DCT
3:24-cv-03117
Inari Medical Inc v. Imperative Care Inc
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: INARI MEDICAL, Inc. (Delaware)
- Defendant: IMPERATIVE CARE, Inc. (Delaware)
- Plaintiff’s Counsel: Perkins Coie LLP
- Case Identification: 5:24-cv-03117, N.D. Cal., 02/07/2025
- Venue Allegations: Venue is alleged to be proper in the Northern District of California because the Defendant maintains its principal place of business in Campbell, Santa Clara County, and has allegedly committed acts of patent infringement within the district.
- Core Dispute: Plaintiff alleges that Defendant’s Symphony Thrombectomy System infringes ten patents related to catheter-based systems and methods for treating blood clots.
- Technical Context: The technology concerns medical devices for mechanical thrombectomy, a procedure to remove blood clots from veins and arteries, primarily for treating life-threatening conditions like deep vein thrombosis (DVT) and pulmonary embolism (PE).
- Key Procedural History: The complaint details pre-suit correspondence beginning in September 2023, wherein Plaintiff notified Defendant of potential infringement. Defendant is alleged to have responded by asserting invalidity of the patents based on prior art. Plaintiff subsequently provided notice of newly allowed and issued patents prior to filing suit.
Case Timeline
| Date | Event |
|---|---|
| 2016-11-01 | Plaintiff's FlowTriever system receives FDA clearance |
| 2017-02-01 | Plaintiff's ClotTriever system receives FDA clearance |
| 2017-09-06 | Earliest priority date for ’921, ’012, ’291, and ’384 Patents |
| 2017-12-01 | Plaintiff receives FDA clearance for ClotTriever with collapsible collection bag |
| 2018-01-26 | Earliest priority date for ’580 and ’669 Patents |
| 2018-05-01 | Plaintiff's FlowTriever system receives expanded FDA clearance for treating PE |
| 2018-08-13 | Earliest priority date for ’910, ’333, ’005, and ’691 Patents |
| 2018-12-01 | Plaintiff receives FDA clearance for telescoping FlowTriever version |
| 2019-09-01 | Plaintiff receives FDA clearance for Triever24 catheter |
| 2020-09-09 | Plaintiff receives FDA clearance to market ClotTriever for DVT treatment |
| 2021-07-01 | Defendant Imperative Care acquires Truvic Medical, Inc. |
| 2023-01-17 | U.S. Patent No. 11,554,005 issues |
| 2023-02-01 | Defendant's Symphony system receives FDA clearance for DVT treatment |
| 2023-06-15 | Defendant begins marketing and selling the accused Symphony system (approx. mid-2023) |
| 2023-07-11 | U.S. Patent No. 11,697,012 issues |
| 2023-09-01 | Plaintiff first contacts Defendant regarding alleged infringement |
| 2023-09-05 | U.S. Patent No. 11,744,691 issues |
| 2023-12-01 | Defendant begins clinical study for Symphony system to treat PE |
| 2023-12-19 | U.S. Patent No. 11,844,921 issues |
| 2024-01-09 | U.S. Patent No. 11,865,291 issues |
| 2024-01-15 | Defendant provides substantive response to Plaintiff's notice letter |
| 2024-04-24 | Plaintiff sends second letter to Defendant regarding alleged infringement |
| 2024-04-30 | U.S. Patent No. 11,969,333 issues |
| 2024-05-07 | U.S. Patent No. 11,974,910 issues |
| 2024-06-25 | U.S. Patent No. 12,016,580 issues |
| 2024-10-08 | U.S. Patent No. 12,109,384 issues |
| 2024-12-03 | U.S. Patent No. 12,156,669 issues |
| 2025-02-07 | Second Amended Complaint filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 11,974,910 - “System for Treating Embolism and Associated Devices and Methods”
The Invention Explained
- Problem Addressed: The patent background describes challenges with prior art thrombectomy devices, which can be highly complex, cause trauma to the blood vessel, or be ineffective at capturing clot material (Compl. ¶89; ’333 Patent, col. 2:33-44).
- The Patented Solution: The invention is a clot treatment system comprising two separate aspiration assemblies. A first, larger catheter (e.g., 24 French) and a second, smaller catheter (e.g., 16 French) that is advanceable through the first. Each catheter is connected to its own pressure source via a fluid control device, allowing for independent or coordinated aspiration to remove clot material, such as a pulmonary embolism (Compl. ¶63; ’910 Patent, Abstract). This telescoping design allows for extended reach to the thrombus while enabling powerful aspiration through two distinct pathways (’910 Patent, col. 5:2-10, Fig. 11).
- Technical Importance: This dual-catheter approach provides procedural flexibility, allowing physicians to aspirate a large central clot with the larger catheter and then advance the smaller catheter to target more distal or difficult-to-reach clot fragments (Compl. ¶20).
Key Claims at a Glance
- The complaint asserts independent claim 1 and dependent claim 3 (Compl. ¶64).
- Independent Claim 1 requires:
- A first clot aspiration assembly, including a first catheter, a first pressure source, and a first movable fluid control device.
- The first pressure source is configured to generate vacuum pressure while the first fluid control device is in a disconnected position.
- A second clot aspiration assembly, including a second catheter (size 16F or greater) advanceable through the first catheter, a second pressure source, and a second movable fluid control device.
- The second pressure source is configured to generate vacuum pressure while the second fluid control device is in a disconnected position, and upon connection, applies vacuum to aspirate a pulmonary embolism.
- The complaint does not explicitly reserve the right to assert other claims for this patent.
U.S. Patent No. 11,969,333 - “System for Treating Embolism and Associated Devices and Methods”
The Invention Explained
- Problem Addressed: As with the related ’910 Patent, the invention addresses the shortcomings of prior art clot-removal devices, including complexity, vessel trauma, and ineffectiveness at capturing clot material (Compl. ¶89; ’333 Patent, col. 2:33-44).
- The Patented Solution: The patent discloses a method of treating deep vein thrombosis (DVT) by advancing an aspiration catheter to the clot, connecting the catheter via a fluid path to a clot canister and an aspiration source, generating vacuum pressure within the canister while a valve in the path is closed (inhibiting flow), and then moving the valve to an open position to apply the pre-charged vacuum to aspirate the clot. The method also requires that the canister include a filter to separate the blood from the clot material (’333 Patent, cl. 20).
- Technical Importance: This "pre-charging" method allows for the instantaneous application of stored vacuum pressure to the catheter, which can generate greater suction forces compared to simply activating a pressure source that is already fluidly connected to the catheter, potentially improving the ability to dislodge and capture clot material (’333 Patent, col. 4:26-40).
Key Claims at a Glance
- The complaint asserts independent claim 20 and dependent claim 22 (Compl. ¶88).
- Independent Claim 20 requires the method steps of:
- Advancing an aspiration catheter proximate to a deep vein thrombosis.
- Generating vacuum pressure within a clot canister while a valve between the canister and catheter is in a first (closed) position.
- Moving the valve to a second (open) position to apply the vacuum pressure to the catheter to aspirate the thrombus and blood.
- The clot canister includes a filter to filter the blood from the aspirated thrombus.
- The complaint does not explicitly reserve the right to assert other claims for this patent.
U.S. Patent No. 11,554,005 - “System for Treating Embolism and Associated Devices and Methods”
- Technology Synopsis: The patent discloses a vacuum aspiration system having a housing with a flow path, an on-off control, and a hemostasis valve. The valve is specifically designed with a support, an actuator, a collapsible tubular sidewall, a filament formed in a loop around the sidewall, and a spring that pulls on the filament to constrict the lumen (Compl. ¶113, ¶116).
- Asserted Claims: At least claim 10 (Compl. ¶114).
- Accused Features: The hemostasis valve within the controller handles of the Symphony system is alleged to practice the claimed invention (Compl. ¶120-121).
U.S. Patent No. 11,744,691 - “System for Treating Embolism and Associated Devices and Methods”
- Technology Synopsis: The patent discloses an aspiration system with "accelerated response," featuring an aspiration pump, a first chamber, and a second, removable chamber positioned between the pump and the aspiration catheter. A valve allows negative pressure to build in the chambers before being connected to the catheter to aspirate clot material (Compl. ¶133).
- Asserted Claims: At least claims 14 and 22 (Compl. ¶134).
- Accused Features: The Symphony system, which includes the Truvic Generator (aspiration pump and first chamber) and a controller handle with a removable clot canister (second chamber) and a user-actuatable valve (Compl. ¶140-144).
U.S. Patent No. 11,844,921 - “Hemostasis Valves and Methods of Use”
- Technology Synopsis: The patent discloses a hemostasis valve with an "active tensioning mechanism" comprising an actuator coupled to a filament that extends around an elongate member defining a lumen. A biasing member biases the actuator to a constricted and sealed position (Compl. ¶159, ¶162).
- Asserted Claims: At least claims 1 and 10 (Compl. ¶160).
- Accused Features: The hemostasis valve in the controller handles of the Symphony system, which is operated by buttons (actuators) and biased by springs (Compl. ¶164, ¶168, ¶171).
U.S. Patent No. 11,697,012 - “Hemostasis Valves and Methods of Use”
- Technology Synopsis: The patent discloses an aspiration catheter system that includes a hemostasis valve on its proximal end. The valve has a constricting mechanism with a first actuator, a first filament formed into a loop around a collapsible tubular sidewall, and a spring to move the actuator and tighten the loop (Compl. ¶183).
- Asserted Claims: At least claim 1 (Compl. ¶184).
- Accused Features: The Symphony system's 16F and 24F aspiration catheters, which have controller handles incorporating a hemostasis valve with the allegedly claimed constricting mechanism (Compl. ¶187-194).
U.S. Patent No. 11,865,291 - “Hemostasis Valves and Methods of Use”
- Technology Synopsis: The patent discloses a hemostasis valve with a support, a movable actuator with at least a first member, a collapsible sidewall defining a lumen, a filament loop around the sidewall, and a spring configured to move the first member to pull the filament and reduce the lumen's diameter (Compl. ¶206, ¶209).
- Asserted Claims: At least claim 1 (Compl. ¶207).
- Accused Features: The hemostasis valves in the Symphony system's controller handles, which allegedly contain a plastic support, a button-and-lever actuator, a collapsible lumen, filament lines, and torsion springs (Compl. ¶210-216).
U.S. Patent No. 12,016,580 - “Single Insertion Delivery System for Treating Embolism and Associated Systems and Methods”
- Technology Synopsis: The patent discloses a method for intravascular treatment that combines aspiration with a mechanical intervention. The method includes pre-charging a vacuum, aspirating a first portion of a clot, unsealing an attachment member, and then advancing an interventional device through the catheter to engage a second portion of the clot. The system also includes a clot reservoir with a removable filter (Compl. ¶228-229).
- Asserted Claims: At least claims 1, 18, and 19 (Compl. ¶230).
- Accused Features: Use of the Symphony system in conjunction with its ProHelix interventional device is alleged to practice the claimed method (Compl. ¶234, ¶243-246).
U.S. Patent No. 12,109,384 - “Hemostasis Valves and Methods of Use”
- Technology Synopsis: The patent discloses a valve assembly with a tubular member, first and second flexible filaments in separate loops, and a pair of actuators. The actuators move between a first position to tension both filaments and constrict the lumen and a second position to loosen them (Compl. ¶261).
- Asserted Claims: At least claims 1 and 3 (Compl. ¶262).
- Accused Features: The hemostasis valve in the Symphony controller handles, which is alleged to have two buttons (actuators) controlling two filament lines that loop around a tubular member (Compl. ¶265-276).
U.S. Patent No. 12,156,669 - “Single Insertion Delivery System for Treating Embolism and Associated Systems and Methods”
- Technology Synopsis: The patent discloses an aspiration system comprising a vacuum source, a catheter, a filter chamber with specific first and second ports, a flow controller, and a hemostasis valve coupled to the catheter along a separate fluid path (Compl. ¶285).
- Asserted Claims: At least claim 15 (Compl. ¶287).
- Accused Features: The Symphony system, which is alleged to include a vacuum source, catheter, a clot container (filter chamber) with ports, a vacuum control lever (flow controller), and a hemostasis valve (Compl. ¶290-305).
III. The Accused Instrumentality
Product Identification
The accused instrumentality is Defendant’s Symphony Thrombectomy System (“Symphony system”) and its components, including the 16F Symphony Catheter, 24F Symphony Catheter, Truvic Generator, Truvic Canister, and the Symphony ProHelix device (Compl. ¶28, ¶64).
Functionality and Market Context
- The Symphony system is a medical device intended for the non-surgical removal of thrombi and emboli from blood vessels using controlled aspiration (Compl. ¶28).
- The system utilizes a telescoping catheter design, where a smaller 16F catheter can be advanced through a larger 24F catheter to extend the reach to a thrombus (Compl. ¶28). This is depicted in a product diagram from Defendant's brochure. (Compl. p. 25).
- Aspiration is provided by the Truvic Generator, which functions as a vacuum pump, connected to the catheters via a controller handle that includes a clot canister and a "Dual-Action Vacuum Control" lever (Compl. ¶28, ¶69).
- The system can be used with an optional Symphony ProHelix device, which is advanced through the catheter to mechanically engage and disrupt clot material (Compl. ¶28).
- The complaint alleges the Symphony system was designed after Plaintiff’s competing FlowTriever system and that it "significantly overlaps with and mirrors" its design (Compl. ¶32). It is alleged to be marketed for DVT treatment and used "off-label" for PE treatment (Compl. ¶29).
IV. Analysis of Infringement Allegations
U.S. Patent No. 11,974,910 - Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| a first clot aspiration assembly, including: a first catheter; a first pressure source; and a first fluid control device between the first catheter and the first pressure source... | The Symphony system's first assembly includes a 24F catheter, a vacuum pump and clot canister (the first pressure source), and a controller handle with a lever-operated Dual-Action Vacuum Control (the first fluid control device). | ¶69 | col. 27:3-11 |
| wherein the first fluid control device is movable between (a) a first position in which the first pressure source is fluidly disconnected from the first catheter and (b) a second position in which the first pressure source is fluidly connected... | The Dual-Action Vacuum Control lever on the 24F catheter's handle moves between an "off" position (disconnecting the vacuum source) and an "on" position (connecting the vacuum source). | ¶70 | col. 27:6-11 |
| wherein the first pressure source is configured to generate vacuum pressure while the first fluid control device is in the first position... | The Truvic Generator creates a vacuum in the clot canister while the control lever is in the "off" position, which is then applied to the 24F catheter to generate suction when the lever is moved to the "on" position. | ¶71 | col. 27:12-19 |
| a second clot aspiration assembly, including: a second catheter advanceable through the first catheter, wherein the second catheter has a size of 16 French or greater... | The Symphony system's second assembly includes a 16F catheter designed to be advanced through the 24F catheter to position its distal end proximate to a pulmonary embolism. | ¶72 | col. 27:20-29 |
| a second pressure source; and a second fluid control device between the second catheter and the second pressure source... | The second assembly includes the same vacuum pump and a separate clot canister (the second pressure source) and a distinct controller handle with its own lever-operated Dual-Action Vacuum Control (the second fluid control device) for the 16F catheter. An annotated diagram illustrates this second handle and its connection to the pressure source. (Compl. p. 26). | ¶73 | col. 27:30-34 |
| wherein the second pressure source is configured to generate vacuum pressure while the second fluid control device is in the first position...to aspirate...a portion of the pulmonary embolism... | The system is operated by creating a vacuum in the canister for the 16F catheter while its control lever is "off," and then moving the lever to "on" to apply suction at the distal portion of the 16F catheter to aspirate the clot. | ¶75 | col. 27:38-48 |
| Claim 3 adds: wherein the first catheter has a size of 24 French, and wherein the size of the [] second catheter [] is 16 French. | The Symphony system includes a 24F catheter and a 16F catheter that is telescoped through the 24F catheter. | ¶76 | col. 28:1-3 |
Identified Points of Contention
- Scope Questions: A central question may be whether a single vacuum generator (the Truvic Generator) that serves two separate catheter lines, each with its own canister and control handle, meets the claim limitation of "a first pressure source" and "a second pressure source." The complaint's theory appears to be that the combination of the generator, canister, and associated tubing for each catheter constitutes a distinct "pressure source."
- Technical Questions: What evidence does the complaint provide that the "off-label" use of the Symphony system for treating pulmonary embolisms is sufficiently widespread and encouraged by the Defendant to support infringement of claims directed to treating a "pulmonary embolism"? The complaint points to ongoing clinical trials for this purpose as evidence (Compl. ¶68).
U.S. Patent No. 11,969,333 - Infringement Allegations
| Claim Element (from Independent Claim 20) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A method of treating a deep vein thrombosis within a vasculature of a patient, the method comprising: advancing an aspiration catheter...proximate to the deep vein thrombosis... | The Symphony system is intended for use in the peripheral vasculature for treating DVT, and its 24F and/or 16F catheters are advanced through a patient's vasculature to a position proximal to the clot material. A video capture in the complaint depicts a catheter tip near a thrombus. (Compl. p. 35). | ¶93-95 | col. 28:23-28 |
| wherein a lumen of the aspiration catheter is fluidly coupled along a fluid path to a clot canister and an aspiration source proximal to the clot canister; | The lumens of the 24F and 16F catheters are coupled through their controller handles to a clot canister, which is in turn coupled to the Truvic Generator (aspiration source), which is located proximal to the canister. | ¶96 | col. 28:29-33 |
| generating vacuum pressure within the clot canister via the aspiration source while a valve...is in a first position that inhibits fluid flow... | During thrombectomy, the user sets the vacuum control lever on the handle to the "OFF" position, which actuates an internal valve to inhibit flow, while the Truvic Generator builds vacuum pressure in the system. | ¶97-98 | col. 28:34-40 |
| moving the valve from the first position to a second position thereby applying the vacuum pressure to the lumen of the aspiration catheter such that at least a portion of the deep vein thrombosis and blood are aspirated into the clot canister... | The user moves the vacuum lever to the "ON" position, which opens the internal valve and applies the pre-charged vacuum to the catheter lumen, aspirating the DVT and blood into the canister. | ¶99 | col. 28:41-48 |
| and wherein the clot canister includes a filter configured to filter the blood from the portion of the deep vein thrombosis. | The clot canisters on the Symphony handles contain a filter that allows blood to pass through while trapping the aspirated clot material. This filtering mechanism is illustrated in annotated screen captures. (Compl. p. 45). | ¶100 | col. 28:49-51 |
| Claim 22 adds: wherein advancing the aspiration catheter comprises inserting a catheter having a size of 20 French or greater through the vasculature. | The Symphony system includes a 24F catheter that is advanced into a patient's vasculature during thrombectomy procedures. | ¶101 | col. 28:54-57 |
Identified Points of Contention
- Scope Questions: As this is a method patent, a key issue will be whether the steps performed by a user following Defendant's "Instructions for Use" or other training materials directly map onto the sequence of steps required by claim 20. The dispute may turn on the precise function and timing of "generating vacuum pressure...while a valve...is in a first position that inhibits fluid flow."
- Technical Questions: What level of proof will be required to establish that Defendant's customers actually perform all the claimed steps in the specified order when using the Symphony system for DVT treatment? The complaint relies on Defendant's product literature, website videos, and Instructions for Use (Compl. ¶93, ¶104).
V. Key Claim Terms for Construction
For U.S. Patent No. 11,974,910
- The Term: "a first pressure source" and "a second pressure source"
- Context and Importance: This terminology is central because the accused Symphony system appears to use a single vacuum generator for both of its telescoping catheters. Infringement of claim 1 hinges on whether the accused system can be found to have two distinct "pressure sources." Practitioners may focus on this term because the complaint's theory relies on a broad interpretation where the combination of the shared pump, a dedicated canister, and tubing for each catheter constitutes a separate "pressure source" (Compl. ¶69, ¶73).
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The claims do not require the pressure sources to be structurally independent or different from one another; they are only recited as a "first" and "second" source, each associated with its respective catheter assembly. The specification describes a pressure source as being coupled to a catheter "via a tubing subsystem including a valve or other fluid control device" (’910 Patent, col. 2:59-62), which may support viewing the entire fluid path assembly, not just the pump, as the "source."
- Evidence for a Narrower Interpretation: The patent's abstract describes coupling "a pressure source" (singular) to a catheter, and Figure 1 depicts a single "Pressure Source 140" (’910 Patent, Fig. 1). Embodiments describing a dual-catheter system also refer to "pressure sources 1040, 1140" as separate sources, potentially suggesting they are distinct hardware units (’910 Patent, col. 9:49-53, Fig. 11).
For U.S. Patent No. 11,969,333
- The Term: "generating vacuum pressure...while a valve...is in a first position that inhibits fluid flow"
- Context and Importance: This "pre-charging" step is a core element of the claimed method. The infringement theory depends on showing that the accused method of use involves first activating the vacuum source while the fluid path to the catheter is blocked, and only subsequently opening that path. Practitioners may focus on this term because it defines the critical sequence of operations that distinguishes the patented method.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The claim language is functional and does not require a specific structure for the valve or a specific duration for the pre-charging step. Any operation where vacuum is generated upstream of a closed valve before that valve is opened could potentially fall within the claim's scope.
- Evidence for a Narrower Interpretation: The specification emphasizes the benefit of this pre-charging step is to "generate greater suction forces" and "rapidly apply the stored vacuum pressure" (’333 Patent, col. 4:35-40). An interpretation could be advanced that requires the generation of a significant, stored vacuum pressure, not merely a transient or incidental pressure difference, while the valve is closed.
VI. Other Allegations
Indirect Infringement
The complaint alleges both induced and contributory infringement for all asserted patents. Inducement is primarily based on allegations that Defendant provides Instructions for Use, product brochures, and online videos that teach and direct physicians to use the Symphony system in an infringing manner. It is also alleged that Defendant's sales representatives attend procedures and instruct users on infringing methods (Compl. ¶78-79, ¶103-104, ¶124-125). Contributory infringement is based on allegations that the Symphony system is a material part of the invention and not a staple article of commerce suitable for substantial non-infringing uses (Compl. ¶80, ¶105, ¶126).
Willful Infringement
The complaint alleges willful infringement based on Defendant's alleged knowledge of the patents-in-suit. This knowledge is asserted to have been established through pre-suit correspondence starting in September 2023 and continuing through April 2024, during which Plaintiff allegedly identified the patents and pending applications and explained its infringement theories (Compl. ¶57-60, ¶81-83, ¶106-108). The complaint alleges that Defendant has continued its infringing activities despite this knowledge.
VII. Analyst’s Conclusion: Key Questions for the Case
This dispute will likely focus on several central issues for the court to resolve.
- A core issue will be one of claim construction and scope: can the claim terms "a first pressure source" and "a second pressure source" in the '910 Patent be construed to read on a system that uses a single vacuum generator connected to two separate catheter assemblies, each with its own canister and controls?
- A second key issue will be one of factual mapping for method claims: do the steps detailed in Defendant’s Instructions for Use and other training materials for the Symphony system, when performed by a user, constitute performance of every step of the asserted method claims of the '333 Patent and others, particularly the "pre-charging" step of generating vacuum while a valve is closed?
- A third evidentiary question will concern willfulness and damages: given the detailed pre-suit notice alleged in the complaint, the case may turn on whether Defendant's conduct after receiving notice was objectively reckless, potentially exposing it to enhanced damages should infringement be found.