[Federal Register Volume 74, Number 34 (Monday, February 23, 2009)]
[Notices]
[Pages 8094-8096]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-3811]


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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.

Quantitative Real-Time RT-PCR Array for Detection of Human Herpesvirus 
6A Gene Expression

    Description of Technology: This invention describes an RT-PCR array 
that allows for the simultaneous transcriptional profiling of the human 
herpesvirus HHV6A genome. It may be used to determine the contribution 
of HHV6A to the development of lymphomas, other types of cancer or 
diseases where an infectious agent is suspected. Primer pairs are 
designed to amplify under identical reaction conditions and are 
rigorously tested to ensure specificity for the HHV6A ORFs to the 
exclusion of all other human herpesviruses including HHV6B and HHV7.
    Recent findings of the association of active viral genes with 
cancer cells have led to new proposed targets for cancer vaccines and 
therapeutics. The ability to distinguish HHV6A from other related 
herpesviruses, and to independently assay viral gene activity, may lead 
to the identification of new viral targets for the treatment of cancers 
and other diseases where HHV6A transcription is active.
    Applications:
     Analysis of whole HHV6A genome expression.
     Identification of HHV6A gene expression and its 
association with disease states.
    Development Status: Late stage.
    Inventors: Rachel K. Bagni (NCI/SAIC), Francis W. Ruscetti (NCI), 
et al.
    Patent Status: U.S. Provisional Application No. 61/114,753 filed 14 
Nov 2008 (HHS Reference No. E-019-2009/0-US-01).
    Licensing Status: Available for licensing.
    Licensing Contact: Jeffrey A. James, PhD; 301-435-5474; 
[email protected].
    Collaborative Research Opportunity: The National Cancer Institute, 
Advanced Technology Program, is seeking statements of capability or 
interest from parties interested in collaborative research to further 
develop, evaluate, or commercialize virus specific quantitative real-
time RT-PCR arrays. Please contact John D. Hewes, PhD at 301-435-3121 
or [email protected] for more information.

In Vivo Quantitative Tissue Oxygen Imaging Using Pulsed Time-Domain 
Electron Paramagnetic Resonance--Echo-Based Single Point Imaging (ESPI)

    Description of Technology: Available for licensing and commercial 
development are patent rights covering an EPR image formation strategy 
for in vivo imaging of physiological function. It emphasizes image 
resolution and quantitative assessment of in vivo tissue oxygen that 
are important in planning radiation and chemotherapeutic treatments for 
patients with cancers. The method pertains exclusively to time-domain 
Fourier Transform EPR imaging (FT-EPRT) with emphasis on spatial and 
temporal resolution, since physiological processes are generally rapid 
and require accurate and rapid time-course information.
    Two most important existing methods are Spin Echo Fourier (SEF) and 
Single Point Imaging (SPI). ESPI (Echo-based Single Point Imaging) 
enables the combination of the advantages of the quantitative 
T2 contrast of SEF strategy and the super high resolution of 
the SPI methodology, leading to reliable EPR imaging for tissue 
physiological function in vivo.
    Applications:
     EPR (Electron Paramagnetic Resonance).
     In vivo imaging.
     Tissue oxygen.
    Inventors: Sankaran Subramanian, Nallathamby Devasahayam, Shingo 
Matsumoto, James Mitchell, Murali Cheruki, John Cook (NCI).
    Patent Status: U.S. Provisional Application No. 61/200,579 filed 29 
Nov 2008 (HHS Reference No. E-250-2008/0-US-01), entitled ``Pulsed 
Time-Domain Electron Paramagnetic Resonance In Vivo Tissue Oxygen 
Imaging Via Cooperative ESE/ESPI''.
    Licensing Status: Available for licensing.
    Licensing Contact: Michael A. Shmilovich, Esq.; 301-435-5019; 
[email protected].
    Collaborative Research Opportunity: The National Cancer Institute 
Radiation Biology Branch is seeking statements of capability or 
interest from parties interested in collaborative research to further 
develop, evaluate, or commercialize Echo-based Single Point Imaging. 
Please contact John D. Hewes, PhD at 301-435-3121 or 
[email protected] for more information.

Microwave-Assisted Freeze Substitution of Biological and Biomedical 
Samples (MWFS)

    Description of Technology: Freeze substitution fixation (FS) of 
hydrated samples frozen in vitreous ice provides exceptional 
preservation of structure for light and electron microscopy, and 
enables immunological detection of thermo-labile antigens that 
otherwise are damaged/destroyed by processing at ambient or elevated 
temperatures. Its use as a research tool or in clinical pathology has, 
however, been limited by the relatively lengthy periods required for 
passive diffusion of fixatives and organic solvents into the frozen 
hydrated material.

[[Page 8095]]

    The instant invention utilizes controlled microwave (MW) 
irradiation to accelerate the FS process; and comprises systems, 
devices and methods for microwave-assisted processing of samples under 
cryo-conditions. The entire MWFS procedure has been accomplished in 
less than 4 hours as compared to the approximately 2-5 days required 
for FS.
    Applications:
     Provides superior preservation and rapid turnaround in 
research and high throughput clinical laboratory settings.
     Applicable to a broad range of biological samples, 
hydrogels, and other hydrated materials.
     Processing for light and electron microscopy.
     Low-temperature synthetic and analytical chemistry.
    Advantages:
     Reduces processing periods from days to hours.
     Improves preservation, approaching native state.
     Enables uncomplicated, programmable operation.
     Provides excellent reproducibility.
    Development Status:
     Proof of concept with varied biological samples.
     Adaptation of existing equipment with manual processing.
     Proposed designs for instrumentation and automation.
    Market:
     Commercial and clinical histology laboratories.
     Pathology and forensic laboratories.
     Biomedical and biological research laboratories.
     Hydrogel and hydrated material research and quality 
control laboratories.
     Pharmaceutical and other synthetic and analytical 
chemistry laboratories.
    Inventors: David Dorward, Vinod Nair, and Elizabeth Fischer 
(NIAID).
    Publications: Manuscripts in preparation.
    Patent Status:
     U.S. Provisional Application No. 61/094,848 filed 05 Sep 
2008 (HHS Reference No. E-238-2008/0-US-01).
     U.S. Provisional Application No. 61/112,575 filed 07 Nov 
2008 (HHS Reference No. E-238-2008/1-US-01).
     No foreign rights available at the present.
    Licensing Status: Available for licensing.
    Licensing Contact: RC Tang, JD, LLM; 301-435-5031; 
[email protected].
    Collaborative Research Opportunity: The National Institute of 
Allergy and Infectious Diseases, Research Technologies Branch, Electron 
Microscopy Unit, is seeking statements of capability or interest from 
parties interested in collaborative research to further develop, 
evaluate, or commercialize potential applications of the above 
mentioned invention, including design and development of 
instrumentation for conducting microwave-assisted freeze (cryo) 
substitution. Please contact Jason (Christopher) Freeman, J.D., NIAID/
OTD, at 301-451-5054 or [email protected] for more information.

Compositions and Methods for Vaccine and Virus Production

    Description of Technology: This technology relates to compositions 
and methods for improving the growth characteristics of cells 
engineered to produce live viruses such as the Influenza virus. 
Featured is a method that uses the gene candidate, siat7e, or its 
expressed or inhibited products in Madin Darby Canine Kidney (MDCK) 
cells. The gene expression modulates anchorage-dependence of the cell 
line thereby allowing scale-up on bioreactor platforms without the use 
of microcarrier beads and reducing production costs. More specifically, 
this technology claims use of the methods embodied in the patent 
application for production of the Influenza viruses (human, avian and 
canine).
    Applications: This technology may be used to improve the production 
of prophylactic compounds against the seasonal flu. Influenza viruses 
are traditionally isolated and propagated in chicken embryonated eggs. 
Egg-derived viruses are the source of Influenza vaccine preparation. 
Issues associated with this current Influenza virus production strategy 
are prolonged planning of egg supplies and cultivation periods, 
variants in antigenic properties of egg-derived viruses, sterility and 
hypersensitivity to egg compounds in a fractional population of 
potential vaccine recipients. Defined cell substrates are currently 
being investigated. MDCK cells have been shown to produce sufficient 
viral titers. However, these cells are anchorage-dependent and thus 
limited in scale-up even with the use of microcarrier beads. This 
technology provides a method for converting the MDCK cells into 
suspension culture and thus a promising alternative for Influenza virus 
production.
    Advantages: This technology offers the ability to improve yields 
and reduce the cost associated with the production of the Influenza 
virus through the genetic modification of the MDCK cell line having:
     Altered growth characteristics.
     Altered adhesion characteristics.
     Altered rate of proliferation.
     Improvement in cell density growth in suspension.
     Improvement in hemagglutinin production.
    Development Status: Late Stage--Ready for Production.
    Market: Based on the marketing data collected during the late 1990s 
and early 2000s, growth of pharmaceutical companies' investments in 
vaccine have generated sales just slightly below $10 billion in 2004 
and this statistic is expected to at least triple by the mid-2010s. It 
has also been reported that egg-based Influenza vaccines account for 
approximately 14% of the total vaccine sales and will approach a market 
size of $4 billion at the end of the decade. However, the belief of an 
impending Influenza pandemic has also spurred the search for a defined 
cell line that can serve as an alternative to the current egg-based 
production. Discovery and characterization of a suitable cell line for 
Influenza virus would be extremely valuable.
    Mammalian cells such as Vero, PER.C6, and especially MDCK cells 
have been under investigation by both academic and industrial groups 
for their suitability to produce commercially viable viral titers. This 
technology details the genetic modification of the MDCK cell line with 
a human gene and consequently the isolation of an anchorage-independent 
MDCK cell line that has consistently produced a higher hemagglutinin 
titer.
    This technology is ready for use in drug/vaccine discovery, 
production and development. The technology provides methods for 
altering the adhesion properties of the MDCK cell line to improve 
growth and production properties. Companies that are actively seeking 
production platforms based on mammalian cell lines that offer high 
efficiency, high throughput systems for Influenza virus production and 
ease of scale-up would be potential licensees of this technology.
    Inventors: Joseph Shiloach, Pratik Jaluria, Michael Betenbaugh and 
Chia Chu (NIDDK).
    Patent Status: U.S. Provisional Application No. 61/124,077 filed 11 
Apr 2008 (HHS Reference No. E-173-2008/0-US-01).
    Licensing Status: Available for licensing.
    Licensing Contact: Peter A. Soukas, J.D.; 301-435-4646; 
[email protected].
    Collaborative Research Opportunity: The Biotechnology Core 
laboratory will consider collaborative research to further develop, 
evaluate, or

[[Page 8096]]

commercialize the above invention. Please contact Dr. Joseph Shiloach 
at [email protected] or 301-496-9719 for more information.

Teniae Coli Guided Navigation and Registration for Virtual Colonoscopy

    Description of Technology: This invention describes a more 
sensitive and efficient method for colon cancer screening using the 
teniae coli as an anatomical reference. Most computed tomographic 
colonography (CTC) protocols for colon cancer screening require that a 
patient is scanned in both the supine and prone positions for increased 
sensitivity; as a result, a reference system between scans is necessary 
for lesion matching. The teniae coli are three equal-distanced bands of 
longitudinal smooth muscle on the surface of the colon between the 
appendix and the sigmoid colon. These muscles can be used as anatomical 
landmarks to derive a coordinate system to better localize and register 
the corresponding supine and prone positions of a CTC study. The 
inventors have devised a semi-automated system for extracting data from 
the teniae coli and defining coordinate systems based on them.
    The invention allows for more detailed detection of anatomical 
features for surgical planning, better camera orientation and virtual 
protocols, more efficient lesion registration, and precise record 
keeping. The algorithm has been used successfully to correctly localize 
several polyps to the same circumferential position in both supine and 
prone scans of a CTC study.
    Applications:
     Positioning virtual cameras for navigating a single 
dataset.
     Synchronizing virtual cameras for virtual colonoscopic 
navigation.
     Predicting lesion candidates in a bound region for both 2D 
and 3D reading paradigms.
     Automatic polyp matching between scans for CAD 
applications.
    Development Status: Late stage.
    Inventors: Hui-Yang Huang (CC), Ronald M. Summers (CC), Dave R. Roy 
(OD).
    Publication: A Huang, DA Roy, RM Summers, M Franaszek, N Petrick, 
JR Choi, PJ Pickhardt. Teniae coli-based circumferential localization 
system for CT colonography: feasibility study. Radiology 2007 
May;243(2):551-560.
    Patent Status:
     U.S. Patent Application No. 11/436,889 filed May 17, 2006 
(HHS Reference No. E-084-2006/0-US-01).
     No foreign rights available.
    Licensing Status: Available for licensing.
    Licensing Contact: Jeffrey A. James, PhD; 301-435-5474; 
[email protected].

Method and Apparatus for Performing Multiple Simultaneous Manipulations 
of Biomolecules in a Two-Dimensional Array

    Description of Technology: This technology concerns a method and 
apparatus for accomplishing and/or facilitating the analysis of 
multiple biomolecules separated in a two-dimensional array, such as 
gel, membrane, tissue biopsy, etc. The invention employs a separator, 
termed an External Movement Inhibitor Device, that allows biomolecules 
to be transferred from an array such as those listed above to another 
support system while maintaining the two-dimensional spatial 
relationship of the biomolecules as in the array. The biomolecules can 
subsequently be subjected to various manipulations such as 
amplification, reverse transcription, labeling, cloning, etc., after 
which multiple well-established methods for quantitative and 
qualitative analysis can be used.
    Applications:
     Two dimensional nucleic acid analysis.
     Two dimensional proteomic analysis.
     Histology/Pathology.
    Advantages: Allows for simultaneous 2D analysis of nucleic acids 
and proteins.
    Development Status: In vitro data can be provided upon request.
    Market:
     Histology/Pathology of tissue samples.
     Tissue arrays.
     Nucleic acid and proteomic analysis.
    Inventors: Michael R. Emmert-Buck et al. (NCI).
    Patent Status:
     International Patent Application No. PCT/US03/37208 filed 
20 Nov 2003 (HHS Ref. No. E-339-2002/0-PCT-02).
     U.S. Patent Application No. 10/535,521 filed 18 May 2005 
(HHS Reference No. E-339-2002/0-US-03).
    Licensing Status: Available for licensing.
    Licensing Contact: Kevin W. Chang, PhD; 301-435-5018, 
[email protected].
    Collaborative Research Opportunity: The National Cancer Institute 
Laboratory of Pathology and Urologic Oncology Branch, Center for Cancer 
Research is seeking statements of capability or interest from parties 
interested in collaborative research to further develop, evaluate, or 
commercialize an external movement inhibitor device for spatially 
restricted PCR amplification of nucleic acids. Please contact John D. 
Hewes, PhD at 301-435-3121 or [email protected] for more information.

    Dated: February 10, 2009.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. E9-3811 Filed 2-20-09; 8:45 am]
BILLING CODE 4140-01-P