[Federal Register Volume 72, Number 163 (Thursday, August 23, 2007)]
[Notices]
[Pages 48286-48288]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-16644]


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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 Tranilast [N-(3',4'-
dimethoxycinnamoyl)anthranilic acid] in the prevention and treatment of 
human polyomavirus infection. Treatment with Tranilast decreases viral 
protein expression for two human polyomavirus species, JC virus (JCV) 
and BK virus (BKV). Furthermore, the increase in JCV/BKV protein 
production observed upon the addition of TGF-[beta] could also be 
effectively abolished by Tranilast co-treatment. This is of relevance 
because TGF-[beta] has previously been demonstrated to increase during 
immunosuppressive conditions, including HIV infection and kidney 
transplantation.
    JCV is responsible for demyelization 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 
serious clinical syndromes such as viruria and viremia, ureteral 
ulceration and stenosis, and hemorrhagic cystitis and has a causative 
role in polyomavirus-associated nephrophathy in as many as 10% of all 
renal transplant recipients. Currently, there are no effective 
antiviral agents available to treat these opportunistic infections. In 
all observed cases, activation of either JCV or BKV in immunosuppressed 
patients has resulted in fatalities.
    Applications: Use in treatment and prevention of polyomavirus 
infection in immunocompromised patients. Specific target is the 
prevention of PML in treatment therapies for MS patients.
    Development Status: In vitro data is currently available and 
inventors are actively developing the technology.

[[Page 48287]]

    Inventors: Veersamy Ravichandran (NINDS), Jeffrey B. Kopp (NIDDK), 
and Eugene O. Major (NINDS)
    Patent Status: U.S. Provisional Application No. 60/948,426 filed 06 
Jul 2007, entitled ``Compositions and Methods for Preventing or 
Treating Disease Caused by Polyomavirus Infection or Reactivation in a 
Mammalian Subject'' (HHS Reference No. E-179-2007/0-US-01).
    Licensing Status: Available for non-exclusive or exclusive 
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, with particular 
interest in JCV and demyelination. Please contact Melissa Maderia, 
Ph.D., at [email protected] for more information.

Measles Virus Strain for Diagnostic Applications

    Description of Technology: This technology describes a low passage 
Edmonston strain of measles virus that is more sensitive to 
neutralization by serum antibodies than the same virus that has been 
passaged more. This strain can be used to detect lower levels of 
measles neutralizing antibody than other measles virus strains. This 
material could also be used to assess effectiveness of anti-measles 
therapeutics or vaccines.
    Application: Measles diagnostic.
    Inventors: Paul Albrecht, Judy Beeler, Susette Audet, Dorothy 
Farrell, G. Richard Burns (CBER/FDA).
    Publication: P Albrect et al. Role of virus strain in conventional 
and enhanced measles plaque neutralization test. J Virol Methods. 1981 
Dec;3(5):251-260.
    Patent Status: HHS Reference No. E-125-2007/0--Research Tool. 
Patent protection is not being sought for this technology.
    Licensing Status: Available for non-exclusive licensing.
    Licensing Contact: Susan Ano, Ph.D.; 301/435-5515; 
[email protected].

Recombinant Baculoviruses Containing Inserts of the Major Structural 
Genes (vp1) of the Human Polyomaviruses JCV and BKV

    Description of Invention: The development of sensitive and specific 
tests for JC virus and BK virus activity may provide tools essential in 
the steps required to find a treatment for these fatal infections. This 
invention describes a Recombinant Vp1 protein (rVp1) that can be used 
(1) as an antigen source for ELISA assays (2) for studies of viral 
proteins in cells and (3) for the self assembly of icosahedral 
particles encapsidating DNA [gene expression of choice in range of up 
to 5.1kb size gene].
    rVp1 can be utilized in ELISA assays to detect both JCV and BKV 
antibodies. The JCV and BKV rVp1 proteins may serve as antigens for the 
production of useful anti-sera and monoclonal-antibodies for 
polyomavirus research, as well as for the detection of existing and/or 
changing levels of antibodies in human sera by way of ELISA assays. 
Such ELISA studies allow for tracking of the spread and/or reactivation 
of polyomavirus infections in the human population, of special 
importance for individuals at high risk of polyomavirus associated 
pathologies. The rVp1s eliminate the need to produce infectious, native 
polyomavirus virions as antigens for such work.
    The rVp1 proteins may also be utilized as vector delivery systems. 
The rVp1 proteins self-assemble into Virus-Like Particles (VLPs) which 
can be dissociated, reconstituted in the presence of exogenous DNA 
(that is non-specifically encapsidated), and then internalized through 
cell membranes that native virions normally cross.
    Applications: JCV or BKV antigens useful for polyomavirus research; 
ELISA studies for individuals at high risk of polyomavirus associated 
pathologies; Vector Delivery systems.
    Developmental Status: ELISA is fully developed and materials are 
available for licensing.
    Inventors: Eugene Major and Peter Jensen (NINDS).
    Publications:
    1. C Goldmann et al. Molecular cloning and expression of major 
structural protein VP1 of the human polyomavirus JC virus: Formation of 
virus-like particles useful for immunological and therapeutic studies. 
J Virol 1999 May;73(5):4465-4469.
    2. RS Hamilton et al. Comparison of antibody titers determined by 
hemagglutination inhibition and enzyme immunoassay for JC virus and BK 
virus. J Clin Microbiol. 2000 Jan;38(1):105-109.
    3. P Lenz et al. Papillomavirus-like particles induce acute 
activation of dendritic cells. J Immunol. 2001 May 1;166(9):5346-5355.
    4. DL Bohl et al. Donor origin of BK virus in renal transplantation 
and role of HLA C7 in susceptibility to sustained BK viremia. Am J 
Transplant. 2005 Sep;5(9):2213-2221.
    5. EO Major and P Matsumura. Human embryonic kidney cells: stable 
transformation with an origin-defective simian virus 40 DNA and use as 
hosts for human papovavirus replication. Mol Cell Biol. 1984 
Feb;4(2):379-382.
    6. EO Major et al. Establishment of a line of human fetal glial 
cells that supports JC virus multiplication. Proc Natl Acad Sci USA. 
1985 Feb;82(4):1257-1261.
    Patent Status: HHS Reference No. E-216-2006/0--Research Material. 
Patent protection is not being sought for this technology.
    Licensing Status: Available for non-exclusive licensing.
    Licensing Contact: Peter A. Soukas, J.D.; 301/435-4646; 
[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.

Probe Set Global Optimization

    Description of Technology: Available for licensing and commercial 
development are methods to optimize sequence-based assays such as 
microarrays, multiplexed PCR or multiplexed antibody methods. This 
computational method uses numerical optimization to identify an optimal 
probe set to be used in an assay for the measurement of a specified set 
of targets. The method incorporates the sequence information of the 
target (protein, DNA, RNA or other polymer), the assay characteristics, 
limits on probe set size and assay probe length in its optimization. 
The method selectively optimizes the total information provided by the 
assay within constraints of individual probe performance and coverage 
of all targets in the target set. For example, the target set of 
sequences could represent known viral or bacterial pathogens, or splice 
variants of a single gene. The method selectively identifies sequences 
within each target sequence with the best individual probe performance 
and providing the most information. An individual probe may be selected 
because it provides specific information about a single target 
(specificity) or because it increases (sensitivity) by providing 
replicate

[[Page 48288]]

measurements of a sequence common to several targets.
    The method's software design allows for large (>10,000) target sets 
and large probe set sizes (2->1,000,000). While current selection 
criteria involve a time consuming iterative and manual process, the 
present invention allows for the identification of a quantitatively 
optimized probe set which balances probe performance criteria and 
simultaneously optimizes the sensitivity and specificity of the assay 
for a given set of targets.
    Applications: The invention has applications in the design of 
various important assays, such as those based on microarrays, 
multiplexed PCR and SPR, targeted protein fragment detection, or any 
sequence-specific binding and detection. It has application where the 
number of probes to be used in an assay is too large for manual design 
and review.
    Inventors: Eric Billings and Kevin E. Brown (NHLBI).
    Patent Status: U.S. Provisional Application No. 60/871,447 filed 21 
Dec 2006, entitled ``Probe Set Global Optimization'' (HHS Reference E-
332-2005/0-US-01).
    Development Status: The technology is ready to be applied and 
validated in many different areas for research and diagnostic purposes.
    Licensing Status: Available for non-exclusive or exclusive 
licensing.
    Licensing Contact: Cristina Thalhammer-Reyero, Ph.D., M.B.A.; 301/
435-4507; [email protected].
    Collaborative Research Opportunity: The National Heart, Lung and 
Blood Institute, Computational Biophysics Laboratory is seeking 
statements of capability or interest from parties interested in 
collaborative research to further develop, evaluate, utilize or 
commercialize a method for optimizing sequence-based assays. Please 
contact Dr. Eric Billings, at (301) 496-6520 or via e-mail at 
[email protected] for more information.

    Dated: August 16, 2007.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
 [FR Doc. E7-16644 Filed 8-22-07; 8:45 am]
BILLING CODE 4140-01-P