[Federal Register Volume 72, Number 118 (Wednesday, June 20, 2007)]
[Notices]
[Pages 34022-34024]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-11830]


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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, HHS.

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.

Methods for Prevention and Treatment of Polyomavirus Infection or 
Reactivation

    Description of Technology: Available for licensing and commercial 
development are methods of using two MAP kinase kinase (MEK) 
inhibitors, PD98059 and U0126, in the prevention and treatment of 
polyomavirus infection. Decrease in viral protein expression upon 
treatment with the MEK inhibitors has been demonstrated

[[Page 34023]]

for two polyomavirus species, JC virus (JCV) and BK virus (BKV). It is 
believed that these MEK inhibitors may also be effective against other 
polyomavirus species in which TGF-[beta] expression is elevated.
    JCV is responsible for the demyelination of the central nervous 
system which is observed in cases of progressive multifocal 
leukoencephalopathy (PML). PML is most frequently seen in patients with 
HIV/AIDS, but is also a contributing factor in fatalities in patients 
with leukemia, lymphoma, and connective tissue diseases, in addition to 
individuals receiving immunosuppressive therapy for autoimmune 
disorders or prevention of transplant rejection.
    BKV is associated with deadly clinical syndromes such as viruria 
and viremia, utreteral ulceration and stenosis, and hemorrhagic 
cystitis. BKV also causes polyomavirus-associated nephrophathy in 1-10% 
of all renal transplant recipients.
    Currently, no effective antiviral agents are available to treat 
these opportunistic infections. In all observed cases, activation of 
either JCV and BKV in immunosuppressed patients has resulted in 
fatality.
    Applications: Treatment and prevention of polyomavirus infection in 
immunocompromised patients.
    Development Status: In vitro data is currently available and 
inventors are actively developing the technology.
    Inventors: Veersamy Ravichandran and Eugene Major (NINDS).
    Publication: V Ravichandran, PN Jensen, EO Major. MEK1/2 inhibitors 
block basal and TGF-[beta]1 stimulated JC virus 
multiplication. J Virol. 2007 Apr 4; Epub ahead of print, doi:10.1128/
JVI.02658-06.
    Patent Status: U.S. Provisional Application No. 60/908,950 filed 29 
Mar 2007 (HHS Reference No. E-101-2007/0-US-01).
    Licensing Status: Available for licensing.
    Licensing Contact: Cristina Thalhammer-Reyero, Ph.D., M.B.A.; 301/
435-4507; [email protected].
    Collaborative Research Opportunity: The National Institute of 
Neurological Disorders and Stroke is seeking statements of capability 
or interest from parties interested in collaborative research to 
further develop, evaluate, or commercialize treatment and prevention of 
polyomavirus infections in immunocompromised patients. Please contact 
Melissa Maderia, Ph.D. at [email protected] for more information.

Monoclonal Antibodies That Bind or Neutralize Hepatitis B Virus

    Description of Technology: Hepatitis B virus (HBV) chronically 
infects over 300 million people worldwide. Many of them will die of 
chronic hepatitis or hepatocellular carcinoma. The present technology 
relates to the isolation and characterization of a novel neutralizing 
chimpanzee monoclonal antibody to HBV. The antibody was identified 
through a combinatorial antibody library constructed from bone marrow 
cells of a chimpanzee experimentally infected with HBV. The selected 
monoclonal antibody has been shown to react equally well with wild-type 
HBV and the most common neutralization escape mutant variants. 
Therefore, this monoclonal antibody with high affinity and broad 
reactivity may have distinct advantages over other approaches to 
immunoprophylaxis and immunotherapy of chronic HBV infection, as most 
of the monoclonal antibodies currently in use are not sufficiently and 
broadly reactive to prevent the emergence of neutralization escape 
mutants of HBV. This technology describes such antibodies, fragments of 
such antibodies retaining hepatitis B virus-binding ability, fully 
human or humanized antibodies retaining hepatitis B virus-binding 
ability, and pharmaceutical compositions including such antibodies. 
This invention further describes isolated nucleic acids encoding the 
antibodies and host cells transformed with nucleic acids. In addition, 
this invention provides methods of employing these antibodies and 
nucleic acids in the in vitro and in vivo diagnosis, prevention and 
therapy of HBV diseases.
    Inventors: Suzanne U. Emerson (NIAID), Robert H. Purcell (NIAID), 
et al.
    Patent Status: U.S. Provisional Application No. 60/644,309 filed 14 
Jan 2005 (HHS Reference No. E-144-2004/0-US-01); PCT Application No. 
PCT/US2006/001336 filed 13 Jan 2006, which published as WO 2006/076640 
on 20 Jul 2006 (HHS Reference No. E-144-2004/0-PCT-02)
    Licensing Contact: Chekesha S. Clingman, Ph.D.; 301/435-5018; 
[email protected].

Endotracheal Tube Using Unique Leak Hole To Lower Dead Space

    Description of Technology: Through injury or diseases, human or 
animal lungs may become too weak to sustain a sufficient flow of oxygen 
to the body and to remove adequate amounts of expired carbon dioxide. 
The present invention is a tracheal tube ventilation apparatus which 
efficiently rids patients of expired gases and promotes healthier 
breathing. This is accomplished by creating one or more leak holes in 
the wall of the endotracheal tube above the larynx, such as in the back 
of the mouth (i.e., oropharynx), so that expired gases can leak out of 
the endotracheal tube. The described apparatus is a two stage tube 
where the first stage 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.
    Applications: Tracheal tube ventilation; Efficiently rid patient of 
expired gases and thereby promote healthier breathing.
    Development Status: System is well developed and operational.
    Inventor: Theodor Kolobow (NHLBI).
    Patent Status: U.S. Patent No. 7,107,991 issued 19 Sep 2006 (HHS 
Reference No. E-269-2001/0-US-01); PCT Application No. PCT/US02/29319 
filed 16 Sep 2002 (HHS Reference No. E-269-2001/0-PCT-02); Canadian 
National Stage Filing, Application No. 2463538, filed 16 Sep 2002 (HHS 
Reference No. E-269-2001/0-CA-03); European National Stage Filing, 
Application No. 02773398.9, filed 28 Mar 2004 (HHS Reference No. E-269-
2001/0-EP-04).
    Licensing Status: Available for non-exclusive or exclusive 
licensing.
    Licensing Contact: Michael A. Shmilovich, Esq.; 301/435-5019; 
[email protected].
    Collaborative Research Opportunity: The NHLBI/Pulmonary Critical 
Care Medicine Branch (PCCMB) is seeking statements of capability or 
interest from parties interested in collaborative research to further 
develop, evaluate, or commercialize innovative endotracheal tube 
technology. Please contact Marianne Lynch at 301-594-4094 or 
[email protected] for more information.

Increased Protein Expression Vector for Vaccine Applications

    Description of Technology: An expression vector with a unique 
promoter that results in higher level of protein expression than 
vectors currently in use is available for licensing from the NIH. The 
elevated

[[Page 34024]]

levels of expression are achieved through use of a specific promoter, 
known as CMV/R, in which the Human T-Lymphotrophic Virus (HTLV-1) Long 
Terminal Repeat (LTR) R-U5 region is substituted for a portion of the 
intron downstream of the CMV immediate early region 1 enhancer (Barouch 
et al., 2005). Sequences of 95% or better homology to CMV/R can be used 
as well. CMV/R vectors are currently being used in a number of clinical 
trials, including vaccines against West Nile Virus, Ebola virus, and 
HIV and achieving promising results. The related HIV vaccine technology 
is available for licensing, as is the Ebola DNA vaccine technology 
(non-exclusive licensing only). The CMV/R vector can be used for any 
DNA vaccine or for the production of recombinant proteins in high 
yields.
    Applications: Vector for DNA vaccines; High yield expression of 
recombinant proteins.
    Inventors: Gary Nabel and Zhi-yong Yang (NIAID).
    Patent Status: U.S. Patent No. 7,094,598 issued 22 Aug 2006 [HHS 
Reference No. E-241-2001/1-US-01 (CMV/R)], applications pending in EP, 
JP, CA, and AU; U.S. Patent Application No. 10/491,121 filed 23 Aug 
2004 [HHS Reference No. E-241-2001/0-US-07 (Ebola DNA vaccine)], 
applications pending in EP, JP, CA, and AU; U.S. Patent Application No. 
11/632,522 filed 16 Jan 2007 [HHS Reference No. E-267-2004/1-US-08 (HIV 
DNA vaccine)].
    Licensing Status: Available for non-exclusive licensing.
    Licensing Contact: Susan Ano, Ph.D.; 301/435-5515; 
[email protected].

    Dated: June 11, 2007.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
 [FR Doc. E7-11830 Filed 6-19-07; 8:45 am]
BILLING CODE 4140-01-P