DCT
1:17-cv-00384
Wright Medical Technology Inc v. KFX Medical Corp
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Wright Medical Technology, Inc. (Delaware)
- Defendant: KFx Medical Corporation (Delaware)
- Plaintiff’s Counsel: Duane Morris LLP
- Case Identification: 1:17-cv-00384, D. Del., 04/06/2017
- Venue Allegations: Venue is alleged to be proper in the District of Delaware because Defendant KFx is a Delaware corporation and therefore resides in the judicial district.
- Core Dispute: Plaintiff Wright Medical seeks a declaratory judgment that its PITON brand of knotless suture anchors do not infringe Defendant KFx's patents, and that those patents are invalid, in response to pre-suit infringement allegations from KFx.
- Technical Context: The technology involves methods and medical devices used in orthopedic surgery to reattach soft tissues, such as tendons, to bone, a common procedure for injuries like a torn rotator cuff.
- Key Procedural History: The complaint states that this declaratory judgment action was initiated in response to communications from KFx. In an August 2016 email, KFx allegedly asserted that Wright Medical’s PITON product infringes the ’311 Patent. In subsequent communications in October 2016, KFx allegedly identified the ’942 and ’969 Patents as additional "primary patents" for consideration.
Case Timeline
| Date | Event |
|---|---|
| 2004-06-02 | Earliest Priority Date for ’311, ’942, and ’969 Patents |
| 2009-09-08 | U.S. Patent No. 7,585,311 Issues |
| 2012-01-24 | U.S. Patent No. 8,100,942 Issues |
| 2012-02-07 | U.S. Patent No. 8,109,969 Issues |
| 2016-08-15 | KFx alleges infringement of the ’311 Patent via email |
| 2016-10-06 | KFx identifies ’942 and ’969 Patents as "primary patents" |
| 2017-04-06 | Complaint for Declaratory Judgment Filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 7,585,311 - "System and Method for Attaching Soft Tissue to Bone", issued September 8, 2009
The Invention Explained
- Problem Addressed: The patent describes challenges in arthroscopic surgery, specifically the difficulty of manipulating sutures and properly adjusting suture tension when using traditional knot-tying techniques to secure a suture to a bone anchor (’311 Patent, col. 1:35-42). Attaching a suture to an anchor before inserting it into bone makes it difficult for a surgeon to judge the final tension accurately (’311 Patent, col. 1:40-44).
- The Patented Solution: The patent discloses methods and devices that allow a surgeon to first insert anchors into bone, then pass a suture over the soft tissue, and finally secure the suture to one of the anchors after the anchor has been placed and the suture tensioned, all without tying knots (’311 Patent, col. 2:11-18). The system employs a "suture capturing anchor" with a mechanism that allows a suture to be moved laterally into it and then clamped or otherwise fixed in place, simplifying the surgical procedure (’311 Patent, col. 3:60-67).
- Technical Importance: This approach aims to make arthroscopic soft tissue repair easier and more reliable by giving the surgeon better control over suture tension while avoiding the complexities of intra-articular knot-tying (’311 Patent, col. 2:48-55).
Key Claims at a Glance
The complaint does not identify specific claims asserted by KFx, but discusses limitations common to the patent's method claims (Compl. ¶22). Independent claim 1 is representative of the "double row" technique at issue.
- Independent Claim 1:
- inserting a first anchor into bone, wherein the first anchor is positioned underneath the soft tissue
- passing a first length of suture from said first anchor over the soft tissue
- inserting a second anchor into bone, wherein the second anchor is positioned beyond the edge of the soft tissue
- after inserting the second anchor, tensioning the first length of suture to compress an area of tissue
- fixedly securing the first length of suture to the second anchor without tying any knots
- The complaint seeks a declaration of non-infringement for all claims of the patent (Compl. ¶23).
U.S. Patent No. 8,100,942 - "System and Method for Attaching Soft Tissue to Bone", issued January 24, 2012
The Invention Explained
- Problem Addressed: The patent addresses the same challenges as its parent ’311 Patent: the difficulty of achieving proper suture tension and avoiding knot-tying in arthroscopic soft tissue repair (’942 Patent, col. 1:39-48).
- The Patented Solution: As a continuation of the ’311 Patent, the ’942 Patent further details the knotless securing method. It claims a specific method where the "second anchor" comprises a movable "proximal member" and a "distal member." After the suture is tensioned, the proximal member is moved toward the distal member to clamp and fixedly secure the suture. (’942 Patent, col. 14:46-51; Abstract). This provides a more detailed mechanical description for the knotless capture mechanism.
- Technical Importance: The invention provides a specific, refined mechanical method for implementing the knotless, post-insertion suture fixation concept, focusing on the interaction between components of the suture-capturing anchor (’942 Patent, col. 2:55-65).
Key Claims at a Glance
The complaint does not identify specific claims asserted by KFx but quotes language from the patent's method claims (Compl. ¶26). Independent claim 1 is representative.
- Independent Claim 1:
- inserting a first anchor into bone
- passing a first length of suture from said first anchor over the soft tissue
- inserting a distal member of a second anchor into bone at a position beyond an edge of the soft tissue
- tensioning the first length of suture to compress an area of tissue
- moving the proximal member of the second anchor distally towards the distal member of the second anchor, thereby fixedly securing the first length of suture at the second anchor position without tying any knots
- The complaint seeks a declaration of non-infringement for all claims of the patent (Compl. ¶27).
Multi-Patent Capsule: U.S. Patent No. 8,109,969 - "System and Method for Attaching Soft Tissue to Bone", issued February 7, 2012
- Technology Synopsis: This patent, also in the same family, discloses methods for attaching soft tissue to bone using a knotless, multi-anchor technique. The claims of the ’969 Patent introduce further specificity by reciting the use of an "anchor inserter attachment member" as part of the surgical procedure, focusing on the interaction between the implant and the surgical tools used to deploy it (’969 Patent, col. 13:46-52; Compl. ¶30).
- Asserted Claims: The complaint refers to the patent's method claims generally without specifying claim numbers (Compl. ¶30).
- Accused Features: The use of Wright Medical's PITON knotless suture anchors by surgeons in a "double row procedure" is the basis for the infringement allegation (Compl. ¶13). Wright Medical specifically denies that it or its users perform a procedure using an "anchor inserter attachment member" as recited in the claims of the ’969 Patent (Compl. ¶30).
III. The Accused Instrumentality
Product Identification
The accused products are knotless suture anchors sold by Wright Medical under the PITON brand (Compl. ¶2, ¶9).
Functionality and Market Context
The complaint describes the PITON anchors as medical devices used by surgeons to attach soft tissue to bone (Compl. ¶10). The infringement allegations center on their use in what KFx calls a "double row procedure," where a suture is extended between a PITON knotless anchor and a second bone anchor (Compl. ¶10). The complaint alleges that Wright Medical does not control how surgeons use the anchors and notes that the other anchor used in such a procedure is often not a Wright Medical product (Compl. ¶11, ¶12).
IV. Analysis of Infringement Allegations
No probative visual evidence provided in complaint. The declaratory judgment complaint is based on KFx’s pre-suit allegations, which are disputed by Wright Medical. The tables below summarize Wright Medical's stated reasons for non-infringement.
7,585,311 Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| tension[] the first length of suture to compress an area of tissue to bone between the edge of the soft tissue and the first anchor | The surgical method allegedly performed by users of the PITON anchor. | ¶22 | col. 14:21-24 |
| fixedly securing the first length of suture to the second anchor without tying any knots | The function of the PITON knotless suture anchor when used by a surgeon in a double row procedure. | ¶22 | col. 14:26-29 |
8,100,942 Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| moving the proximal member of the second anchor distally towards the distal member of the second anchor, thereby fixedly securing the first length of suture at the second anchor position without tying any knots | The knotless mechanism of the PITON anchor as allegedly operated by a surgeon. | ¶26 | col. 14:46-51 |
| tension[] the first length of suture to compress an area of tissue | The surgical method allegedly performed by users of the PITON anchor. | ¶26 | col. 14:42-45 |
Identified Points of Contention
- Divided Infringement: The asserted patents claim surgical methods. Wright Medical sells the suture anchor but does not perform the surgery. The complaint raises the issue that Wright Medical "does not control the manner in which a surgeon chooses to use" its product (Compl. ¶12). This suggests a central dispute will be whether Wright Medical can be held liable for direct or indirect infringement when the full set of claimed steps is performed by a third-party surgeon.
- Factual Mismatch: Wright Medical makes blanket denials that it or its users have ever performed the procedures as recited in the claims (Compl. ¶22, ¶26, ¶30). The case will therefore require a factual determination of what steps are actually performed when a surgeon uses a PITON anchor in a double row procedure and whether those steps meet the claim limitations.
V. Key Claim Terms for Construction
The Term: "fixedly securing ... without tying any knots"
- Context and Importance: This phrase appears in the independent claims of the '311 and '942 Patents and captures the core "knotless" aspect of the invention. The outcome of the dispute may depend on whether the PITON anchor's mechanism for retaining a suture is considered to be "fixedly securing" it as contemplated by the patents.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification describes the concept broadly as allowing a suture to be "securely clamped" or "securely locked" against the anchor base, which could be argued to encompass any effective non-knot retention method (’311 Patent, col. 2:10; col. 6:22-24).
- Evidence for a Narrower Interpretation: The detailed description and figures consistently show a specific two-part anchor where an "anchor top" ratchets down into an "anchor base" to clamp the suture in a groove (’311 Patent, Figs. 6A-6B; col. 5:18-40; col. 7:6-10). It may be argued that "fixedly securing" is limited to this disclosed clamping mechanism.
The Term: "second anchor"
- Context and Importance: The asserted method claims in both the ’311 and ’942 Patents require inserting a "first anchor" and a "second anchor." KFx's allegations are based on the PITON anchor functioning as the "second anchor" in a double row procedure (Compl. ¶10, ¶13). The definition of "second anchor" is critical, as it must be capable of performing the "fixedly securing... without tying any knots" step.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The term itself is generic and could be argued to mean any anchor used second in the sequence.
- Evidence for a Narrower Interpretation: The patent specification extensively describes the "second anchor" as the "suture capturing anchor," which has a specific two-part structure (base and top) and a knotless clamping function (’311 Patent, col. 3:60-67; col. 5:18-40). Wright Medical may argue that the term "second anchor" is not a generic anchor but must be construed to include the specific structural and functional features disclosed for the knotless anchor.
VI. Other Allegations
Indirect Infringement
Wright Medical seeks a declaration that it has not infringed "either directly or indirectly" (Compl. ¶21, ¶25, ¶29). KFx's underlying theory, as presented in the complaint, appears to be one of induced infringement, where Wright Medical provides the PITON anchor (the material component) and surgeons perform the allegedly infringing method. Wright Medical preemptively denies this by stating it has never "instructed users" to perform the allegedly infringing steps (Compl. ¶22, ¶26, ¶30).
Willful Infringement
As this is a declaratory judgment action by the accused infringer, there is no allegation of willfulness against Wright Medical. However, the complaint establishes that KFx provided Wright Medical with notice of the patents-in-suit in August and October 2016, which could form the basis for a future willfulness claim by KFx if infringement is found (Compl. ¶18, ¶19).
VII. Analyst’s Conclusion: Key Questions for the Case
- A central legal question will be one of divided infringement: can Wright Medical, as the seller of a surgical device, be held liable for infringing method claims that are performed in their entirety only by third-party surgeons? The resolution will likely depend on the degree of direction or control Wright Medical is found to have over the actions of its users.
- A key evidentiary question will be one of technical operation: does the accused PITON anchor, when used in the "double row procedure" cited by KFx, actually perform the specific functional steps recited in the patent claims, such as "moving the proximal member... distally towards the distal member" to secure a suture?
- A critical issue for claim construction will be definitional scope: must the term "second anchor" be interpreted narrowly to mean an anchor possessing the specific two-part clamping structure disclosed in the patents, or can it be read more broadly on any anchor used second in a surgical sequence that performs a knotless function?