IP Library Granted Patent US 12,285,008
Granted Patent B2
US 12,285,008 · App. 18/409,181 · Granted Apr 29, 2025

Methods to improve organ viability

Inventor: Jim Potenziano (Hazelwood, MO)
Assignee: MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED
A01N1/021A01N1/0226A01N1/0247A61B17/00A61B2017/00969
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Quick Facts
Patent No.
US 12,285,008
App. No.
18/409,181
Granted
Apr 29, 2025
Kind
B2
Abstract

The present disclosure provides methods to improve the viability of an organ, or organs, by continuously administering a composition comprising NO x gas directly to the organ(s).

Claims (30)

1. A method for increasing superoxide dismutase 2 (SOD2 or manganese-dependent superoxide dismutase (MnSOD)) activity in an organ with ischemia-reperfusion damage, the method comprising:

continuously administering a composition comprising 20 ppm or less of NO gas directly to the organ, wherein MnSOD activity is increased in the organ compared to a control organ that has not been contacted with the composition.

2. The method of claim 1 , wherein MnSOD activity is increased by 5% to 95% in comparison to an organ treated under similar conditions, but that is not directly and continuously administered NO gas.

3. The method of claim 1 , wherein the composition comprises an acellular perfusion fluid.

4. The method of claim 3 , wherein the acellular perfusion fluid comprises sodium caprylate, N-acetyl-DL-tryptophan, and human albumin.

5. The method of claim 1 , wherein the organ is a heart, a lung, or a kidney.

6. The method of claim 1 , wherein administration of the composition is for a time necessary to improve viability of the organ.

7. The method of claim 6 , wherein administration of the composition is for 5 to 60 minutes or 1 to 12 hours.

8. The method of claim 1 , wherein administration begins at the same time as or within about 5 to 30 minutes after the start of the ischemia.

9. The method of claim 1 , wherein administration begins during reperfusion or continues for 1 to 12 hours after reperfusion has begun.

10. A method for inhibiting formation of nitrotyrosine in an organ with ischemia-reperfusion damage, the method comprising:

continuously administering a composition comprising 20 ppm or less of NO gas directly to the organ, wherein formation of nitrotyrosine adduct is inhibited in the organ compared to a control organ that has not been contacted with the composition.

11. The method of claim 10 , wherein nitrotyrosine formation is inhibited by 5% to 95% in comparison to an organ treated under similar conditions, but that is not directly and continuously administered NO gas.

12. The method of claim 10 , wherein the composition comprises an acellular perfusion fluid.

13. The method of claim 12 , wherein the acellular perfusion fluid comprises sodium caprylate, N-acetyl-DL-tryptophan, and human albumin.

14. The method of claim 10 , wherein the organ is a heart, a lung, or a kidney.

15. The method of claim 10 , wherein administration of the composition is for a time necessary to improve viability of the organ.

16. The method of claim 15 , wherein administration of the composition is for 5 to 60 minutes or 1 to 12 hours.

17. The method of claim 10 , wherein administration begins at the same time as or within about 5 to 30 minutes after the start of the ischemia.

18. The method of claim 10 , wherein administration begins during reperfusion or continues for 1 to 12 hours after reperfusion has begun.

19. A method for preventing inactivation of mitochondrial complex I activity, complex II activity, complex III activity, complex IV activity, or a combination thereof, in an organ with ischemia-reperfusion damage, the method comprising:

continuously administering a composition comprising 20 ppm or less of NO gas directly to the organ, wherein administering 20 ppm or less of NO gas prevents inactivation of activity of mitochondrial complex I, complex II, complex III, complex IV, or a combination thereof compared to a control organ.

20. The method of claim 19 , wherein inactivation of activity of mitochondrial complex I, complex II, complex III, complex IV, or a combination thereof is inhibited by 5% to 95% in comparison to an organ treated under similar conditions, but that is not directly and continuously administered NO gas.

21. The method of claim 10 , wherein the composition comprises an acellular perfusion fluid.

22. The method of claim 12 , wherein the acellular perfusion fluid comprises sodium caprylate, N-acetyl-DL-tryptophan, and human albumin.

23. The method of claim 10 , wherein the organ is a heart, a lung, or a kidney.

24. The method of claim 10 , wherein administration of the composition is for a time necessary to improve viability of the organ.

25. The method of claim 15 , wherein administration of the composition is for 5 to 60 minutes or 1 to 12 hours.

26. The method of claim 10 , wherein administration begins at the same time as or within about 5 to 30 minutes after the start of the ischemia.

27. The method of claim 10 , wherein administration begins during reperfusion or continues for 1 to 12 hours after reperfusion has begun.

Assignments (9)
CORRECTIVE ASSIGNMENT TO CORRECT THE INCLUSION OF US PATENT 10828415 AND REMOVE IT FROM THE LISTING PREVIOUSLY RECORDED ON REEL 73375 FRAME 395. ASSIGNOR(S) HEREBY CONFIRMS THE SECURITY INTEREST. Recorded Mar 6, 2026
From: MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED
To: GOLDMAN SACHS BANK USA, AS ADMINISTRATIVE AGENT
Reel/Frame 075021/0263 →
CORRECTIVE ASSIGNMENT TO CORRECT THE INCLUSION OF US PATENT 10828415 AND REMOVE IT FROM THE LISTING PREVIOUSLY RECORDED ON REEL 72331 FRAME 1. ASSIGNOR(S) HEREBY CONFIRMS THE SECURITY INTEREST. Recorded Mar 6, 2026
From: MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED
To: COMPUTERSHARE TRUST COMPANY, NATIONAL ASSOCIATION
Reel/Frame 075021/0204 →
SECURITY INTEREST Recorded Oct 28, 2025
From: MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED
To: GOLDMAN SACHS BANK USA, AS ADMINISTRATIVE AGENT
Reel/Frame 073375/0395 →
RELEASE OF SECURITY INTEREST Recorded Aug 14, 2025
From: ACQUIOM AGENCY SERVICES LLC
To: MALLINCKRODT ENTERPRISES LLC; MALLINCKRODT LLC; MALLINCKRODT PHARMA IP TRADING UNLIMITED COMPANY; MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED; OCERA THERAPEUTICS LLC; SPECGX LLC; STRATATECH CORPORATION; SUCAMPO PHARMA AMERICAS LLC; VTESSE LLC
Reel/Frame 072324/0740 →
SECURITY INTEREST Recorded Aug 1, 2025
From: MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED
To: COMPUTERSHARE TRUST COMPANY, NATIONAL ASSOCIATION
Reel/Frame 072331/0001 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 30, 2025
From: POTENZIANO, JIM
To: MALLINCKRODT HOSPITAL PRODUCTS IP LIMITED
Reel/Frame 070674/0347 →
CHANGE OF NAME Recorded Mar 30, 2025
From: MALLINCKRODT HOSPITAL PRODUCTS IP LIMITED
To: MALLINCKRODT HOSPITAL PRODUCTS IP UNLIMITED COMPANY
Reel/Frame 070674/0403 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 30, 2025
From: MALLINCKRODT HOSPITAL PRODUCTS IP UNLIMITED COMPANY
To: MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED
Reel/Frame 070674/0362 →
SECURITY INTEREST Recorded Apr 24, 2024
From: MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED; STRATATECH CORPORATION
To: ACQUIOM AGENCY SERVICES LLC
Reel/Frame 067215/0426 →