Bardy Diagnostics Inc v. Vital Connect Inc

I. Executive Summary and Procedural Information

• Parties & Counsel:
  • Plaintiff: Bardy Diagnostics, Inc. (Delaware)
  • Defendant: Vital Connect, Inc. (Delaware)
  • Plaintiff’s Counsel: Riley Safer Holmes & Cancila LLP
• Case Identification: 1:22-cv-00351, D. Del., 01/10/2023
• Venue Allegations: Venue is asserted on the basis that the Defendant is a Delaware corporation and therefore resides in the district.
• Core Dispute: Plaintiff alleges that Defendant’s VitalPatch line of wearable cardiac monitors infringes two patents related to the structural design and component configuration of electrocardiography patches.
• Technical Context: The technology concerns wearable, adhesive electrocardiography (ECG) patches designed for long-term, ambulatory monitoring of a patient's cardiac activity.
• Key Procedural History: The complaint alleges that Plaintiff provided Defendant with notice of infringement of the ’743 patent via letters dated May 24, 2022, and October 17, 2022. Notice of infringement of the ’967 patent was allegedly provided in the October 17, 2022 letter. A terminal disclaimer is noted on the face of the ’743 patent. Additionally, subsequent to the filing of this complaint, a disclaimer for claims 1-10 of the ’743 patent was filed on April 21, 2023; the complaint asserts claims 11-20 of this patent.

Case Timeline

Date	Event
2013-09-25	Earliest Priority Date for ’743 and ’967 Patents
2021-07-06	U.S. Patent No. 11,051,743 Issues
2022-05-24	Plaintiff sends letter to Defendant notifying of ’743 patent infringement
2022-09-20	U.S. Patent No. 11,445,967 Issues
2022-10-17	Plaintiff sends letter to Defendant notifying of ’743 and ’967 patent infringement
2023-01-10	First Amended Complaint Filed

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

U.S. Patent No. 11,051,743 - "Electrocardiography Patch," issued July 6, 2021

The Invention Explained

• Problem Addressed: The patent describes conventional long-term ECG monitoring systems, like Holter monitors, as "arduous to employ, cumbersome to the patient, and excessively costly" (’743 Patent, col. 2:1-3). It notes that such devices suffer from issues like skin irritation, poor adhesion over time, and discomfort, which can lead to poor patient compliance and low-quality signal recording (’743 Patent, col. 2:9-26).
• The Patented Solution: The invention is a wearable ECG monitor patch with a unique "hourglass"-like shape, featuring an elongated strip with a mid-section that is narrower than its two ends (’743 Patent, Abstract; col. 4:18-20). This design is intended to improve comfort and fit, particularly on the female anatomy within the intermammary cleft, while being placed over the sternum to improve the quality of P-wave (atrial activity) signal capture (’743 Patent, col. 4:41-47, col. 6:1-8).
• Technical Importance: This design aims to improve the practicality of long-term continuous ECG monitoring by increasing patient comfort and compliance, while simultaneously enhancing the diagnostic quality of the captured signals, particularly atrial signals, which are critical for arrhythmia diagnosis (’743 Patent, col. 4:48-55).

Key Claims at a Glance

• The complaint asserts claims 11-20, with claim 11 being the independent claim.
• Independent Claim 11: An electrocardiography monitor comprising:
  • a backing comprising an elongated strip with a mid-section connecting two ends, wherein the mid-section is narrower than the two ends;
  • an electrocardiographic electrode on each end of the backing;
  • a flexible circuit with a pair of circuit traces electrically coupled to the electrodes;
  • a wireless transceiver to communicate at least a portion of the ECG signals;
  • a battery on one of the ends of the backing;
  • a processor powered by the battery; and
  • a memory electrically interfaced with the processor, operable to store samples of the ECG signals.

U.S. Patent No. 11,445,967 - "Electrocardiography Patch," issued September 20, 2022

The Invention Explained

• Problem Addressed: The patent addresses the same challenges of long-term ambulatory cardiac monitoring as its related ’743 patent, focusing on the need for a wearable device that is both comfortable for extended periods and capable of reliable signal capture (’967 Patent, col. 2:9-26).
• The Patented Solution: The ’967 patent provides a detailed structural arrangement for an ECG patch apparatus. The solution describes a flexible backing with a tapered mid-section and specifies the placement and interaction of numerous components, including having "only two" electrodes, a flexible circuit, a non-conductive receptacle for a battery overlying one end of the strip, an electrical connector, a wireless transceiver, and a processor (’967 Patent, Abstract; col. 3:3-34). The detailed description explains how these components are integrated to create a disposable patch with reusable electronics (’967 Patent, col. 5:43-52).
• Technical Importance: This specific configuration of components aims to create a low-profile, water-resistant, and reliable monitoring device where the disposable adhesive patch can be easily swapped while retaining the more expensive reusable electronics, facilitating continuous long-term use (’967 Patent, col. 9:31-41).

Key Claims at a Glance

• The complaint asserts claim 44, which is an independent claim.
• Independent Claim 44: An apparatus comprising:
  • a flexible backing with an elongated, tapered strip having first and second end sections, a narrower mid-section, and an adhesive-covered surface;
  • a flexible circuit mounted to the backing;
  • "only two" electrocardiographic electrodes coupled to the flexible circuit and conductively exposed on the adhesive surface;
  • a non-conductive receptacle mounted on the flexible circuit overlying only one end section;
  • a battery received in the receptacle;
  • an electrical connector mounted to the flexible circuit, disposed between the circuit and the battery, and in contact with the battery;
  • a wireless transceiver overlying the first end section; and
  • a processor overlying a portion of the flexible circuit, electrically coupled to the electrodes, transceiver, and battery, and configured to process sensed ECG signals.

III. The Accused Instrumentality

Product Identification

• The accused products are the "VitalPatch or VitalConnect Sensor," including the VitalPatch Biosensor, VitalPatch 1.0, 1.5, 2.0, and RTM versions (Compl. ¶13).

Functionality and Market Context

• The complaint describes the VitalPatch as a "battery-operated, wearable device to collect physiological data including... electrocardiographic signals" (Compl. ¶14). The device allegedly includes an adhesive patch, a pair of electrodes, a flexible circuit, a processor, memory, and a Bluetooth transmitter to communicate ECG signals to another device like a server or mobile device. It is also alleged to include a "non-conductive receptacle" for its batteries (Compl. ¶14). These alleged features form the basis of the infringement claims.

IV. Analysis of Infringement Allegations

The complaint references, but does not include, claim chart exhibits (Exhibits 9 and 10) that purportedly detail the infringement (Compl. ¶15-16). The narrative infringement theory is summarized below.

No probative visual evidence provided in complaint.

• ’743 Patent Infringement Allegations: The complaint alleges that the VitalPatch products meet every element of at least claims 11-20 (Compl. ¶15). The core of the allegation is that the VitalPatch constitutes an electrocardiography monitor that embodies the specific structure recited in claim 11. This includes having a backing with an elongated shape where the mid-section is narrower than the ends, along with the claimed arrangement of electrodes, a flexible circuit, a battery, a processor, memory, and a wireless transceiver (Compl. ¶10, ¶14).

• ’967 Patent Infringement Allegations: The complaint alleges that the VitalPatch products meet every element of at least claim 44 (Compl. ¶16). The infringement theory relies on the assertion that the VitalPatch is an apparatus with the highly specific component layout of claim 44. This includes the flexible backing with a tapered mid-section, having only two electrodes, a non-conductive receptacle that receives a battery and overlies one end of the patch, an electrical connector, and a processor and wireless transceiver configured as claimed (Compl. ¶12, ¶14).

• Identified Points of Contention:

  • Scope Questions: A central issue for the ’743 patent may be the construction of "mid-section is narrower than the two ends." The degree of narrowing required and the overall shape of the accused VitalPatch backing will be a factual question for the court. For the ’967 patent, the limitation "overlying only one of the first end section or the second end section" for the receptacle may be a point of dispute regarding the precise positioning and footprint of the components on the accused device.
  • Technical Questions: A key question for the ’967 patent will be whether the accused VitalPatch contains every detail of the specific component architecture recited in claim 44, including the exact nature and placement of the "non-conductive receptacle," the "electrical connector," and its physical relationship to the battery and flexible circuit. Any deviation in the accused product's construction from this detailed claim language could support a non-infringement defense.

V. Key Claim Terms for Construction

• Term: "a mid-section ... narrower than the two ends of the backing" (’743 Patent, Claim 11)

  • Context and Importance: This term defines the core structural innovation of the patent—the "hourglass" shape intended to improve fit and comfort. The infringement analysis for the ’743 patent will hinge on whether the accused VitalPatch's physical form meets this dimensional limitation.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The claim language itself does not specify a degree of narrowing, suggesting any tapering could suffice. The summary states the backing forms an "elongated strip with a mid-section connecting two ends" where the "mid-section is narrower," without further qualification (’743 Patent, col. 4:18-20).
    • Evidence for a Narrower Interpretation: The specification repeatedly refers to the shape as an "elongated 'hourglass'-like shape" (e.g., ’743 Patent, col. 8:37-39). A defendant may argue this context limits the claim to a more pronounced, symmetrical tapering as depicted in figures like Fig. 6, rather than any minor indentation.

• Term: "a non-conductive receptacle mounted to the flexible circuit" (’967 Patent, Claim 44)

  • Context and Importance: This term is critical because claim 44 recites a very specific assembly. The relationship between the receptacle, the flexible circuit it is "mounted to," and the battery it "receives" will be a focal point. Practitioners may focus on this term because the method of attachment and the definition of "receptacle" versus a simple housing could create a non-infringement argument if the accused device uses a different assembly method.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The specification describes the receptacle 25 as being "provided on the top surface of the flexible backing 20" and holding the monitor recorder 14 (’967 Patent, col. 9:5-9). This could be interpreted broadly to cover various forms of housing attached to the patch's circuit layer.
    • Evidence for a Narrower Interpretation: The claim requires the receptacle to be mounted to the flexible circuit, not just the backing. Figure 6 shows the receptacle 25 as a distinct component into which the electronics module is placed. A defendant might argue that an integrated housing, or one attached primarily to the backing material rather than the circuit itself, falls outside the scope of this limitation.

VI. Other Allegations

• Indirect Infringement: The complaint alleges induced infringement, stating that VitalConnect provides detailed instructions in its packaging and on its website that direct patients and healthcare providers to use the VitalPatch in a manner that performs the claimed steps, such as adhering the patch and using it to capture and transmit physiological data (Compl. ¶19, ¶20, ¶25).
• Willful Infringement: Willfulness is alleged based on pre-suit knowledge. The complaint asserts that VitalConnect had knowledge of the ’743 patent since at least a May 24, 2022 letter and of both the ’743 and ’967 patents since at least an October 17, 2022 letter, but continued its allegedly infringing activities (Compl. ¶21-24, ¶28-29).

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

1. A core issue will be one of structural interpretation: Does the physical form of the accused VitalPatch meet the "narrower mid-section" limitation of the ’743 patent? The case may turn on how broadly this term is construed in light of the specification's "hourglass" embodiment.

2. A key evidentiary question will be one of architectural correspondence: Does the accused VitalPatch embody the highly detailed arrangement of components—specifically the relationship between the battery, its receptacle, the flexible circuit, and the electrical connector—as precisely recited in the lengthy independent claim 44 of the ’967 patent?

3. The dispute over willfulness will be significant. The outcome will likely depend on the objective reasonableness of VitalConnect's non-infringement or invalidity positions, particularly in light of the specific pre-suit notice letters alleged by the Plaintiff.