DCT
1:22-cv-00239
Extremity Medical LLC v. Nextremity Solutions Inc
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Extremity Medical, LLC (New Jersey)
- Defendant: Nextremity Solutions, Inc. (Delaware); Zimmer Biomet Holdings, Inc. (Delaware); and Zimmer, Inc. (Delaware)
- Plaintiff’s Counsel: Ashby & Geddes
- Case Identification: 1:22-cv-00239, D. Del., 02/25/2022
- Venue Allegations: Venue is alleged to be proper in the District of Delaware based on each Defendant being a Delaware corporation that transacts business in the state and has allegedly committed tortious acts within the district.
- Core Dispute: Plaintiff alleges that Defendants’ InCore Lapidus System, an orthopedic device, infringes a patent related to intramedullary fixation systems for bone fusion.
- Technical Context: The technology at issue involves orthopedic implants used in foot surgery to reconstruct and stabilize bones, particularly to restore the natural arch of the foot in patients with conditions like Charcot arthropathy.
- Key Procedural History: The complaint alleges Plaintiff provided Defendants with pre-suit notice of infringement of the patent-in-suit via a letter dated November 23, 2021. Subsequent to the filing of this complaint, an Inter Partes Review (IPR) proceeding was initiated against the patent-in-suit (IPR2022-00802). This proceeding resulted in a certificate issued on October 18, 2023, canceling the sole asserted claim in this litigation, Claim 59.
Case Timeline
| Date | Event |
|---|---|
| 2008-06-24 | ’589 Patent Priority Date |
| 2012-11-06 | ’589 Patent Issue Date |
| 2021-11-23 | Plaintiff sends pre-suit notice letter to Defendants |
| 2021-12-15 | Defendants acknowledge receipt of notice letter |
| 2022-01-14 | Defendants acknowledge receipt of notice letter |
| 2022-02-25 | Complaint Filing Date |
| 2022-04-05 | IPR petition filed against the ’589 Patent |
| 2023-10-18 | IPR Certificate issues, canceling Claim 59 of the ’589 Patent |
II. Technology and Patent(s)-in-Suit Analysis
- Patent Identification: U.S. Patent No. 8,303,589, "Fixation System, an Intramedullary Fixation Assembly and Method Of Use," issued November 6, 2012.
- The Invention Explained:
- Problem Addressed: The patent describes challenges in surgically treating conditions like Charcot foot, where the arch of the foot collapses. Prior fixation devices, such as bone screws and plates, are said to not adequately restore the arch and can create surface prominence that increases the risk of wound complications and infection (’589 Patent, col. 1:42-60).
- The Patented Solution: The invention is a multi-component intramedullary fixation system designed to be implanted within the bone canal. It generally comprises a proximal screw member and a distal member that are coupled together at a fixed angle. This predetermined angle is designed to restore the natural arch of the foot upon implantation, while an associated instrument guides the assembly (’589 Patent, Abstract; col. 3:57-61). The system is intended to be less invasive and reduce stress on surrounding tissues (’589 Patent, col. 7:12-19).
- Technical Importance: This approach seeks to provide a more stable, anatomically correct bone fusion while minimizing the soft-tissue complications associated with bulkier, externally-placed hardware (’589 Patent, col. 1:51-60).
- Key Claims at a Glance:
- The complaint asserts independent Claim 59.
- The essential elements of Claim 59 are:
- A fixation system for compressing bone, comprising a first screw member, a second member, and an instrument.
- The first screw member has a head portion and a shaft.
- The second member has a shaft and a bore, where the longitudinal axis of the shaft and the axis of the bore define an angle.
- The instrument is adapted for coupling the first screw member to the second member.
- The first screw member couples to the second member at the defined angle.
- Both the first and second members are adapted for residing substantially within at least one bone.
- The second member comprises first and second circumferentially spaced recesses adapted for coupling to the instrument.
III. The Accused Instrumentality
- Product Identification: The accused instrumentality is Defendants' "InCore Lapidus System," also referred to as the "Infringing System" (Compl. ¶1).
- Functionality and Market Context: The InCore Lapidus System is a medical device system for bone fixation. Based on the complaint's allegations and supporting exhibits from the product's surgical guide, the system includes three primary components: an "InCore Post" (accused second member), a "screw" (accused first screw member), and a "Targeting Guide" (accused instrument) (Compl. ¶18). The complaint alleges the Targeting Guide is used to align and insert the screw into the InCore Post at a specific angle for bone compression and fixation (Compl. ¶¶26-27). An image provided in the complaint shows the Targeting Guide, InCore Post, and their Plantar and Medial Holes (Compl. ¶18, p. 6).
IV. Analysis of Infringement Allegations
’589 Patent Infringement Allegations
| Claim Element (from Independent Claim 59) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| a first screw member comprising a head portion and a first shaft extending along a first longitudinal axis | The "screw" of the Infringing System, which is alleged to have a head portion and a first shaft extending along a first longitudinal axis. An annotated image of the accused screw identifies these features (Compl. ¶24, p. 9). | ¶24 | col. 11:30-33 |
| a second member comprising a second shaft extending along a second longitudinal axis and a bore extending through said second shaft along a bore axis | The "InCore Post" of the Infringing System, which is alleged to have a second shaft, a bore, and corresponding axes. An annotated image of the accused post illustrates these components (Compl. ¶25, p. 10). | ¶25 | col. 11:34-37 |
| an instrument adapted for coupling said first screw member to said second member | The "Targeting Guide" of the Infringing System is alleged to be the claimed instrument used to couple the screw to the InCore Post (Compl. ¶26). | ¶26 | col. 11:38-40 |
| wherein said second longitudinal axis and said bore axis define an angle, wherein said first screw member is adapted for coupling to said second member at said angle | The InCore Post's axes allegedly define an angle, and the screw is adapted for coupling to the post at that angle. The complaint provides a visual purporting to show this angular relationship (Compl. ¶27, p. 12). | ¶27 | col. 11:41-45 |
| wherein each of said first screw member and said second member is adapted for residing substantially within at least one bone | The InCore Post and screw are alleged to be adapted for residing substantially within at least one bone, as depicted in an annotated image showing the system implanted in bone (Compl. ¶28, p. 12). | ¶28 | col. 11:46-49 |
| wherein said second member comprises first and second circumferentially spaced recesses adapted for coupling to said instrument | The InCore Post is alleged to include first and second circumferentially spaced recesses for coupling to the Targeting Guide. An image shows these alleged recesses on the accused post (Compl. ¶28, p. 13). | ¶28 | col. 11:45-48 (sic) |
Note: The complaint cites col. 11:45-48 for the final element, which corresponds to Claim 57. The correct citation for this limitation in Claim 59 is col. 12:45-48.
- Identified Points of Contention:
- Scope Questions: A potential dispute could arise over the meaning of the phrase "instrument adapted for coupling". The infringement theory appears to rely on the Targeting Guide's function of aligning and guiding the screw into the post. A central question may be whether "coupling" in the context of the claim requires only alignment and guidance, or a more direct, temporary mechanical connection between all three components.
- Technical Questions: The complaint provides annotated images that map accused product features directly onto claim limitations. Assuming the accuracy of these depictions, a technical dispute may focus on the actual function of the "circumferentially spaced recesses." What evidence shows that these features are "adapted for coupling" to the instrument in the manner required by the claim, beyond simply providing a location for the instrument to sit?
V. Key Claim Terms for Construction
- The Term: "instrument adapted for coupling said first screw member to said second member"
- Context and Importance: The definition of "coupling" is critical. If construed narrowly to require a rigid, simultaneous mechanical linkage of the instrument to both the screw and the post, infringement may be more difficult to establish. If construed broadly to include guiding one component into the other to achieve a final assembled state, the plaintiff's position may be stronger. Practitioners may focus on this term because it defines the core function of the third element of the claimed system.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification describes the instrument being used to "guide" the proximal member through an aiming device into the distal member (’589 Patent, col. 5:58-62). This could support a reading where "coupling" encompasses the act of guiding the parts into their final, coupled position.
- Evidence for a Narrower Interpretation: The claim requires the instrument to be adapted for coupling the first screw member to the second member. The specification describes the instrument slidably coupling to the distal (second) member's grooves (’589 Patent, col. 5:49-53) and guiding the proximal (first) member through an aperture (’589 Patent, col. 5:58-62), but does not explicitly state the instrument itself mechanically couples to the first member. A defendant could argue this implies a guiding function, not a "coupling" function as applied to both members.
VI. Other Allegations
- Indirect Infringement: The complaint alleges inducement of infringement, asserting that Defendants' surgical guides available on their websites instruct and encourage surgeons to assemble and use the InCore Lapidus System in an infringing manner (Compl. ¶21). Contributory infringement is also alleged, based on the theory that the InCore Post is a material component especially made for use in the infringing system and is not a staple article of commerce with substantial non-infringing uses (Compl. ¶22).
- Willful Infringement: The claim for willfulness is based on alleged pre-suit knowledge of the ’589 Patent. The complaint alleges that Plaintiff sent Defendants a notice letter on November 23, 2021, which identified the patent and accused the InCore Lapidus System of infringing at least Claim 59 (Compl. ¶16).
VII. Analyst’s Conclusion: Key Questions for the Case
- The foremost issue in this case is procedural and fatal to the current complaint: given the post-filing cancellation of Claim 59—the only claim asserted—in a final, appealable IPR decision, the infringement action as currently pleaded is moot. The central question is whether the plaintiff will or can amend its complaint to assert other claims from the ’589 Patent that were not subject to the IPR cancellation.
- Had Claim 59 survived, a key question would have been one of claim construction: does the term "instrument adapted for coupling", as used in the claim, require a direct mechanical linkage between the instrument and both the screw and post simultaneously, or is it satisfied by an instrument that merely guides the screw into the post for their eventual connection?
- A third question would have involved evidentiary proof: what evidence demonstrates that the accused system's components, particularly the "InCore Post" and "screw," are "adapted for residing substantially within at least one bone" in a manner consistent with the patent's teachings, which focus on intramedullary placement for arch restoration.