DCT
1:19-cv-01515
RSB Spine LLC v. DePuy Synthes Sales Inc
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: RSB Spine, LLC (Delaware)
- Defendant: DePuy Synthes Sales, Inc. and DePuy Synthes Products, Inc. (Delaware)
- Plaintiff’s Counsel: Cooley LLP
- Case Identification: 1:19-cv-01515, D. Del., 10/01/2019
- Venue Allegations: Venue is alleged to be proper in the District of Delaware because Defendants are incorporated in Delaware.
- Core Dispute: Plaintiff alleges that Defendant’s spinal fusion implants infringe two patents related to bone plate stabilization systems.
- Technical Context: The technology relates to implantable devices for spinal fusion surgery, designed to stabilize vertebrae while allowing for bone growth and fusion.
- Key Procedural History: The complaint alleges a detailed pre-suit history between Plaintiff and Defendant’s predecessor, Synthes, Inc., beginning in 2003. This history includes meetings under a non-disclosure agreement, and the alleged disclosure of prototypes, technical information, and patent applications related to the technology that would become the '234 Patent. These allegations form the basis for a claim of pre-suit willful infringement. Public records, though not cited in the complaint, indicate that both asserted patents have survived inter partes review (IPR) proceedings at the U.S. Patent and Trademark Office, with all asserted claims in the '537 patent and the majority of asserted claims in the '234 patent having been found patentable.
Case Timeline
| Date | Event |
|---|---|
| 2003-04-21 | Priority Date ('234 and '537 Patents) |
| 2003-05-27 | Plaintiff (RSB) and Defendant's predecessor (Synthes) arrange meeting |
| 2003-07-21 | RSB and Synthes meet under Non-Disclosure Agreement |
| 2003-07-22 | RSB email to Synthes references "patent apps for both products" |
| 2006-01-10 | U.S. Patent No. 6,984,234 Issues |
| 2007-04-01 | Discussions allegedly begin between DePuy Spine, Inc. and RSB |
| 2011-04-27 | Johnson & Johnson acquires Synthes Spine, Inc., forming DePuy Synthes |
| 2017-07-25 | U.S. Patent No. 9,713,537 Issues |
| 2019-10-01 | First Amended Complaint Filed |
II. Technology and Patent(s)-in-Suit Analysis
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 plates, including the risk of screw "backout," damage to surrounding tissues like the esophagus, and "stress shielding," where an overly rigid plate carries too much load, preventing the bone graft from experiencing the necessary forces to heal and fuse properly ('234 Patent, col. 2:5-34).
- The Patented Solution: The invention is a low-profile bone plate system designed to be inserted between two vertebrae, sitting on top of a bone graft. The system uses bone screws inserted at specific, non-perpendicular angles to anchor the plate into the strongest parts of the vertebrae, known as the lip osteophytes ('234 Patent, col. 6:49-54). This angulation is designed to resist spinal forces more effectively. The system also includes a "bone screw retaining means," such as a small cover plate, to prevent the screws from backing out after surgery ('234 Patent, Fig. 6; col. 5:35-42). Certain embodiments also describe features, like an elongated screw slot, that permit controlled micro-movement to facilitate bone fusion ('234 Patent, col. 5:1-9).
- Technical Importance: The design sought to provide robust stabilization while mitigating common failure modes of earlier plates, offering a biomechanically sophisticated approach that accommodates the natural settling process of the spine during fusion.
Key Claims at a Glance
- The complaint asserts independent claims 1 (a method), 22, 35, and 40 (all systems) (Compl. ¶58).
- Independent Claim 1 (Method):
- inserting a base plate between the side surfaces of the bones;
- introducing a first bone screw through the plate into the first bone at an angle of about 20° to 60° relative to the bone's top surface;
- introducing a second bone screw through the plate into the second bone at an angle of about 20° to 70° relative to the bone's top surface; and
- covering at least a part of the screws to prevent them from backing out.
- Independent Claim 22 (System):
- a base plate with first and second ends, with screw holes extending through at specified angles (20-60° and 20-70°);
- first and second bone screws for securing the plate; and
- a "bone screw retaining means" for covering part of the screws to prevent backout.
- The complaint also asserts dependent claims 35 and 40 (Compl. ¶58). It does not explicitly reserve the right to assert other dependent claims.
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: The patent identifies similar problems as the '234 Patent, including screw backout, stress shielding, and inadequate fixation strength that can lead to "collapse of the graft and angulation of the spine" ('537 Patent, col. 2:40-53).
- The Patented Solution: This patent describes a bone plate system focused on a specific anatomical fit. The base plate is "configured to fit primarily between anterior portions of adjacent vertebral bones' lip osteophytes" ('537 Patent, Abstract; col. 4:55-65). By sitting between these bony protrusions, the plate can bear weight to hold the vertebrae in place while also allowing load to be shared with the bone graft material, which is critical for fusion. The design creates a "low profile" device that avoids covering significant portions of the vertebral bodies, reducing the risk of irritating surrounding tissues ('537 Patent, col. 12:2-15).
- Technical Importance: The invention refines the inter-body plate concept by specifying its placement relative to the lip osteophytes, aiming to achieve a zero-profile construct that is both stable and minimally invasive.
Key Claims at a Glance
- The complaint asserts independent claims 1, 15, and 21 (all systems) (Compl. ¶91).
- Independent Claim 1 (System):
- a base plate configured to fit "primarily between" the lip osteophytes of adjacent vertebral bones to bear weight and share weight with a bone graft;
- a plurality of bone screws;
- wherein first and second screw holes are configured to open at least partially toward the side surface of the respective vertebral bones; and
- wherein the screw holes are configured to receive screws angled relative to the plate in an anterior-posterior direction.
- The complaint does not explicitly reserve the right to assert dependent claims.
III. The Accused Instrumentality
Product Identification
- The Accused Products are the DePuy Synthes Zero-P VA Spacer, Zero-P Spacer, Zero-P Natural Plate, Synfix-LR System, and Synfix Evolution System (Compl. ¶56).
Functionality and Market Context
- The complaint alleges that the Accused Products are stand-alone implants used for anterior spinal fusion surgery, including cervical (ACDF) and lumbar (ALIF) procedures (Compl. ¶¶47, 53, 55). They are designed to combine the function of a cervical interbody spacer, which holds bone graft material, with the benefits of an anterior cervical plate, which provides fixation (Compl. ¶47, ¶49). The complaint highlights features such as a "zero-profile midline" and the use of variable angle or divergent locking screws for fixation (Compl. ¶47, ¶55). The image provided in the complaint of the Zero-P VA Spacer shows a spacer component, a plate with screw holes, and a set of corresponding screws (Compl. ¶46). A separate image depicts the Zero-P Spacer implanted between two vertebrae, illustrating its intended use and low-profile placement (Compl. ¶48).
IV. Analysis of Infringement Allegations
’234 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| inserting between the side surfaces of the bones a base plate... | The Accused Zero-P VA Product includes a base plate that is inserted between the side surfaces of adjacent bones. | ¶62 | col. 8:45-48 |
| introducing a first bone screw through the first screw hole and into the first bone, wherein the first bone screw is introduced at an angle relative to the top surface of the bone ranging from about 20° to about 60° | A first bone screw is inserted through a first screw hole into the first bone at an angle relative to the top surface of the bone between 20 and 60 degrees. | ¶63 | col. 9:5-8 |
| introducing a second bone screw through the second screw hole and into the second bone, wherein the second bone screw is introduced at an angle relative to the top surface of the bone ranging from about 20° to about 70° | A second bone screw is inserted through the second screw hole into the second bone at an angle relative to the top surface of the bone between 20 and 70 degrees. | ¶63 | col. 9:9-12 |
| covering at least a part of the first bone screw and at least a part of the second bone screw to prevent the first and second bone screws from backing out... | Part of the first bone screw and part of the second bone screw are covered to prevent the bone screws from backing out of the bones. | ¶64 | col. 9:13-16 |
Identified Points of Contention
- Technical Questions: A primary factual question will be whether the use of the Accused Products meets the specific angular ranges required by the method claims (e.g., "about 20° to about 60°"). This will likely depend on expert analysis of surgical techniques and product design.
- Scope Questions: The interpretation of "top surface of the bone" may become a point of contention, as the plate is inserted between the "side surfaces." The parties may dispute the frame of reference for measuring the claimed angles.
’537 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| a base plate... configured to fit primarily between anterior portions of adjacent vertebral bones' lip osteophytes to bear weight to hold the vertebral bones while sharing weight with bone graft material for fusion | The Accused Products include base plates configured to fit primarily between anterior portions of adjacent vertebral bones' lip osteophytes to bear and share weight. | ¶95 | col. 38:1-6 |
| 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. | ¶96 | col. 38:7-9 |
| 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 that extends from the top surface of the base plate and opens toward the side surface of a vertebral bone. | ¶97 | col. 38:13-17 |
| wherein a second of the bone screw holes... extends at least partially from the top surface of the base plate and opens at least partially toward the lip osteophyte of a second of the vertebral bones | The Accused Products have a second bone screw hole that extends from the top surface of the base plate and opens toward the lip osteophyte of a second vertebral bone. | ¶98 | col. 38:18-22 |
| 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 screws angled relative to the base plate and oriented in an anterior-posterior direction. | ¶99 | col. 38:23-28 |
Identified Points of Contention
- Scope Questions: A central dispute will likely involve the construction of the phrase "fit primarily between... lip osteophytes." The meaning of "primarily" (e.g., whether it implies a geometric constraint like >50%) and the anatomical definition of "lip osteophyte" will be critical. Defendant may argue its products sit flush with the anterior vertebral face and do not fit "between" the osteophytes in the manner claimed. The visual evidence in the complaint showing an implanted device may be used to support Plaintiff's position (Compl. ¶48).
V. Key Claim Terms for Construction
Term ('537 Patent): "fit primarily between... lip osteophytes"
- Context and Importance: This phrase from claim 1 of the '537 Patent is the core structural limitation that distinguishes the invention. Its construction will likely determine whether the accused "zero-profile" products, which are designed to sit flush with the anterior aspect of the vertebrae, fall within the scope of the claims.
- Intrinsic Evidence for a Broader Interpretation: The specification does not provide an explicit numerical or percentage-based definition for "primarily." Plaintiff may argue that as long as the main load-bearing portion of the plate is situated in the space defined by the osteophytes, the limitation is met, even if other parts of the implant are outside this area.
- Intrinsic Evidence for a Narrower Interpretation: The abstract and summary emphasize this specific fit. Defendant may argue that the term requires the bulk of the plate's structure to be recessed between the osteophytes, not just adjacent to them. The patent repeatedly links this fit to achieving a "low profile" ('537 Patent, col. 12:2-6), which a court could see as constraining the term's meaning to a truly inter-osteophyte placement.
Term ('234 Patent): "bone screw retaining means for securedly covering"
- Context and Importance: This term, appearing in means-plus-function format in independent claim 22 of the '234 Patent, is critical for the non-obviousness and infringement of the system claims. The structure that performs this function must be identified from the specification.
- Intrinsic Evidence for a Broader Interpretation: Plaintiff may argue that any structure disclosed in the patent that covers the screw heads to prevent backout is a corresponding structure, including potentially a simple locking cap or individual locking screws if disclosed as performing this function.
- Intrinsic Evidence for a Narrower Interpretation: The specification consistently and repeatedly describes the "retaining means" as a "retaining plate (50)" that is a distinct component placed over the base plate to cover multiple screws ('234 Patent, Figs. 6-7, col. 5:35-42). A court may limit the scope of the "means" to this specific structure—a separate cover plate—and its equivalents.
VI. Other Allegations
Indirect Infringement
- The complaint alleges both induced and contributory infringement for both patents. For inducement, it alleges Defendant provides instruction materials, training, and services that encourage infringing use (Compl. ¶¶85, 114). For contributory infringement, it alleges the Accused Products are material components especially made for infringing use and are not staple articles of commerce (Compl. ¶¶86, 115).
Willful Infringement
- The complaint alleges willful infringement for both patents. For the '234 Patent, willfulness is based on alleged pre-suit knowledge dating back to at least July 2003, arising from detailed licensing discussions and technical disclosures between Plaintiff and Defendant's predecessor, Synthes (Compl. ¶89). For the '537 Patent, willfulness is based on knowledge "since at least the date of the filing of the original Complaint" (Compl. ¶118).
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of definitional scope: can the term "fit primarily between... lip osteophytes," which suggests a recessed, inter-body placement, be construed to read on the accused "zero-profile" implants, which are designed to sit on the anterior face of the vertebrae?
- A key evidentiary question for the '234 patent will be one of factual proof: can Plaintiff demonstrate that the standard surgical use of Defendant's products results in the specific bone screw angulation ranges (e.g., "about 20° to about 60°") required by the method claims?
- A central question for damages will be pre-suit knowledge: will the evidence of the 2003-era interactions between Plaintiff and Defendant's predecessor, Synthes, be sufficient to establish pre-suit willfulness for infringement of the '234 patent, a finding that could support an award of enhanced damages?