IP Library Granted Patent US 11,344,041
Granted Patent B2
US 11,344,041 · App. 16/067,241 · Granted May 31, 2022

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

Inventors: Scott Elster (City of Industry, CA); Joseph Fournell (City of Industry, CA)
Assignee: PROLACTA BIOSCIENCE, INC.
A23C9/206A23L33/40A61K38/018A23C3/02A23C9/1422A23L33/19
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Quick Facts
Patent No.
US 11,344,041
App. No.
16/067,241
Granted
May 31, 2022
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 (20)

1. A method for providing nutrition to a subject who is about to undergo or has undergone surgery for a congenital heart defect, the method comprising enterally or orally administering to said subject a fortified human milk composition comprising a human milk fortifier mixed with human milk,

wherein the human milk fortifier 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;

and

wherein the subject is a full-term infant born with a congenital heart defect.

2. The method of claim 1 , wherein administering the fortified human milk composition improves growth velocity including rate of weight gain, incremental linear growth, and/or incremental rate of head circumference growth, relative to administration of non-human milk based formula.

3. 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.

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

5. The method of claim 1 , wherein the congenital heart defect is single ventricle physiology.

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 the human milk comprises about 20 kcal/ounce.

9. The method of claim 1 , wherein the fortified human milk composition comprises a ratio of the human milk fortifier to the human milk from 30:70 to 50:50.

10. The method of claim 1 , wherein the fortified human milk composition comprises a human protein constituent from about 10 to about 30 mg/ml protein, a human fat constituent from about 40 to about 70 mg/ml fat, and a human carbohydrate constituent from about 80 to about 100 mg/ml carbohydrate.

11. The method of claim 1 , wherein the subject is administered the human milk composition for at least 30 days after the surgery.

12. The method of claim 11 , wherein the subject is fed an exclusive human milk diet for the at least 30 days after the surgery.

13. A method for providing nutrition to a subject who is about to undergo or has undergone surgery for a congenital heart defect, the method comprising enterally or orally administering to said subject a fortified human milk composition comprising a human milk fortifier mixed with human milk,

wherein the human milk fortifier 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;

wherein the fortified human milk composition comprises a ratio of the human milk fortifier to the human milk from 30:70 to 50:50;

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 born with a congenital heart defect.

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 Nov 21, 2018
From: ELSTER, SCOTT; FOURNELL, JOSEPH
To: PROLACTA BIOSCIENCE, INC.
Reel/Frame 047563/0475 →
Continuity (2)
Provisional Application 62273243 · Dec 30, 2015
Related Publication 20190021357A1 · Jan 24, 2019