58930 Federal Register / Vol. 69, No. 190 / Friday, October 1, 2004 / Notices 

Although this technology is still in an 

early stage, our researchers have 

obtained solid evidence of the 

involvement of Smad3 in these 

processes by use of a Smad3 null mouse 

model which they have developed. 

Based on these results, it is believed that 

antisense Smad3 or small molecule 

inhibitors of Smad3 will have clinical 

applications in wound healing, in 

improving growth and reducing 

unwanted fibrosis of autologous skin 

grafts for treatment of burn patients, and 

in treatment of radiation fibrosis and 

other fibrotic diseases associated with 

chronic inflammation. In addition, the 

discovery of inhibitors to Smad3 

signaling may lead to radiation dose 

escalation and accelerated tumor cell 

death while reducing the side effects 

associated with radiation therapy. 

Use of Smad3 Inhibitor in the 

Treatment of Fibrosis Dependent on 

Epithelial to Mesenchymal Transition 

as in the Eye and Kidney 

Anita B. Roberts (NCI) 

PCT Application No. PCT/US04/03563 

Filed 16 Jan 2004 (DHHS Reference No. 

E–062–2003/3–PCT–01) 

Licensing Contact: Marlene ShinnAstor; (301) 435–4426; 

shinnm@mail.nih.gov. 

Fibroid scar tissue has been 

associated with wound healing of the 

epithelial layer following tissue damage 

created by surgery or other means. 

Examples of which include the opaque 

scar tissue associated with cataract 

surgery and the fibroid scar tissue 

produced in several kidney diseases 

such as is seen in unilateral ureteral 

obstruction. 

Smad2 and Smad3 are highly 

homologous cytoplasmic proteins which 

function to mediate signals from 

Transforming Growth Factor Beta (TGF–

B) and activin receptors to promoters of 

target genes found in the nucleus. The 

NIH announces a technology wherein 

Smad 3 is now implicated in TGF–Bdependent transdifferentiation of 

epithelial cells to mesenchymal cells 

(EMT), which blocks the endpoint of 

fibrosis at an early stage of 

differentiation of epithelial cell 

precursors into interstitial fibroblasts. In 

particular, fibrosis was blocked 

following wounding of the lens of the 

eye and damage created to the kidney. 

It is believed that an inhibitor of Smad 

3 could be used to block fibrosis 

following cataract surgery and lens 

implantation in patients, as well as 

slowing the progression of end-stage 

renal disease.

Dated: September 22, 2004. 

Steven M. Ferguson, 

Director, Division of Technology Development 

and Transfer, Office of Technology Transfer, 

National Institutes of Health.

[FR Doc. 04–22148 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, HHS.

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. 

Bovine Adeno-Associated Viral (BAAV) 

Vector and Uses Thereof 

John Chiorini et al. (NIDCR) 

U.S. Provisional Application No. 60/

526,786 Filed 04 Dec 2003 (DHHS 

Reference No. E–329–2003/0–US–01) 

Licensing Contact: Jesse Kindra; (301) 

435–5559; kindraj@mail.nih.gov.

Adeno-associated viruses (AAVs) are 

common in humans, but no disease has 

been associated with AAV infections. 

This, as well as several other properties, 

has made AAVs potentially useful for 

gene therapy. Bovine AAV (BAAV) is 

serologically distinct from AAVs 

isolated from humans and may not be 

neutralized by circulating antibodies in 

patients receiving gene therapy. 

Moreover, BAAV has a unique tropism 

for various cell lines when compared to 

other AAVs. For instance, recombinant 

BAAV transduced murine 

submandibular salivary glands about ten 

times more efficiently than AAV–2. 

Therefore, BAAV may be a useful 

addition to the repertoire of gene 

transfer tools because of its unique 

serological identity, cell tropism, and 

efficient gene transfer in vivo. 

The present invention describes the 

isolation, subcloning and sequencing of 

BAAV and provides a vector comprising 

BAAV viral particles, or a vector 

comprising subparts of the vectors. The 

invention also provides a method of 

delivering a nucleic acid to a cell 

subject. We note that this vector may 

also have future application(s) in the 

cattle industry. 

This invention has been described in 

Schmidt et al. 2004. J. Virol. 78:6509–

16. 

Treatments for Inhibiting Development 

and Progression of Nevi and Melanoma 

Having BRAF Mutations 

Paul S. Meltzer (NHGRI) 

PCT Application No. PCT/US03/32989 

Filed 16 Oct 2003 (DHHS Reference No. 

E–021–2003/0–PCT–01) 

Licensing Contact: Charmaine 

Richman; (301) 451–7337; 

richmanc@mail.nih.gov.

The technology encompasses 

activating mutations in the BRAF gene 

that promote nevi and melanoma 

proliferation. These mutations produce 

an activated form of B–Raf, a serine/

threonine kinase participant in the Ras/

Raf/MEK/ERK MAPK pathway. In one 

example of the activating BRAF

mutations, a 1796 T → A transversion 

produces a V599E mutated form of B–

Raf. This mutated form of B–Raf 

possesses a tenfold greater basal kinase 

activity and induces focus formation in 

NIH3T3 cells 138 times more efficiently 

than does wild type B–Raf. Methods of 

diagnosing BRAF mutations in a subject, 

methods of treating nevi and melanoma 

in subjects having BRAF mutations, 

methods of selecting treatments, 

methods of screening for agents that 

influence B–Raf activity, and methods 

of influencing the expression of BRAF

or BRAF variants are also claimed. 

Nucleotide sequences for use in the 

described methods are also provided, as 

are protein-specific binding agents, such 

as antibodies, that bind specifically to at 

least one epitope of a B–Raf variant 

protein preferentially compared to wild 

type B–Raf. 

Important publications: Oncogene

(2004) 23, 4060–4067; Nature (2002) 

417(6892), 949–54.

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