Edwards Lifesciences Corp v. Colibri Heart Valve LLC

1. Case Identification

• Case #: IPR2020-01649
• Patent #: 9,125,739
• Filed: September 18, 2020
• Petitioner(s): Edwards Lifesciences Corporation and Edwards Lifesciences LLC
• Patent Owner(s): Colibri Heart Valve LLC
• Challenged Claims: 1-5

2. Patent Overview

• Title: Prosthetic Heart Valve
• Brief Description: The ’739 patent describes a prosthetic heart valve assembly for minimally invasive transcatheter implantation. The assembly includes a collapsible and expandable stent member, a valve means with leaflets made from pericardial tissue, and a delivery system.

3. Grounds for Unpatentability

Ground 1: Anticipation over Paniagua - Claims 1-5 are anticipated by Paniagua under 35 U.S.C. §102(b).

• Prior Art Relied Upon: Paniagua (Application # 2005/0113910).
• Core Argument for this Ground:
  • Prior Art Mapping: Petitioner argued that the ’739 patent is not entitled to its claimed January 4, 2002 priority date. The patent’s specification repeatedly describes the inventive valve leaflets as being formed from a “single, continuous, uncut” sheet of tissue, yet the challenged claims broadly cover valves with “two to four individual leaflets,” which could be formed from multiple separate pieces. Petitioner asserted this broader scope lacks written description support in the priority documents and was first introduced in an amendment on April 15, 2014, making this the effective filing date. Paniagua, the published grandparent application of the ’739 patent, was published in 2005 and thus became anticipatory prior art. Because Paniagua’s specification is identical to that of the ’739 patent, it was argued to disclose every limitation of claims 1-5.

Ground 2: Obviousness over Bessler and Teitelbaum/Leonhardt - Claims 1-5 are obvious over Bessler in view of Teitelbaum or Leonhardt under 35 U.S.C. §103.

• Prior Art Relied Upon: Bessler (Patent 5,855,601), Teitelbaum (Patent 5,332,402), and Leonhardt (Patent 5,957,949).
• Core Argument for this Ground:
  • Prior Art Mapping: Petitioner contended that the specification of the ’739 patent copied, nearly verbatim, large sections of Bessler, which discloses a self-expanding prosthetic heart valve, a pericardial tissue valve means, and a catheter-based delivery system with a pusher member. However, Bessler does not explicitly teach the claimed stent structure that "flares at both ends in a trumpet-like configuration." This exact flared stent structure, Petitioner argued, was copied verbatim from Teitelbaum. Alternatively, Leonhardt also taught a well-known flared stent design. The dependent claims add further well-known features taught by Bessler, such as a self-expanding nitinol stent (claims 2-3), two circles of barbs (claim 4), and a controlled release mechanism (claim 5).
  • Motivation to Combine: A POSITA would combine Bessler’s valve system with the flared stent taught by Teitelbaum or Leonhardt to solve the known problem of anchoring the device and preventing paravalvular leakage. Both Teitelbaum and Leonhardt explicitly taught that flared ends improve anchoring and sealing, providing a clear reason to modify Bessler’s stent for a predictable improvement.
  • Expectation of Success: A POSITA would have a high expectation of success, as incorporating a flared stent end was a routine and well-understood design modification in the art to improve stability and performance.

Ground 3: Obviousness over Bessler, Teitelbaum/Leonhardt, and Klint - Claims 1-5 are obvious over Bessler in view of Teitelbaum and Klint, or Bessler in view of Leonhardt and Klint, under §103.

• Prior Art Relied Upon: Bessler (Patent 5,855,601), Teitelbaum (Patent 5,332,402) or Leonhardt (Patent 5,957,949), and Klint (Application # 2001/0044633).
• Core Argument for this Ground:
  • Prior Art Mapping: This ground builds upon the combinations in Ground 2 and specifically addresses the limitation of the valve being "collapsed onto the pusher member" (claim 1[i]). To the extent the Bessler/Teitelbaum or Bessler/Leonhardt combinations were found not to teach this limitation under a narrow construction, Petitioner argued that Klint explicitly teaches it. Klint discloses delivery systems where the pusher member can either be adjacent to the prosthesis (like Bessler) or, alternatively, pass through the interior of the collapsed prosthesis.
  • Motivation to Combine: A POSITA would combine the teachings of Klint with the primary combination of Bessler and Teitelbaum/Leonhardt. Klint explained that having a pusher member extend through the prosthesis is advantageous for longer devices or those prone to buckling. This design also allows an operator to hold the delivery apparatus steady during deployment, increasing precision. A POSITA would see these as known benefits and would be motivated to modify the delivery system accordingly.
  • Expectation of Success: Klint presents its two pusher member designs as known, interchangeable alternatives, demonstrating that a POSITA would have recognized their interchangeability and expected the combination to work predictably.

4. Key Claim Construction Positions

• Petitioner argued that the term "onto" in the claim phrase "wherein the prosthetic heart valve is collapsed onto the pusher member" should be construed as "in contact with."
• This construction was based on the fact that the only description of a "pusher member" in the '739 patent's specification—copied directly from Bessler—shows the pusher member as being adjacent to and in contact with the proximal end of the valve, not passing through its lumen.

5. Arguments Regarding Discretionary Denial

• Petitioner argued that discretionary denial under §314(a) (considering Fintiv factors) or §325(d) would be inappropriate.
• Fintiv Factors: Petitioner is not a party to the co-pending district court litigation, which was in its early stages. Furthermore, the petition's merits were argued to be unusually strong due to the priority date challenge and the evidence of verbatim copying of prior art, weighing heavily against denial.
• §325(d) Factors: The asserted prior art and arguments were not substantively considered during prosecution. While Bessler, Teitelbaum, and Leonhardt were listed in large Information Disclosure Statements, the examiner was never made aware that the patent’s specification copied text directly from them or that a critical priority date issue existed, constituting an error that warrants reconsideration.

6. Relief Requested

• Petitioner requested institution of an inter partes review and cancellation of claims 1-5 of the ’739 patent as unpatentable.