DCT
1:24-cv-01355
Bardy Diagnostics Inc v. iRhythm Tech Inc
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Bardy Diagnostics, Inc. (Delaware)
- Defendant: iRhythm Technologies, Inc. (Delaware)
- Plaintiff’s Counsel: Potter Anderson & Corroon LLP
- Case Identification: 1:24-cv-01355, D. Del., 12/26/2024
- Venue Allegations: Venue is alleged to be proper in the District of Delaware because the defendant, iRhythm Technologies, Inc., is a Delaware corporation and therefore resides in the district.
- Core Dispute: Plaintiff alleges that Defendant’s Next-Generation Zio Monitor, a wearable cardiac monitor, infringes two patents related to the design and functionality of electrocardiography patches.
- Technical Context: The technology involves body-worn, adhesive patches for long-term, ambulatory electrocardiogram (ECG) monitoring, a field that has seen significant growth due to the need for improved diagnosis of sporadic cardiac arrhythmias.
- Key Procedural History: The complaint notes that Plaintiff began seeking patent protection for its innovations in September 2013. The accused product line, including the Zio XT, Zio AT, and the at-issue Next-Generation Zio Monitor, received FDA 510(k) clearance between 2012 and 2021.
Case Timeline
| Date | Event |
|---|---|
| 2012-07-18 | iRhythm's Zio XT Monitor receives FDA 510(k) clearance |
| 2013-09-25 | Earliest priority date for ’473 and ’562 Patents |
| 2017-06-02 | iRhythm's Zio AT Monitor receives FDA 510(k) clearance |
| 2021-05-21 | Accused Next-Generation Zio Monitor receives FDA clearance |
| 2024-12-10 | U.S. Patent No. 12,161,473 issues |
| 2024-12-24 | U.S. Patent No. 12,171,562 issues |
| 2024-12-26 | Complaint filed |
| 2027-2028 | Planned commercial launch of iRhythm's Zio MCT monitor |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 12,161,473 - “Electrocardiography Patch,” issued Dec. 10, 2024
The Invention Explained
- Problem Addressed: The patent's background describes conventional long-term ECG monitoring, such as with Holter monitors, as cumbersome, difficult for patients to manage, and prone to creating skin irritation, which limits the duration and quality of monitoring (’473 Patent, col. 2:26-34, 2:36-47). These challenges make it difficult to capture sporadic cardiac events and obtain high-quality signals, particularly the P-wave, which is crucial for diagnosing atrial arrhythmias (’473 Patent, col. 4:1-4).
- The Patented Solution: The invention is a wearable monitoring system comprising a flexible, disposable electrode patch and a removable, reusable monitor recorder (’473 Patent, col. 5:9-13). The patch has a narrow, "hourglass"-like shape designed to fit comfortably on the patient's sternum, a location chosen to enhance the capture of P-wave signals, and is particularly suited for female anatomy by fitting within the intermammary cleft (’473 Patent, col. 5:5-10, 5:32-49).
- Technical Importance: This design approach sought to enable comfortable, continuous ECG monitoring for extended periods (weeks, not days), thereby increasing the likelihood of capturing diagnostically significant, infrequent cardiac events (’473 Patent, Abstract).
Key Claims at a Glance
- The complaint asserts independent claim 1 and dependent claims 2-3, 6, 8, 10, 13, 15, 16, and 19 (Compl. ¶48).
- Independent Claim 1 recites a wearable electrocardiography monitoring device with the following essential elements:
- A flexible backing with an adhesive first face, comprising a first end section, a second end section, and a "mid-section" that is narrower than the end sections.
- A flexible circuit mounted to the second face of the strip.
- First and second ECG electrodes coupled to the flexible circuit and conductively exposed on the adhesive face at the first and second end sections, respectively, with one electrode including an inline resistor.
- A battery "vertically aligned with a sealed housing," where the housing is coupled to the flexible backing and contains a processor.
- A "wireless transceiver" that draws power from the battery.
- The complaint reserves the right to assert additional claims (Compl. ¶48).
U.S. Patent No. 12,171,562 - “Electrocardiography Patch,” issued Dec. 24, 2024
The Invention Explained
- Problem Addressed: The ’562 Patent addresses the same technical problems as the ’473 Patent: the shortcomings of conventional ambulatory ECG monitoring, including patient discomfort, limited wear time, and difficulty in obtaining clear P-wave signals for accurate arrhythmia diagnosis (’562 Patent, col. 2:26-34, 2:36-47).
- The Patented Solution: Like its sister patent, the ’562 Patent discloses a wearable monitor with a disposable, flexible patch and a reusable electronic recorder (’562 Patent, col. 5:9-13). It similarly emphasizes the sternal placement and ergonomic shape for long-term wear and improved signal quality (’562 Patent, col. 5:32-49). One embodiment adds a patient-operable button to mark symptomatic events, correlating the patient's subjective experience with the objective ECG data (’562 Patent, col. 12:65-13:2).
- Technical Importance: The technology aimed to improve diagnostic yield by making long-term monitoring more practical for patients and by providing higher-fidelity data, particularly atrial signals, to clinicians (’562 Patent, col. 5:5-10).
Key Claims at a Glance
- The complaint asserts independent claims 8 and 15, and dependent claims 9-14 and 16-30 (Compl. ¶52).
- Independent Claim 8 recites a device with elements highly similar to claim 1 of the ’473 Patent, including a flexible backing with a narrow mid-section, a flexible circuit, two electrodes (one with an inline resistor), a battery, a wireless transceiver, and a sealed housing with a processor.
- Independent Claim 15 recites a device with the following essential elements:
- A flexible backing with an adhesive face, first and second end sections, and a narrower mid-section.
- First and second ECG electrodes conductively exposed on the backing.
- A sealed housing coupled to the backing containing a processor.
- A "button disposed on the top surface of the sealed housing...configured to be pressed to mark an event."
- A battery "disposed between the processor and the skin of the patient."
- A wireless transceiver.
- The complaint reserves the right to assert additional claims (Compl. ¶52).
III. The Accused Instrumentality
Product Identification
- The accused instrumentality is iRhythm's "Next-Generation Zio Monitor" (also referred to as the "Zio Monitor") and the associated long-term continuous monitoring service (Compl. ¶12, 39, 40).
Functionality and Market Context
- The Zio Monitor is a wearable, single-use, water-resistant ECG patch designed for long-term monitoring for up to 14 days (Compl. ¶41, 42). A visual from iRhythm’s website depicts the Zio Monitor as a single-piece adhesive patch with an integrated electronic component (Compl. ¶40, Ex. 4). The device includes two electrodes to acquire ECG data and adhesive wings to adhere to the patient's chest (Compl. ¶41; p. 9). The complaint highlights that after the wear period, the patient removes the monitor and returns it by mail to an iRhythm data processing center for analysis (Compl. ¶42). The complaint positions the Zio Monitor as a direct competitor to BardyDx's own CAM Patch in the growing ambulatory cardiac monitoring market (Compl. ¶9, 15).
IV. Analysis of Infringement Allegations
’473 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| a flexible backing including a strip comprising... a mid-section... narrower than the first end section and the second end section | The Zio Monitor is an adhesive patch with an elongated, "hourglass"-like shape, as shown in marketing materials. | ¶40, Ex. 4 | col. 9:1-4 |
| a first electrocardiographic electrode and a second electrocardiographic electrode... conductively exposed at the first face | The Zio Monitor is described as acquiring electrocardiographic data "by two electrodes provided on each end of the Zio Monitor." A diagram identifies an "Electrode" that "acquires ECG data." | ¶41; p. 9 | col. 17:12-29 |
| a battery vertically aligned with a sealed housing | The complaint alleges the Zio Monitor contains a battery and electronics within a housing but does not provide specific details on the internal alignment of the components. | ¶39, 41 | col. 17:30-34 |
| a wireless transceiver, wherein the wireless transceiver draws power from the battery | The complaint alleges iRhythm's technology combines "wearable biosensors and cloud-based data analytics with powerful proprietary algorithms," but does not specify the mechanism of data transfer from the patch itself. | ¶7, 34 | col. 17:41-43 |
’562 Patent Infringement Allegations
| Claim Element (from Independent Claim 8) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| a flexible circuit mounted to the second face of the strip | iRhythm’s CTO is quoted as explaining the device's miniaturization involved moving components to "the more flexible part of the patch instead of on the actual printed circuit board in the housing." | ¶39 | col. 18:10-13 |
| wherein the first electrocardiographic electrode includes an inline resistor | The complaint quotes iRhythm’s CTO describing the miniaturization of the Zio Monitor, which involved "moving some of the big resistors that are required on the device to the more flexible part of the patch." | ¶39 | col. 18:28-29 |
| a wireless transceiver | As with the ’473 Patent, allegations rely on general descriptions of iRhythm’s technology as combining "wearable biosensors" with "cloud-based data analytics." | ¶7, 34 | col. 18:32-34 |
| Claim Element (from Independent Claim 15) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
| :--- | :--- | :--- | :--- |
| a button disposed on the top surface of the sealed housing, wherein the button is configured to be pressed to mark an event | A diagram of the Zio Monitor explicitly identifies a "Zio button" and states, "The patient presses this button when a symptom is felt." | p. 9 | col. 17:31-32 |
Identified Points of Contention
- Scope Questions: A central dispute may arise over the term "wireless transceiver." The complaint describes the Zio Monitor as a data logger that is physically mailed to a processing center (Compl. ¶42), whereas the patents describe a device capable of wireless communication with other local devices like smartphones or servers (’473 Patent, Fig. 3, col. 8:1-12). The court will have to determine if the "wireless transceiver" limitation is met by a device whose workflow relies on physical mail for data offloading.
- Technical Questions: For claim 1 of the ’473 Patent, a key question is whether the Zio Monitor’s internal components satisfy the "battery vertically aligned with a sealed housing" limitation. The complaint does not provide evidence, such as from a teardown analysis, to support this structural allegation.
V. Key Claim Terms for Construction
The Term: "wireless transceiver" (asserted in independent claims of both patents)
Context and Importance: The construction of this term may be dispositive. The accused product's documented workflow involves mailing the device for data retrieval, which appears factually distinct from the real-time or batched wireless data transfer described in the patents' specifications. Practitioners may focus on this term because the infringement case hinges on whether the Zio Monitor's functionality falls within the scope of this limitation.
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The patents state the monitor can connect to a "download station" which "could be a programmer or other device" (’473 Patent, col. 6:62-65). A plaintiff might argue this language does not strictly require over-the-air transmission to a consumer device like a smartphone.
- Evidence for a Narrower Interpretation: The detailed description and Figure 3 repeatedly depict the monitor (12) communicating wirelessly over a network (121) with devices like a smartphone (133), a personal computer (136), or a server (122), a system that appears different from a mail-in service (’473 Patent, Fig. 3, col. 8:1-12).
The Term: "button... to mark an event" (’562 Patent, Claim 15)
Context and Importance: While the complaint provides strong evidence of a "button," its function will be scrutinized. Practitioners may focus on whether the accused button's function of being pressed "when a symptom is felt" is legally equivalent to being "configured to... mark an event" as required by the claim.
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The patent specification describes a "tactile feedback button... which a patient can press to mark events or to perform other functions" (’562 Patent, col. 12:65-13:1), suggesting a general-purpose event-marking capability. The Zio Monitor diagram stating the button is for when a "symptom is felt" appears to fall squarely within this purpose (Compl. p. 9).
- Evidence for a Narrower Interpretation: A defendant could argue for a more specific meaning of "mark an event," for instance, requiring the creation of a specific type of data flag or timestamp in the stored record that is distinct from what the Zio button does, though the specification provides little basis for such a narrow reading.
VI. Other Allegations
- Willful Infringement: The complaint does not explicitly use the word "willful." However, it requests enhanced damages up to three times the award under 35 U.S.C. § 284 and a finding that the case is "exceptional" under 35 U.S.C. § 285, remedies often associated with findings of willful infringement (Compl. p. 11, B, D). The complaint does not allege any specific facts to support pre-suit knowledge by iRhythm, such as prior correspondence or knowledge of the patent family.
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of technological function: can the term "wireless transceiver," which in the patent specification is described as enabling communication with smartphones and servers, be construed to read on the accused Zio Monitor, a device whose described workflow relies on being physically mailed for data analysis? The outcome of this claim construction battle may be determinative for several asserted claims.
- A second key question will be one of evidentiary proof: for structural limitations like the "inline resistor" (’562 Patent) and "battery vertically aligned with a sealed housing" (’473 Patent), the case will depend on the evidence adduced during discovery. While the complaint provides a compelling quote from the defendant's CTO regarding the placement of "resistors," it is silent on the specific physical alignment of the battery and housing, creating a significant proof point for trial.