# US 10,765,653 B2 · Fatty acid formulations and methods of use thereof

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- Number: US 10,765,653 B2
- Document ID: US10765653B2
- Status: Granted
- Kind: B2
- Application number: 16/506,663
- Filed: 2019-07-09
- Published: 2019-10-31
- Granted: 2020-09-08
- Earliest claimed: 2007-02-22
- Assignees: Children's Hospital & Research Center Oakland
- Applicants: Children's Hospital & Research Center Oakland
- Inventors: Claudia R. Morris
- Web page: https://patentgrep.com/patent/US10765653B2

## CPC

- A61K 31/202: having three or more double bonds, e.g. linolenic (eicosanoids, e.g. leukotrienes A61K31/557)
- A23L 33/12: Fatty acids or derivatives thereof
- A23L 33/15: Vitamins
- A61K 9/0053: {Mouth and digestive tract, i.e. intraoral and peroral administration}
- A61K 9/48: Preparations in capsules, e.g. of gelatin, of chocolate {(A61K9/0004 takes precedence; bite capsules A61K9/0056)}
- A61K 31/122: having the oxygen directly attached to a ring, e.g. quinones, vitamin K1, anthralin
- A61K 31/201: having one or two double bonds, e.g. oleic, linoleic acids
- A61K 31/205: Amine addition salts of organic acids; Inner quaternary ammonium salts, e.g. betaine, carnitine
- A61K 31/355: Tocopherols, e.g. vitamin E
- A61K 31/375: Ascorbic acid, i.e. vitamin C; Salts thereof
- A61K 31/385: having two or more sulfur atoms in the same ring
- A61K 31/593: 9,10-Secocholestane derivatives, e.g. cholecalciferol, i.e. vitamin D3
- A61K 31/661: Phosphorus acids or esters thereof not having P—C bonds, e.g. fosfosal, dichlorvos, malathion {or mevinphos}
- A61K 33/30: Zinc; Compounds thereof
- A61K 38/43: Enzymes; Proenzymes; Derivatives thereof
- 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
- A61P 37/08: Antiallergic agents (antiasthmatic agents A61P11/06; ophthalmic antiallergics A61P27/14)
- A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
- A23V 2002/00: Food compositions, function of food ingredients or processes for food or foodstuffs
- 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)
- 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
- A23V: INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION

## Abstract

The present invention provides dietary formulations comprising polyunsaturated fatty acids and vitamin E. The present invention further provides methods of treating various conditions, generally involving administering to an individual in need thereof an effective amount of a subject dietary formulation.

## Claims

### Claim 1

A method of treating apraxia and/or autism spectrum disorder, the method comprising orally administering to an individual in need thereof an effective amount of a formulation comprising:
a) eicosapentaenoic acid (EPA);
b) docosahexaenoic acid (DHA);
c) α-tocopherol; and
d) γ-tocopherol,
wherein the ratio of EPA to DHA is in a range of from about 1.5:1 to about 5:1,
wherein the EPA is present in an amount of from 500 mg to 3000 mg per unit dose,
wherein the DHA is present in an amount of from 100 mg to 400 mg per unit dose,
wherein the α-tocopherol is present in an amount of from about 300 mg to about 3000 mg per unit dose, and
wherein the γ-tocopherol is present in an amount of from about 100 mg to about 1000 mg per unit dose.

### Claim 2 (depends on 1)

The method of claim 1, wherein the formulation is administered three times daily.

### Claim 3 (depends on 1)

The method of claim 1, wherein the formulation is administered twice daily.

### Claim 4 (depends on 1)

The method of claim 1, wherein the formulation is administered once daily.

### Claim 5 (depends on 1)

The method of claim 1, wherein said administration is effective to increase the percentile score of at least one of oral movement score, simple phonemic/syllabic score, complex phonemic/syllabic score, and spontaneous length and complexity score.

### Claim 6 (depends on 1)

The method of claim 1, wherein the formulation further comprises α-lipoic acid in an amount of from about 50 mg to about 600 mg per unit dose.

### Claim 7 (depends on 1)

The method of claim 1, wherein the formulation further comprises carnitine in an amount of from about 200 mg to about 3000 mg per unit dose.

### Claim 8 (depends on 1)

The method of claim 1, wherein the formulation further comprises an omega-6 fatty acid.

### Claim 9 (depends on 8)

The method of claim 8, wherein the omega-6 fatty acid is γ-linolenic acid.

### Claim 10 (depends on 1)

The method of claim 1, wherein the formulation further comprises an omega-9 fatty acid.

### Claim 11 (depends on 10)

The method of claim 10, wherein the omega-9 fatty acid is oleic acid.

### Claim 12 (depends on 1)

The method of claim 1, wherein the formulation further comprises vitamin C in an amount of from about 200 mg to about 500 mg.

### Claim 13 (depends on 1)

The method of claim 1, wherein the formulation further comprises vitamin K.

### Claim 14 (depends on 1)

The method of claim 1, wherein the formulation further comprises phosphocholine.

### Claim 15 (depends on 1)

The method of claim 1, wherein the formulation further comprises zinc.

### Claim 16 (depends on 1)

The method of claim 1, wherein the formulation further comprises one or more additional components selected from coenzyme Q, selenium, vitamin A, vitamin B1, riboflavin, vitamin B6, vitamin B12, vitamin D, arginine, calcium, magnesium, vitamin B7, vitamin B9, vitamin B5, tetrahydrobiopterin, and vitamin B3.

### Claim 17 (depends on 1)

The method of claim 1, wherein the formulation further comprises a pancreatic enzyme.

### Claim 18 (depends on 1)

The method of claim 1, wherein the formulation further comprises a leukotriene inhibitor.

### Claim 19 (depends on 1)

The method of claim 1, wherein the formulation is in a dosage form selected from a tablet, a capsule, a powder, a gel, and a liquid.

### Claim 20 (depends on 1)

The method of claim 1, wherein the formulation further comprises one or more food-grade components fit for human consumption.

### Claim 21 (depends on 9)

The method of claim 9, wherein the γ-linolenic acid is present in an amount of from about 50 mg to about 75 mg.

### Claim 22 (depends on 1)

The method of claim 1, wherein the formulation further comprises:
vitamin K1 in an amount of from 100 μg to 10 mg; and
vitamin K2 in an amount of from 100 μg to 2 mg.

### Claim 23 (depends on 1)

The method of claim 1, wherein the formulation further comprises vitamin D3.

### Claim 24 (depends on 23)

The method of claim 23, wherein the vitamin D3 is present in an amount of from 200 IU to 800 IU.

### Claim 25 (depends on 1)

The method of claim 1, wherein the formulation further comprises an anti-oxidant.

### Claim 26 (depends on 1)

The method of claim 1, wherein the formulation further comprises an anti-inflammatory agent.

### Claim 27 (depends on 1)

The method of claim 1, wherein the formulation further comprises an amino acid.