Ethicon Inc v. EndoEvolutION LLC

1. Case Identification

• Case #: IPR2016-00071
• Patent #: 6,923,819
• Filed: October 22, 2015
• Petitioner(s): Ethicon, Inc.
• Patent Owner(s): Endoevolution, LLC
• Challenged Claims: 1, 2, 6-10, 15-17, 25-31, 40, 46-52, and 59-62

2. Patent Overview

• Title: Apparatus and Method for Surgical Suturing with Thread Management
• Brief Description: The ’819 patent discloses a surgical suturing apparatus and corresponding method. The claimed device generally comprises an actuator handle with a trigger, a cartridge holder assembly for a disposable needle cartridge, an arcuate suturing needle housed within the cartridge, and a needle rotation drive to advance the needle through tissue.

3. Grounds for Unpatentability

Ground 1: Anticipation over Meade - Claims 1, 2, 6-10, 16, 17, and 25-31 are anticipated by Meade under 35 U.S.C. §102.

• Prior Art Relied Upon: Meade (Patent 5,437,681).
• Core Argument for this Ground:
  • Prior Art Mapping: Petitioner argued that Meade, which shares common inventors with the ’819 patent and was cited but not substantively examined during prosecution, discloses every element of the challenged apparatus claims. Meade teaches a suturing device with all four main components recited in independent claim 1: an actuator (lever 16), a cartridge (14) with a protective housing (22), an arcuate suturing needle (34), and a pusher assembly (driver mechanism 42). Crucially, Petitioner asserted that Meade’s disclosure that its needle "does not project materially into the aperture" when in its "home" position directly reads on the claim limitation "positioned within the protective housing," under Petitioner’s proposed construction of that term.
  • Key Aspects: The core of this ground is that the allegedly novel invention was already fully disclosed in an earlier patent by the same inventors.

Ground 2: Obviousness over Meade in View of Beurrier - Claims 1, 2, 6-10, 16, 17, and 25-31 are obvious over Meade in view of Beurrier under 35 U.S.C. §103.

• Prior Art Relied Upon: Meade (Patent 5,437,681) and Beurrier (Patent 5,306,281).
• Core Argument for this Ground:
  • Prior Art Mapping: This ground was presented as an alternative to Ground 1, contingent on the Board adopting a stricter claim construction for "positioned within the protective housing" to mean the needle tip "does not project at all outside of the protective housing." Petitioner argued Meade discloses all limitations except this stricter interpretation. Beurrier was introduced for its explicit teaching that the point of its arcuate needle is "safely protected in cassette 101 avoiding injury or the spread of infection to a user."
  • Motivation to Combine: A POSITA would combine Meade's established suturing device with Beurrier's explicit safety teaching to address the known risk of accidental needle pricks. Both references disclose similar devices and address common problems in the art, providing a strong motivation to incorporate Beurrier's safety feature into Meade's design.
  • Expectation of Success: A POSITA would have had a high expectation of success in modifying Meade’s device—for example, by slightly shortening the arcuate extent of the needle or extending the housing—to ensure the needle tip did not protrude at all, as this would be a simple and predictable mechanical modification.

Ground 3: Obviousness over Andersson in View of Taylor and Beurrier - Claims 40 and 51 are obvious over Andersson in view of Taylor and Beurrier.

• Prior Art Relied Upon: Andersson (Patent 4,557,265), Taylor (Patent 5,911,727), and Beurrier (Patent 5,306,281).

• Core Argument for this Ground:

  • Prior Art Mapping: This combination was argued to render method claims 40 and 51 obvious. Andersson taught the core method, including an arcuate suture needle, an actuator (foot pedal), and a needle rotation drive. Petitioner contended Andersson also taught the "deactivating the actuator...to cause" limitation, as deactivating its foot pedal interrupts a pressure surge, causing a return spring to withdraw a plunger and form a continuous suture. Taylor taught a similar suturing device that comprised a removable cartridge. Beurrier again provided the teaching of a fully protected needle tip for safety.
  • Motivation to Combine: A POSITA would combine these references to improve upon known shortcomings in the art, such as needle slippage and safety. Specifically, a POSITA would be motivated to incorporate the disposable cartridge taught by Taylor into the suturing device of Andersson, and further modify it according to Beurrier's safety principles to ensure the needle was fully contained after rotation, thereby creating a safer, more convenient, and disposable device.
  • Expectation of Success: The combination involved applying known components (disposable cartridges, safety housings) from analogous prior art devices to achieve their predictable functions, leading to a high expectation of success.

• Additional Grounds: Petitioner asserted additional obviousness challenges, including that claim 15 is obvious over Meade in view of Chironis (a mechanical engineering handbook) for teaching a mounting clip mechanism, and also presented multiple grounds contingent on alternative claim constructions.

4. Key Claim Construction Positions

• "positioned within the protective housing": Petitioner proposed this term means the pointed end of the needle "does not project materially outside of the protective housing" after rotation. This construction was central to the anticipation argument (Ground 1). The petition also argued in the alternative under a narrower construction of "does not project at all outside," which formed the basis for several obviousness grounds (e.g., Ground 2).
• "deactivating the actuator . . . to cause": Petitioner proposed this phrase means "returning or resetting the actuator . . . to produce" a subsequent action. This construction was based on the specification's use of "to cause" to link a user action with a direct device action. This interpretation was key to mapping Andersson to the method claims in Ground 3.
• "cartridge holder assembly": Petitioner proposed this term be construed as "an assembly for releasably attaching the cartridge," based on explicit descriptions in the ’819 patent specification.

5. Relief Requested

• Petitioner requests institution of an inter partes review and cancellation of claims 1, 2, 6-10, 15-17, 25-31, 40, 46-52, and 59-62 of the ’819 patent as unpatentable.