PTAB

IPR2022-00637

Dexcom Inc v. Abbott Diabetes Care Inc

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Petition
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1. Case Identification

2. Patent Overview

  • Title: Medical Device Inserters and Processes of Inserting and Using Medical Devices
  • Brief Description: The ’440 patent describes an apparatus for inserting a medical device, such as a glucose sensor, into a subject's skin. The inserter assembly uses a first spring combined with a rotor to drive a needle and sensor for insertion, and a second spring to automatically retract the needle while leaving the sensor in place.

3. Grounds for Unpatentability

Ground 1: Obviousness over Brister and Gravesen - Claims 1-25 are obvious over Brister in view of Gravesen.

  • Prior Art Relied Upon: Brister (Application # 2009/0076360) and Gravesen (Application # 2009/0099521).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that Brister taught a glucose monitoring system with a sensor, a mounting unit with an adhesive, and a manual inserter applicator. Crucially, Brister expressly disclosed that "spring-loaded mechanisms [] can be triggered to automatically insert and/or retract the sensor, [and] needle." Gravesen taught the very automated, spring-based insertion/retraction mechanism that Brister suggested but did not detail. Gravesen's device used a first driving spring to advance a "first slidable body" (needle holder) and a second compression spring to retract a "second slidable body" (a smaller, separate needle holder), leaving a medical device (a cannula) implanted. The combination of Brister's sensor system with Gravesen's automated two-spring mechanism allegedly rendered all limitations of the challenged claims obvious.
    • Motivation to Combine: A Person of Ordinary Skill in the Art (POSITA) reading Brister's express suggestion to automate its inserter with springs would be motivated to look for known methods of doing so. Gravesen provided a well-understood, spring-based solution for the same purpose: automatically inserting a medical device via a needle to minimize patient pain. Petitioner asserted that the interchangeability of inserters for sensors (Brister) and cannulas (Gravesen) was well-known in the art, making the combination a predictable solution to a known problem.
    • Expectation of Success: Because both references described similar needle-based insertion mechanisms for transcutaneous medical devices, a POSITA would have a high expectation of success in combining them. The combination involved substituting one known automated inserter (Gravesen) for a manual one (Brister) to achieve the predictable result of automated sensor insertion.

Ground 2: Obviousness over Brister, Gravesen, and Yodfat - Claims 1-25 are obvious over Brister in view of Gravesen, further in view of Yodfat.

  • Prior Art Relied Upon: Brister (Application # 2009/0076360), Gravesen (Application # 2009/0099521), and Yodfat (Application # 2008/0319414).
  • Core Argument for this Ground:
    • Prior Art Mapping: This ground was presented as an alternative in the event the claims were interpreted to require features Petitioner argued were not explicitly in Gravesen: a rotor with an overall cylindrical shape and a housing with a distinct recess for receiving the rotor. While Gravesen taught a rotating lever arm, Yodfat taught an automatic inserter with a ratchet crank ("rotor") having an overall cylindrical shape that was received within a dedicated recess in the housing. Petitioner argued that adding Yodfat's teachings to the Brister/Gravesen combination supplied these specific structural features.
    • Motivation to Combine: A POSITA would find it obvious to modify the Brister/Gravesen combination with the teachings of Yodfat as a simple design choice. Yodfat's cylindrical rotor represented a known alternative to Gravesen's lever-arm for converting spring-powered rotation into linear motion. A POSITA would be motivated to use Yodfat's design to achieve better stability or packaging. Similarly, using a dedicated recess as taught by Yodfat would be an advantageous and obvious choice for centrally positioning the rotor and allowing a user to load the torsion spring, preventing premature firing.
    • Expectation of Success: The use of cylindrically shaped rotors in torsion spring-powered insertion systems was well-understood in the art. Substituting Yodfat's rotor and recess design into the Brister/Gravesen combination was a predictable integration of known components to achieve the same overall function.

4. Arguments Regarding Discretionary Denial

  • Petitioner argued that the Board should not exercise discretionary denial under Fintiv despite a parallel district court litigation. The petition asserted that the trial in the parallel case was scheduled for October 2023, well after the statutory deadline for a Final Written Decision (FWD) in the inter partes review (IPR). Furthermore, Petitioner stated its intent to seek a stay of the litigation if the IPR was instituted, which would minimize any potential overlap of issues.

5. Relief Requested

  • Petitioner requested institution of an IPR and cancellation of claims 1-25 of the ’440 patent as unpatentable.