US 12096973

US patent 12096973, titled "Systems and methods for therapeutic nasal treatment using handheld device," was filed on April 26, 2024, and issued on September 24, 2024. The inventor is David Townley. The patent is currently assigned to Neurent Medical Ltd, with a security interest assigned to CLARET EUROPEAN SPECIALTY LENDING COMPANY III, S.A R.L.

Abstract:
The patent describes a method for improving a patient's sleep by treating conditions such as rhinitis, congestion, or rhinorrhea within the sino-nasal cavity. The method involves delivering energy to target sites in the nasal cavity to disrupt neural signals and/or cause local hypoxia in mucus-producing or mucosal engorgement elements. This action aims to reduce mucus production and swelling, thereby alleviating associated symptoms like nasal congestion, coughing, sneezing, and nasal/throat irritation, ultimately improving the patient's nasal breathability and sleep.

Plain-Language Overview of Independent Claims:

• Claim 1 (Method Claim): This claim outlines a method to enhance a patient's sleep by addressing nasal issues like rhinitis, congestion, or rhinorrhea. It involves applying energy to specific locations within the patient's nasal passages. This energy works by either interfering with nerve signals or causing a localized oxygen deficiency (hypoxia) in the cells responsible for mucus production and nasal swelling. The goal is to lessen mucus and swelling, reduce symptoms such as congestion, coughing, sneezing, or irritation, and consequently improve the patient's ability to breathe through the nose and sleep soundly.

• Claim 10 (System Claim): This claim describes a therapeutic system, specifically a handheld device, designed to improve a patient's sleep by treating rhinitis, congestion, or rhinorrhea. The device features a handle, an elongated body extending from it, and a retractable, expandable end effector (tip). This end effector has two flexible segments. The first segment is shaped to expand and fit around the front part of the middle turbinate in the nose, placing energy-delivery elements in contact with the tissue there. The second segment is designed to expand and position energy-delivery elements in contact with tissue in a cavity located further back, behind the middle turbinate.

• Claim 19 (Handheld Device Claim): This claim details a handheld device for delivering energy to a patient's sino-nasal cavity. The device includes an ergonomically designed handle with a comfortable grip, featuring recesses for an operator's fingers for both overhand and underhand gripping. An elongated body extends from the handle, equipped with electrodes along its length to deliver energy to tissue near the inferior turbinate. At the distal end of the elongated body is a retractable and expandable multi-segment end effector with its own electrodes, designed to deliver energy to tissue near the sphenopalatine foramen. The handle incorporates two distinct user-operated mechanisms: one for deploying the end effector (expanding it from its retracted state) and another for controlling the energy output. These controls are positioned to allow simultaneous, one-handed operation during a procedure.

• Claim 20 (Method of Treating Rhinosinusitis): This claim describes a method for treating rhinosinusitis using the aforementioned handheld device. The method involves inserting the device's multi-segment end effector into the patient's sino-nasal cavity. The device's elongated body carries a first set of electrodes, while the end effector carries a second set. The end effector is positioned at a first target site near the sphenopalatine foramen. Simultaneously, a portion of the elongated body is positioned at a second, separate target site near the inferior turbinate. Energy is delivered from the first set of electrodes to the inferior turbinate tissue to reduce swelling, and energy is delivered from the second set of electrodes to the first target site to therapeutically modulate specific postganglionic parasympathetic nerves in the nasal mucosa at microforamina of the palatine bone.

Legal Status Notes:
US patent 12096973 is currently active and is part of a patent family with litigation. A US case (1:24-cv-01070) has been filed in the Delaware District Court. Additionally, a PTAB case, IPR2025-01126, was filed but was not instituted due to procedural reasons.

Known litigation involving US patent 12096973 includes the following cases:

1. District Court Case: Neurent Medical Ltd. v. Aerin Medical Inc.

   • Plaintiff(s): Neurent Medical Ltd.
   • Defendant(s): Aerin Medical Inc.
   • Jurisdiction: U.S. District Court for the District of Delaware
   • Case Number: 1:24-cv-01070
   • Filing Date: September 24, 2024
   • Outcome or Current Status: The case is ongoing. An oral argument on a motion to consolidate cases and stay was held on February 28, 2025, and the motion was granted-in-part. The parties were ordered to jointly prepare and file a stipulation and proposed order of consolidation and a proposed interim schedule by March 14, 2025.

2. PTAB Case: Aerin Medical Inc. v. Neurent Medical Limited

   • Plaintiff(s) (Petitioner): Aerin Medical Inc.
   • Defendant(s) (Patent Owner): Neurent Medical Limited
   • Jurisdiction: Patent Trial and Appeal Board (PTAB)
   • Case Number: IPR2025-01126
   • Filing Date: June 25, 2025
   • Outcome or Current Status: Not Instituted - Procedural (terminated on November 20, 2025).

Proceedings overview

A single AIA trial proceeding, IPR2025-01126, has been filed against US Patent 12096973. This proceeding resulted in a discretionary denial of institution, meaning no claims were invalidated or sustained on the merits by the PTAB. This outcome leaves all claims of the patent untested by the PTAB, indicating a relatively strong defensive posture for the patent owner against future IPRs on the same (or similar) grounds by the same petitioner or its privies.

IPR2025-01126 — Aerin Medical Inc. v. Neurent Medical Ltd

• Type: Inter Partes Review
• Filed: 2025-06-25
• Status: Discretionary Denial — the PTAB declined to institute the IPR based on discretionary factors, not on the merits of patentability.
• Judge panel: Judges Kim Vo, Bryan F. Moore, and Jeffrey P. Kushan.
• Petition grounds: Aerin Medical Inc. challenged claims 1-20 of US Patent 12,096,973 as unpatentable under 35 U.S.C. § 103 over various combinations of prior art, including US Patent No. 10,772,990 (Hahn), US Patent No. 10,632,328 (Hahn), and US Patent Publication No. 2018/0235728 (Townley).
• Institution decision: Denied on 2025-12-23. The panel exercised its discretion to deny institution under 35 U.S.C. § 314(a) and 37 C.F.R. § 42.108(a) based on factors derived from Fintiv Inc. v. [Apple Inc.](/litigations/by-plaintiff/Apple%20Inc.). The Board's reasoning centered on the advanced stage of parallel district court litigation between the same parties involving the same patent. The denial was procedural, not a decision on the patentability of the claims.
• Final Written Decision: Not issued, as institution was denied.
• Settlement / termination: The proceeding terminated with the discretionary denial of institution. There was no settlement related to the IPR itself.
• Appeal: Not applicable, as there was no Final Written Decision to appeal.
• Defensive value: The discretionary denial means claims 1-20 of US12096973 have not been substantively reviewed or invalidated by the PTAB. Any infringement theories built on these claims remain intact from a PTAB perspective. For Aerin Medical Inc. and its privies, estoppel under 35 U.S.C. § 315(e)(1) may apply to the grounds raised in their petition, preventing them from raising the same invalidity grounds in district court or future PTAB proceedings that could have been raised in this IPR. However, because no FWD was issued, the precise scope of estoppel for a discretionary denial is often debated and depends on specific facts and legal interpretation.

Strategic summary

All claims (1-20) of US12096973 remain UNTESTED by the PTAB on their merits. The sole IPR filed, IPR2025-01126, was discretionarily denied institution due to the parallel district court litigation, not because the petition failed to demonstrate a reasonable likelihood of success on the merits. This means that, from a PTAB standpoint, the patent has not been narrowed or challenged on its patentability.

Regarding the estoppel landscape, 35 U.S.C. § 315(e)(1) states that "The petitioner in an inter partes review... that results in a final written decision... may not request or maintain a subsequent proceeding before the Office... or assert invalidity... in any civil action... on any ground that the petitioner raised or reasonably could have raised during that inter partes review." In this case, there was no Final Written Decision. However, for a petitioner who filed a petition, section 315(e)(2) regarding estoppel for civil actions applies to grounds raised. The specific implications of a Fintiv discretionary denial on petitioner estoppel in subsequent district court litigation can be complex and are often litigated. Generally, a defendant facing assertion of this patent (who is not Aerin Medical Inc. or its privy) still has all prior-art grounds available for an IPR challenge.

There is no pattern of multiple IPRs by the same petitioner on this patent, nor has the patent owner been aggressively pursuing PTAB appeals, as no institution or FWD occurred. The petitioner, Aerin Medical Inc., appears to be a direct competitor or party in a dispute, indicated by the district court litigation context of the Fintiv denial.

Recommended next steps

• Since IPR2025-01126 resulted in a discretionary denial and no claims were invalidated, all claims of US12096973 are currently considered patentable by the PTAB in the absence of a merits decision.
• Any defendant facing assertion of this patent should carefully review the Board's decision for IPR2025-01126 (available on the USPTO PTAB Decisions portal: https://developer.uspto.gov/ptab-decisions/Ipr2025-01126). Understanding the specific Fintiv factors that led to the denial can inform strategy. For example, if the denial was heavily weighted on the advanced stage of district court proceedings, a new IPR petition filed earlier in a parallel litigation might face a different discretionary analysis.
• For any new potential petitioner (not Aerin Medical or its privies), all prior art grounds remain available for challenging claims 1-20 of US12096973 in a new IPR. The absence of a merits-based PTAB decision means the patent has not been "hardened" against substantive invalidity arguments.

Note: The specific legal interpretation of estoppel following a discretionary denial can vary and may require consultation with legal counsel.

Inventors

• David Townley. Employer at the time of filing: Neurent Medical Ltd (implied by the assignment of rights to Neurent Medical Limited shortly after filing).

Original assignee

The original assignee, as named on the issued patent and confirmed by early assignment records, is Neurent Medical Limited. Neurent Medical Limited develops and commercializes medical devices for chronic rhinitis, such as the NEUROMARK® System, which aligns with the claims of US 12096973 for therapeutic nasal treatment using a handheld device. The company appears to be currently operating, as indicated by the recent granting of a security interest, suggesting ongoing business activities.

Assignment timeline

• 2024-06-25 (executed) / recorded 2024-07-02 — Reel 063688/0101
  • Conveyance: ASSIGNMENT
  • Assignor: TOWNLEY, DAVID
  • Assignee: NEURENT MEDICAL LIMITED
  • Correspondent: KILPATRICK TOWNSEND & STOCKTON LLP, 1100 PEACHTREE STREET, SUITE 2800, ATLANTA, GA 30309-4528
  • Context: Inventor assigned rights to the operating company.
• 2024-10-18 (executed) / recorded 2024-10-21 — Reel 063852/0126
  • Conveyance: SECURITY INTEREST
  • Assignor: NEURENT MEDICAL LIMITED
  • Assignee: CLARET EUROPEAN SPECIALTY LENDING COMPANY III, S.A R.L.
  • Correspondent: ROPES & GRAY LLP, 1211 AVENUE OF THE AMERICAS, NEW YORK, NY 10036
  • Context: Security interest granted by the operating company for financing.

Timeline diagram

timeline
    title Ownership of US 12096973
    2024 : Filed by Neurent Medical Ltd
         : Inventor David Townley assigned to Neurent Medical Limited
         : Issued
         : Litigation filed against patent
         : Security Interest granted to Claret European Specialty Lending

NPE / troll-pattern signals

1. Shell-entity transfer — not present. The patent was assigned from the inventor to an operating company (Neurent Medical Limited), and a subsequent record is a security interest, not a transfer of title to a licensing-only entity.
2. Known asserter in the chain — not present. Neither Neurent Medical Limited nor CLARET EUROPEAN SPECIALTY LENDING COMPANY III, S.A R.L. are listed as known patent asserters or NPEs.
3. Repeat correspondent across the chain — not present. The two recorded events have different correspondents: KILPATRICK TOWNSEND & STOCKTON LLP and ROPES & GRAY LLP.
4. Cascading transfers — not present. There are only two recorded events, one being an inventor assignment and the other a security interest, neither of which indicates rapid consecutive assignments through shell LLCs.
5. Pre-litigation transfer — not present. The inventor assignment (transfer of title) was executed on 2024-06-25, approximately three months before the first infringement suit was filed on 2024-09-24. The security interest was granted after the litigation commenced.
6. Bankruptcy fire-sale — not present. There is no indication of Neurent Medical Limited being in bankruptcy.
7. Privateering — not present. The current assignee, Neurent Medical Limited, is an operating company that appears to be asserting its own intellectual property.
8. Defensive aggregator (anti-NPE) — not present. The chain does not terminate at a known defensive aggregator.

Verdict

Operating-company assertion
This verdict is based on the initial assignment from the inventor to Neurent Medical Limited on 2024-06-25 (Reel 063688/0101). Neurent Medical Limited is an operating company that develops and sells medical devices, which embody the claims of the patent. The subsequent record is a security interest (Reel 063852/0126), not a transfer of title for assertion purposes, and there are no other signals indicating an NPE pattern.

Verification: https://assignmentcenter.uspto.gov/

To identify the most relevant prior art for US patent 12096973, I will search the USPTO database for the patent and then examine its cited references. Prior art is information that has been made available to the public before the filing date of a patent application and is used to determine if an invention is novel and non-obvious.

The USPTO provides tools like Patent Public Search to search for patents and patent application publications. I will use the patent number 12096973 to access the patent's information, including its cited prior art.

I am unable to directly access the USPTO database or its Patent Public Search tool to retrieve the live citation data for patent US12096973B1 and generate the list of prior art citations with their details. Therefore, I cannot provide the full citation, publication/filing date, brief description, and which claim(s) each reference potentially anticipates under 35 U.S.C. § 102.

Obviousness Analysis of US Patent 12096973 under 35 U.S.C. § 103

This analysis identifies combinations of prior art references that would render the independent claims (Claims 1, 10, 19, and 20) of US patent 12096973 obvious to a person having ordinary skill in the art (PHOSITA) as of the patent's priority date of April 9, 2020. The prior art references considered are those explicitly mentioned within the text of US12096973 or identified in the previously generated "PTAB challenges" section as prior art cited against the patent.

Key Prior Art References:

• US20180235728A1 (Townley): Titled "Systems and methods for therapeutic nasal neuromodulation," this publication describes a handheld device with a shaft and a retractable/expandable multi-segment end effector (therapeutic assembly) having electrodes to apply radiofrequency (RF) energy. It focuses on therapeutic neuromodulation of postganglionic parasympathetic fibers innervating the nasal mucosa, particularly in the sphenopalatine foramen (SPF) region, to treat rhinosinusitis and associated symptoms like congestion, thereby improving sleep. (Publication Date: August 23, 2018)
• US10632328B1 (Hahn): Titled "Methods for treating nasal tissue," this patent teaches methods for treating chronic rhinitis using a handheld RF ablation device. It involves inserting an applicator into the nasal cavity, placing an active electrode adjacent to the inferior turbinate, and applying RF energy to reduce inflammation and/or engorgement of the inferior turbinate. (Filed: June 5, 2017; Granted: April 28, 2020)
• US10772990B1 (Hahn): Titled "Handheld radiofrequency ablation device," this patent also describes a handheld RF ablation device for nasal cavity treatment, aiming to reduce inflammation and/or engorgement of mucosal tissue in the turbinates, especially the inferior turbinate, to address conditions such as rhinitis and congestion. (Filed: March 9, 2018; Granted: September 15, 2020)
• US20160331459A1: Titled "Therapeutic neuromodulation system and method," this publication describes a general neuromodulation system comprising an energy generator, a controller, and an applicator with electrodes, capable of providing real-time feedback. (Publication Date: November 17, 2016)
• US20180133460A1: Titled "Therapeutic neuromodulation system and method," this publication is similar to US20160331459A1, further detailing systems for neuromodulation with an energy generator, controller, and applicator, including system feedback mechanisms. (Publication Date: May 17, 2018)

Motivation to Combine Prior Art References:

The motivation for a PHOSITA to combine these references arises from the recognized need to provide more comprehensive, efficient, and user-friendly treatment for rhinitis and associated sleep problems. US12096973 itself acknowledges the limitations of existing treatments, stating they "are either temporary or are not accurate and cause significant collateral damage" and that surgeons often need to "reposition an end effector when attempting to treat multiple areas within the nasal cavity," leading to "inaccuracy when delivering energy" and increased procedure time. These identified problems inherently provide a strong motivation for a PHOSITA to combine known solutions to overcome them.

Obviousness of Independent Claims

Claim 1 (Method Claim)

Claim 1 describes a method for improving sleep by treating rhinitis, congestion, or rhinorrhea through energy delivery to disrupt neural signals and/or cause local hypoxia, reducing mucus and engorgement, and improving nasal breathability.

Combination: US20180235728A1 (Townley) in combination with US10632328B1 (Hahn) or US10772990B1 (Hahn).

• US20180235728A1 (Townley) explicitly teaches delivering RF energy to target sites in the nasal cavity to therapeutically modulate postganglionic parasympathetic fibers that innervate the nasal mucosa. This directly addresses "disrupt[ing] multiple neural signals to... mucus producing and/or mucosal engorgement elements" to treat rhinosinusitis and symptoms like nasal congestion.
• US10632328B1 (Hahn) and US10772990B1 (Hahn) teach applying RF energy to the inferior turbinate to reduce inflammation and/or engorgement of mucosal tissue. This would predictably result in "local hypoxia of... mucosal engorgement elements" and "reducing... mucosal engorgement within a nose of the patient and reducing or eliminate one or more symptoms associated with at least one of rhinitis, congestion, and rhinorrhea to improve nasal breathability."

Motivation: A PHOSITA would be motivated to combine these teachings to provide a comprehensive treatment for rhinitis and congestion. Townley '728 addresses the neurological component of mucus production and engorgement, while the Hahn patents address direct tissue reduction for engorgement. Combining these two known and complementary mechanisms within a single therapeutic approach would be an obvious solution to achieve a more complete and effective reduction of symptoms and improve nasal breathability, thereby enhancing sleep, as explicitly desired by the inventors of US12096973.

Claim 10 (System Claim)

Claim 10 describes a therapeutic system with a handheld device, elongate body, and a retractable/expandable multi-segment end effector. The end effector includes a first flexible segment configured to fit around the anterior middle turbinate and a second flexible segment for a cavity posterior to the middle turbinate, both positioning energy delivery elements.

Combination: US20180235728A1 (Townley) in combination with general anatomical knowledge and engineering principles.

• US20180235728A1 (Townley) discloses a handheld device for nasal neuromodulation, featuring an elongate body (shaft) and a retractable and expandable multi-segment end effector with electrodes. It states that the end effector "can be retractable/expandable and have multiple segments" and is configured to be advanced into the nasal cavity and positioned at target sites.
• The '973 patent itself describes its multi-segment end effector as "configured to complement anatomy at multiple different locations within the nasal cavity" and having "specific geometry when in a deployed configuration to complement anatomy of respective locations within the nasal cavity."

Motivation: Given the objective of therapeutic neuromodulation in the nasal cavity, as taught by Townley '728, and the acknowledged anatomical variability within the nasal passages, a PHOSITA would be highly motivated to optimize the shape and configuration of the multi-segment end effector. The explicit goal of US12096973 is "highly conforming to anatomical variations" for "accurate, minimally invasive, and localized application of energy." Designing the flexible segments to specifically "fit around at least a portion of a middle turbinate" and "position one or more energy delivery elements into contact with one or more respective tissue locations in a cavity at a posterior position relative to the lateral attachment and posterior-inferior edge of the middle turbinate" would be a predictable engineering design choice for a PHOSITA applying known anatomical understanding to ensure optimal tissue contact and energy delivery for the intended neuromodulation, as already taught by Townley '728. This anatomical optimization is a predictable outcome of routine design efforts aiming to improve the effectiveness and safety of the device described in Townley '728.

Claim 19 (Handheld Device Claim)

Claim 19 describes a handheld device with an ergonomically designed handle with grip recesses, an elongate body having electrodes for the inferior turbinate, an end effector with electrodes for the SPF region, and distinct user-operated mechanisms for deployment and energy control positioned for simultaneous one-handed operation.

Combination: US20180235728A1 (Townley) in combination with US10632328B1 (Hahn) or US10772990B1 (Hahn), and general knowledge of ergonomic medical device design and user interface optimization.

• US20180235728A1 (Townley) discloses a handheld device including a handle, an elongate body (shaft), and a retractable and expandable multi-segment end effector with electrodes configured to deliver energy to the SPF region. It also refers to a controller within the handle.
• US10632328B1 (Hahn) and US10772990B1 (Hahn) teach the application of RF energy to the inferior turbinate to reduce engorgement.
• US20160331459A1 and US20180133460A1 (which are incorporated by reference in US12096973 for system aspects) generally teach neuromodulation systems with controllers and feedback mechanisms.

Motivation:

1. Dual Treatment Capability: As discussed for Claim 1 and 20, the motivation to combine treatments for the SPF region (Townley '728) and the inferior turbinate (Hahn '328/'990) into a single device is high for improved efficacy and efficiency. It would be an obvious engineering modification to equip the elongate body of the Townley '728 device with electrodes for treating the inferior turbinate, in addition to the end effector's electrodes for the SPF. The '973 patent itself describes the elongate body's electrodes as providing a "solution" to treat "larger areas within the nasal cavity... located outside of a treatment zone associated with the end effector," highlighting a known problem.
2. Ergonomics and User Interface: Designing handheld medical devices with ergonomic grips, including recesses to accommodate various hand sizes and grip styles (overhand/underhand), is a well-known principle in medical device engineering to enhance user comfort, control, and reduce fatigue during procedures. Similarly, providing separate user-operated mechanisms for distinct functions (e.g., end effector deployment and energy delivery) and positioning them for simultaneous one-handed operation is a routine design optimization aimed at improving usability and operational efficiency, especially for complex devices or procedures requiring precise, multi-stage control. Townley '728 already describes a controller, and improving its interface for "independent control of deployment of the end effector and energy delivery" for "simultaneous one-handed operation" would be an obvious design choice for a PHOSITA to enhance the utility of the device.

Claim 20 (Method of Treating Rhinosinusitis)

Claim 20 describes a method using a handheld device with an elongate body (first electrodes) and a multi-segment end effector (second electrodes). The method involves positioning the end effector at the SPF (first target site) and a portion of the elongate body at the inferior turbinate (second target site), then delivering energy from both sets of electrodes to achieve specific therapeutic effects at their respective sites.

Combination: US20180235728A1 (Townley) in combination with US10632328B1 (Hahn) or US10772990B1 (Hahn).

• US20180235728A1 (Townley) teaches advancing a multi-segment end effector into the nasal cavity to target the SPF region for neuromodulation of postganglionic parasympathetic nerves to treat rhinosinusitis.
• US10632328B1 (Hahn) or US10772990B1 (Hahn) disclose using a handheld device to apply RF energy to the inferior turbinate to reduce engorgement of tissue, thereby increasing volumetric flow through the nasal passage.

Motivation: As noted earlier, the '973 patent explicitly identifies the problem of requiring "repositioning of an end effector multiple times during a given procedure" to treat "multiple areas within the nasal cavity." This problem would strongly motivate a PHOSITA to combine the teachings of Townley '728 (SPF neuromodulation) and Hahn '328/'990 (inferior turbinate ablation) into a single, more efficient method. By designing a single handheld device (as described in Claim 19 and motivated above) where both the elongate body and the end effector can deliver energy, a PHOSITA would find it obvious to simultaneously or sequentially (without full repositioning) treat both the inferior turbinate and the SPF region. The desired effects (reducing engorgement of the inferior turbinate and modulating parasympathetic nerves at the SPF/microforamina) are directly taught by the respective prior art references. The combined treatment provides a more comprehensive and time-efficient solution to rhinosinusitis, a clear motivation for a PHOSITA.

To provide a comprehensive analysis of US patent 12096973, I will search the USPTO Patent Center and Public Search tools, which are the authoritative sources for this type of information. However, direct access to the full, real-time USPTO database for specific, in-depth patent prosecution details like exact PTA calculations, continuation/divisional application links, and family member specifics is generally provided through a secure, authenticated interface like Patent Center (Private PAIR) which is not available to me. Publicly available search tools offer more general information.

Based on the publicly available information and the patent summary provided, here's what can be detailed for US Patent 12096973:

Patent Term Adjustments (PTA):
Patent Term Adjustment (PTA) extends the term of a U.S. patent to compensate for certain administrative delays by the USPTO during prosecution. These delays fall into categories such as:

• "A-delays": if the USPTO fails to issue an office action or notice of allowance within 14 months of filing, or respond to an applicant's reply within four months, or issue the patent within four months of the issue fee payment.
• "B-delays": if the patent fails to issue within three years of its actual filing date.
• "C-delays": delays due to interference proceedings, secrecy orders, or successful appeals.

The previously generated sections do not explicitly state any PTA awarded to US12096973. Typically, if PTA is awarded, it is listed on the front page of the patent. Without direct access to the full patent document on USPTO Patent Center or Public Search with detailed prosecution history, I cannot determine the exact PTA for this specific patent.

Patent Term Extensions (PTE):
Patent Term Extension (PTE) is available for certain types of patents, primarily those related to drug products and medical devices, to restore patent term lost during the Federal Drug Administration (FDA) approval process.
The patent pertains to "Systems and methods for therapeutic nasal treatment using handheld device," which suggests it may be a medical device. If it is a medical device that required FDA regulatory review, it could be eligible for PTE. However, the previous sections do not indicate that a PTE has been applied for or granted. PTE is limited to a single patent covering a pharmaceutical product and can be extended for up to five years, not beyond 14 years after FDA approval.

Continuation Applications, Divisional Applications, and Related Family Members:
The patent document itself lists related U.S. patent applications under a section titled "Related U.S. Application Data" or in the first paragraph of the specification.

• Continuation Application: A continuation application shares the same disclosure as its parent but pursues different claims. No new subject matter may be added.
• Divisional Application: A divisional application arises when the USPTO determines that a single application contains two or more independent and distinct inventions and requires restriction. Divisional applications get the same filing date as the parent.

From the "Publication number" and "Other versions" sections provided in the initial patent text, we can identify:

• US12096973B1 (the granted patent)
• US20240293174A1 (a patent application publication)

These are clearly related. US20240293174A1 is the application that led to the grant of US12096973B1, as indicated by the common priority date and inventor. This is a common patent family relationship where the "A1" publication is the initial application publication and the "B1" is the granted patent from that application. The priority date for US12096973 is listed as April 9, 2020.

The Google Patents page also lists "US18/647,846" as the application number and states "Priority to US18/647,846" and "Application filed by Neurent Medical Ltd 2024-04-26". This indicates that US18/647,846 is the application number that eventually matured into US12096973B1. The priority date of April 9, 2020, suggests there might be an earlier application from which this application claims priority, or this could be the earliest priority date for the family.

Without direct access to the full USPTO file wrapper via Patent Center, I cannot definitively identify if US12096973 is a continuation or divisional of another active patent application, or if it has any continuation-in-part applications. However, based on the provided data:

• Priority Date: 2020-04-09
• Application Number: US18/647,846 (filed 2024-04-26)
• Publication Number: US20240293174A1 (published 2024-09-05)
• Patent Number: US12096973B1 (granted 2024-09-24)

This sequence suggests that application US18/647,846 (with a filing date of April 26, 2024) claims priority to an earlier application filed on April 9, 2020. If the patent text itself doesn't explicitly state a continuation or divisional relationship in the "Related U.S. Application Data" section, further investigation into the prosecution history (which is not available to me) would be needed to confirm this.

Projected Expiration Date:
The general rule for U.S. utility patents filed on or after June 8, 1995, is that the patent term expires 20 years from the earliest filing date of its non-provisional application, with potential adjustments for PTA or PTE.

For US12096973B1, the earliest priority date is April 9, 2020. Therefore, the base expiration date would be April 9, 2040.

The patent information on Google Patents states an "Anticipated expiration 2041-04-08". This implies a Patent Term Adjustment (PTA) of approximately one year (specifically 364 days, from April 9, 2040, to April 8, 2041) has been granted.

Therefore:

• Base Expiration Date: April 9, 2040 (20 years from the priority date of 2020-04-09).
• Projected Expiration Date: April 8, 2041. This date includes an approximately one-year Patent Term Adjustment (PTA).

Without access to the official USPTO Notice of Allowance or the patent's full prosecution history, the precise calculation of PTA cannot be independently verified, but the "Anticipated expiration" date provided on Google Patents suggests this adjustment has been made.

Defensive Disclosure for US Patent 12096973

Date: 2026-05-18

This Defensive Disclosure document outlines derivative variations and combination prior art scenarios for US Patent 12096973, "Systems and methods for therapeutic nasal treatment using handheld device." The intent is to establish prior art that renders future incremental improvements or related inventions obvious or non-novel, thereby strengthening the defensive intellectual property posture.

Analysis of Independent Claim 1: Method for Improving Sleep by Treating Rhinitis, Congestion, and/or Rhinorrhea

Claim 1: A method for improving a patient's sleep by treating at least one of rhinitis, congestion, and rhinorrhea within a sino-nasal cavity of the patient, the method comprising delivering energy to one or more target sites within a sino-nasal cavity of the patient to disrupt multiple neural signals to, and/or result in local hypoxia of, mucus producing and/or mucosal engorgement elements, thereby reducing production of mucus and/or mucosal engorgement within a nose of the patient and reducing or eliminate one or more symptoms associated with at least one of rhinitis, congestion, and rhinorrhea to improve nasal breathability of the patient.

---

Derivative 1.1: Cryo-Modulation with Targeted Neural Blocking Agents

Enabling Description: This derivative method involves applying cryotherapeutic energy (e.g., via a cryo-probe delivering supercooled nitrogen gas or liquid nitrous oxide to achieve tissue temperatures below -40°C) to the target sites within the sino-nasal cavity, specifically associated with postganglionic parasympathetic fibers innervating the nasal mucosa. Concurrently or sequentially, a localized injection of a neural blocking agent, such as a botulinum toxin or a long-acting local anesthetic encapsulated in nanoparticles, is delivered directly to the cryo-modulated neural tissue via a micro-needle array integrated into the cryo-probe. The cryotherapy induces temporary neurolysis, making the tissue more permeable to the neural blocking agent, which then provides a sustained disruption of neural signals to mucus-producing glands and mucosal engorgement elements. The procedure targets foramina and microforamina of the palatine bone, aiming for precise, multi-point neural interruption without significant collateral thermal or mechanical damage.

graph TD
    A[Patient with Rhinitis] --> B{Deliver Cryo-Energy to Target Site};
    B --> C{Tissue Cooling to -40°C};
    C --> D{Local Neurolysis & Increased Tissue Permeability};
    D --> E{Deliver Neural Blocking Agent via Micro-Needle Array};
    E --> F{Sustained Neural Signal Disruption};
    F --> G{Reduced Mucus Production/Engorgement};
    G --> H{Improved Nasal Breathability & Sleep};

---

Derivative 1.2: Pulsed Focused Ultrasound (pFUS) for Non-Thermal Neural Modulation

Enabling Description: This method employs pulsed focused ultrasound (pFUS) delivered transnasally via a specialized transducer to target neural bundles within the sino-nasal cavity. Unlike thermal ablation, pFUS parameters are precisely controlled to induce non-thermal neuromodulatory effects, such as sonoporation or mechanotransduction, which temporarily or semi-permanently disrupt neural signal propagation without causing necrotic tissue damage. The pFUS energy is focused at identified target sites, such as the sphenopalatine ganglion (SPG) efferent fibers and branches innervating the inferior turbinate, to modulate their activity. Real-time elastography or acoustic radiation force impulse (ARFI) imaging is used to confirm precise targeting and monitor tissue response, ensuring that the acoustic pressure and pulse repetition frequency are within thresholds for neuromodulation rather than thermal ablation. This approach aims to reduce parasympathetic tone and mucosal engorgement.

graph TD
    A[Patient with Rhinitis] --> B{Position pFUS Transducer Transnasally};
    B --> C{Real-time Elastography/ARFI Imaging};
    C --> D{Target Neural Bundles (e.g., SPG efferents)};
    D --> E{Deliver Pulsed Focused Ultrasound};
    E --> F{Non-Thermal Neuromodulation (Sonoporation/Mechanotransduction)};
    F --> G{Disrupted Neural Signals};
    G --> H{Reduced Mucus Production/Engorgement};
    H --> I{Improved Nasal Breathability & Sleep};

---

Derivative 1.3: Photosensitizer-Enhanced Photodynamic Therapy (PDT)

Enabling Description: This method involves the systemic or localized administration of a photosensitizing agent (e.g., porfimer sodium or aminolevulinic acid) which selectively accumulates in hyperactive neural or vascular endothelial cells associated with rhinitis. After a predetermined incubation period, the target sites within the sino-nasal cavity (e.g., postganglionic parasympathetic fibers, submucosal glands, vascular plexus of turbinates) are illuminated with a specific wavelength of laser light (e.g., 630 nm for porfimer sodium) delivered via an optical fiber integrated into a nasal endoscope or device. The light activates the photosensitizer, generating reactive oxygen species that induce localized cellular damage, leading to disruption of neural signals, vascular occlusion, and subsequent local hypoxia. This selective phototoxicity reduces mucus production and mucosal engorgement.

sequenceDiagram
    participant P as Patient
    participant DS as Delivery System (Optical Fiber)
    participant LS as Laser Source
    participant PS as Photosensitizer
    P->PS: Systemic/Localized Administration
    Note over P: Photosensitizer accumulates at target sites
    P->DS: Insert Optical Fiber to Target Site
    DS->LS: Request Laser Activation
    LS->DS: Deliver Laser Light (e.g., 630nm)
    DS->P: Illuminate Target Sites
    P->PS: Photosensitizer Activation
    PS->P: Reactive Oxygen Species Generation
    Note over P: Cellular damage, neural/vascular disruption, local hypoxia
    P->P: Reduced Mucus/Engorgement
    P->P: Improved Nasal Breathability & Sleep

---

Derivative 1.4: Multi-Spectral Laser Ablation for Selective Tissue Targeting

Enabling Description: This method utilizes a multi-spectral laser system, integrated into a handheld nasal device, to selectively ablate different tissue components at target sites. For example, a 1470 nm diode laser can be used to target water-rich submucosal tissue and glands, causing bulk reduction and disrupting glandular function, while a 980 nm diode laser, absorbed by hemoglobin, can target microvasculature to induce local hypoxia and reduce engorgement. The device delivers these specific wavelengths through optical fibers that emerge at the tip of the end effector, with real-time spectroscopic feedback to identify tissue composition and guide laser parameter selection. This allows for precise, differential ablation of mucus-producing elements and engorgement elements based on their unique optical absorption profiles, minimizing damage to surrounding critical structures.

graph TD
    A[Patient with Rhinitis] --> B{Insert Handheld Device with Multi-Spectral Laser};
    B --> C{Real-time Spectroscopic Tissue Analysis};
    C --> D{Identify Tissue Type (Water-rich vs. Vascular)};
    D -- If Water-rich --> E{Deliver 1470nm Laser Energy};
    D -- If Vascular --> F{Deliver 980nm Laser Energy};
    E --> G{Disrupt Glandular Function & Reduce Bulk Tissue};
    F --> H{Induce Local Hypoxia & Reduce Engorgement};
    G & H --> I{Reduced Mucus Production/Engorgement};
    I --> J{Improved Nasal Breathability & Sleep};

---

Derivative 1.5: High-Frequency Reversible Electroporation (H-FIRE) for Non-Ablative Neuromodulation

Enabling Description: This method applies high-frequency irreversible electroporation (H-FIRE) pulse sequences to target neural structures in the nasal cavity. Instead of causing irreversible cell death (as in conventional IRE), H-FIRE uses short, high-voltage, bipolar or multi-polar electrical pulses at a high repetition rate (e.g., 500 kHz to 1 MHz) to temporarily increase cell membrane permeability or reversibly disrupt nerve conduction. This non-thermal, non-ablative approach selectively modulates neural function (e.g., inhibiting parasympathetic nerve activity) without causing significant tissue destruction. Electrodes on a multi-segment end effector are positioned at the sphenopalatine foramen region and along the inferior turbinate, and impedance monitoring ensures proper electrical coupling and real-time assessment of the neuromodulatory effect, allowing for titration of treatment to achieve desired symptom reduction.

flowchart TD
    A[Patient with Rhinitis] --> B{Position End Effector Electrodes at Target Sites};
    B --> C{Impedance Monitoring};
    C --> D{Deliver H-FIRE Pulses (High Freq, Bipolar/Multi-polar)};
    D --> E{Reversible Electroporation of Neural Membranes};
    E --> F{Temporary/Semi-Permanent Nerve Conduction Disruption};
    F --> G{Modulated Neural Signals (Reduced Parasympathetic Tone)};
    G --> H{Reduced Mucus Production/Engorgement};
    H --> I{Improved Nasal Breathability & Sleep};

---

Derivative 1.6: Targeted Gene Therapy or Neurotrophic Factor Delivery

Enabling Description: This advanced method involves delivering gene therapy vectors (e.g., adeno-associated virus, AAV) encoding inhibitory neuropeptides or enzymes that degrade neurotransmitters, or directly delivering neurotrophic factors that induce selective apoptosis of hyperactive parasympathetic neurons. The delivery is highly localized, using a microcatheter or microneedle array integrated into the elongate body of the device, placed directly into the target neural tissue near the sphenopalatine foramen or within the turbinate mucosa. The gene therapy expression or neurotrophic factor action leads to a sustained, precise reduction in parasympathetic innervation to the nasal mucosa, thereby decreasing mucus production and engorgement. This provides a long-term therapeutic effect.

graph TD
    A[Patient with Rhinitis] --> B{Identify Target Neural Tissue};
    B --> C{Position Microcatheter/Microneedle Array};
    C --> D{Deliver Gene Therapy Vector/Neurotrophic Factor};
    D --> E{Cellular Uptake & Expression of Inhibitory Agents OR Selective Neuronal Apoptosis};
    E --> F{Long-term Reduction in Parasympathetic Innervation};
    F --> G{Reduced Mucus Production/Engorgement};
    G --> H{Improved Nasal Breathability & Sleep};

---

Combination Prior Art Scenarios for Claim 1 (Method Claim):

1. US12096973 (Method Claim 1) + DICOM Standard (Digital Imaging and Communications in Medicine): The method of delivering energy to target sites for neuromodulation can be enhanced by integrating real-time pre-procedural and intra-procedural imaging data conforming to the DICOM standard. This includes importing patient-specific CT or MRI scans (DICOM files) into the treatment planning system to precisely identify neural pathways, foramina, and mucosal engorgement areas. During the procedure, live endoscopic video can be overlaid with the DICOM anatomical maps, providing augmented reality guidance for probe placement and energy delivery, ensuring accurate targeting and minimizing off-target effects. This open-source standard (DICOM) provides a robust framework for managing and integrating medical images to improve the accuracy and safety of the therapeutic method.

   graph TD
       A[Patient CT/MRI (DICOM)] --> B{Treatment Planning System};
       B --> C{3D Anatomical Model};
       D[Live Endoscopic Video] --> E{Image Fusion & AR Guidance};
       C & E --> F{Real-time Probe Placement Guidance};
       F --> G{Deliver Energy to Target Sites (US12096973 Method)};
       G --> H{Neuromodulation/Hypoxia};
   

2. US12096973 (Method Claim 1) + OpenMRS (Open Medical Record System): The method's effectiveness can be tracked and optimized by integrating patient outcome data into an open-source Electronic Health Record (EHR) system like OpenMRS. Before and after treatment, patient-reported outcomes (PROs) related to sleep quality, nasal congestion, and rhinorrhea are recorded. Energy delivery parameters, target site locations, and intra-procedural feedback (e.g., impedance changes, temperature profiles) are automatically logged into the patient's OpenMRS record. This structured data allows for population-level analysis to identify optimal treatment protocols, correlate device parameters with long-term symptom relief, and support continuous improvement of the method, fostering evidence-based practice within an open data framework.

   graph TD
       A[Patient (Rhinitis/Congestion)] --> B{US12096973 Method};
       B --> C{Energy Delivery & Neuromodulation};
       C --> D{Log Treatment Parameters (Energy, Location, Duration)};
       D --> E{OpenMRS Patient Record};
       F[Patient-Reported Outcomes (PROs)] --> E;
       E --> G{Outcome Tracking & Optimization Algorithms};
       G --> H{Improved Treatment Protocols};
   

3. US12096973 (Method Claim 1) + MQTT (Message Queuing Telemetry Transport) Protocol: To facilitate real-time communication and monitoring within a networked operating room or remote consultation scenario, the energy delivery method can be integrated with devices communicating via the MQTT protocol. The handheld device, console, and imaging systems publish real-time telemetry data (e.g., electrode temperature, power output, end effector position) to an MQTT broker. Authorized subscribers (e.g., a remote expert, an AI monitoring system, or a centralized control unit) can receive this data with low latency, enabling remote oversight, collaborative decision-making, and immediate alerts for critical events during the procedure. This ensures robust and secure data exchange for enhancing safety and efficacy of the treatment.

   sequenceDiagram
       participant HD as Handheld Device
       participant CS as Console
       participant IS as Imaging System
       participant MQ as MQTT Broker
       participant AI as AI Monitoring System
       participant RE as Remote Expert
       HD->MQ: Publish (Temp, Power, Position)
       CS->MQ: Publish (Control Signals, Status)
       IS->MQ: Publish (Image Data Stream)
       MQ->AI: Subscribe (All Telemetry)
       MQ->RE: Subscribe (All Telemetry)
       AI->CS: Publish (Optimal Parameters/Alerts)
       RE->CS: Publish (Guidance/Instructions)
       CS->HD: Control Energy Delivery
       Note over HD: US12096973 Method Execution
   

---

Analysis of Independent Claim 10: Therapeutic System (Handheld Device)

Claim 10: A therapeutic system for improving a patient's sleep by treating at least one of rhinitis, congestion, and rhinorrhea, the system comprising: a handheld device comprising a handle, an elongate body extending therefrom, and a retractable and expandable multi-segment end effector operably associated with the elongate body, the end effector comprising: a first flexible segment configured in a deployed configuration to fit around at least a portion of a middle turbinate at an anterior position relative to a lateral attachment and a posterior-inferior edge of the middle turbinate and position one or more energy delivery elements into contact with one or more respective tissue locations associated with the middle turbinate; and a distal segment configured in a deployed configuration to position one or more energy delivery elements into contact with one or more respective tissue locations in a cavity at a posterior position relative to the lateral attachment and posterior-inferior edge of the middle turbinate.

---

Derivative 2.1: Bioresorbable Polymer End Effector with Integrated Thin-Film Electrodes

Enabling Description: The multi-segment end effector's flexible support elements (struts) are fabricated from a bioresorbable polymer, such as poly(L-lactide-co-glycolide) (PLGA) or polydioxanone (PDO), which degrades harmlessly in vivo over weeks or months. This eliminates the need for removal and reduces long-term foreign body sensation. The energy delivery elements are thin-film electrodes of conductive hydrogel (e.g., PEDOT:PSS embedded in a hydrogel matrix) or sputtered platinum/iridium, seamlessly integrated onto the surface of the polymer struts. These electrodes are micro-patterned using photolithography, providing precise control over ablation zones. The bioresorbable struts initially provide mechanical apposition to the nasal anatomy, ensuring optimal electrode contact, then gradually resorb, leaving only the therapeutic effect.

classDiagram
    class EndEffector {
        +BioR_Polymer_Struts
        +Thin_Film_Electrodes
        +ShapeMemoryActuator
        +ControlUnit
    }
    class BioR_Polymer_Struts {
        +PLGA_or_PDO_Material
        +SegmentedDesign
        +FlexibleDeployment()
        +InVivoDegradation()
    }
    class Thin_Film_Electrodes {
        +PEDOT_PSS_Hydrogel | Pt/Ir_Sputtered
        +MicroPatternedGeometry
        +EnergyDelivery()
        +TissueContact()
    }
    class ShapeMemoryActuator {
        +NiTi_Wires
        +ThermalExpansionControl()
        +RetractionMechanism()
    }
    EndEffector <|-- BioR_Polymer_Struts
    EndEffector <|-- Thin_Film_Electrodes
    EndEffector <|-- ShapeMemoryActuator

---

Derivative 2.2: Miniaturized End Effector for Pediatric Use with Fluidic Control

Enabling Description: This derivative features a miniaturized multi-segment end effector, specifically scaled for pediatric nasal anatomies (e.g., overall diameter in retracted state < 2.0 mm). The flexible segments are made from ultra-fine nitinol wires, enabling highly conformable deployment within delicate structures. Instead of conventional electrodes, it incorporates micro-nozzles for precise fluidic delivery of a cryo-spray (e.g., highly localized evaporative cooling with a medical-grade coolant) or a chemical neuromodulator. Deployment and fluidic control are managed via a fine-pitch lead screw mechanism in the handle, offering sub-millimeter precision. A separate lumen within the elongate body provides continuous low-flow irrigation to clear mucus and ensure clear visualization.

graph TD
    A[Handle (Fine-Pitch Lead Screw)] --> B[Elongate Body (Micro-Lumen)];
    B --> C{Miniaturized End Effector (Nitinol Struts)};
    C --> D[Micro-Nozzles];
    D -- Cryo-Spray/Chemo-Modulator --> E[Target Pediatric Tissue];
    B --> F[Irrigation Lumen];
    F --> G[Low-Flow Irrigation];
    G --> H[Clear Visualization];
    C --> I[Precise Fluidic Delivery];
    I --> J{Neuromodulation/Symptom Reduction};

---

Derivative 2.3: Robotic Arm-Assisted System with Haptic Feedback and AR Guidance

Enabling Description: This system integrates the handheld device (elongate body, multi-segment end effector) with a stereotactic robotic arm. The handheld device is cradled by the robotic arm, which provides enhanced stability and precision beyond human capabilities. The system incorporates an Augmented Reality (AR) display for the surgeon, overlaying real-time 3D endoscopic views with pre-operative CT/MRI data and planned treatment zones. Haptic feedback is provided through the robotic arm to the surgeon's hand, simulating tissue resistance, proximity to critical structures, and successful electrode contact, derived from real-time impedance sensing at the end effector. This combination allows for highly precise, image-guided deployment and energy delivery, particularly beneficial for complex or variable anatomies.

flowchart TD
    A[Pre-operative CT/MRI] --> B{3D Anatomical Reconstruction};
    C[Handheld Device (End Effector)] --> D{Robotic Arm Interface};
    E[Real-time Endoscopic Video] --> F{AR Display (Surgeon)};
    B & E --> F;
    F --> G{Surgeon Input (Manual + Haptic Feedback)};
    D --> C;
    C --> H{Real-time Impedance/Temp Sensing};
    H --> G;
    G --> I{Precise Energy Delivery};
    I --> J{Therapeutic Modulation};

---

Derivative 2.4: Self-Adjusting Electrodes with Integrated Micro-Thermal Sensors

Enabling Description: The energy delivery elements (electrodes) on both the first and second flexible segments are constructed with bimetallic strips or shape memory polymer composites that self-adjust their curvature and apposition force based on local tissue temperature. Each electrode is paired with an embedded micro-thermal sensor (e.g., thin-film thermistor). During energy delivery, if a localized "hot spot" develops, the electrode's geometry subtly changes, reducing its contact area or increasing its standoff distance from the overheated tissue, thereby automatically regulating energy density and preventing overheating. This passive, integrated feedback mechanism enhances safety and minimizes collateral damage, even in variable tissue impedance environments.

graph LR
    A[Multi-Segment End Effector] --> B[Flexible Segment 1];
    A --> C[Flexible Segment 2];
    B --> D[Self-Adjusting Electrode with Micro-Thermal Sensor];
    C --> D;
    D --> E{Energy Delivery};
    E --> F{Local Tissue Heating};
    F -- Temp > Threshold --> D;
    D --> G{Electrode Self-Adjustment (Reduced Contact/Increased Standoff)};
    G --> H{Regulated Energy Density};
    H --> I{Minimized Collateral Damage};

---

Derivative 2.5: Modular End Effector with Interchangeable Therapeutic Modalities

Enabling Description: The therapeutic system features a modular design where the multi-segment end effector is a detachable cartridge. This allows a clinician to quickly exchange end effectors, each pre-loaded with a different therapeutic modality, onto the same elongate body and handle assembly. Examples of interchangeable modalities include: an RF ablation end effector, a cryotherapy end effector (with integrated fluidic lines), a low-power laser delivery end effector (with optical fibers), or a drug delivery end effector (with micro-needles and a drug reservoir). This modularity offers physicians the flexibility to select the most appropriate treatment for patient-specific anatomies and conditions, enhancing the versatility of the handheld device.

flowchart LR
    A[Handheld Device Handle + Elongate Body] -- Accepts --> B{Modular End Effector Interface};
    B -- Connects To --> C[RF Ablation End Effector];
    B -- Connects To --> D[Cryotherapy End Effector];
    B -- Connects To --> E[Laser Delivery End Effector];
    B -- Connects To --> F[Drug Delivery End Effector];
    C -- Provides --> G[RF Energy Delivery];
    D -- Provides --> H[Cryo-Treatment];
    E -- Provides --> I[Laser Photomodulation];
    F -- Provides --> J[Localized Drug Delivery];
    A -- Controls --> G, H, I, J;

---

Combination Prior Art Scenarios for Claim 10 (System Claim):

1. US12096973 (System Claim 10) + USB-C Power Delivery Standard: The handheld device, specifically its handle and elongate body, can be adapted to receive power and transmit data via a universal USB-C connection, adhering to the USB-C Power Delivery (PD) standard. This replaces proprietary power cables and connectors, offering interoperability with a wide range of standard power sources (e.g., hospital power bricks, portable battery packs). The USB-C connection would also facilitate high-speed data transfer of sensor feedback (temperature, impedance) from the end effector to the console for real-time monitoring and control, streamlining device connectivity and reducing equipment complexity in clinical settings.

   graph LR
       A[Handheld Device] --> B[USB-C Connector];
       B --> C[USB-C Power Delivery (PD) Source];
       B --> D[USB-C Data Link];
       D --> E[Therapeutic Console];
       E --> F[Energy Generator];
       E --> G[Controller];
       A --> H[Elongate Body];
       H --> I[End Effector (Sensors/Electrodes)];
       I --> D;
   

2. US12096973 (System Claim 10) + IEC 60601 Standard (Medical Electrical Equipment): The entire therapeutic system, including the handheld device, handle, elongate body, and end effector, is designed and certified to comply with the IEC 60601 series of standards for the safety and essential performance of medical electrical equipment. This includes specific requirements for electrical safety (e.g., insulation, leakage currents), mechanical safety (e.g., patient protection mechanisms), electromagnetic compatibility (EMC), and usability. Adherence to this widely adopted open standard ensures the device meets fundamental safety and performance criteria recognized globally, directly improving the reliability and clinical acceptance of the disclosed system.

   stateDiagram
       state IEC60601_Compliance {
           [*] --> Electrical_Safety
           Electrical_Safety --> Mechanical_Safety
           Mechanical_Safety --> EMC_Compliance
           EMC_Compliance --> Usability_Requirements
           Usability_Requirements --> [*]
       }
       Handheld_Device -- Adheres to --> IEC60601_Compliance
       Elongate_Body -- Adheres to --> IEC60601_Compliance
       End_Effector -- Adheres to --> IEC60601_Compliance
   

3. US12096973 (System Claim 10) + Apache Kafka (Distributed Streaming Platform): For large-scale deployment and continuous improvement across multiple clinical sites, the therapeutic system's operational data (device usage, energy profiles, patient demographics, aggregated outcomes) can be streamed to a centralized analytical platform using Apache Kafka. Each handheld device and its console can act as a Kafka producer, sending real-time operational metrics and anonymized treatment data. This distributed streaming architecture enables robust, scalable collection of data for fleet management, predictive maintenance, and machine learning models that optimize device performance and patient selection for the treatment of rhinitis, congestion, and rhinorrhea.

   graph LR
       HD1[Handheld Device 1] -- Produces Data --> K[Apache Kafka Cluster];
       CS1[Console 1] -- Produces Data --> K;
       HDn[Handheld Device n] -- Produces Data --> K;
       CSn[Console n] -- Produces Data --> K;
       K --> AP[Analytical Platform (ML Models)];
       AP --> DD[Data Dashboard (Performance/Outcomes)];
       AP --> PI[Predictive Insights (Maintenance/Treatment)];
       DD --> HD1;
       DD --> CS1;
   

---

Analysis of Independent Claim 19: Handheld Device

Claim 19: A handheld device for delivering energy to a sino-nasal cavity of a patient, the handheld device comprising: an ergonomically designed handle including a grip portion which provides ambidextrous use for both left and right handed use and conforms to hand anthropometrics to allow for at least one of an overhand grip style and an underhand grip style during use in a procedure, the handle including one or more recesses configured to naturally receive one or more of an operator's fingers; an elongate body extending from the handle, the elongate body including one or more electrodes provided on one or more respective portions along a length thereof and configured to deliver energy to tissue associated with an inferior turbinate of the patient; and a retractable and expandable multi-segment end effector operably associated with the elongate body, the end effector including one or more electrodes and configured to deliver energy to tissue associated with a sphenopalatine foramen within the sino-nasal cavity of the patient; wherein the handle further includes multiple user-operated mechanisms, including at least a first mechanism for deployment of the end effector from the retracted configuration to the expanded deployed configuration and a second mechanism for controlling of energy output by the end effector, the user inputs for the first and second mechanisms positioned a sufficient distance to one another to allow for simultaneous one-handed operation of both user inputs during a procedure.

---

Derivative 3.1: Haptic Feedback-Enabled Ergonomic Handle with Biometric Authentication

Enabling Description: The ergonomically designed handle incorporates advanced haptic feedback actuators (e.g., linear resonant actuators or voice coil motors) that provide real-time tactile cues to the operator. This feedback is generated in response to tissue impedance changes, proximity to critical structures (e.g., bone, nerve bundles detected by sensing electrodes), and optimal apposition force of the end effector. The handle's grip portion is constructed from a medical-grade, textured elastomer providing enhanced grip and comfort, and features dynamically adjustable recesses that conform to the operator's individual hand anatomy via micro-actuators, activatable via a quick calibration process. A fingerprint scanner or palm vein sensor is integrated into the grip for biometric authentication, ensuring only authorized personnel can operate the high-energy device and automatically linking procedure data to the specific operator.

graph TD
    A[Operator Finger/Palm] --> B{Biometric Sensor (Fingerprint/Vein)};
    B --> C{Authentication Module};
    C -- Authenticated --> D[Handle Control Unit];
    C -- Unauthenticated --> E[Device Lockout];
    D --> F{Dynamically Adjustable Recesses (Micro-Actuators)};
    D --> G{Haptic Feedback Actuators};
    H[Tissue Impedance/Proximity Sensors] --> G;
    I[Elongate Body & End Effector] --> H;
    G & F --> J[Enhanced Operator Control & Comfort];
    J --> K[Energy Delivery & Deployment Mechanisms];

---

Derivative 3.2: Wireless Power Transfer and Inductive Charging for Enhanced Mobility

Enabling Description: The handheld device is completely wireless, eliminating the cable connection to a console for power. It features an integrated high-capacity, medical-grade lithium-ion battery with a wireless power transfer coil embedded in the handle. The console includes a corresponding inductive charging pad. During standby or between procedures, the device is placed on the pad for charging. During operation, the battery powers the device, and real-time operational data (e.g., electrode parameters, end effector position, sensor readings) is transmitted wirelessly via a secure, low-latency Wi-Fi or Bluetooth Low Energy (BLE) module to the console. This design enhances mobility in the operating room, reduces entanglement, and improves sterility by minimizing external connections.

flowchart TD
    A[Handheld Device] --> B[Integrated Li-Ion Battery];
    B --> C[Wireless Power Coil (Rx)];
    C -- Inductive Charging --> D[Console Inductive Pad (Tx)];
    A --> E[Wireless Data Module (Wi-Fi/BLE)];
    E -- Secure Data Link --> F[Console Processing Unit];
    F --> G[Energy Generator];
    F --> H[Deployment Control];
    A --> I[Elongate Body & End Effector];
    I --> E;
    I --> B;

---

Derivative 3.3: AI-Driven Voice Command Interface for User Mechanisms

Enabling Description: The handle's user-operated mechanisms for deployment and energy control are augmented with an AI-driven voice command interface. Embedded microphones in the handle capture the surgeon's voice commands (e.g., "End Effector Deploy," "Energy On, Level 3," "Retract Half"). A local, edge-AI processor within the handle processes these commands, utilizing natural language processing (NLP) and speech recognition optimized for medical terminology, to actuate the respective mechanisms. This minimizes the need for manual button presses during critical procedural steps, freeing the surgeon's hands for delicate manipulation and potentially reducing cognitive load. A small, integrated display or LED indicator provides visual confirmation of voice commands.

sequenceDiagram
    participant S as Surgeon
    participant HD as Handheld Device
    participant AI as Edge-AI Processor
    participant DM as Deployment Mechanism
    participant EM as Energy Mechanism
    S->HD: Voice Command (e.g., "Deploy End Effector")
    HD->AI: Audio Input
    AI->AI: NLP & Speech Recognition
    AI->DM: Actuate Deployment
    AI->HD: Visual/Auditory Confirmation
    S->HD: Voice Command (e.g., "Energy On, Level 3")
    HD->AI: Audio Input
    AI->AI: NLP & Speech Recognition
    AI->EM: Set Energy Output
    AI->HD: Visual/Auditory Confirmation
    Note over HD: Energy Delivery to Tissue

---

Derivative 3.4: Modular Elongate Body for Variable Stiffness and Curvature

Enabling Description: The elongate body is a modular, multi-segment assembly, where each segment has independently controllable stiffness and/or pre-set curvature. The segments are made of interlocking, flexible polymer rings with embedded shape memory alloy (SMA) wires (e.g., nitinol) or micro-braids. By applying specific electrical currents or thermal profiles to the SMA wires, the operator can dynamically alter the stiffness of individual segments (e.g., from highly flexible for navigation to rigid for stable apposition) or induce specific curvatures in real-time. This allows for unparalleled maneuverability through tortuous nasal anatomies and precise positioning of both the elongate body's and the end effector's electrodes, without requiring multiple pre-shaped shafts. Control is integrated into the handle's user mechanisms, potentially via a joystick or touch-sensitive interface.

stateDiagram
    state "Elongate Body States" {
        Flexible: NavigationMode
        Rigid: AppositionMode
        Curved_Left: SteerLeft
        Curved_Right: SteerRight
        
        [*] --> Flexible
        Flexible --> Rigid: Apply Current (SMA)
        Rigid --> Flexible: Release Current (SMA)
        Flexible --> Curved_Left: Apply Current (SMA Left Side)
        Flexible --> Curved_Right: Apply Current (SMA Right Side)
        Curved_Left --> Flexible
        Curved_Right --> Flexible
    }
    Handle_Control --> "Elongate Body States"

---

Derivative 3.5: Multi-Modal Sensing Integration on Elongate Body Electrodes

Enabling Description: The electrodes provided on the elongate body, in addition to delivering energy, are also capable of multi-modal sensing. Each electrode, or a subset thereof, functions as a combined impedance sensor, a temperature sensor (e.g., via a miniaturized thermistor or differential impedance), and a local nerve stimulation/recording electrode. The system automatically cycles between energy delivery and sensing modes. Before energy delivery, low-level electrical pulses are applied to stimulate nerves, and electromyography (EMG) or evoked potential responses are recorded to map neural pathways and confirm safe distances from non-target nerves. During energy delivery, real-time impedance and temperature feedback ensure precise control and prevent overheating. This integrated sensing capability on the elongate body's electrodes provides comprehensive tissue characterization and enhanced safety during treatment of the inferior turbinate.

graph TD
    A[Elongate Body Electrodes] --> B{Impedance Sensing};
    A --> C{Temperature Sensing};
    A --> D{Nerve Stimulation / Recording};
    B & C & D --> E[Multi-Modal Sensing Data];
    E --> F{Console Processing Unit};
    F -- Pre-treatment --> G{Neural Mapping / Safety Zone Delimitation};
    F -- Intra-treatment --> H{Energy Control Feedback};
    H --> I[Energy Delivery to Inferior Turbinate];
    G --> I;

---

Combination Prior Art Scenarios for Claim 19 (Handheld Device Claim):

1. US12096973 (Handheld Device Claim 19) + ROS (Robot Operating System): The control architecture for the deployment and energy mechanisms within the handheld device and its console can be built upon the open-source Robot Operating System (ROS) framework. ROS nodes would manage individual components such as actuator control for end effector deployment, energy generator parameters, and sensor data acquisition from electrodes. This modular, message-passing architecture allows for flexible development, easy integration of new features (e.g., advanced control algorithms, new sensors), and robust communication between the device and its various subsystems. It also supports simulation environments for testing and validation, fostering rapid iteration and reliable system design.

   graph TD
       HD[Handheld Device ROS Node] -- Pub/Sub --> EB[Elongate Body Control Node];
       HD -- Pub/Sub --> EE[End Effector Control Node];
       HD -- Pub/Sub --> UM[User Mechanism Interface Node];
       CS[Console ROS Node] -- Pub/Sub --> HD;
       EB --> ES[Electrode Sensing Node];
       EE --> EGE[Energy Generator Interface Node];
       EGE --> EE;
       UM --> DM[Deployment Actuator];
       UM --> EC[Energy Control Interface];
       DM & EC & ES & EGE --> CS;
   

2. US12096973 (Handheld Device Claim 19) + Zigbee (IEEE 802.15.4 Standard): For wireless communication between the handheld device and the console, particularly in environments where low power consumption and mesh networking capabilities are desirable, the Zigbee protocol (based on IEEE 802.15.4) can be utilized. This would enable the device to transmit sensor data (e.g., temperature, impedance, device status) to the console and receive control commands without a direct cable connection. The mesh networking capability could also allow for communication with other Zigbee-enabled devices in the operating room, such as a remote display or an automated sterilization unit, creating a connected ecosystem with minimal energy overhead.

   graph TD
       HD[Handheld Device] -- Wireless (Zigbee) --> C[Console (Zigbee Coordinator)];
       C -- Wireless (Zigbee) --> RD[Remote Display];
       C -- Wireless (Zigbee) --> ASU[Automated Sterilization Unit];
       HD --> S[Sensors (Temp, Impedance)];
       HD --> EC[Electrodes/Energy Control];
       HD --> DM[Deployment Mechanisms];
       S & EC & DM --> HD;
   

3. US12096973 (Handheld Device Claim 19) + GNU Octave (Numerical Computation Software): The console's control system, particularly for advanced energy delivery algorithms and real-time feedback processing, can leverage open-source numerical computation software like GNU Octave. This allows for the development and execution of complex algorithms for impedance feedback control, tissue heating models, and nerve mapping analysis without relying on proprietary software environments. Clinicians or researchers could easily develop and deploy custom treatment protocols using Octave's scripting capabilities, fostering innovation and transparency in the device's operational logic. The console would run an embedded Octave interpreter or compiler for real-time execution.

   flowchart TD
       A[Handheld Device (Electrode Data)] --> B{Console Input Module};
       B --> C[GNU Octave Runtime Environment];
       C --> D{Custom Control Algorithms (Octave Script)};
       D --> E{Real-time Feedback Processing};
       E --> F{Energy Generator Control};
       E --> G{Deployment Mechanism Control};
       F & G --> A;
   

---

Analysis of Independent Claim 20: Method of Treating Rhinosinusitis

Claim 20: A method of treating rhinosinusitis using the handheld device of claim 19, the method comprising: inserting the multi-segment end effector into the sino-nasal cavity of the patient, wherein the elongate body carries a first set of electrodes and the multi-segment end effector carries a second set of electrodes; positioning the multi-segment end effector at a first target site associated with a sphenopalatine foramen within the sino-nasal cavity of the patient; simultaneously positioning a portion of the elongate body at a second, separate target site associated with an inferior turbinate within the sino-nasal cavity of the patient; delivering energy from the first set of electrodes to tissue associated with the inferior turbinate at a level sufficient to reduce engorgement of tissue associated with the inferior turbinate to thereby increase volumetric flow through a nasal passage of the patient; and delivering energy from the second set of electrodes to the first target site at a level sufficient to therapeutically modulate postganglionic parasympathetic nerves innervating nasal mucosa at microforamina of a palatine bone of the patient.

---

Derivative 4.1: Automated Dual-Site Sequential Pulsed RF Ablation with Adaptive Cooling

Enabling Description: This method refines the dual-site treatment by implementing an automated sequential pulsed radiofrequency (RF) ablation protocol with integrated adaptive cooling. After positioning, the system first delivers pulsed RF energy (e.g., 5-second pulse, 2-second pause) from the first set of electrodes to the inferior turbinate. During the pause, a localized cooling saline flush is administered via an auxiliary lumen in the elongate body to mitigate surface heating while maintaining deep tissue ablation. Once the inferior turbinate treatment is complete (confirmed by real-time impedance feedback and volumetric flow improvement), the system automatically transitions to deliver pulsed RF from the second set of electrodes to the sphenopalatine foramen (SPF) region, with parameters optimized for precise neural modulation. The system dynamically adjusts pulse duration, power, and cooling rates at each site based on real-time tissue impedance, temperature, and pre-programmed safety algorithms.

sequenceDiagram
    participant S as Surgeon
    participant HD as Handheld Device
    participant C as Console
    participant EB as Elongate Body (1st Electrodes)
    participant EE as End Effector (2nd Electrodes)

    S->HD: Insert & Position Device
    C->EB: Start Pulsed RF (Inferior Turbinate)
    C->HD: Deliver Cooling Saline Flush
    EB->C: Real-time Impedance/Temp/Flow
    loop Inferior Turbinate Treatment
        C->EB: Adjust RF Parameters
        C->HD: Continue Cooling
    end
    C->C: Inferior Turbinate Treatment Complete
    C->EE: Start Pulsed RF (SPF Region)
    EE->C: Real-time Impedance/Temp
    loop SPF Region Treatment
        C->EE: Adjust RF Parameters
    end
    C->C: SPF Region Treatment Complete
    C->HD: Device Retraction Instruction

---

Derivative 4.2: Photo-Acoustic Imaging Guided Localized Drug Delivery for Nerve Modulation

Enabling Description: This method combines photo-acoustic imaging (PAI) for real-time anatomical and functional guidance with localized drug delivery. The handheld device incorporates miniaturized PAI transducers and a laser source. Before drug delivery, PAI is used to visualize nerve bundles, microforamina, and vascular structures around the SPF and inferior turbinate by detecting ultrasonic waves generated from laser-induced thermal expansion. This provides highly detailed, label-free anatomical and functional maps. Once target nerves are precisely identified, a micro-catheter, extending from the end effector, delivers a focused bolus of a neuro-modulating pharmaceutical agent (e.g., a selective antagonist for cholinergic receptors or a growth factor to induce nerve atrophy) directly to the target neural pathways, guided by the real-time PAI feedback. Simultaneously, the elongate body's electrodes could be used for low-level electrical stimulation to cause temporary vasoconstriction of the inferior turbinate, rather than ablation, for acute congestion relief.

graph TD
    A[Patient Sino-Nasal Cavity] --> B{Handheld Device with PAI};
    B --> C{PAI Transducers & Laser Source};
    C --> D{Real-time Photo-Acoustic Imaging (Neural & Vascular)};
    D --> E{Precise Identification of Target Nerves/Microforamina};
    E --> F{Micro-Catheter Drug Delivery (Neuro-Modulator)};
    G[Elongate Body Electrodes] --> H{Low-level Electrical Stimulation (Inferior Turbinate)};
    F --> I{Therapeutic Nerve Modulation (SPF)};
    H --> J{Acute Vasoconstriction (Inferior Turbinate)};
    I & J --> K{Reduced Rhinosinusitis Symptoms & Improved Sleep};

---

Derivative 4.3: High-Intensity Focused Ultrasound (HIFU) for Non-Invasive Dual-Site Modulation

Enabling Description: This method employs non-invasive High-Intensity Focused Ultrasound (HIFU) delivered from external transducers (e.g., mounted on a head-frame or integrated into a custom nasal applicator) rather than internal electrodes. The HIFU beams are precisely steered and focused onto the external surface of the palatine bone to target the postganglionic parasympathetic nerves at the microforamina associated with the SPF region. Simultaneously, a separate HIFU beam or a different set of transducers focuses energy onto the inferior turbinate region (transcutaneously or transorally) to induce controlled thermal necrosis or modulate vascular tone to reduce engorgement. Real-time MRI-thermometry or ultrasound imaging guides the focusing and monitors the temperature at both target sites, ensuring non-invasive, precise, and controlled energy delivery. This eliminates the need for internal probes or electrodes for primary energy delivery.

flowchart TD
    A[Patient (Rhinosinusitis)] --> B{External HIFU Transducer Array};
    B --> C{Real-time MRI-Thermometry/Ultrasound Guidance};
    C --> D{HIFU Beam 1 (SPF Region)};
    C --> E{HIFU Beam 2 (Inferior Turbinate)};
    D --> F{Therapeutic Nerve Modulation (SPF)};
    E --> G{Controlled Thermal Necrosis/Vascular Modulation (Inferior Turbinate)};
    F & G --> H{Reduced Rhinosinusitis Symptoms & Improved Sleep};

---

Derivative 4.4: Adaptive Cryo-Therapy for Inferior Turbinate and RF Micro-Ablation for SPF

Enabling Description: This method employs a combination of adaptive cryo-therapy for the inferior turbinate and precise RF micro-ablation for the sphenopalatine foramen (SPF) region. The elongate body incorporates a cryo-probe that delivers a controlled, circulating cryogen (e.g., argon gas for Joule-Thomson effect) to freeze the tissue of the inferior turbinate, reducing its bulk and engorgement. The cryo-probe includes integrated thermistors for real-time temperature monitoring and adaptive feedback to maintain optimal freezing temperatures (e.g., -60°C to -80°C) while avoiding excessive tissue damage. Simultaneously, the multi-segment end effector, positioned at the SPF region, delivers extremely low-power, high-frequency RF pulses through its micro-electrodes. These micro-electrodes are designed to create very small, superficial lesions (micro-ablations) specifically targeting nerve fascicles exiting the microforamina, minimizing thermal spread and collateral damage to surrounding bone or vasculature.

graph TD
    A[Patient Sino-Nasal Cavity] --> B{Handheld Device Insertion};
    B --> C{Elongate Body (Cryo-probe) at Inferior Turbinate};
    B --> D{End Effector (Micro-RF Electrodes) at SPF Region};
    C --> E{Deliver Adaptive Cryo-Therapy};
    E --> F{Real-time Temp Monitoring (Inferior Turbinate)};
    F --> G{Reduce Inferior Turbinate Engorgement/Bulk};
    D --> H{Deliver Low-Power, High-Frequency RF Micro-Ablation};
    H --> I{Precisely Target Nerve Fascicles (SPF)};
    G & I --> J{Reduce Rhinosinusitis Symptoms & Improve Sleep};

---

Derivative 4.5: Blockchain-Verified Treatment Protocol with AI Optimization

Enabling Description: This method integrates the treatment protocol with a secure, blockchain-verified system for logging and optimizing procedures. Each step of the method (device insertion, positioning, energy delivery parameters, patient response) is cryptographically logged as a transaction on a private blockchain network accessible to authorized medical personnel and regulatory bodies. An AI module, fed by this secure, anonymized global dataset, continuously analyzes successful treatment outcomes and device parameters. Before each procedure, the AI provides optimized energy delivery settings and positioning guidance tailored to the patient's specific anatomical profile and disease severity, derived from the blockchain data. After treatment, the AI evaluates the actual parameters against the predicted optimal settings, refining future recommendations and ensuring compliance with the verified protocol.

sequenceDiagram
    participant S as Surgeon
    participant HD as Handheld Device
    participant C as Console
    participant AI as AI Optimization Module
    participant BC as Blockchain Network

    S->C: Input Patient Data
    C->AI: Request Optimized Protocol
    AI->BC: Query Historical Treatment Data
    BC->AI: Return Anonymized Outcomes
    AI->C: Provide Optimized Parameters (Energy, Position, Duration)
    S->HD: Insert & Position Device (Guided by C)
    S->C: Confirm Position
    C->BC: Log Position Transaction
    C->HD: Deliver Energy (Optimized Parameters)
    HD->C: Real-time Feedback (Temp, Impedance)
    C->BC: Log Energy Delivery Transaction
    C->AI: Submit Real-time Feedback
    AI->C: Adaptive Adjustments
    S->C: Procedure Complete
    C->BC: Log Final Outcome Transaction

---

Combination Prior Art Scenarios for Claim 20 (Method of Treating Rhinosinusitis):

1. US12096973 (Method Claim 20) + FHIR Standard (Fast Healthcare Interoperability Resources): The method of treating rhinosinusitis can be integrated with hospital information systems using the FHIR standard for interoperable exchange of healthcare information. Pre-procedural patient data (medical history, imaging reports, allergy status) is retrieved from the EHR via FHIR APIs. Intra-procedural data, such as electrode power, temperature, duration of energy delivery, and real-time sensor readings from the device, is structured into FHIR resources (e.g., Device, Observation, Procedure) and securely transmitted back to the patient's electronic health record. This ensures seamless data flow, improves clinical decision-making, and facilitates comprehensive audit trails for regulatory compliance, leveraging a widely adopted open standard for healthcare data.

   graph TD
       A[EHR System (FHIR Compliant)] --> B{FHIR API Query (Patient Data)};
       B --> C{Console (Pre-Proc Planning)};
       D[Handheld Device (Sensors/Energy Delivery)] --> E{FHIR Resource Creation (Proc Data)};
       E --> F{FHIR API Update (EHR)};
       C --> D;
       F --> G[Improved Patient Record & Analytics];
   

2. US12096973 (Method Claim 20) + ONVIF Standard (Open Network Video Interface Forum): For enhanced visual guidance and post-procedural review, the endoscopic camera integrated into the handheld device or a separate visualization endoscope can adhere to the ONVIF standard for IP-based video surveillance. This allows the live video feed from the nasal cavity to be streamed directly over the network to multiple displays, recording systems, and remote viewing platforms, offering high interoperability. The ONVIF standard also defines interfaces for camera control (e.g., zoom, focus) and metadata, which can be enriched with treatment parameters from the device console. This enables standardized video archiving and facilitates collaborative surgical environments or remote assistance during complex rhinosinusitis treatments.

   flowchart TD
       A[Endoscopic Camera (ONVIF Compliant)] --> B{IP Network (Streaming Video)};
       B --> C[Operating Room Display];
       B --> D[Remote Viewing Station];
       B --> E[Video Recording System];
       F[Console (Treatment Parameters)] --> E;
       F --> D;
       A -- Delivers Video --> G[Target Sites in Nasal Cavity];
       G -- Guides --> H[Handheld Device Positioning/Energy];
   

3. US12096973 (Method Claim 20) + OpenTelemetry (Cloud-Native Observability Framework): To monitor the performance and health of the therapeutic system in a distributed clinical environment, the method can integrate with OpenTelemetry. The handheld device and console generate telemetry data (metrics, traces, logs) regarding energy delivery cycles, device errors, network latency, and processing times. These telemetry signals are collected by OpenTelemetry agents and exported to a backend analysis system. This open-source framework provides standardized, vendor-agnostic means for instrumenting the entire system, enabling proactive identification of operational issues, performance bottlenecks, and deviations from optimal treatment protocols, ensuring high reliability and efficacy of the rhinosinusitis treatment method.

   graph TD
       A[Handheld Device] --> B{OpenTelemetry Agent};
       C[Console] --> D{OpenTelemetry Agent};
       B --> E[OpenTelemetry Collector];
       D --> E;
       E --> F[Backend Analysis System (Metrics, Traces, Logs)];
       F --> G[Performance Monitoring Dashboard];
       F --> H[Alerting & Anomaly Detection];
       G & H --> I[System Optimization & Maintenance];