Dexcom Inc v. Abbott Diabetes Care Inc

1. Case Identification

• Case #: IPR2023-01409
• Patent #: 11,202,591
• Filed: October 11, 2023
• Petitioner(s): Dexcom, Inc.
• Patent Owner(s): Abbott Diabetes Care Inc.
• Challenged Claims: 1-30

2. Patent Overview

• Title: Analyte Sensor and Apparatus for Insertion of the Sensor
• Brief Description: The ’591 patent discloses an insertion assembly for on-body medical devices, such as glucose monitors. The assembly comprises an on-body unit containing a sensor and electronics, and an inserter with a sharp (e.g., a needle) that passes through openings in the on-body unit to place the sensor under a user's skin.

3. Grounds for Unpatentability

Ground 1: Claims 1-6, 9-14, 16-24, 27, and 29-30 are obvious over Stafford in view of Cote.

• Prior Art Relied Upon: Stafford (Application # 2008/0097246) and Cote (Application # 2005/0101932).
• Core Argument for this Ground:
  • Prior Art Mapping: Petitioner argued that Stafford disclosed the core components of the claimed on-body unit, including a housing with top and bottom openings, a glucose sensor, and associated electronics. However, Stafford taught a simple, manual introducer that presented a risk of needle sticks. Petitioner asserted that Cote taught a sophisticated inserter device with an automatically retracting needle, which was designed to deploy an on-body infusion set ("site"). The combination of Stafford’s on-body unit with Cote’s inserter mechanism allegedly rendered the limitations of the independent claims obvious. For example, Cote’s inserter advanced an on-body unit from a first position to a second to pierce the skin, and then automatically retracted the sharp while leaving the on-body unit in place, as recited in claim 1.
  • Motivation to Combine: A person of ordinary skill in the art (POSITA) would combine Stafford and Cote to improve the safety and usability of Stafford’s device. Cote’s inserter directly addressed the needle-stick risks identified in Stafford by teaching a shrouded, auto-retracting needle. Furthermore, a POSITA would be motivated to use Cote's all-in-one, pre-loaded assembly to achieve Stafford’s goal of a "single disposable assembly," thereby increasing patient comfort and simplifying the insertion process.
  • Expectation of Success: A POSITA would have a reasonable expectation of success because both references are directed to transcutaneous medical devices for diabetes care and their teachings are complementary. Integrating Stafford's sensor and on-body unit into a Cote-like inserter was presented as a predictable combination of known elements to achieve a known goal.

Ground 2: Claims 4, 7-8, 14-15, and 19-30 are obvious over Stafford and Cote in view of Say.

• Prior Art Relied Upon: Stafford (Application # 2008/0097246), Cote (Application # 2005/0101932), and Say (Patent 6,175,752).
• Core Argument for this Ground:
  • Prior Art Mapping: This ground built upon the Stafford and Cote combination by adding teachings from Say to address specific dependent claim limitations. Petitioner argued Stafford itself incorporated Say by reference for details of the data processing unit. Say allegedly disclosed sensor electronics including a data storage unit (relevant to claims 4 and 19), a "sleep mode" to conserve battery power prior to use (relevant to claim 7), and an on-body unit with a low-profile height of 7 mm or less (relevant to claim 14).
  • Motivation to Combine: The primary motivation was Stafford's explicit reference to Say, which would have directed a POSITA to consult Say for further details on the sensor electronics. A POSITA would have been motivated to incorporate Say's teachings to improve the functionality of the combined Stafford/Cote device by adding memory, extending battery life with a sleep mode, and achieving a more desirable low-profile design.
  • Expectation of Success: Success was expected because Say's teachings were directed to the same type of on-skin sensor control units as Stafford, making the integration of features like a data storage unit or sleep mode straightforward for a POSITA.

Ground 3: Claims 18, 21-24, 27, and 29-30 are obvious over Stafford and Cote in view of Brenneman.

• Prior Art Relied Upon: Stafford (Application # 2008/0097246), Cote (Application # 2005/0101932), and Brenneman (WO 2008/115409).

• Core Argument for this Ground:

  • Prior Art Mapping: This ground added Brenneman to the base combination to address claims requiring a "second opening" on the top surface of the on-body unit housing (claims 18 and 21). Petitioner asserted that Brenneman taught an inserter that coupled to an on-body unit via projections on the inserter that engaged with peripheral apertures (a "second opening") on the top surface of the unit. This mechanism created a "snug fit" to securely hold the on-body unit and prevent tilting or rotation within the inserter before deployment.
  • Motivation to Combine: A POSITA would be motivated to incorporate Brenneman’s coupling mechanism into the Stafford/Cote device to solve the known problem of securing an on-body unit within an inserter during shipping and use. This would prevent dislodging and ensure proper alignment, improving the reliability of the insertion process. This approach was presented as a known and desirable design choice for coupling inserters and on-body units.
  • Expectation of Success: A POSITA would have reasonably expected success, as Brenneman’s teachings provided a well-understood mechanical solution for coupling two components, a common challenge in the field of medical device design.

• Additional Grounds: Petitioner asserted additional obviousness challenges, including Ground 4 (adding Shah for an opening in sensor electronics) and Grounds 5-8, which presented various four- and five-way combinations of Stafford, Cote, Say, Brenneman, and Shah to address the patent's indirectly dependent claim structure.

4. Arguments Regarding Discretionary Denial

• Petitioner argued that discretionary denial would be improper. Under §325(d), Petitioner asserted that key prior art references, Cote and Brenneman, were never cited nor discussed during the original prosecution, meaning the Examiner did not previously consider the core arguments of the petition. Regarding potential Fintiv factors, Petitioner noted that the parallel district court trial was scheduled for March 2026, arguing the IPR would conclude well in advance of that date and would not be an inefficient use of Board resources.

5. Relief Requested

• Petitioner requested institution of an inter partes review and cancellation of claims 1-30 of the ’591 patent as unpatentable.