DCT
1:23-cv-16471
Meac Engineering Ltd v. Cardinal Health Inc
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: M.E.A.C. Engineering, LTD (Israel)
- Defendant: Cardinal Health, Inc. (Ohio)
- Plaintiff’s Counsel: DNL ZITO CASTELLANO
- Case Identification: 1:23-cv-16471, N.D. Ill., 04/18/2024
- Venue Allegations: Plaintiff alleges venue is proper in the Northern District of Illinois because Defendant has regular and established places of business in the district, including facilities in Waukegan, Illinois, with a direct connection to the accused products.
- Core Dispute: Plaintiff alleges that Defendant’s Negative Pressure Wound Therapy (NPWT) systems infringe two patents related to wound closure and drainage systems that use a vented air-flow design.
- Technical Context: The technology at issue is Negative Pressure Wound Therapy (NPWT), a widely used medical treatment that applies suction to a wound to promote healing and remove infectious material.
- Key Procedural History: The currently operative complaint is an Amended Complaint. The complaint alleges that Defendant was made aware of the patents-in-suit at least as early as the filing of the original complaint on December 4, 2023, which may form the basis for allegations of post-filing willful infringement. The patents-in-suit share a specification, with the later-issued patent being a continuation of the earlier patent's application.
Case Timeline
| Date | Event |
|---|---|
| 2005-07-24 | Earliest Priority Date for '554 and '534 Patents |
| 2013-08-13 | U.S. Patent No. 8,506,554 Issued |
| 2014-10-14 | U.S. Patent No. 8,858,534 Issued |
| 2023-12-04 | Alleged Date of Defendant's Knowledge (Original Lawsuit Filing) |
| 2024-04-18 | Amended Complaint Filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 8,506,554 - "Wound closure and drainage system," issued August 13, 2013
The Invention Explained
- Problem Addressed: The patent describes deficiencies in prior art portable Negative Pressure Wound Therapy (NPWT) systems, including the risk of pump contamination, bulky collection canisters, and the potential for suction tubing to become occluded if wound exudate coagulates (Compl. ¶10; ’554 Patent, col. 1:40-64). Conventional airtight seals, while creating negative pressure, could exacerbate this occlusion problem.
- The Patented Solution: The invention is an "enclosure" (a wound dressing) for an NPWT system that includes a "venting arrangement" located outside the sealed wound area (Compl. ¶17; ’554 Patent, col. 2:5-18). This arrangement, such as a small orifice integrated into the suction tube, allows a controlled amount of ambient air to be drawn into the tube along with wound exudate. This constant airflow is intended to prevent the exudate from stagnating and clogging the tube, thereby improving the system's reliability without requiring complex pressure-relief valves (’554 Patent, col. 6:29-41, Fig. 1).
- Technical Importance: This design aims to create a more reliable, convenient, and cost-effective portable NPWT system by mitigating a common failure point (tube occlusion) and simplifying the pressure management system (’554 Patent, col.2:5-6).
Key Claims at a Glance
- The complaint asserts infringement of claims 1-29, with a focus on independent Claim 1 (Compl. ¶42).
- The essential elements of independent Claim 1 (as corrected) include:
- An enclosure for applying negative pressure to a wound, attachable to define a confined volume, and comprising a tube and a venting arrangement.
- The enclosure has an outlet connectable to a vacuum source via the tube.
- The venting arrangement is located outside the enclosure and includes a flow restrictor.
- The venting arrangement is configured such that ambient air can enter the tube and flow to the vacuum source without having to enter the enclosure itself.
- The complaint reserves the right to assert other claims, including dependent claims (Compl. ¶19).
U.S. Patent No. 8,858,534 - "Wound closure and drainage system," issued October 14, 2014
The Invention Explained
- Problem Addressed: The '534 Patent shares its specification with the '554 Patent and thus addresses the same problems of pump contamination, system bulk, and exudate occlusion in portable NPWT systems (’534 Patent, col. 1:42-68).
- The Patented Solution: This patent claims a complete vacuum system that incorporates the vented enclosure concept. The claimed system comprises the enclosure, a venting arrangement, a tube, a vacuum source, and a controller (Compl. ¶16). The invention lies in the combination of these elements, where the controller is configured to operate the vacuum source while the venting arrangement simultaneously provides a controlled flow of ambient air "upstream of the vacuum source" to maintain a desired level of negative pressure in the wound and ensure continuous drainage (’534 Patent, col. 5:35-40).
- Technical Importance: By claiming the entire operational system, including the controller, this patent provides broader protection for the integrated device, covering not just the disposable dressing component but the interaction between the pump, controller, and the vented tubing (’534 Patent, col. 7:41-50).
Key Claims at a Glance
- The complaint asserts infringement of claims 1-22, with a focus on independent Claim 1 (Compl. ¶47).
- The essential elements of independent Claim 1 include:
- A vacuum system comprising an enclosure, a venting arrangement, a tube, a vacuum source, and a controller.
- The enclosure is attachable to a wound to define a confined volume with an outlet connectable to the vacuum source.
- The venting arrangement has a flow restrictor to provide a controlled flow of ambient air into the vacuum system upstream of the vacuum source.
- The controller is configured to control the vacuum source while the system is being vented to provide a desired level of negative pressure.
- The complaint reserves the right to assert other claims, including dependent claims (Compl. ¶19).
III. The Accused Instrumentality
Product Identification
- The complaint names the Catalyst, SVED, Ally, and Pro models of Cardinal Health's NPWT devices, along with their associated replacement parts and supplies (Compl. ¶11). These are collectively referred to as the "accused products."
Functionality and Market Context
- The accused products are Negative Pressure Wound Therapy systems that include a powered suction pump, a controller unit, a wound dressing (enclosure), and tubing (Compl. ¶¶11, 26). A key feature identified in the complaint is the use of "Dual-lumen tubing," which allegedly "provides a negative pressure vacuum in one lumen and a controlled vent in the other lumen" (Compl. p. 10). The complaint alleges this dual-lumen tubing provides the functionality of the claimed "venting arrangement" (Compl. p. 10). A provided visual shows the NPWT pump unit, which serves as the vacuum source and controller (Compl. p. 11).
IV. Analysis of Infringement Allegations
’534 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A vacuum system for applying negative pressure to a wound, the vacuum system comprising: an enclosure, a venting arrangement, a tube, a vacuum source, and a controller | The accused Cardinal Health products are identified as NPWT systems that include a vacuum source and controller, and are used with an enclosure and tubing. A product image shows the various system models (Compl. p. 9). | ¶26, p. 9 | col. 6:15-22 |
| the enclosure being attachable to a periphery of the wound so as to define a confined volume | The system's polyurethane drape is trimmed and placed over the wound dressing to create a seal on the surrounding skin. An instructional diagram illustrates this application (Compl. p. 10). | ¶26, p. 10 | col. 6:23-25 |
| the enclosure having an enclosure outlet connectable to said vacuum source via said tube | A "SpeedConnect™" port is placed over a hole in the dressing and connects to tubing, which in turn connects to the pump unit. A series of diagrams shows this connection process (Compl. p. 9). | ¶26, p. 9 | col. 6:26-29 |
| the venting arrangement comprising a flow restrictor to restrict flow...and to thereby provide a controlled flow of ambient air into said vacuum system upstream of the vacuum source | The accused products' "Dual-lumen tubing" is alleged to provide a "controlled vent" in one of its lumens, which serves as the claimed venting arrangement and flow restrictor. A visual depicts a cross-section of this tubing (Compl. p. 10). | ¶26, p. 10 | col. 6:42-46 |
| the controller configured for controlling operation of the vacuum source while providing venting of the vacuum system...to provide a desired level of said negative pressure | The accused controller unit has operational buttons and works in concert with the dual-lumen tubing, which "maintains and monitors pressure at the wound site." An annotated image of the "ALLY" controller is provided (Compl. p. 11). | ¶26, p. 11 | col. 7:36-50 |
’554 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| An enclosure for applying negative pressure to a wound...comprising a tube and a venting arrangement | The accused systems are sold and used with an enclosure (drape) and tubing (the accused dual-lumen tube), which allegedly constitutes the claimed "venting arrangement" (Compl. p. 10). | ¶26, p. 10 | col. 6:15-19 |
| said venting arrangement located outside said enclosure...such that ambient air can enter said tube via said venting arrangement...without having to enter said enclosure | The venting function is allegedly performed by one lumen of the dual-lumen tube. As the tube itself is external to the sealed wound area, this arrangement is alleged to be "located outside said enclosure" and to introduce air directly into the tube (Compl. p. 10). | ¶26, p. 10 | col. 6:29-41 |
- Identified Points of Contention:
- Scope Question: A primary issue may be whether the accused "dual-lumen tubing" falls within the scope of the claimed "venting arrangement comprising a flow restrictor." The patents describe embodiments like a "bleeding orifice" or a foam-plugged hole, and a court may have to determine if an integrated second lumen in a tube is structurally and functionally equivalent to these descriptions.
- Location Question (’554 Patent): For the ’554 patent, a key dispute will likely be the interpretation of "located outside said enclosure." The defense may argue that this requires a component that is physically separate from the suction tube itself, whereas the plaintiff's theory appears to be that the venting feature, being part of the external tube, meets this limitation.
- Technical Question: The complaint alleges the dual-lumen tubing provides a "controlled vent" and acts as a "flow restrictor," but does not specify the technical mechanism by which flow is restricted. The case may require expert testimony to establish whether the dimensions or properties of the second lumen actually perform this claimed function.
V. Key Claim Terms for Construction
The Term: "venting arrangement"
- Context and Importance: This term is the central inventive concept of both patents. Its construction will be dispositive of infringement, as the core of the plaintiff's case is that the defendant's "dual-lumen tubing" is a "venting arrangement."
- Intrinsic Evidence for a Broader Interpretation: The specification states that a "bleeding orifice 35 is provided within the enclosure 12, or adjacent to it as a tube orifice 37" (’554 Patent, col. 6:29-32). This language suggests the arrangement is not limited to being a hole in the dressing itself and could be part of the tube assembly, potentially supporting the plaintiff’s theory.
- Intrinsic Evidence for a Narrower Interpretation: The patent repeatedly describes the concept as a "bleeding orifice" or a "hole plugged with open cell foam," which may suggest a discrete component designed to leak air (’554 Patent, col. 6:42-46). A defendant could argue this implies something different from a purpose-built second channel for pressure monitoring or venting, as may be the case in the accused dual-lumen tube.
The Term: "flow restrictor"
- Context and Importance: Both asserted independent claims require the "venting arrangement" to comprise a "flow restrictor." To prove infringement, the plaintiff must show that the accused dual-lumen tube contains a structure that meets this definition.
- Intrinsic Evidence for a Broader Interpretation: The patent does not define the term with great specificity, stating only that its purpose is to provide a "controlled flow of ambient air" (’534 Patent, col. 5:29-34). This functional language may allow for any structure that limits airflow, including a narrow-gauge lumen, to be considered a "flow restrictor."
- Intrinsic Evidence for a Narrower Interpretation: The specification provides examples such as a "calibrated orifice," a "hole plugged with open cell foam," or a "sintered metal plug" (’534 Patent, col. 2:20-24). Practitioners may focus on whether the accused dual-lumen tube's vent has a specific structure analogous to these examples, or if it is merely an open channel.
VI. Other Allegations
- Indirect Infringement: The complaint alleges inducement of infringement based on Defendant providing "detailed instructions on the assembly" and use of the accused products to end-users and healthcare professionals (Compl. ¶22). It alleges contributory infringement on the basis that Defendant supplies material components of the invention (e.g., dual-lumen tubing, enclosures) that are "not a staple articles of commerce" and are especially adapted for use in an infringing manner (Compl. ¶23).
- Willful Infringement: The complaint alleges that Defendant has been aware of the patents-in-suit "at least as early as the December 4, 2023 filing date of this action" and has continued its allegedly infringing conduct (Compl. ¶39). This allegation forms the basis for a claim of post-suit willful infringement.
VII. Analyst’s Conclusion: Key Questions for the Case
The resolution of this dispute will likely depend on the court's answers to the following central questions:
A core issue will be one of claim construction: can the term "venting arrangement comprising a flow restrictor," which is exemplified in the patent as a "bleeding orifice," be construed to read on the accused "dual-lumen tubing" technology?
A related question for the ’554 patent is one of locational scope: does a venting feature integrated within the suction tube at its connection point to the wound dressing satisfy the claim limitation requiring the arrangement to be "located outside said enclosure"?
Finally, a key evidentiary question will be whether the plaintiff can demonstrate, through technical evidence, that the accused "controlled vent" lumen functions as a "flow restrictor" in the manner required by the claims, or if it serves a different, non-infringing purpose.