[Federal Register Volume 65, Number 2 (Tuesday, January 4, 2000)]
[Notices]
[Pages 302-303]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-62]


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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.

ACTION: Notice.

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SUMMARY: The invention listed below is owned by an agency of the U.S. 
Government and is available for licensing in the U.S. (and in selected 
foreign markets) in accordance with 35 U.S.C. 207 to achieve 
expeditious commercialization of results of federally-funded research 
and development.

ADDRESSES: Licensing information may be obtained by contacting Marlene 
Shinn at the Office of Technology Transfer, National Institutes of 
Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852-3804; 
telephone: 301/496-7056 ext. 285; fax: 301/402-0220; e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: The NIH announces the issuance of U.S. 
Patent 5,958,778, entitled ``Container for Drying Biological Samples, 
Method of Making Such Container, and Method of Using Same,'' developed 
by Dr. Geoffrey L. Kidd of the National Eye Institute.

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 forgo 
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.


[[Page 303]]


    Dated: December 29, 1999.
Jack Spiegel,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 00-62 Filed 1-3-00; 8:45 am]
BILLING CODE 4140-01-M