Neurent Medical Inc v. Aerin Medical Inc

1. Case Identification

• Case #: IPR2024-00277
• Patent #: 11,241,271
• Filed: January 18, 2024
• Petitioner(s): Neurent Medical Inc. & Neurent Medical Ltd.
• Patent Owner(s): Aerin Medical Inc.
• Challenged Claims: 1-4, 6-12, 16

2. Patent Overview

• Title: Method for Treating a Nasal Airway
• Brief Description: The ’271 patent describes a method for reducing mucus production by treating a nasal airway. The method involves applying radiofrequency (RF) energy through the nasal mucosa to an underlying target tissue using a device featuring two rows of bipolar electrode pairs.

3. Grounds for Unpatentability

Ground I: Obviousness over Edwards-’535, Kong, and Stern - Claims 1-3, 6-12, 16 are obvious over Edwards-’535 in view of Kong and Stern.

• Prior Art Relied Upon: Edwards-’535 (Patent 6,517,535), Kong (a March 2005 clinical journal article), and Stern (Patent 5,562,720).
• Core Argument for this Ground:
  • Prior Art Mapping: Petitioner argued that the claimed method was taught by the combination. Edwards-’535 disclosed a device for RF ablation of a nasal concha (turbinate) using an expandable member that contacts the nasal mucosa and features a row of bipolar electrodes, with surface cooling to prevent mucosal damage. Kong disclosed a method of applying RF energy to the inferior turbinate to damage underlying parasympathetic nerves specifically to reduce mucus production and treat rhinitis. Petitioner asserted that combining these teachings provided the core method steps. Stern was used to supply the specific limitation of "two rows of bipolar electrode pairs," as it taught an ablation device with such a configuration on an expandable member for treating tissue linings.
  • Motivation to Combine: A POSITA would combine Edwards-’535 with Kong to apply a superior, less damaging ablation technique to achieve the known therapeutic goal taught by Kong—reducing mucus by targeting submucosal nerves. Petitioner argued that because Edwards-’535 disclosed multiple bipolar electrodes but omitted implementation details, a POSITA would be motivated to look to analogous art like Stern for a well-understood configuration. Stern’s two-row design offered clear benefits for a nasal procedure, including precise control over energy delivery, ensuring even heating of heterogeneous tissue, and treating a larger surface area.
  • Expectation of Success: The combination involved applying known RF ablation techniques to the same anatomical location to achieve predictable results. Petitioner asserted that Kong's reported 94.3% clinical effectiveness rate would provide a POSITA with a strong expectation of success.

Ground II: Obviousness over Edwards-’535, Liang, and Stern - Claims 1-3, 6-12, 16 are obvious over Edwards-’535 in view of Liang and Stern.

• Prior Art Relied Upon: Edwards-’535 (Patent 6,517,535), Liang (an August 1999 clinical journal article), and Stern (Patent 5,562,720).

• Core Argument for this Ground:

  • Prior Art Mapping: This ground was structured similarly to Ground I, substituting Liang for Kong as the reference teaching mucus reduction. Petitioner contended that Liang taught applying RF energy to the ethmoidal nerve within the middle turbinate to treat allergic rhinitis and explicitly to reduce "runny nose" (i.e., mucus production). The petition noted that Edwards-’535 was applicable to any turbinate, including the middle one. The device structure, including the "two rows of bipolar electrode pairs," was again supplied by combining the teachings of Edwards-’535 and Stern.
  • Motivation to Combine: The motivation to combine was parallel to that for Kong: using the superior Edwards-’535 device to perform the nerve ablation taught by Liang for mucus reduction. Petitioner highlighted that Liang reported side effects like "bloody secretions," which would directly motivate a POSITA to adopt the less-damaging surface-cooling technique of Edwards-’535. Furthermore, the precise control afforded by Stern's two-row electrode arrangement would be particularly useful, as Liang emphasized the need to avoid perforating the nasal septum, a risk that targeted energy delivery would mitigate.
  • Expectation of Success: Liang's high reported effectiveness rate of 95.5% would give a POSITA a reasonable expectation of success in achieving mucus reduction with the combined method.

• Additional Grounds: Petitioner asserted additional obviousness challenges against claim 4 (Grounds II and IV), which added Edwards-’886 (Patent 6,273,886) to the primary combinations to teach the specific limitation of applying energy in the form of a 460 kHz sinusoid wave.

4. Arguments Regarding Discretionary Denial

• Petitioner argued that discretionary denial under 35 U.S.C. §325(d) was not warranted because the asserted prior art combinations were not previously considered by the USPTO. The petition stated that Edwards-’535, Stern, Liang, and Edwards-’886 were not before the examiner. While Kong was cited during prosecution, it was among nearly 200 other references, was not substantively discussed, and was originally in Chinese without evidence that a full translation was considered.
• The petition also argued against discretionary denial under §314(a) based on Fintiv factors. It asserted that the parallel district court litigation was in a nascent stage, having not progressed beyond pleadings, with no case schedule or trial date set. Petitioner contended that a Final Written Decision in the IPR would likely issue well before any potential trial.

5. Relief Requested

• Petitioner requested the institution of an inter partes review and the cancellation of claims 1-4, 6-12, and 16 of Patent 11,241,271 as unpatentable.