Roche Diabetes Care Inc v. Trividia Health Inc

1. Case Identification

• Case #: IPR2025-00553
• Patent #: 8,128,981
• Filed: March 6, 2025
• Petitioner(s): Roche Diabetes Care, Inc.
• Patent Owner(s): Trividia Health, Inc.
• Challenged Claims: 1-13, 15-16, 18-30, and 32-37

2. Patent Overview

• Title: Method of Manufacturing Test Strips
• Brief Description: The ’981 patent discloses a method for manufacturing electrochemical test strips, such as for glucose monitoring, using a reel-to-reel process. The method involves using multiple, different laser beams that move relative to a conductive layer on a base substrate to form distinct kerfs (ablated gaps) that define electrodes and other features.

3. Grounds for Unpatentability

Ground 1: Obviousness over Bhullar, Boogaard, and Angell - Claims 18-30 and 32-37 are obvious over Bhullar in view of Boogaard and Angell.

• Prior Art Relied Upon: Bhullar (Application # 2004/0200721), Boogaard (a 1986 SPIE article), and Angell (a 1997 SPIE article).
• Core Argument for this Ground:
  • Prior Art Mapping: Petitioner argued that Bhullar taught a method for manufacturing glucose biosensor strips using laser ablation in a reel-to-reel process, including forming electrodes by creating gaps in a conductive layer and forming a wider recess that also removes some of the underlying polymer substrate. However, Bhullar only generally described laser ablation. The combination with Boogaard and Angell provided the specific laser technologies required by the claims. Boogaard taught using a focused Nd:YAG laser with a positioning system to create very small, precise kerfs in thin metal films, corresponding to the ’981 patent’s “first kerf.” Angell taught using a focused CO2 laser to machine both metals and plastics, noting it was more efficient for ablating plastics than an Nd:YAG laser. This CO2 laser corresponded to the “second laser beam” used to form the wider and deeper “second kerf” (recess) that cuts through both the conductive and base layers, as disclosed in Bhullar.
  • Motivation to Combine: A Person of Ordinary Skill in the Art (POSITA) starting with Bhullar’s manufacturing method would be motivated to consult prior art for specific, suitable laser ablation techniques. A POSITA would combine Boogaard to implement the known technique of using a focused, movable Nd:YAG laser for the precise scribing of electrodes in the conductive layer. To form Bhullar’s wider recess that removes both metal and polymer, a POSITA would be motivated to select Angell’s CO2 laser, as it was known to be better suited for ablating plastics and providing wider beam widths than the Nd:YAG laser, thus improving efficiency.
  • Expectation of Success: A POSITA would have a reasonable expectation of success because all references operated in the same field of micro-machining for microelectronics. Boogaard and Angell provided well-understood laser systems and parameters for ablating the exact types of materials (gold, polymers) on the micron scale used in Bhullar’s method.

Ground 2: Obviousness over Edelbrock, Boogaard, and Angell - Claims 1-13, 15-16, 18-30, and 32-34 are obvious over Edelbrock in view of Boogaard and Angell.

• Prior Art Relied Upon: Edelbrock (Application # 2009/0159197), Boogaard (a 1986 SPIE article), and Angell (a 1997 SPIE article).

• Core Argument for this Ground:

  • Prior Art Mapping: Petitioner asserted that Edelbrock disclosed a method of manufacturing multilayer test sensors using a reel-to-reel "web process." Edelbrock explicitly taught using different lasers at different times to form distinct sets of laser cuts: finer cuts to form narrow boundaries and wider cuts to form larger insulating gaps between conductive components. Independent claim 1 requires forming conductive components using different processing sources for different boundaries. Petitioner mapped the first processing source (forming fine boundaries) to Boogaard’s Nd:YAG laser and the second processing source (forming wider gaps) to Angell’s CO2 laser. A third processing source, a mechanical punch taught by Edelbrock for singulation, was mapped to claim limitations requiring a non-laser process.
  • Motivation to Combine: Edelbrock disclosed the general concept of using different lasers (including YAG and CO2 lasers) for different cuts but did not provide specific implementation details. A POSITA seeking to practice Edelbrock's method would have been motivated to consult the prior art for these details. Boogaard provided the necessary teachings for a focused Nd:YAG laser with a positioning system suitable for creating Edelbrock’s fine boundaries. Angell provided the teachings for a focused CO2 laser with a wider beam suitable for efficiently creating Edelbrock’s larger ablated gaps. The motivation was to implement Edelbrock’s disclosed method using known, optimized laser tools for their respective, stated purposes.
  • Expectation of Success: A POSITA would have a reasonable expectation of success because Boogaard and Angell provided specific, predictable solutions to implement the general steps disclosed in Edelbrock. The references involved the same materials (e.g., gold on polymer substrates) and the same field of laser micro-machining, ensuring the techniques were directly applicable and would yield predictable results.

• Additional Grounds: Petitioner asserted an additional obviousness challenge for claims 35-37 based on the combination of Edelbrock, Boogaard, and Angell, further in view of Bhullar. This ground argued a POSITA would be motivated to add Bhullar's teaching of a laser-ablated code pattern onto the test strip manufactured by the primary combination.

4. Arguments Regarding Discretionary Denial

• §325(d): Petitioner argued denial under §325(d) would be inappropriate because the grounds relied on prior art (Edelbrock, Bhullar, Boogaard, Angell) and arguments never presented to or considered by the Examiner during prosecution. The Examiner’s allowance was based on overcoming a rejection over a different reference (Groll) by adding limitations for a "focused laser beam" and "movement" of the laser, which Petitioner contended are explicitly taught by the newly cited art.
• §314(a) / Fintiv: Petitioner argued the Fintiv factors weighed against discretionary denial. The co-pending district court case was in its early stages, with no Markman hearing scheduled and minimal discovery. Critically, Petitioner noted the court had indicated it would be amenable to a stay if an inter partes review (IPR) was instituted, and Petitioner had filed a Sotera stipulation, agreeing not to pursue the same invalidity grounds in district court if the IPR is instituted.

5. Relief Requested

• Petitioner requests institution of IPR and cancellation of claims 1-13, 15-16, 18-30, and 32-37 of the ’981 patent as unpatentable.