Medtronic CoreValve LLC v. Colibri Heart Valve LLC

1. Case Identification

• Case #: IPR2020-01454
• Patent #: 9,125,739
• Filed: September 2, 2020
• Petitioner(s): Medtronic CoreValve LLC
• Patent Owner(s): Colibri Heart Valve LLC
• Challenged Claims: 1-5

2. Patent Overview

• Title: Implantable Replacement Heart Valve
• Brief Description: The ’739 patent discloses a percutaneously delivered replacement heart valve assembly. The device comprises a self-expanding stent with flared, "trumpet-like" ends and a valve means (e.g., fixed pericardial tissue) residing entirely within the stent's inner channel, distinguished by the claimed absence of additional reinforcing members inside the stent.

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. Garrison disclosed a replacement cardiac valve with a "stentless tissue valve" portion that resided entirely within an expandable "support structure" (stent), which Petitioner contended met the "no reinforcing members" limitation. Garrison also disclosed a delivery catheter system with a pusher member ("rod 78" and "pusher element 80") and a movable outer sheath ("outer wall 74") for percutaneous delivery.
  • Motivation to Combine (Implicit): While a single-reference ground, the motivation argument focused on Garrison's own teachings. Petitioner asserted that Garrison taught its support structure could have "all features" of its separate "valve displacer," which included flared ends. Therefore, a Person of Ordinary Skill in the Art (POSITA) would have found it obvious to create a support structure with the claimed "trumpet-like" configuration to ensure the valve device conforms to the vessel wall, a predictable result.
  • Expectation of Success: A POSITA would have a reasonable expectation of success in applying the well-known technique of using fixed pericardial tissue (as admitted in the ’739 patent) to Garrison's described porcine tissue valve to reduce antigenicity and improve durability.

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

• Prior Art Relied Upon: Garrison (Patent 6,425,916), Leonhardt (Patent 5,957,949).
• Core Argument for this Ground:
  • Prior Art Mapping: This ground used Garrison as the primary reference for the base valve and delivery system. Leonhardt was introduced to expressly teach any potentially missing features. Specifically, Leonhardt taught a replacement valve stent that "flair[s]...at both ends" in a trumpet-like shape to help it "conform and seal" to the tissue. Leonhardt also explicitly showed a "biological valve" that resided entirely within the inner channel of the stent.
  • Motivation to Combine: A POSITA would combine Leonhardt's specific flared stent shape with Garrison's support structure to achieve the advantageous and well-understood result of better conforming and sealing the device against the native vasculature. This was a known solution to a common problem in the field.
  • Expectation of Success: The combination involved applying a known stent shape for its predictable sealing function to a similar device, leading to a high expectation of success.

Ground 3: 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), Gabbay (Patent 7,025,780).

• Core Argument for this Ground:

  • Prior Art Mapping: This ground asserted a different combination, with Andersen as the base reference. Andersen taught a "valve prosthesis" with a valve residing entirely within a collapsible, self-expanding cylindrical stent, satisfying the "no reinforcing members" limitation. Because Andersen stated "any prior art technique" could be used for delivery, Petitioner turned to Limon, which taught a "stent-delivery catheter system" with a pusher member, a movable sheath, and a guidewire lumen. To address the stent shape and material, Petitioner cited Gabbay, which disclosed a self-expanding nitinol stent that flares outwardly at both ends ("trumpet-like") and a valve made of fixed pericardial tissue.
  • Motivation to Combine: A POSITA would combine these references because Andersen provided a basic stented valve but left the specific delivery system and stent configuration to the skill of the artisan. A POSITA would look to Limon for an advantageous and known delivery system and to Gabbay for a well-known flared stent design and material (nitinol) to improve stability and reduce the risk of displacement.
  • Expectation of Success: Combining these known components for their established and predictable functions would have been a straightforward design choice with a high expectation of success.

• Additional Grounds: Petitioner asserted additional obviousness challenges, including combinations using Phelps (WO 00/15147) as an alternative to Gabbay for teaching a flared nitinol stent, and Nguyen (Patent 5,961,549) for further teaching the use of fixed pericardial tissue. Additional grounds also added Garrison to the Andersen combination to teach the inclusion of barbs for claim 4.

4. Key Claim Construction Positions

• "valve means" (claim 1): Petitioner argued this term is not a means-plus-function limitation under 35 U.S.C. §112 ¶6 because the claim itself does not recite a corresponding function. Even if it were, Petitioner contended the function and structure were well-known and disclosed by the prior art.
• "controlled release mechanism" (claim 5): Petitioner argued this term is presumptively not a means-plus-function limitation. If construed as such, the function would be controlling the device's release, and the corresponding structure—a pusher member that can be advanced to partially deploy the valve from a sheath—was disclosed in the prior art.

5. Arguments Regarding Discretionary Denial

• §325(d) - Same or Substantially Same Art: Petitioner argued against discretionary denial under §325(d), asserting that the primary combinations relied upon references (Andersen, Limon, Leonhardt) that the Examiner never considered during prosecution. Furthermore, where Garrison was used, Petitioner argued it relied on different embodiments and arguments than those the Examiner reviewed, who had erroneously focused on an inverted valve embodiment.
• §314(a) - Fintiv Factors: Petitioner argued against discretionary denial under Fintiv, contending that the factors weighed in favor of institution. Petitioner stated its intent to seek a stay in the co-pending district court litigation, noted the median time to trial was well after the deadline for a Final Written Decision (FWD), and confirmed it had stipulated not to pursue the same invalidity grounds in litigation if the IPR was instituted.

6. Relief Requested

• Petitioner requested the institution of an inter partes review (IPR) and the cancellation of claims 1-5 of the ’739 patent as unpatentable under 35 U.S.C. §103.