Xenomics

Patents

Our patented technology uses safe and simple urine collection and can be applied to a broad range of testing including: prenatal genetic testing, tumor detection and monitoring, tissue transplantation, infectious disease, forensic identification, drug development and bio-terrorism.

We own proprietary technology protected by broad patents covering the fields of prenatal genetic diagnosis, cancer detection and transplantation. We also have rights to pending patent applications that we expect to further extend coverage to the use of diagnostic applications of Tr-DNA for use in detection of specific cancer genetic mutations (NPM), non-urinary tract infections from bacteria such as TB and H. pylori, viruses such as HIV and parasites such as plasmodium the causative agent for malaria.

Of prime importance to our positioning in the market will be the need for adoption by key diagnostics laboratories and certain diagnostic companies that will need access to our patents in order to enter the market for urine DNA testing.

Our joint venture company, SpaXen, in partnership with the Istituto Nazionale per le Malattie Infettive (INMI) (Rome) has developed extensions of our technology in the area of infectious disease. We have entered into a license agreement with INMI that grants to SpaXen an exclusive license to newly developed intellectual property assigned to INMI, which relates to Tr- DNA technology in the field of infectious diseases. Under a separate license, SpaXen granted to us an exclusive sublicense to manufacture, use, import and/or sell any products covered by the same INMI intellectual property licensed by SpaXen from INMI.

In the US, Xenomics, or its partner INMI, have filed nine patent applications, has been granted three US patents, and has six patents pending. The three granted US patents that Xenomics holds rights to are summarized below.

The company´s Intelectual Property is managed by Dr. Ivor R. Elrifi of Mintz Levin Cohn Ferris Glovsky and Popeo P.C., and by Dr. David Ladner, Director of Licensing and Intellectual Property of Xenomics Inc.

Issued Patents
www.uspto.gov

United States Patent 6,251,638
Methods For Detection Of Nucleic Acid Sequences In Urine
June 26, 2001
Samuil R. Umansky, Anatoly V. Lichtenstein, and Hovsep S. Melkonyan

The patent claims non-invasive methods for detecting specific DNA markers in DNA fragments that have originated in a fetus, have crossed the placenta and entered the mother’s bloodstream, have passed through the mother’s kidney barrier, and have been excreted in the mother’s urine.

United States Patent 6,287,820
Methods For Detection Of Nucleic Acid Sequences In Urine
September 11, 2001
Samuil R. Umansky, Anatoly V. Lichtenstein, and Hovsep S. Melkonyan

This patent claims non-invasive methods for detecting the presence of specific DNA markers in transrenal DNA fragments that have originated outside the genitourinary tract, passed through the body’s kidney filter, and have been excreted in urine. Specifically, first, this patent claims methods for detecting specific DNA alterations associated with diseases such as cancer. Second, it claims methods of analyzing DNA alterations for the diagnosis of cancer and the monitoring of its treatment.

United States Patent 6,492,144
Methods For Detection Of Nucleic Acid Sequences In Urine
December 11, 2002
Samuil R. Umansky, Anatoly V. Lichtenstein, and Hovsep S. Melkonyan

This patent claims non-invasive methods for detecting the presence of specific DNA markers in transrenal DNA fragments that have originated outside the genitourinary tract, passed through the body’s kidney filter, and have been excreted in urine. Specifically, it claims methods of analyzing donor DNA present in recipient urine for the purpose of tracking the success of transplanted cells, tissues, and organs.

In addition to its three granted US patents, Xenomics, alone or through its JV partner INMI, currently has four US patent applications under review at the USPTO.

These are

1) US 10/992639, a reissue application for US Patent No. 6,492,144 to extend claims relating to infectious diseases.

2) US 11/137934 (under license agreement with INMI) which relates to bacterial infections,

3) US 11/351799, (under license agreement with INMI) a continuance-in-part of 11/137934, which additionally relates to parasitic infections,

4) US 11/137935 (under license agreement with INMI) which relates to viral infections,

In the international arena, Xenomics has made six patent applications including two to the World Intellectual Property Organization, two to the European Union, and two in Italy. The European Union has allowed one patent, which will be validated in key countries of the EU, while the second is pending. All other international patent claims remain pending.

European Union – On April 19, 2006 , Xenomics announced that its first European patent had been granted:

EP 0920539B

Methods For Detection Of Nucleic Acid Sequences In Urine

The allowed claim covers methods for detecting specific DNA markers in DNA fragments that have originated in a fetus, have crossed the placenta and entered the mother’s bloodstream, have passed through the mother’s kidney barrier, and have been excreted in the mother’s urine.

A divisional application of the above is also pending:

EP 1634966A

Methods For Detection Of Nucleic Acid Sequences In Urine

The pending claims cover methods for detecting transrenal DNA for diagnosing and monitoring cancer, infectious diseases, and transplanted cells, tissues, and organs.

Xenomics has also filed two applications with the World Intellectual Property Organization (WIPO) (www.wipo.int) under the Patent Convention Treaty (PCT) to extend coverage of its pending US applications 11/351799 and 11/137935 internationally.

In addition to its own proprietary inventions, Xenomics has recently licensed the exclusive rights to use a recently discovered genetic marker for Acute Myeloid Leukemia (AML) in combination with its proprietary DNA diagnostic technology. This technology was discovered by Drs. Cristina Mecucci and Brunangelo Falini, collaborators at the Institute of Hematology at the University of Perugia in Italy. The worldwide rights are described in PCT application WO2006/046270, entitled

Nucleophosmin Protein (NPM) Mutants, Corresponding Gene Sequences And Uses Thereof