PTAB

IPR2025-00989

Imperative Care Inc v. Inari Medical Inc

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Key Events
Petition
petition

1. Case Identification

2. Patent Overview

  • Title: Hemostasis Valve
  • Brief Description: The ’291 patent discloses a hemostasis valve for sealing medical instruments, such as catheters, during intravascular procedures. The valve features a collapsible tubular sidewall that is constricted by a filament, which is looped around the sidewall and controlled by a spring-biased actuator mechanism.

3. Grounds for Unpatentability

Ground 1: Anticipation and Obviousness over Schaffer - Claims 1-3, 5-8, and 12-17 are anticipated by or obvious over Schaffer.

  • 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 the challenged claims. Schaffer describes a hemostasis valve with a collapsible "seal module" (the claimed "collapsible tubular sidewall") enclosed in a housing ("support"). The valve is operated by two opposing, spring-loaded actuator buttons ("first and second members") connected to U-shaped "actuating members" that encircle and constrict the seal module. Petitioner contended these actuating members, which resemble ribbons or flat wires, meet the patent's broad definition of a "filament." The springs in Schaffer bias the actuator buttons outward, pulling on the actuating members to reduce the lumen's diameter, thus meeting the "spring" limitation.
    • Key Aspects: The viability of this ground depends heavily on Petitioner’s proposed claim construction for "filament," which does not require flexibility and encompasses structures like ribbons or flat wires.

Ground 2: Obviousness over Schaffer in view of Hartley or Eller - Claims 1-8 and 12-17 are obvious over Schaffer in view of Hartley or Eller.

  • Prior Art Relied Upon: Schaffer (Application # 2003/0225379), Hartley (Application # 2003/0116731), and Eller (Patent 9,980,813).
  • Core Argument for this Ground:
    • Prior Art Mapping: As an alternative, Petitioner argued that if Schaffer’s U-shaped actuating members are not considered a "filament," a person of ordinary skill in the art (POSITA) would have found it obvious to replace them with the known flexible filaments disclosed in Hartley (a string) or Eller (a wire member). Hartley and Eller both teach using flexible, thread-like filaments looped around a collapsible member to provide a constricting seal in a hemostasis valve.
    • Motivation to Combine: A POSITA would combine the references to improve the sealing capability of Schaffer’s valve. Petitioner asserted that a flexible filament like a string or wire can conform more closely to medical tools of various sizes and non-circular shapes than Schaffer’s more rigid members, leading to a more effective seal. This was presented as a simple substitution of one known constricting element for another to achieve a predictable improvement.
    • Expectation of Success: A POSITA would have had a high expectation of success because the modification was a simple mechanical substitution. Schaffer’s spring-loaded actuator buttons would predictably pull on the ends of the Hartley string or Eller wire to constrict the seal module, and the components would function as intended. The finite, predictable options for constricting elements (e.g., rigid members, strings, wires) made this an obvious design choice.

Ground 3: Obviousness of System Claims over Garrison and Schaffer - Claims 18-19 are obvious over Garrison in view of Schaffer, optionally combined with Hartley or Eller.

  • Prior Art Relied Upon: Garrison (Application # 2015/0173782), Schaffer (Application # 2003/0225379), and optionally Hartley or Eller.

  • Core Argument for this Ground:

    • Prior Art Mapping: Claim 18 recites an "aspiration catheter system" comprising an aspiration catheter and the hemostasis valve of claim 1. Petitioner argued Garrison discloses an aspiration catheter system and explicitly teaches that it can be used with various types of hemostasis valves, including an "adjustable-opening valve," but does not detail the valve's internal structure. Schaffer discloses a suitable adjustable-opening hemostasis valve designed for use with catheters.
    • Motivation to Combine: A POSITA would be motivated to combine Garrison's system with Schaffer's valve to create a complete, functional aspiration catheter system. Garrison's express suggestion to incorporate such a valve provides a clear motivation to look to known valves like Schaffer's to fulfill this need and achieve the predictable result of minimizing blood loss.
    • Expectation of Success: Combining a known catheter system with a known, compatible valve was argued to be a routine and predictable integration for a POSITA.

  • Additional Grounds: Petitioner asserted that claim 19 is unpatentable over the same combinations for the same reasons. Claim 4, which requires a "continuous filament," was argued to be obvious over Schaffer combined with either Hartley or Eller, as both secondary references disclose continuous string or wire filaments.

4. Key Claim Construction Positions

  • Petitioner argued that the term “filament” should be construed as “one or more threads, lines, cords, ropes, ribbons, flat wires, sheets, or tapes.”
  • This construction is taken directly from an explicit definition in the ’291 patent’s specification. A key aspect of Petitioner's argument is that the patent does not use the word "flexible" to describe the filament, and therefore the claim term should not be limited to only flexible materials. This construction is central to the anticipation argument, as it allows Schaffer’s potentially rigid "actuating members" to qualify as a "filament."

5. Arguments Regarding Discretionary Denial

  • Petitioner provided a Sotera stipulation, stating that if the Board institutes this inter partes review (IPR), Petitioner will not pursue in the co-pending district court litigation the same grounds asserted in the petition, nor any other ground that could have been reasonably raised in the IPR.
  • This stipulation was offered to mitigate Fintiv factors by eliminating concerns of duplicative efforts and the potential for inconsistent rulings between the PTAB and the district court.

6. Relief Requested

  • Petitioner requests institution of an IPR and cancellation of claims 1-8 and 12-19 of the ’291 patent as unpatentable.