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###### 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.                     

## High-Level Expression and Purification of Untagged and Histidine-Tagged Human Immunodeficiency Virus type-1 (HIV-1) Reverse Transcriptase 

*Description of Technology:*                     This invention includes plasmids and protocols to express and purify large quantities of histidine-tagged and untagged HIV-1 reverse transcriptase (RT). Conditions have been optimized for overexpression and purification of p66 and p51 heterodimer RT in E. coli. High-level of expression was reached as RT represented approximately 30%-40% of total cell proteins. The subject invention enables the purification of large quantities of heterodimer RT necessary for structural and kinetic studies and facilitates subunit-specific amino acid alterations essential for structure/function investigations.                 

*Applications:*                     Research Tool.                 

*Development Status:*                     In vitro data available.                 

*Inventors:*                     Samuel H. Wilson, Rajendra Prasad, Esther W. Hou (NIEHS).                 

*Related Publication:*                     EW Hou, R Prasad, WA Beard, SH Wilson. High-level expression and purification of untagged and histidine-tagged HIV-1 reverse transcriptase. Protein Expr Purif. 2004 Mar;34(1):75-86.                 

*Patent Status:*                     HHS Reference No. E-141-2007/0—Research Tool.                 

*Licensing Status:*                     Available for non-exclusive licensing as biological material and research tool.                 

*Licensing Contact:*                     Sally Hu, PhD; 301/435-5606; HuS@mail.nih.gov.                 

## Methods of Determining the Prognosis of an Adenocarcinoma 

*Description of Technology:*                     Available for licensing and commercial development is a novel method for determining the prognosis of a subject with adenocarcinoma in an organ, such                           ( print page 15705)                        as the lung, and to aid in the selection of a specific therapeutic regimen. Lung adenocarcinoma (AC) is the predominant histological subtype of lung cancer, which is the leading cause of cancer deaths worldwide. The risk of metastasis remains substantial in AC patients, even when a curative resection of early-stage AC is performed. The prognosis includes the determination of the likelihood of survival, the likelihood of metastasis, or both. The method includes quantization of the expression of a plurality of Th1 and Th2 cytokines of interest in the adenocarcinoma and in non-cancerous tissue in the organ. Altered expression of one or more of the Th1 and Th2 cytokines in the adenocarcinoma as compared to the non-cancerous tissue determines the prognosis for the subject. The method is capable of distinguishing patients with lymph node metastasis versus those with short term survival. Furthermore, methods are provided for evaluating the effectiveness of anti-cancer agents.                 

*Applications:*                     Prognosis of adenocarcinoma, aid in the selection of specific therapeutic regimens and evaluation of the effectiveness of anti-cancer agents.                 

*Development Status:*                     The technology is in early stage of development.                 

*Inventors:*                     Curtis C. Harris, Masahiro Seike, Xin Wei Wang (NCI).                 

*Patent Status:*

1. U.S. Provisional Application No. 60/830,936 filed 14 Jul 2006 (HHS Reference No. E-263-2006/0-US-01). 

2. U.S. Provisional Application No. 60/885,101 filed 17 Jan 2007 (HHS Reference No. E-085-2007/0-US-01). 

*Licensing Status:*                     Available for non-exclusive or exclusive licensing.                 

*Licensing Contact:*                     Cristina Thalhammer-Reyero, PhD, M.B.A.; 301/435-4507;                     *thalhamc@mail.nih.gov*.                 

## Codon Optimized Genes for Subunit Vaccines 

*Description of Technology:*                     Available for licensing from the NIH are gene constructs that express immunogenic proteins based on viral genes that have been optimized for expression in mammalian cells. Using vaccine vectors expressing respiratory syncytial virus (RSV) proteins from the optimized genes, this technology was shown to result in a potent RSV-specific cellular immune responses with favorable phenotypic patterns. Such optimized genes could be essential for development of an effective RSV subunit vaccine. Further, this optimization could have possible application to gene-based vectors for other viral vaccines.                 

*Potential Applications of Technology:*                     Vaccines; Improved protein expression.                 

*Inventors:*                     Barney S. Graham and Teresa R. Johnson (VRC/NIAID).                 

*Patent Status:*                     U.S. Provisional Application No. 60/872,071 filed 30 Nov 2006 (HHS Reference No. E-326-2006/0-US-01).                 

*Licensing Status:*                     Available for non-exclusive or exclusive licensing.                 

*Licensing Contact:*                     Susan Ano, PhD; 301/435-5515;                     *anos@mail.nih.gov.*

## Dual Expression Vector for DNA Vaccines 

*Description of Technology:*                     Available for licensing from the NIH is an expression vector for improved DNA vaccines. Activation of co-stimulatory molecules (e.g. signaling molecules, cytokines, chemokines) and the timing of the activation are important for adaptive immune response. This technology describes a new vector that expresses an antigen and a co-stimulatory molecule, the latter after a delay to allow accumulation of the antigen. It is known that in some circumstances an optimal immune response is achieved by administration of a co-stimulatory molecule after antigen delivery. The subject technology improves upon the existing concept by providing a vector for accomplishing this optimization in a single step. Exemplary animal studies have shown that the delayed expression of some co-stimulatory molecules in important signaling pathways resulted in enhancement of the cellular and/or humoral immune responses using HIV Env as a representative antigen.                 

*Potential Applications:*                     Improved DNA vaccines.                 

*Inventors:*                     Gary J. Nabel and Wataru Akahata (VRC/NIAID).                 

*Patent Status:*                     1. U.S. Provisional Application No. 60/737,896 filed 18 Nov 2005 (HHS Reference No. E-043-2006/0-US-01).                 

2. PCT Application No. PCT/US2006/044552 filed 20 Nov 2006 (HHS Reference No. E-043-2006/2-PCT-01). 

*Licensing Status:*                     Available for non-exclusive or exclusive licensing.                 

*Licensing Contact:*                     Susan Ano, PhD; 301/435-5515;                     *anos@mail.nih.gov.*

## Methods and Systems for Efficient Analysis and Microdissection of Intact Biological Specimens 

*Description of Technology:*                     Efficient and accurate analysis of intact biological specimens is needed to provide information related to a broad range of pathologies as well as normal physiological states. The available technology includes novel systems, methods, and platforms for selective analysis of biological material such as whole cells, tissues and tumors. This platform may be used to identify and independently characterize specific components, such as cells, proteins, nucleic acids or other molecules that make-up the specimen.                 

The methods include placing the sample of interest on a surface such as a membrane, and activating the surface at selected sites adjacent to the section of interest. The activated sites become permeable and the cells or cell components adjacent to the permeable sites can then be selectively extracted and their content analyzed by standard biochemical procedures. In addition, the extract may be applied to microarray devices, such as cDNA arrays, for analysis of gene expression etc. The technique presents a convenient alternative to existing methods of tissue microdissection. For further convenience, the technique can be directly combined with a variety of analytical devices such as ELISAs, microarray biochips, or other devices which include multiple regions carrying multiple capture molecules. 

*Applications:*                     Analysis of biological specimens such as whole cell tissues and tumors; High throughput analysis of individual components of intact biological specimens.                 

*Inventors:*                     Michael R. Emmert-Buck (NCI), Chad R. Englert-Haldeman (NCI), Robert F. Bonner (NICHD), and Lance A. Liotta (NCI).                 

*Patent Status:*                     1. Patent Cooperation Treaty Application No. PCT/US01/08095 filed 14 Mar 2001, which published as WO 02/10751 on 07 Feb 2002; claiming priority to 26 Jul 2000 (HHS Reference No. E-197-2000/0-PCT-02).                 

2. National Phase Applications in: 

a. U.S., Serial No. 10/333,374 filed 10 Jul 2003 (HHS Reference No. E-197-2000/0-US-03). 

b. Canada, Serial No. 2415864 filed 14 Mar 2001 (HHS Reference No. E-197-2000/0-CA-04). 

c. Europe, Serial No. 01918647.0 filed 14 Mar 2001 (HHS Reference No. E-197-2000/0-EP-05). 

*Licensing Status:*                     Availability for non-exclusive or exclusive licensing.                 

*Licensing Contact:*                     Susan Ano, PhD; 301/435-5515;                     *anos@mail.nih.gov*.                 

Dated: March 26, 2007. 

Steven M. Ferguson, 

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

 [FR Doc. E7-6066 Filed 3-30-07; 8:45 am] 

BILLING CODE 4140-01-P