Derivative works — US Patent 12096974

Defensive Disclosure for US Patent 12096974

This Defensive Disclosure document outlines a series of derivative variations for the systems and methods described in US Patent 12096974. The intent of this disclosure is to establish prior art, thereby precluding or limiting the patentability of future incremental improvements by competitors through the doctrines of obviousness and lack of novelty under 35 U.S.C. §§ 102 and 103. These disclosures expand upon the core claims by exploring alternative materials and components, extreme operational parameters, cross-domain applications, integration with emerging technologies, and inverse/failure modes.

Independent Claim 1 Analysis and Derivative Variations

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: Material & Component Substitution - Multi-Modal Energy Delivery via Integrated Transducers

Enabling Description: The method comprises delivering energy to target sites using an elongate body and multi-segment end effector, where the energy delivery elements are substituted with a combination of high-intensity focused ultrasound (HIFU) transducers and miniaturized cryogenic spray nozzles. The HIFU transducers are configured to precisely ablate neural tissues (e.g., postganglionic parasympathetic fibers innervating the nasal mucosa) to disrupt neural signals, while the cryogenic spray nozzles deliver a localized burst of refrigerant (e.g., liquid nitrogen or a mixture of nitrous oxide and carbon dioxide) to induce rapid cellular necrosis and local hypoxia within mucosal engorgement elements (e.g., in the inferior turbinate). Each energy modality is independently controllable via a console, allowing for sequential or synchronized application. Temperature sensors (e.g., thermistors or fiber optic temperature probes) integrated adjacent to the HIFU transducers and spray nozzles provide real-time feedback to the console, ensuring targeted tissue temperatures (e.g., >60°C for HIFU ablation, <-20°C for cryo-ablation) are achieved without collateral damage.

flowchart TD
    A[Start Method] --> B{Introduce Device with HIFU/Cryo Elements}
    B --> C{Position HIFU Transducers at Neural Target Site}
    B --> D{Position Cryo Nozzles at Mucosal Engorgement Site}
    C --> E[Deliver HIFU Energy to Disrupt Neural Signals]
    D --> F[Deliver Cryogenic Spray for Local Hypoxia]
    E & F --> G{Monitor Tissue Temperature & Impedance}
    G -- Feedback --> E
    G -- Feedback --> F
    G -- Optimal Outcome --> H[Reduce Mucus/Engorgement, Improve Sleep]
    H --> I[End Method]

Derivative 1.2: Operational Parameter Expansion - Ultra-High Frequency Pulsed RF Ablation with Nanosecond Pulses

Enabling Description: The method involves delivering energy using an end effector where the radiofrequency (RF) energy is applied as ultra-high frequency (UHF) pulsed RF (e.g., 900 MHz to 2.4 GHz) with pulse durations in the nanosecond (e.g., 50-500 ns) to picosecond (e.g., 10-100 ps) range, at high peak power (e.g., 100W-1kW) and low average power. This non-thermal or minimally thermal approach aims for precise neural signal disruption via electroporation and cellular membrane breakdown without significant bulk tissue heating, thus minimizing collateral thermal damage. The pulse repetition frequency is adaptable (e.g., 10 kHz to 1 MHz) based on real-time impedance and local field potential feedback from micro-electrodes integrated with the energy delivery elements. This allows for fine-tuned energy delivery to achieve localized hypoxia at a cellular level or highly selective neural pathway interruption, optimized to a specific neural bundle diameter (e.g., 10-100 µm).

sequenceDiagram
    participant D as Device
    participant C as Console/Generator
    participant T as Tissue Target
    C->D: Initiate UHF Pulsed RF (900MHz, 100ns, 500Wpeak)
    D->T: Apply UHF Pulses
    T->D: Impedance & Local Field Potential Feedback
    D->C: Transmit Feedback Data
    C->C: Analyze & Adjust Pulse Parameters
    C->D: New Pulse Parameters
    alt If Neural Disruption Not Optimal
        C->D: Increase Peak Power / Adjust Freq
    else If Thermal Damage Risk
        C->D: Decrease Average Power / Increase PRF
    end
    D->T: Continue Targeted Treatment
    C->D: Terminate Treatment

Derivative 1.3: Cross-Domain Application - Precision Agriculture: Targeted Crop Pest Neuromodulation

Enabling Description: The method is adapted for precision agriculture to disrupt neural signals in specific crop pests (e.g., aphids, mites) without harming the host plant. A handheld device, analogous to US12096974, is fitted with an elongate body and a micro-segment end effector that can navigate plant foliage. The end effector deploys flexible micro-electrodes (e.g., 50-100 µm diameter) that conform to the cuticle of target pests. Low-level pulsed electrical energy (e.g., 5-10V, 100Hz-1kHz) is delivered to induce neural signal disruption, leading to paralysis or reproductive inhibition of the pests. Localized hypoxia is induced in pest feeding apparatus using controlled bursts of a non-toxic gas (e.g., CO2) via integrated micro-nozzles. This targeted approach minimizes the need for broad-spectrum pesticides, reducing environmental impact and improving crop yield by selectively treating only affected areas.

graph TD
    A[Agricultural Handheld Device] --> B{Micro-Segment End Effector}
    B --> C[Flexible Micro-electrodes]
    B --> D[Micro-nozzles for Gas Delivery]
    C --> E[Target Crop Pest Cuticle]
    D --> F[Target Pest Feeding Apparatus]
    E --> G{Apply Pulsed Electrical Energy}
    F --> H{Apply Localized Non-toxic Gas}
    G & H --> I[Disrupt Pest Neural Signals / Induce Local Hypoxia]
    I --> J[Pest Paralysis / Reproductive Inhibition]
    J --> K[Improved Crop Yield]

Derivative 1.4: Integration with Emerging Tech - AI-Optimized Treatment with IoT Monitoring and Blockchain Audit Trail

Enabling Description: The method integrates an AI-driven optimization engine that utilizes real-time physiological data (e.g., nasal airflow, impedance, mucosal temperature, patient-reported sleep metrics collected via IoT sensors in a smart sleep mask) to dynamically adjust energy delivery parameters. Pre-procedural 3D anatomical scans (e.g., CT, MRI) are fed into the AI to generate a patient-specific neural map and optimal treatment plan. During the procedure, IoT sensors embedded in the end effector and external nasal monitors provide continuous data streams to the AI, which modulates RF power, pulse duration, and electrode activation patterns to achieve precise neuromodulation and local hypoxia while minimizing side effects. All treatment parameters, patient physiological responses, and AI decisions are immutably logged onto a private blockchain network. This creates a secure, auditable record for regulatory compliance, post-market surveillance, and personalized treatment efficacy tracking, ensuring data integrity and patient privacy.

graph TD
    A[Patient Data (3D Scans, Sleep Metrics)] --> B(AI Optimization Engine)
    B --> C{Treatment Plan Generation}
    C --> D[Handheld Device with IoT Sensors]
    D -- Real-time Feedback --> B
    D --> E[Energy Delivery to Target Sites]
    E --> F[Physiological Response (Airflow, Impedance, Temp)]
    F --> G(IoT Smart Sleep Mask)
    G --> H(Patient-Reported Outcomes)
    H -- Encrypted Data --> I[Blockchain Ledger]
    F -- Encrypted Data --> I
    E -- Encrypted Data --> I
    D -- Encrypted Data --> I
    I --> J[Secure Audit Trail & Efficacy Tracking]

Derivative 1.5: The "Inverse" or Failure Mode - Diagnostic-Only, Low-Power Sensing Mode with Gradual, Reversible Neuromodulation

Enabling Description: The method initiates with a "diagnostic-only, low-power sensing mode" prior to any therapeutic energy delivery. In this mode, the end effector's electrodes function solely as impedance sensors and local field potential (LFP) detectors, operating at micro-ampere currents (e.g., 1-10 µA) and sub-mV potentials. This allows for precise neural mapping and tissue characterization without causing any therapeutic effect. Should an impedance spike or abnormal LFP indicate proximity to non-target neural structures (e.g., trigeminal nerve branches), the system defaults to a "gradual, reversible neuromodulation mode." In this mode, extremely low-power pulsed electrical stimulation (e.g., 0.1-0.5V, 1-100ms pulses, 1Hz) is applied to temporarily, non-destructively inhibit neural activity for a defined period (e.g., 30-60 minutes). This allows for confirmation of desired target engagement and a "test run" of symptom relief before irreversible ablation. Upon detection of critical system faults (e.g., power supply instability, uncommanded temperature rise), the energy delivery system autonomously initiates a safe shutdown, retracting the end effector and isolating all energy delivery circuits to prevent unintended tissue damage.

stateDiagram
    [*] --> Init
    Init --> DiagnosticMode: Power On
    DiagnosticMode --> NeuralMapping: Low-Power Sensing
    NeuralMapping --> TissueChar: Impedance/LFP Detect
    TissueChar --> ReadyForTherapy: Target Confirmed
    ReadyForTherapy --> ReversibleModulation: Apply Low Power Stimulation
    ReversibleModulation --> AblationMode: Confirmed Efficacy
    AblationMode --> TreatmentComplete: Deliver Full Energy
    TreatmentComplete --> [*]
    DiagnosticMode --> FailSafe: Anomaly Detected
    NeuralMapping --> FailSafe: Anomaly Detected
    ReversibleModulation --> FailSafe: Anomaly Detected
    AblationMode --> FailSafe: Anomaly Detected
    FailSafe --> Shutdown: Critical Fault
    Shutdown --> [*]

Independent Claim 10 Analysis and Derivative Variations

Claim 10: A therapeutic device comprising: a handle; an elongate body extending from the handle, the elongate body comprising an outer sheath and a hypotube disposed within the outer sheath; and a retractable and expandable multi-segment end effector operably associated with the elongate body, the end effector comprising a plurality of energy delivery elements and having at least a first flexible segment and a second flexible segment that are spaced apart from one another, each of the first and second segments comprising a plurality of energy delivery elements, wherein the first segment comprises a first set of flexible support elements 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 wherein the second segment comprises a second set of flexible support elements 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 10.1: Material & Component Substitution - Shape Memory Polymer Actuators with Liquid Metal Electrodes

Enabling Description: The device comprises a handle, an elongate body, and a multi-segment end effector. The flexible support elements of both the first and second segments are fabricated from a high-modulus, biocompatible shape memory polymer (SMP) matrix, such as a poly(ester urethane) or a crosslinked poly(caprolactone), embedded with micro-resistive heating elements. These SMP elements are thermally actuated (e.g., via localized resistive heating to above glass transition temperature, Tg, and subsequent cooling) to transition from a constrained retracted configuration to a pre-programmed expanded configuration, providing precise anatomical conformity. The energy delivery elements are substituted with flexible, liquid metal electrodes (e.g., eutectic gallium-indium alloy encapsulated within a thin, biocompatible polymer membrane) integrated directly onto the SMP struts. This liquid metal offers superior conformability to irregular tissue surfaces and maintains excellent electrical conductivity even with significant deformation. The outer sheath incorporates a low-friction, antimicrobial hydrogel coating for enhanced lubricity during insertion and reduced biofouling.

classDiagram
    class Device {
        +Handle
        +ElongateBody
        +MultiSegmentEndEffector
    }
    class ElongateBody {
        +OuterSheath: Hydrogel-coated polymer
        +Hypotube
    }
    class MultiSegmentEndEffector {
        +FirstSegment: SMP Actuators
        +SecondSegment: SMP Actuators
        +LiquidMetalElectrodes
        +MicroResistiveHeatingElements
    }
    Device "1" -- "1" Handle
    Device "1" -- "1" ElongateBody
    Device "1" -- "1" MultiSegmentEndEffector
    ElongateBody "1" -- "1" OuterSheath
    ElongateBody "1" -- "1" Hypotube
    MultiSegmentEndEffector "1" -- "*" LiquidMetalElectrodes
    MultiSegmentEndEffector "1" -- "*" MicroResistiveHeatingElements

Derivative 10.2: Operational Parameter Expansion - Micro-Scale End Effector for Sub-Millimeter Targeting with Variable Rigidity Actuation

Enabling Description: The therapeutic device features an elongate body and a multi-segment end effector miniaturized to operate at a micro-scale, with a deployed diameter of the end effector segments ranging from 0.5 mm to 2.0 mm. This enables sub-millimeter precision targeting of individual neural fascicles within the palatine bone microforamina (e.g., 100-500 µm diameter). The flexible support elements are composed of a series of electro-active polymer (EAP) micro-actuators that allow for continuous and variable rigidity adjustment from a highly flexible (e.g., 0.1 N/m bending stiffness) retracted state to a rigid (e.g., 10 N/m bending stiffness) deployed state, conforming precisely to intricate micro-anatomical structures. The energy delivery elements are arrays of platinum-iridium micro-electrodes (e.g., 50 µm tip diameter, 200 µm spacing), capable of bipolar RF energy delivery at frequencies up to 10 MHz with a spatial resolution of 100 µm. The hypotube includes integrated micro-channels for localized fluid irrigation (e.g., saline) to maintain stable tissue impedance during high-frequency energy delivery.

graph TD
    A[Micro-Device (0.5-2.0mm Ø)] --> B{Elongate Body}
    B --> C[Outer Sheath]
    B --> D[Hypotube with Micro-Channels]
    A --> E{Multi-Segment End Effector}
    E --> F[EAP Micro-Actuators]
    F --> G[Variable Rigidity Control]
    E --> H[Pt-Ir Micro-Electrode Array (50µm tips)]
    H --> I[Bipolar RF (10MHz, 100µm resolution)]
    E --> J[Sub-millimeter Target (e.g., Neural Fascicles)]
    D --> K[Local Fluid Irrigation]

Derivative 10.3: Cross-Domain Application - Autonomous Subterranean Exploration Probe

Enabling Description: The therapeutic device is re-envisioned as an autonomous subterranean exploration probe for geological or planetary applications. The handle is replaced by an on-board control module and power source. The elongate body, constructed from high-strength, corrosion-resistant titanium alloy, functions as a primary drilling/insertion shaft. The outer sheath incorporates hardened, abrasion-resistant ceramic segments. The retractable and expandable multi-segment end effector is designed to deploy within subterranean voids or fissures. The first segment deploys to anchor around irregular rock formations (analogous to the middle turbinate) using grippers with tactile sensors, providing stability. The second segment, equipped with a plurality of geophysical sensors (e.g., seismic, electromagnetic, radiometric sensors) and micro-drills for sample collection, expands to contact the surrounding cavern walls for in-situ analysis (analogous to posterior tissue contact). The deployment mechanism is designed for extreme temperature variations (e.g., -100°C to +300°C) and high pressures (e.g., up to 100 MPa).

graph TD
    A[Autonomous Subterranean Probe] --> B(On-Board Control Module)
    B --> C[Power Source]
    A --> D{Elongate Drilling Shaft (Titanium Alloy)}
    D --> E[Outer Sheath (Ceramic Segments)]
    D --> F[Hypotube with Data/Power Conduits]
    A --> G{Multi-Segment End Effector}
    G --> H[First Segment (Rock Grippers, Tactile Sensors)]
    G --> I[Second Segment (Geophysical Sensors, Micro-Drills)]
    H --> J[Anchor to Rock Formations]
    I --> K[Contact Cavern Walls for Analysis]
    G --> L[Extreme Environment Operation]

Derivative 10.4: Integration with Emerging Tech - Haptic Feedback & Augmented Reality Guided Device with Self-Optimizing Conformation

Enabling Description: The therapeutic device incorporates advanced haptic feedback mechanisms within the handle, providing real-time tactile sensations to the operator regarding tissue contact, pressure, and impedance changes detected by IoT sensors on the end effector. An augmented reality (AR) display, projected onto the operator's field of view (e.g., via smart glasses), overlays a 3D reconstruction of the patient's nasal anatomy, including a dynamic rendering of the end effector's position, deployment status, and real-time tissue interaction, based on pre-operative imaging and intra-operative optical coherence tomography (OCT) data. The multi-segment end effector integrates a self-optimizing conformation algorithm driven by an embedded AI module. This AI analyzes the OCT data and haptic feedback to automatically adjust the deployment and contouring of the flexible support elements to achieve optimal, sub-millimeter anatomical fit and electrode-tissue contact, independent of operator dexterity. The system automatically records and verifies optimal treatment geometry and energy delivery parameters onto a secure, distributed ledger.

sequenceDiagram
    participant O as Operator
    participant H as Handle (Haptic)
    participant AR as AR Display (Smart Glasses)
    participant D as Device (IoT, AI)
    participant T as Tissue
    participant B as Blockchain Ledger

    O->D: Advance Device
    D->T: Contact Tissue
    T->D: Impedance/Pressure (IoT Sensors)
    D->H: Haptic Feedback
    D->AR: Real-time 3D Anatomy (OCT)
    D->D: AI Self-Optimizing Conformation
    D->D: Adjust Segment Deployment
    AR->O: Visual Guidance
    H->O: Tactile Feedback
    D->B: Log Optimal Geometry & Parameters
    O->D: Deliver Energy
    D->B: Log Treatment Event

Derivative 10.5: The "Inverse" or Failure Mode - Bio-Resorbable Segment Deployment with Diagnostic Fallback

Enabling Description: The device's multi-segment end effector features flexible support elements and energy delivery elements constructed from bio-resorbable polymers (e.g., poly-lactic-co-glycolic acid (PLGA)) and dissolvable metallic conductors (e.g., magnesium alloys). In a critical failure mode (e.g., severe over-current detected, uncontrolled temperature excursion, or structural integrity compromise of the hypotube), the device initiates a "bio-resorbable segment release" protocol. A controlled, localized release of a chemical agent (e.g., enzymatic solution) or mild thermal pulse is applied to the connection points, causing the end effector segments to safely detach and begin a programmed dissolution process within the nasal cavity, minimizing permanent foreign body presence. Simultaneously, the device enters a "diagnostic fallback mode" where the remaining elongate body, equipped with an integrated fiber-optic camera and saline irrigation port, provides visual and flush capabilities for post-failure assessment, without any energy delivery capabilities. This ensures patient safety by eliminating the potential for embedded problematic components and facilitating visual inspection.

graph TD
    A[Therapeutic Device] --> B{Multi-Segment End Effector (Bio-Resorbable)}
    B --> C[Flexible Support Elements (PLGA)]
    B --> D[Energy Delivery Elements (Mg Alloy)]
    A --> E{Elongate Body}
    E --> F[Handle]
    F --> G[Control Unit]
    G -- Critical Failure Detected --> H[Initiate Bio-Resorbable Release]
    H --> I[Chemical/Thermal Release Protocol]
    I --> J[Segments Detach & Dissolve]
    H --> K[Enter Diagnostic Fallback Mode]
    K --> L[Fiber-Optic Camera (Elongate Body)]
    K --> M[Saline Irrigation Port]
    J & L & M --> N[Safe Failure & Post-Failure Assessment]

Independent Claim 15 Analysis and Derivative Variations

Claim 15: A therapeutic device comprising: a handle; an elongate body extending from the handle, the elongate body comprising a plurality of energy delivery elements provided along a length thereof configured to deliver energy to a first target site within a nasal cavity of a patient; and a retractable and expandable multi-segment end effector operably associated with the elongate body, the end effector comprising a plurality of energy delivery elements configured to deliver energy to a second target site within the nasal cavity, wherein the second target site is separate and remote from the first target site, and wherein the end effector is configured to transition from a retracted configuration to an expanded configuration for positioning the plurality of energy delivery elements of the end effector at the second target site.

Derivative 15.1: Material & Component Substitution - Independent Electromagnetic & Optical Fiber Energy Delivery

Enabling Description: The therapeutic device utilizes an elongate body with integrated arrays of electromagnetic (EM) emitters (e.g., miniaturized microwave antennae operating at 2.45 GHz or 5.8 GHz) for delivering volumetric thermal energy to the first target site (e.g., inferior turbinate for engorgement reduction). The multi-segment end effector, instead of traditional electrodes, is equipped with flexible optical fiber bundles (e.g., 200 µm core diameter silica fibers) coupled to a high-power laser source (e.g., Nd:YAG or diode laser, 1064nm wavelength). These optical fibers deliver precisely focused laser energy for highly localized thermal ablation or photomodulation of neural structures at the second, remote target site (e.g., palatine bone microforamina). Each energy delivery system (EM and laser) operates independently with dedicated power sources and cooling circuits within the handle. The outer sheath of the elongate body is constructed from a ceramic-polymer composite with integrated liquid cooling channels for EM emitter temperature regulation.

graph TD
    A[Therapeutic Device] --> B(Handle)
    B --> C[EM Power Source]
    B --> D[Laser Power Source]
    B --> E[Cooling System]
    A --> F{Elongate Body}
    F --> G[EM Emitter Array (2.45GHz/5.8GHz)]
    G --> H[Ceramic-Polymer Outer Sheath]
    H --> I[Liquid Cooling Channels]
    A --> J{Multi-Segment End Effector}
    J --> K[Flexible Optical Fiber Bundles]
    K --> L[High-Power Laser Delivery]
    F --> M[First Target Site (Volumetric Thermal)]
    J --> N[Second Target Site (Localized Photoablation)]

Derivative 15.2: Operational Parameter Expansion - Differential Frequency Co-Ablation with Adaptive Pulse Sequencing

Enabling Description: The device delivers energy to the first target site (elongate body electrodes) using a low-frequency RF current (e.g., 40 kHz, 20-50W) optimized for bulk tissue heating and reduction of engorgement. Concurrently or sequentially, the multi-segment end effector's electrodes deliver high-frequency pulsed RF (e.g., 500 kHz to 1 MHz, 5-15W peak power, 10-50 µs pulse duration) to the second target site, specifically tailored for selective neural ablation. The system employs adaptive pulse sequencing, where the timing and duration of energy pulses from each set of electrodes are dynamically adjusted based on real-time tissue impedance changes, temperature gradients (from integrated thermistors), and neural activity monitoring (e.g., electromyography from accessory sensing electrodes). This allows for a synchronized "co-ablation" effect, where the bulk reduction of engorgement primes the tissue for more efficient and localized neural modulation, or vice-versa, depending on the desired therapeutic pathway.

sequenceDiagram
    participant G as Energy Generator
    participant EB as Elongate Body (Low-Freq RF)
    participant EFE as End Effector (High-Freq Pulsed RF)
    participant T1 as Target Site 1 (Engorgement)
    participant T2 as Target Site 2 (Neural)
    participant S as Sensors (Impedance, Temp, EMG)
    participant C as Controller

    C->G: Initialize Co-Ablation Protocol
    G->EB: Deliver 40kHz RF
    EB->T1: Bulk Heating
    G->EFE: Deliver 500kHz Pulsed RF
    EFE->T2: Selective Neural Ablation
    T1->S: Impedance/Temp Feedback
    T2->S: Impedance/Temp/EMG Feedback
    S->C: Real-time Data Stream
    C->C: Adaptive Pulse Sequencing Algorithm
    alt Adjust EB Parameters
        C->G: Modulate 40kHz Power/Duration
    else Adjust EFE Parameters
        C->G: Modulate 500kHz Power/Pulse Duration
    end
    Note right of C: Optimize for T1 reduction & T2 modulation
    C->G: Terminate Protocol

Derivative 15.3: Cross-Domain Application - Robotic Multi-Zone Industrial Surface Treatment System

Enabling Description: This device translates to a robotic multi-zone industrial surface treatment system. The handle becomes a robotic arm manipulator. The elongate body is a robotic tool arm equipped with a linear array of directed energy deposition heads (e.g., micro-plasma torches or focused laser deposition nozzles). These heads are configured to deliver material (e.g., corrosion-resistant coatings, wear-resistant layers) or localized thermal treatment (e.g., surface hardening) to a first target zone on a large industrial component (e.g., a turbine blade or pipeline section). A retractable and expandable multi-segment end effector, deployed from the main tool arm, comprises a plurality of non-contact inspection sensors (e.g., ultrasonic transducers, eddy current probes, hyperspectral cameras). These sensors expand to conform to complex geometries of a second, remote target zone on the component, performing real-time defect detection, material thickness measurement, or compositional analysis. The simultaneous operation of deposition/treatment and inspection significantly enhances manufacturing efficiency and quality control.

graph TD
    A[Robotic System] --> B(Robotic Arm Manipulator)
    B --> C{Elongate Tool Arm}
    C --> D[Linear Array of Directed Energy Deposition Heads]
    D --> E[First Target Zone (Surface Treatment)]
    C --> F{Retractable Multi-Segment End Effector}
    F --> G[Non-Contact Inspection Sensor Array]
    G --> H[Second Target Zone (Quality Control)]
    E & H --> I[Simultaneous Operation]
    I --> J[Enhanced Manufacturing Efficiency]

Derivative 15.4: Integration with Emerging Tech - AI-Driven Predictive Maintenance Drone with IoT Sensor Array & Blockchain Authenticated Records

Enabling Description: The therapeutic device is adapted into an autonomous drone system for predictive maintenance in large-scale infrastructure (e.g., wind turbines, bridges, solar farms). The handle and elongate body are replaced by a drone platform with a multi-jointed robotic arm. The robotic arm incorporates an array of non-destructive testing (NDT) IoT sensors (e.g., thermal cameras, LiDAR scanners, acoustic sensors) that constitute the "plurality of energy delivery elements" (re-purposed for emitting diagnostic signals) along its length, configured to scan and deliver diagnostic energy (e.g., pulsed infrared, ultrasonic waves) to a first target site for structural integrity assessment (e.g., detecting cracks, delamination). A retractable and expandable multi-segment end effector, deployed from the robotic arm, is equipped with a complementary array of specialized IoT environmental sensors (e.g., gas detectors, particulate counters, humidity/temperature sensors) that expand to conform and sample from a second, remote target site (e.g., confined spaces, exhaust vents). An onboard AI analyzes the combined NDT and environmental data to predict potential failures, and all sensor readings, AI analysis, and maintenance recommendations are timestamped and immutably recorded on a public blockchain, ensuring data integrity for regulatory audits and operational history.

graph TD
    A[Autonomous Drone] --> B(Robotic Arm)
    B --> C[NDT IoT Sensor Array]
    C --> D[First Target Site (Structural Integrity)]
    B --> E{Multi-Segment End Effector}
    E --> F[IoT Environmental Sensor Array]
    F --> G[Second Target Site (Environmental Sampling)]
    C & F --> H(Onboard AI)
    H --> I[Predictive Maintenance Analysis]
    H --> J[Blockchain Record (Sensor Data, AI Analysis, Recs)]
    J --> K[Auditable Operational History]

Derivative 15.5: The "Inverse" or Failure Mode - Diagnostic Scan & Limited Functionality Mode with Prioritized Emergency Irrigation

Enabling Description: The therapeutic device incorporates a "diagnostic scan mode" as its primary default operation, where both the elongate body and multi-segment end effector's energy delivery elements function only as low-power impedance and temperature sensors, coupled with an integrated optical coherence tomography (OCT) scanner in the end effector. No therapeutic energy is delivered until explicit operator command and confirmation of all safety parameters. In the event of detected tissue overheating at the first target site (elongate body) or potential perforation at the second target site (end effector), the system automatically aborts energy delivery and initiates a "limited functionality mode." This mode prioritizes activation of an emergency irrigation system, delivering chilled, sterile saline via the hypotube lumen to the affected area(s). Simultaneously, the end effector automatically retracts to a semi-deployed "safety profile," minimizing contact forces, while the OCT scanner remains active to provide real-time visualization of the tissue for damage assessment. All non-essential electronic components are de-energized to conserve power for irrigation and imaging.

stateDiagram
    [*] --> Off
    Off --> DiagnosticScan: Power On
    DiagnosticScan --> SafetyCheck: Low-Power Sensing, OCT Scan
    SafetyCheck --> ReadyForTreatment: All Clear
    ReadyForTreatment --> FullTreatment: Operator Command
    FullTreatment --> TissueOverheating: Overheat Detected (T1)
    FullTreatment --> PerforationRisk: Perforation Detected (T2)
    TissueOverheating --> LimitedFunctionality: Abort Energy, Prioritize Irrigation
    PerforationRisk --> LimitedFunctionality: Abort Energy, Prioritize Irrigation
    LimitedFunctionality --> EndEffectorRetract: Safety Profile
    LimitedFunctionality --> OCTActive: Damage Assessment
    LimitedFunctionality --> NonEssentialOff: Power Conservation
    LimitedFunctionality --> OperatorIntervention: Alert Operator
    ReadyForTreatment --> Off: Power Off
    LimitedFunctionality --> Off: System Reset/Off

Independent Claim 19 Analysis and Derivative Variations

Claim 19: 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: advancing a treatment device into the sino-nasal cavity of the patient, the treatment device comprising an elongate body extending from a handle and a retractable and expandable end effector operably associated with the elongate body; delivering energy from one or more electrodes of the elongate body to tissue associated with an inferior turbinate within the sino-nasal cavity of the patient at a level sufficient to reduce engorgement of tissue associated therewith to thereby increase volumetric flow through a nasal passage of the patient and improve a patient's ability to breathe; and delivering energy from one or more electrodes of the end effector to one or more target sites associated with postganglionic parasympathetic nerves innervating nasal mucosa at microforamina of a palatine bone of the patient at a level sufficient to therapeutically modulate the postganglionic parasympathetic nerves, to thereby reduce or eliminate one or more symptoms associated with at least one of rhinitis, congestion, and rhinorrhea to improve nasal breathability of the patient and improve a patient's sleep.

Derivative 19.1: Material & Component Substitution - Sequential Cryo-Thermal Ablation

Enabling Description: The method for improving patient sleep utilizes a treatment device where the elongate body's electrodes are replaced by a series of miniaturized Peltier effect thermoelectric cooling elements integrated into the outer sheath. These elements deliver localized cryo-ablation (e.g., -20°C to -40°C) to the inferior turbinate tissue, causing ice crystal formation and cellular necrosis to reduce engorgement. Subsequently, or concurrently in adjacent regions, the end effector's electrodes are substituted with miniature focused microwave antennas (e.g., 915 MHz or 2.45 GHz, 5-10W output) that deliver thermal energy (e.g., >60°C) to the microforamina of the palatine bone for precise thermal coagulation of postganglionic parasympathetic nerves. The cooling elements and microwave antennas are driven by independent power supplies and controlled by a console that allows for fine-tuning of temperature profiles and microwave power, ensuring effective sequential or parallel energy delivery for both engorgement reduction and neural modulation.

flowchart TD
    A[Start Method] --> B{Advance Device (Cryo-Thermo)}
    B --> C{Activate Peltier Elements on Elongate Body}
    C --> D[Cryo-Ablate Inferior Turbinate (-20°C)]
    D --> E[Reduce Engorgement & Increase Airflow]
    B --> F{Deploy End Effector}
    F --> G{Activate Microwave Antennas on End Effector}
    G --> H[Microwave Ablate Palatine Bone Nerves (>60°C)]
    H --> I[Modulate Parasympathetic Nerves]
    E & I --> J[Improve Nasal Breathability & Sleep]
    J --> K[End Method]

Derivative 19.2: Operational Parameter Expansion - Multi-Frequency Adaptive Neuromodulation with Depth Control

Enabling Description: The method employs a treatment device capable of multi-frequency adaptive neuromodulation with real-time depth control. For the inferior turbinate, the elongate body's electrodes deliver RF energy at two distinct low frequencies (e.g., 20 kHz and 100 kHz) with variable duty cycles (e.g., 10-50%) to achieve differential heating depths—superficial heating for mucosal edema reduction and deeper heating for sub-mucosal engorgement. The pulse sequence and frequency are dynamically adjusted based on real-time impedance measurements and thermography from integrated infrared sensors. For the palatine bone microforamina, the end effector's electrodes deliver highly focused, high-frequency pulsed RF energy (e.g., 480 kHz with a 100 µs pulse duration at 10 Hz repetition rate) to precisely ablate neural fibers while sparing surrounding bone tissue. The system utilizes a closed-loop feedback control where a micro-ultrasound transducer array on the end effector provides real-time tissue depth imaging (e.g., 100 µm resolution) to ensure the RF energy's thermal lesion is confined to the targeted neural bundles (e.g., 0.5-1.5 mm depth) without affecting deeper structures.

sequenceDiagram
    participant D as Treatment Device
    participant G as RF Generator
    participant C as Controller
    participant EB as Elongate Body (20/100kHz)
    participant EFE as End Effector (480kHz Pulsed)
    participant T_IT as Inferior Turbinate
    participant T_PN as Palatine Nerves
    participant S_EB as EB Sensors (Impedance, IR)
    participant S_EFE as EFE Sensors (Impedance, Micro-US)

    C->D: Initiate Treatment
    C->G: Activate EB Multi-Freq RF
    G->EB: Deliver 20kHz/100kHz RF (Variable Duty Cycle)
    EB->T_IT: Reduce Engorgement (Superficial & Deep)
    T_IT->S_EB: Impedance, IR Feedback
    C->G: Activate EFE Pulsed RF
    G->EFE: Deliver 480kHz Pulsed RF
    EFE->T_PN: Modulate Nerves (0.5-1.5mm depth)
    T_PN->S_EFE: Impedance, Micro-US Feedback
    S_EB->C: Data Stream
    S_EFE->C: Data Stream
    C->C: Adaptive Frequency/Pulse/Depth Algorithm
    alt Adjust EB Treatment
        C->G: Modulate 20kHz/100kHz parameters
    else Adjust EFE Treatment
        C->G: Modulate 480kHz parameters
    end
    C->D: Terminate Treatment

Derivative 19.3: Cross-Domain Application - Multi-Target Biofuel Crop Optimization

Enabling Description: The method is adapted for biofuel crop optimization to improve plant growth and resource allocation. A robotic agricultural system advances a treatment device into the soil around a plant. The "elongate body" is a soil probe with electrochemical electrodes that deliver pulsed electrical stimulation (e.g., 1-5V, 100Hz) to the root system (first target site), encouraging nutrient uptake and root hair growth, analogous to reducing engorgement to improve flow. Simultaneously, a retractable and expandable "end effector" deploys micro-laser emitters (e.g., low-power green laser, 532nm) into specific leaf stomata (second target site, remote from roots). These micro-lasers therapeutically modulate guard cell activity, optimizing CO2 uptake and water retention, analogous to modulating parasympathetic nerves. This dual-action approach enhances photosynthetic efficiency and overall biomass yield, improving biofuel production.

flowchart TD
    A[Robotic Ag System] --> B{Advance Soil Probe}
    B --> C[Electrochemical Electrodes (Probe)]
    C --> D[Stimulate Root System (1-5V, 100Hz)]
    D --> E[Enhance Nutrient Uptake & Root Growth]
    B --> F{Deploy Micro-Laser End Effector}
    F --> G[Micro-Laser Emitters (End Effector)]
    G --> H[Modulate Leaf Stomata (532nm Laser)]
    H --> I[Optimize CO2 Uptake & Water Retention]
    E & I --> J[Increase Photosynthetic Efficiency & Biomass Yield]
    J --> K[Biofuel Crop Optimization]

Derivative 19.4: Integration with Emerging Tech - Personalized AI-Driven Therapy with Biometric Feedback and Decentralized Health Records

Enabling Description: The method integrates an AI-driven personalized therapy engine. Prior to treatment, the patient undergoes a comprehensive biometric and genetic analysis, which, combined with historical treatment data, informs the AI. The AI then generates a patient-specific treatment protocol, dynamically adjusting energy delivery parameters (e.g., RF power, pulse width, temperature limits) for both the elongate body and the end effector in real-time. During the procedure, the treatment device's integrated IoT sensors (e.g., continuous glucose monitor, heart rate variability, skin conductance sensors on the patient) stream physiological data directly to the AI. This biometric feedback allows the AI to fine-tune energy delivery to optimize the reduction of inferior turbinate engorgement and the neuromodulation of palatine bone nerves, maximizing individual therapeutic response and sleep improvement. All aspects of the personalized protocol, real-time biometric data, and treatment outcomes are immutably recorded on a decentralized health record (DHR) system, leveraging blockchain technology for enhanced patient data security, interoperability, and privacy.

graph TD
    A[Patient Biometric & Genetic Data] --> B(AI Personalized Therapy Engine)
    B --> C{Patient-Specific Treatment Protocol}
    C --> D[Treatment Device (IoT Sensors)]
    D --> E[Deliver EB Energy (Inferior Turbinate)]
    D --> F[Deliver EFE Energy (Palatine Nerves)]
    E & F --> G[IoT Biometric Sensors (Patient)]
    G -- Real-time Feedback --> B
    B --> H[Dynamic Adjustment of Energy Parameters]
    H --> E
    H --> F
    E & F & G & H --> I[Decentralized Health Record (Blockchain)]
    I --> J[Secure & Interoperable Patient Data]
    J --> K[Improved Sleep & Symptoms]

Derivative 19.5: The "Inverse" or Failure Mode - Adaptive Safety Shutdown with Reversible Diagnostic Micro-Ablation

Enabling Description: The method incorporates an "adaptive safety shutdown" protocol. During energy delivery to the inferior turbinate via the elongate body, if continuous impedance monitoring detects a sudden, rapid drop or spike (indicative of potential tissue perforation or critical thermal runaway), the system immediately halts energy delivery to that zone and activates an audible/visual alert. Concurrently, the end effector's electrodes transition into a "reversible diagnostic micro-ablation" mode. Instead of full therapeutic power, they deliver extremely brief, low-energy micro-pulses (e.g., 10 J/cm², 100 µs pulse) to the palatine bone microforamina, designed to cause temporary, non-permanent neural stunning or hyperpolarization rather than irreversible ablation. This allows for a "test" of the neural pathway response and confirms correct positioning without lasting damage, enabling the operator to verify targeting while other safety protocols are addressed. If any critical component failure (e.g., power supply, control circuit) is detected, the entire system defaults to a zero-energy state, retracts the end effector, and initiates a remote diagnostic logging function while providing only basic visual feedback via the GUI, without any therapeutic function.

stateDiagram
    [*] --> Init
    Init --> AdvanceDevice: Insert
    AdvanceDevice --> EB_Treatment: Apply Energy to Inferior Turbinate
    EB_Treatment --> CheckImpedance: Monitor Impedance
    CheckImpedance --> CriticalImpedanceAnomaly: Drop/Spike Detected
    CriticalImpedanceAnomaly --> AdaptiveSafetyShutdown: Halt EB Energy, Alert
    AdaptiveSafetyShutdown --> EFE_DiagnosticMicroAblation: Activate Reversible Micro-Pulses
    EFE_DiagnosticMicroAblation --> VerifyTargeting: Observe Neural Response
    VerifyTargeting --> OperatorDecision: Manual Override/Adjust
    EB_Treatment --> EFE_Treatment: EB Complete, Proceed to EFE
    EFE_Treatment --> Complete: Therapy Done
    CriticalImpedanceAnomaly --> RemoteDiagnosticLog: Critical Component Failure
    EFE_DiagnosticMicroAblation --> RemoteDiagnosticLog: Critical Component Failure
    RemoteDiagnosticLog --> ZeroEnergyState: System Safe Mode
    ZeroEnergyState --> [*]

Combination Prior Art Scenarios

Here are three combination prior art scenarios where US Patent 12096974 could be combined with existing open-source standards to render future incremental improvements obvious.

US Patent 12096974 + DICOM Standard (Digital Imaging and Communications in Medicine):
- Scenario: A therapeutic device (US12096974, Claims 10, 15) capable of delivering energy to the sino-nasal cavity is combined with the DICOM standard for medical image management.
- Disclosure: A system wherein pre-operative patient 3D anatomical imaging data (e.g., CT, MRI) is acquired and stored in a DICOM-compliant format. This DICOM data is then seamlessly integrated into the neuromodulation console (console 104, controller 107) of the US12096974 device. The console's graphical user interface (GUI 112) is capable of displaying real-time visual guidance, aligning the patient's anatomical DICOM data with the physical positioning and deployment of the device's elongate body and multi-segment end effector within the nasal cavity. This allows for precise, image-guided navigation and targeting of neural structures (e.g., microforamina of the palatine bone) and mucosal engorgement elements (e.g., inferior turbinate). The treatment plan, including target coordinates and energy delivery parameters, can be pre-programmed based on the DICOM data and executed under continuous visual correlation. Post-procedure, a new DICOM study (e.g., follow-up imaging) can be used to assess the efficacy and safety of the treatment in relation to the initial plan.
- Obviousness Argument: It would be obvious to a person skilled in the art of medical device design and clinical practice to integrate a therapeutic neuromodulation device, especially one requiring precise anatomical targeting, with a widely accepted medical imaging standard like DICOM to enhance visualization, planning, and real-time guidance, thereby improving accuracy and safety.
US Patent 12096974 + MQTT Protocol (Message Queuing Telemetry Transport):
- Scenario: The therapeutic device (US12096974, Claims 10, 15) with its embedded sensors (e.g., temperature, impedance, nerve monitoring system 108) is combined with the lightweight MQTT protocol for real-time data communication.
- Disclosure: The US12096974 device's internal sensors (e.g., electrodes 136, 137, temperature sensors, impedance sensors) continuously generate data streams. This sensor data, along with device status (e.g., end effector deployed/retracted, energy delivery active/inactive) and control commands from the handle (first mechanism 126, second mechanism 128), is transmitted wirelessly using the MQTT protocol. A dedicated MQTT broker (potentially integrated into the console 104 or a separate edge computing device) receives these messages, allowing for low-latency, real-time monitoring and control of the procedure from a remote workstation or an augmented reality display. This also enables secure publication of critical alerts (e.g., threshold exceedances, fault conditions) to subscribed clients, facilitating multi-operator supervision or integration with hospital information systems. All data transmitted via MQTT can be subsequently archived in a secure, timestamped database for post-procedure analysis and regulatory compliance.
- Obviousness Argument: For a medical device operating in a sensitive anatomical region and requiring continuous feedback and control, it would be obvious to leverage a robust, lightweight, and low-latency messaging protocol like MQTT for efficient, secure, and real-time data exchange between the handheld device, its console, and other monitoring/control systems. This improves operational awareness and enables more sophisticated remote monitoring capabilities.
US Patent 12096974 + OpenSSL Library (Secure Communications Protocol):
- Scenario: The communication between the handheld device and the console (cable 120, or wireless connection as mentioned) in US12096974 (Claims 1, 10, 15, 19) is secured using cryptographic protocols provided by the OpenSSL library.
- Disclosure: All data transmission between the neuromodulation device 102 (handheld) and the neuromodulation console 104, whether wired or wireless, is encrypted and authenticated using Transport Layer Security (TLS) or Datagram Transport Layer Security (DTLS) protocols, implemented via the OpenSSL cryptographic library. This includes sensor data (temperature, impedance, nerve activity), control commands (energy activation, end effector deployment), and feedback algorithms (evaluation/feedback algorithms 110). Certificates are utilized to authenticate both the device and the console, preventing unauthorized access or tampering with the medical procedure. This ensures the integrity and confidentiality of patient data and treatment parameters throughout the procedure, especially critical in networked hospital environments or for future telehealth applications involving remote monitoring.
- Obviousness Argument: Given the sensitive nature of medical data and the criticality of medical device operations, it would be obvious to any person skilled in the art of secure system design to implement industry-standard cryptographic libraries like OpenSSL to establish secure, authenticated, and encrypted communication channels between a medical device and its control console. This protects patient privacy, device integrity, and prevents malicious interference during a therapeutic procedure.

The information for the analysis was exclusively derived from the provided patent text for US12096974B1 (https://patents.google.com/patent/US12096974/en) and the previous sections of this patent analysis.## Defensive Disclosure for US Patent 12096974