# US 11,298,381 B2 · Modulation of immune function by Bacillus coagulans

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- Number: US 11,298,381 B2
- Document ID: US11298381B2
- Status: Granted
- Kind: B2
- Application number: 16/396,876
- Filed: 2019-04-29
- Published: 2019-10-31
- Granted: 2022-04-12
- Earliest claimed: 2018-04-30
- Assignees: Sami Labs Limited
- Applicants: Muhammed Majeed; Kalyanam Nagabhushanam; Furqan Ali; Sivakumar Arumugam; Shaheen Majeed; Lakshmi Mundkur; Anurag Pande
- Inventors: Muhammed Majeed; Kalyanam Nagabhushanam; Furqan Ali; Sivakumar Arumugam; Shaheen Majeed; Lakshmi Mundkur; Anurag Pande
- Web page: https://patentgrep.com/patent/US11298381B2

## CPC

- A61K 35/742: Spore-forming bacteria, e.g. Bacillus coagulans, Bacillus subtilis, clostridium or Lactobacillus sporogenes
- A61P 37/02: Immunomodulators
- C12N 1/20: Bacteria; Culture media therefor
- C12N 3/00: Spore forming or isolating processes
- 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)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- C12N: MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA (microbiological testing media C12Q1/00)

## Abstract

The present invention discloses a composition comprising heat inactivated spores and/or comprising heat inactivated vegetative cells of probiotic bacteria Bacillus coagulans, and a process for preparing the same. The invention also discloses a method of modulating immune function in mammals by activating macrophages, using a composition comprising Bacillus coagulans in the form of live or heat inactivated spore and/or vegetative cells.

## Claims

### Claim 1

A method of modulating immune function by macrophage polarization in mammals, said method comprising step of bringing into contact mammalian macrophages with an effective concentration of Bacillus coagulans MTCC 5856 in the form of spore or vegetative cells, to bring about the effect of immune modulation by polarizing macrophages to M1 type.

### Claim 2 (depends on 1)

The method as in claim 1, wherein the spores include heat inactivated or dead spores of Bacillus coagulans.

### Claim 3 (depends on 1)

The method as in claim 1, wherein the vegetative cells include heat inactivated or dead or lysed vegetative cells of Bacillus coagulans.

### Claim 4 (depends on 1)

The method as in claim 1, wherein the polarisation of macrophages to M1 type is brought about by inducing the expression of pro-inflammatory genes and cells surface receptors.

### Claim 5 (depends on 1)

The method as in claim 1, wherein the pro-inflammatory genes are selected from the group comprising IL-1β, IL-6, IL-12p40, IL23, TNF-α, TNOS and iNOS.

### Claim 6 (depends on 1)

The method as in claim 1, wherein the cell surface receptors are selected from the group comprising CD80, CD83, CD86, MHC-II, F4/80 and CD16/32.

### Claim 7 (depends on 1)

The method as in claim 1, wherein the mammal is human.

### Claim 8 (depends on 1)

The method as in claim 1, wherein the composition comprising heat inactivated spores and/or vegetative cells of Bacillus coagulans is formulated with pharmaceutically/nutraceutically accepted excipients, adjuvants in the form of powder, infant formulation, suspension, syrup, emulsion, tablets, capsules, eatable or chewable.