DCT
1:24-cv-01023
Inari Medical Inc v. Inquis Medical Inc
Key Events
Amended Complaint
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Inari Medical, Inc. (Delaware)
- Defendant: Inquis Medical, Inc. (Delaware)
- Plaintiff’s Counsel: Hueston Hennigan LLP
- Case Identification: 1:24-cv-01023, D. Del., 11/12/2025
- Venue Allegations: Venue is alleged to be proper in the District of Delaware because Defendant is a Delaware corporation and therefore resides in the district.
- Core Dispute: Plaintiff alleges that Defendant’s thrombectomy and clot management systems infringe four patents related to systems and methods for treating vascular embolisms.
- Technical Context: The technology at issue involves catheter-based medical devices designed for mechanical thrombectomy, a procedure to remove blood clots from blood vessels.
- Key Procedural History: This amended complaint follows an initial complaint filed on September 11, 2024. The filing alleges a broader narrative of trade secret misappropriation by a former Plaintiff employee who later consulted for Defendant, allegedly enabling Defendant to secure expedited FDA clearance for its competing products. Plaintiff alleges it sent Defendant a cease-and-desist letter detailing infringement of the asserted patents on September 10, 2024, and that Defendant had become aware of the patents between March and June 2024.
Case Timeline
| Date | Event |
|---|---|
| 2018-08-13 | Earliest Priority Date for '180, '332, '909, and '382 Patents |
| 2023-11-01 | FDA Clearance for Aventus Thrombectomy System |
| 2024-02-06 | U.S. Patent No. 11,890,180 Issues |
| 2024-03-XX | Defendant Allegedly Becomes Aware of '180 Patent |
| 2024-04-30 | U.S. Patent No. 11,969,332 Issues |
| 2024-05-XX | FDA Clearance for 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 |
| 2024-06-XX | Defendant Allegedly Becomes Aware of '332, '909, and '382 Patents |
| 2024-09-10 | Plaintiff Sends Cease-and-Desist Letter to Defendant |
| 2024-09-11 | Plaintiff Files Initial Complaint |
| 2025-11-03 | First Commercial Cases of Accused Product Allegedly Announced |
| 2025-11-12 | Plaintiff Files Amended and Supplemental Complaint |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 11,890,180 - “System for Treating Embolism and Associated Devices and Methods”
The Invention Explained
- Problem Addressed: The patent’s background describes existing techniques for removing blood clots, such as surgical embolectomy and percutaneous thrombolysis, as being potentially traumatic, slow, or ineffective for certain types of clots. (’180 Patent, col. 1:49-2:48).
- The Patented Solution: The invention is a system for aspirating clot material that uses a pressure source (like a syringe) connected to a catheter via a fluid control device (a valve). The key innovation is pre-charging a vacuum in the pressure source while the valve is closed, and then rapidly opening the valve. This method is described as applying an instantaneous or nearly instantaneous vacuum to the catheter, generating greater suction forces and higher fluid flow velocities to aspirate the clot. (’180 Patent, Abstract; col. 4:17-34).
- Technical Importance: This pre-charging approach is intended to create suction forces sufficient to remove strongly lodged or chronic clots that might resist aspiration from systems where suction is generated concurrently with its application. (’180 Patent, col. 9:15-27, col. 10:38-46).
Key Claims at a Glance
- The complaint asserts independent claim 22. (Compl. ¶156).
- The essential elements of Claim 22 are:
- A catheter configured to be positioned at least partially within the vasculature proximate to the clot material;
- A pressure source configured to generate negative pressure; and
- A fluid control device fluidically coupled between the pressure source and the catheter, wherein the 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 generate a flow rate within the catheter of greater than about 60 cubic centimeters per second to aspirate at least a portion of the clot material.
- The complaint does not explicitly reserve the right to assert dependent claims for this patent.
U.S. Patent No. 11,969,332 - “System for Treating Embolism and Associated Devices and Methods”
The Invention Explained
- Problem Addressed: During thrombectomy, significant amounts of blood can be aspirated along with the clot material. The patent addresses the problem of patient blood loss that occurs when this aspirated blood is discarded. (’332 Patent, col. 31:4-9).
- The Patented Solution: The patent discloses a method for filtering the aspirated blood and returning it to the patient. The method involves aspirating blood and clot into a first container, decoupling it from the catheter, coupling it to a filter assembly, driving the mixture through the filter to produce filtered blood which is collected in a second container, and then driving the filtered blood from the second container back into the patient’s vasculature via a catheter. (’332 Patent, Claim 1).
- Technical Importance: This method provides a workflow for autologous blood transfusion during a thrombectomy, which can minimize patient blood loss and associated complications. (Compl. ¶21).
Key Claims at a Glance
- The complaint asserts independent claim 1. (Compl. ¶182).
- The essential elements of Claim 1 are:
- positioning a first catheter at least partially within the vasculature proximate to the clot material;
- 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;
- decoupling the first container from the first catheter;
- coupling the first container to a filter assembly;
- driving the portion of the clot material and the blood from the first container into the filter assembly... to produce filtered blood;
- receiving the filtered blood from the filter assembly within a second container coupled to the filter assembly;
- decoupling the second container from the filter assembly;
- coupling the second container to a second catheter at least partially positioned within the vasculature; and
- driving the filtered blood from the second container through the second catheter into the vasculature.
- The complaint does not explicitly reserve the right to assert dependent claims for this patent.
U.S. Patent No. 11,974,909 - “System for treating embolism and associated devices and methods”
Technology Synopsis
This patent discloses a method for treating clot material where a vacuum pressure is generated within a clot canister while a valve between the canister and an aspiration catheter is closed. The valve is then opened to apply the vacuum to the catheter to aspirate clot material and blood into the canister, which contains a filter to separate the blood from the clot. The filtered blood is then received and reintroduced into the patient's vasculature. (Compl. ¶¶ 205, 211).
Asserted Claims
The complaint asserts independent claim 1. (Compl. ¶211).
Accused Features
The combined use of the Aventus Thrombectomy System and Aventus Clot Management System is alleged to practice the claimed method. (Compl. ¶¶ 210, 212-219).
U.S. Patent No. 11,986,382 - “System for treating embolism and associated devices and methods”
Technology Synopsis
This patent claims a method of filtering clot material from blood. The method involves coupling a first syringe containing blood and clot to a filter device, coupling a second syringe to another connector on the filter device, depressing the plunger of the first syringe to drive the material into the filter device, and then withdrawing the plunger of the second syringe to draw the filtered blood into it. (Compl. ¶¶ 230, 236).
Asserted Claims
The complaint asserts independent claim 1. (Compl. ¶236).
Accused Features
The use of the Aventus Clot Management System, involving a "dual action manual syringe" to inject aspirant into a Clot Canister and a second syringe to receive the filtered blood, is alleged to practice the claimed method. (Compl. ¶¶ 238-241).
III. The Accused Instrumentality
Product Identification
The Inquis Aventus Thrombectomy System and the Aventus Clot Management System (collectively, the "Accused Products"). (Compl. ¶91).
Functionality and Market Context
The Aventus Thrombectomy System is described as a catheter-based manual aspiration system for the non-surgical removal of emboli and thrombi from blood vessels. (Compl. ¶¶ 92, 94). The Aventus Clot Management System is indicated for use with the Thrombectomy System to perform autologous blood transfusion. (Compl. ¶93). In operation, aspirated clot material and blood from the thrombectomy procedure are injected into a clot canister, where the blood passes through a dual-layer filter into a syringe connected to the filter assembly, allowing the filtered blood to be returned to the patient. (Compl. ¶94). The complaint alleges these products are "highly similar" to Plaintiff's FlowTriever and FlowSaver products and that Defendant used Plaintiff's products as predicate devices in FDA 510(k) submissions. (Compl. ¶¶ 59, 76). An overview image in the complaint shows the system components, including an aspiration catheter, a clot canister, and syringes. (Compl. ¶97).
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 removal of emboli and thrombi from the peripheral vasculature. | ¶158 | col. 5:28-34 |
| a pressure source configured to generate negative pressure; | The system includes a 60-cc manual syringe or a vacuum source that "charges" a canister to a desired vacuum level. | ¶161 | col. 5:55-60 |
| a fluid control device fluidically coupled between the pressure source and the catheter... | The system uses flow-control valves, including an on/off valve, to direct the flow of fluids between the vacuum source, canister, and aspiration catheter. | ¶162 | col. 6:3-12 |
| 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; | An on/off valve is configured to be closed to disconnect the catheter from the vacuum source, allowing the vacuum source to charge a canister to a desired vacuum level. | ¶163 | col. 7:25-30 |
| the fluid control device is configured to be opened... 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... | After the canister is charged with a vacuum, an aspiration valve is opened, drawing blood and thrombus material through the aspiration catheter. The complaint alleges on information and belief that this generates a flow rate greater than 60 cc/s due to the system's catheter size and pressure source volume. | ¶¶164-165 | col. 7:25-34 |
- Identified Points of Contention:
- Evidentiary Question: A central factual dispute may concern the "flow rate... of greater than about 60 cubic centimeters per second" limitation. The complaint alleges this on "information and belief" based on the accused system's components rather than direct measurement (Compl. ¶165), raising the question of what evidence Plaintiff will produce to prove the accused system meets this quantitative performance threshold.
- Scope Question: The analysis may turn on how the elements of the claim map to the accused system. For example, questions may arise as to whether the combination of a syringe, canister, and multiple valves in the accused system constitutes the claimed "pressure source" and "fluid control device" configured to operate in the specific sequence recited.
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 Accused Products involves advancing a catheter to a location adjacent to unwanted clot material within the vascular anatomy. | ¶184 | col. 15:55-60 |
| 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 manual syringe (the alleged "first container") is used as the aspiration source to draw blood and clot material from the patient through the aspiration catheter. | ¶186 | col. 31:4-9 |
| decoupling the first container from the first catheter; | The manual syringe containing the aspirant is decoupled from the aspiration catheter before being connected to the filter assembly. | ¶187 | col. 32:41-43 |
| coupling the first container to a filter assembly; | The manual syringe is coupled to the Clot Canister (the alleged "filter assembly") to inject the aspirant into it. | ¶188 | col. 32:44-50 |
| driving the portion of the clot material and the blood from the first container into the filter assembly... to produce filtered blood; | The aspirant within the manual syringe is injected into the Clot Canister, which includes a dual-layer polyester screen filter that separates clot from blood. | ¶¶189-190 | col. 32:51-54 |
| 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 alleged "second container") that is pre-connected to an outlet of the filter assembly. | ¶191 | col. 32:55-61 |
| decoupling the second container from the filter assembly; | The second syringe, now filled with filtered blood, is decoupled from the filter assembly. | ¶192 | col. 32:62-67 |
| coupling the second container to a second catheter...; and | The second syringe is coupled to a "suitable blood transfusion filter" and a "blood return circuit place[d] in the vasculature" (the alleged "second catheter"). | ¶193 | col. 32:62-67 |
| driving the filtered blood from the second container through the second catheter into the vasculature. | The filtered blood is returned from the second syringe to the patient via the blood return circuit. | ¶194 | col. 32:62-67 |
- Identified Points of Contention:
- Scope Question: The infringement theory relies on mapping the claim terms "first container" and "second container" to syringes used in the accused process. A potential dispute is whether a syringe, which functions as both a receptacle and an actuator, falls within the scope of the term "container" as used in the patent.
- Technical Question: The claim recites a specific sequence of decoupling and coupling steps. The analysis will depend on whether the alleged use of the Accused Products necessarily follows this precise workflow, including the steps of decoupling the second syringe and coupling it to a "second catheter" for reinfusion.
V. Key Claim Terms for Construction
For the ’180 Patent:
- The Term: "a flow rate within the catheter of greater than about 60 cubic centimeters per second"
- Context and Importance: This quantitative limitation is a critical element of the infringement allegation. Practitioners may focus on this term because infringement will depend on factual evidence proving the accused system meets this specific performance benchmark, and the term "about" introduces ambiguity that will likely be debated.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification's use of "about" may suggest the 60 cc/s value is not a rigid cutoff. The patent presents tables with exemplary flow rates for a large-bore system that are substantially higher than 60 cc/s (e.g., 120, 300, 600 cc/s), which may support an argument that the term covers any system achieving similarly high-flow performance, not just those strictly above a precise number. (’180 Patent, col. 10:5-15, Table 2).
- Evidence for a Narrower Interpretation: The specification contrasts a conventional syringe system achieving flow rates below 60 cc/s (Table 1) with the disclosed large-bore system achieving rates above 60 cc/s (Table 2), suggesting that 60 cc/s is a specific, technically significant threshold differentiating the invention from prior approaches. (’180 Patent, col. 9:48-10:15).
For the ’332 Patent:
- The Term: "first container" and "second container"
- Context and Importance: The complaint's infringement theory maps these terms to syringes. The construction of "container" will be central, as Defendant may argue that a syringe is functionally distinct from a passive "container" and that the claim requires separate, dedicated vessels.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The patent does not explicitly define "container." Embodiments show syringes used to hold and transfer fluids (e.g., syringe 340 in FIG. 20B receives filtered blood), which aligns with the ordinary meaning of a container. (’332 Patent, FIG. 20B, col. 32:5-10). Claim 2 recites "wherein the first container is a first pressure source," which explicitly contemplates that a container can also be a pressure source like a syringe.
- Evidence for a Narrower Interpretation: The specification also depicts embodiments where a filter device (e.g., 2150) has a "chamber" (2154) that acts as a passive collection vessel, separate from the syringes (340, 2170) used to move the fluid. An argument could be made that this embodiment informs a narrower construction where a "container" is a passive chamber rather than an active syringe. (’332 Patent, FIG. 21A, col. 33:12-16).
VI. Other Allegations
- Indirect Infringement: The complaint alleges both induced and contributory infringement for all four asserted patents. Inducement is based on allegations that Defendant provides instructions, marketing materials, and training to customers (hospitals and physicians) on how to use the Accused Products in an infringing manner, with knowledge and intent that such use would constitute infringement. (Compl. ¶¶ 153, 179, 208, 233).
- Willful Infringement: The complaint alleges willful infringement for all four asserted patents. The basis for willfulness is alleged pre-suit knowledge, stemming from Defendant's awareness of the patents in March and June 2024, followed by Plaintiff's cease-and-desist letter on September 10, 2024, and the filing of the initial complaint on September 11, 2024. The complaint alleges that Defendant continued its infringing activities despite this knowledge. (Compl. ¶¶ 171, 174, 200, 203, 225, 228, 247, 250).
VII. Analyst’s Conclusion: Key Questions for the Case
- A central issue will be one of evidentiary proof of performance: can Plaintiff demonstrate through testing and expert analysis that the accused Aventus Thrombectomy System, in operation, actually achieves a "flow rate... greater than about 60 cubic centimeters per second" as required by Claim 22 of the '180 patent, a quantitative fact alleged only on "information and belief"?
- The case may also turn on questions of claim scope and mapping: does the term "container," as used in the method claims of the '332 patent, properly read on the dual-function syringes of the accused system, and does the operational sequence of the accused devices align with the specific, multi-step coupling and decoupling limitations recited in the asserted method claims?
- A significant legal question will be one of intent and knowledge: given the complaint's extensive allegations of trade secret misappropriation by an executive who moved between the parties, the court will have to evaluate what knowledge of Plaintiff's technology and patent portfolio can be imputed to the Defendant and when, which will be critical for the determination of willful infringement.