[Federal Register Volume 61, Number 248 (Tuesday, December 24, 1996)]
[Notices]
[Page 67840]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-32580]


-----------------------------------------------------------------------


DEPARTMENT OF HEALTH AND HUMAN SERVICES

Government-Owned Inventions; Availability for Licensing

AGENCY: National Institutes of Health.

ACTION: Notice.

-----------------------------------------------------------------------

    The invention listed below is owned by an agency of the U.S. 
Government and is 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 patent referenced below may be obtained by contacting David 
Sadowski at the Office of Technology Transfer, National Institutes of 
Health, 6011 Executive Boulevard, Suite 325, Rockville, Maryland 20852-
3804 (telephone 301/496-7735 ext 288; fax 301/402-0220). A signed 
Confidential Disclosure Agreement will be required to receive a copy of 
the patent application.

Container for Drying Biological Samples, Method of Making Such 
Container, and Method of Using Same

Kidd, G.L. (NEI)
Filed 20 Sep 96 (claiming priority date of 22 Sep 95)
Serial No. 08/717,114

    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: November 26, 1996.
Barbara M. McGarey,
Deputy Director, Office of Technology Transfer.
[FR Doc. 96-32580 Filed 12-23-96; 8:45 am]
BILLING CODE 4140-01-M