DCT
2:22-cv-00019
Arthrex Inc v. Parcus Medical LLC
Key Events
Complaint
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Arthrex, Inc. (Delaware)
- Defendant: Parcus Medical, LLC (Wisconsin)
- Plaintiff’s Counsel: Hahn Loeser & Parks LLP; Carlson, Gaskey & Olds, P.C.
- Case Identification: 2:22-cv-00019, M.D. Fla., 01/11/2022
- Venue Allegations: Venue is alleged to be proper based on Defendant having a regular and established place of business within the Middle District of Florida.
- Core Dispute: Plaintiff alleges that Defendant’s surgical kits for ankle repair induce and contribute to the infringement of two patents covering methods of ankle syndesmosis repair using adjustable, knotless suture-button constructs.
- Technical Context: The technology relates to orthopedic medical devices used to stabilize the tibia and fibula bones following a severe ankle injury known as a syndesmosis disruption.
- Key Procedural History: The complaint notes a prior patent infringement lawsuit between the parties filed in 2011. It also alleges that Defendant was aware of the patent family during the prosecution of its own patent applications, citing the parent U.S. patent publication in an Information Disclosure Statement. Plaintiff also sent a formal notice letter regarding infringement approximately one month prior to filing suit.
Case Timeline
| Date | Event |
|---|---|
| 2010-11-17 | Priority Date for ’028 and ’686 Patents |
| 2019-04-09 | U.S. Patent No. 10,251,686 Issues |
| 2019-10-25 | Parent patent publication allegedly cited by USPTO Examiner in rejection of a Parcus patent application |
| 2020-10-22 | Parcus allegedly cites parent patent publication in an Information Disclosure Statement for its own patent application |
| 2020-12-15 | U.S. Patent No. 10,864,028 Issues |
| Sometime in or before 2021 | Accused Synd-EZ Kits Allegedly Launched |
| 2021-12-15 | Plaintiff sends notice letter to Defendant regarding alleged infringement |
| 2022-01-11 | Complaint Filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 10,864,028 - Adjustable Suture-Button Construct for Ankle Syndesmosis Repair
- Patent Identification: U.S. Patent No. 10,864,028, Adjustable Suture-Button Construct for Ankle Syndesmosis Repair, issued December 15, 2020.
The Invention Explained
- Problem Addressed: The patent addresses ankle injuries involving a disruption of the syndesmosis—the ligaments that connect the tibia and fibula. The background notes that prior surgical repair constructs required surgeons to tie knots to secure the device, a step the invention seeks to eliminate (’028 Patent, col. 1:38-54).
- The Patented Solution: The patent describes a method using an "adjustable, knotless button/loop construct" to stabilize the two bones (’028 Patent, Abstract). The system involves two "fixation devices" (buttons) connected by a flexible suture loop. In the claimed method, a surgeon drills a hole through both bones, passes the first button through the hole, and then "flips" it to anchor against the far side of the bone. The second button is placed on the near side, and the suture loop is cinched tight, securing the bones without requiring traditional surgical knots (’028 Patent, col. 7:56-8:12). Adjustability is achieved through one or more "spliced" sections in the suture loop, which allows for one-way tightening (’028 Patent, col. 6:2-6).
- Technical Importance: This approach provides surgeons with a method for achieving stable fixation of the syndesmosis that can be adjusted and secured without the technical step of tying knots under tension.
Key Claims at a Glance
- The complaint asserts independent claim 1 (Compl. ¶26).
- The essential elements of claim 1 are:
- preparing a hole through a fibula and a tibia with a drill bit;
- passing a first fixation device through the hole until it exits at a medial side of the tibia;
- flipping the first fixation device to an engagement position relative to the tibia;
- positioning a second fixation device at a lateral side of the fibula;
- wherein the devices are "knotlessly secured"; and
- wherein a "flexible suture construct" connecting the devices includes at least one "spliced section" formed by splicing a strand of the construct through itself.
U.S. Patent No. 10,251,686 - Adjustable Suture-Button Construct for Ankle Syndesmosis Repair
- Patent Identification: U.S. Patent No. 10,251,686, Adjustable Suture-Button Construct for Ankle Syndesmosis Repair, issued April 9, 2019.
The Invention Explained
- Problem Addressed: As with the related ’028 Patent, the background section describes the need for a fixation technique for syndesmosis repair that does not require the tying of knots to secure the implant (’686 Patent, col. 1:38-54).
- The Patented Solution: The invention is a method using a similar adjustable, knotless, two-button construct. A surgeon prepares a "bone tunnel" through the fibula and tibia, passes the first button through, and flips it so it "rests against a medial cortex of the tibia." The second button is positioned on the lateral side of the fibula, and an "adjustable loop" containing a "spliced section" is tightened to secure the construct "without tying knots" (’686 Patent, Abstract; col. 7:46-8:12).
- Technical Importance: This method provides an alternative to fixation with screws or knot-based suture systems, aiming to simplify the surgical procedure while providing stable, adjustable compression across the injured syndesmosis.
Key Claims at a Glance
- The complaint asserts independent claim 1 (Compl. ¶62).
- The essential elements of claim 1 are:
- preparing a bone tunnel through a fibula and a tibia;
- passing a first fixation device through the bone tunnel until it exits on a medial side of the tibia;
- flipping the first fixation device so it rests against a medial cortex of the tibia;
- positioning a second fixation device at a lateral side of the fibula;
- wherein the devices are "knotlessly secured...without tying knots"; and
- wherein an "adjustable loop" connecting the devices includes at least one "spliced section" formed by splicing a strand of the loop through itself.
III. The Accused Instrumentality
Product Identification
The Parcus Synd-EZ Titanium Kit (part no. 11223) and Parcus Synd-EZ SS Kit (part no. 11224), referred to as the "Accused Synd-EZ Kits" (Compl. ¶11).
Functionality and Market Context
The Accused Synd-EZ Kits are medical device systems intended for ankle syndesmosis repair (Compl. ¶11). The complaint alleges that Defendant provides instructional materials that guide surgeons to use these kits to perform the patented methods of repair (Compl. ¶¶27, 29). An image provided in the complaint shows the accused device, which consists of two button-style anchors connected by a flexible suture loop (Compl. ¶11, p. 3). Plaintiff alleges that Defendant is a direct competitor in the "relatively small ankle syndesmosis repair market" and that the accused kits incorporate features of Plaintiff's own "TightRope®" products (Compl. ¶12, ¶37).
IV. Analysis of Infringement Allegations
The complaint alleges indirect infringement, asserting that surgeons directly infringe the method claims by using the Accused Synd-EZ Kits according to Defendant's instructions (Compl. ¶¶27, 63). The complaint references claim chart exhibits (Exhibits 3 and 7) that were not attached to the publicly filed document; the analysis below is based on the narrative allegations.
’028 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| preparing a hole through a fibula and a tibia with a drill bit | The surgical method instructed by Defendant for use with the Accused Synd-EZ Kits allegedly requires a surgeon to prepare a hole through the patient's tibia and fibula. | ¶¶27-28 | col. 7:56-57 |
| passing a first fixation device through the hole until the first fixation device exits at a medial side of the tibia | The instructed method allegedly requires passing one of the kit's fixation devices completely through the prepared hole. | ¶¶27-28 | col. 7:60-64 |
| flipping the first fixation device to an engagement position relative to the tibia | The instructed method allegedly requires manipulating the first fixation device after it exits the bone so that it engages the medial tibial cortex. | ¶¶27-28 | col. 8:1-3 |
| positioning a second fixation device at a lateral side of the fibula | The instructed method allegedly requires placing the second fixation device from the kit against the lateral side of the fibula. | ¶¶27-28 | col. 8:6-8 |
| wherein the first fixation device and the second fixation device are knotlessly secured relative to the tibia and the fibula | The Accused Synd-EZ Kit, when used as instructed, allegedly secures the bones by cinching the suture construct without the tying of traditional knots. | ¶¶27-28 | col. 4:1-5 |
| wherein a flexible suture construct...includes at least one spliced section formed by splicing a strand of the flexible suture construct through itself | The flexible suture component of the Accused Synd-EZ Kit allegedly contains a "spliced section" that allows for one-way, adjustable tightening. | ¶¶27-28 | col. 6:2-6 |
- Identified Points of Contention:
- Scope Questions: A primary question will be whether the structure of the suture loop in the Accused Synd-EZ Kit constitutes a "spliced section" as that term is used in the patent. The complaint does not provide technical details of the accused device's suture construction.
- Technical Questions: What evidence does the complaint or its (unseen) exhibits provide that Defendant's instructions require surgeons to perform every claimed step, particularly the "flipping" and "knotless" securing steps?
’686 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| preparing a bone tunnel through a fibula and a tibia of an ankle joint | The surgical method instructed by Defendant allegedly requires a surgeon to prepare a bone tunnel through the patient's tibia and fibula. | ¶¶63-64 | col. 7:46-51 |
| passing a first fixation device through the bone tunnel...until the first fixation device exits on a medial side of the tibia | The instructed method allegedly requires passing one of the kit's fixation devices through the prepared bone tunnel. | ¶¶63-64 | col. 7:51-54 |
| flipping the first fixation device so it rests against a medial cortex of the tibia | The instructed method allegedly requires manipulating the first fixation device after it exits the bone so that it rests against the medial tibial cortex. | ¶¶63-64 | col. 8:1-3 |
| positioning a second fixation device at a lateral side of the fibula | The instructed method allegedly requires placing the second fixation device from the kit against the lateral fibula. | ¶¶63-64 | col. 8:6-8 |
| wherein the first fixation device and the second fixation device are knotlessly secured relative to the tibia and the fibula without tying knots | The Accused Synd-EZ Kit, when used as instructed, allegedly secures the bones by cinching the construct, avoiding the need to tie knots. | ¶¶63-64 | col. 9:1-2 |
| wherein an adjustable loop...includes at least one spliced section formed by splicing a strand of the adjustable loop through itself | The adjustable suture loop of the Accused Synd-EZ Kit allegedly contains a "spliced section" that enables tightening. | ¶¶63-64 | col. 6:2-6 |
- Identified Points of Contention:
- Scope Questions: As with the ’028 Patent, the central dispute may turn on the construction of "spliced section." Further, a question may arise as to whether there is a meaningful distinction between the ’028 Patent’s "engagement position relative to the tibia" and the ’686 Patent’s more specific requirement that the device "rests against a medial cortex of the tibia."
V. Key Claim Terms for Construction
The Term: "spliced section"
Context and Importance: This term describes the core technical feature that allegedly enables the claimed "adjustable" and "knotless" functionality. The infringement analysis for both patents will likely depend heavily on whether the suture mechanism of the Accused Synd-EZ Kit falls within the scope of this term.
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification describes the creation of a splice by passing a needle "through the center of the braid" (’686 Patent, col. 5:46-48). Plaintiff may argue this supports a broad construction covering any self-cinching loop formed by interweaving a suture through its own braided structure.
- Evidence for a Narrower Interpretation: The specification provides a detailed, multi-step description and figures (e.g., ’686 Patent, FIGS. 11-13) illustrating a specific method of creating the splice. Defendant may argue the term should be limited to this disclosed embodiment, especially since the patent incorporates by reference other documents for details on forming splices (’686 Patent, col. 6:35-42).
The Term: "knotlessly secured" / "without tying knots"
Context and Importance: This limitation is presented in the patent as a key advantage over prior art. The dispute will be whether the final configuration of the accused device, when used as instructed, achieves secure fixation without creating a structure that could be construed as a "knot."
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: Plaintiff may argue that the term simply means the absence of traditional surgical knots (e.g., a square knot or surgeon's knot), which the accused method allegedly avoids.
- Evidence for a Narrower Interpretation: Defendant may argue that the specific intertwining of sutures in its device, while not a "traditional" knot, functions as one, or that the patent's own description of an intertwined "X" structure on the fixation device defines the scope of what is considered "knotless" (’686 Patent, col. 5:19-25; FIGS. 7A-7B).
VI. Other Allegations
- Indirect Infringement: The complaint alleges both inducement and contributory infringement for each patent. The inducement claim is based on Defendant's alleged marketing and provision of instructional materials, such as a "Technique Guide" and "Instructions for Use," that allegedly direct surgeons to perform the patented methods (Compl. ¶¶29, 65). The contributory infringement claim is based on the allegation that the Accused Synd-EZ Kits are a material part of the invention, are specially made for this infringing use, and have no substantial non-infringing uses (Compl. ¶¶46-47, 82-83).
- Willful Infringement: Willfulness is alleged based on both pre- and post-suit knowledge. The complaint alleges pre-suit knowledge based on: (i) Defendant's alleged awareness of the parent patent application during its own patent prosecution in 2019 and 2020 (Compl. ¶¶32, 68); (ii) Defendant's status as a direct competitor with knowledge of Plaintiff's portfolio from prior litigation (Compl. ¶¶33, 69); and (iii) a formal notice letter sent by Plaintiff on December 15, 2021 (Compl. ¶¶30, 66).
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of definitional scope: can the term "spliced section," which is described with significant particularity in the patent's specification and figures, be construed broadly enough to read on the specific suture construction of the accused Parcus Synd-EZ Kit?
- A key evidentiary question will be one of technical correspondence: does the surgical method actually taught in Defendant's instructional literature direct surgeons to perform every step of the asserted method claims, and does the resulting physical construct meet claim limitations such as being "knotlessly secured"?
- The determination of willfulness may turn on the timing and quality of Defendant's alleged knowledge. The allegation that Defendant cited the parent application during its own patent prosecution, if proven, could establish knowledge of the technology and patent family long before the formal notice letter, potentially strengthening the willfulness claim.