DCT

5:24-cv-03117

Inari Medical Inc v. Imperative Care Inc

Log In

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • 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, Imperative Care, Inc., maintains its principal place of business in Campbell, Santa Clara County, within the district, and has allegedly committed acts of patent infringement there.
  • Core Dispute: Plaintiff alleges that Defendant’s Symphony Thrombectomy System infringes ten patents related to catheter-based systems and methods for removing blood clots from a patient's vasculature.
  • Technical Context: The technology concerns mechanical thrombectomy devices used to treat life-threatening conditions like pulmonary embolism (PE) and deep vein thrombosis (DVT) by aspirating or mechanically disrupting blood clots.
  • Key Procedural History: The complaint alleges that Plaintiff provided Defendant with notice of potential infringement via letters in September 2023 and April 2024, prior to filing suit. These communications allegedly put Defendant on notice of the patents-in-suit and their applicability to the accused products, which may be relevant to the allegations of willful infringement.

Case Timeline

Date Event
2017-09-06 Priority Date for Hemostasis Valve Patents ('921', '012', '291', '384')
2018-08-13 Priority Date for Embolism Treatment System Patents ('910', '333', '005', '691')
2021-07-01 Imperative Care acquires Truvic Medical, Inc.
2023-01-17 U.S. Patent No. 11,554,005 Issues
2023-02-01 Truvic receives FDA clearance to market Symphony system for DVT treatment
2023-06-30 Truvic begins marketing and selling its Symphony system (stated as "no later than mid-2023")
2023-07-11 U.S. Patent No. 11,697,012 Issues
2023-09-05 U.S. Patent No. 11,744,691 Issues
2023-09-01 Inari contacts Truvic with notice of certain patents
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 Truvic provides substantive response to Inari's September 2023 letter
2024-04-24 Inari sends second letter to Truvic identifying additional patents
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 Complaint Filing Date

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

U.S. Patent No. 11,974,910 - "System for Treating Embolism and Associated Devices and Methods"

  • Patent Identification: U.S. Patent No. 11,974,910, “System for Treating Embolism and Associated Devices and Methods,” issued May 7, 2024.
  • The Invention Explained:
    • Problem Addressed: The patent family specification describes prior art clot-removal devices as highly complex, leading to manufacturing and quality control difficulties, causing trauma to the treatment vessel, and being ineffective at capturing clot material (Compl. ¶89; ’333 Patent, 2:33-44).
    • The Patented Solution: The invention is a clot treatment system featuring two distinct clot aspiration assemblies designed to work together (Compl. ¶63). A key aspect is a telescoping catheter design, where a smaller, second catheter (e.g., 16F) can be advanced through a larger, first catheter (e.g., 24F) to reach distal clots (Compl. ¶¶63, 67). Each catheter assembly has its own pressure source and a dedicated fluid control device, allowing for independent operation and aspiration using vacuum pressure (Compl. ¶63; ’910 Patent, cl. 1). This dual-assembly approach provides procedural flexibility for treating clots of varying sizes and locations within a patient's vasculature ('005 Patent, Fig. 11).
    • Technical Importance: This telescoping, dual-catheter approach allows physicians to use a large-bore catheter for proximal clots and then extend a smaller catheter for more distal or difficult-to-reach clots in a single procedure, enhancing treatment options for complex pulmonary embolisms (Compl. ¶20).
  • Key Claims at a Glance:
    • The complaint asserts independent claim 1 and dependent claim 3 (Compl. ¶64).
    • Essential elements of independent claim 1 include:
      • A first clot aspiration assembly with a first catheter, a first pressure source, and a first movable fluid control device.
      • A second clot aspiration assembly with a second catheter that is advanceable through the first catheter, a second pressure source, and a second movable fluid control device.
      • Both pressure sources are configured to generate vacuum pressure while their respective fluid control devices are in a first (disconnected) position, and apply that vacuum to generate suction when the devices are moved to a second (connected) position.
    • The complaint does not explicitly reserve the right to assert other dependent claims for this patent.

U.S. Patent No. 11,969,333 - "System for Treating Embolism and Associated Devices and Methods"

  • Patent Identification: U.S. Patent No. 11,969,333, “System for Treating Embolism and Associated Devices and Methods,” issued April 30, 2024.
  • The Invention Explained:
    • Problem Addressed: As with the related ’910 Patent, this patent addresses the shortcomings of prior art clot-removal devices, including their complexity, potential for vessel trauma, and inefficiency (Compl. ¶89; ’333 Patent, 2:33-44).
    • The Patented Solution: This patent claims a method for treating deep vein thrombosis (DVT). The method involves advancing an aspiration catheter to the clot, where the catheter is fluidly coupled to a clot canister and an aspiration source (Compl. ¶90). The core of the patented method is the step of "pre-charging" a vacuum: first, generating vacuum pressure within the clot canister while a valve between the canister and catheter is closed; and second, moving the valve to an open position to apply the stored vacuum pressure to the catheter and aspirate the clot (Compl. ¶90; ’333 Patent, cl. 20). The method also includes a clot canister with a filter to separate the aspirated blood from the clot material ('333 Patent, cl. 20).
    • Technical Importance: Pre-charging the vacuum allows for a rapid and powerful application of suction directly at the clot site, which can be more effective at dislodging and capturing thrombus compared to methods where suction is generated only after the system is opened ('005 Patent, col. 2:47-52).
  • Key Claims at a Glance:
    • The complaint asserts independent claim 20 and dependent claim 22 (Compl. ¶92).
    • Essential steps of independent claim 20 include:
      • 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 and aspirate the thrombus and blood into the canister.
      • The clot canister includes a filter to separate the blood from the thrombus.
    • The complaint does not explicitly reserve the right to assert other dependent claims for this patent.

U.S. Patent No. 11,554,005 - "System for Treating Embolism and Associated Devices and Methods"

  • Patent Identification: U.S. Patent No. 11,554,005, “System for Treating Embolism and Associated Devices and Methods,” issued January 17, 2023 (Compl. ¶41).
  • Technology Synopsis: Part of the same family as the '910 and '333 patents, this patent discloses a vacuum aspiration system comprising a housing with a flow path, an on-off control, and a catheter (Compl. ¶113). The invention focuses on an improved hemostasis valve within the housing, which is configured to receive a second catheter and direct it through the first, featuring a specific mechanical structure with a support, actuator, collapsible sidewall, and a filament loop tensioned by a spring to create a seal (Compl. ¶116).
  • Asserted Claims: At least claim 10 (Compl. ¶114).
  • Accused Features: The controller handles of the Symphony system are alleged to have a housing, a flow path with an on-off control, a clot canister, and a hemostasis valve with a claimed mechanical structure comprising a support, actuator, collapsible lumen, and filament loops tensioned by springs (Compl. ¶¶ 118-121).

U.S. Patent No. 11,744,691 - "System for Treating Embolism and Associated Devices and Methods"

  • Patent Identification: U.S. Patent No. 11,744,691, “System for Treating Embolism and Associated Devices and Methods,” issued September 5, 2023 (Compl. ¶43).
  • Technology Synopsis: This patent, from the same family as the '910, '333, and '005 patents, discloses an aspiration system with an "accelerated response" (Compl. ¶133). The system comprises an aspiration pump, a first chamber, and a removable second chamber (e.g., a canister) positioned between the pump and the aspiration catheter. A user-actuatable valve allows negative pressure to build up in both chambers before being connected to the catheter, causing a rapid decrease in pressure to aspirate clot material (Compl. ¶¶ 133, 136).
  • Asserted Claims: At least claims 14 and 22 (Compl. ¶134).
  • Accused Features: The Symphony system's Truvic Generator (aspiration pump and first chamber) and its handle controllers containing a removable clot canister (second chamber) are alleged to meet the claimed structure. The vacuum control lever on the handles is alleged to function as the user-actuatable valve (Compl. ¶¶ 141, 143-144).

U.S. Patent No. 11,844,921 - "Hemostasis Valves and Methods of Use"

  • Patent Identification: U.S. Patent No. 11,844,921, “Hemostasis Valves and Methods of Use,” issued December 19, 2023 (Compl. ¶45).
  • Technology Synopsis: This patent discloses a hemostasis valve with a lumen that can be constricted by an "active tensioning mechanism" (Compl. ¶¶ 158-159, 162). The mechanism includes an actuator coupled to a filament that extends at least partially around the lumen. A biasing member biases the actuator to a first, constricted position, and the actuator can be moved to a second, at least partially open position. Claim 10 recites a valve with two such actuator/filament/biasing member mechanisms (Compl. ¶163).
  • Asserted Claims: At least claims 1 and 10 (Compl. ¶160).
  • Accused Features: The hemostasis valve in the Symphony controller handles, which is alleged to have a tubular lumen, two button-lever actuators, two filaments, and torsion springs that bias the actuators to a constricted position (Compl. ¶¶ 164, 170-171).

U.S. Patent No. 11,697,012 - "Hemostasis Valves and Methods of Use"

  • Patent Identification: U.S. Patent No. 11,697,012, “Hemostasis Valves and Methods of Use,” issued July 11, 2023 (Compl. ¶47).
  • Technology Synopsis: From the same family as the '921 patent, this patent discloses an aspiration catheter system incorporating a hemostasis valve at its proximal end (Compl. ¶183). The valve features a constricting mechanism with a first actuator, a first filament looped around a collapsible tubular sidewall, and a first spring configured to move the actuator to pull on the filament, thereby reducing the lumen's diameter (Compl. ¶186).
  • Asserted Claims: At least claim 1 (Compl. ¶184).
  • Accused Features: The Symphony system's 16F and 24F aspiration catheters with controller handles containing hemostasis valves. These valves are alleged to have the claimed constricting mechanism, including button-lever actuators, filaments, and torsion springs (Compl. ¶¶ 187-189, 193-194).

U.S. Patent No. 11,865,291 - "Hemostasis Valves and Methods of Use"

  • Patent Identification: U.S. Patent No. 11,865,291, “Hemostasis Valves and Methods of Use,” issued January 9, 2024 (Compl. ¶49).
  • Technology Synopsis: Also in the same family as the '921 and '012 patents, this patent discloses a valve with a support, an actuator with at least a first member movably coupled to the support, a collapsible tubular sidewall, a filament loop, and a spring that moves the first member to pull the filament and reduce the lumen 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 are alleged to comprise a plastic support, a button-lever actuator mechanism, a collapsible tubular lumen, filament loops, and torsion springs that pull the actuator levers to constrict the lumen (Compl. ¶¶ 211-212, 214-216).

U.S. Patent No. 12,016,580 - "Single Insertion Delivery System for Treating Embolism and Associated Systems and Methods"

  • Patent Identification: U.S. Patent No. 12,016,580, “Single Insertion Delivery System for Treating Embolism and Associated Systems and Methods,” issued June 25, 2024 (Compl. ¶51).
  • Technology Synopsis: This patent discloses a method for intravascular clot treatment that combines aspiration with mechanical engagement (Compl. ¶228). The method includes pre-charging a vacuum, aspirating a first portion of a clot, and then advancing an interventional device through an unsealed attachment member to engage a second portion of the clot (Compl. ¶231). The invention also covers collecting the aspirated clot in a removable filter chamber (Compl. ¶¶ 229, 232-233).
  • Asserted Claims: At least claims 1, 18, and 19 (Compl. ¶230).
  • Accused Features: The use of the Symphony system with its ProHelix device. The process allegedly involves pre-charging a vacuum, aspirating a clot, unsealing the hemostasis valve, advancing the ProHelix to engage the remaining clot, and collecting the aspirated material in the system's removable clot canister (Compl. ¶¶ 236, 239, 243-246).

U.S. Patent No. 12,109,384 - "Hemostasis Valves and Methods of Use"

  • Patent Identification: U.S. Patent No. 12,109,384, “Hemostasis Valves and Methods of Use,” issued October 8, 2024 (Compl. ¶53).
  • Technology Synopsis: From the same family as the '921, '012, and '291 patents, this patent claims a valve assembly with a tubular member, first and second flexible filament loops, and a pair of actuators (Compl. ¶261, 263). Each filament has portions acted upon by both actuators, which are movable between a first tensioned/constricted position and a second loosened/open position, with the actuators biased to the first position (Compl. ¶263).
  • Asserted Claims: At least claims 1 and 3 (Compl. ¶262).
  • Accused Features: The hemostasis valves in the Symphony controller handles, which are alleged to utilize two button-lever actuators to control two flexible, braided filament loops that constrict a tubular lumen, with torsion springs biasing the system closed (Compl. ¶¶ 267, 269, 272, 274).

U.S. Patent No. 12,156,669 - "Single Insertion Delivery System for Treating Embolism and Associated Systems and Methods"

  • Patent Identification: U.S. Patent No. 12,156,669, “Single Insertion Delivery System for Treating Embolism and Associated Systems and Methods,” issued December 3, 2024 (Compl. ¶55).
  • Technology Synopsis: From the same family as the '580' patent, this patent discloses an aspiration system comprising a vacuum source, a catheter, and a filter chamber with specific port configurations (Compl. ¶285, 288). The system includes a flow controller between the filter chamber and the catheter, and a separate hemostasis valve on a second fluid path configured to maintain hemostasis when an interventional device is inserted (Compl. ¶288).
  • Asserted Claims: At least claim 15 (Compl. ¶287).
  • Accused Features: The Symphony system, which is alleged to have a vacuum source (Truvic Generator), catheter, and a filter chamber (clot canister) with inlet and outlet ports. The vacuum control lever is alleged to be the flow controller, and the system's hemostasis valve is alleged to be on a second fluid path for use with the ProHelix interventional device (Compl. ¶¶ 291, 294, 297, 302, 304).

III. The Accused Instrumentality

  • Product Identification: The accused instrumentality is the Symphony Thrombectomy System, developed by Truvic Medical, Inc. and marketed by its parent company, Imperative Care, Inc. (Compl. ¶¶ 9, 27). The system includes multiple components, such as the 24F and 16F Symphony Catheters, the Truvic Generator (a vacuum pump), the Truvic Canister, and the Symphony ProHelix, an interventional tool for mechanical clot disruption (Compl. ¶28).
  • Functionality and Market Context: The Symphony system is designed for the "non-surgical removal of fresh, soft emboli and thrombi from blood vessels" using controlled aspiration (Compl. ¶28). A key operational feature is the ability to telescope the smaller 16F catheter through the larger 24F catheter for extended reach to a thrombus (Compl. ¶28). The complaint alleges this design "significantly overlaps with and mirrors" Plaintiff's own FlowTriever system (Compl. ¶32). The Symphony system received FDA clearance for treating DVT and began marketing in mid-2023; it is also allegedly being used "off-label" and in clinical trials for treating PE, a market Plaintiff claims to have "single-handedly created" (Compl. ¶¶ 4, 29, 30, 68). An annotated diagram from Defendant's brochure shows the 16F catheter extending from the 24F catheter to reach a clot in a blood vessel (Compl. ¶72, p. 25).

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 includes a 24F catheter, a vacuum pump and clot canister (pressure source), and a controller handle with a Dual-Action Vacuum Control lever (fluid control device). ¶69 '005 Patent, col. 5:45-6:3
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 to the first catheter... The Dual-Action Vacuum Control lever on the 24F catheter handle moves between an "off" position (disconnecting the vacuum) and an "on" position (connecting the vacuum). ¶70 '005 Patent, col. 5:11-20
wherein the first pressure source is configured to generate vacuum pressure while the first fluid control device is in the first position, and wherein, upon movement... the vacuum pressure is applied to the first catheter to generate suction... The Truvic generator creates vacuum in the canister while the lever is "off," and when the lever is moved to "on," this pre-charged vacuum is applied to the 24F catheter to generate suction. ¶71 '005 Patent, col. 2:47-52
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 includes a 16F catheter (second catheter) that is shaped to be advanced and telescoped through the 24F catheter (first catheter) to reach a thrombus. ¶72 '005 Patent, col. 8:43-46

U.S. Patent No. 11,969,333 Infringement Allegations

Claim Element (from Independent Claim 20) Alleged Infringing Functionality Complaint Citation Patent Citation
advancing an aspiration catheter at least partially through the vasculature of the patient such that a distal end portion... is positioned proximate to the deep vein thrombosis... The Symphony system's 16F and/or 24F catheters are advanced through a patient's peripheral vasculature to a position proximate to a DVT. ¶94 '005 Patent, col. 2:39-44
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 Symphony catheters are fluidly coupled through a controller handle to a clot canister, which is in turn coupled to a vacuum pump (aspiration source). ¶96 '005 Patent, col. 5:58-6:3
generating vacuum pressure within the clot canister via the aspiration source while a valve... is in a first position that inhibits fluid flow... The user sets the vacuum control lever on the handle to the "OFF" position, which actuates an internal valve to close the fluid path to the catheter, while the Truvic Generator builds vacuum in the canister. ¶97-98 '005 Patent, col. 2:47-52
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 control lever to the "ON" position, opening the internal valve and applying the pre-charged vacuum to the catheter lumen to aspirate the DVT. ¶99 '005 Patent, col. 2:47-52
and wherein the clot canister includes a filter configured to filter the blood from the portion of the deep vein thrombosis. The clot canisters of the Symphony system handles contain a filter that allows blood to pass through while trapping the aspirated clot material. An annotated video screenshot shows the clot material trapped in the canister (Compl. ¶100, p. 45). ¶100 '005 Patent, col. 9:51-58
  • Identified Points of Contention:
    • Scope Questions: A potential point of contention for the '910 patent may be whether the Symphony system's single Truvic Generator, which serves both the 16F and 24F catheters, can be considered to meet the claim limitations of "a first pressure source" for the first assembly and "a second pressure source" for the second assembly, or if the claims require two physically distinct sources.
    • Technical Questions: For the '333 patent's method claims, a key question will be evidentiary: what proof demonstrates that users of the Symphony system actually perform the claimed steps in the specified order, particularly the "pre-charging" of the vacuum in the canister while the valve to the catheter is closed, before then opening the valve to apply suction? The analysis may focus on Defendant's instructions for use and training materials. An instruction diagram in the complaint directs the user to turn on the generator to build vacuum before moving the handle lever to the "ON" position to begin aspiration (Compl. ¶75, p. 30).

V. Key Claim Terms for Construction

The Term: "fluid control device" ('910 Patent, claim 1)

  • Context and Importance: This term appears for both the first and second aspiration assemblies. The infringement theory hinges on the "Dual-Action Vacuum Control operated by a lever" on the Symphony handles meeting this limitation (Compl. ¶69). The dispute will likely center on whether this lever mechanism performs the specific two-position (connected/disconnected) function while allowing the pressure source to pre-charge a vacuum, as required by the claim.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The claim language itself is functional, describing the device as being "movable between (a) a first position... disconnected... and (b) a second position... connected" ('910 Patent, cl. 1). The specification refers generally to "a valve or other fluid control device" ('005 Patent, Abstract), suggesting the term is not limited to a specific structure.
    • Evidence for a Narrower Interpretation: The specification describes specific embodiments, such as a stopcock, that could be used to argue for a more limited interpretation of the types of mechanisms covered ('005 Patent, col. 5:9-11). Defendant may argue that its specific lever-actuated internal valve operates differently from the embodiments described in the patent.

The Term: "generating vacuum pressure within the clot canister... while a valve... is in a first position that inhibits fluid flow" ('333 Patent, claim 20)

  • Context and Importance: This "pre-charging" step is the core of the asserted method. Practitioners may focus on this term because the infringement case depends on demonstrating that the accused method involves building a vacuum reservoir in the canister before that vacuum is applied to the catheter.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The claim describes the sequence of functions rather than specific hardware. Any method that first generates vacuum in a canister and then, as a separate action, opens a valve to apply it would arguably fall within this language.
    • Evidence for a Narrower Interpretation: The patent's abstract describes the sequence as: "while the valve is closed, activating the pressure source to charge a vacuum. The valve can then be opened to apply the vacuum" ('005 Patent, Abstract). This language may support an interpretation requiring a distinct, two-step sequence where vacuum generation is completed or substantially completed before the valve is opened, which could be a point of factual dispute regarding the operation of the Symphony system.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges inducement of infringement by alleging Defendant provides Instructions for Use (IFU), brochures, and training videos that teach and encourage physicians to use the Symphony system in an infringing manner (Compl. ¶¶ 79, 104). It is further alleged that Defendant's sales representatives attend procedures and instruct physicians on infringing methods, including for off-label uses such as PE treatment (Compl. ¶79). Contributory infringement is also pled, based on allegations that the Symphony system is a material part of the patented inventions, is not a staple article of commerce, and is especially made for use in an infringing manner (Compl. ¶¶ 80, 105).
  • Willful Infringement: The complaint alleges willful infringement based on both pre- and post-suit knowledge. Pre-suit knowledge is alleged based on correspondence starting in September 2023, where Plaintiff explicitly identified its patents and infringement concerns (Compl. ¶¶ 57, 81, 106). Post-suit knowledge is alleged based on the filing of the original and subsequent amended complaints (Compl. ¶¶ 82, 107). The complaint asserts that Defendant's continued marketing and sales activities despite this knowledge constitute egregious and willful infringement (Compl. ¶¶ 83, 108).

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

  • A central issue will be one of claim scope and technical operation: For the system patents, can Plaintiff prove that the single Truvic Generator, which services both catheters, satisfies the '910 patent's requirement for a "first pressure source" and a "second pressure source"? For the method patents, does the accused Symphony system, when operated as instructed, perform the claimed "pre-charging" of vacuum in the canister distinctly before the valve to the catheter is opened, or is there a functional difference in its operational sequence?
  • A key evidentiary question will concern the hemostasis valve patents: The complaint relies heavily on teardown photographs of the accused valve's internal mechanism. The case will likely involve a detailed, expert-driven comparison of whether the accused levers, filaments, and springs meet the specific structural and functional limitations of an "actuator," "filament," and "biasing member" as defined and claimed in the patents.
  • A third major question will be one of intent: Given the detailed allegations of pre-suit notice letters and discussions between the parties, the court will need to evaluate the evidence of Defendant's knowledge and intent to determine whether any infringement, if found, was willful, which would expose Defendant to the possibility of enhanced damages.