DCT
2:20-cv-01862
Novastep SAS v. Fusion Orthopedics LLC
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Novastep SAS (France) and Novastep Inc. (New York)
- Defendant: Fusion Orthopedics, LLC (Arizona)
- Plaintiff’s Counsel: MotoSalas Law, PLLC; Cantor Colburn LLP
- Case Identification: 2:20-cv-01862, D. Ariz., 09/23/2020
- Venue Allegations: Venue is alleged to be proper in the District of Arizona because the Defendant is an Arizona company, is subject to personal jurisdiction, and has allegedly committed acts of patent infringement in the District.
- Core Dispute: Plaintiff alleges that the ornamental design of Defendant’s orthopedic surgical staple inserters infringes a design patent covering a proprietary implantation instrument.
- Technical Context: The technology is in the field of specialized medical devices, specifically surgical instruments used for implanting staples during orthopedic procedures like bone fixation and joint arthrodesis.
- Key Procedural History: The complaint alleges that the Plaintiff provided the Defendant with actual notice of infringement on multiple occasions, with the earliest notice dating back to at least August 1, 2019, over a year before the complaint was filed.
Case Timeline
| Date | Event |
|---|---|
| 2014-09-11 | ’258 Patent Filing Date (Priority Date) |
| 2016-01-26 | ’258 Patent Issue Date |
| 2019-04-29 | Accused Product FDA Device Publish Date |
| 2019-08-01 | Alleged Earliest Notice of Infringement |
| 2020-09-23 | Complaint Filing Date |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Design Patent No. D748,258 - "Clips for Surgical Purposes"
The Invention Explained
- Problem Addressed: As a design patent, the ’258 Patent does not articulate a technical problem to be solved; rather, it protects the unique, non-functional ornamental appearance of a surgical instrument (Compl. ¶14; ’258 Patent, Claim).
- The Patented Solution: The patent protects the specific visual appearance and overall aesthetic impression of a surgical instrument, as depicted in the patent’s six figures (’258 Patent, Figs. 1-6). The claimed design features an elongated body with a lever-style actuator at the proximal end and a distinctively shaped head at the distal, working end, creating a specific overall visual configuration (’258 Patent, Fig. 1).
- Technical Importance: The design provides a unique ornamental appearance for a proprietary implantation instrument used to insert Plaintiff's ARCAD® compression staples, distinguishing it in the marketplace (Compl. ¶13, ¶14).
Key Claims at a Glance
- The single claim asserted is for: "the ornamental design for a clips for surgical purposes, as shown and described" (’258 Patent, Claim).
- The scope of the claim is defined by the visual representations in Figures 1-6 of the patent, which depict the design from perspective, side, top, alternate position, and front views.
III. The Accused Instrumentality
Product Identification
The accused products are Fusion Orthopedics' "DynaBridge Inserters," also identified as "Tray Based Inserter[s]," which are offered in multiple sizes (e.g., 9mm, 11mm, 13mm, etc.) (Compl. ¶16, ¶17).
Functionality and Market Context
The DynaBridge Inserters are described as medical device implantation instruments used by surgeons to insert the Defendant's "DynaBridge" compression staples during orthopedic procedures involving the hand and foot (Compl. ¶15, ¶16). The complaint alleges these products are designed, manufactured, sold, and imported by the Defendant (Compl. ¶16). Attached FDA Medical Device Identification Reports classify the device as an "Orthopaedic bone staple driver" (Compl. ¶18; Compl. Ex. B, p. 15).
IV. Analysis of Infringement Allegations
The complaint alleges that the accused DynaBridge Inserters are "substantially the same" as the patented design, such that an ordinary observer would be deceived (Compl. ¶23). To support its allegations, the complaint provides a side-by-side visual comparison showing figures from the ’258 patent alongside photographs of the accused product from multiple angles (Compl. ¶19).
D748,258 Infringement Allegations
| Visual Feature from '258 Patent Figures | Alleged Infringing Visual Feature of DynaBridge Inserter | Complaint Citation | Patent Citation |
|---|---|---|---|
| The overall ornamental design as depicted in a perspective view in Figure 1, characterized by an elongated body, a proximal lever-style actuator, and a distal head. | The complaint alleges the accused DynaBridge Inserter embodies a substantially similar overall ornamental design, as shown in the side-by-side photographic comparison. | ¶19, ¶23 | ’258 Patent, Fig. 1 |
| The specific side profile shown in Figure 2, including the contours of the body and actuator lever. | The complaint's visual comparison table alleges that the side profile of the accused product is substantially the same as the patented design, creating a similar visual impression. | ¶19, ¶23 | ’258 Patent, Fig. 2 |
| The top-down profile shown in Figure 3, including the shape of the distal head and the openings along the body. | The complaint alleges that the top-down view of the accused product is substantially the same as the patented design, including similar shapes and feature placements. | ¶19, ¶23 | ’258 Patent, Fig. 3 |
| The design's appearance in an alternate, actuated position as shown in Figure 4. | The visual comparison provided in the complaint shows the accused product in what is alleged to be a similar actuated position, mirroring the patented design's appearance. | ¶19, ¶23 | ’258 Patent, Fig. 4 |
- Identified Points of Contention:
- Substantial Similarity: The central question will be whether an "ordinary observer" (e.g., a surgeon) would find the overall visual appearance of the accused DynaBridge Inserter to be substantially the same as the patented design. The Defendant may argue that differences in color, proportion, or specific surface details are significant enough to create a different overall impression.
- Functionality: A potential defense could be that the similarities between the patented design and the accused product are dictated by the functional requirements of a surgical staple inserter. This raises the question of which specific features of the design are purely ornamental and non-functional, and whether those ornamental features are present in the accused product.
V. Key Claim Terms for Construction
In design patent litigation, claim construction focuses on the scope of the design as a whole, as depicted in the figures, rather than on construing specific textual terms.
- The Term: "the ornamental design for a clips for surgical purposes, as shown and described"
- Context and Importance: The entire infringement analysis depends on the visual scope of the design protected by the patent. The dispute will not center on the definition of a word but on the overall visual impression created by the drawings. Practitioners may focus on identifying the specific ornamental features that create this impression and distinguishing them from any functional elements.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The claim covers the design "as shown," and all features in the drawings are rendered in solid lines, suggesting they are all part of the claimed design (’258 Patent, Figs. 1-6). The description clarifies that views show mirror images, encompassing the full three-dimensional object (’258 Patent, Description).
- Evidence for a Narrower Interpretation: The scope is limited to the specific combination of shapes, lines, and proportions depicted in the drawings (’258 Patent, Figs. 1-6). A party could argue that any deviation from these precise visual elements in an accused product places it outside the claim's scope. The title itself, "Clips for Surgical Purposes," defines the article of manufacture to which the design applies (’258 Patent, (54)).
VI. Other Allegations
- Indirect Infringement: The complaint alleges that Fusion induces infringement by "encouraging and promoting the use and/or sale by others" of the accused inserters to parties such as distributors, hospitals, and surgeons (Compl. ¶24). It further alleges that Fusion sells the products with the intent that end-users will infringe (Compl. ¶25).
- Willful Infringement: The complaint alleges willful infringement based on pre-suit knowledge. It states that Novastep provided Fusion with "actual notice of its infringement on repeated occasions, including at least as early as August 1, 2019" (Compl. ¶28). The complaint also alleges that Fusion's acts were undertaken with knowledge of the ’258 patent (Compl. ¶29).
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of visual comparison: Applying the "ordinary observer" test, are the ornamental features of the accused DynaBridge Inserter "substantially the same" as the patented design, or do visual differences in color, proportion, and surface detail create a distinct overall impression for a typical purchaser?
- A key legal and factual question will be the functionality doctrine: To what extent are the shared design elements between the patent and the accused product dictated by their function as surgical staple inserters, and does the accused product copy ornamental features that are not functionally required?
- A central damages question will relate to willfulness: Does the evidence support the allegation that Fusion had pre-suit knowledge of the ’258 patent and its alleged infringement as early as August 2019, potentially exposing it to claims for enhanced damages?