# US 2013/0156872 A1 · Integrated Neuromodulation System for Mood Enhancement of a Living Human Subject

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- Number: US 2013/0156872 A1
- Document ID: US20130156872A1
- Status: Published application
- Kind: A1
- Application number: 13/689,980
- Filed: 2012-11-30
- Published: 2013-06-20
- Earliest claimed: 2012-10-04
- Assignees: InVivo Beverages LLC
- Inventors: Vincent Giuliano; James Manley
- Web page: https://patentgrep.com/patent/US20130156872A1

## CPC

- A61K 36/48: Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
- A61K 9/0095: {Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches (A61K9/0007 takes precedence; eatable gels or foams A61K9/0056; oral mucosa adhesive forms A61K9/006)}
- A61K 31/133: having hydroxy groups, e.g. sphingosine
- A61K 31/137: Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine {or methadone}
- A61K 31/195: having an amino group
- A61K 31/197: the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid or pantothenic acid (carnitine A61K31/205)
- A61K 31/198: Alpha-amino acids, e.g. alanine or edetic acid [EDTA] (betaine A61K31/205; proline A61K31/401; tryptophan A61K31/405; histidine A61K31/4172; peptides not degraded to individual amino acids A61K38/00)
- A61K 31/522: having oxo groups directly attached to the heterocyclic ring, e.g. hypoxanthine, guanine, acyclovir
- A61K 31/7076: containing purines, e.g. adenosine, adenylic acid
- A61K 36/41: Crassulaceae (Stonecrop family)
- A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
- A61P 25/00: Drugs for disorders of the nervous system
- 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

## Abstract

The present invention is an ingestable blended formulation which will cause a series of distinct biochemical changes in-vivo; initiate desirable psychological consequences in that person; and induce an observable increase in cognitive functions for that living human subject. In particular, the initiated psychological events will generate a positive change in one's personal perceptions, evoke optimism as the subjective state of mind, and elicit a more sociable attitude and favorable mood as the observable behavior of the affected human person. Moreover, in addition to the initiation of a more positive state of mind, another major result and effect of ingesting the blended formulation is an observable amplification of human brain functions and a substantive increase of human concentration, focus and memory.

## Claims

### Claim 1

A non-prescription blended formulation suitable for ingestion by a living human subject, and which after ingestion is able to induce a more positive mood for and to initiate an observable enhancement of cognitive functions in a living human subject, said blended formulation comprising:
a controlled admixture of five essential active ingredients, each of which is able to pass the blood-brain barrier in-vivo, said controlled admixture being limited to
(a) not less than two different naturally existing nootropic dopamine neurotransmitter agonist,
(b) not less than one naturally existing nootropic acetylecholine neurotransmitter agonist,
(c) not less than one naturally existing nootropic serotonin neurotransmitter agonist,
(d) not less than one naturally existing nootropic gamma-aminobutyric acid (GABA) neurotransmitter agonist, and
(e) at least one nootropic adenosine antagonists,
wherein the ratio of all individual nootropic neurotransmitter agonists to all individual nootropic adenosine antagonists is proportionally not less than 5:1, and
wherein the neurotransmitter replenishment balance for the admixture of essential active agents mathematically is zero (“0”) in value.

### Claim 2 (depends on 1)

The blended formulation recited by claim 1, wherein each of said different nootropic neurotransmitter agonists is one selected from the group consisting of precursor compositions and synapse active molecules.

### Claim 3 (depends on 2)

The blended formulation recited by claim 2, wherein said biocompatible and non-toxic carrier medium is one selected from the group consisting of aqueous liquids and semi-solid hydrogels.

### Claim 4 (depends on 1)

The blended formulation recited by claim 1, wherein the individual nootropic dopamine neurotransmitter agonist is selected from the group consisting of L-phenylalanine, L-tyrosine, N-acetyl-L-tyrosine, L-3,4-dihydroxyphenylalanine (L-DOPA), phenylethylamine, biopterin, amineptine, methylphenidate, selegiline, rasagiline, ropinirole, pramipexole, mucuna pruriens, modafinil, and citicoline.

### Claim 5 (depends on 1)

The blended formulation recited by claim 1, wherein the individual nootropic acetylecholine neurotransmitter agonist is selected from the group consisting of choline, 2-dimethylaminoethanol (DMAE), meclofenoxate, alpha-glycerylphosphorylcholine (alpha-GPC), acetylcarnitine, pantothenic acid (Vitamin B5). galantamine, huperzine A, donepezil, ispronicline, nicotine, and arecoline.

### Claim 6 (depends on 1)

The blended formulation recited by claim 1, wherein said nootropic serotonin neurotransmitter agonist is selected from the group consisting of 5-hydroxytryptophan (or 5-HTP, 5-hydroxy-L-tryptophan), pyridoxal phosphate, pyridoxal-5′-phosphate, mesembrine, resveratrol, curcumin, piperine, harmal, rhodiola rosea, and tianeptine.

### Claim 7 (depends on 1)

The blended formulation recited by claim 1, wherein the individual nootropic gamma-aminobutyric acid neurotransmitter agonist is selected from the group consisting of ethanol, picrotoxin, and L-theanine.

### Claim 8 (depends on 1)

The blended formulation recited by claim 1, wherein the individual nootropic adenosine receptor antagonist is selected from the group consisting of caffeine, theophylline, apaxanthine, theobromide. 8-cyclopentyl-1,3-dimethylxanthine (or CPX, 8-cyclopentyltheophylline), 8-cyclopentyl-1,3-dipropylxanthine (or DPCPX), 8-phenyl-1,3-dipropylxanthine, bamifylline, and rolofylline.

### Claim 9

A fluid, non-prescription, blended formulation suitable for oral ingestion by a living human subject, and which after ingestion is able to initiate a more positive mood and to induce an observable enhancement of cognitive functions in a living human subject, said fluid blended formulation comprising:
a controlled fluid admixture of five essential active ingredients, each of which is able to pass the blood-brain barrier in-vivo, said controlled admixture being limited to
(i) at least two and not more than six different naturally existing nootropic dopamine neurotransmitter agonists,
(ii) at least one and not more than four different naturally existing nootropic acetylecholine neurotransmitter agonists,
(iii) at least one and not more than three different naturally existing nootropic serotonin neurotransmitter agonists,
(iv) at least one and not more than three different naturally existing nootropic gamma-aminobutyric acid neurotransmitter agonists,
(v) at least one and not more than three different naturally existing nootropic adenosine antagonists,
wherein the ratio of all individual nootropic neurotransmitter agonists to all individual nootropic adenosine antagonists is proportionally not less than 5:1 and not more than 16:3, and
wherein the neurotransmitter replenishment balance for the admixture of essential active agents mathematically is zero (“0”) in value; and
a biocompatible and non-toxic liquid carrier medium suitable for ingestion by a living human subject.

### Claim 10 (depends on 9)

The blended formulation recited by claim 9, wherein each of said different nootropic neurotransmitter agonists is one selected from the group consisting of precursor compositions and synapse active molecules.

### Claim 11 (depends on 10)

The blended formulation recited by claim 10, wherein said biocompatible and non-toxic carrier medium is one selected from the group consisting of aqueous liquids and semi-solid hydrogels.

### Claim 12 (depends on 9)

The blended formulation recited by claim 9, wherein the individual nootropic dopamine neurotransmitter agonist is selected from the group consisting of L-phenylalanine, L-tyrosine, N-acetyl-L-tyrosine, L-3,4-dihydroxyphenylalanine (L-DOPA), phenylethylamine, biopterin, amineptine, methylphenidate, selegiline, rasagiline, ropinirole, pramipexole, mucuna pruriens, modafinil, and citicoline.

### Claim 13 (depends on 9)

The blended formulation recited by claim 9, wherein the individual nootropic acetylecholine neurotransmitter agonist is selected from the group consisting of choline, 2-dimethylaminoethanol (DMAE), meclofenoxate, alpha-glycerylphosphorylcholine (alpha-GPC), acetylcarnitine, pantothenic acid (Vitamin B5). galantamine, huperzine A, donepezil, ispronicline, nicotine, and arecoline.

### Claim 14 (depends on 9)

The blended formulation recited by claim 9, wherein said nootropic serotonin neurotransmitter agonist is selected from the group consisting of 5-hydroxytryptophan (or 5-HTP, 5-hydroxy-L-tryptophan), pyridoxal phosphate, pyridoxal-5′-phosphate, mesembrine, resveratrol, curcumin, piperine, harmal, rhodiola rosea, and tianeptine.

### Claim 15 (depends on 9)

The blended formulation recited by claim 9, wherein the individual nootropic gamma-aminobutyric acid neurotransmitter agonist is selected from the group consisting of ethanol, picrotoxin, and L-theanine.

### Claim 16 (depends on 9)

The blended formulation recited by claim 9, wherein the individual nootropic adenosine receptor antagonist is selected from the group consisting of caffeine, theophylline, apaxanthine, theobromide. 8-cyclopentyl-1,3-dimethylxanthine (or CPX, 8-cyclopentyltheophylline), 8-cyclopentyl-1,3-dipropylxanthine (or DPCPX), 8-phenyl-1,3-dipropylxanthine, bamifylline, and rolofylline.

### Claim 17

A method for initiating an improvement of human mood and inducing an observable enhancement of cognitive functions in a living human subject, said method comprising the steps of:
obtaining an orally ingestable non-prescription blended formulation comprising an admixture of essential agents limited to
(a) not less than two and not more than six different naturally existing nootropic dopamine neurotransmitter agonists which are present in a total quantity ranging from about 200 mg/L to about 36,000 mg/L,
(b) not less than one and not more than four different naturally existing nootropic acetylecholine neurotransmitter agonists which are present in a total quantity ranging from about 20 mg/L to about 6,000 mg/L,
(c) at least one and not more than three naturally existing nootropic serotonin neurotransmitter agonists which are present in a total quantity ranging from about 10 mg/L to about 4,800 mg/L,
(d) at least one and not more than three naturally existing nootropic gamma-aminobutyric acid neurotransmitter agonists which are present in a total quantity ranging from about 10 mg/L to about 15,000 mg/L, and
(e) at least one and not more than three nootropic adenosine antagonists which are present in a total quantity ranging from about 10 mg/L to about 300 mg/L,
wherein the ratio of all individual nootropic neurotransmitter agonists to all individual nootropic adenosine antagonists is proportionally not less than 5:1 and not more than 16:3, and
wherein the minimal weight to volume (mg/L) ratio for all individual neurotransmitter agonists to all individual adenosine antagonists is proportionally not less than about 23:1, and
wherein the neurotransmitter replenishment balance for the admixture of essential active agents mathematically is zero (“0”) in value;
orally administering said blended formulation to a living human subject in a predetermined quantity sufficient to initiate an improvement of human mood and induce an observable enhancement of cognitive functions in a living human subject;
allowing at least a minimal time period after ingestion for said orally administered quantity of blended formulation to become assimilated by and to act within the body of said living human subject;
periodically monitoring the human subject for objective indications of a positive mental state and an observable enhancement of cognitive functions; and
determining from said objective indications that a more positive mental state exists and an observable enhancement of cognitive functions has occurred in the living human subject.