PTAB

IPR2025-01021

Imperative Care Inc v. Inari Medical Inc

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Key Events
Petition
petition

1. Case Identification

2. Patent Overview

  • Title: Methods of Aspirating Material from a Vasculature
  • Brief Description: The ’333 patent relates to methods for treating pulmonary embolism (PE) or deep vein thrombosis (DVT) by aspirating clot material from a patient’s vasculature. The disclosed methods utilize a system comprising an aspiration catheter, a clot canister with an internal filter, a user-actuatable valve, and an aspiration source.

3. Grounds for Unpatentability

Ground 1: Obviousness over Laub in view of Garrison - Claims 1-5, 9-10, 14-16, 18-19, 20-24, 28-29, 33-35, 37-38 are obvious over Laub in view of Garrison.

  • Prior Art Relied Upon: Laub (Application # 2017/0043066) and Garrison (Application # 2015/0173782).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that Laub taught a complete aspiration system for treating PE and DVT, including an aspiration catheter, a filter housing (clot canister), and a pump (aspiration source), fluidly coupled along a path. Petitioner asserted that Garrison taught an aspiration system for cerebral thrombectomy featuring a key missing element: a user-actuatable valve (e.g., a stopcock) positioned in the fluid path. Garrison’s valve could be closed to allow the aspiration source to "pre-charge" or build up a vacuum, which could then be rapidly released by opening the valve to achieve maximum aspiration force.
    • Motivation to Combine: A POSITA would combine Garrison's pre-charging valve mechanism with Laub’s PE/DVT aspiration system to achieve a more rapid and powerful initial suction. Petitioner contended this combination would yield the predictable result of a safer and more effective clot removal procedure. Further motivation was based on the argument that adapting a cerebral aspiration system (Garrison) for treating PE/DVT was a routine and predictable optimization, as the general components and procedures for aspiration are similar across different vasculatures.
    • Expectation of Success: Petitioner asserted a high expectation of success because incorporating a simple, well-understood mechanical component like a stopcock into Laub’s existing fluid path was straightforward. The common practice of adapting aspiration systems for different anatomical locations supported this expectation.

Ground 2: Obviousness over Laub and Garrison in view of Goff - Claims 6-8, 17, 25-27, and 36 are obvious over Laub and Garrison in view of Goff.

  • Prior Art Relied Upon: Laub (Application # 2017/0043066), Garrison (Application # 2015/0173782), and Goff (WO 2006/124307).
  • Core Argument for this Ground:
    • Prior Art Mapping: This ground builds on the combination of Laub and Garrison to address the limitations of claims requiring a removable filter (claim 6) and subsequent clot removal (claim 7). Petitioner argued that while Laub and Garrison taught filter canisters, they did not explicitly describe removing the internal filter element. Goff allegedly cured this deficiency by disclosing a filter assembly with an upper and lower shell that could be taken apart to "permit introduction, removal, and replacement of the filter element."
    • Motivation to Combine: A POSITA would have been motivated to modify the Laub/Garrison filter canister to incorporate Goff’s removable filter design. This would allow a physician to easily retrieve captured clot material for analysis, clean the filter for reuse, or empty the canister during a procedure, which are all desirable functionalities.
    • Expectation of Success: Success was reasonably expected because designing a housing with simple mechanical features like threads, hinges, or clips to be openable was a well-understood and predictable design choice for a POSITA.

Ground 3: Obviousness over Laub, Garrison, and Schaffer, optionally in view of Hartley - Claims 11-12 and 30-31 are obvious over Laub and Garrison in view of Schaffer and optionally Hartley.

  • Prior Art Relied Upon: Laub (’066 application), Garrison (’782 application), Schaffer (Application # 2003/0225379), and Hartley (Application # 2003/0116731).

  • Core Argument for this Ground:

    • Prior Art Mapping: This ground addressed claims requiring a hemostasis valve with a "filament" that is tensioned to inhibit fluid flow and relaxed to permit flow. Petitioner argued that Schaffer taught a "fluid stasis valve" using U-shaped "actuating members" (argued to be a "filament" under the proposed claim construction) that applied compressive force to a seal module. Depressing actuator buttons released this tension, opening the valve. As an alternative, Petitioner asserted Hartley taught a hemostasis valve using a "string" (filament) that could be substituted for Schaffer’s actuating members if they were not considered a filament.
    • Motivation to Combine: A POSITA would incorporate a known hemostasis valve like Schaffer's into the Laub/Garrison system to prevent blood loss when introducing instruments. Petitioner argued this was a simple combination of known elements for their known purpose. The motivation to further combine Hartley was to provide an improved sealing mechanism, as Hartley’s string would conform more precisely to various tool diameters than Schaffer’s potentially more rigid members.
    • Expectation of Success: A POSITA would have reasonably expected success in combining these components, as hemostasis valves were standard, predictable components used with catheter systems, and the proposed modifications involved simple, known mechanical principles.

  • Additional Grounds: Petitioner asserted numerous additional grounds, primarily substituting Aklog (Patent 8,734,374) for Laub. These grounds relied on analogous arguments, as Aklog also disclosed a complete aspiration system for treating PE/DVT, providing a similar base system for combination with Garrison, Goff, Schaffer, and Hartley.

4. Key Claim Construction Positions

  • Petitioner argued that the term "filament" (claims 11-12, 30-31) should be construed broadly based on its definition in an application incorporated by reference into the ’333 patent.
  • The proposed construction for "filament" was at least "one or more threads, lines, cords, ropes, ribbons, flat wires, sheets, or tapes." This broad construction was critical to Petitioner's argument that the "U-shaped actuating members" of the Schaffer reference met the "filament" limitation.

5. Key Technical Contentions (Beyond Claim Construction)

  • A central technical contention was that adapting a medical device designed for one part of the vasculature (e.g., Garrison's cerebral thrombectomy system) for use in another (e.g., treating PE/DVT in larger, peripheral vessels) was a common, routine, and predictable practice for a POSITA in 2018.
  • Petitioner argued that systems designed for the more challenging and delicate neurovasculature, like Garrison's, could be readily and obviously adapted for use in less tortuous environments like the pulmonary arteries, reinforcing the motivation to combine Garrison with references like Laub or Aklog.

6. Arguments Regarding Discretionary Denial

  • To preempt discretionary denial under Fintiv, Petitioner included a Sotera stipulation.
  • Petitioner stipulated that if the Board institutes this inter partes review (IPR), it will not pursue in the co-pending district court litigation any ground that was raised or reasonably could have been raised in the IPR petition. This was intended to assure the Board there would be no overlap or inefficiency between the two proceedings.

7. Relief Requested

  • Petitioner requested institution of an IPR and cancellation of claims 1-12, 14-31, and 33-38 of the ’333 patent as unpatentable.