DCT

2:23-cv-00192

4web Inc v. NuVasive Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:23-cv-00192, E.D. Tex., 11/03/2023
  • 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 through its employees' required physical presence in hospitals and surgery centers for sales, technical support during surgeries, and inventory management.
  • Core Dispute: Plaintiff alleges that Defendant’s Modulus line of 3D-printed titanium spinal implants infringes eleven U.S. patents related to truss-based structures for orthopedic implants.
  • Technical Context: The technology involves orthopedic implants, particularly for spinal fusion, that utilize complex truss or lattice geometries to provide structural support while creating a scaffold designed to promote and enhance bone growth and fusion.
  • Key Procedural History: The complaint alleges a significant history between the parties, including partnership and licensing discussions in 2015 under a Non-Disclosure Agreement, during which Plaintiff allegedly put Defendant on notice of its "2015 IP Portfolio," including the earliest asserted patent. The complaint further alleges that Defendant later cited publications related to several of the patents-in-suit as prior art during the prosecution of its own patent application. This history forms the primary basis for the allegations of willful infringement.

Case Timeline

Date Event
2008-12-18 Earliest Priority Date ('930, '516, '317, '421 Patents)
2012-02-01 Plaintiff begins patent marking on products
2012-09-25 Priority Date ('845, '823, '669, '235, '756, '137 Patents)
2013-03-15 Priority Date ('226 Patent)
2013-04-30 '930 Patent Issued
2015-02-27 Parties hold meeting to discuss potential partnership
2015-05-07 Parties execute Mutual Non-Disclosure Agreement
2015-08-29 Partnership discussions allegedly terminated
2016-03-01 '845 Patent Issued
2017-01-24 '823 Patent Issued
2017-02-21 '669 Patent Issued
2017-05-02 '226 Patent Issued
2017-09-12 '235 Patent Issued
2018-06-05 '137 Patent Issued
2018-06-18 '516 Patent Issued
2019-04-30 Defendant allegedly discloses '930, '845, and '226 patents/applications in an IDS for its own patent prosecution
2020-12-01 '756 Patent Issued
2022-03-22 '421 Patent Issued
2023-11-03 Amended Complaint Filed

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

U.S. Patent No. 8,430,930 - "Truss Implant"

  • Issued: April 30, 2013

The Invention Explained

  • Problem Addressed: The patent's background describes drawbacks of prior art spinal implants, noting that designs with large, solid rims can impede bone growth, reduce the size of the bone column fusing the vertebrae, and create stress concentrations on the vertebral endplates (U.S. Patent No. 8430930, col. 1:28-40).
  • The Patented Solution: The invention is an implant featuring a "truss structure" on one or more of its bone-contacting faces. This structure consists of multiple struts that extend away from the main body of the implant, creating open spaces between them. This design is intended to provide structural support while simultaneously creating a scaffold that allows for bone to grow through the openings, thereby enhancing the fusion of the implant to the adjacent bone (U.S. Patent No. 8,430,930, Abstract; col. 2:50-67).
  • Technical Importance: The use of an engineered truss structure at the bone-contacting surface represents a shift from implants as passive spacers to structures actively designed to participate in and guide the biological healing process (Compl. ¶29).

Key Claims at a Glance

  • The complaint asserts independent claims 1 and 18 (Compl. ¶71). Claim 1 includes the following essential elements:
    • An implant body comprising one or more contact faces configured to be disposed at or near a bony structure;
    • A truss structure coupled to at least one of the contact faces, configured to be disposed adjacent the bony structure during use;
    • Wherein the truss structure comprises two or more struts extending from the contact face, away from an interior of the implant; and
    • Wherein two or more of the struts define an opening configured to enable bone through growth through the opening.
  • The complaint also asserts dependent claims 2-10 (Compl. ¶71).

U.S. Patent No. 9,999,516 - "Implant Device Having a Non-Planar Surface"

  • Issued: June 18, 2018

The Invention Explained

  • Problem Addressed: The patent addresses the need for spinal implants that can conform to the natural curvature of the spine (e.g., lordosis) while still benefiting from the structural and bone-growth-promoting properties of a truss-based design ('516 Patent, col. 8:11-20).
  • The Patented Solution: The patent discloses an implant constructed from modular building blocks called "planar truss units." The key inventive concept is that the angles between struts in some of these units are intentionally different from the angles in others. By coupling these "non-equivalent angle planar truss units" with connecting struts, an implant with a "varied height" or other non-planar, anatomically conforming shape can be constructed from a repeating, web-like structure ('516 Patent, Abstract; col. 4:10-47).
  • Technical Importance: This approach provides a method for creating anatomically complex implant shapes using a systematic, truss-based geometry, potentially combining the strength and porosity of a truss with the improved fit of a custom-shaped device.

Key Claims at a Glance

  • The complaint asserts independent claims 1 and 18 (Compl. ¶82). Claim 1 includes the following essential elements:
    • An implant comprising an internal web structure;
    • The web structure comprises a plurality of planar truss units coupled to each other, which in turn are made of struts coupled at nodes;
    • Wherein one or more angles defined by two struts and a node of one planar truss unit are different than one or more corresponding angles of another planar truss unit;
    • Wherein connecting exterior surface struts couple the nodes of these non-equivalent angle units to each other such that the implant has a varied height; and
    • Wherein one planar truss unit lies in a plane that is not substantially parallel to a plane of another unit with which it shares a strut.
  • The complaint also asserts dependent claims 4, 6, and 8 (Compl. ¶82).

Other Asserted Patents

  • Patent Identification: US9545317B2, "Implant Interface System And Device," issued January 17, 2017.

  • Technology Synopsis: This patent describes an orthopedic implant with a specific "bone interface structure" that protrudes from the main implant body. This interface structure is itself a web composed of struts and nodes, and it comprises both an "external frame" and an "internal truss structure," creating a defined scaffold intended to be disposed at least partially into a bone structure to promote integration (Compl. ¶93).

  • Asserted Claims: At least claims 1-22, including independent claims 1 and 12 (Compl. ¶92).

  • Accused Features: The Modulus implants' lattice structure, which allegedly has a bone interface portion that protrudes and contains both an external frame and internal truss elements (Compl. ¶93; Compl. p. 37).

  • Patent Identification: US11278421B2, "Implant Device Having Curved or Arced Struts," issued March 22, 2022.

  • Technology Synopsis: This patent claims an implant with an internal space truss structure that is distinguished by having at least one "strut that curves or arcs" between two nodes within the truss. This geometry is combined with the concept of non-parallel planar truss units to create complex, strong, and porous three-dimensional shapes (Compl. ¶103).

  • Asserted Claims: At least claims 1-3, 7, 9-12, 14, 15, and 20, including independent claims 1 and 11 (Compl. ¶102).

  • Accused Features: The lattice structure of the Modulus implants, which is alleged to contain curved or arced struts connecting nodes within its internal truss (Compl. ¶103; Compl. p. 41).

  • Patent Identification: US9271845B2, "Programmable Implants And Methods Of Using Programmable Implants To Repair Bone Structures," issued March 1, 2016.

  • Technology Synopsis: This patent introduces the concept of a "programmable" implant, wherein the physical characteristics of the truss struts (diameter, length, and/or density) are "predetermined" to achieve a specific biomechanical effect. The patent claims that these predetermined characteristics cause the web structure, when under load, to create a "microstrain" in adjacent bone tissue that stimulates an "osteogenetic response," actively promoting bone growth (Compl. ¶113; '845 Patent, col. 14:1-11).

  • Asserted Claims: At least claims 1-3, 11, 13-15, 18, and 21-26, including independent claims 1 and 14 (Compl. ¶112).

  • Accused Features: The optimized nature of the Modulus implants' lattice, which is alleged to be predetermined to create microstrain and stimulate an osteogenetic response in bone (Compl. ¶113; Compl. p. 47).

  • Patent Identification: US9549823B2, "Programmable Implant Having Curved or Arced Struts," issued January 24, 2017.

  • Technology Synopsis: This patent combines the "programmable" implant technology of the '845 Patent with the geometric feature of using "curved or arced struts." The claims require that the strut characteristics be predetermined to create a microstrain for an osteogenetic response in an implant that contains curved struts (Compl. ¶124).

  • Asserted Claims: At least claims 1-3, 11, 13-17, 20, and 22-24, including independent claims 1 and 16 (Compl. ¶123).

  • Accused Features: The optimized lattice of the Modulus implants, which is alleged to be predetermined to cause microstrain and also to contain curved or arced struts (Compl. ¶125; Compl. p. 52).

  • Patent Identification: US9572669B2, "Programmable Implant Having An Angled Exterior Surface," issued February 21, 2017.

  • Technology Synopsis: This patent combines the "programmable" microstrain concept with the geometric features for creating a varied implant height described in patents like the '516 Patent. It claims an implant with non-equivalent angles between its planar truss units, creating a varied height, where the strut characteristics are also predetermined to generate an osteogenetic response (Compl. ¶135).

  • Asserted Claims: At least claims 1-3, 11, 13-17, 19, and 22-24, including independent claims 1 and 16 (Compl. ¶134).

  • Accused Features: The Modulus implants' optimized lattice structure, which allegedly has a varied height created by non-equivalent truss angles and is also predetermined to cause a therapeutic microstrain (Compl. ¶136; Compl. p. 58).

  • Patent Identification: US9757235B2, "Spinal Programmable Implant," issued September 12, 2017.

  • Technology Synopsis: This patent is another variation on the "programmable" implant technology from the '845 patent family, focusing on a spinal implant. It claims a web structure where strut diameter, length, and/or density are predetermined to create a microstrain in adhered osteoblasts when the implant is in contact with bone (Compl. ¶146).

  • Asserted Claims: At least claims 1-3, 11, 13-17, 20, and 22-24, including independent claims 1 and 16 (Compl. ¶145).

  • Accused Features: The Modulus implants' optimized lattice, alleged to be predetermined to create a specific microstrain in bone tissue to stimulate an osteogenetic response (Compl. ¶147; Compl. p. 64).

  • Patent Identification: US10849756B2, "Programmable Implant," issued December 1, 2020.

  • Technology Synopsis: This patent claims an implant where the "density of the web structure is predetermined" to create a microstrain in adhered bone tissue. It focuses on the density of the truss as the key programmable parameter for inducing an osteogenetic response, distinct from individual strut length or diameter (Compl. ¶168).

  • Asserted Claims: At least claims 1-3, 8-10, and 15, including independent claims 1 and 9 (Compl. ¶167).

  • Accused Features: The optimized lattice of the Modulus implants, whose density is alleged to be predetermined to create the claimed microstrain effect (Compl. ¶169; Compl. p. 76).

  • Patent Identification: US9987137B2, "Programmable Implant Having Curved Or Arced Struts," issued June 5, 2018.

  • Technology Synopsis: This patent is another combination of the "programmable" microstrain technology with the use of curved or arced struts, similar to the '823 patent. It claims a spinal implant with a web structure containing curved or arced struts where the strut characteristics are predetermined to create an osteogenetic response under load (Compl. ¶157).

  • Asserted Claims: At least claims 1-3, 11, 13-17, 20, and 22-24, including independent claims 1 and 16 (Compl. ¶156).

  • Accused Features: The Modulus implants' optimized lattice, which is alleged to both contain curved struts and be predetermined to cause a therapeutic microstrain (Compl. ¶158; Compl. p. 70).

  • Patent Identification: US9636226B2, "Traumatic Bone Fracture Repair Systems and Methods," issued May 2, 2017.

  • Technology Synopsis: This patent applies the truss structure concept to general traumatic bone fracture repair. The key claimed feature is a web structure comprising a space truss that includes "one or more cylindrical channels extending through the space truss." These channels are designed to accommodate fasteners (e.g., screws) for securing the implant to bone fragments (Compl. ¶179).

  • Asserted Claims: At least claims 1, 3, 4, 7, 9, and 15 (Compl. ¶178).

  • Accused Features: The Modulus ALIF product, which is alleged to have a web structure with cylindrical channels for receiving fasteners (Compl. ¶179; Compl. p. 80).

III. The Accused Instrumentality

Product Identification

  • The accused products are a series of spinal implant products sold by Nuvasive Inc under the brand name "Modulus," including the Modulus ALIF, Modulus Cervical (or Modulus-C), Modulus XLIF, Modulus TLIF-0, and Modulus TLIF-A models (collectively, the "Modulus implants") (Compl. ¶62).

Functionality and Market Context

  • The complaint alleges that the Modulus implants are manufactured using a 3D printing process to create a titanium device with an "optimized body lattice structure" (Compl. ¶63). This structure is described as providing a "fully porous architecture" designed to promote "osseointegration – bone on-growth and in-growth" when implanted for intervertebral body fusion (Compl. ¶¶63, 65). The complaint includes a series of screenshots from a NuVasive animation that purports to show the layer-by-layer 3D printing manufacturing process for the implants (Compl. p. 28). Plaintiff asserts that these products directly compete with its own truss-based implant products (Compl. ¶55). NuVasive is described as a "global medical technology company" with net sales of $1.2 billion for the year ending December 31, 2022 (Compl. ¶56).

IV. Analysis of Infringement Allegations

U.S. Patent No. 8,430,930 Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
an implant body [A] comprising one or more contact faces [B] configured to be disposed at or near a bony structure [C] The accused Modulus XLIF implant has a main body [A] with upper and lower contact faces [B] for placement against vertebrae [C]. ¶73; p. 30 col. 4:42-45
a truss structure [D] coupled to at least one of the contact faces [B], wherein the truss structure [D] is configured to be disposed adjacent the bony structure [C] during use The accused implant has a porous lattice structure [D] on its contact faces [B] that sits adjacent to the vertebrae [C] when implanted. ¶73; p. 30 col. 4:46-51
wherein the truss structure [D] comprises two or more struts [E] extending from the contact face, away from an interior [F] of the implant defined, in part by one or more of the contact faces [B] The lattice structure [D] is composed of interconnected struts [E] that protrude from the contact faces and away from the implant's hollow interior [F]. ¶73; p. 30 col. 4:52-57
and wherein two or more of the struts [E] define an opening [G] configured to enable bone through growth through the opening The struts [E] of the lattice form pores or openings [G] that are designed to permit bone to grow through them. ¶73; p. 30 col. 4:57-60
  • Identified Points of Contention:
    • Scope Questions: The central dispute may turn on whether NuVasive's "optimized body lattice structure" (Compl. ¶63) meets the definition of the claimed "truss structure." The complaint uses the terms interchangeably, but a key question for the court will be whether the specific arrangement of struts in the accused product, which may be algorithmically generated, falls within the scope of a "truss" as construed from the patent.
    • Technical Questions: A potential point of contention could be the limitation requiring struts that extend "away from an interior of the implant." The complaint's visual evidence shows the Modulus XLIF implant having a complex, interconnected lattice (Compl. p. 30). The parties may dispute whether this geometry satisfies the specific directional and relational requirements of this claim element.

U.S. Patent No. 9,999,516 Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
An implant comprising an internal web structure [P] The accused Modulus XLIF implant comprises an internal lattice or web structure [P]. ¶83; p. 33 col. 4:10-12
a plurality of planar truss units [S] coupled to each other, the planar truss units [S] comprising a plurality of struts [R] coupled to a plurality of nodes [Q] The web structure is allegedly composed of multiple planar truss units [S, S1, S2] made of struts [R] joined at nodes [Q]. ¶83; p. 33 col. 4:13-20
wherein one or more angles [X] defined by two struts [R] and a node [Q] of one or more planar truss units [S1] are different than one or more corresponding angles [Y]... of one or more other planar truss units [S2] The complaint alleges that the angles [X] in some constituent truss units [S1] are different from the angles [Y] in other units [S2] to create the implant's overall shape. ¶83; p. 33 col. 4:21-28
wherein connecting exterior surface struts [Z] couple the nodes [Q] of the non-equivalent angle planar truss units [S1, S2] to each other such that the implant has a varied height These different-angled units [S1, S2] are allegedly joined by exterior struts [Z], resulting in an implant with a non-uniform, varied height. ¶83; p. 33 col. 4:29-34
  • Identified Points of Contention:
    • Scope Questions: A primary question will be whether the accused lattice can be conceptually deconstructed into the claimed "planar truss units." Defendant may argue its product is a unitary, monolithic structure, whereas Plaintiff's theory requires viewing it as an assembly of discrete, definable units.
    • Technical Questions: Proving infringement will require evidence that the angles within these conceptual "units" are, in fact, different in the specific manner claimed and that this is the mechanism that results in the implant's varied height. The complaint's annotated photograph provides a visual theory for this allegation (Compl. p. 33).

V. Key Claim Terms for Construction

  • The Term: "truss structure" ('930 Patent)

  • Context and Importance: This term is the central element of the asserted claims of the '930 patent. Its construction will be critical, as the infringement dispute may focus on whether Defendant's "lattice structure" is equivalent to the patented "truss structure." Practitioners may focus on this term because the patent provides an explicit, multi-part definition, creating a specific scope that will be heavily litigated.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The specification provides a general definition: "a 'truss structure' is a structure having one or more elongate struts connected at joints referred to as nodes" ('930 Patent, col. 4:5-7). This broad language may be argued to cover any structure made of interconnected struts.
    • Evidence for a Narrower Interpretation: The specification also defines specific types of trusses, such as "planar truss" and "space truss," and provides examples based on "triangular truss units" ('930 Patent, col. 4:10-41). Defendant may argue that the term should be limited to these more ordered, geometrically regular arrangements depicted in the embodiments, rather than a more random or algorithmically generated lattice.

  • The Term: "planar truss units" ('516 Patent)

  • Context and Importance: The infringement theory for the '516 patent depends on identifying these "units" as the building blocks of the accused implant. The term's construction will determine whether a complex, 3D-printed lattice can be considered an aggregation of these claimed two-dimensional units.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The patent defines a "planar truss unit" as a truss unit where "each of the struts is a substantially straight strut and the entirety of the struts and the nodes of the truss unit lie in substantially the same plane" ('516 Patent, col. 4:17-20). This functional definition could be argued to apply to any localized, planar grouping of struts within the accused lattice.
    • Evidence for a Narrower Interpretation: The specific embodiments heavily feature triangular units (e.g., Fig. 3A, "planar triangular truss"). Defendant may argue that the term "planar truss units" should be construed to require the discrete, geometrically regular, and separable character of the triangular building blocks shown in the patent's figures, not just any arbitrary planar section of a complex lattice.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges that NuVasive induces infringement by providing the Modulus implants to surgeons with instructions, tools, indications for use, and assistance for their surgical implantation in patients (Compl. ¶¶74, 84).
  • Willful Infringement: The complaint alleges willful infringement based on extensive pre-suit knowledge. The allegations state that NuVasive had actual knowledge of 4web Inc's patent portfolio, including the issued '930 patent, as early as May 2015 during partnership discussions held under an NDA (Compl. ¶¶49, 75). It further alleges that NuVasive's own patent attorneys cited publications of several asserted patents as prior art during prosecution of a NuVasive patent, allegedly confirming knowledge of the technology (Compl. ¶54).

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

  • A core issue will be one of definitional scope: can the term "truss structure," which is defined in the patents with reference to discrete struts, nodes, and geometric units, be construed to read on the accused "optimized body lattice structure," which Defendant may characterize as a monolithic, algorithmically generated mesh?
  • A central evidentiary question will concern pre-suit knowledge and intent: what was the scope and impact of the technical information allegedly disclosed to NuVasive during the 2015 partnership discussions, and do these facts, combined with the subsequent prosecution history of NuVasive's own patents, provide a sufficient basis for a finding of willful infringement?
  • A key technical question spanning multiple asserted patents will be one of programmable function: does the evidence show that the accused Modulus implants are designed by "predetermining" specific strut characteristics (e.g., density, length, diameter) to create the claimed "microstrain" necessary to produce an "osteogenetic response," or is their structure simply optimized for general strength and porosity without regard to this specific claimed biological mechanism?