PTAB

IPR2017-00135

Cook Group Inc v. Boston Scientific Scimed Inc

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1. Case Identification

2. Patent Overview

  • Title: Hemostatic Clip Apparatus
  • Brief Description: The ’371 patent relates to a hemostatic clipping apparatus used to treat internal bleeding by clamping tissue. The system comprises a disposable clip assembly (including a capsule, clip arms, and a yoke) mounted on a reusable delivery device, which allows a physician to remotely position, clamp, and detach the clip through an endoscope.

3. Grounds for Unpatentability

Ground 1: Anticipation over Adams - Claims 1, 3, 8, 9, 11, and 15 are anticipated by Adams

  • Prior Art Relied Upon: Adams (Patent 8,685,048).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that the "J-Hook" embodiment of Adams disclosed every element of independent claims 1 and 11. Specifically, Petitioner mapped Adams’ lock sleeve (113) to the claimed "capsule," its clip (101) to the "clip assembly," its retainer (110) to the "bushing," and its control wire (108) with a j-hook (107) to the "control member." Petitioner contended that the releasable connection between the j-hook and a cut-out (106) on the clip assembly constituted the claimed "frangible link," as it unlinks under tensile force. Dependent claims were also allegedly disclosed, with Adams' handle meeting claim 3's handle limitation and the mating retainer tabs and holes meeting the "keyed portion" limitations of claims 8 and 9.

Ground 2: Obviousness over Adams in view of Sackier - Claims 10 and 17 are obvious over Adams in view of Sackier

  • Prior Art Relied Upon: Adams (Patent 8,685,048), Sackier (Patent 5,749,881).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner asserted that Adams taught all limitations of the base claims (1 and 11), while Sackier supplied the missing element of claims 10 and 17: a "tension member" biasing the clip arms to an open, expanded configuration. Sackier explicitly disclosed a surgical clip device with a spring (52) located in its hinge to perform this exact biasing function.
    • Motivation to Combine: A person of ordinary skill in the art (POSITA) would have been motivated to incorporate Sackier's biasing spring into the Adams device for the predictable purpose of improving its performance. Ensuring the clip arms open as widely as possible is a known design goal for achieving reliable tissue capture, and adding a spring was a well-known technique to achieve this result.
    • Expectation of Success: The combination involved applying a known technique (spring biasing) to a known device (a surgical clip) to achieve a predictable result (improved opening). Therefore, a POSITA would have had a reasonable expectation of success.

Ground 3: Anticipation over Kimura - Claims 11-13 are anticipated by Kimura

  • Prior Art Relied Upon: Kimura (Application # 2002/0045909).

  • Core Argument for this Ground:

    • Prior Art Mapping: Petitioner argued that Kimura, when properly interpreted, anticipated all limitations of independent claim 11. Kimura disclosed a clip assembly, a capsule, and a control element comprising a manipulation wire (7), a hook section (12), and a link member (3). Petitioner contended that upon applying tensile force, the link member (3) breaks at a reduced-diameter fracture section (3d), which constitutes the claimed "frangible link." A distal portion of the link member (the claw hook 3a) remains with the clip and functions as the "connector element," while the proximal portion is removed with the delivery system.
    • Key Aspects: This ground centered on correcting an alleged mischaracterization of Kimura by the Patent Owner during prosecution. Petitioner argued the Patent Owner had persuaded the Examiner to withdraw an anticipation rejection by incorrectly asserting that the entire link member in Kimura remained with the clip after fracture. Petitioner's detailed analysis asserted that the link member in fact breaks in two, with the distal piece remaining as the claimed "connector element," thereby demonstrating that Kimura taught the claimed detachment mechanism.

  • Additional Grounds: Petitioner asserted additional challenges, including obviousness of claims 4, 5, 7, 13, and 14 over different embodiments within Adams alone; anticipation and obviousness of various claims over Sackier alone or in combination with Adams; and obviousness of claims 10 and 17 over Kimura combined with Sackier.

4. Key Claim Construction Positions

  • "bushing 'coupled to the sheath'": Petitioner adopted the Patent Owner's litigation position that this term's plain and ordinary meaning includes a bushing that is merely "slideable inside the sheath" and "confined" by it. This construction was crucial for arguing that the retainer in Adams, which is slidable within but not fixed to the sheath, met the claim limitation.
  • "frangible link": Petitioner adopted the Patent Owner's construction that a "frangible link" is one "that become[s] unlinked when a tensile load is applied," explicitly including non-destructive disconnections like a ball-and-socket joint being pulled apart. This broad definition allowed Petitioner to map the J-hook in Adams and the ball-and-socket joints in both Adams and Sackier to the claimed feature.

5. Key Technical Contentions (Beyond Claim Construction)

  • Misinterpretation of Kimura's Detachment Mechanism: Petitioner's anticipation argument against Kimura was founded on the contention that the Patent Owner had prevailed during prosecution by misrepresenting a key technical feature of the reference. Petitioner argued that the Patent Owner incorrectly stated that Kimura's hook section disconnects from the entire link member. In contrast, Petitioner asserted that a correct reading shows the link member itself fractures, leaving a distal piece behind with the clip. This corrected technical interpretation was presented as newly demonstrating that Kimura taught the claimed invention.

6. Relief Requested

  • Petitioner requested the institution of an inter partes review and the cancellation of claims 1, 3-15, and 17 of the ’371 patent as unpatentable.