[Federal Register Volume 69, Number 243 (Monday, December 20, 2004)]
[Notices]
[Pages 75989-75991]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 04-27723]


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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 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 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.

Human Monoclonal Antibodies Against Hendra and Nipah Viruses

    Dimiter S. Dimitrov et al. (NCI). U.S. Provisional Application 
filed 1 Nov 2004 (DHHS Reference No. E-004-2005/0-US-01); Related to 
the Phage Display Library described in DHHS Reference No. E-005-2005/0.
    Licensing Contact: Michael Shmilovich; 301/435-5019; 
shmilovm@mail.nih.gov.
    Available for licensing are neutralizing human monoclonal 
antibodies against the envelope proteins (Envs) of Hendra virus (HeV) 
and Nipah virus (NiV) for uses in immunotherapy, vaccine development 
and as diagnostic or research reagents. Monoclonal antibody variable 
region fragments (Fabs and scFvs) have been isolated from screening a 
human phage display library against the Envs. The phage display library 
(DHHS Ref. No. E-005-2005) is useful for screening other viral or 
cancer antigens and can be licensed from DHHS under a biological 
materials license.
    In addition to licensing, the technology is available for further 
development through collaborative research with the inventors via a 
Cooperative Research and Development Agreement (CRADA).

Human Antibody Phage Display Library

    Dimiter S. Dimitrov et al. (NCI). DHHS Reference No. E-005-2005/0--
Research Tool; Related to the Monoclonal Antibodies Against Hendra and 
Nipah Viruses described in U.S. Provisional Application filed 1 Nov 
2004 (DHHS Reference No. E-004-2005/0-US-01).
    Licensing Contact: Michael Shmilovich; 301/435-5019; 
shmilovm@mail.nih.gov.
    Available for licensing as a biological material for either 
internal use or commercial distribution is a human Fab 
immunoglobulin/antibody fragment phage display library. The library 
contains 10\10\ Fabs derived from the peripheral blood of 
ten (10) healthy human donors. The high quality of the library was 
demonstrated in the successful selection of high affinity antibodies 
specific for Hendra and Nipah viruses; however, the library is useful 
for selecting a variety of antigen specific immunoglobulin/antibody 
Fab fragments especially for cancer or viruses.
    In addition to licensing, the technology is available for further 
development through collaborative research with the inventors via a 
Cooperative Research and Development Agreement (CRADA).

Vaccines Against Crimean-Congo Hemorrhagic Fever

    Dimiter Dimitrov and Xiadong Xiao (NCI). U.S. Provisional Patent 
Application filed 3 Nov 2004 (DHHS Reference Nos. E-299-2004/0-US-01 
and E-299-2004/1-US-01).
    Licensing Contact: Michael Shmilovich; 301/435-5019; 
shmilovm@mail.nih.gov.
    Crimean-Congo hemorrhagic fever (CCHF) is a tick-borne public 
health concern in many regions of the world including Africa, the 
Middle East, Europe, and Western Asia. The disease is etiologically 
linked to Crimean-Congo hemorrhagic fever virus (CCHFV) from the 
Nairovirus genus of the Bunyaviridae family of viruses and is 
transmitted primarily through the bite of Ixodid ticks. Available for 
licensing and commercial development are antigens, immunogens, and 
nucleic acid constructs for the development of vaccines against CCHFV. 
The antigens and immunogens are peptides corresponding to the soluble 
ectodomains of CCHFV G1 (Gc) and G2 (Gn) glycoproteins. Also provided 
are coupled proteins that include soluble peptide fragments derived 
from the G1 (Gc) or G2 (Gn) ectodomains or portions thereof; 
peptidomimetics; vaccines; immunogenic compounds methods for 
vaccination and inhibitors of CCHFV cell entry. Expression vectors and 
DNA vaccines encoding these peptides are also within the scope of the 
invention as well as antibodies, aptamers and kits containing 
antibodies or aptamers that bind to these peptides. CCHFV has been 
implicated as a pathogen of biodefense significance.

Intracellular Contrast Agents for Magnetic Resonance Imaging

    Mrinal K. Dewanjee (NIHCC). U.S. Provisional Patent Application 
filed 8 Oct 2004 (DHHS Reference No. E-291-2004/0-US-01).
    Licensing Contact: Michael Shmilovich; 301/435-5019; 
shmilovm@mail.nih.gov.
    Available for licensing and commercial development are contrast 
agents for magnetic resonance imaging (MRI). These agents are composed 
of charge neutral and lipid-soluble complexes of paramagnetic cations 
bound by chelators. Unlike conventional extra-cellular contrast agents, 
these agents of the present

[[Page 75990]]

invention penetrate into the cells and thus permit higher spatial 
resolution in MRI. The paramagnetic cation is preferably 
Gd+\3\, Dy+\3\ and Fe+\3\ with three 
equivalents of a charge neutralizing chelator that provides a neutral 
lipid-soluble complex of the paramagnetic cation. The complex is 
extracted rapidly and retained intracellularly, when mammalian cells 
are incubated in buffer or plasma media. Hence, they may be used in 
imaging vascular plaque after intra-arterial injection and tracking the 
distribution patterns of injected immune cells in localizing the 
inflammatory disease or implanted stem cells in regenerative medicine.

Electromagnetically Tracked Tissue Ablation Device

    Bradford J. Wood (NIHCC). U.S. Provisional Patent Application filed 
5 Nov 2004 (DHHS Reference No. E-278-2004/0-US-01).
    Licensing Contact: Michael Shmilovich; 301/435-5019; 
shmilovm@mail.nih.gov.
    Available for licensing, development, manufacturing and commercial 
distribution is an ablation device coupled with electromagnetic 
tracking for procedural navigation. Minimally invasive interventions 
exemplified by devices like this are rapidly increasing in popularity. 
This device improves accuracy and may improve outcomes by using pre-
procedural imaging (like CT, MRI, PET) during procedures, to assist 
with guidance of ablation probes to a target that shows up on pre-
procedural imaging. This allows use of exquisite diagnostic imaging 
during interventional procedures, that otherwise would not be 
available. This device is similar to having a miniaturized version of 
an automobile GPS (global positioning system) on the tip of a small 
needle. Image guided surgery is not truly ``image guided'' without 
being able to use all pre-operative imaging during the procedure. One 
example allows accurate identification and treatment of a tumor that is 
only briefly seen on CT scan, then disappears, or is only seen with 
PET. Tissue burns during thermal ablation, releasing gas that obscures 
the real-time ultrasound image. This device allows use of CT and other 
enhanced imaging during repositioning of ablation needles, which is the 
most difficult part of the procedure.
    One design can include a guidance needle and grid to direct the 
ablation needle. Another design includes a plate with an aperture and 
button coupled to the plate wherein the plate has a beveled surface and 
a slideable hub coupled to the plate by a rod. An added advantage is an 
inclusion of a plurality of guide apertures to focus the needle. The 
needle is inserted into and guided by one of the guide apertures of the 
grid as the needle is introduced into a body of a patient to a target 
site. The device is useful for therapy or for biopsy and includes a 
button defining an aperture, a hub defining an aperture being slideably 
coupled to the button by a rod, and a lock mechanism configured to lock 
the hub relative to the button on the rod. The system also includes a 
removable probe inserted through the hub and the button and a miniature 
magnetically trackable sensor coil that fits inside a 22 Gauge needle. 
A pictorial representation of the device is shown here.
[GRAPHIC] [TIFF OMITTED] TN20DE04.136

    In addition to licensing, the technology is available for further 
development through collaborative research with the inventors via a 
Cooperative Research and Development Agreement (CRADA).

Grid Etcher for Generating Defined Growth Areas

    Rea Ravin, James Sullivan, Daniel Hoeppner, David Munno, Ronald

[[Page 75991]]

McKay (NINDS). U.S. Patent Application filed 14 Oct 2004 (DHHS 
Reference No. E-125-2004/0-US-01).
    Licensing Contact: Michael Shmilovich; 301/435-5019; 
shmilovm@mail.nih.gov.
    Available for licensing and commercial development is a cell 
culture tool kit for etching confined growth areas on substrates coated 
with tissue culture growth matrix, such as fibronectin. The kit 
includes three components: an etching comb (etcher) with rectangular 
teats, a back plate, and an open chamber with guides to direct the 
etcher.
    Overview: Cells are plated over a glass cover slide previously 
coated with growth matrix. Perpendicular channels are etched into the 
culture, removing both growth matrix and plated cells, resulting in 
rectangular growth areas containing only the cells plated originally to 
each growth area. This protocol allows high-density cultures to grow 
freely within a confined growth area. Specifically, this procedure 
prevents emigration out of the growth area and also prevents 
immigration from individual cells or sphere clusters into the growth 
area, common if cells are plated on pre-defined surfaces.
    Method: A coated cover slide is plated with cells. The cover slide 
is then sandwiched between the back plate, and open chamber with 
etching guides, then secured in place. The chamber is filled with media 
and the etcher is drawn across the cover slip to generate a first set 
of channels. The etcher is then drawn across the cover slip in a 
perpendicular direction to generate a second set of channels, resulting 
in rectangular growth areas. The number of the teats on the etcher 
determines the number of squares in the grid, the width of each teat 
will determine the distance between the squares and the gap between the 
teats will determine the size of the squares.
    This tool kit enables the production of a slide for monitoring 
dynamic cell processes especially for the proliferation and migration 
of stem cells or other migratory cells. Beside complexity, a 
significant problem with existing containment systems is the inability 
to keep cells within the field of observation and to keep out cells not 
present in the field of view at the onset of the experiment. The 
present invention provides a simple and flexible solution that enables 
long-term cell culture in a defined growth area.

Chlorine Dioxide Gas Decontamination Apparatus

    Deborah E. Wilson, D.Ph. (ORS). U.S. Provisional Application 60/
620,095 filed 18 Oct 2004 (DHHS Reference No. E-190-2004/0-US-01).
    Licensing Contact: Michael Shmilovich; 301/435-5019; 
shmilovm@mail.nih.gov.
    Available for licensing and commercial development is an apparatus 
for decontaminating articles and areas contaminated with one or more 
biosafety level 2, 3, or 4 pathogens. Particularly, the focus of 
decontamination is a piece of laboratory equipment, such as a 
biological safety cabinet. The apparatus is portable, and includes a 
moveable cart, a source of chlorine dioxide gas, a humidification 
means, an inlet conduit for introducing a flow of chlorine dioxide gas 
from the source of chlorine dioxide gas into the environment and for 
simultaneously humidifying the environment, and an outlet conduit for 
withdrawing gas from the environment. The apparatus further includes a 
blower for circulating gas between the environment to the humidifier 
and vice versa. Of particular advantage, the moveable cart weighs less 
than 200 pounds. The patent application covering this apparatus can be 
reviewed under a confidentiality nondisclosure agreement.

    Dated: December 9, 2004.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 04-27723 Filed 12-17-04; 8:45 am]
BILLING CODE 4140-01-P