Document Headings

                    Document headings vary by document type but may contain                    the following:                  
                -                       the agency or agencies that issued and signed a document                    
                -                       the number of the CFR title and the number of each part                      the document amends, proposes to amend, or is directly                      related to                    
                -                       the agency docket number / agency internal file number                    
                -                       the RIN which identifies each regulatory action listed in                      the Unified Agenda of Federal Regulatory and Deregulatory                      Actions                    

                    See the                                          Document Drafting Handbook                                        for more details.                  

###### Department of Health and Human Services

###### National Institutes of Health

# AGENCY:

National Institutes of Health, Public Health Service, HHS.

# ACTION:

Notice.

# 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.

## Retroviral Vectors for Selective Reversible Immortalization of Stimulus-responding Primary Cells

*Description of Invention:*                     Researchers at the National Cancer Institute-Frederick, NIH, have developed a novel set of retroviral vectors and producer cell lines useful for selective reversible immortalization of primary cells (                    *i.e.*                     lymphocytes) that respond to a stimulus, such as a viral antigen (                    *e.g.*      ( print page 23273)                        HIV toxoids), a tumor antigen, or a growth factor.                

Derived from the murine leukemia virus (MuLV), these retroviral vectors will only infect dividing cells. Therefore, only primary cells activated by the stimulus will be infected and immortalized, thereby creating an “antigen-specific trap.”

The primary cells to be immortalized can be in targeted tissue or in stimulated ex vivo culture. The transduced cells can be expanded to large numbers without differentiating, and returned to the primary cell stage by removal of the introduced genes using a vector excision strategy.

### Applications

      - Isolation/replication of normally short-lived primary cells that respond to a stimulus.
      - Immortalization of antigen-specific T cells for vaccine development or adoptive transfer immunotherapy.
      - Production of primary cell lines for large-scale production of cell-secreted factors, cytokines, and other molecules.

### Advantages

      - System acts as an anti-senescence treatment: Cells that are normally short-lived can be kept in culture for years.
      - Vectors with different markers are available to identify transduced cells and for cell selection.
      - Excision allows for gene/marker removal.
      - The MuLV-based system only infects dividing ( e.g.                      activated) cells                

*Inventors:*                     Eugene V. Barsov and David E. Ott (NCI).                

### Relevant Publications

                    1. E Barsov                     *et al.*                     Capture of antigen-specific T lymphocytes from human blood by selective immortalization to establish long-term T-cell lines maintaining primary cell characteristics. Immunol Lett. 2006 May 15;105(1):26-37. [PubMed: 16442639]                

                    2. H Andersen                     *et al.*                     Transduction with human telomerase reverse transcriptase immortalizes a rhesus macaque CD8+ T cell clone with maintenance of surface marker phenotype and function. AIDS Res Hum Retroviruses 2007 Mar;23(3):456-465. [PubMed: 17411379]                 

*Patent Status:*                     HHS Reference No. E-140-2010/0—Research Tool. Patent protection is not being pursued for this technology.                

*Licensing Status:*                     Available for biological materials licensing only.                

*Licensing Contact:*                     Patrick P. McCue, PhD; 301-435-5560;                     *mccuepat@mail.nih.gov.*

*Collaborative Research Opportunity:*                     The Center for Cancer Research, AIDS and Cancer Virus Program, is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize this technology. Please contact John Hewes, PhD at 301-435-3131 or                     *hewesj@mail.nih.gov.*                     for more information.                

## A Method of Measuring Ultraviolet A (UVA) Protection in Sunscreen Products

*Description of Invention:*                     There are different types of ultraviolet (UV) rays in sunlight. UVB radiation causes redness (erythema) or sunburn. While UVA radiation, which absorbs deep into the skin, causes more long-term effects such as wrinkles, skin aging and skin cancer.                

Effective sunscreens are expected to block both UVA and UVB radiation. The Sun Protection Factor (SPF) label found on all over-the-counter sunscreen products is a better measure for UVB protection than UVA protection. Currently, there is no standard in vivo test to determine the amount of UVA protection in sunscreen products, despite the fact that many products are advertised as effectively blocking both UVA and UVB radiation.

This invention describes sets of genes useful for measuring UVA exposure in human skin and assessing sunscreen products for their ability to block UVA radiation.

*Application:*                     A test for measuring UVA protection provided by sunscreens.                

*Development Status:*                     Early stage.                

*Market:*                     According to a report by the Global Industry Analysts, Inc., the sun care market is projected to reach $5.6 billion by the year 2015.                

*Inventors:*                     Atsushi Terunuma and Jonathan C. Vogel (NCI).                

*Related Publication:*                     In preparation.                

*Patent Status:*                     U.S. Provisional Application No. 61/309,179 filed 01 Mar 2010 (HHS Reference No. E-097-2010/0-US-01).                

*Licensing Status:*                     Available for licensing.                

*Licensing Contact:*                     Charlene Sydnor, PhD; 301-435-4689;                     *sydnorc@mail.nih.gov.*

*Collaborative Research Opportunity:*                     The Center for Cancer Research, Dermatology Branch, is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize this technology. Please contact John Hewes, PhD at 301-435-3131 or                     *hewesj@mail.nih.gov*                     for more information.                

## Laser Scanning Microscopy for Three Dimensional Motion Tracking for Volumetric Data

*Description of Invention:*                     The technology offered for licensing and for further development is in the field of volumetric tissue scanning microscopy. More specifically, the invention provides for a device, system and methods that can acquire and analyze volumetric data from a high-speed laser-scanning microscope and compute motion of the sample under the microscope in three dimensions. This computed motion is used to adjust position of the sample in real time to maintain field of view and relative location. This motion compensation scheme can be used to collect micron-scale information over time, which can be important in a number of research or medical device applications.                

### Applications

      - Biomedical research involving in vivo microscopy.
      - Real time tracking of cells or cellular structures.
      - Tracking tissue during various physiological perturbations and observation of dynamic physiological processes. Physiological perturbations include metabolic substrates, drug delivery and anoxia.
      - Potential applications in molecular diagnostic imaging.
      - Potential applications in medical procedures such as biopsy and microsurgery where information has to be collected from a specific microscope location over a period of time.

### Advantages

      - Improved analytical capabilities for biological processes.
      - Improved capabilities of accurately examining and studying physiological perturbations.
      - Potential improvement in medical procedures such as biopsy.
      - May readily be adaptable to commercial microscopes.

*Development Status:*                     The invention is fully developed. Further work needs to be done in the following areas:                
      - Adaptation to different types of microscopes.
      - Further demonstration of utility of in-vivo imaging.

*Inventors:*                     James L. Schroeder (NHLBI)                     *et al.*

*Related Publication:*                     Schroeder JL, Luger-Hamer M, Pursley R, Pohida T, Chefd'Hotel C, Kellman P, Balaban RS. Short communication: Subcellular motion compensation for minimally invasive microscopy, in vivo: evidence for oxygen gradients in resting muscle.                           ( print page 23274)                        Circ Res. 2010 Apr 2;106(6):1129-1133. [PubMed: 20167928].                

*Patent Status:*                     U.S. Provisional Application No. 61/245,586 filed 24 Sep 2009 (HHS Reference No. E-290-2009/0-US-01).                

*Licensing Status:*                     Available for licensing.                

*Licensing Contacts:*                     Uri Reichman, PhD, MBA; 301-435-4616;                     *UR7a@nih.gov,*                     or Michael Shmilovich, Esq.; 301-435-5019;                     *ShmilovichM@mail.nih.gov.*

*Collaborative Research Opportunity:*                     The National Heart, Lung, and Blood Institute, Laboratory of Cardiac Energetics, is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize automatic 3D volumetric motion tracking systems for use during in vivo microscopy. Please contact Denise Crooks, PhD at 301-435-0103 or                     *crooksd@nhlbi.nih.gov*                     for more information.                

Dated: April 26, 2010.

Richard U. Rodriguez,

Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health.

[FR Doc. 2010-10264 Filed 4-30-10; 8:45 am]

BILLING CODE 4140-01-P