IP Library › Granted Patent US 12,685,331
Granted Patent B2
US 12,685,331 · App. 17/943,652 · Granted Jul 21, 2026

Nutritional compositions and infant formula for promoting de novo myealination

Inventors: Nora Schneider (Epalinges, CH); Jonas Hauser (Lausanne, CH); Sean Deoni (Providence, RI); Tamas Bartfai (Stockholm, SE)
Assignee: Societe des Produits Nestle S.A.
A23L33/40A23L33/12A23L33/15A23L33/16A23L33/30A24B15/38A61K9/0095A61K31/14A61K31/202A61K31/519A61K31/661A61K31/70A61K31/714A61K33/00A61K33/06A61K33/26A61K33/30A61K33/42A61K45/06A61P25/28A23V2002/00A23V2200/322A23V2250/1564A23V2250/1578A23V2250/1588A23V2250/1592A23V2250/161A23V2250/1618A23V2250/1642A23V2250/1846A23V2250/185A23V2250/1852A23V2250/1862A23V2250/1886A23V2250/5424A23V2250/7056A23V2250/706
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Quick Facts
Patent No.
US 12,685,331
App. No.
17/943,652
Filed
Sep 13, 2022
Granted
Jul 21, 2026
Kind
B2
Art Unit
1611
USPC
426/72
Abstract

A synthetic nutritional composition comprising a mineral 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 (11)

1 . A method for promoting, supporting or optimizing de novo myelination, the method comprising administering, to a formula fed infant having a suboptimal de novo myelination trajectory, a synthetic nutritional composition comprising greater than 4 mg of iron/100 g dry weight of the synthetic nutritional composition.

2 . The method according to claim 1 , wherein the synthetic nutritional composition comprises the iron in an amount greater than 5 mg/100 g dry weight of the synthetic nutritional composition.

3 . The method according to claim 1 , wherein the synthetic nutritional composition comprises one or more ingredients selected from the group consisting of a vitamin, choline, a phospholipid, and a compound comprising a fatty acid, other than a phospholipid.

4 . The method according to claim 1 , wherein the synthetic nutritional composition comprises one or more ingredients selected from the group consisting of docosahexaenoic acid, arachidonic acid, phosphatidylcholine, phosphatidylinositole, phosphatidylserine, phosphatidylethanolamine, sphingomyelin, and any mixture of any of the foregoing.

5 . The method according to claim 1 , wherein the synthetic nutritional composition comprises one or more ingredients selected from the group consisting of folic acid in an amount greater than 100 mcg/100 g dry weight of the synthetic nutritional composition, vitamin B12 in an amount greater than 5 mcg/100 g dry weight of the synthetic nutritional composition, sphingomyelin in an amount greater than 300 mg/kg dry weight of the synthetic nutritional composition, a fatty acid derivative that comprises DHA in an amount of 60 to 350 mg/100 g dry weight of the synthetic nutritional composition, and a fatty acid derivative that comprises arachidonic acid in an amount of 60 to 350 mg/100 g dry weight of the synthetic nutritional composition.

6 . 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 that is 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.

7 . The method according to claim 1 , wherein the method optimises cognitive function such that the formula fed infant has scores in a standardized neurodevelopmental test that are less than one standard deviation different from that of an exclusively breastfed subject of a well-nourished mother.

8 . The method according to claim 1 , wherein the synthetic nutritional composition comprises one or more ingredients selected from the group consisting of vitamin B12, folic acid, docosahexaenoic acid, arachidonic acid, nervonic acid, stearic acid, and mixtures thereof.

9 . The method according to claim 1 , wherein the synthetic nutritional composition comprises one or more ingredients selected from the group consisting of zinc in an amount greater than 0.08 mg/100 g dry weight of the synthetic nutritional composition, calcium in an amount greater than 0.8 mg/100 g dry weight of the synthetic nutritional composition, phosphorus in an amount greater than 1.7 mg/100 g dry weight of the synthetic nutritional composition, copper in an amount greater than 10 mcg/100 g dry weight of the synthetic nutritional composition, magnesium in an amount greater than 0.2 mg/100 g dry weight of the synthetic nutritional composition, and mixtures thereof.

10 . A method for promoting, supporting or optimizing an outcome selected from the group consisting of de novo myelination trajectory, brain structure, brain connectivity, intellectual potential, cognitive potential, learning potential, cognitive functioning, and combinations thereof in a human formula fed infant having a suboptimal de novo myelination trajectory, the method comprising administering a synthetic nutritional composition comprising greater than 4 mg of iron/100 g dry weight of the synthetic nutritional composition to the human formula fed infant having a suboptimal de novo myelination trajectory, and wherein brain structure refers to the 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 human formula fed infant has scores in a standardized neurodevelopmental test that are less than one standard deviation different from that of an exclusively breastfed subject of a well-nourished mother.

11 . The method according to claim 10 , wherein the iron is administered to the human formula fed infant having a suboptimal de novo myelination trajectory separately, sequentially and/or simultaneously to one or more ingredients selected from the group consisting of: choline; folic acid; vitamin B12; a fatty acid derivative comprising docosahexaenoic acid and/or arachidonic acid and/or nervonic acid and/or stearic acid; and a phospholipid.

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 7, 2025
From: SCHNEIDER, NORA; HAUSER, JONAS; DEONI, SEAN
To: NESTEC S.A.
Reel/Frame 071052/0281 →
MERGER Recorded May 7, 2025
From: NESTEC S.A.
To: SOCIETE DES PRODUITS NESTLE S.A.
Reel/Frame 071218/0624 →
Priority Claims (5)
EP 15199752 · Dec 14, 2015 · regional
EP 15199757 · Dec 14, 2015 · regional
EP 15199758 · Dec 14, 2015 · regional
EP 15199764 · Dec 14, 2015 · regional
EP 15199769 · Dec 14, 2015 · regional
Continuity (8)
Continuation 16061061 · Dec 13, 2016
Provisional Application 62328068 · Apr 27, 2016
Provisional Application 62315238 · Mar 30, 2016
Provisional Application 62315187 · Mar 30, 2016
Provisional Application 62315224 · Mar 30, 2016
Provisional Application 62315249 · Mar 30, 2016
Provisional Application 62315198 · Mar 30, 2016
Related Publication 20230015563A1 · Jan 19, 2023
References Cited (70)
US 20040202765A1 · McMahon · 2004 [cited by examiner]
US 20070036870A1 · Bryan et al. · 2007 [cited by applicant]
US 20080003330A1 · Rueda et al. · 2008 [cited by applicant]
US 20080248100A1 · Liu et al. · 2008 [cited by applicant]
US 20090318394A1 · Nauroth et al. · 2009 [cited by applicant]
US 20110132927A1 · Ankudinov · 2011 [cited by applicant]
US 20110294757A1 · Shulman et al. · 2011 [cited by applicant]
US 20120171178A1 · Fleith · 2012 [cited by examiner]
US 20130122117A1 · Ben et al. · 2013 [cited by applicant]
US 20150148316A1 · Bar Yosef et al. · 2015 [cited by applicant]
CL 201801602 · 2018 [cited by applicant]
CL 201801603 · 2018 [cited by applicant]
CL 201801604 · 2018 [cited by applicant]
CL 201801605 · 2018 [cited by applicant]
CL 201801595 · 2018 [cited by applicant]
CL 201801597 · 2018 [cited by applicant]
CL 201801598 · 2018 [cited by applicant]
CL 201801599 · 2018 [cited by applicant]
CL 201801600 · 2018 [cited by applicant]
CN 102240374 · 2011 [cited by applicant]
CN 103533933 · 2014 [cited by applicant]
CN 103610064 · 2014 [cited by applicant]
CN 104883909 · 2015 [cited by applicant]
EP 3100737 · 2016 [cited by applicant]
JP 2002332069 · 2002 [cited by applicant]
JP 2014516749 · 2014 [cited by applicant]
JP 2016512976 · 2016 [cited by applicant]
WO 2011046451 · 2011 [cited by applicant]
WO 2014109863 · 2014 [cited by applicant]
WO 2015016285 · 2015 [cited by applicant]
WO 2015086719 · 2015 [cited by applicant]
WO 2017102714 · 2017 [cited by applicant]
WO 2017102717 · 2017 [cited by applicant]
Mintel (“Snow Nutratect Smart Baby Step 1 Infant Formula with Iron”, Jan. 2014) (Year: 2014). [cited by examiner]
Deoni et al (Neurolmage 82:77-86, 2013) (Year: 2013). [cited by examiner]
Deoni et al (Neurolmage 178:649-659, 2018) (Year: 2018). [cited by examiner]
Roncagliolo et al. “Evidence of altered central nervous system development in infants with iron deficiency anemia at 6 mo: delayed maturation of auditory brainstem responses” American Journal of Clinical Nutrition, 1998… [cited by applicant]
Bund et al. “Copper Uptake Induces Self-Assembly of 18.5 kDa Myelin Basic Protein (MBP)” Biophysical Journal, 2010, vol. 99, pp. 3020-3028. [cited by applicant]
Kursula “Structural properties of proteins specific to the myelin sheath” Amino Acids, 2008, vol. 34, pp. 175-185. [cited by applicant]
Brochure Entitled “Follow-On Formula Milk (Stage 3)” Mintel, Jul. 2014, 4 pages. [cited by applicant]
Smith et al. “The interaction of zinc with membrane-associated 18.5 kDa myelin basic protein: an attenuated total reflectance-Fourier transform infrared spectroscopic study” Amino Acids, 2010, vol. 39, pp. 739-750. [cited by applicant]
Nair, “Importance of Phosphorus in Body” Value Food Nutrition and Health Information Portal, 2014, pp. 1-10, XP055364668. [cited by applicant]
Klevay “Myelin and traumatic brain injury: The copper deficiency hypothesis” Medical Hypotheses, 2013, vol. 81 pp. 995-998. [cited by applicant]
Collins “Preserve Your Myelin Sheath Function and Protect Your Brain from Decay” 2012, 2 pages, printed from the Internet at http://undergroundhealthreporter.com/myelin-sheath-function-protect-your-brain/. [cited by applicant]
Madan et al. “Developmental and Neurophysiologic Deficits in Iron Deficiency in Children” Indian Journal of Pediatrics, 2011, vol. 78, pp. 58-64. [cited by applicant]
Article Entitled “The Magic of Copper Water”, 2016, pp. 1-8, XP55365349, printed from the Internet at http://samsaramindanbody.com/blog/ayurveda/magic-copper-water. [cited by applicant]
Earl et al. “Zinc Ions Stabilise the Association of Basic Protein with Brain Myelin Membranes” Journal of Neurochemistry, 1988, vol. 51, pp. 718-724. [cited by applicant]
Wlassof (Vitamin B12 Deficiency and its Neurological Consequences, available online at https://brainblogger.com/2014/07/30/ vitamin-b12-deficiency-and-its-neurological-consequences/, Jul. 30, 2014) (Year: 2014). [cited by applicant]
Nyaradi et al, “The Role of Nutrition in Children's Neurocognitive Development, from Pregnancy through Childhood”, Frontiers in Human Neuroscience, vol. 7, Issue No. 97, Mar. 31, 2013, pp. 1-16. [cited by applicant]
Gu, “Nutrition of Brain Development”, Compilation of the 19th Nutrition Knowledge Update Class of China Nutrition Society, Sep. 7, 2009, pp. 1-13. [cited by applicant]
Sun, “Nutrition and tile Brain Development and Function in Children”, Journal of Clinical Pediatrics, Issue No. 6, Jun. 30, 2003, pp. 380-381. [cited by applicant]
Office Action Received for Application No. CN20168007299-1.-1, mailed on Jul. 5, 2021, 18 Pages(? Pages of English Translation and 11 Pages of Official Copy). [cited by applicant]
Lozoff et al (Nutr Rev 65:S34-S91, 2006) (Year: 2006). [cited by applicant]
Farquharson et al., “Effect of Diet on the Fatty Acid Composition of tile Major Phospholipids of Infant Cerebral Cortex”. Archives of Disease in Child?1ood, vol. 72, Issue No. 3, Mar. 1, 1995, pp. 198-203. [cited by applicant]
Brazilion Office Action for Appl No. BR11201801265-2 dated Dec. 19, 2019. [cited by applicant]
Deoni et al (NeuroImage 82:77-86, 2013) (Year: 2013). [cited by applicant]
Oshida et al (Pediatric Research 53:589-593, 2003) (Year: 2003). [cited by applicant]
Anonymous, “Infant Formula Milk (Stage 1 )”, Record ID: 2558549, Apr. 11, 2016, pp. 1-4, XP55264049, available on http://www.gnpd.com/sinatra/recordpage/2558549/from_search/4nDi9ti2FC/. [cited by applicant]
Philippines Office Action for Appl No. 1/2022/550428 dated Oct. 16, 2024, 6 pages. [cited by applicant]
“Infant Formula Stage 1”, Mintel, Record ID 1779748, Apr. 2012, pp. 1-4, XP093277557. [cited by applicant]
Venkatramanan et al., “Vitamin B-12 and Cognition in Children1-3”, American Society for Nutrition, vol. 7, Issue No. 5, 2016, pp. 879-888, XP093197151. [cited by applicant]
Black, “Effects of VitaminB12 and Folate Deficiency on Brain Development in Children”, Food and Nutrition Bulletin, vol. 29, Issue No. 2, 2008, pp. S126-S131, XP093277448. [cited by applicant]
“Stage 1 Baby Formula”, Mintel, Record ID 1593523, Aug. 2011, pp. 1-4, XP093277596. [cited by applicant]
“Stage 2 Infant Formula”, Mintel, Record ID 3012703, Mar. 2015, pp. 1-5, XP093277604. [cited by applicant]
“Step 1 Infant Formula with Iron”, Mintel, Record ID 2286613, Jan. 2014, pp. 1-5, XP093278009. [cited by applicant]
European Office Action for Appl No. 23 169 130.4-1105 dated May 23, 2025, 14 pages. [cited by applicant]
European Office Action for Appl No. 23 169 130.4-1105 dated Mar. 26, 2026, 9 pages. [cited by applicant]
Systematic Nutrition Theory, edited by JIANG Feng et al., China Medical Science and Technology Press, Jul. 2012, the 2nd edition, the 1st printing, pp. 50-51. [cited by applicant]
Chinese Pediatric Clinical Handbook, edited by JIANG Zaifang, Shandong Science and Technology Press, the 1st edition, the 1st printing, Jul. 1998, p. 29. [cited by applicant]
Pharmacology, edited by LI Changling et al., Beijing Medical University Press, Aug. 2001, the 1st edition, the 1st printing, p. 136. [cited by applicant]