# US 12,191,023 B1 · Systems and methods for patient targeted therapy development

> Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt

- Number: US 12,191,023 B1
- Document ID: US12191023B1
- Status: Granted
- Kind: B1
- Application number: 18/166,251
- Filed: 2023-02-08
- Granted: 2025-01-07
- Earliest claimed: 2018-03-30
- Assignees: Flagship Pioneering Innovations VI, LLC
- Applicants: Flagship Pioneering Innovations VI, LLC
- Inventors: Douglas Gowers Cole; Aaron Garth Day-Williams
- Web page: https://patentgrep.com/patent/US12191023B1

## CPC

- G16H 20/40: relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture
- G16H 50/30: for calculating health indices; for individual health risk assessment
- G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA

## Abstract

Described herein are platforms for use in targeted therapy development for an individual or group of individuals. Targeted therapy development as described herein comprises developing a therapeutic or therapeutic modality that is specific to or customized to an individual or group of individuals.

## Claims

### Claim 1

A process for targeting a therapy to a subgroup of individuals having a health-related condition, abnormality, or disease, the process comprising:
determining respective characterization parameters for individuals based at least in part on data relating to the individuals as extracted from computer storage, wherein the characterization parameters include a physical parameter and a behavioral parameter;
determining genetic information for the individuals based on respective biological samples obtained or derived from the individuals;
generating first data representing a first grouping of the individuals, wherein the individuals in the first grouping have the health-related condition, abnormality, or disease, and wherein the first grouping is based at least in part on the respective characterization parameters and the respective genetic information, such that the first grouping includes individuals who share one or more of the characterization parameters and one or more of the genetic information;
applying a stimulation based on the therapy to respective cell cultures grown from cells taken from respective biological samples obtained or derived from selected individuals in the first grouping;
measuring any respective modulation in the respective cell cultures caused by the stimulation to a characterization parameter or genetic information from among the one or more of the characterization parameters and the one or more of the genetic information defining the first grouping, thereby generating respective screening results for the biological samples;
generating data representing a second grouping of the individuals, such that the second grouping includes individuals from the first grouping who further share one or more of an additional characterization parameter or genetic information correlated with the respective screening results indicating the individuals in the second grouping are predicted to respond to the therapy; and
administering the therapy to an individual who shares the one or more of the characterization parameters and the one or more of the genetic information with the individuals in the first grouping and who further shares the one or more of the additional characterization parameter or genetic information with the individuals in the second grouping.

### Claim 2 (depends on 1)

The process of claim 1, wherein the physical parameter comprises a cell culture parameter including one or more of cell count, cell density, growth rate, metabolic properties, response to a stimulus, or response to a therapeutic.

### Claim 3 (depends on 2)

The process of claim 2, wherein the physical parameter further comprises one or more of height, weight, age, body mass index, blood pressure, heart rate, stroke volume, urine output, blood levels, urine analysis, radiology results, stress test results, electroencephalograph (EEG) results, or electrocardiogram (ECG) results.

### Claim 4 (depends on 3)

The process of claim 3, wherein the behavioral parameter comprises one or more more of activity level, compliance with treatments, diet behavior, tobacco use, illicit drug use, alcohol use, stress management, sleep habits, hygiene practices, or employment.

### Claim 5 (depends on 2)

The process of claim 2, wherein the respective biological samples include samples selected from the group consisting of a blood sample, a skin sample, a stool sample, a hair sample, and a urine sample.

### Claim 6 (depends on 1)

The process of claim 1, wherein the cell cultures include fibroblasts extracted from the respective biological samples.

### Claim 7 (depends on 1)

The process of claim 1, wherein the cell cultures include stem cells derived from fibroblasts extracted from the respective biological samples.

### Claim 8 (depends on 1)

The process of claim 1, wherein the cell cultures include cells differentiated in vitro from cells derived from the respective biological samples.

### Claim 9 (depends on 1)

The process of claim 1, wherein the cell cultures include nerve cells.

### Claim 10 (depends on 9)

The process of claim 9, wherein applying the stimulation to the cell cultures comprises applying an electric current to the nerve cells.

### Claim 11 (depends on 10)

The process of claim 10, wherein the electric current causes the nerve cells to display the respective modulation of the characterization parameter or the genetic information.

### Claim 12 (depends on 11)

The process of claim 11, wherein the therapy is targeted to treat epilepsy.

### Claim 13 (depends on 1)

The process of claim 1, wherein applying the stimulation comprises screening with a compound.

### Claim 14 (depends on 1)

The process of claim 1, wherein the characterization parameter modulated by the stimulation includes one or more of cell count, cell density, growth rate, metabolic properties, response to a stimulus, or response to a therapeutic.

### Claim 15

A process for targeting a therapy to a subgroup of individuals having a health-related condition, abnormality, or disease, the process comprising:
determining respective characterization parameters for individuals based at least in part on data relating to the individuals as extracted from computer storage, wherein the characterization parameters include a physical parameter and a behavioral parameter;
determining genetic information for the individuals based on respective biological samples obtained or derived from the individuals;
generating first data representing a first grouping of the individuals, wherein the individuals in the first grouping have the health-related condition, abnormality, or disease, and wherein the first grouping is based at least in part on the respective characterization parameters and the respective genetic information, such that the first grouping includes individuals who share one or more of the characterization parameters and one or more of the genetic information;
applying a stimulation based on the therapy to respective cell cultures grown from cells taken from respective biological samples obtained or derived from selected individuals in the first grouping;
measuring any respective modulation in the respective cell cultures caused by the stimulation to a characterization parameter or genetic information from among the one or more of the characterization parameters and the one or more of the genetic information defining the first grouping, thereby generating respective screening results for the biological samples;
generating data representing a second grouping of the individuals, such that the second grouping includes individuals from the first grouping who further share one or more of an additional characterization parameter or genetic information correlated with the respective screening results indicating the individuals in the second grouping are predicted to respond to the therapy;
outputting the data representing the second grouping as indicative of the subgroup of the individuals having the health-related condition, abnormality, or disease who are predicted to respond to the therapy; and
administering the therapy to an individual who shares the one or more of the characterization parameters and the one or more of the genetic information with the individuals in the first grouping and who further shares the one or more of the additional characterization parameter or genetic information with the individuals in the second grouping.

### Claim 16 (depends on 15)

The process of claim 15, wherein the characterization parameter modulated by the stimulation includes one or more of cell count, cell density, growth rate, metabolic properties, response to a stimulus, or response to a therapeutic.

### Claim 17 (depends on 15)

The process of claim 15, wherein the cell cultures include fibroblasts extracted from the respective biological samples.

### Claim 18 (depends on 15)

The process of claim 15, wherein the cell cultures include stem cells derived from fibroblasts extracted from the respective biological samples.

### Claim 19 (depends on 15)

The process of claim 15, wherein the cell cultures include cells differentiated in vitro from cells derived from the respective biological samples.

### Claim 20 (depends on 15)

The process of claim 15, wherein the cell cultures include nerve cells.
