# US 9,040,051 B2 · Marker genes for regulatory T cells from human blood

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- Number: US 9,040,051 B2
- Document ID: US9040051B2
- Status: Granted
- Kind: B2
- Application number: 12/681,263
- Filed: 2008-10-02
- Published: 2011-04-28
- Granted: 2015-05-26
- Earliest claimed: 2007-10-02
- Assignees: Universitaet Zu Koeln; Becton, Dickinson and Company
- Applicants: Joachim Ludwig Schultze; Marc Daniel Beyer; Noel Warner; Ravi Hingorani
- Inventors: Joachim Ludwig Schultze; Marc Daniel Beyer; Noel Warner; Ravi Hingorani
- Web page: https://patentgrep.com/patent/US9040051B2

## CPC

- C07K 14/705: Receptors; Cell surface antigens; Cell surface determinants {(tumour specific antigens C07K14/4748)}
- A61K 35/17: Lymphocytes; B-cells; T-cells; Natural killer cells; Interferon-activated or cytokine-activated lymphocytes (when activated by a specific antigen A61K39/00)
- A61P 37/02: Immunomodulators
- C07K 16/28: against receptors, cell surface antigens or cell surface determinants
- C12N 5/0636: {T lymphocytes}
- A61K 38/00: Medicinal preparations containing peptides (peptides containing beta-lactam rings A61K31/00; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, A61K31/00; ergot alkaloids of the cyclic peptide type A61K31/48; containing macromolecular compounds having statistically distributed amino acid units A61K31/74; medicinal preparations containing antigens or antibodies A61K39/00; medicinal preparations characterised by the non-active ingredients, e.g. peptides as drug carriers, A61K47/00)
- A61K 2039/5154: {Antigen presenting cells [APCs], e.g. dendritic cells or macrophages}
- A61K 2039/5158: {Antigen-pulsed cells, e.g. T-cells}
- C12N 2501/23: Interleukins [IL]
- C12N 2501/24: Interferons [IFN]
- C12N 2501/51: B7 molecules, e.g. CD80, CD86, CD28 (ligand), CD152 (ligand)
- C12N 2501/515: CD3, T-cell receptor complex
- C12N 2502/11: blood or immune system cells
- C12N 2799/027: where the vector is derived from a retrovirus
- 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)
- 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
- C12N: MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA (microbiological testing media C12Q1/00)

## Abstract

The present invention provides novel marker genes for the specific identification and characterization of human suppressive and/or regulatory T cells including natural, adaptive, and expanded CD4+CD25+FOXP3+ T cells in healthy individuals as well as tumor patients or patients with autoimmune diseases.

## Claims

### Claim 1

A method for isolating, identifying or characterizing suppressive and/or regulatory human T cells obtained from human blood, comprising:
(a) contacting the human blood with one or more antibodies or antibody fragments that specifically bind to CD4, CD25 and/or CD127 on the T cells in order to isolate cells obtained from human blood;
(b) contacting the cells obtained from human blood with one or more antibodies or antibody fragments that specifically bind to one or more marker proteins comprising a sequence consisting of SEQ ID NO: 8; and
(c) isolating, identifying or characterizing antibody-bound or antibody-fragment-bound cells, wherein the antibody-bound or antibody-fragment-bound cells are suppressive and/or regulatory human T cells from the human blood.

### Claim 2

A method for isolating, identifying or characterizing suppressive and/or regulatory human T cells obtained from human blood, comprising:
(a) contacting the cells obtained from human blood with one or more antibodies or antibody fragments that specifically bind to one or more marker proteins comprising a sequence consisting of SEQ ID NO: 8;
(b) isolating, identifying or characterizing antibody-bound or antibody-fragment-bound cells, wherein the antibody-bound or antibody-fragment-bound cells are suppressive and/or regulatory human T cells from the human blood; and
(c) assaying for FOXP3 expression.