Government-Owned Inventions; Availability for Licensing, 32940-32943 [E9-16299]
Download as PDF
<![CDATA[
32940
Federal Register / Vol. 74, No. 130 / Thursday, July 9, 2009 / Notices
autoimmunity. Annu Rev Immunol.
2008;26:57–79.
2. WJ Leonard and R Spolski.
Interleukin-21: A modulator of
lymphoid proliferation, apoptosis and
differentiation. Nat Rev Immunol. 2005
Sep;5(9):688–698.
3. G Wang et al. In vivo antitumor
activity of interleukin 21 mediated by
natural killer cells. Cancer Res. 2003
Dec15;63(24):9016–9022.
Patent Status: U.S. Patent Application
No. 10/508,978 filed 19 Nov 2004 (HHS
Reference No. E–137–2002/0–US–03).
Licensing Status: Available for
licensing.
Licensing Contact: Jennifer Wong;
301–435–4633; wongje@mail.nih.gov.
Dated: July 1, 2009.
Richard U. Rodriguez,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. E9–16300 Filed 7–8–09; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
rmajette on DSK29S0YB1 with NOTICES
AGENCY: National Institutes of Health,
Public Health Service, HHS.
ACTION: Notice.
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.
qPCR Assay for Detection of JC Virus
Description of Invention: JC Virus
causes a fatal disease in the brain called
progressive multifocal
leukoencephalopathy (PML) that occurs
VerDate Nov<24>2008
15:49 Jul 08, 2009
Jkt 217001
in many patients with
immunocompromised conditions. For
example, more than five percent (5%) of
AIDS patients develop PML.
Additionally, these conditions include,
but are not limited to, cancers such as
leukemias and lymphomas, organ
transplants such as kidney, heart and
autoimmune conditions with treatment
that modulates the immune system such
as Multiple Sclerosis (MS), rheumatoid
arthritis, psoriasis, and systemic lupus
erythematosus. The finding of JCV DNA
in the patients with neurological
symptoms of PML is a diagnostic
criterion and is needed to confirm the
diagnosis of PML to rule out other
neurological conditions.
This technology describes a qPCR
assay that utilizes viral DNA standards
and testing samples to detect the
presence of the JC viral genome in
patients’ cerebrospinal fluid and blood,
blood products, and tissue samples from
biopsy or autopsy.
Application: Development of JC Virus
(JCV) diagnostics, calibration of existing
JCV assays.
Advantages: Assay is sensitive,
reproducible and highly specific
because the amount of JCV DNA in
cerebrospinal fluid or blood or blood
product samples may be very small.
Development Status: Materials and
assay have been developed and tested.
Inventors: Eugene O. Major and
Caroline Ryschkewitsch (NINDS).
Publications
1. ML Landry et al. False negative
PCR despite high levels of JC virus DNA
in spinal fluid: Implications for
diagnostic testing. J Clin Virol. 2008
Oct;43(2):247–249.
2. C Ryschkewitsch et al. Comparison
of PCR-southern hybridization and
quantitative real-time PCR for the
detection of JC and BK viral nucleotide
sequences in urine and cerebrospinal
fluid. J Virol Methods. 2004
Nov;121(2):217–221.
3. T Yousry et al. Evaluation of
patients treated with natalizumab for
progressive multifocal
leukoencephalopathy. N Engl J Med.
2006 Mar 2;354(9):924–933.
Patent Status: HHS Reference No. E–
152–2009/0—Research Material. Patent
protection is not being pursued for this
technology.
Licensing Status: Available for
licensing.
Licensing Contact: Peter A. Soukas,
J.D.; 301–435–4646;
soukasp@mail.nih.gov.
PO 00000
Frm 00065
Fmt 4703
Sfmt 4703
A Locking Device for Permanently
Securing Surgical Suture Loops
Description of Invention: This
technology relates to a device that can
be used to non-invasively secure
surgical suture loops when combined
with a percutaneous delivery system. It
has been shown to be effective in
correcting mitral valve regurgitation
(MVR) in an animal model. During the
procedure, a guidewire is
percutaneously conveyed to the atrium
of the heart and is used to secure the
‘‘cerclage’’ suture encircling the mitral
valve annulus, which is delivered using
a delivery catheter. The locking device
is advanced over the suture by the
delivery catheter and it permanently
secures the suture and maintains the
tension on the annulus once the
delivery system is removed. This
locking device, in combination with the
percutaneous procedure, allows for
more complete coaptation of the valve
leaflets and correction of MVR without
the need for open heart surgery and its
associated risks. The locking device is
also adjustable, allowing the user to
vary the tension on the suture if further
tightening or loosening is required. It is
also MRI compatible and all follow-up
studies can be performed under MRI.
This invention has demonstrated its
ability to correct MVR in animals where
the locking device was observed to
maintain the correct position and
tension after implantation. This device
has the potential to replace the
traditional loop and knot method used
for surgical correction of MVR, and may
also be useful for other conditions that
require permanently secured suture
loops.
Applications: Non-invasive and
effective correction of MVR and other
conditions; Tensioning device for
securing suture loops.
Advantages: Technology amenable to
a non-invasive technique; Control of
tension on surgical sutures.
Development Status: Early stage.
Inventor: Ozgur Kocaturk (NHLBI).
Patent Status: U.S. Provisional
Application No. 61/157,267 filed 04 Mar
2009 (HHS Reference No. E–048–2009/
0–US–01).
Licensing Status: Available for
licensing.
Licensing Contact: Jeffrey A. James,
Ph.D.; 301–435–5474;
jeffreyja@mail.nih.gov.
Collaborative Research Opportunity:
The National Heart, Lung and Blood
Institute Cardiac Catheterization Lab is
seeking statements of capability or
interest from parties interested in
collaborative research to further
develop, evaluate, or commercialize the
E:\FR\FM\09JYN1.SGM
09JYN1
Federal Register / Vol. 74, No. 130 / Thursday, July 9, 2009 / Notices
rmajette on DSK29S0YB1 with NOTICES
tension fixation device. Please contact
Peg Koelble at 301–594–4095 or
koelblep@nhlbi.nih.gov for more
information.
PXR pathway. Please contact Lisa
Finkelstein, PhD at 301–451–7458 or
lfinkels@mail.nih.gov for more
information.
Modulators of Pregnane X Receptor
(PXR) as Therapeutics for Bowel
Disorders (BD)
Description of Invention: This
technology is based on the novel
findings that susceptibility to BD is
strongly associated with genetic
variation in the PXR gene, a member of
the nuclear receptor family, and
rifaximin is a specific activator of
human PXR. PXR is an integral
component of the body’s defense
mechanism involved in endogenous and
xenobiotic detoxication. Based on these
novel findings, the present technology
provides (a) methods of screening for
compositions that modulate
inflammatory bowel disease (IBD), (b)
methods of inhibiting inflammation of
the bowel and related tissues and
organs, and (c) methods of treatment of
inflammatory bowel disease.
Applications: Therapeutics for bowel
disorders; Screening assays for
candidate drugs to treat bowel
disorders.
Development Status: Early stage.
Market: It is estimated that as many as
one (1) million Americans have IBD,
with that number evenly split between
Crohn’s disease and Ulcerative Colitis
(UC). Further, it is estimated that the
IBD therapeutic market will grow to
reach four (4) billion U.S. dollars in
2017.
Inventors: Frank J. Gonzalez (NCI),
Xiaochao Ma (NCI), et al.
Publication: X Ma, Y Shah, C Cheung,
GL Guo, L Feigenbaum, KW Krausz, JR
Idle, FJ Gonzalez. The PREGnane X
receptor gene-humanized mouse: a
model for investigating drug-drug
interactions mediated by cytochromes
P450 3A. Drug Metab Dispos. 2007
Feb;35(2):194–200.
Patent Status: U.S. Provisional
Application No. 60/999,234 filed 17 Oct
2007 (HHS Reference No. E–002–2008/
0–US–01); PCT Patent Application
(HHS Reference No. E–002–2008/0–
PCT–02).
Licensing Status: Available for
licensing.
Licensing Contact: Suryanarayana
(Sury) Vepa, PhD, J.D.; 301–435–5020;
vepas@mail.nih.gov.
Collaborative Research Opportunity:
The Laboratory of Metabolism, Center
for Cancer Research, NCI, is seeking
statements of capability or interest from
parties interested in collaborative
research to further develop, evaluate, or
commercialize compounds that
ameliorate bowel disorders through the
The Protein Cyanovirin Inactivates HIV
and Influenza
Description of Invention: CyanovirinN (CV–N) potently and irreversibly
inactivates diverse primary strains of
HIV–1, including M-tropic forms
involved in sexual transmission of HIV,
as well as T-tropic and dual-tropic
forms. CV–N also blocks cell-to-cell
transmission of HIV infection. CV–N
interacts in an unusual manner with the
viral envelope, binding with extremely
high affinity to poorly immunogenic
epitopes on gp120. Further, CV–N and
homologous proteins and peptides
potently inhibit diverse isolates of
influenza viruses A and B, the two
major types of influenza virus that infect
humans.
The described technology includes
glycosylation-resistant mutants, which
code sequences to enable ultra largescale recombinant production of
functional CV–Ns in non-bacterial (yeast
or insect) host cells or in transgenic
animals or plants. Therefore, these
glycosylation-resistant mutants may
allow industry to produce CV–Ns on a
large scale and make CV–Ns cheap
enough for developing countries to
benefit from this invention.
CV–N was benign in vivo when tested
in the rabbit/monkey vaginal toxicity/
irritancy model and was not cytotoxic in
vitro against human immune cells and
lactobacilli. CV–N is readily soluble in
aqueous media, is remarkably resistant
to physicochemical degradation and is
amenable to very large-scale production
by a variety of genetic engineering
approaches.
VerDate Nov<24>2008
15:49 Jul 08, 2009
Jkt 217001
Applications
• Therapeutics and prevention of HIV
and influenza infections.
• Topical microbicide to protect HIV
infection.
• Ex vivo devices incorporating CV–
N to remove or inactivate HIV from fluid
samples.
Advantages
• Potent anti-HIV and anti-influenza
activity.
• Can be applied both systematically
or locally.
• Can be applied both in vivo and ex
vivo.
• Inexpensive and large scale
manufacturing.
Development Status
• Preclinical (rabbit/monkey) data in
microbicide field are available at this
time.
PO 00000
Frm 00066
Fmt 4703
Sfmt 4703
32941
• Initial animal efficacy studies (both
mouse and ferret) against influenza
(H1N1) have been completed and
published.
Market: For HIV therapeutics market,
a published report by the financial
services firm Griffin Securities
suggested that sales of HIV/AIDS drugs
reached $13 billion annually in 2007
(https://www.hivandhepatitis.com).
For microbicide market, it has been
estimated that the global market size of
microbicide will reach to $900 million
by 2011 and will reach the sales of over
$1.8 billion by 2020). ‘‘Promising
microbicides’’ Frontline (Volume 21—
Issue 14, Jul. 03–16, 2004).
For influenza market, based on Report
Buyer which is a UK-based independent
online store supplying business
information on major industry sectors:
By 2010, the worldwide influenza
market is likely to reach $7.1 billion,
with average annual growth estimated at
19.8%.
Inventors: Michael R. Boyd (NCI),
Barry R. O’Keefe (NCI), et al.
Publications
1. B Giomarelli, R Provvedi, F Meacci,
T Maggi, D Medaglini, G Pozzi, T Mori,
JB McMahon, R Gardella, MR Boyd. The
microbicide cyanovirin-N expressed on
the surface of commensal bacterium
Streptococcus gordonii captures HIV–1.
AIDS. 2002 Jul 5;16(10):1351–1356.
2. CC Tsai, P Emau, Y Jiang, MB Agy,
RJ Shattock, A Schmidt, WR Morton, KR
Gustafson, MR Boyd. Cyanovirin-N
inhibits AIDS virus infections in vaginal
transmission models. AIDS Res Hum
Retroviruses. 2004 Jan; 20(1):11–18.
3. DF Smee, KW Bailey, MH Wong,
BR O’Keefe, KR Gustafson, VP Mishin,
LV Gubareva. Treatment of influenza A
(H1N1) virus infections in mice and
ferrets with cyanovirin-N. Antiviral Res.
2008 Dec;80(3):266–271.
Patent Status
• E–117–1995/0—US Patent Numbers
5,843,882; 6,015,876; 5,962,653;
6,245,737 and 6,586,392.
• E–117–1995/1—US Patent Numbers
5,821,081; 5,998,587; 6,987,096; and
5,962,668.
• E–117–1995/2–PCT–01 (WO 96/
34107)—entered in AU with Patent
Numbers 707781 and 746809; in CA
with Patent application Numbers
2219105; in JP with Patent Numbers
3803115 and 4081484; and in EP with
Patent Number 836647 and registration
GB, FR, DE, BE and CH.
• E–117–1995/3–PCT–02 (WO 00/
11036)—entered in USA with Patent
Number 6,193,982; in AU with Patent
Number 746313; in CA with Patent
Application Number 2340787; in JP
E:\FR\FM\09JYN1.SGM
09JYN1
32942
Federal Register / Vol. 74, No. 130 / Thursday, July 9, 2009 / Notices
rmajette on DSK29S0YB1 with NOTICES
with Patent Application Number
566308/2000; and in EP with Patent
Application Number 99943784.1.
• E–074–1999/0—US Patent Numbers
6,420,336 and 6,743,577.
• E–074–1999/1—US Patent Numbers
7,105,169; 7,048,935; and 6,428,790.
• E–074–1999/2–PCT–01 (WO 00/
53213)—entered in AU with Patent
Numbers 762704 and 2003252207; in
CA with Patent Application Numbers
2364500; in JP with Patent Application
Number 603702/2000; and in EP with
Patent Number 1162992 and registration
GB, FR, DE, BE and CH.
• E–074–1999/3–PCT–02 (WO 02/
077189)—entered in USA with Patent
Numbers 7,339,037 & 6,780,847 and
Patent Application Number 10/857,265;
in AU with Patent Number 2002254382;
in CA with Patent Application Number
2441287; in JP with Patent Application
Number 576632/2002; and in EP with
Patent Number 1456382 and registration
GB, FR, DE, BE and CH.
• E–198–2006/0–PCT–02 (WO 2008/
022303)—entered in USA with Patent
Application Number 12/377875; and in
EP with Patent Application Number
07814209.8.
Licensing Status: Available for
licensing.
Licensing Contact: Sally Hu, PhD,
301–435–5606, HuS@mail.nih.gov.
Collaborative Research Opportunity:
The National Cancer Institute,
Molecular Targets Development
Program, is seeking statements of
capability or interest from parties
interested in collaborative research to
further develop, evaluate, or
commercialize this technology. Please
contact John D. Hewes, PhD at 301–435–
3121 or hewesj@mail.nih.gov for more
information.
Novel Osteobiologic Proteins for
Treatment of Osteoporosis, Rheumatoid
and Neurologic Diseases
Description of Invention: In an effort
to find effective strategies for treatment
of body tissue and structural damage as
the result of trauma, cancer and other
diseases, scientists at the National
Institutes of Health (NIH) and the Food
and Drug Administration (FDA) have
identified proteins and associated
pathways instrumental in replacing or
regenerating damaged tissue. The
identified proteins include CartilageDerived Morphogenetic Proteins
(CDMP), Bone Morphogenetic Proteins
(BMPs) and a tissue fate modifying
FRZB Protein. Each has unique
activities likely to be useful as stand
alone agents or in construction of
engineered tissues.
CDMPs appear helpful in the healing
of bone and joint surface lesions, and
VerDate Nov<24>2008
15:49 Jul 08, 2009
Jkt 217001
also for the repair or reconstruction of
cartilaginous tissues, tendons and
ligaments. BMP antagonists will be
useful in the study of stem cell
differentiation. FRZB Protein, a tissue
fate modifying secretable antagonist of
Wnt signaling, is involved in the
formation of cartilage, bone, neural and
muscle tissue.
Potential Areas of Application
• Rheumatic diseases of the bone.
• Osteoporosis and osteoarthritis.
• Wound healing.
• Neurodegenerative disorders.
• Growth and repair of
musculoskeletal tissues.
• Tissue engineering.
Cartilage-Derived Morphogenetic
Proteins (HHS Reference No. E–138–
1994/0)
• Useful in the therapeutic induction,
repair, and maintenance of skeletal
tissues and cartilage growth.
• Polynucleotides encoding these
proteins are effective diagnostic reagents
for detecting genetic abnormalities
associated with poor skeletal
development.
Tissue Fate Modifying FRZB Protein
(HHS Reference Nos. E–127–1995/0/1/2)
• Involved in the formation of
cartilage, bone, neural and muscle
tissue.
• Regenerative agent to treat
degenerative disorders (i.e.,
Huntington’s, Alzheimer’s or spinal
cord injuries), myodegenerative
disorders (i.e., muscular dystrophy,
myasthenia gravis or myotonic
myopathies) and osteodegenerative
disorders (i.e., osteoporosis or
osteoarthritis)
• Selectively blocks diseases
associated with Wnt family of signaling
molecules including neoplasias.
Bone Morphogenetic Protein Variants
(HHS Reference No. E–196–2004/0)
• Promote repair of menisci, cruciate
and collateral ligaments of the knee, and
rotator cuff or other tendons and/or
ligaments.
• Induce the proliferation and
differentiation of progenitor cells into
functional bone, cartilage, tendon, or
ligament tissue.
Advantages: Osteobiologics, such as
BMPs, have the ability to stimulate
musculo-skeletal repair instead of using
donated human tissue allografts and
synthetic materials.
Market Size: Ankylosing spondylitis
afflicts least half a million people in the
United States. Currently, there remains
a need for the development of effective
therapeutics for treating
PO 00000
Frm 00067
Fmt 4703
Sfmt 4703
spondyloarthropathies that could
overcome the disadvantages of current
drugs.
Osteoarthritis overall affects an
estimated 30 million US adults. Direct
medical expenses for arthritis and other
rheumatic conditions are estimated at
$80.8 billion. In the United States, 10
million people have Osteoporosis.
Osteoporosis related fractures attributed
for $21 billion with the number
expected to rise to $26 billion in 2025.
Inventors: Malcolm C. Moos Jr. (FDA),
Frank P. Luyten (NIDCR), et al.
Related Publications
1. K Lin, S Wang, MA Julius, J
Kitajewski, M Moos Jr., FP Luyten. The
cysteine-rich frizzled domain of Frzb-1
is required and sufficient for the
modulation of Wnt signaling. Proc Natl
Acad Sci. USA 1997 Oct
14;94(21):11196–11200.
2. B Hoang, M Moos Jr, S Vukicevic,
FP Luyten. Primary structure and tissue
distribution of FRZB, a novel protein
related to Drosophila frizzled, suggests a
role in skeletal morphogenesis. J Biol
Chem. 1996 Oct 18;271(42):26131–
26137.
Patent Status
Cartilage-Derived Morphogenetic
Proteins (HHS Reference No. E–138–
1994/0)
• U.S. Patent 7,148,036 issued 12 Dec
2006.
• U.S. Patent 7,220,558 issued 22
May 2007.
• U.S. Patent Application No. 11/
592,811 (allowed).
Tissue Growth-Inducing FRZB Protein
(HHS Reference Nos. E–127–1995/0/1/2)
• U.S. Patent 6,884,871 issued 26 Apr
2005.
• U.S. Patent 6,924,367 issued 02 Aug
2005.
• U.S. Patent 7,049,291 issued 23
May 2006.
• U.S. Patent Application No. 11/
184,005 (allowed).
• U.S. Patent Application No. 11/
369,089 (pending).
Bone Morphogenetic Variants (HHS
Reference No. E–196–2004/0)
• U.S. Patent Application No. 11/
916,990 (pending).
Licensing Status: Available for
licensing.
Licensing Contact: Surekha Vathyam,
PhD; 301–435–4076;
vathyams@mail.nih.gov.
E:\FR\FM\09JYN1.SGM
09JYN1
Federal Register / Vol. 74, No. 130 / Thursday, July 9, 2009 / Notices
Dated: June 30, 2009.
Richard U. Rodriguez,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. E9–16299 Filed 7–8–09; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Mental Health;
Notice of Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
rmajette on DSK29S0YB1 with NOTICES
Name of Committee: National Institute of
Mental Health Special Emphasis Panel; Time
Sensitive Applications.
Date: July 16, 2009.
Time: 1 p.m. to 2 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852, (Telephone
Conference Call).
Contact Person: Aileen Schulte, PhD,
Scientific Review Officer, Division of
Extramural Activities, National Institute of
Mental Health, NIH, Neuroscience Center,
6001 Executive Blvd, Room 6140, MSC 9608,
Bethesda, MD 20892–9608, 301–443–1225,
aschulte@mail.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.242, Mental Health Research
Grants; 93.281, Scientist Development
Award, Scientist Development Award for
Clinicians, and Research Scientist Award;
93.282, Mental Health National Research
Service Awards for Research Training,
National Institutes of Health, HHS)
Dated: July 1, 2009.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E9–16214 Filed 7–8–09; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Centers for Disease Control and
Prevention
National Institute of Diabetes and
Digestive and Kidney Diseases; Notice
of Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Diabetes and Digestive and Kidney Diseases
Special Emphasis Panel, IBD Genetics
Ancillary Studies.
Date: July 29, 2009.
Time: 1:30 p.m. to 2:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, Two
Democracy Plaza, 6707 Democracy
Boulevard, Bethesda, MD 20892 (Telephone
Conference Call).
Contact Person: Dan E. Matsumoto, Ph.D.,
Scientific Review Administrator, Review
Branch, DEA, NIDDK, National Institutes of
Health, Room 749, 6707 Democracy
Boulevard, Bethesda, MD 20892–5452, (301)
594–8894, matsumotod@extra.niddk.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.847, Diabetes,
Endocrinology and Metabolic Research;
93.848, Digestive Diseases and Nutrition
Research; 93.849, Kidney Diseases, Urology
and Hematology Research, National Institutes
of Health, HHS)
Dated: July 1, 2009.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E9–16092 Filed 7–8–09; 8:45 am]
BILLING CODE 4140–01–P
BILLING CODE 4140–01–P
VerDate Nov<24>2008
15:49 Jul 08, 2009
Jkt 217001
32943
PO 00000
Frm 00068
Fmt 4703
Sfmt 4703
Subcommittee on Procedures
Reviews, Advisory Board on Radiation
and Worker Health (ABRWH), National
Institute for Occupational Safety and
Health (NIOSH)
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the Centers for Disease
Control and Prevention (CDC)
announces the following meeting for the
aforementioned subcommittee:
Time and Date: 10 a.m.–5 p.m., August 13,
2009.
Place: Cincinnati Airport Marriott, 2395
Progress Drive, Hebron, Kentucky 41018.
Telephone (859) 334–4611, Fax (859) 334–
4619.
Status: Open to the public, but without a
public comment period. To access by
teleconference dial the following information
1(866)659–0537, Participant Pass Code
9933701.
Background: The Advisory Board was
established under the Energy Employees
Occupational Illness Compensation Program
Act of 2000 to advise the President on a
variety of policy and technical functions
required to implement and effectively
manage the compensation program. Key
functions of the Advisory Board include
providing advice on the development of
probability of causation guidelines that have
been promulgated by the Department of
Health and Human Services (HHS) as a final
rule; advice on methods of dose
reconstruction which have also been
promulgated by HHS as a final rule; advice
on the scientific validity and quality of dose
estimation and reconstruction efforts being
performed for purposes of the compensation
program; and advice on petitions to add
classes of workers to the Special Exposure
Cohort (SEC).
In December 2000, the President delegated
responsibility for funding, staffing, and
operating the Advisory Board to HHS, which
subsequently delegated this authority to CDC.
NIOSH implements this responsibility for
CDC. The charter was issued on August 3,
2001, renewed at appropriate intervals, and
will expire on August 3, 2009.
Purpose: The Advisory Board is charged
with (a) Providing advice to the Secretary,
HHS, on the development of guidelines
under Executive Order 13179; (b) providing
advice to the Secretary, HHS, on the
scientific validity and quality of dose
reconstruction efforts performed for this
program; and (c) upon request by the
Secretary, HHS, advise the Secretary on
whether there is a class of employees at any
Department of Energy facility who were
exposed to radiation but for whom it is not
feasible to estimate their radiation dose, and
on whether there is reasonable likelihood
that such radiation doses may have
endangered the health of members of this
class. The Subcommittee on Procedures
E:\FR\FM\09JYN1.SGM
09JYN1
]]>Agencies
[Federal Register Volume 74, Number 130 (Thursday, July 9, 2009)]
[Notices]
[Pages 32940-32943]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-16299]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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.
qPCR Assay for Detection of JC Virus
Description of Invention: JC Virus causes a fatal disease in the
brain called progressive multifocal leukoencephalopathy (PML) that
occurs in many patients with immunocompromised conditions. For example,
more than five percent (5%) of AIDS patients develop PML. Additionally,
these conditions include, but are not limited to, cancers such as
leukemias and lymphomas, organ transplants such as kidney, heart and
autoimmune conditions with treatment that modulates the immune system
such as Multiple Sclerosis (MS), rheumatoid arthritis, psoriasis, and
systemic lupus erythematosus. The finding of JCV DNA in the patients
with neurological symptoms of PML is a diagnostic criterion and is
needed to confirm the diagnosis of PML to rule out other neurological
conditions.
This technology describes a qPCR assay that utilizes viral DNA
standards and testing samples to detect the presence of the JC viral
genome in patients' cerebrospinal fluid and blood, blood products, and
tissue samples from biopsy or autopsy.
Application: Development of JC Virus (JCV) diagnostics, calibration
of existing JCV assays.
Advantages: Assay is sensitive, reproducible and highly specific
because the amount of JCV DNA in cerebrospinal fluid or blood or blood
product samples may be very small.
Development Status: Materials and assay have been developed and
tested.
Inventors: Eugene O. Major and Caroline Ryschkewitsch (NINDS).
Publications
1. ML Landry et al. False negative PCR despite high levels of JC
virus DNA in spinal fluid: Implications for diagnostic testing. J Clin
Virol. 2008 Oct;43(2):247-249.
2. C Ryschkewitsch et al. Comparison of PCR-southern hybridization
and quantitative real-time PCR for the detection of JC and BK viral
nucleotide sequences in urine and cerebrospinal fluid. J Virol Methods.
2004 Nov;121(2):217-221.
3. T Yousry et al. Evaluation of patients treated with natalizumab
for progressive multifocal leukoencephalopathy. N Engl J Med. 2006 Mar
2;354(9):924-933.
Patent Status: HHS Reference No. E-152-2009/0--Research Material.
Patent protection is not being pursued for this technology.
Licensing Status: Available for licensing.
Licensing Contact: Peter A. Soukas, J.D.; 301-435-4646;
soukasp@mail.nih.gov.
A Locking Device for Permanently Securing Surgical Suture Loops
Description of Invention: This technology relates to a device that
can be used to non-invasively secure surgical suture loops when
combined with a percutaneous delivery system. It has been shown to be
effective in correcting mitral valve regurgitation (MVR) in an animal
model. During the procedure, a guidewire is percutaneously conveyed to
the atrium of the heart and is used to secure the ``cerclage'' suture
encircling the mitral valve annulus, which is delivered using a
delivery catheter. The locking device is advanced over the suture by
the delivery catheter and it permanently secures the suture and
maintains the tension on the annulus once the delivery system is
removed. This locking device, in combination with the percutaneous
procedure, allows for more complete coaptation of the valve leaflets
and correction of MVR without the need for open heart surgery and its
associated risks. The locking device is also adjustable, allowing the
user to vary the tension on the suture if further tightening or
loosening is required. It is also MRI compatible and all follow-up
studies can be performed under MRI.
This invention has demonstrated its ability to correct MVR in
animals where the locking device was observed to maintain the correct
position and tension after implantation. This device has the potential
to replace the traditional loop and knot method used for surgical
correction of MVR, and may also be useful for other conditions that
require permanently secured suture loops.
Applications: Non-invasive and effective correction of MVR and
other conditions; Tensioning device for securing suture loops.
Advantages: Technology amenable to a non-invasive technique;
Control of tension on surgical sutures.
Development Status: Early stage.
Inventor: Ozgur Kocaturk (NHLBI).
Patent Status: U.S. Provisional Application No. 61/157,267 filed 04
Mar 2009 (HHS Reference No. E-048-2009/0-US-01).
Licensing Status: Available for licensing.
Licensing Contact: Jeffrey A. James, Ph.D.; 301-435-5474;
jeffreyja@mail.nih.gov.
Collaborative Research Opportunity: The National Heart, Lung and
Blood Institute Cardiac Catheterization Lab is seeking statements of
capability or interest from parties interested in collaborative
research to further develop, evaluate, or commercialize the
[[Page 32941]]
tension fixation device. Please contact Peg Koelble at 301-594-4095 or
koelblep@nhlbi.nih.gov for more information.
Modulators of Pregnane X Receptor (PXR) as Therapeutics for Bowel
Disorders (BD)
Description of Invention: This technology is based on the novel
findings that susceptibility to BD is strongly associated with genetic
variation in the PXR gene, a member of the nuclear receptor family, and
rifaximin is a specific activator of human PXR. PXR is an integral
component of the body's defense mechanism involved in endogenous and
xenobiotic detoxication. Based on these novel findings, the present
technology provides (a) methods of screening for compositions that
modulate inflammatory bowel disease (IBD), (b) methods of inhibiting
inflammation of the bowel and related tissues and organs, and (c)
methods of treatment of inflammatory bowel disease.
Applications: Therapeutics for bowel disorders; Screening assays
for candidate drugs to treat bowel disorders.
Development Status: Early stage.
Market: It is estimated that as many as one (1) million Americans
have IBD, with that number evenly split between Crohn's disease and
Ulcerative Colitis (UC). Further, it is estimated that the IBD
therapeutic market will grow to reach four (4) billion U.S. dollars in
2017.
Inventors: Frank J. Gonzalez (NCI), Xiaochao Ma (NCI), et al.
Publication: X Ma, Y Shah, C Cheung, GL Guo, L Feigenbaum, KW
Krausz, JR Idle, FJ Gonzalez. The PREGnane X receptor gene-humanized
mouse: a model for investigating drug-drug interactions mediated by
cytochromes P450 3A. Drug Metab Dispos. 2007 Feb;35(2):194-200.
Patent Status: U.S. Provisional Application No. 60/999,234 filed 17
Oct 2007 (HHS Reference No. E-002-2008/0-US-01); PCT Patent Application
(HHS Reference No. E-002-2008/0-PCT-02).
Licensing Status: Available for licensing.
Licensing Contact: Suryanarayana (Sury) Vepa, PhD, J.D.; 301-435-
5020; vepas@mail.nih.gov.
Collaborative Research Opportunity: The Laboratory of Metabolism,
Center for Cancer Research, NCI, is seeking statements of capability or
interest from parties interested in collaborative research to further
develop, evaluate, or commercialize compounds that ameliorate bowel
disorders through the PXR pathway. Please contact Lisa Finkelstein, PhD
at 301-451-7458 or lfinkels@mail.nih.gov for more information.
The Protein Cyanovirin Inactivates HIV and Influenza
Description of Invention: Cyanovirin-N (CV-N) potently and
irreversibly inactivates diverse primary strains of HIV-1, including M-
tropic forms involved in sexual transmission of HIV, as well as T-
tropic and dual-tropic forms. CV-N also blocks cell-to-cell
transmission of HIV infection. CV-N interacts in an unusual manner with
the viral envelope, binding with extremely high affinity to poorly
immunogenic epitopes on gp120. Further, CV-N and homologous proteins
and peptides potently inhibit diverse isolates of influenza viruses A
and B, the two major types of influenza virus that infect humans.
The described technology includes glycosylation-resistant mutants,
which code sequences to enable ultra large-scale recombinant production
of functional CV-Ns in non-bacterial (yeast or insect) host cells or in
transgenic animals or plants. Therefore, these glycosylation-resistant
mutants may allow industry to produce CV-Ns on a large scale and make
CV-Ns cheap enough for developing countries to benefit from this
invention.
CV-N was benign in vivo when tested in the rabbit/monkey vaginal
toxicity/irritancy model and was not cytotoxic in vitro against human
immune cells and lactobacilli. CV-N is readily soluble in aqueous
media, is remarkably resistant to physicochemical degradation and is
amenable to very large-scale production by a variety of genetic
engineering approaches.
Applications
Therapeutics and prevention of HIV and influenza
infections.
Topical microbicide to protect HIV infection.
Ex vivo devices incorporating CV-N to remove or inactivate
HIV from fluid samples.
Advantages
Potent anti-HIV and anti-influenza activity.
Can be applied both systematically or locally.
Can be applied both in vivo and ex vivo.
Inexpensive and large scale manufacturing.
Development Status
Preclinical (rabbit/monkey) data in microbicide field are
available at this time.
Initial animal efficacy studies (both mouse and ferret)
against influenza (H1N1) have been completed and published.
Market: For HIV therapeutics market, a published report by the
financial services firm Griffin Securities suggested that sales of HIV/
AIDS drugs reached $13 billion annually in 2007 (https://www.hivandhepatitis.com).
For microbicide market, it has been estimated that the global
market size of microbicide will reach to $900 million by 2011 and will
reach the sales of over $1.8 billion by 2020). ``Promising
microbicides'' Frontline (Volume 21--Issue 14, Jul. 03-16, 2004).
For influenza market, based on Report Buyer which is a UK-based
independent online store supplying business information on major
industry sectors: By 2010, the worldwide influenza market is likely to
reach $7.1 billion, with average annual growth estimated at 19.8%.
Inventors: Michael R. Boyd (NCI), Barry R. O'Keefe (NCI), et al.
Publications
1. B Giomarelli, R Provvedi, F Meacci, T Maggi, D Medaglini, G
Pozzi, T Mori, JB McMahon, R Gardella, MR Boyd. The microbicide
cyanovirin-N expressed on the surface of commensal bacterium
Streptococcus gordonii captures HIV-1. AIDS. 2002 Jul 5;16(10):1351-
1356.
2. CC Tsai, P Emau, Y Jiang, MB Agy, RJ Shattock, A Schmidt, WR
Morton, KR Gustafson, MR Boyd. Cyanovirin-N inhibits AIDS virus
infections in vaginal transmission models. AIDS Res Hum Retroviruses.
2004 Jan; 20(1):11-18.
3. DF Smee, KW Bailey, MH Wong, BR O'Keefe, KR Gustafson, VP
Mishin, LV Gubareva. Treatment of influenza A (H1N1) virus infections
in mice and ferrets with cyanovirin-N. Antiviral Res. 2008
Dec;80(3):266-271.
Patent Status
E-117-1995/0--US Patent Numbers 5,843,882; 6,015,876;
5,962,653; 6,245,737 and 6,586,392.
E-117-1995/1--US Patent Numbers 5,821,081; 5,998,587;
6,987,096; and 5,962,668.
E-117-1995/2-PCT-01 (WO 96/34107)--entered in AU with
Patent Numbers 707781 and 746809; in CA with Patent application Numbers
2219105; in JP with Patent Numbers 3803115 and 4081484; and in EP with
Patent Number 836647 and registration GB, FR, DE, BE and CH.
E-117-1995/3-PCT-02 (WO 00/11036)--entered in USA with
Patent Number 6,193,982; in AU with Patent Number 746313; in CA with
Patent Application Number 2340787; in JP
[[Page 32942]]
with Patent Application Number 566308/2000; and in EP with Patent
Application Number 99943784.1.
E-074-1999/0--US Patent Numbers 6,420,336 and 6,743,577.
E-074-1999/1--US Patent Numbers 7,105,169; 7,048,935; and
6,428,790.
E-074-1999/2-PCT-01 (WO 00/53213)--entered in AU with
Patent Numbers 762704 and 2003252207; in CA with Patent Application
Numbers 2364500; in JP with Patent Application Number 603702/2000; and
in EP with Patent Number 1162992 and registration GB, FR, DE, BE and
CH.
E-074-1999/3-PCT-02 (WO 02/077189)--entered in USA with
Patent Numbers 7,339,037 & 6,780,847 and Patent Application Number 10/
857,265; in AU with Patent Number 2002254382; in CA with Patent
Application Number 2441287; in JP with Patent Application Number
576632/2002; and in EP with Patent Number 1456382 and registration GB,
FR, DE, BE and CH.
E-198-2006/0-PCT-02 (WO 2008/022303)--entered in USA with
Patent Application Number 12/377875; and in EP with Patent Application
Number 07814209.8.
Licensing Status: Available for licensing.
Licensing Contact: Sally Hu, PhD, 301-435-5606, HuS@mail.nih.gov.
Collaborative Research Opportunity: The National Cancer Institute,
Molecular Targets Development Program, is seeking statements of
capability or interest from parties interested in collaborative
research to further develop, evaluate, or commercialize this
technology. Please contact John D. Hewes, PhD at 301-435-3121 or
hewesj@mail.nih.gov for more information.
Novel Osteobiologic Proteins for Treatment of Osteoporosis, Rheumatoid
and Neurologic Diseases
Description of Invention: In an effort to find effective strategies
for treatment of body tissue and structural damage as the result of
trauma, cancer and other diseases, scientists at the National
Institutes of Health (NIH) and the Food and Drug Administration (FDA)
have identified proteins and associated pathways instrumental in
replacing or regenerating damaged tissue. The identified proteins
include Cartilage-Derived Morphogenetic Proteins (CDMP), Bone
Morphogenetic Proteins (BMPs) and a tissue fate modifying FRZB Protein.
Each has unique activities likely to be useful as stand alone agents or
in construction of engineered tissues.
CDMPs appear helpful in the healing of bone and joint surface
lesions, and also for the repair or reconstruction of cartilaginous
tissues, tendons and ligaments. BMP antagonists will be useful in the
study of stem cell differentiation. FRZB Protein, a tissue fate
modifying secretable antagonist of Wnt signaling, is involved in the
formation of cartilage, bone, neural and muscle tissue.
Potential Areas of Application
Rheumatic diseases of the bone.
Osteoporosis and osteoarthritis.
Wound healing.
Neurodegenerative disorders.
Growth and repair of musculoskeletal tissues.
Tissue engineering.
Cartilage-Derived Morphogenetic Proteins (HHS Reference No. E-138-1994/
0)
Useful in the therapeutic induction, repair, and
maintenance of skeletal tissues and cartilage growth.
Polynucleotides encoding these proteins are effective
diagnostic reagents for detecting genetic abnormalities associated with
poor skeletal development.
Tissue Fate Modifying FRZB Protein (HHS Reference Nos. E-127-1995/0/1/
2)
Involved in the formation of cartilage, bone, neural and
muscle tissue.
Regenerative agent to treat degenerative disorders (i.e.,
Huntington's, Alzheimer's or spinal cord injuries), myodegenerative
disorders (i.e., muscular dystrophy, myasthenia gravis or myotonic
myopathies) and osteodegenerative disorders (i.e., osteoporosis or
osteoarthritis)
Selectively blocks diseases associated with Wnt family of
signaling molecules including neoplasias.
Bone Morphogenetic Protein Variants (HHS Reference No. E-196-2004/0)
Promote repair of menisci, cruciate and collateral
ligaments of the knee, and rotator cuff or other tendons and/or
ligaments.
Induce the proliferation and differentiation of progenitor
cells into functional bone, cartilage, tendon, or ligament tissue.
Advantages: Osteobiologics, such as BMPs, have the ability to
stimulate musculo-skeletal repair instead of using donated human tissue
allografts and synthetic materials.
Market Size: Ankylosing spondylitis afflicts least half a million
people in the United States. Currently, there remains a need for the
development of effective therapeutics for treating
spondyloarthropathies that could overcome the disadvantages of current
drugs.
Osteoarthritis overall affects an estimated 30 million US adults.
Direct medical expenses for arthritis and other rheumatic conditions
are estimated at $80.8 billion. In the United States, 10 million people
have Osteoporosis. Osteoporosis related fractures attributed for $21
billion with the number expected to rise to $26 billion in 2025.
Inventors: Malcolm C. Moos Jr. (FDA), Frank P. Luyten (NIDCR), et
al.
Related Publications
1. K Lin, S Wang, MA Julius, J Kitajewski, M Moos Jr., FP Luyten.
The cysteine-rich frizzled domain of Frzb-1 is required and sufficient
for the modulation of Wnt signaling. Proc Natl Acad Sci. USA 1997 Oct
14;94(21):11196-11200.
2. B Hoang, M Moos Jr, S Vukicevic, FP Luyten. Primary structure
and tissue distribution of FRZB, a novel protein related to Drosophila
frizzled, suggests a role in skeletal morphogenesis. J Biol Chem. 1996
Oct 18;271(42):26131-26137.
Patent Status
Cartilage-Derived Morphogenetic Proteins (HHS Reference No. E-138-1994/
0)
U.S. Patent 7,148,036 issued 12 Dec 2006.
U.S. Patent 7,220,558 issued 22 May 2007.
U.S. Patent Application No. 11/592,811 (allowed).
Tissue Growth-Inducing FRZB Protein (HHS Reference Nos. E-127-1995/0/1/
2)
U.S. Patent 6,884,871 issued 26 Apr 2005.
U.S. Patent 6,924,367 issued 02 Aug 2005.
U.S. Patent 7,049,291 issued 23 May 2006.
U.S. Patent Application No. 11/184,005 (allowed).
U.S. Patent Application No. 11/369,089 (pending).
Bone Morphogenetic Variants (HHS Reference No. E-196-2004/0)
U.S. Patent Application No. 11/916,990 (pending).
Licensing Status: Available for licensing.
Licensing Contact: Surekha Vathyam, PhD; 301-435-4076;
vathyams@mail.nih.gov.
[[Page 32943]]
Dated: June 30, 2009.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. E9-16299 Filed 7-8-09; 8:45 am]
BILLING CODE 4140-01-P
