PTAB

IPR2022-00913

Abbott Diabetes Care Inc v. Dexcom Inc

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Petition
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1. Case Identification

2. Patent Overview

  • Title: Transcutaneous Sensor Calibration
  • Brief Description: The ’213 patent relates to systems and methods for processing data from a transcutaneous analyte sensor, such as a continuous glucose monitor (CGM). The purported invention is the calibration of sensor data using pre-insertion information without requiring post-insertion reference measurements from the user (e.g., finger-prick blood tests).

3. Grounds for Unpatentability

Ground 1: Obviousness over Heller - Claims 1, 20, 21, and 23 are obvious over Heller in view of the knowledge of a POSITA.

  • Prior Art Relied Upon: Heller (International Publication No. WO 02/058537).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued Heller discloses a complete glucose monitoring system with a transcutaneous sensor that is calibrated using "factory-determined calibration measurements." This pre-loaded data, which a person of ordinary skill in the art (POSITA) would understand includes sensitivity information, allows the system's processor to calibrate sensor signals without needing post-insertion reference measurements. Heller further disclosed adjusting a known sensor profile based on temperature, satisfying limitations in claims 20 and 21. For claim 23, Petitioner contended a POSITA would recognize that Heller’s factory-determined in vitro sensitivity data would be used to predict the sensor’s in vivo sensitivity, thus establishing the claimed "predictive relationship."
    • Motivation to Combine: This ground primarily asserted that Heller’s teachings, when interpreted by a POSITA, rendered the claims obvious. The motivation was to apply known principles of sensor calibration (e.g., the predictive nature of in vitro testing for in vivo performance) to the system disclosed by Heller to achieve the known goal of a factory-calibrated sensor.
    • Expectation of Success: A POSITA would have a high expectation of success, as factory calibration and the use of in vitro data to predict in vivo performance were well-understood concepts in the art.

Ground 2: Anticipation by Gross - Claims 1, 4-6, and 23-26 are anticipated by Gross.

  • Prior Art Relied Upon: Gross (Patent 6,275,717).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner asserted Gross discloses a two-part analyte monitoring device that is factory-calibrated using an in vitro "theoretical curve." After insertion, the system uses a post-insertion saturation current—a signal generated by the sensor itself, not an independent reference measurement—to map the sensor's individual in vivo performance to the factory curve. This provides the microprocessor with "complete information" to provide a calibrated output without a post-insertion reference analyte measurement. Gross also disclosed programming the microprocessor to sound an alarm if initial measurements fall outside a predetermined range of the factory values, thereby teaching the validation (claim 4), error detection (claim 5), and user notification (claim 6) limitations.
    • Key Aspects: The core of this argument relied on Petitioner's interpretation that Gross's use of a "saturation current" is not a "reference analyte concentration measurement" as required by the claims for post-insertion calibration. This interpretation is detailed in Section 4.

Ground 3: Obviousness over Heller and Mastrototaro - Claims 4-6 and 24-26 are obvious over Heller in view of Mastrototaro.

  • Prior Art Relied Upon: Heller (WO 02/058537), Mastrototaro (Patent 6,424,847).

  • Core Argument for this Ground:

    • Prior Art Mapping: Heller was argued to provide the base system of a factory-calibrated CGM that does not require post-insertion reference measurements. Mastrototaro was cited for its teachings on improving glucose monitor functionality by validating the conversion function after calibration. Mastrototaro disclosed comparing calculated glucose readings against out-of-range limits and, if a reading exceeds a limit, triggering a "calibration cancellation event" and notifying the user via an alarm. This combination taught validating the conversion function (claims 4, 24), detecting an error upon failure (claims 5, 25), and modifying information on a display to warn the user (claims 6, 26).
    • Motivation to Combine: A POSITA would combine Mastrototaro's validation techniques with Heller's system to enhance the functionality, safety, and reliability of the device. Validating calibrated output to ensure its accuracy was a known objective in the field of glucose monitoring.
    • Expectation of Success: A POSITA would expect predictable and successful results from incorporating known validation and alarm features into a CGM system.

  • Additional Grounds: Petitioner asserted additional obviousness challenges, including claims obvious over Heller in view of Mastrototaro and Heise (for predicting future glucose values) and claims obvious over Gross in view of Mastrototaro and/or Heise, relying on similar motivations to add validation and prediction functionalities to the base systems.

4. Key Technical Contentions (Beyond Claim Construction)

  • "Reference Analyte Concentration Measurement": A central technical contention was that the claim term "reference analyte concentration measurement" requires a value of analyte concentration (e.g., mg/dL) obtained from a source independent of the sensor being calibrated. Petitioner argued that the "saturation current" disclosed by Gross is not such a measurement because it is (1) a sensor current (e.g., in nanoamps), not a concentration value, and (2) it is generated by the sensor being calibrated, not an independent source like a finger-stick meter. This interpretation was crucial for Petitioner's argument that Gross anticipates the claims by calibrating without a post-insertion reference measurement.

5. Arguments Regarding Discretionary Denial

  • §314(a) (Fintiv Factors): Petitioner argued against discretionary denial under Fintiv, asserting that the petition was filed expeditiously after infringement contentions were narrowed in parallel litigation. Petitioner highlighted the uncertainty of the district court trial date and venue, the minimal investment in the parallel litigation prior to the petition's filing, and the strong merits of the petition as factors weighing in favor of institution.
  • §325(d) (Advanced Bionics Framework): Petitioner argued that the primary prior art references, including Heller and Gross, were not substantively examined during prosecution. Although listed in a 3,951-reference Information Disclosure Statement (IDS), the Examiner initialed the IDS when facially overbroad claims were pending and never relied on the references in any rejection of the challenged claims. Petitioner contended this constituted a material error by the Office, as it failed to consider specific, highly relevant teachings that impact patentability.

6. Relief Requested

  • Petitioner requested institution of an inter partes review and cancellation of claims 1, 4-6, 8, 20, 21, and 23-26 of the ’213 patent as unpatentable.