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Federal Register announcement published November 3, 1995, by the NIH

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Federal Register: November 3, 1995 (Volume 60, Number 213)]
[Notices]
[Page 55847]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Government-Owned Inventions; Availability for Licensing

AGENCY: National Institutes of Health.

ACTION: Notice.

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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 U.S. companies and may also be available for licensing.

ADDRESSES: Licensing information and a copy of the U.S. patent
application and/or the issued patent referenced below may be obtained
by contacting the indicated Licensing Specialist at the Office of
Technology Transfer, National Institutes of Health, 6011 Executive
Boulevard, Suite 325, Rockville, Maryland 20852-3804 (telephone 301/
496-7735; fax 301/402-0220). A signed Confidential Disclosure Agreement
will be required to receive a copy of the patent application.

Monoclonal Antibodies for Binding HTLV-III (HIV-1) Proteins, and Cell
Lines for Their Production

Sarngadharan, M., Veronese, F., Gallo, R. (NCI)
Serial No. 06/816,573
Patent Issued 27 June 89
U.S. Patent No. 4,843,011
Licensing Contact: Steven Ferguson, 301/496-7735 ext 266

Monoclonal antibodies and hybridoma cell lines for their production
are disclosed for three specific proteins that characterize HIV-1, the
virus that has been identified with AIDS. This invention relates to all
monoclonal antibodies that demonstrate immune reactivity with specific
antigens that identify the HIV-1 virus: p41, a transmembrane envelope
glycoprotein; p24, a major core protein; and p17. These antibodies
provide a means for directly detecting the virus in the sera, blood or
blood products of AIDS patients or HIV-1 carriers. Such methods are an
important advance over the indirect antibody detection methods
presently used. Methods based on antibody detection give false
negatives if no antibodies have yet been produced. These antibodies are
believed to provide a positive indication of the presence of the virus
at any stage of the disease in a patient or in a healthy carrier of
virus.

Sterile-Lyophilization Tube

Kidd, G.L. (NEI)
Filed 22 Sep 95
DHHS Reference No.: E-015-95/0
Licensing Contact: David Sadowski, 301/496-7735 ext. 288

Problem Addressed by This Invention: Many compounds, such as drugs,
growth factors, etc., must be kept sterile and must be aliquotted for
storage. Usually, these aliquots are best stored lyophilized. Yet,
researchers have never had a way to keep aliquots sterile through the
lyophilization process. Consequently, each aliquot has had to be
filter-sterilized when reconstituted for use. This process has the
disadvantages of consuming excessive filters, syringes, sterile,
receptacles, and time and results in serious loss of precious sample
due to absorption by the filters (especially with small aliquots less
than 1 ml). Alternatively, researchers have had to forego
lyophilization and store their solutions in the less-stable frozen
form.
Solution Offered by This Invention: Sterile-lyophilization tubes
having a 0.22 micron filter built into the cap. This unique feature
allows a sterile solution to remain sterile throughout lyophilization,
even after the vacuum is released and air reenters the tube. Thus, a
starting solution is simply filter-sterilized while in a relatively
large volume, using a single filter and therefore suffering minimal
loss and consuming little time. It is then aliquotted into sterile-
lyophilization tubes and lyophilized. The tubes can then be transferred
directly to the freezer, if desired. The compound is reconstituted when
needed, and may then be used immediately without further filtration.
Potential Applications of This Invention: All researchers worldwide
who utilize sterile, labile compounds will have an interest in this
product, including governmental, university, institutional, and drug
company laboratories. Most notably in need are investigators involved
in drug-testing, which is normally done either in cell cultures,
laboratory animals, or humans, and which requires sterility of many
aliquots of many drugs. Additionally, this product will have a large
market relating to basic research utilizing microbial, plant, or animal
cell or organ cultures, to which sterile compounds such as growth
factors are commonly added. Research in drugs, growth factors, etc., is
expanding ever more rapidly, and generally requires a cell culture
system in which to study such compounds. Most of these compounds are
quite expensive. Loss of potency during storage and loss of material
during filtration are widespread problems which may be overcome with
this invention. Therefore, there exists a tremendous need, and immense
market for, this sterile-lyophilization vessel.
Stage of Development: Development is complete and invention has
been successfully tested. Prototypes are available.

Dated: October 26, 1995.
Barbara M. McGarey,
Deputy Director, Office of Technology Transfer.
[FR Doc. 95-27321 Filed 11-2-95; 8:45 am]
BILLING CODE 4140-01-P