# US 12,112,838 B2 · Production and delivery tracking and sample verification of patient-specific therapeutics

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- Number: US 12,112,838 B2
- Document ID: US12112838B2
- Status: Granted
- Kind: B2
- Application number: 18/523,564
- Filed: 2023-11-29
- Published: 2024-03-21
- Granted: 2024-10-08
- Earliest claimed: 2018-10-15
- Assignees: NantCell, Inc.
- Applicants: NantCell, Inc.
- Inventors: Kayvan Niazi; Nicholas James Witchey
- Web page: https://patentgrep.com/patent/US12112838B2

## CPC

- G16H 10/40: for data related to laboratory analysis, e.g. patient specimen analysis
- G01N 33/58: involving labelled substances (G01N33/53 takes precedence)
- G06F 16/2379: {Updates performed during online database operations; commit processing}
- G06Q 50/04: Manufacturing
- G16H 20/10: relating to drugs or medications, e.g. for ensuring correct administration to patients
- G06Q 2220/00: Business processing using cryptography
- G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
- G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q)
- G06F: ELECTRIC DIGITAL DATA PROCESSING (computer systems based on specific computational models G06N)
- G06Q: INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL OR SUPERVISORY PURPOSES; SYSTEMS OR METHODS SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL OR SUPERVISORY PURPOSES, NOT OTHERWISE PROVIDED FOR

## Abstract

Systems and methods for tracking biological samples are presented. Intrinsic and extrinsic biological sample data and/or intrinsic and extrinsic patient data may be used to label a biological sample obtained at a point-of-care facility, which may be sent to a processing facility, wherein the labeled biological sample undergoes analysis and/or processing into a labeled therapeutic. The labeled therapeutic is delivered back to the point-of-care facility, wherein the labeled therapeutic is tested for the presence of the additives prior to administration to a patient. Multi-factor validation is performed, including validating the identity of the patient to a container, validating the identity of the labeled biological sample/therapeutic to the container, and thus, validating the identity of the labeled therapeutic to the patient. The entire life cycle of a biological sample used to generate a personalized therapeutic is validated, and ensures that mix-ups or errors in administration are reduced or eliminated.

## Claims

### Claim 1

A computer assisted method of authenticating a therapeutic agent at a point of care, thereby validating therapy administration at the point of care, the computer assisted method comprising:
obtaining the biological sample from a patient;
labeling the biological sample with one or more first additives by inserting the one or more first additives into a container comprising the biological sample, wherein the one or more first additives uniquely label the biological sample among a population of biological samples, and wherein the one or more first additives include at least one of a primer, a monoclonal antibody, a rare earth metal, an isotope, or an autologous mitochondria;
obtaining, via at least one processor, first identifying digital data for the biological sample, wherein the identifying digital data is subjected to a sample tracking protocol to produce a sample tracking chain data structure stored in at least one computer memory, wherein the sample tracking chain data structure is indexed and thereby searchable for the first identifying digital data and the one or more first additives;
generating a current state block of the distributed digital ledger by executing a secure hash function on at least the one or more first additives and intrinsic biological data of the biological sample;
providing the labeled biological sample to a manufacturing facility for generation of a labeled patient-specific therapeutic, wherein the labeled therapeutic is subjected to the sample tracking protocol and thereby added, via the at least one processor, to the sample tracking chain data structure;
receiving the labeled therapeutic from the manufacturing facility, wherein the labeled therapeutic is associated with second identifying digital data;
performing an assay on the labeled therapeutic at the point of care, thereby validating the labeled therapeutic for administration to the patient, by detecting the presence of one or more second additives via the assay which uniquely label the therapeutic among a population of therapeutics, wherein the validation is subjected to the sample tracking protocol and thereby added, via the at least one processor, to the sample tracking chain data structure, the validation includes validating a timestamp of a state block of the distributed digital ledger associated with the second identifying digital data, based on an external public ledger, to confirm the state block associated with the second identifying digital data has not been modified or tampered with, and the sample tracking chain data structure is indexed and thereby searchable for the second identifying digital data and the one or more second additives.

### Claim 2 (depends on 1)

The computer assisted method of claim 1, wherein the one or more second additives are selected from the group consisting of isotopes, primers, antigens, dyes, rare earth metals, and monoclonal antibodies.

### Claim 3 (depends on 1)

The computer assisted method of claim 1, wherein the first identifying data comprises extrinsic and/or intrinsic patient data.

### Claim 4 (depends on 3)

The computer assisted method of claim 3, wherein the first identifying data comprises extrinsic and/or intrinsic biological sample data identifying the one or more first additives, and wherein the intrinsic biological sample data is used to validate the biological sample at the manufacturing facility.

### Claim 5 (depends on 1)

The computer assisted method of claim 1, wherein the second additives comprise at least three rare earth metals, at least four rare earth metals, at least five rare earth metals, at least six rare earth metals, at least seven rare earth metals, at least eight rare earth metals, at least nine rare earth metals, or at least ten rare earth metals.

### Claim 6 (depends on 5)

The computer assisted method of claim 5, further comprising validating the labeled therapeutic by detecting the presence of the second additives using mass spectrometry and comparing the detected second additives to a listing of second additives provided in the second identifying data.

### Claim 7 (depends on 1)

The computer assisted method of claim 1, further comprising:
comparing first patient intrinsic information associated with the biological sample with second patient intrinsic information obtained from the patient to which the labeled therapeutic is to be administered, wherein the first and the second patient intrinsic information include one or more of a fingerprint, an iris scan, or an image of the patient; and
validating the labeled therapeutic for administration to the patient when the first patient intrinsic information and the second patient intrinsic information are determined to match.

### Claim 8 (depends on 1)

The computer assisted method of claim 1, wherein the additives include one or more primers.

### Claim 9 (depends on 8)

The computer assisted method of claim 8, further comprising validating the labeled therapeutic by detecting the presence of the second additives by nucleic acid hybridization and comparing the detected second additives to a listing of additives provided in the second identifying data.

### Claim 10 (depends on 1)

The computer assisted method of claim 1, wherein the additives include two or more therapeutically approved monoclonal antibodies.

### Claim 11 (depends on 10)

The computer assisted method of claim 10, wherein:
the assay is an enzyme linked immuno-absorbant assay (ELISA) or a lateral flow assay; and
validating the labeled therapeutic includes detecting the presence of the second additives by the ELISA or the lateral flow assay and comparing the detected second additives to a listing of additives provided in the second identifying data.

### Claim 12 (depends on 11)

The computer assisted method of claim 11, wherein the lateral flow assay comprises a first band of gold-conjugated antigens and a second band of non-labeled antigens, the method further comprising:
binding the monoclonal antibody to its corresponding gold-conjugated antigen;
migrating the bound gold-conjugated antigen down a lateral flow test strip;
binding the monoclonal antibody to a non-labeled antigen; and
depositing the gold-conjugated antigen onto the lateral test strip to form a stain indicating the presence of the monoclonal antibody.

### Claim 13 (depends on 11)

The computer assisted method of claim 11, wherein the assay is the ELISA, and the one or more second additives includes an anti-IgG antibody which binds to a monoclonal antibody.

### Claim 14 (depends on 1)

The computer assisted method of claim 1, wherein the one or more second additives include ratios of isotopes, and wherein the detecting of the presence of the one or more second additives comprises identifying the ratios of isotopes by mass spectrometry.

### Claim 15 (depends on 1)

The computer assisted method of claim 1, wherein the biological sample is obtained from a tumor, a blood sample, a urine sample, a normal tissue, or saliva.

### Claim 16 (depends on 1)

The computer assisted method of claim 1, wherein a notification is sent to a user when the labeled therapeutic fails validation.

### Claim 17 (depends on 1)

The computer assisted method of claim 1, wherein the sample tracking chain data structure is indexed by the corresponding intrinsic or extrinsic properties related to various states of patient identification, sample collection, processing, and transport, and manufacturing of the therapeutic.

### Claim 18 (depends on 1)

The computer assisted method of claim 1, wherein the sample tracking chain data structure is indexed by a sample tracking engine, wherein the sample tracking engine links the current sample state object to the previous sample state object in the sample tracking chain.

### Claim 19 (depends on 1)

The computer assisted method of claim 1, further comprising a sample search engine, wherein the digital data of the sample tracking chain data structure is searched and validated for fidelity to patient sample tracking and therapeutic administration across a distributed network.

### Claim 20 (depends on 1)

The computer assisted method of claim 1, wherein performing the assay at the point of care includes performing the assay prior to administration of the labeled therapeutic to the patient.