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[Federal Register Volume 76, Number 76 (Wednesday, April 20, 2011)]
[Notices]
[Pages 22109-22110]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-9571]

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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.

NAG-1 Transgenic Mouse Model

    Description of Technology: The nonsteroidal anti-inflammatory drug-
activated gene-1 (NAG-1) encodes a protein that has anti-inflammatory, 
proapoptotic, and antitumor properties. It plays a pivotal role in 
antitumorigenesis induced by chemopreventive compounds. Transgenic mice 
expressing human NAG-1 have been developed by the NIH investigator and 
collaborator.
    The NAG-1 transgenic mice are shown to develop few tumors in 
response to carcinogenic stimuli than wild type mice. They are also 
leaner with less fat than their wild type counterparts. As such, these 
mice can be used to investigate the development of cancers, and they 
could be of value in studying obesity and the relationship to cancer 
risk, and inflammation.
    Inventors: Thomas E. Eling (NIEHS), et al.
    Publications:

1. Baek SJ, Okazaki R, Lee SH, Martinez J, Kim JS, Yamaguchi K, 
Mishina Y, Martin DW, Shoieb A, McEntee MF, Eling TE. Nonsteroidal 
anti-inflammatory drug activated gene-1 overexpression in transgenic 
mice suppresses intestinal neoplasia. Gastroenterology. 2006 
Nov;131(5):1553-1560. [PubMed: 17101328]
2. Cekanova M, Lee SH, Donnell RL, Sukhthankar M, Eling TE, Fischer 
SM, Baek SJ. Nonsteroidal anti-inflammatory drug-activated gene-1 
expression inhibits urethane-induced pulmonary tumorigenesis in 
transgenic mice. Cancer Prev Res (Phila). 2009 May;2(5):450-458. 
[PubMed: 19401523]

    Patent Status: HHS Reference No. E-093-2011/0--Research Tool. 
Patent protection is not being pursued for this technology.
    Licensing Status: Available for licensing under a Biological 
Materials License Agreement.
    Licensing Contact: Betty B. Tong, PhD; 301-594-6565; 
[email protected].
    Collaborative Research Opportunity: The NIEHS 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, NIEHS Office of 
Technology Transfer, [email protected], 919-541-0981, for more 
information.

Altered miRNA Expression as Diagnostics and Therapeutics for 
Adrenocortical Carcinomas

    Description of Technology: This technology describes that altered 
human miRNA expression such as miRNA-483 and miRNA 100 can accurately 
predict if a patient's adrenal cortex tumor is benign or malignant. 
Adrenocortical carcinomas (ACC) are rare but aggressive cancers and 
typically have a poor prognosis. Currently, there are limited options 
for molecular diagnosis to distinguish malignant tumors from benign 
tumors of this type. As a result there are few treatment strategies for 
ACC.
    Additionally, preliminary results suggest that altering the 
expression of this miRNA in ACC cells can effect cancer cell growth. 
Therefore, inhibiting a miRNA may serve as a therapeutic option for 
ACC.
    Applications:
     Technology can be developed into a diagnostic and 
prognostic marker for ACC.
     Inhibiting miRNA can serve as a potential therapeutics for 
ACC.
    Advantages:
     Distinguishes malignant Adrenal cortex tumor from a benign 
tumor, options for such distinction are limited at this time.
     Technology can help in increased and improved diagnosis 
and therapeutic options for ACC.
    Development Status:
     Pre-clinical.
     Clinical study to test the markers in biopsy and serum 
samples being planned.
    Inventors: Electron Kebebew (CCR, NCI) and Erin E. Patterson (CCR, 
NCI)
    Publication: Patterson E. E. et al. (Cancer, 2010). [PubMed: 
21061324]
    Patent Status: U.S. Provisional Application No. 12/961,298 filed 
December 6, 2010 (HHS Reference No. E-026-2011/0-US-01)
    Licensing Status: Available for licensing.
    Licensing Contact: Sabarni Chatterjee, PhD, M.B.A.; 301-435-5587; 
[email protected]
    Collaborative Research Opportunity: The Center for Cancer Research, 
Surgery Branch, is seeking statements of capability or interest from 
parties interested in collaborative research to further develop, 
evaluate, or commercialize the use of diagnostic miRNAs and to target 
these miRNAs for treatment. Please contact John Hewes, PhD at 301-435-
3121 or [email protected] for more information.

Novel Inhibitors of Thymic Stromal Lymphopoietin (TSLP) for Cancer 
Therapy

    Description of Technology: With estimated overall costs in the U.S. 
in 2006 at $206.3 billion and WHO predictions of 15 million new cases 
globally by 2020, the overall economic cost of cancer is staggering. 
There remains a significant unmet need for therapies to control the 
spread (metastasis) of cancers to other organs in the body. Available 
for licensing are compositions and methods of using antagonists of 
thymic stromal lymphopoietin (TSLP) to prevent cancer progression and 
metastasis.
    TSLP, an IL-7-like type 1 inflammatory cytokine that is often 
associated with the induction of Th2-type allergic responses in the 
lungs, is also expressed in cancers regulating their escape (1-3). The 
cancer-promoting activity of TSLP primarily required signaling through 
the TSLP receptor on CD4+ T cells, promoting Th2-skewed immune 
responses and production of immunosuppressive factors such as IL-10 and 
IL-13. Expression of TSLP therefore may be a useful prognostic marker 
and its

[[Page 22110]]

targeting could have therapeutic potential. Inactivation of TSLP 
expression or its receptor signaling can effectively control cancer 
progression and metastasis (1).
    Applications:
     In treatments to control cancer invasion and spreading
     Cancer treatment that circumvents cancer-induced immune 
suppression
     As a means to augment anti-tumor immune responses
     For the development of prognostic markers for disease 
outcome in cancer patients
    Inventors: Arya Biragyn (NIA), Warren J. Leonard (NHLBI)
    Relevant Publications:
    1. Olkhanud PB, Rochman Y, Bodogai M, Malchinkhuu E, Wejksza K, Xu 
M, Gress RE, Hesdorffer C, Leonard WJ, Biragyn A. Thymic stromal 
lymphopoietin is a key mediator of breast cancer progression. J 
Immunol. 2011;V:186, In Press.
    2. De Monte L, Reni M, Tassi E, Clavenna D, Papa I, Recalde H, 
Braga M, Di Carlo V, Doglioni C, Protti MP. Intratumor T helper type 2 
cell infiltrate correlates with cancer-associated fibroblast thymic 
stromal lymphopoietin production and reduced survival in pancreatic 
cancer. J Exp Med. 2011 Mar 14;208(3):469-478. [PubMed: 21339327]
    3. Pedroza-Gonzalez A, Xu K, Wu TC, Aspord C, Tindle S, Marches F, 
Gallegos M, Burton EC, Savino D, Hori T, Tanaka Y, Zurawski S, Zurawski 
G, Bover L, Liu YJ, Banchereau J, Palucka AK. Thymic stromal 
lymphopoietin fosters human breast tumor growth by promoting type 2 
inflammation. J Exp Med. 2011 Mar 14;208(3):479-490. [PubMed: 21339324]
    Patent Status: U.S. Provisional Application No. 61/416,619 filed 
November 23, 2010 (HHS Reference No. E-019-2011/0-US-01)
    Licensing Status: Available for licensing.
    Licensing Contact: Patrick P. McCue, PhD; 301-435-5560; 
[email protected]
    Collaborative Research Opportunity: The National Institute on 
Aging, Immunotherapeutics Unit, is seeking statements of capability or 
interest from parties interested in collaborative research to further 
develop, evaluate, or commercialize clinical application of TSLP in 
cancers. Please contact Nicole Guyton, PhD at 301-435-3101 or 
[email protected] for more information.

System and Method for Producing Nondiffracting Light Sheets That 
Improves the Performance of Selective Plane Illumination Microscopy 
(SPIM)

    Description of Technology: The technology offered for licensing 
relates to a system and method of producing nondiffracting beams of 
light that spatially overlap, but do not interfere with each other when 
intersecting the detection plane of an optical arrangement. The system 
includes an illumination source (i.e., ultrafast laser) for 
transmitting a beam of light through the optical arrangement that 
includes a diffraction grating for diffracting the light beam to 
produce beams of light having different wavelengths, which are then 
passed through an annular aperture that transforms the beams of light 
into nondiffracting beams having different wavelengths. The method can 
be readily utilized in Selective Plane Illumination Microscopy (SPIM), 
a system that provides optical sectioning of a sample that is labeled 
with fluorescent dyes. SPIM can provide quantitative three-dimensional 
maps of the distribution of a flurophore within the sample with high 
spatiotemporal resolution and an excellent signal-to-noise ratio. The 
standard SPIM technique however produces nonuniform axial resolution, 
which is caused by the diffraction of the laser beam through the 
sample, causing degradation in the optical sectioning, and forcing a 
compromise between field of view and axial resolution. Techniques for 
decoupling field of view and axial resolution have previously utilized 
nondiffracting beams (e.g., Bessel beams) for sample illumination. The 
resulting interference from multiple nondiffracting beams degrades the 
quality of optical sectioning and the quality of the image. The present 
technology utilizing nondiffracting noninterfering beams is intended to 
alleviate the problems associated with the currently used SPIM 
techniques.
    Applications: In Selective Plane Illumination Microscopy (SPIM) 
used for optical sectioning and imaging of biological samples.
    Development Status: Proof of concept has been demonstrated.
    Inventors: Andrew York, Yicong Wu, Hari Shroff (NIBIB)
    Relevant Publications:

1. Durnin J, Micheli J Jr, Eberly JH. Diffraction-free beams. Phys 
Rev Lett. 1987 Apr 13;58(15):1499-1501.
2. Greger K, Swoger J, Stelzer EH. Basic building units and 
properties of a fluorescence single plane illumination microscope. 
Rev Sci Instrum. 2007 Feb;78(2):023705. [PubMed: 17578115]
3. Fahrbach F, Rohrbach A. Microscopy with Non-diffracting Beams. 
Abstract at 2009 Focus on Microscopy Conference, http://www.focusonmicroscopy.org/2009/PDF/28l_Fahrbach.pdf.
4. Rohrbach A. Artifacts resulting from imaging in scattering media: 
a theoretical prediction. Opt Lett. 2009 Oct 1;34(19):3041-3043. 
[PubMed: 19794809]

    Patent Status: U.S. Provisional Application No. 61/360,352 filed 30 
Jun 2010, entitled ``System and Method of Producing Nondiffracting 
Light Sheets by a Multiplicity of Spatially Overlapping, Minimally 
Interfering Nondiffracting Optical Beams'' (HHS Reference No. E-118-
2010/0-US-01)
    Licensing Status: Available for licensing.
    Licensing Contacts:
     Uri Reichman, PhD, MBA; 301-435-4616; [email protected] Michael Shmilovich, Esq.; 301-435-5019; 
[email protected]
    Collaborative Research Opportunity: The NIBIB Section on High 
Resolution Optical Imaging is seeking statements of capability or 
interest from parties interested in collaborative research to further 
develop, evaluate, or commercialize the nondiffracting Light Sheets for 
SPIM. Please contact Hari Shroff at 301-435-1995 or [email protected] 
for more information.

     Dated: April 14, 2011.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2011-9571 Filed 4-19-11; 8:45 am]
BILLING CODE 4140-01-P
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