DCT
4:19-cv-00131
Trudell Medical Intl v. D R Burton Healthcare LLC
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Trudell Medical International (Ontario, Canada)
- Defendant: D R Burton Healthcare LLC (Nevada)
- Plaintiff’s Counsel: Womble Bond Dickinson (US) LLP; Brinks Gilson & Lione
- Case Identification: 4:19-cv-00131, E.D.N.C., 09/17/2019
- Venue Allegations: Venue is alleged based on Defendant’s substantial business activities within the Eastern District of North Carolina, including the acts of alleged infringement and false advertising.
- Core Dispute: Plaintiff alleges that Defendant’s line of oscillating positive expiratory pressure (OPEP) devices infringes its patent and that Defendant’s “Made in the USA” marketing constitutes false advertising under the Lanham Act and state law.
- Technical Context: The technology concerns hand-held respiratory therapy devices that generate oscillating pressure during patient exhalation to help clear mucus from the airways.
- Key Procedural History: The complaint notes a separate, related lawsuit between the same parties in the same district (No. 4:18-cv-00009), in which Plaintiff accused Defendant of infringing a different patent related to OPEP devices. The patent-in-suit was issued on the same day this complaint was filed.
Case Timeline
| Date | Event |
|---|---|
| 2011-06-06 | Earliest Priority Date for U.S. Patent No. 10,413,698 |
| 2013-05-16 | Plaintiff's Aerobika® device receives FDA 510(k) clearance |
| 2017-01-30 | Earliest import arrival date for accused product components listed in complaint |
| 2017-10-17 | Date of alleged false advertising tweet by Defendant's CEO |
| 2019-05-27 | Latest import arrival date for accused product components listed in complaint |
| 2019-09-17 | U.S. Patent No. 10,413,698 Issues |
| 2019-09-17 | Complaint Filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 10,413,698 - "Oscillating Positive Expiratory Pressure Device"
- Patent Identification: U.S. Patent No. 10,413,698, “Oscillating Positive Expiratory Pressure Device,” issued September 17, 2019 (’698 Patent).
The Invention Explained
- Problem Addressed: The patent describes the difficulty individuals with bronchial obstructions, such as chronic obstructive lung disease, have in clearing bronchial secretions (sputum) from collapsed or obstructed airways, noting that a single cough is often insufficient (’698 Patent, col. 1:25-31).
- The Patented Solution: The invention is a portable device that generates oscillating back pressure as a patient exhales into it. This is achieved through a mechanism containing a "restrictor member" or "blocking segment" that moves in coordination with a "vane." The patient's exhalation causes the vane to reciprocate, which in turn repeatedly moves the blocking segment to open and close an air passage, thereby creating therapeutic pressure oscillations that are transmitted to the lungs to help loosen secretions (’698 Patent, Abstract; col. 1:53-67).
- Technical Importance: The development of portable OPEP devices enables patients to self-administer this therapy conveniently in a home setting, providing an alternative to hospital-based treatments (’698 Patent, col. 1:41-46).
Key Claims at a Glance
- The complaint asserts independent claim 1, among others (Compl. ¶61, 72, 76, 88).
- Independent Claim 1 of the ’698 Patent requires:
- A respiratory treatment device comprising an inlet, an outlet, and an exhalation flow path between them.
- A "blocking segment" configured to rotate between a closed position, where airflow is restricted, and an open position.
- An "orifice" positioned in the flow path with an "elongated shape" having a shorter first dimension and a larger, perpendicular second dimension.
- A "vane" configured to repeatedly rotate the blocking segment between the open and closed positions during a single exhalation in response to airflow.
- The vane is prohibited from completing a full revolution.
- The complaint asserts infringement of dependent claims 2-23 for some products, and a narrower set for others (Compl. ¶61, 72, 76, 88).
III. The Accused Instrumentality
Product Identification
- The vPEP®, vPEP HC®, iPEP®, and PocketPEP® devices are accused of infringement (Compl. ¶58).
Functionality and Market Context
- The accused products are handheld OPEP devices marketed for respiratory therapy (Compl. ¶11). The complaint alleges the vPEP® and vPEP HC® are functionally equivalent and differ only in the plastics from which they are made (Compl. ¶13). The iPEP® is a larger device that can incorporate a smaller, removable "OPEP module," which the complaint alleges is the functional core of the infringement and is also sold as the standalone PocketPEP® device (Compl. ¶89-90). An instructional diagram in the complaint illustrates that parts from the iPEP® can be reassembled to create the smaller PocketPEP® device (Compl. ¶89).
IV. Analysis of Infringement Allegations
’698 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 vPEP® device includes an inlet for receiving a user's exhaled air | ¶64 | col. 9:1-3 |
| an outlet configured to permit exhaled air to exit the device | The vPEP® device includes an outlet to allow air to exit | ¶65 | col. 9:3-5 |
| an exhalation flow path defined between the inlet and the outlet | An exhalation flow path is defined within the device housing, running from the inlet to the outlet | ¶66 | col. 9:21-34 |
| a blocking segment configured to rotate between a closed position where the flow of air...is restricted, and an open position where the flow of air...is less restricted | A component identified as a "blocking segment" is alleged to rotate between positions that restrict and un-restrict airflow. A photograph provided in the complaint shows the alleged blocking segment and illustrates its rotational axis with blue lines (Compl. ¶67). | ¶67 | col. 10:2-9 |
| an orifice positioned along the exhalation flow path...wherein the orifice has an elongated shape comprising a shorter first dimension and a larger second dimension perpendicular to the first dimension | The device is alleged to include an orifice with the claimed elongated shape | ¶68 | col. 10:11-15 |
| a vane configured to rotate the blocking segment during a single period of exhalation repeatedly between the closed position and the open position in response to a flow of air along the exhalation flow path | A component identified as a "vane" is alleged to be configured to repeatedly rotate the blocking segment during a single exhalation in response to airflow | ¶69 | col. 10:25-30 |
| wherein the vane is prohibited from completing a full revolution | The vane is alleged to be prohibited from making a full revolution | ¶70 | col. 1:64-67 |
- Identified Points of Contention:
- Scope Questions: Claim 1 requires an "orifice" with a specific "elongated shape" defined by a "shorter first dimension" and a "larger second dimension." The litigation may focus on whether the accused product's opening meets this precise geometric definition. This raises the question of whether the claim term is definite and how it applies to the physical structure of the accused devices.
- Technical Questions: The claim requires that the "vane" rotates the "blocking segment" "repeatedly" within a "single period of exhalation" and that this rotation occurs "in response to a flow of air." The defense may question the evidence supporting this specific causal and functional relationship. A key technical question is what evidence demonstrates that the accused vane's movement is the cause of the blocking segment's rotation, as opposed to both components oscillating due to general aerodynamic flutter within the exhalation path.
V. Key Claim Terms for Construction
The Term: "blocking segment"
Context and Importance: This term identifies the core active component that modulates airflow. The outcome of the infringement analysis may depend on whether this term is construed broadly to cover any structure that cyclically restricts flow or is limited more narrowly to the specific shapes disclosed in the patent's embodiments. Practitioners may focus on this term because the accused component appears visually distinct from the primary "disk-shaped" embodiment shown in the patent’s figures.
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The claim uses the general functional term "blocking segment." The specification also uses the general term "restrictor member" when describing the component, suggesting an intent to cover the function rather than a specific form (’698 Patent, Abstract; col. 10:2-9).
- Evidence for a Narrower Interpretation: A party arguing for a narrower scope may point to the detailed description, which primarily illustrates a "generally circular face" and "disk-shaped" restrictor member (’698 Patent, col. 10:35-41; Figs. 8-10). This could support an argument that the claims should be limited to the disclosed embodiments.
The Term: "orifice"
Context and Importance: Claim 1 defines this term with specific geometric constraints ("elongated shape comprising a shorter first dimension and a larger second dimension perpendicular to the first dimension"). Infringement will hinge on whether the accused product's air passage meets this definition.
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The patent specification describes an embodiment with a "generally rectangular" orifice, which aligns with the "elongated shape" language of the claim (’698 Patent, col. 12:12-14; Fig. 12). Plaintiff may argue that this language provides a clear standard that reads on the accused product.
- Evidence for a Narrower Interpretation: A defendant may argue that the term, as defined in the claim, is indefinite if the "first" and "second" dimensions are not clearly ascertainable. A party could also point to descriptions of the orifice as part of a "variable nozzle" or a "duck-bill type valve" to argue that the term should be construed more narrowly to include features of those specific embodiments (’698 Patent, col. 11:29-38).
VI. Other Allegations
- Indirect Infringement: The complaint alleges both induced and contributory infringement. The inducement claim is based on Defendant allegedly providing instructions that encourage and enable end-users to operate the devices in an infringing manner (Compl. ¶97-98). The contributory infringement claim alleges Defendant sells "non-staple articles of commerce" (the OPEP devices) that are especially adapted for infringing use (Compl. ¶103-104).
- Willful Infringement: Willfulness is alleged based on Defendant’s continued infringement following the service of the complaint, which would establish knowledge of the ’698 patent (Compl. ¶93, 99). The patent was issued on the same day the lawsuit was filed, so the willfulness allegation is predicated on post-filing conduct.
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of claim construction: Can the term "orifice", with its specific geometric definition in Claim 1, be interpreted to read on the accused product's air passage, and is that definition sufficiently clear to be enforceable?
- A key evidentiary question will be one of functional proof: Does the accused device's "vane" actually cause the "blocking segment" to rotate repeatedly during a single exhalation as the claim requires, or is the oscillation a result of a different technical mechanism not covered by the patent?
- Beyond patent law, a central question for the false advertising counts will be one of geographic origin: Can Plaintiff produce evidence that the accused products, which are marketed as "Made in the USA," contain more than a "negligible" amount of foreign content, thereby violating the FTC standard and making the representation factually false and material to consumers?