Edwards Lifesciences Corp v. Aortic Innovations LLC

1. Case Identification

• Case #: IPR2024-00390
• Patent #: 11,497,634
• Filed: January 5, 2024
• Petitioner(s): Edwards Lifesciences Corporation and Edwards Lifesciences LLC
• Patent Owner(s): Aortic Innovations LLC
• Challenged Claims: 1-7 and 9

2. Patent Overview

• Title: Transcatheter Aortic Heart Valve Assembly
• Brief Description: The ’634 patent relates to a transcatheter aortic heart valve assembly featuring a frame, a graft covering, and outwardly extending fibers intended to create a seal against native valve leaflets to prevent paravalvular leakage. The patent focuses on specific structural features, including spacings between the fibers and uncovered apices on the frame.

3. Grounds for Unpatentability

Ground 1: Claims 1-7 and 9 are obvious over Spenser, Spenser II, and Birdsall

• Prior Art Relied Upon: Spenser (Patent 7,510,575), Spenser II (WO 2006/005015), and Birdsall (Patent 7,524,331).
• Core Argument for this Ground:
  • Prior Art Mapping: Petitioner argued that Spenser taught the foundational transcatheter heart valve (THV), including a metallic open-cell frame, prosthetic leaflets, and an inner polymeric graft covering. To address the known problem of paravalvular leakage (PVL), a person of ordinary skill in the art (POSITA) would have been motivated to add the compressible sealing material with outwardly extending, arcuate, and spaced-apart fibers disclosed by Spenser II to the exterior of Spenser’s frame. To address the "uncovered apices" limitation, Petitioner contended that Birdsall explicitly taught a THV with an external barrier material (comprising microfibers) that does not cover the frame’s proximal apices.
  • Motivation to Combine: A POSITA would combine Spenser and Spenser II to improve sealing and reduce PVL, a well-known objective in the field. The Board previously found this motivation compelling in prior IPRs involving related patents. A POSITA would have been further motivated by Birdsall to slightly shorten Spenser II’s material to leave the apices uncovered. Petitioner asserted this was a simple and predictable design choice to reduce material, lower the device profile, and was shown to be effective by Birdsall.
  • Expectation of Success: Petitioner asserted a POSITA would have had a high expectation of success, as the combination involved applying known solutions (Spenser II’s seal, Birdsall’s seal placement) to a known device (Spenser’s valve) to achieve predictable results in solving a known problem (PVL).

Ground 2: Claims 1-7 and 9 are obvious over Spenser, Chuter, and Birdsall

• Prior Art Relied Upon: Spenser (Patent 7,510,575), Chuter (Application # 2002/0151958), and Birdsall (Patent 7,524,331).
• Core Argument for this Ground:
  • Prior Art Mapping: This ground is similar to the first, but substituted Chuter for Spenser II as the source of the external sealing fibers. Petitioner argued Spenser provided the base THV. Chuter, which was not considered during prosecution, disclosed an endovascular stent with a "fiber pile" of spaced-apart, outwardly extending fibers that could be attached directly to a frame. This fiber pile was designed to fill gaps and promote tissue ingrowth, thereby preventing PVL. As in the previous ground, Birdsall provided the teaching of leaving the frame's proximal apices uncovered by the sealing material.
  • Motivation to Combine: A POSITA would combine Spenser and Chuter to leverage Chuter’s fiber pile for its known benefits of enhanced sealing and tissue integration. The motivation to then incorporate Birdsall’s teaching of uncovered apices remained the same: a predictable modification to reduce material and profile. Petitioner argued that a POSITA had a finite number of predictable ways to arrange external fibers, and Chuter and Birdsall taught two of them.
  • Expectation of Success: Petitioner argued for a high expectation of success, noting that Chuter taught its fiber pile could be used with a wide range of expandable stent frames, including types similar to Spenser's. Combining these known elements for their intended purposes would yield predictable improvements.

Ground 3: Claims 1-7 and 9 are obvious over Bailey, in view of Birdsall or Chuter

• Prior Art Relied Upon: Bailey (Application # 2003/0023300), Birdsall (Patent 7,524,331), and Chuter (Application # 2002/0151958).

• Core Argument for this Ground:

  • Prior Art Mapping: This ground used Bailey, which was not considered during prosecution, as the primary reference. Petitioner asserted Bailey disclosed a complete THV with an inner graft, an outer graft for sealing, and, crucially, a frame where the proximal apices are already uncovered by the grafts. A POSITA would then be motivated to replace Bailey’s simple outer graft with the superior sealing materials from Birdsall (microfiber barrier material) or Chuter (fiber pile) to provide a more robust seal against PVL.
  • Motivation to Combine: The primary motivation was to improve the sealing performance of Bailey’s valve. Petitioner contended that replacing one known sealing element (Bailey’s outer graft) with another, more effective known sealing element (from Birdsall or Chuter) was a routine and obvious path for a POSITA seeking to enhance device performance.
  • Expectation of Success: Petitioner argued success would be reasonably expected because the valve frames in Bailey, Birdsall, and Chuter shared common features (e.g., balloon-expandable, open-cell construction), making the substitution straightforward and the results predictable.

• Additional Grounds: Petitioner asserted additional obviousness challenges, including claims 1-7 and 9 as obvious over Spenser + Spenser II; Spenser + Birdsall; Spenser + Spenser II + Bailey; Spenser + Chuter + Bailey; Bailey + Spenser II; and Bailey + Chuter. These grounds relied on similar arguments regarding the combination of known sealing elements with base valve designs.

4. Arguments Regarding Discretionary Denial

• Petitioner argued that the Board should not deny institution under 35 U.S.C. §325(d). It contended that key prior art references, Bailey and Chuter, were never considered by the Examiner and are not cumulative of the cited art. Petitioner further argued that the Examiner made material errors during prosecution by allowing the patent based on the "Uncovered Apices" and "Spacings" limitations, which Petitioner alleged are clearly disclosed or rendered obvious by the new art. The Examiner also allegedly erred by accepting Patent Owner’s arguments regarding the prior art that were previously rejected by the Board in related IPRs.

5. Relief Requested

• Petitioner requests institution of an inter partes review and cancellation of claims 1-7 and 9 of the ’634 patent as unpatentable under 35 U.S.C. §103.