Federal Register / Vol. 69, No. 190 / Friday, October 1, 2004 / Notices 58931

Lentivirus Vector System 

Suresh K. Arya (NCI) 

U.S. Provisional Application No. 60/

115,247 Filed 07 Jan 1999 (DHHS 

Reference No. E–231–1998/0–US–01) 

PCT Application No. PCT/US/00/00390 

Filed 06 Jan 2000, which published as 

WO 00/40741 on 13 Jul 2000 (DHHS 

Reference No. E–231–1998/0–PCT–02) 

U.S. Patent Application No. 09/869,588 

Filed 28 Jun 2001 (DHHS Reference No. 

E–231–1998/0–US–03) 

U.S. Patent Application No. 10/731,988 

Filed 09 Dec 2003 (DHHS Reference No. 

E–231–1998/0–US–04) 

Licensing Contact: Jesse Kindra; (301) 

435–5559; kindraj@mail.nih.gov. 

This application relates to the field of 

gene therapy. More particularly the 

application describes a vector system 

useful in gene therapy. The vectors 

employed in this system are lentiviral 

vectors, particularly retroviral vectors 

based on HIV2. Retroviral vectors based 

on HIV2, unlike most other retroviral 

vectors such as MuLV, are capable of 

infecting non-proliferating cells thereby 

making them useful in situations where 

other retroviral vectors are not. The 

vector system uses a two vector 

approach to minimize the possibility of 

HIV infection and comprises a transfer 

vector, for carrying the foreign gene of 

interest, and a packaging vector. The 

transfer vector carries a specific 

modification that demonstrates an 

improved ability to package and express 

the gene of interest when compared to 

a control. In the experimental system 

this increase was 25 fold. This improved 

packaging and expression ability is one 

means to address current low viral titers 

which are problematic in the gene 

therapy field. 

This research has been published, in 

part, in Human Gene Therapy 1998 June 

10; 9(9): 1371–86. 

Food Quality Indicator Device 

Dwight W. Miller, Jon G. Wilkes, Eric D. 

Conte (FDA) 

U.S. Provisional Application No. 60/

052,674 Filed 17 Jul 1997 (DHHS 

Reference No. E–093–1997/0–US–01) 

PCT Application No. PCT/US98/14780 

Filed 16 Jul 1998, which published as 

WO 99/04256 on 28 Jan 1999 (DHHS 

Reference No. E–093–1997/0–PCT–04) 

U.S. Patent Application No. 09/116,152 

Filed 16 Jul 1998 (DHHS Reference No. 

E–093–1997/0–US–02) 

U.S. Patent Application No. 10/005,004 

Filed 04 Dec 2001 (DHHS Reference No. 

E–093–1997/0–US–03) 

Licensing Contact: George Pipia; (301) 

435–5560; pipiag@mail.nih.gov. 

Scientists at the U.S. Food and Drug 

Administration have invented an 

effective way to monitor food quality 

and freshness in real time. The major 

factor for food spoilage is the release of 

volatile gases due to the action of 

enzymes contained within the food or 

produced by microorganisms, such as 

bacteria, yeasts and molds growing in 

the food. The rate of release of such 

gases depends on food’s storage history. 

In this technology, a reactive dye locked 

in a water-repellent material reacts with 

the gases released during food 

decomposition, and changes color. Thus 

a rapid and informed decision can be 

made about quality of food and its shelf 

life under the storage conditions used. 

Since the detection is based on 

biological processes that are the root 

cause for food spoilage, these indicators 

are much more reliable. 

This technology provides an excellent 

alternative to the current methods for 

assessing food quality that cannot 

accurately estimate shelf life of food 

products due to unreliable storage 

history. This technology is also much 

less expensive than the current 

methods. These indicators have been 

successfully tested on seafood and 

meats and can be easily adapted to dairy 

products. This product is fully 

developed, market-tested and ready for 

full commercial rollout.

Dated: September 22, 2004. 

Steven M. Ferguson, 

Director, Division of Technology Development 

and Transfer, Office of Technology Transfer, 

National Institutes of Health.

[FR Doc. 04–22149 Filed 9–30–04; 8:45 am] 

BILLING CODE 4140–01–P

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.

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; anos@mail.nih.gov.

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 

58932 Federal Register / Vol. 69, No. 190 / Friday, October 1, 2004 / Notices 

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; anos@mail.nih.gov.

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; joynesr@mail.nih.gov.

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; joynesr@mail.nih.gov.

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-g 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; joynesr@mail.nih.gov.

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, Gprotein 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