Trudell Medical v. D R Burton Healthcare: OPEP Patent Suit Stayed Pending Federal Circuit
Trudell Medical International filed suit in the Eastern District of North Carolina asserting US10413698B2, covering an oscillating positive expiratory pressure (OPEP) device, against D R Burton Healthcare. After 1,290 days, Judge Boyle stayed the case sua sponte, deferring to a Federal Circuit appeal in a closely related action between the same parties.
OPEP Patent Dispute Frozen Pending Appellate Guidance
On September 17, 2019, Trudell Medical International — a Canadian medical device company and holder of US10413698B2 — filed an infringement action in the Eastern District of North Carolina against D R Burton Healthcare, LLC, alleging unauthorised use of technology covering an oscillating positive expiratory pressure device. The case was assigned to Judge Terrence W. Boyle and proceeded through claim construction preparation, including a Markman hearing referral to a magistrate judge.
On March 30, 2023, the Court acted sua sponte, issuing an order staying this action and removing it from the active docket. The trigger was a direct appeal filed by Trudell on March 21, 2023, to the United States Court of Appeals for the Federal Circuit in a closely related predecessor case — Trudell Medical International v. D R Burton Healthcare LLC, No. 4:18-CV-9-BO — also in the Eastern District of North Carolina. Although that case involves different patents, Judge Boyle determined the Federal Circuit's analysis would provide guidance sufficient to warrant a stay under the court's inherent docket-management authority.
The case has now been stayed for an indeterminate period, with both parties ordered to notify the court within five days of the Federal Circuit's mandate in the related appeal. The Markman referral to the magistrate judge was simultaneously withdrawn, with the Court reserving claims construction for itself after the stay lifts. The public record does not disclose the precise scope of the overlapping legal issues, leaving the full strategic rationale for the stay — and its impact on US10413698B2 — partially opaque until the Federal Circuit rules.
See Complete Case & Patent Analysis →Filing to Case Stayed in 1290 days
1,290 days active before stay — above average for a first-instance patent case that never reached trial
US10413698B2 — Oscillating Positive Expiratory Pressure Device
Any company manufacturing, importing, or distributing oscillating positive expiratory pressure devices in the United States should treat US10413698B2 as a live FTO concern. Trudell Medical has already demonstrated willingness to assert multiple patents against a single defendant across parallel proceedings. With claims construction still pending before Judge Boyle, the precise scope of enforceable claims is undefined — making a pre-emptive FTO assessment more valuable, not less.
Official order — verbatim text
The court's order is procedural rather than substantive — no merits ruling was reached on infringement or validity of US10413698B2. Acting on its own initiative under inherent docket-management authority (citing Ryan v. Gonzales, 568 U.S. 57), Judge Boyle determined the Federal Circuit's forthcoming guidance in the related No. 4:18-CV-9-BO appeal was sufficient justification to halt parallel proceedings. The order preserves all claims and defences; neither party has won or lost anything on the merits. The commercial and legal exposure associated with US10413698B2 therefore remains entirely open.
Full party and counsel information
| Role | Name | Type | Detail |
|---|---|---|---|
| Plaintiff | Trudell Medical International | Individual | Canadian medical device company — holder of US10413698B2 (OPEP device technology)Search in Eureka ↗ |
| Defendant | D R Burton Healthcare, LLC | Company | D R Burton Healthcare, LLC — US medical device distributor accused of OPEP patent infringementSearch in Eureka ↗ |
| Plaintiff counsel | Andrew J. Avsec | Attorney | Counsel for Trudell Medical InternationalSearch in Eureka ↗ |
| Plaintiff counsel | David P. Lindner | Attorney | Counsel for Trudell Medical InternationalSearch in Eureka ↗ |
| Plaintiff counsel | David R. Boaz | Attorney | Counsel for Trudell Medical InternationalSearch in Eureka ↗ |
| Plaintiff counsel | Jafon L. Fearson | Attorney | Counsel for Trudell Medical InternationalSearch in Eureka ↗ |
| Plaintiff counsel | John F. Morrow | Attorney | Counsel for Trudell Medical InternationalSearch in Eureka ↗ |
| Plaintiff counsel | Judy K. He | Attorney | Counsel for Trudell Medical InternationalSearch in Eureka ↗ |
| Plaintiff counsel | Madison B. Waller | Attorney | Counsel for Trudell Medical InternationalSearch in Eureka ↗ |
| Plaintiff counsel | Samuel B. Hartzell | Attorney | Counsel for Trudell Medical InternationalSearch in Eureka ↗ |
| Plaintiff counsel | William H. Frankel | Attorney | Counsel for Trudell Medical InternationalSearch in Eureka ↗ |
| Plaintiff law firm | Brinks Gilson & Lione PC | Law Firm | Representing Trudell Medical InternationalSearch in Eureka ↗ |
| Plaintiff law firm | Crowell & Moring LLP | Law Firm | Representing Trudell Medical InternationalSearch in Eureka ↗ |
| Plaintiff law firm | Womble Bond Dickinson (US) LLP | Law Firm | Representing Trudell Medical InternationalSearch in Eureka ↗ |
| Defendant counsel | Alan B. Felts | Attorney | Counsel for D R Burton Healthcare, LLCSearch in Eureka ↗ |
| Defendant counsel | Albert P. Allan | Attorney | Counsel for D R Burton Healthcare, LLCSearch in Eureka ↗ |
| Defendant counsel | Brian Eutermoser | Attorney | Counsel for D R Burton Healthcare, LLCSearch in Eureka ↗ |
| Defendant counsel | Christoper C. Campbell | Attorney | Counsel for D R Burton Healthcare, LLCSearch in Eureka ↗ |
| Defendant counsel | Jeffrey D. Mills | Attorney | Counsel for D R Burton Healthcare, LLCSearch in Eureka ↗ |
| Defendant counsel | Jeffrey Scott Southerland | Attorney | Counsel for D R Burton Healthcare, LLCSearch in Eureka ↗ |
| Defendant law firm | Allan Law Firm PLLC | Law Firm | Representing D R Burton Healthcare, LLCSearch in Eureka ↗ |
| Defendant law firm | King & Spalding LLP | Law Firm | Representing D R Burton Healthcare, LLCSearch in Eureka ↗ |
| Defendant law firm | Tuggle Duggins, PA | Law Firm | Representing D R Burton Healthcare, LLCSearch in Eureka ↗ |
| Presiding judge | Judge Terrence W Boyle | Judge | North Carolina Eastern District CourtSearch in Eureka ↗ |
R&D signals in the oscillating positive expiratory pressure device space
Forward-looking patent and innovation intelligence derived from Trudell Medical's enforcement of US10413698B2 against D R Burton Healthcare in the OPEP therapy sector.
Trudell Medical's OPEP patent estate shows layered enforcement intent
Trudell's decision to assert different patents against the same defendant across two parallel actions suggests a deliberate portfolio strategy. Mapping Trudell's full US filing activity in oscillating PEP, inhaled drug delivery, and airway clearance reveals where future assertion risk may concentrate — particularly in continuation and divisional applications stemming from US16/272168.
Enforcement portfolio riskOPEP device patent filings: competitive density and white space
The OPEP therapy segment has attracted growing patent activity as respiratory chronic disease prevalence rises. Mapping filing trends around oscillation frequency control, pressure valve mechanisms, and patient compliance monitoring reveals which sub-domains are densely filed versus open for differentiated innovation — particularly relevant for entrants designing around Trudell's claims.
Filing trend analysisD R Burton Healthcare's defensive patent position in respiratory devices
As a defendant in two Trudell actions, D R Burton's own IP position — or lack thereof — in the OPEP space is commercially significant. Understanding whether it holds any design patents, utility models, or has filed inter partes review petitions against Trudell patents provides intelligence on the durability of its market position and potential design-around leverage.
Defensive IP assessmentAdjacent R&D opportunities near US10413698B2 claim boundaries
With claims construction for US10413698B2 still unresolved, the boundary between infringing and non-infringing OPEP designs remains fluid. Adjacent technical spaces — including digital adherence monitoring for OPEP devices, smart valve actuation, and combination inhaler-PEP platforms — represent potential white-space opportunities for R&D teams seeking to innovate without entering Trudell's asserted claim scope.
White space opportunitySimilar OPEP and respiratory device patent cases in US district courts
Explore related patent infringement actions involving oscillating positive expiratory pressure and airway clearance device technology litigated in US district courts.
What this stay signals for the OPEP device IP landscape
A Federal Circuit ruling in the related case could reshape claim scope and enforcement strategy for oscillating positive expiratory pressure device patents.
Monitor the Federal Circuit appeal in No. 4:18-CV-9-BO closely
The stay in this action is expressly conditional on the Federal Circuit mandate in the related Trudell v. D R Burton case. Any ruling on claim construction, obviousness, or infringement in that appeal will directly set the trajectory for US10413698B2. Competitors and product teams in the OPEP space should track the appeal's docket as a leading indicator.
Claims construction on US10413698B2 is still unresolved
Judge Boyle withdrew the magistrate referral and reserved Markman analysis for himself post-stay. This means the scope of key claims in US10413698B2 remains judicially undefined — a material uncertainty for any party designing or distributing OPEP devices in the US market. An FTO analysis based solely on the patent text carries elevated risk until the court issues its construction order.
International v D — key questions answered
As of March 30, 2023, the case is stayed. Judge Boyle issued a sua sponte order removing it from the active docket pending a final Federal Circuit ruling in the related case No. 4:18-CV-9-BO. The stay lifts when both parties notify the court within five days of that mandate being entered.
Trudell Medical asserted US10413698B2, filed under application number US16/272168. The patent covers an oscillating positive expiratory pressure (OPEP) device — a respiratory therapy technology used for airway clearance in patients with conditions such as cystic fibrosis and COPD.
Judge Boyle exercised the court's inherent authority to manage its docket, citing Ryan v. Gonzales, 568 U.S. 57. He determined that the Federal Circuit's forthcoming ruling in the related case No. 4:18-CV-9-BO — involving different patents but overlapping issues — would likely provide guidance material to resolving this action. A stay avoids potentially inconsistent rulings and wasted judicial resources.
A Markman hearing took place, and the case had been referred to a magistrate judge for a memorandum and recommendation on claim construction. However, when Judge Boyle issued the stay order on March 30, 2023, he simultaneously withdrew that referral. The Court reserved the right to enter its own claims construction order after the stay is lifted.
The stay leaves the infringement and validity of US10413698B2 legally unresolved. No claims construction order has been issued, so the precise scope of enforceable claims is undefined. This creates ongoing FTO uncertainty for any company making or selling OPEP devices in the US market. The risk window is likely to last for the duration of the Federal Circuit appeal in No. 4:18-CV-9-BO, which could extend 18–36 months from the March 2023 notice of appeal.
PatSnap Eureka searches patents and litigation data to answer instantly.