PTAB

IPR2018-00105

St Jude Medical LLC v. Snyders Heart Valve LLC

Key Events

Petition

petition

Title: Artificial Heart Valve
Brief Description: The ’782 patent discloses a collapsible artificial heart valve for repairing a damaged native valve. The invention features a conical, "bird-cage" style wire frame supporting a unitary, flexible, funnel-shaped valve member designed for transcatheter implantation.

Prior Art Relied Upon: Leonhardt (Patent 5,957,949).
Core Argument for this Ground:
- Prior Art Mapping: Petitioner argued that Leonhardt, which teaches a self-expanding heart valve with a nitinol stent and a biological porcine valve, discloses every limitation of the challenged claims. The argument hinged on applying the Patent Owner's own proposed claim constructions from a parallel district court litigation, which Petitioner contended were broad enough to read on the prior art. Petitioner mapped Leonhardt’s self-expanding stent to the claimed "flexibly resilient frame," its cylindrical portions and flared ends to "peripheral anchors," and its graft material to a "band." The porcine valve in Leonhardt was asserted to meet the limitations of the "flexible valve element," including its shape and attachment points. Leonhardt was also argued to disclose the required delivery instrument.

Prior Art Relied Upon: Leonhardt (Patent 5,957,949) and Andersen (Patent 5,411,552).
Core Argument for this Ground:
- Prior Art Mapping: Petitioner asserted that Leonhardt discloses the primary valve structure and that any alleged differences are rendered obvious by Andersen. Andersen, which also teaches a collapsible valve with a biological insert for transcatheter delivery, discloses key features such as a stent frame constructed from multiple securable rings and explicitly U-shaped members, which Petitioner argued were analogous to the claimed elements.
- Motivation to Combine: A Person of Ordinary Skill in the Art (POSA) would combine these references because they address the same problem with a finite and predictable set of known components. Petitioner argued that Andersen's modular stent design offers flexibility and improved migration resistance, providing a clear motivation to incorporate its stent features into the Leonhardt valve system to create a more robust device.
- Expectation of Success: A POSA would have a high expectation of success in combining the references due to the significant functional and structural similarities of the components in both patents, which are presumed to be enabling.

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 proposed substituting Leonhardt's biological valve with the more durable, synthetic funnel-shaped valve taught by Johnson. Petitioner argued that Johnson’s disclosure of a "birdcage-like" frame supporting a flexible funnel valve made of "springy" material closely resembles the structure described in the ’782 patent. The Imachi reference was cited as providing an alternative, well-known method for mounting such a funnel valve within a tubular structure.
- Motivation to Combine: A POSA would be motivated to make this substitution for several reasons. First, Leonhardt expressly suggests that its biological valve could be replaced with mechanical or synthetic alternatives. Second, a POSA would seek to improve valve durability, a critical factor for transcatheter valves implanted in frail patients, and Johnson specifically teaches a durable valve design.
- Expectation of Success: The proposed combination involves a straightforward substitution of one known valve type (Johnson's funnel valve) for another (Leonhardt's biological valve) within an established stent-based system, making success predictable and the combination obvious.

Petitioner's primary claim construction strategy was to demonstrate unpatentability by applying the Patent Owner's own proposed constructions from a co-pending district court case.
Petitioner argued that Patent Owner’s broad proposed definitions for key terms—such as "flexibly resilient frame," "peripheral anchor," and "band"—were so expansive that they encompassed conventional structures found in the prior art.
For example, Petitioner asserted that under Patent Owner's definitions, any part of Leonhardt's stent frame could be considered a "peripheral anchor," and its circumferential graft material or rows of frame elements qualified as a "band," thereby causing the claims to read directly on the prior art.

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