DCT
3:18-cv-01653
Omni MedSci Inc v. Dexcom Inc
Key Events
Complaint
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Omni MedSci, Inc. (Michigan)
- Defendant: Dexcom, Inc. (Delaware)
- Plaintiff’s Counsel: BROOKS KUSHMAN P.C.
- Case Identification: 3:18-cv-01653, S.D. Cal., 07/20/2018
- Venue Allegations: Venue is asserted on the basis that Defendant’s principal place of business is located within the Southern District of California.
- Core Dispute: Plaintiff alleges that Defendant’s G4, G5, and G6 Mobile Continuous Glucose Monitoring (CGM) Systems infringe patents related to integrated apparatuses for measuring physiological parameters.
- Technical Context: The technology involves systems that use physiological sensors coupled to a patient to communicate data through a local transmitter to a software application on a general-purpose control system (e.g., a smartphone), and then to a remote host for further distribution and analysis.
- Key Procedural History: The patents-in-suit descend from a long chain of applications sharing a 2002 priority date. The complaint notes that Plaintiff has not yet sold any products covered by the asserted patents, which may be relevant to issues of commercial success and marking.
Case Timeline
| Date | Event |
|---|---|
| 2002-09-03 | Priority Date for ’174 and ’402 Patents |
| 2017-09-26 | U.S. Patent No. 9,770,174 Issued |
| 2018-06-26 | U.S. Patent No. 10,004,402 Issued |
| 2018-07-20 | Complaint Filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 9,770,174 - System and Method for Voice Control of Measurement Apparatus, issued September 26, 2017
The Invention Explained
- Problem Addressed: The patent addresses the need for integrated medical diagnostic systems that can be controlled efficiently, potentially reducing fatigue for medical professionals during procedures (’402 Patent, col. 5:48-55).
- The Patented Solution: The invention describes a comprehensive measurement apparatus that links a physiological sensor to a user’s smart device and a remote host. A sensor coupled to tissue communicates through a "base device" to a software application running on a "control system" (e.g., a smartphone), which is equipped with its own sensors (e.g., proximity, positioning) and user interfaces (e.g., touch screen, voice input). This control system, in turn, transmits data to a remote "host" (e.g., a cloud server), which can then generate and communicate status updates to other remote devices (’174 Patent, Abstract). The detailed description explains that such a system facilitates remote monitoring and control by a medical professional (’402 Patent, col. 6:50-58).
- Technical Importance: This architecture leverages the ubiquity of smartphones and cloud computing to create a networked physiological monitoring ecosystem, moving beyond standalone medical devices.
Key Claims at a Glance
- The complaint asserts independent claim 1 and dependent claim 3 (Compl. ¶12).
- Independent Claim 1 of the ’174 Patent recites:
- A measurement apparatus with one or more sensors adapted to be coupled to tissue comprising blood.
- The apparatus is configured to communicate through a "base device" to a software application on a "control system".
- The "control system" itself comprises a touch-screen, a proximity sensor, circuitry for obtaining movement information, a mechanical system with actuators, and a wireless transmitter to send data to a "host".
- The "control system" is further configured to receive voice and manually entered input signals.
- The "host" is configured to generate status information and communicate it to one or more remote display devices.
U.S. Patent No. 10,004,402 - Measurement Apparatus for Physiological Parameters, issued June 26, 2018
The Invention Explained
- Problem Addressed: Similar to the ’174 Patent, the invention seeks to provide an integrated and user-friendly medical diagnostic system (’402 Patent, col. 1:41-42).
- The Patented Solution: The ’402 Patent claims a similar overall architecture but introduces a specific component: "feedback control circuitry." In this configuration, the sensor communicates signals to this "feedback control circuitry," which is "capable of generating physiological information" from those signals. A software application on a separate "control system" then receives this already-generated physiological information (’402 Patent, Abstract; col. 1:52-2:2). This architecture suggests that initial data processing occurs in a dedicated piece of hardware (the feedback control circuitry) before the data is sent to a general-purpose device.
- Technical Importance: By defining a separate "feedback control circuitry" for generating physiological data, this architecture may allow for more specialized, efficient, or robust signal processing closer to the patient sensor.
Key Claims at a Glance
- The complaint asserts independent claim 1 and dependent claims 3, 5, 6, 7, 11, 12, and 21 (Compl. ¶48).
- Independent Claim 1 of the ’402 Patent recites:
- A measurement apparatus with one or more sensors adapted to be coupled to tissue and communicate to "feedback control circuitry".
- The "feedback control circuitry" is capable of generating physiological information from the sensor signals.
- A software application operates on a "control system" and is capable of receiving the physiological information.
- The "control system" is configured to receive voice and manual inputs and comprises a touch-screen, proximity sensor, circuitry for movement information, a mechanical system, and a wireless transmitter to send data to a "host".
III. The Accused Instrumentality
Product Identification
- The accused instrumentalities are the Dexcom G4, G5, and G6 Mobile Continuous Glucose Monitoring (CGM) Systems (Compl. ¶¶ 45, 69).
Functionality and Market Context
- The complaint alleges the accused systems operate as an integrated apparatus for measuring blood glucose levels (Compl. ¶¶ 14, 25, 36). Functionally, they are described as comprising a sensor that is inserted into tissue, a transmitter worn by the user (identified as the "base device" or "feedback control circuitry"), and a software application (e.g., Dexcom G5 Mobile App) that runs on a smart device like an iPhone (identified as the "control system") (Compl. ¶¶ 17, 28, 52-53). The complaint further alleges this system transmits data to a remote "host" (e.g., "the cloud"), which can then share blood glucose status information with remote "followers" (Compl. ¶¶ 22, 33). The complaint relies on Dexcom's product literature, such as that attached as Exhibits C1-C5, to confirm the functionality of the accused G4 system (Compl. ¶14).
IV. Analysis of Infringement Allegations
’174 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A measurement apparatus | The accused G4, G5, and G6 Systems are measurement apparatuses for measuring blood glucose levels. | ¶14 | col. 2:9 |
| one or more sensors configured to generate signals... wherein at least one of the one or more sensors is adapted to be coupled to a tissue comprising blood. | The G4/G5/G6 System has at least one sensor that is inserted into tissue and generates signals associated with blood glucose levels. | ¶¶15-16 | col. 2:10-14 |
| configured to communicate through a base device to a software application configured to operate on a control system adapted to receive and process physiological information. | The system communicates via a transmitter (the "base device") to a Dexcom app (the "software application") running on a smart device (the "control system"). | ¶17 | col. 2:14-18 |
| the control system comprising a touch-screen, a proximity sensor, circuitry for obtaining movement information from a positioning sensor, a mechanical system comprising one or more actuators, and a wireless transmitter to transmit data over a wireless link to a host. | The smart device (e.g., an iPhone) on which the app operates comprises all the listed hardware components and transmits data to a host ("the cloud"). | ¶19 | col. 2:18-24 |
| the control system is further configured to receive voice input signals and manually entered input signals. | The smart device is configured to receive both voice and manual inputs. | ¶21 | col. 2:25-27 |
| the host is configured to generate status information... and comprises: a memory storage device... and a communication device for communicating... to one or more display output devices... located remotely from the host. | The host ("the cloud") generates blood glucose status information and communicates it over a network to remote display devices, such as a follower's smart device. | ¶22 | col. 2:28-34 |
’402 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A measurement apparatus | The accused G4, G5, and G6 Systems are measurement apparatuses. | ¶50 | col. 1:52 |
| one or more sensors... adapted to be coupled to a tissue comprising blood and to communicate to feedback control circuitry... | The sensor is coupled to tissue by insertion and communicates signals to the transmitter (the alleged "feedback control circuitry"). | ¶¶51-52 | col. 1:52-57 |
| the feedback control circuitry capable of generating physiological information from the at least a portion of the signals... | The transmitter (the "feedback control circuitry") is alleged to be capable of generating blood glucose information from the sensor signals. | ¶52 | col. 1:57-2:2 |
| a software application configured to operate on a control system that is capable of receiving at least some of the physiological information. | The Dexcom Share2 App is a software application operating on a smart device (the "control system") that is capable of receiving the blood glucose information. | ¶53 | col. 2:2-5 |
| the control system configured to receive voice input signals and manually entered input signals and comprising a touch-screen, a proximity sensor, circuitry configured to determine movement information... | The smart device (e.g., iPhone) is configured to receive voice/manual inputs and comprises the listed hardware components. | ¶54 | col. 2:5-13 |
- Identified Points of Contention:
- Scope Questions: The apparatus claims in both patents require a "control system" that includes a specific list of hardware (touch-screen, proximity sensor, actuators, etc.). The complaint identifies this "control system" as a third-party smart device (e.g., an iPhone) owned by the end-user, not sold by Dexcom (Compl. ¶19). This raises a central question of divided infringement: can Dexcom be liable for directly infringing an apparatus claim when a claimed component is supplied and controlled by a customer?
- Technical Questions: For the ’402 Patent, a key factual dispute may arise over the function of the "feedback control circuitry," which the complaint equates with the Dexcom transmitter (Compl. ¶52). The analysis will question what evidence shows that the transmitter itself performs the claimed step of "generating physiological information" (e.g., converting raw sensor data to a calibrated glucose value), as opposed to merely relaying raw or minimally processed signals to the smartphone app for generation there.
V. Key Claim Terms for Construction
The Term: "control system" (in both patents)
- Context and Importance: The definition of this term is critical to the divided infringement issue. The claims are for an "apparatus," and liability for direct infringement typically requires a single entity to make, use, sell, or control all components. Practitioners may focus on whether the "control system" must be a dedicated device supplied by the defendant or if it can be a general-purpose device (e.g., a smartphone) owned by a third-party user, as the complaint alleges.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification suggests the "control system" can be a general-purpose computer, stating a "host" (which performs similar functions) may comprise "a desktop computer, a laptop computer, a server computer, a personal digital assistant" (’402 Patent, col. 8:41-44). Plaintiff may argue this supports construing "control system" broadly to include such devices.
- Evidence for a Narrower Interpretation: Both patents claim the "control system" as comprising a long list of specific hardware (touch-screen, proximity sensor, positioning sensor, actuators, wireless transmitter) (’174 Patent, col. 2:18-24). A defendant may argue this recitation of specific hardware within the apparatus claim points to an integrated, single-entity device, not a combination of the defendant's product and a third-party smartphone.
The Term: "feedback control circuitry" (’402 Patent)
- Context and Importance: This term distinguishes the ’402 Patent’s claimed invention. The core of the dispute will likely involve where this circuitry resides and what it does. Practitioners may focus on this term because it appears to shift the function of "generating physiological information" from the software application (as in the ’174 Patent) to a dedicated hardware component.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The patent does not appear to provide an explicit definition in the specification, which may support a broader construction based on the term's plain and ordinary meaning to one of skill in the art.
- Evidence for a Narrower Interpretation: Claim 1 of the ’402 Patent creates a clear sequence: the sensor communicates to the "feedback control circuitry," which in turn is "capable of generating physiological information." The "software application" on the "control system" then "is capable of receiving" this information. This structure strongly suggests the "feedback control circuitry" is a distinct component that performs the generation step before the information reaches the control system/software app. The complaint alleges this is the transmitter (Compl. ¶52), which will be a key factual question.
VI. Other Allegations
- Willful Infringement: The complaint does not contain an explicit allegation of willful infringement. However, the prayer for relief requests a declaration that the case is "exceptional" and an award of attorney fees pursuant to 35 U.S.C. § 285 (Compl., Prayer for Relief ¶E).
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of single-entity infringement: can Plaintiff prove that Defendant directly infringes the asserted apparatus claims when a key element, the "control system," is a third-party smartphone that Defendant does not make, sell, or operate? The resolution will depend on the construction of the term "control system" and the application of law governing divided infringement.
- A key evidentiary question for the ’402 Patent will be one of functional allocation: does the accused Dexcom transmitter function as the claimed "feedback control circuitry" by "generating physiological information," or is it primarily a data relay that passes signals to the smartphone application for the substantive generation step? The outcome will turn on technical evidence regarding the internal operations of the accused products.