02-1439. Government-Owned Inventions; Availability for Licensing

AGENCY:

National Institutes of Health, Public Health Service, DHHS.

ACTION:

Notice.

SUMMARY:

The inventions listed below are owned by agencies of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

ADDRESSES:

Licensing information and copies of the U.S. patent applications listed below may be obtained by contacting Marlene Shinn, J.D., at the Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, Maryland 20852-3804; telephone: [phone] ext. 285; fax: [phone]; e-mail: [e-mail]. A signed Confidential Disclosure Agreement will be required to receive copies of the patent applications.

Thermostable DNA Polymerases that Bypass Lesions in DNA

Dr. Roger Woodgate (NICHD) and Dr. Francois Boudsocq (NICHD)

DHHS Reference No. E-232-01/0—Research tool

Lesions in DNA often block DNA polymerases, especially in those polymerases used in the Polymerase Chain Reaction (PCR). Old DNA, such as that from forensic samples, is often damaged and cannot be used for PCR analysis.

The NIH announces the identification of two novel Y-family DNA polymerases—called Dbh and Dpo4—from the archea Sulfolobus solfactaricus P1 and Sulfolobus solfactaricus P2, respectively. The Y family of polymerases are characterized by their ability to replicate through DNA lesions that may block the activity of other, more conventional, polymerases such as the thermostable enzymes used in PCR. Both Dbh and Dpo4 enzymes have been shown to be as thermostable as the Taq polymerase (Dpo4, in particular) and can copy stretches of DNA up to 1300 bp in length. Because these polymerases are in general more efficient at coping with DNA lesions, they may be useful in the amplification of damaged DNA and could be useful in forensic PCR applications.

A Novel Human DNA Polymerase, POL IOTA, Involved in DNA Repair and Mutagenesis

Drs. Roger Woodgate and John McDonald (NICHD)

DHHS Reference No. E-229-01/0—Research tool

The NIH announces the identification of a novel DNA polymerase called POL IOTA, that is highly error prone and may be responsible for causing mutations that ultimately lead to human cancer formation.

The polymerase could be useful as a target for chemotherapeutic agents that block the polymerase's enzyme activity. This in turn could lead to an increase in the cure rate of cancer patients. In addition, a diagnostic assay could be developed to identify enzyme expression patterns and their mutations, so as to recognize humans with an increased risk of cancers. Therefore, the polymerase could be used as a research tool, or with more development, into a kit that could be used in both research and clinical labs.

TMC1 and TMC2 and Applications to Hereditary Deafness

Dr. Andrew Griffith et al. (NIDCD)

DHHS Reference No. E-168-01/0 filed 19 Sep 2001

Hearing loss is a common communication disorder effecting nearly 1 in 1,000 children in the United States alone, and nearly 50% of adults by the age of eighty. Deafness can be caused by both environmental and disease-related factors, however, in at least 50% of the cases, deafness is an inherited trait.

The NIH announces the isolation and purification of two novel genes termed TMC1 and TMC2 that may encode the mammalian hair cell mechanotransduction channel. It is known that the mechanotransduction channel is the critical molecule within the hearing pathway, which detects sound within the inner ear. Our investigators have discovered that dominant and recessive mutations in TMC1 underlie two forms of hereditary deafness known as DFNA36 and DFNB7/11, respectively. This technology would be useful to a company interested in finding new therapies to treat or prevent hearing loss as well as identifying persons at increased risk of developing aminoglycoside-induced hearing loss. This technology is also available for collaboration with a partner under a Cooperative Research and Development Award.

Gene Involved in Dietary Sterol Absorption and Excretion and Uses Therefor

Drs. Michael Dean and Shailendra Patel (NCI)

DHHS Reference No. E-295-99/1 filed 25 Sep 2001 (PCT/US01/29859)

The ATP binding cassette proteins are involved in cholesterol regulation. Cholesterol absorption from the diet is an important mechanism for regulating serum cholesterol levels. It is well known that high serum cholesterol levels are found in several diseases such as diabetes, atherosclerosis, and cardiovascular disease.

The NIH announces the identification and characterization of the ABCG5 gene. The gene maps to human chromosome 2, which has been identified as playing a role in the genetic disorder sitosterolemia. Patients with sitosterolemia display an abnormally high level of blood sterol debri from plants and fish, which can lead to coronary artery disease, atherosclerosis, and arthritis, as well as other diseases. The inventors believe that mutations in the ABCG5 gene interfere with sterol transport thereby causing sitosterolemia. Companies working in this area would find this technology useful in searching for agents that can treat or prevent any disease or condition that has associated with it high cholesterol levels.

Dated: January 11, 2002.

Jack Spiegel,

Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health.