# US 12,004,528 B2 · Human milk products useful in pre- and post-operative care > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 12,004,528 B2 - Document ID: US12004528B2 - Status: Granted - Kind: B2 - Application number: 17/559,284 - Filed: 2021-12-22 - Published: 2022-06-16 - Granted: 2024-06-11 - Earliest claimed: 2015-12-30 - Assignees: Prolacta Bioscience, Inc. - Applicants: Prolacta Bioscience, Inc. - Inventors: Scott Elster; Joseph Fournell - Web page: https://patentgrep.com/patent/US12004528B2 ## CPC - A23C 9/206: {Colostrum; Human milk} - A23L 33/40: {Complete food formulations for specific consumer groups or specific purposes, e.g. infant formula} - A61K 38/018: {from milk} - A23B 11/12: by heating (by irradiation, e.g. by microwaves A23B11/16) - A23C 9/1422: {by ultrafiltration, microfiltration or diafiltration of milk, e.g. for separating protein and lactose; Treatment of the UF permeate} - A23L 33/19: Dairy proteins - A23C: DAIRY PRODUCTS, e.g. MILK, BUTTER OR CHEESE; MILK OR CHEESE SUBSTITUTES; PREPARATION THEREOF (preservation thereof A23B11/00) - A23L: FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF (preservation thereof A23B) - 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) - A23B: PRESERVATION OF FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES; CHEMICAL RIPENING OF FRUIT OR VEGETABLES ## Abstract The present disclosure relates to human milk compositions and methods of making and using the same. In particular, the disclosure features methods of using human milk compositions to feed subjects before and/or after surgery or medical operations and that are useful in promoting recovery. ## Claims ### Claim 1 A method for providing nutrition to a subject who is about to undergo or has undergone surgery, the method comprising enterally or orally administering to said subject a fortified human milk composition, wherein the fortified human milk composition comprises human milk and human milk fortifier; wherein the fortified human milk composition comprises a human protein constituent from about 10 to about 30 mg/ml protein and a human fat constituent from about 40 to about 70 mg/ml fat; and wherein the subject is a full-term infant. ### Claim 2 (depends on 1) The method of claim 1, wherein the fortified human milk composition comprises a human carbohydrate constituent from about 80 to about 100 mg/ml carbohydrate. ### Claim 3 (depends on 1) The method of claim 1, wherein the fortified human milk composition comprises a human protein constituent from about 20 to about 30 mg/ml protein, a human fat constituent from about 60 to about 70 mg/ml fat, and a human carbohydrate constituent from about 80 to about 100 mg/ml carbohydrate. ### Claim 4 (depends on 1) The method of claim 1, wherein the fortified human milk composition comprises a human protein constituent from about 10 to about 20 mg/ml protein, a human fat constituent from about 40 to about 50 mg/ml fat, and a human carbohydrate constituent from about 80 to about 90 mg/ml carbohydrate. ### Claim 5 (depends on 1) The method of claim 1, wherein the human milk fortifier component of the fortified human milk composition comprises a human protein constituent from about 35 mg/mL to about 45 mg/mL and a human fat constituent from about 80 mg/mL to about 100 mg/mL. ### Claim 6 (depends on 1) The method of claim 1, wherein the human milk is mother's own milk. ### Claim 7 (depends on 1) The method of claim 1, wherein the human milk is donor milk. ### Claim 8 (depends on 1) The method of claim 1, wherein is subject is 7 days old or younger. ### Claim 9 (depends on 1) The method of claim 1, wherein the surgery is for a congenital birth defect of the heart. ### Claim 10 (depends on 9) The method of claim 9, wherein the surgery is for wherein the congenital birth defect of the heart comprises single ventricle physiology. ### Claim 11 (depends on 1) The method of claim 1, wherein the surgery is for a congenital birth defect of the intestine. ### Claim 12 (depends on 11) The method of claim 11, wherein the congenital defect of the intestine comprises gastroschisis or omphalocele. ### Claim 13 (depends on 1) The method of claim 1, wherein administering the fortified human milk composition improves one or more clinical outcomes, wherein the one or more clinical outcomes comprise: neurodevelopmental outcomes; growth velocity including rate of weight gain, incremental linear growth, or incremental rate of head circumference growth; and/or reduced length of stay in the hospital, and/or a reduction of the days of parenteral nutrition relative to administration of non-human milk based formula. ### Claim 14 (depends on 1) The method of claim 1, wherein administering the fortified human milk composition reduces incidence of feeding intolerance, sepsis, and/or necrotizing enterocolitis (NEC), relative to administration of non-human milk based formula. ### Claim 15 (depends on 1) The method of claim 1, wherein the fortified human milk composition is administered to the subject at about 67 kcal/day to about 139 kcal/day. ### Claim 16 (depends on 1) The method of claim 1, wherein the fortified human milk composition is administered to the subject at about 90 kcal/day to about 100 kcal/day.