[Federal Register Volume 66, Number 103 (Tuesday, May 29, 2001)]
[Notices]
[Pages 29153-29155]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-13345]


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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 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.

Ocular Therapeutic Agent Delivery Devices And Methods

Michael R. Robinson (NEI), Karl G. Csaky (NEI), Peng Yuan (NEI), 
Cynthia Sung (EM), Robert B. Nussenblatt (NEI), Janine A. Smith (NEI)
Serial No. 09/808,149, filed Mar. 15, 2001
Licensing Contact: Dale Berkley; 301/496-7735 ext. 223; e-mail: 
<a href="/cdn-cgi/l/email-protection#7c1e190e17101905183c131852121514521b130a"><span class="__cf_email__" data-cfemail="4a282f3821262f332e0a252e64242322642d253c">[email protected]</span></a>

    The invention is directed to ocular implant devices for the 
delivery of therapeutic agents to the eye in a controlled and sustained 
manner. Implants suitable for either subconjunctival or intravitreal 
placement are the subject of the invention. These implants permit

[[Page 29154]]

continuous release of therapeutic agents into the eye over specified 
periods of time, which can be weeks, months or years. In one aspect of 
the invention a therapeutic agent is included in both an inner core or 
pellet and an exterior composite matrix layer to provide a dual mode 
release of the therapeutic agent. That is, a loading dose is initially 
delivered to the eye by the matrix layer followed by a transition in 
release rate to a relatively steady maintenance dosage that is 
sustained over a prolonged period of time. In another aspect of the 
invention, methods for making and using the implants are described. The 
time-dependent delivery of one or more drugs to the eye by this 
invention makes it possible to maximize the pharmacological and 
physiological effects of the eye treatment for human and veterinary 
applications.

Vessel Surface Reconstruction with a Tubular Deformable Model

Yim et al. (CC)
DHHS Reference No. E-202-00/1, filed Feb 15, 2001
Licensing Contact: Dale Berkley; 301/496-7735 ext. 270; e-mail: 
<a href="/cdn-cgi/l/email-protection#6d0f081f06010814092d020943030405430a021b"><span class="__cf_email__" data-cfemail="9af8ffe8f1f6ffe3fedaf5feb4f4f3f2b4fdf5ec">[email protected]</span></a>

    The invention is a method for modeling a carotid or renal artery to 
measure stenosis from 3D angiographic data that may otherwise exhibit 
limited image resolution and contrast. The method reconstructs vessel 
surfaces from 3D angiographic data using a deformable model that 
employs a tubular coordinate system. Vertex merging is incorporated 
into the coordinate system to maintain even vertex spacing and to avoid 
problems of self-intersection of the surface. This method produces 
reconstructed surfaces that have a realistic smooth appearance and 
accurately represent vessel shape. The method allows for an objective 
evaluation of vessel shape and may improve the precision of shape 
measurements from 3D angiography.

User Friendly Integrated Database for the Management of Animal 
Study Proposals

Antonia F. Calzone (NIAAA), Etienne Lamoreaux (NIAAA), Karen Montijo 
(NIDDK)
DHHS Reference No. E-215-00/0
Licensing Contact: Dale Berkley; 301/496-7735 ext. 223; e-mail: 
<a href="/cdn-cgi/l/email-protection#751710071e19100c11351a115b1b1c1d5b121a03"><span class="__cf_email__" data-cfemail="f49691869f98918d90b49b90da9a9d9cda939b82">[email protected]</span></a>

    The invention is a set of templates written in FileMaker-
Pro<SUP>TM</SUP> script that provides a convenient integrated database 
management system for tracking the care and disposition of laboratory 
animals. This software is a multifunction program that meets the needs 
of facility veterinarians, animal facility managers, and animal care 
personnel with respect to in-house records keeping and federal 
reporting requirements. The invention builds on the framework of the 
FileMaker Pro<SUP>TM</SUP> software, and results in a database system 
that stores information pertinent to all current Animal Study Proposals 
(ASPs). This design permits users to access the data from a networked 
centralized Windows NT based server using either a Macintosh or IBM 
compatible workstation. The invention comprises features that 
facilitate the day-to-day management of the animal facility as well as 
powerful information storage capabilities.

Identification of New Malaria Parasite Erythrocyte Binding Protein 
(BAEBL) that Binds to Human Red Cells

Ghislaine D. Mayer, Louis H. Miller (NIAID)
DHHS Reference No. E-328-00/0, filed Apr 03, 2001
Licensing Contact: Carol Salata; 301/496-7735 ext. 232; e-mail: 
<a href="/cdn-cgi/l/email-protection#4e3d2f222f3a2f2d0e212a6020272660292138"><span class="__cf_email__" data-cfemail="c8bba9a4a9bca9ab88a7ace6a6a1a0e6afa7be">[email protected]</span></a>

    Malaria is endemic in many parts of the world, particularly in 
tropical regions such as Asia, Central America and South America. 
Recent estimates of the number of cases of malaria worldwide are 
between five hundred million and one billion. There are approximately 
two to three hundred million new cases of malaria each year and malaria 
causes a minimum of one million deaths each year. This invention 
relates to the identification and characterization of the binding 
specificity of BAEBL, a novel Plasmodium falciparum erythrocyte binding 
ligand that interacts with human erythrocytes in a sialic acid 
dependent manner. This novel Plasmodium falciparum erythrocyte binding 
ligand is unique and quite distinct from previously described 
Plasmodium falciparum erythrocyte binding proteins EBA-175. BAEBL may 
be used as a malaria vaccine to block human red cell recognition and 
invasion.

Attenuated Host-Range Restricted Dengue Viruses Derived by Site-
Directed Mutagenesis of the Conserved 3'-Stem and Loop Structure in 
Genomic RNA for Use as Vaccines

Lingling Zeng, Lewis Markoff (CBER/FDA)
DHHS Reference No. E-067-98/2, filed Mar 02, 2001
Licensing Contact: Carol Salata; 301/496-7735 ext. 232; e-mail: 
<a href="/cdn-cgi/l/email-protection#4635272a2732272506292268282f2e68212930"><span class="__cf_email__" data-cfemail="89fae8e5e8fde8eac9e6eda7e7e0e1a7eee6ff">[email protected]</span></a>

    Although flaviviruses cause a great deal of human suffering and 
economic loss, there is a shortage of effective vaccines. The present 
invention is directed toward vector stage replication-defective 
flaviviruses that are replication-defective in mosquito vectors that 
transmit them to humans. The replication-defective flaviviruses of the 
present invention demonstrate a limited ability to replicate in the 
vector organisms that transmit flaviviruses from one host to another. 
More specifically, the present invention is directed toward the 
construction and propagation of flaviviruses that possess 3'-noncoding 
regions altered in such a way as to prevent or severely limit viral 
reproduction in a vector organism. Not only is the dengue 1 mutant 
replication defective in mosquitoes, but it is also attenuated and 
immunogenic in monkeys. Moreover, it protects against challenge, thus 
it has strong potential as a dengue vaccine.

A Chimeric Protein Comprising Non-Toxic Pseudomonas Exotoxin A and 
Type IV Pilin Sequences

David FitzGerald (NCI)
DHHS Reference No. E-283-00/0, filed Dec 21, 2000
Licensing Contact: Carol Salata; 301/496-7735 ext. 232; e-mail: 
<a href="/cdn-cgi/l/email-protection#0576646964716466456a612b6b6c6d2b626a73"><span class="__cf_email__" data-cfemail="5427353835203537143b307a3a3d3c7a333b22">[email protected]</span></a>

    This invention provides candidate chimeric vaccines that generate 
antibodies which interfere with adherence of Pseudomonas aeruginosa 
exotoxin A to epithelial cells and neutralize the cytotoxicity of 
exotoxin A. This invention specifically relates to a chimeric protein 
wherein key sequences from a Type IV pilin protein are inserted into a 
non toxic version of Pseudomonas aeruginosa exotoxin A. Pilin is a 
protein that is present on the surface of bacteria and other 
microorganisms, including P. aeruginosa. The key sequences are known to 
interact with asialoGM1 receptors on human epithelial cells, and allow 
bacteria and other microorganisms to adhere to epithelial cells and 
colonize. The present invention may be particularly useful for cystic 
fibrosis patients who are prone to infections with P. aeruginosa. Also, 
this invention could be a broad approach to vaccines against all gram 
negative bacteria, not just Pseudomonas aeruginosa. Pilin epitopes of 
other gram negative bacteria could be inserted into the Pseudomonas 
aeruginosa exotoxin A and used as a vaccine against that specific 
bacteria.
    Dr. FitzGerald and his colleagues have demonstrated that the 
chimeric protein reacted with asialoGM1, a receptor on

[[Page 29155]]

epithelial cells and blocked adherence of P. aeruginosa on epithelial 
cells. When the chimeric protein was injected into rabbits, the rabbits 
produced antibodies that blocked bacterial adherence and neutralized 
the cell killing activity of native exotoxin A.

A Plasmid for Expression of a More Soluble Form of HIV Integrase 
Protein in E. coli

Robert Craigie (NIDDK)
DHHS Reference No. E-110-01/0
Licensing Contact: Sally Hu; 301/496-7056 ext. 265; e-mail: 
<a href="/cdn-cgi/l/email-protection#8ae2fff9cae5eea4e4e3e2a4ede5fc"><span class="__cf_email__" data-cfemail="71190402311e155f1f18195f161e07">[email protected]</span></a>

    The invention describes a plasmid that provides a convenient method 
for producing large quantities of integrase protein. This integrase 
protein is more soluble because amino acid residue Phe185 is changed to 
Lsy. This change does not affect the in vitro activity of the protein, 
but the improved solubility facilitates large-scale purification and 
handling. Since HIV integrase is a candidate target for antiviral drugs 
and an assay system or a source of HIV integrase is required to 
identify lead compounds, this invention could be very useful for an 
efficient means of producing integrase protein on a large scale. The 
integrase protein could be used in screening for integrase inhibitors 
that could be developed as anti-HIV drugs. This invention is available 
for licensing through a Biological Materials License, as no patent 
application exists.

Benzoylalkylindolepyridinium Compounds and Pharmaceutical 
Compositions Comprising Such Compounds

William G. Rice, Mingjun Huang, Robert W. Buckheit, Jr., David G, 
Covell, Grzegorz Czerwinski, Christopher Michejda, and Vadim Makarov 
(NCI)
DHHS Reference Nos. E-278-98/0 and E-278-98/1, filed Dec 18, 2000
Licensing Contact: Sally Hu; 301/496-7056 ext. 265; e-mail: 
<a href="/cdn-cgi/l/email-protection#bfd7caccffd0db91d1d6d791d8d0c9"><span class="__cf_email__" data-cfemail="8ee6fbfdcee1eaa0e0e7e6a0e9e1f8">[email protected]</span></a>

    The present invention provides novel antiviral compounds active 
against HIV. These compounds, referred to as 
benzoylalkylindolepyridinium compounds (BAIPs) are effective against 
HIV isolates that have developed mutations rendering conventional drugs 
ineffective. BAIPs apparently do not require intracellular 
phosphorylation nor bind to the reverse transcriptase (RT) active site, 
which distinguishes their mechanism of action from the 
dideoxynucleoside (ddN) and acyclic nucleoside phosphonate (ANP) 
nucleoside analog drugs. ddN and ANP have proven clinically effective 
against limiting human immunodeficiency virus (HIV) infection, but 
resistance rapidly emerges due to mutations in and around the RT active 
site. The BAIPs also may be distinguished from non-nucleoside reverse 
transcriptase inhibitors (NNRTIs), in part because the BAIPs bind to a 
different site on the RT enzyme. The usage of NNRTIs is limited by the 
rapid emergence of resistant strains also. Moreover, unlike the NNRTIs, 
BAIPs of the present invention have been shown to be effective against 
HIV-1, HIV-2 and simian immunodeficiency virus (SIV) proliferation. 
Thus, BAIPs are broadly antiviral, non-nucleoside reverse transcriptase 
inhibitors (BANNRTIs).
    This abstract modifies an abstract for this technology published in 
the Federal Register on Tuesday, February 13, 2001 (66 FR 10027).

    Dated: May 17, 2001.
Jack Spiegel,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 01-13345 Filed 5-25-01; 8:45 am]
BILLING CODE 4140-01-P


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