DCT

1:23-cv-00756

Aerin Medical Inc v. Neurent Medical Inc

Log In

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:23-cv-00756, D. Del., 10/16/2023
  • Venue Allegations: Venue is alleged to be proper as to Neurent Medical Inc. because it is incorporated in Delaware, and as to Neurent Medical Ltd. because it is a foreign corporation not resident in the United States.
  • Core Dispute: Plaintiffs allege that Defendants’ NEUROMARK® System, a medical device for treating chronic rhinitis, infringes eight U.S. patents related to methods and devices for treating nasal airways and delivering therapeutic agents.
  • Technical Context: The technology concerns medical devices that apply radiofrequency energy to tissues within the nasal cavity to treat conditions like chronic rhinitis and nasal obstruction, which represent a significant market affecting a large patient population.
  • 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 and Defendants' own citation of the asserted patents and their families during the prosecution of Defendants' patent applications. The complaint also notes that Defendants identified Plaintiffs' commercial product, the RhinAer®, as a predicate device in a 510(k) submission to the FDA. The original complaint was filed on July 11, 2023.

Case Timeline

Date Event
2005-07-22 Earliest Priority Date for ’675, ’011, ’077 Patents
2011-06-14 Earliest Priority Date for ’597, ’194, ’318, ’271, ’286 Patents
2015-07-07 U.S. Patent No. 9,072,597 Issues
2016-08-16 U.S. Patent No. 9,415,194 Issues
2020-02-18 Defendant allegedly aware of ’597, ’194, and application for ’318 Patent
2020-04-07 U.S. Patent No. 10,610,675 Issues
2020-04-10 Defendant allegedly aware of ’675 Patent
2021-01-19 U.S. Patent No. 10,894,011 Issues
2021-06-15 U.S. Patent No. 11,033,318 Issues
2021-10-22 FDA Letter regarding 510(k) premarket notification for Neuromark system
2022-02-08 U.S. Patent No. 11,241,271 Issues
2022-09-28 Plaintiff Aerin notifies Defendant of five patents-in-suit
2022-10-26 FDA Letter regarding 510(k) premarket notification for Neuromark system
2023-02-03 Defendant announces commercial release of Neuromark system in the U.S.
2023-06-20 U.S. Patent No. 11,679,077 Issues
2023-07-11 Original Complaint filed
2023-09-26 U.S. Patent No. 11,766,286 Issues
2023-10-12 Plaintiffs notify Defendant of ’286 Patent
2023-10-16 Amended Complaint filed

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

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

  • Patent Identification: U.S. Patent No. 9072597, "Methods and Devices to Treat Nasal Airways", issued July 7, 2015 (Compl. ¶25).

The Invention Explained

  • Problem Addressed: The patent describes inadequate nasal airflow resulting from abnormalities of the nasal valve, which can be caused by congenital deficiencies, surgery, or trauma. The patent notes that existing surgical corrections are invasive, while external dilators are temporary and can be unsightly (US 9072597 B2, col. 1:49-2:4).
  • The Patented Solution: The invention provides methods and devices for treating nasal airways by applying energy, such as radiofrequency (RF) energy, to reshape nasal tissue and improve airflow. The solution involves pressing a treatment element against the tissue to deform it into a desired shape and then applying energy to cause the tissue to retain that new shape (US9072597B2, col. 5:45-63).
  • Technical Importance: This technology offers a minimally invasive approach to addressing structural nasal obstruction, potentially allowing for in-office procedures that avoid the risks and recovery time of more invasive surgery (US 9,072,597 B2, col. 2:13-17).

Key Claims at a Glance

  • The complaint asserts independent claim 9 (Compl. ¶106).
  • Essential elements of claim 9 include:
    • positioning a treatment element of a treatment device adjacent to nasal tissue to be treated;
    • deforming the nasal tissue into a desired shape by pressing a surface of the treatment element against the nasal tissue;
    • delivering radiofrequency (RF) energy to one or more electrodes to locally heat the nasal tissue;
    • wherein delivering RF energy while deforming the nasal tissue causes the nasal tissue to change shape; and
    • removing the treatment element from the nasal airway.
  • The complaint asserts additional dependent claims and reserves the right to assert others (Compl. ¶106).

U.S. Patent No. 9,415,194 - "Post Nasal Drip Treatment"

  • Patent Identification: U.S. Patent No. 9415194, "Post Nasal Drip Treatment", issued August 16, 2016 (Compl. ¶27).

The Invention Explained

  • Problem Addressed: The patent addresses Post Nasal Drip Syndrome (PNDS), which results from an overproduction of mucus that causes irritation. It notes that existing pharmacological treatments like antihistamines and steroids can have undesirable side effects or lose effectiveness over time, while immunotherapy requires a prolonged course of injections (US 9415194 B2, col. 1:47-2:48).
  • The Patented Solution: The invention is a method for reducing mucus secretion by advancing an energy-based treatment device into the nostril to contact mucosal tissue without piercing it. The device delivers energy to the mucosal tissue and/or underlying tissue to modify its properties, thereby treating post-nasal drip or chronic cough (US9415194B2, col. 2:49-3:8).
  • Technical Importance: The invention provides a targeted, minimally invasive therapeutic method for a common ailment, potentially offering a long-lasting, single-treatment alternative to chronic medication (US 9,415,194 B2, col. 2:38-48).

Key Claims at a Glance

  • The complaint asserts independent claim 1 (Compl. ¶121).
  • Essential elements of claim 1 include:
    • 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;
    • delivering a treatment from the treatment delivery portion to at least one tissue selected from the group of the mucosal tissue and 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 asserts additional dependent claims and reserves the right to assert others (Compl. ¶121).

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

  • Patent Identification: U.S. Patent No. 10610675, "Systems and Methods for Delivery of a Therapeutic Agent", issued April 7, 2020 (Compl. ¶29).
  • Technology Synopsis: This patent addresses the problem of delivering highly toxic therapeutic agents, like botulinum toxin, in a safer, non-toxic manner. The solution involves delivering only the active fragment (the "light chain") of the toxin and using energy to temporarily make target cell membranes permeable, allowing the fragment to enter and take effect without the toxicity associated with the whole toxin molecule (’675 Patent, col. 2:58-3:6).
  • Asserted Claims: Independent claims 1 and 17 are asserted (Compl. ¶136).
  • Accused Features: The complaint alleges the NEUROMARK® System's application of RF energy to disrupt neural activity infringes by delivering energy to target tissue in a nasopharyngeal passage to treat a nasal condition (Compl. ¶136; ’675 Patent, col. 27:39-28:30).

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

  • Patent Identification: U.S. Patent No. 10894011, "Systems and Methods for Delivery of a Therapeutic Agent", issued January 19, 2021 (Compl. ¶31).
  • Technology Synopsis: This patent is in the same family as the ’675 Patent and relates to the same technology of delivering a therapeutic agent fragment combined with energy application to make cell membranes permeable in the nasal cavity (’011 Patent, col. 1:29-45).
  • Asserted Claims: Independent claims 1 and 23 are asserted (Compl. ¶151).
  • Accused Features: The complaint accuses the NEUROMARK® System's use of RF energy to treat rhinitis in the nasal passage of infringement (Compl. ¶151; ’011 Patent, col. 27:61-28:23).

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

  • Patent Identification: U.S. Patent No. 11033318, "Methods and Devices to Treat Nasal Airways", issued June 15, 2021 (Compl. ¶33).
  • Technology Synopsis: This patent is in the same family as the ’597 Patent and relates to devices and methods for reshaping nasal tissue using energy. The technology involves modifying the shape and/or structural properties of the nasal valve tissues to improve airflow (’318 Patent, col. 2:20-33).
  • Asserted Claims: Independent claims 1 and 9 are asserted (Compl. ¶166).
  • Accused Features: The complaint accuses the NEUROMARK® System's structure and function of applying RF energy to nasal tissue of infringement (Compl. ¶166; ’318 Patent, col. 47:4-48:65).

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

  • Patent Identification: U.S. Patent No. 11241271, "Methods of Treating Nasal Airways", issued February 8, 2022 (Compl. ¶35).
  • Technology Synopsis: This patent is in the same family as the ’597 Patent and relates to methods for treating nasal airways by delivering energy to modify tissue properties. A key aspect is the use of a device with two rows of protruding electrodes to deliver RF energy (’271 Patent, col. 8:10-24).
  • Asserted Claims: Independent claim 1 is asserted (Compl. ¶181).
  • Accused Features: The complaint alleges the NEUROMARK® System, with its multiple electrodes on leaflets, infringes by delivering RF energy to the nasal airway (Compl. ¶181; ’271 Patent, col. 47:48-48:24).

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

  • Patent Identification: U.S. Patent No. 11679077, "Systems and Methods for Delivery of a Therapeutic Agent", issued June 20, 2023 (Compl. ¶37).
  • Technology Synopsis: This patent is in the same family as the ’675 Patent and relates to the same technology of delivering therapeutic agents to the nasal cavity by applying energy (’077 Patent, col. 1:29-45).
  • Asserted Claims: Independent claims 1 and 9 are asserted (Compl. ¶196).
  • Accused Features: The complaint accuses the NEUROMARK® System's application of RF energy to treat rhinitis in the nasopharyngeal passage of infringement (Compl. ¶196; ’077 Patent, col. 27:39-28:28).

U.S. Patent No. 11,766,286 - "Methods and Devices to Treat Nasal Airways"

  • Patent Identification: U.S. Patent No. 11766286, "Methods and Devices to Treat Nasal Airways", issued September 26, 2023 (Compl. ¶39).
  • Technology Synopsis: This patent is in the same family as the ’597 Patent and relates to devices and methods for treating nasal airways. It describes a device with a treatment element having a convex surface for pressing against and creating a concavity in nasal tissue while applying energy (’286 Patent, Abstract).
  • Asserted Claims: Independent claim 1 is asserted (Compl. ¶211).
  • Accused Features: The complaint alleges the NEUROMARK® System infringes by using a device to apply energy to nasal tissue to treat a nasal condition (Compl. ¶211; ’286 Patent, col. 51:41-52:5).

III. The Accused Instrumentality

Product Identification

  • The NEUROMARK® System, which consists of the reusable NEUROMARK® Radiofrequency (RF) Generator and the single-use, handheld NEUROMARK® Device (Compl. ¶74).

Functionality and Market Context

  • The NEUROMARK® System is designed to treat chronic rhinitis by applying low-power RF energy to disrupt posterior nasal nerves within the nasal cavity (Compl. ¶76, 77). The NEUROMARK® Device features a malleable shaft and a treatment tip, referred to as an end effector, which comprises multiple leaflets containing an array of bipolar electrodes (Compl. ¶79, 80). In use, the device is inserted into a patient's nostril, advanced to the posterior nasal nerves, and the leaflets are deployed to make contact with the mucosal tissue (Compl. ¶85, 88). The complaint includes a diagram from Defendant's literature showing the NEUROMARK Device and its end effector (Compl. ¶79, Fig. 2). The system is marketed as a "precision and control" platform for Otolaryngologists and was commercially launched in the United States in February 2023 (Compl. ¶73, 75).

IV. Analysis of Infringement Allegations

U.S. Patent No. 9,072,597 Infringement Allegations

Claim Element (from Independent Claim 9) Alleged Infringing Functionality Complaint Citation Patent Citation
positioning a treatment element of a treatment device adjacent to nasal tissue to be treated The Neuromark Device is introduced into the nasal cavity and advanced to the posterior recesses of the meatus to treat tissue in the nasal passageway. ¶82, 85 col. 43:39-44
deforming the nasal tissue into a desired shape by pressing a surface of the treatment element against the nasal tissue The end effector's leaflets are described as "super elastic and spring out to enforce mucosal apposition on the lateral wall," which allegedly deforms the tissue. ¶88 col. 5:58-63
delivering radiofrequency (RF) energy to one or more electrodes to locally heat the nasal tissue The Neuromark system, comprising a device and RF generator, applies "controlled low-power radio frequency (RF) energy to target regions of the nasal cavity." ¶74, 77 col. 5:64-66
wherein delivering RF energy while deforming the nasal tissue causes the nasal tissue to change shape The application of RF energy is alleged to create lesions in mucosal tissue by coagulation necrosis, thereby changing the tissue. ¶67, 77 col. 5:64-67
removing the treatment element from the nasal airway Defendant's Instructions for Use direct the physician to remove the device from the nasal cavity after the treatment cycle is complete. ¶91 col. 44:11-13
  • Identified Points of Contention:
    • Scope Questions: The ’597 Patent specification focuses extensively on reshaping cartilage and structural components of the nasal valve to improve airflow (US 9,072,597 B2, col. 1:49-2:4). A central question may be whether the term "change shape" as used in claim 9 can be construed to cover the "creation of lesions" and "disruption of posterior nasal nerves" performed by the accused device (Compl. ¶76, 77), or if the claim is limited to structural remodeling of the nasal airway.
    • Technical Questions: What evidence does the complaint provide that the "mucosal apposition" of the accused device's leaflets (Compl. ¶88) constitutes "deforming the nasal tissue into a desired shape" as required by the claim? A defendant could argue this is merely incidental contact required for energy delivery, not the intentional mechanical reshaping described in the patent. The complaint shows an animation of the accused device's electrodes activating in sequence (Compl. ¶81, Ex. CC), which may be presented as evidence of the controlled application of energy to effect this change.

U.S. Patent No. 9,415,194 Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
advancing a treatment delivery portion of an energy-based treatment device into a nostril of the patient The Neuromark Device is introduced into the nasal cavity and advanced to the posterior recesses of the inferior/middle/superior meatus. ¶82, 85 col. 3:49-54
contacting mucosal tissue of the upper airway with the treatment delivery portion, without piercing the mucosal tissue The end effector leaflets are described as making "mucosal apposition on the lateral wall," and the device is described as a "surface contacting electrode array device." ¶67, 88 col. 3:55-60
delivering a treatment... to at least one tissue selected from the group of the mucosal tissue and another tissue underlying the mucosal tissue The accused system applies RF energy to create lesions in mucosal tissue to disrupt posterior nasal nerves, which are located within and beneath the mucosa. ¶76, 77 col. 3:61-67
to modify a property of the at least one tissue The creation of RF lesions and disruption of nerve signals is alleged to modify the properties of the tissue, such as its ability to facilitate mucus creation. ¶76, 77 col. 4:1-3
and thus treat at least one of post nasal drip or chronic cough in the patient The accused system is indicated for treating chronic rhinitis, which the complaint alleges causes symptoms including post-nasal drip. ¶75, 76 col. 4:4-6
  • Identified Points of Contention:
    • Scope Questions: The claim requires treating "post nasal drip or chronic cough." The accused product is indicated for "chronic rhinitis" (Compl. ¶76). A point of contention may be whether treating the general condition of chronic rhinitis necessarily meets the claim limitation of treating the specific symptom of post-nasal drip, and what evidence connects the accused product's mechanism of action to that specific symptom. The complaint uses an anatomical illustration from Defendant's literature to show the location of the targeted nerve fibers (Compl. ¶83, Fig. 1).
    • Technical Questions: Does the accused system's general application of RF energy to "target regions of the nasal cavity" (Compl. ¶77) meet the limitation of delivering treatment to "mucosal tissue and another tissue underlying the mucosal tissue"? The analysis will require evidence of the depth and effect of the RF energy applied by the Neuromark system.

V. Key Claim Terms for Construction

’597 Patent, Claim 9

  • The Term: "causes the nasal tissue to change shape"
  • Context and Importance: This term is critical because the Plaintiffs' theory equates the "creation of lesions" and "nerve disruption" with a "change in shape." Defendants may argue that "change shape" should be limited to the structural remodeling of cartilage to improve airflow, as described extensively in the patent's specification. Practitioners may focus on this term as its construction could determine whether the patent's scope, seemingly directed at mechanical/structural problems, can extend to a device addressing nerve-mediated inflammation.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The plain meaning of "change shape" is not inherently limited to a specific type of structural alteration and could arguably encompass changes at a microscopic level, such as the formation of a lesion.
    • Evidence for a Narrower Interpretation: The patent’s background and detailed description repeatedly discuss modifying the "shape, structure and/or air flow characteristics of an internal nasal valve" and "reshaping" cartilage to address "nasal valve collapse" (US 9,072,597 B2, Abstract; col. 1:49-67), suggesting the "change in shape" is tied to macroscopic, structural alteration for improved airflow.

’194 Patent, Claim 1

  • The Term: "modify a property of the at least one tissue"
  • Context and Importance: The infringement allegation hinges on this term covering the disruption of nerve signals. The definition of "property" will be central. A narrow definition focused on physical tissue characteristics (e.g., stiffness, thickness) might favor the Defendant, while a broader functional definition (e.g., ability to transmit nerve signals) may favor the Plaintiff.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The patent does not explicitly define "property," which may allow for an interpretation that includes the tissue's functional or physiological characteristics, such as its role in the neural pathways that trigger mucus production.
    • Evidence for a Narrower Interpretation: The patent's abstract discusses modifying a property "to decrease the number and/or mucus producing ability of mucus producing cells," which could be interpreted as a direct modification of the cells themselves, rather than the separate underlying nerves. The specification also discusses modifying "the shape, structure, and/or air flow characteristics" of nasal airways, tying "property" to physical attributes (US 9,415,194 B2, Abstract).

VI. Other Allegations

  • Indirect Infringement: The complaint alleges induced infringement based on Defendants' marketing materials, Instructions for Use, and clinical studies, which allegedly instruct and encourage physicians to perform the patented methods using the NEUROMARK® System (Compl. ¶92, 110-112). The complaint also alleges contributory infringement, asserting that the NEUROMARK® System is a material part of the invention, is not a staple article of commerce, and has no substantial non-infringing uses (Compl. ¶113-116).
  • Willful Infringement: Willfulness is alleged based on Defendants' purported knowledge of the patents-in-suit both before and after the lawsuit was filed. Pre-suit knowledge is supported by allegations of direct notice letters from Plaintiffs and, significantly, by Defendants' citation to the asserted patents and related family members during the prosecution of their own patent applications at the USPTO (Compl. ¶41-66). Post-suit willfulness is based on Defendants' continued alleged infringement after the original complaint was filed on July 11, 2023 (Compl. ¶70, 105).

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

  • A core issue will be one of technological scope: can the claims of the '597 patent family, which describe "reshaping" nasal tissue and "changing its shape" in the context of improving airway structure, be construed to cover the accused product's method of creating RF lesions to ablate posterior nasal nerves for the purpose of treating rhinitis?
  • A second central issue will concern claim construction of functional terms: will the phrase "modify a property of... tissue" from the '194 patent be interpreted broadly to include the disruption of neural signals, as Plaintiffs allege, or will it be limited to changing the physical or structural characteristics of the mucosal tissue itself?
  • A key evidentiary question for willfulness and indirect infringement will be the impact of pre-suit knowledge: how will the court weigh the extensive evidence of Defendants' pre-suit awareness of the patents, gained from both notice letters and their own patent prosecution activities, in determining whether Defendants acted with the specific intent required for inducement and the objective recklessness relevant to willfulness?