# US 11,297,872 B2 · Nutritional composition and infant formula for promoting de novo myelination

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- Number: US 11,297,872 B2
- Document ID: US11297872B2
- Status: Granted
- Kind: B2
- Application number: 16/061,121
- Filed: 2016-12-13
- Published: 2018-12-20
- Granted: 2022-04-12
- Earliest claimed: 2015-12-14
- Assignees: Societe des Produits Nestle S.A.
- Applicants: Nestec S.A.
- Inventors: Nora Schneider; Jonas Hauser; Sean Deoni; Tamas Bartfai; Jonathan O'Regan
- Web page: https://patentgrep.com/patent/US11297872B2

## CPC

- A23L 33/40: {Complete food formulations for specific consumer groups or specific purposes, e.g. infant formula}
- A23L 33/12: Fatty acids or derivatives thereof
- A23L 33/15: Vitamins
- A23L 33/16: Inorganic salts, minerals or trace elements
- A23L 33/30: {Dietetic or nutritional methods, e.g. for losing weight (A23L33/10 takes precedence)}
- A24B 15/38: having only nitrogen as hetero atom
- 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 31/14: Quaternary ammonium compounds, e.g. edrophonium, choline (betaines A61K31/205)
- A61K 31/202: having three or more double bonds, e.g. linolenic (eicosanoids, e.g. leukotrienes A61K31/557)
- A61K 31/519: ortho- or peri-condensed with heterocyclic rings
- A61K 31/661: Phosphorus acids or esters thereof not having P—C bonds, e.g. fosfosal, dichlorvos, malathion {or mevinphos}
- A61K 31/70: Carbohydrates; Sugars; Derivatives thereof (sorbitol A61K31/047)
- A61K 31/714: Cobalamins, e.g. cyanocobalamin, i.e. vitamin B12
- A61K 33/00: Medicinal preparations containing inorganic active ingredients
- A61K 33/06: Aluminium, calcium or magnesium; Compounds thereof {, e.g. clay}
- A61K 33/26: Iron; Compounds thereof
- A61K 33/30: Zinc; Compounds thereof
- A61K 33/42: Phosphorus; Compounds 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 25/28: for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
- A23V 2002/00: Food compositions, function of food ingredients or processes for food or foodstuffs
- A23V 2200/322: having an effect on the health of the nervous system or on mental function
- A23V 2250/1564: Aluminium
- A23V 2250/1578: Calcium
- A23V 2250/1588: Copper
- A23V 2250/1592: Iron
- A23V 2250/161: Magnesium
- A23V 2250/1618: Phosphorus
- A23V 2250/1642: Zinc
- A23V 2250/1846: Phosphatidyl Choline
- A23V 2250/185: Phosphatidyl Inositol
- A23V 2250/1852: Phosphatidyl Serine
- A23V 2250/1862: Arachidonic acid
- A23V 2250/1886: Stearic acid
- A23V 2250/5424: Dairy protein
- A23V 2250/7056: Vitamin B8 Folic acid
- A23V 2250/706: Vitamin B12
- A23L: FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF (preservation thereof A23B)
- A24B: MANUFACTURE OR PREPARATION OF TOBACCO FOR SMOKING OR CHEWING; TOBACCO; SNUFF
- 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
- A23V: INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION

## Abstract

A synthetic nutritional composition comprising a phospholipid and/or a metabolic precursor and/or metabolite thereof for use to promote, support or optimise de novo myelination, in particular the de novo myelination trajectory, and/or brain structure, and/or brain connectivity, and/or intellectual potential and/or cognitive potential, and/or learning potential and/or cognitive functioning in a subject, in particular a formula fed subject.

## Claims

### Claim 1

A method to reduce a risk of or mitigate sub-optimal de novo myelination trajectory in a formula fed infant up to 12 months of age, the method comprising administering to the formula fed infant a synthetic nutritional composition comprising sphingomyelin in an amount greater than 300 mg/kg dry weight of the synthetic nutritional composition.

### Claim 2 (depends on 1)

The method according to claim 1, wherein the synthetic nutritional composition further comprises at least an ingredient selected from the group consisting of a vitamin, a mineral, a choline, and a fatty acid derivative other than the sphingomyelin.

### Claim 3 (depends on 2)

The method according to claim 2, wherein the vitamin is selected from the group consisting of vitamin B12, folic acid, and combinations thereof; the mineral is selected from the group consisting of iron, zinc, calcium, phosphorus, copper and combinations thereof; and the fatty acid derivative is selected from the group consisting of docosahexaenoic acid, arachidonic acid, stearic acid, nervonic acid, and combinations thereof.

### Claim 4 (depends on 1)

The method according to claim 1, wherein the synthetic nutritional composition further comprises at least one ingredient selected from the group consisting of iron in an amount greater than 5 mg/100 g, DHA in an amount of 60 to 350 mg/100 g, arachidonic acid in an amount of 60 to 350 mg/100 g, folic acid in an amount of at least 100 mcg/kg, and vitamin B12 in an amount of at least 5 mcg/100 g, wherein all amounts are by dry weight of the synthetic nutritional composition.

### Claim 5 (depends on 1)

The method according to claim 1, wherein the synthetic nutritional composition is in a form selected from the group consisting of an infant formula, a composition for infants to be added or diluted with human breast milk, and a food stuff for consumption by infants either alone or in combination with human breast milk.

### Claim 6 (depends on 1)

The method according to claim 1, wherein the synthetic nutritional composition is administered to the formula fed infant separately, sequentially and/or simultaneously with an ingredient selected from the group consisting of folic acid, vitamin B12, iron, and a fatty acid derivative other than the sphingomyelin.

### Claim 7 (depends on 1)

The method according to claim 1, wherein the synthetic nutritional composition comprises iron, sphingomyelin, folic acid, choline, DHA, zinc, and phosphatidylcholine.

### Claim 8 (depends on 1)

The method according to claim 1, wherein the synthetic nutritional composition further comprises at least one compound comprising a fatty acid selected from the group consisting of a monoacylglycerol, a diacylglycerol, a triacylgylcerol, a cholesterol ester and the at least one compound comprising nervonic acid or stearic acid.