PTAB

IPR2025-01025

Imperative Care Inc v. Inari Medical Inc

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Key Events
Petition
petition

1. Case Identification

2. Patent Overview

  • Title: Clot Treatment System
  • Brief Description: The ’910 patent discloses a system for intravascular removal of clot material, such as a pulmonary embolism (PE). The system comprises first and second clot aspiration assemblies, each including a catheter, a pressure source to generate a vacuum, and a fluid control device.

3. Grounds for Unpatentability

Ground 1: Obviousness over Garrison and Laub - Claims 1-6, 8, 11-15, and 18-20 are obvious over Garrison in view of Laub.

  • Prior Art Relied Upon: Garrison (Application # 2015/0173782) and Laub (Application # 2017/0043066).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that Garrison, which was before the Examiner during prosecution, discloses nearly every element of the challenged claims. Garrison teaches a clot treatment system with first and second aspiration assemblies, each having a catheter, pressure source, and fluid control device (a valve or stopcock). The Examiner only allowed the ’910 patent after concluding that Garrison was limited to treating cerebral clots with smaller catheters and that it would be unreasonable to modify it for treating PEs with a larger catheter (16 French or greater). Petitioner contended this was an error. Laub, which was not before the Examiner, explicitly discloses a system for removing thrombi from a patient's vasculature, including removing clots from patients suffering from PEs. Crucially, Laub teaches using aspiration catheters with a size of "at least 16 Fr" to treat PEs, directly addressing the alleged deficiencies in Garrison.
    • Motivation to Combine: A POSITA would combine Garrison and Laub because both relate to aspirating clots from vasculature. Petitioner asserted that the general procedure for aspirating a clot is similar regardless of its location (brain, lungs, etc.). A POSITA, seeking to apply Garrison's dual-catheter system to treat a known danger like PEs, would have looked to analogous art like Laub, which teaches the successful use of larger, 16 Fr or greater catheters for that exact purpose. The combination would involve the simple and predictable substitution of Garrison's smaller catheters with the appropriately sized catheters taught by Laub.
    • Expectation of Success: A POSITA would have a high expectation of success because upsizing catheters for different applications was a routine and common practice. Laub's own disclosure of successfully using ≥16 Fr catheters for PE treatment confirmed the viability of the approach, making the outcome of the combination predictable.

Ground 2: Obviousness over Garrison, Laub, and Hartley - Claims 6-7 and 20 are obvious over Garrison in view of Laub and Hartley.

  • Prior Art Relied Upon: Garrison (Application # 2015/0173782), Laub (Application # 2017/0043066), and Hartley (Application # 2003/0116731).

  • Core Argument for this Ground:

    • Prior Art Mapping: This ground builds on the Garrison and Laub combination to address the specific limitations of claims 6 and 7, which require a hemostasis valve with a "filament" that constricts a tubular member to seal around the second catheter. While Garrison teaches the use of hemostasis valves (e.g., a "Tuohy-Borst or rotating hemostasis valve"), it does not detail the internal structure. Hartley discloses a rotating hemostasis valve that uses a "string" (a "filament" under the Petitioner's proposed construction) that, when actuated, pulls on and constricts a cylindrical elastomeric diaphragm (a "tubular member") to seal around an instrument, such as a catheter.
    • Motivation to Combine: A POSITA would be motivated to incorporate Hartley’s valve into the Garrison/Laub system for a clear reason. Garrison expressly suggests combining its catheters with a "rotating hemostasis valve." Hartley discloses exactly such a valve. A POSITA seeking to implement Garrison's suggestion would have looked to known rotating hemostasis valve designs like Hartley's to achieve the predictable result of reducing blood loss when introducing a catheter. This represents combining known elements for their intended purposes.
    • Expectation of Success: Success was expected because hemostasis valves were ubiquitous components in catheter systems. Combining a known type of valve (Hartley's) with a catheter system (Garrison's) was a routine integration that a POSITA would have been familiar with.

  • Additional Grounds: Petitioner asserted additional obviousness challenges, including:

    • Claims 1-6, 8, 11-15, and 18-20 are obvious over Garrison in view of Aklog (Patent 8,734,374), where Aklog serves as an alternative to Laub for teaching the treatment of PEs with large catheters.
    • Claims 3, 12, and 18 are obvious over the primary combinations further in view of Pasha (a 2014 journal article), which discloses using an even larger 26-French catheter to treat PEs, further motivating the upsizing of Garrison's catheters.

4. Key Claim Construction Positions

  • "filament" (Claim 7): Petitioner argued this term is not described in the ’910 patent specification itself but is incorporated by reference from the ’519 application. Based on the ’519 application, Petitioner contended a POSITA would understand "filament" to mean "one or more threads, lines, cords, ropes, ribbons, flat wires, sheets, or tapes." This construction is critical for mapping the "string" taught in the Hartley reference to the "filament" limitation.

5. Arguments Regarding Discretionary Denial

  • Petitioner argued that discretionary denial under Fintiv would be inappropriate. It noted that the co-pending district court litigation is in its early stages, with no trial date set and a case schedule established only through claim construction. To further mitigate any concerns, Petitioner provided a Sotera stipulation, agreeing not to pursue in district court any grounds raised or that reasonably could have been raised in the IPR if the petition is instituted.

6. Relief Requested

  • Petitioner requests institution of an inter partes review and cancellation of claims 1-8, 11-15, and 18-20 of Patent 11,974,910 as unpatentable.