Dexcom Inc v. Abbott Diabetes Care Inc

1. Case Identification

• Case #: IPR2023-01251
• Patent #: 11,298,056
• Filed: August 1, 2023
• Petitioner(s): Dexcom, Inc.
• Patent Owner(s): Abbott Diabetes Care Inc.
• Challenged Claims: 1-12, 14-28, 30

2. Patent Overview

• Title: Methods and Systems for Early Signal Attenuation Detection and Processing
• Brief Description: The ’056 patent discloses a continuous glucose monitoring system that graphically displays glucose data. The system is configured to identify an adverse condition, such as a loss of wireless communication, display a corresponding "data gap" on the graph, and subsequently backfill the gap with stored sensor data after the adverse condition is corrected.

3. Grounds for Unpatentability

Ground 1: Obviousness over Patel-2009 and Paradigm® REAL-Time - Claims 1-3, 5-8, 11-12, 17-24, 26-28, and 30 are obvious over Patel-2009 in view of Paradigm® REAL-Time.

• Prior Art Relied Upon: Patel-2009 (Application # 2009/0085768) and Paradigm® REAL-Time (a 2007 Medtronic website publication and user manual).
• Core Argument for this Ground:
  • Prior Art Mapping: Petitioner argued that Patel-2009 teaches a continuous glucose monitoring (CGM) system with a sensor transceiver that calculates and stores glucose values, including during periods of failed communication with a remote monitor. It further discloses synchronizing these stored values to the monitor once communication is re-established. Paradigm® REAL-Time, a user manual for a commercial Medtronic CGM system, explicitly discloses the user interface claimed in the ’056 patent: displaying a "data gap" on a glucose graph upon loss of communication and "re-populating" (backfilling) that gap with up to 40 minutes of data stored in the transmitter's memory when communication resumes. Petitioner asserted that combining Patel-2009's back-end data handling with Paradigm's front-end display functionality renders the claimed system obvious.
  • Motivation to Combine: A person of ordinary skill in the art (POSITA) would combine these references to improve the system of Patel-2009. While Patel-2009 provides for data recovery, it lacks a clear method for displaying the data interruption to the user. A POSITA would look to well-known commercial products like the Medtronic Paradigm system to implement a proven, user-friendly graphical interface for indicating data loss and recovery. The fact that both references originate from Medtronic further supports the motivation to combine them.
  • Expectation of Success: A POSITA would have a high expectation of success, as the combination involves applying a known user interface feature from Paradigm to the similar underlying CGM architecture of Patel-2009. This would primarily involve routine software modifications to the monitor described in Patel-2009.

Ground 2: Obviousness over Patel-2009, Paradigm® REAL-Time, and Causey - Claims 4, 9-10, 15-16, and 25 are obvious over Patel-2009 and Paradigm® REAL-Time in view of Causey.

• Prior Art Relied Upon: Patel-2009 (Application # 2009/0085768), Paradigm® REAL-Time (a 2007 Medtronic website publication), and Causey (Patent 6,641,533).
• Core Argument for this Ground:
  • Prior Art Mapping: This ground builds upon the combination in Ground 1 to address dependent claims reciting more specific "adverse conditions," such as sensor instability, calibration failures, and out-of-range analyte levels. Petitioner argued that Causey teaches monitoring sensor signals to detect these exact types of conditions (e.g., sensor instability, faulty readings) and then prompting or delaying calibration accordingly. Causey also discloses updating historical data graphs with newly calibrated data. Adding Causey's teachings provides the specific error-handling logic for the adverse conditions that trigger the data gap and backfill process established by the primary combination.
  • Motivation to Combine: A POSITA seeking to create a robust and reliable CGM system based on Patel-2009 and Paradigm would be motivated to incorporate the advanced error and calibration management techniques taught by Causey. Effectively handling sensor instability and calibration errors is crucial for CGM accuracy, making Causey's solutions a logical and desirable enhancement.
  • Expectation of Success: Success would be expected because it involves integrating known error-detection and calibration-management software routines from Causey into the CGM system of Ground 1, which is a predictable engineering task.

Ground 3: Obviousness over Patel-2008 and Incorporated References - Claims 1-12, 14-18, 20-28, and 30 are obvious over Patel-2008 in view of its incorporated references.

• Prior Art Relied Upon: Patel-2008 (Application # 2008/0119705), which incorporates by reference Mastrototaro (Application # 2006/0202859), Shahmirian (Application # 2004/0122353), and Causey (Patent 6,641,533).
• Core Argument for this Ground:
  • Prior Art Mapping: Petitioner presented this as an alternative ground where Patel-2008 serves as a primary reference and a roadmap for building the claimed invention. Patel-2008 discloses a diabetes management system on a consumer electronic device (e.g., smartphone) that displays a graph with a "blank white space" to indicate missing data. It explicitly incorporates Mastrototaro (describing the sensor/transmitter hardware), Shahmirian (describing bi-directional wireless communication, including retransmitting missed data packets to fill gaps), and Causey (describing monitoring and display functions). Petitioner contended that these incorporated disclosures teach all elements of the claimed system, including the hardware, the mechanism for data recovery (retransmission), and the display of a data gap that can be filled upon said recovery.
  • Motivation to Combine: The motivation is provided directly by Patel-2008, which expressly incorporates the other references to describe the system's components and functionalities. A POSITA would be directly led to combine these teachings to assemble the complete system envisioned by Patel-2008.
  • Expectation of Success: A POSITA would expect success in combining these references as they are presented as compatible, modular components of a single, coherent diabetes management system described by Patel-2008.

4. Arguments Regarding Discretionary Denial

• Petitioner argued that discretionary denial under 35 U.S.C. §325(d) is inappropriate because the core prior art references and arguments presented in the petition are not substantially the same as those considered during prosecution. Key references, including Paradigm® REAL-Time, Patel-2008, Causey, and Mastrototaro, were not applied or discussed by the Examiner.
• Petitioner also argued that denial under 35 U.S.C. §314(a) based on Fintiv factors is not warranted because, at the time the petition was filed, a trial date had not yet been set in the parallel district court litigation.

5. Relief Requested

• Petitioner requests institution of an inter partes review and cancellation of claims 1-12, 14-28, and 30 of the ’056 patent as unpatentable.