PTAB

IPR2018-00107

St Jude Medical LLC v. Snyders Heart Valve LLC

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Key Events
Petition
petition

1. Case Identification

2. Patent Overview

  • Title: Artificial Heart Valve
  • Brief Description: The ’297 patent relates to a collapsible artificial heart valve for repairing a damaged native heart valve. The invention describes a valve architecture comprising a flexibly resilient frame and a flexible valve element, which can be delivered percutaneously via a catheter to avoid invasive open-heart surgery.

3. Grounds for Unpatentability

Ground 1: Anticipation over Bessler - Claims 1-3, 8-9, 22-23, 31-35, 37-39, and 45 are anticipated under 35 U.S.C. §102 by Bessler.

  • Prior Art Relied Upon: Bessler (Patent 5,855,601).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that Bessler, which was of record during prosecution but not applied by the Examiner, discloses every element of the challenged claims under the Patent Owner’s own proposed claim constructions from parallel litigation. Bessler taught an artificial replacement valve with a flexibly resilient, self-expanding nitinol stent (the “frame”) that includes peripheral anchors (barbs and zig-zag bends) and a central portion. It further disclosed a flexible valve element (FVE) made of flexible, non-thrombogenic material attached to the frame’s central portion. Bessler’s device was shown to have an opening for receiving a delivery implement and included all features of the dependent claims, such as a delivery catheter with a holder, manipulator, and installer.
    • Key Aspects: Petitioner contended that Bessler’s disclosure of a self-expanding stent with barbs, a central attachment point for a valve member, and a complete delivery system met all limitations of the independent and dependent claims.

Ground 2: Anticipation over Leonhardt - Claims 1-3, 8-9, 22-23, 31-35, 37-39, and 45 are anticipated under 35 U.S.C. §102 by Leonhardt.

  • Prior Art Relied Upon: Leonhardt (Patent 5,957,949).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner asserted that Leonhardt, which was not of record, also anticipated all challenged claims. Leonhardt described a percutaneously delivered, self-expanding artificial heart valve using a biological valve (preferably an intact porcine valve) as the FVE. This FVE was attached within the central portion of a self-expanding nitinol stent frame. The frame included peripheral anchors (flared ends and the stent’s structure) that engage tissue. Petitioner argued that Leonhardt’s disclosure of a tricuspid porcine valve inherently possessed the claimed convex/concave shape and functioned identically to the valve described in the claims. The reference also disclosed a full delivery system, including a catheter, guidewire, and releasable fasteners (suture loops).

Ground 7: Obviousness over Bessler and Johnson - Claims 1-3, 8-9, 22-23, 31-35, 37-39, and 45 are obvious over Bessler in view of Johnson.

  • Prior Art Relied Upon: Bessler (Patent 5,855,601) and Johnson (Patent 4,339,831).

  • Core Argument for this Ground:

    • Prior Art Mapping: Petitioner argued that even if Bessler alone did not anticipate the claims, it would have been obvious to combine Bessler with Johnson. Bessler provided the foundational self-expanding stent frame, peripheral anchors, and delivery system for a percutaneous valve. Johnson, which was of record in the parent application’s prosecution, taught a funnel-type valve design with superior durability compared to traditional leaflet valves. Johnson explicitly addressed durability problems caused by attaching leaflets at their periphery, proposing instead a central attachment that reduces stress.
    • Motivation to Combine: The motivation to combine stemmed from a recognized problem in the art: the need for durable percutaneous heart valves, especially for frail patients for whom repeat procedures are undesirable. A person of ordinary skill in the art (POSITA) would look to Johnson’s more durable, flexible, funnel-shaped valve design and see it as an advantageous and obvious component to substitute for the leaflet-based valve element in Bessler’s established delivery frame and system.
    • Expectation of Success: A POSITA would have a reasonable expectation of success in this combination. It involved the substitution of one known type of valve element for another within a known type of stent frame to achieve the predictable benefits of improved durability taught by Johnson. Both references operate in the same field, address the same problems, and are presumed enabling.

  • Additional Grounds: Petitioner asserted additional challenges, including obviousness of all claims over Bessler alone (Ground 3) and Leonhardt alone (Ground 4). Further obviousness grounds combined Bessler with Thompson (Patent 6,623,518) or Taylor (WO 1997/016133) to teach alternative releasable fastener mechanisms (Grounds 5 and 6). Finally, three-way combinations of Bessler, Johnson, and either Thompson or Taylor were asserted (Grounds 8 and 9).

4. Key Claim Construction Positions

  • Petitioner argued that for the purposes of the IPR, the Board should adopt the claim constructions proposed by the Patent Owner in a co-pending district court litigation. Petitioner contended these constructions were admissions against the Patent Owner’s interest.
  • By adopting the Patent Owner’s own broad definitions, Petitioner asserted that the prior art more clearly reads on the claims. For example, the Patent Owner’s construction of "central portion" as simply "any location between a plurality of peripheral anchors" was argued to be a broad definition easily met by the structures in Bessler and Leonhardt.
  • Similarly, the broad construction of "flexible valve element" as "a flexible part of the valve" was argued to encompass the valve members of Bessler, Leonhardt, and Johnson without requiring the specific "funnel-shaped" structure detailed in the ’297 patent’s specification.

5. Relief Requested

  • Petitioner requested institution of an inter partes review and cancellation of claims 1-3, 8-9, 22-23, 31-35, 37-39, and 45 of the ’297 patent as unpatentable.