# US 12,494,289 B2 · Method and diagnostic apparatus for determining enteritis using machine learning model

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- Number: US 12,494,289 B2
- Document ID: US12494289B2
- Status: Granted
- Kind: B2
- Application number: 18/460,796
- Filed: 2023-09-05
- Published: 2023-12-21
- Granted: 2025-12-09
- Earliest claimed: 2021-03-26
- Assignees: Hem Pharma Inc.
- Applicants: Hem Pharma Inc.
- Inventors: Yo Sep Ji; So Young Park
- Web page: https://patentgrep.com/patent/US12494289B2

## CPC

- G16H 50/20: for computer-aided diagnosis, e.g. based on medical expert systems
- A61B 5/00: Measuring for diagnostic purposes (radiation diagnosis A61B6/00; diagnosis by ultrasonic, sonic or infrasonic waves A61B8/00); Identification of persons
- G06N 20/00: Machine learning
- G16B 5/00: ICT specially adapted for modelling or simulations in systems biology, e.g. gene-regulatory networks, protein interaction networks or metabolic networks
- G16B 40/00: ICT specially adapted for biostatistics; ICT specially adapted for bioinformatics-related machine learning or data mining, e.g. knowledge discovery or pattern finding
- G16B 40/20: Supervised data analysis
- G16H 10/40: for data related to laboratory analysis, e.g. patient specimen analysis
- G16H 40/67: for remote operation
- G16H 50/70: for mining of medical data, e.g. analysing previous cases of other patients
- G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- G06N: COMPUTING ARRANGEMENTS BASED ON SPECIFIC COMPUTATIONAL MODELS
- G16B: BIOINFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR GENETIC OR PROTEIN-RELATED DATA PROCESSING IN COMPUTATIONAL MOLECULAR BIOLOGY

## Abstract

A method for determining whether enteritis is present by using a machine learning model may include a process of analyzing a mixture of a gut-derived substance collected from a subject and a gut environment-like composition, a process of extracting multiple microbial data based on an analysis result of the mixture, a process of selecting microbe-related features to be used in the machine learning model from the multiple microbial data based on a predetermined feature selection algorithm, a process of training the machine learning model with the microbe-related features, and a process of inputting, to the trained machine learning model, the microbial data collected from the subject to be tested and determining whether enteritis is present. The microbe-related features may include the amount of one or more microbes selected from genera included in families, Ruminococcaceae, Lactobacillaceae, Prevotellaceae, Barnesiellaceae, Bacteroidaceae, Lachnospiraceae, and UCG.010→Lachnospiraceae, Veillonellaceae, Tannerellaceae, Clostridia, Coriobacteriaceae, Butyricicoccaceae, Streptococcaceae, Bacteroidaceae, UCG.010, Prevotellaceae.

## Claims

### Claim 1

A method for diagnosing the presence or absence of enteritis by using a machine learning model, comprising:
(a) analyzing a mixture of a gut-derived substance collected from a subject and a gut environment-like composition, the analyzing comprising:
(a-1) culturing the mixture under anaerobic conditions for a period of 18 to 24 hours,
(a-2) centrifuging the cultured mixture to separate a supernatant and a precipitate, and
(a-3) analyzing the supernatant and precipitate;
(b) extracting multiple microbial data based on an analysis result of the mixture;
(c) selecting microbe-related features to be used in the machine learning model from the multiple microbial data based on a predetermined feature selection algorithm;
(d) training the machine learning model with the selected microbe-related features; and
(e) diagnosing whether enteritis is present in a test subject by inputting microbial data from the test subject into the trained machine learning model,
wherein the microbe-related features include an amount of one or more microbes selected from genera included in families, Lachnospiraceae, Veillonellaceae, Tannerellaceae, Clostridia, Coriobacteriaceae, Butyricicoccaceae, Streptococcaceae, Bacteroidaceae, UCG.010, and Prevotellaceae,
wherein the gut environment-like composition includes at least one of sodium chloride (NaCl), sodium carbonate (NaHCO3), potassium chloride (KCl), hemin, or any combination thereof, and
wherein the feature selection algorithm includes at least one of a Boruta algorithm, a recursive feature elimination (RFE) algorithm, or any combination thereof.

### Claim 2 (depends on 1)

The method of claim 1,
wherein the number of the microbe-related features to be used in the machine learning model is 11 to 16.

### Claim 3 (depends on 1)

The method of claim 1,
wherein the microbial data include at least one of an amount, concentration, or kind of a substance contained in the cultured mixture, or kind, concentration, amount, or diversity changes of bacteria included in microbiota, or any combination thereof and
the substance contained in the cultured mixture includes at least one of endotoxins, hydrogen sulfides, short-chain fatty acids (SCFAs), microbiota-derived metabolites, or any combination thereof.

### Claim 4 (depends on 1)

The method of claim 1,
wherein the machine learning model includes at least one of a linear regression analysis (LRA) model, a random forest model, a generalized linear (GLM) model, a gradient boosting model, an extreme gradient boosting (XGB) model, or any combination thereof.

### Claim 5 (depends on 1)

The method of claim 1,
wherein the microbe-related features include the amount of one or more microbes selected from species included in genera, Coprococcus, Anaerostipes, Megasphaera, Parabacteroides, Clostridia, Collinsella, Butyricicoccus, Streptococcus, Bacteroides, UCG.010, and Prevotella.

### Claim 6

An apparatus for diagnosing the presence or absence of enteritis by using a machine learning model, comprising:
a processor;
a microbial data extraction unit configured to extract multiple microbial data by analyzing a mixture of a gut-derived substance collected from a subject and a gut environment-like composition, the analyzing comprising culturing the mixture under anaerobic conditions for a period of 18 to 24 hours, centrifuging the cultured mixture to separate a supernatant and a precipitate, and analyzing the supernatant and the precipitate;
a feature selection unit configured to select microbe-related features to be used in the machine learning model from the multiple microbial data based on a predetermined feature selection algorithm;
a training unit configured to train the machine learning model with the selected microbe-related features; and
a diagnosis unit configured to input, to the trained machine learning model, microbial data collected from a test subject and diagnose whether enteritis is present in the test subject,
wherein the microbe-related features include the amount of one or more microbes selected from genera included in families, Lachnospiraceae, Veillonellaceae, Tannerellaceae, Clostridia, Coriobacteriaceae, Butyricicoccaceae, Streptococcaceae, Bacteroidaceae, UCG.010, and Prevotellaceae,
wherein the gut environment-like composition includes sodium chloride (NaCl), sodium carbonate (NaHCO3), potassium chloride (KCl), hemin, or any combination thereof, and
wherein the feature selection algorithm includes at least one of a Boruta algorithm, a recursive feature elimination (RFE) algorithm, or any combination thereof.

### Claim 7 (depends on 6)

The apparatus of claim 6,
wherein the number of the microbe-related features to be used in the machine learning model is 11 to 16.

### Claim 8 (depends on 6)

The apparatus of claim 6,
wherein the microbial data include at least one of an amount, concentration, or kind of a substance contained in the cultured mixture, or kind, concentration, amount, or diversity changes of bacteria included in microbiota, or any combination thereof and
the substance contained in the cultured mixture includes at least one of endotoxins, hydrogen sulfides, short-chain fatty acids (SCFAs), microbiota-derived metabolites, or any combination thereof.

### Claim 9 (depends on 6)

The apparatus of claim 6,
wherein the machine learning model includes at least one of a linear regression analysis (LRA) model, a random forest model, a generalized linear (GLM) model, a gradient boosting model, an extreme gradient boosting (XGB) model, or any combination thereof.

### Claim 10 (depends on 6)

The apparatus of claim 6,
wherein the microbe-related features include the amount of one or more microbes selected from species included in genera, Coprococcus, Anaerostipes, Megasphaera, Parabacteroides, Clostridia, Collinsella, Butyricicoccus, Streptococcus, Bacteroides, UCG.010, and Prevotella.