# US 9,753,042 B2 · Kits for determining male fertility by measuring levels of a2V-ATPase, G-CSF, MIP 1 alpha, MCP-1, and methods and kits for improving reproductive outcomes in artificial insemination procedures

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- Number: US 9,753,042 B2
- Document ID: US9753042B2
- Status: Granted
- Kind: B2
- Application number: 14/258,674
- Filed: 2014-04-22
- Published: 2014-10-23
- Granted: 2017-09-05
- Earliest claimed: 2013-04-23
- Assignees: Rosalind Franklin University of Medicine and Science
- Applicants: Rosalind Franklin University of Medicine and Science
- Inventors: Kenneth Beaman
- Web page: https://patentgrep.com/patent/US9753042B2

## CPC

- G01N 33/689: {related to pregnancy or the gonads}
- 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)

## Abstract

The present invention provides a kit for determining male fertility including a container system containing a plurality of enzyme-linked antibodies one of each capable of binding to analytes Atp6v0a2, G-CSF, MIP 1α, and MCP-1. The kit further includes suitable packaging and a set of instructions for using the enzyme-linked antibodies with a seminal sample to determine the fertility of the sample.

## Claims

### Claim 1

A kit for determining male fertility comprising:
a first container system consisting essentially of four different batches of antibodies each linked to a functional group one of each of the four batches of antibodies capable of binding selectively to one of each of the analytes Atp6v0a2, G-CSF, MIP 1α, and MCP-1;
packaging for holding the first container system; and
instructions for using the four batches of antibodies with a seminal sample to determine the fertility of the sample.

### Claim 2 (depends on 1)

The kit of claim 1 further comprising in the first container system four batches of microspheres, each batch of the four batches of microspheres having a unique characteristic that distinguishes one batch from all of the other batches, one of each of the four batches of antibodies being exclusively bound to one of each of the four batches of microspheres.

### Claim 3 (depends on 2)

The kit of claim 2 wherein the unique characteristic is a size, shape, color, or electromagnetic spectrum.

### Claim 4 (depends on 2)

The kit of claim 2 wherein the microspheres are made from plastic or metal.

### Claim 5 (depends on 2)

The kit of claim 2 wherein the microspheres are magnetic.

### Claim 6 (depends on 3)

The kit of claim 3 wherein each color is defined by a ratio of the amount of a first dye and an amount of a second dye.

### Claim 7 (depends on 1)

The kit of claim 1 further comprising a second container system containing a capacitation buffer.

### Claim 8 (depends on 7)

The kit of claim 7 wherein the capacitation buffer comprises Krebs Ringer Buffer.

### Claim 9 (depends on 1)

The kit of claim 1 further comprising a container of isotonic saline.

### Claim 10 (depends on 1)

The kit of claim 1 further comprising a plate having a plurality of spaced wells for receiving one of each of the four batches of antibodies and a control.

### Claim 11 (depends on 1)

The kit of claim 1 further comprising a third container system of streptavidin bound to a chromophore.

### Claim 12 (depends on 11)

The kit of claim 11 wherein the streptavidin is monovalent.

### Claim 13 (depends on 11)

The kit of claim 11 wherein the chromophore is phycoerythrin.

### Claim 14 (depends on 1)

The kit of claim 1 wherein the antigen recognized by the antibody for Atp6v0a2 comprises SEQ. ID NO. 1.