# US 12,180,464 B2 · Microbial compositions and methods of use for canine enteropathy and dysbiosis

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- Number: US 12,180,464 B2
- Document ID: US12180464B2
- Status: Granted
- Kind: B2
- Application number: 17/818,834
- Filed: 2022-08-10
- Published: 2022-12-08
- Granted: 2024-12-31
- Earliest claimed: 2020-02-10
- Assignees: Native Microbials, Inc.
- Applicants: Native Microbials, Inc.
- Inventors: Mallory Embree; Grant Gogul; Fan Yang
- Web page: https://patentgrep.com/patent/US12180464B2

## CPC

- C12N 1/205: Bacterial isolates
- A23K 10/16: Addition of microorganisms or extracts thereof, e.g. single-cell proteins, to feeding-stuff compositions (A23K10/12 takes precedence)
- A23K 10/18: of live microorganisms
- A23K 20/163: Sugars; Polysaccharides
- A23K 20/174: Vitamins
- A23K 40/30: by encapsulating; by coating
- A23K 50/40: for carnivorous animals, e.g. cats or dogs
- A23K 50/42: Dry feed
- A23K 50/48: Moist feed
- A61P 1/12: Antidiarrhoeals
- C12N 1/20: Bacteria; Culture media therefor
- A23V 2002/00: Food compositions, function of food ingredients or processes for food or foodstuffs
- C12N: MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA (microbiological testing media C12Q1/00)
- A23K: FODDER
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A23V: INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION

## Abstract

The disclosure relates to isolated microorganisms—including novel strains of the microorganisms—microbial ensembles, and compositions comprising the same. Furthermore, the disclosure teaches methods of utilizing the described microorganisms, microbial compositions, and compositions comprising the same, in methods for treating or preventing gastrointestinal enteropathy or dysbiosis in canines. In particular aspects, the disclosure provides methods of treating or preventing morbidity and mortality caused by GI pathogenesis or autoimmunity.

## Claims

### Claim 1

A composition comprising:
(a) a purified population of bacteria comprising:
(i) a bacterium comprising a 16S nucleic acid sequence sharing at least 99.5% sequence identity to SEQ ID NO: 19;
(ii) a bacterium comprising a 16S nucleic acid sequence sharing at least 99.5% sequence identity to SEQ ID NO: 172; and
(iii) optionally, a bacterium comprising a 16S nucleic acid sequence sharing at least 99.5% sequence identity to SEQ ID NO: 326; and
(b) one or more carriers suitable for canine administration;
wherein the bacteria in the composition are lyophilized; and wherein the bacteria present in the composition are in an amount effective to improve one or more traits in a canine administered the composition.

### Claim 2 (depends on 1)

The composition of claim 1, wherein the purified population of bacteria comprises: a bacterium having a 16S nucleic acid sequence of SEQ ID NO: 19; and a a bacterium having a 16S nucleic acid sequence of SEQ ID NO: 172; and optionally, a bacterium having a 16S nucleic acid sequence of SEQ ID NO: 326.

### Claim 3 (depends on 1)

The composition of claim 1, wherein the purified population of bacteria comprises: a bacterium having a 16S nucleic acid sequence of SEQ ID NO: 19; a a bacterium having a 16S nucleic acid sequence of SEQ ID NO: 172; and a bacterium having a 16S nucleic acid sequence of SEQ ID NO: 326.

### Claim 4 (depends on 1)

The composition of claim 1, wherein the purified population of bacteria comprises: a bacterium deposited as NRRL B-67972; a bacterium deposited as NRRL B-67975; and a bacterium deposited as NRRL B-67977.

### Claim 5 (depends on 1)

The composition of claim 1, wherein the purified population further comprises one or more bacteria with a 16S nucleic acid sequence that shares at least 97% sequence identity with a nucleic acid sequence selected from: SEQ ID NOs: 237 and 327-331.

### Claim 6 (depends on 1)

The composition of claim 1, wherein the one or more carriers are selected from the group consisting of: an edible feed grade material, an aluminosilicate-containing mineral, a zeolite, calcium carbonate, a prebiotic, and a flavoring agent.

### Claim 7 (depends on 6)

The composition of claim 6, wherein the prebiotic is inulin, an oligosaccharide, and/or a vitamin.

### Claim 8 (depends on 6)

The composition of claim 6, wherein the flavoring agent is dried yeast, cheese flavoring, beef flavoring, fish flavoring, chicken flavoring, and/or pork flavoring.

### Claim 9 (depends on 1)

The composition of claim 1, wherein the one or more carriers are inulin and/or dried yeast.

### Claim 10 (depends on 1)

The composition of claim 1, wherein the bacteria are present in the composition at a concentration of at least 102 cells per gram of said composition.

### Claim 11 (depends on 1)

The composition of claim 1, wherein the composition is mixed with or sprinkled on top of animal food.

### Claim 12 (depends on 1)

The composition of claim 1, wherein the composition is formulated as a tablet, a pill, a capsule, a powder, a solution, a suspension, a food, or an emulsion.

### Claim 13 (depends on 12)

The composition of claim 12, wherein the composition is formulated as a dry food, a wet food, a kibble, or a raw food.

### Claim 14 (depends on 1)

The composition of claim 1, wherein the purified population of bacteria comprises: a bacterium deposited as NRRL B-67975; a bacterium deposited as NRRL B-67977, and optionally, a bacterium deposited as NRRL B-67972.

### Claim 15 (depends on 1)

The composition of claim 1, wherein the purified population of bacteria comprises: a bacterium comprising a 16S nucleic acid sequence sharing at least 99.5% sequence identity to SEQ ID NO: 19; a bacterium comprising a 16S nucleic acid sequence sharing at least 99.5% sequence identity to SEQ ID NO: 172; and a bacterium comprising a 16S nucleic acid sequence sharing at least 99.5% sequence identity to SEQ ID NO: 326.

### Claim 16 (depends on 1)

The composition of claim 1, wherein the one or more traits is an improvement in gastrointestinal health of the canine.

### Claim 17 (depends on 1)

The composition of claim 1, wherein the improvement in gastrointestinal health of the canine is reduced incidence of diarrhea, reduced dysbiosis, reduced enteropathy, reduced inflammation, improved fecal consistency, an increase in regular bowel movements, reduced incidence of constipation, or less straining during defecation.

### Claim 18 (depends on 1)

The composition of claim 1, wherein the one or more traits are selected from a group consisting of: reduced incidence of diarrhea, reduced dysbiosis, reduced enteropathy, reduced inflammation, decreased incidence of infectious or non-infectious disease, improved fecal consistency, increased regular bowel movements, improved fur or coat quality, increased appetite, increased energy, improved performance, and increased lifespan.
