PTAB

IPR2025-01562

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 ’384 patent discloses hemostasis valves used to seal medical devices, such as catheters, during intravascular procedures. The valve comprises a collapsible tubular member that is constricted by first and second filaments, which are in turn tensioned by a pair of spring-biased actuators.

3. Grounds for Unpatentability

Ground 1: Claims 1-4, 6-18, and 20-30 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: Petitioner argued that Schaffer taught all major elements of the claimed valve, including a collapsible tubular member ("seal module"), a pair of spring-biased actuators with buttons, and actuating members to constrict the tubular member. However, Schaffer’s actuating members are two U-shaped components that collectively form a single loop. Petitioner contended that the key missing element—a first and second filament each forming its own loop—was disclosed by both Hartley and Eller. Hartley disclosed a hemostasis valve using a constricting "string" (which Petitioner argued comprises at least two filaments) that loops around a tubular member, while Eller explicitly taught using one, two, or more "wire members" (filaments) that loop around a collapsible sleeve to create a seal.
    • Motivation to Combine: A POSITA would combine Schaffer with Hartley or Eller to create a more effective and reliable seal. Petitioner asserted that Schaffer's U-shaped members, having fixed attachment points, could create gaps when sealing around instruments of varying diameters. Replacing them with the flexible, looping filaments from Hartley or Eller would provide a more conformable and robust seal. Furthermore, Eller’s teaching that a skilled artisan can select a suitable number of filaments would have motivated a POSITA to use two filaments to increase the sealing area and add redundancy, as suggested by Hartley’s preference for winding its string twice.
    • Expectation of Success: A POSITA would have had a reasonable expectation of success because the combination represented a simple substitution of one known constricting element for another to achieve a predictable result. The methods for attaching filaments to actuators (e.g., knots, adhesives, welding) were conventional and well within the ordinary skill in the art.

Ground 2: Claims 11-14, 20-22, and 28-30 are obvious over Schaffer and Hermann in view of Hartley or Eller.

  • Prior Art Relied Upon: Schaffer (Application # 2003/0225379), Hermann (Patent 5,599,305), Hartley (Application # 2003/0116731), and Eller (Patent 9,980,813).

  • Core Argument for this Ground:

    • Prior Art Mapping: This ground targeted dependent claims requiring the valve's tubular member to have a large open diameter (at least 14, 16, 20, or 24 French). Petitioner argued that while Schaffer taught a generic hemostasis valve for use with catheters, it did not specify these large diameters. Hermann, however, expressly disclosed a "Large-Diameter Introducer Sheath" system with a hemostasis valve designed to accommodate catheters as large as 30 French. Hermann further taught that a "wide variety of hemostasis valves would be suitable" for its system.
    • Motivation to Combine: A POSITA would have been motivated to incorporate the improved Schaffer valve (as modified by Hartley or Eller) into Hermann's large-diameter system. This would allow practitioners to use the more effective and adjustable sealing mechanism of the modified Schaffer valve with the large-bore catheters required for certain procedures, as described by Hermann. The known clinical need for large-diameter access provided a strong reason to scale up the Schaffer design.
    • Expectation of Success: Success was predictable because sizing a hemostasis valve to accommodate known, standard catheter diameters was a routine design optimization for a POSITA. The art, including Hermann, was replete with examples of large-diameter hemostasis valves, confirming the feasibility and predictability of such a modification.

  • Additional Grounds: Petitioner asserted additional obviousness challenges based on the three-way combination of Schaffer, Hartley, and Eller, arguing Eller provided further motivation for using a multi-filament design.

4. Key Claim Construction Positions

  • Petitioner argued that independent claims 15 and 23, which do not explicitly recite "flexible" filaments, should not be limited by such a requirement. This position was based on the doctrine of claim differentiation, as dependent claims 17 and 27 add the "flexible" limitation, implying its absence from the independent claims. However, Petitioner noted this dispute was immaterial to its grounds, as Hartley and Eller both disclosed flexible filaments.

5. Arguments Regarding Discretionary Denial

  • Petitioner stipulated that if the Board institutes this inter partes review (IPR), it will not pursue in district court the grounds asserted in the petition or any other grounds that could have been reasonably raised. Petitioner argued this Sotera stipulation obviates any concerns of duplicative efforts. It also noted that the co-pending district court case is in a very early stage, with the schedule vacated and no trial date set, weighing against a discretionary denial under Fintiv.

6. Relief Requested

  • Petitioner requests institution of an IPR and cancellation of claims 1-4, 6-18, and 20-30 of the ’384 patent as unpatentable.