# US 2019/0167769 A1 · Feed additive composition

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- Number: US 2019/0167769 A1
- Document ID: US20190167769A1
- Status: Published application
- Kind: A1
- Application number: 16/208,829
- Filed: 2018-12-04
- Published: 2019-06-06
- Earliest claimed: 2012-08-03
- Assignees: Dupont Nutrition Biosciences Aps
- Applicants: Dupont Nutrition Biosciences Aps
- Inventors: Luis Romero; Peter Plumstead; Luke Barnard
- Web page: https://patentgrep.com/patent/US20190167769A1

## CPC

- A61K 38/465: {acting on ester bonds (3.1), e.g. lipases, ribonucleases}
- A23K 10/18: of live microorganisms
- A23K 20/174: Vitamins
- A23K 20/189: Enzymes
- A23K 20/20: Inorganic substances, e.g. oligoelements
- A23K 40/20: by moulding, e.g. making cakes or briquettes
- A23K 40/25: by extrusion
- A23K 50/30: for swines
- A23K 50/75: for poultry
- A61K 35/66: Microorganisms or materials therefrom (fungi, yeasts or candida A61K36/06)
- A61K 35/742: Spore-forming bacteria, e.g. Bacillus coagulans, Bacillus subtilis, clostridium or Lactobacillus sporogenes
- A61K 38/46: Hydrolases (3)
- A61P 1/00: Drugs for disorders of the alimentary tract or the digestive system
- A61P 1/04: for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
- A61P 1/14: Prodigestives, e.g. acids, enzymes, appetite stimulants, antidyspeptics, tonics, antiflatulents
- A61P 31/04: Antibacterial agents
- A61P 37/02: Immunomodulators
- A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
- C12Y 301/03008: 3-Phytase (3.1.3.8)
- C12Y 301/03026: 4-Phytase (3.1.3.26), i.e. 6-phytase
- C12Y 301/03: Phosphoric monoester hydrolases (3.1.3)
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A23K: FODDER
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- C12Y: ENZYMES

## Abstract

A method for improving the performance of a subject or for improving digestibility of a raw material in a feed (e.g. nutrient digestibility, such as amino acid digestibility), or for improving nitrogen retention, or for improving dietary phosphorus absorption and retention, or for improving the efficacy of the phytase, or for improving the subject's resistance to necrotic enteritis or for improving feed conversion ratio (FCR) or for improving weight gain in a subject or for improving feed efficiency in a subject or for modulating (e.g. improving) the immune response of the subject or for reducing populations of pathogenic bacteria in the gastrointestinal tract of a subject, or for reducing nutrient excretion in manure, which method comprising administering to a subject at least one direct fed microbial in combination with a phytase, wherein the phytase is administered to the subject at a dosage of more than about 1500 FTU/kg feed.

## Claims

### Claim 1

A method for improving the performance of a subject or for improving digestibility of a raw material in a feed (e.g. nutrient digestibility, such as amino acid digestibility), or for improving nitrogen retention, or for improving dietary phosphorus absorption and retention, or for improving the efficacy of the phytase, or for improving the subject's resistance to necrotic enteritis or for improving feed conversion ratio (FCR) or for improving weight gain in a subject or for improving feed efficiency in a subject or for modulating (e.g. improving) the immune response of the subject or for reducing populations of pathogenic bacteria in the gastrointestinal tract of a subject, or for reducing nutrient excretion in manure, which method comprising administering to a subject at least one direct fed microbial in combination with a phytase, wherein the phytase is administered to the subject at a dosage of more than about 1500 FTU/kg feed.

### Claim 2

(canceled)

### Claim 3 (depends on 1)

A method according to claim 1 wherein the direct fed microbial is an antipathogen direct fed microbial.

### Claim 4 (depends on 1)

A method according to claim 1 wherein the direct fed microbial is a viable bacterium.

### Claim 5 (depends on 1)

A method according to claim 1 wherein the phytase is administered to the subject at a dosage of more than about 2000 FTU/kg feed.

### Claim 6 (depends on 1)

A method according to claim 1 wherein the phytase is administered to the subject at a dosage of more than about 3000 FTU/kg feed.

### Claim 7 (depends on 1)

A method according to claim 1 wherein the composition comprises as least three direct fed microbials.

### Claim 8 (depends on 1)

A method according to claim 1 wherein the direct fed microbial is a strain which inhibits intestinal establishment of pathogenic microorganisms (such as Clostridium perfringens and/or E.coli)

### Claim 9 (depends on 1)

A method according to claim 1 wherein the direct fed microbial comprises a bacterium from one or more of the following genera: Bacillus, Enterococcus, Pediococcus, Saccharomyces, Bifidobacterium, Propionibacterium, Lactobacillus, Lactococcus, Aspergillus and combinations thereof.

### Claim 10 (depends on 1)

A method according to claim 1 wherein the direct fed microbial comprises a bacterium from one or more of the following species: Bacillus subtilis, Bacillus licheniformis, Bacillus amyloliquefaciens, Bacillus cereus, Enterococcus faecium, Pediococcus acidilactici, Saccharomyces cerevisiae, Bifidobacterium animalis spp animalis, Lactobacillus reuteri, Lactobacillus rhamnosus, Lactobacillus acidophilus, Lactobacillus brevis, Lactobacillus salivarius ssp salivarius, Lactobacillus farciminis, Lactococcus lactis, Lactobacillus casei, Lactobacillus salivarius, Lactobacillus rhamnosus, Clostridium butyricum, Aspergillus oryzae, Propionibacterium acidipropionici, Propionibacterium jensenii, Enterococcus faecium, Pediococcus acidilactici and combinations thereof.

### Claim 11 (depends on 1)

A method according to claim 1 wherein the direct fed microbial is one or more of the following strains: Bacillus subtilis BS18 (NRRL B-50633), Bacillus subtilis BS278 (NRRL 50634), Bacillus subtilis 4-7d (NRRL B-50505), Bacillus subtilis 3-5h (NRRL B-50507), Bacillus subtilis AGTP BS3BP5 (NRRL B-50510), Bacillus subtilis BS918 (NRRL B-50508), Bacillus subtilis AGTP BS1013 (NRRL-50509), B. subtilis AGTP 944 (NRRL B-50548), Bacillus subtilis AGTP BS442 (NRRL B-50542), B. subtilis AGTP BS1069 (NRRL B-50544), B. subtilis AGTP BS521 (NRRL B-50545), B. subtilis BS2084 (NRRL B-50013), B. subtilis LSSA01 (NRRL B-50104), B. subtilis B27 (NRRL B-50105), B. subtilis 3A-P4 (PTA-6506), Bacillus subtilis 15A-P4 (PTA-6507), B. subtilis 22C-P1 (PTA-6508), B. subtilis BL21 (NRRL B-50134), Bacillus licheniformis BL21 (NRRL B-50134), Bacillus licheniformis 3-12a (NRRL B-50504), Bacillus licheniformis 4-2a (NRRL B-50506), Bacillus licheniformis 842 (NRRL B-50516), Propionibacterium acidipropionici P261 (NRRL B-50131), Propionibacterium acidipropionici P179 (NRRL B-50133), Propionibacterium acidipropionici P169 (PTA 5271), Propionibacterium acidipropionici P170 (PTA 5272), Propionibacterium jensenii P63 (NRRL B-30979), Propionibacterium jensenii P195 (NRRL B-50132), Lactococcus lactis ID7 (PTA 6103), Lactococcus lactis JD19 (PTA 6104), Lactobacillus acidophilus A2020 (NRRL B-30977), Lactobacillus acidophilus A4000h (NRRL B-30978), Lactobacillus acidophilus PIBc6 (NRRL B-50103), Lactobacillus brevis LBR 1000 (NRRL B-30982), Lactobacillus casei LC222 (NRRL B-30983), Lactobacillus johnsonii PLCB6 (NRRL B-50518), Lactobacillus salivarius o246i33w (NRRL B-50102), Lactobacillus brevis AJ25 (PTA-6099), Lactobacillus brevis HE17 (PTA-6100), Lactobacillus brevis 1E-1 (PTA-6509), Lactobacillus lactis C115 (PTA-6101), Lactobacillus lactis DJ6 (PTA-6102), Lactobacillus rhamnosus (CNCM 1-3698), Lactobacillus farciminis (CNCM 1-3699), Enterococcus faecium EF141 (EN-1) (NRRL B-30981), Enterococcus faecium 2-id (NRRL B-50519), Pediococcus acidilactici PIJe3 (NRRL B-50101), Pediococcus acidilactici o246e42 (NRRL B-50171) and combinations thereof.

### Claim 12 (depends on 1)

A method according to claim 1 wherein the phytase is a 6-phytase or a 3-phytase.

### Claim 13 (depends on 12)

A method according to claim 12 wherein the phytase is a 6-phytase.

### Claim 14 (depends on 1)

A method according to claim 1 wherein the phytase is an E. coli phytase or a Buttiauxella phytase or a Citrobacter phytase or a Hafnia phytase or an Aspergillus phytase or a Penicillium phytase or a Trichoderma phytase or an E. coli phytase or a Hansenula phytase or a Peniphora phytase.

### Claim 15 (depends on 1)

A method according to claim 1 wherein the DFM is present at a dosage of 3.75×107 CFU/g feed additive composition and 1×1011 CFU/g feed additive composition.

### Claim 16 (depends on 1)

A method according to claim 1 wherein a clinical or subclinical intestinal disease challenge is present in the subject.

### Claim 17 (depends on 16)

A method according to claim 16 wherein the clinical or subclinical intestinal disease challenge may be caused by a pathogenic bacteria, such as Clostridium perfringens or E.coli.

### Claim at position 18

-30. (canceled)

### Claim 31

A method of preparing a feed additive composition, comprising admixing at least one direct fed microbial with a phytase, such that the dosage of phytase in the composition is:
a. about 30,000 FTU/g composition or more when dosed in a feed at at least 50 g/metric ton (MT) of feed,
b. about 20,000 FTU/g composition or more when dosed in a feed at at least 75 g/metric ton (MT) of feed,
c. about 15,000 FTU/g composition or more when dosed in a feed at at least 100 g/metric ton (MT) of feed,
d. about 15,000 FTU/g composition or more when dosed in a feed at at least 100 g/metric ton (MT) of feed,
e. about 10,000 FTU/g composition or more when dosed in a feed at at least 150 g/metric ton (MT) of feed,
f. about 7,500 FTU/g composition or more when dosed in a feed at at least 200 g/metric ton (MT) of feed,
g. about 5,000 FTU/g composition or more when dosed in a feed at at least 300 g/metric ton (MT) of feed,
and the dosage of the direct fed microbial in the feed additive composition in a range from 2.5×103 CFU DFM: 1 FTU enzyme to 6.7×106 CFU:1 FTU enzyme, and optionally packaging.

### Claim 32 (depends on 31)

A method according to claim 31 wherein the dosage of the direct fed microbial in the feed additive composition in a range from 3.8×103 CFU DFM: 1 FTU enzyme to 2.0×105 CFU:1 FTU enzyme.

### Claim at position 21

-40. (canceled)