# US 12,061,198 B2 · Diagnosis and treatment of viral diseases

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- Number: US 12,061,198 B2
- Document ID: US12061198B2
- Status: Granted
- Kind: B2
- Application number: 16/601,627
- Filed: 2019-10-15
- Published: 2020-04-09
- Granted: 2024-08-13
- Earliest claimed: 2013-01-08
- Assignees: Enzo Biochem, Inc.
- Applicants: Enzo Biochem, Inc
- Inventors: Gerard Nuovo; Virginia Nivar
- Web page: https://patentgrep.com/patent/US12061198B2

## CPC

- G01N 33/56994: {Herpetoviridae, e.g. cytomegalovirus, Epstein-Barr virus}
- C07K 16/085: Orthoherpesviridae (F), e.g. pseudorabies virus or Epstein-Barr virus
- C07K 16/244: {Interleukins [IL]}
- C12Q 1/6883: for diseases caused by alterations of genetic material
- C12Q 1/6886: for cancer (immunoassay for cancer G01N33/575)
- C12Q 1/701: {Specific hybridization probes}
- C12Q 1/705: {for herpetoviridae, e.g. herpes simplex, varicella zoster}
- C07K 2317/33: Crossreactivity, e.g. for species or epitope, or lack of said crossreactivity
- C07K 2317/76: Antagonist effect on antigen, e.g. neutralization or inhibition of binding
- C12N 2710/16021: Viruses as such, e.g. new isolates, mutants or their genomic sequences
- C12Q 2600/118: Prognosis of disease development
- C12Q 2600/158: Expression markers
- G01N 2333/03: Herpetoviridae, e.g. pseudorabies virus
- G01N 2800/7052: Fibrosis
- 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)
- 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)
- C12Q: MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS (immunoassay G01N33/53); COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
- C12N: MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA (microbiological testing media C12Q1/00)

## Abstract

Provided are methods of diagnosing a viral disease such as idiopathic pulmonary fibrosis, Castleman's disease, a lymphoma, a thymoma or a sarcoma in a patient by identifying one or more virus-specific elements such as a nucleic acid or a viral protein or a patient antibody to a virus-specific element, as well as to kits for diagnosing the viral disease in a patient. Further provided are methods of monitoring disease progression and/or the efficacy of therapy by measuring the levels of a virus-specific element in a sample from a patient, and methods of identifying therapeutic agents that show efficacy in reducing levels of virus-specific agents in vitro. Still further provided are methods of treating idiopathic pulmonary fibrosis, a lymphoproliferative disease and cancer, as well as to methods of preventing viral infection, including Herpesvirus saimiri infection.

## Claims

### Claim 1

A composition comprising a viral nucleic acid target sequence hybridized to
a non-radioactively labeled nucleic acid comprising one or more nucleic acid sequences complementary to Herpesvirus saimiri, wherein the non-radioactive label comprises a fluorescent label, a chemiluminescent label, a hapten label, a chromogenic label, or an energy transfer pair element, wherein the non-radioactively labeled nucleic acid is completely complementary to a sequence of at least 20 contiguous nucleotides within ID NO: 11, SEQ ID NO: 12, SEQ ID NO: 13 or SEQ ID NO: 14
and wherein the composition is present in a human cell in an isolated lung tissue specimen.

### Claim 2 (depends on 1)

The composition of claim 1, wherein the viral nucleic acid target sequence has the nucleotide sequence of Herpesvirus saimiri.

### Claim 3 (depends on 1)

The composition of claim 1, wherein the non-radioactively labeled nucleic acid is labeled with biotin.

### Claim 4 (depends on 1)

The composition of claim 1, wherein the non-radioactively labeled nucleic acid comprises at least one locked nucleic acid (LNA) oligonucleotide.

### Claim 5 (depends on 1)

The composition of claim 1, wherein the non-radioactively labeled nucleic acid comprises a nucleotide sequence of SEQ ID:5, SEQ ID NO:6, SEQ ID NO:7 or SEQ ID NO:8.