Abbott Diabetes Care Inc v. Dexcom Inc

1. Case Identification

• Case #: IPR2024-00860
• Patent #: 11,510,625
• Filed: May 9, 2024
• Petitioner(s): Abbott Diabetes Care Inc.
• Patent Owner(s): DexCom, Inc.
• Challenged Claims: 1-9, 13-19, and 22-30

2. Patent Overview

• Title: Systems and Methods for Measuring an Analyte in a Host
• Brief Description: The ’625 patent relates to continuous glucose monitoring (CGM) systems, specifically an applicator for an on-skin sensor assembly. The invention purports to solve the problem of unwanted rotation of the sensor-implanting needle by incorporating an "anti-rotation feature" on a needle hub that engages with a complementary aperture in the on-skin sensor assembly.

3. Grounds for Unpatentability

Ground 1: Obviousness over Rao - Claims 1-9, 13-19, and 22-30 are obvious over Rao.

• Prior Art Relied Upon: Rao (Application # 2018/0235520).
• Core Argument for this Ground:
  • Prior Art Mapping: Petitioner argued that Rao, which describes CGM applicators, discloses every limitation of the challenged claims. Rao's "sharp module 2600" was identified as the claimed "needle hub," which includes a base and is coupled to an insertion element ("sharp 2602"). Critically, Petitioner asserted that Rao’s "bend fin guide 2620" is an "anti-rotation feature comprising a key" that extends from the base of the needle hub. This key is configured to be at least partially disposed within an aperture in Rao's "sensor module 504" (the on-skin sensor assembly). The engagement between Rao's bend fin guide and the sensor module's aperture, which has a complementary shape, prevents rotational movement of the needle hub, thus meeting the central limitations of independent claims 1, 13, 22, and 28. Petitioner further mapped Rao's disclosure of standard CGM components to the dependent claims, including electronics units, adhesive patches, and insertion elements with open sides for receiving a sensor.

Ground 2: Obviousness over Rao and Lundquist - Claims 4-5, 14-15, 26-27, and 30 are obvious over Rao in view of Lundquist.

• Prior Art Relied Upon: Rao (Application # 2018/0235520) and Lundquist (Application # 2014/0188053).
• Core Argument for this Ground:
  • Prior Art Mapping: Petitioner contended that this combination renders obvious the claims that recite specific methods of coupling the needle to the needle hub. Rao provided the foundational CGM applicator system with an anti-rotation feature. Lundquist was introduced to supply the teaching of coupling a needle to a hub via "insert molding" and using a "locking element." Specifically, Lundquist disclosed a method of securing a hollow needle to a hub where polymeric material flows into and fills notches on the needle during an insert molding process. Petitioner argued these notches constitute the claimed "locking element" and that Lundquist explicitly teaches the "insert molding" process recited in the claims.
  • Motivation to Combine: A POSITA would combine Lundquist’s secure coupling method with Rao’s applicator system to solve a known problem. Rao disclosed the importance of ensuring the needle is securely coupled to the hub to achieve "full retraction" of the sharp from the user after insertion. Lundquist taught a method for effectively securing a cannula to a hub to withstand operating conditions. Therefore, a POSITA would have been motivated to incorporate Lundquist’s robust insert molding technique into Rao's device to improve the reliability of needle retraction, a stated goal of Rao.
  • Expectation of Success: A POSITA would have a reasonable expectation of success because the combination involved applying a known manufacturing process (Lundquist) to a known type of device (Rao). Lundquist stated its method was applicable to needles of "any sized and shaped," and Rao’s device used a conventional needle, making the integration predictable and straightforward.

4. Key Claim Construction Positions

• Product-by-Process Limitations: Petitioner argued that claim terms reciting methods of coupling, such as "by heat staking, snap-fit, friction-fit, clamshell, or insert molding" (e.g., claim 4) and "by insert molding" (e.g., claim 5), should be construed as product-by-process limitations. Petitioner asserted that because the ’625 patent did not disclose any novel structure resulting from these processes, the claims should be unpatentable if the final product is the same as or obvious from a prior art product, regardless of the manufacturing process used.

5. Arguments Regarding Discretionary Denial

• §314(a) (Fintiv Factors): Petitioner argued against discretionary denial under Fintiv, stating that this is the first IPR petition filed against the ’625 patent. The parallel district court litigation was described as being in a very early stage, with claim construction just underway and a trial date set for July 2026, many months after the statutory deadline for a Final Written Decision in this proceeding. Petitioner contended these factors weigh heavily against denial.
• §325(d): Petitioner asserted that denial under §325(d) is unwarranted because the primary references, Rao and Lundquist, were not before the Examiner during the prosecution of the ’625 patent. Therefore, the petition raised new art and arguments that were not previously considered by the USPTO, failing the first prong of the Advanced Bionics framework.

6. Relief Requested

• Petitioner requests institution of inter partes review and cancellation of claims 1-9, 13-19, and 22-30 of the ’625 patent as unpatentable.