Abbott Laboratories v. Edwards Lifesciences Corp

1. Case Identification

• Patent #: 6,719,767
• Filed: January 28, 2020
• Petitioner(s): Abbott Laboratories; Abbott Cardiovascular Systems, Inc.; Evalve, Inc.
• Patent Owner(s): Edwards Lifesciences Corp.; Edwards Lifesciences LLC
• Challenged Claims: 1-3, 5, and 14

2. Patent Overview

• Title: Device and a Method for Treatment of Atrioventricular Regurgitation
• Brief Description: The ’767 patent discloses a device and method for treating atrioventricular (mitral) valve regurgitation. The invention centers on a clip, described as a "suturing means," that is delivered percutaneously via a catheter to grasp and bind the two mitral valve leaflets together, improving valve closure without requiring open-heart surgery.

3. Grounds for Unpatentability

Ground 1: Claims 1-3, 5, and 14 are anticipated by St.Goar under 35 U.S.C. §102.

• Prior Art Relied Upon: St.Goar (Patent 6,629,534)
• Core Argument for this Ground:
  • Prior Art Mapping: Petitioner argued that St.Goar, which was not cited during prosecution, discloses every limitation of the challenged claims. St.Goar teaches catheter-based clips for mitral valve repair that are nearly identical in structure and function to the clip of the ’767 patent. Independent claim 1 requires a "suturing means" for treating atrioventricular regurgitation that is transitional between an open and a closed state, and is biased toward the closed state. Petitioner asserted that St.Goar’s clips (e.g., Figs. 69 and 73) meet these limitations, as they are used for the same purpose, are delivered via catheter, transition from an open state (for grasping leaflets) to a closed state, and are inherently biased closed by their V-shape or through the use of shape-memory material. Dependent claims 2, 3, and 5 are also anticipated, as St.Goar’s device is a "clip" (claim 2), has pivotally connected arms forming a V-shape (claim 3), and is delivered with a catheter system that includes a retractable outermost sheet in the form of a guide catheter (claim 5). Independent claim 14, which has limitations similar to claims 1, 2, and 5, was also argued to be anticipated for the same reasons.
  • Key Aspects: Petitioner emphasized the structural similarity between St.Goar's Figure 69C clip and the '767 patent's Figure 2 clip, arguing they are essentially identical. Petitioner also leveraged the Patent Owner's own litigation positions in a separate matter to assert that a "guide catheter," as disclosed in St.Goar, satisfies the "outermost sheet" limitation of claims 5 and 14.

Ground 2: Claims 5 and 14 are obvious over St.Goar in view of the knowledge of a POSITA.

• Prior Art Relied Upon: St.Goar (Patent 6,629,534) and the general knowledge of a Person of Ordinary Skill in the Art (POSITA).
• Core Argument for this Ground:
  • Prior Art Mapping: This ground was presented as an alternative to the anticipation argument for claims 5 and 14. Petitioner contended that even if St.Goar's guide catheter were not considered to be explicitly "retractable" as required by the claims, a POSITA would have found it obvious to make it so. All other elements of the claims are disclosed by St.Goar as argued in Ground 1.
  • Motivation to Combine: A POSITA would have been motivated to ensure the guide catheter in St.Goar's system was movable relative to the inner delivery catheter. This movability is essential for proper positioning and orientation of the interventional tool (the clip), a concern explicitly highlighted in St.Goar. Furthermore, using a retractable guide catheter as an outermost sheath was a well-known technique to protect a patient's vasculature from damage by the implantable device during delivery.
  • Expectation of Success: Retractable guide catheters were ubiquitous in the art at the time. A POSITA would have had a high expectation of success in implementing this standard feature into St.Goar's system to enhance positioning flexibility and patient safety, as it was a common solution to a known problem.

Ground 3: Claims 5 and 14 are obvious over St.Goar in view of Garrison and the knowledge of a POSITA.

• Prior Art Relied Upon: St.Goar (Patent 6,629,534) and Garrison (Patent 6,425,916).
• Core Argument for this Ground:
  • Prior Art Mapping: As a further alternative, Petitioner argued that if St.Goar's guide catheter is deemed insufficient to teach the "outermost sheet" limitation, a POSITA would look to other analogous art like Garrison. Garrison explicitly teaches a "protective sheath" that is an outermost, retractable layer for delivering cardiac implants via catheter, including to the mitral valve.
  • Motivation to Combine: A POSITA would combine Garrison’s retractable protective sheath with St.Goar’s clip and delivery system for several predictable reasons. The primary motivations were to: (1) protect the patient’s blood vessels and heart tissue from the sharp tips of the St.Goar clip during transit; (2) protect the clip itself from damage or dislodgement against calcified areas; and (3) improve the ability to position and reposition the clip for precise placement, a known challenge. Both references are in the same field of endeavor (catheter-based cardiac valve intervention) and address the same problems.
  • Expectation of Success: The combination was argued to be a simple application of a known technology (Garrison's retractable sheath) to a similar system (St.Goar's clip delivery system) to achieve a predictable result. The use of retractable sheaths was a common and well-established solution for delivering delicate or potentially traumatic implants through a patient’s vasculature.

4. Key Claim Construction Positions

• "suturing means": This term, appearing in the independent claims (via dependency), was a central point of contention. Petitioner noted that while it believes the term should be construed as a means-plus-function (MPF) limitation under §112, for the purposes of the petition it adopted the Patent Owner's asserted non-MPF construction. Petitioner also presented an alternative argument that the claims are invalid even under an MPF construction, because St.Goar’s Figure 69 clip has an equivalent structure to the single embodiment disclosed in the ’767 patent.
• "biased towards its second state": Petitioner contended this phrase means that when any restraint on the device is released, it automatically assumes its closed state. This property was argued to be explicitly disclosed in St.Goar’s clips, which are described as "normally closed" or using "shape memory material" to tend to pinch inwardly.

5. Arguments Regarding Discretionary Denial

• Petitioner argued that the Board should not exercise discretionary denial under Fintiv based on a parallel district court litigation. The primary reasons given were that the district court trial date was not yet set and was speculative. More importantly, Petitioner asserted that the IPR would not be duplicative of the district court proceedings because Ground 3 (the combination of St.Goar and Garrison) was not part of its invalidity contentions in the district court and therefore would not be adjudicated in that forum.

6. Relief Requested

• Petitioner requested that the Board institute an inter partes review and find claims 1-3, 5, and 14 of the ’767 patent unpatentable.