DCT
1:25-cv-00506
New Directions Technology Consulting LLC v. Abbott Laboratories Inc
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: New Directions Technology Consulting, LLC (Delaware)
- Defendant: Abbott Laboratories Inc. (Delaware) and Bigfoot Biomedical, Inc. (Delaware)
- Plaintiff’s Counsel: Heyman Enerio Gattuso & Hirzel LLP; Hecht Partners LLP
- Case Identification: 1:25-cv-00506, D. Del., 04/25/2025
- Venue Allegations: Venue is alleged to be proper in the District of Delaware because both Defendants are incorporated in Delaware and therefore reside in the district.
- Core Dispute: Plaintiff alleges that Defendants’ connected medical device systems, including glucose monitors and pacemakers, infringe four patents related to remote device monitoring, data reporting, and medication telemanagement.
- Technical Context: The technology at issue involves systems and methods for medical devices or their containers to sense usage, location, and other data, and communicate that information to a central facility, often via a mobile device, to improve patient care and adherence.
- Key Procedural History: The complaint alleges that Defendants had pre-suit knowledge of the Asserted Patents since at least January 20, 2016, based on a conference presentation, and again from a June 2021 online article, which forms the basis for the willfulness allegations.
Case Timeline
| Date | Event |
|---|---|
| 2006-07-13 | Earliest Priority Date for ’393, ’778, ’111, and ’658 Patents |
| 2011-01-18 | U.S. Patent No. 7,871,393 Issues |
| 2011-10-25 | U.S. Patent No. 8,044,778 Issues |
| 2012-04-03 | U.S. Patent No. 8,149,111 Issues |
| 2012-07-03 | U.S. Patent No. 8,212,658 Issues |
| 2016-01-20 | Alleged first date of Defendants’ pre-suit knowledge of patents |
| 2021-06-30 | Alleged second date of Defendants’ pre-suit knowledge of patents |
| 2025-04-25 | Complaint Filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 7,871,393 - "Injection Device with Reporting Ability", issued January 18, 2011 (’393 Patent)
The Invention Explained
- Problem Addressed: The patent describes the need for improved management and tracking of medical products, particularly emergency-use injection devices. A key problem is that after a self-administered injection in a high-threat situation (e.g., for an allergic reaction), rescue personnel need to know the patient's location and the substance that was administered to provide effective aid (Compl. ¶16; ’393 Patent, col. 14:15-22).
- The Patented Solution: The invention is a "central facility" that communicates with a smart injector. The patent describes an injector that can compare its own location at different times to determine if it is being carried. If it is not being carried, it sends a signal to the central facility, which can then issue a reminder to the associated person. The central facility maintains a database linking the injector's ID to its contents and its user, enabling an appropriate and informed response (Compl. ¶32; ’393 Patent, Abstract; col. 15:28-41).
- Technical Importance: This technology provided a framework for automated remote monitoring of patient adherence (i.e., carrying a required device) and for initiating an emergency response with critical contextual data about the patient, location, and treatment administered (’393 Patent, col. 14:15-36).
Key Claims at a Glance
- The complaint asserts independent Claim 1 (Compl. ¶31).
- The essential elements of Claim 1 are:
- A central facility comprising:
- A communications interface for receiving a signal indicating an injector is not being carried by its associated person, where the signal results from a comparison at the injector of two of its location reports;
- A database storing a record linking the injector to its contents, its user, and a contact method; and
- Means for generating a reminder to carry the injector, using the contact method, in response to the received signal.
- The complaint does not explicitly reserve the right to assert dependent claims for this patent.
U.S. Patent No. 8,044,778 - "Injection Device and Case with Reporting Ability", issued October 25, 2011 (’778 Patent)
The Invention Explained
- Problem Addressed: The patent addresses the general need for better data collection and reporting related to medical products, including tracking a product through its lifecycle, monitoring usage, and reporting exception events to a central facility (Compl. ¶17; ’778 Patent, col. 1:13-18).
- The Patented Solution: The invention is a "container for a product" (such as a case for an auto-injector) that is itself intelligent. The container includes a "location circuit" to determine its location, a storage element for identification and access codes, and data acquisition components to monitor at least two characteristics, one of which must indicate "use of the product." The container uses a communication interface to generate and send a signal with this collected data to a central facility (’778 Patent, Abstract; col. 44:8-27).
- Technical Importance: This approach extended the concept of a "smart device" from the medical product itself to its carrying case or container, enabling the system to track and monitor the product's status, location, and usage history remotely (’778 Patent, col. 1:13-18).
Key Claims at a Glance
- The complaint asserts independent Claims 1, 9, 11, 23, 25, 27, and 29 (Compl. ¶¶41-47, 137).
- The essential elements of independent Claim 1 are:
- A container for a product comprising:
- A location circuit for determining the container's location;
- A storage element for an access code and a container identification code;
- A plurality of data acquisition components to acquire the status of at least two characteristics, with one characteristic indicating product use; and
- A communication interface to generate and send an event signal containing the access code, container ID, location, and status of the characteristics.
- The complaint does not explicitly reserve the right to assert dependent claims for this patent.
U.S. Patent No. 8,149,111 - "Central Facility that Communicates with Portable Container via Mobile Device", issued April 3, 2012 (’111 Patent)
Technology Synopsis
This patent addresses the integration of multiple data streams from a portable medical container. The invention is a method for a central facility computer to receive usage data (from a usage sensor in the container), environmental data (from an environmental sensor), and patient data (from a patient sensor) via a mobile device (Compl. ¶140; ’111 Patent, Abstract). The central facility stores this data, analyzes it against "situational rules" to determine an action, and sends action data back to the mobile device and/or notice data to a third party (’111 Patent, Abstract).
Asserted Claims
The complaint asserts independent Claim 1 (Compl. ¶139).
Accused Features
The complaint alleges that the central facilities (Bigfoot Clinic Hub and Merlin.Net PCN) perform the claimed method by communicating with the Accused Glucose Monitor and Accused Pacemakers (the "portable container") via a smartphone (the "mobile device") to receive, store, analyze, and transmit data (Compl. ¶¶141, 145-154).
U.S. Patent No. 8,212,658 - "Product Container for Use with Device Capable of Long-Range and Short-Range Communications", issued July 3, 2012 (’658 Patent)
Technology Synopsis
This patent describes a smart product container designed to identify a nearby person in addition to sensing its own status. The claimed container includes components for detecting that it has been opened, for sensing the identity of a nearby person who is a member of a registered group, and for sensing use of the product (Compl. ¶163; ’658 Patent, Abstract). A processor directs a local communication interface to send this information, along with access codes and instructions for location reporting, to an external device (e.g., a smartphone) for transmission to a central facility (’658 Patent, Abstract).
Asserted Claims
The complaint asserts independent Claims 1, 9, 11, and 17 (Compl. ¶¶162, 170, 175, 180).
Accused Features
The Accused Glucose Monitor and Accused Pacemakers are alleged to be infringing "containers" that sense product use and the identity of the nearby person (the patient), who is registered at the central facility (Compl. ¶¶167-168, 188-190).
III. The Accused Instrumentality
Product Identification
The complaint names two categories of Accused Products: (i) the "Accused Glucose Monitor," identified as the Bigfoot Unity Diabetes Management system which includes a smart insulin pen cap, sensor, and mobile application; and (ii) the "Accused Pacemaker Products," which include the CardioMEMS HF System, various pacemakers (AVEIR, Assurity, Endurity), and the Merlin.Net patient care network (Compl. ¶6).
Functionality and Market Context
- The Accused Glucose Monitor is described as a system where a smart cap for an insulin pen automatically captures glucose and dosing data and uploads it to a central online portal (the "Bigfoot Clinic Hub") via a patient's smartphone (Compl. ¶34). The system provides dosing recommendations on the pen cap's screen and sends alerts to the smartphone app (Compl. ¶¶34, 36).
- The Accused Pacemaker and CardioMEMS systems are described as implantable devices that communicate patient data, such as cardiac activity or pulmonary artery pressure readings, to a central facility known as the Merlin.Net PCN (Compl. ¶¶73, 108, 145). This communication occurs via an external device, such as a patient's smartphone running a mobile app (e.g., myMerlinPulse) or a dedicated Merlin@home transmitter (Compl. ¶¶73, 108, 146). The complaint alleges these products are central to Defendants' offerings for cardiovascular and diabetes care (Compl. ¶11).
- No probative visual evidence provided in complaint.
IV. Analysis of Infringement Allegations
’393 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A central facility comprising: a communications interface for receiving a signal relating to an injector, the signal indicating that the injector is not being carried by a person associated with the injector... | The Bigfoot Clinic Hub is a central facility with an interface for receiving signals related to the injector (the smart pen cap and insulin pen). | ¶34 | col. 16:6-9 |
| ...the signal resulting from a comparison at the injector of two location reports of the injector, | The signal indicates the injector is "out of range," which allegedly corresponds to not being carried. | ¶36 | col. 16:9-12 |
| a database for storing a record relating to the injector, the record indicating the contents of the injector, an identity of the person associated with the injector, and a contact method for contacting the person... | The central facility includes a database that stores glucose readings, dosage recommendations (contents), and the identity of the person associated with the injector. | ¶35 | col. 16:13-17 |
| means for generating a reminder to carry the injector, according to the contact method, in response to the signal... | The central facility sends alerts to the patient's smartphone to remind them to carry the injector. | ¶36 | col. 16:18-22 |
’778 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A container for a product, comprising: | The pen caps in combination with the insulin pen, the housing for the CardioMEMS sensor, and the housing for the pacemakers are alleged to be the "container." | ¶¶49, 75, 104 | col. 44:9 |
| a location circuit for determining the location of the container, | The RFID or chip in the pen caps, the Patient Electronics System for CardioMEMS, and wireless telemetry for the pacemakers are alleged to be the "location circuit." | ¶¶50, 76, 122 | col. 44:10-11 |
| a storage element for storing an access code for a central facility, and a container identification code, | The Bigfoot Clinic Hub, Merlin.Net PCN, and associated apps or memory store access codes and container/device identification codes (e.g., UDI number). | ¶¶51, 79, 105-106 | col. 44:12-14 |
| a plurality of data acquisition components for acquiring status of at least two characteristics... one of the characteristics indicating use of the product, and | The systems acquire at least two characteristics, such as tracking the time since the last insulin dose, detecting the emission of RF signals, or detecting a cardiac pacing event, which allegedly indicates "use of the product." | ¶¶52, 80, 107 | col. 44:15-20 |
| a communication interface for generating and sending an event communication signal including (a) the access code... (b) the container identification code... (c) the location... and (d) the status of the at least two characteristics... | The systems generate and send communication signals containing the required data elements via data sharing between the apps, devices, and central facilities. | ¶¶53-56, 81-87, 108-112 | col. 44:21-27 |
Identified Points of Contention
- Scope Questions: For the ’778 Patent, a question may arise as to whether the term "container for a product," as used in the patent, can be construed to read on the housing of an implantable medical device itself, such as a pacemaker's pulse generator casing, as alleged (Compl. ¶104). Similarly, the scope of "location circuit" raises a question: does this term read on an RFID chip that is passively located by an external reader, or does it require a self-contained capability to determine its own geographic coordinates, such as a GPS receiver?
- Technical Questions: The infringement theory for Claim 1 of the ’393 Patent hinges on whether the accused system generates "a signal resulting from a comparison at the injector of two location reports." The complaint alleges the central facility is informed that the injector is "out of range" (Compl. ¶36). This raises the evidentiary question of where the comparison of location data occurs. If the comparison is performed at the smartphone or the central facility rather than at the injector itself, it may not meet this specific claim limitation.
V. Key Claim Terms for Construction
Term 1 (’393 Patent): "signal resulting from a comparison at the injector"
- Context and Importance: The location of the "comparison" is central to the infringement analysis for the ’393 Patent. The claim language specifies the comparison of location reports happens "at the injector." If this is construed to mean within the physical injector device itself, infringement may depend on whether the accused pen cap performs this local computation before signaling is sent to the smartphone or central facility.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: A party might argue that "at the injector" should be interpreted functionally to include the injector's immediate electronic environment, such as a paired smartphone that is essential to its operation, thus encompassing a comparison that happens on the phone.
- Evidence for a Narrower Interpretation: The plain language "at the injector" provides strong support for a narrow construction requiring the comparison to be performed by a processor within the injector device itself. The patent specification separately describes an embodiment where a central facility performs the comparison, but Claim 1 is worded differently, suggesting the claim's scope is intentionally narrower than the full disclosure (’393 Patent, col. 15:35-41).
Term 2 (’778 Patent): "location circuit"
- Context and Importance: The definition of this term is critical because the complaint maps it to different technologies across the accused products, including an "RFID or chip" and "wireless RF telemetry" (Compl. ¶¶50, 122). Practitioners may focus on this term because its construction will determine whether these technologies, which are typically located by an external system, meet the claim requirement of a "circuit for determining the location of the container."
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: A party could argue that in the context of the invention, any electronic circuit that enables the system to determine the container's location satisfies this element, regardless of whether the computation is performed locally or externally.
- Evidence for a Narrower Interpretation: The patent's abstract explicitly states that "Generally, the location circuit uses the global positioning system (GPS)" (’778 Patent, Abstract). This language provides strong intrinsic evidence that the inventor contemplated a circuit with the capability to determine its own geographic coordinates, which could support a narrower construction that excludes passive RFID tags or general telemetry transponders.
VI. Other Allegations
Indirect Infringement
While not pleaded as separate counts, the complaint contains allegations that may support claims of indirect infringement. The complaint alleges that Defendants manufacture and sell the accused systems, which include mobile applications and user instructions that direct patients and healthcare providers on how to use the systems in an allegedly infringing manner (Compl. ¶¶31, 34, 40, 73).
Willful Infringement
The complaint includes a specific count for willful infringement, alleging that Defendants have known of the Asserted Patents and their infringement since at least January 20, 2016 (Compl. ¶¶210-218). The basis for this alleged pre-suit knowledge is a presentation by Plaintiff's Managing Director at a conference that Defendants' representatives allegedly attended, and a subsequent online article published in June 2021 on a website to which Defendants were allegedly subscribers (Compl. ¶¶21-25).
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of functional locus: for the ’393 patent, can the claim requirement of a "comparison at the injector" be met by a system where the operative comparison of location data may occur on a connected smartphone or at a remote central server, rather than within the physical injector device itself?
- A second central issue will be one of definitional scope: for the ’778 patent, can the term "location circuit" be construed broadly to cover passive technologies like RFID chips that are located by an external reader, or is it limited by the patent's disclosure to systems with an active, self-contained capability for determining geographic position, such as a GPS receiver?
- A key evidentiary question for willfulness will be whether Plaintiff can establish that Defendants had actual, pre-suit knowledge of the specific patents-in-suit and their alleged infringement based on the alleged attendance at a 2016 conference and subscription to an online publication.