IP Library Granted Patent US 12,258,458
Granted Patent B2
US 12,258,458 · App. 18/516,696 · Granted Mar 25, 2025

Compositions on plasma-treated surfaces

Inventors: Byron J. Knight (San Diego, CA); David Opalsky (San Diego, CA)
Assignee: GEN-PROBE INCORPORATED
C08J7/048B01L3/5085C08J7/043C08J7/065C08J7/123C08J7/18C12Q1/686B01L2200/12B01L2200/16B01L2300/161C08J2345/00G01N3/303
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Quick Facts
Patent No.
US 12,258,458
App. No.
18/516,696
Filed
Nov 21, 2023
Granted
Mar 25, 2025
Kind
B2
Art Unit
1787
USPC
428/411.1
Abstract

A kit includes a vessel having a plasma-treated interior surface, solid composition adhered to the plasma-treated interior surface, and a reconstitution liquid. The solid composition has a mass ranging from about 600 micrograms to about 20 grams and is in the form of a lyophilized pellet adhered to the plasma-treated interior surface. The solid composition is macroscopic in three orthogonal dimensions, such that the solid composition is not a coating and has a length, a width, and a height of greater than 1 mm.

Claims (67)

1. A kit comprising:

a vessel having a plasma-treated interior surface;

solid composition adhered to the plasma-treated interior surface, wherein the solid composition has a mass from about 600 micrograms to about 20 grams, wherein the solid composition is in the form of a lyophilized pellet adhered to the plasma-treated interior surface, wherein the solid composition is macroscopic in three orthogonal dimensions, such that the solid composition is not a coating and has a length, a width, and a height of greater than 1 mm; and

a reconstitution liquid.

2. The kit of claim 1 , wherein the solid composition is sufficiently adhered to remain substantially attached to the plasma-treated interior surface following a package performance test in which the plasma-treated surface containing the solid composition is dropped from a height of about 20 mm to about 1000 mm onto a substrate.

3. The kit of claim 1 , wherein the vessel comprises one or more tubes or one or more a multiwell plate, each comprising two or more wells.

4. The kit of claim 1 , comprising a plurality of solid compositions supplied in separate vessels.

5. The kit of claim 1 , wherein the vessel comprises one or more multiwell plates, each multiwell plate including multiple solid compositions in two or more sealed wells of the multiwell plate.

6. The kit of claim 1 , wherein the reconstitution liquid is contained in a separate vessel from the solid composition.

7. The kit of claim 1 , wherein the reconstitution liquid is contained in the same vessel as the solid composition.

8. The kit of claim 1 , wherein a vessel containing the reconstitution liquid is separated from the vessel containing the solid composition by a frangible material.

9. The kit of claim 1 , wherein the reconstitution liquid comprises at least one of water, a polar organic solvent, and a nonpolar organic solvent.

10. The kit of claim 1 , wherein the interior surface of the vessel is plasma-treated by at least one of a cold cathode discharge, hollow cathode discharge, DC-induced discharge, radio frequency (RF)-induced discharge, corona discharge, glow discharge, or charged particle beam.

11. The kit of claim 1 , wherein the solid composition comprises at least one of:

(a) a DNA-dependent polymerase, reverse transcriptase or other enzyme at a concentration from about 0.20 U/μl to about 0.72 U/μl or from about 0.1 U/μl to about 0.6 U/μl;

(b) a labeled oligonucleotide comprising a fluorescent, chemiluminescent, affinity, or radioactive label;

(c) a labeled detection probe oligomer comprising a fluorescent, chemiluminescent, affinity, or radioactive label;

(d) a nucleoside triphosphates present in the solution in an amount ranging from about 0.1 mM to about 0.3 mM or from about 0.2 mM to about 0.6 mM;

(e) an RNase inhibitor at a concentration from about 0.12 U/μl to about 0.20 U/μl; and/or

(f) a chelating agent at a concentration from about 1.5 mM to about 2.0 mM.

12. The kit of claim 1 , wherein the solid composition comprises a bulking agent and at least one of an enzyme and an oligonucleotide.

13. The kit of claim 12 , wherein the bulking agent comprises a saccharide, glycine, or hydroxyethyl starch.

14. The kit of claim 12 , wherein the bulking agent comprises a saccharide comprising at least one of sucrose, mannitol, raffinose, or trehalose.

15. The kit of claim 1 , wherein the plasma-treated interior surface comprises plastic.

16. The kit of claim 15 , wherein the plastic comprises at least one of a polyethylene, polyethylene terephtalate, polypropylene, polymethacrylate, polyvinyl chloride, polystyrene, polyolefin, polycarbonate, polyurethane, starch-derived plastic, and a cyclic olefin copolymer.

17. The kit of claim 15 , wherein the plasma-treated surface is a surface comprising a polyolefin and has a contact angle of 5° to 50°.

18. The kit of claim 15 , wherein the plasma-treated surface is a surface comprising a polyolefin and has a surface energy from 33 to 55 dynes/cm.

19. The kit of claim 15 , wherein the plasma-treated surface is a surface comprising a polyethylene or polypropylene and has a surface energy from 35 to 55 dynes/cm.

20. The kit of claim 1 , wherein the solid composition has a mass ranging from about 5 mg to about 20 g, about 200 mg to about 20 g, about 1 g to about 20 g, about 5 g to about 20 g, about 5 mg to about 1 g, about 5 mg to about 500 mg, about 5 mg to about 200 mg, about 5 mg to about 100 mg, about 5 mg to about 50 mg, about 5 mg to about 20 mg, about 5 mg to about 10 mg, about 10 mg to about 200 mg, about 20 mg to about 200 mg, about 50 mg to about 200 mg, or about 100 mg to about 200 mg.

21. The kit of claim 1 , wherein the solid composition comprises one or more enzymes including at least one of a DNA polymerase, an RNA polymerase, a ligase, a kinase, a phosphatase, a protease, an exonuclease, and an endonuclease.

22. The kit of claim 1 , wherein the solid composition comprises a salt.

23. The kit of claim 1 , wherein the solid composition is free of inorganic salt or has an inorganic salt concentration of 5 mM or less.

24. The kit of claim 1 , wherein the solid composition comprises at least one oligonucleotide useful for performing a molecular assay and one or more nucleoside triphosphates.

25. The kit of claim 1 , wherein the solid composition contains a single unit dose of amplification or detection reagents.

26. The kit of claim 1 , wherein the solid composition contains a pharmaceutically active agent.

27. The kit of claim 1 , wherein the vessel and the solid composition adhered to the plasma-treated interior surface of the vessel are sealed.

28. A method of preparing a solid composition adhered to a plasma-treated surface and forming a reconstituted composition from the solid composition, the method comprising:

(a) dispensing a solution onto a plasma-treated surface of a vessel;

(b) drying the solution on the plasma-treated surface to form the solid composition adhered to the plasma-treated surface within the vessel, wherein the solid composition is not a coating on the plasma-treated surface and the solid composition is in the form of a lyophilized pellet adhered to the plasma-treated surface within the vessel, wherein the solid composition is macroscopic in three orthogonal dimensions, such that the solid composition has a length, a width, and a height of greater than 1 mm, and wherein the solid composition has a mass from about 600 micrograms to about 20 grams; and

(c) forming the reconstituted composition by combining a reconstitution liquid and the solid composition within the vessel and causing the solid composition to be completely solubilized within the vessel.

29. A vessel comprising:

cyclic olefin copolymer surface having a concavity, wherein the surface is plasma-treated and has a surface energy from about 35 dynes/cm to about 55 dynes/cm or a contact angle of about 5° to about 50°; and

a solid composition within the concavity, wherein the solid composition is in the form of a lyophilized pellet adhered to the plasma-treated surface, wherein the solid composition is macroscopic in three orthogonal dimensions, such that the solid composition is not a coating and has a length, a width, and a height of greater than 1 mm, and wherein the solid composition has a mass from about 600 micrograms to about 20 grams.

30. The vessel of claim 29 , wherein the solid composition is sufficiently adhered to remain substantially attached to the plasma-treated interior surface following a package performance test in which the plasma-treated surface containing the solid composition is dropped from a height of about 20 mm to about 1000 mm onto a substrate.

31. The vessel of claim 29 , wherein the vessel comprises a tube or a multiwell plate.

32. The vessel of claim 29 , wherein the vessel comprises a multiwell plate, and wherein the solid composition is disposed in two or more sealed wells of the multiwell plate.

33. The vessel of claim 32 , further comprising a reconstitution liquid contained in at least one well of the multiwell plate.

34. The vessel of claim 33 , wherein a well containing the reconstitution liquid is separated from a well containing the solid composition by a frangible material.

35. The vessel of claim 29 , wherein the surface is plasma-treated by at least one of a cold cathode discharge, hollow cathode discharge, DC-induced discharge, radio frequency (RF)-induced discharge, corona discharge, glow discharge, or charged particle beam.

36. The vessel of claim 29 , wherein the solid composition comprises at least one of:

(a) a DNA-dependent polymerase, reverse transcriptase or other enzyme at a concentration from about 0.20 U/μl to about 0.72 U/μl or from about 0.1 U/μl to about 0.6 U/μl;

(b) a labeled oligonucleotide comprising a fluorescent, chemiluminescent, affinity, or radioactive label;

(c) a labeled detection probe oligomer comprising a fluorescent, chemiluminescent, affinity, or radioactive label;

(d) a nucleoside triphosphates present in the solution in an amount ranging from about 0.1 mM to about 0.3 mM or from about 0.2 mM to about 0.6 mM;

(e) an RNase inhibitor at a concentration from about 0.12 U/μl to about 0.20 U/μl; and/or

(f) a chelating agent at a concentration from about 1.5 mM to about 2.0 mM.

37. The vessel of claim 29 , wherein the solid composition comprises a bulking agent and at least one of an enzyme and an oligonucleotide.

38. The vessel of claim 37 , wherein the bulking agent comprises a saccharide, glycine, or hydroxyethyl starch.

39. The vessel of claim 37 , wherein the bulking agent comprises a saccharide comprising at least one of sucrose, mannitol, raffinose, or trehalose.

40. The vessel of claim 29 , wherein the solid composition has a mass ranging from about 5 mg to about 20 g, about 200 mg to about 20 g, about 1 g to about 20 g, about 5 g to about 20 g, about 5 mg to about 1 g, about 5 mg to about 500 mg, about 5 mg to about 200 mg, about 5 mg to about 100 mg, about 5 mg to about 50 mg, about 5 mg to about 20 mg, about 5 mg to about 10 mg, about 10 mg to about 200 mg, about 20 mg to about 200 mg, about 50 mg to about 200 mg, or about 100 mg to about 200 mg.

41. The vessel of claim 29 , wherein the solid composition comprises one or more enzymes including at least one of a DNA polymerase, an RNA polymerase, a ligase, a kinase, a phosphatase, a protease, an exonuclease, and an endonuclease.

42. The vessel of claim 29 , wherein the solid composition comprises a salt.

43. The vessel of claim 29 , wherein the solid composition is free of inorganic salt or has an inorganic salt concentration of 5 mM or less.

44. The vessel of claim 29 , wherein the solid composition comprises at least one oligonucleotide useful for performing a molecular assay and one or more nucleoside triphosphates.

45. The vessel of claim 29 , wherein the solid composition contains a single unit dose of amplification or detection reagents.

46. The vessel of claim 29 , wherein the solid composition contains a pharmaceutically active agent.

47. The vessel of claim 29 , wherein the vessel and the solid composition adhered to the plasma-treated interior surface of the vessel are sealed.

Assignments (4)
RELEASE OF SECURITY INTEREST RECORDED AT REEL/FRAME 069172/0436 Recorded Apr 28, 2026
From: BANK OF AMERICA, N.A., AS COLLATERAL AGENT
To: HOLOGIC, INC.; GEN-PROBE INCORPORATED; FAXITRON BIOPTICS, LLC
Reel/Frame 075503/0086 →
SECURITY INTEREST Recorded Apr 8, 2026
From: BIOTHERANOSTICS, INC.; GEN-PROBE INCORPORATED; GEN-PROBE PRODESSE, INC.; CYTYC CORPORATION; SUROS SURGICAL SYSTEMS, INC.; GYNESONICS, INC.; BOLDER SURGICAL, LLC; FAXITRON BIOPTICS, LLC; HEALTH BEACONS, INC.; HOLOGIC, INC.
To: ROYAL BANK OF CANADA, AS COLLATERAL AGENT
Reel/Frame 075462/0440 →
SECURITY INTEREST Recorded Oct 14, 2024
From: HOLOGIC, INC.; GEN-PROBE INCORPORATED; FAXITRON BIOPTICS, LLC
To: BANK OF AMERICA, N.A., AS COLLATERAL AGENT
Reel/Frame 069172/0436 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 13, 2023
From: KNIGHT, BYRON J.; OPALSKY, DAVID
To: GEN-PROBE INCORPORATED
Reel/Frame 065862/0303 →
Continuity (4)
Division 17076448 · Oct 21, 2020
Division 15720467 · Sep 29, 2017
Provisional Application 62402446 · Sep 30, 2016
Related Publication 20240092986A1 · Mar 21, 2024
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