# US 12,005,083 B1 · Nutritional compositions with MFGM and certain human milk oligosaccharides and uses thereof

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- Number: US 12,005,083 B1
- Document ID: US12005083B1
- Status: Granted
- Kind: B1
- Application number: 16/910,849
- Filed: 2020-06-24
- Granted: 2024-06-11
- Earliest claimed: 2019-06-24
- Assignees: PBM Nutritionals, LLC
- Applicants: PBM Nutritionals, LLC
- Inventors: Michael Bernard Miklus; Anja Monika Wittke; Pedro Antonio Prieto; Cynthia M. Barber
- Web page: https://patentgrep.com/patent/US12005083B1

## CPC

- A61K 35/20: Milk; Whey; Colostrum
- A23L 2/66: Proteins
- A23L 33/10: using additives (addition of substantially indigestible substances A23L33/21)
- A23L 33/115: Fatty acids or derivatives thereof; Fats or oils
- A23L 33/12: Fatty acids or derivatives thereof
- A23L 33/125: containing carbohydrate syrups; containing sugars; containing sugar alcohols; containing starch hydrolysates (indigestible substances A23L33/21)
- A23L 33/15: Vitamins
- A23L 33/19: Dairy proteins
- A23L 33/40: {Complete food formulations for specific consumer groups or specific purposes, e.g. infant formula}
- A61K 9/0056: {Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals}
- 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 31/202: having three or more double bonds, e.g. linolenic (eicosanoids, e.g. leukotrienes A61K31/557)
- A61K 31/355: Tocopherols, e.g. vitamin E
- A61K 31/375: Ascorbic acid, i.e. vitamin C; Salts thereof
- 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 31/685: one of the hydroxy compounds having nitrogen atoms, e.g. phosphatidylserine, lecithin
- A61K 31/702: Oligosaccharides, i.e. having three to five saccharide radicals attached to each other by glycosidic linkages
- 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)
- 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 nutritional composition that includes a milk fat globule membrane component, at least one human milk oligosaccharide, and at least one additional component chosen from the group consisting of DHA, ARA, Vitamin E, Vitamin C, and sphingomyelin. The nutritional composition is in the form of a ready-to-drink composition, a food supplement, an extruded food bar, or a solid oral dosage form. The nutritional composition is typically administered or provided to adults, children, or infants through consumption.

## Claims

### Claim 1

A method for supporting cognitive function and/or neuron cellular health in an individual in need thereof, comprising the step of administering to the individual a therapeutically effective amount of a nutritional composition,
wherein the nutritional composition comprises a milk fat globule membrane component, at least one human milk oligosaccharide, and docosahexaenoic acid (DHA),
wherein the DHA is converted to a phospholipid form of the DHA in the gastrointestinal tract of the individual, and
wherein the level of the phospholipid form of the DHA in the blood of the individual is increased following said administering as compared to blood of an individual administered an otherwise identical nutritional composition not comprising said at least one human milk oligosaccharide.

### Claim 2 (depends on 1)

The method of claim 1, wherein the at least one human milk oligosaccharide comprises 2′-fucosyllactose (2′FL) and the nutritional composition further comprises at least one additional component chosen from the group consisting of arachidonic acid (ARA), Vitamin E, Vitamin C, and sphingomyelin.

### Claim 3 (depends on 1)

The method of claim 1, wherein the milk fat globule membrane has a lactose content of not more than about 5% by weight of the milk fat globule membrane component.

### Claim 4 (depends on 3)

The method of claim 3, wherein the milk fat globule membrane component has a protein content of at least about 75% by weight of the milk fat globule membrane component.

### Claim 5 (depends on 1)

The method of claim 1, wherein the at least one human milk oligosaccharide consists of 2′FL and is free of any dietary butyrate.

### Claim 6 (depends on 1)

The method of claim 1, wherein the at least one human milk oligosaccharide comprises at least one human milk oligosaccharide chosen from the group consisting of fucosyllactose, 2′FL, 3FL, Lacto-N-fucopentaose I (LNFP I), LNFP II, LNFP III, LNFP V, and mixtures thereof.

### Claim 7 (depends on 6)

The method of claim 6, wherein the at least one human milk oligosaccharide is 2′FL and the milk fat globule membrane component comprises from about 10% to about 25% fat by weight of the milk fat globule component; water present in an amount such that the milk fat globule component has a moisture content of not more than 7% by weight of the milk fat globule component; ash present in an amount of not more than 5% by weight of the milk fat globule component; and one or more phospholipids where the total amount of phospholipids in the milk fat globule component is from about 4% to about 9% by weight of the milk fat globule component.

### Claim 8 (depends on 1)

The method of claim 1, wherein the nutritional composition is free of butyrate.
