1:25-cv-01147
Nyxoah SA v. Inspire Medical Systems Inc
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Nyxoah SA (Belgium) and Nyxoah, Inc. (Delaware)
- Defendant: Inspire Medical Systems, Inc. (Delaware)
- Plaintiff's Counsel: Duane Morris LLP
- Case Identification: 1:25-cv-01147, D. Del., 04/03/2026
- Venue Allegations: Venue is alleged to be proper in the District of Delaware because the Defendant is a Delaware corporation that maintains a registered agent in the district.
- Core Dispute: Plaintiff alleges that Defendant's implantable nerve stimulation systems for treating sleep apnea infringe three U.S. patents related to neural modulation devices and methods.
- Technical Context: The technology domain is implantable neurostimulation devices designed to treat obstructive sleep apnea by electrically stimulating the hypoglossal nerve, which controls key tongue muscles responsible for maintaining an open airway during sleep.
- Key Procedural History: The filing is a First Amended Complaint, superseding an original complaint. The complaint alleges Defendant's knowledge of the patents-in-suit dates to "at least since the filing of the original Complaint." Plaintiff expressly reserves the right to assert claims of pre-suit indirect infringement and willfulness at a later stage, suggesting the current allegations are focused on post-filing conduct.
Case Timeline
| Date | Event |
|---|---|
| 2011-09-30 | Priority Date for '183, '215, and '216 Patents |
| 2014-04-15 | U.S. Patent No. 8,700,183 Issued |
| 2016-08-16 | U.S. Patent No. 9,415,215 Issued |
| 2016-08-16 | U.S. Patent No. 9,415,216 Issued |
| 2026-04-03 | First Amended Complaint for Patent Infringement Filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 8,700,183 - "Devices and Methods for Low Current Neural Modulation"
The Invention Explained
- Problem Addressed: The patent addresses obstructive sleep apnea (OSA), a condition where pharyngeal muscles, particularly the genioglossus muscle of the tongue, relax during sleep and obstruct the airway '183 Patent, col. 1:41-50
- The Patented Solution: The invention is an implantable device designed to be placed near the hypoglossal nerve, which controls the genioglossus muscle '183 Patent, col. 2:55-59 The device delivers a low-current electrical signal (less than about 1.6 milliamps) to electrodes, which in turn generate an electric field '183 Patent, abstract This field modulates the nerve from a location spaced apart from the nerve itself, causing the tongue muscle to contract and prevent airway collapse '183 Patent, col. 14:35-43
- Technical Importance: This approach proposes a treatment for OSA via an implantable neurostimulator that does not require direct physical contact with the nerve, which may address potential issues of device migration or tissue growth over time '183 Patent, col. 17:18-34
Key Claims at a Glance
- The complaint asserts at least Claim 1 Compl. ¶26
- The essential elements of independent Claim 1 are:
- An implantable circuit.
- At least one pair of implantable electrodes connected to the circuit, configured for implantation near a genioglossus muscle and hypoglossal nerve.
- The circuit is configured to deliver an electrical signal with a current less than about 1.6 milliamps.
- The electrodes are configured to emit an electric field where a portion of the field lines extend along the hypoglossal nerve, causing nerve modulation from a location spaced apart from the nerve.
U.S. Patent No. 9,415,215 - "Methods for Treatment of Sleep Apnea"
The Invention Explained
- Problem Addressed: The patent addresses OSA caused by the relaxation of pharyngeal muscles and subsequent airway obstruction during sleep '215 Patent, col. 2:7-21
- The Patented Solution: The invention is a method for treating sleep apnea. The method involves receiving a modulation signal at an implant unit placed on the underside of a subject's chin, applying that signal to electrodes to generate an electric field, and thereby causing modulation of the hypoglossal nerve '215 Patent, claim 1 A key aspect of the claimed solution is its anatomical precision: the nerve modulation is "confined to a medial branch of the hypoglossal nerve" and is "initiated from a single modulation site" along that branch '215 Patent, claim 1 '215 Patent, col. 31:10-24
- Technical Importance: The method aims to provide a more targeted neurostimulation by focusing the electrical effect on a specific nerve branch, potentially increasing therapeutic efficacy while minimizing off-target stimulation of other muscles '215 Patent, col. 31:10-24
Key Claims at a Glance
- The complaint asserts at least Claim 1 Compl. ¶36
- The essential elements of independent Claim 1 are:
- Receiving a modulation signal at an implant unit implanted on the underside of a subject's chin.
- Applying the signal to at least one pair of electrodes to generate an electric field.
- Causing modulation of the subject's hypoglossal nerve in response to the electric field, wherein the modulation is confined to a medial branch of the nerve and initiated from a single modulation site.
U.S. Patent No. 9,415,216 - "Devices for Treatment of Sleep Apnea"
Technology Synopsis
The '216 Patent claims a system for treating sleep apnea comprising a flexible carrier with at least one pair of stimulation electrodes and a neurostimulation device to power them '216 Patent, claim 1 The system is configured for precise anatomical placement to cause airway dilation "solely through stimulation of a portion of the subject's hypoglossal nerve" by applying an electric field to a "single section of a medial branch of the hypoglossal nerve distal of a terminal bifurcation" '216 Patent, abstract '216 Patent, claim 1 This patent, like the '215 patent, emphasizes specific anatomical targeting to achieve the therapeutic effect.
Asserted Claims
The complaint asserts at least Claim 1 Compl. ¶46
Accused Features
The complaint alleges that the complete Inspire IV and Inspire V systems, which are used to treat sleep disorders through nerve stimulation, embody the claimed system Compl. ¶25 Compl. ¶46
III. The Accused Instrumentality
Product Identification
The Inspire IV and Inspire V systems (collectively, the "Accused Products") Compl. ¶25
Functionality and Market Context
The complaint describes the Accused Products as systems that "treat patients with a sleep disorder through synchronous nerve stimulation therapy methods" Compl. ¶25 When implanted and activated, these systems are alleged to "automatically implement" these methods Compl. ¶35 The complaint does not provide further technical details regarding the specific operation or components of the Inspire IV and V systems. No probative visual evidence provided in complaint.
IV. Analysis of Infringement Allegations
The complaint alleges that the Accused Products directly infringe at least Claim 1 of the '183 Patent and the '216 Patent, and that the methods performed by the Accused Products infringe at least Claim 1 of the '215 Patent Compl. ¶26 Compl. ¶36 Compl. ¶46 The infringement allegations are supported by reference to claim charts provided as Exhibits 4, 5, and 6, respectively Compl. ¶26 Compl. ¶36 Compl. ¶46 As these exhibits were not attached to the publicly filed complaint, a detailed element-by-element analysis of the infringement allegations is not possible from the pleading alone. The narrative allegations suggest an infringement theory based on the overall function of the Accused Products as implantable neurostimulation systems for treating sleep apnea.
Identified Points of Contention (based on the '183 Patent):
- Scope Questions: A potential point of dispute may be the claim term "less than about 1.6 milliamps." The construction of "about" and the evidence regarding the actual current delivered by the Accused Products will be central.
- Technical Questions: The infringement analysis may turn on whether the Accused Products generate an electric field where "a portion of the field lines extend along a length of the hypoglossal nerve" and achieve modulation "from a location spaced apart from the hypoglossal nerve," as required by the claim. This raises the evidentiary question of how the Accused Products' electric field is shaped and how it interacts with the nerve tissue.
Identified Points of Contention (based on the '215 Patent):
- Scope Questions: A core issue will be whether the modulation performed by the Accused Products is "confined to a medial branch" of the hypoglossal nerve. The definition of "confined" will be a critical issue for claim construction, raising the question of whether any amount of electrical leakage outside the medial branch avoids infringement.
- Technical Questions: The analysis will require evidence that the modulation is "initiated from a single modulation site." The parties may dispute what constitutes a "single" site and where the modulation is "initiated" in the accused method.
V. Key Claim Terms for Construction
'183 Patent, Claim 1
- The Term: "a location spaced apart from the hypoglossal nerve"
- Context and Importance: This term is central to the patent's teaching of non-contact neuromodulation. Its construction will determine whether direct contact between an electrode and the nerve is required to avoid infringement. Practitioners may focus on this term because it distinguishes the invention from prior art that may have required nerve cuffs or direct electrode-to-nerve contact.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification states that the location of the implant unit "does not require contact with nerve 115 for effective neuromodulation" and that intervening tissue may exist, which could support a construction where any physical separation constitutes a "location spaced apart" '183 Patent, col. 5:36-40
- Evidence for a Narrower Interpretation: Figures 10a-10c and the accompanying text illustrate specific electrode configurations designed to generate a parallel electric field to modulate a nerve from a distance, which might suggest the term implies a specific and intentional non-contact configuration rather than any incidental separation '183 Patent, col. 14:35-50
'215 Patent, Claim 1
- The Term: "confined to a medial branch"
- Context and Importance: This term defines the anatomical precision of the claimed method. The dispute will likely center on the degree of confinement required and whether the Accused Products achieve it. The patentability of the claim may depend on this limitation, making its construction critical to both infringement and validity.
- Evidence for Interpretation:
- Evidence for a Broader Interpretation: The term could be construed to mean that the primary or therapeutically significant modulation occurs on the medial branch, allowing for some incidental or de minimis electrical effect on surrounding tissues. The specification discusses targeting the genioglossus muscle, which is innervated by the medial branch, supporting this functional interpretation '215 Patent, col. 31:10-24
- Evidence for a Narrower Interpretation: The word "confined" suggests a strict boundary. A defendant may argue this requires near-total or complete electrical isolation, pointing to language about "selective modulation" to argue that the invention's purpose was to avoid stimulating other nerve branches entirely '215 Patent, col. 31:55-60
VI. Other Allegations
Indirect Infringement
The complaint alleges induced infringement for all three patents. The factual basis for inducement is Defendant's alleged provision of "instructions, training materials and demonstrations" that show physicians how to implant and use the Accused Products and patients how to activate and use them in a manner that allegedly performs the claimed steps Compl. ¶29 Compl. ¶39 Compl. ¶49
Willful Infringement
The complaint alleges knowledge of infringement "at least since the filing of the original Complaint in this action" for all three patents Compl. ¶30 Compl. ¶40 Compl. ¶50 This allegation supports a claim for post-suit willfulness. Notably, the complaint includes a footnote expressly reserving the right to amend to add claims for pre-suit indirect infringement and willfulness should discovery warrant it, indicating the current pleading is narrowly tailored to post-suit conduct Compl. p. 11, fn. 1
VII. Analyst's Conclusion: Key Questions for the Case
This dispute will likely center on questions of anatomical and operational specificity. The key open questions for the court appear to be:
A core issue will be one of anatomical precision: Does the electrical stimulation from the accused Inspire systems operate in a manner that is "confined to a medial branch" of the hypoglossal nerve, as required by the '215 patent, and targeted to a "single section ... distal of a terminal bifurcation" as required by the '216 patent? This will involve detailed factual evidence regarding the Accused Products' placement and field of electrical effect.
A key evidentiary question will be one of technical functionality: Do the Accused Products operate via non-contact modulation by generating an electric field with "field lines [that] extend along a length of the hypoglossal nerve," as claimed in the '183 patent, or is there a fundamental mismatch in the physical principles of operation?
The case will also involve a question of definitional scope: How much leeway does the term "about" provide in the "less than about 1.6 milliamps" limitation of the '183 patent, and do the Accused Products operate within the construed range?