Why this page exists: Protecting the intellectual property of the KidneScience system is essential before publishing the whitepaper. This page documents the provisional patent application outlining three novel claim areas to secure a Freedom to Operate (FTO) under the USPTO Micro Entity pathway.
How to use this for your Kidney Trial:
Show Johnny the **Filing Metadata** panel. Confirm that you and Lebensfluss e.V. will file as co-inventors under the $320 Micro Entity rate.
Review **Claim Area 1 (NP-1)** which covers the core method of aggregating tongue, voice, iris, and HRV parameters into a ZKP-committed vector.
Examine **Claim Area 2 (NP-2)** detailing the federated ZKP verification and differential privacy synthetic data generation.
Check **Claim Area 3 (NP-3)** outlining the deterministic XAI explanation system with the mandatory regulatory scope firewall.
๐ก Review these claims with your patent counsel or legal advisors prior to formal submission.โก๏ธ Next Step: Science Portal Hub โ
A computer-implemented method for generating a cryptographically verifiable multi-modal holistic biomarker vector, the method comprising:
a) receiving, at a computing device, a plurality of distinct physiological measurement parameters from two or more non-invasive sensor modalities, wherein the sensor modalities comprise at least two of: (i) a visual topography analysis of oral mucosal tissue, (ii) an acoustic frequency analysis of vocal output, (iii) a photoplethysmographic analysis of cardiac inter-beat intervals, and (iv) a visual analysis of iris tissue morphology;
b) aggregating the plurality of physiological measurement parameters into a structured multi-modal holistic vector;
c) computing a cryptographic hash commitment of the multi-modal holistic vector using a one-way hash function prior to any storage or transmission of the vector;
d) inserting the cryptographic hash commitment as a leaf node into a Merkle tree data structure, wherein the Merkle tree generates a root hash providing tamper-evidence for all committed leaf nodes; and
e) storing the Merkle tree root hash in association with a pseudonymous patient identifier, wherein no biometric raw data is stored in association with any network-accessible storage system.
Claim 2: The method of claim 1, wherein the oral mucosal tissue analysis comprises computing a Water Element score by analyzing pixel density distribution in a posterior zone region of a tongue photograph using computer vision algorithms.
Claim 3: The method of claim 1, wherein the acoustic frequency analysis comprises computing a fundamental frequency (F0) using a YIN pitch detection algorithm and computing perturbation metrics including jitter and shimmer.
Claim 4: The method of claim 1, wherein the photoplethysmographic analysis comprises computing SDNN (standard deviation of NN intervals) and a coherence score from a 5-minute inter-beat interval time series.
Claim 5: The method of claim 1, further comprising receiving an explicit digital consent signature from a patient via a EUDI-compliant digital identity wallet prior to any biometric data capture, and committing the consent signature hash as an additional Merkle tree leaf node.
Claim 6 (System): A system comprising one or more processors and memory storing instructions that, when executed, perform the method of claims 1-5.
Known Prior Art (IDS Disclosure)
US10,726,958Systems for collecting and analyzing physiological data (Apple Inc.) โ Distinguishable: no holistic vector aggregation, no ZKP commitment, no wellness-research framing
WO2021/243180Medchain โ Blockchain health data (Chen et al.) โ Distinguishable: uses public blockchain (not ZKP Merkle), no multi-modal holistic instrument aggregation
US9,858,387Patient data anonymization (IBM) โ Distinguishable: k-anonymity approach, not cryptographic ZKP commitment
Novel Over Prior Art
First combination of TCM tongue + iris + voice + HRV in a single structured vector
ZKP Merkle tree commitment at capture time (pre-analysis tamper-evidence) is novel in holistic measurement context
Pseudonymous patient token with no raw biometric remote storage โ unique privacy architecture
EUDI wallet consent hash committed to same Merkle tree as data โ consent-data cryptographic linkage
NP-2
Claim Area 2
Federated ZKP Aggregation with Differential Privacy Synthetic Export
Independent Claim 7 (Method)
A computer-implemented method for privacy-preserving aggregation and synthetic export of multi-modal holistic biomarker vectors across a federated research network, the method comprising:
a) receiving, at an aggregation server, a plurality of ZKP Merkle tree root hashes from a plurality of geographically distributed practitioner nodes, wherein each root hash represents a committed collection of multi-modal holistic biomarker vectors as described in claim 1;
b) verifying the cryptographic integrity of each received root hash against a canonical Merkle verification algorithm without accessing any raw biometric data;
c) computing population-level statistical parameters from the verified vector collections under a differential privacy mechanism, wherein the differential privacy mechanism adds calibrated Laplace noise with privacy budget ฮต โค 1.0;
d) generating a synthetic dataset from the population-level statistical parameters using a generative statistical model, wherein no individual patient vector is recoverable from the synthetic dataset; and
e) publishing the synthetic dataset to an open science repository with the aggregated Merkle root hash as a cryptographic integrity anchor.
Claim 8: The method of claim 7, wherein the differential privacy mechanism uses the Laplace mechanism with sensitivity calibrated to the range of each measurement parameter.
Claim 9: The method of claim 7, further comprising generating a GDPR Art.89 research exemption attestation document linked to the published synthetic dataset.
Novel Over Prior Art
ZKP root hash verification without raw data access is novel in federated health research
Combining Merkle integrity proof with differential privacy synthetic export is a new composition
Open science publication with Merkle anchor for verifiable data provenance is novel
NP-3
Claim Area 3
Deterministic XAI Explanation Report Method for EU AI Act Art.13 Compliance in Wellness Measurement Systems
Independent Claim 10 (Method)
A computer-implemented method for generating a deterministic explainability report for a wellness measurement system that satisfies EU AI Act Art.13 transparency obligations and EU MDR 2017/745 scope definition requirements, the method comprising:
a) for each measurement output of a multi-modal wellness measurement system, computing a deterministic feature contribution vector that maps each input feature to its numerical contribution to the output score using a pre-defined, auditable algorithm with no stochastic elements;
b) generating a machine-readable and human-readable explanation report comprising: (i) the feature contribution vector, (ii) the processing algorithm identifier and version, (iii) a mandatory scope disclaimer statement asserting that the output is a physiological parameter measurement and not a clinical diagnosis, and (iv) the ZKP commitment hash of the underlying raw measurement session;
c) associating the explanation report with the corresponding ZKP Merkle tree leaf node such that the explanation report is cryptographically linked to the original measurement; and
d) making the explanation report accessible to the patient and practitioner via a user interface that prominently displays the scope disclaimer statement before displaying any measurement scores.
Claim 11: The method of claim 10, wherein the scope disclaimer statement is presented in a visually distinct format with higher prominence than any measurement output value.
Claim 12: The method of claim 10, wherein the explanation report includes a session-linked EUDI wallet consent signature hash, creating an auditable chain: consent โ measurement โ explanation.
Novel Over Prior Art
Deterministic (non-stochastic) XAI specifically designed for regulatory scope compliance is novel
Mandatory scope firewall disclaimer as a structural element of XAI output is novel
Cryptographic linkage of explanation to ZKP Merkle leaf is novel