DCT

1:24-cv-01023

Inari Medical Inc v. Inquis Medical Inc

Log In

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:24-cv-01023, D. Del., 09/11/2024
  • Venue Allegations: Venue is alleged to be proper in the District of Delaware because Defendant is incorporated in Delaware and therefore resides in the district.
  • Core Dispute: Plaintiff alleges that Defendant’s thrombectomy and blood management systems infringe four patents related to systems and methods for treating embolism by aspirating blood clots.
  • Technical Context: The technology at issue involves catheter-based mechanical thrombectomy devices, which are used to remove life-threatening blood clots from vessels such as the pulmonary arteries.
  • Key Procedural History: The complaint contains extensive allegations that Defendant hired a former high-level regulatory employee of Plaintiff who then misappropriated Plaintiff’s confidential FDA 510(k) submission documents. Plaintiff alleges these trade secrets were used to improperly accelerate the FDA clearance process for Defendant’s accused products. Plaintiff also alleges it sent a cease-and-desist letter one day prior to filing the complaint.

Case Timeline

Date Event
2011-07-01 Plaintiff Inari Medical, Inc. was formed
2017-02-01 Inari received FDA clearance for its ClotTriever system
2018-08-13 Priority Date for ’180, ’332, ’909, and ’382 Patents
2020-11-10 Inari submitted its 510(k) for the FlowSaver device
2021-07-22 Inari's FlowSaver 510(k) was cleared by the FDA
2023-03-01 Inquis retained former Inari VP as a consultant
2023-09-07 Inquis submitted the 510(k) for the Accused Aventus Thrombectomy System
2023-11-01 FDA cleared the Accused Aventus Thrombectomy System
2024-02-06 U.S. Patent No. 11,890,180 issues
2024-04-30 U.S. Patent No. 11,969,332 issues
2024-05-01 Inquis received FDA clearance for the Accused Aventus Clot Management System
2024-05-07 U.S. Patent No. 11,974,909 issues
2024-05-21 U.S. Patent No. 11,986,382 issues
2024-09-10 Plaintiff sent a cease-and-desist letter to Defendant
2024-09-11 Complaint Filing Date

II. Technology and Patent(s)-in-Suit Analysis

U.S. Patent No. 11,890,180 - "System for Treating Embolism and Associated Devices and Methods"

  • Patent Identification: U.S. Patent No. 11,890,180, issued February 6, 2024 (’180 Patent).

The Invention Explained

  • Problem Addressed: The patent’s background section describes the drawbacks of existing techniques for removing blood clots, noting that surgical embolectomies are traumatic and percutaneous methods using clot-dissolving agents are slow and carry risks of hemorrhage. ( ’180 Patent, col. 2:1-32). Existing mechanical devices are described as sometimes being overly complex or unable to completely capture the clot material. (’180 Patent, col. 2:33-48).
  • The Patented Solution: The invention is a system for removing clot material that utilizes a "pre-charged" vacuum. A pressure source, such as a syringe, is fluidly coupled to a catheter via a valve. The valve is kept closed while the pressure source is activated to generate and store a vacuum. The valve is then opened to apply this stored vacuum pressure nearly instantaneously to the catheter, generating strong suction forces intended to aspirate the clot material from the blood vessel. (’180 Patent, col. 5:20-51; FIG. 1).
  • Technical Importance: This "pre-charging" approach is described as being capable of generating "greater suction forces (and corresponding fluid flow velocities)" than systems where a vacuum is generated while already fluidly connected to the catheter. (’180 Patent, col. 5:45-51).

Key Claims at a Glance

  • The complaint asserts independent claim 22. (Compl. ¶147).
  • The essential elements of Claim 22 are:
    • A system for intravascular treatment of clot material from a patient's vasculature, comprising:
    • a catheter configured for positioning within the vasculature proximate to the clot;
    • a pressure source configured to generate negative pressure; and
    • a fluid control device fluidically coupled between the pressure source and the catheter, wherein the fluid control device is configured to be:
      • closed to fluidically disconnect the pressure source from the catheter when the pressure source generates the negative pressure; and
      • opened to fluidically connect the pressure to the catheter after the pressure source generates the negative pressure to create a flow rate within the catheter of greater than about 60 cubic centimeters per second to aspirate the clot.
  • The complaint reserves the right to assert additional claims, including dependent claims. (Compl. ¶143).

U.S. Patent No. 11,969,332 - "System for Treating Embolism and Associated Devices and Methods"

  • Patent Identification: U.S. Patent No. 11,969,332, issued April 30, 2024 (’332 Patent).

The Invention Explained

  • Problem Addressed: The technical problem is consistent with that of the ’180 Patent: the need for improved systems for removing blood clots from vessels. (’332 Patent, col. 1:47-col. 2:48).
  • The Patented Solution: This patent claims a method that extends beyond simple aspiration to include autologous blood transfusion. The method involves aspirating clot and blood into a first container, decoupling that container, coupling it to a filter assembly to separate the clot from the blood, receiving the filtered blood into a second container, and then coupling the second container to a catheter to drive the filtered blood back into the patient's vasculature. (’332 Patent, col. 41:1-42). This process is illustrated in figures showing a filter device coupled between two syringes. (’332 Patent, FIG. 20A-21B).
  • Technical Importance: The claimed method provides a way to minimize patient blood loss during a thrombectomy procedure, which can be a significant clinical benefit, by enabling the safe return of the patient's own aspirated and filtered blood. (Compl. ¶21).

Key Claims at a Glance

  • The complaint asserts independent claim 1. (Compl. ¶168).
  • The essential steps of Claim 1 are:
    • A method for treating clot material, comprising:
    • positioning a first catheter proximate to the clot;
    • aspirating clot and blood through the first catheter into a first container;
    • decoupling the first container from the first catheter;
    • coupling the first container to a filter assembly;
    • driving the blood and clot from the first container into the filter assembly to produce filtered blood;
    • receiving the filtered blood from the filter assembly into a second container;
    • decoupling the second container from the filter assembly;
    • coupling the second container to a second catheter; and
    • driving the filtered blood from the second container into the vasculature.
  • The complaint reserves the right to assert additional claims. (Compl. ¶163).

U.S. Patent No. 11,974,909 - "System for Treating Embolism and Associated Devices and Methods"

  • Patent Identification: U.S. Patent No. 11,974,909, issued May 7, 2024 (’909 Patent).
  • Technology Synopsis: The ’909 Patent discloses a method for treating clot material using a system comprising an aspiration catheter, a clot canister, and an aspiration source. The method involves generating a vacuum within the clot canister while a valve between the canister and catheter is closed, then opening the valve to apply the vacuum to aspirate the clot. The method further includes filtering the aspirated blood within the canister and reintroducing it to the patient. (Compl. ¶186, 192).
  • Asserted Claims: Independent claim 1 is asserted. (Compl. ¶192).
  • Accused Features: The complaint alleges that the combined use of the Aventus Thrombectomy System and Aventus Clot Management System practices the claimed method by using an aspiration source to pre-charge a vacuum in the clot canister before a valve is opened to aspirate, filter, and ultimately return blood to the patient. (Compl. ¶191, 193-200).

U.S. Patent No. 11,986,382 - "System for Treating Embolism and Associated Devices and Methods"

  • Patent Identification: U.S. Patent No. 11,986,382, issued May 21, 2024 (’382 Patent).
  • Technology Synopsis: The ’382 Patent claims a method of filtering clot material from blood. The method involves coupling a first syringe containing the blood and clot mixture to one port of a filter device and a second syringe to another port. The plunger of the first syringe is depressed to drive the mixture into a filter chamber, and the plunger of the second syringe is withdrawn to draw the now-filtered blood through the filter and into the second syringe. (Compl. ¶206, 212).
  • Asserted Claims: Independent claim 1 is asserted. (Compl. ¶212).
  • Accused Features: The complaint alleges that the use of the Aventus Clot Management System with two syringes for filtering aspirated material practices this method. One syringe is used to inject the aspirant into the system's "Clot Cannister" (the filter device), while a second pre-connected syringe fills with filtered blood drawn through the filter. (Compl. ¶211, 213-217).

III. The Accused Instrumentality

Product Identification

  • The Aventus Thrombectomy System and the Aventus Clot Management System, collectively referred to as the "Accused Products." (Compl. ¶89).

Functionality and Market Context

  • The Aventus Thrombectomy System is a catheter-based system for the non-surgical removal of emboli and thrombi from blood vessels. (Compl. ¶90). It uses a catheter navigated to the clot site, where negative pressure is applied to aspirate the thrombus and blood into a container. (Compl. ¶92). An overview slide from a presentation depicts the system as a "fully integrated dilator, navigation, aspiration, and blood return system" including an aspiration catheter and a clot canister. (Compl. p. 24). The Aventus Clot Management System is used with the Thrombectomy System for autologous blood transfusion. (Compl. ¶91). Aspirated material is injected into a clot canister where a dual-layer filter separates the clot from the blood, which can then be returned to the patient via a syringe. (Compl. ¶92). Defendant allegedly began marketing the products after receiving FDA clearances in November 2023 and May 2024. (Compl. ¶93).

IV. Analysis of Infringement Allegations

11,890,180 Patent Infringement Allegations

Claim Element (from Independent Claim 22) Alleged Infringing Functionality Complaint Citation Patent Citation
a catheter configured to be positioned at least partially within the vasculature proximate to the clot material; The Aventus Thrombectomy System includes an Aspiration Catheter designed for intravascular placement near a thrombus. ¶149 col. 5:19-24
a pressure source configured to generate negative pressure; The system is provided with a 60-cc manual syringe or includes a vacuum source configured for charging a canister to a desired vacuum level. ¶152 col. 5:55-62
a fluid control device fluidically coupled between the pressure source and the catheter, wherein—the fluid control device is configured to be closed to fluidically disconnect the pressure source from the catheter when the pressure source generates the negative pressure; The system allegedly includes an on/off valve that is configured to be closed, disconnecting the catheter from the vacuum source to allow the source to charge a canister with negative pressure. ¶153-154 col. 5:25-31
and the fluid control device is configured to be opened to fluidically connect the pressure to the catheter after the pressure source generates the negative pressure to generate a flow rate within the catheter of greater than about 60 cubic centimeters per second... The on/off valve is opened after the canister is charged, applying the vacuum to the catheter. The complaint alleges on information and belief that this generates a flow rate exceeding 60 cc/sec. ¶155-156 col. 5:31-44
  • Identified Points of Contention:
    • Technical Question: A central evidentiary dispute may arise over the claimed flow rate. The complaint alleges, on "information and belief," that the accused system generates a flow rate "greater than about 60 cubic centimeters per second." (Compl. ¶156). What factual basis supports this specific quantitative limitation, and will testing of the accused product confirm it meets this threshold?
    • Scope Questions: The interpretation of "pressure source" may be contested. The complaint points to both a "manual syringe" and a "vacuum source" that charges a "cannister." (Compl. ¶152). How these components map to the single "pressure source" required by the claim could be a point of dispute.

11,969,332 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
positioning a first catheter at least partially within the vasculature proximate to the clot material; Use of the Aventus Thrombectomy System involves positioning its aspiration catheter near a clot within a blood vessel. ¶170 col. 17:10-18
aspirating at least a portion of the clot material and blood through the first catheter and into a first container coupled to the first catheter; A 60-cc dual-action manual syringe (the "first container") is used to aspirate blood and clot through the aspiration catheter. ¶172 col. 18:29-37
decoupling the first container from the first catheter; The manual syringe, containing the aspirant, is decoupled from the aspiration catheter. ¶173 col. 19:35-42
coupling the first container to a filter assembly; The manual syringe is coupled to the Aventus Clot Canister, which contains a "dual layer...polyester screen filter" (the "filter assembly"). ¶174 col. 20:55-61
driving the portion of the clot material and the blood from the first container into the filter assembly...to produce filtered blood; The aspirant is injected from the syringe into the Clot Canister, where the filter separates the clot from the blood. ¶175-176 col. 20:62-65
receiving the filtered blood from the filter assembly within a second container coupled to the filter assembly; Filtered blood passes through the filter and fills a second syringe (the "second container") that is pre-connected to an outlet below the filter. ¶177 col. 21:1-8
decoupling the second container from the filter assembly; After being filled, the second syringe may be decoupled from the filter assembly. ¶178 col. 21:1-8
coupling the second container to a second catheter at least partially positioned within the vasculature; and The second syringe is then coupled to a circuit for returning the blood to the patient's vasculature. ¶179 col. 21:1-8
driving the filtered blood from the second container through the second catheter into the vasculature. The filtered blood is returned to the patient via the blood return circuit. ¶180 col. 21:1-8
  • Identified Points of Contention:
    • Scope Questions: The identity of the "first container" will be a critical issue for claim construction. The complaint's infringement theory maps this term to the aspiration syringe. (Compl. ¶172). However, a defendant may argue that the "Clot Canister" is the "first container," which would render the claimed sequence of "decoupling the first container from the first catheter; coupling the first container to a filter assembly" nonsensical in the context of the accused system's operation.
    • Technical Questions: Does the accused method require a "second catheter" as distinct from the first? The complaint alleges the filtered blood is returned via a "blood return circuit place[d] in the vasculature," which it maps to the "second catheter" element. (Compl. ¶179). Whether this return circuit constitutes a "catheter" within the meaning of the claim raises a question of technical and legal scope.

V. Key Claim Terms for Construction

  • The Term: "a flow rate... of greater than about 60 cubic centimeters per second" (’180 Patent, Claim 22)

    • Context and Importance: This quantitative limitation is a key differentiator of the claimed invention and a potential weak point in the infringement allegation, which is based on "information and belief." Practitioners may focus on this term because proving that a manually operated device consistently achieves this specific, high flow rate could be challenging.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The specification emphasizes that pre-charging the vacuum generates "greater suction forces (and corresponding fluid flow velocities)" than prior art methods. (’180 Patent, col. 5:45-51). Table 2 in the specification explicitly lists calculated flow rates ranging from 66.7 to 600.0 cc/sec for a 60 cc syringe, suggesting such rates are contemplated by the invention. (’180 Patent, col. 10:1-12).
      • Evidence for a Narrower Interpretation: A defendant could argue that the term "about" cannot broaden the claim to cover a device that does not reliably and intentionally operate at this high-flow-rate threshold. They may argue the term implies a system specifically designed for rapid, high-volume aspiration, which may not be the primary design feature of the accused manual syringe system.

  • The Term: "first container" (’332 Patent, Claim 1)

    • Context and Importance: The infringement reading of this multi-step method claim depends on the aspiration syringe being the "first container." If the Clot Canister is construed as the "first container," the claimed sequence of steps does not align with the accused method, potentially defeating the infringement allegation.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The patent does not provide a specific definition for "container." A plain and ordinary meaning could encompass a syringe, which contains fluid. The specification depicts various syringe-based pressure sources which necessarily contain fluid before and after aspiration. (’332 Patent, FIG. 2, 3A).
      • Evidence for a Narrower Interpretation: The patent figures consistently show aspirated material being collected in a "canister" or "filter device," such as filter device 2150 in FIG. 21A, which has a distinct chamber 2154. (’332 Patent, FIG. 21A). A party could argue that these dedicated collection chambers, not the actuating syringes, are what the patent contemplates as the "container" for the aspirated material.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges that Defendant induces infringement by providing instructions to its customers, such as hospitals and physicians, on how to use the Accused Products in a manner that directly infringes the asserted method claims. (Compl. ¶144, 165, 189, 209).
  • Willful Infringement: Willfulness is alleged based on Defendant’s knowledge of the patents since at least the receipt of a cease-and-desist letter on September 10, 2024, and its continued alleged infringement thereafter. (Compl. ¶160, 184, 204, 221). The complaint’s overarching narrative of trade secret misappropriation may be used to support the allegation that Defendant’s conduct has been deliberate and egregious.

VII. Analyst’s Conclusion: Key Questions for the Case

  • A central issue will be one of evidentiary proof: can Plaintiff substantiate its allegation that the accused Aventus system achieves the specific quantitative limitation of a "flow rate... greater than about 60 cubic centimeters per second" as required by the ’180 Patent, or will physical testing show a functional mismatch?
  • A key question of claim construction will be the definition of "container" in the asserted method patents. The case may turn on whether a simple syringe can be construed as the claimed "first container" and "second container," or if those terms are limited to the dedicated canister shown in the patents, a distinction that could either validate or dismantle Plaintiff's infringement theory for the ’332 Patent.
  • An overarching question will be the interplay between the trade secret and patent claims: how might the extensive allegations of trade secret misappropriation, which suggest a deliberate effort to copy Plaintiff's technology and regulatory strategy, influence the court's perception of intent and willfulness in the patent infringement context?