DCT
1:18-cv-01973
RSB Spine LLC v. Medacta USA Inc
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: RSB Spine, LLC (Delaware)
- Defendant: Medacta USA, Inc. (Delaware)
- Plaintiff’s Counsel: Morris, Nichols, Arsht & Tunnell LLP
- Case Identification: 1:18-cv-01973, D. Del., 12/13/2018
- Venue Allegations: Venue is alleged to be proper in the District of Delaware because the Defendant is a Delaware corporation.
- Core Dispute: Plaintiff alleges that Defendant’s MectaLIF spinal fusion device infringes two patents related to bone plate stabilization systems used in spinal surgery.
- Technical Context: The technology concerns medical implants, specifically bone plates and screws, designed to stabilize adjacent vertebrae to promote fusion after the removal of a degenerative intervertebral disk.
- Key Procedural History: The complaint does not mention any significant prior litigation, licensing history, or other procedural events relevant to the patents-in-suit.
Case Timeline
| Date | Event |
|---|---|
| 2003-04-21 | Priority Date for U.S. Patent No. 6,984,234 |
| 2003-04-21 | Earliest Priority Date for U.S. Patent No. 9,713,537 |
| 2006-01-10 | U.S. Patent No. 6,984,234 Issued |
| 2017-07-25 | U.S. Patent No. 9,713,537 Issued |
| 2018-12-13 | 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’s background section identifies shortcomings in prior art spinal fixation devices, including excessively rigid fixation that causes "stress shielding" (which can prevent bone fusion), insecure screw locking that can lead to "screw backout," and high shearing stresses on screws installed perpendicular to a bone plate (’234 Patent, col. 2:17-32).
- The Patented Solution: The invention is a bone plate system designed to sit between adjacent vertebrae, often on a bone graft, rather than over the front of the vertebral bodies. This "low profile" design uses angled screws to anchor into stronger parts of the bone, enhancing stability. Critically, the system is designed to permit limited, controlled movement or "settling" between the bones and the plate during the healing process, which is believed to promote successful fusion (’234 Patent, Abstract; ’234 Patent, col. 4:15-24). Figure 3 illustrates the plate (20) positioned on a bone graft (12) between two vertebral bodies (14, 16).
- Technical Importance: This approach aimed to provide robust spinal stabilization while avoiding the biological problem of stress shielding and reducing the physical profile of the implant to minimize irritation of surrounding soft tissues (’234 Patent, col. 8:5-15).
Key Claims at a Glance
- The complaint asserts independent claim 35 (Compl. ¶37).
- The essential elements of claim 35 are:
- A base plate for retaining bone graft material between two adjacent bone bodies and for permitting force transmission through the graft.
- The base plate is sized for an "inter-fit" between the bone bodies.
- At least first and second bone screws for retaining the plate.
- The base plate has a "means for interacting" with the screws, which includes a "means for permitting movement" of at least one bone body relative to the base plate.
- The complaint alleges infringement of "at least claim 35," reserving the right to assert other claims (Compl. ¶36).
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: As a continuation of the family including the ’234 Patent, this patent addresses the same general problems of providing stable fixation that is not overly rigid, preventing screw backout, and minimizing the implant's profile (’537 Patent, col. 2:15-31).
- The Patented Solution: The ’537 Patent describes a bone stabilization plate specifically "configured to fit primarily between anterior portions of adjacent vertebral bones' lip osteophytes" (’537 Patent, Abstract). This design is intended to bear and share weight with the bone graft material, holding the vertebrae for fusion. The claims detail the specific geometry of the plate and the orientation of its screw holes designed to engage these strong, bony ridges (the osteophytes) for secure anchoring (’537 Patent, col. 37:58-38:23).
- Technical Importance: The claimed configuration, which fits between the vertebral osteophytes, represents a design philosophy aimed at creating a "zero-profile" construct that is less obtrusive and potentially less irritating to surrounding tissues than traditional anterior plating systems (’537 Patent, col. 12:36-49).
Key Claims at a Glance
- The complaint asserts independent claims 1, 15, and 21 (Compl. ¶50). The analysis will focus on claim 1.
- The essential elements of claim 1 are:
- A base plate with top and bottom surfaces and screw holes, configured to fit "primarily between" the lip osteophytes of adjacent vertebrae to bear and share weight.
- A plurality of bone screws.
- A first screw hole that extends from the top surface and opens toward the side surface of a first vertebral bone.
- A second screw hole that extends from the top surface and opens toward the lip osteophyte of a second vertebral bone.
- Each screw hole is configured to receive a screw that is angled in an anterior-posterior direction.
- The complaint explicitly asserts claims 1, 15, and 21, reserving the right to assert others (Compl. ¶50).
III. The Accused Instrumentality
Product Identification
- Medacta’s MectaLIF Anterior Stand Alone – Flush (the "Accused Product") (Compl. ¶32).
Functionality and Market Context
- The Accused Product is described as a "modular anterior interbody fusion device" used to treat degenerative disc disease (Compl. ¶33). The complaint alleges that its design creates a "zero-profile construct" and features "exclusive divergent and convergent screws and a horizontal screw angle that reduces screw back outs" (Compl. ¶33). The complaint provides an illustration of the accused product, including views of its placement between vertebrae and a table of screw sizes (Compl., p. 7). The complaint alleges that Medacta manufactures, distributes, markets, and sells the Accused Product throughout the United States (Compl. ¶4, ¶5, ¶43).
IV. Analysis of Infringement Allegations
U.S. Patent No. 6,984,234 Infringement Allegations
| Claim Element (from Independent Claim 35) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| a base plate for retaining bone graft material between first and second longitudinally-aligned, adjacent bone bodies and for permitting force transmission between the first and second bone bodies through the bone graft material, | The Accused Product includes a base plate that retains bone graft material between vertebrae and permits force transmission through it (Compl. ¶39). | ¶39 | col. 4:15-20 |
| the base plate being sized to have an inter-fit between the first and second adjacent bone bodies and adjacent to lateral extents of the bone graft material such that the first and second bone bodies engage the bone graft material, | The Accused Product’s base plate is sized for an "inter-fit" where the adjacent vertebrae engage the bone graft material (Compl. ¶40). | ¶40 | col. 6:46-51 |
| at least first and second bone screws for extending into the first and second bone bodies, respectively, to retain the base plate between the first and second bone bodies, | The Accused Product has first and second bone screws that extend into the respective vertebral bodies (Compl. ¶41). | ¶41 | col. 4:45-49 |
| the base plate having means for interacting with the first and second bone screws, the means for interacting including means for permitting movement of at least one of the first and second bone bodies relative to the base plate. | The Accused Product’s base plate allegedly has a means for permitting movement of at least one of the vertebrae relative to the base plate (Compl. ¶42). | ¶42 | col. 5:1-9 |
Identified Points of Contention
- Scope Questions: A central dispute may involve the means-plus-function limitation "means for permitting movement... relative to the base plate." The structure disclosed in the ’234 Patent to perform this function is an "elongated bone screw slot" (’234 Patent, col. 5:1-9). The infringement analysis will turn on whether the Accused Product contains an identical or equivalent structure. The complaint's allegations are conclusory on this point, raising the question of what specific feature of the Accused Product allegedly performs this function.
- Technical Questions: What evidence does the complaint provide that the Accused Product, as it operates in situ, actually permits the specific type of "movement" (e.g., sliding or settling to facilitate fusion) described in the patent? The provided visual evidence shows angled screws but does not clearly depict a mechanism for such movement (Compl., p. 7).
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 Product is a bone stabilization system with a base plate that has a top surface, bottom surface, and multiple screw holes, and is configured to fit between osteophytes to bear weight (Compl. ¶53, ¶54). | ¶53, ¶54 | col. 13:46-52 |
| a plurality of bone screws configured to fit in the plurality of bone screw holes, respectively; | The Accused Product has multiple bone screws that fit in the screw holes (Compl. ¶55). | ¶55 | col. 13:28-32 |
| wherein the vertebral bones have top surfaces and have side surfaces generally facing each other; | The Accused Product is used with vertebral bones having these anatomical features (Compl. ¶55). | ¶55 | col. 1:40-48 |
| 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 Product has a first screw hole with the claimed orientation relative to the first vertebral bone (Compl. ¶56). | ¶56 | col. 9:10-24 |
| 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 Product has a second screw hole with the claimed orientation relative to the second vertebral bone's lip osteophyte (Compl. ¶57). | ¶57 | col. 11:25-33 |
| 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 Product’s screw holes are configured to receive screws angled in an anterior-posterior direction (Compl. ¶58). | ¶58 | col. 9:53-60 |
Identified Points of Contention
- Scope Questions: The construction of "fit primarily between... lip osteophytes" will be dispositive. Does this require the plate to be almost entirely situated in the space defined between the bony protrusions of the two vertebrae, or can it be read more broadly to include devices that are merely nested near or partially overlapping them?
- Technical Questions: What evidence will be presented to show that the Accused Product is "configured to... bear weight to hold the vertebral bones while sharing weight with bone graft material for fusion"? This functional limitation describes a complex biomechanical interaction that may require expert testimony and testing to prove or disprove.
V. Key Claim Terms for Construction
For the ’234 Patent
- The Term: "means for permitting movement of at least one of the first and second bone bodies relative to the base plate" (Claim 35).
- Context and Importance: This term is drafted in means-plus-function format under 35 U.S.C. § 112, para. 6. Its scope is not the literal words but is instead limited to the specific structure disclosed in the specification for performing the stated function, and its equivalents. The entire infringement question for this element rests on identifying that structure and assessing its equivalence to the Accused Product.
- Intrinsic Evidence for Interpretation:
- Evidence for a Narrower Interpretation: The specification explicitly identifies the corresponding structure as an "elongated bone screw slot 48" which is "designed so that the second bone screw 25 can slide within the slot relative to the base plate 20" (’234 Patent, col. 9:63-65; col. 5:1-3). This suggests the scope is limited to a physical slot that allows for linear sliding motion.
- Evidence for a Broader Interpretation: A plaintiff might argue that other features allowing for settling or toggling, such as oversized screw holes, could be structural equivalents to the disclosed slot, thereby performing the same function (permitting movement) in substantially the same way to achieve the same result (controlled subsidence).
For the ’537 Patent
- The Term: "configured to fit primarily between anterior portions of adjacent vertebral bones' lip osteophytes" (Claim 1).
- Context and Importance: This phrase defines the fundamental positioning and function of the claimed plate. Whether the Accused Product meets this limitation is a threshold question for infringement. Practitioners may focus on this term because it ties the device's geometry directly to specific, and potentially variable, anatomical landmarks.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The use of the word "primarily" suggests that the fit does not have to be exclusively or entirely between the osteophytes. A plaintiff could argue that as long as the main body or functional core of the plate is situated between the osteophytes, the limitation is met, even if other parts are not (’537 Patent, col. 13:46-52).
- Evidence for a Narrower Interpretation: The patent repeatedly emphasizes this specific placement as a key feature, distinguishing it from prior art. The abstract and detailed description both specify the fit is "between an anterior portion of a first bone's lip osteophyte and an anterior portion of a second, adjacent bone's lip osteophyte" (’537 Patent, Abstract). A defendant could argue this language, combined with figures like Fig. 3, requires the device to be physically wedged in the space created by the osteophytes, not merely resting near them.
VI. Other Allegations
- Indirect Infringement: The complaint alleges both induced and contributory infringement for both patents. Inducement is premised on Medacta's alleged "advertising and distributing the Accused Product and providing instruction materials, training, and services" that encourage and instruct surgeons and others on an infringing use (Compl. ¶45, ¶73). Contributory infringement is alleged on the basis that the Accused Product is a material component specifically made for an infringing use and is not a staple article of commerce (Compl. ¶46, ¶74).
- Willful Infringement: The complaint alleges that Medacta acted with "specific intent or willful blindness" in inducing infringement (Compl. ¶44, ¶72). The complaint does not plead facts indicating pre-suit knowledge of the patents, suggesting the willfulness allegation may be based on post-filing conduct or a theory of deliberate indifference.
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of definitional scope and equivalence: For the ’234 Patent, can the "means for permitting movement," which is disclosed as a physical slot, be construed to cover the mechanism in the Accused Product, or will it be deemed structurally non-equivalent? For the ’537 Patent, what is the precise anatomical meaning of "fit primarily between... lip osteophytes," and does the Accused Product’s placement meet that definition?
- A key evidentiary question will be one of functional operation: Beyond the physical structure, what evidence will be required to prove or disprove the functional limitations of the claims? Specifically, does the Accused Product actually facilitate the claimed "movement" relative to the plate (’234 Patent) and "share weight" with the bone graft (’537 Patent) in the manner required by the patents?