PTAB

IPR2018-00106

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 ’782 patent discloses a collapsible, implantable artificial heart valve for repairing a damaged native heart valve. The technology centers on a specific valve architecture comprising a flexibly resilient frame, a band, and a flexible valve element, designed for transcatheter delivery into a patient's vasculature.

3. Grounds for Unpatentability

Ground 1: Anticipation of Claims 1-2, 4-8, 10-13, 17-19, 21-22, and 25-30 under §102 by Bessler

  • Prior Art Relied Upon: Bessler (Patent 5,855,601).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that Bessler, a prior art patent issued in 1999, disclosed every element of the challenged claims. Bessler described a self-expanding transcatheter heart valve with a frame, a band, and a flexible valve element (FVE) for placement in a native valve annulus. Petitioner contended that Bessler’s self-expanding stent met the “flexibly resilient frame” limitation; its barbs and zig-zag bends constituted “peripheral anchors”; its cuff met the “band” limitation; and its use of a porcine or synthetic valve satisfied the “flexible valve element” limitation. Furthermore, Petitioner asserted that the operational characteristics of Bessler’s valve, including its movement in response to blood flow, mapped directly onto the functional language of the independent claims.
    • Key Aspects: The core of this argument relied on applying the Patent Owner's own proposed claim constructions from a parallel district court litigation to the Bessler reference, contending that under those definitions, Bessler was squarely anticipatory.

Ground 2: Obviousness of Claims 1-2, 4-8, 10-13, 17-19, 21-22, and 25-30 under §103 over Bessler in view of Andersen

  • Prior Art Relied Upon: Bessler (Patent 5,855,601) and Andersen (Patent 5,411,552).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that, to the extent Bessler was found not to anticipate every limitation, any differences would have been rendered obvious by Andersen. Andersen disclosed a similar collapsible prosthetic heart valve mounted on a stent frame composed of “U-shaped” members. Petitioner asserted that Andersen provided any potentially missing details regarding specific frame structures (e.g., U-shaped elements) or valve attachment methods. For example, Andersen’s stent with two rings of U-shaped members provided an explicit example of the frame structure required by certain dependent claims.
    • Motivation to Combine: A Person of Ordinary Skill in the Art (POSA) would combine the teachings of Bessler and Andersen as a matter of routine engineering. Both references addressed the same problem of providing a transcatheter replacement heart valve. A POSA would have been motivated to use Andersen’s stent design, which offered flexibility and could be extended to prevent migration, with Bessler's valve components. This represented a simple substitution of one known type of stent for another to achieve the predictable result of a functional transcatheter valve.
    • Expectation of Success: A POSA would have had a high expectation of success in combining these references. Both disclosed functional, enabled devices using similar components (stents, bands, biological valves) for the same purpose, making their combination straightforward and predictable.

Ground 3: Obviousness of Claims 1-2, 4-8, 10-13, 17-19, 21-22, and 25-30 under §103 over Johnson in view of Bessler and Imachi

  • Prior Art Relied Upon: Johnson (Patent 4,339,831), Bessler (Patent 5,855,601), and Imachi (Patent 5,413,599).

  • Core Argument for this Ground:

    • Prior Art Mapping: This ground proposed combining a durable surgical funnel valve (Johnson) with a known transcatheter delivery stent (Bessler). Johnson disclosed a flexible, collapsible funnel-shaped valve with a conical, "birdcage" frame, but it required surgical implantation. Bessler disclosed a self-expanding stent with barbs for secure, non-surgical anchoring. The combination involved mounting Johnson's valve onto Bessler's stent. Imachi was cited to show that attaching a funnel valve primarily at its central apex, as would be required in the combination, was a known design choice, rendering the specific attachment method obvious.
    • Motivation to Combine: The primary motivation was to overcome the known risks of open-heart surgery by adapting Johnson's durable surgical valve for transcatheter delivery. Johnson's design was promoted as having superior durability compared to traditional leaflet valves. A POSA would therefore be motivated to mount the Johnson valve onto a well-known transcatheter platform like Bessler’s stent to create a durable, less-invasive replacement valve.
    • Expectation of Success: A POSA would have reasonably expected success because the combination involved applying a known technique (mounting a valve on a stent) to known components to solve a well-understood problem. The functions of Johnson’s valve and Bessler’s stent were maintained in the combination.

  • Additional Grounds: Petitioner asserted an additional obviousness challenge over Bessler in view of Johnson and Imachi (Ground 4), arguing from the perspective of modifying Bessler's valve with Johnson's more durable design.

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 parallel district court proceeding.
  • Petitioner’s central strategy was to demonstrate that the challenged claims were unpatentable even under the Patent Owner's own, allegedly broad, definitions for key terms. For instance, by adopting the Patent Owner's construction of "flexibly resilient frame" as simply "a structure designed to shape or support" that can spring back, Petitioner argued that the stents in Bessler and Andersen clearly met the limitation. This approach was used to contend that structures the Patent Owner asserted were covered by the claims were, in fact, already present in the prior art.

5. Relief Requested

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