DCT

1:25-cv-00986

Route 92 Medical Inc v. Balt USA LLC

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:25-cv-00986, D. Del., 09/08/2025
  • Venue Allegations: Venue is alleged to be proper in the District of Delaware because Defendant is a Delaware limited liability company and therefore resides in the district.
  • Core Dispute: Plaintiff alleges that Defendant’s neurovascular catheter systems, used for treating ischemic strokes, infringe five patents related to catheter design and methods of use.
  • Technical Context: The technology concerns advanced catheter systems for mechanical thrombectomy, a procedure to remove blood clots from cerebral arteries to restore blood flow after a stroke.
  • Key Procedural History: The complaint is a First Amended Complaint. It alleges that Plaintiff marks its own commercial products (HiPoint® and FreeClimb® systems) with the asserted patents. No prior litigation or administrative proceedings are mentioned.

Case Timeline

Date Event
2015-02-04 ’972 Patent Priority Date
2018-05-17 ’9770 and ’5770 Patents Priority Date
2019-08-02 ’9770 Patent Filing Date
2020-09-03 ’036 Patent Priority Date
2021-01-19 ’972 Patent Filing Date
2022-01-25 ’9770 Patent Issue Date
2022-12-16 ’032 Patent Filing Date
2023-04-07 ’5770 Patent Filing Date
2023-10-24 ’972 Patent Issue Date
2023-11-07 ’032 Patent Issue Date
2024-03-12 ’5770 Patent Issue Date
2025-01-16 ’036 Patent Filing Date
2025-07-01 ’036 Patent Issue Date
2025-09-08 First Amended Complaint Filing Date

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

U.S. Patent No. 11,229,770 - "Aspiration catheter systems and methods of use"

The Invention Explained

  • Problem Addressed: The patent's background describes the technical difficulty and time required to navigate interventional devices through the complex and tortuous anatomy of the cerebral arteries to treat acute ischemic stroke, a time-critical procedure (’9770 Patent, col. 1:21-2:53).
  • The Patented Solution: The invention is a coaxial catheter system comprising a larger aspiration catheter and a smaller, inner "catheter advancement element." The advancement element is designed with a highly flexible, tapered polymer tip that has specific, defined bending force characteristics. This design allows it to be positioned snugly within the larger catheter to create a smooth, tapered profile for the entire system, which reduces the "ledge effect" and facilitates easier navigation through challenging arterial pathways. (’9770 Patent, Abstract; col. 3:1-4:12).
  • Technical Importance: This streamlined system aims to reduce the time and procedural complexity required to reach and remove a cerebral blood clot, which is critical to improving clinical outcomes for stroke patients. (Compl. ¶13).

Key Claims at a Glance

  • The complaint asserts at least independent claim 1 (Compl. ¶29).
  • Essential elements of claim 1 include:
    • A coaxial catheter system comprising a catheter and a catheter advancement element.
    • The catheter has a distal portion with a lumen of at least about 0.052" inner diameter.
    • The catheter advancement element has a tubular portion, a less flexible proximal extension, and a tubular, polymer tip portion.
    • The tubular portion has a "snug point" where the difference between its outer diameter and the catheter's inner diameter is no more than about 0.010".
    • The tip portion has defined points with specific bending forces (e.g., a distal point with a force no greater than about 0.05 Newtons).
    • The system has defined flexibility slope characteristics, including a ratio of the "third flexibility slope" to the "average tip portion flexibility slope" of less than about 25.
  • The complaint does not explicitly reserve the right to assert dependent claims for this patent.

U.S. Patent No. 11,793,972 - "Rapid aspiration thrombectomy system and method"

The Invention Explained

  • Problem Addressed: The patent addresses the challenge of rapidly and safely delivering thrombectomy devices through the neurovasculature to treat acute ischemic stroke, a procedure complicated by the brain's intricate arterial anatomy. (’972 Patent, col. 1:22-2:51).
  • The Patented Solution: The invention is an intravascular access catheter featuring a flexible, elongate body with a distinct tapered region at its distal end. Critically, it includes two radiopaque markers visible under fluoroscopy: a first marker at the distal end of the tapered section and a second marker at the proximal end. The second marker is specifically configured to identify the location of the catheter's maximum outer diameter, aiding the physician in precise positioning and navigation. (’972 Patent, Abstract; col. 3:1-37).
  • Technical Importance: The dual-marker system provides enhanced visualization, allowing clinicians to more accurately track both the catheter's tip and its maximum diameter, which can improve the speed, safety, and success rate of clot removal procedures. (Compl. ¶13).

Key Claims at a Glance

  • The complaint asserts at least independent claim 1 (Compl. ¶45).
  • Essential elements of claim 1 include:
    • An intravascular access catheter for advancing a medical device.
    • A flexible elongate body with a single lumen and a plurality of regions, including a tapered region.
    • A first marker, visible under fluoroscopy, disposed at a distal end of the tapered region.
    • A second marker, visible under fluoroscopy, disposed at a proximal-most end of the tapered region and configured to identify a maximum outer diameter of the flexible elongate body.
    • A proximal extension extending proximally from the flexible elongate body.
  • The complaint does not explicitly reserve the right to assert dependent claims for this patent.

U.S. Patent No. 11,806,032 - "Aspiration catheter systems and methods of use"

  • Patent Identification: U.S. Patent No. 11,806,032, "Aspiration catheter systems and methods of use," issued November 7, 2023 (Compl. ¶25).
  • Technology Synopsis: The patent describes a medical system comprising an outer catheter and an inner catheter advancement device. The advancement device is constructed with a flexible elongate body having segments of different polymer hardness (durometer) and a tapered tip, designed to facilitate the advancement of the outer catheter through cerebral vessels. (’032 Patent, Abstract).
  • Asserted Claims: At least independent claim 1 (Compl. ¶57).
  • Accused Features: The accused Carrier-Raptor system, where the Carrier catheter allegedly functions as the claimed catheter advancement device for the Raptor outer catheter, embodying the claimed variable stiffness and tapered tip structure (Compl. ¶¶59-64).

U.S. Patent No. 11,925,770 - "Aspiration catheter systems and methods of use"

  • Patent Identification: U.S. Patent No. 11,925,770, "Aspiration catheter systems and methods of use," issued March 12, 2024 (Compl. ¶26).
  • Technology Synopsis: The patent describes a catheter system with an aspiration catheter and a catheter advancement element. The invention claims specific bending force characteristics measured at defined points along the advancement element's tapered tip and along the assembled coaxial system, which are designed to optimize navigation and reduce the "ledge effect" when delivering the larger catheter. (’5770 Patent, Abstract).
  • Asserted Claims: At least independent claim 1 (Compl. ¶72).
  • Accused Features: The accused Carrier-Raptor system, which is alleged to have an assembled configuration that meets the claimed bending force and flexibility slope ratios at specific millimeter-defined points along the catheters (Compl. ¶¶74-79).

U.S. Patent No. 12,343,036 - "Methods and systems for treatment of acute ischemic stroke"

  • Patent Identification: U.S. Patent No. 12,343,036, "Methods and systems for treatment of acute ischemic stroke," issued July 1, 2025 (Compl. ¶27).
  • Technology Synopsis: The patent describes a three-component system for treating stroke: a catheter, an inner member sized to slide within it, and a guidewire sized to slide within the inner member. The system is designed such that the inner member's tapered distal portion creates a smooth transition in both size and flexibility from the guidewire to the outer catheter, facilitating delivery past tortuous anatomy. (’036 Patent, Abstract).
  • Asserted Claims: At least independent claim 1 (Compl. ¶87).
  • Accused Features: The accused "Carrier-Raptor-Hybrid system," where the Raptor is the outer catheter, the Carrier is the inner member, and the Hybrid Guidewire is the guidewire, which are alleged to work together to provide the claimed smooth transition in flexibility (Compl. ¶¶89-97).

III. The Accused Instrumentality

Product Identification

The complaint accuses the "Carrier-Raptor system," the "Carrier-Raptor-Hybrid system," and the "Carrier" delivery catheter, which are comprised of Defendant Balt's Carrier Delivery Catheter ("Carrier"), Raptor Aspiration Catheter ("Raptor"), and Hybrid Guidewire (Compl. ¶¶22, 29, 45, 87).

Functionality and Market Context

  • The Carrier is a delivery catheter used to guide other devices, such as the Raptor, to treatment sites within the neurovasculature (Compl. ¶22). The Raptor is an aspiration catheter used to mechanically remove blood clots during an acute ischemic stroke (Compl. ¶22). The Hybrid Guidewire is used to aid in the insertion of diagnostic or therapeutic catheters (Compl. ¶¶22, 95).
  • The complaint alleges these components are used together as a coaxial system, where the Carrier is positioned inside the Raptor, and the Hybrid Guidewire may be positioned inside the Carrier (Compl. ¶¶31, 89). A promotional video screenshot in the complaint shows the Carrier Delivery Catheter inside the Raptor Aspiration Catheter, which is described as being "optimized for ledge effect reduction" (Compl. ¶31). This system is taught to clinicians for treating acute ischemic stroke in the neurovasculature (Compl. ¶22).

IV. Analysis of Infringement Allegations

’9770 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
a coaxial catheter system comprising: a catheter...and a catheter advancement element The accused Carrier-Raptor system is a coaxial system where the Raptor is the catheter and the Carrier is the catheter advancement element. ¶31 col. 2:54-56
the catheter comprising: a distal, catheter portion having a lumen...the lumen having an inner diameter at the distal end region of at least about 0.052" The Raptor catheter has a distal portion with a lumen having an inner diameter of 0.071" or 0.074". ¶32 col. 2:57-61
the catheter advancement element comprising: a tubular portion having an inner diameter that is at least about 0.014" up to about 0.024"... wherein a difference between the inner diameter of the distal, catheter portion and the outer diameter of the tubular portion at such snug point is no more than about 0.010" The Carrier has a tubular portion with an inner diameter of 0.021". The difference between the Raptor's inner diameter (e.g., 0.071") and the Carrier's maximum outer diameter (e.g., 0.059") is alleged to be no more than about 0.010" at the snug point. ¶33 col. 2:63-3:4
and a tubular, polymer tip portion located distal to the at least one snug point of the tubular portion, wherein the tip portion has a length and tapers along at least a portion of the length of the tip portion The Carrier has a tubular, tapered polymer tip portion. ¶33 col. 3:5-9
an advancement configuration characterized by the catheter advancement element positioned coaxially within the lumen of the distal catheter portion, wherein the at least one snug point of the tubular portion is substantially aligned with the distal end region of the distal catheter portion The Carrier-Raptor system is configured with the Carrier positioned coaxially within the Raptor, with the snug point of the Carrier aligned with the distal end region of the Raptor, as depicted in a promotional video screenshot. ¶34 col. 3:9-15
wherein the tip portion in the advancement configuration has at least three points spaced along the length of the tip portion...the distal point having a first bending force that is no greater than about 0.05 Newtons On information and belief, the Carrier's tip portion has at least three points with bending forces, with the distal point having a bending force of no greater than 0.5 Newtons [sic]. The complaint's visual depicts these points along the device. ¶35 col. 3:16-24
a ratio of the third flexibility slope to the average tip portion flexibility slope is less than about 25 On information and belief, the Carrier-Raptor system has a ratio of the third flexibility slope to the average tip portion flexibility slope of less than about 25. ¶37 col. 4:1-5

Identified Points of Contention

  • Evidentiary Questions: The complaint alleges on "information and belief" that the accused system meets the specific numerical limitations for bending forces and flexibility slopes (Compl. ¶¶35-37). A central point of contention will be whether physical testing of the accused products confirms these specific quantitative performance characteristics required by claim 1. The complaint's allegation of a bending force "no greater than 0.5 Newtons" (Compl. ¶35) appears to contain a typographical error, as the claim requires "no greater than about 0.05 Newtons" (’9770 Patent, col. 3:23-24), which may become a point of dispute regarding the sufficiency of the pleading.
  • Scope Questions: The definition of "snug point" will be critical. The parties may dispute whether the point of maximum outer diameter on the Carrier, which creates the alleged 0.010" clearance with the Raptor, constitutes a "snug point" as understood in the context of the patent specification.

’972 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
an intravascular access catheter...comprising: a flexible elongate body having a proximal end, a distal-most end, and a single lumen extending therebetween The Carrier is an intravascular access catheter with a flexible elongate body, proximal end, distal-most end, and a single lumen. A diagram from the product's IFU is provided as evidence. ¶¶47-48 col. 3:1-6
the flexible elongate body comprises a plurality of regions, including a tapered region The Carrier is described as a "variable stiffness, composite catheter" with a "tapered tip" or "tapered distal segment." ¶48 col. 3:6-8
a first marker that is visible under fluoroscopy disposed at a distal end of the tapered region The Carrier incorporates two radiopaque markers, with the first marker disposed at the distal end of the tapered region, as shown in a provided diagram. ¶49 col. 3:10-12
a second marker that is visible under fluoroscopy disposed at a proximal-most end of the tapered region and configured to identify a maximum outer diameter of the flexible elongate body A second marker is disposed at the proximal-most end of the tapered region. The complaint alleges this marker is configured to identify the maximum outer diameter by referencing the product's IFU table, which lists the maximum OD. ¶49 col. 3:12-16
the tapered region comprises an unreinforced polymer On information and belief, the tapered region of the Carrier comprises an unreinforced polymer. ¶49 col. 3:16-17
a proximal extension extending proximally from the proximal end of the flexible elongate body to an extracorporeal proximal end The Carrier has a proximal extension extending to an extracorporeal proximal end. ¶50 col. 3:18-21

Identified Points of Contention

  • Scope Questions: The infringement theory for the "configured to identify" limitation relies on an interpretation that the marker's physical location at the point of maximum outer diameter is sufficient to meet the claim element (Compl. ¶49). A key legal question will be whether this phrase requires only positional correspondence, or if it implies a specific structural or functional aspect of the marker itself that performs the "identifying" function, which the complaint does not allege.
  • Technical Questions: The allegation that the tapered region comprises an "unreinforced polymer" is made on "information and belief" (Compl. ¶49). This will likely be a factual question requiring discovery and potentially materials analysis of the accused Carrier catheter.

V. Key Claim Terms for Construction

’9770 Patent, Claim 1

  • The Term: "snug point"
  • Context and Importance: This term is foundational to the patent's claimed solution for reducing the "ledge effect." The definition of what constitutes a "snug point" is critical for determining whether the specific dimensional tolerance of "no more than about 0.010"" is met and, therefore, whether the accused system infringes. Practitioners may focus on this term because the infringement allegation hinges on the dimensional relationship at this specific location.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The claim language requires "at least one snug point," suggesting it can be a single, discrete point of minimum clearance rather than a continuous region of contact (’9770 Patent, col. 2:65-66).
    • Evidence for a Narrower Interpretation: The specification describes the snug point in the context of creating a seal upon applying aspiration pressure and discusses the length of the tubular portion where the snug point is located, which could suggest the term implies more than just a single point of minimum clearance (’9770 Patent, col. 4:35-37; col. 4:26-28).

’972 Patent, Claim 1

  • The Term: "configured to identify a maximum outer diameter"
  • Context and Importance: This is a functional limitation applied to the second radiopaque marker. Its construction will determine whether the mere placement of a standard marker at the location of the maximum outer diameter is infringing, or if the claim requires the marker to have a special feature or property for the purpose of identification. The dispute over this term may be dispositive for the ’972 patent.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The patent specification does not appear to describe any special physical characteristics of the second marker itself that perform the "identifying" function, beyond its placement. The figures simply show a marker band at that location, which may support an interpretation that its position alone configures it for identification. (’972 Patent, Fig. 1).
    • Evidence for a Narrower Interpretation: The patent consistently describes the second marker with this functional language, suggesting the "configured to" language was an intentional limitation. A defendant may argue that if placement alone were sufficient, the claim would have simply recited "disposed at the maximum outer diameter," and that the chosen language requires some additional identifying capability. (’972 Patent, Abstract; col. 3:14-16).

VI. Other Allegations

Indirect Infringement

The complaint alleges induced infringement for all five patents, stating that Defendant provides "instructions for use, teachings, guides, manuals, demonstrations, [and] trainings" that instruct clinicians to use the accused systems in an infringing manner (e.g., Compl. ¶¶39, 52, 66). Contributory infringement is also alleged on the basis that the accused products are material parts of the patented inventions, are not staple articles of commerce, and are known by Defendant to be especially adapted for infringement (e.g., Compl. ¶¶40, 67).

Willful Infringement

Willfulness is alleged for all asserted patents. The complaint bases this on Defendant's alleged knowledge of the patents "no later than the filing of the Complaint" and its continued infringement thereafter (e.g., Compl. ¶41, 53). It also alleges pre-suit knowledge based on Plaintiff's "notoriety in the field" and its marking of its commercial products with the asserted patents (e.g., Compl. ¶38, 51).

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

  • A core issue will be one of evidentiary proof: for the asserted ’9770 and ’5770 patents, which depend on specific quantitative limits for flexibility and bending forces, can Plaintiff produce technical evidence demonstrating that the accused Carrier-Raptor system actually performs within these claimed numerical ranges, particularly when the allegations are currently made only on "information and belief"?
  • A key legal question will be one of functional claim scope: can the phrase "configured to identify a maximum outer diameter" in the ’972 patent be construed to cover a standard radiopaque marker that is merely located at the point of maximum diameter, or does the claim require a distinct structural or functional attribute of the marker itself that performs the identifying function?
  • A central technical question across multiple asserted patents will be the nature of system interoperability: does the combination of the accused Carrier, Raptor, and Hybrid Guidewire create the specific "smooth transition in flexibility" and reduction of "ledge effect" as claimed in the ’032 and ’036 patents, or is there a fundamental mismatch in their combined technical operation compared to the patented systems?