# US 10,119,977 B2 · Therapeutic and diagnostic methods for autism spectrum disorders and other conditions

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- Number: US 10,119,977 B2
- Document ID: US10119977B2
- Status: Granted
- Kind: B2
- Application number: 15/136,021
- Filed: 2016-04-22
- Published: 2016-11-17
- Granted: 2018-11-06
- Earliest claimed: 2012-06-25
- Assignees: The Johns Hopkins University
- Applicants: The Johns Hopkins University
- Inventors: Avindra Nath; Tongguang Wang; Christina Michelle Morris-Berry; Harvey Singer
- Web page: https://patentgrep.com/patent/US10119977B2

## CPC

- G01N 33/6854: {Immunoglobulins}
- A61K 31/4184: condensed with carbocyclic rings, e.g. benzimidazoles
- A61K 31/4525: containing a five-membered ring with oxygen as a ring hetero atom
- A61K 31/7105: Natural ribonucleic acids, i.e. containing only riboses attached to adenine, guanine, cytosine or uracil and having 3'-5' phosphodiester links
- A61K 39/3955: {against proteinaceous materials, e.g. enzymes, hormones, lymphokines}
- G01N 33/6893: {related to diseases not provided for elsewhere}
- C07K 16/2869: {against hormone receptors (for antibodies against neuromediator receptors C07K16/286)}
- C07K 2317/10: characterized by their source of isolation or production
- C07K 2317/21: from primates, e.g. man
- C07K 2317/73: Inducing cell death, e.g. apoptosis, necrosis or inhibition of cell proliferation
- C07K 2317/75: Agonist effect on antigen
- G01N 2333/705: Assays involving receptors, cell surface antigens or cell surface determinants
- G01N 2333/726: G protein coupled receptor, e.g. TSHR-thyrotropin-receptor, LH/hCG receptor, FSH
- G01N 2800/30: Psychoses; Psychiatry
- G01N 2800/50: Determining the risk of developing a disease
- 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)
- 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)
- 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 relates to the field of autism. More specifically, the present invention provides methods for treating individuals with autism spectrum disorders. The present invention also provides methods for predicting a likelihood of ASD. In one embodiment, a method for treating a female patient having a high risk factor of having children with ASD comprises the steps of (a) identifying in a sample taken from the female patient the presence of AT-1 antibodies; and (b) administering an effective amount of an AT-1 inhibitor or inhibitor of AT-1 antibodies to the female patient.

## Claims

### Claim 1

A method of screening a female patient for a high risk of having children with an autism spectrum disorder (ASD) comprising the steps of:
(a) obtaining a sample from the female patient, wherein the serum is suspected of comprising an antibody to angiotensin II type 1 receptor;
(b) contacting the serum sample obtained from the female patient with an AT-1 polypeptide;
(c) incubating the serum sample with the AT-1 polypeptide under conditions sufficient to allow the formation of AT-1 antibody:AT-1 polypeptide complexes;
(d) detecting the presence or absence of the AT-1 antibody:AT-1 polypeptide complexes;
(e) identifying the female patients as having a high risk of having children with ASD if AT-1 antibody:AT-1 polypeptide complexes are detected and identifying the female patient as not having a high risk of having children with ASD if AT-1 antibody:AT-1 polypeptide complexes are not detected; and
(f) treating the female patients identified as having a high risk of having children with ASD with an effective amount of Telmisartan, a selective serotonin reuptake inhibitor (SSRI) and/or plasmaphoresis or immunophoresis to remove the AT-1 antibodies.

### Claim 2 (depends on 1)

The method of claim 1, wherein the female patient is pregnant.

### Claim 3 (depends on 1)

The method of claim 1, wherein the female patient is not pregnant.

### Claim 4 (depends on 1)

The method of claim 1, wherein the SSRI is fluoxetine, fluvoxamine, paroxetine, sertraline or mianserin.