DCT

1:17-cv-03448

Boston Scientific Corp v. Cook Group Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:17-cv-03448, S.D. Ind., 08/17/2021
  • Venue Allegations: Plaintiffs allege venue is proper in the Southern District of Indiana because Defendants are subject to personal jurisdiction there and a substantial part of the events giving rise to the claims occurred in the District.
  • Core Dispute: Plaintiffs allege that Defendants’ endoscopic hemoclip products infringe three U.S. patents related to devices for endoscopically stopping gastrointestinal bleeding.
  • Technical Context: Endoscopic hemostatic clips are medical devices delivered through an endoscope to mechanically clamp bleeding tissue, such as ulcers, in the gastrointestinal tract, offering a minimally invasive alternative to surgery.
  • Key Procedural History: This action was initiated via an Original Complaint on October 27, 2015. The currently operative pleading is the Second Amended and Supplemental Complaint. Subsequent to the original filing, Inter Partes Review (IPR) proceedings were instituted against all three patents-in-suit. The IPRs resulted in the cancellation of numerous claims, including some that serve as the basis for claims asserted in the current complaint, a fact that may significantly narrow the scope of the dispute or raise threshold questions of claim viability.

Case Timeline

Date Event
2001-10-05 Priority Date for ’048 Patent and ’731 Patent
2004-05-05 Priority Date for ’371 Patent
2013-01-01 Accused Instinct™ Endoscopic Hemoclip Launch (on or before this date)
2014-04-01 ’048 Patent Issued
2015-03-10 ’371 Patent Issued
2015-10-27 Original Complaint Filed
2015-11-17 Plaintiffs allegedly sent letter to Defendants regarding application for ’731 Patent
2016-03-01 ’731 Patent Issued
2016-03-09 First Amended and Supplemental Complaint Filed
2016-10-27 IPR filed against ’048 Patent (IPR2017-00132)
2016-10-27 IPR filed against ’371 Patent (IPR2017-00135)
2016-12-13 IPR filed against ’731 Patent (IPR2017-00435)
2021-01-01 Accused Instinct Plus™ Clipping Device Launch (on or before this date)
2021-02-08 IPR Certificate Issued for ’048 Patent
2021-02-09 IPR Certificate Issued for ’371 Patent
2021-04-19 IPR Certificate Issued for ’731 Patent
2021-06-15 Plaintiffs filed claim charts under seal
2021-08-17 Second Amended and Supplemental Complaint Filed

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

U.S. Patent No. 8,685,048 - "Device and Method for Through the Scope Endoscopic Hemostatic Clipping"

The Invention Explained

  • Problem Addressed: The patent’s background section describes limitations of prior endoscopic treatments for gastrointestinal bleeding. It notes that existing endoscopic clips were often not "reversible," meaning once the closing process began, the clip could not be reopened for repositioning, potentially leading to improper placement and the need to deploy multiple clips (’048 Patent, col. 2:38-44).
  • The Patented Solution: The invention is a hemostatic clipping device featuring a clip that can be repeatedly opened and closed by the operator before it is permanently locked and detached (’048 Patent, col. 3:5-9). This is achieved through a control wire within a sheath that actuates the clip's legs, coupled with a "frangible link" mechanism that allows the operator to release the clip only after being satisfied with its position (’048 Patent, col. 5:42-52; Fig. 1).
  • Technical Importance: The ability to reposition the clip before final deployment was intended to increase the success rate of pinching the target vessel, reduce the number of clips used per procedure, and shorten overall procedure time (’048 Patent, col. 3:5-18).

Key Claims at a Glance

  • The complaint asserts claims 3, 4, 7, and 14, all of which depend from independent claim 1 (’048 Patent, Claims; Compl. ¶22).
  • The essential elements of independent claim 1 are:
    • A clip having first and second clip legs.
    • A control wire operable to both open and close the clip legs.
    • A sheath enclosing the control wire.
    • A link coupling the control wire to the clip, where the link is movable from a "coupled configuration" to a "released configuration" in which arms of the link move radially outward to release the control wire.
    • An actuator to move the control wire to open/close the clip and move the link to its released configuration.
  • The complaint reserves the right to assert additional claims (Compl. ¶22).

U.S. Patent No. 8,974,371 - "Through the Scope Tension Member Release Clip"

The Invention Explained

  • Problem Addressed: The patent describes the challenge for an endoscope operator to be certain of the status of a deployed clip, noting the need for "positive indication that all of the deployed clips have been fully deployed and completely released from the tool" before withdrawal (’371 Patent, col. 1:35-41).
  • The Patented Solution: The invention provides a clip assembly with multiple components—a capsule, a clip, a tension member, and a yoke—that interact to provide distinct stages of user feedback. The design provides a first feedback upon clip closure and a second, separate feedback upon the frangible release of the clip assembly from the delivery device, confirming successful deployment (’371 Patent, col. 2:42-67).
  • Technical Importance: This multi-stage feedback mechanism was designed to reduce procedural uncertainty by giving the operator distinct tactile and potentially auditory cues confirming both proper clamping on tissue and successful detachment of the clip (’371 Patent, col. 9:30-43).

Key Claims at a Glance

  • The complaint asserts claim 13 (’371 Patent, Claims; Compl. ¶33). Claim 13 depends from dependent claim 12, which in turn depends from independent claim 11.
  • A post-grant IPR proceeding cancelled independent claim 11, upon which asserted claim 13 ultimately depends (’371 Patent, IPR Certificate p. 2). This procedural history raises a threshold question as to the validity of asserted claim 13.
  • The essential elements of the now-cancelled independent claim 11 are:
    • An apparatus comprising a capsule.
    • A clip assembly housed within the capsule.
    • A control element with a connector element removably connected to the clip assembly.
    • The control element detaches from the connector element via a "frangible link."
    • A sheath covering a portion of the control element, with the sheath's distal end releasably coupled to the capsule.
  • The complaint reserves the right to assert additional claims (Compl. ¶33).

U.S. Patent No. 9,271,731 - "Device and Method for Through the Scope Endoscopic Hemostatic Clipping"

  • Technology Synopsis: This patent, part of the same family as the ’048 Patent, discloses a hemostatic clip device where an "opening element" engages the inner walls of the clip arms to urge them apart. A control wire is used to pull the clip proximally relative to the opening element, causing the arms to close and capture tissue (’731 Patent, Abstract; col. 2:54-68).
  • Asserted Claims: The complaint asserts claims 5 and 19 (Compl. ¶46). Claim 5 is an independent claim that survived IPR. Claim 19 depends from claim 12, which was cancelled during IPR, raising a question as to the validity of claim 19 (’731 Patent, IPR Certificate p. 2).
  • Accused Features: The complaint alleges that the Instinct Plus™ Endoscopic Clipping Device infringes the ’731 Patent (Compl. ¶46).

III. The Accused Instrumentality

Product Identification

  • The accused instrumentalities are the "Instinct™ Endoscopic Hemoclip" and the "Instinct Plus™ Endoscopic Clipping Device" (Compl. ¶¶14, 15).

Functionality and Market Context

  • The complaint alleges that the accused products are endoscopic hemostasis clips intended to stop bleeding in the gastrointestinal tract (Compl. ¶10, ¶14). They are positioned as direct competitors to Plaintiffs' own "Resolution™ Clip" product (Compl. ¶10, ¶14, ¶16).
  • The complaint does not provide a detailed technical description of the accused products' operation, but references product datasheets and quick reference guides that were purportedly obtained from Defendants' website (Compl. ¶14, ¶15). No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The complaint references claim charts that were filed under seal and are not publicly available (Compl. ¶27, ¶38, ¶51). The narrative allegations are summarized below.

  • ’048 Patent Narrative Summary: The complaint alleges that Defendants' making, using, selling, or importing of the Instinct™ and Instinct Plus™ devices infringes, either literally or under the doctrine of equivalents, at least claims 3, 4, 7, and 14 of the ’048 Patent (Compl. ¶22). All asserted claims depend from independent claim 1.
  • ’371 Patent Narrative Summary: The complaint alleges that the same accused activities infringe, either literally or under the doctrine of equivalents, at least claim 13 of the ’371 Patent (Compl. ¶33).
  • Identified Points of Contention:
    • Legal Question (viability of asserted claims): For the ’371 Patent, a threshold dispute will concern whether asserted claim 13 remains valid, given that the independent claim from which it depends (claim 11) was cancelled in an IPR proceeding. A similar question exists for claim 19 of the ’731 Patent.
    • Scope Questions (’048 Patent): For the surviving claims of the ’048 Patent, the dispute may center on the scope of key claim terms. A central question may be whether the mechanism in the accused devices that connects and disconnects the clip from the delivery tool constitutes a "link" that moves from a "coupled configuration" to a "released configuration" as defined by the claims.
    • Technical Questions (’048 Patent): A related factual question will be how the release mechanism of the accused products actually operates and whether that operation involves "arms of the link... mov[ing] radially outward" as required by claim 1.

V. Key Claim Terms for Construction

Analysis based on independent claim 1 of the ’048 Patent.

  • The Term: "link coupling the control wire to the clip"
  • Context and Importance: The structure and function of the "link" is the core of the claimed release mechanism. The outcome of the case for the ’048 patent may depend on whether the corresponding component in the accused devices falls within the construed scope of this term. Practitioners may focus on this term because Defendants will likely argue their product's connection mechanism is fundamentally different from what the patent teaches and claims.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The plain language of the claim uses the general term "link," which is not inherently limited to a specific structure (’048 Patent, col. 16:36-37).
    • Evidence for a Narrower Interpretation: The specification describes a specific preferred embodiment of the link as a "j-hook" that is "frangible" and releases by being forcibly straightened (’048 Patent, col. 5:42-44; col. 7:26-44). Defendants may argue that the term "link" should be limited to this or structurally similar frangible embodiments described in the patent.
  • The Term: "a released configuration in which first and second arms of the link are configured to move radially outward at an area of the sheath to release the control wire from the clip"
  • Context and Importance: This phrase defines the specific manner of release required by the claim. Infringement will require proof that the accused device releases its clip via a component with "arms" that "move radially outward."
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The claim language itself does not specify the degree or exact mechanism of the outward radial movement, potentially allowing for a range of equivalent structures.
    • Evidence for a Narrower Interpretation: The specification illustrates this function with a specific "retainer 110" having tabs that are forced out of corresponding cut-outs in an "outer sleeve 112" (’048 Patent, col. 5:45-52; Fig. 6). An accused infringer may argue this detailed embodiment limits the claim's scope to mechanisms where distinct arms physically expand out of a constraining sleeve.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges both induced and contributory infringement. The inducement allegations are based on Defendants' marketing, sales, and distribution activities, including providing "video and print instructions" that allegedly instruct customers on how to use the accused products in an infringing manner (Compl. ¶23, ¶34, ¶47). The contributory infringement allegations are based on the assertion that the accused products are especially made for infringing use and are not staple articles of commerce (Compl. ¶23, ¶34, ¶47).
  • Willful Infringement: The complaint alleges willful infringement for all three patents. It bases this allegation on Defendants' knowledge of the patents, dating knowledge for the ’048 and ’371 Patents to at least the filing of the Original Complaint on October 27, 2015 (Compl. ¶21, ¶32), and for the ’731 Patent to at least a November 17, 2015 letter concerning the underlying patent application (Compl. ¶43-44).

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

  • A central question will be one of claim viability: can Plaintiffs proceed with infringement allegations on claims 13 of the ’371 Patent and 19 of the ’731 Patent, when the independent claims from which they depend were cancelled in post-grant IPR proceedings? The court must first resolve this threshold legal issue.
  • For the surviving claims of the ’048 Patent, a core issue will be one of definitional scope: how broadly will the court construe the term "link" and its required "released configuration"? The case may turn on whether the specific "j-hook" embodiment described in the patent limits the scope of the claims to frangible, deformable structures, or if the term can be read more broadly to cover the release mechanism of the accused products.
  • Finally, a key question for damages will be willfulness: given the documented litigation history and alleged pre-suit notice, did Defendants act with the requisite state of mind to support an enhancement of damages, should infringement be found on any valid and asserted claim?