DCT
1:24-cv-01070
Neurent Medical Ltd v. Aerin Medical Inc
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Neurent Medical Ltd. (Ireland)
- Defendant: Aerin Medical Inc. (Delaware)
- Plaintiff’s Counsel: Morris, Nichols, Arsht & Tunnell LLP; Wilmer Cutler Pickering Hale and Dorr LLP
- Case Identification: 1:24-cv-01070, D. Del., 09/24/2024
- Venue Allegations: Venue is alleged to be proper as Defendant is a Delaware corporation that resides in and conducts extensive business in the district.
- Core Dispute: Plaintiff alleges that Defendant’s RhinAer System, a medical device for treating chronic rhinitis, infringes three patents related to systems and methods for therapeutic nasal treatment using a handheld device.
- Technical Context: The technology concerns handheld radiofrequency (RF) ablation devices designed for minimally invasive surgical procedures to disrupt posterior nasal nerves and treat symptoms of chronic rhinitis.
- Key Procedural History: The complaint alleges that Plaintiff sent a pre-suit notice letter to Defendant on September 18, 2024, identifying the asserted patents and providing claim charts detailing the alleged infringement, which may form a basis for allegations of willful infringement.
Case Timeline
| Date | Event |
|---|---|
| 2020-04-09 | Patent Priority Date (’973, ’974, ’889 Patents) |
| 2022-07-29 | FDA 510(k) clearance for accused RhinAer Stylus (Model FG1393) |
| 2022-09-XX | Accused RhinAer System launched |
| 2024-09-17 | ’889 Patent Issued |
| 2024-09-18 | Plaintiff sends pre-suit notice letter to Defendant |
| 2024-09-24 | ’973 Patent Issued |
| 2024-09-24 | ’974 Patent Issued |
| 2024-09-24 | Complaint Filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 12,096,973 - "Systems and Methods for Therapeutic Nasal Treatment Using Handheld Device"
- Patent Identification: **U.S. Patent No. 12,096,973**, "Systems and Methods for Therapeutic Nasal Treatment Using Handheld Device," issued September 24, 2024 (’973 Patent). (Compl. ¶21).
The Invention Explained
- Problem Addressed: The patent’s background section describes the drawbacks of conventional treatments for rhinitis, noting that aids like nasal sprays are temporary and medications can have suboptimal efficacy and side effects. It further states that existing surgical options are not always accurate, can cause significant collateral damage, and fail to adequately treat all underlying symptoms. (’973 Patent, col. 1:44-2:37).
- The Patented Solution: The invention is a handheld therapeutic device featuring a "retractable and expandable multi-segment end effector." This end effector is designed to be inserted into the nasal cavity and then expanded to conform to anatomical structures, allowing for the precise and localized application of energy to disrupt specific neural signals that cause rhinitis symptoms. The system is described as providing a high level of control and feedback to the operator. (’973 Patent, Abstract; col. 2:38-3:4).
- Technical Importance: This technology aims to provide a minimally invasive surgical treatment for rhinitis that is more accurate and causes less collateral damage than prior procedures, with the goal of offering longer-term symptom relief. (’973 Patent, col. 3:1-16).
Key Claims at a Glance
- The complaint asserts independent claims 1 and 16, along with their respective dependent claims. (Compl. ¶43).
- The essential elements of independent claim 1 include:
- A method for treating rhinitis by advancing a multi-electrode end effector into the sino-nasal cavity.
- The end effector comprises at least six electrodes that extend beyond the surface of the device's shaft.
- The electrodes are "oriented at an angle less than 90 degrees relative to the shaft."
- The end effector has at least a first and a second electrode, each exposed and extending outward to interact with anatomy at first and second locations within the nasal cavity.
- The method includes delivering energy via the electrodes to disrupt neural signals, thereby reducing mucus production or mucosal engorgement to improve nasal breathability.
- The complaint explicitly reserves the right to assert additional claims. (Compl. ¶5, n.1).
U.S. Patent No. 12,096,974 - "Systems and Methods for Therapeutic Nasal Treatment Using Handheld Device"
- Patent Identification: **U.S. Patent No. 12,096,974**, "Systems and Methods for Therapeutic Nasal Treatment Using Handheld Device," issued September 24, 2024 (’974 Patent). (Compl. ¶22).
The Invention Explained
- Problem Addressed: The patent addresses the same technical problems as the ’973 Patent, namely the inadequacy of prior temporary or inaccurate treatments for rhinitis that risk significant collateral damage. (’974 Patent, col. 1:44-2:37).
- The Patented Solution: The invention is a method of treatment using a handheld device with a multi-electrode end effector. The key distinguishing feature recited in the asserted independent claim is a structural one: "at least one portion of the multi-electrode end effector comprises a diameter that is larger than a diameter of the shaft." This suggests a specific physical configuration for the treatment tip relative to the instrument's shaft, which may aid in positioning or treatment delivery. (’974 Patent, Abstract; Claim 1).
- Technical Importance: This design provides a specific geometric relationship between the treatment tip and the shaft, which may enhance the device's stability, contact with tissue, or safety during a procedure. (’974 Patent, col. 2:50-3:4).
Key Claims at a Glance
- The complaint asserts independent claim 1 and its dependent claims. (Compl. ¶81).
- The essential elements of independent claim 1 include:
- A method for treating rhinitis by advancing a multi-electrode end effector into the sino-nasal cavity.
- The end effector comprises at least a first and a second spaced-apart electrode.
- A key structural limitation requires that at least one portion of the end effector has a diameter that is larger than the diameter of the shaft.
- The first and second electrodes are exposed and extend in outward directions to interact with anatomy at first and second locations.
- The method includes delivering energy via the electrodes to disrupt neural signals and improve nasal breathability.
- The complaint reserves the right to assert additional claims. (Compl. ¶77, n.14).
U.S. Patent No. 12,098,889 - "Systems and Methods for Therapeutic Nasal Treatment Using Handheld Device"
- Patent Identification: **U.S. Patent No. 12,098,889**, "Systems and Methods for Therapeutic Nasal Treatment Using Handheld Device," issued September 17, 2024 (’889 Patent). (Compl. ¶23).
- Technology Synopsis: The patent describes the problems associated with conventional rhinitis treatments, including their temporary nature or surgical risks. (’889 Patent, col. 1:28-2:36). The patented solution is a method of using a handheld device with a multi-electrode end effector to deliver energy to disrupt neural signals associated with the posterior nasal nerve and/or inferior turbinate, thereby alleviating rhinitis symptoms. (’889 Patent, Abstract).
- Asserted Claims: The complaint asserts claims 1-20, including independent claim 1. (Compl. ¶109).
- Accused Features: The accused features are the use of the RhinAer System to perform a method of treating rhinitis by advancing its stylus into the nasal cavity to deliver RF energy to target sites. (Compl. ¶112).
III. The Accused Instrumentality
Product Identification
The accused instrumentality is the RhinAer® System, which consists of the RhinAer® Stylus (at least Model FG1393) and the RhinAer® Console (at least Model FG226). (Compl. ¶3).
Functionality and Market Context
The RhinAer System is a medical device used to perform methods for treating chronic rhinitis. (Compl. ¶36). The system's console provides radiofrequency (RF) energy to the stylus, a handheld instrument that is inserted into the patient's sino-nasal cavity to ablate tissue. (Compl. ¶16-18). The complaint alleges that the currently accused version of the RhinAer Stylus, Model FG1393, received FDA clearance on July 29, 2022, and was launched in or around September 2022 as a "next generation" product with "enhancements." (Compl. ¶36, ¶39). A photo in the complaint shows the accused system, including its console with a touch-screen interface and the connected stylus. (Compl. p. 2).
IV. Analysis of Infringement Allegations
’973 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| advancing a multi-electrode end effector into the sino-nasal cavity of the patient, wherein the multi-electrode end effector comprises a plurality of electrodes, wherein the plurality of electrodes comprises at least six electrodes extend beyond surface of the shaft and are oriented at an angle less than 90 degrees relative to the shaft for the delivery of RF energy... | The RhinAer System's stylus is advanced into the patient's nasal cavity and includes a treatment tip with an electrode array of at least six electrodes that extend beyond the shaft surface at an angle less than 90 degrees. A marketing image in the complaint shows the "NEW" stylus tip. | ¶46 (p. 17-22) | col. 12:41-45 |
| the first electrode is exposed from a surface of the multi-electrode end effector and is positioned at a discrete portion thereon, the first electrode extending in a first outward direction relative to a longitudinal axis of the shaft to interact with anatomy at a first location within the nasal cavity; and | The treatment tip on the stylus includes a first exposed electrode that extends outward to interact with target tissue at a first location to apply RF energy. A diagram from the product's user manual shows the stylus tip with labeled electrodes. | ¶46 (p. 23-25) | col. 19:35-50 |
| the second electrode is exposed from the surface of the multi-electrode end effector and is positioned at a discrete portion thereon, the second electrode extending in a second outward direction relative to a longitudinal axis of the shaft to interact with anatomy at a second location within the nasal cavity; and | The treatment tip on the stylus includes a second exposed electrode, distinct from the first, that extends outward to interact with tissue at a second location. | ¶46 (p. 26-28) | col. 19:35-50 |
| delivering energy, via the first and second electrodes, to one or more target sites within a sino-nasal cavity of the patient to disrupt multiple neural signals... thereby reducing production of mucus and/or mucosal engorgement... to improve nasal breathability of the patient. | The RhinAer System delivers RF energy to target sites within the nasal cavity to disrupt neural signals, thereby treating symptoms of chronic rhinitis and improving nasal breathability. | ¶46 (p. 28-31) | col. 2:38-3:4 |
’974 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| advancing a multi-electrode end effector into the sino-nasal cavity of the patient... wherein at least one portion of the multi-electrode end effector comprises a diameter that is larger than a diameter of the shaft... | The RhinAer System is used in a method that includes advancing its stylus into the nasal cavity, where the treatment tip (the end effector) has a portion with a diameter larger than the diameter of the stylus shaft. A close-up image of the stylus tip is provided as evidence. | ¶84 (p. 78-84) | col. 2:50-54 |
| the first electrode is exposed from a surface of the multi-electrode end effector and is positioned at a discrete portion thereon, the first electrode extending in a first outward direction... to interact with anatomy at a first location... | The treatment tip on the stylus includes a first exposed electrode that extends outward from the tip's surface to interact with target tissue during treatment. | ¶84 (p. 85-87) | col. 19:35-50 |
| the second electrode is exposed from the surface of the multi-electrode end effector and is positioned at a discrete portion thereon, the second electrode extending in a second outward direction... to interact with anatomy at a second location... | The treatment tip includes a second exposed electrode, at a different location from the first, that extends outward to interact with tissue at a second location. | ¶84 (p. 88-90) | col. 19:35-50 |
| delivering energy... to disrupt multiple neural signals... thereby reducing production of mucus and/or mucosal engorgement... to improve nasal breathability... | The system delivers energy to disrupt neural signals within the patient's nose, thereby reducing symptoms of rhinitis and improving nasal breathability. | ¶84 (p. 91-94) | col. 2:38-3:4 |
Identified Points of Contention
- Scope Questions: A primary question may be whether the term "multi-electrode end effector" as used in the patents, which is described in the specification as a "retractable and expandable" structure, can be construed to read on the accused RhinAer stylus tip, which appears to be a more rigid structure. (Compl. p. 14).
- Technical Questions: For the ’973 Patent, a key factual question is whether the accused stylus has "at least six electrodes" and whether its tip is "oriented at an angle less than 90 degrees relative to the shaft" as claimed. For the ’974 Patent, a key factual question will be the precise measurement of the diameters of the "end effector" and the "shaft" and where the boundary between these two components lies on the accused device.
V. Key Claim Terms for Construction
Term: "multi-electrode end effector" (appearing in asserted claims of all three patents)
- Context and Importance: This term defines the operative portion of the claimed invention. Its construction is critical because the patents’ specifications and figures heavily feature an "expandable" and "deployable" structure, resembling a set of opening petals, while the accused device appears to be a more solid, fixed-shape tip. Practitioners may focus on this term to determine if the scope is limited to the expandable embodiments shown.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The claims themselves do not explicitly recite the terms "expandable" or "deployable," which may support an interpretation covering any structure at the end of the device that carries out the claimed function of delivering energy via multiple electrodes.
- Evidence for a Narrower Interpretation: The patent abstracts consistently introduce the invention as a "retractable and expandable multi-segment end effector." (’973 Patent, Abstract). The detailed descriptions and figures almost exclusively depict this expandable, flower-like structure, which may support an argument that the invention is limited to such embodiments. (’973 Patent, Figs. 5A-5F).
Term: "oriented at an angle less than 90 degrees relative to the shaft" (’973 Patent, Claim 1)
- Context and Importance: This limitation is central to the infringement allegation for the ’973 Patent. The complaint points to marketing material stating the accused device's "tip now tilts backward 10 degrees." (Compl. p. 31). The dispute will likely center on whether this fixed or malleable tilt meets a limitation described in the patent in the context of a dynamically expanding device.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The plain language of the claim does not require the angle to be adjustable or created upon deployment; it only requires the orientation to exist. This could support reading the claim on a device with a fixed-angle tip.
- Evidence for a Narrower Interpretation: The specification describes the end effector’s ability to "expand to a specific shape" and "deploy," with figures showing the angle being a result of this expansion mechanism. (’973 Patent, col. 18:5-12). This context may support a narrower construction requiring a deployable or articulated structure, not a fixed one.
VI. Other Allegations
- Indirect Infringement: The complaint alleges that Defendant induces infringement by providing Instructions for Use (IFU), promotional materials, and other literature that instruct and encourage physicians to use the RhinAer System in a manner that practices the steps of the asserted method claims. (Compl. ¶44-45, ¶82-83).
- Willful Infringement: Willfulness is alleged based on both pre-suit and post-suit knowledge of the patents and infringement. The complaint alleges Defendant is a sophisticated competitor that tracks Neurent's patent portfolio. (Compl. ¶29-30). More specifically, it alleges Defendant had pre-suit knowledge from a notice letter sent on September 18, 2024, which included claim charts detailing the infringement, and post-suit knowledge from the filing of the complaint. (Compl. ¶32, ¶34). Continued alleged infringement after these notices is asserted as the basis for willfulness. (Compl. ¶76, ¶104, ¶132).
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of structural scope: can the term "multi-electrode end effector," which is described throughout the patents' specifications in the context of an "expandable" and "deployable" mechanism, be construed to cover the accused RhinAer stylus, which appears to be a more rigid, fixed-geometry tip?
- A second central issue will be one of claim construction and factual application: does the accused stylus’s fixed "10 degree" backward tilt satisfy the ’973 Patent’s requirement for electrodes "oriented at an angle less than 90 degrees relative to the shaft," or does the patent’s context imply a deployable structure?
- A key question for willfulness and damages will be the timing and impact of knowledge: given that the ’973 and ’974 patents issued on the same day the complaint was filed, the court will likely scrutinize what knowledge Defendant gained from the pre-suit notice letter sent six days prior, and whether its conduct in that brief window and thereafter was objectively reckless.