IP Library Granted Patent US 8,409,412
Granted Patent B2
US 8,409,412 · App. 12/861,822 · Granted Apr 2, 2013

Enzymatic reagent inks for use in test strips having a predetermined calibration code

Inventors: Gary Young (Inverness, GB); Michael O'Connell (Muir of Ord, GB); Ian McArthur (Inverness, GB); Alan McNeilage (Inverness, GB); Nick Phippen (Inverness, GB); Manuel Alvarez-Icaza (Inverness, GB)
Assignee: LifeScan Scotland, Ltd.
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Quick Facts
Patent No.
US 8,409,412
App. No.
12/861,822
Granted
Apr 2, 2013
Kind
B2
Abstract

The invention provides an enzyme ink useful in test strips that provides a test strip bias, at the low and high glucose ends, falling within a desired target range. The ink of the invention permits an improved method for the production of single calibration code strip lots with good yields.

Claims (12)

1. An enzyme ink composition, comprising an enzyme capable of selectively recognizing glucose in a blood sample, a mediator, and a first and a second fumed silica, wherein the first fumed silica comprises a BET measured surface area of about 130 to 170 m 2 /g and a carbon content of about 0.8 to about 1.23 weight percent and the second fumed silica comprises a BET measured surface area of about 270 to 330 m 2 /g and a carbon content of about 1.4 to about 2.6 weight percent.

2. The enzyme ink of claim 1 , wherein the first fumed silica is present in an amount of about 99 to about 1 weight percent of the total amount of the fumed silicas and the second fumed silica is present in amount of about 1 to about 99 weight percent.

3. The enzyme ink of claim 1 , wherein the first fumed silica is present in an amount of about 75 to about 45 weight percent of the total amount of the fumed silicas and the second fumed silica is present in amount of about 25 to about 55 weight percent.

4. The enzyme ink of claim 1 , wherein the enzyme is elected from the group consisting of glucose oxidase, glucose dehydrogenase, glucose dehydrogenase with a pyrrolo-quinolone co-factor, and glucose dehydrogenase with a flavin adenine dinucleotide co-factor and the mediator is selected from the group consisting of ferricyanide and ruthenium hexamine trichloride.

5. The enzyme ink of claim 1 , wherein the enzyme is glucose oxidase mediator is ferricyanide.

6. An enzyme ink, comprising about 0.3 percent by mass of an antifoam compound, about 0.6 percent by mass of polyvinyl alcohol, about 0.6 percent by mass citric acid, about 1.9 percent by mass trisodium citrate, about 0.6 percent by mass polyvinylpyrrolidone-vinyl acetate copolymer, about 3.27 percent by mass hydroxyethyl cellulose, about 3.6 percent by mass of a first fumed silica with a BET measured surface area of about 130 to 170 m 2 /g and a carbon content of about 0.8 to about 1.23 weight percent, about 1.3 percent by mass of a second fumed silica with a BET measured surface area of about 270 to 330 m 2 /g and a carbon content of about 1.4 to about 2.6 weight percent, about 0.03 percent by mass potassium hexacyanoferrate III, about 23 percent by mass of potassium ferricyanide; about 2.1 percent by mass glucose oxidase and about 62.4 percent by mass water.

7. A test strip comprising at least two co-planar electrodes, wherein at least one of the electrodes comprises an enzyme ink composition comprising an enzyme capable of selectively recognizing glucose in a blood sample, a mediator, and a first and a second fumed silica, wherein the first fumed silica comprises a BET measured surface area of about 130 to 170 m 2 /g and a carbon content of about 0.8 to about 1.23 weight percent and the second fumed silica comprises a BET measured surface area of about 270 to 330 m 2 /g and a carbon content of about 1.4 to about 2.6 weight percent.

8. The test strip of claim 7 , wherein the first fumed silica is present in an amount of about 99 to about 1 weight percent of the total amount of the fumed silicas and the second fumed silica is present in amount of about 1 to about 99 weight percent.

9. The test strip of claim 7 , wherein the first fumed silica is present in an amount of about 75 to about 45 weight percent of the total amount of the fumed silicas and the second fumed silica is present in amount of about 25 to about 55 weight percent.

10. The test strip of claim 7 , wherein the enzyme is elected from the group consisting of glucose oxidase, glucose dehydrogenase, glucose dehydrogenase with a pyrrolo-quinolone co-factor, and glucose dehydrogenase with a flavin adenine dinucleotide co-factor and the mediator is selected from the group consisting of ferricyanide and ruthenium hexamine trichloride.

11. The test strip of claim 7 , wherein the enzyme is glucose oxidase mediator is ferricyanide.

12. The test strip of claim 7 , wherein the enzyme ink comprises about 0.3 percent by mass of an antifoam compound, about 0.6 percent by mass of polyvinyl alcohol, about 0.6 percent by mass citric acid, about 1.9 percent by mass trisodium citrate, about 0.6 percent by mass polyvinylpyrrolidone-vinyl acetate copolymer, about 3.27 percent by mass hydroxyethyl cellulose, about 3.6 percent by mass of a first fumed silica with a BET measured surface area of about 130 to 170 m 2 /g and a carbon content of about 0.8 to about 1.23 weight percent, about 1.3 percent by mass of a second fumed silica with a BET measured surface area of about 270 to 330 m 2 /g and a carbon content of about 1.4 to about 2.6 weight percent, about 0.03 percent by mass potassium hexacyanoferrate III, about 23 percent by mass of potassium ferricyanide; about 2.1 percent by mass glucose oxidase and about 62.4 percent by mass water.

Assignments (18)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 18, 2026
From: LIFESCAN GLOBAL CORPORATION; LIFESCAN CHINA, LLC; LIFESCAN IP HOLDINGS, LLC
To: LIFESCAN ENTERPRISES LLC
Reel/Frame 075848/0012 →
RELEASE OF SECURITY INTEREST Recorded Dec 8, 2025
From: ANKURA TRUST COMPANY, LLC
To: LIFESCAN IP HOLDINGS, LLC
Reel/Frame 073929/0495 →
RELEASE OF SECURITY INTEREST Recorded Dec 8, 2025
From: WILMINGTON SAVINGS FUND SOCIETY, FSB
To: LIFESCAN IP HOLDINGS, LLC
Reel/Frame 073929/0316 →
RELEASE OF SECURITY INTEREST Recorded Dec 8, 2025
From: WILMINGTON SAVINGS FUND SOCIETY, FSBWILMINGTON SAVINGS FUND SOCIETY, FSB
To: LIFESCAN IP HOLDINGS, LLC
Reel/Frame 073928/0626 →
SECURITY INTEREST Recorded Dec 8, 2025
From: LIFESCAN ENTERPRISES LLC
To: ACQUIOM AGENCY SERVICES LLC, AS COLLATERAL AGENT
Reel/Frame 073890/0305 →
SECURITY AGREEMENT Recorded Dec 8, 2025
From: LIFESCAN ENTERPRISES LLC
To: WELLS FARGO BANK, NATIONAL ASSOCIATION
Reel/Frame 073893/0622 →
ASSIGNMENT OF PATENT SECURITY INTERESTS (1ST LIEN) Recorded Aug 22, 2025
From: BANK OF AMERICA, N.A.
To: WILMINGTON SAVINGS FUND SOCIETY, FSB, AS SUCCESSOR AGENT
Reel/Frame 072567/0482 →
TRANSFER OF SECURITY AGREEMENT RECORDED AT REEL 063740, FRAME 0080 Recorded Nov 12, 2024
From: BANK OF AMERICA, N.A., AS RESIGNING AGENT
To: WILMINGTON SAVINGS FUND SOCIETY, FSB, AS SUCCESSOR AGENT
Reel/Frame 069340/0243 →
TRANSFER OF SECURITY AGREEMENT RECORDED AT REEL 047179, FRAME 0150 Recorded Nov 11, 2024
From: BANK OF AMERICA, N.A., AS RESIGNING AGENT
To: ANKURA TRUST COMPANY, LLC, AS SUCCESSOR AGENT
Reel/Frame 069314/0022 →
RELEASE OF SECOND LIEN PATENT SECURITY AGREEMENT RECORDED OCT. 3, 2018, REEL/FRAME 047186/0836 Recorded Jun 28, 2023
From: BANK OF AMERICA, N.A.
To: LIFESCAN IP HOLDINGS, LLC; JANSSEN BIOTECH, INC.; JOHNSON & JOHNSON CONSUMER INC.
Reel/Frame 064206/0176 →
SECOND LIEN PATENT SECURITY AGREEMENT Recorded May 23, 2023
From: LIFESCAN IP HOLDINGS, LLC
To: BANK OF AMERICA, N.A.
Reel/Frame 063740/0080 →
FIRST LIEN PATENT SECURITY AGREEMENT Recorded May 22, 2023
From: LIFESCAN IP HOLDINGS, LLC
To: BANK OF AMERICA, N.A.
Reel/Frame 063712/0430 →
CORRECTIVE ASSIGNMENT TO CORRECT THE DELETING PROPERTY NUMBER 6990849, 7169116, 7351770, 7462265,7468125, 7572356, 8093903, 8486245, 8066866 AND ADD 10431140 PREVIOUSLY RECORDED AT REEL: 050839 FRAME: 0634. ASSIGNOR(S) HEREBY CONFIRMS THE ASSIGNMENT. Recorded May 12, 2023
From: LIFESCAN SCOTLAND LTD.
To: CILAG GMBH INTERNATIONAL
Reel/Frame 064656/0141 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 28, 2019
From: CILAG GMBH INTERNATIONAL
To: LIFESCAN IP HOLDINGS, LLC
Reel/Frame 050840/0006 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 28, 2019
From: LIFESCAN SCOTLAND LTD.
To: CILAG GMBH INTERNATIONAL
Reel/Frame 050839/0634 →
SECURITY AGREEMENT Recorded Oct 3, 2018
From: LIFESCAN IP HOLDINGS, LLC
To: BANK OF AMERICA, N.A., AS COLLATERAL AGENT
Reel/Frame 047186/0836 →
SECURITY AGREEMENT Recorded Oct 2, 2018
From: LIFESCAN IP HOLDINGS, LLC
To: BANK OF AMERICA, N.A., AS COLLATERAL AGENT
Reel/Frame 047179/0150 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 15, 2010
From: YOUNG, GARY; O'CONNELL, MICHAEL; MCARTHUR, IAN; MCNEILAGE, ALAN; PHIPPEN, NICK; ALVAREZ-ICAZA, MANUEL
To: LIFESCAN SCOTLAND, LTD.
Reel/Frame 024994/0692 →
Continuity (1)
Related Publication 20120043204A1 · Feb 23, 2012