PTAB

IPR2017-00435

Cook Group Inc v. Boston Scientific Scimed Inc

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1. Case Identification

2. Patent Overview

  • Title: Medical Clip
  • Brief Description: The ’731 patent relates to medical compression clips used for hemostasis of blood vessels, particularly in the gastrointestinal tract. The device includes a clip with two arms, a control wire for actuation, and an "opening element" designed to urge the clip arms into an open, tissue-receiving configuration.

3. Grounds for Unpatentability

Ground 1: Claims 1-4, 6, 9-18, and 20 are anticipated under 35 U.S.C. § 102 by Malecki Embodiment #1.

  • Prior Art Relied Upon: Malecki (Patent 5,626,607), specifically the embodiment depicted in Figure 28A ("Embodiment #1").
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that Malecki's Embodiment #1 discloses every limitation of the challenged claims. The clamp 304C with jaws 308C and 310C was identified as the claimed "clip" with "clip arms." The combination of links 402, 404 and connector 406 was asserted to be the claimed "opening element," as it engages the clip arms to urge them apart. Petitioner further argued that Malecki discloses a control wire (drive body 346B, shaft 398) coupled to the clip via a "separable link," allowing the clip to be deployed and left in the body. The movement from an open to a closed configuration via this mechanism was also mapped to the claim limitations.

Ground 2: Claims 1-4, 6-18, and 20 are obvious under 35 U.S.C. § 103 over Malecki Embodiment #1.

  • Prior Art Relied Upon: Malecki (Patent 5,626,607), referencing Embodiment #1 in combination with other teachings and embodiments within the same reference.
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner presented this ground as an alternative to Ground 1. If the engagement point in Malecki's Embodiment #1 is not considered an "inner wall," Petitioner contended it would have been obvious to modify it. Malecki discloses a finite number of wall surfaces (outward-facing, inward-facing, lateral), and modifying the linkage to engage the inward-facing walls would be a predictable design choice. Furthermore, Petitioner argued that if the rotational actuation of Embodiment #1 is not considered a "proximal tensile force," a person of ordinary skill in the art (POSITA) would find it obvious to substitute it with a conventional push-pull mechanism, which is also disclosed in other embodiments within Malecki (e.g., Fig. 31C).
    • Motivation to Combine: A POSITA would combine these known elements to create a simpler, more intuitive device for physicians. Substituting rotation with a push-pull mechanism was a known design choice to achieve the predictable result of opening and closing a clip. Incorporating a locking feature, also taught in Malecki, would have been a straightforward modification to prevent inadvertent opening.
    • Expectation of Success: A POSITA would have a high expectation of success, as the proposed modifications involve applying known techniques and components disclosed within the same prior art reference to achieve their intended, predictable functions.

Ground 3: Claims 1-2, 4, 10-13, and 15 are anticipated under § 102 by Malecki Embodiment #2.

  • Prior Art Relied Upon: Malecki (Patent 5,626,607), specifically the embodiment depicted in Figures 25-27 ("Embodiment #2").

  • Core Argument for this Ground:

    • Prior Art Mapping: Petitioner asserted that Malecki's Embodiment #2 also teaches all limitations of the specified claims. In this embodiment, the clamp 304B with jaws 308B and 310B constitutes the claimed clip. The "opening element" is a "torsion spring" (explicitly mentioned in the text for this embodiment and shown in the similar embodiment of Fig. 30B), which is normally biased to urge the clip arms open. The linear ends of this spring were argued to be the "link arms" that engage the inner surfaces of the clip arms. This embodiment was also alleged to disclose a control wire (stabilizing rod 378 and shaft 382) and a "separable link" for deployment.

  • Additional Grounds: Petitioner asserted an additional obviousness challenge (Ground 4) against claims 3, 5-9, 14, and 16-20 based on Malecki Embodiment #2, relying on similar theories of design modification as presented in Ground 2.

4. Key Claim Construction Positions

Petitioner dedicated a substantial portion of its argument to claim construction, preemptively adopting the constructions advanced by the Patent Owner (BSSI) in co-pending district court litigation for the purposes of the IPR.

  • "opening element": Petitioner accepted BSSI's proposed construction that this term, which does not appear in the ’731 patent's specification, means any structure that "engages the inner walls of the clip arms and urges them away from one another."
  • "engaging inner walls...": Petitioner accepted BSSI's position that this requires the opening element to "contact" the inner walls and be positioned between them, without requiring a physical connection.
  • "link arms are axially aligned with one another": Petitioner noted its disagreement with BSSI's broad litigation interpretation of this term but accepted it for the purposes of the IPR proceeding to demonstrate that the prior art meets the limitation even under the Patent Owner's own definition.

5. Relief Requested

  • Petitioner requests institution of an inter partes review and cancellation of claims 1-20 of the ’731 patent as unpatentable.