IP Library Granted Patent US 11,337,449
Granted Patent B2
US 11,337,449 · App. 16/061,047 · Granted May 24, 2022

Compositions and their use

Inventors: Nora Schneider (Epalinges, CH); Jonas Hauser (Lausanne, CH); Sean Deoni (Providence, RI); Tamas Bartfai (Stockholm, SE)
Assignee: Societe des Produits Nestle S.A.
A23L33/15A23L33/12A23L33/16A23L33/30A23L33/40A23V2002/00A23V2200/322A23V2250/1578A23V2250/1588A23V2250/1592A23V2250/161A23V2250/1618A23V2250/1642A23V2250/185A23V2250/1846A23V2250/1852A23V2250/1862A23V2250/1886A23V2250/5424A23V2250/706A23V2250/7056
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Quick Facts
Patent No.
US 11,337,449
App. No.
16/061,047
Granted
May 24, 2022
Kind
B2
Abstract

A synthetic nutritional composition comprising a vitamin 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 (33)

1. A method for promoting, supporting or optimizing de novo myelination, 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 formula fed subject, the method comprising:

administering to the formula fed subject a synthetic nutritional composition comprising vitamin B12 in an amount of 4 to 8.5 mcg/100 g dry weight of the composition,

wherein the brain structure refers to an amount and/or spatial distribution of myelinated matter throughout the brain, and/or in specific brain regions, and wherein the cognitive function is optimized if the formula fed subject's scores in a standardized neurodevelopmental test are less than one standard deviation different from that of an exclusively breastfed subject of a well-nourished mother.

2. The method according to claim 1 , wherein the formula fed subject is a human infant or child.

3. The method according to claim 1 , wherein the synthetic nutritional composition further comprises folic acid.

4. The method according to claim 3 , wherein the synthetic nutritional composition comprises the folic acid in an amount greater than 50 mcg/100 g dry weight of the composition.

5. The method according to claim 1 , wherein the synthetic nutritional composition further comprises an ingredient selected from the group consisting of a mineral, choline, a phospholipid, and a fatty acid derivative.

6. The method according to claim 5 , wherein the mineral is selected from the group consisting of iron, zinc, calcium, phosphorus, copper and combinations thereof; wherein the fatty acid derivative comprises docosahexaenoic acid and/or arachidonic acid and/or stearic acid and/or nervonic acid, and wherein the phospholipid is a compound of formula (I) or a mixture of compounds of formula (I)

wherein,

R 1 is O;

X is NH or O;

R 2 is a C2-C44 saturated or unsaturated, linear or branched acyl group;

R 3 is a substituent of formula (II) or formula (III):

Wherein, R 5 is a C2-C44 saturated or unsaturated, linear or branched acyl group and

R 6 is a C2-C44 saturated alkyl or alkenyl group; and

R 4 is selected from a C5 or C6 substituted or unsubstituted cyclic alkyl or alkenyl group, or,

—(CH 2 ) n —R 7 , wherein n is an integer ranging from 1 to 4, and R 7 is —N(CH 3 ) 3 + , NH 3 + , or a substituent of formula (IV) and,

7. The method according to claim 6 , wherein the phospholipid is selected from the group consisting of sphingomyelin, phosphatidylcholine, phosphatidylinositole, phosphatidylserine, and mixtures of the foregoing.

8. The method according to claim 1 , wherein the synthetic nutritional composition further comprises at least one additional ingredient selected from the group consisting of (a) iron in an amount greater than 5 mg/100 g dry weight of the composition, (b) sphingomyelin in an amount greater than 300 mg/kg dry weight of the composition, (c) a fatty acid derivative comprising docosahexaenoic acid in an amount of 60 to 350 mg/100 g dry weight of the composition, and (d) a fatty acid derivative comprising arachidonic acid in an amount of 60 to 350 mg/100 g dry weight of the composition.

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

10. The method according to claim 1 , wherein the formula fed subject to whom the composition is administered is an infant of 9 months of age or less.

11. The method according to claim 1 , wherein the formula fed subject to whom the composition is administered is an infant of 6 months of age or less.

12. The method according to claim 1 , wherein the formula fed subject to whom the composition is administered is an infant of 3 months of age or less.

13. The method according to claim 6 , wherein the n is an integer ranging from 1 to 2.

14. The method according to claim 1 , wherein the vitamin B12 is in an amount of 5 to 8 mcg/100 g dry weight of the composition.

15. The method according to claim 1 , wherein the method is for promoting, supporting or optimizing the de novo myelination trajectory.

16. A method to promote, support or optimise de novo myelination, 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, the method comprising:

feeding to the subject a composition comprising vitamin B12 in an amount of 4 to 8.5 mcg/100 g dry weight of the composition, and the composition further comprising at least one ingredient selected from the group consisting of a mineral, choline, a phospholipid, and a fatty acid derivative,

wherein the brain structure refers to an amount and/or spatial distribution of myelinated matter throughout the brain, and/or in specific brain regions, and wherein the cognitive function is optimised if the subject's scores in a standardized neurodevelopmental test are less than one standard deviation different from that of an exclusively breastfed subject of a well-nourished mother.

17. The method according to claim 16 , wherein the subject to whom the composition is fed is an infant of 9 months of age or less.

18. The method according to claim 16 , wherein the subject to whom the composition is fed is an infant of 6 months of age or less.

19. The method according to claim 16 , wherein the subject to whom the composition is fed is an infant of 3 months of age or less.

20. The method according to claim 16 , wherein the method is to promote, support or optimize the de novo myelination trajectory.

Assignments (6)
CORRECTIVE ASSIGNMENT TO CORRECT THE PATENT NUMBER 16062921 PREVIOUSLY RECORDED ON REEL 049391 FRAME 0756. ASSIGNOR(S) HEREBY CONFIRMS THE PATENT NUMBER SHOULD HAVE BEEN 16062912. Recorded Jul 3, 2020
From: NESTEC S.A.
To: SOCIÉTÉ DES PRODUITS NESTLÉ S.A.
Reel/Frame 054082/0001 →
CORRECTIVE ASSIGNMENT TO CORRECT THE PATENT NUMBER 16062921 PREVIOUSLY RECORDED ON REEL 049391 FRAME 0756. ASSIGNOR(S) HEREBY CONFIRMS THE PATENT NUMBER SHOULD HAVE BEEN 16062912. Recorded Jul 3, 2020
From: NESTEC S.A.
To: SOCIÉTÉ DES PRODUITS NESTLÉ S.A.
Reel/Frame 054082/0165 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 25, 2019
From: SCHNEIDER, NORA; HAUSER, JONAS; DEONI, SEAN; BARTFAI, TAMAS
To: NESTEC S.A.
Reel/Frame 049859/0339 →
MERGER Recorded Jul 25, 2019
From: NESTEC S.A.
To: SOCIETE DES PRODUITS NESTLE S.A.
Reel/Frame 049859/0365 →
CORRECTIVE ASSIGNMENT TO CORRECT THE ENGLISH TRANSLATION TO SHOW THE FULL AND CORRECT NEW NAME IN SECTION 51. PREVIOUSLY RECORDED AT REEL: 049391 FRAME: 0756. ASSIGNOR(S) HEREBY CONFIRMS THE MERGER. Recorded Jun 13, 2019
From: NESTEC S.A.
To: SOCIÉTÉ DES PRODUITS NESTLÉ S.A.
Reel/Frame 049853/0398 →
MERGER Recorded Jun 6, 2019
From: NESTEC S.A.
To: SOCIÉTÉ DES PRODUITS NESTLÉ S.A.
Reel/Frame 049391/0756 →