[Federal Register: September 25, 2003 (Volume 68, Number 186)]
[Notices]
[Page 55398-55399]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr25se03-66]
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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; shimlovm@mail.nih.gov
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; shmilovm@mail.nih.gov
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; ghoshpr@mail.nih.gov
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: hus@mail.nih.gov
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; heftib@mail.nih.gov
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