DCT

6:24-cv-00001

Prytime Medical Devices Inc v. Front Line Medical Tech Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 6:24-cv-00001, W.D. Tex., 01/02/2024
  • Venue Allegations: Venue is alleged to be proper on the basis that the Defendant is a foreign corporation not residing in any U.S. judicial district.
  • Core Dispute: Plaintiff alleges that Defendant’s COBRA-OS aortic occlusion device infringes a patent related to low-profile occlusion balloon catheters.
  • Technical Context: The technology relates to Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA), a medical procedure used to temporarily stop blood flow in major arteries to control life-threatening hemorrhage, particularly in trauma and emergency settings.
  • Key Procedural History: The complaint alleges that Defendant had pre-suit knowledge of the patented technology based on the April 21, 2022, publication of a patent application to which the patent-in-suit claims priority. The patent-in-suit was assigned to the Plaintiff in 2018.

Case Timeline

Date Event
2015-03-19 Earliest Priority Date Claimed for ’737 Patent (U.S. Provisional 62/135,603)
2022-04-21 Publication of U.S. Patent Application 17/563,669 (alleged basis for pre-suit knowledge)
2024-01-02 Issue Date of U.S. Patent No. 11,857,737
2024-01-02 Complaint Filing Date

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

U.S. Patent No. 11,857,737 - “System and Method for Low-Profile Occlusion Balloon Catheter”

The patent issued January 2, 2024.

The Invention Explained

  • Problem Addressed: The patent describes challenges in managing severe blood loss, particularly the risks of hypertension during arterial occlusion and subsequent hypotension when blood flow is restored (’737 Patent, col. 2:9-20). Conventional procedures often require complex imaging like fluoroscopy, making them difficult to perform in emergency field settings (’737 Patent, col. 2:38-40).
  • The Patented Solution: The invention is a low-profile occlusion catheter system designed for easier and safer use. It features a compliant balloon to occlude an artery and a distinctive atraumatic tip that helps guide the catheter into position without a separate guidewire (’737 Patent, col. 3:1-4). A key feature is the use of a solid wire as a stiffener, which allows for a smaller profile compared to catheters with hollow-lumen stiffeners, and a pressure sensor located near the tip to monitor physiological parameters (’737 Patent, Abstract; col. 30:10-18).
  • Technical Importance: The technology aims to make REBOA procedures faster, safer, and accessible outside of fully equipped operating rooms by providing a low-profile, guidewire-free catheter system (’737 Patent, col. 3:30-40).

Key Claims at a Glance

  • The complaint asserts at least independent claim 1 (Compl. ¶26).
  • The essential elements of independent claim 1 include:
    • A proximal hub and a flow valve.
    • Proximal and distal catheter sections.
    • An intervening compliant occlusion balloon.
    • A lumen for fluid communication with the balloon.
    • A "solid wire" secured within the proximal hub and extending through the proximal catheter section, the balloon, and into the distal catheter section.
    • An "atraumatic tip" at the end of the distal catheter section.
    • A greatest outer diameter of "less than 6 Fr in an uninflated configuration."
  • The complaint does not explicitly reserve the right to assert dependent claims but makes a general allegation against the patent.

III. The Accused Instrumentality

Product Identification

The COBRA-OS Device (“Accused Product”) (Compl. ¶4).

Functionality and Market Context

The complaint describes the Accused Product as an "aortic occlusion device" that is developed, manufactured, marketed, imported, and sold in the United States market (Compl. ¶4). It is used to "halt blood loss in emergency situations" and has received FDA approval (Compl. ¶10, ¶20). The complaint does not provide further technical details about the specific construction or operation of the Accused Product.

IV. Analysis of Infringement Allegations

The complaint alleges that the COBRA-OS Device infringes at least claim 1 of the ’737 patent and states that this infringement is detailed in a claim chart attached as Exhibit B (Compl. ¶26). However, Exhibit B was not filed with the complaint. The complaint’s narrative allegations do not map specific features of the Accused Product to the limitations of claim 1. The infringement theory is therefore limited to the general assertion that the COBRA-OS Device, by being offered for sale and sold, infringes the claims of the ’737 Patent, either literally or under the doctrine of equivalents (Compl. ¶26).

No probative visual evidence provided in complaint.

V. Key Claim Terms for Construction

  • The Term: "solid wire"

    • Context and Importance: This term appears in independent claim 1 and defines a core structural element of the claimed catheter. The infringement analysis may turn on whether the stiffening element within the Accused Product is a "solid wire" or a different type of structure, such as a hollow hypotube or a braided shaft. Practitioners may focus on this term because the patent contrasts this "solid wire" embodiment with other embodiments that use a catheter with a lumen as the stiffening element.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The term is not explicitly defined. A plaintiff might argue that its function is to provide stiffness and that "solid" should be interpreted in the context of distinguishing it from a component with a primary fluid-transport lumen, not necessarily requiring a monolithic, non-tubular structure.
      • Evidence for a Narrower Interpretation: The patent specification describes an alternative embodiment in detail that includes a "solid stiffener member 530, which replaces the first catheter 130 with the first lumen 230 therein" (’737 Patent, col. 30:10-13). This direct comparison between a lumen-bearing catheter and a "solid" member suggests the term was intended to mean a component without a lumen, supporting a narrower construction.

  • The Term: "atraumatic tip"

    • Context and Importance: This feature is critical to the patent's stated advantage of enabling guidewire-free insertion. Whether the Accused Product infringes may depend on whether its tip possesses the specific structure and function required by the claims as informed by the specification.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The term itself is general. A plaintiff may argue it should be given its plain and ordinary meaning, covering any tip designed to prevent vessel trauma during insertion.
      • Evidence for a Narrower Interpretation: The specification describes the "atraumatic tip" in significant detail, including a preferred embodiment with a pre-formed curve that returns to a relaxed, J-like configuration after exiting an introducer sheath to "inhibit introduction of the catheter system...into smaller vessels" (’737 Patent, col. 24:10-25; Fig. 4). A defendant may argue this detailed description limits the term to a tip with this specific self-orienting structural design and function.

VI. Other Allegations

  • Willful Infringement: The complaint alleges that Defendant’s infringement is and has been willful (Compl. ¶23). This allegation is based on alleged knowledge of the patented technology as of April 21, 2022, the publication date of the U.S. patent application from which the ’737 Patent issued, and knowledge as of the date the complaint was filed (Compl. ¶21-22).

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

  • A central issue will be one of definitional scope: does the term "solid wire" as used in claim 1 require a monolithic, non-hollow stiffener, and does the Accused Product’s internal structure meet that definition? The patent's explicit contrast between "solid wire" and lumen-bearing catheter embodiments may be a significant factor in claim construction.
  • A key evidentiary question will be one of technical and functional comparison: does the Accused Product’s tip perform the specific self-orienting function of the claimed "atraumatic tip" as detailed in the specification, or does it employ a more generic soft-tip design? The answer will likely determine literal infringement of this element.
  • An initial procedural question will be the sufficiency of the pleadings: given that the complaint's infringement allegations rely entirely on an unfiled exhibit, a key focus will be on whether the Plaintiff can substantiate its claims with sufficient factual evidence during discovery to survive potential dispositive motions.