# US 12,222,352 B2 · Diagnosis of scleroderma

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- Number: US 12,222,352 B2
- Document ID: US12222352B2
- Status: Granted
- Kind: B2
- Application number: 16/476,480
- Filed: 2018-01-29
- Published: 2021-12-30
- Granted: 2025-02-11
- Earliest claimed: 2017-01-30
- Assignees: Cedars-Sinai Medical Center
- Applicants: Cedars-Sinai Medical Center
- Inventors: Mark Pimentel; Daniel Furst
- Web page: https://patentgrep.com/patent/US12222352B2

## CPC

- G01N 33/564: for pre-existing immune complex or autoimmune disease {, i.e. systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, rheumatoid factors or complement components C1-C9}
- A61P 21/00: Drugs for disorders of the muscular or neuromuscular system
- G01N 33/68: involving proteins, peptides or amino acids {(involving lipoproteins G01N33/92)}
- G01N 33/6854: {Immunoglobulins}
- G01N 2800/24: Immunology or allergic disorders
- 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

## Abstract

Described herein are methods of diagnosing systemic sclerosis (SSc) involving the detection of anti-vinculin antibodies. Also described herein are methods of selecting treatment of subjects diagnosed with systemic sclerosis (SSc), and methods of treating systemic sclerosis (SSc).

## Claims

### Claim 1

A method of measuring the level of anti-vinculin antibodies in a subject who has systemic sclerosis, comprising:
measuring a level of anti-vinculin antibodies in a whole blood, serum or plasma sample obtained from the subject who has systemic sclerosis by using vinculin or a fragment thereof to assay the biological sample.

### Claim 2 (depends on 1)

The method of claim 1, wherein the vinculin or a fragment thereof is SEQ ID NO: 1 or a fragment thereof.

### Claim 3 (depends on 1)

The method of claim 1, wherein measuring the level of anti-vinculin antibodies comprises using enzyme-linked immunosorbent assay (ELISA).

### Claim 4 (depends on 1)

The method of claim 1, wherein measuring the level of anti-vinculin antibodies comprises using immunohistochemistry, flow cytometry, fluorescence in situ hybridization (FISH), radioimmuno assay, or affinity purification.

### Claim 5 (depends on 1)

A method of selecting a therapy for systemic sclerosis for a subject who has systemic sclerosis, comprising:
measuring a level of anti-vinculin antibodies by the method of claim 1; and
selecting a therapy for systemic sclerosis to treat systemic sclerosis when the level of anti-vinculin antibodies is higher than a reference value.

### Claim 6 (depends on 1)

The method of claim 1, wherein measuring the level of anti-vinculin antibodies in a biological sample comprises using vinculin protein or the fragment thereof at about 1.2 μg/ml concentration.

### Claim 7 (depends on 1)

The method of claim 1, wherein measuring the level of anti-vinculin antibodies in a biological sample comprises using the biological sample used at about 1:32 dilution.

### Claim 8 (depends on 5)

The method of claim 5, wherein the selected therapy is a course of antibiotic therapy.