Therapy Efficacy Assessment via Non-Invasive Tissue Molecular Changes

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Solution Overview

Problem

Determining the efficacy of therapeutic agents is challenging due to limited pharmacokinetic and pharmacodynamic information, and conventional methods struggle with identifying optimal treatment protocols and dosing intervals, especially for different therapeutic agents and formulations.

Innovation Solution

A non-invasive biological tissue characterization technique, such as X-ray diffraction, is used to measure and analyze changes in molecular structures of biological tissues over time to determine therapeutic agent efficacy, allowing for precision medicine approaches tailored to individual patient characteristics.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If conventional therapeutic drug monitoring methods are used to determine drug efficacy, then pharmacokinetic and pharmacodynamic information can be obtained, but the information is limited and cannot accurately identify optimal treatment protocols and dosing intervals

Engineering Contradiction:
Improvetherapeutic efficacy assessment accuracyVSAvoidpharmacokinetic and pharmacodynamic information
Core Design Contradiction:
Measurement precisionVSLoss of information

Solution Approach 1:

The patent introduces Raman spectroscopy as an intermediary technique to indirectly assess therapeutic efficacy by monitoring molecular vibrations and chemical bonds in biological tissues. This mediator provides detailed molecular information without requiring invasive sampling, thereby improving measurement precision while minimizing information loss.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent replaces conventional mechanical/invasive methods (blood sampling, tissue biopsies) with optical-based Raman spectroscopy. This substitution eliminates the need for physical intrusion while providing rich molecular information, thus improving both measurement accuracy and information retention.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

2Loss of information

If invasive methods are used to obtain detailed pharmacokinetic and pharmacodynamic information, then more comprehensive data can be collected, but patient comfort and safety are compromised

Engineering Contradiction:
Improvepharmacokinetic and pharmacodynamic informationVSAvoidpatient discomfort and safety risks
Core Design Contradiction:
Loss of informationVSObject-affected harmful factors

Solution Approach 1:

The patent substitutes invasive mechanical sampling methods with non-invasive optical Raman spectroscopy. The technique uses laser excitation to induce molecular vibrations that can be detected externally, providing comprehensive pharmacokinetic and pharmacodynamic information without penetrating the patient's body, thus eliminating discomfort and safety risks.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

Raman spectroscopy acts as an intermediary that bridges the gap between non-invasive measurement and comprehensive molecular information acquisition. By detecting scattered light from tissue molecules, it provides detailed pharmacokinetic and pharmacodynamic data without requiring blood draws or tissue biopsies.

Inventive Principle:
Principle #24Intermediary (Mediator)

3Measurement precision

If non-invasive biological tissue characterization techniques are used to measure molecular structure changes, then accurate therapeutic efficacy assessment can be achieved, but the technique complexity increases

Engineering Contradiction:
Improvemolecular structure measurement accuracyVSAvoidnon-invasive characterization technique complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent uses Raman spectroscopy to create a molecular 'fingerprint' or spectral copy of the tissue's chemical composition and molecular structure. This spectral copy contains detailed information about molecular vibrations, bond types, and chemical environments, enabling accurate therapeutic efficacy assessment without physically disturbing the tissue.

Inventive Principle:
Principle #26Copying

Solution Approach 2:

The patent monitors changes in Raman spectral parameters (wavenumber, intensity, peak shape) before and after therapy administration. By tracking these parameter changes, the system accurately detects molecular structure modifications in response to treatment, providing precise efficacy assessment despite the complexity of the measurement technique.

Inventive Principle:
Principle #35Parameter changes

Applied Scientific Principles

This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.

Function Achieved in This Case

This method provides accurate and non-invasive assessment of therapeutic efficacy, enabling rational dosing regimens that prevent under-dosing or overdosing, thereby improving treatment outcomes and reducing toxicity.

Implementation Method 1

measuring a molecular structure of a biological tissue of an animal at a first time and at a second time using a non-invasive biological tissue characterization technique

Methodology Applied
Scientific EffectX-ray diffraction: X-Ray

Implementation Method 2

low angle fiber X-ray diffraction techniques, have been used to measure tissue samples in humans

Methodology Applied
Scientific EffectDiffraction: Diffraction

Data Source

PatentUS12599349B2Determining a therapy efficacy
Publication Date: 2026.04.14 AURA DIAGNOSTICS INC
  • US12599349B2 patent drawing
  • US12599349B2 patent drawing
  • US12599349B2 patent drawing

AI summary

The present disclosure relates to determining an efficacy of a therapeutic agent. A method for determining an efficacy of a therapeutic agent for a target disease can include measuring a molecular structure of a biological tissue of an animal at a first time and at a second time using a non-invasive biological tissue characterization technique. The method can further include observing a change of the molecular structure of the biological tissue between the first time and the second time, and determining the efficacy of the therapeutic agent based on the observed change in the molecular structure of the biological tissue. Before the first time, or between the first time and the second time, the animal received the therapeutic agent.