# US 10,371,702 B2 · Detection and treatment of autoimmune disorders

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- Number: US 10,371,702 B2
- Document ID: US10371702B2
- Status: Granted
- Kind: B2
- Application number: 14/874,851
- Filed: 2015-10-05
- Published: 2016-05-12
- Granted: 2019-08-06
- Earliest claimed: 2007-10-01
- Assignees: Seattle Children's Hospital
- Applicants: Seattle Children's Hospital
- Inventors: Neelufar Mozaffarian; Anne M. Stevens
- Web page: https://patentgrep.com/patent/US10371702B2

## 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}
- A61B 5/0082: {adapted for particular medical purposes}
- A61B 5/4842: {Monitoring progression or stage of a disease}
- A61K 31/713: Double-stranded nucleic acids or oligonucleotides
- A61K 38/06: Tripeptides
- A61K 38/07: Tetrapeptides
- A61K 39/3955: {against proteinaceous materials, e.g. enzymes, hormones, lymphokines}
- A61P 19/02: for joint disorders, e.g. arthritis, arthrosis
- A61P 37/02: Immunomodulators
- C07K 16/2803: {against the immunoglobulin superfamily}
- C07K 2317/76: Antagonist effect on antigen, e.g. neutralization or inhibition of binding
- G01N 2333/70503: Immunoglobulin superfamily, e.g. VCAMs, PECAM, LFA-3
- G01N 2800/102: Arthritis; Rheumatoid arthritis, i.e. inflammation of peripheral joints
- G01N 2800/104: Lupus erythematosus [SLE]
- G01N 2800/56: Staging of a disease; Further complications associated with the disease
- Y10S 436/811: Test for named disease, body condition or organ function
- 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)
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- 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)
- Y10S: TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS

## Abstract

Disclosed herein are methods of treatment of autoimmune diseases such as systemic lupus erythematosus (SLE) as well as clinical assays for detection of autoimmune disease activity in patients utilizing a PD1 ligand.

## Claims

### Claim 1

A kit comprising:
(i) a detectably labeled antibody specific for PD-L1 for use in determining a PD-L1 level in a blood sample obtained from a human individual; and
(ii) at least one antibody specific for a cell surface marker of a monocyte or a dendritic cell.

### Claim 2 (depends on 1)

The kit of claim 1, wherein the antibody specific for PD-L1 is fluorescently-labeled.

### Claim 3 (depends on 1)

The kit of claim 1, wherein the blood sample comprises peripheral blood lymphocytes.

### Claim 4 (depends on 1)

The kit of claim 1, wherein the PD-L1 level is the amount of PD-L1 in immature myeloid dendritic cells (mDC) or monocytes in the blood sample.

### Claim 5 (depends on 1)

The kit of claim 1, wherein the PD-L1 level is the number of immature mDC or monocytes in the blood sample that express PD-L1.

### Claim 6 (depends on 5)

The kit of claim 5, wherein the monocytes comprise CD14+/CD11c+ monocytes.

### Claim 7 (depends on 5)

The kit of claim 5, wherein the immature mDCs comprise CD14−/LO/CD11c+ mDCs.

### Claim 8 (depends on 1)

The kit of claim 1, wherein the human individual has rheumatoid arthritis (RA) or systemic lupus erythematosus (SLE).

### Claim 9

A kit comprising:
(i) a detectably labeled antibody specific for PD-L1 for use in determining a PD-L1 level in a blood sample obtained from a human individual; and
(ii) at least one antibody specific for a cell surface marker selected from the group of CD11c and CD14.

### Claim 10 (depends on 9)

The kit of claim 9, wherein the cell surface marker is CD11c.

### Claim 11 (depends on 9)

The kit of claim 9, wherein the cell surface marker is CD14.

### Claim 12 (depends on 9)

The kit of claim 9, wherein the antibody specific for PD-L1 is fluorescently-labeled.

### Claim 13 (depends on 9)

The kit of claim 9, wherein the blood sample comprises peripheral blood lymphocytes.

### Claim 14 (depends on 9)

The kit of claim 9, wherein the PD-L1 level is the amount of PD-L1 in immature mDC or monocytes in the blood sample.

### Claim 15 (depends on 9)

The kit of claim 9, wherein the PD-L1 level is the number of immature mDC or monocytes in the blood sample that express PD-L1.

### Claim 16 (depends on 15)

The kit of claim 15, wherein the monocytes comprise CD14+/CD11c+ monocytes.

### Claim 17 (depends on 15)

The kit of claim 15, wherein the immature mDCs comprise CD14−/LO/CD11c+ mDCs.

### Claim 18 (depends on 9)

The kit of claim 9, wherein the human individual has RA or SLE.