# US 12,213,505 B2 · Composition for promoting restful sleep and methods of making and using the same

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- Number: US 12,213,505 B2
- Document ID: US12213505B2
- Status: Granted
- Kind: B2
- Application number: 17/855,430
- Filed: 2022-06-30
- Published: 2023-02-09
- Granted: 2025-02-04
- Earliest claimed: 2021-07-05
- Assignees: Healthy Ingredient Solutions, LLC
- Applicants: Celesta Company LLC
- Inventors: David Wilfred Lafond; Christine Lynn O'Neil; Jean-Pierre Montmayeur
- Web page: https://patentgrep.com/patent/US12213505B2

## CPC

- A23L 33/105: Plant extracts, their artificial duplicates or their derivatives
- A61P 25/24: Antidepressants
- A23L 2/52: Adding ingredients (adding preservatives A23B70/10)
- A23L 33/15: Vitamins
- A61K 9/0053: {Mouth and digestive tract, i.e. intraoral and peroral administration}
- 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 31/047: having two or more hydroxy groups, e.g. sorbitol
- A61K 31/05: Phenols {(cannabinoids A61K31/658)}
- A61K 31/122: having the oxygen directly attached to a ring, e.g. quinones, vitamin K1, anthralin
- A61K 31/194: having two or more carboxyl groups, e.g. succinic, maleic or phthalic acid
- 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 31/216: of acids having aromatic rings, e.g. benactizyne, clofibrate
- A61K 31/353: 3,4-Dihydrobenzopyrans, e.g. chroman, catechin
- A61K 31/4045: Indole-alkylamines; Amides thereof, e.g. serotonin, melatonin
- A61K 31/4415: Pyridoxine, i.e. Vitamin B6 (pyridoxal phosphate A61K31/675)
- A61K 31/7004: Monosaccharides having only carbon, hydrogen and oxygen atoms
- A61K 31/7016: Disaccharides, e.g. lactose, lactulose (lactobionic acid A61K31/7032)
- A61K 31/7028: Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages
- A61K 31/7032: attached to a polyol, i.e. compounds having two or more free or esterified hydroxy groups, including the hydroxy group involved in the glycosidic linkage, e.g. monoglucosyldiacylglycerides, lactobionic acid, gangliosides
- A61K 33/06: Aluminium, calcium or magnesium; Compounds thereof {, e.g. clay}
- A61K 36/185: Magnoliopsida (dicotyledons)
- A61K 36/3486: {Humulus}
- A61K 36/41: Crassulaceae (Stonecrop family)
- A61K 36/534: Mentha (mint)
- A61K 36/575: Magnolia
- A61K 36/82: Theaceae (Tea family), e.g. camellia
- A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
- A23L: FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF (preservation thereof A23B)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- 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)

## Abstract

Compositions promote restful sleep and/or to a feeling of restful sleep. Specifically, the compositions of the present invention comprise a combination of hops extract, magnolia bark extract, melatonin, magnesium, rhodiola extract, L-theanine, vitamin B6, and spearmint extract and/or green tea extract to promote restful sleep and/or a feeling of restful sleep in an individual or animal. Methods of making and using the same are further provided.

## Claims

### Claim 1

A dietary composition formulated in a therapeutic effective amount to promote restful sleep in humans or animals consisting of a blend of:
a first substance selected from the group consisting of humulone, xanthohumol, myrcenol, and combinations thereof;
a second substance selected from the group consisting of honokiol, magnolol, and combinations thereof;
a third substance selected from the group consisting of rosavine, tyrosol, salidroside, and combinations thereof;
a fourth substance selected from the group consisting of rosmarinic acid, epigallocatechin gallate, and combinations thereof;
melatonin;
L-theanine;
magnesium;
vitamin B6 and
optionally an excipient;
wherein the dietary composition is in the form of a pill, a capsule, a tablet, a softgel, a lozenge, a powder, a liquid, a food, a beverage, a gummy, or an orally-dissolving film strip.

### Claim 2 (depends on 1)

The dietary composition of claim 1, wherein the first substance is derived from hops.

### Claim 3 (depends on 2)

The dietary composition of claim 2, wherein the first substance is in the form of hops extract.

### Claim 4 (depends on 1)

The dietary composition of claim 1, wherein the third substance is derived from rhodiola.

### Claim 5 (depends on 4)

The dietary composition of claim 4, wherein the third substance is in the form of rhodiola extract.

### Claim 6 (depends on 1)

The dietary composition of claim 1, wherein the fourth substance is derived from an ingredient selected from the group consisting of spearmint, green tea, and a blend thereof.

### Claim 7 (depends on 6)

The dietary composition of claim 6, wherein the fourth substance is in the form of an ingredient selected from the group consisting of spearmint extract, green tea extract, and a blend thereof.

### Claim 8 (depends on 1)

The dietary composition of claim 1, wherein the second substance is derived from magnolia.

### Claim 9 (depends on 8)

The dietary composition of claim 8, wherein the second substance is in the form of magnolia bark extract.

### Claim 10 (depends on 1)

The dietary composition of claim 1, wherein the first substance is from hops extract and the hops extract is present in the blend in an amount between about 0.1% and about 70% by weight, wherein the second substance is from magnolia bark extract and the magnolia bark extract is present in the blend in an amount between about 0.1% and about 65% by weight, wherein the melatonin is present in the blend in an amount between about 0.1% and about 75% by weight, wherein the magnesium is present in the blend in an amount between about 0.1% and about 75% by weight, wherein the third substance is from rhodiola extract and the rhodiola extract is present in the blend in an amount between about 0.1% and about 80% by weight, wherein L-theanine is present in the blend in an amount between about 0.1% and about 75% by weight, wherein the fourth substance is from an ingredient selected from the group consisting of spearmint extract, green tea extract, and a combination thereof and the ingredient is present in the blend in an amount between about 0.1% and about 95% by weight, and the vitamin B6 is present in the blend in an amount between about 0.01% and about 30% by weight.

### Claim 11 (depends on 1)

The dietary composition of claim 1, wherein the first substance is from hops extract and the hops extract is present in the blend in an amount between about 1% and about 20% by weight, wherein the second substance is from magnolia bark extract and the magnolia bark extract is present in the blend in an amount between about 1% and about 40% by weight, wherein the melatonin is present in the blend in an amount between about 0.1% and about 10% by weight, wherein the magnesium is present in the blend in an amount between about 1% and about 40% by weight, wherein the third substance is from rhodiola extract and the rhodiola extract is present in the blend in an amount between about 1% and about 40% by weight, wherein L-theanine is present in the blend in an amount between about 1% and about 50% by weight, wherein the fourth substance is from an ingredient selected from the group consisting of spearmint extract, green tea extract, and combinations thereof and the ingredient is present in the blend in an amount between about 1% and about 60% by weight, and the vitamin B6 is present in the blend in an amount between about 0.1% and about 10% by weight.

### Claim 12 (depends on 1)

The dietary composition of claim 1, wherein the first substance is from hops extract and the hops extract is present in the dietary composition in an amount between about 10 mg and about 500 mg, wherein the second substance is from magnolia bark extract and the magnolia bark extract is present in the dietary composition in amount between about 5 mg and about 400 mg, wherein the melatonin is present in the dietary composition in an amount between about 0.5 mg and about 700 mg, wherein the magnesium is present in the dietary composition in an amount between about 10 mg and about 350 mg, wherein the third substance is from rhodiola extract and the rhodiola extract is present in the dietary composition in an amount between about 20 mg and about 1000 mg, wherein L-theanine is present in the dietary composition in an amount between about 20 mg and about 600 mg, wherein the fourth substance is from an ingredient selected from the group consisting of spearmint extract, green tea extract, and combinations thereof and the ingredient is present in the dietary composition in an amount between about 200 mg and about 800 mg, and the vitamin B6 is present in the dietary composition in an amount between about 2 mg and about 100 mg.

### Claim 13 (depends on 1)

The dietary composition of claim 1, wherein the first substance is from hops extract and the hops extract is present in the dietary composition in an amount between about 15 mg and about 35 mg, wherein the second substance is from magnolia bark extract and the magnolia bark extract is present in the dietary composition in amount between about 50 mg and about 150 mg, wherein the melatonin is present in the dietary composition in an amount between about 1 mg and about 3 mg, wherein the magnesium is present in the dietary composition in an amount between about 100 mg and about 300 mg, wherein the third substance is from rhodiola extract and the rhodiola extract is present in the dietary composition in an amount between about 100 mg and about 500 mg, wherein L-theanine is present in the dietary composition in an amount between about 100 mg and about 400 mg, wherein the fourth substance is from an ingredient selected from the group consisting of spearmint extract, green tea extract, and combinations thereof and the ingredient is present in the dietary composition in an amount between about 300 mg and about 600 mg, and the vitamin B6 is present in the dietary composition in an amount between about 5 mg and about 50 mg.

### Claim 14 (depends on 1)

The dietary composition of claim 1, wherein the first substance is from hops extract and the hops extract is present in the dietary composition in an amount of about 20 mg, wherein the second substance is from magnolia bark extract and the magnolia bark extract is present in the dietary composition in amount of about 100 mg, wherein the melatonin is present in the dietary composition in an amount of about 2 mg, wherein the magnesium is present in the dietary composition in an amount of about 200 mg, wherein the third substance is from rhodiola extract and the rhodiola extract is present in the dietary composition in an amount of about 200 mg, wherein L-theanine is present in the dietary composition in an amount of about 200 mg, wherein the fourth substance is from an ingredient selected from the group consisting of spearmint extract, green tea extract, and combinations thereof and the ingredient is present in the dietary composition in an amount of about 485 mg, and the vitamin B6 is present in the dietary composition in an amount of about 10 mg.

### Claim 15

A method of promoting restful sleep in humans or animals comprising the steps of:
providing a dietary composition formulated in a therapeutic effective amount to promote restful sleep in humans or animals consisting of a blend of a first substance selected from the group consisting of humulone, xanthohumol, myrcenol, and combinations thereof; a second substance selected from the group consisting of honokiol, magnolol, and combinations thereof; a third substance selected from the group consisting of rosavine, tyrosol, salidroside, and combinations thereof; a fourth substance selected from the group consisting of rosmarinic acid, epigallocatechin gallate, and combinations thereof; melatonin; L-theanine; magnesium; vitamin B6; and an optional excipient and
forming the dietary composition into an ingestible form wherein the ingestible form is a pill, a capsule, a tablet, a softgel, a lozenge, a powder, a liquid, a food, a beverage, a gummy, or an orally-dissolving film strip.

### Claim 16 (depends on 15)

The method of claim 15, wherein the first substance is from hops extract, the second substance is from magnolia bark extract, the third substance is from rhodiola extract, and the fourth substance is from an ingredient selected from the group consisting of spearmint extract, green tea extract, and a combination thereof.

### Claim 17 (depends on 16)

The method of claim 16, wherein the hops extract is present in the blend in an amount between about 0.1% and about 70% by weight, the magnolia bark extract is present in the blend in an amount between about 0.1% and about 65% by weight, wherein the melatonin is present in the blend in an amount between about 0.1% and about 75% by weight, wherein the magnesium is present in the blend in an amount between about 0.1% and about 75% by weight, wherein the rhodiola extract is present in the blend in an amount between about 0.1% and about 80% by weight, wherein L-theanine is present in the blend in an amount between about 0.1% and about 75% by weight, wherein the ingredient selected from the group consisting of spearmint extract, green tea extract, and a combination thereof is present in the blend in an amount between about 0.1% and about 95% by weight, and the vitamin B6 is present in the blend in an amount between about 0.01% and about 30% by weight.

### Claim 18 (depends on 16)

The method of claim 16, wherein the hops extract is present in the dietary composition in an amount between about 10 mg and about 500 mg, wherein the magnolia extract is present in the dietary composition in an amount between about 5 mg and about 400 mg, wherein the melatonin is present in the dietary composition in an amount between about 0.5 mg and about 700 mg, wherein the magnesium is present in the dietary composition in an amount between about 10 mg and about 350 mg, wherein the third substance is from rhodiola extract and the rhodiola extract is present in the dietary composition in an amount between about 20 mg and about 1000 mg, wherein L-theanine is present in the dietary composition in an amount between about 20 mg and about 600 mg, wherein the ingredient selected from the group consisting of spearmint extract, green tea extract, and a combination thereof is present in an amount between about 200 mg and about 800 mg, and the vitamin B6 is present in the dietary composition in an amount between about 2 mg and about 100 mg.