DCT

3:24-cv-01021

4web Inc v. NuVasive Inc

Log In

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:23-cv-192, E.D. Tex., 11/03/2023
  • Venue Allegations: Plaintiff alleges venue is proper because Defendant maintains a "regular and established place of business" in the district through its employees' required presence and business activities in hospitals and surgery centers, and because Defendant employs full-time, exclusive employees who reside in the district.
  • Core Dispute: Plaintiff alleges that Defendant’s Modulus line of 3D-printed spinal implants infringes eleven patents related to truss-based implant structures designed to promote bone fusion.
  • Technical Context: The technology involves orthopedic implants, particularly for spinal fusion, that utilize complex, lightweight truss or lattice geometries to provide structural support while encouraging osseointegration.
  • Key Procedural History: The complaint details significant pre-suit history between the parties, alleging that beginning in 2015, NuVasive engaged in partnership discussions with 4WEB, entered into a mutual non-disclosure agreement, and conducted due diligence on 4WEB's intellectual property portfolio, which included the asserted patents or their antecedents. The complaint also notes that NuVasive cited the earliest asserted patent and related applications during the prosecution of its own patent, which may be significant for establishing knowledge in the context of willfulness allegations.

Case Timeline

Date Event
2008-12-18 Priority Date for ’930, ’516, ’317, and ’421 Patents
2012-09-25 Priority Date for ’845, ’823, ’669, ’235, ’756, and ’137 Patents
2013-03-15 Priority Date for ’226 Patent
2013-04-30 U.S. Patent No. 8,430,930 Issues
2015-02-27 Meeting between 4WEB and NuVasive executives to discuss potential partnership
2015-03-03 Mutual Non-Disclosure Agreement between parties becomes effective
2015-05-13 NuVasive proposes partnership framework to 4WEB, acknowledging due diligence on 4WEB's IP
2015-08-29 Partnership discussions between parties allegedly terminated
2016-03-01 U.S. Patent No. 9,271,845 Issues
2017-01-17 U.S. Patent No. 9,545,317 Issues
2017-01-24 U.S. Patent No. 9,549,823 Issues
2017-02-21 U.S. Patent No. 9,572,669 Issues
2017-05-02 U.S. Patent No. 9,636,226 Issues
2017-09-12 U.S. Patent No. 9,757,235 Issues
2018-06-05 U.S. Patent No. 9,987,137 Issues
2018-06-18 U.S. Patent No. 9,999,516 Issues
2018-08-29 Parties' obligations under the Non-Disclosure Agreement allegedly terminated
2019-04-30 NuVasive representative discloses ’930 Patent and related applications in an IDS for a NuVasive patent
2020-12-01 U.S. Patent No. 10,849,756 Issues
2022-03-22 U.S. Patent No. 11,278,421 Issues
2023-11-03 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 then-existing spinal implants, which often featured large, solid rims that could impede bone growth and concentrate stress on small areas of the vertebrae ('930 Patent, col. 1:18-47).
  • The Patented Solution: The invention is an implant with a "truss structure" comprising struts that extend from the bone-contacting face. This design provides structural support while creating open spaces, which allows bone to grow through the implant itself, creating a strong, interlocked fusion ('930 Patent, Abstract; col. 5:4-16). Figure 1A illustrates an implant body (100) with an external truss structure (105) designed for this purpose ('930 Patent, FIG. 1A).
  • Technical Importance: The truss approach allows the implant to be an active participant in the healing and fusion process, rather than acting as a simple static spacer between vertebrae (Compl. ¶29).

Key Claims at a Glance

  • The complaint asserts independent claims 1 and 18, and dependent claims 2-10 (Compl. ¶71).
  • Independent claim 1 requires:
    • 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.

U.S. Patent No. 9,999,516 - Implant Device Having a Non-Planar Surface (issued June 18, 2018)

The Invention Explained

  • Problem Addressed: Similar to the '930 patent, this patent addresses the limitations of conventional solid implants in promoting bone fusion ('516 Patent, col. 1:20-50).
  • The Patented Solution: The invention is an "internal web structure" built from multiple "planar truss units." The key innovation is that the angles formed by struts and nodes within different truss units vary, and these units are connected by "exterior surface struts" to create an implant with a "varied height." This allows the creation of implants with complex, non-planar surfaces to better match patient anatomy, such as lordotic curves for the spine ('516 Patent, Abstract; col. 4:10-45).
  • Technical Importance: This design enables the creation of anatomically correct implant shapes that promote spinal alignment while retaining the open, porous structure conducive to bone growth.

Key Claims at a Glance

  • The complaint asserts independent claims 1 and 18, and dependent claims 4, 6, and 8 (Compl. ¶82).
  • Independent claim 1 requires:
    • An implant comprising an internal web structure;
    • The internal web structure comprises a plurality of planar truss units coupled to each other, with each unit comprising struts coupled to nodes;
    • Wherein one or more angles defined by struts and a node of one planar truss unit are different than corresponding angles in another planar truss unit;
    • Wherein connecting exterior surface struts couple the nodes of the non-equivalent angle planar truss units to create a varied implant height; and
    • Wherein the planar truss units are coupled such that one or more units lie in a plane that is not substantially parallel to the plane of another unit.

U.S. Patent No. 9,545,317 - Implant Interface System And Device (issued January 17, 2017)

The Invention Explained

  • This patent describes an orthopedic implant with a "bone interface structure" that protrudes from the main implant body's bone interface surface. This structure is composed of a web of struts and nodes, and is designed to be disposed at least partially into a bone structure to promote fixation and fusion (Compl. ¶93).
  • Accused Features: The Modulus implants are alleged to have a bone interface structure with struts and nodes configured to be disposed at least partially into vertebrae (Compl. ¶93).

Key Claims at a Glance

  • At least claims 1-22 are asserted (Compl. ¶92).

U.S. Patent No. 11,278,421 - Implant Device Having Curved or Arced Struts (issued March 22, 2022)

The Invention Explained

  • This patent covers an implant with an external frame that partially encloses an "internal space truss structure." A key feature is that at least two nodes within this internal truss are connected by a strut that "curves or arcs" ('421 Patent, Abstract). This allows for more complex and potentially stronger internal geometries.
  • Accused Features: The Modulus implants are alleged to have an external frame and an internal space truss structure with planar truss units and curved struts joining nodes (Compl. ¶103).

Key Claims at a Glance

  • At least claims 1-3, 7, 9-12, 14, 15, and 20 are asserted (Compl. ¶102).

U.S. Patent No. 9,271,845 - Programmable Implants And Methods Of Using Programmable Implants To Repair Bone Structures (issued March 1, 2016)

The Invention Explained

  • This patent focuses on the biomechanical properties of the implant's web structure. It claims an implant where the diameter, length, or density of the struts are "predetermined" to create a specific "microstrain" in adhered bone cells (osteoblasts) when under load. This microstrain is intended to stimulate an "osteogenetic response," actively promoting bone growth ('845 Patent, Abstract; col. 2:13-25).
  • Accused Features: The complaint alleges that the trusses of the Modulus implants are optimized (i.e., predetermined) by modifying strut length, diameter, and/or density to induce an osteogenetic response and promote bone growth (Compl. ¶113).

Key Claims at a Glance

  • At least claims 1-3, 11, 13-15, 18 and 21-26 are asserted (Compl. ¶112).

U.S. Patent No. 9,549,823 - Programmable Implant Having Curved or Arced Struts (issued January 24, 2017)

The Invention Explained

  • This patent combines the concepts of the '845 and '421 patents. It claims a spinal implant with a web structure whose strut characteristics are predetermined to create microstrain and stimulate bone growth, and where at least one of the planar truss units that make up the structure has a "curved or arced strut" ('823 Patent, col. 18:22-26).
  • Accused Features: The Modulus implants are alleged to have an optimized web structure that includes curved or arced struts and is predetermined to produce an osteogenetic response (Compl. ¶124).

Key Claims at a Glance

  • At least claims 1-3, 11, 13-17, 20, and 22-24 are asserted (Compl. ¶123).

U.S. Patent No. 9,572,669 - Programmable Implant Having An Angled Exterior Surface (issued February 21, 2017)

The Invention Explained

  • This patent is similar to the '845 patent but adds geometric constraints related to creating a varied height. It claims an implant with a predetermined microstrain-inducing web structure where connecting exterior struts couple non-equivalent angle planar truss units, resulting in a varied implant height ('669 Patent, col. 18:3-13).
  • Accused Features: The Modulus implants are alleged to have an optimized, microstrain-inducing web structure with features that result in a varied height for anatomical fit (Compl. ¶135).

Key Claims at a Glance

  • At least claims 1-3, 11, 13-17, 19, and 22-24 are asserted (Compl. ¶134).

U.S. Patent No. 9,757,235 - Spinal Programmable Implant (issued September 12, 2017)

The Invention Explained

  • This patent is directed to a spinal implant with a web structure comprising a plurality of struts joined at nodes to form a space truss. The key limitations are that the strut characteristics are predetermined to create microstrain for osteogenesis, and the implant has a shape and size specifically allowing it to be implanted between vertebrae ('235 Patent, col. 18:15-32).
  • Accused Features: The complaint alleges the Modulus implants are spinal implants with a web structure having predetermined strut characteristics designed to create microstrain and promote bone growth (Compl. ¶146).

Key Claims at a Glance

  • At least claims 1-3, 11, 13-17, 20, and 22-24 are asserted (Compl. ¶145).

U.S. Patent No. 10,849,756 - Programmable Implant (issued December 1, 2020)

The Invention Explained

  • This patent claims an implant with a web structure where the density of the structure is predetermined to create microstrain in bone cells upon contact. The structure comprises a space truss with two or more planar truss units ('756 Patent, Abstract). This focuses on density as the key design parameter for stimulating bone growth.
  • Accused Features: The Modulus implants are alleged to have a web structure with a predetermined density modified to provide an osteogenetic response (Compl. ¶168).

Key Claims at a Glance

  • At least claims 1-3, 8-10, and 15 are asserted (Compl. ¶167).

U.S. Patent No. 9,987,137 - Programmable Implant Having Curved Or Arced Struts (issued June 5, 2018)

The Invention Explained

  • This patent is substantially similar to the '823 patent. It claims a spinal implant with a web structure whose strut characteristics are predetermined to create microstrain and stimulate bone growth, and where at least one of the planar truss units comprises one or more curved or arced struts ('137 Patent, col. 18:25-41).
  • Accused Features: The complaint alleges the Modulus implants have an optimized web structure that includes curved or arced struts and is predetermined to produce an osteogenetic response (Compl. ¶157).

Key Claims at a Glance

  • At least claims 1-3, 11, 13-17, 20, and 22-24 are asserted (Compl. ¶156).

U.S. Patent No. 9,636,226 - Traumatic Bone Fracture Repair Systems and Methods (issued May 2, 2017)

The Invention Explained

  • This patent describes an implant for general bone interfacing, not just spinal. It claims a web structure comprising a space truss with "one or more cylindrical channels extending through" it. These channels have exits on at least two sides of the structure, allowing for the passage of fasteners like bone screws ('226 Patent, Abstract).
  • Accused Features: The Modulus ALIF product is specifically accused of having a web structure with cylindrical channels for fasteners extending through the space truss (Compl. ¶179).

Key Claims at a Glance

  • At least claims 1, 3, 4, 7, 9, and 15 are asserted (Compl. ¶178).

III. The Accused Instrumentality

Product Identification

  • The accused products are a series of spinal implant products identified as Modulus ALIF, Modulus Cervical (or Modulus-C), Modulus XLIF, Modulus TLIF-0, and Modulus TLIF-A (collectively, the "Modulus implants") (Compl. ¶62).

Functionality and Market Context

  • The Modulus implants are described as 3D-printed titanium interbody fusion devices for spine surgery (Compl. ¶¶ 64-66). Their design allegedly integrates "endplate porosity with an optimized body lattice structure, providing a fully porous architecture and favorable environment for osseointegration – bone on-growth and in-growth" (Compl. ¶63). The complaint includes a series of screenshots from a NuVasive animation depicting the 3D printing process where a laser selectively melts powdered titanium to build the implant layer by layer (Compl. p. 28). NuVasive is presented as a major competitor to 4WEB in the spinal implant market, and the Modulus products are described as "market disrupting" and part of an "Advanced Materials Science portfolio" (Compl. ¶¶ 55, 57-58, 63).

IV. Analysis of Infringement Allegations

’930 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
an implant body comprising one or more contact faces configured to be disposed at or near a bony structure The Modulus XLIF implant has a body [A] with upper and lower contact faces [B] that are configured for placement near vertebrae [C]. ¶73, p. 30 col. 5:5-10
a truss structure coupled to at least one of the contact faces, wherein the truss structure is configured to be disposed adjacent the bony structure during use The implant includes a lattice/truss structure [D] coupled to the contact faces [B] and is configured to be adjacent to the vertebrae [C] when implanted. ¶73, p. 30 col. 5:10-13
wherein the truss structure comprises two or more struts extending from the contact face, away from an interior of the implant defined, in part by one or more of the contact faces The truss structure [D] is composed of multiple struts [E] that extend from the contact faces and away from the interior [F] of the implant. ¶73, p. 30 col. 5:13-16
and wherein two or more of the struts define an opening configured to enable bone through growth through the opening The struts [E] form openings [G] throughout the structure that are configured to permit bone to grow through them. ¶73, p. 30 col. 5:15-18
  • Identified Points of Contention:
    • Scope Questions: A primary question may be whether the accused "optimized body lattice structure" (Compl. ¶63) falls within the scope of the term "truss structure" as it is used and defined in the '930 Patent. A defendant could argue that its more complex, algorithmically-generated lattice is distinct from the more regular geometric truss arrangements disclosed in the patent.
    • Technical Questions: Analysis may focus on the limitation requiring struts that are "extending from the contact face, away from an interior of the implant." The complaint's visual evidence shows an integrated lattice structure (Compl. p. 30). The court may need to determine whether this structure can be technically characterized as having struts that extend "from" a face and "away" from an interior, or if it is a different configuration altogether.

’516 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
An implant comprising an internal web structure [P] The Modulus XLIF implant is alleged to be or contain an internal web structure [P]. ¶83, p. 33 col. 4:19-21
wherein the internal web structure comprises: a plurality of planar truss units 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 alleged to be composed of multiple planar truss units [S] made of struts [R] joined at nodes [Q]. ¶83, p. 33 col. 4:21-24
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] defined by two struts [R] and a node [Q] of one or more other planar truss units [S2] The complaint alleges that angles [X] in one part of the structure [S1] are different from corresponding angles [Y] in another part [S2]. ¶83, p. 33 col. 4:26-32
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 It is alleged that connecting struts [Z] join the different planar truss units, resulting in an implant with a varied height to conform to spinal anatomy. ¶83, p. 33 col. 4:32-36
wherein the plurality of planar truss units are coupled to one another such that one or more planar truss units lie in a plane that is not substantially parallel to a plane of a planar truss unit that shares at least one strut with the one or more planar truss units [S1, S2] The complaint alleges the planar truss units are arranged in three dimensions, such that their respective planes are not substantially parallel. ¶83, p. 34 col. 4:37-45
  • Identified Points of Contention:
    • Scope Questions: A central dispute will likely be whether the accused lattice can be conceptually and technically deconstructed into the claimed "plurality of planar truss units." A defendant may argue its product is a monolithic, homogenous 3D lattice that lacks the discrete, identifiable "planar" sub-units required by the claim.
    • Technical Questions: The complaint's infringement theory relies on identifying these discrete "planar truss units" [S1, S2] and the "connecting exterior surface struts" [Z] in the accused product's integrated lattice (Compl. p. 33). A key evidentiary question will be whether the actual geometry of the Modulus implant satisfies the specific structural and relational limitations between these claimed units, such as differing angles and non-parallel planes.

V. Key Claim Terms for Construction

  • "truss structure" ('930 Patent)

    • Context and Importance: This term is fundamental to the infringement allegation against the '930 patent. NuVasive describes its accused feature as a "lattice structure" (Compl. ¶63). The case may turn on whether "lattice structure" is merely a synonym for "truss structure" or describes a technically distinct configuration outside the claim's scope.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The '930 patent specification defines a "truss" broadly as "a structure having one or more elongate struts connected at joints referred to as nodes" and lists several variants ('930 Patent, col. 3:51-55). This could support a broad definition covering any strut-based framework.
      • Evidence for a Narrower Interpretation: The specification's examples and figures consistently depict ordered, geometric arrangements based on recognizable units like triangles and pyramids ('930 Patent, FIG. 1A, FIG. 3A). This could support a narrower construction that excludes more random or algorithmically complex lattice structures.

  • "planar truss units" ('516 Patent)

    • Context and Importance: The infringement theory for the '516 patent depends on identifying these discrete "units" within the accused product's lattice. Practitioners may focus on this term because if the accused lattice cannot be technically parsed into these claimed sub-components, the claim's subsequent limitations regarding their relationships (e.g., different angles, non-parallel planes) may not be met.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The '516 patent describes that a space truss can be formed from planar truss units that are "angled with respect to one another (e.g., not parallel to one another)" ('516 Patent, col. 4:29-32). This suggests the term can be applied to constituent parts of a larger 3D structure.
      • Evidence for a Narrower Interpretation: The patent explicitly defines a "planar truss" as a structure where "all of the struts and nodes lie substantially within a single two-dimensional plane" ('516 Patent, col. 4:10-13). A defendant may argue that in a continuously formed 3D-printed lattice, no such truly two-dimensional sub-units exist, making the term inapplicable.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges inducement of infringement for all eleven patents. The basis for this allegation is that NuVasive provides the accused Modulus implants to surgeons along with "indications for use and with instructions, tools, and assistance for surgically inserting" the products, allegedly with the specific intent that surgeons will use them in an infringing manner (Compl. ¶¶ 74, 84, 94).
  • Willful Infringement: The complaint alleges willful infringement for all eleven patents. The basis for willfulness is extensive alleged pre-suit knowledge. The complaint asserts that NuVasive was on "full notice" of 4WEB's intellectual property as early as May 2015 due to partnership discussions, due diligence conducted under a mutual non-disclosure agreement, and NuVasive's own citation of the '930 patent and its parent applications in an Information Disclosure Statement during the prosecution of a NuVasive patent (Compl. ¶¶ 49-54, 75).

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

  • A core issue will be one of definitional scope: can the patent terms "truss structure" and "planar truss units," which are described in the patents with reference to ordered geometric shapes, be construed to cover the accused products' "optimized body lattice structure," which the complaint itself acknowledges is a key feature of a "market disrupting" design?
  • A second central issue will be willfulness based on pre-suit knowledge: the complaint provides detailed factual allegations regarding a prior business relationship, including due diligence on the asserted patent families and citations in NuVasive's own patent prosecution. A key question for the court will be whether this history establishes that any infringement, if found, was willful, potentially exposing the defendant to enhanced damages.
  • A third key question will be one of claim differentiation and redundancy: with eleven patents asserted against the same product line based on overlapping truss-based technologies, the case will require a determination of whether each asserted claim presents a unique and patentably distinct question of infringement, or if the dispute can be streamlined by focusing on a smaller set of representative claims.