DCT

4:18-cv-00009

Trudell Medical Intl v. D R Burton Healthcare LLC

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 4:18-cv-00009, E.D.N.C., 05/09/2019
  • Venue Allegations: Venue is alleged to be proper based on Defendant's substantial business activity within the Eastern District of North Carolina, including the occurrence of the alleged infringement in the district.
  • Core Dispute: Plaintiff alleges that Defendant’s line of oscillating positive expiratory pressure (OPEP) devices infringes a patent related to the mechanical design of such devices for respiratory therapy.
  • Technical Context: The technology involves handheld medical devices that create oscillating air pressure during user exhalation to help clear mucus from the lungs of patients with respiratory conditions.
  • Key Procedural History: The filing is a Second Amended Complaint, indicating the case was initiated prior to this filing date and has undergone at least two pleading revisions. The complaint references prior service of the original complaint and preliminary infringement contentions, suggesting the case has moved beyond its initial stages.

Case Timeline

Date Event
2008-05-27 ’588 Patent Priority Date
2013-05-16 Plaintiff's Aerobika® device receives FDA 510(k) clearance
2017-11-07 ’588 Patent Issue Date
2019-01-25 Plaintiff serves Preliminary Infringement Contentions
2019-05-09 Second Amended Complaint Filing Date

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

U.S. Patent No. 9,808,588 - "Oscillating Positive Respiratory Pressure Device" (Issued Nov. 7, 2017)

The Invention Explained

  • Problem Addressed: The patent's background section notes that for individuals with significant bronchial obstructions, such as collapsed airways, a normal cough may be insufficient to effectively clear mucus and other secretions from the lungs (’588 Patent, col. 1:21-29).
  • The Patented Solution: The invention is a respiratory device that uses a patient's own exhalation to create oscillating pressure. As a user exhales into the device, the airflow causes a "restrictor member" with vanes to rotate. This rotation causes a "blocking segment" to periodically obstruct the exhalation flow path, generating a pulsed back pressure that is transmitted to the user's lungs to help loosen secretions (’588 Patent, Abstract; col. 2:50-68). This mechanism is designed to operate independently of the device's physical orientation.
  • Technical Importance: The technology provides a portable and self-contained method for administering OPEP therapy, which can be easily used by patients in a hospital or home setting without complex equipment (’588 Patent, col. 1:40-45).

Key Claims at a Glance

  • The complaint asserts claims 1-18 and 20-26, with independent claim 1 detailed as a representative example (Compl. ¶20, ¶21).
  • The essential elements of independent claim 1 include:
    • An inlet to receive exhaled air.
    • An outlet to permit air to exit.
    • An opening positioned in the exhalation flow path between the inlet and outlet.
    • A blocking segment that rotates relative to the opening, moving between a restricted "closed position" and a less-restricted "open position."
    • A vane that rotates the blocking segment in response to airflow through the opening.
    • A blocking surface on the segment that is equal to or greater in size than the opening.
  • The complaint reserves the right to assert other claims, including dependent claims (Compl. ¶20, ¶30, ¶50).

III. The Accused Instrumentality

Product Identification

  • The accused instrumentalities are Defendant’s vPEP®, vPEP HC®, iPEP®, and PocketPEP® devices (Compl. ¶17).

Functionality and Market Context

  • The complaint alleges these products are oscillating positive expiratory pressure (OPEP) devices used for respiratory treatment (Compl. ¶10). The infringement allegations focus on the mechanical components that generate the pressure oscillations. The complaint contends that the infringing mechanism in the iPEP® and PocketPEP® devices is contained within a shared, interchangeable "OPEP module" (Compl. ¶42-43). A diagram from the defendant's own "Instructions For Use" is included to illustrate this modularity, showing how the "OPEP module" is inserted into different device bodies (Compl. ¶42, p. 15). The complaint does not contain specific allegations regarding the products' market share but identifies them as being manufactured, marketed, and sold in the United States (Compl. ¶10).

IV. Analysis of Infringement Allegations

The complaint provides annotated photographs of the vPEP®, PocketPEP®, and vPEP HC® devices to map their components to the elements of claim 1 of the ’588 Patent. The analysis for the vPEP® device is summarized below.

  • ’588 Patent Infringement Allegations
Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
an inlet configured to receive exhaled air into the device The accused vPEP® device includes an inlet, identified by a red arrow in an annotated photograph, for receiving a user's exhaled air. The photo shows the mouthpiece where a user would exhale (Compl. ¶23). ¶23 col. 3:65-66
an outlet configured to permit air to exit the device The vPEP® device includes an outlet, identified by red arrows, which permits air to exit the device after passing through the internal mechanism (Compl. ¶24). ¶24 col. 3:66
an opening positioned in an exhalation flow path defined between the inlet and the outlet An internal opening is shown in the vPEP® device, which is positioned in the path of the exhaled air (Compl. ¶25). ¶25 col. 5:46-48
a blocking segment configured to rotate relative to the opening between a closed position where the flow of air through the opening is restricted, and an open position where the flow of air through the opening is less restricted The vPEP® device includes a component, identified as a "blocking segment," that rotates. Annotated photographs depict this segment in both a "closed position" restricting the opening and an "open position" where the opening is less restricted (Compl. ¶26). ¶26 col. 2:59-62
a vane configured to rotate the blocking segment between the closed position and the open position in response to the flow of air through the opening The vPEP® device allegedly contains a "vane" that is configured to cause the rotation of the blocking segment as air flows through the device (Compl. ¶27). ¶27 col. 2:55-58
wherein a size of a blocking surface of the blocking segment is equal to or greater than a size of the opening An annotated photograph purports to show that the surface area of the blocking segment is greater than the surface area of the opening it is designed to block (Compl. ¶28). ¶28 col. 12:23-25
  • Identified Points of Contention:
    • Scope Questions: The complaint alleges literal infringement and, in the alternative, infringement under the doctrine of equivalents (Compl. ¶19). This raises the question of whether the components of the accused devices fall within the literal scope of the claim terms, or if not, whether any differences are insubstantial.
    • Technical Questions: The complaint's infringement theory relies heavily on visual comparisons of the accused devices' components to the claimed elements. A key technical question will be whether the accused components actually function as described. For example, what evidence demonstrates that the alleged "vane" (Compl. ¶27) is the component that actually drives the rotation of the "blocking segment" (Compl. ¶26) in response to airflow, as required by the claim?

V. Key Claim Terms for Construction

  • The Term: "vane"

    • Context and Importance: This term is critical as it defines the mechanism that drives the oscillation. The infringement case hinges on whether the component that causes rotation in the accused devices is properly classified as a "vane." Practitioners may focus on this term because the defendant could argue its air-driven rotator is not a "vane" in the patented sense, but a different type of aerodynamic structure.
    • Intrinsic Evidence for a Broader Interpretation: The patent functionally describes "a plurality of vanes configured to rotate the restrictor member in response to exhaled air" (’588 Patent, col. 2:55-58), which could be argued to encompass any surface designed to achieve rotation via airflow.
    • Intrinsic Evidence for a Narrower Interpretation: The patent illustrates specific embodiments, such as the curved structures (567) shown in Figure 12 (’588 Patent, Fig. 12). A party could argue the term should be construed more narrowly in light of these specific examples.

  • The Term: "blocking segment"

    • Context and Importance: This term defines the structure that physically restricts the airflow to create pressure pulses. Its relationship to the "opening" and its movement are central to the claim.
    • Intrinsic Evidence for a Broader Interpretation: The claim language itself defines the term functionally: a component that rotates between a "closed position" and an "open position" to restrict airflow (’588 Patent, col. 12:14-19). This suggests a broad, function-oriented definition.
    • Intrinsic Evidence for a Narrower Interpretation: The specification provides additional details, stating that the blocking segment "may have a cross-sectional area greater than a cross-sectional area of the one of the inlet or the outlet" (’588 Patent, col. 3:1-3). A defendant might argue this descriptive language should be used to narrow the scope of what qualifies as a "blocking segment."

VI. Other Allegations

  • Indirect Infringement: The complaint alleges induced infringement (Count 2), stating that Defendant provides instructions encouraging and enabling others, such as physicians and patients, to use the accused devices in an infringing manner (Compl. ¶61). Specific reference is made to the "Instructions for Use" included with the iPEP® device (Compl. ¶42). The complaint also alleges contributory infringement (Count 3), asserting the accused devices are non-staple articles of commerce especially adapted for infringing use (Compl. ¶68).
  • Willful Infringement: Willfulness is alleged based on Defendant’s continued infringement after receiving notice of the ’588 Patent through service of the original complaint, subsequent amended complaints, and preliminary infringement contentions (Compl. ¶45-46, ¶60, ¶63).

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

  • A central issue will be one of technical and factual correspondence: The complaint presents annotated photographs suggesting the accused devices are nearly identical copies of the patented technology. The case will likely depend on whether discovery reveals any subtle but legally significant differences in the structure, materials, or aerodynamic operation of the accused devices' components compared to the limitations recited in the asserted claims.
  • A key legal question will concern claim construction: Despite the apparent visual similarities, the outcome may turn on the scope assigned to key terms such as "vane" and "blocking segment". The litigation will likely focus on whether the definitions of these terms are limited to the specific embodiments shown in the patent or can be interpreted more broadly to read on the accused products.
  • For the iPEP® and PocketPEP® devices, a pivotal question will be one of modular infringement: The dispute will likely examine whether the sale and instructed use of the self-contained "OPEP module" constitutes direct and induced infringement of the system claims, particularly given the plaintiff's reliance on the defendant's own user manuals as evidence of intent (Compl. ¶42, ¶61).