[Federal Register Volume 65, Number 146 (Friday, July 28, 2000)]
[Notices]
[Pages 46475-46477]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-19151]


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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.

[[Page 46476]]

V1 Knockout Mice for Screening New Vaccines Against Streptococcus 
Pneumoniae

Qing-Sheng Mi, James J. Kenny, Dan L. Longo (NIA)
DHHS Reference No. E-140-00/0
Licensing Contact: Uri Reichman; 301/496-7056 ext. 240; e-mail: 
[email protected]

    Streptococcus pneumonia (SP) is a bacterial agent found in both 
mild mucosa and severe systemic infection; it is also often responsible 
for pneumonia, a disease that takes over one million lives a year. 
Recent SP strains prove resistant to Penicillin and other antibiotics, 
making the development of a Pneumococcal vaccine crucial. The existing 
vaccine is only about eighty percent effective at preventing SP 
infection in adults, but is much less effective in infants, aged, or 
immune deficient patients. Antibodies to phosphocholine (PC), an 
immunodominant epitope in the cell wall of Streptococcus pneumoniae, 
protect mice from lethal pneumococcal infection. The heavy chain of the 
PC protecting antibody is encoded by the V1 segment of the S107 
VH gene family. The V1 knockout mice which are available for 
licensing, cannot produce protective antibodies against the PC epitope 
of Streptococcus pneumonia. They are however, capable of producing 
normal antibodies to other cell wall proteins following bacteria 
immunization and get partial protection against lethal pneumococcal 
infection. Thus, the V1 knockout mice can facilitate the screening of 
protective antigens other than PC. This may result in new vaccine 
candidates against Streptococcus pneumonia. Screening for new vaccine 
candidates can be done as follows: The V1 knockout mice can be 
immunized with avirulent SP bacteria. The immune serum will be utilized 
to detect and isolate the antigenic cell wall proteins, using standard 
affinity binding procedures. The antigenic proteins will then be 
cloned, sequenced and purified. Normal mice will be immunized with 
these proteins and then challenged with virulent SP bacteria to 
determine whether these proteins have protective function.

Methods and Compositions for Co-Stimulation of Immunological 
Responses to Peptide Antigens

Samir Khleif, Jay Berzofsky (NCI)
DHHS Reference No. E-128-00/0 filed 15 Mar 2000
Licensing Contact: Peter Soukas; 301/496-7056 ext. 268; e-mail: 
[email protected]

    This invention relates to peptide vaccines comprising administering 
a peptide comprising at least one T cell epitope coordinately with a 
non-viral vector comprising a polynucleotide encoding a T cell co-
stimulatory molecule useful for eliciting cellular immune responses. 
The inventors have found that intradermal vaccination of mice with a 
DNA vector carrying the mouse co-stimulatory immunoglobulin B7.1 (CD80) 
in combination with a Human Papilloma Virus (HPV) E7 peptide 
significantly enhances the E7 specific cytotoxic lymphocyte response. 
Delivery of the B7.1 molecule as non-replicating DNA with antigenic 
peptides overcomes the problems of low antigenicity associated with 
some viral vectors as well as the instability, exogenous presentation 
and conformational maintenance problems associated with the delivery of 
full-length protein delivery. Furthermore, polynucleotides encoding the 
B7.1 construct can potentially be used along with any other form of 
antigen vaccine delivery systems, including peptides, full proteins and 
naked DNA antigens and are inexpensive to produce.

Full-Length Infectious cDNA Clones of Tick Borne Flavivirus

Alexander Pletnev, Robert M. Chanock (NIAID)
DHHS Reference No. E-281-98/0 filed 10 Feb 2000
Licensing Specialist: Carol Salata; 301/496-7735 ext. 232; e-mail: 
[email protected]

    The tick-borne encephalitis virus complex of flavivirus family 
includes tick-borne encephalitis (TBEV), Kyasanur forest disease, 
Langat, Louping ill, Negishi, Omsk hemorrhagic fever and Povassan 
viruses. These viruses are endemic throughout most of the Northern 
Hemisphere and except for Langat, cause human disease of varying 
severity that can have mortality as high as 20 to 30%. Tick-borne 
encephalitis remains a pressing public health problem in Eastern Europe 
and Russia, where 9,000 to 12,000 patients are diagnosed annually and 
there is a need for a vaccine which can prevent this disease. This 
invention relates to an infectious full length Langat virus cDNA which 
has been successfully constructed and can be used to further attenuate 
this naturally attenuated tick-borne flavivirus. This full length 
Langat virus can be used as a live attenuated virus vaccine for the 
prevention of severe, often fatal disease caused by its more virulent 
tick-borne flavivirus relatives such as tick-borne encephalitis virus.

Polypeptides That Bind HIV gp120 and Related Nucleic Acids, 
Antibodies, Compositions, and Methods of Use

Carl Saxinger (NCI)
DHHS Reference No. E-245-99/0 filed 27 Aug 1999
Licensing Contact: J.P. Kim; 301/496-7056 ext. 264; e-mail: 
[email protected]

    The presence of chemokines has been observed to have an inhibitory 
effect on HIV-1 attachment to, and infection of, susceptible cells. The 
interaction between gp120 and CD4, or at least one chemokine receptor 
is obligatory for HIV-1 infection. Reagents which interfere with the 
binding of gp120 to chemokine receptors and to CD4 are used in the 
biological and medical arts; however, there remains a need for 
additional reagents that can compete with one or more proteins of the 
gp120-CD4-chemokine-receptor complex to assist in the development of 
HIV therapeutics.
    The present invention relates to such polypeptides with homology to 
domains of the human chemokine receptors CCR5, CXCR4, and STRL33, as 
well as domains of CD4 that bind with human immunodeficiency virus 
(HIV), in particular the HIV-1 glycoprotein 120 (gp120) envelope 
protein. These receptor polypeptides were identified through the 
application of a recent technological advance in the design and 
synthesis of synthetic peptide arrays (see Saxinger, WC: An automated 
peptide design and synthesis; U.S. Patent 6,031,074 issued 29 Feb 
2000). The binding of gp120 to receptor peptide arrays was highly 
linearly correlated with structure/activity relationships between 
biological receptors and HIV infectivity in vitro (r=>95%, p=0.03). The 
binding of gp120 by active receptor polypeptides was unrestricted by 
viral or receptor strain or subtype suggesting that the polypeptides 
participated in an early stage of infection common to multiple virus 
strains, thus potentially addressing problems of virus variation and 
multiple virus strains. The invention further provides for nucleic 
acids encoding such polypeptides, antibodies, compositions comprising 
such polypeptides, nucleic acids or antibodies, and methods of use 
thereof, such as in therapeutics and vaccine design.

System and Method for Simulating a Two-Dimensional Radiation 
Intensity Distribution of Photon or Electron Beams

J van de Geijn, H Xie (NCI)

[[Page 46477]]

Serial No. 08/368,589 filed 06 Jan 1995; U.S. Patent No. 5,526,395 
issued 11 Jun 1996
Licensing Contact: [email protected]

    The present invention provides a method for computer-assisted, 
interactive 3-dimensional radiation treatment planning and 
optimization. The computerized system is capable of processing and 
analyzing data obtained from x-ray, CT, MRI, PET, SPECT, and 
gammacamera devices. Hence, the system can be used as a training 
device, alleviating the need for training centers to purchase each of 
these devices. The computerized system comprises a fast, versatile, and 
user-friendly software package and computer components which are 
commercially available and which can be used without significant 
modification. Because the hardware costs of this system are much lower 
than the cost of systems of comparable ability, this invention ought to 
be particularly attractive to smaller radiation oncology facilities 
which seek a powerful treatment planning system. The low cost of the 
system is also particularly advantageous for medical training 
facilities, including medical schools. The invention also has potential 
use as a monitor for clinical quality assurance.

Combination Therapies for Viral Infection

Lori et al. (NCI); Malley & Vila
Serial Nos. 08/065,814 filed 21 May 1993; 08/245,259 filed 17 May 1994; 
08/169,253 filed 20 Dec 1993; 08/378,219 filed 25 Jan 1995; 08/401,488 
filed 08 Mar 1995; 08/577,322 filed 22 Dec 1995; 08/617,421 filed 18 
Mar 1996; 09/497,700 filed 03 Feb 2000
Licensing Contact: J.P. Kim; 301/496-7056 ext. 264; e-mail: 
[email protected]

    The subject inventions provide for formulations and methods for 
inhibiting replication of reverse transcription dependent viruses in 
animals cells comprising administering a compound that depletes the 
intracellular pool of deoxyribonucleoside phosphate, and further 
comprising administering a compound that serves to inhibit replication 
of the virus by terminating DNA chain elongation.

    Dated: July 19, 2000.
Jack Spiegel,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 00-19151 Filed 7-27-00; 8:45 am]
BILLING CODE 4140-01-P