# US 12,000,844 B2 · Diagnostic drug and diagnostic method for Alzheimer's disease

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- Number: US 12,000,844 B2
- Document ID: US12000844B2
- Status: Granted
- Kind: B2
- Application number: 17/265,805
- Filed: 2019-08-06
- Published: 2021-06-03
- Granted: 2024-06-04
- Earliest claimed: 2018-08-07
- Assignees: Sumitomo Pharma Co., Ltd.
- Applicants: Sumitomo Pharma Co., Ltd.
- Inventors: Atsushi Ono; Yasuhiro Teranishi; Masanori Kusumoto; Masakazu Hashimoto; Shoji Kashiwabara; Maki Hashimoto
- Web page: https://patentgrep.com/patent/US12000844B2

## CPC

- G01N 33/6896: {Neurological disorders, e.g. Alzheimer's disease}
- A61P 25/28: for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
- A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
- C07K 14/4711: {Alzheimer's disease; Amyloid plaque core protein}
- C07K 14/705: Receptors; Cell surface antigens; Cell surface determinants {(tumour specific antigens C07K14/4748)}
- C07K 16/18: against material from animals or humans
- C07K 16/28: against receptors, cell surface antigens or cell surface determinants
- G01N 33/15: Medicinal preparations {; Physical properties thereof, e.g. dissolubility}
- G01N 33/531: Production of immunochemical test materials
- C07K 2317/34: Identification of a linear epitope shorter than 20 amino acid residues or of a conformational epitope defined by amino acid residues
- 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
- 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

The present invention provides a polypeptide consisting of any of the following amino acid sequences and useful for determining Alzheimer's disease: (1) the amino acid sequence shown in SEQ ID NO: 1; and (2) an amino acid sequence resulting from substitution, deletion, addition or insertion of one to several amino acids in the amino acid sequence shown in SEQ ID NO: 1.

## Claims

### Claim 1

An antibody recognizing a S38AA polypeptide, wherein the S38AA polypeptide consists of the amino acid sequence of SEQ ID NO: 1, or an amino acid sequence resulting from substitution, deletion, addition, or insertion of one to several amino acids in the amino acid sequence of SEQ ID NO: 1, and wherein the antibody is
(a) an antibody comprising the heavy chain variable region of SEQ ID NO: 4, and the light chain variable region of SEQ ID NO: 5,
(b) an antibody comprising the heavy chain variable region of SEQ ID NO: 6, and the light chain variable region of SEQ ID NO: 7,
(c) an antibody comprising the heavy chain variable region of SEQ ID NO: 8, and the light chain variable region of SEQ ID NO: 9,
(d) an antibody comprising the heavy chain variable region of SEQ ID NO: 10, and the light chain variable region of SEQ ID NO: 11,
(e) an antibody comprising the heavy chain variable region of SEQ ID NO: 12, and the light chain variable region of SEQ ID NO: 13,
(f) an antibody comprising the heavy chain variable region of SEQ ID NO: 14, and the light chain variable region of SEQ ID NO: 15,
(g) an antibody comprising the heavy chain variable region of SEQ ID NO: 16, and the light chain variable region of SEQ ID NO: 17,
(h) an antibody comprising the heavy chain variable region of SEQ ID NO: 18, and the light chain variable region of SEQ ID NO: 19,
(i) an antibody comprising the heavy chain variable region of SEQ ID NO: 20, and the light chain variable region of SEQ ID NO: 21, or
(j) an antibody comprising the heavy chain variable region of SEQ ID NO: 22, and the light chain variable region of SEQ ID NO: 23.

### Claim 2 (depends on 1)

The antibody of claim 1, further recognizing the polypeptide of SEQ ID NO: 2.

### Claim 3 (depends on 1)

The antibody of claim 1, wherein the S38AA polypeptide consists of the amino acid sequence of SEQ ID NO: 1.

### Claim 4 (depends on 1)

The antibody of claim 1, wherein the antibody is an antibody comprising the heavy chain variable region of SEQ ID NO: 4, and the light chain variable region of SEQ ID NO: 5.

### Claim 5 (depends on 1)

The antibody of claim 1, wherein the antibody is an antibody comprising the heavy chain variable region of SEQ ID NO: 6, and the light chain variable region of SEQ ID NO: 7.

### Claim 6 (depends on 1)

The antibody of claim 1, wherein the antibody is an antibody comprising the heavy chain variable region of SEQ ID NO: 8, and the light chain variable region of SEQ ID NO: 9.

### Claim 7 (depends on 1)

The antibody of claim 1, wherein the antibody is an antibody comprising the heavy chain variable region of SEQ ID NO: 10, and the light chain variable region of SEQ ID NO: 11.

### Claim 8 (depends on 1)

The antibody of claim 1, wherein the antibody is an antibody comprising the heavy chain variable region of SEQ ID NO: 12, and the light chain variable region of SEQ ID NO: 13.

### Claim 9 (depends on 1)

The antibody of claim 1, wherein the antibody is an antibody comprising the heavy chain variable region of SEQ ID NO: 14, and the light chain variable region of SEQ ID NO: 15.

### Claim 10 (depends on 1)

The antibody of claim 1, wherein the antibody is an antibody comprising the heavy chain variable region of SEQ ID NO: 16, and the light chain variable region of SEQ ID NO: 17.

### Claim 11 (depends on 1)

The antibody of claim 1, wherein the antibody is an antibody comprising the heavy chain variable region of SEQ ID NO: 18, and the light chain variable region of SEQ ID NO: 19.

### Claim 12 (depends on 1)

The antibody of claim 1, wherein the antibody is an antibody comprising the heavy chain variable region of SEQ ID NO: 20, and the light chain variable region of SEQ ID NO: 21.

### Claim 13 (depends on 1)

The antibody of claim 1, wherein the antibody is an antibody comprising the heavy chain variable region of SEQ ID NO: 22, and the light chain variable region of SEQ ID NO: 23.

### Claim 14 (depends on 1)

An agent for determining Alzheimer's disease or the progression of Alzheimer's disease in a subject, comprising the antibody of claim 1.

### Claim 15 (depends on 1)

A kit comprising the antibody of claim 1.

### Claim 16 (depends on 15)

The kit of claim 15, further comprising a S38AA polypeptide, wherein the S38AA polypeptide consists of the amino acid sequence of SEQ ID NO: 1, or an amino acid sequence resulting from substitution, deletion, addition, or insertion of one to several amino acids in the amino acid sequence of SEQ ID NO: 1.

### Claim 17 (depends on 1)

A method for detecting a S38AA polypeptide, wherein the S38AA polypeptide consists of the amino acid sequence of SEQ ID NO: 1, or an amino acid sequence resulting from substitution, deletion, addition, or insertion of one to several amino acids in the amino acid sequence of SEQ ID NO: 1, which method comprises a step of contacting a test sample with the antibody of claim 1.