PTAB

IPR2025-00376

iRhythm Inc v. Welch Allyn Inc

Key Events

Petition

petition

Title: Body-Worn Physiological Sensor
Brief Description: The ’484 patent relates to a body-worn physiological monitoring system, such as a heart monitor, that comprises a flexible circuit layer with both disposable and reusable components. The system includes a disposable module with electrodes for skin contact and a reusable computation-communication module that connects to the disposable part.

Prior Art Relied Upon: Matsumura (Japanese Publication # JP2004/121360).
Core Argument for this Ground:
- Prior Art Mapping: Petitioner argued that Matsumura, which was not considered during prosecution, discloses all limitations of the challenged claims. Matsumura teaches a body-worn "bioelectric potential detector" with a disposable "bioelectrode pad" and a reusable "signal processor." Petitioner contended this maps directly to the ’484 patent's claimed elements: the signal processor is a computation-communication module in a housing; the bioelectrode pad is a flexible circuit layer coupled to the skin; the components are attached via hooks; and the device includes both adhesive tape and protective release liners.
- Motivation to Combine (for §103 grounds): For claim 15, which requires a "flexible printed circuit layer," Petitioner asserted a person of ordinary skill in the art (POSA) would have been motivated to modify Matsumura’s layered conductive material into a single, printed circuit. This modification would use well-known techniques to make manufacturing and assembly easier and more efficient, replacing separate coated sheets with a single substrate containing printed-ink traces.
- Expectation of Success (for §103 grounds): A POSA would have had a high expectation of success, as creating flexible printed circuits with conductive ink was a conventional and predictable process.

Prior Art Relied Upon: Jensen (Application # 2003/0149349).
Core Argument for this Ground:
- Prior Art Mapping: Petitioner argued that Jensen, though cited in an Information Disclosure Statement, was never substantively examined and teaches all elements of the claims. Jensen discloses a body-worn "smart patch" with a disposable sensor assembly and a reusable portion. Petitioner mapped Jensen's electronics circuit (containing a microcontroller and transmitter) to the claimed computation-communication module, its top and bottom cases to the housing, its flexible circuit assembly to the flexible circuit layer, its adhesive sensor pads for skin coupling, and its peel-off cover to the protective covering.
- Motivation to Combine (for §103 grounds): To meet the limitation of claim 5 ("a plurality of openings sized to receive electrode gels"), Petitioner asserted it would have been obvious for a POSA to modify Jensen to integrate commercially available, pre-gelled electrodes. This modification would involve creating openings in the flexible layer to accommodate such standard components, which would simplify manufacturing and improve the stability of the electrode gels.
- Expectation of Success (for §103 grounds): A POSA would expect success in this simple integration, as it involved combining a known device structure with standard, commercially available components.

Prior Art Relied Upon: Matsumura (Japanese Publication # JP2004/121360) and Ozguz (Application # 2005/0096513).
Core Argument for this Ground:
- Prior Art Mapping: This ground primarily addressed the "hard-wired communication cable" limitation recited in claims 6 and 7. Petitioner asserted that while Matsumura discloses a wireless device, Ozguz explicitly teaches a bio-sensor module that includes a "port 86" for a hard-wired connection to a computer for downloading and analyzing data.
- Motivation to Combine (for §103 grounds): A POSA would combine Ozguz’s teachings with Matsumura's device to add a valuable backup feature. While Matsumura’s device is wireless, incorporating a hard-wired connection option from Ozguz provides a reliable way to download large amounts of stored data or recover data in case of power loss or wireless transmission failure. Ozguz provides the specific circuit architecture and port design that Matsumura lacks, making it a logical supplement to improve Matsumura's design.
- Expectation of Success (for §103 grounds): The combination would have been straightforward, as adding a data port to an electronic device was a well-understood and predictable modification.
Additional Grounds: Petitioner asserted an additional obviousness challenge based on Ozguz and the general knowledge of a POSA (Ground 3), arguing Ozguz's flexible bio-sensor module taught all limitations.

Petitioner argued against discretionary denial under §314(a) and §325(d). Regarding the Fintiv factors, Petitioner asserted that the co-pending district court litigation was in its earliest stages, with no trial date set and minimal investment of resources. Regarding §325(d), Petitioner noted that the primary references of Matsumura and Ozguz were never presented to or considered by the USPTO during prosecution. While Jensen was cited in an IDS, the Examiner did not substantively address it or provide any analysis of its teachings, meaning the Office never considered the specific unpatentability arguments presented in the petition.

Petitioner requests institution of an inter partes review (IPR) and cancellation of claims 1-8, 11-12, and 15-20 of the ’484 patent as unpatentable.