DCT
1:15-cv-11803
CardioNet LLC v. InfoBionic Inc
Key Events
Complaint
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: CardioNet, LLC (Delaware) and Braemar Manufacturing, LLC (Delaware)
- Defendant: InfoBionic, Inc. (Delaware)
- Plaintiff’s Counsel: Ropes & Gray LLP
- Case Identification: 1:15-cv-11803, D. Mass., 05/08/2015
- Venue Allegations: Plaintiff alleges venue is proper in the District of Massachusetts because Defendant’s principal place of business is in Lowell, Massachusetts, and it actively solicits and conducts business within the district.
- Core Dispute: Plaintiff alleges that Defendant’s MoMe® Kardia System, a remote cardiac monitoring platform, infringes four patents related to remote sensor monitoring and arrhythmia data analysis.
- Technical Context: The technology at issue is in the field of Mobile Cardiac Telemetry (MCT), which enables real-time, event-driven monitoring and analysis of a patient's cardiac data for arrhythmia detection and management.
- Key Procedural History: The complaint alleges that Defendant’s 510(k) submission for its accused product cited Plaintiff’s own commercial device as a predicate. It further alleges that numerous members of Defendant’s management team, including its co-founder and former CTO, are former employees of Plaintiff with direct experience related to the patented technology. The complaint also alleges specific instances of pre-suit knowledge of the patents-in-suit, including through citation in Defendant’s own patent prosecution and via direct communications between the parties’ counsel.
Case Timeline
| Date | Event |
|---|---|
| 1997-03-07 | Earliest Priority Date for '403 and '901 Patents |
| 2001-05-01 | '901 Patent Issue Date |
| 2003-11-26 | Earliest Priority Date for '850 and '996 Patents |
| 2005-09-06 | '403 Patent Issue Date |
| 2007-05-01 | '850 Patent Issue Date |
| 2011-01-01 | InfoBionic Founded (approximate, complaint states "in 2011") |
| 2011-03-15 | '996 Patent Issue Date |
| 2012-07-20 | Alleged Date of InfoBionic's Awareness of '901 and '996 Patents |
| 2012-12-31 | Patents-in-Suit Assigned to Braemar and Licensed to CardioNet |
| 2015-01-13 | Alleged Date of InfoBionic's Awareness of '403 Patent via Counsel |
| 2015-05-08 | Complaint Filing Date |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 6,940,403 - "Reprogrammable Remote Sensor Monitoring System"
Issued September 6, 2005.
The Invention Explained
- Problem Addressed: The patent addresses the need to monitor remotely located individuals, such as the elderly or infirm, who may not be able to recognize or report signs of distress, noting that periodic manual checks by phone or in person can be unreliable and untimely (’901 Patent, col. 1:36-54).
- The Patented Solution: The invention provides a system with a patient-worn portable monitoring unit and a central monitoring device. To conserve power, the portable unit’s microprocessor remains in an "inactive state" until awakened by an "activating parameter," such as a predefined sensor reading (e.g., an abnormal heartbeat) or a request from the central device. Upon activation, it transmits the subject's status and location to the central device for analysis and potential intervention (’901 Patent, Abstract; col. 2:1-23).
- Technical Importance: This event-driven approach enabled continuous, real-time remote monitoring that was more reliable than periodic check-ins while addressing the critical constraint of battery life in portable medical devices (’901 Patent, col. 1:55-61).
Key Claims at a Glance
- The complaint asserts independent claim 1 (Compl. ¶26).
- The essential elements of claim 1 include:
- An apparatus for remote monitoring comprising at least one automatic sensor and a portable monitoring unit.
- The portable monitoring unit is capable of communicating with a central monitoring device.
- The portable unit contains a programmable microprocessor that is responsive to activating parameters, which can be either a preselected state of the sensor or a request signal from an external source.
- The portable unit also includes a transceiver for communication and a power supply.
- The complaint does not explicitly reserve the right to assert dependent claims.
U.S. Patent No. 6,225,901 - "Reprogrammable Remote Sensor Monitoring System"
Issued May 1, 2001.
The Invention Explained
- Problem Addressed: As a parent to the ’403 patent, this patent addresses the same problem of providing reliable, real-time monitoring for remote subjects while overcoming the limitations of manual checks (’901 Patent, col. 1:36-54).
- The Patented Solution: The solution is functionally identical to that of the ’403 patent, centered on a portable monitoring unit that uses an event-based activation system to transmit sensor and location data to a central device. This patent’s claims, however, distinctly recite a "central monitoring device" as a required element of the apparatus and specify that the microprocessor is "remotely programmable" (’901 Patent, Abstract; col. 2:45-48).
- Technical Importance: The invention provided a framework for adaptable, power-efficient, real-time remote monitoring systems that could be updated or reconfigured without physical access to the device (’901 Patent, col. 6:45-52).
Key Claims at a Glance
- The complaint asserts independent claim 1 (Compl. ¶39).
- The essential elements of claim 1 include:
- An apparatus for remote monitoring comprising a central monitoring device, at least one automatic sensor, and a portable monitoring unit.
- The portable monitoring unit contains a remotely programmable microprocessor responsive to activating parameters (a preselected sensor state or an external request signal).
- The portable unit also includes a transceiver and a power supply.
- The complaint does not explicitly reserve the right to assert dependent claims.
U.S. Patent No. 7,212,850 - "System and Method for Processing and Presenting Arrhythmia Information to Facilitate Heart Arrhythmia Identification and Treatment"
- Patent Identification: U.S. Patent No. 7,212,850, "System and Method for Processing and Presenting Arrhythmia Information to Facilitate Heart Arrhythmia Identification and Treatment," issued May 1, 2007 (Compl. ¶9).
- Technology Synopsis: This patent describes a system for reporting arrhythmia information. The system processes physiological data to identify arrhythmia events, receives human-assessed arrhythmia information from a monitoring station (e.g., a technician's review), and presents the information pictographically. The presentation uses a common time scale to show heart rate trends alongside "arrhythmia event burden," which represents the duration and frequency of arrhythmia episodes (’850 Patent, Abstract; col. 2:45-53).
- Asserted Claims: Independent claim 31 (Compl. ¶53).
- Accused Features: The complaint accuses the MoMe® Kardia System, specifically its cloud server and reporting interface, which allegedly receives automated ECG data, accepts human assessments from clinicians, and generates a graphical display showing heart rate trends and arrhythmia events over a 24-hour period (Compl. ¶56-60).
U.S. Patent No. 7,907,996 - "System and Method for Processing and Presenting Arrhythmia Information to Facilitate Heart Arrhythmia Identification and Treatment"
- Patent Identification: U.S. Patent No. 7,907,996, "System and Method for Processing and Presenting Arrhythmia Information to Facilitate Heart Arrhythmia Identification and Treatment," issued March 15, 2011 (Compl. ¶10).
- Technology Synopsis: This patent claims a machine-readable medium (e.g., software) embodying instructions for processing cardiac data. The claimed operations include identifying atrial fibrillation (AFib) events, receiving a human assessment of a subset of those events, and, based on that human assessment, pictographically presenting heart rate data aligned with AFib activity. The presentation shows a heart rate trend with AFib burden and includes a range of heart rates and an average heart rate for given time intervals (’996 Patent, Abstract; Claim 12).
- Asserted Claims: Independent claim 12 (Compl. ¶66).
- Accused Features: The complaint accuses the software of the MoMe® Kardia System. It alleges the software identifies AFib events, allows for human review and assessment, and generates a display that presents heart rate trends with AFib burden, including minimum, maximum, and average heart rate data (Compl. ¶69-73).
III. The Accused Instrumentality
Product Identification
- The accused instrumentality is Defendant InfoBionic's MoMe® Kardia System (Compl. ¶15).
Functionality and Market Context
- The MoMe® Kardia System is a remote patient monitoring platform designed for cardiac arrhythmia detection. It comprises a "front end device worn by the patient" that collects ECG, heart rate, and motion data, which it streams to a dedicated smartphone (Compl. ¶29). The smartphone then transmits this data via a cellular network to a "remote server" or "cloud server" for analysis using proprietary algorithms (Compl. ¶30, ¶32). The system allows physicians to remotely switch between Holter, Event, and MCT monitoring modes (Compl. ¶15). The cloud server is also configured to receive assessments of detected arrhythmias from technicians and physicians through a computer interface (Compl. ¶57).
- The complaint alleges the MoMe® Kardia System is a direct competitor to Plaintiff's MCOT™ system and that its FDA 510(k) submission relied on the MCOT™ as a predicate device (Compl. ¶17-18).
IV. Analysis of Infringement Allegations
'403 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| at least one automatic sensor associated with and monitoring the condition of the human subject | The system's "front end device" is worn by the patient and uses electrodes to collect ECG, heart rate, and motion data. | ¶29 | col. 2:26-27 |
| a portable monitoring unit capable of communicating with a central monitoring device | The combination of the front-end device and a dedicated smartphone allegedly constitutes the portable unit, which transmits data to a remote cloud server that acts as the central monitoring device. | ¶30 | col. 4:10-16 |
| a programmable microprocessor...being responsive to the occurrence of any of a set of activating parameters...selected from the group consisting of a preselected state of the at least one automatic sensor and a request signal from an external source | The microprocessor allegedly controls data collection and accepts requests for data from the cloud server upon arrhythmia detection, which constitutes both a sensor-based trigger and an external request. | ¶31 | col. 2:10-14 |
| a first transceiver in communication with the microprocessor, for communicating signals between the microprocessor and the central monitoring device | Data is transmitted from the patient-worn device to a smartphone via Bluetooth® and from the smartphone to the cloud server via a cellular network, which involves transceivers. | ¶32 | col. 4:24-28 |
| a power supply connected to provide power to at least one of the microprocessor and the first transceiver | The patient-worn device and the smartphone each contain a battery to power their respective components, including the microprocessor and transceivers. | ¶33 | col. 5:21-25 |
'901 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| a central monitoring device | The system's "remote server" and "cloud computing based ambulatory ECG monitoring and arrhythmia detection system" allegedly constitute the central monitoring device. | ¶42 | col. 2:40-45 |
| at least one automatic sensor associated with and monitoring the condition of the human subject | The "front end device" worn by the patient uses electrodes to collect ECG, heart rate, and motion data. | ¶43 | col. 2:26-27 |
| a portable monitoring unit...comprising a remotely programmable microprocessor...responsive to the occurrence of any of a set of activating parameters... | The microprocessor in the device allegedly controls data collection, responds to triggers, and is "remotely programmable because it is able to accept data and instructions from the MoMe® Kardia cloud server." | ¶45 | col. 2:45-48 |
| a first transceiver in communication with the microprocessor, for communicating signals between the microprocessor and the central monitoring device | Data is transmitted via Bluetooth® from the device to a smartphone and then via a cellular network to the cloud server. | ¶46 | col. 4:24-28 |
Identified Points of Contention
- Scope Questions: The infringement theory for the ’403 and ’901 patents relies on combining a "front end device" and a separate "dedicated smartphone" to meet the single "portable monitoring unit" limitation. This raises the question of whether the claimed term, depicted as an integrated device in the patent figures, can be construed to cover a distributed, two-part physical architecture (’901 Patent, Fig. 1).
- Technical Questions: For the ’850 and ’996 patents, the complaint provides a screenshot of the accused system's reporting interface, which allegedly shows heart rate data and arrhythmia events on a common time scale (Compl. p. 18, ¶60). A key technical question will be whether this pictographical presentation, which includes human-verified events, performs the specific functions required by the claims, such as presenting a "heart rate trend" with "arrhythmia event burden" in the manner claimed (’850 Patent, col. 15:10-16). The complaint includes a second reference to the same visual, noting it displays minimum, maximum, and average heart rate, which maps to a limitation in the ’996 patent (Compl. p. 23, ¶73).
V. Key Claim Terms for Construction
The Term: "portable monitoring unit"
(from claims 1 of both the '403 and '901 patents)
- Context and Importance: The definition of this term is critical because the accused MoMe® Kardia System consists of two separate physical devices (a sensor pod and a smartphone), which the complaint collectively identifies as the "portable monitoring unit" (Compl. ¶30, ¶44). The patent specification, particularly Figure 1, visually depicts the "portable monitoring unit" as a single, integrated apparatus. Practitioners may focus on this term because its construction will determine whether a distributed architecture can infringe claims that may be interpreted as requiring a unitary device.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The patent abstract states the unit is "carried or worn by a person or animal," which does not foreclose a multi-component system worn together (’901 Patent, Abstract). The claims focus on the functional relationship between components (microprocessor, sensor, transceiver) rather than their physical housing.
- Evidence for a Narrower Interpretation: Figure 1 of the patent depicts all core components of the "portable monitoring unit (12)" enclosed within a single dotted line, suggesting they are part of a single physical device (’901 Patent, Fig. 1). The specification repeatedly refers to "the portable monitoring unit" in the singular, which could imply a single piece of hardware.
The Term: "remotely programmable microprocessor"
(from claim 1 of the '901 patent)
- Context and Importance: This term distinguishes the ’901 patent and is central to the infringement allegation, which states the microprocessor is programmable because it can "accept data and instructions" from the cloud server (Compl. ¶45). The dispute will likely center on what level of "instructions" qualifies as "reprogramming."
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification discusses changing "activating parameters and the functioning of the portable monitoring unit" remotely, which could encompass receiving commands or updating operational settings short of a full software rewrite (’901 Patent, col. 4:46-49).
- Evidence for a Narrower Interpretation: The detailed description provides examples of reprogramming that include downloading "a new version of the application PMU software" and performing "reconfiguration," which suggests a more substantial modification than receiving routine operational commands or data requests (’901 Patent, col. 6:45-52; col. 8:44-46).
VI. Other Allegations
Indirect Infringement
- The complaint focuses its formal counts on direct infringement under 35 U.S.C. § 271. It does not explicitly plead separate counts for induced or contributory infringement.
Willful Infringement
- The complaint makes detailed allegations of willful infringement for all four patents-in-suit. The allegations are based on both pre-suit and post-suit knowledge. The bases for willfulness include: (1) InfoBionic’s alleged hiring of numerous former CardioNet employees with knowledge of the patented technology (Compl. ¶19-24, ¶35); (2) InfoBionic’s citation of the ’901 and ’996 patents as prior art during the prosecution of its own patents, allegedly establishing knowledge as early as July 2012 (Compl. ¶48, ¶74); and (3) specific notice provided by Plaintiff’s counsel to Defendant’s counsel regarding the patents prior to the lawsuit (Compl. ¶34, ¶48).
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of architectural scope: can the term "portable monitoring unit," described in the '403 and '901 patent specifications and depicted in figures as an integrated device, be construed to read on the accused MoMe® Kardia System's two-part architecture of a separate sensor pod and a smartphone?
- A key evidentiary question will be one of operational function: does the accused system's microprocessor, which the complaint alleges "streams" data for subsequent cloud-based analysis, perform the claimed function of being locally "responsive to... a preselected state of the... sensor" to trigger transmission, or is there a fundamental mismatch in the operational trigger mechanism required by the '403 and '901 patent claims?
- The analysis of the '850 and '996 patents will likely turn on a hybrid data question: does the accused system's graphical display, which combines automated arrhythmia detection with subsequent "human-assessed" verification, satisfy the specific claim limitations requiring the pictographical presentation of a "heart rate trend" with "arrhythmia event burden"?