Prytime Medical Devices Inc v. Certus Critical Care Inc

I. Executive Summary and Procedural Information

• Parties & Counsel:
  • Plaintiff: Prytime Medical Devices, Inc. (Delaware)
  • Defendant: Certus Critical Care, Inc. (Delaware)
  • Plaintiff’s Counsel: Panitch Schwarze Belisario & Nadel, LLP
• Case Identification: 1:22-cv-01352, D. Del., 10/13/2022
• Venue Allegations: Plaintiff alleges venue is proper because Defendant is a Delaware corporation and has committed acts of infringement and has a regular and established place of business in the District of Delaware.
• Core Dispute: Plaintiff seeks a declaratory judgment that Defendant’s forthcoming Endovascular Aortic Control (“EVAC”) System, a type of balloon catheter, will infringe its patent on occlusion catheter technology.
• Technical Context: The technology involves catheters used to temporarily block major blood vessels, such as the aorta, to control severe, otherwise non-compressible bleeding in trauma situations.
• Key Procedural History: This action for declaratory judgment of anticipated infringement was filed by the patent owner after Defendant publicly announced its intent to seek FDA approval for and launch a competing product. Plaintiff asserts it provided Defendant with notice of the patent-in-suit prior to filing the complaint. The patent-in-suit was developed with U.S. government funding.

Case Timeline

Date	Event
2016-06-02	U.S. Patent No. 11,253,264 Earliest Priority Date
2022-02-22	U.S. Patent No. 11,253,264 Issue Date
2022-07-27	Plaintiff sends notice letter to Defendant
2022-10-13	Complaint Filing Date
2023	Planned launch date for Accused EVAC System

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

• Patent Identification: U.S. Patent No. 11,253,264, titled "System and Method for Low Profile Occlusion Balloon Catheter," issued on February 22, 2022.
• The Invention Explained:
  • Problem Addressed: The patent describes a problem with conventional balloon catheters used for Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA). When such balloons are partially deflated to allow some blood flow (partial perfusion), they can become unstable, vibrate, and shift out of position within the blood vessel (’264 Patent, col. 2:5-32).
  • The Patented Solution: The invention described in the patent's specification is an occlusion catheter system that includes both a main occlusion balloon and a secondary "inflatable spine" running alongside it (’264 Patent, Abstract). When inflated, this spine is designed to press against the vessel wall, creating defined channels that permit controlled partial blood flow while keeping the main balloon stable and centered, thus preventing unwanted movement (’264 Patent, col. 4:1-12; Fig. 1E).
  • Technical Importance: This design purports to allow for safer and more finely-controlled partial perfusion during emergency procedures, mitigating the risks of both total occlusion (e.g., downstream tissue damage) and balloon instability associated with prior art devices (’264 Patent, col. 3:6-13).
• Key Claims at a Glance:
  • The complaint asserts at least independent claim 1 (Compl. ¶15).
  • The essential elements of independent claim 1 are:
    • An inflation catheter member with specific components including a stiffener member and an atraumatic tip.
    • An occlusion balloon connected to the catheter member.
    • A proximal pressure sensor attached to the proximal portion of the catheter.
    • A control hub in communication with the proximal pressure sensor.
    • A pump configured to introduce and withdraw pressurized fluid from the balloon.
    • A controller configured to receive signals from the proximal pressure sensor and communicate with the pump to manage fluid in the balloon based on those signals.
  • The complaint does not explicitly reserve the right to assert dependent claims, but the "at least claim 1" language suggests this possibility.

III. The Accused Instrumentality

• Product Identification: Defendant’s Endovascular Aortic Control (“EVAC”) System with a balloon catheter (Compl. ¶15).
• Functionality and Market Context: The complaint alleges the EVAC System is a balloon catheter that Defendant is actively seeking FDA approval for, with plans for a commercial launch in the United States in 2023 (Compl. ¶15). It is alleged that the EVAC System will compete directly with Plaintiff's own Resuscitative Endovascular Balloon Occlusion of the Aorta (“REBOA”) catheters (Compl. ¶15). The complaint does not provide sufficient detail for analysis of the specific technical operation of the EVAC System.

IV. Analysis of Infringement Allegations

The complaint alleges that the EVAC System will directly infringe at least Claim 1 of the ’264 Patent and references a claim chart in an external "Exhibit C" (Compl. ¶¶15, 22). As Exhibit C was not filed with the complaint itself, a detailed element-by-element analysis based on the Plaintiff's specific infringement contentions is not possible. No probative visual evidence provided in complaint.

• Identified Points of Contention:
  • Scope Questions: A central issue may be the potential mismatch between the asserted claim and the key inventive concept described in the patent. The specification heavily emphasizes the "inflatable spine" as the novel solution, yet independent claim 1 does not recite this element; it is first introduced in dependent claim 2 (’264 Patent, cl. 1-2). The litigation may therefore raise the question of whether infringement can be established based on a claim that omits what the patent itself presents as a primary point of novelty over the prior art.
  • Technical Questions: The infringement action is anticipatory, filed before the accused product is on the market (Compl. ¶15). A key evidentiary question will be whether the final, FDA-approved version of the EVAC System contains the specific system components required by Claim 1, including a "proximal pressure sensor", a "pump", and a "controller" that operates "based on the proximal pressure signals" as claimed.

V. Key Claim Terms for Construction

• The Term: "controller configured to receive proximal pressure signals... and communicate with the pump... based on the proximal pressure signals"

• Context and Importance: This limitation defines the functional relationship at the core of the claimed system. The interpretation of "configured to... based on" will be critical for determining the scope of the claim. Practitioners may focus on this term because its construction will determine whether the claim is limited to a fully automated, closed-loop feedback system or if it can also cover systems with more limited, user-mediated control.

• Intrinsic Evidence for Interpretation:

  • Evidence for a Broader Interpretation: A party could argue the plain language does not explicitly require full automation, only that the controller's communication with the pump is informed by the pressure signals, which could include displaying the pressure to a user who then directs the pump.
  • Evidence for a Narrower Interpretation: The specification describes embodiments where the controller is "set to maintain" a specific pressure or pressure ratio "by continually adjusting the volume or pressure of the fluid" (’264 Patent, col. 38:45-53). A party may argue this supports a narrower construction limited to a closed-loop system that operates automatically in response to pressure feedback.

• The Term: "proximal pressure sensor attached to the proximal portion"

• Context and Importance: The location of this sensor is a specific structural limitation of claim 1. The ambiguity of "proximal portion" makes its construction important for the infringement analysis.

• Intrinsic Evidence for Interpretation:

  • Evidence for a Broader Interpretation: A party may argue "proximal portion" should be given its plain meaning, covering any location on the catheter member that is proximal to the distal end, potentially including the external control hub.
  • Evidence for a Narrower Interpretation: A party may point to figures showing the proximal pressure sensor (171) located on the catheter body near the proximal end of the occlusion balloon (140c), but still inside the patient (’264 Patent, Fig. 1A; col. 17:45-51). This could support an argument that the term requires the sensor to be positioned near the balloon itself, not externally.

VI. Other Allegations

• Willful Infringement: The complaint alleges that Defendant has had actual notice of the ’264 Patent since at least July 27, 2022, as a result of a letter from Plaintiff's counsel (Compl. ¶18). It further alleges that any future infringement, upon launch of the EVAC System, will be willful and deliberate (Compl. ¶24).

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

• A core issue will be one of claim scope versus disclosed invention: can infringement be proven based on Claim 1, which recites a pressure-controlled system but omits the "inflatable spine" feature that the patent specification touts as the primary technical solution to problems in the prior art?
• A key evidentiary question will be one of anticipatory proof: since the infringement allegation targets a product not yet on the market, the case will depend on evidence of the EVAC System's final, as-launched technical specifications and whether they meet the functional and structural limitations of the asserted claim.
• The case may also turn on a functional definition: will the claimed "controller" be construed to require a fully automated, closed-loop feedback system as suggested by certain embodiments, or can it be interpreted more broadly to encompass systems where user intervention is part of the control process?