# US 11,998,574 B2 · Method and system for modulating an individual's skin microbiome

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- Number: US 11,998,574 B2
- Document ID: US11998574B2
- Status: Granted
- Kind: B2
- Application number: 18/235,686
- Filed: 2023-08-18
- Published: 2024-01-25
- Granted: 2024-06-04
- Earliest claimed: 2013-12-20
- Assignees: Seed Health, Inc.
- Applicants: Seed Health, Inc.
- Inventors: Sheri Simmons; Tye Jensen; Raja Dhir; Joseph E. Kovarik
- Web page: https://patentgrep.com/patent/US11998574B2

## CPC

- A61K 35/74: Bacteria (therapeutic use of a bacterial protein A61K38/00)
- A61K 31/58: containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin (digitoxin {A61K31/7048})
- A61K 31/715: Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
- A61K 35/741: Probiotics (probiotic yeast, e.g. saccharomyces A61K36/06)
- A61K 35/742: Spore-forming bacteria, e.g. Bacillus coagulans, Bacillus subtilis, clostridium or Lactobacillus sporogenes
- A61K 35/745: Bifidobacteria
- A61K 35/747: Lactobacilli, e.g. L. acidophilus or L. brevis
- A61K 38/1709: {from mammals}
- A61K 38/1758: {p53}
- A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
- A61K 2035/11: {Medicinal preparations comprising living procariotic cells}
- A61K 2035/115: {Probiotics}
- Y02A 50/30: Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change
- 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)
- Y02A: TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE

## Abstract

Compositions, systems and methods of improving the health of the microbiome of an individual's skin relate to the provision of skin contacting formulations containing beneficial bacteria, postbiotics, metabolites and other microbe components to foster the growth and maintenance of a healthy skin microbiome. One embodiment includes a topical application of Lactobacillus crispatus to ameliorate skin barrier damage and inflammation using unique combinations of probiotics, prebiotics, postbiotics, and other skin-beneficial ingredients, effectively treating inflammatory skin diseases, such as atopic dermatitis, psoriasis and acne, through the production of tryptophan metabolites that act as AHR agonists.

## Claims

### Claim 1

A method of modulating an individual's skin microbiome, comprising: administering to a region of an individual's skin who has a skin condition a therapeutically effective amount of a bacterial formulation comprising at least one bacteria selected from the group consisting of Lactobacillus reuteri, Lactobacillus johnsonii, Janthinobacterium, Lactobacillus crispatus, Cutibacterium acnes, and Nitrosomonas eutropha, said bacterial formulation comprising a lotion, ointment or gel adapted to be rubbed onto a region of the individual's skin, and abiotic augmentations comprising fatty acids, wherein said at least one bacteria comprises a heat-killed bacteria and wherein the bacterial formulation is in an amount effective to treat, inhibit or reduce a skin condition selected from the group consisting of eczema, atopic dermatitis, acne, allergic inflammation, ultra-violet-induced skin damage, and skin hypersensitivity.

### Claim 2 (depends on 1)

The method as set forth in claim 1, wherein the bacterial formulation further comprises one or more of Staphylococcus, Bifidobacterium, and Streptococcus.

### Claim 3 (depends on 1)

The method as set forth in claim 1, further comprising administering to the individual one of a prebiotic, a metabolite, and a postbiotic.

### Claim 4 (depends on 1)

The method as set forth in claim 1, further comprising administering to the individual a cleanser composition comprising at least one of sodium methyl cocoyl taurate, sodium cocoyl glutamate, coco glucoside, caprylyl/capryl glucoside, sodium cocoyl Isethionate, and cetearyl alcohol; a serum composition comprising at least two of the following: indole-3-carbinol, resveratrol, niacinamide, nicotinic acid, nicotinamide mononucleotide, nicotinamide riboside, quercetin, tryptophan, diiodomethane, Boswellia serrata, and indirubin; and at least one barrier-restoring oil comprising at least one of sunflower oil, coconut oil, murumuru oil, sea buckthorn oil, sachi inchi oil, and babbasu oil.

### Claim 5 (depends on 1)

The method as set forth in claim 1, wherein at least some bacteria in the bacterial formulation have been modified by using a using a clustered regularly interspaced short palindromic repeats (CRISPR) CRISPR associated protein (Cas) system or a CRISPR from Prevotella and Francisella 1 (Cpf1) system to reduce the production of a virulence factor.

### Claim 6 (depends on 1)

The method as set forth in claim 1, wherein the at least one bacteria is one of Cutibacterium acnes and Janthinobacterium.

### Claim 7 (depends on 1)

The method as set forth in claim 1, wherein the at least one bacteria in the bacterial formulation produce short-chain fatty acids selected from the group consisting of propionate, acetate, butyrate and valerate.

### Claim 8 (depends on 1)

The method as set forth in claim 1, wherein the at least one bacteria in the bacterial formulation does at least one of: suppress the growth of S. aureus; reduce the colonization of S. aureus on the individual's skin; and inhibit biofilm formation by S. epidermidis.

### Claim 9 (depends on 1)

The method as set forth in claim 1, further comprising killing or retarding the growth of a pathogenic bacteria within the individual, said pathogenic bacteria selected from the group consisting of Staphylococcus aureus; Pseudomonas aeruginosa; Klebsiella; Streptococcus; Salmonella; Shigella; Mycobacterium tuberculosis; Enterococcus; E coli; Clostridium; Neisseria gonorrhoeae; Acinetobacter baumannii; and Campylobacter.

### Claim 10 (depends on 1)

The method as set forth in claim 1, wherein said method further comprises enhancing the growth of a beneficial bacteria in the individual selected from the group consisting of C. acnes, Akkermansia, Bacteroides, Bifidobacterium, Fusobacterium, Coprococcus, Lactobacillus, Propionibacterium, Nitrosomonas eutropha, Ruminococcus, Veillonella, Prevotella, and Streptococcus bacteria.

### Claim 11 (depends on 1)

The method as set forth in claim 1, further comprising administering at least two probiotic strains to the individual's skin in a concentration of at least 1×108 Arbitrary Fluorescence Units (AFU), said at least two probiotic strains being either live or heat-killed and selected from the group consisting of Cutibacterium, Staphylococcus, Corynebacterium, Micrococcus spp., Actinobacteria, Proteobacteria, and Firmicutes.

### Claim 12 (depends on 1)

The method as set forth in claim 1, further comprising administering to the individual's skin at least one probiotic strain that does not upregulate innate immune response genes selected from the group consisting of CXCL1, CXCL3, CXCL8, CXCL10.

### Claim 13 (depends on 1)

The method as set forth in claim 1, further comprising administering to the individual's skin at least one probiotic strain that does not upregulate innate immune response genes selected from the group consisting of IL10RA, PTGS2, F2RL1, TRIM29, TRAF4, LGALS3, CD55, TRIM8, CASP4, IFNGR1, ADA, NOD1, NOS2, and APP.

### Claim 14

A method of modulating an individual's skin microbiome, comprising, administering to a region of an individual's skin who has a skin condition a therapeutically effective amount of a bacterial formulation comprising Lactobacillus crispatus, and at least two bacteria selected from the group consisting of Lactobacillus reuteri, Lactobacillus johnsonii, Cutibacterium acnes, Janthinobacterium and Nitrosomonas eutropha, said bacterial formulation comprising a lotion, ointment or gel adapted to be rubbed onto a region of the individual's skin, and abiotic augmentations comprising fatty acids, wherein the at least two bacteria comprise heat-killed bacteria and wherein the skin condition is selected from the group consisting of eczema, atopic dermatitis, acne, allergic inflammation, impetigo, ultra-violet-induced skin damage, and skin hypersensitivity.

### Claim 15 (depends on 14)

The method as set forth in claim 14, wherein the skin condition is selected from the group consisting of atopic dermatitis, and wherein the individual has a skin infection associated with a topical pathogenic microorganism comprising Staphylococcus aureus.

### Claim 16 (depends on 14)

The method as set forth in claim 14 further comprising administering to the individual a prebiotic, metabolite, and a postbiotic.

### Claim 17 (depends on 14)

The method as set forth in claim 14, wherein said bacterial formulation further comprises bacteria selected from the group consisting of Faecalibacterium prausnitzii, Bifidobacterium, Lachnospira, Veillonella, Coprococcus, Akkermansia muciniphila and Rothia.

### Claim 18

A method of modulating an individual's skin microbiome, comprising, topically administering to a region of an individual's skin a therapeutically effective amount of a bacterial formulation comprising heat-killed Lactobacillus crispatus bacteria, and at least one of Lactobacillus reuteri, Lactobacillus johnsonii, Lactobacillus crispatus, Cutibacterium acnes, Bifidobacterium lognum and Nitrosomonas eutropha, said bacterial formulation comprising a lotion, ointment or gel adapted to be rubbed onto a region of the individual's skin, and wherein the bacterial formulation further comprises Janthinobacterium.

### Claim 19 (depends on 18)

The method as set forth in claim 18, further comprising administering to the individual's skin one of arabinogalactan and a UV protectant chemical.

### Claim 20 (depends on 18)

The method as set forth in claim 18, wherein the bacterial formulation is administered to an individual's skin who has a skin condition in an amount sufficient for the bacterial formulation to generate an amount of tryptophan metabolites sufficient to act as aryl hydrocarbon receptor (AHR) agonists to thereby reduce inflammation on the individual's skin, wherein the skin condition is selected from the group consisting of eczema, atopic dermatitis, acne, allergic inflammation, ultra-violet-induced skin damage, and skin hypersensitivity.