DCT
1:18-cv-01974
RSB Spine LLC v. Precision Spine Inc
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: RSB Spine, LLC (Delaware)
- Defendant: Precision Spine, Inc. (Delaware)
- Plaintiff’s Counsel: Morris, Nichols, Arsht & Tunnell LLP; Cooley LLP
- Case Identification: 1:18-cv-01974, D. Del., 04/17/2019
- Venue Allegations: Venue is alleged to be proper in the District of Delaware because the defendant, Precision Spine, is a Delaware corporation that conducts regular business in the state.
- Core Dispute: Plaintiff alleges that Defendant’s spinal fusion systems infringe two patents related to bone plate stabilization devices used in surgical arthrodesis.
- Technical Context: The technology involves spinal implants designed to stabilize adjacent vertebrae, typically in the cervical or lumbar spine, to facilitate bone fusion for treating conditions like degenerative disc disease.
- Key Procedural History: The complaint alleges that Plaintiff provided Defendant with notice of infringement via a letter on July 5, 2018. The '537 Patent is a continuation of a family of applications tracing priority to the filing date of the '234 Patent. Inter Partes Review (IPR) proceedings were initiated against both patents after the complaint was filed. In IPRs IPR2020-00265 and IPR2020-00274, the Patent Trial and Appeal Board found numerous asserted and related claims of the '234 Patent patentable. In IPR2020-00264, the Board similarly found numerous asserted and related claims of the '537 Patent patentable. These post-grant validity challenges, which largely affirmed the patentability of the asserted claims, may significantly influence the litigation.
Case Timeline
| Date | Event |
|---|---|
| 2003-04-21 | Priority Date for '234 and '537 Patents |
| 2006-01-10 | '234 Patent Issued |
| 2017-07-25 | '537 Patent Issued |
| 2018-07-05 | Plaintiff sends notice letter to Defendant |
| 2019-04-17 | First Amended Complaint Filed |
| 2023-01-12 | IPR Certificate Issued for '234 Patent (claims confirmed) |
| 2023-01-13 | IPR Certificate Issued for '537 Patent (claims confirmed) |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 6,984,234 - Bone Plate Stabilization System and Method for its Use
- Patent Identification: U.S. Patent No. 6,984,234, Bone Plate Stabilization System and Method for its Use, issued January 10, 2006.
The Invention Explained
- Problem Addressed: The patent describes disadvantages of prior art spinal fixation devices, including over-rigid fixation that leads to "stress shielding" and prevents bone fusion, insecure screw locking that can result in screw "backout," and the risk of damage to the spinal cord from overpenetration of screws ('234 Patent, col. 2:6-25). The complaint notes that prior art devices had an "inability to properly affix the device to the spine" and "bear the weight of adjacent vertebral bodies" (Compl. ¶24).
- The Patented Solution: The invention is a bone plate system that uses screws inserted at specific, divergent angles to achieve a secure purchase in the adjacent vertebral bodies ('234 Patent, Abstract). The system includes a retaining mechanism, such as a cover plate, to prevent the screws from backing out while still allowing for a limited amount of movement or "toggling" ('234 Patent, col. 5:14-21). This controlled micromotion is intended to allow partial weight sharing across the bone graft, which is critical for promoting fusion ('234 Patent, col. 2:56-61).
- Technical Importance: This design sought to create a more dynamic stabilization system that could provide robust fixation while avoiding the biological problem of stress shielding seen in overly rigid constructs ('234 Patent, col. 2:17-25).
Key Claims at a Glance
- The complaint asserts independent claims 1 (method), 22 (system), and 35 (system) (Compl. ¶40).
- Claim 1 (method) requires: inserting a base plate between bones; introducing first and second bone screws at specified angular ranges (20°-60° and 20°-70°, respectively); and covering the screws to prevent back-out (Compl. ¶41).
- Claim 22 (system) requires: a base plate with screw holes angled at 20°-60° and 20°-70° relative to the plate's bottom surface; first and second bone screws; and a "bone screw retaining means" to cover the screws (Compl. ¶47).
- Claim 35 (system) requires: a base plate sized for "inter-fit" between bones to retain graft material; bone screws; and a "means for interacting" with the screws that "permits movement of at least one of the... bone bodies relative to the base plate" (Compl. ¶52).
- The complaint reserves the right to assert additional claims, including dependent claims (Compl. ¶40).
U.S. Patent No. 9,713,537 - Bone Plate Stabilization System and Method for its Use
- Patent Identification: U.S. Patent No. 9,713,537, Bone Plate Stabilization System and Method for its Use, issued July 25, 2017.
The Invention Explained
- Problem Addressed: This patent, from the same family as the '234 patent, also addresses issues of stress shielding and screw back-out ('537 Patent, col. 2:15-24). It further highlights the problem of high-profile plates aggravating surrounding tissues like the esophagus ('537 Patent, col. 2:54-57).
- The Patented Solution: The '537 patent describes a low-profile bone plate specifically "configured to fit primarily between anterior portions of adjacent vertebral bones' lip osteophytes" ('537 Patent, Abstract). By sitting in this recessed anatomical space, the plate avoids irritating soft tissues and anchors into the osteophytes, which are structurally strong parts of the vertebrae, while sharing weight with the bone graft material to promote fusion ('537 Patent, col. 1:52-67). The design provides for "subsidence control," managing the settling of the vertebrae during the healing process ('537 Patent, col. 1:35-37).
- Technical Importance: This "in-between the osteophytes" approach provides a method for secure, low-profile fixation that leverages the patient's own anatomy for both anchoring and placement.
Key Claims at a Glance
- The complaint asserts independent claims 1, 15, and 21 (all for a system) (Compl. ¶66).
- Claim 1 (system) requires: a base plate "configured to fit primarily between anterior portions of adjacent vertebral bones' lip osteophytes"; a plurality of bone screws; and screw holes angled to direct screws toward specific bone surfaces or osteophytes (Compl. ¶67).
- Claim 15 (system) requires: a base plate configured to fit "primarily between ... lip osteophytes, without covering significant portions of the top surfaces of the bone bodies," to bear weight and permit force transmission through the graft material; and screws configured to "anchor primarily into the lip osteophytes" (Compl. ¶75).
- Claim 21 (system) requires: a base plate configured to fit "primarily between an anterior portion of the first bone's lip osteophyte and an anterior portion of the second bone's lip osteophyte"; a "first bone engaging region fully extending uninterrupted between lateral extents of the first end"; and first and second bone screws (Compl. ¶80).
- The complaint reserves the right to assert additional claims, including dependent claims (Compl. ¶66).
III. The Accused Instrumentality
Product Identification
- The Vault® ALIF (Anterior Lumbar Interbody Fusion) System and the Vault® C ACDF (Anterior Cervical Discectomy and Fusion) System (Compl. ¶38).
Functionality and Market Context
- The Vault ALIF System is a stand-alone device for fusion of the lumbar spine (L2 to S1) to treat degenerative disc disease and spondylolisthesis. It is designed for use with an autograft and does not require supplementary fixation (Compl. ¶35).
- The Vault C ACDF System is an implant for the cervical spine, inserted from an anterior approach. It is available in various footprints, packed with bone graft, and features serrations on its surfaces to grip the vertebral endplates. It uses screws for fixation and provides mechanical support until biological fusion is achieved (Compl. ¶37).
- The complaint provides a visual of the Vault C ACDF System highlighting its "42° SCREW ANGULATION" feature (Compl. ¶36). This visual directly supports allegations of infringement of claims requiring specific screw angles.
IV. Analysis of Infringement Allegations
U.S. Patent No. 6,984,234 Infringement Allegations
| Claim Element (from Independent Claim 22) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| a base plate having bottom surface and first and second ends, the first end comprising a first bone screw region having a first bone screw hole extending therethrough at an angle relative to the bottom surface of the base plate ranging from about 20° to about 60°... | The Accused Products include a base plate with a first bone screw hole extending at an angle of 20 to 60 degrees. A provided image of the Vault C ACDF System is labeled "42° SCREW ANGULATION" and an image of the Vault ALIF System is labeled "20°". | ¶49, ¶34, ¶36 | col. 2:62-67 |
| ...and the second end comprising a second bone screw region having a second bone screw hole extending therethrough at an angle relative to the bottom surface of the base plate ranging from about 20° to about 70°; | The Accused Products include a second bone screw hole that extends at an angle from 20 to 70 degrees relative to the bottom surface of the base plate. | ¶49 | col. 3:1-3 |
| a first bone screw capable of securing the base plate to a first bone by insertion through the first bone screw hole; | The Accused Products include first and second bone screws capable of securing the base plate to the first and second bones, respectively. | ¶50 | col. 3:4-10 |
| a bone screw retaining means for securedly covering at least a part of the first and second bone screws to prevent the bone screws from backing out from the first and second bones. | The Accused Products include a "bone screw retaining means." A provided image of the Vault C ACDF System is labeled "ONE STEP LOCKING MECHANISM". | ¶51, ¶36 | col. 5:35-43 |
U.S. Patent No. 9,713,537 Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| a base plate having a top surface, first and second ends, a bottom surface, and a plurality of bone screw holes, wherein the base plate is configured to fit primarily between anterior portions of adjacent vertebral bones' lip osteophytes to bear weight... | The Accused Products include base plates configured to fit primarily between the anterior portions of adjacent vertebral bones' lip osteophytes and to bear weight. | ¶70 | col. 1:52-58 |
| a plurality of bone screws configured to fit in the plurality of bone screw holes, respectively; | The Accused Products have multiple bone screws configured to fit in multiple bone screw holes. | ¶71 | col. 1:59-62 |
| wherein a first of the bone screw holes...extends at least partially from the top surface of the base plate and opens at least partially toward the side surface of a first of the vertebral bones; | The Accused Products have a first bone screw hole configured to extend from the top surface of the base plate and open toward the side surface of a first vertebral bone. | ¶72 | col. 1:63-67 |
| wherein each and every one of the plurality of bone screw holes is configured to receive one of the bone screws angled relative to the base plate and oriented generally in an anterior-posterior direction... | The Accused Products have bone screw holes configured to receive bone screws angled relative to a base plate and oriented in an anterior-posterior direction through the top surface of the plate. | ¶74 | col. 14:11-16 |
- Identified Points of Contention:
- Scope Questions: For the '234 patent, the scope of the means-plus-function limitation "means for...permitting movement" in claim 35 will be a central issue. The analysis will question whether the accused products' "ONE STEP LOCKING MECHANISM" (Compl. ¶36) is structurally equivalent to the elongated slot or toggling screw head arrangements disclosed in the '234 patent's specification ('234 Patent, col. 4:63-col. 5:9).
- Technical Questions: For the '537 patent, a primary technical question is whether the Accused Products are, in fact, "configured to fit primarily between" the lip osteophytes as required by the claims (Compl. ¶70). This raises a factual dispute over the intended placement and design of the accused devices versus their actual use and geometry. The definition of "primarily" will be critical to this analysis.
V. Key Claim Terms for Construction
- The Term: "configured to fit primarily between anterior portions of adjacent vertebral bones' lip osteophytes" ('537 Patent, Claim 1)
- Context and Importance: This phrase is central to the asserted claims of the '537 patent and distinguishes it from prior art. The infringement case for the '537 patent hinges on whether the accused products meet this specific positional and structural limitation. Practitioners may focus on this term because it defines the low-profile, anatomically-specific placement that is the core of the asserted invention.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: A party might argue that "primarily" does not require the device to be exclusively between the osteophytes, but rather that the principal portion of the device resides in that space. The specification’s goal of creating a "low profile" device could be used to argue that any configuration achieving this goal by sitting mostly between the osteophytes meets the limitation ('537 Patent, col. 7:6-14).
- Evidence for a Narrower Interpretation: A party could point to the patent's figures, such as Figure 1, which depict the device (10, 21, 22) nestled between the vertebral bodies (14, 16) in a way that suggests it is substantially contained within the boundaries set by the osteophytes. The term "inter-fit" used in related patent '234 suggests a more precise, recessed placement rather than simply sitting on top of the anterior vertebral face ('234 Patent, col. 11:15-25).
VI. Other Allegations
- Indirect Infringement: The complaint alleges induced infringement for both patents. It asserts that Precision provides instruction manuals, training, and advertising that actively encourage and instruct surgeons to use the Accused Products in an infringing manner (Compl. ¶¶ 59-60, 88-89).
- Willful Infringement: The complaint alleges willful infringement of both patents based on Precision’s alleged knowledge of the patents since at least July 5, 2018, the date of a notice letter from RSB. The complaint alleges that Precision did not respond to the notice and continued its allegedly infringing conduct (Compl. ¶¶ 64, 94).
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of definitional scope and placement: For the '537 Patent, can the phrase "configured to fit primarily between...lip osteophytes" be construed to read on the accused Vault® systems? This will require a factual determination of the accused products' geometry and intended surgical placement relative to the specific anatomical landmarks recited in the claims.
- A key evidentiary question will be one of structural equivalence: For the '234 Patent's means-plus-function claim, does the accused products' "ONE STEP LOCKING MECHANISM" perform the claimed function of "permitting movement" in a way that is structurally equivalent to the specific elongated slot and toggling-head embodiments disclosed in the patent's specification?
- A third question relates to damages and willfulness: Given the notice letter and subsequent IPR proceedings that confirmed the patentability of asserted claims, a central issue will be whether Defendant's conduct post-notice and post-IPR rises to the level of willfulness, potentially exposing it to enhanced damages.