Imperative Care Inc v. Inari Medical Inc

1. Case Identification

• Case #: IPR2025-00156
• Patent #: 11,697,012
• Filed: November 8, 2024
• Petitioner(s): Imperative Care, Inc.
• Patent Owner(s): Inari Medical, Inc.
• Challenged Claims: 1-9

2. Patent Overview

• Title: Aspiration Catheter with Hemostasis Valve
• Brief Description: The ’012 patent discloses a medical delivery system comprising a catheter and a hemostasis valve. The valve features a constricting mechanism with a filament, actuators, and springs to selectively collapse a compliant tubular member, thereby sealing the catheter to prevent blood loss during intravascular procedures.

3. Grounds for Unpatentability

Ground 1: Claims 1-9 are anticipated by Schaffer under 35 U.S.C. §102.

• Prior Art Relied Upon: Schaffer (Application # 2003/0225379).
• Core Argument for this Ground:
  • Prior Art Mapping: Petitioner argued that Schaffer, which was not considered during prosecution, discloses every limitation of claims 1-9. Schaffer describes a hemostasis valve with a collapsible "seal module 100" (the claimed collapsible tubular sidewall) and a constricting mechanism. This mechanism includes two U-shaped "actuating members 55" (the claimed filament), two circular "actuators 50" with buttons, and two "resilient members 267" (springs). Petitioner asserted that Schaffer’s spring-biased actuators pull the ends of the U-shaped members to constrict the seal module in a first, undepressed position, and depressing the actuators releases tension to open the valve lumen, directly corresponding to the ’012 patent’s claimed functionality.
  • Key Aspects: The core of this ground is the contention that Schaffer’s "actuating members" meet the definition of the claimed "filament" as explicitly described in the ’012 patent's own specification (e.g., a ribbon, flat wire, or sheet made of metal or polymer).

Ground 2: Claims 1-9 are obvious over Schaffer in view of Hartley under 35 U.S.C. §103.

• Prior Art Relied Upon: Schaffer (Application # 2003/0225379) and Hartley (Application # 2003/0116731).
• Core Argument for this Ground:
  • Prior Art Mapping: This ground was presented as an alternative in case the Board found Schaffer’s "actuating member" was not a "filament." Petitioner argued that Hartley explicitly discloses a "string 14" (a filament) looped around a collapsible elastomeric diaphragm, which is tensioned by a rotary actuator to constrict the valve. Schaffer provides the complete valve structure, including the opposing, spring-loaded linear actuators.
  • Motivation to Combine: A POSITA would combine Hartley’s filament-based constriction with Schaffer’s valve for predictable results. The primary motivation was to improve sealing performance. Petitioner contended that Hartley’s string, which fully encircles the lumen, would provide a more uniform and effective seal around inserted instruments of various sizes compared to Schaffer's U-shaped members, which could potentially leave gaps. This substitution of one known constricting element (Hartley's string) for another (Schaffer's actuating member) would have been an obvious design choice.
  • Expectation of Success: A POSITA would have a high expectation of success, as both references teach constricting a flexible tube using tension applied to an element looped around it. Integrating Hartley's simple string with Schaffer's actuator mechanism (e.g., by knotting the string ends to the actuator buttons) would use conventional and well-understood mechanical principles.

Ground 3: Claims 1-9 are obvious over Schaffer in view of Garrison under 35 U.S.C. §103.

• Prior Art Relied Upon: Schaffer (Application # 2003/0225379) and Garrison (Application # 2015/0173782).

• Core Argument for this Ground:

  • Prior Art Mapping: This ground was presented to address the "aspiration catheter" limitation in the preamble, in the event the Board finds the term limiting. Garrison discloses a complete aspiration system, including an "aspiration catheter 2030" with a proximal hub for attaching a hemostasis valve to prevent blood loss while introducing other devices. Schaffer provides the specific filament-based hemostasis valve as claimed.
  • Motivation to Combine: A POSITA would combine Schaffer's valve with Garrison's aspiration catheter because it was a known and common practice to use hemostasis valves with such catheters for their stated purpose. Garrison explicitly teaches attaching a separate hemostasis valve, and Schaffer's valve is an adjustable-opening type suitable for this purpose. A POSITA would be motivated to use Schaffer's valve to simplify the procedure, as its spring-biased, normally-closed design would be more convenient than prior-art rotating valves that required manual sealing.
  • Expectation of Success: A POSITA would reasonably expect success because combining a known type of valve with a known type of catheter to perform a conventional function (preventing blood loss) is a straightforward application of existing technology. Both components were designed for this type of integration.

• Additional Grounds: Petitioner asserted additional obviousness challenges, including claims 1-9 as obvious over Schaffer alone, Schaffer in view of Eller (Patent 9,980,813), and combinations including Garrison with Hartley or Eller, all relying on similar filament-substitution or system-integration rationales.

4. Key Claim Construction Positions

• "filament": Petitioner proposed that "filament" should be construed to mean at least "one or more threads, lines, cords, ropes, ribbons, flat wires, sheets, or tapes," based on the explicit definition provided in the ’012 patent’s specification. This construction is broad enough to encompass Schaffer’s U-shaped "actuating members" made of metal or plastic.
• "aspiration" in the Preamble: Petitioner argued the term "aspiration" in the preamble of claim 1 is a non-limiting statement of intended use. The argument was that the claim body describes a structurally complete invention (a hemostasis valve), and the term "aspiration" provides no essential structure and was not relied upon to distinguish prior art during prosecution.

5. Arguments Regarding Discretionary Denial

• Petitioner argued that the Board should not deny institution under §325(d). The core reason provided was that the primary prior art reference, Schaffer, which anticipates or renders obvious all challenged claims, was never submitted to or considered by the examiner during the prosecution of the ’012 patent. While other references (Hartley, Eller, Garrison) were of record, the examiner did not apply them in the specific combinations asserted in the petition.

6. Relief Requested

• Petitioner requests institution of an inter partes review and cancellation of claims 1-9 of the ’012 patent as unpatentable.