PTAB

IPR2025-01127

Aerin Medical Inc v. Neurent Medical Ltd

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Petition
petition

1. Case Identification

2. Patent Overview

  • Title: Method for Treating Rhinitis, Congestion, and Rhinorrhea
  • Brief Description: The ’974 patent discloses methods for treating rhinitis and related symptoms within a patient's sino-nasal cavity. The method involves using a neuromodulation device featuring a multi-electrode end effector to deliver energy and disrupt neural signals associated with mucus production and mucosal engorgement.

3. Grounds for Unpatentability

Ground 1: Obviousness over Townley - Claims 1-20 are obvious over Townley

  • Prior Art Relied Upon: Townley (Application # 2016/0331459).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that Townley, which is the inventor’s own prior work, discloses nearly every limitation of the challenged claims. Townley teaches a therapeutic neuromodulation system for treating rhinosinusitis by disrupting parasympathetic pathways. It discloses various multi-electrode end effectors, including expandable basket structures, operably associated with a shaft for advancement into the nasal cavity. These end effectors include first and second electrodes that are spaced apart, exposed, and extend outward to interact with nasal tissue. Townley further discloses delivering RF energy via these electrodes to disrupt neural activity, thereby reducing mucus production and vessel engorgement. For dependent claims, Townley teaches the use of temperature sensors, a console for controlling RF energy delivery based on temperature feedback, and specific treatment parameters like time and temperature thresholds.
    • Motivation to Combine (for §103 grounds): As a single-reference ground, the argument is that Townley itself contains all necessary elements. While Townley does not explicitly state its treatment "improves nasal breathability," Petitioner asserted this is an obvious and inherent result of treating the claimed symptoms of rhinitis, congestion, and rhinorrhea, which were well-known causes of nasal obstruction.
    • Expectation of Success (for §103 grounds): A person of ordinary skill in the art (POSITA) would have had a high expectation of success because Townley's disclosed methods were designed to treat the root causes of nasal obstruction. Therefore, successfully performing the disclosed treatment would predictably result in improved breathability.

Ground 2: Obviousness over Wolf-003 and Wolf-290 - Claims 1-4 and 8-12 are obvious over Wolf-003 alone or in view of Wolf-290

  • Prior Art Relied Upon: Wolf-003 (Application # 2015/0202003) and Wolf-290 (Application # 2019/0282290).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner contended that Wolf-003 discloses an energy-based treatment device with a multi-electrode end effector for use in the nasal cavity. This device includes a shaft, spaced-apart RF electrodes, and a temperature sensor. It is described for treating post-nasal drip by delivering ablative energy to mucosal tissue, including nerves and goblet cells in the inferior turbinate. Petitioner argued this device meets all structural and functional limitations of independent claim 1. While Wolf-003 focuses on post-nasal drip, its mechanism of action—ablating nerve and mucus-producing cells—is the same required to treat rhinitis.
    • Motivation to Combine (for §103 grounds): A POSITA would have been motivated to use the device of Wolf-003 to treat rhinitis, as confirmed by Wolf-290. Wolf-290 explicitly teaches that delivering ablative energy to nasal nerve fibers and goblet cells is a known method for treating rhinitis. The motivation would be to leverage an existing, effective device (Wolf-003) for a closely related and predictable application (treating rhinitis), thereby providing a more comprehensive treatment for patients, expanding the device's market, and avoiding the cost of developing a new device.
    • Expectation of Success (for §103 grounds): A POSITA would have had a reasonable expectation of success because the target tissues and mechanism of action disclosed in Wolf-003 for treating mucus overproduction are the same tissues (nerves, goblet cells) and mechanism (ablation) that Wolf-290 identifies for treating rhinitis. The device was already configured to operate in the correct anatomical location.

Ground 3: Obviousness over Wolf-003, Wolf-290, and Angeles - Claims 8-20 are obvious over Wolf-003 and Wolf-290 in view of Angeles

  • Prior Art Relied Upon: Wolf-003 (Application # 2015/0202003), Wolf-290 (Application # 2019/0282290), and Angeles (Application # 2020/0129223).
  • Core Argument for this Ground:
    • Prior Art Mapping: This ground builds on Ground 2 to address the detailed console limitations in claims 8-20. Petitioner argued that Wolf-003 discloses a basic external control system but lacks implementation details. Angeles, which shares an assignee and inventor with Wolf-003, remedies this by disclosing a sophisticated electrosurgical console. The Angeles console includes an integrated RF energy generator, a computer processor, and a touchscreen display. It is configured to monitor temperature and elapsed time, provide feedback to the operator, and automatically control and adjust RF energy output based on predetermined parameters (e.g., a maximum temperature of 60°C and an elapsed time of 18 seconds), directly mapping to the limitations of claims 8-20.
    • Motivation to Combine (for §103 grounds): A POSITA would have been motivated to implement the basic control system of Wolf-003 using the detailed console teachings of Angeles. Angeles discloses its console is for use with a variety of nasal treatment devices developed by Aerin Medical, which would include the device of Wolf-003. The combination would create a desirable, integrated system with a smaller footprint and an improved, user-friendly touchscreen interface that enhances physician control, customization of treatment, and safety.
    • Expectation of Success (for §103 grounds): Success would have been highly predictable, as implementing the combination would involve routine hardware and software integration. Given that the references originate from the same assignee, a POSITA would have understood the components were designed for compatibility.

4. Relief Requested

  • Petitioner requests institution of an inter partes review and cancellation of claims 1-20 of Patent 12,096,974 as unpatentable.