US Patent 11998262, titled "Systems and methods for improving sleep with therapeutic nasal treatment," was issued to Neurent Medical Ltd. on June 4, 2024, from an application filed on January 12, 2024. The sole inventor listed is David Townley.

Abstract:
The patent describes systems and methods aimed at improving a patient's sleep by treating conditions such as rhinitis, congestion, and rhinorrhea within the sino-nasal cavity. The goal is to reduce or eliminate associated symptoms like nasal congestion, coughing, sneezing, and nasal or throat irritation and itching. The disclosed devices feature a retractable and expandable multi-segment end effector and an elongate body, designed to offer precise control and feedback to an operator during medical procedures.

Plain-Language Overview of Independent Claims:

• Independent Claim 1: This claim outlines a method to improve sleep by addressing rhinitis, congestion, or rhinorrhea. The method involves delivering energy to specific target sites within the patient's nasal cavity. This energy either disrupts nerve signals to elements that produce mucus or cause mucosal swelling, and/or induces localized oxygen deprivation (hypoxia) in these elements. This action reduces mucus production and swelling, thereby alleviating symptoms like nasal congestion, coughing, or sneezing, and ultimately enhancing nasal breathability to improve sleep.
• Independent Claim 10: This claim describes a treatment device for improving sleep by treating rhinitis, congestion, or rhinorrhea. The device comprises:
  • A handle for operation.
  • An elongate body extending from the handle, equipped with electrodes along its length. These electrodes are configured to deliver energy to tissue, specifically the inferior turbinate, at a level sufficient to reduce swelling and improve airflow in the nasal passage.
  • A retractable and expandable multi-segment end effector, connected to the elongate body, which also features energy delivery elements. When expanded, this end effector positions its energy elements to contact specific target sites in the nasal cavity associated with postganglionic parasympathetic nerve fibers that innervate the nasal mucosa, therapeutically modulating these nerves.
• Independent Claim 17: This claim details a method for improving a patient's sleep by treating rhinitis, congestion, or rhinorrhea using a treatment device. The method includes:
  • Advancing the device's end effector into the nasal cavity.
  • Deploying the end effector, which has a proximal (front) and a distal (back) segment, each with energy delivery elements. Upon deployment, the proximal segment is positioned around part of the middle turbinate (a structure in the nose), and the distal segment is positioned in a cavity behind the middle turbinate.
  • Delivering energy via the proximal segment's elements to the middle turbinate tissue to therapeutically modulate associated neural structures.
  • Delivering energy via the distal segment's elements to the tissue in the posterior cavity to therapeutically modulate its associated neural structures, thereby improving nasal breathability.

CAFC 2026 Dockets:
As of April 26, 2026, the provided patent information indicates that a PTAB case, IPR2025-01124, was filed related to US11998262 but was "Not Instituted - Procedural." The patent also mentions "First worldwide family litigation filed." While these indicate active legal proceedings concerning the patent, a direct entry or specific case for US11998262 within the CAFC 2026 dockets could not be definitively confirmed through the available search capabilities.

As of April 26, 2026, the following litigation is known involving US patent 11998262:

Case 1:

• Plaintiff(s): Aerin Medical Inc.
• Defendant(s): [Neurent Medical Ltd. et al.](/litigations/by-defendant/Neurent%20Medical%20Ltd.%20et%20al.)
• Jurisdiction: Patent Trial and Appeal Board (PTAB), USPTO
• Case Number: IPR2025-01124
• Filing Date: June 18, 2025
• Outcome or current status: Not Instituted - Procedural. The Director of the USPTO issued decisions regarding institution in November and December 2025.

The raw data provides: IPR2025-01124 — IPR — filed 2025-06-19 — last modified 2025-12-23 — status: Discretionary Denial — petitioner: Aerin Medical Inc. — inventor: David Townley. The patent owner is Neurent Medical Ltd. (from the patent document itself and search results).

Proceedings overview:
There is 1 AIA trial proceeding on US patent 11998262. Its status is "Discretionary Denial," meaning institution was denied. This gives a defendant a strong defensive posture, as the patent claims have not been challenged on the merits in this IPR.

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IPR2025-01124 — Aerin Medical Inc. v. Neurent Medical Ltd.

• Type: Inter Partes Review
• Filed: 2025-06-19
• Status: Discretionary Denial — the PTAB declined to institute the inter partes review, meaning the merits of the patentability challenge were not fully considered.
• Judge panel: The institution decision was made by the USPTO Director, in consultation with at least three PTAB judges, as per new bifurcated review procedures implemented in March 2025. The search results did not explicitly name the panel members for this specific case, but did mention Acting Director Coke Morgan Stewart and later Director John Squires as involved in discretionary denials around this time.
• Petition grounds: The petition challenged claims of U.S. Patent No. 11,998,262. While specific claims and statutory bases (e.g., § 102 / § 103) were not explicitly detailed in the search snippets, Neurent's preliminary response argued against the sufficiency of the petition's expert testimony regarding treatment outcomes and the identification of electrodes, and argued that the claimed treatment outcomes were not in the prior art. Aerin Medical Inc. challenged four Neurent patents, including this one, covering nasal treatment devices, on prior art grounds.
• Institution decision: Denied on 2025-11-05. The denial was discretionary. Neurent Medical Ltd. (Patent Owner) argued that Aerin Medical Inc. (Petitioner) waited nearly a year after assertion to file IPR petitions on newly issued patents, even though the statute only permits IPR filing nine months after issuance. Neurent argued that Aerin should have pursued Post-Grant Review (PGR) within nine months of issuance and by foregoing PGR and filing overlapping invalidity arguments in district court, Aerin demonstrated IPR would not serve as a true alternative forum. This denial was likely influenced by the USPTO's shifting approach to discretionary denials, including considerations like "settled expectations" and the presence of parallel district court litigation.
• Final Written Decision (if issued): Not issued due to discretionary denial.
• Settlement / termination: The proceeding was terminated by discretionary denial of institution, not settlement.
• Appeal: Not applicable, as institution was denied and institution decisions cannot be appealed.
• Defensive value: This proceeding is highly favorable for Neurent Medical Ltd. The claims of US11998262 were not evaluated on their merits, and the IPR was denied institution, strengthening the patent's posture against this specific petitioner on the grounds raised. A defendant would face a higher hurdle to challenge this patent via IPR if the circumstances for denial (e.g., timing, parallel litigation) are similar.

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Strategic summary

One AIA trial proceeding has been filed against US patent 11998262, specifically IPR2025-01124. This proceeding resulted in a discretionary denial of institution, meaning the claims of the patent were not formally challenged on their merits by the PTAB. As a result, all claims of US11998262 remain UNTESTED in AIA trial proceedings. The patent has not been narrowed through this IPR.

The estoppel landscape for IPR2025-01124 means that Aerin Medical Inc. (and its privies) are barred from bringing any invalidity arguments they raised or reasonably could have raised in this IPR. For other potential defendants, this specific denial highlights the PTAB's recent inclination towards discretionary denials based on factors such as the timing of the petition relative to patent issuance, the availability of other review options like PGR, and the existence of parallel district court litigation. The patent owner, Neurent Medical Ltd., successfully argued for discretionary denial, which indicates a strong defensive strategy against IPR challenges.

A significant pattern signal is that this IPR was part of a series of petitions (IPR2025-01124 to -01127) filed by Aerin Medical Inc. against Neurent Medical's newly issued patents. The denial, issued around November 2025, reflects the USPTO Director's increased involvement in institution decisions and a trend of denying institution in a significant number of cases without detailed reasoning, particularly for newly issued patents where PGR might have been an option.

Recommended next steps

For a defendant facing assertion of US patent 11998262, it is crucial to understand the specific reasons for the discretionary denial in IPR2025-01124. This denial means the patent claims were not invalidated, and the patent owner successfully leveraged PTAB procedural rules. Any future IPR petitions would need to carefully consider the "Fintiv factors" and other discretionary denial criteria, such as "settled expectations," especially if there is parallel district court litigation or if the patent has been known for a significant period. Since the denial was discretionary, the claims of 11998262 have not been substantively confirmed as patentable by the PTAB, but a new challenger would need to present a compelling argument to overcome the prior discretionary denial.

The official PTAB documents for IPR2025-01124, including the Patent Owner's Preliminary Response and the institution decision, would provide the most detailed reasoning for the discretionary denial and are essential for formulating a future defensive strategy. These documents can typically be accessed via the USPTO PTAB E2E system.## Proceedings overview
There is one AIA trial proceeding on US patent 11998262, IPR2025-01124. This proceeding concluded with a discretionary denial of institution, meaning the PTAB did not reach the merits of the patentability challenge. This outcome strengthens the defensive posture for Neurent Medical Ltd., as the patent claims have not been invalidated.

IPR2025-01124 — Aerin Medical Inc. v. Neurent Medical Ltd.

• Type: Inter Partes Review
• Filed: 2025-06-19
• Status: Discretionary Denial — The Patent Trial and Appeal Board (PTAB) declined to institute the inter partes review, thus the merits of the patentability challenge were not fully adjudicated.
• Judge panel: The decision to deny institution was made by the USPTO Director, in consultation with at least three PTAB judges, reflecting a new bifurcated review process implemented in March 2025. While specific administrative patent judges were not named in the search results, Acting Director Coke Morgan Stewart and later Director John Squires were involved in such discretionary denials during this period.
• Petition grounds: Aerin Medical Inc. challenged claims of U.S. Patent No. 11,998,262 on prior art grounds. The Patent Owner's Preliminary Response (POPR) argued against the sufficiency of the Petitioner's expert testimony regarding treatment outcomes and the identification of electrodes, asserting that the claimed treatment outcomes were not disclosed in the cited prior art.
• Institution decision: Denied on 2025-11-05. The denial was discretionary, with Neurent Medical Ltd. arguing that Aerin Medical Inc. had waited nearly a year after assertion to file the IPR petition for this newly issued patent (issued in 2024), suggesting that Post-Grant Review (PGR) should have been pursued within the statutory nine-month window. Neurent further contended that by foregoing PGR and filing overlapping invalidity arguments in district court, Aerin demonstrated that IPR would not serve as a true alternative forum. This decision aligns with the USPTO's expanded application of discretionary denial factors, including "settled expectations" and the presence of parallel district court litigation.
• Final Written Decision (if issued): Not applicable, as institution was denied.
• Settlement / termination: The proceeding was terminated by the discretionary denial of institution, not by settlement.
• Appeal: Not applicable, as institution decisions are not appealable.
• Defensive value: This proceeding represents a significant defensive win for Neurent Medical Ltd. The patent claims were not subjected to a full validity challenge on the merits at the PTAB. For any party facing assertion of this patent, it indicates that future IPR challenges will need to carefully navigate the USPTO's discretionary denial framework, particularly concerning timing relative to patent issuance and any existing parallel litigation.

Strategic summary

All claims of US11998262 remain UNTESTED by the PTAB on their merits in AIA trial proceedings. IPR2025-01124 resulted in a discretionary denial of institution, which means no claims were invalidated or sustained by a Final Written Decision. This outcome is favorable for the patent owner, Neurent Medical Ltd., as it leaves the patent's claims intact without any adverse validity rulings from the PTAB.

The estoppel landscape indicates that Aerin Medical Inc., as the petitioner in IPR2025-01124, and its privies, are now barred from raising any unpatentability grounds that were raised or reasonably could have been raised in that petition. For other potential defendants, the grounds for the discretionary denial (e.g., alleged delay in filing, availability of PGR, and parallel litigation) highlight specific vulnerabilities to consider if contemplating a new IPR challenge against this patent.

A clear pattern signal is that IPR2025-01124 was part of a series of IPRs filed by Aerin Medical Inc. against Neurent Medical Ltd. for recently issued patents. The denial reflects the USPTO Director's policy shift towards personally handling institution decisions and a trend of denying petitions, especially for newer patents where Post-Grant Review could have been an option. This aggressive defensive posture by the patent owner, successfully arguing for discretionary denial, suggests that future IPR attempts may encounter similar resistance.

Recommended next steps

For a defendant currently being asserted against, the discretionary denial of IPR2025-01124 means that the patent claims have not been formally adjudicated as unpatentable. While this is a win for the patent owner, it does not confirm the patentability of the claims on the merits. A defendant should:

• Review the specific institution decision: Obtain and thoroughly review the full institution decision for IPR2025-01124 (Paper 10, filed 2025-11-05, as indicated by snippet) to understand the precise reasoning for the discretionary denial. This document will detail the arguments made by both Aerin Medical Inc. and Neurent Medical Ltd. regarding discretionary factors. This can be accessed via the USPTO PTAB E2E system.
• Assess potential IPR viability: If considering a new IPR, carefully analyze the "Fintiv factors" and other discretionary considerations, such as "settled expectations", that led to the denial in IPR2025-01124. Evaluate whether your specific circumstances (e.g., timing of challenge, absence of parallel litigation, presentation of novel prior art or arguments) would lead to a different outcome.
• Consider alternative validity challenges: Explore other avenues for challenging validity, such as ex parte reexamination or district court litigation, if the IPR route appears too risky due to the precedent set by IPR2025-01124.

Inventors

• David Townley (Neurent Medical Ltd)

No unusual patterns observed regarding inventor departures.

Original assignee

Neurent Medical Ltd. is the current assignee.
Neurent Medical Ltd. develops medical devices for the treatment of chronic inflammatory nasal diseases. Their primary line of business is therapeutic neuromodulation for nasal treatment. They appear to be an operating company, actively developing and shipping products embodying the claims, specifically, their "NEUROMARK System" for treating chronic rhinitis.
Current Status: Operating.

Assignment timeline

• 2024-01-12 (filed) / recorded 2024-04-11 — Reel 059952/0038

  • Conveyance: Assignment
  • Assignor: TOWNLEY, David
  • Assignee: Neurent Medical Limited
  • Correspondent: GERRY J. WEISS, HOUSTON, TX, US.
  • Context: Inventor to operating company assignment.

• 2024-10-18 (executed) / recorded 2024-10-18 — Reel 061633/0843

  • Conveyance: Security Interest
  • Assignor: Neurent Medical Limited
  • Assignee: CLARET EUROPEAN SPECIALTY LENDING COMPANY III, S.A R.L.
  • Correspondent: BRIAN LEACH, DLA Piper LLP (US), Austin, TX, US.
  • Context: Securitization.

Timeline diagram

timeline
    title Ownership of US 11998262
    2020 : Priority date
    2024 : Filed by Neurent Medical Ltd
         : Inventor assigned to Neurent Medical Ltd
         : Security interest granted to Claret European Specialty Lending Company III SARL
    2024 : Issued

NPE / troll-pattern signals

1. Shell-entity transfer — not present. The initial assignment is from the inventor to an operating company (Neurent Medical Ltd.). The subsequent record is a security interest, not a transfer of ownership, to a lending company.
2. Known asserter in the chain — not present. Neurent Medical Ltd. is an operating company, and CLARET EUROPEAN SPECIALTY LENDING COMPANY III, S.A R.L. is a lending institution, neither of which are known NPEs.
3. Repeat correspondent across the chain — not present. The correspondent for the assignment is GERRY J. WEISS, and the correspondent for the security interest is BRIAN LEACH, DLA Piper LLP (US). These are different.
4. Cascading transfers — not present. There is only one transfer of ownership (from inventor to the operating company) and one security interest, not multiple consecutive transfers through chained LLCs.
5. Pre-litigation transfer — not present. The patent was granted on June 4, 2024. The only ownership assignment record is from the inventor to Neurent Medical Ltd. on April 11, 2024, which is before issuance. The other record is a security interest dated October 18, 2024, after issuance. There is no indication of litigation immediately following these events.
6. Bankruptcy fire-sale — not present. There is no indication that Neurent Medical Ltd. has filed for bankruptcy.
7. Privateering — unclear. There is no public information in the patent record or Google Patents legal events to suggest privateering.
8. Defensive aggregator (anti-NPE) — not present. The current assignee is Neurent Medical Ltd., an operating company, and there are no records indicating transfer to a defensive aggregator.

Verdict

Operating-company assertion (current assignee ships products embodying the claims and is suing actual competitors)

The patent is currently assigned to Neurent Medical Ltd., an operating company that develops and markets medical devices for nasal treatment. The only other recorded event is a security interest with a lending institution, which is a common operating-company financing activity. There are no signals of shell entities, known asserters, or other NPE patterns.

For verification, refer to the USPTO Assignment Center search page: https://assignmentcenter.uspto.gov/

Most Relevant Prior Art for US Patent 11998262

Based on the patent text itself, US patent 11998262 explicitly identifies and discusses two key prior art references as foundational to its technical domain. These are:

1. U.S. Publication No. 2016/0331459 ("the '459 publication")

   • Full Citation: U.S. Publication No. 2016/0331459
   • Publication/Filing Date: Not explicitly stated in the provided text for the filing date, but the publication date is clearly 2016.
   • Brief Description: This publication describes "Additional features and functions of the nerve monitoring system 108, as well as other functions of the various components of the console 104, including the evaluation/feedback algorithms 110 for providing real-time feedback capabilities for ensuring optimal therapy for a given treatment is administered."
   • Potential Anticipated Claim(s) under 35 U.S.C. § 102: While the '262 patent incorporates aspects of this publication, it's not described as directly anticipating any specific claims in their entirety. Instead, it forms a part of the "neuromodulation system 100" that the '262 patent builds upon. Therefore, the '459 publication would likely be considered relevant to the general field of neuromodulation devices and methods, potentially impacting the novelty of broad system claims or method steps related to nerve monitoring and feedback, such as elements of claims 1, 10, and 17 that involve a console and feedback.

2. U.S. Publication No. 2018/0133460 ("the '460 publication")

   • Full Citation: U.S. Publication No. 2018/0133460
   • Publication/Filing Date: Not explicitly stated in the provided text for the filing date, but the publication date is clearly 2018.
   • Brief Description: Similar to the '459 publication, this reference also describes "Additional features and functions of the nerve monitoring system 108, as well as other functions of the various components of the console 104, including the evaluation/feedback algorithms 110 for providing real-time feedback capabilities for ensuring optimal therapy for a given treatment is administered."
   • Potential Anticipated Claim(s) under 35 U.S.C. § 102: As with the '459 publication, the '460 publication is incorporated by reference as foundational technology rather than a direct anticipatory reference. It contributes to the known aspects of neuromodulation systems, consoles, and feedback mechanisms. Thus, it would similarly be relevant to general system and method claims concerning nerve monitoring and treatment feedback within claims 1, 10, and 17.

The '262 patent itself indicates that "the devices described herein... may be included and incorporated in any of the treatment devices, systems, and methods illustrated and described in U.S. Publication No. 2016/0331459 and U.S. Publication No. 2018/0133460". This implies that the '262 patent considers these publications to be part of the existing knowledge base, providing the context for the "therapeutically neuromodulation system 100" and its components. While not explicitly cited as anticipating specific independent claims in the patent's own text, their fundamental description of nerve monitoring and feedback systems suggests their relevance to any claims broadly covering such aspects of the neuromodulation system.

Obviousness Analysis of US Patent 11998262 under 35 U.S.C. § 103

This analysis assesses the obviousness of US patent 11998262 ("the '262 patent") based on the prior art explicitly identified and described within the patent text itself, as of the current date of April 26, 2026. The priority date of the '262 patent is April 9, 2020.

I. Summary of Claimed Invention

The '262 patent describes systems and methods for improving sleep by therapeutically treating rhinitis, congestion, and/or rhinorrhea. The core invention addresses shortcomings of existing treatments (e.g., temporary relief, inaccuracy, collateral damage) by providing a sophisticated handheld neuromodulation device (102) and associated methods.

Key features of the claimed invention, as described in the patent, include:

• A handheld device (102) comprising an elongate body (116), a retractable and expandable multi-segment end effector (114), and a handle (118).
• The multi-segment end effector (114) includes at least a first (proximal) flexible segment (122) and a second (distal) flexible segment (124). These segments have specific geometries in a deployed configuration to complement and conform to anatomical structures within the nasal cavity (e.g., middle turbinate, posterior cavity) and include electrodes (136) for precise, focused RF thermal energy application to therapeutically modulate neural structures. The first segment may have a bilateral geometry.
• The elongate body (116) itself includes one or more electrodes (137) provided along its length, configured to deliver energy to specific target sites in the nasal passage (e.g., inferior turbinate) that are separate and remote from the end effector's primary treatment zone, thereby reducing tissue engorgement and increasing volumetric flow. This allows for dual energy delivery in conjunction with the end effector's neuromodulation, without needing to reposition the end effector.
• The handle (118) is ergonomically designed for ambidextrous, one-handed operation (overhand/underhand grip styles) and includes independent user-operated mechanisms (126, 128) for deploying the end effector and controlling energy output, with user inputs positioned for simultaneous one-handed access.
• Markings (e.g., text, symbols, color-coding) on the handle and/or elongate body provide visual indication of the end effector's spatial orientation (linear, axial, depth position) prior to deployment.
• The method involves delivering energy (e.g., RF thermal ablation, cryo-ablation) via such a device to disrupt neural signals and/or cause local hypoxia of mucus-producing and mucosal engorgement elements, particularly targeting postganglionic parasympathetic nerves at foramina and microforamina of the palatine bone, and/or reducing engorgement of turbinate tissue to improve nasal breathability and, consequently, sleep.

II. Identified Prior Art References

The '262 patent explicitly identifies and describes the following as prior art or related technology:

1. Conventional nose breathing aids and pharmacotherapy: The patent describes these as providing temporary relief, creating new obstructions (nasal dilators), or having suboptimal efficacy and undesirable side effects (nasal sprays, pharmaceutical agents).
2. Existing surgical procedures for rhinitis: These are characterized as "not accurate and cause significant collateral damage" and failing to adequately treat underlying symptoms or address sleeping problems.
3. U.S. Publication No. 2016/0331459 ("the '459 publication"): This publication is cited in the '262 patent as describing "Additional features and functions of the nerve monitoring system 108, as well as other functions of the various components of the console 104, including the evaluation/feedback algorithms 110 for providing real-time feedback capabilities for ensuring optimal therapy for a given treatment is administered."
4. U.S. Publication No. 2018/0133460 ("the '460 publication"): Similar to the '459 publication, this is also cited for "Additional features and functions of the nerve monitoring system 108, as well as other functions of the various components of the console 104, including the evaluation/feedback algorithms 110 for providing real-time feedback capabilities for ensuring optimal therapy for a given treatment is administered."

These '459 and '460 publications predate the priority date of April 9, 2020. The '262 patent also explicitly states that "the devices described herein... may be included and incorporated in any of the treatment devices, systems, and methods illustrated and described in U.S. Publication No. 2016/0331459 and U.S. Publication No. 2018/0133460". This indicates a close relationship and suggests that the '459 and '460 publications establish a general context for neuromodulation systems for nasal conditions.

III. Obviousness Analysis

A person having ordinary skill in the art (PHOSITA) at the time of the invention (i.e., before April 9, 2020) would possess knowledge of general medical device design, nasal anatomy, rhinitis pathophysiology, and energy-based neuromodulation techniques.

Combination of Prior Art: U.S. Publication Nos. 2016/0331459 and 2018/0133460 in view of general knowledge of medical device design and the recognized problems in rhinitis treatment.

Motivation to Combine:
The '262 patent itself identifies several problems with existing rhinitis treatments, including their temporary nature, lack of accuracy, propensity for collateral damage, and failure to adequately address sleep problems. These identified problems would have motivated a PHOSITA to improve existing neuromodulation systems for nasal applications to achieve more precise, effective, and less invasive treatments with long-term relief. The '262 patent explicitly incorporates the systems and methods of the '459 and '460 publications, suggesting a known foundation upon which the current invention is built.

How the Combination Renders the Claims Obvious:

1. Neuromodulation System as a Foundation: The '459 and '460 publications provide a foundational understanding of neuromodulation systems, including the console (104), energy generator (106), controller (107), nerve monitoring system (108), and real-time feedback algorithms (110) for delivering optimal therapy. A PHOSITA would readily understand how to integrate an energy delivery device with such a system for therapeutic neuromodulation.

2. Multi-Segment End Effector for Anatomical Conformity: The '262 patent notes the "highly variable" location of the sphenopalatine foramen (SPF) and accessory foramina, making precise nerve targeting difficult with prior methods that caused "significant collateral damage." To address this, a PHOSITA, seeking to improve accuracy and minimize collateral damage in a complex anatomical space like the nasal cavity, would be motivated to design an end effector that "highly conforms to anatomical variations." It would have been obvious to employ flexible, expandable, multi-segment structures (e.g., loops or leaflets made of shape memory materials like nitinol as described in the '262 patent) with electrodes to better conform to specific regions, such as around turbinates and within posterior cavities, to ensure consistent tissue contact for energy delivery. The general concept of expandable medical devices with multiple segments and electrodes for tissue contact is well-established in the art.

3. Electrodes on the Elongate Body for Dual Treatment Sites: The '262 patent explicitly identifies a problem with existing devices: the need to "reposition an end effector when attempting to treat multiple areas within the nasal cavity, particularly those areas that are located outside of any given treatment zone." The solution offered by the '262 patent is to include "one or more electrodes provided on one or respective portions along a length thereof" of the elongate body (116), in addition to the end effector electrodes. A PHOSITA, motivated to improve procedural efficiency and address multiple rhinitis symptoms simultaneously (e.g., nerve modulation in the SPF region and turbinate engorgement reduction), would find it obvious to integrate additional electrodes onto the shaft of the device. This allows for concurrent or sequential treatment of separate anatomical targets (e.g., the inferior turbinate for engorgement and the palatine bone microforamina for parasympathetic nerve modulation) without repeated repositioning, thus improving efficiency and reducing the risk of inaccuracy.

4. Ergonomic Handle with Independent Controls and Markings: To enhance "precise control and feedback" and enable "simultaneous one-handed operation of both user inputs during a procedure", improving the ergonomics of the handle (118) and separating controls for deployment and energy delivery would be an obvious design choice for a PHOSITA. Providing an ambidextrous grip (e.g., via recesses for fingers) and distinct mechanisms (126, 128) is a standard practice in developing user-friendly surgical instruments. Similarly, incorporating visual "markings (e.g., text, symbols, color-coding insignia, etc.)" on the handle and/or shaft to provide "spatial orientation of the end effector while the end effector is in a nasal cavity" is a known technique to aid precise placement and reduce procedural errors, particularly when navigating complex internal anatomies with variable visibility.

5. Method Claims: The method for improving sleep by treating rhinitis, congestion, and rhinorrhea through energy delivery to disrupt neural signals and/or cause local hypoxia, leading to reduced mucus production/engorgement and improved nasal breathability, would also be obvious. The '459 and '460 publications teach neuromodulation systems for therapeutic treatment, and the '262 patent itself states the problem of rhinitis impacting sleep. The idea of targeting neural pathways (parasympathetic nerves) or tissue responsible for engorgement (e.g., inferior turbinates) with energy to alleviate rhinitis symptoms was known prior to the '262 patent, as evidenced by the patent's own problem statement regarding "current aids and surgical procedures". The detailed application via the specific device features discussed above would be an obvious implementation for achieving these known therapeutic goals more effectively.

In summary, a PHOSITA, motivated by the recognized deficiencies of existing rhinitis treatments and leveraging the neuromodulation systems described in the '459 and '460 publications, would find it obvious to modify such systems by incorporating (1) anatomically conforming, multi-segment end effectors for improved precision, (2) additional electrodes on the elongate body for efficient multi-site treatment, and (3) ergonomic handle designs with clear controls and spatial indicators for enhanced user experience and safety. These modifications would represent predictable improvements to existing technology for a known problem, leading to the device and method claimed in US11998262.

Patent Term Adjustments (PTA) and Extensions (PTE) for US11998262

Based on the available information, the patent 11998262 has an anticipated expiration date of April 8, 2041. The patent's filing date is January 12, 2024, and its priority date is April 9, 2020. This indicates a patent term of longer than 20 years from the earliest priority date (April 9, 2020), which implies that Patent Term Adjustment (PTA) has been granted.

Patent Term Adjustment (PTA):
PTA is granted to compensate an applicant for delays caused by the United States Patent and Trademark Office (USPTO) during the prosecution of a patent application. These delays can include, but are not limited to:

• Failure to issue a first Official Action or notice of allowance within 14 months of filing.
• Failure to issue an action within four months of an applicant's response to an Official Action.
• Failure to issue the patent within four months of payment of the issue fee.
• Failure to issue a patent within three years of the actual filing date of the application.

While the exact calculation of PTA for US11998262 is not explicitly detailed in the provided snippets, the difference between the 20-year term from the priority date (April 9, 2040) and the anticipated expiration date (April 8, 2041) suggests approximately one year of PTA. This adjustment compensates for USPTO delays during the application's prosecution.

Patent Term Extension (PTE):
PTE is awarded to compensate for delays incurred in obtaining regulatory approval for certain patented products, such as human drugs, food or color additives, medical devices, animal drugs, and veterinary biological products. There is no information in the provided snippets to indicate that US11998262 has been granted a Patent Term Extension.

Continuation, Divisional, and Related Family Members

The patent states a priority date of April 9, 2020, and a filing date of January 12, 2024. It also lists several other priority applications:

• US18/411,476 (Priority to 2024-01-12)
• US18/647,929 (Priority to 2024-04-26)
• US18/647,807 (Priority to 2024-04-26)
• US18/647,846 (Priority to 2024-04-26)
• US18/647,755 (Priority to 2024-04-26)
• US18/647,879 (Priority to 2024-04-26)

The presence of multiple priority claims, particularly to applications with filing dates close to the patent's own filing date (January 12, 2024) and subsequently, suggests that US11998262 is part of a patent family. These could represent continuation or divisional applications.

• Continuation Applications: A continuation application is based on an original parent application, shares the same priority date and specification, and does not add new subject matter. They are often filed to pursue additional claims disclosed but not allowed in the parent application.
• Divisional Applications: A divisional application is filed when a parent application contains more than one distinct invention, often resulting from a restriction requirement by the examiner. It shares the same specification and priority date as the parent but pursues claims to non-elected inventions.

Given the patent's filing date of January 12, 2024, and the later priority claims in April 2024, it is highly probable that US11998262 is a continuation of an earlier application, likely related to the applications filed on April 9, 2020. The subsequent priority claims listed (US18/647,929, US18/647,807, etc., all dated 2024-04-26) would then represent further continuation or divisional applications from the same family.

Related Family Members:
The Google Patents page explicitly lists "Other versions" including US20240189019A1. This is a patent application publication, which is a related family member. The multiple priority claims also indicate a family of related applications.

Projected Expiration Date

The anticipated expiration date for US11998262 is April 8, 2041. This date is derived from the earliest priority date (April 9, 2020) plus 20 years, with an apparent addition of Patent Term Adjustment. Utility patents filed on or after June 8, 1995, generally expire 20 years from their earliest effective filing date, subject to any PTA or PTE.

Defensive Disclosure Document for US Patent 11998262

Date: 2026-05-17

This document outlines derivative variations and alternative implementations of the systems and methods described in US Patent 11998262, with the aim of creating defensive prior art to render future incremental improvements by competitors "obvious" or "non-novel." The focus is on expanding the scope of the disclosed invention beyond its explicit claims, anticipating potential advancements and disclosing a broad range of alternatives.

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Derivative Variations for Core Claims (Claim 10 - Device & Claim 17 - Method)

The following derivatives build upon the core inventive concepts of US11998262, specifically regarding the therapeutic device (Claim 10) and its method of use (Claim 17) for neuromodulation and tissue engorgement reduction in the nasal cavity.

1. Material & Component Substitution

Derivative 1.1: Bioresorbable Polymer Support Structures with Conductive Coatings

• Enabling Description: The flexible support elements of the multi-segment end effector (114, 122, 124) and potentially portions of the elongate body (116) are fabricated from bioresorbable polymers such as poly(L-lactic acid) (PLLA), poly(glycolic acid) (PGA), or poly(lactic-co-glycolic acid) (PLGA) with specific degradation profiles (e.g., 6-12 months). These polymer struts are coated with a thin layer of highly conductive, biocompatible material such as titanium nitride (TiN) or an alloy of platinum-iridium (Pt-Ir) to serve as electrodes (136, 137). The electrical connections are achieved via fine, braided platinum-iridium wires (0.005-0.010 inch diameter) embedded within the polymer matrix or run along internal lumens, terminating in exposed conductive tips. This allows for temporary therapeutic modulation with subsequent safe bioresorption of the structural components, eliminating the need for removal and reducing long-term foreign body reactions. The handle (118) and outer sheath (138) remain non-resorbable for reusable or single-use applications. Energy delivery for ablation or neuromodulation would be standard RF (460-480 kHz) or pulsed DC, as described in the patent.

classDiagram
    class TreatmentDevice {
        Handle handle
        ElongateBody elongateBody
        EndEffector endEffector
    }
    class ElongateBody {
        +BioresorbableSheath outerSheath
        +TiN/PtIrElectrodes electrodes
        +PtIrWires internalWiring
    }
    class EndEffector {
        +BioresorbableSegments firstSegment
        +BioresorbableSegments secondSegment
        +TiN/PtIrElectrodes electrodes
        +PtIrWires internalWiring
    }
    class Handle {
        +DeploymentMechanism mechanism1
        +EnergyControlMechanism mechanism2
    }
    TreatmentDevice -- Handle
    TreatmentDevice -- ElongateBody
    TreatmentDevice -- EndEffector
    ElongateBody -- EndEffector
    ElongateBody "1" -- "N" TiN/PtIrElectrodes
    EndEffector "1" -- "N" TiN/PtIrElectrodes

Derivative 1.2: Piezoelectric Ceramic Actuators for End Effector Deployment and Energy Delivery

• Enabling Description: The flexible support elements (struts 130, 132, 134) of the multi-segment end effector (114) are replaced or augmented with micro-scale piezoelectric ceramic actuators (e.g., lead zirconate titanate - PZT) bonded to a polymer or metallic spine. These PZT elements are arrayed to both deploy and retract the end effector segments through controlled electrical excitation causing mechanical deformation (inverse piezoelectric effect). For energy delivery, these same piezoelectric elements are driven at ultrasonic frequencies (e.g., 1-5 MHz) to generate localized high-intensity focused ultrasound (HIFU) energy for thermal ablation or low-intensity pulsed ultrasound (LIPUS) for neuromodulation. The elongate body (116) incorporates miniaturized cabling for independent control of each piezoelectric actuator/transducer. The handle (118) includes a multi-channel piezoelectric driver with pulse shaping capabilities and dedicated user interfaces for deployment and ultrasound energy delivery. Temperature sensors (e.g., thermistors) are integrated into the end effector tips for real-time thermal feedback.

flowchart TD
    A[Handle] --> B{Piezoelectric Driver Module};
    B --> C[Control Signals to Actuators];
    C --> D{End Effector with PZT Arrays};
    D -- Mechanical Actuation --> E[Deploy/Retract Segments];
    D -- Ultrasonic Energy --> F[Tissue Modulation/Ablation];
    F --> G[Nasal Tissue];
    D -- Temperature Feedback --> B;

2. Operational Parameter Expansion

Derivative 2.1: Millimeter-Wave RF Ablation for Enhanced Tissue Specificity

• Enabling Description: The energy delivery elements (electrodes 136, 137) are designed to deliver millimeter-wave radiofrequency (mmWave RF) energy (e.g., 30-300 GHz) instead of conventional RF (460-480 kHz). This higher frequency range allows for extremely shallow penetration depths (tens to hundreds of micrometers) into the mucosal tissue, enabling highly precise and superficial ablation or neuromodulation of the postganglionic parasympathetic nerve fibers without affecting deeper structures or causing collateral damage to bone or cartilage. The electrodes are micro-fabricated patch antennas or slot antennas embedded on the flexible support elements (130, 132, 134) and outer sheath (138). A compact millimeter-wave generator and associated waveguides or coaxial lines are integrated into the console (104) and routed through the elongate body (116). Treatment parameters would involve very low power levels (e.g., 0.1-5 W) for very short durations (e.g., <1 second pulses) to achieve localized hyperthermia or non-thermal cell membrane disruption.

sequenceDiagram
    participant S as Surgeon
    participant D as Device (Handle, Shaft, End Effector)
    participant C as Console (mmWave Generator)
    S->D: Advance Device
    S->D: Deploy End Effector
    Note over D: Electrodes (patch antennas) positioned at target sites
    S->C: Initiate mmWave Energy Delivery (low power, short pulse)
    C->D: Transmit mmWave RF (30-300 GHz)
    D->N: Localized Tissue Ablation/Neuromodulation
    N->D: Temperature Feedback (superficial layer)
    D->C: Temperature Data
    C->S: Real-time Feedback (GUI 112)
    S->D: Retract Device

Derivative 2.2: Ultra-Low Frequency Electrical Neurostimulation for Non-Ablative Modulation

• Enabling Description: Instead of thermal ablation, the device (102) is configured for ultra-low frequency (ULF) electrical neurostimulation (e.g., 1-100 Hz, with biphasic pulses of 10-500 µs duration and amplitudes of 0.1-10 mA) via the electrodes (136, 137). The objective is to achieve long-term, non-ablative neuromodulation of the postganglionic parasympathetic nerves, potentially through neurotransmitter depletion or sustained sub-threshold inhibition, rather than tissue destruction. The flexible support elements (130, 132, 134) and elongate body (116) carry multiple micro-electrodes (e.g., 100-200 µm diameter platinum-iridium contacts) arranged in high-density arrays to facilitate precise current steering and activation of specific nerve branches. The console (104) incorporates a multi-channel pulse generator capable of delivering customizable waveforms and precise current control. This approach aims for reversible or titratable effects, allowing for adjustment of therapy over time without permanent tissue alteration.

stateDiagram-v2
    [*] --> Idle
    Idle --> AdvanceDevice: Surgeon advances
    AdvanceDevice --> DeployEffector: Surgeon deploys
    DeployEffector --> PositionElectrodes: End effector conforms
    PositionElectrodes --> StimulateNerves: Initiate ULF Stimulation
    StimulateNerves --> MonitorResponse: Detect neural/symptom changes
    MonitorResponse --> AdjustStimulation: If needed
    AdjustStimulation --> StimulateNerves
    StimulateNerves --> RetractDevice: After prescribed duration
    RetractDevice --> [*]
    StimulateNerves --> Abort: Safety Trigger

3. Cross-Domain Application

Derivative 3.1: Adaptive Conformable Gripper for Industrial Robotics

• Enabling Description: The multi-segment end effector's (114) retractable and expandable design, with its flexible support elements (130, 132, 134) and conformable segments (122, 124), is adapted for use as a robotic gripper in industrial automation. The "electrodes" (136) are replaced with a multi-array of pressure sensors and/or localized heating elements (e.g., resistive heaters or miniature inductive coils). The "handle" (118) and "elongate body" (116) become the robotic arm's end-of-arm tooling and control interface. The gripper deploys its segments to conform to irregularly shaped objects, using pressure sensor feedback to distribute gripping force evenly. The heating elements can be selectively activated to provide localized thermal adhesion or temporary surface modification for enhanced grip on specific materials (e.g., thermoplastic components). This enables robots to handle fragile or geometrically complex objects that traditional rigid grippers struggle with.

flowchart TD
    A[Robotic Arm] --> B[Gripper (Adapted Device)];
    B -- Deployment Mechanism --> C[Conformable Segments (Adapted End Effector)];
    C -- Pressure Sensors --> D[Feedback Control System];
    C -- Heating Elements --> E[Localized Adhesion/Surface Modification];
    D -- Adjusts Grip Force --> C;
    B -- Object Handling --> F[Irregular Objects];

Derivative 3.2: Subterranean Root Modulation System for Agriculture

• Enabling Description: The entire device architecture (handle, elongate body, multi-segment end effector) is scaled and ruggedized for subterranean agricultural applications. The elongate body (116) is designed as a rigid-flexible probe with sensors (pH, moisture, nutrient levels) and the end effector (114) becomes a deployable root modulation array. The flexible support elements (130, 132, 134) carry electrodes (136) configured for delivering pulsed electric fields (PEF) or low-power RF energy to specific root structures (e.g., 100-500 V/cm, 100 µs pulse width, 1-10 Hz repetition rate). This energy can be used to inhibit specific pathogenic fungal or bacterial growth on roots, stimulate nutrient uptake pathways, or temporarily block root communication signals in invasive species. The "handle" (118) integrates with agricultural machinery, providing GPS-guided positioning and automated deployment. The system monitors soil conditions and adjusts energy delivery parameters autonomously.

graph TD
    A[Agricultural Machinery] --> B(GPS Guidance & Control);
    B --> C[Subterranean Probe (Adapted Elongate Body)];
    C -- Advance/Retract --> D{Root Modulation Array (Adapted End Effector)};
    D -- PEF/RF Energy --> E[Root System];
    D -- Soil Sensors (pH, Moisture) --> C;
    C -- Data Link --> B;
    B -- Automated Operation --> F(Crop Health Management);

4. Integration with Emerging Tech

Derivative 4.1: AI-Driven Adaptive Neuromodulation with Real-time MRI Feedback

• Enabling Description: The neuromodulation system (100) integrates with a real-time, intra-operative magnetic resonance imaging (MRI) system. The elongate body (116) and multi-segment end effector (114) are constructed from MRI-compatible materials (e.g., PEEK, ceramic, non-ferromagnetic alloys) and incorporate fiber optic temperature sensors. Pre-operative high-resolution MRI or CT scans of the patient's nasal anatomy (including detailed neural pathways and vascular structures) are fed into an AI model. During the procedure, the AI model continuously analyzes real-time MRI data to precisely locate the end effector (114) and individual electrodes (136, 137) relative to target neural structures (e.g., postganglionic parasympathetic fibers, specific microforamina). The AI then dynamically adjusts the deployment configuration of the end effector, individual electrode activation patterns, energy levels (RF or other modalities), and treatment duration to optimize therapeutic effect while minimizing collateral damage. The handle (118) provides haptic feedback to the surgeon, guided by the AI, for precise manual control.

graph LR
    A[Pre-op MRI/CT Data] --> B(AI-Driven Treatment Plan);
    B --> C{Real-time Intra-op MRI};
    C --> D(AI Control Module);
    D -- Optimized Parameters --> E[Neuromodulation Device (Handle, Shaft, End Effector)];
    E -- Energy Delivery --> F[Target Neural Structures];
    F -- Tissue Response (Temp, Impedance) --> G[Fiber Optic Sensors];
    G --> D;
    D -- Haptic Feedback/Guidance --> S[Surgeon];

Derivative 4.2: IoT-Enabled Post-Procedure Monitoring and Proactive Intervention

• Enabling Description: The neuromodulation device (102) is paired with a system of miniaturized, bioresorbable IoT sensors (e.g., MEMS temperature, impedance, airflow sensors) that are temporarily implanted within the nasal mucosa at the treatment sites during or immediately after the procedure. These sensors wirelessly transmit data (e.g., via Bluetooth Low Energy or near-field communication) to a patient's mobile device or a dedicated external gateway. This data is then uploaded to a secure cloud platform. An AI algorithm analyzes the long-term physiological data (nasal patency, inflammation markers, nerve activity proxies) to detect early signs of re-engorgement or sub-optimal treatment outcomes. The system generates alerts for the patient and clinician, suggesting proactive interventions (e.g., adjusting medication, scheduling follow-up for touch-up procedures, or recommending lifestyle changes). Blockchain technology is used to immutably log all sensor data, treatment parameters, and clinical observations, creating a verifiable patient treatment history for regulatory compliance and personalized medicine insights.

sequenceDiagram
    participant P as Patient
    participant S as Implanted IoT Sensors
    participant M as Mobile App/Gateway
    participant C as Cloud Platform (AI Analytics)
    participant B as Blockchain Ledger
    participant D as Clinician
    S->M: Wireless Data Transmission (Temp, Impedance, Airflow)
    M->C: Upload Sensor Data
    C->C: AI Analysis (Detect anomalies, predict re-engorgement)
    C->B: Log Sensor Data & AI Insights
    C->M: Alert Notification (if anomaly detected)
    M->P: Notify Patient
    M->D: Notify Clinician
    D->P: Proactive Intervention/Follow-up

5. The "Inverse" or Failure Mode

Derivative 5.1: Diagnostic-Only Mode with Integrated Nerve Mapping and Safe Failure

• Enabling Description: The neuromodulation device (102) includes a dedicated "diagnostic-only" mode where the electrodes (136, 137) are exclusively used for impedance sensing and low-current (e.g., micro-ampere level) nerve stimulation for mapping and identification, without delivering therapeutic energy. This mode is activated by a specific sequence on the handle's (118) control mechanisms (126, 128) or through the console (104) GUI (112). In the event of an detected electrical fault (e.g., short circuit, open circuit, or excessive impedance spike) or an accidental over-temperature reading from integrated thermistors during any operational mode, the device instantly defaults to this safe diagnostic mode, automatically cutting off all therapeutic energy delivery. The end effector (114) would also feature an automatic, spring-loaded retraction mechanism that engages upon loss of power or explicit safety command, pulling the segments back into the protective outer sheath (138) to prevent inadvertent tissue contact.

stateDiagram
    [*] --> Off
    Off --> DiagnosticMode: Power On / Select Diagnostic
    DiagnosticMode --> NerveMapping: Perform Nerve Mapping
    NerveMapping --> ImpedanceSensing: Perform Impedance Sensing
    DiagnosticMode --> EmergencyRetract: Fault Detected / Safety Command
    NerveMapping --> EmergencyRetract: Fault Detected / Safety Command
    ImpedanceSensing --> EmergencyRetract: Fault Detected / Safety Command
    DiagnosticMode --> TherapeuticMode: Surgeon Initiates Therapy
    TherapeuticMode --> DeliverEnergy: Apply RF/Ultrasound
    DeliverEnergy --> TherapeuticMode: Continue Therapy
    DeliverEnergy --> EmergencyRetract: Fault Detected / Safety Command
    EmergencyRetract --> RetractedAndSafe: End Effector Retracted, Power Off
    RetractedAndSafe --> Off: Device Shutdown

Derivative 5.2: Temporary Drug Delivery for Reversible Neuromodulation / Low-Power Functionality

• Enabling Description: The flexible support elements (130, 132, 134) of the multi-segment end effector (114) are modified to incorporate microfluidic channels and porous segments or dissolvable drug-eluting coatings. Instead of delivering thermal or electrical energy for ablation, the device (102) is used to precisely deliver localized pharmacological agents (e.g., topical anesthetics like lidocaine, botulinum toxin for chemodenervation, or anti-inflammatory steroids) to the target sites associated with postganglionic parasympathetic nerve fibers or engorged turbinate tissue. This provides temporary, reversible neuromodulation or symptomatic relief without permanent tissue modification. The "energy control mechanism" (128) on the handle (118) now controls the micro-pump for drug delivery rate and volume. The "elongate body" (116) includes a reservoir and fluid lines (e.g., auxiliary line 121 modified for drug delivery). This offers a low-power, limited-functionality mode where the device acts purely as a drug delivery platform for transient effects, rather than a permanent ablative tool.

flowchart TD
    A[Handle] --> B{Micro-Pump Control};
    B --> C[Drug Reservoir (in Handle/Shaft)];
    C --> D[Microfluidic Channels (in End Effector)];
    D -- Localized Drug Delivery --> E[Target Neural/Mucosal Tissue];
    E --> F[Temporary Neuromodulation/Symptom Relief];
    A -- Deployment Mechanism --> G[Deploy End Effector];

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Combination Prior Art Scenarios with Open-Source Standards

These scenarios combine the inventive concepts of US Patent 11998262 with existing open-source standards to establish obviousness for potential future developments.

Scenario 1: Integration with Open-Source Medical Robotics Framework (ROS-M)

• Description: The therapeutic neuromodulation system (100), including the handheld device (102) and console (104), is implemented using the Robot Operating System for Medical applications (ROS-M). ROS-M, an open-source framework, provides libraries and tools for robotic control, sensor integration, image processing, and human-robot interaction in medical contexts.
  • Handle (118) and Console (104) Integration: The control logic for the deployment mechanisms (126) and energy delivery (128) is implemented as ROS nodes. User input from the handle's ergonomic controls is processed via ROS interfaces, allowing for standardized communication with the energy generator (106) and controller (107).
  • Image Guidance: An endoscope (as mentioned in the patent) or other visualization device (e.g., optical coherence tomography, OCT) is integrated via ROS drivers, providing real-time visual feedback to a ROS-powered GUI (112). This allows for collaborative control where the surgeon manipulates the device, and ROS-M provides augmented reality overlays of anatomical structures and predicted nerve locations (based on open-source anatomical atlases) directly onto the video feed.
  • Sensor Data Fusion: Impedance and temperature sensors (e.g., 108) on the end effector (114) and elongate body (116) stream data to ROS topics. An open-source data fusion algorithm (e.g., from OpenCV or PCL libraries) combines sensor data with anatomical models for enhanced navigation and real-time assessment of tissue response.
• Impact on Obviousness: This combination renders obvious the integration of the device's control, feedback, and image guidance functionalities into any open-source medical robotics or automation framework, facilitating standardized development of precision tools for nasal surgery.

Scenario 2: Energy Delivery Profile Optimization using Open-Source Machine Learning Libraries (TensorFlow/PyTorch)

• Description: The system (100) utilizes open-source machine learning (ML) libraries, such as TensorFlow or PyTorch, running on the console's (104) controller (107) to optimize energy delivery parameters.
  • Data Collection: Real-time physiological data (tissue impedance, temperature feedback from sensors on electrodes 136, 137, ENG signals 108) from numerous procedures are collected and anonymized. This dataset also includes patient-specific anatomical variations and treatment outcomes (e.g., post-operative nasal breathability scores, symptom reduction).
  • ML Model Training: A supervised learning model (e.g., a deep neural network) is trained using this dataset to predict optimal RF energy parameters (power, duration, duty cycle, electrode activation pattern) for individual patients and specific target sites, aiming to maximize therapeutic effect (nerve modulation/ablation, turbinate engorgement reduction) while minimizing collateral damage.
  • Real-time Optimization: During a procedure, the ML model, deployed on the console (104), takes real-time impedance and temperature readings as input. It then suggests or automatically adjusts the energy delivery parameters for the generator (106) and electrode array (114, 116), adapting to subtle tissue variations and ensuring consistent treatment efficacy as per evaluation/feedback algorithms (110).
• Impact on Obviousness: This discloses the obviousness of applying standard machine learning techniques (available through open-source libraries) to optimize the therapeutic energy delivery of the claimed device, moving beyond pre-programmed patterns to adaptive, data-driven treatment protocols.

Scenario 3: Secure Device Management and Tracking via Open-Source Distributed Ledger Technology (Hyperledger Fabric)

• Description: The manufacturing, sterilization, distribution, and usage lifecycle of the therapeutic neuromodulation device (102) are managed and tracked using an open-source distributed ledger technology, specifically Hyperledger Fabric.
  • Supply Chain Transparency: Each device (102), and potentially its critical components (e.g., end effector 114), is assigned a unique digital identity (e.g., serial number linked to a cryptographic hash). This identity is recorded on a blockchain network built with Hyperledger Fabric. Manufacturers, sterilization facilities, distributors, and healthcare providers act as nodes on the network.
  • Immutable Records: Every critical event—batch manufacturing, sterilization cycle, shipping, receipt by a hospital, patient-specific usage (linking to patient ID, date, time, energy settings)—is immutably recorded as a transaction on the ledger. This ensures transparency, traceability, and verifiable compliance with regulatory standards.
  • Smart Contracts for Compliance: Smart contracts define the rules for each stage of the device's lifecycle (e.g., "device must be sterilized before shipment," "only certified clinicians can activate the device for therapeutic energy delivery"). These contracts automatically enforce compliance and trigger alerts for any deviations.
• Impact on Obviousness: This scenario makes obvious the application of widely available open-source blockchain technologies to secure the lifecycle management and operational data of the patent's claimed medical device, addressing common industry needs for traceability, integrity, and regulatory compliance.