Dexcom Inc v. Abbott Diabetes Care Inc

1. Case Identification

• Case #: IPR2023-01396
• Patent #: 11,266,335
• Filed: October 6, 2023
• Petitioner(s): Dexcom, Inc.
• Patent Owner(s): Abbott Diabetes Care Inc.
• Challenged Claims: 1-4, 8-9, 11-27

2. Patent Overview

• Title: Medical Device Inserters and Processes of Inserting and Using Medical Devices
• Brief Description: The ’335 patent describes a glucose monitoring assembly. The assembly consists of an inserter with a sharp and a wearable on-body electronics unit, which includes a housing, a glucose sensor, and electronics. The inserter is configured to engage the housing via multiple recesses on the housing’s periphery to insert the sensor into a user.

3. Grounds for Unpatentability

Ground 1: Obviousness over Stafford and Raymond (+ Turner) - Claims 1-4, 8-9, 11-15, and 17-27 are obvious over Stafford in view of Raymond, with Turner as supporting art.

• Prior Art Relied Upon: Stafford (Application # 2008/0097246), Raymond (Application # 2009/0124979), and Turner (Application # 2007/0135774).
• Core Argument for this Ground:
  • Prior Art Mapping: Petitioner argued that Stafford disclosed an integrated glucose sensor assembly, including the on-body electronics unit with a sensor and a sharp introducer for manual insertion. However, Stafford recognized but did not solve the problem of post-insertion needlesticks. Raymond disclosed a safety-focused insertion device for an infusion set that included a fully enclosed, retractable needle and base-retaining arms ("gripping arms") that engaged recesses on a medical device base to secure it. The proposed combination substitutes Stafford’s manual introducer with Raymond’s safer, automated insertion mechanism, applying it to Stafford's glucose monitoring unit. Turner was cited as background art showing the common practice of using plural recesses to prevent rotation between an inserter and an on-body device.
  • Motivation to Combine: A POSITA would combine Stafford and Raymond to address the known need for preventing accidental needlesticks after sensor insertion, a deficiency explicitly noted in Stafford. Raymond provided an elegant and known solution from the analogous field of infusion set inserters. The combination would improve the safety and ease of use of Stafford’s device by incorporating Raymond’s pre-assembled, auto-retracting needle design.
  • Expectation of Success: Petitioner asserted a high expectation of success, arguing that adapting an inserter from a cannula-based system (Raymond) to a sensor-based system (Stafford) was a well-known and routine practice for a POSITA. The mechanical engagement via arms and recesses was a simple, predictable implementation.

Ground 2: Obviousness over Stafford, Raymond, and Say (+ Turner) - Claim 16 is obvious over Stafford, Raymond, and Say, and further in view of Turner.

• Prior Art Relied Upon: Stafford (Application # 2008/0097246), Raymond (Application # 2009/0124979), Say (Patent 6,175,752), and Turner (Application # 2007/0135774).
• Core Argument for this Ground:
  • Prior Art Mapping: This combination builds on the primary Stafford and Raymond combination to specifically address the limitations of claim 16, which recites a "sensor hub." Petitioner argued that Say disclosed a support structure, functioning as a sensor hub, positioned within a sensor control unit housing. This hub’s purpose was to ensure adequate and reliable electrical contact between the analyte sensor and the sensor electronics. Petitioner proposed incorporating Say's sensor hub into the on-body electronics unit of the primary Stafford/Raymond combination.
  • Motivation to Combine: A POSITA would be motivated to add Say's support hub to ensure a stable and reliable electrical connection for the sensor within the housing of the combined device. This addressed the known and critical goal of maintaining signal integrity in sensor-based systems.
  • Expectation of Success: Petitioner contended that success was predictable because the sensors in both Stafford and Say have similar forms and are supported in a similar fashion. Integrating a simple mechanical support like the one in Say into the Stafford electronics unit would require only ordinary skill.

Ground 3: Obviousness over Stafford, Raymond, and Bickoff (+ Turner) - Claim 16 is obvious over Stafford, Raymond, and Bickoff, and further in view of Turner.

• Prior Art Relied Upon: Stafford (Application # 2008/0097246), Raymond (Application # 2009/0124979), Bickoff (Application # 2009/0240121), and Turner (Application # 2007/0135774).

• Core Argument for this Ground:

  • Prior Art Mapping: As an alternative to Say, this ground asserted that Bickoff also taught the "sensor hub" limitation of claim 16. Bickoff disclosed a hub designed to receive the proximal portion of a sensor to help retain it and maintain good electrical contact with sensor electronics. Petitioner argued for incorporating Bickoff's hub into the on-body electronics unit of the primary Stafford/Raymond combination for the same purpose as described for the Say reference.
  • Motivation to Combine: The motivation was identical to that for combining Say: to ensure a robust and reliable electrical connection between the sensor and electronics, a fundamental requirement for device performance that a POSITA would have sought to implement.
  • Expectation of Success: Petitioner argued success was expected because the combination involved implementing a known solution (a retaining hub) for a known problem (maintaining electrical contact) using a simple combination of known elements.

• Additional Grounds: Petitioner asserted additional obviousness challenges for claims 17-18 based on the combination of Stafford, Raymond, and Shah (Application # 2007/0073129), which disclosed an aperture in a flexible circuit through which a sensor passes.

4. Arguments Regarding Discretionary Denial

• Petitioner argued that discretionary denial under §325(d) would be inappropriate because the specific combinations and key teachings asserted in the petition were never considered by the patent examiner. Although some references were part of a large Information Disclosure Statement, there was no evidence the examiner substantively reviewed their relevant disclosures.
• Petitioner also contended that denial based on a parallel district court proceeding was unwarranted. The trial in that case is scheduled for March 2026, which is well after the one-year statutory deadline for a Final Written Decision, ensuring the IPR would conclude long before trial.

5. Relief Requested

• Petitioner requests institution of an inter partes review and cancellation of claims 1-4, 8-9, and 11-27 of the ’335 patent as unpatentable.