PTAB

IPR2023-00381

Vital Connect Inc v. Bardy Diagnostics Inc

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Key Events
Petition
petition

1. Case Identification

2. Patent Overview

  • Title: ELECTROCARDIOGRAPHY PATCH
  • Brief Description: The ’743 patent discloses a wearable wireless monitor patch for electrocardiographic and physiological monitoring. The claims are directed to the basic structure of a wireless patch, including electrodes, a flexible circuit board, and a wireless transceiver, characterized by an elongated backing with a mid-section that is narrower than its two ends.

3. Grounds for Unpatentability

Ground 1: Obviousness over Mazar in view of Yang - Claims 1-20 are obvious over Mazar in view of Yang.

  • Prior Art Relied Upon: Mazar (WO 2010/104952) and Yang (Patent 11,116,447).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that Mazar, which discloses a patient health monitoring patch, teaches all limitations of the challenged claims. Mazar’s adherent patch includes a backing with an hourglass shape, which Petitioner asserted meets the limitation of an elongated strip with a mid-section narrower than its two ends. Mazar also disclosed placing electrocardiographic (ECG) electrodes on each end of the backing, a flexible printed circuit board with traces coupling the electrodes, and a wireless transceiver. For independent claim 11, Petitioner contended Mazar teaches the required battery, processor, and memory for storing physiological signals. Yang, which discloses a modular wearable sensor, was used to support the obviousness of specific design choices. For example, Yang taught a simpler two-electrode configuration and a cost-effective design with a battery positioned directly on the backing, reinforcing the obviousness of Mazar's configuration.
    • Motivation to Combine: Petitioner asserted a person of ordinary skill in the art (POSITA) would combine Mazar and Yang because both references address the same problem of creating comfortable, cost-effective, and durable ECG monitoring patches for at-home use. A POSITA would have been motivated to incorporate the simpler, cost-effective structural features of Yang into the established patch design of Mazar to reduce weight, minimize components, improve patient comfort, and lower manufacturing costs.
    • Expectation of Success: A POSITA would have had a reasonable expectation of success because the combination involved integrating well-known and predictable components (e.g., batteries, electrodes, flexible circuits) from the same technical field to achieve a known goal.

Ground 2: Obviousness over Oster in view of Yang - Claims 1-20 are obvious over Oster in view of Yang.

  • Prior Art Relied Upon: Oster (Application # 2011/0077497) and Yang (Patent 11,116,447).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that Oster, which discloses a biomedical sensor system, teaches the core limitations of the challenged claims. Oster’s system comprises a central hub and two satellite electrodes connected by narrower, flexible connectors. Petitioner asserted this arrangement meets the limitation of an elongated strip with a mid-section narrower than its ends, where the support members of the connectors serve as the backing. Oster also taught using electrodes to capture ECG signals, flexible circuits (connectors with wire conductors), and wireless communication from the hub. For claim 11, Petitioner argued that while Oster explicitly discloses a processor and memory, the inclusion of a battery to power the wireless system would have been an obvious addition. Yang was again cited to teach a simple, cost-effective two-electrode design and a disposable module with an integrated battery, which a POSITA could readily apply to Oster's system.
    • Motivation to Combine: Petitioner argued a POSITA would combine Oster and Yang as both are directed at creating effective and comfortable remote health monitors. A POSITA would be motivated to integrate Yang's simpler, two-electrode configuration and disposable battery module with Oster's flexible sensor system to reduce costs, complexity, and manufacturing waste while improving ease of use. This combination would predictably result in a more efficient and user-friendly ECG patch.
    • Expectation of Success: Success was expected because the combination involved applying the well-understood concept of a two-electrode, battery-powered disposable patch (Yang) to another flexible patch system (Oster) using conventional and predictable engineering principles.

4. Key Claim Construction Positions

  • "a battery on one of the ends of the backing" (claim 11): Petitioner argued this term should be construed according to its plain and ordinary meaning, which does not require direct physical contact between the battery and the backing. Petitioner contended the term governs the general positioning of the battery on one of the two ends of the patch. This construction is supported by the ’743 patent’s own figures, which depict intervening components (a non-conductive receptacle and a flexible circuit) between the battery compartment and the flexible backing. Petitioner asserted that a construction requiring direct contact would improperly exclude the patent's own disclosed embodiments.

5. Arguments Regarding Discretionary Denial

  • Petitioner argued against discretionary denial under Fintiv. The petition asserted that the co-pending district court litigation was in its very early stages, with discovery having only recently opened and no claim construction positions exchanged. With a trial date set for November 2024, well after the statutory deadline for a Final Written Decision (FWD) in the inter partes review (IPR), Petitioner argued there would be no significant overlap or inefficiency. Petitioner also emphasized that the invalidity grounds presented were exceptionally strong, a factor that weighs against denial.

6. Relief Requested

  • Petitioner requests institution of an IPR and cancellation of claims 1-20 of the ’743 patent as unpatentable.