PTAB

IPR2018-00105

St. Jude Medical, LLC v. Snyders Heart Valve LLC

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1. Case Identification

2. Patent Overview

  • Title: Artificial Heart Valve
  • Brief Description: The ’782 patent describes a collapsible and self-expanding artificial heart valve for repairing a damaged native valve. The invention centers on a specific architecture comprising a "stented funnel valve prosthesis," which includes a "conical geodesic 'bird-cage' styled" support frame and a "unitary flexible funnel-shaped member" located within the frame. The device is designed for transcatheter implantation, avoiding open-heart surgery.

3. Grounds for Unpatentability

Ground 1: Anticipation by Leonhardt - Claims 1, 2, 4-8, 10-13, 17-19, 21, 22, and 25-30 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 argued that Leonhardt, a reference not considered during prosecution, discloses every element of the challenged claims. This argument relies heavily on applying the claim constructions proposed by the Patent Owner in a co-pending district court litigation. Petitioner contended that under these broad definitions, Leonhardt’s percutaneously delivered, self-expanding heart valve anticipates the claims. Leonhardt’s device includes a flexibly resilient nitinol stent (the "frame"), a biological porcine valve (the "flexible valve element" or FVE), graft material and stent portions that function as the claimed "bands," and a delivery system with a sheath and push-rod, all of which Petitioner mapped to corresponding claim limitations.
    • Key Aspects: The core of this ground is the assertion that structures in Leonhardt, such as its self-expanding stent with flared ends and a tricuspid porcine valve, directly meet the claim terms as broadly defined by the Patent Owner in its infringement contentions. For example, Petitioner argued Leonhardt's stent has "peripheral anchors" and a "central portion," and its porcine valve has the claimed convex/concave geometry.

Ground 2: Obviousness over Leonhardt and Andersen - Claims 1, 2, 4-8, 10-13, 17-19, 21, 22, and 25-30 are obvious over Leonhardt in view of Andersen.

  • Prior Art Relied Upon: Leonhardt (Patent 5,957,949) and Andersen (Patent 5,411,552).
  • Core Argument for this Ground:
    • Prior Art Mapping: As an alternative to anticipation, Petitioner asserted that any minor differences between Leonhardt and the challenged claims would have been obvious to a person of ordinary skill in the art (POSA) in light of Andersen. Both Leonhardt and Andersen disclose collapsible heart valves comprising a stent, a biological valve (specifically porcine), and a band, all for transcatheter delivery. Andersen teaches a flexibly resilient frame with "U-shaped" members and discloses using multiple stent rings that can be sutured together to extend the device length.
    • Motivation to Combine: Petitioner argued a POSA would have been motivated to combine the teachings of these highly similar references. Both references address the same problem with analogous solutions. A POSA would have recognized the interchangeability of their respective components as a matter of routine engineering. Specifically, Andersen's teaching of using additional rings to extend the stent provides design flexibility and could help prevent migration, motivating a POSA to incorporate or substitute Andersen's stent design into Leonhardt's system.
    • Expectation of Success: A POSA would have had a reasonable expectation of success in combining these elements. Both are enabled U.S. patents describing similar structures that function in the same way to achieve the same purpose.

Ground 3: Obviousness over Leonhardt, Johnson, and Imachi - Claims 1, 2, 4-8, 10-13, 17-19, 21, 22, and 25-30 are obvious over Leonhardt in view of Johnson and Imachi.

  • Prior Art Relied Upon: Leonhardt (Patent 5,957,949), Johnson (Patent 4,339,831), and Imachi (Patent 5,413,599).
  • Core Argument for this Ground:
    • Prior Art Mapping: This ground proposes substituting the biological valve of Leonhardt with the mechanical, funnel-type valve taught by Johnson. Leonhardt provides the foundational self-expanding stent and graft for transcatheter delivery. Johnson, which was a reference in the ’782 patent's prosecution, teaches a durable, funnel-shaped valve within a "birdcage-like" frame made of springy material. Petitioner asserted that Johnson's valve design is functionally equivalent to Leonhardt's biological valve but offers superior durability. Imachi was cited as further teaching a funnel valve secured within a tubular structure.
    • Motivation to Combine: Petitioner argued that Leonhardt itself suggests substituting mechanical or synthetic valves for its preferred biological valve. Johnson provides a strong motivation for this substitution by teaching that its central-attachment funnel valve design avoids localized stress points common in tissue valves, resulting in "extreme durability." For a POSA designing a device for elderly or frail patients, achieving greater durability to avoid follow-on procedures would have been a primary objective.
    • Expectation of Success: The substitution of one known valve type for another within a known stent-graft system was presented as a predictable design choice. Because all components were known and their functions understood, a POSA would have had a high expectation of success in creating a functional, more durable heart valve.

4. Key Claim Construction Positions

  • Petitioner’s primary strategy revolved around claim construction. The petition argued that the claim constructions the Patent Owner advanced in a parallel district court case were admissions against interest.
  • Petitioner asserted that these constructions, representing the ordinary and customary meaning of the terms, were so broad that they encompassed structures readily found in the prior art.
  • The central legal argument was that under the principle of “that which would literally infringe if later in time anticipates if earlier,” the prior art devices (especially Leonhardt) anticipated the challenged claims when read through the lens of the Patent Owner’s own broad infringement theory. For the purposes of the inter partes review (IPR), Petitioner adopted these constructions to demonstrate invalidity.

5. Relief Requested

  • Petitioner requests institution of an IPR and cancellation of claims 1, 2, 4-8, 10-13, 17-19, 21, 22, and 25-30 of the ’782 patent as unpatentable.