[Federal Register Volume 74, Number 157 (Monday, August 17, 2009)]
[Notices]
[Pages 41440-41443]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-19693]


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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.

Development of a New Carbohydrate Antibody to GalNac1-3Gal

    Description of Technology: The present invention provides a 
monoclonal antibody that binds

[[Page 41441]]

specifically to the antigen GalNAc1-3Gal present in human cancers, 
including squamous cell cancer, human cervical cancer, human esophageal 
cancer, human laryngeal cancer, and human skin cancer. The antibody can 
be used to monitor expression of this carbohydrate for a variety of 
purposes. In immunohistochemical staining of tissues, the antibody 
stains a variety of carcinomas, with good staining of cervical, larynx, 
and skin squamous cell carcinomas. Positive antibody staining of 
cervical cancer tissue correlates with a good prognosis (increased 5 
year survival rate) and as such may be useful as a prognostic marker. 
NCI also has the parent cell line for production of the antibody and 
several other variant antibodies with similar reactivity.

Applications

     Cervical cancer diagnostics and prognosis.
     A research tool.

Market

     Cancer is the second leading cause of death in the U.S.A. 
There is an acute need for cancer biomarkers that can be detected from 
clinically relevant samples and used for early diagnosis, therapeutic 
follow-up and prognosis of malignant diseases.
     Estimated new cases and deaths from cervical (uterine 
cervix) cancer in the United States in 2009: 11,270 new cases; 4,070 
deaths according to the National Cancer Institute.
    Inventors: Jeffrey C. Gildersleeve et al. (NCI).
    Patent Status: U.S. Provisional Application No. 61/165, 675 filed 
01 Apr 2009 (HHS Reference No. E-058-2009/0-US-01).
    Licensing Status: Available for licensing.
    Licensing Contact: Betty B. Tong, Ph.D.; 301-594-6565; 
[email protected].

Deletion of the Beta 20-21 Loop in HIV GP120 Exposes the CD4 Binding 
Site for Improved Antibody Binding and Antibody

    Description of Technology: With the number of individuals infected 
with HIV approaching nearly one percent (1%) of the world's population, 
an effective vaccine is urgently needed. As an enveloped virus, HIV 
hides most of its proteins and genes from humoral recognition behind a 
protective lipid bilayer. An available exposed viral target for 
neutralizing antibodies is the envelope spike. Genetic, immunologic and 
structural studies of the HIV envelope glycoproteins have revealed 
extraordinary diversity as well as multiple overlapping mechanisms of 
humoral evasion, including self-masquerading glycan, immunodominant 
variable loops, and conformational masking. These evolutionarily-honed 
barriers of antigenic diversity and immune evasion have confounded 
traditional means of vaccine development. It is believed that 
immunization with effectively immunogenic HIV gp120 envelope 
glycoprotein can elicit a neutralizing response directed against gp120, 
and thus HIV. The need exists for immunogens that are capable of 
eliciting a protective immune response.
    This application claims isolated immunogens, including variant 
gp120 polypeptides and the use of these polypeptides to induce an 
immune response to HIV. This application also claims virus-like 
particles including the variant gp120 polypeptides. More specifically, 
this application claims virus-like particles including variant gp120-
HBsAg hybrid constructs, which may also include at least one TLR 
ligand.
    Application: Development of Human Immunodeficiency Virus (HIV) 
vaccines, therapeutics and diagnostics.
    Advantages: VLP gp120 vaccine, use of HBsAg vector for delivery.
    Development Status: Vaccine candidates have been synthesized and 
preclinical studies have been performed.
    Inventor: Ira Berkower (FDA).
    Publication: I Berkower et al. Targeted deletion in the beta20-
beta21 loop of HIV envelope glycoprotein gp120 exposes the CD4 binding 
site for antibody binding. Virology. 2008 Aug 1;377(2):330-338.
    Patent Status: U.S. Provisional Application 61/155,782 filed 26 Feb 
2009 (HHS Reference No. E-299-2008/0-US-01).
    Licensing Status: Available for licensing.
    Licensing Contact: Peter A. Soukas, J.D.; 301-435-4646; 
[email protected].

Multilayered RF Coil System for Improving Transmit B1 Field Homogeneity 
in High-Field MRI

    Description of Technology: Available for licensing and commercial 
development is a multilayered radio-frequency (RF) coil system for 
improving the transmit B1 field homogeneity for magnetic resonance 
imaging (MRI) at high field strengths. The current invention aims at 
manipulating the inhomogeneous profile of the transmit B1 field, which 
causes MR images to become less uniform as the magnetic field strength 
is increased, by utilizing an inner array of RF elements (e.g. surface 
coils) within and coupled to an outer transmit unit (e.g. a birdcage 
coil or other volume coil). Improvement in B1 field homogeneity is 
achieved by tuning the surface coils of the inner layer to an 
appropriate resonant frequency and then passively coupling them to the 
outer-layer volume coil. Furthermore, the amount of coupling is 
determined by the intrinsic properties of the transmit unit and can be 
adjusted accordingly. The current design provides an effective approach 
for reducing B1 field homogeneity at high fields and can be implemented 
without the need for independent RF channels, thereby reducing MRI 
system complexity. Furthermore it can be readily implemented on 
existing MRI coil systems by detuning surface coils rather than 
decoupling them during the transmit phase.

Applications

     High-Field MRI.
     Improvement of MR Image Uniformity.
    Market: Manufacturers of MRI hardware and accessories.
    Development Status: The technology is ready to be used and requires 
only testing in humans for development.
    Inventors: Alan Koretsky, Jeff Duyn, Shumin Wang, Hellmut Merkle 
(NINDS).

Publications

    1. S Wang and JH Duyn, ``Three-Dimensional Automatic Mesh 
Generation for Hybrid Electromagnetic Simulations'', IEEE Antennas 
and Propagation Magazine, Vol. 51, pp. 71-85, April 2009.
    2. H Merkle, J Murphy-Boesch, S Wang, P van Gelderen, AP 
Koretsky, and JH Duyn, ``Graded Transmit B1 Field Correction at 7T 
Using Tunable Inner Elements'', ISMRM High-field Workshop, Rome, 
Italy, October 2008.
    3. H Merkle, S Wang, P van Gelderen, TQ Li, J Murphy-Boesch, AP 
Koretsky, and JH Duyn, ``B1 Transmit Field Correction at 7T Using 
Coupled Inner Elements'', ISMRM 2008, Toronto, Canada, May, 2008.
    4. S Wang, H Merkle, AP Koretsky, and JH Duyn, ``Improving High-
Field Transmit B1 Field Homogeneity Using Coupled Inner Elements'', 
15th Scientific Meeting and Exhibition, International Society for 
Magnetic Resonance in Medicine, Berlin, Germany, May 2007.

Patent Status

     U.S. Provisional Application No. 60/900,972 filed 13 Feb 
2007 (HHS Reference No. E-020-2007/0-US-01).
     PCT Application No. PCT/US2008/001911 filed 13 Feb 2008 
(HHS Reference No. E-020-2007/0-PCT-02).

[[Page 41442]]

    Licensing Status: Available for licensing.
    Licensing Contact: John Stansberry, Ph.D.; 301/435-5236; 
[email protected].
    Collaborative Research Opportunity: The Laboratory of Functional 
and Molecular Imaging (LFMI) at the National Institute of Neurological 
Disorders and Stroke (NINDS) is seeking statements of capability or 
interest from parties interested in collaborative research to further 
develop, evaluate, or commercialize MRI applications that aim to 
provide novel functional and molecular imaging techniques to study 
brain structure and function. Please contact Melissa Maderia, Ph.D. at 
[email protected] or 301-451-3943 for more information.

Quantifying Gene Relatedness via Nonlinear Prediction of Gene 
Expression Levels

    Description of Technology: This invention relates to a new way to 
analyze the function of a newly identified gene. Working together, the 
genes within a genomic system constitute a control system for 
modulating gene expression activity and protein production. Regulation 
within this control system depends on multivariate relations among 
genes. Therefore, a key window into understanding genomic activity is 
to quantify the manner in which the expression profile among a set of 
genes can be used to predict the expression levels of other genes. This 
invention provides the experimental, statistical, and computational 
basis for nonlinear and linear multivariate prediction and co-
determination among gene expression levels, and it is applied in the 
context of cDNA microarrays. Using these measures of multi-gene 
interactivity, it is possible to infer genomic regulatory mechanisms 
and thereby identify the manner in which genetic malfunction 
contributes to cancer and developmental anomalies.
    Inventors: Michael Bittner (NHGRI), Yidong Chen (NHGRI), et al.
    Patent Status: U.S. Patent No. 7,003,403 issued 21 Feb 2006 (HHS 
Reference No. E-059-2000/0-US-01).
    Licensing Status: Available for licensing.
    Licensing Contact: Jeffrey A. James, Ph.D.; 301-435-5474; 
[email protected].

Isolated Helicobacter hepaticus

    Description of Technology: An isolated bacterium of the genus 
Helicobacter, characterized by the 16S ribosomal RNA encoding 
nucleotide sequence defined in the Sequence Listing as SEQ ID NO:1 is 
provided. An isolated nucleic acid having the nucleotide sequence 
defined in the Sequence Listing as SEQ ID NO:1 is provided. Such a 
nucleic acid can be used for diagnosis of infection with H. hepaticus. 
A nucleic acid of the present invention in a vector suitable for 
expression of the nucleic acid is also provided. The vector can be in a 
host suitable for expressing the nucleic acid. A purified antigen 
specific for H. hepaticus is provided. A method of making an animal 
model for chronic Helicobacter infection is also provided.
    Inventors: Jerrold M. Ward et al. (NCI).
    Patent Status: U.S. Patent 5,610,060 issued 11 Mar 1997 (HHS 
Reference No. E-010-1994/0-US-01).
    Licensing Status: Available for licensing.
    Licensing Contact: Jeffrey A. James, Ph.D.; 301-435-5474; 
[email protected].

Recombinant Vaccines Based on Poxvirus Vectors

    Description of Technology: The technology offered for licensing is 
foundational in the area of recombinant DNA vaccines. In the last 
several years, facilitated through a licensing program of the NIH, the 
technology has been broadly applied in the development and 
commercialization of several novel human and veterinary vaccines in the 
areas of infectious disease as well as cancer therapeutics. The NIH 
wishes to expand its licensing program of the subject technology in a 
variety of applications that will benefit public health.
    Briefly, the technology describes and claims methods of 
constructing recombinant vaccines utilizing any recombinant poxvirus, 
and in particular vaccinia virus (i.e. Modified Vaccinia Ankara or 
other strains) as a backbone that carries a foreign DNA. The foreign 
DNA can be related to a viral pathogen for example, or to a tumor-
associated antigen. Upon administration of the recombinant virus to a 
human or animal subject, the foreign gene is expressed in vivo to 
elicit an immune response against the respective pathogen or the 
respective tumor.
    The technology takes advantage of the unique properties of 
poxviruses as a delivering vehicle and of the ease of preparation of 
such constructs.
    The applications of this technology have been extensively covered 
by many publications, including more than 100 publications from the 
inventor (see sampling below). The publications cover a wide variety of 
vaccines such as HIV, papilloma virus, influenza and others.


    Note: Samples of plasmids and vaccinia virus used in the 
invention are deposited in the American Type Culture Collection and 
in the NIH and may be available for licensees upon request.


Applications

     Prophylactic and/or therapeutic vaccines.
     Infectious disease and cancer Human and animal vaccines.
     Immunotherapy.
     Protein expression system.
    Advantages: Recombinant Poxviruses vectors in DNA vaccines have 
exhibited some advantages as compared to other viral vectors such as 
adenovirus, retrovirus or papillomavirus:
     High safety profile.
     Wide host range.
     Ability to accommodate large amounts of foreign DNA 
including multiple genes.
     No loss of infectivity upon insertion of foreign DNA.
     Unique transcriptional regulatory signals of the virus 
facilitates flexibility in genome strategy.
    In addition, the following properties have been demonstrated:
     Immunization with vaccinia-vectored vaccines provides 
long-lasting protection.
     Vaccinia virus is very stable and no cold-chain is 
required in distribution network.
     Induce mucosal immune response.
     Induce humeral and cellular immunity.
    Development Status: Fully developed. The technology has been 
already successfully implemented in commercial veterinary vaccines 
(i.e. rabies) and is in advance clinical trials in several companies in 
the area of cancer immunotherapy.

Market

     The market for vaccines against infectious diseases is in 
the multibillion dollars and keeps growing at an annual rate of 
approximately 40%. This is compared to approximately 8% growth for the 
overall pharmaceutical companies. Live recombinant vaccines as offered 
in the subject technology offer an attractive alternative to existing 
vaccines as well as for future vaccines and therefore may be 
commercially attractive for vaccine and pharmaceutical companies.
     The market for therapeutic cancer vaccines, which is the 
subject of this technology, is expected to mirror the growth seen in 
the monoclonal antibody market and reach sales in excess of $5

[[Page 41443]]

billion by 2012 according to some reports.
    Overall, the potential commercial opportunity based on the subject 
technology is immense.
    Inventors: Bernard Moss et al. (NIAID).
    Publications: The inventor, Dr. Bernard Moss, is an author of more 
than 100 publications in the area covered by the subject patents. The 
following is just a sampling of his publications in the area:

    1. B Moss and PL Earl. Overview of the vaccinia virus expression 
system. Curr Protoc Mol Biol. 2002 Nov; Chapter 16: Unit16.15.
    2. HL Robinson, S Sharma, J Zhao, S Kannanganat, L Lai, L 
Chennareddi, T Yu, DC Montefiori, RR Amara, LS Wyatt, B Moss. 
Immunogenicity in macaques of the clinical product for a clade B 
DNA/MVA HIV vaccine: elicitation of IFN-gamma, IL-2, and TNF-alpha 
coproducing CD4 and CD8 T cells. AIDS Res Hum Retroviruses. 2007 
Dec;23(12):1555-1562.
    3. LS Wyatt, PL Earl, J Vogt, LA Eller, D Chandran, J Liu, HL 
Robinson, B Moss. Correlation of immunogenicities and in vitro 
expression levels of recombinant modified vaccinia virus Ankara HIV 
vaccines. Vaccine 2008 Jan 24;26(4):486-493.
    4. M Hebben, J Brants, C Birck, JP Samama, B Wasylyk, D Spehner, 
K Pradeau, A Domi, B Moss, P Schultz, R Drillien. High level protein 
expression in mammalian cells using a safe viral vector: modified 
vaccinia virus Ankara. Protein Expr Purif. 2007 Dec;56(2):269-278.

    Patent Status: The technology is described and claimed in the 
following four (4) patents that were issued in the U.S. in 2006 (HHS 
Reference E-552-1982/2):
    1. USPN 6,998,252 issued February 14, 2006, ``Recombinant 
Poxviruses Having Foreign DNA Expressed under the Control of Poxvirus 
Regulatory Sequences''.
    2. USPN 7,015,024 issued March 21, 2006, ``Compositions Containing 
Recombinant Poxviruses Having Foreign DNA Expressed Under the Control 
of Poxvirus Regulatory Sequences''.
    3. USPN 7,045,313 issued May 16, 2006, ``Recombinant Vaccinia Virus 
Containing Chimeric Gene Having Foreign DNA Flanked by Vaccinia 
Regulatory DNA''.
    4. USPN 7,045,136 issued May 16, 2006, ``Methods of Immunization 
Using Recombinant Poxviruses Having Foreign DNA Expressed Under the 
Control of Poxvirus Regulatory Sequences''.
    Licensing Status: Available for licensing.
    Licensing Contacts: Uri Reichman, Ph.D., MBA; 301-435-4616; 
[email protected]; RC Tang, JD, LLM; 301-435-5031; [email protected].

    Dated: August 10, 2009.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. E9-19693 Filed 8-14-09; 8:45 am]
BILLING CODE 4140-01-P