3:26-cv-00254
Zavation Medical Products LLC v. Jackson
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Zavation Medical Products, LLC (Mississippi)
- Defendant: Roger P. Jackson, M.D. (Kansas); Thomas Gemmell (Illinois/California); Iqra Iqbal (California); and Polsinelli PC (Missouri)
- Plaintiff’s Counsel: Phelps Dunbar LLP
- Case Identification: 3:26-cv-00254, S.D. Miss., 05/01/2026
- Venue Allegations: Venue is based on the defendants having directed infringement accusations and licensing demands to the plaintiff's principal place of business in Flowood, Mississippi.
- Core Dispute: Plaintiff seeks a declaratory judgment of non-infringement and invalidity for eighteen patents related to spinal fixation devices, and further alleges that Defendants' assertion of these patents violates the Mississippi Bad Faith Assertions of Patent Infringement Act.
- Technical Context: The technology involves polyaxial pedicle screws and related instrumentation used in posterior spinal fixation surgery to correct deformities and stabilize the spine.
- Key Procedural History: This declaratory judgment action arises from a nearly two-year licensing campaign initiated by the Defendants. The complaint alleges that a 2014 agreement between Defendant Jackson and NuVasive, Inc. automatically assigned rights to several of the asserted patents to NuVasive, raising a question of Jackson's standing to sue. This standing issue was previously litigated in a Delaware case (Jackson v. Highridge Medical LLC), where a court dismissed Jackson's claims on similar patents for lack of standing. The complaint also centers on the alleged insufficiency of claim charts provided by the Defendants, which forms the basis for the bad faith assertion claim under Mississippi state law.
Case Timeline
| Date | Event |
|---|---|
| 2005-02-22 | Earliest Priority Date ('638 Patent) |
| 2007-09-17 | Earliest Priority Date ('078, '958 Patents) |
| 2007-11-19 | Earliest Priority Date ('452, '577, '095, '301, '079, '080, '069 Patents) |
| 2008-03-05 | Original Development and License Agreement (Jackson & NuVasive) |
| 2008-08-22 | Earliest Priority Date ('392 Patent) |
| 2008-09-29 | Earliest Priority Date ('856 Patent) |
| 2008-11-19 | Earliest Priority Date ('932 Patent) |
| 2009-05-18 | Earliest Priority Date ('319 Patent) |
| 2009-09-08 | Earliest Priority Date ('352 Patent) |
| 2009-10-05 | Earliest Priority Date ('938 Patent) |
| 2010-12-23 | Earliest Priority Date ('853 Patent) |
| 2011-02-07 | Earliest Priority Date ('027 Patent) |
| 2013-01-15 | Issue Date: U.S. Patent No. 8,353,932 |
| 2013-10-15 | Issue Date: U.S. Patent No. 8,556,938 |
| 2014-12-31 | Amended and Restated Agreement (Jackson & NuVasive) |
| 2016-04-12 | Issue Date: U.S. Patent No. 9,308,027 |
| 2016-10-04 | Issue Date: U.S. Patent No. 9,456,853 |
| 2018-06-19 | Issue Date: U.S. Patent No. 9,999,452 |
| 2018-08-07 | Issue Date: U.S. Patent No. 10,039,577 |
| 2019-04-02 | Issue Date: U.S. Patent No. 10,245,078 |
| 2019-10-15 | Issue Date: U.S. Patent No. 10,441,319 |
| 2020-08-25 | Issue Date: U.S. Patent No. 10,751,095 |
| 2021-07-06 | Issue Date: U.S. Patent No. 11,051,856 |
| 2021-11-30 | Issue Date: U.S. Patent No. 11,185,352 |
| 2022-08-23 | Issue Date: U.S. Patent No. 11,419,638 |
| 2023-07-25 | Issue Date: U.S. Patent No. 11,707,301 |
| 2023-11-28 | Issue Date: U.S. Patent No. 11,826,079 |
| 2024-03-12 | Issue Date: U.S. Patent No. 11,925,392 |
| 2024-03-19 | Issue Date: U.S. Patent No. 11,931,080 |
| 2024-05-02 | Defendants' Initial Demand Letter to Zavation |
| 2024-07-02 | Issue Date: U.S. Patent No. 12,023,069 |
| 2025-11-18 | Issue Date: U.S. Patent No. 12,471,958 |
| 2026-03-29 | Highridge Opinion Issued by D. Delaware Court |
| 2026-05-01 | Complaint Filing Date |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 8,353,932 - "Polyaxial Bone Anchor Assembly With Non-Round Compressible Pressure Insert And Elongate Member"
- Issued: January 15, 2013
The Invention Explained
- Problem Addressed: The patent describes the difficulty in spinal surgery of aligning and connecting multiple bone screws to a single corrective rod, especially when the vertebrae are misaligned (’932 Patent, col. 1:23-45). While polyaxial screws allow the screw head to pivot, securely locking them at the desired angle without slippage remains a challenge.
- The Patented Solution: The invention is a polyaxial bone screw assembly that uses a specialized "pressure insert" to lock the screw's angle. The assembly includes the screw shank, a receiver that holds the spinal rod, and the insert ('932 Patent, Fig. 1). When a closure cap is tightened onto the receiver, it forces the rod against the insert, which in turn compresses and locks against the head of the screw shank ('932 Patent, abstract). A key feature is that the insert has a "non-round" portion that mates with the receiver to prevent the insert itself from rotating during tightening, ensuring a secure lock ('932 Patent, col. 2:1-17).
- Technical Importance: This design aims to provide surgeons with both the flexibility of polyaxial movement for screw placement and a more reliable mechanism for rigidly locking the final spinal construct.
Key Claims at a Glance
- The complaint does not specify which claims were asserted by the Defendants. For the purpose of this analysis, independent claim 22 is representative.
- Key elements of independent claim 22 include:
- A medical implant assembly comprising a pair of opposed polyaxial bone screw assemblies and a longitudinal connecting member.
- Each assembly including a receiver, a shank, and a pressure insert.
- The pressure insert being "compressible" and having at least one "non-round" portion.
- The insert being top-loadable into the receiver and sized to engage the shank.
- A closure top that engages the receiver to bear against the connecting member, which in turn bears against the insert to lock the shank.
- The complaint seeks a declaration of non-infringement for all claims of the patent ('932 Patent, prayer S).
U.S. Patent No. 8,556,938 - "Polyaxial Bone Anchor With Non-Movable Expandable Retainer, And Pop-On Shank, Some With Friction Fit"
- Issued: October 15, 2013
The Invention Explained
- Problem Addressed: The patent addresses the need for polyaxial bone screws that are easy to assemble during surgery and can be securely locked in place (’938 Patent, col. 1:20-35). It notes that pre-assembled screw-and-receiver units can be bulky and that assembling them in situ can be difficult.
- The Patented Solution: This invention provides a polyaxial screw assembly where the screw shank can be "popped on" or "snapped on" to the receiver during the surgical procedure ('938 Patent, col. 2:22-30). This is accomplished using an "expandable, non-movable retainer" that is pre-seated in the receiver. When the shank head is pushed into the receiver, it expands the retainer, which then snaps back to capture the shank head, allowing pivotal motion but preventing disassembly ('938 Patent, abstract; '938 Patent, Fig. 1).
- Technical Importance: The "pop-on" feature simplifies the surgical workflow by allowing the surgeon to first place the screw shank into the bone and then attach the receiver, which may be more efficient than handling a pre-assembled unit.
Key Claims at a Glance
- The complaint does not specify which claims were asserted by the Defendants. For the purpose of this analysis, independent claim 31 is representative.
- Key elements of independent claim 31 include:
- A medical implant assembly comprising a receiver, a shank, a retainer, an insert, and a closure.
- An "expandable, non-movable retainer" having a "first, non-expanded configuration and a second expanded configuration."
- The retainer being loaded into the receiver and returning to the non-expanded configuration to capture the shank upper portion.
- The shank upper portion cooperating with the insert to "create a ball and socket joint."
- The complaint seeks a declaration of non-infringement for all claims of the patent ('938 Patent, prayer T).
U.S. Patent No. 9,308,027 - "Polyaxial Bone Screw With Shank Articulation Pressure Insert And Method"
- Issued: April 12, 2016
- Technology Synopsis: Describes a polyaxial bone screw with a U-shaped cradle insert that engages the screw shank. Downward pressure from a rod and closure top on the insert locks the screw's polyaxial position (’027 Patent, abstract).
- Asserted Claims: Unspecified claims (Compl. ¶157). Independent claims 1 and 24 are representative.
- Accused Features: Zavation’s Corelink Tiger and Centrafix spinal systems and related product line extensions (Compl. ¶158).
U.S. Patent No. 9,456,853 - "Polyaxial Bone Screw With Shank Articulation Pressure Insert And Method"
- Issued: October 4, 2016
- Technology Synopsis: Similar to the '027 patent, this patent describes a polyaxial bone screw assembly with an insert. The focus is on the geometry of the insert and its interaction with the screw head and a spinal rod to create a locked, stable construct (’853 Patent, abstract).
- Asserted Claims: Unspecified claims (Compl. ¶161). Independent claims 1 and 4 are representative.
- Accused Features: Zavation’s Corelink Tiger and Centrafix spinal systems and related product line extensions (Compl. ¶162).
U.S. Patent No. 9,999,452 - "Bone Anchor Receiver With Upper Tool Engaging Grooves And Planar Faces"
- Issued: June 19, 2018
- Technology Synopsis: This patent focuses on the design of the receiver part of a bone anchor, specifically including tool-engaging grooves and planar surfaces on the receiver's arms. These features are designed to interface with surgical installation tools (’452 Patent, abstract).
- Asserted Claims: Unspecified claims (Compl. ¶165). Independent claim 1 is representative.
- Accused Features: Zavation’s Corelink Tiger and Centrafix spinal systems and related product line extensions (Compl. ¶166).
U.S. Patent No. 10,039,577 - "Bone Anchor Receiver With Horizontal Rod Thoracolumbar Tool Attachment Structures And Parallel Planar Outer Surfaces"
- Issued: August 7, 2018
- Technology Synopsis: Details a bone anchor receiver with specific attachment structures for surgical tools, including features for rod reduction and stabilization. The geometry of the receiver arms is designed for secure engagement with these tools (’577 Patent, abstract).
- Asserted Claims: Unspecified claims (Compl. ¶169). Independent claim 1 is representative.
- Accused Features: Zavation’s Corelink Tiger and Centrafix spinal systems and related product line extensions (Compl. ¶170).
U.S. Patent No. 10,245,078 - "Bone Anchor With Symmetrical Horizontally Extending Open-Sided Upper Tool Engaging Grooves"
- Issued: April 2, 2019
- Technology Synopsis: This invention relates to a polyaxial bone screw assembly that includes an insert with a slide surface. A pressure member engages the insert to lock the screw head's angulation. The design focuses on the interaction between the insert, pressure member, and receiver (’078 Patent, abstract).
- Asserted Claims: Unspecified claims (Compl. ¶173). Independent claim 1 is representative.
- Accused Features: Zavation’s Corelink Tiger and Centrafix spinal systems and related product line extensions (Compl. ¶174).
U.S. Patent No. 10,441,319 - "Pivotal Bone Anchor With Tool Engagement Grooves And Break-Off Extensions"
- Issued: October 15, 2019
- Technology Synopsis: The patent describes a polyaxial bone screw assembly with a receiver having break-off extensions for tool engagement. It includes a retainer and compression insert to lock the screw's angulation (’319 Patent, abstract).
- Asserted Claims: Unspecified claims (Compl. ¶177). Independent claims 1 and 15 are representative.
- Accused Features: Zavation’s Corelink Tiger and Centrafix spinal systems and related product line extensions (Compl. ¶178).
U.S. Patent No. 10,751,095 - "Closures With Splay Resisting Threads For Bone Anchor Receivers Having Horizontal Radially-Extending Tool Attachment Grooves"
- Issued: August 25, 2020
- Technology Synopsis: This patent focuses on the closure mechanism for a bone anchor. It describes a closure with a "splay resisting" thread form (e.g., a buttress thread) that engages the receiver arms to prevent them from splaying outward when a rod is locked in place (’095 Patent, abstract).
- Asserted Claims: Unspecified claims (Compl. ¶181). Independent claim 28 is representative.
- Accused Features: Zavation’s Corelink Tiger spinal system and related product line extensions (Compl. ¶182).
U.S. Patent No. 11,051,856 - "Pivotal Bone Anchor Receiver with Upper Tool Engagement Grooves and Protruding Structures"
- Issued: July 6, 2021
- Technology Synopsis: Details a bone anchor receiver featuring specific grooves and protruding structures for engagement with surgical tools. It also describes a pressure insert for locking the polyaxial mechanism (’856 Patent, abstract). This patent is one of the "Assigned Patents" for which standing is disputed (Compl. ¶73).
- Asserted Claims: Unspecified claims (Compl. ¶185). Independent claims 1 and 15 are representative.
- Accused Features: Zavation’s Centrafix, Tiger 2, and Tiger OCT spinal systems and related product line extensions (Compl. ¶186).
U.S. Patent No. 11,185,352 - "Pivotal Bone Anchor Assembly With Pop-On Insert Positioning and Break-Off Extensions and Horizontal Tool Engagement Grooves"
- Issued: November 30, 2021
- Technology Synopsis: This invention describes a polyaxial screw with a "pop-on" insert and break-off extensions on the receiver for tool engagement. The design facilitates assembly and manipulation during surgery (’352 Patent, abstract).
- Asserted Claims: Unspecified claims (Compl. ¶189). Independent claims 1 and 15 are representative.
- Accused Features: Zavation’s Tiger MIS and Tiger X-Tabs spinal systems and related product line extensions (Compl. ¶190).
U.S. Patent No. 11,419,638 - "Pivotal Bone Anchor Assembly With Cannulated Shank Having A Planar Top Surface Surrounding An Internal Drive Socket"
- Issued: August 23, 2022
- Technology Synopsis: The patent relates to a cannulated (hollow) bone screw shank. The shank has a planar top surface around an internal drive socket, designed to cooperate with a pressure insert to lock the screw's angulation (’638 Patent, abstract). This patent is one of the "Assigned Patents" for which standing is disputed (Compl. ¶73).
- Asserted Claims: Unspecified claims (Compl. ¶193). Independent claims 1 and 19 are representative.
- Accused Features: Zavation’s Corelink Tiger spinal systems and related product line extensions (Compl. ¶194).
U.S. Patent No. 11,707,301 - "Threaded Closure For Bone Anchor Receiver With Splay-Resisting Buttress Thread, And Horizontally-Extending Outer Surfaces, And Method Of Use"
- Issued: July 25, 2023
- Technology Synopsis: This invention focuses on a threaded closure for a bone anchor receiver that uses a buttress-style thread to resist the splaying of the receiver arms under load. It also describes tool engagement features on the closure (’301 Patent, abstract).
- Asserted Claims: Unspecified claims (Compl. ¶197). Independent claims 1 and 17 are representative.
- Accused Features: Zavation’s Corelink Tiger and Centrafix spinal systems and related product line extensions (Compl. ¶198).
U.S. Patent No. 11,826,079 - "Closures With Splay Limiting Threads For Bone Anchor Receivers Having Horizontally-Extending Tool Engagement Grooves"
- Issued: November 28, 2023
- Technology Synopsis: Similar to other patents in the family, this patent describes a closure for a bone anchor with threads designed to prevent the receiver arms from splaying. It emphasizes the geometry of the tool engagement grooves (’079 Patent, abstract).
- Asserted Claims: Unspecified claims (Compl. ¶201). Independent claims 1 and 17 are representative.
- Accused Features: Zavation’s Corelink Tiger and Centrafix spinal systems and related product line extensions (Compl. ¶202).
U.S. Patent No. 11,925,392 - "Pivotal Bone Anchor Assembly With Bottom-Loading Pressure Insert And Shank Head Having A Planar Upper Surface"
- Issued: March 12, 2024
- Technology Synopsis: The invention concerns a polyaxial screw assembly where the pressure insert is loaded from the bottom of the receiver. The screw shank head features a planar upper surface that interfaces with the insert (’392 Patent, abstract). This patent is one of the "Assigned Patents" for which standing is disputed (Compl. ¶73).
- Asserted Claims: Unspecified claims (Compl. ¶205). Independent claims 1 and 19 are representative.
- Accused Features: Zavation’s CentraFix, Tiger, Tiger 2, Tiger MIS, Tiger X-Tabs, and Tiger OCT spinal systems (Compl. ¶206).
U.S. Patent No. 11,931,080 - "Closures With Splay Resisting Threads For Pivotal Bone Anchors"
- Issued: March 19, 2024
- Technology Synopsis: This patent describes a closure mechanism for a bone anchor assembly featuring a splay-resisting thread. The closure engages the receiver to lock a spinal rod, and the thread form is designed to counteract outward forces on the receiver arms (’080 Patent, abstract).
- Asserted Claims: Unspecified claims (Compl. ¶209). Independent claims 1 and 10 are representative.
- Accused Features: Zavation’s Tiger and CentraFix spinal systems and related product line extensions (Compl. ¶210).
U.S. Patent No. 12,023,069 - "Closures For Pivotal Bone Anchor Assemblies Having Splay Limiting Thread Forms"
- Issued: July 2, 2024
- Technology Synopsis: This invention also pertains to a closure with splay-limiting threads for use with a polyaxial bone anchor. It describes specific thread geometries and guide structures that resist deformation of the receiver when the assembly is tightened (’069 Patent, abstract).
- Asserted Claims: Unspecified claims (Compl. ¶213). Independent claims 1 and 4 are representative.
- Accused Features: Zavation’s Tiger and CentraFix spinal systems and related product line extensions (Compl. ¶214).
U.S. Patent No. 12,471,958 - "Polyaxial Bone Screw Assembly With Cannulated Screw Shank Having An Internal Drive Socket Surrounded By A Planar Top End Surface"
- Issued: November 18, 2025
- Technology Synopsis: This patent describes a polyaxial screw with a cannulated shank and a planar top surface around an internal drive socket. A pressure insert engages this planar surface to lock the screw's angulation (’958 Patent, abstract). This patent is one of the "Assigned Patents" for which standing is disputed (Compl. ¶73).
- Asserted Claims: Unspecified claims (Compl. ¶217). Independent claims 1 and 10 are representative.
- Accused Features: Zavation’s Tiger MIS and Tiger MIS X-Tabs spinal systems and related product line extensions (Compl. ¶218).
III. The Accused Instrumentality
Product Identification
- The accused instrumentalities are Zavation’s posterior fixation product lines, specifically identified as the "CoreLink Tiger MIS," "Tiger 2," "Tiger X-Tabs," "Tiger OCT," and "CoreLink Centrafix" spinal systems, along with related product line extensions (Compl. ¶29).
Functionality and Market Context
- The complaint describes these products as part of Zavation's portfolio of spinal hardware, used in thoracolumbar, cervical, interbody fusion, and minimally invasive surgery (Compl. ¶25). Images provided in the complaint show these products to be spinal screw assemblies, which are fundamental components for constructing rigid frameworks to stabilize the spine (Compl. ¶29). The complaint characterizes Zavation as a "leading manufacturer" in this field, suggesting the products have significant commercial presence (Compl. ¶25). The complaint shows an image of the "CoreLink Tiger MIS" and other accused products, which appear to be variations of a polyaxial pedicle screw (Compl. ¶29).
IV. Analysis of Infringement Allegations
The complaint is for declaratory judgment of non-infringement and does not contain traditional infringement allegations or claim charts mapping patent claims to the accused products. Instead, the central thrust of the complaint is that the Defendants' pre-suit infringement contentions were legally and factually deficient (Compl. ¶¶ 76; 85-86). The complaint alleges that the claim charts provided by the Defendants failed to identify where specific claim elements were found in any specific Zavation product (Compl. ¶86).
As evidence of these deficiencies, the complaint provides several excerpts from the Defendants' purported claim charts. For example, an excerpt of a chart for the '095 patent allegedly includes the handwritten word "Omit" at the top, suggesting no analysis was performed (Compl. ¶99). This image shows four components of what is labeled as the "CoreLink Tiger" product (Compl. ¶99). Another excerpt for the '027 patent allegedly shows the names of accused products handwritten and then crossed out, creating confusion as to what product is even being accused (Compl. ¶95). A further example concerning the '027 patent shows claim language next to a figure from an unrelated patent, with the word "omit" handwritten next to several key claim limitations (Compl. ¶¶96-98).
The complaint does not provide sufficient detail for a conventional infringement analysis because its purpose is to challenge the adequacy of the Defendants' allegations rather than to rebut a well-pleaded infringement theory.
V. Key Claim Terms for Construction
The complaint does not identify any specific claim terms as being in dispute. However, based on the technology and the representative claims, the following terms may become central to the case if it proceeds to the merits.
Term from '932 Patent (Claim 22): "compressible"
- Context and Importance: The claim requires a "compressible" pressure insert. The degree and nature of the required compressibility will be critical. Whether the material of Zavation's inserts meets this limitation will likely be a point of contention.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification does not limit the term to a specific material, stating the insert may be made from "biocompatible metal alloys" or "polymers" ('932 Patent, col. 9:26-34). This could support a reading that covers any material that deforms elastically or plastically under the force of the closure top.
- Evidence for a Narrower Interpretation: The term is used in the context of the insert deforming to create a "frictional or interference fit" that locks the shank ('932 Patent, col. 2:10-15). A party could argue this implies a specific type or degree of compression sufficient to achieve a robust lock, potentially excluding materials that only minimally deform.
Term from '938 Patent (Claim 31): "non-movable retainer"
- Context and Importance: This term is key to the "pop-on" feature. The dispute will likely center on whether the retainer in Zavation's products is "non-movable" in the way claimed by the patent after it is seated in the receiver.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: "Non-movable" could be interpreted broadly to mean the retainer is not intended to be removed during normal use or surgery, as opposed to being absolutely immobile. The specification states the retainer is "not intended to be removed from the receiver" ('938 Patent, col. 2:28-30).
- Evidence for a Narrower Interpretation: The abstract states the retainer is "non-movably and frictionally retained within the receiver bore." ('938 Patent, abstract). Defendants may argue this requires a specific structural arrangement that creates a permanent, friction-based lock, and that "non-movable" means it cannot be practically removed without destroying the component.
VI. Other Allegations
Bad Faith Patent Assertion: The central allegation, beyond non-infringement and invalidity, is that the Defendants violated the Mississippi Bad Faith Assertions of Patent Infringement Act (BFAPIA) (Compl. ¶¶ 347-354). The complaint alleges this bad faith is evidenced by:
- Demand letters that lack specificity and fail to identify the accused products or the location of infringing features (Compl. ¶142).
- Asserting patents that have expired (Compl. ¶138).
- Asserting patents for which Defendant Jackson allegedly lacks standing (Compl. ¶¶ 355-364).
- Providing deficient claim charts that rely on figures from other patents and fail to map limitations to accused products (Compl. ¶¶ 85-88).
Patent Misuse / Lack of Standing: The complaint alleges that Defendant Jackson lacks standing to assert five of the patents ('932, '856, '638, '392, '958) because he previously assigned his rights to NuVasive, Inc. via a 2014 agreement (Compl. ¶¶ 73; 357). The complaint alleges that Jackson's continued assertion of these patents constitutes patent misuse, as it is an attempt to leverage rights he no longer possesses (Compl. ¶¶ 358-360). This allegation is supported by reference to a 2026 Delaware court opinion that found Jackson lacked standing to assert related patents for the same reason (Compl. ¶¶ 60-67).
VII. Analyst’s Conclusion: Key Questions for the Case
This case appears poised to turn on several threshold legal issues before any substantive infringement analysis occurs.
- A primary issue will be one of ownership and standing: Does Defendant Jackson possess the exclusionary rights necessary to assert the five "Assigned Patents," or did the 2014 agreement with NuVasive automatically transfer those rights, thereby divesting him of standing to sue as alleged by *Zavation Medical Products LLC v. Jackson* and previously found by a Delaware court regarding related patents?
- A second core issue is one of statutory compliance: Did the Defendants' pre-suit communications, including the demand letters and allegedly deficient claim charts, fail to meet the specificity requirements of the Mississippi Bad Faith Assertions of Patent Infringement Act, exposing them to liability under that statute?
- Should the case proceed to the merits, a dispositive technical question will be one of structural identity: Do Zavation's various spinal screw products contain the specific "compressible," "non-round" inserts, "non-movable" retainers, and "splay-resisting" closure threads as recited in the independent claims of the eighteen asserted patents, or are there fundamental structural and operational differences that place them outside the scope of the claims?