Aerin Medical Inc v. Neurent Medical Ltd

1. Case Identification

• Case #: IPR2025-01124
• Patent #: 11,998,262
• Filed: June 19, 2025
• Petitioner(s): Aerin Medical Inc.
• Patent Owner(s): Neurent Medical Ltd.
• Challenged Claims: 1-20

2. Patent Overview

• Title: Method for Improving Sleep by Treating Sino-Nasal Conditions
• Brief Description: The ’262 patent discloses methods for improving a patient's sleep by treating conditions like rhinitis, congestion, and rhinorrhea. The methods involve advancing a neuromodulation device with a multi-electrode end effector into the sino-nasal cavity to deliver energy, disrupting 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 with a multi-electrode end effector advanced into the nasal cavity to deliver radiofrequency (RF) energy to treat rhinosinusitis. This treatment involves modulating parasympathetic pathways to reduce mucus production and vessel engorgement, directly mapping to the method steps of claim 1.
  • Motivation to Combine (N/A - Single Reference): The core obviousness argument asserted that although Townley does not explicitly state its treatment improves sleep, a person of ordinary skill in the art (POSITA) would have found it obvious that treating the symptoms of rhinosinusitis—such as congestion and rhinorrhea—would improve a patient’s sleep and nasal breathability. This link was allegedly well-established in the art.
  • Expectation of Success: A POSITA would have a high expectation of success, as the known and intended result of treating rhinosinusitis symptoms, as taught by Townley, is improved breathing and consequently, improved sleep.

Ground 2: Obviousness over Wolf-003 and Wolf-290 - Claims 1-9 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 alone discloses all structural and functional aspects of the method in claim 1, including a multi-electrode end effector on a shaft advanced into the nasal cavity to deliver RF energy. Wolf-003 is directed to treating post-nasal drip and cough by delivering ablative energy to mucosal tissue, which inherently disrupts neural signals and reduces mucus production.
  • Motivation to Combine: While arguing Wolf-003 alone renders the claims obvious, Petitioner added Wolf-290 to confirm the obviousness of applying Wolf-003’s device to treat rhinitis, congestion, and rhinorrhea (RCR). Wolf-290 explicitly teaches that delivering ablative energy to nasal tissues to damage nerve fibers and goblet cells treats rhinitis. A POSITA would combine these teachings to expand the utility of the Wolf-003 device, thereby gaining clinical and commercial advantages by treating a broader range of common nasal conditions.
  • Expectation of Success: A POSITA would have a reasonable expectation of success because Wolf-003’s device is already configured to deliver ablative energy to the specific anatomical locations (e.g., inferior turbinates) that contain the nerve fibers and goblet cells responsible for the symptoms of RCR.

Ground 3: Obviousness over Wolf-003, Wolf-290, and Angeles - Claims 5-20 are obvious over the Ground 2 references 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 specific console unit limitations in claims 5-20. Petitioner argued that Wolf-003 discloses a generic, high-level "control system" without implementation details. Angeles remedies this deficiency by disclosing a detailed electrosurgical console that includes a housing, an integrated RF energy generator, a computer processor, and a touchscreen display. Angeles further teaches specific functionalities recited in the dependent claims, such as monitoring temperature and elapsed time, providing operator feedback, and allowing user adjustment of treatment parameters.
  • Motivation to Combine: A POSITA would combine Angeles's detailed console teachings with the Wolf-003 device to implement Wolf-003’s generic control system in a predictable and technologically straightforward manner. Angeles’s console was presented as a highly desirable option because it offers an integrated, compact design and an advanced user interface that allows for precise customization of treatment, which are known advantages for medical devices.
  • Expectation of Success: Success would be expected, as implementing the control and user interface features from Angeles with the Wolf-003 device was argued to be a routine matter of applying conventional hardware and software engineering principles.

4. Arguments Regarding Discretionary Denial

• To preempt a potential discretionary denial under 35 U.S.C. §314(a) based on the parallel district court litigation (Aerin Medical Inc. v. Neurent Medical Inc., D. Del.), Petitioner stipulated that if trial is instituted in this inter partes review (IPR), it will not pursue the same grounds, or any grounds it reasonably could have raised, in the co-pending litigation. This stipulation directly addresses the Fintiv factor concerning overlapping issues and the desire to avoid duplicative efforts between the U.S. Patent and Trademark Office and federal courts.

5. Relief Requested

• Petitioner requests institution of an IPR and cancellation of claims 1-20 of the ’262 patent as unpatentable.