[Federal Register Volume 79, Number 186 (Thursday, September 25, 2014)]
[Notices]
[Pages 57563-57565]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-22763]


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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, 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. 209 and 37 CFR Part 404 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.

FOR FURTHER INFORMATION CONTACT: 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.

SUPPLEMENTARY INFORMATION: Technology descriptions follow.

Miniature Serial Microtome for Block-Face Imaging

    Description of Technology: A microtome device is used in a variety 
of microcopy techniques to remove very thin (e.g., in the tens of 
nanometers range) portions from the top of a sample between successive 
images. This technology discloses a design for a microtome device that 
offers several

[[Page 57564]]

unique features and advantages over commercially available microtomes. 
A prototype of the microtome has been built and demonstrated to work 
with a serial block-face scanning electron microscopy in order to 
serially collect ultrathin sections from plastic embedded biological 
tissues, specifically from brain tissues. This microtome design allows 
for a sample to be cut at a location removed from the electron beam 
axis, thus reducing interference from debris and allowing imaging at a 
greater range of working distances. This microtome device is 
lightweight and easy to install utilizing the built-in stage of 
existing microscopes such that a sample's position and orientation can 
be controlled along three-axes of rectilinear translation and two axes 
of rotation. This microtome design utilizes a diamond blade coupled to 
both the base plate and an actuator to control the movement of the 
blade in a direction perpendicular to the exposed surface of the 
pedestal, while producing an output signal that indicates the blade 
location with respect to the base plate. Advantageously, this allows 
for a stage coupled pedestal to be moved accurately from an imaging 
location on the beam axis to a cutting location off the beam axis.
    Potential Commercial Applications:
    Can be used in a variety of microscopy techniques:

 Scanning electron microscopy.
 light-based (optical, fluorescence) microscopy.
 cathodoluminescence microscopy.

    Can be used to study any of various types of sample materials:

 tissue microscopy.
 brain research.
 tissue sectioning.
 imaging.

    Competitive Advantages:

 Is compatible with multiple microscopy systems.
 incorporates a feedback sensor to monitor and optimize cutting 
thickness/forces.
 can cut reproducible sections as thin as 25 nanometers.
 performs cutting off-axis to prevent contamination.
 mounts rapidly onto an existing SEM stage and does not require 
a custom vacuum chamber door.
 uses the full range of an existing SEM stage for positioning 
samples.
 incorporates a stage translation that is rectilinear.
 utilizes a pivot flexure bearing for frictionless rotation 
during cutting.
 cleans knife edge after each cut.

    Development Stage:

 In vitro data available.
 Prototype.

    Inventor: Kevin Briggman (NINDS).
    Intellectual Property: HHS Reference No. E-121-2014/0--US 
Provisional Application No. 61/991,929 filed 12 May 2014.
    Licensing Contact: Michael Shmilovich, Esq., CLP; 301-435-5019; 
[email protected].
    Collaborative Research Opportunity: The National Institute of 
Neurological Disorders and Stroke is seeking statements of capability 
or interest from parties interested in collaborative research to 
further develop, evaluate or commercialize the microtome device. For 
collaboration opportunities, please contact Melissa Maderia, Ph.D., 
M.B.A. at [email protected] or 240-276-5533.

Chimeric Receptors Targeting CD-19

    Description of Technology: Available for licensing are compositions 
and methods for targeting and destroying CD19-expressing cancers, 
especially B-cell malignancies such as lymphomas and leukemias.
    The antibody used in this technology is called anti-CD19. CD19 
antibodies have been used to treat people with lymphoma and Leukemia. 
This technology has changed the anti-CD19 antibody so that instead of 
floating free in the blood, its CD19-binding domain is now joined to a 
T cell. When an antibody is joined to a T cell in this way it is called 
a chimeric receptor. Once localized at a CD19-expressing cancer cell, 
the T-cell portion of the chimeric receptor stimulates an immune 
response to destroy the cancer cell.
    Potential Commercial Applications: Therapeutic agents to treat or 
prevent CD19-expressing cancers, including B-cell malignancies.
    Competitive Advantages: Reduced toxicity and immunogenicity in 
humans of previous anti-CD19 chimeric receptors containing mouse 
sequences.
    Development Stage:

 Early-stage.
 In vitro data available.

    Inventor: James Kochenderfer (NCI).
    Intellectual Property: HHS Reference No. E-042-2014/0--US 
Provisional Application No. 62/006,313 filed 02 June 2014.
    Licensing Contact: Patrick McCue, Ph.D.; 301-435-5560; 
[email protected].
    Collaborative Research Opportunity: The National Cancer Institute 
is seeking statements of capability or interest from parties interested 
in collaborative research to further develop, evaluate or commercialize 
chimeric antigen receptors targeting CD19. For collaboration 
opportunities, please contact John D. Hewes, Ph.D. at 
[email protected].

Use of Small Molecules To Treat PARP1-Deficient Cancers

    Description of Technology: Scientists at the National Human Genome 
Research Institute and the National Center for Advancing Translational 
Sciences have identified a class of small molecules synergistically 
working with known Poly (ADP-ribose) polymerase 1 (PARP-1)-inhibitors. 
These new small molecules can each effectively kill specific PARP-1 
defective tumors cells and show synergy with known PARP1 inhibitors 
(PARP-1i) in killing tumor cells.
    PARP1, a highly conserved DNA binding protein, is essential for 
repairing DNA damage and plays important roles in multiple DNA damage 
response pathways. Many cancer therapies utilize DNA-damaging agents to 
kill tumor cells, which often triggers DNA repair (e.g., by activating 
PARP1 pathways). Additionally, a variety of cancer types may also carry 
PARP1 mutation(s), such as glioma, breast cancer, and prostate cancer. 
Such mutations render the cancer cells resistant to these therapies. 
The key feature of these PARP-1i sensitizing molecules can be applied 
either as useful sensitizers in combinatorial treatment to increase the 
efficacy of DNA-damaging agents in cancer therapy, or selective 
targeting of cancer cells with specific DNA PARP-1 defects; thereby 
allowing for the development of new therapies.
    Potential Commercial Applications: Therapies for cancers associated 
with PARP-1 defects.
    Competitive Advantages:

 Utilizes proven small-molecule technology.
 Specificity of mode of action may reduce potential side-
effects.
 Novel mode of action may limit market competition.
 Combinatorial therapies of cancers with PARP-1 inhibitors.

    Development Stage: In vitro data available.
    Inventors: Kyungjae Myung (NHGRI), et al.
    Publications:
    1. Papeo G, et al. PARP inhibitors in cancer therapy: an update. 
Expert Opin Ther Pat. 2013 Apr;23(4):503-14. [PMID 23379721].
    2. Chiarugi A. A snapshot of chemoresistance to PARP inhibitors. 
Trends Pharmacol Sci. 2012 Jan;33(1):42-8. [PMID 22055391].

[[Page 57565]]

    3. Yu H, et al. Association between PARP-1 V762A polymorphism and 
cancer susceptibility: a meta-analysis. Genet Epidemiol. 2012 
Jan;36(1):56-65. [PMID 22127734].
    Intellectual Property:

 HHS Reference No. E-039-2014/0--U.S. Patent Application No. 
61/930,291 filed 22 Jan 2014.
 HHS Reference No. E-039-2014/1--U.S. Patent Application No. 
61/988,502 filed 05 May 2014.

    Licensing Contact: Eggerton Campbell, Ph.D.; 301-435-5282; 
[email protected].
    Collaborative Research Opportunity: The National Human Genome 
Research Institute is seeking statements of capability or interest from 
parties interested in collaborative research to further develop, 
evaluate or commercialize small molecules to treat PARP1-deficient 
cancer. For collaboration opportunities, please contact Anna Solowiej, 
Ph.D., J.D. at [email protected].

    Dated: September 22, 2014.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2014-22763 Filed 9-24-14; 8:45 am]
BILLING CODE 4140-01-P