Neurent Medical Inc v. Aerin Medical Inc

1. Case Identification

• Case #: IPR2024-00276
• Patent #: 9,415,194
• Filed: January 18, 2024
• Petitioner(s): Neurent Medical Inc. & Neurent Medical Ltd.
• Patent Owner(s): Aerin Medical Inc.
• Challenged Claims: 1-3, 6, 12, 14, 16, 18, and 19

2. Patent Overview

• Title: Techniques for Treating Upper Airway Conditions
• Brief Description: The ’194 patent discloses methods for treating conditions like post-nasal drip and chronic cough by advancing an energy-based treatment device into a patient’s nostril to deliver treatment to mucosal tissue without piercing it.

3. Grounds for Unpatentability

Ground 1: Anticipation over Baker - Claims 1-3, 12, 14, 16, and 18 are anticipated by Baker under 35 U.S.C. §102.

• Prior Art Relied Upon: Baker (WO Publication No. 2010/077980).
• Core Argument for this Ground:
  • Prior Art Mapping: Petitioner argued that Baker discloses every limitation of the challenged claims. Baker teaches methods for treating rhinitis and its symptoms (including post-nasal drip) by inserting an energy-based device into a nostril. The device delivers acoustic (ultrasound) energy to treat tissue surfaces like nasal passages and turbinates. Petitioner asserted that Baker’s device, particularly an embodiment with a flexible and deformable inflatable chamber, contacts mucosal tissue without piercing it. Baker's disclosure of ablating tissue met the "injuring" limitation of claim 12, and its mention of treating skin surfaces met the tissue-type limitation of claim 14. Further, Baker’s goal of achieving a "reduction of mucus" without reshaping tissue was alleged to meet the limitations of claim 16.

Ground 2: Obviousness over Baker - Claims 1-3, 12, 14, 16, 18, and 19 are obvious over Baker under 35 U.S.C. §103.

• Prior Art Relied Upon: Baker (WO Publication No. 2010/077980).
• Core Argument for this Ground:
  • Prior Art Mapping: As an alternative to anticipation, Petitioner contended that to the extent Baker does not explicitly disclose treating "post nasal drip" or "chronic cough," it would have been obvious to do so. Baker expressly teaches treating allergic rhinitis, and post-nasal drip was a well-known symptom of rhinitis, which in turn was a primary cause of chronic cough. For claim 19, Petitioner argued that Baker teaches treating nasal turbinates generally, and selecting the inferior turbinate and its posterior aspect would have been an obvious choice from a finite number of known anatomical locations.
  • Motivation to Combine (for §103 grounds): A POSITA would have been motivated to apply Baker's disclosed method for treating rhinitis to treat its known symptoms and resulting conditions, as this represented a known medical strategy of treating an underlying cause to alleviate its effects.
  • Expectation of Success: A POSITA would have had a reasonable expectation of success because treating the underlying cause (rhinitis) was a well-understood and effective way to resolve post-nasal drip and chronic cough.

Ground 3: Obviousness over Baker, Edwards-’535, and Chen - Claims 1-3, 6, 12, 14, 16, 18, and 19 are obvious over Baker in view of Edwards-’535 and Chen.

• Prior Art Relied Upon: Baker (WO 2010/077980), Edwards-’535 (Patent 6,517,535), and Chen (a March 2005 journal article on radiofrequency treatment).
• Core Argument for this Ground:
  • Prior Art Mapping: This combination addresses all challenged claims, including claim 6, which requires ablating nerve tissue underlying the mucosa. Petitioner argued Baker discloses a device for treating rhinitis and suggests using it with radiofrequency (RF) energy but lacks implementation details. Edwards-’535 was cited for its detailed teachings of a non-piercing RF energy device with an expandable member for ablating nasal tissue. Chen was cited for its clinical study demonstrating that RF ablation of nerves within the inferior turbinate is a highly effective treatment for allergic rhinitis, thereby reducing gland secretion. The combined teachings allegedly disclose a non-piercing device (Baker, Edwards-’535) delivering RF energy (Edwards-’535) to ablate nerves underlying the mucosa (Chen) to treat rhinitis and its symptoms.
  • Motivation to Combine (for §103 grounds): A POSITA would combine these references because Baker expressly suggests incorporating RF energy into its system. The POSITA would have looked to a reference like Edwards-’535 for a suitable non-piercing RF device design and to a clinical reference like Chen to identify effective anatomical targets (e.g., specific nerves) and confirm the therapeutic benefits for treating the same condition.
  • Expectation of Success: The combination of known elements for their intended purposes would yield predictable results. Edwards-’535 teaches the benefits of bloodless, non-penetrating RF ablation, and Chen provides clinical data confirming the efficacy of this approach for treating rhinitis, giving a POSITA a strong expectation of success.

4. Arguments Regarding Discretionary Denial

• Petitioner argued against discretionary denial under Fintiv, stating that the parallel district court litigation is at a very early stage with no trial date set, meaning a Final Written Decision in the IPR would issue well before trial.
• Petitioner also argued that denial under §325(d) is unwarranted because the primary prior art references asserted in the petition (Baker, Edwards-’535, and Chen) were never before the examiner during the original prosecution of the ’194 patent.

5. Relief Requested

• Petitioner requests institution of an inter partes review and cancellation of claims 1-3, 6, 12, 14, 16, 18, and 19 of the ’194 patent as unpatentable.