DCT
1:17-cv-01110
Bareholdtech LLC v. Roche Diabetes Care Inc
Key Events
Complaint
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Bareholdtech LLC (Texas)
- Defendant: Roche Diabetes Care, Inc. (Delaware)
- Plaintiff’s Counsel: Stamoulis & Weinblatt LLC; Fee, Smith, Sharp & Vitullo, L.L.P.
- Case Identification: 1:17-cv-01110, D. Del., 08/08/2017
- Venue Allegations: Venue is alleged to be proper in the District of Delaware because the Defendant is incorporated in Delaware and is therefore deemed to reside in the district.
- Core Dispute: Plaintiff alleges that Defendant’s Accu-Chek Aviva Connect blood glucose monitoring system infringes a patent related to a prescription compliance device and method.
- Technical Context: The technology concerns remote health monitoring systems that track a patient's adherence to a prescribed therapy and provide notifications based on that compliance data.
- Key Procedural History: The complaint does not mention any prior litigation, Inter Partes Review (IPR) proceedings, or licensing history related to the patent-in-suit.
Case Timeline
| Date | Event |
|---|---|
| 2001-06-22 | U.S. Patent No. 7,944,342 Priority Date (Provisional) |
| 2011-05-17 | U.S. Patent No. 7,944,342 Issued |
| 2017-08-08 | Complaint Filed |
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 describes prior art compliance devices as being "complex and costly, inconvenient to program, and have not been flexible enough in establishing varying time intervals at which the medication needs to be administered" (’342 Patent, col. 1:41-44).
- The Patented Solution: The invention is a programmable device that aids patient compliance with medication regimens. It includes a microcontroller, memory for storing regimens, a display, and an alarm (’342 Patent, Abstract). The device can be programmed directly by the user or remotely via a wireless link to an external device like a personal computer, which can select a regimen and program the device accordingly (’342 Patent, col. 2:46-55). When a patient takes a dose, they activate an "event switch" which records the event and calculates the next scheduled dose time (’342 Patent, col. 2:34-39).
- Technical Importance: The invention aimed to provide a more flexible and user-friendly system for managing complex, multi-medication schedules, including remote programming and data access capabilities for caregivers or physicians (’342 Patent, col. 2:12-17).
Key Claims at a Glance
- The complaint asserts at least independent claims 1 and 3 (Compl. ¶11).
- Independent Claim 1 (Method):
- measuring therapy compliance of a patient using a device connected to a base station via a wireless connection;
- transmitting the therapy compliance measurements to the base station via the wireless connection;
- storing the therapy compliance measurements at the base station;
- evaluating patient compliance at the base station based on the stored therapy compliance measurements;
- identifying instances in the evaluating in which patient compliance meets predetermined compliance requirements; and
- sending a notification, about one or more of the instances, to a party based on patient compliance such that action can be taken by the party.
- Independent Claim 3 (Device):
- a measuring unit configured to measure therapy compliance of a patient; and
- a communication unit configured to connect to a base station which stores the therapy compliance measurements, evaluates patient compliance, identifies instances where compliance meets requirements, sends a notification for action, and transmits the compliance measurements to the base station.
- The complaint does not explicitly reserve the right to assert dependent claims.
III. The Accused Instrumentality
Product Identification
- The "Accu-Chek Aviva Connect" system, which includes a blood glucose meter, a smartphone application, and an online portal (Compl. ¶12).
Functionality and Market Context
- The Accu-Chek Aviva Connect meter measures a patient's blood glucose levels (Compl. ¶12). The system uses wireless technology to "Automatically send test results to your smartphone" and an associated "online portal" (Compl. ¶12). An image from the product's website shows the meter, its packaging, and promotional text describing its wireless connectivity. (Compl. ¶12, p. 4). The complaint alleges this system is used for "facilitating patient compliance to medical therapy" (Compl. ¶12).
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 Accu-Chek Aviva Connect meter measures blood glucose levels and connects wirelessly to a smartphone, which the complaint implicitly defines as the "base station." | ¶9, ¶12 | col. 29:63-66 |
| transmitting the therapy compliance measurements to the base station via the wireless connection | The meter wirelessly transmits the test results to the smartphone app and online portal. | ¶9, ¶12 | col. 30:1-3 |
| storing the therapy compliance measurements at the base station | The smartphone app and online portal store the transmitted test results. | ¶9, ¶12 | col. 30:4-5 |
| evaluating patient compliance at the base station based on the stored therapy compliance measurements | The complaint alleges the Accused Instrumentality performs this function, but does not provide specific facts detailing how the smartphone app or portal evaluates the stored data. | ¶9, ¶12 | col. 30:6-9 |
| identifying instances in the evaluating in which patient compliance meets predetermined compliance requirements | The complaint alleges the system performs this step but does not specify what "predetermined compliance requirements" are used or how instances of meeting them are identified. | ¶9, ¶12 | col. 30:10-13 |
| sending a notification, about one or more of the instances, to a party based on patient compliance such that action can be taken by the party | The complaint alleges a notification is sent but does not identify the nature of the notification, the party to whom it is sent, or the action to be taken. | ¶9, ¶12 | col. 30:14-18 |
- Identified Points of Contention:
- Scope Questions: A primary question will be whether the term "base station", as used in the patent, can be construed to cover a general-purpose smartphone running an application, as alleged by the complaint. Similarly, it raises the question of whether measuring blood glucose falls within the scope of "measuring therapy compliance" as contemplated by the patent, which focuses on medication-taking events.
- Technical Questions: The complaint alleges that the accused system "evaluates" compliance and "sends a notification...such that action can be taken." A central technical question will be what evidence demonstrates that the accused smartphone app and portal perform these specific logical functions, as opposed to merely logging and displaying data for user review. The complaint does not provide factual detail on these operational steps.
V. Key Claim Terms for Construction
The Term: "base station"
Context and Importance: The definition of "base station" is critical because the infringement theory depends on casting the user's smartphone as this central component. The defense may argue that a "base station" in the context of the ’342 patent implies a more dedicated piece of hardware or a system with specific functionalities not present in a standard smartphone.
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification discloses that the system can be programmed remotely via a wireless link from an "input device, such as a personal computer (PC)" (’342 Patent, col. 10:50-53), which may support construing "base station" to include general-purpose computing devices.
- Evidence for a Narrower Interpretation: The detailed description and figures of the "first embodiment" depict a dedicated prescription compliance device communicating with external systems but do not explicitly show a general-purpose mobile phone acting as the primary "base station" for storage and evaluation (’342 Patent, FIG. 7, col. 10:40-53).
The Term: "evaluating patient compliance"
Context and Importance: This term is crucial because infringement requires more than just data logging; it requires an active "evaluation." Practitioners may focus on this term because the complaint offers no facts on how the accused system performs this step. The outcome may depend on whether "evaluation" requires the specific logic for missed or early doses described in the patent or if a more general analysis of data trends suffices.
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The plain language of the claim itself does not specify a particular method of evaluation, which could support a construction that covers any process of assessing compliance based on stored data.
- Evidence for a Narrower Interpretation: The specification provides detailed flowcharts and descriptions of how the invention evaluates compliance, such as by detecting a missed dose and displaying "MISS" or an early dose and displaying "ERR" (’342 Patent, FIG. 3D, col. 7:20-38). This may support a narrower construction limited to these or similar specific evaluative functions.
VI. Other Allegations
- Indirect Infringement: The complaint alleges that the Defendant induces infringement by "intentionally instruct[ing] its customers to infringe the ’342 patent" (Compl. ¶13). The complaint does not, however, cite specific user manuals, marketing materials, or other instructions that allegedly direct infringing use.
- Willful Infringement: Willfulness is alleged based on Defendant’s knowledge of the patent "from at least the date of the filing of this lawsuit" (Compl. ¶16). This asserts post-suit willfulness.
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 describes in the context of a dedicated compliance device or a PC, be construed to cover a user's general-purpose smartphone running an application?
- A key evidentiary question will be one of functional operation: does the Accu-Chek Connect system, which is marketed for logging blood glucose data, actually perform the specific, multi-step method of "evaluating" compliance, "identifying instances" of meeting requirements, and "sending a notification...such that action can be taken," as mandated by the claims? The complaint's lack of specific factual allegations on these points suggests this will be a central area of dispute.