PTAB

IPR2025-00728

Imperative Care Inc v. Inari Medical Inc

Log In
Key Events
Petition
petition

1. Case Identification

2. Patent Overview

  • Title: Hemostasis Valve
  • Brief Description: The ’921 patent discloses a hemostasis valve for sealing medical catheters to prevent blood loss during intravascular procedures. The valve features a collapsible "elongate member" with a lumen, which is constricted by a "filament" tensioned by a movable actuator (e.g., button) that is typically biased into a closed position by a spring.

3. Grounds for Unpatentability

Ground 1: Anticipation and Obviousness over Schaffer, alone or in view of Hartley or Eller - Claims 1-7, 9-10, 15-18, and 20-24 are anticipated by or obvious over Schaffer, or 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, a prior art reference not considered during prosecution, discloses all elements of the challenged claims. Schaffer describes a hemostasis valve with a collapsible "seal module" (the claimed elongate member), two spring-loaded actuator buttons (the claimed actuator), and two U-shaped "actuating members" that constrict the seal module (the claimed filament). Schaffer’s springs (resilient members) also meet the "biasing member" limitation by biasing the actuators toward the closed position.
    • Motivation to Combine (for §103 grounds): If the Board were to find Schaffer’s U-shaped actuating members are not "filaments," Petitioner contended a person of ordinary skill in the art (POSITA) would combine Schaffer with Hartley or Eller. Both Hartley and Eller disclose alternative constricting elements (a "string" and a "wire member," respectively) for the same purpose in similar valves. The motivation to substitute these elements into Schaffer’s valve was to achieve a more effective seal over a wider range of tool diameters and shapes, as a string or wire conforms more closely to an inserted tool than Schaffer's more rigid members. This was presented as a simple substitution of one known element for another to obtain predictable results.
    • Expectation of Success (for §103 grounds): A POSITA would have a high expectation of success because Hartley's string and Eller's wire member were known, well-understood constricting elements from a finite number of design choices. Integrating them into Schaffer’s valve would involve straightforward mechanical modifications, such as attaching the string or wire to Schaffer's existing actuator buttons.

Ground 2: Obviousness over Hartley in view of Eller - Claims 1-3, 5-6, 9-10, 15-18, and 21-24 are obvious over Hartley in view of Eller.

  • Prior Art Relied Upon: Hartley (Application # 2003/0116731) and Eller (Patent 9,980,813).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that during prosecution, the Examiner found Hartley disclosed every limitation of the independent claims except for a "biasing member." Hartley teaches a hemostasis valve with a cylindrical elastomeric diaphragm (elongate member) constricted by a string (filament) that is tensioned by a rotary actuator. Eller, which was cited in an Information Disclosure Statement but not applied by the Examiner, explicitly discloses adding a biasing member (a torsion spring) to a similar hemostasis valve with a rotating actuator to bias it toward the closed position.
    • Motivation to Combine (for §103 grounds): A POSITA would combine Eller's torsion spring with Hartley’s valve to improve its function and safety. The primary motivations were to ensure the valve seals quickly and automatically when a device is removed, minimizing blood loss, and to prevent a physician from inadvertently leaving the valve open. Adding a biasing member also simplifies the procedure by reducing the manual steps required to seal the valve.
    • Expectation of Success (for §103 grounds): Success was predictable because both references are in the same field of endeavor and share many common features, including a housing, a rotational actuator, and a constricting element. Positioning a torsion spring between a housing and a rotating actuator was a conventional and well-understood mechanical design choice.

4. Key Claim Construction Positions

  • "filament": Petitioner argued this term should be construed to mean "one or more threads, lines, cords, ropes, ribbons, flat wires, sheets, or tapes." This construction is based on explicit examples in the ’921 patent's specification. This broad construction is critical to Petitioner's argument that Schaffer’s "actuating members"—which are described as being made of plastic or aluminum and resemble a ribbon or flat wire—fall within the scope of the term, supporting the anticipation ground. Petitioner also contended that the term does not inherently require the filament to be "thin and flexible," as the Patent Owner had previously argued in a related case.

5. Arguments Regarding Discretionary Denial

  • Petitioner argued that the Board should not discretionarily deny institution under 35 U.S.C. §314(a) or §325(d). To avoid denial under the Fintiv factors, Petitioner stipulated that it would not pursue in district court the same grounds raised in the inter partes review (IPR) petition if instituted. Petitioner also noted that the parallel litigation is in its earliest stages, with no trial date set.
  • Denial under §325(d) was argued to be inappropriate because the primary reference, Schaffer, was not before the Examiner during prosecution. Furthermore, while Hartley and Eller were cited in an IDS, the Examiner never considered or discussed the obviousness combination of the two, thereby materially erring by overlooking a key deficiency in Hartley (the lack of a biasing member) that Eller remedies.

6. Relief Requested

  • Petitioner requests institution of an IPR and cancellation of claims 1-7, 9-10, 15-18, and 20-24 of Patent 11,844,921 as unpatentable.