[Federal Register Volume 73, Number 219 (Wednesday, November 12, 2008)]
[Notices]
[Pages 66907-66910]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-26786]


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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.

System for Correction of MRI Head Motion

    Description of Technology: Motion artifacts continue to be a 
significant problem in MRI of human brain. Prospective motion 
correction based on external tracking systems has been proposed to 
ameliorate this issue. However, the calibration of these systems is 
very complicated and time consuming, as it requires a camera system 
calibration as well as a calibration between camera and MRI system 
using dedicated phantoms. An alternative motion correction method for 
MRI that does not require calibration and can work with just a single 
video camera has been developed and is available for licensing. This 
technology can be broadly applied in MRI to account for motion 
artifacts in order to improve acquisition time and provide enhanced 
resolution. This technique will provide a needed method to obtain 
reliable MRI scans for uncooperative patients (children, seizure 
patients, etc.)

[[Page 66908]]

without the need and expense of multiple scans.
    Applications:
     Magnetic Resonance Imaging.
     Diagnostics.
    Inventors: Jeff Duyn and Lei Qin (NINDS)
    Publications:
    1. JH Duyn, P van Gelderen, TQ Li, JA de Zwart, AP Koretsky, M 
Fukunaga. High-field MRI of brain cortical substructure based on signal 
phase. Proc Natl Acad Sci USA. 2007 Jul 10;104(28):11796-17801.
    2. TQ Li, P van Gelderen, H Merkle, L Talagala, AP Koretsky, J 
Duyn. Extensive heterogeneity in white matter intensity in high-
resolution T2*-weighted MRI of the human brain at 7.0 T. Neuroimage. 
2006 Sep;32(3):1032-1040.
    Patent Status: U.S. Provisional Application No. 61/045,782 filed 17 
Apr 2008 (HHS Ref. No. E-144-2008/0-US-01).
    Licensing Status: Available for licensing.
    Licensing Contact: John Stansberry, PhD; 301-435-5236; 
[email protected].
    Collaborative Research Opportunity: The National Institute of 
Neurological Disorders and Stroke--Advanced MRI Section--Laboratory of 
Functional and Molecular Imaging is seeking statements of capability or 
interest from parties interested in collaborative research to further 
develop, evaluate, or commercialize MRI methods to improve data 
collection by improved homogeneity, resolution, etc. Please contact Dr. 
Melissa Maderia at 301-451-3943 or [email protected] for more 
information.

Methods for Using Interferon Gamma To Absorb Fluid From the Subretinal 
Space

    Description of Technology: The accumulation of subretinal fluid is 
associated with certain adverse ocular conditions (including chronic 
macular edema, age related macular degeneration, and diabetic 
retinopathy), or retinal injury, or post-surgical complications. Often 
aberrant proliferation and migration of retinal pigment epithelial 
(RPE) cells is also associated with these ocular conditions. The RPE is 
a highly specialized derivative of the neuroectoderm with multiple 
roles in the maintenance of normal ocular function. Dysfunction of RPE 
cells has been implicated in inflammatory, degenerative, and dystrophic 
diseases of the retina and choroid. Interferon gamma (IFN[gamma]) has 
been implicated in the pathogenesis of a number of intraocular 
inflammatory diseases of infectious or presumed autoimmune origin. 
IFN[gamma] has been detected in vitreous aspirates of patients with 
uveitis, proliferative vitreoretinopathy, and idiophathic inflammatory 
eye diseases.
    The technology provides for methods by which interferon-gamma (IFN-
[gamma]) can be used to remove subretinal fluid. The application of 
INF-[gamma] may be by external application (e.g. eye drops or 
ointments) or by subretinal injection. The claims in the pending patent 
application are directed to methods for treating decreases in visual 
acuity that are associated with diseases that cause the accumulation of 
fluid in the subretinal space. Additional claims are directed at 
methods for treating age-related macular degeneration, chronic macular 
edema, diabetic retinopathy, retinal detachment, or glaucoma that 
comprise decreasing the amount of fluid present in the subretinal space 
of patients suffering from such disorders by administering an amount of 
interferon gamma to the eyes of the patients effective to decrease the 
amount of fluid present in the subretinal space of the patients.
    Applications:
     Treatment and prevention of age-related macular 
degeneration (AMD), chronic macular edema, diabetic retinopathy, 
retinal detachment, or glaucoma.
     Treatment of decreases in visual acuity that are 
associated with diseases that cause the accumulation of fluid in the 
subretinal space.
    Market: Diabetic retinopathy and age-related macular degeneration 
are the leading causes of blindness for those above age 45 and 60, 
respectively. These two diseases account for approximately 6-7 million 
cases of blindness each year in the U.S.
    Development Status: Preclinical and animal model studies are in 
progress.
    Inventors: Rong Li, Sheldon S. Miller, and Arvydas Maminishkis 
(NEI).
    Patent Status: U.S. Provisional Application No. 61/089,157 filed 15 
Aug 2008 (HHS Reference No. E-169-2008/0-US-01).
    Licensing Status: Available for licensing.
    Licensing Contact: Suryanarayana (Sury) Vepa, PhD, JD; 301-435-
5020; [email protected].
    Collaborative Research Opportunity: The National Eye Institute, 
Section on Epithelial and Retinal Physiology and Disease, is seeking 
statements of capability or interest from parties interested in 
collaborative research to further develop, evaluate, or commercialize 
methods that activate immune system mediated fluid removal from the 
distal retina. Please contact John D. Hewes, PhD at 301-435-3121, or 
[email protected] for more information.

Retinal Pigment Epithelia-Enriched MicroRNAs To Prevent Cell-
Differentiation, Proliferation, and Migration

    Description of Technology: The retinal pigment epithelium (RPE) 
plays a significant role in regulating the microenvironment around the 
photoreceptors in the distal retina, where the events of 
phototransduction take place.
    Expression profiling of microRNA (miRNAs) in RPE and the adjacent 
retina and choroid was used to identify six miRNAs enriched in RPE. The 
potential use of anti-miRNAs specifically directed against miRNA 204 
and miRNA 211 to prevent epithelial cell differentiation, proliferation 
and migration is disclosed. The miRNA 204 and miRNA 211 play a critical 
role in the control transepithelial electrical resistance. This 
technology further describes the significance of miRNAs in regulating 
junctional complexes in epithelial cells.
    The claims in the pending patent application are directed towards 
methods and compositions containing anti-miRNAs or miRNA mimics for 
preventing or treating detrimental epithelial cell proliferation or 
loss of epithelial cell differentiation.
    Applications:
     Treatment and prevention of age-related macular 
degeneration (AMD) and proliferative vitreal retinopathy.
     Treatment and prevention of neovascular diseases and 
carcinoma.
    Market: AMD is the most common cause of adult blindness in Western, 
developed countries. A recent study has estimated that advanced AMD 
affects about 1.75 million Americans.
    Development Status: Preclinical animal model studies and gene 
knockout studies are in progress.
    Inventors: Fei Wang and Sheldon Miller (NEI).
    Patent Status: U.S. Provisional Application No. 61/043,330 filed 08 
Sep 2008 (HHS Reference No. E-056-2008/0-US-01).
    Licensing Status: Available for licensing.
    Licensing Contact: Suryanarayana (Sury) Vepa, PhD, JD; 301-435-
5020; [email protected].
    Collaborative Research Opportunity: The National Eye Institute, 
Section on Epithelial and Retinal Physiology and Disease, is seeking 
statements of capability or interest from parties interested in 
collaborative research to

[[Page 66909]]

further develop, evaluate, or commercialize the use of RPE-specific 
micro RNAs or anti-miRNAs or miRNA mimics for the treatment and 
prevention of age-related macular degeneration (AMD) and proliferative 
vitreal retinopathy and more generally for preventing or treating 
detrimental epithelial cell proliferation or loss of epithelial cell 
differentiation, e.g., in the treatment and prevention of neovascular 
diseases and carcinoma. Please contact John D. Hewes, PhD, at 301-435-
3121 or [email protected] for more information.

Human Monoclonal Antibodies Against Yersinia pestis

    Description of Technology: The technology describes a group of 
three (3) human monoclonal antibodies directed against the Yersinia 
pestis (Y. pestis) bacterium, the etiologic pathogen of the fatal 
disease Plague. These antibodies are specifically directed against two 
of the bacterium's virulent factors, the F1 capsid protein (one 
antibody) and the low-calcium response antigen V (LcrV) (two 
antibodies). The antibodies have been shown to provide protection 
against Y. pestis challenge in a mouse model, with the highest 
protection attained with a combination of all three. The NIH offers the 
subject antibodies for licensing primarily for the development of 
therapeutic and/or prophylactic treatment against Y. pestis infections. 
Additionally, the antibodies may find use in research related to the 
pathogenicity of Y. pestis as well as for the development of new 
treatment against this pathogen.
    Although human plague in the United States has occurred as mostly 
scattered cases in rural areas (an average of 10 to 15 persons each 
year), and globally, according to the World Health Organization, there 
are only 1,000 to 3,000 cases of plague every year, it is however of 
significant importance to develop effective treatment against the 
plague disease, because of its biodefense significance. Y. pestis is 
included in the CDC and NIH's category A agents that can be readily 
used as a biological weapon in the hands of bioterrorists.
    Applications:
     The antibodies offered for licensing can be used to 
develop therapeutic and/or prophylactic treatment against Y. pestis, 
the causative pathogen of Plague, which can be readily used as a 
biological weapon and thus has been considered a category A biodefense 
agent by the CDC and NIH.
     The antibodies offered for licensing may find use in 
research related to Y. pestis and for development of new treatment 
against Plague.
    Advantages: Currently there is no effective therapeutic or 
prophylactic treatment available against plague. Antibiotics are 
primarily used to treat persons infected with Y. pestis.
    Market:
     Plague, the disease caused by Y. pestis, is characterized 
by symptoms such as fever, chills, cough and difficulty in breathing. 
If not treated early, the disease can lead to death.
     Although the market size for treating plague is small 
(1,000 to 3,000 worldwide cases every year and 10 to 15 cases in the 
United States), a development of effective treatment is of utmost 
importance as the bacterium can be used as a biological weapon. It is 
therefore included in the list of category A biodefense agents as 
defined by the CDC and NIH, and received a significant attention with 
respect to preparedness against bioterrorism.
    Development Status:
     The inventors have demonstrated the protective 
effectiveness of the antibodies using model mice challenged with the 
bacterium.
     Further development including clinical trials will be 
needed to develop the technology to the point of practical application.
    Inventors: Dimiter S. Dimitrov (NCI), Xiaodong Xiao (NCI), et al.
    Relevant Publications:
    1. RD Perry and JD Fatherston. Yersinia pestis--etiologic agent of 
plague. Clin Microbiol Rev. 1997 Jan;10(1):35-66.
    2. J Hill, SE Leary, KF Griffin, ED Williamson, RW Titball. Regions 
of Yersinia pestis V antigen that contribute to protection against 
plague by passive and active immunization. Infect Immun. 1997 
Nov;65(11):4476-4482.
    3. GW Anderson Jr, PL Worsham, CR Bolt, GP Andrews, SL Welkos, AM 
Friedlander, JP Burans. Protection of mice from fatal bubonic and 
pneumonic plague by passive immunization with monoclonal antibodies 
against F1 protein of Yersinia pestis. Am J Trop Med Hyg. 1997 
Apr;56(4):471-473.
    Patent Status: HHS Reference No. E-013-2008--Research Tool. Patent 
protection is not being pursued for this technology.
    Licensing Status: The technology is available for non-exclusive 
licensing under a Biological Materials License Agreement.
    Licensing Contact: Uri Reichman, PhD; 301-435-4616; 
[email protected]
    Collaborative Research Opportunity: The National Cancer Institute 
CCRNP, Protein Interactions Group, is seeking statements of capability 
or interest from parties interested in collaborative research to 
further develop, evaluate, or commercialize human monoclonal antibodies 
against Yersinia Pestis. Please contact John D. Hewes, PhD at 301-435-
3121 or [email protected] for more information.
    Related Technology: U.S. Patent Application No. 11/944,230 filed 21 
Nov 2007 (HHS Reference No. E-189-2007/0), entitled ``Manufacturing 
Process Improvements for Purification of F1-V as a Vaccine Potentially 
Protective Against Bubonic and Pneumonic Plague,'' by Steven L. 
Giardina and David F. Nellis (NIAID)

Viral Inactivation Using Crosslinkers and Detergents

    Description of Technology: The subject technology is a method of 
inactivating enveloped viruses by hydrophobic photoactivatable chemical 
crossing-linking compounds and detergent treatment. The inactivated 
viruses may be used as vaccines against the diseases caused by those 
viruses or as reagents in experimental procedures that require 
inactivated viral particles. The compounds diffuse into the lipid 
bilayer of biological membranes and upon UV irradiation will bind to 
proteins and lipids in this domain, thereby inactivating fusion of 
enveloped viruses with their corresponding target cells. Furthermore, 
the selective binding of these chemical crosslinking agents to protein 
domains in the lipid bilayer may preserve the structural integrity and 
therefore immunogenicity of proteins on the exterior of the inactivated 
virus. The additional detergent step effectively eliminates the 
infectivity of any residual viral particles that are not adequately 
crosslinked.
    Applications:
     Vaccines for enveloped viruses
     Vaccine for Human Immunodeficiency Virus
    Advantages:
     Novel method of inactivating enveloped viruses
     May maintain native conformational structures and viral 
epitopes for generating an effective immune response
    Development Status: In vitro data can be provided upon request
    Market: Vaccines
    Inventors: Julie M. Belanger et al. (NCI)
    Patent Status:
     U.S. Provisional Application No. 61/025,424 filed 01 Feb 
2008 (HHS Reference No. E-331-2007/0-US-01)
     U.S. Provisional Application No. 61/088,294 filed 12 Aug 
2008 (HHS Ref. No. E-331-2007/1-US-01)
    Licensing Status: Available for exclusive or non-exclusive 
licensing.

[[Page 66910]]

    Licensing Contact: Kevin W. Chang, PhD; 301-435-5018; 
[email protected]
    Collaborative Research Opportunity: The National Cancer Institute, 
Center for Cancer Research, Nanobiology Program is seeking statements 
of capability or interest from parties interested in collaborative 
research to further develop, evaluate, or commercialize the use of 
hydrophobic crosslinkers for their use in vaccine development. 
Interested collaborators are also invited to provide statements for 
proposed in vitro or in vivo studies using various enveloped viruses. 
Please contact John D. Hewes, PhD at 301-435-3121 or 
[email protected] for more information.

Indoline Compounds for the Treatment of Spinal Muscular Atrophy (SMA) 
and Other Diseases

    Description of Technology: With the goal to treat SMA in patients, 
several indoline compounds were made and tested for activity. Tests in 
cells demonstrate that these drugs increased the levels of active SMN 
protein. This is encouraging since low levels of this protein appears 
to be the cause of neuronal death that leads to SMA. This class of 
compounds appears to operate via read-through of a non-sense stop-codon 
to produce full length, functional protein in SMA models. This 
mechanism may have utility in several other neurological disorders, 
including cystic fibroses and Duchene's Muscular Dystrophy.
    In addition, these compounds have also been shown to increase the 
concentration of a glutamate transporter protein in cells, which acts 
to recover glutamate back into neurons after release. Since the toxic 
effect of unrecovered excess glutamate is observed in many notorious 
neurological conditions, these compounds have potential for prevention 
or treatment.
    Applications:
     Treatment of SMA in infants and children.
     Treat genetic-based diseases that result from a premature 
stop of protein synthesis such as muscular dystrophy and cystic 
fibrosis.
     Treating or preventing neurological diseases presenting 
glutamate toxicity like multiple sclerosis, Parkinson's, Alzheimer's, 
amyotrophic lateral sclerosis (ALS), or others.
    Market:
     SMA is a rare genetic disease estimated to affect 1 in 
6,000 births and leading genetic cause of death in infants and 
toddlers.
     Over 25,000 Americans are believed to suffer from SMA and 
the market size has been estimated between $250 million and $750 
million.
    Development Status: Pre-clinical, Toxicology and Safety Studies, 
Animal Models (Dogs and Primates).
    Inventors: Jill E. Heemskerk (NINDS) et al.
    Related Publication: MR Lunn, DE Root, AM Martino, SP Flaherty, BP 
Kelley, DD Coovert, AH Burghes, NT Man, GE Morris, J Zhou, EJ Androphy, 
CJ Sumner, BR Stockwell. Indoprofen upregulates the survival motor 
neuron protein through a cyclooxygenase-independent mechanism. Chem 
Biol. 2004 Nov;11(11):1489-1493.
    Patent Status:
     U.S. Provisional Application No. 60/975,675 filed 27 Sept 
2007 (HHS Reference No. E-187-2007/0-US-01);
     PCT Application No. PCT/US2008/077936 filed 26 Sep 2008 
(HHS Reference No. E-187-2007/0-PCT-02).
    Licensing Status: Available for exclusive or non-exclusive 
licensing.
    Licensing Contact: Norbert Pontzer, PhD, JD; 301-435-5502; 
[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 drugs for the treatment of 
SMA, as well as investigation into novel uses for these indoline 
compounds. Please contact Dr. Melissa Maderia at [email protected] 
or 301-451-3943 for more information.

Discovery of and Use of Fragments of DOC1 as Antiangiogenic and 
Antitumor Therapy

    Description of Technology: This invention describes small cDNA 
fragments of the coding region for wild type filamin A interacting 
protein 1-like (FILIP1L), previously known as down-regulated in ovarian 
cancer 1-like (DOC1) and variant 2 of FILIP1L genes that encode 
proteins that result in the inhibition of cell migration and motility, 
induce cell apoptosis and inhibit cell proliferation. These effects can 
be seen on endothelial cells and on tumor cells. These coding sequences 
have successfully been delivered to endothelial cells and tumor cells 
both in vitro and in vivo, and have demonstrated significant anti-tumor 
activity. In addition, the inventors have for the first time expressed 
the recombinant protein and developed antibodies to detect the protein 
fragments by Western, ELISA and immunohistochemistry. The significance 
of this invention is that it could provide for a series of new anti-
cancer therapeutics and for the diagnostic means to follow their 
expression levels.
    Applications: This invention could provide new anti-cancer 
therapeutics and diagnostics.
    Market:
     An estimated 1,444,920 new cancer diagnoses in the U.S. in 
2007.
     600,000 deaths caused by cancer in the U.S. in 2006.
     Cancer is the second leading cause of death in the U.S.
     Cancer drug market will likely double to $50 billion in 
2010 from $25 billion in 2006.
    Development Status: The technology is currently in the pre-clinical 
stage of development.
    Inventors: Steven K. Libutti et al. (NCI).
    Relevant Publication: Mijung Kwon et al. Functional 
characterization of filamin A interacting protein 1-like, a novel 
candidate for antivascular cancer therapy. Cancer Res. 2008 Sep 
15;68(18):7332-7341.
    Patent Status: U.S. Provisional Application No. 61/005,363 filed 03 
Dec 2007 (HHS Reference No. E-166-2007/0-US-01).
    Licensing Status: Available for exclusive and non-exclusive 
license.
    Licensing Contact: Adaku Nwachukwu, JD; 301-435-5560; 
[email protected].
    Collaborative Research Opportunity: The National Cancer Institute 
Hatfield Clinical Research Center is seeking statements of capability 
or interest from parties interested in collaborative research to 
further develop, evaluate, or commercialize Discovery of and Use of 
Fragments of DOC1 as Antiangiogenic and Antitumor Therapy. Please 
contact John D. Hewes, PhD at 301-435-3121 or [email protected] for 
more information.

    Dated: November 3, 2008.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
 [FR Doc. E8-26786 Filed 11-10-08; 8:45 am]
BILLING CODE 4140-01-P