# US 12,181,477 B2 · Methods of detecting prostate cancer

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- Number: US 12,181,477 B2
- Document ID: US12181477B2
- Status: Granted
- Kind: B2
- Application number: 18/171,569
- Filed: 2023-02-20
- Published: 2023-09-07
- Granted: 2024-12-31
- Earliest claimed: 2013-03-09
- Assignees: Immunis.Ai, Inc.
- Applicants: Immunis.Ai, Inc.
- Inventors: Amin I. Kassis; Harry Stylli; Colleen Kelly; Geoffrey Erickson; Kirk J. Wojno
- Web page: https://patentgrep.com/patent/US12181477B2

## CPC

- G01N 33/57555: of the prostate
- C12Q 1/6886: for cancer (immunoassay for cancer G01N33/575)
- C12Q 2600/106: Pharmacogenomics, i.e. genetic variability in individual responses to drugs and drug metabolism
- C12Q 2600/118: Prognosis of disease development
- C12Q 2600/158: Expression markers
- G01N 2333/46: from vertebrates
- G01N 2333/7158: for chemokines
- G01N 2333/90: Enzymes; Proenzymes
- G01N 2500/00: Screening for compounds of potential therapeutic value
- G01N 2500/04: Screening involving studying the effect of compounds C directly on molecule A (e.g. C are potential ligands for a receptor A, or potential substrates for an enzyme A)
- G01N 2800/50: Determining the risk of developing a disease
- G01N 2800/52: Predicting or monitoring the response to treatment, e.g. for selection of therapy based on assay results in personalised medicine; Prognosis
- G01N 2800/54: Determining the risk of relapse
- 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)
- 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

## Abstract

The invention described herein provides biological markers for the diagnosis, prognosis, and monitoring of prostate cancer

## Claims

### Claim 1

A method for measuring the level of a marker in a sample from a subject, the method comprising the steps of:
a) measuring the levels of five or more markers comprising ALPL, PI3, CXCR2, GPR97, and MMP9 in a population of the subject's macrophage cells;
b) measuring the levels of the five or more markers in a population of the subject's non-phagocytic cells;
wherein measuring levels of the five or more markers occurs prior to the subject receiving treatment for prostate cancer.

### Claim 2 (depends on 1)

The method of claim 1, wherein measuring levels of the markers comprises measuring gene expression levels.

### Claim 3 (depends on 2)

The method of claim 2, wherein the gene expression levels are measured by a sequencing technique selected from the group consisting of direct sequencing, RNA sequencing, whole transcriptome shotgun sequencing, random shotgun sequencing, Sanger dideoxy termination sequencing, whole-genome sequencing, sequencing by hybridization, pyrosequencing, capillary electrophoresis, gel electrophoresis, duplex sequencing, cycle sequencing, single-base extension sequencing, solid-phase sequencing, high-throughput sequencing, massively parallel signature sequencing, emulsion PCR, sequencing by reversible dye terminator, paired-end sequencing, near-term sequencing, exonuclease sequencing, sequencing by ligation, short-read sequencing, single-molecule sequencing, sequencing-by-synthesis, real-time sequencing, reverse-terminator sequencing, nanopore sequencing, 454 sequencing, Solexa Genome Analyzer sequencing, MS-PET sequencing, mass spectrometry, and a combination thereof.

### Claim 4 (depends on 2)

The method of claim 2, wherein the gene expression levels are measured by polymerase chain reaction (PCR) analysis, sequencing analysis, electrophoretic analysis, restriction fragment length polymorphism (RFLP) analysis, Northern blot analysis, quantitative PCR, reverse-transcriptase-PCR analysis (RT-PCR), allele specific oligonucleotide hybridization analysis, comparative genomic hybridization, heteroduplex mobility assay (HMA), single strand conformational polymorphism (SSCP), denaturing gradient gel electrophisis (DGGE), RNAase mismatch analysis, mass spectrometry, tandem mass spectrometry, matrix assisted laser desorption/ionization-time of flight (MALDI-TOF) mass spectrometry, electrospray ionization (ESI) mass spectrometry, surface-enhanced laser desorption/ionization-time of flight (SELDI-TOF) mass spectrometry, quadrupole time of flight (Q-TOF) mass spectrometry, atmospheric pressure photoionization mass spectrometry (APPI-MS), Fourier transform mass spectrometry (FTMS), matrix-assisted laser desorption/ionization-Fourier transform-ion cyclotron resonance (MALDI-FT-ICR) mass spectrometry, secondary ion mass spectrometry (SIMS), surface plasmon resonance, Southern blot analysis, in situ hybridization, fluorescence in situ hybridization (FISH), chromogenic in situ hybridization (CISH), immunohistochemistry (IHC), microarray, comparative genomic hybridization, karyotyping, multiplex ligation-dependent probe amplification (MLPA), Quantitative Multiplex PCR of Short Fluorescent Fragments (QMPSF), microscopy, methylation specific PCR (MSP) assay, Hpaii tiny fragment Enrichment by Ligation-mediated PCR (HELP) assay, radioactive acetate labeling assays, colorimetric DNA acetylation assay, chromatin immunoprecipitation combined with microarray (ChiP-on-chip) assay, restriction landmark genomic scanning, Methylated DNA immunoprecipitation (MeDIP), molecular break light assay for DNA adenine methyltransferase activity, chromatographic separation, methylation-sensitive restriction enzyme analysis, bisulfite-driven conversion of non-methylated cytosine to uracil, methyl-binding PCR analysis, or a combination thereof.

### Claim 5 (depends on 2)

The method of claim 2, wherein the gene expression levels are measured by an amplification assay or a sequencing assay.

### Claim 6 (depends on 1)

The method of claim 1, wherein the non-phagocytic cells are T cells, B cells, null cells, basophils, or mixtures thereof.

### Claim 7 (depends on 1)

The method of claim 1, further comprising measuring at least one standard parameter associated with prostate cancer.

### Claim 8 (depends on 7)

The method of claim 7, wherein the standard parameter is selected from the group consisting of tumor stage, tumor grade, tumor size, tumor visual characteristics, tumor growth, tumor thickness, tumor progression, tumor metastasis, tumor distribution within the body, odor, molecular pathology, genomics, or tumor angiograms.

### Claim 9 (depends on 1)

The method of claim 1, wherein measuring levels of the markers comprises measuring the levels at a first time point and measuring the levels at a second time point, wherein at least the first time point occurs prior to the subject receiving treatment for prostate cancer.

### Claim 10 (depends on 9)

The method of claim 9, wherein the second time point occurs after the subject receives treatment for prostate cancer.