# US 9,750,802 B2 · Method and system for targeting the microbiome to promote health and treat allergic and inflammatory diseases

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- Number: US 9,750,802 B2
- Document ID: US9750802B2
- Status: Granted
- Kind: B2
- Application number: 15/270,034
- Filed: 2016-09-20
- Published: 2017-01-26
- Granted: 2017-09-05
- Earliest claimed: 2013-12-20
- Applicants: Katherine Rose Kovarik; Joseph E. Kovarik
- Inventors: Katherine Rose Kovarik; Joseph E. Kovarik
- Web page: https://patentgrep.com/patent/US9750802B2

## CPC

- A61K 39/35: Allergens
- A61K 9/0034: {Urogenital system, e.g. vagina, uterus, cervix, penis, scrotum, urethra, bladder; Personal lubricants}
- A61K 9/0043: {Nose}
- A61K 9/007: {Pulmonary tract; Aromatherapy}
- A61K 35/74: Bacteria (therapeutic use of a bacterial protein A61K38/00)
- 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 39/0008: {Antigens related to auto-immune diseases; Preparations to induce self-tolerance}
- A61K 39/39: characterised by the immunostimulating additives, e.g. chemical adjuvants
- A61K 39/395: Antibodies (agglutinins A61K38/36 {; as drug carriers A61K47/50}); Immunoglobulins; Immune serum, e.g. antilymphocytic serum
- A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
- C07K 16/00: Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
- A61K 2039/505: {comprising antibodies}
- A61K 2039/541: {Mucosal route}
- A61K 2039/544: {to the airways}
- A61K 2039/55: {characterised by the host/recipient, e.g. newborn with maternal antibodies}
- A61K 2039/55583: {Polysaccharides}
- A61K 2039/577: {tolerising response}
- A61K 2039/58: {raising an immune response against a target which is not the antigen used for immunisation}
- A61K 2039/70: {Multivalent vaccine}
- 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)
- C07K: PEPTIDES (peptides in foodstuffs A23; obtaining protein compositions for foodstuffs, working-up proteins for foodstuffs A23J; preparations for medicinal purposes A61K; peptides containing beta-lactam rings C07D; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, C07D; ergot alkaloids of the cyclic peptide type C07D519/02; macromolecular compounds having statistically distributed amino acid units in their molecules, i.e. when the preparation does not provide for a specific; but for a random sequence of the amino acid units, homopolyamides and block copolyamides derived from amino acids C08G69/00; macromolecular products derived from proteins C08H1/00; preparation of glue or gelatine C09H; single cell proteins, enzymes C12N; genetic engineering processes for obtaining peptides C12N15/00; compositions for measuring or testing processes involving enzymes C12Q; investigation or analysis of biological material G01N33/00)

## Abstract

A method and system for targeting the microbiome to promote health involves exposing an expectant mother to a mixture of farm derived manure-containing soil to reduce the chances her baby will suffer allergies and autoimmune diseases. City dwelling expectant mothers are exposed to immunologic agents and allergens in a fashion (e.g., via exposure to farm animal manure-containing soils) that charges their immune system and that of their fetus(es) so that their babies, once born, are provided with immunity against a variety of autoimmune diseases, including allergies commonly and increasingly experienced in modern urban environments.

## Claims

### Claim 1

A method of reducing a likelihood of an allergic disease developing, comprising: dispersing, in the air of an urban dwelling where an expectant mother human female resides, a prophylactic immune stimulating composition comprising: at least 5 grams of bovine manure components from a bovine that has not been administered an antibiotic effective against one of Lactobacillus johnsonii, and Bifidobacterium longum bv. Infantis, and an extract derived from a helminth selected from the group consisting of: Capillaria hepatica, Dicrocoelium dendriticum, Ascaris lumbricoides, Enterobius vermicularis, Trichuris trichiura, Ancylostoma duodenale, Necator americanus, Strongyloides stercoralis, Haemonchus contortus, and Trichinella spiralis, wherein said step of dispersing includes exposing the expectant mother to said immune stimulating composition so that the expectant mother can inhale the immune stimulating composition laden air within the urban dwelling at least three times a week for at least a 5 minute time period, for at least the expectant mother's last trimester, and applying to the expectant mother's birth canal prior to the birth of her baby with a composition including a bacterial formulation that comprises at least one of: Prevotella; Lactobacillus johnsonii; Bacteroides fragilis, Lactobacillus ruminus, Bifidobacterium longum bv. Infantis, and an extract derived from a helminth selected from the group consisting of: Capillaria hepatica, Dicrocoelium dendriticum, Ascaris lumbricoides, Enterobius vermicularis, Trichuris trichiura, Ancylostoma duodenale, Necator americanus, Strongyloides stercoralis, Haemonchus contortus, and Trichinella spiralis.

### Claim 2 (depends on 1)

The method of claim 1, wherein the immune stimulating composition is enhanced by the addition of at least one of the following: L. infantitis, L. johnsonii, and helminthes.

### Claim 3 (depends on 1)

The method of claim 1, wherein the composition comprises an extract derived from at least two of: Capillaria hepatica, Dicrocoelium dendriticum, Ascaris lumbricoides, Enterobius vermicularis, Trichuris trichiura, Ancylostoma duodenale, Necator americanus, Strongyloides stercoralis, Haemonchus contortus, and Trichinella spiralis.

### Claim 4 (depends on 1)

The method according to claim 1, further comprising providing an air flow device adapted to convey air about said bovine manure components and the urban dwelling.

### Claim 5 (depends on 1)

The method according to claim 1, wherein said bovine manure components include at least one bacteroidetes selected from a phylum of bacteria of the group Bacteroides, Flavobacteria, and Sphingobacteria, and at least one gram-positive firmicute.

### Claim 6 (depends on 1)

The method according to claim 1, wherein said immune stimulating composition further comprises at least 1000 bacteria selected from the group of Bifidobacterium longum biovar infantis, and Lactobacillus johnsonii.

### Claim 7 (depends on 1)

The method according to claim 1, wherein said immune stimulating composition further comprises at least 1 gram of a helminthes extract derived from a helminth selected from the group consisting of: Capillaria hepatica, Dicrocoelium dendriticum, Ascaris lumbricoides, Enterobius vermicularis, Trichuris trichiura, Ancylostoma duodenale, Necator americanus, Strongyloides stercoralis, Haemonchus contortus, Trichinella spiralis and Trichuris suis ova.

### Claim 8 (depends on 1)

The method according to claim 1, wherein the immune stimulating composition further includes a separate additive including at least one arabinogalactan.

### Claim 9 (depends on 1)

The method according to claim 1, wherein the immune stimulating composition further includes cyclodextrin.

### Claim 10 (depends on 1)

The method according to claim 1, wherein the immune stimulating composition includes Lactococcus lactis.

### Claim 11 (depends on 1)

The method according to claim 1, wherein the immune stimulating composition includes Lactococcus Latis and at least one arabinogalactan.

### Claim 12

A method of reducing a likelihood of an allergic disease developing, comprising: dispersing, in the air of an urban dwelling where an expectant mother human female resides, a prophylactic immune stimulating composition comprising: at least 5 grams of bovine manure components from a bovine that has not been administered an antibiotic effective against one of Lactobacillus johnsonii, and Bifidobacterium longum bv. Infantis, and an extract derived from a helminth selected from the group consisting of: Capillaria hepatica, Dicrocoelium dendriticum, Ascaris lumbricoides, Enterobius vermicularis, Trichuris trichiura, Ancylostoma duodenale, Necator americanus, Strongyloides stercoralis, Haemonchus contortus, and Trichinella spiralis, wherein said step of dispersing includes exposing the expectant mother to said immune stimulating composition so that the expectant mother can inhale the immune stimulating composition laden air within the urban dwelling at least three times a week for at least a 5 minute time period, for at least the expectant mother's last trimester, and applying to the expectant mother's birth canal prior to the birth of her baby with a composition including a bacterial formulation that comprises at least one of: Prevotella; Lactobacillus johnsonii; Bacteroides fragilis, Lactobacillus ruminus, Bifidobacterium longum bv. Infantis.

### Claim 13 (depends on 12)

The method according to claim 12, wherein said bovine manure components include at least one bacteroidetes selected from a phylum of bacteria of the group Bacteroides, Flavobacteria, and Sphingobacteria, and at least one gram-positive firmicute.

### Claim 14 (depends on 12)

The method according to claim 12, wherein the immune stimulating composition further includes a separate additive including at least one arabinogalactan.

### Claim 15 (depends on 12)

The method according to claim 12, wherein the immune stimulating composition further includes cyclodextrin.

### Claim 16 (depends on 12)

The method according to claim 12, wherein the immune stimulating composition includes Lactococcus lactis.

### Claim 17

A method of reducing a likelihood of an allergic disease developing, comprising: dispersing, in the air of an urban dwelling where an expectant mother human female resides, a prophylactic immune stimulating composition comprising: at least 5 grams of bovine manure components from a bovine that has not been administered an antibiotic effective against one of Lactobacillus johnsonii, and Bifidobacterium longum bv. Infantis, and an extract derived from a helminth selected from the group consisting of: Capillaria hepatica, Dicrocoelium dendriticum, Ascaris lumbricoides, Enterobius vermicularis, Trichuris trichiura, Ancylostoma duodenale, Necator americanus, Strongyloides stercoralis, Haemonchus contortus, and Trichinella spiralis, wherein said step of dispersing includes exposing the expectant mother to said immune stimulating composition so that the expectant mother can inhale the immune stimulating composition laden air within the urban dwelling at least three times a week for at least a 5 minute time period, for at least the expectant mother's last trimester, and applying to the expectant mother's birth canal prior to the birth of her baby with a composition including an extract derived from a helminth selected from the group consisting of: Capillaria hepatica, Dicrocoelium dendriticum, Ascaris lumbricoides, Enterobius vermicularis, Trichuris trichiura, Ancylostoma duodenale, Necator americanus, Strongyloides stercoralis, Haemonchus contortus, and Trichinella spiralis.

### Claim 18 (depends on 17)

The method according to claim 17, wherein the immune stimulating composition further includes a separate additive including at least one arabinogalactan.

### Claim 19 (depends on 17)

The method according to claim 17, wherein the immune stimulating composition further includes cyclodextrin.

### Claim 20 (depends on 17)

The method according to claim 17, wherein the immune stimulating composition includes Lactococcus lactis.

### Claim 21 (depends on 1)

The method according to claim 1, wherein the immune stimulating composition includes Clostridium clostridioforme.

### Claim 22 (depends on 1)

The method according to claim 1, wherein the allergic disease comprises one of asthma and food allergies.

### Claim 23 (depends on 12)

The method according to claim 12, wherein the immune stimulating composition includes Clostridium clostridioforme.

### Claim 24 (depends on 12)

The method according to claim 12, wherein the allergic disease comprises one of asthma and food allergies.

### Claim 25 (depends on 17)

The method according to claim 17, wherein the immune stimulating composition includes Clostridium clostridioforme.

### Claim 26 (depends on 17)

The method according to claim 17, wherein the allergic disease comprises one of asthma and food allergies.