Edwards Lifesciences Corp v. Colibri Heart Valve LLC

1. Case Identification

• Case #: IPR2021-00775
• Patent #: 9,125,739
• Filed: April 6, 2021
• Petitioner(s): Edwards Lifesciences Corporation and Edwards Lifesciences LLC
• Patent Owner(s): Colibri Heart Valve LLC
• Challenged Claims: 1-5

2. Patent Overview

• Title: Implantable Heart Valve and Delivery System
• Brief Description: The ’739 patent discloses an implantable replacement heart valve system. The system features a collapsible, self-expanding stent containing a valve made of fixed pericardial tissue, which is characterized by the asserted novelty of having no reinforcing members residing within the stent’s inner channel. The patent also describes a transcatheter delivery assembly comprising a pusher member and a moveable sheath for deployment.

3. Grounds for Unpatentability

Ground 1: Obviousness over Garrison - Claims 1-5 are obvious over Garrison.

• Prior Art Relied Upon: Garrison (Patent 6,425,916).
• Core Argument for this Ground:
  • Prior Art Mapping: Petitioner argued that Garrison taught all elements of the challenged claims. Specifically, Garrison disclosed a prosthetic heart valve (cardiac valve 6A) with a "stentless tissue valve" (valve portion 38) that resided entirely within an expandable support structure (stent 26A), which itself formed an inner channel and lacked internal reinforcing members. Garrison also taught a complete delivery system, including a pusher element (80) and a moveable sheath (outer wall 74), for percutaneous delivery. The valve was shown collapsed onto the pusher member and restrained by the sheath.
  • Motivation to Combine (for §103 grounds): As a single-reference ground, the argument centered on inherent disclosure and obvious design choices. Petitioner contended that Garrison's disclosure of a "tri-leaflet stentless porcine valve" made it obvious to a person of ordinary skill in the art (POSITA) to use fixed pericardial tissue, a well-known material for such valves acknowledged in the ’739 patent itself, to reduce antigenicity and improve durability.
  • Expectation of Success: A POSITA would have a high expectation of success in substituting one common, biocompatible tissue material (fixed pericardial tissue) for another (porcine tissue) in a known valve design to achieve predictable benefits.

Ground 2: Obviousness over Garrison in view of Leonhardt - Claims 1-5 are obvious over Garrison in view of Leonhardt.

• Prior Art Relied Upon: Garrison (Patent 6,425,916) and Leonhardt (Patent 5,957,949).
• Core Argument for this Ground:
  • Prior Art Mapping: This ground relied on Garrison for the base valve and delivery system, as detailed in Ground 1. Leonhardt was introduced to explicitly teach the "trumpet-like configuration" of the stent, wherein the stent flares at both ends. Petitioner asserted that while Garrison’s disclosure of a valve displacer with flared ends made this feature obvious, Leonhardt provided an express teaching of this exact stent structure.
  • Motivation to Combine (for §103 grounds): A POSITA would combine Leonhardt’s flared stent design with Garrison’s valve system to achieve the known and predictable benefits of improved anchoring and sealing of the prosthesis against the vessel wall. Garrison itself suggested its support structure could have the same features as its flared valve displacer.
  • Expectation of Success: Combining a known stent shape for improved anchoring with a known valve and delivery system was presented as a straightforward and predictable design modification.

Ground 5: Obviousness over Andersen, Limon, and Gabbay - Claims 1-3 and 5 are obvious over Andersen in view of Limon and Gabbay.

• Prior Art Relied Upon: Andersen (Patent 5,840,081), Limon (Patent 6,077,295), and Gabbay (Patent 7,025,780).

• Core Argument for this Ground:

  • Prior Art Mapping: This ground asserted a different combination of references. Andersen was argued to teach the core valve-in-stent prosthesis: a self-expandable stent containing a collapsible valve with leaflets residing entirely within the stent’s inner channel, with no reinforcing members. Limon was cited for teaching the claimed delivery system: a catheter with an inner pusher member and an outer moveable sheath specifically for deploying self-expanding stents. Gabbay was used to teach constructing the stent from nitinol and flaring its ends to create the "trumpet-like" shape for better anchoring.
  • Motivation to Combine (for §103 grounds): A POSITA would combine these references because Andersen taught a valve prosthesis but suggested using "any prior art technique" for implantation, making Limon's specific delivery system an obvious choice. A POSITA would further incorporate Gabbay’s flared nitinol stent design into Andersen's device to solve the known problem of prosthesis migration and improve sealing, a common and well-understood objective in the field.
  • Expectation of Success: The combination involved applying known components for their established and predictable functions—a delivery system for delivery, a flared stent for anchoring—creating a high expectation of success.

• Additional Grounds: Petitioner asserted additional obviousness challenges, including claims 1-3 and 5 over Andersen in view of Limon and Phelps; claim 4 over Andersen in view of Limon, Garrison, and either Gabbay or Phelps; and further combinations including Nguyen for the explicit teaching of fixed pericardial tissue leaflets.

4. Key Claim Construction Positions

• "trumpet-like" (claim 1): Petitioner argued that regardless of the term's precise scope, the increasingly flared openings taught by references like Garrison, Leonhardt, and Gabbay clearly disclosed this limitation.
• "valve means" (claim 1): Petitioner contended this term was not a means-plus-function limitation under 35 U.S.C. §112 ¶6 because the claim recited sufficient structure. Even if it were, the corresponding structure was simply a valve, which was well-known and fully disclosed in the cited prior art.

5. Arguments Regarding Discretionary Denial

• Petitioner argued that the Board should not exercise its discretion to deny institution under 35 U.S.C. §325(d). The primary prior art references relied upon in several grounds, including Andersen, Limon, and Leonhardt, were never considered by the Examiner during the original prosecution. Furthermore, Petitioner argued that its invalidity contentions relied on different embodiments and arguments regarding Garrison than those the Examiner had previously reviewed, meaning the prior art and arguments were not substantially the same.

6. Relief Requested

• Petitioner requests institution of an inter partes review and cancellation of claims 1-5 of Patent 9,125,739 as unpatentable.