Dexcom Inc v. Abbott Diabetes Care Inc

1. Case Identification

• Case #: IPR2024-00521
• Patent #: 11,298,056
• Filed: February 9, 2024
• Petitioner(s): Dexcom, Inc.
• Patent Owner(s): Abbott Diabetes Care Inc.
• Challenged Claims: 13 and 29

2. Patent Overview

• Title: Methods and Systems for Early Signal Attenuation Detection and Processing
• Brief Description: The ’056 patent describes a continuous glucose monitoring (CGM) system that addresses data gaps caused by adverse conditions, such as a loss of wireless communication between a sensor/transmitter unit and a receiver unit. The system displays a gap in a graphical data trend and subsequently backfills the missing data from memory once the condition is resolved.

3. Grounds for Unpatentability

Ground 1: Obviousness over Patel-2009 and Paradigm REAL-Time - Claim 13 is obvious over Patel-2009 in view of Paradigm REAL-Time.

• Prior Art Relied Upon: Patel-2009 (Application # 2009/0085768) and Paradigm REAL-Time (a Medtronic user manual publicly available by October 2007).
• Core Argument for this Ground:
  • Prior Art Mapping: Petitioner argued that the combination of Patel-2009 and Paradigm REAL-Time taught all limitations of independent claim 1 and dependent claim 13. Patel-2009 disclosed a CGM system with a sensor transceiver that processes sensor signals, stores calculated glucose values in memory, and transmits them to a remote monitor for display as a trend graph. Paradigm REAL-Time, a user manual for a commercial Medtronic CGM system, explicitly taught displaying a "data gap" on a graph when communication with the transmitter is lost and then "re-populating" (i.e., backfilling) the gap with up to 40 minutes of data stored in the transmitter's memory once communication is restored. For claim 13, which requires the adverse condition to be a "sensor misposition error," Petitioner adopted the Patent Owner's apparent litigation construction that this term encompasses signal loss due to the relative positions of the transmitter and receiver. Paradigm REAL-Time taught this exact scenario, noting communication can be lost if the pump and transmitter are too far apart or due to their orientation on the body.
  • Motivation to Combine: A person of ordinary skill in the art (POSITA) would combine these references to improve the user interface of the Patel-2009 system. A POSITA would have been motivated to incorporate Paradigm REAL-Time’s established method for visually communicating data interruptions and subsequent data recovery to provide a user with more complete and accurate glucose information, which is critical for diabetes management. The fact that both references relate to similar Medtronic CGM systems made the combination a natural and predictable step.
  • Expectation of Success: A POSITA would have had a high expectation of success in combining the teachings. The integration primarily involved modifying the software of Patel-2009's monitor to implement the display logic taught by Paradigm REAL-Time, a task well within the skill of an ordinary artisan at the time.

Ground 2: Obviousness over Patel-2009, Paradigm REAL-Time, and Goldsmith - Claim 29 is obvious over Patel-2009 in view of Paradigm REAL-Time and Goldsmith.

• Prior Art Relied Upon: Patel-2009 (Application # 2009/0085768), Paradigm REAL-Time (a Medtronic user manual), and Goldsmith (Application # 2007/0093786).
• Core Argument for this Ground:
  • Prior Art Mapping: This ground built upon the combination in Ground 1, adding Goldsmith to teach the limitations of claim 29. Claim 29 adds a "secondary receiver unit" that is a "watch" configured to receive processed sensor data. Goldsmith explicitly taught a "Watch Controller for a Medical Device" used in an infusion system to display glucose values and trends. Goldsmith disclosed that its watch could receive sensor data in two ways: directly from the on-body sensor/transmitter or indirectly via an intermediary device like an infusion pump. Petitioner argued this combination rendered claim 29 obvious regardless of whether the claim required direct or indirect communication to the watch, thereby addressing both a plain reading of the claim and the Patent Owner's allegedly broader litigation interpretation.
  • Motivation to Combine: A POSITA would be motivated to add the Goldsmith watch to the Patel-2009/Paradigm REAL-Time system to gain the benefits expressly taught by Goldsmith. These benefits included improved convenience, ease of use, and discretion, as a watch is a "more socially acceptable" and "less noticeable" way for a user to monitor glucose data compared to a larger, dedicated receiver or insulin pump.
  • Expectation of Success: A POSITA would have reasonably expected success in this combination. Goldsmith described integrating a watch into a CGM system with the same fundamental components (sensor, transmitter, pump) as the base combination. The wireless communication protocols needed to link the devices, such as Bluetooth, were well-established and their implementation was a matter of routine engineering.

4. Key Claim Construction Positions

• "sensor misposition error" (claim 13): For the purpose of the petition, Petitioner adopted the Patent Owner’s apparent litigation position that this term is not limited to a physical displacement of the sensor but can be satisfied by a signal loss or communication issue between the data transmitter and receiver caused by their relative positions or orientation.
• "receive processed sensor data from the data processing and transmitter unit" (claim 29): Petitioner argued claim 29 is obvious under two potential interpretations. The first is a plain reading where the secondary receiver (watch) directly receives data from the transmitter unit. The second is the Patent Owner’s apparent broader litigation construction, which encompasses the watch indirectly receiving data from an intermediary device (e.g., an insulin pump that first received the data from the transmitter).

5. Arguments Regarding Discretionary Denial

• Petitioner argued that discretionary denial under §325(d) was unwarranted because the primary prior art, Paradigm REAL-Time, was never before the examiner, and the other references (Patel-2009, Goldsmith) were merely cited in a large Information Disclosure Statement without evidence of substantive review.
• Regarding serial petition concerns (General Plastic factors), Petitioner asserted that this petition should be instituted despite a prior-filed petition (IPR2023-01251) on the same patent. Petitioner contended this was not an improper "follow-on" petition because it challenged different claims (13 and 29) that were asserted by the Patent Owner for the first time months after the initial petition was filed, and with unforeseeable claim interpretations. Petitioner claimed it acted diligently in filing this new petition upon learning of the new assertions.

6. Relief Requested

• Petitioner requests institution of an inter partes review and cancellation of claims 13 and 29 of the ’056 patent as unpatentable.