DCT
1:17-cv-00712
Monaghan Medical Corp v. Smiths Medical ASD Inc
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Monaghan Medical Corp. (New York)
- Defendant: Smiths Medical ASD, Inc. (Delaware)
- Plaintiff’s Counsel: Heyman Enerio Gattuso & Hirzel LLP; Brinks Gilson & Lione
- Case Identification: 1:17-cv-00712, D. Del., 06/09/2017
- Venue Allegations: Plaintiff alleges venue is proper because Defendant is incorporated in Delaware and transacts business, including the sale of related medical devices, within the district.
- Core Dispute: Plaintiff seeks a declaratory judgment that its Aerobika® respiratory device does not infringe any claim of Defendant’s patent related to positive expiratory pressure devices.
- Technical Context: The technology involves hand-held oscillating positive expiratory pressure (OPEP) devices used in respiratory therapy to help patients with conditions like COPD clear mucus from their lungs.
- Key Procedural History: The action was precipitated by a November 23, 2016 letter from Defendant Smiths Medical to Plaintiff’s owner, asserting that a license to the patent-in-suit was required to sell the Aerobika® device in the U.S. Subsequent discussions failed to resolve the dispute, creating what Plaintiff alleges is an actual and immediate controversy warranting a declaratory judgment.
Case Timeline
| Date | Event |
|---|---|
| 1999-11-24 | ’324 Patent Priority Date |
| 2006-06-13 | ’324 Patent Issue Date |
| 2016-11-23 | Smiths Medical sends letter to Monaghan's owner asserting patent |
| 2017-02-27 | Licensing discussions between parties end without agreement |
| 2017-06-09 | Complaint for Declaratory Judgment filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 7,059,324 - "Positive Expiratory Pressure Device"
- Patent Identification: U.S. Patent No. 7,059,324, "Positive Expiratory Pressure Device", issued June 13, 2006.
The Invention Explained
- Problem Addressed: The patent describes a need for an improved respiratory therapy device for patients with mucus-producing conditions (Compl., Ex. A, ’324 Patent, col. 1:21-27). Specifically, it seeks to improve upon existing Positive Expiratory Pressure (PEP) therapy by combining it with airway oscillation in a device that is easy to disassemble for cleaning and is not dependent on its physical orientation during use (’324 Patent, col. 2:7-10).
- The Patented Solution: The invention is a hand-held device containing an "expiratory-air-driven oscillatory rocker assembly" within a housing (’324 Patent, col. 3:5-13). When a patient exhales into the device, the airflow causes a "rocker portion" to pivot, moving a cone-shaped closure into and out of a "non-linear discharge outlet" (’324 Patent, col. 4:42-54). This repeated blocking and unblocking of the airflow generates an oscillating positive pressure back to the patient's airways, which helps loosen secretions (’324 Patent, col. 8:50-65). The design aims to function regardless of how the patient holds the device (’324 Patent, col. 4:29-32).
- Technical Importance: The invention provided a means to combine two therapeutic actions—positive pressure and oscillation—in a single, portable, orientation-independent device that could be adjusted and easily cleaned by the patient (’324 Patent, col. 1:50-54, col. 2:7-10).
Key Claims at a Glance
The complaint seeks a declaratory judgment of non-infringement of "any claim of the '324 patent" (Compl. ¶20). Independent claim 12 is representative of the core technology.
- Independent Claim 12:
- An oscillatory positive expiratory pressure therapy device, comprising:
- an air-flow tube having a path of air flow movement from an inlet to an outlet;
- an expiratory air responsive closure means positioned in the air flow path and movable between an open and closed position in response to expiratory air pressure;
- the closure means includes a normally closed non-linear discharge outlet that opens in response to a predetermined pressure and closes in response to a pressure decrease; and
- the closure means is an "oscillatory rocker assembly" with a "rocker portion pivotally supported on a rocker support portion."
III. The Accused Instrumentality
Product Identification
- The Aerobika® device (Compl. ¶10).
Functionality and Market Context
- The complaint describes the Aerobika® device as a "hand-held oscillating positive expiratory pressure ('OPEP') device" (Compl. ¶10). Its stated function is to assist in mucus clearance by "providing intermittent resistance and creating positive pressure and oscillations simultaneously to open weak or collapsed airways" (Compl. ¶11). The complaint does not provide specific details on the internal mechanism by which the device achieves this functionality. No probative visual evidence provided in complaint.
IV. Analysis of Infringement Allegations
As this is a complaint for declaratory judgment of non-infringement, it does not contain affirmative infringement allegations or a claim chart. The following table summarizes the likely infringement theory of the patentee (Defendant Smiths Medical), based on the patent claims and the high-level description of the accused product in the complaint.
'324 Patent Infringement Allegations
| Claim Element (from Independent Claim 12) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| an oscillatory positive expiratory pressure therapy device | The accused Aerobika® device is described as a "hand-held oscillating positive expiratory pressure ('OPEP') device." | ¶10 | col. 3:4-9 |
| an air-flow tube having a path of air flow movement from an inlet opening for receiving expiratory air... through an outlet opening for discharging the expiratory air | The complaint describes a device that a patient uses for respiration, which inherently requires an air path from an inlet to an outlet. | ¶11 | col. 4:51-54 |
| said expiratory air responsive closure means... actuable between an open position and a closed position in response to the pressure of expiratory air passed thereto | The device is alleged to provide "intermittent resistance," suggesting a mechanism that opens and closes in response to the user's exhalation. | ¶11 | col. 14:35-46 |
| said expiratory air responsive closure means being... an oscillatory rocker assembly including a rocker portion pivotally supported on a rocker support portion | The complaint alleges the device creates "oscillations," which the patentee would likely argue is achieved by a mechanism that meets this limitation. | ¶10, ¶11 | col. 4:18-24 |
- Identified Points of Contention:
- Structural Questions: A central factual dispute will be whether the internal mechanism of the Aerobika® device constitutes an "oscillatory rocker assembly including a rocker portion pivotally supported on a rocker support portion," as recited in claim 12 and detailed in the patent's specification. The complaint lacks the technical detail to resolve this, making it a primary subject for discovery.
- Functional Questions: The case may raise the question of whether the "intermittent resistance" provided by the Aerobika® device (Compl. ¶11) is generated by a "normally closed non-linear discharge outlet" that opens and closes in the specific manner claimed by the patent.
V. Key Claim Terms for Construction
The Term: "oscillatory rocker assembly"
Context and Importance: This term appears in independent claim 12 and describes the core mechanism of the invention. Whether the Aerobika® device's internal components meet this limitation will be central to the infringement analysis. Practitioners may focus on this term because its construction will define the structural requirements for infringement.
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The claim language itself does not impose many structural limits beyond requiring a "rocker portion pivotally supported on a rocker support portion" that creates oscillation. A party could argue this language should not be limited to the exact embodiment in the figures.
- Evidence for a Narrower Interpretation: The specification provides a highly detailed description of this assembly, identifying "rocker portion 440" and "rocker support or platform portion 480" as distinct components that "act together" ('324 Patent, col. 3:14-18, FIG. 2). A party could argue the term should be limited to a two-part structure consistent with this detailed disclosure.
The Term: "non-linear discharge outlet"
Context and Importance: This term, found in independent claims such as claim 1, 6, and 12, defines the orifice that the "oscillatory rocker assembly" interacts with. The geometry of this outlet is described as being important for generating the desired therapeutic pressure oscillations.
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: A party could argue that "non-linear" is a broad term meaning any shape that is not a straight-sided passage, and that it is not limited to any particular curve.
- Evidence for a Narrower Interpretation: The specification repeatedly describes the outlet's geometry with more specific terms, such as "bell-shaped" (col. 4:45-46, claim 6) or "trumpet-shaped" (col. 4:46, claim 7). A party could argue these specific descriptions limit the scope of the more general term "non-linear" to these types of flared shapes.
VI. Other Allegations
- Indirect Infringement: Plaintiff seeks a declaration that it does not infringe "either directly or indirectly" (Compl. ¶20). The complaint does not contain specific factual allegations that would form the basis of an indirect infringement claim by the patentee.
- Willful Infringement: The complaint does not mention willfulness. However, it affirmatively pleads that Defendant Smiths Medical provided Plaintiff with notice of the ’324 patent and its relevance to the Aerobika® device on November 23, 2016 (Compl. ¶14). This documented pre-suit knowledge could serve as the basis for a potential future counterclaim for willful infringement by the Defendant.
VII. Analyst’s Conclusion: Key Questions for the Case
- A primary issue will be one of structural and functional correspondence: Once the internal mechanism of the Aerobika® device is produced in discovery, the key question will be whether it operates using an "oscillatory rocker assembly" that is structurally equivalent to the one claimed and described in the ’324 patent, or if it achieves a similar outcome (oscillation) through a materially different design.
- The case will also turn on a question of claim scope: Will the court adopt a narrow construction of terms like "non-linear discharge outlet," limiting it to the specific "bell-shaped" or "trumpet-shaped" embodiments in the specification, or will it find the term encompasses a wider range of geometries? The outcome of this legal determination will significantly impact the factual infringement analysis.