[Federal Register Volume 66, Number 38 (Monday, February 26, 2001)]
[Notices]
[Pages 11594-11595]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-4617]


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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.

Plasmids Expressing START Domains of StAR and MLN64

Dr. Yosuke Tsujishita and Dr. James Hurley (NIDDK)
DHHS Reference No. E-020-01/0
Licensing Contact: Marlene Shinn; 301/496-7056 ext. 285; e-mail: 
[email protected]


[[Page 11595]]


    Steroidogenic acute regulatory protein (StAR) manages acute 
steroidogenesis in the adrenal cortex and gonads by promoting the 
translocation of cholesterol to the mitochondrial inner membrane where 
initial steroid biosynthesis is catalyzed. Within StAR are StAR related 
lipid transfer (START) domains which are 200-210 amino acid motifs that 
occur in a remarkably wide range of proteins involved in diverse cell 
functions such as lipid transport and metabolism, signal transduction 
and transcription regulation. The closest homolog to StAR is MLN64, 
with 35% sequence identity between their START domains.
    The technology embodied in this invention encompasses plasmids 
expressing START domains of StAR and MLN64. These fragments enable 
expression of proteins for many biochemical studies and specifically 
towards cholesterol transfer in acute steroidegenesis. Possible 
commercial applications include targets for cancer treatment to known 
over expressed MLN64 in breast carcinoma.

Macromolecular Enzyme Substrates

Glen L. Hortin (CC)
DHHS Reference No. E-233-99/0 filed 31 Jul 2000
Licensing Contact: Dennis Penn; 301/496-7056 ext. 211; e-mail: 
[email protected]

    This invention discloses a new class of reagents used to measure 
the activity of enzymes. The inventor discovered that connecting a 
small reagent molecule onto a polymer that serves as a large carrier 
molecule confers advantages in the measurement of enzyme activity. 
Advantages of the new class of reagents are: (1) Better modeling of the 
size of natural targets (substrates) of many biologically important 
enzymes, (2) improved specificity of measurements, (3) ability to 
measure the influence of substrates size on enzyme activity (carrier 
group size can be varied over a wide range), (4) improved substrate 
solubility, and (5) the potential for easier methods of synthesis and 
purification of some enzyme substrates. Reagents of this class can be 
used to measure the activity of components forming and breaking down 
blood clots, of digestive components, of components of the complement 
system, and of many other components with essential biological 
functions.

Efficient Generation of Midbrain Neurons From Mouse Embryonic Stem 
Cells

Sang-Hun Lee, Nadya Lumelsky, Lorenz Studer and Ronald McKay (NINDS)
DHHS Reference No. E-291-99/0 filed May 1, 2000
Licensing Contact: Norbert Pontzer; 301/496-7735, ext. 284; e-mail: 
[email protected]

    Parkinson's disease is a progressive neurological disorder 
affecting an estimated one million patients in the United States. 
Parkinson's disease occurs when dopamine producing cells in the central 
nervous system degenerate. Currently patients receive medications to 
treat the symptoms, but not cure or stop the progression of the 
disease. As the disease progresses the medications usually become less 
effective. One encouraging new form of therapy replaces the lost 
dopamine producing neurons with transplanted cells. A major obstacle to 
cell replacement therapy has been obtaining sufficient dopamine 
producing cells. Therapeutic or ethical problems exit for all presently 
available sources of cells for transplantation.
    This invention provides a method for efficiently generating 
dopaminergic neurons from embryonic stem cells. Embryonic cells are 
totipotent cells which can proliferate indefinitely in the 
undifferentiated state. A method of generating specific differentiated 
cells from embryonic stem cells thus provides a potentially unlimited 
source of those cells. A sequence of culturing steps involving exposure 
to specific neurotrophic factors and other agents produces a high 
percentage of cultured dopaminergic neurons. An unlimited supply of 
dopaminergic neurons which may be suitable for transplantation is thus 
provided. Details of some aspects of this invention can be found in 
Nature Biotechnology Vol. 18, pages 675-679, June 2000.

Methods for Delivering Biologically Active Molecules Into Cells

Jeffrey L. Miller, Urszula Wojda, Paul K. Goldsmith (NIDDK)
DHHS Reference Nos. E-174-98/0 filed 15 Jan 1999 and E-174-98/1 
filed 14 Jan 2000
Licensing Contact: Dennis Penn; 301/496-7056 ext. 211; e-mail: 
[email protected]

    The appropriate gene therapy delivery system depends greatly on the 
cells being targeted and the means by which delivery is anticipated. 
Numerous clinical trials are currently ongoing for gene therapy, each 
typically usually a different mode of delivery. It is still too early 
to determine which mode will be approved and which will be the most 
effective. The polyethylenimineDNA (PEI-DNA) complex is known to be an 
effective system for delivery of DNA. In vitro models of a new delivery 
system based on the cationic properties of PEI have found that the 
cellular incorporation is significantly enhanced using an Avidin-PEI-
DNA complex. Experiments have shown that there is, at a minimum, a 3x 
to 10x increase in the cellular uptake of the DNA. It is believed that 
this gene delivery system can be targeted to any cell of interest. It 
was demonstrated that the transfection can be targeted to native and 
biotinylated cells. For cells, with a known surface phenotype, 
biotinylated monoclonal antibodies can be attached to specific sites 
and the Avidin-PEI-DNA complex then binds and enters the cell via 
endocytosis.
    Alternatively, cells without a known surface phenotype, biotin can 
be covalently attached to the cell surface and the Avidin-PEI-DNA 
complex is then able to bind and carry the DNA into the cells. This 
system appears to be not only applicable to gene therapy, but to the 
diagnostic market and to the delivery of other anionic materials into 
cells. This Avidin-PEI-DNA system may find a niche market or it may 
become utilitarian, such that it can be effectively utilized in more 
than one gene therapy treatment. This technology is available for 
immediate licensing and independent commercialization and/or a 
Cooperative and Development Research Agreement can be considered.

    Dated: February 15, 2001.
Jack Spiegel,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 01-4617 Filed 2-23-01; 8:45 am]
BILLING CODE 4140-01-P