PTAB

IPR2020-00051

Intuitive Surgical Inc v. Ethicon LLC

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Petition
petition

1. Case Identification

2. Patent Overview

  • Title: SURGICAL STAPLING INSTRUMENT HAVING A CLEARANCED OPENING
  • Brief Description: The ’379 patent describes an endoscopic surgical stapling instrument featuring a lockout mechanism. This mechanism is designed to prevent the advancement of a firing member when a detachable staple cartridge is either missing from or spent within the instrument's stapling assembly, thereby preventing unintended tissue cutting without stapling. The key components include a firing bar with a middle pin that, in a lockout condition, is forced by a spring into a lockout recess in the staple channel, physically obstructing its forward motion.

3. Grounds for Unpatentability

Ground 1: Claims 1-3 are anticipated by Shelton '818

  • Prior Art Relied Upon: Shelton ’818 (Patent 7,000,818).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that Shelton ’818, a single prior art reference, discloses every limitation of challenged claims 1-3. Shelton '818 teaches a surgical stapling instrument with a frame, opposing jaws (an anvil and an elongate channel for receiving a staple cartridge), and a staple firing member. For the critical "lockout" limitation, Petitioner contended that Shelton ’818 expressly incorporates by reference the entire disclosure of U.S. Patent Application Publication No. 2004/0232195 ("Shelton '195"). Petitioner asserted that the incorporated disclosure of Shelton '195 describes a lockout mechanism that functions identically to the one claimed in the ’379 patent. Specifically, Shelton '195 discloses a pair of "bent spring fingers" that, in the absence of a fresh staple cartridge's wedge sled, spring up to block the path of a "middle pin" on the firing bar. This action prevents the firing bar's distal advancement, thus meeting the claim limitation of a lockout configured to block advancement when the staple cartridge is not attached.
    • Key Aspects: The anticipation argument's foundation rests on the legal principle that the full technical disclosure of Shelton '195 is properly treated as part of the Shelton '818 reference due to the explicit incorporation-by-reference statement.

Ground 2: Claims 1-3 are obvious over Green in view of Solyntjes

  • Prior Art Relied Upon: Green (Patent 4,429,695) and Solyntjes (Patent 5,413,267).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner asserted that Green discloses the fundamental components of a surgical stapler as claimed, including a frame, a first jaw with a channel for a disposable staple cartridge, a second jaw, and a staple firing member (a "pusher bar and knife assembly" with "upper and lower shoes"). However, Petitioner acknowledged that Green does not explicitly teach the claimed lockout feature. To supply this element, Petitioner relied on Solyntjes, which discloses a surgical stapler with a safety lockout. The Solyntjes mechanism includes a locking pin or plate that is biased to move into the path of the firing member (ram) when a staple cartridge is not present or is spent, thereby preventing its advancement. Petitioner argued that adding the lockout taught by Solyntjes to the stapler taught by Green would render the claimed invention obvious.
    • Motivation to Combine: Petitioner argued a person of ordinary skill in the art (POSITA) would combine the teachings of Green and Solyntjes for several reasons. The primary motivation was to solve the well-known and dangerous problem of firing a stapler that contains a spent cartridge or no cartridge at all, which could lead to patient injury and wasted time during surgery. Solyntjes explicitly addresses this problem. Therefore, a POSITA would have been motivated to incorporate Solyntjes's known safety solution into a conventional stapler like Green's to improve its safety and reliability.
    • Expectation of Success: A POSITA would have had a high expectation of success in this combination. Both references relate to surgical staplers, and the integration of a mechanical lockout into such a device was a straightforward engineering task. The combination involved applying a known technique (a lockout) to a known apparatus (a stapler) to yield the predictable result of enhanced safety, without altering the primary functions of either component.

4. Arguments Regarding Discretionary Denial

  • Petitioner argued that the Board should not discretionarily deny institution under 35 U.S.C. §314(a) based on parallel litigation, including a stayed U.S. District Court case and a co-pending U.S. International Trade Commission (ITC) investigation. Petitioner contended that the district court case would not proceed to trial before a Final Written Decision (FWD) in the IPR. Furthermore, it argued that the ITC's target completion date is not dispositive, as appeals could extend the final resolution of the ITC matter for years, well beyond the IPR's conclusion. The Petitioner also noted that the ITC might find non-infringement and thus never reach a decision on patent validity, leaving the PTAB as the first and only forum to rule on the merits. Finally, Petitioner asserted that the merits of the case, particularly the strong anticipation ground, weigh heavily in favor of granting institution to promote the AIA’s goal of efficiently resolving patent validity disputes.

5. Relief Requested

  • Petitioner requests institution of an inter partes review and cancellation of claims 1-3 of Patent 9,844,379 as unpatentable.