[Federal Register Volume 72, Number 62 (Monday, April 2, 2007)]
[Notices]
[Pages 15704-15705]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-6066]


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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.

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; <a href="/cdn-cgi/l/email-protection#92dae7c1d2fff3fbfebcfcfbfabcf5fde4"><span class="__cf_email__" data-cfemail="d098a58390bdb1b9bcfebeb9b8feb7bfa6">[email protected]</span></a>.

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

[[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; <a href="/cdn-cgi/l/email-protection#691d0108050108040a290408000547070001470e061f"><span class="__cf_email__" data-cfemail="0f7b676e63676e626c4f626e66632161666721686079">[email protected]</span></a>.

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; <a href="/cdn-cgi/l/email-protection#34555a5b477459555d581a5a5d5c1a535b42"><span class="__cf_email__" data-cfemail="0b6a6564784b666a626725656263256c647d">[email protected]</span></a>.

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; <a href="/cdn-cgi/l/email-protection#1a7b7475695a777b737634747372347d756c"><span class="__cf_email__" data-cfemail="1677787965567b777f7a38787f7e38717960">[email protected]</span></a>.

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; <a href="/cdn-cgi/l/email-protection#90f1feffe3d0fdf1f9fcbefef9f8bef7ffe6"><span class="__cf_email__" data-cfemail="cbaaa5a4b88ba6aaa2a7e5a5a2a3e5aca4bd">[email protected]</span></a>.

    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


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