[Federal Register Volume 67, Number 49 (Wednesday, March 13, 2002)]
[Notices]
[Pages 11348-11349]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-5931]


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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.

Artificial Chromosomes That Can Shuttle Between Bacteria, Yeast, 
and Mammalian Cells

Larionov et al. (NCI)

DHHS Reference No. E-253-00/0 filed April 6, 2001
Licensing Contact: Pradeep Ghosh; 301/496-7736 ext. 211; e-mail 
[email protected].

    Development of a novel cloning system in mammalian cells based on 
Mammalian Artificial Chromosome (MAC) may have profound effects on 
human gene therapy. The technology described in invention pertains to 
methods and compositions that allow for the selective isolation of 
centromeric regions from mammalian chromosomes, including those of 
humans. Also included in the invention are cloned and characterized 
centromeric regions of humans and other mammalian chromosomes. The 
isolation of these centromeric regions provides a material for 
engineering of MACs that are capable of being shuttled between 
bacterial, yeast and mammalian cells, such as human cells. These MACs 
may serve as effective tools for the characterization of cis-active 
loci controlling transmission of mammalian chromosomes. The present 
invention has broad utilities in studies related to genetic diseases. 
It can be used for studying of expression of entire copies of human 
genes. Gene therapy may have therapeutic and preventative applications 
and a range of gene therapy approaches are currently being evaluated 
for treatment of cancer and a large number of autoimmune and genetic 
disorders. Gene therapy necessitates an efficient system for gene 
delivery. The MACs constructed in this invention provide useful 
vehicles for the delivery and expression of transgenes within cells. 
Thus, the present invention provides a novel method allowing a direct 
isolation of mammalian centromeres and efficient system for gene 
delivery associated with gene therapy.

Treatment of Pain Based on Parathyroid Hormone-2 (PTH2) Receptors

Ted B. Usdin (NIMH)

DHHS Reference No. E-079-01/0 filed Jun 13 2001
Licensing Contact: Norbert Pontzer; 301/496-7736 ext. 284; e-mail: 
[email protected].

    Current medications for pain, especially chronic pain, are only 
partially effective and can involve unacceptable side effects. A unique 
receptor (PTH2) and an endogenous ligand (TIP39) which binds to the 
receptor were previously discovered by this inventor. The PTH2 receptor 
and the endogenous ligand were found to have an anatomical distribution 
suggesting a role in nociception. The PTH2 receptor is present at 
relatively high levels in nerve terminals within the outer layers of 
the dorsal horn of the spinal cord where it is primarily coupled to 
generation of cAMP (Usdin, T.B., et al., 1999, Nature Neurosci. 2: 941-
943; Wang, T., et al, 2000, Neuroscience 100: 629-49; Usdin, T.B., et 
al, 2000, Front Neuroendocrinol 21: 349-83) The DRG neurons that 
project to this area are largely nociceptors and this region contains 
the central nervous system neurons they activate. Most receptors 
present in the central terminals of DRG neurons are also found in their 
peripheral terminals. Thus, activation of the PTH2 receptor could 
modulate peripheral excitation of nociceptors, neurotransmitter release 
from their central terminals in the spinal cord, and some of their 
postsynaptic effects.
    This inventor has now shown the PTH2 receptor system to have very 
potent actions in animal tests of nociception. Both peripheral and

[[Page 11349]]

intrathecal administration of TIP39 cause nocifensive responses. 
Intrathecal delivery of an antibody that sequesters TIP39 decreases 
sensitivity in several acute nociceptive assays, and administration of 
TIP39 potentiates responses in these same tests. Neurochemical changes 
that occur in neurons in outer layers of the dorsal horn in response to 
intense pain or injury may lead to manifestations of chronic pain, 
including hyperalgesia and allodynia. As TIP39 potentiates pain 
perception and increases cAMP, the PTH2 receptor system may be involved 
in the transition from acute to chronic pain. Novel drugs which block 
this system could thus be useful in treating acute or chronic pain. The 
invention described and claimed in the pending patent application 
provides novel methods of treating pain and methods of screening to 
find new and useful drugs acting on this newly discovered pain 
modulation system.

Development of a Plant Derived Recombinant Subunit Vaccine 
Candidate Against Hepatitis C

Lev G. Nemchinov and Jerry M. Keith (NIDCR)

DHHS Reference No. E-249-01/0
Licensing Contact: Carol Salata; 301/496-7735 ext. 232; 
[email protected].

    Hepatitis C virus (HCV) is a major cause of acute and chronic 
hepatitis with over 180 million cases worldwide. Development of a 
vaccine to combat HCV has been difficult. Presently, the virus cannot 
be grown in tissue culture and there is no vaccine or effective therapy 
against this virus. This technology relates to the development of an 
experimental plant-derived subunit vaccine against HCV. A tobamoviral 
vector was engineered to encode a consensus sequence of hypervariable 
region 1 (HVR1), a potential neutralizing epitope of HCV, which was 
genetically fused to the C-terminus of the B subunit of cholera toxin 
(CTB). This epitope was selected from the amino acid sequences of HVR1 
``mimotopes'' previously derived by phage display technology. The 
nucleotide sequence encoding this epitope was designed utilizing plant 
codons. This mimotope is capable of inducing cross-neutralizing 
antibodies against different variants of the virus. Plants infected 
with recombinant tobacco mosaic virus (TMV) engineered to express the 
HVR1/CTB chimeric protein, contained intact TMV particles and produced 
the HVR1 consensus peptide fused to the functionally active, pentameric 
B subunit of cholera toxin. Plant-derived HVR1/CTB reacted with HVR1-
specific monoclonal antibodies and immune sera from individuals 
infected with virus from four of the major genotypes of HCV. Intranasal 
immunization of mice with a crude plant extract containing the 
recombinant HVR1/CTB protein elicited both anti-CTB serum antibody and 
anti-HVR1 serum antibody which specifically bound to HCV virus-like 
particles. Using plant-virus transient expression to produce this 
unique chimeric antigen will facilitate the development and production 
of an experimental HCV vaccine. A plant-derived recombinant HCV vaccine 
can potentially reduce expenses normally associated with production and 
delivery of conventional vaccines.

Endotracheal Tube Using Leak Hole to Lower Dead Space

Theodor Kolobow (NHLBI)

Serial No. 09/967,903 filed Sep 28, 2001
Licensing Contact: Dale Berkley; 301/496-7735 ext. 223; e-mail: 
[email protected].

    The invention is a tracheal tube ventilation apparatus which, 
through the use of one or more tube leak holes or connecting tubes 
positioned in the wall of the endotracheal tube above the larynx, is 
able to efficiently rid the patient of expired gases and promote 
healthier breathing. A first stage of the apparatus has a smaller 
diameter such that it fits within the confined area of the lower 
trachea and the second stage has a larger diameter, which fits properly 
within the larger diameter of the patient's pharynx. The endotracheal 
tube is preferably wire reinforced and ultra-thin walled so as to 
reduce airway resistance. The invention substantially reduces 
endotracheal dead space and is expected to benefit those patients with 
both early and late stage acute respiratory failure, and reduce or 
obviate the need for mechanical pulmonary ventilation in many patients.

    Dated: March 5, 2002.
Jack Spiegel,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 02-5931 Filed 3-12-02; 8:45 am]
BILLING CODE 4140-01-P