DCT

0:25-cv-00769

Moskowitz Family LLC v. Medtronic Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 0:25-cv-00769, D. Minn., 02/28/2025
  • Venue Allegations: Venue is alleged to be proper in the District of Minnesota because the Medtronic Defendants maintain regular and established places of business in the district, and because Medtronic, Inc. is incorporated and headquartered in Minnesota.
  • Core Dispute: Plaintiff alleges that Defendant’s spinal fusion systems and related instrumentation infringe eleven patents related to intervertebral implants, fixation devices, and surgical tools.
  • Technical Context: The technology concerns medical devices for spinal fusion surgery, a procedure to permanently connect two or more vertebrae in the spine to improve stability, correct a deformity, or reduce pain.
  • Key Procedural History: The complaint details extensive pre-suit interactions between the inventor, Dr. Moskowitz, and Medtronic spanning from 2005 to 2016. These interactions allegedly included technology presentations, disclosures of patent claims, and formal notice letters sent by counsel in 2015 that identified the '293 patent and the patent application that issued as the '674 patent. The complaint also notes that Medtronic acquired Titan Spine, Inc. in 2019, after Titan Spine had separately been put on notice of the '293 patent in 2015.

Case Timeline

Date Event
2005-04-12 Earliest Priority Date for all Asserted Patents
2005-01-01 First alleged interaction between Dr. Moskowitz and Medtronic
2015-04-14 U.S. Patent No. 9,005,293 Issues
2015-07-01 Dr. Moskowitz's counsel allegedly sends notice letter to Titan Spine identifying '293 patent
2015-08-01 Medtronic counsel allegedly acknowledges receipt of notice letter and awareness of patent portfolio
2016-01-01 Medtronic allegedly informs Dr. Moskowitz it does not wish to pursue an acquisition or license
2018-03-06 U.S. Patent No. 9,907,674 Issues
2018-07-10 U.S. Patent No. 10,016,284 Issues
2018-09-04 U.S. Patent No. 10,064,738 Issues
2019-01-01 Medtronic acquires Titan Spine, Inc.
2019-03-26 U.S. Patent No. 10,238,505 Issues
2019-10-01 U.S. Patent No. 10,426,633 Issues
2020-03-31 U.S. Patent No. 10,603,183 Issues
2021-08-24 U.S. Patent No. 11,096,797 Issues
2022-07-05 U.S. Patent No. 11,376,136 Issues
2024-01-09 U.S. Patent No. 11,864,755 Issues
2024-06-18 U.S. Patent No. 12,011,367 Issues
2025-02-28 Complaint Filing Date

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

U.S. Patent No. 9,005,293 - 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 background describes complications associated with prior spinal fusion techniques, including neural or vascular injury, prolonged recovery, and implant/screw displacement resulting from static, non-expandable implants and separate plating systems (Compl. ¶9; '293 Patent, Background).
  • The Patented Solution: The invention is a stand-alone intervertebral implant (or "screw box") that combines the functions of a spacer (to maintain disc height) and a fixation device ('293 Patent, col. 4:40-45). It features internal guides that direct "bi-directional fixating transvertebral" (BDFT) screws through the implant and into the adjacent vertebral bodies at opposing angles, providing stability without the need for an external plate that could damage surrounding tissue ('293 Patent, Abstract; col. 4:25-34).
  • Technical Importance: This "zero-profile" approach aims to provide the stability of traditional fusion with plates and screws in a less invasive, single-step construct, potentially reducing complications and surgical time (Compl. ¶10).

Key Claims at a Glance

  • The complaint asserts exemplary claim 43 (Compl. ¶53).
  • Claim 43 is a method claim comprising the essential steps of:
    • Providing a "zero-profile, intervertebral cage" with internal screw trajectory guides.
    • Inserting the cage into a disc space between adjacent vertebral bodies.
    • Providing a tool with an "internal screw trajectory guide" for guiding a screw.
    • Guiding the screw through the tool's guide and the cage's internal guide into a vertebral body.
  • The complaint does not explicitly reserve the right to assert dependent claims for this patent.

U.S. Patent No. 9,907,674 - Bi-directional fixating transvertebral body screws and posterior cervical and lumbar interarticulating joint calibrated stapling devices for spinal fusion, issued March 6, 2018

The Invention Explained

  • Problem Addressed: Similar to the '293 Patent, this patent addresses the drawbacks of traditional spinal fusion, such as the need for supplemental pedicle screws or anterior plating, which can lead to complications like tissue damage and prolonged recovery ('674 Patent, col. 1:55-2:16).
  • The Patented Solution: The invention discloses a stand-alone intervertebral cage with integrated, bi-directionally oriented screw guides designed to obviate the need for supplemental fixation ('674 Patent, Abstract; col. 2:37-45). The solution combines the functions of an intervertebral spacer and a bone-fixating screw apparatus into a single construct, which can be filled with bone fusion material ('674 Patent, col. 2:37-45).
  • Technical Importance: This integrated system is designed to provide segmental spinal fusion in a "safe, effective, zero-profile and minimally invasive" manner, applicable to various surgical approaches (Compl. ¶10; '674 Patent, col. 4:46-53).

Key Claims at a Glance

  • The complaint asserts exemplary claim 34 (Compl. ¶72).
  • Claim 34 is a method claim comprising the essential steps of:
    • Providing an intervertebral cage with a top wall, bottom wall, and sidewalls defining an open space, and having first and second internal screw guides.
    • Inserting a first screw into the first internal screw guide and a second screw into the second internal screw guide.
    • Screwing the first and second screws into first and second vertebral bodies, respectively.
    • Locking the screws in their final positions by embedding a portion of the screws into a screw locking mechanism of the cage.
  • The complaint does not explicitly reserve the right to assert dependent claims for this patent.

U.S. Patent No. 10,016,284 - 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 describes expandable intervertebral spacer devices that can be adjusted after insertion to achieve a customized fit ('284 Patent, Abstract). The invention covers various mechanisms for "calibrated expansion" and includes embodiments with and without integrated bi-directional fixating screws, aiming to provide distraction and fusion for the entire spine through multiple surgical approaches ('284 Patent, col. 1:8-19).
  • Asserted Claims: Exemplary claim 1 (Compl. ¶94).
  • Accused Features: The Elevate and Catalyft systems and instrumentation are accused of infringing this patent (Compl. ¶93).

U.S. Patent No. 10,064,738 - 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, issued September 4, 2018

  • Technology Synopsis: This patent focuses on an intervertebral cage system that includes bi-directional transvertebral screws and a "central screw locking lever" ('738 Patent, Abstract). The locking lever is designed to prevent the screws from backing out after they have been inserted into the vertebral bodies, providing a stand-alone construct without supplemental plating ('738 Patent, col. 4:51-55).
  • Asserted Claims: Exemplary claim 1 (Compl. ¶113).
  • Accused Features: The Sovereign systems and instrumentation are accused of infringing this patent (Compl. ¶112).

U.S. Patent No. 10,238,505 - Bi-directional fixating/locking transvertebral body screw/intervertebral cage stand-alone constructs, issued March 26, 2019

  • Technology Synopsis: This invention relates to a bi-directional fixating transvertebral (BDFT) screw/cage apparatus featuring a plurality of internal angled screw guides and screw locking mechanisms ('505 Patent, Abstract). The system is designed as a stand-alone implant for various spinal placements, with cage indentations that work with other locking mechanisms to prevent screws from pulling out of the angled guides ('505 Patent, col. 1:29-37).
  • Asserted Claims: Exemplary claim 1 (Compl. ¶135).
  • Accused Features: The Divergence systems and instrumentation are accused of infringing this patent (Compl. ¶134).

U.S. Patent No. 10,426,633 - 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: This patent, similar to the '284 patent, discloses universal, zero-profile expandable intervertebral spacers ('633 Patent, Abstract). It details multiple embodiments with unique mechanisms for calibrated expansion, including some that incorporate bi-directional screws and some that do not, intended for use throughout the spine via various surgical approaches ('633 Patent, col. 1:8-19).
  • Asserted Claims: Exemplary claim 1 (Compl. ¶156).
  • Accused Features: The Elevate and Catalyft systems and instrumentation are accused of infringing this patent (Compl. ¶155).

U.S. Patent No. 10,603,183 - 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, issued March 31, 2020

  • Technology Synopsis: This patent, similar to the '738 patent, describes a stand-alone intervertebral cage construct with bi-directional screws and a central screw locking lever ('183 Patent, Abstract). The technology is designed to provide segmental fusion by securing the implant to adjacent vertebrae without requiring supplemental pedicle screws or anterior plating ('183 Patent, col. 2:50-55).
  • Asserted Claims: Exemplary claim 1 (Compl. ¶175).
  • Accused Features: The Sovereign systems and instrumentation are accused of infringing this patent (Compl. ¶174).

U.S. Patent No. 11,096,797 - Zero-profile expandable intervertebral spacer devices for distraction and spinal fusion and a universal tool for their placement and expansion, issued August 24, 2021

  • Technology Synopsis: This patent also relates to zero-profile expandable intervertebral spacers with various mechanisms for calibrated expansion ('797 Patent, Abstract). The technology encompasses universal designs for use throughout the spine and includes embodiments with and without integrated bi-directional fixating screws, along with a tool for implantation and expansion ('797 Patent, col. 1:8-19).
  • Asserted Claims: Exemplary claim 16 (Compl. ¶197).
  • Accused Features: The Elevate and Catalyft systems and instrumentation are accused of infringing this patent (Compl. ¶196).

U.S. Patent No. 11,376,136 - Expandable spinal implant and tool system, issued July 5, 2022

  • Technology Synopsis: This invention discloses a self-drilling bone fusion screw apparatus that includes at least two sliding boxes and an adjuster to control their height ('136 Patent, Abstract). The system allows screw members to be inserted into vertebral bodies to achieve fusion and can be integrated with a plate or cage ('136 Patent, col. 2:37-45).
  • Asserted Claims: Exemplary claim 1 (Compl. ¶219).
  • Accused Features: The Elevate and Catalyft systems and instrumentation are accused of infringing this patent (Compl. ¶218).

U.S. Patent No. 11,864,755 - Artificial expandable implant systems, issued January 9, 2024

  • Technology Synopsis: This patent describes an apparatus for joining members using either a self-drilling screw system or a stapling apparatus ('755 Patent, Abstract). The screw apparatus includes a shell and first and second screw members driven in opposite directions. The stapling apparatus includes lever arms that interlock staples from cartridges ('755 Patent, col. 1:57-2:7).
  • Asserted Claims: Exemplary claim 1 (Compl. ¶241).
  • Accused Features: The T2 Stratosphere systems and instrumentation are accused of infringing this patent (Compl. ¶240).

U.S. Patent No. 12,011,367 - Expandable intervertebral device, issued June 18, 2024

  • Technology Synopsis: This patent covers a universal, zero-profile expandable intervertebral spacer device for spinal fusion and distraction ('367 Patent, Abstract). It describes various embodiments with unique mechanisms for calibrated expansion, some of which incorporate bi-directional fixating screws, intended for use throughout the spine ('367 Patent, col. 2:8-19).
  • Asserted Claims: Exemplary claims 8 or 17 (Compl. ¶260).
  • Accused Features: The Elevate and Catalyft systems and instrumentation are accused of infringing this patent (Compl. ¶259).

III. The Accused Instrumentality

Product Identification

  • The accused instrumentalities are Medtronic's Elevate™ Spinal System, Divergence™ Anterior Cervical Fusion System, Sovereign™ Spinal System, Catalyft™ PL Expandable Interbody System, Catalyft™ PL40 Expandable Interbody System, Endoskeleton™ TAS Interbody System, Endoskeleton™ TCS Interbody System, and T2 Stratosphere™ Expandable Corpectomy System (Compl. ¶11).

Functionality and Market Context

  • The complaint describes the accused products as spinal surgery products used for spinal fusion procedures (Compl. ¶11). These include expandable and non-expandable interbody fusion devices and titanium implants designed for insertion between vertebrae (Compl. ¶¶15, 39). The complaint alleges that Medtronic is the "world's largest medical device company and a dominant force in the spinal surgery market" and that these products strengthen its market dominance (Compl. ¶¶11, 16). No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The complaint references, but does not contain, claim chart exhibits that map elements of the asserted claims to the accused products. The narrative infringement theories are summarized below.

'293 Patent Infringement Allegations

  • The complaint alleges infringement of at least exemplary claim 43, a method claim for providing and using an intervertebral cage and an associated surgical tool (Compl. ¶53). The infringement theory is that Medtronic's Divergence, Sovereign, Endoskeleton TAS, and Endoskeleton TCS systems, when used by surgeons and other medical professionals according to Medtronic's supplied instructions, directly perform the steps of the claimed method (Compl. ¶¶52, 55-56).
  • Identified Points of Contention:
    • Scope Questions: A central question may be whether the term "zero-profile," as used in the patent, can be construed to read on the profiles of the accused Divergence and Sovereign systems, which are alleged to infringe (Compl. ¶52).
    • Technical Questions: What evidence does the complaint provide that the use of the accused products requires a tool that performs the specific "guiding" function recited in claim 43, as distinguished from a tool that merely holds or inserts the implant?

'674 Patent Infringement Allegations

  • The complaint alleges infringement of at least exemplary claim 34, a method claim for inserting and locking bi-directional screws within an intervertebral cage (Compl. ¶72). The infringement theory alleges that surgeons using the accused Divergence systems and instrumentation perform the claimed steps of inserting screws into the cage's internal guides and embedding them into a "screw locking mechanism" (Compl. ¶¶71, 74-75).
  • Identified Points of Contention:
    • Scope Questions: Does the term "screw locking mechanism" as defined and used in the '674 Patent encompass the specific means by which screws are secured in the accused Divergence systems?
    • Technical Questions: A key factual question may be whether the accused products actually perform the claimed step of "locking the first screw member and the second screw member in the final position by embedding a portion of the first screw member and the second screw member into a screw locking mechanism."

V. Key Claim Terms for Construction

For the '293 Patent:

  • The Term: "zero-profile"
  • Context and Importance: This term is central to the invention's purported advantage of avoiding complications associated with traditional plating systems that sit proud of the vertebral surface. The infringement analysis may depend on whether the accused products, when implanted, have a profile that meets the patent’s definition of "zero-profile."
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The specification states that "zero-profile" devices "do not damage or indent overlying soft tissue or vascular structures," which could support an interpretation based on functional impact rather than a strict geometric boundary (U.S. Patent No. 10016284, col. 4:3-5).
    • Evidence for a Narrower Interpretation: The detailed description of embodiments may show that the implant's surfaces are intended to be entirely flush with or recessed within the vertebral endplates, potentially supporting a narrower, more literal definition (U.S. Patent No. 10,016,284, Background).

For the '674 Patent:

  • The Term: "screw locking mechanism"
  • Context and Importance: Claim 34 requires "locking" the screws by "embedding" a portion of them into this mechanism. The nature and operation of this "mechanism" will be critical, as Medtronic may argue its products use a different, non-infringing method of screw retention. Practitioners may focus on whether this term requires a specific structure or covers any means of preventing screw backout.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The patent abstract mentions a "central screw locking lever," but the claims use the broader term "screw locking mechanism," which may suggest the claim is not limited to the specific lever embodiment ('674 Patent, Abstract).
    • Evidence for a Narrower Interpretation: The specification repeatedly describes specific locking mechanisms, such as a "screw locking horizontal bracket" or a "central rotating locking lever" ('674 Patent, col. 8:40-42). These specific examples could be used to argue for a narrower construction limited to similar structures.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges induced infringement under 35 U.S.C. § 271(b) across all asserted patents. The allegations are based on Medtronic's alleged provision of "instructions, manuals, brochures, documentation, tutorials, videos," and technical support that instruct and encourage third parties like surgeons and hospitals to use the accused products in an infringing manner (e.g., Compl. ¶¶56, 75, 97).
  • Willful Infringement: Willfulness is alleged for all asserted patents. The allegations are based on Medtronic's alleged pre-suit knowledge of the patents and technology, stemming from extensive discussions and meetings with the inventor between 2005 and 2016 (Compl. ¶¶39-42), and formal notice letters sent in 2015 that identified the '293 patent and the application leading to the '674 patent (Compl. ¶43). The complaint further alleges that the Medtronic Defendants have cited the asserted patents during the prosecution of their own patent applications, demonstrating awareness (e.g., Compl. ¶¶60, 79, 101).

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

  • A central issue will be one of willfulness and pre-suit knowledge: The complaint alleges a decade-long history of communication, technology disclosure, and formal notice between the parties. A key question for the court will be to determine the extent of Medtronic's knowledge of the asserted patent portfolio and whether its subsequent actions, if found to be infringing, rise to the level of willful misconduct warranting enhanced damages.
  • A key technical question will be one of operative functionality: Do the fixation and locking features of Medtronic's accused products, such as the Sovereign and Divergence systems, operate in substantially the same way as the specific "bi-directional fixating transvertebral" screws and "screw locking mechanisms" described and claimed in the patents, or is there a fundamental mismatch in their mechanical operation?
  • A dispositive issue will be one of definitional scope: The dispute may turn on the construction of foundational terms such as "zero-profile." How the court defines this term—whether functionally (based on avoiding tissue contact) or strictly geometrically (based on being flush with the vertebrae)—will likely determine the infringement outcome for a significant portion of the accused products.