[Federal Register Volume 69, Number 190 (Friday, October 1, 2004)]
[Notices]
[Pages 58931-58932]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-22150]


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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, DHHS.

ACTION: Notice.

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SUMMARY: The inventions listed below are owned by an agency 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.

DNA-Based Vaccination of Retroviral Infected Individuals Undergoing 
Treatment

Barbara K. Felber et al. (NCI)
U.S. Provisional Application filed 09 Jul 2004 (DHHS Reference No. E-
249-2004/0-US-01); PCT Application No. PCT/US01/45624 filed 01 Nov 
2001, which published as WO02/36806 on 10 May 2002 (DHHS Reference No. 
E-308-2000/0-PCT-02); National Stage filed in EP, CA, AU, JP, and U.S. 
(DHHS Reference No. E-308-2000/0-US-07)
Licensing Contact: Susan Ano; 301/435-5515; [email protected].

    This technology describes DNA-based vaccine vectors that produce 
either secreted or intracellularly degraded antigens that can be 
administered to individuals receiving antiretroviral therapy (ART) 
against HIV. Because some of the virus is sequestered in reservoirs, 
thus evading ART, drug regimen does not result in complete clearance of 
the virus, and prolonged ART is associated with toxicity and 
development of virus resistance. These vectors have recently been shown 
to work unusually well in controlling viremia when administered as DNA 
vaccines to SIV-infected monkeys that

[[Page 58932]]

are undergoing treatment with antiretroviral agents. The current 
technology would decrease the drug dependence and assist in clearing or 
reducing virus burden. The nucleic acids utilized used as a DNA 
immunization plasmids in the current technologies encode a fusion 
protein containing a destabilizing amino acid sequence or encode a 
secreted fusion protein.

Inhibition of HIV-1 Expression by PSP2

Barbara K. Felber et al. (NCI)
U.S. Provisional Application No. 60/573,135 filed 21 May 2004 (DHHS 
Reference No. E-136-2004/0-US-01)
Licensing Contact: Susan Ano; 301/435-5515; [email protected].

    This technology describes methods of identifying inhibitors of HIV-
1 gene expression, where such inhibitors are small molecules or nucleic 
acids. The compounds thus identified could be used as potential anti-
retroviral therapeutics. The candidate agents are those that affect the 
interaction of human paraspeckle protein 2 (PSP2) (also known as SYT-
interacting protein or SIP, RNA binding motif protein 14 or RBM 14, and 
coactivator activator or CoAA) with inhibitory sequences (INS) present 
in the HIV-1 genome. PSP2 has been shown to act via INS present in the 
HIV genome, thus decreasing the levels of retrovirus gene expression 
like gag and env. Therefore, compounds that modulate or enhance effects 
of PSP2 on INS are potential inhibitors of retrovirus expression. The 
methods involve analyzing the effects of PSP2 on INS and evaluating the 
level of retrovirus gene expression in the presence of a candidate 
agent. The technology provides for PSP2 to be introduced into the cell 
using an expression vector that encodes PSP2.

Anti-Plasmodium Compositions and Methods of Use

David Narum (NIAID), Kim Le Sim (EM)
U.S. Patent Application Nos. 09/924,154 filed 07 Aug 2001 (DHHS 
Reference No. E-049-2004/0-US-02) and 10/630,629 filed 29 Jul 2003 
(DHHS Reference No. E-049-2004/0-US-04), with priority to 07 Aug 2000
Licensing Contact: Robert Joynes; 301/594-6565; [email protected].

    This invention describes methods and compositions of peptides that 
inhibit the binding of Plasmodium falciparum (P. falciparum) to 
erythrocytes. Malarial parasites enter the red blood cell through 
several erythrocyte receptors, each being specific for a given species 
of Plasmodia. For P. falciparum, the erythrocyte binding antigen (EBA-
175) is the ligand of the plasmodia merozoites that interacts with the 
receptor glycophorin A on the surface of red blood cells. Inhibiting 
this ligand/receptor interaction is one method of preventing further 
malarial attacks and is an active area of vaccine research.
    This invention describes another specific peptide and antibodies 
that inhibit this ligand/receptor binding, thus is a potential source 
for vaccine development. The peptide described herein is a paralogue of 
EBA-175, identified as EBP2. Further, the invention includes antibodies 
and peptides that are specific for the claimed paralogue. Claims 
include the development of vaccines to the EBA-175 and EBP2. In 
addition, these antibodies and peptides can be developed as diagnostic 
and analytical reagents as well. Methods include the use of the 
peptides and the antibodies for the diagnosis, prevention and potential 
treatment of malaria. Further claims include their use in detection of 
P. falciparum in biological samples and culture methods.

A Novel Interferon-Gamma-Inducible Secretoglobin

Anil B. Mukherjee et al. (NICHD)
U.S. Provisional Application No. 60/534,381 filed 06 Jan 2004 (DHHS 
Reference No. E-028-2004/0-US-01); U.S. Provisional Application No. 60/
570,088 filed 12 May 2004 (DHHS Reference No. E-028-2004/1-US-01)
Licensing Contact: Robert Joynes; 301/594-6565; [email protected].

    Interferons (IFNs) are a family of cytokines that are paramount in 
protecting the host from viral infections. The effects of the IFNs are 
mediated through interactions with specific cellular receptors, 
activation of second messenger systems effecting the expression of 
several antiviral and immunomodulatory proteins.
    This invention describes a novel gene that is induced by IFN-
[gamma] treatment of lymphoblast cells. This gene, termed IIS (IFN-
gamma-inducible Secretoglobin) is a member of the Secretoglobin (SCG) 
superfamily in which uteroglobin (UG) is the founding member. IIS 
shares 30% amino acid identity with UG. Data shows that IIS is 
expressed in virtually all tissues with highest levels found in lymph 
nodes, tonsils, lymphoblasts and ovary. IIS levels are also highly 
elevated in CD8\+\ and CD19\+\ cells. In further experiments, treatment 
of immune cells with antisense-s-oligonucleotides to IIS are shown to 
prevent chemotactic migration and invasion. Taken together, these data 
give insight into the immunological function of this novel IIS gene.
    These results are described in MS Choi et al., IFN-gamma stimulates 
the expression of a novel secretoglobin that regulates chemotactic cell 
migration and invasion, J. Immunol. (2004) 172:4245-5252.

Solid Supported Membranes Inside Porous Substrates and Their Use in 
Biosensors

Klaus Gawrisch et al. (NIAAA)
U.S. Provisional Application No. 60/534,380 filed 06 Jan 2004 (DHHS 
Reference No. E-011-2004/0-US-01) and U.S. Provisional Application No. 
60/547,067 filed 09 Jun 2004 (DHHS Reference No. E-011-2004/1-US-01)
Licensing Contact: Robert Joynes; 301/594-6565; [email protected].

    This invention relates to reagents and methods for forming tubular 
single lipid bilayer membranes containing high concentrations of 
membrane receptors inside porous solid supports for use in biosensors. 
It reports compositions and methods for forming a high surface area 
lipid bilayer matrix in which the membrane is separated from the 
support by a closed and stable aqueous cushion. The membranes inside 
the porous substrate have a very large surface area that is freely 
accessible from an outside solution. The aluminum oxide-based support 
provides the advantage of high flow rates to exchange solutions, 
efficient particle retention, rigid, uniform surface, and transparency 
(when wet). Using this technology, G-protein coupled membrane receptors 
(GPCR), purified from natural sources, as well as recombinant receptors 
expressed in E-coli were incorporated into the bilayer in functional 
form. Membrane loaded supports can be stored at low temperature. The 
setup is ideal for ligand binding studies, including drug testing. The 
technology may be applied to a broad variety of membrane receptors but 
appears to be particularly useful for GPCR. The use of single lipid 
bilayers greatly reduces nonspecific interactions of ligands with the 
substrate therefore enhancing sensitivity and reproducibility of 
binding studies. The water layer between the membrane and the solid 
support prevents perturbation of receptor function. The substrates are 
compatible with signal detection by fluorescence, radiotracers, NMR, 
and other methods.

    Dated: September 22, 2004.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 04-22150 Filed 9-30-04; 8:45 am]
BILLING CODE 4140-01-P