DCT

8:19-cv-00791

Tissue Anchor Innovations LLC v. Fountain Valley Regional Hospital Medical Center

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 8:19-cv-00791, C.D. Cal., 04/30/2019
  • Venue Allegations: Venue is alleged to be proper in the Central District of California because the Defendants are incorporated in, do business in, operate facilities in, and/or have committed acts of infringement within the district.
  • Core Dispute: Plaintiff, the exclusive licensee, alleges that Defendant Boston Scientific’s surgical sling systems for treating urinary incontinence, and the use of these systems by the co-defendant hospitals, infringe a patent related to tissue anchoring systems.
  • Technical Context: The technology relates to medical devices for the surgical treatment of stress urinary incontinence (SUI), a common condition, by implanting an anchor to support a surgical sling.
  • Key Procedural History: The complaint alleges a long history of pre-suit interaction between the patent owner and Defendant Boston Scientific, beginning in September 2004. This history includes a formal proposal by Boston Scientific to purchase the patent in January 2005, which predates the alleged 2008 launch of the accused products. The complaint also alleges that Plaintiff sent a formal notice letter with a claim chart to Boston Scientific in March 2017. These allegations form the basis of the willfulness claim.

Case Timeline

Date Event
1998-05-21 '190 Patent Priority Date
2003-01-14 '190 Patent Issue Date
2004-09-09 Counsel for inventor allegedly identified '190 Patent to Boston Scientific
2004-11-02 Boston Scientific allegedly confirmed receipt of '190 Patent
2004-12-29 Boston Scientific allegedly provided a confidentiality agreement
2005-01-13 Boston Scientific allegedly proposed to purchase the '190 Patent
~2008 Boston Scientific allegedly began U.S. sales of Accused Systems
2017-03-03 Boston Scientific allegedly received formal infringement notice letter
2019-04-30 Complaint Filing Date

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

U.S. Patent No. 6,506,190 - "Tissue Anchor System"

  • Patent Identification: U.S. Patent No. 6,506,190, "Tissue Anchor System," issued January 14, 2003.

The Invention Explained

  • Problem Addressed: The patent’s background section describes problems with existing surgical procedures for stress urinary incontinence, noting that improper tensioning of supporting sutures or slings can lead to under-correction (persistent incontinence) or over-correction (voiding dysfunction and other complications) ( ’190 Patent, col. 2:25-44).
  • The Patented Solution: The invention is a "tissue anchoring system" comprising a delivery device and a tissue anchor, which can be used to secure a sling to support the bladder neck (’190 Patent, col. 2:56-58). The system is designed to solve the tensioning problem by providing anchors that can be "adjustable," including for "intra- or post-operative adjustments," allowing a surgeon to fine-tune the support provided by the sling after the initial implantation (’190 Patent, Abstract; col. 3:4-5).
  • Technical Importance: The capacity for post-operative adjustment addresses a significant challenge in SUI surgery by allowing for tension modifications after a patient is no longer under anesthesia, which could improve surgical outcomes and reduce the need for corrective procedures (’190 Patent, col. 2:25-44).

Key Claims at a Glance

  • The complaint does not specify which claims of the ’190 Patent are asserted, stating only that an exemplary claim chart was provided in an exhibit (Compl. ¶23). Independent claim 1 is representative of the basic system.
  • Independent Claim 1 recites the following essential elements:
    • A tissue anchor system comprising a delivery device and a tissue anchor
    • The delivery device having a housing and a plunger slidably positioned in the housing
    • The anchor having a barb end, with a barb thereon having a tip shaped to penetrate soft tissue
    • The anchor having an attachment member
    • The anchor is advanced away from the housing upon operation of the plunger
    • The barb is adapted to resist removal from a tissue once inserted
  • The complaint does not explicitly reserve the right to assert dependent claims.

III. The Accused Instrumentality

Product Identification

The "Solyx Single-Incision Sling System," including but not limited to the "Solyx SIS System, Solyx Blue Single Incision Sling System, and any prior versions of these products" (collectively, the "Accused Systems") manufactured and sold by Boston Scientific (Compl. ¶15).

Functionality and Market Context

The Accused Systems are medical devices marketed and used for the surgical treatment of stress urinary incontinence (Compl. ¶15). They are alleged to include "at least a delivery device and mesh assembly," which are used by medical professionals at hospitals, including co-defendants FVRH and LAMC, to implant the systems in patients (Compl. ¶¶15-16, 53). The complaint notes that a 2019 FDA action regarding certain mesh products did not affect the Accused Systems, which remain on the market (Compl. ¶15, fn. 1).

IV. Analysis of Infringement Allegations

The complaint alleges infringement of the ’190 Patent but provides the specific infringement theory in an attached claim chart (Exhibit B), which was not included in the filed document (Compl. ¶22). Therefore, a detailed element-by-element analysis is not possible from the provided materials.

The narrative infringement theory is that Boston Scientific’s Accused Systems, which are comprised of a "delivery device and mesh assembly," embody the inventions of the ’190 Patent (Compl. ¶¶15, 33). The complaint alleges that Boston Scientific directly infringes by making, using, and selling these systems (Compl. ¶34). It further alleges that the hospital defendants, FVRH and LAMC, directly infringe by using the Accused Systems to perform surgical procedures and by selling the systems to patients as part of the procedure's cost (Compl. ¶¶53, 59).

No probative visual evidence provided in complaint.

  • Identified Points of Contention:
    • Scope Questions: A central issue will be whether the components and operation of the Accused Systems fall within the scope of the asserted patent claims. For example, a question may arise as to whether the mechanism of the Solyx "delivery device" meets the specific claim limitations of a "housing" and a "plunger."
    • Technical Questions: A likely area of dispute will be the structural and functional correspondence between the accused product and the patent claims. For instance, the analysis may focus on whether the part of the Solyx system that anchors its "mesh assembly" in tissue functions as the claimed "barb adapted to resist removal from a tissue."

V. Key Claim Terms for Construction

The Term: "plunger"

  • Context and Importance: This term appears in independent claim 1 and is integral to the claimed method of deploying the anchor. The infringement analysis may turn on whether the mechanism in the Solyx delivery device can be characterized as a "plunger." Practitioners may focus on this term because if the accused device uses a different type of deployment mechanism, it could support a non-infringement defense.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The patent's objective is to provide a system for deploying an anchor; one could argue that "plunger" should be construed to encompass any component that, upon operation, advances the anchor from the housing. The specification states a "plunger 5 [has] an anchor end 10 adapted to engage an anchor 20" without strictly limiting its form (’190 Patent, col. 5:2-4).
    • Evidence for a Narrower Interpretation: The figures depict specific embodiments of the "plunger" as a slidable rod-like structure (e.g., element 5 in Fig. 2; elements 301/302 in Fig. 13). A party could argue the term should be limited to these depicted structures.

The Term: "attachment member"

  • Context and Importance: This element, recited in claim 1, is the component of the anchor that connects to the suture or sling. Its definition is critical for determining if the way the accused Solyx "mesh assembly" connects to its anchor is covered by the patent.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The specification suggests this term is broad, describing it as a "structure... for engaging a material, such as a suture or tissue sample" (’190 Patent, col. 8:51-53). Claim 22 further defines the member as potentially being "a ring, a tissue clamp, an annular projection, a series of indentations, or an aperture formed in said anchor shaft," supporting a broad construction covering various connection types (’190 Patent, col. 22:4-7).
    • Evidence for a Narrower Interpretation: A party seeking a narrower definition might point to the specific physical structures shown in the figures, such as the apertures (50a) in the tab of Figure 6a, to argue the term requires a similar, discrete structure for attachment.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges that Boston Scientific induces infringement by providing customers with Instructions for Use (IFU), marketing materials, and customer support services that instruct on the infringing use of the Accused Systems (Compl. ¶¶19, 35). It further alleges contributory infringement, stating the Accused Systems are "not a staple article," have no substantial non-infringing use, and are "especially made or adapted for infringement" (Compl. ¶¶17-18, 36).
  • Willful Infringement: The willfulness claim is heavily based on allegations of pre-suit knowledge. The complaint asserts that Boston Scientific was aware of the ’190 Patent as early as September 2004, received a proposal to purchase the patent in 2005, and nonetheless began selling the Accused Systems around 2008 (Compl. ¶¶25, 28, 38). The claim is further supported by allegations of continued infringement after receiving a formal notice letter and claim chart in March 2017 (Compl. ¶¶23, 42). The complaint also states that Boston Scientific has not challenged the patent's validity and has not relied on a formal opinion of counsel (Compl. ¶¶43, 45).

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

  • A core issue will be one of claim scope and infringement: whether the specific mechanical components of Boston Scientific’s Solyx system—particularly its delivery tool and the means by which its mesh sling is secured—fall within the scope of the ’190 patent’s claim terms, such as "plunger" and "barb".
  • A key factual question will relate to willfulness: given the extensive history of alleged pre-suit knowledge dating back to 2004, including a patent purchase offer, the court will need to determine Boston Scientific's state of mind during the development and sale of the Accused Systems to assess whether its conduct constitutes willful infringement.