75992 Federal Register / Vol. 69, No. 243 / Monday, December 20, 2004 / Notices 

development through collaborative 

research with the inventors via a 

Cooperative Research and Development 

Agreement (CRADA). 

Treatment of Human Viral Infections 

(Imatinib) 

Drs. Steven Zeichner and Vyjayanthi 

Krishnan (NCI). 

U.S. Provisional Application No. 60/

588,015 filed 13 Jul 2004 (DHHS 

Reference No. E–281–2004/0–US–01). 

Licensing Contact: Sally Hu; 301/435–

5606; hus@mail.nih.gov.

This application describes the 

methods for treating or preventing a HIV 

infection by the administration of ablkinase inhibitor called imatinib and its 

derivatives. Several available agents can 

inhibit HIV replication by targeting one 

or another viral protein, such as the 

viral reverse transcriptase, protease, 

envelope fusion process, or integrase, or 

by targeting the interaction of a viral 

component with a host cell component, 

for example the host cell viral receptor 

or co-receptor. However, HIV can 

readily become resistant to these drugs, 

and new therapeutic approaches for HIV 

infection are needed. The studies 

described in the application show that 

the expression of many host cell genes 

changes in response to HIV replication, 

and show that targeting one of these 

changes with imatinib can inhibit viral 

replication. Thus targeting the host cell, 

and making the host cell less hospitable 

to the virus can inhibit viral replication. 

The application thus describes a new 

agent that inhibits viral replication by 

acting on the host cell, which may offer 

new approaches to therapy for HIV 

infection. These approaches may be less 

likely to engender rapid resistance in 

the virus to the therapy. 

This abstract replaces one published 

in the Federal Register on Friday, 

October 22, 2004 (69 FR 62060).

Dated: December 13, 2004. 

Steven M. Ferguson, 

Director, Division of Technology Development 

and Transfer, Office of Technology Transfer, 

National Institutes of Health.

[FR Doc. 04–27780 Filed 12–17–04; 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. 

AAV4 Vector and Uses Thereof 

John A. Chiorini (NHLBI/NIDCR), 

Robert M. Kotin (NHLBI), Brian Safer 

(NHLBI). U.S. Patent 6,468,524 issued 

22 Oct 2002 (DHHS Reference No. E–

071–2000/0–US–01). 

Licensing Contact: Jesse Kindra; (301) 

435–5559; kindraj@mail.nih.gov. 

The invention described and claimed 

in this patent application relates to the 

delivery of heterologous nucleic acids or 

genes to particular target cells. In 

particular, the application relates to 

methods of delivering a heterologous 

nucleic acid or gene of interest to 

particular target cells using AdenoAssociated Virus of serotype 4 (AAV4). 

The particular target cells identified are 

the ependymal cells of the brain. The 

methods described herein may be useful 

in carrying out gene therapy for diseases 

of the brain or central nervous system. 

This work has been published in part 

at Davidson, BL, et al. ‘‘Recombinant 

adeno-associated virus type 2, 4, and 5 

vectors: transduction of variant cell 

types and regions in the mammalian 

central nervous system’’ PNAS USA 

97(7):3428–32 (March 28, 2000). 

In addition, PHS owns additional 

intellectual property related to this 

technology describing an AAV4-based 

vector system. The material contained 

in the patent application has been 

published as WO 98/11244 (March 19, 

1998) and the research corresponding 

thereto has been published in J. 

Virology 71(9): 6823–33 (Sept 1997). 

AAV5 Vector for Transducing Brain 

Cells and Lung Cells 

John A. Chiorini (NHLBI/NIDCR), 

Robert M. Kotin (NHLBI). 

U.S. Patent Application No. 09/

533,427 filed 22 Mar 2000 (DHHS 

Reference No. E–072–2000/0–US–01). 

Licensing Contact: Jesse Kindra; (301) 

435–5559; kindraj@mail.nih.gov. 

The invention described and claimed 

in this patent application is related to 

the delivery of heterologous nucleic 

acids or genes to particular target cells. 

In particular, the application relates to 

methods of delivering a heterologous 

nucleic acid or gene of interest to 

particular target cells using an AdenoAssociated Virus of serotype 5 (AAV5). 

The particular target cells identified 

include the alveolar cells of the lung 

and cerebellar and ependymal cells of 

the brain. The methods described herein 

may be useful in carrying out gene 

therapy related to diseases of the brain 

or central nervous system and the 

respiratory tract. 

This work has been published, in 

part, at Davidson BL, et al. PNAS, USA 

97(7):3428–32 (March 28, 2000) and 

Zabner J, et al. J Virol. 74(8):3852–8 

(April 2000). 

In addition to this patent application, 

PHS owns additional intellectual 

property related to this technology. The 

patent application has been published 

as WO 99/61601 on December 2, 1999 

and the research corresponding thereto 

has been published at Chiorini JA, et al.

J. Virol. 73(5): 4293–98 (May 1999) and 

Chiorini JA, et al. J. Virol. 73(2): 1309–

19 (Feb. 1999). 

TTP as a Regulator of GM-CSF mRNA 

Deadenylation and Stability

Ester Carballo-Jane, Wi S. Lai, Perry J. 

Blackshear (NIEHS). U.S. Provisional 

Application No. 60/148,810 filed 13 

Aug 1999 (DHHS Reference No. E–204–

1999/0–US–01); PCT Application No. 

PCT/US00/22199 filed 12 Aug 2000, 

which published as WO 01/12213 on 22 

Feb 2001 (DHHS Reference No. E–204–

1999/0–PCT–02); U.S. Patent 

Application No. 10/049,586 filed 12 Feb 

2002 (DHHS Reference No. E–204–1999/

0–US–03). 

Licensing Contact: Jesse Kindra; (301) 

435–5559; kindraj@mail.nih.gov. 

The disclosed invention provides 

materials and methods to treat 

granulocytopenia (low white cell count 

in the blood) which is characterized by 

a reduced number of granulocytes 

(relative) or an absence of granulocytes 

(absolute). This condition is commonly 

associated with cancer chemotherapy, 

but is seen less frequently in a number 

of conditions including the use of 

propylthiouracil, radiotherapy for 

marrow ablation for bone marrow 

transplantation, aplastic anemia, 

systemic lupus erythematosus, AIDS 

and a variety of other situations. The 

Federal Register / Vol. 69, No. 243 / Monday, December 20, 2004 / Notices 75993

invention proposes a method to increase 

GM–CSF levels in a treated subject, and 

this increase is achieved by inhibiting 

the degradation of GM–CSF messenger 

RNA (mRNA). Tristetraprolin (TTP) is 

one member of a family of cys-cys-cyshis (CCCH) zinc finger proteins, and it 

is a factor that binds to and causes the 

instability of GM–CSF mRNA. Methods 

are provided for the development of 

screening assays for molecules that 

inhibit the binding of TTP and its 

related proteins to GM–CSF mRNA, or 

otherwise inhibit the effect of TTP to 

promote breakdown of the mRNA, 

leading in turn to increased mRNA 

stability and enhanced production of 

GM–CSF. Compounds identified by 

such screens, and their derivatives, 

could be useful in treating 

granulocytopenia from whatever cause. 

Additional information about this 

technology may be found in the 

following research articles: 

Carballo, E, Lai, WS and Blackshear, 

PJ. Evidence that tristetraprolin (TTP) is 

a physiological regulator of granulocytemacrophage colony-stimulating factor 

(GM–CSF) mRNA deadenylation and 

stability. 2000; Blood 95:1891–1899. 

Lai, WS, Carballo, E, Thorn, JM, 

Kennington, EA and Blackshear, PJ. 

Interactions of CCCH zinc finger 

proteins with mRNA. 1. Binding of 

tristetraprolin-related zinc finger 

proteins to AU-rich elements and 

destabilization of mRNA. 2000; J. Biol. 

Chem., 275:17827–19837. 

In addition to licensing, the 

technology is available for further 

development through collaborative 

research with the inventors via a 

Cooperative Research and Development 

Agreement (CRADA).

Dated: December 13, 2004. 

Steven M. Ferguson, 

Director, Division of Technology Development 

and Transfer, Office of Technology Transfer, 

National Institutes of Health.

[FR Doc. 04–27782 Filed 12–17–04; 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. 

The Use of Rabbits With Defined 

Immunoglobulin Light Chain Genes 

(Ckappa b Allotypes) To Optimize 

Production of Chimeric and Humanized 

Monoclonal Antibodies for 

Therapeutic, Imaging and Diagnostic 

Applications 

Rose G. Mage, Cornelius Alexander 

(NIAID). 

DHHS Reference No. E–332–2004/0—

Research Tool. 

Licensing Contact: Pradeep Ghosh; (301) 

435–5282; ghoshpr@mail.nih.gov.

Biological materials are important 

research tools that can be used for 

diagnostic as well as therapeutic 

purposes. Antibodies have become 

viable drugs in the market today and 

there is a general market need for 

systems that may facilitate production 

of efficient and effective antibodies. In 

recent years, monoclonal antibodies 

have gained significant importance in 

their use, both as diagnostics and 

therapeutics, to intervene and combat 

diseases such as cancer, cardiovascular 

diseases, and infections. The present 

invention relates to the discovery of 

rabbits, genetically defined as b9, as the 

biological vehicle for the isolation of 

chimeric phage displaying Fab with 

human constant regions and rabbit 

immunoglobulin heavy and light chain 

variable regions for the development of 

diagnostic antibodies and humanized 

monoclonal therapeutic antibodies of 

high affinity and specificity (Popkov et 

al., J. Molec. Biol. 325: 325–335, 2003; 

Popkov et al. J. Immunol. Methods 288: 

149–164, 2004). Recently, many 

effective antibodies have been 

developed as a result of the integration 

of antibody libraries with phage display 

technology. The rabbit model described 

in this invention may be used for 

production of antibodies that may cross 

react with both human and mouse 

antigens. Rabbit monoclonal antibodies 

that react with both human and mouse 

antigens are of particular relevance for 

the preclinical evaluation of therapeutic 

antibodies in mouse models of human 

diseases. Therefore, this invention has a 

broad commercial potential in its use as 

a source for producing monoclonal 

antibodies for therapeutic interventions 

in infectious, autoimmune and 

neurological diseases, nerve damage and 

cancer. 

Methods for Diagnosis of 

Atherosclerosis 

Paul Hwang et al. (NHLBI). 

U.S. Provisional Application No. 60/

607,031 filed 03 Sep 2004 (DHHS 

Reference No. E–276–2004/0–US–01). 

Licensing Contact: Fatima Sayyid; 301/

435–4521; sayyidf@mail.nih.gov.

In industrialized countries coronary 

heart disease and stroke due to 

atherosclerosis are the leading causes of 

morbidity and mortality. Coronary heart 

disease is the single largest cause of 

death in the U.S.A. and will cost 

approximately $133.2 billion according 

to the 2004 American Heart Association 

statistics update. 

The identification of more sensitive 

and specific markers of atherosclerosis 

that are non-invasive and cost-effective 

may have profound impacts on public 

health. One such strategy involves the 

detection of marker genes or their 

products in blood or serum. Such 

markers may help identify high-risk 

patients with subclinical atherosclerosis 

who may benefit from intensive primary 

prevention or they may help determine 

the activity of established disease for 

monitoring response to treatment, 

resulting in more targeted secondary 

prevention.

The present invention relates to 

methods for detecting atherosclerosis 

using highly reactive biomarkers (FOS 

and/or DUSP1) expressed in blood cells 

or released into serum. Because these 

markers are also involved in 

pathogenesis, they may serve as 

potential targets for drug discovery and 

for intervention to modify disease 

progression. 

An Improved Method To Separate and 

Expand Antigen-Specific T Cells 

Jonming Li and John Barrett (NHLBI). 

U.S. Provisional Application No. 60/

606,197 filed 31 Aug 2004 (DHHS 

Reference No. E–246–2004/0–US–01). 

Licensing Contact: Fatima Sayyid; (301) 

435–4521; sayyidf@mail.nih.gov.

Stem cell transplants can be used to 

treat patients with leukemia or other 

disorders. Transplanted donor T cells 

(lymphocytes) exert strong alloimmune