DCT

8:22-cv-02837

Tenjin LLC v. Parcus Medical LLC

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 8:22-cv-02837, M.D. Fla., 12/15/2022
  • Venue Allegations: Venue is alleged to be proper in the Middle District of Florida, as this is where Defendant Parcus Medical, LLC maintains its principal place of business.
  • Core Dispute: Plaintiff alleges that Defendant’s orthopedic surgical anchor systems infringe three patents related to methods and devices for attaching tissue grafts to bone, with the alleged infringement occurring after Plaintiff terminated a prior licensing agreement between the parties.
  • Technical Context: The technology at issue falls within the field of orthopedic sports medicine, specifically concerning knotless suture anchor systems used in arthroscopic surgery to reattach soft tissues, such as tendons or ligaments, to bone.
  • Key Procedural History: The complaint alleges a complex business history between the parties, beginning with confidential disclosures under a non-disclosure agreement in 2014, followed by a licensing agreement in 2016. Plaintiff alleges it terminated this license in 2019 for breach due to insufficient royalty payments. The suit includes parallel claims for breach of contract and for correction of inventorship on Defendant’s own patents, which Plaintiff alleges were improperly filed using its confidential information.

Case Timeline

Date Event
2014-03-03 Earliest Priority Date for ’224, ’587, and ’496 Patents
2014-08-18 Non-Disclosure Agreement executed between Plaintiff and Defendant
2016-03-01 Licensing Agreement executed between Plaintiff and Defendant
2017-08-01 U.S. Patent No. 9,717,587 Issues
~2018-01-01 Complaint alleges infringing activities began
2018-06-19 U.S. Patent No. 9,999,496 Issues
2019-06-06 Plaintiff notifies Defendant of Licensing Agreement termination
2022-11-22 U.S. Patent No. 11,504,224 Issues
2022-12-15 Complaint Filed

II. Technology and Patent(s)-in-Suit Analysis

U.S. Patent No. 11,504,224 - "Implant placement systems and one-handed methods for tissue fixation using same"

  • Patent Identification: U.S. Patent No. 11,504,224, titled "Implant placement systems and one-handed methods for tissue fixation using same," issued on November 22, 2022.

The Invention Explained

  • Problem Addressed: The patent’s background section describes challenges in arthroscopic surgery where rotating a driver to insert a threaded anchor can inadvertently twist the attached sutures ("suture spin") or cause the tissue graft to shift ("graft shift") (’224 Patent, col. 3:20-30). This unwanted movement can compromise the final position and tension of the repair, potentially affecting healing (’224 Patent, col. 3:46-52).
  • The Patented Solution: The invention proposes a placement system composed of two main coaxial components: an inner, non-rotating "insertion device" and an outer, rotating "driver device." The insertion device holds the sutures and graft in a fixed position, while the outer driver rotates independently to screw the anchor into the bone. This separation of functions is designed to insulate the suture and graft from the rotational torque of the driver, ensuring they remain in the desired position and under the correct tension during anchor placement (’224 Patent, Abstract; col. 5:10-24).
  • Technical Importance: This approach aims to provide surgeons with greater control and predictability during knotless anchor fixation, reducing a common mode of failure and simplifying the surgical procedure (’224 Patent, col. 36:50-67).

Key Claims at a Glance

  • The complaint does not identify specific claims but asserts infringement of one or more provisions of the patent (Compl. ¶43). Independent claim 1 is representative of the core system.
  • Essential elements of Independent Claim 1 include:
    • An implant placement system for affixing a soft tissue graft to a prepared socket in a boney surface via a cannulated anchoring implant.
    • The system comprises a cannulated driver device and an elongate insertion device slidably received within the driver device.
    • The insertion device has a distal end configured to receive one or more sutures and a first end configured to receive an axial control assembly.
    • The axial control assembly has a first constrained configuration and a second free configuration, where in the first configuration, the insertion device is maintained in a fixed axial and rotational position inside the driver device.
  • The complaint reserves the right to assert additional claims (Compl. ¶43).

U.S. Patent No. 9,717,587 - "Multiple implant constructions and fixation methods associated therewith"

  • Patent Identification: U.S. Patent No. 9,717,587, titled "Multiple implant constructions and fixation methods associated therewith," issued on August 1, 2017.

The Invention Explained

  • Problem Addressed: The patent addresses the limitations of conventional "single row" and "double row" rotator cuff repairs (’587 Patent, col. 3:35-4:3). Specifically, existing methods often make it difficult to tension sutures properly and do not allow for easy adjustment or repositioning of an anchor once it has been placed, requiring a surgeon to abandon the implant if the tension or location is suboptimal (’587 Patent, col. 4:53-67).
  • The Patented Solution: The patent discloses a method for creating multi-implant constructs, particularly for double-row repairs, where the fixation is removable. A suture is passed from a first (medial) anchor, over the tissue graft, and is then secured by a second (lateral) anchor. Crucially, the second anchor fixes the suture by trapping it between the anchor body and the wall of the bone socket, rather than by a permanent knot or internal lock (’587 Patent, col. 11:1-12). This allows the surgeon to place the anchor, assess the tension, and if necessary, back the anchor out to readjust the suture tension or relocate the implant entirely (’587 Patent, col. 26:2-17).
  • Technical Importance: This method provides surgeons with the ability to fine-tune a repair construct in situ, improving the biomechanical outcome by ensuring appropriate tissue compression without committing to a potentially flawed anchor placement (’587 Patent, Abstract).

Key Claims at a Glance

  • The complaint does not identify specific claims but asserts infringement of one or more provisions of the patent (Compl. ¶47). Independent method claim 1 is representative.
  • Essential steps of Independent Claim 1 include:
    • Positioning a soft tissue graft on a boney surface.
    • Securing a first end of a suture to the bone with a first implant.
    • Passing the suture over the graft and preparing a second socket.
    • Establishing a desired tension in the suture.
    • Placing a second implant into the second socket to "simultaneously fix" the suture by trapping it between the implant's outer surface and the socket wall, maintaining the desired tension.
  • The complaint reserves the right to assert additional claims (Compl. ¶47).

U.S. Patent No. 9,999,496 - "Multiple implant constructions and fixation methods associated therewith"

  • Patent Identification: U.S. Patent No. 9,999,496, titled "Multiple implant constructions and fixation methods associated therewith," issued on June 19, 2018.
  • Technology Synopsis: As a continuation of the application leading to the ’587 Patent, this patent further details methods for creating multi-implant, double-row repairs of tissue grafts. It addresses the problem of achieving and maintaining proper suture tension across a repair construct by teaching methods where sutures are tensioned and then secured with implants that allow for subsequent adjustment or relocation, ensuring the graft is properly compressed against the bone for healing (’496 Patent, Abstract; col. 4:35-52).
  • Asserted Claims: The complaint does not specify which claims are asserted (Compl. ¶52).
  • Accused Features: The complaint alleges that PARCUS’s products, including its knotless anchor systems, are configured to be used in a manner that practices the methods claimed in the patent (Compl. ¶38, ¶40, ¶52).

III. The Accused Instrumentality

Product Identification

  • The complaint identifies the accused instrumentalities as the "Twist Knotless DEX," the "SLik Fix Screw-In Tenodesis System," and associated "anchors and other hardware designed for use with these systems" (Compl. ¶40).

Functionality and Market Context

  • The complaint alleges these products are orthopedic surgical devices that form a "knotless anchor system" for attaching tissue to bone (Compl. ¶13, ¶38). The products are alleged to be configured to carry out the methods claimed in the patents-in-suit (Compl. ¶38). The complaint references a "Rotator Cuff Repair" document and a PARCUS catalog for further description of the products, but provides no further technical detail on their operation within the pleading itself (Compl. ¶38, ¶40).
  • The complaint alleges that PARCUS has "made, sold, or offered to sell" these products since approximately 2018 (Compl. ¶32).

IV. Analysis of Infringement Allegations

The complaint does not provide claim charts or detailed infringement contentions. The following summary is based on the general allegations that the accused products are configured to practice the patented inventions.

No probative visual evidence provided in complaint.

U.S. Patent No. 11,504,224 Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
an implant placement system for affixing a soft tissue graft... The accused "Twist Knotless DEX" and "SLik Fix Screw-In Tenodesis System" are alleged to be implant placement systems for affixing tissue grafts. ¶40 col. 37:19-22
a cannulated driver device... and an elongate insertion device slidably received within said driver device... The complaint alleges the accused systems are knotless anchor systems incorporating a driver, implying the presence of components analogous to the claimed driver and insertion devices. ¶13, ¶40 col. 37:23-28
said axial control assembly having a first constrained configuration... wherein said insertion device is maintained in a fixed axial and rotational position... The core infringement theory suggests that the accused systems must operate in a way that prevents rotational torque from being transmitted to the suture during anchor insertion, which would require a mechanism analogous to the claimed "fixed" configuration. ¶38, ¶43 col. 37:34-42

U.S. Patent No. 9,717,587 Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
establishing a desired tension in said first length of said suture... The complaint alleges the accused products are used to perform the patented methods, which would include surgeons using the system to apply tension to a suture before final fixation. ¶38, ¶47 col. 26:10-13
placing said second implant into said prepared socket so as to simultaneously fix the placement of said second free end of said suture... The infringement theory alleges that surgeons using the accused PARCUS anchor systems perform this step of placing a second anchor to secure a tensioned suture. ¶38, ¶47 col. 26:14-17
whereby said desired tension... is maintained throughout step (g). The theory alleges that the accused systems, when used as instructed, fix the suture by trapping it between the anchor and bone, thereby maintaining the pre-set tension as claimed. ¶38, ¶47 col. 26:21-24

Identified Points of Contention

  • Scope Questions: A primary question for the ’224 Patent will be whether the accused PARCUS systems include a component that meets the definition of an "insertion device" that is "maintained in a fixed axial and rotational position" relative to the driver during anchor insertion. For the ’587 Patent, a key question will be whether the term "placing said second implant" to "fix" the suture requires a removable fixation, as emphasized in the specification, and whether the accused products provide this functionality.
  • Technical Questions: The complaint does not provide evidence demonstrating how the accused PARCUS systems actually operate. A central evidentiary question will be whether the accused systems technically function by separating rotational and tensioning functions as claimed in the ’224 Patent, and whether their use involves the specific method of adjustable, trappable suture fixation claimed in the ’587 Patent.

V. Key Claim Terms for Construction

For the ’224 Patent

  • The Term: "fixed axial and rotational position" (from Claim 1)
  • Context and Importance: This term is central to the invention's purported novelty of preventing "suture spin." The infringement analysis will depend entirely on whether the components of the accused PARCUS system are "fixed" in the manner required by the claim. Practitioners may focus on this term because it defines the core mechanical constraint that distinguishes the invention from prior art drivers that transmit torque.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The claim language itself does not specify a particular mechanism for achieving the "fixed" state. A party could argue it means any configuration that substantially prevents the insertion device from co-rotating with the driver.
    • Evidence for a Narrower Interpretation: The specification discloses specific embodiments to achieve this, such as a "removable key" (1200) that engages slots on both the driver and insertion device handles (’224 Patent, col. 7:50-60; Fig. 1). A party could argue that "fixed" should be limited to such explicit mechanical interlocks, rather than mere frictional resistance.

For the ’587 Patent

  • The Term: "placing said second implant... so as to simultaneously fix the placement of said... suture" (from Claim 1)
  • Context and Importance: This step defines how the suture is secured. The patent’s emphasis is on a fixation that is adjustable. The outcome of the case may depend on whether "fix" can encompass only a non-permanent, trappable connection or if it could also read on more permanent forms of fixation.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The word "fix" in isolation could be given its plain and ordinary meaning of simply "to secure."
    • Evidence for a Narrower Interpretation: The specification repeatedly contrasts the invention with prior art by highlighting the ability to remove and reposition the implant to adjust tension (’587 Patent, col. 11:1-12). This context suggests that "fix" should be construed as a releasable fixation achieved by trapping the suture, which is what enables the novel adjustability of the claimed method.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges that Defendant contributes to and induces infringement of all three patents-in-suit (Compl. ¶43, ¶47, ¶52). The factual basis appears to be Defendant’s sale of the accused anchor systems, which are alleged to be material components for practicing the patents and are configured to be used in the infringing manner, implicitly through user instructions or surgical technique guides (Compl. ¶38, ¶40).
  • Willful Infringement: The complaint alleges that Defendant’s infringement has been and continues to be willful and deliberate (Compl. ¶44, ¶48, ¶53). The allegations are supported by the extensive pre-suit history between the parties, including a non-disclosure agreement, confidential disclosures of patent applications, and a multi-year licensing agreement that Plaintiff claims to have terminated. This history is alleged to establish that Defendant had actual knowledge of the patent applications and resulting patents both before and after the alleged infringement began (Compl. ¶14, ¶16, ¶20, ¶36-37).

VII. Analyst’s Conclusion: Key Questions for the Case

  • Contractual Standing: A threshold issue for the court will be the status of the 2016 Licensing Agreement. Was the agreement properly terminated by Plaintiff in 2019, as alleged? If the license remained in effect, the patent infringement claims may be precluded by the doctrine of patent exhaustion, shifting the core dispute to a breach of contract claim over royalty payments.
  • Inventorship and Technical Overlap: The case presents an intertwined dispute over inventorship and infringement. A central question will be whether the technology in Defendant’s accused products is merely an independent development or if it is, as Plaintiff alleges, derived from confidential information and prototypes disclosed by Plaintiff. The outcome of the correction of inventorship claim could significantly influence the infringement analysis.
  • Claim Scope and Functional Equivalence: Beyond the contractual and inventorship issues, a key technical question will be one of functional operation. Does the accused PARCUS system operate using a "fixed" non-rotating insertion device as specifically claimed in the ’224 Patent? Furthermore, does the surgical method enabled by the PARCUS products allow for the removable and adjustable suture fixation that is a central teaching of the ’587 and ’496 Patents, or is there a fundamental mismatch in technical operation and capability?