[Federal Register Volume 68, Number 186 (Thursday, September 25, 2003)]
[Notices]
[Pages 55398-55399]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-24193]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Government-Owned Inventions; Availability for Licensing

AGENCY: National Institutes of Health, Public Health Service, HHS.

ACTION: Notice.

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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 writing to the indicated 
licensing contact at the Office of Technology Transfer, National 
Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, 
Maryland 20852-3804; telephone: (301) 496-7057; fax: (301) 402-0220. A 
signed Confidential Disclosure Agreement will be required to receive 
copies of the patent applications.

Soluble SARS Coronavirus Spike Protein (S Protein)

Dimiter Dimitrov, Xiadong Xiao (NCI)
DHHS Reference No. E-228-2003/0-US-01 filed 22 Jul 2003
Licensing Contact: Michael Shmilovich; 301/435-5019; 
[email protected]
    The SARS coronavirus is etiologically linked to severe acute 
respiratory syndrome. Soluble forms of the SARS coronavirus spike 
protein have been isolated and are available for licensing for use in 
generating vaccines, antibodies, and kits containing antibodies that 
bind to the spike protein for treating disease. The filed patent 
application additionally claims the associated spike protein 
polypeptides, peptide fragments, and conservative variants thereof; 
nucleic acid segments and constructs that encode the spike protein, 
polypeptides and peptide fragments of the spike protein, and 
conservative variants thereof and coupled proteins that include the 
spike protein or a portion thereof and peptidomimetics.
[GRAPHIC] [TIFF OMITTED] TN25SE03.000

Internal Control Nucleic Acid Molecule for Real-Time Polymerase Chain 
Reaction

Michael Vickery, Angelo DePaola, George Blackstone (FDA)
U.S. Provisional Patent Application No. 60/471,121 filed 16 May 2003 
(DHHS Reference No. E-213-2003/0-US-01)
Licensing Contact: Michael Shmilovich; 301/435-5019; 
[email protected]
    The invention provides a PCR internal control system for use in 
both real-time

[[Page 55399]]

PCR (also known as kinetic or Q-PCR) and conventional PCR. This 
flexible system has a number of novel design qualities which make it 
universally adaptable for use in virtually any real-time or 
conventional PCR assay, including RT-PCR and multiplex PCR 
applications, regardless of the organism/gene/nucleic acid being 
targeted. It provides the user/assay developer a choice of control 
product sizes, fluorogenic probe reporting systems, and thermal cycling 
options, allowing ease of incorporation into various assay formats and 
instrument platforms. This unique internal control also can be readily 
incorporated into virtually any existing quantitative multiplex real-
time PCR assay. The invention also provides methods of using the 
internal control system and kits of the invention.
    Additional information may be found in Vickery et al., ``Detection 
and Quantification of Total and Potentially Virulent Vibrio 
parahaemolyticus Using a 4-Channel Multiplex Real-Time PCR Targeting 
the tl, tdh, and trh Genes and a Novel PCR Internal Control,'' 
published abstract, 103rd General Meeting of the American Society for 
Microbiology, May 18-23, 2003, Washington, DC.

Compositions and Methods for Diagnostics and Therapeutics For 
Hydrocephalus

Perry J. Blackshear et al. (NIEHS)
U.S. Provisional Patent Application No. 60/374,184 filed 19 Apr 2002 
(DHHS Reference No. E-163-2002/0-US-01); U.S. Provisional Patent 
Application No. 60/388,266 filed 13 Jun 2002 (DHHS Reference No. E-163-
2002/1-US-01); PCT Application No. PCT/US03/12348 filed 18 Apr 2003 
(DHHS Reference No. E-163-2002/2-PCT-01)
Licensing Contact: Pradeep Ghosh; 301/435-5282; [email protected]
    Congenital hydrocephalus is a public health problem, with 
approximately 1 in 1667 newborns suffering from this birth defect in 
the United States. Many cases of congenital hydrocephalus are caused by 
chromosome X-linked genetic mutations, but the genetic causes of the 
non-X-linked cases are unknown. This invention relates to RFX4--v3 
proteins and nucleic acids encoding the RFX4--v3 proteins. Deficiencies 
in the RFX4--v3 protein are associated with congenital hydrocephalus in 
mice; specifically, the hydrocephalus is non-communicating and 
associated with aqueductal stenosis. The present invention provides 
assays for the detection of human RFX4--v3 polymorphisms or 
deficiencies that may lead to the determination of an individual's risk 
of developing hydrocephalus. Congenital hydrocephalus can have an 
adverse effect on developing brain and may predispose to neurological 
defects in children and adults. These defects can be manifested as 
mental retardation, cerebral palsy, epilepsy and visual disabilities. 
The cost of treatment for such disorders may exceed $100 million 
annually. Efficient diagnostics to determine the risks of development 
of this type of hydrocephalus are lacking in the market. The present 
invention would be most useful in developing diagnostic tests to 
determine whether parents are at risk to have a child with this type of 
hydrocephalus, and also to determine the causes of congenital 
hydrocephalus in affected children.

Sigma-2 Receptor Agonists Inhibit HIV Infection and Replication in 
Lymphocytes

Keith W. Crawford (NIDDK), Wayne D. Bowen (NIDDK), James E. Hildreth 
(EM)
U.S. Provisional Application No. 60/440,367 filed 16 Jan 2003 (DHHS 
Reference No. E-145-2002/0-US-01)
Licensing Contact: Sally Hu; 301/435-5606; e-mail: [email protected]
    This invention describes that the compounds, which activate sigma-2 
receptors, decrease a particular lipid called sphingomyelin. 
Sphingomyelin is a component of lipid rafts, microdomains in the 
membrane which sequester specific proteins. Lipid rafts have been shown 
to play a major role in both entry and exit of HIV virus particles in 
cells. Disruption of lipid rafts blocks HIV infection. Treating 
lymphocytes with the compounds results in decrease in membrane 
sphingomyelin, blocks HIV infection and halts the replication of virus 
in lymphocytes. Thus, this discovery may have direct clinical 
applications in the treatment of HIV disease. In addition, these 
compounds should be effective against HIV that is resistant to multiple 
antiretroviral drugs because viral proteins are not the targets. Then, 
this finding uncovers a totally new approach for treating HIV 
infections and may represent potential new therapeutics for treatment 
of retroviral infections, including AIDS.
    This research is also described, in part, in: Crawford et al., 
Cancer Research 62:313-319, 2002; Crawford et al., Eur. J. Pharmacol. 
443:207-209, 2002; Gebreselassie & Bowen, Proc. of the American Assoc. 
for Cancer Research 43:725, 3597, 2002; Liao et al., AIDS Res. 
Hum. Retroviruses, 17:1009-19, 2001; Nguyen & Hildreth, J. Virol., 74: 
3264-3272, 2000; Vilner & Bowen, J. Pharmacol Exp Ther., 292:900-911, 
2000.

Hepatitis A Virus Receptor and Methods of Use

Gerardo Kaplan, Stephen M. Feinstone (FDA)
U.S. Patent 5,622,861 issued 22 Apr 1997 (DHHS Reference No. E-150-
1994/0-US-01)
Licensing Contact: Brenda Hefti; 301/435-4632; [email protected]
    This invention describes the discovery and isolation of HAVcr-1, a 
simian cellular receptor for the hepatitis A virus (HAV). Cells 
nonpermissive to HAV infection transfected with HAVcr-1 cDNA, a novel 
cell surface mucin-like glycoprotein, gain susceptibility to HAV 
infection. The invention claims nucleic acids encoding cellular 
receptors to HAV that hybridize with HAVcr-1 probes, including the 
human homologs of HAVcr-1 (hHAVcr-1). The invention also claims 
peptides encoded by the above-mentioned HAV receptor nucleic acid, 
antibodies against HAVcr-1 receptors, and ligands to HAVcr-1 receptors.
    The human homolog of HAVcr-1 (hHAVcr-1) has been shown to be a 
marker of renal injury (given the alias of kidney injury molecule 1 or 
KIM-1) and kidney cancer as well as a putative asthma determinant gene 
and modulator of T cell helper responses (given the alias of T-cell 
immunoglobulin mucin 1 or TIM-1). Use of HAVcr-1 nucleic acids and 
derived peptides, antibodies, ligands, etc. for diagnosis and therapy 
are also covered in this patent.
    Potential areas of application include use of HAVcr-1 receptors and 
homologs for diagnostics; use of HAVcr-1 receptors for treatment of 
patients; development of therapeutic compounds capable of interacting 
with HAVcr-1 receptors that could block or activate these receptors, 
development of transgenic animals carrying HAVcr-1 receptors or 
portions of the receptors that could be used for vaccine production and 
testing and other applications.
    HAVcr-1 has been molecularly cloned and its cDNA is available for 
further development. This invention is available for licensing on an 
exclusive or nonexclusive basis.

    Dated: September 16, 2003.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 03-24193 Filed 9-24-03; 8:45 am]
BILLING CODE 4140-01-P