IP Library Granted Patent US 12,004,528
Granted Patent B2
US 12,004,528 · App. 17/559,284 · Granted Jun 11, 2024

Human milk products useful in pre- and post-operative care

Inventors: Scott Elster (Duarte, CA); Joseph Fournell (Duarte, CA)
Assignee: PROLACTA BIOSCIENCE, INC.
A23C9/206A23L33/40A61K38/018A23C3/02A23C9/1422A23L33/19
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Quick Facts
Patent No.
US 12,004,528
App. No.
17/559,284
Granted
Jun 11, 2024
Kind
B2
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 (16)

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.

2. 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.

3. 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.

4. 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.

5. 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.

6. The method of claim 1 , wherein the human milk is mother's own milk.

7. The method of claim 1 , wherein the human milk is donor milk.

8. The method of claim 1 , wherein is subject is 7 days old or younger.

9. The method of claim 1 , wherein the surgery is for a congenital birth defect of the heart.

10. The method of claim 9 , wherein the surgery is for wherein the congenital birth defect of the heart comprises single ventricle physiology.

11. The method of claim 1 , wherein the surgery is for a congenital birth defect of the intestine.

12. The method of claim 11 , wherein the congenital defect of the intestine comprises gastroschisis or omphalocele.

13. 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.

14. 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.

15. 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.

16. 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.

Assignments (4)
RELEASE OF SECURITY INTEREST Recorded Jun 5, 2026
From: HAYFIN SERVICES LLP, AS AGENT
To: PROLACTA BIOSCIENCE, INC.
Reel/Frame 074862/0454 →
SECURITY INTEREST Recorded Jun 5, 2026
From: PROLACTA BIOSCIENCE, INC.
To: WELLS FARGO BANK, NATIONAL ASSOCIATION
Reel/Frame 074871/0441 →
SECURITY INTEREST Recorded Dec 21, 2023
From: PROLACTA BIOSCIENCE, INC.
To: HAYFIN SERVICES LLP, AS COLLATERAL AGENT
Reel/Frame 065935/0511 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 22, 2021
From: ELSTER, SCOTT; FOURNELL, JOSEPH
To: PROLACTA BIOSCIENCE, INC.
Reel/Frame 058462/0654 →
Continuity (3)
Continuation 16067241
Provisional Application 62273243 · Dec 30, 2015
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