[Federal Register Volume 74, Number 96 (Wednesday, May 20, 2009)]
[Notices]
[Pages 23729-23731]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-11705]


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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.

Antibody and Immunotoxin Treatments for Mesothelin-Expressing Cancers

    Description of Technology: Mesothelin is a cell surface protein 
that is highly expressed in aggressive cancers such as malignant 
mesothelioma, ovarian cancer and pancreatic cancer. As a result, 
mesothelin is an excellent candidate for tumor targeted 
immunotherapeutics. However, the antibodies against mesothelin that are 
available for clinical trials are of murine origin. These antibodies 
have the potential to elicit immune responses in patients, which may 
adversely affect the ability to provide patients with repeated doses. 
Thus, the clinical application of the antibodies may be limited.
    In order to address the issue of immunogenicity in patients, NIH 
inventors have generated anti-mesothelin antibody variable fragments 
(Fv) of human origin. These antibody fragments (HN1 and HN2) have the 
ability to efficiently recognize mesothelin on the surface of numerous 
cancer cells. As a result, these antibody fragments represent an 
attractive therapeutic alternative to the murine anti-mesothelin 
antibodies currently being tested in clinical trials.
    Application:
     Use as an antibody therapeutic for mesotheliomas, 
pancreatic tumors and ovarian tumors.
     Use in an immunotoxin therapeutic for mesotheliomas, 
pancreatic tumors and ovarian tumors.
     Diagnostic for the detection of mesothelin positive 
tumors.
     Research agent for the detection of mesothelin.
    Advantages:
     Fully human antibody reduces potential immunogenicity, 
thereby allowing repeated dosing.
     Antibody specificity improves the therapeutic efficacy of 
the agent.
    Development Status: Preclinical stage of development with some pre-
clinical data available.
    Inventors: Mitchell Ho et al. (NCI).
    Patent Status: U.S. Provisional Application No. 61/162,778, filed 
24 Mar 2009 (HHS Reference E-091-2009/0-US-01)
    Related Technologies/Publications:
     U.S. Patent 6,083,502 entitled ``Mesothelium Antigen and 
Methods and Kits For Targeting It.''
     PCT Application PCT/US97/0224 entitled ``Mesothelium 
Antigen and Methods and Kits For Targeting It.''
     U.S. Patent 6,809,184 entitled ``Antibodies, Including Fv 
Molecules, and Immunoconjugates Having High Binding Affinity for 
Mesothelin and Methods for Their Use.''
     PCT Application PCT/US98/25270 entitled ``Antibodies, 
Including Fv Molecules, and Immunoconjugates Having High Binding 
Affinity for Mesothelin and Methods for Their Use.''
     U.S. Patent 7,081,518 entitled ``Anti-mesothelin 
antibodies having high binding affinity.''
     PCT Application PCT/US00/14829 entitled ``Immunoconjugates 
Having High Binding Affinity Improvement of scFVsr Ab's with Higher 
Affinity for Mesothelin.''
    Licensing Status: Available for licensing.
    Licensing Contact: David A. Lambertson, Ph.D.; 301-435-4632; 
[email protected].
    Collaborative Research Opportunity: The National Cancer Institute 
Laboratory of Molecular Biology is seeking statements of capability or 
interest from parties interested in collaborative research to further

[[Page 23730]]

develop, evaluate, or commercialize antibody-based treatments of 
mesothelin-expressing cancers. Please contact John D. Hewes, Ph.D. at 
301-435-3121 or [email protected] for more information.

Simple Biosensors Based on Electrical Percolation Biological 
Semiconductors

    Description of Technology: The invention offered for licensing is 
in the field of biosensors with application in diagnostics and in 
regulation of implantable biomedical devices. More specifically, it is 
related to biological semiconductors based on the electrical 
percolation of single-walled carbon nanotubes (SWNTs). The nanotubes 
are embedded with biological ligands (e.g., antibodies). The electrical 
resistance of a semiconducting SWNT is found to dramatically increase 
upon the actuation by a specific antigen. Measurement of the change in 
resistance correlates with the concentration of the specific antigen 
and thus provides for quantitative determination and diagnostics of 
biological samples. The simple printing fabrication of electrical 
percolation biological semiconductors (EPBSC) can facilitate assembly 
of numerous types of gates (e.g., antibodies, DNA, etc.) and print many 
of such gates on the same chip for the creation of biological CPUs for 
various biomedical applications, including direct biodetection and 
regulation of implantable biomedical devices.
    Applications:
    (a) Miniaturized biosensors for various biomedical applications, 
including: (i) Direct biodetection of microbial pathogens and their 
toxins ii) diagnostics and prognostics of human diseases (e.g., cancer, 
cardiovascular, or other biomarkers) (iii) detection and analysis of 
nucleic acids (e.g., DNA, RNA) (iv) detection and analysis of other 
analytes (carbohydrates, fatty acids, organic or inorganic compounds).

--Point of Care (POC) diagnostics (e.g., Physician's office, home-use)
--Military applications (e.g., remote sensing of biowarfare agents)
    (b) Monitor food safety and detection of environmental pollution.
    (c) Regulation of implantable biomedical devices such as insulin 
pumps or artificial hearts.
    (d) New generation of personal detectors (e.g., food allergens, 
cardiovascular event, etc.).
    Advantages:
    (a) The electrical percolation biological semiconductors (EPBSC) 
are relatively simple to assemble, and do not require specialized 
fabrication facilities or experience which may broaden the use of EPBSC 
in a similar way that PDMS (Polydimethylsiloxane) technology has 
broadened the use of lab-on-a-chip.
    (b) Many EPBSC can be fabricated into the same chip enabling 
simultaneous detection of many analytes.
    (c) Electronic based EPBS detection enable simple digital signal 
amplification and analysis.
    (d) EPBSC can be relatively stable with respect to retention of 
biological viability and thus can be stored for a long period of time 
before use.
    (e) EPBSC enable device miniaturization.
    (f) EPBSC are relatively simple to use and may not require special 
equipment or a skilled operator. Thus, these biosensors can be utilized 
in a Physician Office setting, for military applications and for 
possibly remote sensing for detections of biowarfare materials.
    (g) EPBSC devices will offer speed of detection, ease of use, and 
it will be inexpensive to make.
    Development Status: Proof of concept was demonstrated. For example, 
using anti-Staphylococcal Enterotoxin B (SEB) IgG antibodies as a gate, 
and the SEB antigen as an actuator, the inventors could detect as 
little as 0.1 ng/mL of SEB.
    Market: According to market research reports from 2003-2004 the 
global market for biosensors was projected to grow from approximately 
$7.0 billion in 2004 to approximately $9.5 billion in 2009, an average 
annual growth of about 7.0%. Ninety-nine percent (99%) of the 
biosensor's market is dominated by biomedical and life sciences, while 
only one percent (1.0%) with applications in environmental monitoring.
    Because of the unique advantages offered by this technology (i.e., 
diversity of applications, simplicity of use and low cost), there is a 
good probability that if technically successful it will become 
commercially successful and financially rewarding.
    Inventors: Avraham Rasooly (NCI) et al.
    Patent Status: U.S. Provisional Application No. 61/115,546 filed 18 
Nov 2008, entitled ``Electrical Percolation Biomedical Semiconductors'' 
(HHS Reference No. E-040-2009/0-US-01).
    Licensing Status: Available for licensing.
    Licensing Contacts: Uri Reichman, Ph.D., MBA; 301-435-4616; 
[email protected]; Michael Shmilovich, JD; 301-435-5019; 
[email protected].
    Collaborative Research Opportunity: The National Cancer Institute, 
Cancer Diagnostic Program, and the Food and Drug Administration, the 
Center for Devices and Radiological Health, Office of Science and 
Engineering Laboratories, is seeking statements of capability or 
interest from parties interested in collaborative research to further 
develop, evaluate, or commercialize Electrical Percolation Biological 
Semiconductors for biodetection. Please contact John D. Hewes, Ph.D. at 
301-435-3121 or [email protected] for more information.

C57BL/6J Embryonic Stem Cell Lines Generated Using Serum-Free Media

    Description of Technology: NIH investigators have generated 
Embryonic Stem (ES) cell clones from C57BL/6J mice in a defined medium. 
These cell lines enable direct genetic alteration of mice in a pure 
genetic background.
    Using a defined media supplement, knockout serum replacement (KSR) 
with knockout DMEM (KSR-KDMEM), the investigators established ES cell 
lines from blastocysts of C57BL/6J mice. One specific cell line, HGTC-8 
was found to be karyotypically stable and germline competent, both 
prior to manipulation and after gene targeting. These cell lines 
transfected more efficiently, and exhibited increased efficiencies of 
cell cloning and chimera generation, when maintained in KSR-KDMEM.
    Applications:
     Generation of knockout mice without the need to backcross.
     Generation of mice via targeted mutations.
    Inventors: Jun Cheng, Lisa Garrett-Beal, and Pamela L. Schwartzberg 
(NHGRI).
    Publication: J Cheng, A Dutra, A Takesono, L Garrett-Beal, PL 
Schwartzberg. Improved generation of C57BL/6J mouse embryonic stem 
cells in a defined serum-free media. Genesis. 2004 June; 39(2):100-104.
    Patent Status: HHS Reference No. E-038-2009/0--Research Tool. 
Patent protection is not being pursued for this technology.
    Licensing Status: Available for licensing under a Biological 
Materials License Agreement.
    Licensing Contact: Suryanarayana (Sury) Vepa, Ph.D., J.D.; 301-435-
5020; [email protected].

Identification of Renal Cell Carcinoma Biomarkers

    Description of Technology: This invention describes the 
identification of potential renal cancer biomarkers which could be 
utilized in the development of a renal cancer diagnostics. The 
invention identified cancer protein biomarkers from clinically relevant 
samples including peripheral blood and

[[Page 23731]]

fresh frozen tissues. Vast availability of fresh frozen tissues and 
peripheral blood specimens that are easily obtained could lead to 
clinical tests amenable to therapeutic, prognostic and even early 
screening tests for renal cell carcinoma and other malignancies.
    Applications: Renal cell carcinoma diagnostics, therapeutics and 
prognostics.
    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.
     The incidence of renal cell cancer has been rising 
steadily. Renal Cell Carcinoma is the most common type of kidney 
cancer, and the most common type in adults, responsible for 
approximately 80% of cases.
    Inventors: Josip Blonder et al. (NCI).
    Patent Status: PCT Application No. PCT/US2009/037855 filed 20 Mar 
2009 (HHS Reference No. E-317-2008/0-PCT-01)
    Licensing Status: Available for licensing.
    Licensing Contact: Betty B. Tong, Ph.D.; 301-594-6565; 
[email protected].
    Collaborative Research Opportunity: The National Cancer Institute 
Laboratory of Proteomics and Analytical Technologies is seeking 
statements of capability or interest from parties interested in 
collaborative research to further develop, evaluate, or commercialize 
diagnostic, therapeutic and prognostic cancer biomarkers from clinical 
specimens. Please contact John D. Hewes, Ph.D. at 301-435-3121 or 
[email protected] for more information.

    Dated: May 13, 2009.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. E9-11705 Filed 5-19-09; 8:45 am]
BILLING CODE 4140-01-P