Imperative Care Inc v. Inari Medical Inc

1. Case Identification

• Case #: IPR2025-00289
• Patent #: 11,554,005
• Filed: December 13, 2024
• Petitioner(s): Imperative Care, Inc.
• Patent Owner(s): Inari Medical, Inc.
• Challenged Claims: 1-15

2. Patent Overview

• Title: Vacuum Aspiration System
• Brief Description: The ’005 patent discloses a system for removing clot material from a patient’s vasculature using suction. The system includes a catheter, an aspiration source, a flow path with an on-off control, a clot canister, and a hemostasis valve designed to prevent blood loss during the procedure.

3. Grounds for Unpatentability

Ground 1: Claims 1-12 and 14-15 are obvious over Garrison in view of Schaffer.

• Prior Art Relied Upon: Garrison (Application # 2015/0173782) and Schaffer (Application # 2003/0225379).
• Core Argument for this Ground:
  • Prior Art Mapping: Petitioner argued that Garrison discloses a complete vacuum aspiration system with all the general components of challenged claim 1, including a housing, flow path, on-off control, first catheter, connector, and clot canister. However, Garrison only generally suggests the use of an "adjustable-opening valve" without detailing its structure. Petitioner contended that Schaffer, a reference not before the Examiner, discloses the specific hemostasis valve limitations recited in the claims. Schaffer’s valve includes a "seal module" (tubular member), a constricting mechanism with U-shaped "actuating members" (argued to be the claimed "filament"), "actuator buttons" (the actuator), and springs (the biasing system). For dependent claims, Schaffer was alleged to teach a pliable tubular member (claim 2), actuator buttons (claim 4), and compression springs (claim 8), among other limitations.
  • Motivation to Combine: A Person of Ordinary Skill in the Art (POSITA) would combine Schaffer's hemostasis valve with Garrison's aspiration system because Garrison explicitly teaches that its system can use an "adjustable-opening valve" to prevent blood loss. Schaffer provides just such a valve, and its use would have been a predictable solution to a known problem. Furthermore, incorporating Schaffer’s spring-biased valve would simplify the operation of Garrison’s system by automatically closing the valve, an improvement over prior art valves requiring manual sealing.
  • Expectation of Success: A POSITA would have had a reasonable expectation of success, as the combination involves attaching a known type of valve to a known catheter system according to conventional methods to achieve the predictable result of minimizing blood loss.

Ground 2: Claims 1-3, 5-6, and 9-15 are obvious over Garrison in view of Hartley and Eller.

• Prior Art Relied Upon: Garrison (Application # 2015/0173782), Hartley (Application # 2003/0116731), and Eller (Patent 9,980,813).

• Core Argument for this Ground:

  • Prior Art Mapping: This ground presents an alternative combination using references that were listed on an Information Disclosure Statement (IDS) but allegedly not properly considered by the Examiner. As in Ground 1, Garrison provides the foundational aspiration system. Hartley discloses a rotating hemostasis valve with a clear "filament" (a string) and a rotary actuator, but it lacks a biasing system. Petitioner argued that Eller remedies this deficiency by teaching an optional biasing system, specifically a torsion spring, for use with a similar rotating hemostasis valve to bias it toward a sealed state.
  • Motivation to Combine: A POSITA would have been motivated to combine Hartley’s rotating hemostasis valve with Garrison's system because Garrison expressly suggests using such valves. A POSITA would then be motivated to add Eller's biasing system (torsion spring) to Hartley's valve to simplify its operation, ensure the valve seals quickly, and prevent inadvertent blood loss. This combination would eliminate the need for an operator to manually seal the valve, a known design improvement.
  • Expectation of Success: A POSITA would have reasonably expected success in combining the references, as both Hartley and Eller relate to hemostasis valves with similar structures (rotational actuators, constricting members). Positioning a conventional torsion spring between the housing and actuator, as taught by Eller, to bias Hartley's valve would have been a straightforward modification.

• Additional Grounds: Petitioner asserted additional obviousness challenges over Garrison and Schaffer, further in view of Hartley or Eller (Grounds 2 and 3 in the petition). These grounds argued that if Schaffer's "actuating members" were not considered a "filament," a POSITA would have been motivated to substitute them with the explicit string "filament" from Hartley or the wire member "filament" from Eller to achieve a more effective seal across various instrument diameters.

4. Key Claim Construction Positions

• "filament": Petitioner argued this term is central to the unpatentability analysis and should be construed as "one or more threads, lines, cords, ropes, ribbons, flat wires, sheets, or tapes." This construction was derived from the ’519 application, which the ’005 patent purports to incorporate by reference. Petitioner contended this broader construction is necessary to encompass embodiments like Schaffer's U-shaped "actuating members." Petitioner specifically argued against a narrower construction requiring the filament to be "thin" or "flexible," asserting that such limitations are absent from the specification and would improperly exclude disclosed embodiments.

5. Arguments Regarding Discretionary Denial

• Petitioner argued that the Board should not discretionarily deny institution. To avoid denial under §314(a) and the Fintiv factors, Petitioner stipulated that if the IPR is instituted, it will not pursue in the parallel district court litigation the same grounds asserted in the petition or any other grounds that could have been reasonably raised.
• Petitioner further argued against denial under §325(d), contending that the Examiner materially erred during prosecution. The petition asserted that Schaffer, a primary reference for several grounds, was never before the Examiner. Additionally, while Garrison, Hartley, and Eller were listed on an IDS, the specific combinations and arguments presented in the petition were never considered by the Patent Office.

6. Relief Requested

• Petitioner requests institution of an inter partes review and cancellation of claims 1-15 of Patent 11,554,005 as unpatentable.