[Federal Register Volume 74, Number 199 (Friday, October 16, 2009)]
[Notices]
[Pages 53265-53267]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-24871]


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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.

Biological/Research Material for H1N1 Influenza Virus Vaccine Research

    Description of Technology: Offered for licensing is a recombinant 
attenuated vaccinia virus, MVA, that expresses the haemagglutinin (HA) 
and nucleoprotein (NP) of influenza virus A/PR/8/34 (H1N1). The virus 
has been shown to stimulate protective immunity to influenza virus in 
mice.
    The materials can be used for research purposes and in particular 
in the area of influenza virus vaccines.
    The related publications listed below demonstrate the usefulness of 
this biological material in influenza virus vaccine research.
    Applications: Research reagents useful in research and development 
in the area of H1N1 Influenza virus vaccines.
    Development Status: Fully developed. The usefulness of the 
materials has been shown in Dr. Moss' laboratory.

[[Page 53266]]

    Inventors: Bernard Moss and Linda S. Wyatt (NIAID).
    Publications:
    1. G Sutter, LS Wyatt, PL Foley, JR Bennink, B Moss. A recombinant 
vector derived from the host range-restricted and highly attenuated MVA 
strain of vaccinia virus stimulates protective immunity in mice to 
influenza virus. Vaccine 1994 Aug;12(11):1032-1040.
    2. B Bender, CA Rowe, SF Taylor, LS Wyatt, B Moss, PA Small Jr. 
Oral immunization with a replication-deficient recombinant vaccinia 
virus protects mice against influenza. J Virol. 1996 Sep;70(9): 6418-
6424.
    Patent Status: HHS Reference No. E-260-2009/0--Research Material. 
Patent protection is not being sought for this technology.
    Related Technologies: HHS Reference No. E-552-1982/2--
    1. U.S. Patent No. 6,998,252 issued 14 Feb 2006, ``Recombinant 
Poxviruses Having Foreign DNA Expressed Under the Control of Poxvirus 
Regulatory Sequences''
    2. U.S. Patent No. 7,015,024 issued 21 Mar 2006, ``Compositions 
Containing Poxviruses Having Foreign DNA Expressed Under the Control of 
Poxvirus Sequences''
    3. U.S. Patent No. 7,045,313 issued 16 May 2006, ``Recombinant 
Vaccinia Virus Containing Chimeric Gene Having Foreign DNA Flanked by 
Vaccinia Regulatory DNA''
    4. U.S. Patent No. 7,045,136 issued 16 May 2006, ``Methods of 
Immunization Using Recombinant Poxviruses Having Foreign DNA Expressed 
Under the Control of Poxvirus Regulatory Sequences''
    An abstract describing these technologies may be viewed at http://www.ott.nih.gov/Technologies/abstractDetails.aspx?RefNo=2000.
    Licensing Status: Available for licensing.
    Licensing Contacts: Uri Reichman, Ph.D., MBA; 301-435-4616; 
[email protected]; RC Tang, JD, LLM; 301-435-5031; [email protected].

Biological/Research Material for HIV Vaccine Research

    Description of Technology: Offered for licensing is a recombinant 
attenuated vaccinia virus, MVA, that expresses SIV 239gagpol. The 
materials can be used for research purposes and in particular in the 
area of HIV/AIDS vaccines.
    Plasmid insertion vector pJH-4, containing the foreign gene SIV 239 
GagPol controlled by vaccinia early/late promoter, inserts into del III 
of attenuated vaccinia MVA virus to make recombinant MVA virus. The 
resulting recombinant virus made from pJH4, MVA/SIV239gagpol, expresses 
the SIV 239gagpol gene and thus can be used to conduct vaccine studies 
in animal models such as Rhesus macaques.
    The list of publications shown below demonstrates the usefulness of 
this biological material in HIV vaccine research.
    Applications: Research reagents useful in research and development 
in the area of HIV/AIDS vaccines.
    Development Status: Fully developed. Material has been used 
extensively in research.
    Inventors: Bernard Moss and Linda S. Wyatt (NIAID).
    Publications:
    1. RR Amara, F Villinger, JD Altman, SL Lydy, SP O'Neil, SI 
Staprans, DC Montefiori, Y Xu, JG Herndon, LS Wyatt, MA Candido, NL 
Kozyr, PL Earl, JM Smith, HL Ma, BD Grimm, ML Hulsey, J Miller, HM 
McClure, JM McNicholl, B Moss, HL Robinson. Control of a mucosal 
challenge and prevention of AIDS by a multiprotein DNA/MVA vaccine. 
Science 2001 Apr 6;292(5514):69-74.
    2. PL Earl, LS Wyatt, DC Montefiori, M Bilska, R Woodward, PD 
Markbam, JD Malley, TU Vogel, TM Allen, DI Watkins, N Miller, B Moss. 
Comparison of vaccine strategies using recombinant env-gag-pol MVA with 
or without an oligomeric Env protein boost in the SHIV rhesus macaque 
model. Virology 2002 Mar 15;294(2):270-281.
    3. RR Amara, JM Smith, SI Staprans, DC Montefiori, F Villinger, JD 
Altman, SP O'Neil, NL Kozyr, Y Xu, LS Wyatt, PL Earl, JG Herndon, JM 
McNicholl, HM McClure, B Moss, HL Robinson. Critical role for Env as 
well as Gag-Pol in control of a simian-human immunodeficiency virus 
89.6P challenge by a DNA prime/recombinant modified vaccinia virus 
Ankara vaccine. J Virol. 2002 Jun;76(12):6138-6146.
    4. RR Amara, F Villinger, SI Staprans, JD Ahman, DC Montefiori, NL 
Kozyr, Y Xu, LS Wyatt, PL Earl, JG Herndon, HM McClure, B Moss, HL 
Robinson. Different patterns of immune responses but similar control of 
simian human immunodeficiency virus 89.6P mucosal challenge by modified 
vaccinia virus Ankara (MVA) and DNA/MVA vaccines. J Virol. 2002 
Aug;76(15):7625-7631.
    5. S Sadagopal, RR Amara, DC Montefiori, LS Wyatt, SI Staprans, NL 
Kozyr, HM McClure, B Moss, HL Robinson. Signature for long-term 
vaccine-mediated control of a Simian and human immunodeficiency virus 
89.6P challenge: stable low-breath and low-frequency T-cell response 
capable of coproducing gamma interferon and interleukin-2. J Virol. 
2005 Mar;79(6):3243-3253.
    Patent Status: HHS Reference No. E-258-2009/0--Research Material. 
Patent protection is not being pursued for this technology.
    Related Technologies: HHS Reference No. E-552-1982/2--
    1. U.S. Patent No. 6,998,252 issued 14 Feb 2006, ``Recombinant 
Poxviruses Having Foreign DNA Expressed Under the Control of Poxvirus 
Regulatory Sequences''
    2. U.S. Patent No. 7,015,024 issued 21 Mar 2006, ``Compositions 
Containing Poxviruses Having Foreign DNA Expressed Under the Control of 
Poxvirus Sequences''
    3. U.S. Patent No. 7,045,313 issued 16 May 2006, ``Recombinant 
Vaccinia Virus Containing Chimeric Gene Having Foreign DNA Flanked by 
Vaccinia Regulatory DNA''
    4. U.S. Patent No. 7,045,136 issued 16 May 2006, ``Methods of 
Immunization Using Recombinant Poxviruses Having Foreign DNA Expressed 
Under the Control of Poxvirus Regulatory Sequences''
    An abstract describing these technologies may be viewed at http://www.ott.nih.gov/Technologies/abstractDetails.aspx?RefNo=2000.
    Licensing Status: Available for licensing.
    Licensing Contacts: Uri Reichman, Ph.D., MBA; 301-435-4616; 
[email protected]; RC Tang, JD, LLM; 301-435-5031; [email protected].

A Target for the Development of Diagnostics and Therapeutics for 
Abnormal Hematopoiesis

    Description of Technology: The zinc finger protein ZFP36L2 has been 
shown by the inventors to play an essential role in hematopoiesis, a 
process that is dysregulated in hematological cancers, anemia, and 
other conditions. Thus, ZFP36L2 has promise for use in a diagnostic 
test to detect abnormal hematopoiesis, or as a target for the 
development of therapeutics to treat abnormal hematopoiesis.
    Hematopoiesis is the formation of blood cellular components, 
through the differentiation of hematopoietic stem cells into lineages 
with a variety of roles, such as carrying oxygen, immune function, and 
blood clotting. Abnormally high hematopoiesis can be caused by 
hematological cancers such as leukemia or lymphoma, or by other 
myeloproliferative disorders. Abnormally low hematopoiesis can be 
caused by diseases such as anemia, thrombocytopenia, or myelodysplastic 
syndrome, and is often a secondary symptom of other conditions, such as 
cancer, infection, or dialysis.

[[Page 53267]]

    The inventors have discovered that Zinc finger protein 36 like 
type-2 (ZFP36L2) plays an essential role in hematopoiesis, possibly by 
affecting the stability of mRNAs involved in this process. ZFP36L2 is a 
member of the tristetraprolin (TTP) family, which are mRNA-binding 
proteins involved in mRNA processing and degradation. The invention 
discloses methods of detecting abnormal hematopoiesis by detecting 
abnormal ZFP36L2 expression or a mutation in the ZFP36L2 gene, and 
methods of controlling abnormal hematopoiesis by modulating levels of 
ZFP36L2 protein.
    Applications:
     Diagnostic test to detect abnormal hematopoiesis.
     Therapy for abnormal hematopoiesis.
    Development Status: Discovery stage.
    Market:
     Over 3.5 million people in the United States suffer from 
anemia, according to NHLBI, and more than half of all chemotherapy 
treatment for cancer results in anemia.
     The American Cancer Society estimates that approximately 
4300 cases of chronic myelogenous leukemia are diagnosed in the United 
States every year.
    Inventors: Perry J. Blackshear and Deborah J. Stumpo (NIEHS).
    Related Publication: DJ Stumpo, HE Broxmeyer, T Ward, S Cooper, G 
Hangoc, YJ Chung, WC Shelley, EK Richfield, MK Ray, MC Yoder, PD Aplan, 
PJ Blackshear. Targeted disruption of Zfp36l2, encoding a CCCH tandem 
zinc finger RNA-binding protein, results in defective hematopoiesis. 
Blood 2009 Sep 17;114(12):2401-2410.
    Patent Status: PCT Application Serial No. PCT/US08/68900 filed on 
01 Jul 2008 (HHS Reference No. E-255-2007/0-PCT-02).
    Licensing Status: Available for licensing.
    Licensing Contact: Tara Kirby, Ph.D.; 301-435-4426; 
[email protected].
    Collaborative Research Opportunity: The NIEHS Laboratory of Signal 
Transduction, Polypeptide Hormone Action Group, is seeking statements 
of capability or interest from parties interested in collaborative 
research to further develop, evaluate, or commercialize this 
technology. Please contact Elizabeth M. Denholm, Ph.D., Director, 
Office of Technology Transfer, NIEHS, at [email protected] for 
more information.

Susceptibility-Matched Multiwell Plates for High-Throughput Screening 
by Magnetic Resonance Imaging and Nuclear Magnetic Resonance 
Spectroscopy

    Description of Technology: Available for licensing and commercial 
development is a patent estate that covers multi-well assay plates for 
high-throughput screening by magnetic resonance imaging (MRI) and 
nuclear magnetic resonance (NMR) spectroscopy. Multi-well plates are 
used in a wide variety of high-throughput measurements in clinical 
chemistry and immunology, as well as in drug discovery and other 
research applications. Magnetic resonance imaging (MRI) of multi-well 
plates offers the possibility of performing new kinds of high-
throughput assays, including the detection of magnetic nanoparticles 
attached to or within cells. Moreover, MRI-guided localized nuclear 
magnetic resonance (NMR) spectroscopy could be used to perform detailed 
chemical analysis of complex mixtures of metabolites not possible by 
any other common analytical technique. Best of all, conventional MRI 
techniques exist which would permit all samples in one or more multi-
well plate(s) to be analyzed simultaneously. Unfortunately, 
conventional multi-well plates typically give poor performance for MRI-
based assays since they provide inadequate matching of magnetic 
susceptibility between the plate, the sample and their surroundings. 
This results in distortion of the magnetic field within the scanner and 
thus reduces the sensitivity for detecting magnetic particles and the 
resolution of NMR spectra.
    This invention relates to a new multi-well plate design 
incorporating one-piece polyetherimide plastic construction for 
improved magnetic susceptibility matching for aqueous samples. This 
design can easily be extended to non-aqueous samples by the selection 
of an appropriate, commercially available plastic resin or resin blend. 
Further enhancement in susceptibility matching can be accomplished by 
combining the new plate design with plugs for each well constructed 
from the same plastic as the plate. These plugs would allow the entire 
thickness of each sample to be scanned in chemical analyses, improving 
signal-to-noise ratio and sensitivity. These plugs can optionally be 
integrated into a single ``cap mat'' so that the entire assembly can be 
filled and manipulated by standard robotic laboratory equipment already 
in wide use in the pharmaceutical industry. Alternatively, spherical 
wells, accessed by narrow fill holes, may be molded into a solid plate, 
eliminating the need for individual plugs to seal each well. The new 
multi-well plate/plug design reduces magnetic field distortions and 
should dramatically improve spectral resolution and sensitivity for NMR 
and MRI-based high-throughput screening.
    Applications:
     NMR Spectroscopy,
     MRI Imaging of magnetic nanoparticles,
     Clinical Chemistry,
     Immunology,
     Drug Discovery,
     Combinatorial Chemistry, and
     Quality Control in the pharmaceutical, chemical and 
agricultural industries.
    Advantages:
     Increased signal-to-noise ratio and sensitivity relative 
to conventional multi- well plates
     Portability
     Compatible with existing high-throughput robots.
    Development Status: Used actively in inventor's lab.
    Inventor: Kenneth W Fishbein (NIA).
    Patent Status: U.S. Patent Application No. 12/083,501 filed 30 Dec 
2008 (HHS Reference No. E-243-2005/0-US-03).
    Licensing Status: Available for licensing.
    Licensing Contact: Michael Shmilovich, Esq.; 301-435-5019; 
[email protected].
    Collaborative Research Opportunity: The National Institute on 
Aging, Magnetic Resonance Imaging & Spectroscopy Section, is seeking 
statements of capability or interest from parties interested in 
collaborative research to further develop, evaluate, or commercialize 
this technology. Please contact Nicole Darack, Ph.D. at 301-435-3101 or 
[email protected] for more information.

    Dated: October 5, 2009.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. E9-24871 Filed 10-15-09; 8:45 am]
BILLING CODE 4140-01-P