# US 8,771,972 B2 · Clozapine immunoassay

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- Number: US 8,771,972 B2
- Document ID: US8771972B2
- Status: Granted
- Kind: B2
- Application number: 13/186,147
- Filed: 2011-07-19
- Published: 2012-11-29
- Granted: 2014-07-08
- Earliest claimed: 2011-05-24
- Assignees: Saladax Biomedical Inc.
- Applicants: Salvatore J. Salamone; Jodi Blake Courtney; Howard Sard; Christopher Spedaliere
- Inventors: Salvatore J. Salamone; Jodi Blake Courtney; Howard Sard; Christopher Spedaliere
- Web page: https://patentgrep.com/patent/US8771972B2

## CPC

- G01N 33/5308: {for analytes not provided for elsewhere, e.g. nucleic acids, uric acid, worms, mites}
- A61P 25/18: Antipsychotics, i.e. neuroleptics; Drugs for mania or schizophrenia
- C07D 243/38: [b, e]- or [b, f]-condensed with six-membered rings
- C07D 403/12: linked by a chain containing hetero atoms as chain links
- C07K 16/44: against material not provided for elsewhere {, e.g. haptens, metals, DNA, RNA, amino acids}
- G01N 33/94: involving narcotics {or drugs or pharmaceuticals, neurotransmitters or associated receptors}
- C07K 2317/33: Crossreactivity, e.g. for species or epitope, or lack of said crossreactivity
- G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- C07D: HETEROCYCLIC COMPOUNDS (macromolecular compounds C08)
- C07K: PEPTIDES (peptides in foodstuffs A23; obtaining protein compositions for foodstuffs, working-up proteins for foodstuffs A23J; preparations for medicinal purposes A61K; peptides containing beta-lactam rings C07D; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, C07D; ergot alkaloids of the cyclic peptide type C07D519/02; macromolecular compounds having statistically distributed amino acid units in their molecules, i.e. when the preparation does not provide for a specific; but for a random sequence of the amino acid units, homopolyamides and block copolyamides derived from amino acids C08G69/00; macromolecular products derived from proteins C08H1/00; preparation of glue or gelatine C09H; single cell proteins, enzymes C12N; genetic engineering processes for obtaining peptides C12N15/00; compositions for measuring or testing processes involving enzymes C12Q; investigation or analysis of biological material G01N33/00)

## Abstract

Novel conjugates and immunogens derived from clozapine and antibodies generated by these immunogens are useful in immunoassays for the quantification and monitoring of clozapine in biological fluids.

## Claims

### Claim 1

An immunoassay for detecting clozapine in a sample comprising providing a mixture of a) said sample, b) an antibody selectively reactive with clozapine and not substantially cross-reactive with N-desmethylclozapine and clozapine-N-oxide, and c) a conjugate of a carrier having either a reactive thiol or amino group with a compound of the formula:
wherein B is: —(C═O)—, —(C═O)—NH—, —(C═O)—O—, —CH2-;
Y is an organic spacing group;
X is a terminal functional group capable of binding to said carrier; and
p is an integer from 0 to 1;
or salts thereof;
causing the clozapine in the sample and said conjugate in said mixture to bind with said antibody and thereafter measuring the amount of said conjugate in said mixture which is bound or unbound to said antibody whereby the presence of clozapine in the sample can be determined.

### Claim 2 (depends on 1)

The immunoassay of claim 1, wherein the sample is a human sample.

### Claim 3 (depends on 2)

The immunoassay of claim 2, wherein said antibody is generated from an immunogen comprising an immunogenic carrier having a reactive thiol or amino group conjugated to a compound of the formula:
wherein B is: —(C═O)—, —(C═O)—NH—, —(C═O)—O—, —CH2-;
Y is an organic spacing group;
X is a terminal functional group capable of binding to said immunogenic carrier; and
p is an integer from 0 to 1;
or salts thereof.

### Claim 4 (depends on 3)

The immunoassay of claim 3, wherein said immunogenic carrier has a reactive thiol group and X in the compound which is conjugated to said immunogenic carrier is a terminal functional group capable of binding to said reactive thiol group.

### Claim 5 (depends on 4)

The immunoassay of claim 4, wherein X is

### Claim 6 (depends on 5)

The immunoassay of claim 5, wherein Y is C1-C10 alkylene.

### Claim 7 (depends on 6)

The immunoassay of claim 6 wherein the immunogenic carrier contains as the functional group
wherein v is an integer from 1 to 6.

### Claim 8 (depends on 2)

The immunoassay of claim 2, wherein the antibody is attached to a solid support.

### Claim 9 (depends on 8)

The immunoassay of claim 8, wherein the solid support is microtiter plates.

### Claim 10 (depends on 9)

The immunoassay of claim 9, wherein the solid support is nanoparticles.

### Claim 11

A kit for determining the presence of clozapine in a patient sample comprising reagents in separate containers, one of the reagents being a conjugate of a carrier having either a reactive thiol or amino group with a compound of the formula:
wherein B is: —(C═O)—, —(C═O)—NH—, —(C═O)—O—, —CH2—;
Y is an organic spacing group;
X is a terminal functional group capable of binding to said carrier; and
p is an integer from 0 to 1;
or salts thereof; and the second container containing an antibody selectively reactive with clozapine and not substantially cross-reactive with N-desmethylclozapine and clozapine-N-oxide.

### Claim 12 (depends on 11)

The kit of claim 11, wherein said conjugate is present in a predetermined amount in said first container.

### Claim 13 (depends on 12)

The kit of claim 12, wherein said kit is used to determine the amount of clozapine in said sample.

### Claim 14 (depends on 13)

The kit of claim 13, wherein said carrier has a reactive thiol group and X is a terminal functional group capable of binding to said reactive thiol group.

### Claim 15 (depends on 14)

The kit of claim 14, wherein X is