DCT
1:17-cv-00910
Bareholdtech LLC v. Telcare Medical Supply Inc
Key Events
Complaint
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Bareholdtech LLC (Texas)
- Defendant: Telcare Medical Supply, Inc. d/b/a Telcare, Inc. (Delaware)
- Plaintiff’s Counsel: Stamoulis & Weinblatt LLC; Fee, Smith, Sharp & Vitullo, L.L.P.
- Case Identification: 1:17-cv-00910, D. Del., 07/06/2017
- Venue Allegations: Venue is alleged to be proper in the District of Delaware because Defendant is a Delaware corporation and is therefore deemed to reside in the district.
- Core Dispute: Plaintiff alleges that Defendant’s cellular-enabled blood glucose meter and associated remote monitoring system infringes a patent related to facilitating and tracking patient compliance with medical therapy.
- Technical Context: The technology concerns the use of wireless communication to connect a patient-side medical device with a remote server or "base station" to enable centralized data collection, evaluation, and feedback for managing patient treatment.
- Key Procedural History: The complaint does not reference any prior litigation, inter partes review proceedings, or licensing history related to the patent-in-suit. The patent face indicates it is subject to a terminal disclaimer.
Case Timeline
| Date | Event |
|---|---|
| 2001-06-22 | '342 Patent Priority Date (U.S. Prov. App. 60/299,761) |
| 2011-05-17 | '342 Patent Issue Date |
| 2017-07-06 | Complaint Filing Date |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 7,944,342 - “Prescription Compliance Device and Method of Using Device”
- Patent Identification: U.S. Patent No. 7,944,342, “Prescription Compliance Device and Method of Using Device,” issued May 17, 2011.
The Invention Explained
- Problem Addressed: The patent’s background section identifies a need for a patient compliance aid that is less complex, less costly, and more flexible than prior art devices, which were often inconvenient to program and use ('342 Patent, col. 1:39-44).
- The Patented Solution: The invention is a system for aiding patient compliance that comprises a patient-side device and a remote programming capability. The device can be programmed with medication regimens, provide alerts, and record when a patient takes a dose ('342 Patent, Abstract). A key aspect is the use of a wireless link to communicate with an external device, such as a personal computer, for remote programming and data exchange, moving beyond standalone reminder tools ('342 Patent, col. 9:41-53).
- Technical Importance: The invention describes a framework for connecting a patient monitoring device to a remote computer system for data management, a foundational concept in the field of telemedicine and remote patient monitoring.
Key Claims at a Glance
- The complaint asserts independent claims 1 (a method) and 3 (a device) ('Compl. ¶11).
- Independent Claim 1 (Method) includes the essential elements of:
- Measuring therapy compliance using a device connected to a base station via a wireless connection
- Transmitting the measurements to the base station
- Storing the measurements at the base station
- Evaluating patient compliance at the base station
- Identifying instances where compliance meets predetermined requirements
- Sending a notification to a party based on the evaluation
- Independent Claim 3 (Device) includes the essential elements of:
- A monitoring device with a measuring unit for therapy compliance
- A communication unit configured to connect to a base station and transmit the compliance measurements to it
- The claim recites that the base station performs the functions of storing, evaluating, identifying instances of compliance, and sending a notification
- The complaint reserves the right to assert additional claims ('Compl. ¶20).
III. The Accused Instrumentality
Product Identification
- The "Telcare BGM" system, which includes a blood glucose meter and associated services ('Compl. ¶12).
Functionality and Market Context
- The Telcare BGM is a blood glucose meter that incorporates cellular communication technology to transmit patient data wirelessly ('Compl. p. 5). The complaint includes a visual from Defendant's website depicting the Telcare BGM device, a web-based portal on a laptop, and a mobile application, which collectively form the accused system ('Compl. p. 5). The device measures a patient's blood glucose, transmits the reading to a remote server, and can display feedback messages to the user, such as "You are right on target" ('Compl. p. 5). The web and mobile portals allegedly allow for the storage and review of patient compliance data ('Compl. p. 5).
IV. Analysis of Infringement Allegations
’342 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| measuring therapy compliance of a patient using a device connected to a base station via a wireless connection | The Telcare BGM device measures a patient's blood glucose level and contains a cellular modem for wireless connection to Defendant's servers (the alleged "base station"). | ¶12; p. 5 | col. 29:60-63 |
| transmitting the therapy compliance measurements to the base station via the wireless connection | The Telcare BGM device wirelessly transmits the blood glucose measurement data to Defendant's servers. | ¶12; p. 5 | col. 29:64-66 |
| storing the therapy compliance measurements at the base station | Defendant's servers allegedly store the transmitted blood glucose data, which is then made accessible through a web portal. The complaint includes a screenshot of a web portal displaying historical patient data ('Compl. p. 5). | ¶12; p. 5 | col. 30:1-2 |
| evaluating patient compliance at the base station based on the stored therapy compliance measurements | Defendant's servers allegedly evaluate the glucose data against predetermined targets to generate compliance feedback. | ¶12; p. 5 | col. 30:3-5 |
| identifying instances in the evaluating in which patient compliance meets predetermined compliance requirements | The system allegedly identifies when a reading is "on target," which is presented as meeting a compliance requirement. | ¶12; p. 5 | col. 30:6-8 |
| and sending a notification, about one or more of the instances, to a party based on patient compliance | The system sends a notification to the patient on the device screen (e.g., "You are right on target..."). The complaint includes a picture of the Telcare BGM displaying such a message ('Compl. p. 5). | ¶12; p. 5 | col. 30:9-12 |
- Identified Points of Contention:
- Scope Questions: A central issue may be whether the term "base station", which the patent’s specification describes as a "personal computer (PC)" ('342 Patent, col. 9:51-53), can be construed to cover the accused system’s distributed, cloud-based server infrastructure.
- Technical Questions: The patent's disclosure focuses on tracking compliance with medication-taking schedules. A question for the court will be whether "measuring therapy compliance" as claimed is broad enough to encompass measuring a physiological parameter (blood glucose) as an indicator of adherence to a broader disease management therapy.
- Technical Questions: The claims require the "evaluating" and "identifying" steps to occur "at the base station." A factual dispute may arise over whether these functions are performed at Defendant's remote servers, as alleged, or in whole or in part on the Telcare BGM device itself.
V. Key Claim Terms for Construction
The Term: "base station"
- Context and Importance: This term's construction is critical, as it defines a core component of the claimed system. The infringement case depends on this term covering Defendant's modern cloud-server architecture. Practitioners may focus on this term because the patent’s only specific embodiment describes a "personal computer" connected to a wireless transceiver via a "standard RS-232 serial interface" ('342 Patent, col. 9:51-53), which may suggest a more localized apparatus than the accused server system.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The claims define the "base station" by its function (storing, evaluating, etc.) rather than its physical structure, which may support an interpretation that is not limited to a specific type of computer like a PC.
- Evidence for a Narrower Interpretation: A party may argue that the specification’s consistent and sole example of a "personal computer" limits the scope of "base station" to a user-proximate, local computer and not a remote, distributed network of servers.
The Term: "measuring therapy compliance"
- Context and Importance: The resolution of this term will determine if the patent applies to monitoring physiological states (like blood glucose) or is limited to tracking the act of taking medication. The accused product measures a physiological state, whereas the patent specification is focused on medication adherence.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: Plaintiff may argue that for a disease like diabetes, "therapy" is a broad concept that includes monitoring blood glucose, and a measurement of that level is a direct measurement of "compliance" with the overall therapeutic regimen.
- Evidence for a Narrower Interpretation: The patent’s Abstract, Background, and Summary of the Invention repeatedly frame the invention in the context of "taking prescription medication" and following "medication-taking regimens" ('342 Patent, Abstract; col. 1:21-44), which may support an interpretation limited to tracking the event of consuming a dose.
VI. Other Allegations
- Indirect Infringement: The complaint alleges induced infringement, asserting Defendant "instructs its customers to infringe" and has done so with knowledge since at least the filing of the complaint ('Compl. ¶13-14). It also alleges contributory infringement, stating the accused system is "especially made or adapted" for infringement and has "no substantial non-infringing use" ('Compl. ¶15).
- Willful Infringement: Willfulness allegations are limited to conduct occurring "from at least the date of the filing of this lawsuit," suggesting a focus on post-suit conduct ('Compl. ¶16).
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of definitional scope: can the term "base station," which the patent discloses in the context of a 2001-era personal computer, be construed to cover the accused system's modern, cloud-based server infrastructure?
- A second central issue will be one of functional scope: does the claim term "measuring therapy compliance," rooted in the patent’s disclosure of tracking medication doses, extend to the accused product’s function of measuring a physiological state like a blood glucose level?
- A key evidentiary question will likely concern the location of the claimed data processing: what evidence will show that the "evaluating" and "identifying" functions are performed at the remote "base station," as required by the claims, rather than on the patient's local monitoring device?