringing, rises to the level of willfulness required for enhanced damages.
  • A third key question will involve patent-by-patent and product-by-product analysis: With ten patents asserted against seven distinct product families, the case will require a complex series of infringement analyses. A central issue will be whether the specific technologies embodied in each accused product line (e.g., integrated fixation, expandability, motion preservation) map onto the claims of the specific patents asserted against them.