Aerin Medical Inc v. Neurent Medical Inc

I. Executive Summary and Procedural Information

• Parties & Counsel:
  • Plaintiff: Aerin Medical Inc. (Delaware) and The Foundry LLC, LLC (California)
  • Defendant: Neurent Medical Inc. (Delaware) and Neurent Medical Ltd. (Ireland)
  • Plaintiff’s Counsel: McCarter & English LLP; Finnegan Henderson Farabow Garrett & Dunner LLP
• Case Identification: 1:23-cv-00756, D. Del., 07/11/2023
• Venue Allegations: Venue is alleged to be proper in the District of Delaware because Defendant Neurent Medical Inc. is incorporated and resides in Delaware, and Defendant Neurent Medical Ltd. is a foreign corporation not resident in the United States.
• Core Dispute: Plaintiffs allege that Defendants’ NEUROMARK® System for treating chronic rhinitis infringes seven U.S. patents related to methods and devices for treating nasal airways and delivering therapeutic agents.
• Technical Context: The technology resides in the medical device field of otolaryngology (ENT), specifically concerning the use of radiofrequency (RF) energy to treat chronic rhinitis by disrupting nerves within the nasal passages.
• Key Procedural History: The complaint alleges that Defendants had pre-suit knowledge of the patents-in-suit through multiple channels, including formal notice letters from Plaintiffs, Defendants’ own citation of the patents-in-suit during the prosecution of their own patent applications, and Defendants’ identification of Plaintiffs’ commercial product (RhinAer) as a predicate device in a 510(k) submission to the U.S. Food and Drug Administration (FDA).

Case Timeline

II. Technology and Patent(s)-in-Suit Analysis

U.S. Patent No. 9,072,597 - "Methods and Devices to Treat Nasal Airways," issued July 7, 2015

The Invention Explained

• Problem Addressed: The patent’s background section describes inadequate nasal airflow resulting from conditions that cause a narrowing or collapse of the nasal valve, which is the narrowest part of the nasal airway and a primary regulator of airflow resistance (’597 Patent, col. 1:49-53, col. 2:54-61).
• The Patented Solution: The invention is a method and device for treating nasal airways by applying energy, such as radiofrequency energy, to reshape, remodel, or strengthen nasal tissues like cartilage and mucosa. This is intended to increase the cross-sectional area of the nasal valve, thereby decreasing airflow resistance without requiring surgical implants (’597 Patent, Abstract; col. 4:10-15). The device is advanced into a nostril to contact the target tissue and deliver the energy therapy (’597 Patent, col. 5:40-52).
• Technical Importance: The technology provides a minimally invasive approach to address structural issues within the nasal valve that cause breathing difficulties for a significant patient population.

Key Claims at a Glance

• The complaint asserts dependent claims 9, 14, 16, 18, 20, 22-24, 44, and 46, which depend from independent claims 1 and 30 (Compl. ¶74).
• Independent Claim 1 (Method):
  • advancing a treatment element of a treatment device into a nostril of the patient;
  • contacting the treatment element with a mucosal tissue of the upper airway;
  • delivering an energy based therapy to the mucosal tissue and/or an underlying tissue;
  • to modify a property of the at least one tissue and thus treat at least one of post nasal drip or chronic cough in the patient.
• Independent Claim 30 (Device):
  • an energy delivery member sized to be inserted into a nose and configured to deliver energy to tissues within the nose to modify at least one property of the at least one tissue;
  • a shaft extending from the energy delivery member; and
  • a handle attached to the shaft.
• The complaint also asserts claims under the doctrine of equivalents (Compl. ¶74).

U.S. Patent No. 9,415,194 - "Post Nasal Drip Treatment," issued August 16, 2016

The Invention Explained

• Problem Addressed: The patent describes post nasal drip syndrome (PNDS) and upper airway cough syndrome (UACS) as conditions resulting from an overproduction of mucus or thicker-than-usual mucus in the nasal passages, which can be triggered by viruses, infections, or other irritants (’194 Patent, col. 1:43-46).
• The Patented Solution: The invention provides a method for reducing mucus secretion by advancing a treatment device into the nostril to deliver energy-based therapy to the mucosal tissue and/or underlying tissue. This therapy is intended to modify a property of the tissue, such as by deactivating mucus-producing cells, to alleviate PNDS or chronic cough (’194 Patent, Abstract; col. 2:50-61).
• Technical Importance: The technology offers a targeted, minimally invasive treatment for a common and irritating condition that is often managed with medications that may have side effects or lose effectiveness over time.

Key Claims at a Glance

• The complaint asserts independent claim 1 and dependent claims 2, 3, 6, 12, 14, 16, 18, and 19 (Compl. ¶87).
• Independent Claim 1 (Method):
  • advancing a treatment delivery portion of an energy-based treatment device into a nostril of the patient;
  • contacting mucosal tissue of the upper airway with the treatment delivery portion, without piercing the mucosal tissue; and
  • delivering a treatment from the treatment delivery portion to the mucosal tissue and/or another tissue underlying the mucosal tissue to modify a property of the at least one tissue and thus treat at least one of post nasal drip or chronic cough in the patient.
• The complaint also asserts claims under the doctrine of equivalents (Compl. ¶87).

U.S. Patent No. 10,610,675 - "Systems and Methods for Delivery of a Therapeutic Agent," issued April 7, 2020

• Technology Synopsis: This patent describes methods and systems for delivering a therapeutic agent, such as a fragment of a neurotoxin, to a target region like a nasal cavity. The delivery is facilitated by using energy (e.g., RF, ultrasonic) to temporarily make cell membranes permeable, allowing the agent to enter the cells and produce a therapeutic effect ('675 Patent, Abstract; col. 3:24-34).
• Asserted Claims: 1, 2, 3, 7, 9, 10, 17-25 (Compl. ¶100).
• Accused Features: The complaint alleges that the NEUROMARK system infringes by being a system with an elongate body and energy delivery element used for treating rhinitis in a nasal cavity (Compl. ¶¶100, Ex. V).

U.S. Patent No. 10,894,011 - "Systems and Methods for Delivery of a Therapeutic Agent," issued January 19, 2021

• Technology Synopsis: As a continuation of the '675 patent, this patent similarly covers systems and methods for delivering a therapeutic agent to target cells by using energy to induce cell permeabilization. The invention is described in the context of treating conditions in the nasal cavity (’011 Patent, Abstract; col. 4:1-12).
• Asserted Claims: 1, 2, 5, 8, 9, 10, 12, and 14 (Compl. ¶113).
• Accused Features: The NEUROMARK system is accused of being an apparatus for treating a nasal condition by altering function of a nasopharyngeal passage using an energy source and transmission element (Compl. ¶¶113, Ex. W).

U.S. Patent No. 11,033,318 - "Methods and Devices to Treat Nasal Airways," issued June 15, 2021

• Technology Synopsis: Continuing the '597 patent family, this patent discloses methods and devices for improving airflow by treating nasal airways. The technology involves using energy to modify the shape, structure, or airflow characteristics of the internal or external nasal valve (’318 Patent, Abstract; col. 2:32-38).
• Asserted Claims: 1, 4, 5, 6, 9, 10, 12, 13, 15, 16, and 17 (Compl. ¶126).
• Accused Features: The NEUROMARK system is accused of infringing by being a device for treating nasal airways that includes an energy delivery element for reshaping or remodeling tissue (Compl. ¶¶126, Ex. X).

U.S. Patent No. 11,241,271 - "Methods of Treating Nasal Airways," issued February 8, 2022

• Technology Synopsis: Also in the '597 patent family, this patent focuses on methods of treating a nasal airway by delivering energy from a treatment element to modify a property of the tissue, such as the mucosal tissue, without requiring a surgical incision or implant. The method is intended to decrease airflow resistance (’271 Patent, Abstract).
• Asserted Claims: 1, 2, 3, 4, 6, 7, 11, 12, and 16 (Compl. ¶139).
• Accused Features: The use of the NEUROMARK system to deliver RF energy to nasal tissue to reduce mucus production is alleged to infringe (Compl. ¶¶139, Ex. Y).

U.S. Patent No. 11,679,077 - "Systems and Methods for Delivery of a Therapeutic Agent," issued June 20, 2023

• Technology Synopsis: As a continuation in the '675 patent family, this patent covers systems for delivering a therapeutic agent to a nasal cavity using energy to permeabilize cell membranes. The system comprises an elongate body with a distal portion for positioning in the nasal cavity and multiple radiofrequency electrodes (’077 Patent, Abstract; Claim 1).
• Asserted Claims: 1, 2, 3, 4, 5, 6, 7, 8, and 11 (Compl. ¶152).
• Accused Features: The NEUROMARK system is accused of being an apparatus for treating rhinitis in a nasal cavity that has a distal portion with multiple RF electrodes (Compl. ¶¶152, Ex. Z).

III. The Accused Instrumentality

Product Identification

• The accused instrumentality is the NEUROMARK® System, which includes the handheld NEUROMARK Device and the NEUROMARK Generator (also called the NEUROMARK® Radiofrequency (RF) Console) (Compl. ¶¶1, 52).

Functionality and Market Context

• The NEUROMARK system is designed to treat chronic rhinitis by disrupting posterior nasal nerves using radiofrequency energy (Compl. ¶¶54, 55). The system consists of a hand-held, single-use device with a malleable shaft and a treatment tip comprising an array of bipolar electrodes, which is connected to a reusable RF generator (Compl. ¶¶56, 57). The complaint alleges that the end effector of the device "consists of multiple leaflets, each of which contain several bipolar electrode pairs allowing for the creation of several discrete ablation sites" (Compl. ¶58). A diagram in the complaint shows the handheld device with a multi-stage end effector at its distal tip (Compl. p. 17, Fig. 2). In use, the device is inserted into a patient's nostril, advanced to the posterior nasal nerves, and the end effector is deployed to apply RF energy to the target tissue (Compl. ¶59). The complaint alleges that Defendants target the U.S. market exclusively for the commercial release of the system (Compl. ¶22).

IV. Analysis of Infringement Allegations

’597 Patent Infringement Allegations

• Identified Points of Contention:
  • Scope Questions: A central question may be how the claimed method of treating "post nasal drip or chronic cough" by modifying tissue properties relates to the accused system's stated indication for "chronic rhinitis." While the conditions are related, the complaint relies on showing that rhinitis symptoms include post-nasal drip to bridge this potential gap (Compl. ¶54), a connection that could be contested.
  • Technical Questions: The complaint alleges the NEUROMARK system's leaflets "spring out to enforce mucosal apposition" (Compl. ¶65). A factual question will be whether this action constitutes "contacting" the tissue as required by claim 1, and whether the nature and quality of that contact is sufficient for the claimed "delivering an energy based therapy."

’194 Patent Infringement Allegations

• Identified Points of Contention:
  • Scope Questions: The claim requires "contacting... without piercing." The complaint alleges the device's leaflets "enforce mucosal apposition" (Compl. ¶65). The nature of this contact and whether it achieves the functionality described in the patent without any form of piercing will be a key factual determination.
  • Technical Questions: What evidence does the complaint provide that the accused product's treatment of "chronic rhinitis" by disrupting posterior nasal nerves necessarily results in treating "post nasal drip or chronic cough" as required by the claim? The complaint links these conditions through medical literature and product marketing (Compl. ¶54), but the direct causal link in the context of infringement could be a point of contention.

V. Key Claim Terms for Construction

• The Term: "modify a property of the at least one tissue" (’597 Patent, Claim 1; ’194 Patent, Claim 1)

  • Context and Importance: This term is central to the infringement theory for both the '597 and '194 patents. The definition will determine whether the accused product's function of "nerve disruption" and "neurolysis" falls within the scope of the claimed "modification." Practitioners may focus on this term because its breadth is critical to whether the patents cover nerve ablation in addition to the tissue reshaping and remodeling described in the specification.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The specification states that the treatment may "reshape, remodel, strengthen, or change the properties of the tissues of the nose" and can "modify a mechanical property of at least one nasal valve" (’597 Patent, col. 6:5-8). This language suggests a wide range of possible modifications beyond simple reshaping.
    • Evidence for a Narrower Interpretation: The detailed description and figures in the '597 and '194 patent families heavily emphasize mechanical reshaping and altering the structural integrity of cartilage and other tissues to improve airflow (’597 Patent, Figs. 8A-8J; col. 4:10-15). A defendant may argue that "modify a property" should be limited to these structural and mechanical changes, rather than encompassing the distinct physiological process of nerve ablation.

• The Term: "energy delivery member" (’597 Patent, Claim 30)

  • Context and Importance: The physical structure of this element is a potential point of dispute. The infringement allegation rests on the NEUROMARK device's multi-leaflet end effector meeting this definition. The construction of this term will determine if the accused product's specific design is covered by the claim's structural limitations.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: Claim 30 itself is broad, requiring only that the member is "sized to be inserted into a nose and configured to deliver energy." The specification describes the element functionally, for example, as comprising "one or more electrodes" (’597 Patent, col. 5:1-5).
    • Evidence for a Narrower Interpretation: The patent specification depicts numerous specific embodiments of the "energy delivery member," including various configurations of monopolar and bipolar plates and needles (’597 Patent, Figs. 8A-8J). A defendant could argue that these specific examples limit the term's scope to electrode configurations distinct from the accused multi-leaflet array.

VI. Other Allegations

• Indirect Infringement: The complaint alleges both induced and contributory infringement for all asserted patents. The basis for inducement is the allegation that Defendants provide Instructions for Use, product descriptions, promotional materials, and other literature that actively instruct and encourage physicians to use the NEUROMARK system in a manner that infringes the patents-in-suit (Compl. ¶¶79, 92, 105, 118, 131, 144, 157). Contributory infringement is alleged on the basis that the NEUROMARK system is not a staple article of commerce and has no substantial non-infringing uses (Compl. ¶¶82, 83, 95, 96).
• Willful Infringement: The complaint alleges willful infringement for all asserted patents. The basis for willfulness is alleged pre-suit knowledge stemming from multiple sources: (1) notice letters sent by Plaintiffs to Defendants identifying specific patents (Compl. ¶¶40, 41); (2) Defendants’ citation of several patents-in-suit to the USPTO during the prosecution of their own patent applications (Compl. ¶¶42-46); and (3) Defendants' alleged awareness of Plaintiffs' patent-marked RhinAer product, which Defendants identified as a predicate device in an FDA 510(k) submission (Compl. ¶¶48, 49).

VII. Analyst’s Conclusion: Key Questions for the Case

• A core issue will be one of definitional scope: How will the term "modify a property of the ... tissue" be construed? Will the court find that this language, described in the patents primarily in the context of structural tissue reshaping, is broad enough to read on the accused product's function of nerve disruption and neurolysis to treat rhinitis symptoms?
• A second key question will be one of willfulness and damages: Given the extensive allegations of pre-suit knowledge, including Defendants' own citations of the patents-in-suit to the patent office, a central focus will be on whether any infringement found was willful. The outcome of this question could substantially impact potential damages.
• A third issue may arise from the multi-patent assertion strategy: With seven patents asserted from two distinct patent families—one directed generally to energy-based nasal treatment ('597 family) and the other to energy-assisted delivery of a therapeutic agent ('675 family)—the case will involve complex claim construction and infringement analyses across different technological disclosures, raising the question of how these distinct inventive concepts apply to a single accused product that delivers only energy.