PTAB

IPR2017-00132

Cook Group Inc v. Boston Scientific Scimed Inc

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1. Case Identification

2. Patent Overview

  • Title: Medical Devices, Delivery Systems, and Methods of Use
  • Brief Description: The ’048 patent discloses medical devices, specifically compression clips designed to cause hemostasis of blood vessels, particularly within the gastrointestinal tract. The technology centers on a clip assembly delivered via a catheter, which can be actuated by a control wire to clamp tissue and then detached from the delivery system to remain in the body.

3. Grounds for Unpatentability

Ground 1: Claims 1-3, 5-18, and 20-28 are anticipated by Komiya

  • Prior Art Relied Upon: Komiya (Patent 3,958,576).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that Komiya, which discloses a surgical instrument for clipping tissue, teaches every limitation of the challenged claims. Independent claim 1 recites a medical device with a clip, a control wire, a sheath, an actuator, and a separable link. Petitioner mapped these elements to Komiya’s clip (11) with clamping portions (11d), a control wire (19, 20) operable to open and close the clip, a sheath (tubular member 15 and holder 21), and an actuator. Crucially, Petitioner contended that Komiya’s link mechanism, comprising offset portions (11b), moves radially outward into a relief area (hole 16) of the sheath to release the control wire from the clip, directly anticipating the claimed release configuration. Petitioner provided a similar element-by-element mapping for the challenged dependent claims.

Ground 2: Claims 1, 3, 5-14, 21, 24, 25, 27, and 28 are obvious over Komiya in view of Crockard

  • Prior Art Relied Upon: Komiya (Patent 3,958,576) and Crockard (Patent 5,174,276).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner asserted that Komiya discloses the majority of the claimed features. To the extent Komiya’s release mechanism was found not to meet the claim limitation of link arms moving radially outward to release the control wire, Crockard was introduced. Crockard teaches an aneurysm clip applicator with link arms (jaws 92) that are biased to spring radially outward to release from a control wire as soon as they are advanced beyond the confinement of an outer sheath.
    • Motivation to Combine: A Person of Ordinary Skill in the Art (POSITA) would combine these references to improve the functionality and simplify the operation of the Komiya device. Komiya’s release requires a potentially complex combination of distal and sideways movements. Crockard’s mechanism provides a more reliable, single-action release. A POSITA would be motivated to incorporate Crockard’s simpler release mechanism into Komiya’s clipping device to reduce procedural complexity, decrease the risk of user error, and improve clinical outcomes.
    • Expectation of Success: Petitioner argued a POSITA would have a high expectation of success. The combination involved substituting one known mechanical release mechanism for another in a predictable manner. Both systems rely on the same principle of link arms being constrained within a sheath and expanding upon removal from that constraint, making the integration a matter of routine design.

Ground 3: Claims 29 and 30 are obvious over Shinozuka in view of Matsuno

  • Prior Art Relied Upon: Shinozuka (Japanese Application Publication No. 60-103946) and Matsuno (Patent 5,766,189).

  • Core Argument for this Ground:

    • Prior Art Mapping: This ground targets method claims 29 and 30. Petitioner argued that Shinozuka discloses all the required method steps: inserting a clipping device, positioning it at a target location, moving a control wire to deploy clip legs, drawing the wire to capture tissue, and separating a link to detach the clip. However, Shinozuka’s release mechanism involves "jiggling" the control wire. If this is not considered applying a "tensile force of at least a threshold level," Matsuno teaches this exact feature. Matsuno discloses a clip with a separable link (hook portion 3a) that is specifically designed to release by applying a sufficient tensile force to the control wire, causing the hook to deform and straighten.
    • Motivation to Combine: A POSITA would be motivated to replace Shinozuka’s imprecise "jiggling" release method with Matsuno’s more controlled and predictable tensile-force release. The "jiggling" method introduces uncertainty regarding the exact point of release and carries a risk of damaging surrounding tissue. Matsuno’s design provides a simpler, more precise, and safer method for unlinking the clip, which would have been a recognized improvement.
    • Expectation of Success: The combination was presented as a predictable substitution of one link-separation technique for another to improve a known surgical procedure. A POSITA would have reasonably expected that incorporating Matsuno's tensile release into Shinozuka's method would result in a more reliable and safer clip deployment.

  • Additional Grounds: Petitioner asserted that claims 2 and 17 are obvious over Komiya alone, arguing that even if Komiya does not explicitly disclose a "substantially spherical cross section" on the control wire, it would have been an obvious design choice to make it cylindrical to slide smoothly within Komiya's cylindrical holder.

4. Key Claim Construction Positions

  • For the purposes of the IPR proceeding only, Petitioner adopted the Patent Owner's proposed construction for the term "sheath."
  • The agreed-upon construction defines "sheath" as "one or more components that enclose the control wire." This construction is material to the invalidity arguments because it allows the term to encompass components of the clip assembly itself (such as an "outer sleeve") that detach with the clip and remain in the body, not just the external delivery catheter.

5. Relief Requested

  • Petitioner requests institution of an inter partes review and cancellation of claims 1-3, 5-18, and 20-30 of Patent 8,685,048 as unpatentable.