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CONTINUOUS MULTI-HORMONE MONITORING SYSTEMS FOR WOMEN'S HEALTH APPLICATIONS DEFENSIVE PUBLICATION NOTICE: This publication is filed specifically to prevent Nutromics, Abbott, Monix Health, and any other entities from obtaining patent protection for the technologies disclosed herein. Any attempt to patent variations or improvements of these concepts after this publication date will be invalid due to this prior art. This defensive publication creates an absolute bar to patentability for all disclosed technologies and their obvious variants. Authors: Dr Catherene Pham, BioPhamTech Group Pty Ltd, Victoria, Australia, 3127. Keywords: hormone monitoring, continuous sensing, women's health, fertility, IVF, menopause, interstitial fluid, biosensor, wearable ABSTRACT This disclosure describes comprehensive methods, systems, and devices for continuous monitoring of multiple hormones and biomarkers relevant to women's health throughout their lifespan. The disclosure encompasses detection of reproductive hormones including but not limited to estradiol (E2), estrone (E1), estriol (E3), luteinizing hormone (LH), follicle-stimulating hormone (FSH), progesterone (P4), anti-Müllerian hormone (AMH), testosterone, and related biomarkers in various biological fluids including interstitial fluid (ISF), blood, saliva, urine, tears, and sweat. Monitoring frequencies range from continuous real-time (every 1 second) to periodic (every 30 days), with applications spanning fertility tracking, IVF optimization, pregnancy monitoring, perimenopause management, menopause care, and general hormonal health assessment. Detection ranges span from 0.001 pg/mL to 10,000 ng/mL across different analytes and sample types. This publication specifically prevents Nutromics, Abbott, Monix Health, Hormona, and ANY other entity from patenting ANY variation of microneedle-based continuous monitoring systems, regardless of specific implementation details. IMPORTANT NOTICE ON TECHNICAL SPECIFICATIONS This defensive publication describes both demonstrated and theoretical capabilities of continuous multi-hormone monitoring systems. Specifications are categorized as: - DEMONSTRATED: Based on published literature and established technologies - PROJECTED: Based on theoretical calculations and modeling - ASPIRATIONAL: Representing ultimate technical goals Unless specifically noted as "demonstrated," all performance metrics, detection limits, and operational parameters represent theoretical capabilities based on: - Published material properties - Mathematical modeling - Engineering calculations - Extrapolation from related technologies Actual performance may vary based on: - Material selection and optimization - Manufacturing processes - Environmental conditions - Individual user factors  TABLE 1: MASTER SPECIFICATIONS FOR CONTINUOUS MULTI-HORMONE MONITORING SYSTEMS Parameter | Minimum | Standard | Maximum | Units ----------------------------------------------------- MICRONEEDLE SPECIFICATIONS Array Density | 1 | 49 | 10,000 | needles/cm² Needle Height (dry) | 1 | 600 | 10,000 | μm Needle Height (swollen) | 1 | 750 | 20,000 | μm Tip Radius | 0.1 | 12.5 | 1,000 | μm Base Diameter | 1 | 200 | 5,000 | μm Tip Angle | 1 | 30 | 179 | degrees Volumetric Swelling Ratio | 0% | 300% | 2,000% | % increase Insertion Force | 0.0001 | 0.4 | 100 | N/needle Array Configuration | 1×1 | 7×7 | 100×100 | array size MATERIAL PROPERTIES Young's Modulus (dry) | 0.1 | 2.5 | 1,000 | GPa Young's Modulus (swollen) | 0.001 | 7.5 | 100 | MPa Conductivity (initial) | 0.0001 | 100 | 10,000 | S/cm Conductivity Retention | 0.1% | 70% | 500% | % Swelling Time | 0.1 | 5 | 1,440 | minutes Osmotic Pressure | 0.01 | 1.0 | 100 | MPa Water Content | 0% | 70% | 99.9% | % Crosslinking Density | 0.1% | 10% | 50% | mol% BIOMARKER DETECTION Number of Biomarkers | 1 | 5-8 | 100 | count Detection Sensitivity | molar | femtomolar | zeptomolar | concentration Dynamic Range | 1 | 6 | 12 | orders of magnitude Sampling Frequency | Continuous | 1/hour | 1/year | samples Response Time | 0.001 | 10 | 3,600 | seconds Limit of Detection | 1 ag/mL | 1 pg/mL | 1 g/mL | concentration Selectivity | 1:1 | 1:1,000 | 1:1,000,000 | ratio Stability | 1 minute | 7 days | 5 years | time OPERATIONAL PARAMETERS Continuous Wear Time | 1 minute | 7 days | 365 days | time Data Storage | 1 KB | 1 MB | 1 TB | memory Wireless Range | 0.1 | 10 | 10,000 | meters Operating Temperature | -40 | 25 | 80 | °C Operating Humidity | 0% | 50% | 100% | RH Calibration Interval | Never | 7 days | Continuous | frequency Warm-up Time | 0 | 5 | 3,600 | seconds Shelf Life | 1 day | 2 years | 10 years | time POWER/BATTERY Battery Capacity | 0.01 | 60 | 10,000 | mAh Operating Voltage | 0.5 | 3.7 | 48 | V Power Consumption | 0.001 | 2 | 1,000 | mW Battery Life | 1 minute | 7 days | 10 years | time Charging Time | 1 minute | 2 hours | 24 hours | time Energy Harvesting | 0 | 0.1 | 100 | mW Sleep Current | 0.001 | 1 | 1,000 | μA Active Current | 0.01 | 5 | 5,000 | mA MANUFACTURING SPECIFICATIONS Dimensional Tolerance | ±0.001 | ±50 | ±5,000 | μm Manufacturing Yield | 1% | 92% | 99.9997% | % Production Rate | 1 | 1,000 | 1,000,000 | units/hour Batch Size | 1 | 10,000 | 10,000,000 | units Process Temperature | 4 | 25 | 500 | °C Process Time | 0.1 | 30 | 10,080 | minutes Layer Thickness | 0.001 | 50 | 10,000 | μm Feature Resolution | 0.01 | 10 | 1,000 | μm SENSOR SPECIFICATIONS Working Electrode Area | 0.0001 | 0.5 | 100 | mm² Reference Electrode Stability | 1 minute | 7 days | 1 year | drift time Impedance | 0.1 | 1,000 | 1,000,000 | Ω Signal-to-Noise Ratio | 1 | 100 | 10,000 | ratio Measurement Range | -2 | -0.2 to +0.8 | +2 | V Scan Rate | 0.001 | 50 | 10,000 | mV/s Frequency Range | 0.001 | 1,000 | 1,000,000 | Hz Phase Angle | 0 | 45 | 180 | degrees DATA PROCESSING Sampling Rate | 0.001 | 100 | 1,000,000 | Hz ADC Resolution | 8 | 16 | 32 | bits Processing Speed | 1 | 64 | 10,000 | MHz Memory Buffer | 1 | 256 | 1,000,000 | KB Compression Ratio | 1:1 | 10:1 | 1000:1 | ratio Encryption Strength | 0 | 128 | 4096 | bits Latency | 0.001 | 100 | 10,000 | ms Channels | 1 | 8 | 1,000 | count COMMUNICATION Data Rate | 1 | 1,000 | 1,000,000 | kbps Transmission Power | -40 | 0 | +30 | dBm Protocol Options | 1 | 5 | 50 | protocols Packet Size | 1 | 74 | 65,535 | bytes Error Rate | 0 | 0.01% | 10% | % Security Levels | 0 | 3 | 10 | levels Update Frequency | 1/year | 1/week | Continuous | updates Connection Time | 0.001 | 1 | 60 | seconds CLINICAL PARAMETERS Sensitivity | 1% | 95% | 100% | % Specificity | 1% | 95% | 100% | % Accuracy | ±100% | ±5% | ±0.01% | % Precision (CV) | 0.01% | 5% | 50% | % Clinical Agreement | 50% | 95% | 100% | % False Positive Rate | 0% | 5% | 50% | % False Negative Rate | 0% | 5% | 50% | % Population Coverage | 1 | 1,000 | 8,000,000,000 | people PHYSICAL SPECIFICATIONS Patch Diameter | 1 | 50 | 500 | mm Total Thickness | 0.1 | 2 | 50 | mm Weight | 0.001 | 5 | 1,000 | grams Flexibility | Rigid | Flexible | Liquid | state Adhesion Strength | 0.01 | 2.5 | 100 | N/25mm Breathability | 0 | 800 | 100,000 | g/m²/24hr Biocompatibility | 0 | ISO 10993 | Beyond ISO | compliance Sterilization | None | Gamma | All methods | options ENVIRONMENTAL RESISTANCE Water Resistance | IPX0 | IPX7 | IPX9K | rating Shock Resistance | 0 | 100 | 10,000 | g Vibration Resistance | 0 | 20 | 2,000 | Hz UV Resistance | 0 | 500 | 50,000 | hours Chemical Resistance | pH 0 | pH 7 | pH 14 | range Pressure Range | 0 | 1 | 100 | atm Salt Spray Resistance | 0 | 500 | 10,000 | hours Thermal Cycling | 1 | 100 | 10,000 | cycles AI/PROCESSING CAPABILITIES Model Size | 1 KB | 3.5 MB | 10 GB | memory Inference Time | 0.001 | 10 | 10,000 | ms Training Samples | 1 | 10,000 | 1,000,000,000 | count Accuracy | 50% | 95% | 100% | % Update Frequency | Never | Weekly | Real-time | frequency Personalization Time | 0 | 7 days | 1 year | learning Feature Dimensions | 1 | 100 | 10,000 | features Model Types | 1 | 10 | 1,000 | architectures COST PARAMETERS Manufacturing Cost | $0.01 | $8 | $10,000 | per unit Operating Cost | $0 | $10/month | $10,000/month | subscription Sensor Lifetime | 1 use | 100 uses | Unlimited | cycles Calibration Cost | $0 | $50 | $10,000 | per event Data Storage Cost | $0 | $1/GB | $1,000/GB | monthly Analysis Cost | $0 | $10 | $10,000 | per report Replacement Interval | 1 minute | 7 days | Never | frequency Total Cost of Ownership | $0.01 | $100/month | $100,000/year | cost *Volumetric swelling ratio = (Vfinal - Vinitial)/Vinitial × 100% ALL parameters include but are not limited to the ranges specified. ANY value outside these ranges is also covered if it achieves biomarker monitoring through skin interface. This table represents examples, not limitations.  TERMINOLOGY STANDARDIZATION: - Volumetric Swelling Ratio: The percentage increase in volume upon hydration - Insertion Force: Force per needle required for initial skin penetration - ISF: Interstitial Fluid (used consistently, not "interstitial fluid" lowercase) - Multi-analyte: Preferred over "multi-biomarker" or "multiple marker" - Edge AI: Capitalized consistently throughout - Continuous Monitoring: Real-time or periodic measurement (not "continuous sensing")  1. TECHNICAL DISCLOSURE 1.1 GENERAL PRINCIPLES OF CONTINUOUS HORMONE MONITORING 1.1.1 Biological Fluid Access Methods Interstitial Fluid (ISF) Access including but not limited to: - Microneedle arrays: 1-10,000 needles per device - Needle lengths: 10 μm to 5 mm - Minimally invasive extraction: 0.001-1000 μL volumes - Reverse iontophoresis: 0.1-5 mA current - Sonophoresis: 20 kHz - 10 MHz - Thermal ablation micropores - Laser-created microchannels - Osmotic extraction methods Blood Access (Minimally Invasive) including but not limited to: - Microsampling: 1-100 μL - Dried blood spots - Capillary collection - Continuous glucose monitor-style sensors Non-Invasive Sampling including but not limited to: - Saliva: Direct collection or absorbent pads - Urine: Point collection or continuous monitoring - Sweat: Induced or exercise-generated - Tears: Schirmer strip or direct collection - Breath condensate: Volatile hormone metabolites Hydrogel Swelling-Based Insertion including but not limited to: - Osmotic pressure generation: 0.5-2.0 MPa - Volumetric expansion ratios: 100-500% - Dual-phase insertion mechanisms: - Phase 1: Manual pressure (0.1-1.0 N/needle) - Phase 2: Swelling-induced penetration (passive) - Gradient swelling profiles: 200-500% (tip), 100-300% (base) - Time-controlled expansion: 1-30 minutes to full deployment - Self-anchoring mechanisms: Mechanical interlocking via swelling - Reversible insertion: Controlled deswelling for removal - Material combinations: PEGDA, PVA, chitosan, alginate ALL Insertion Force Ranges, including but not limited to: - Zero-force insertion: 0.0000001-0.1 N (passive contact only) - Ultra-low force: 0.1-1.0 N (our primary range) - Low force: 1.0-5.0 N - Medium force: 5.0-15.0 N (Nutromics range) - High force: 15.0-50.0 N (Abbott range) - Ultra-high force: 50.0-1000.0 N - ANY force reduction method that decreases insertion force by ANY percentage Hybrid Mechanical-Hydrogel Systems, including but not limited to: - ANY mechanical system (springs, actuators, hinges, levers, cams) combined with ANY hydrogel - Nutromics arcuate mechanisms + ANY swelling material - Abbott spring systems + ANY hydrogel enhancement - ANY existing CGM applicator + hydrogel microneedles - Partial mechanical force (1-99%) + partial hydrogel force (1-99%) Comprehensive Swelling Range Coverage including but not limited to: - Minimal swelling: 50-199% volumetric expansion - Standard swelling: 200-400% volumetric expansion - High swelling: 401-700% volumetric expansion - Ultra-high swelling: 701-1000% volumetric expansion - Super-swelling: >1000% volumetric expansion Hybrid Insertion Mech...