Government-Owned Inventions; Availability for Licensing, 50922-50924 [2014-20183]
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50922
Federal Register / Vol. 79, No. 165 / Tuesday, August 26, 2014 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Type of respondents
Graduate Student—Entrance Survey (online survey) .....................................
Graduate Student—Interim Survey (online survey) .........................................
Graduate Student—Graduation Survey (online survey) ..................................
Graduate Student—Post-graduation 2-year Follow-up Survey (online survey) ...............................................................................................................
Postdoctoral Scientist—Entrance Survey (online survey) ...............................
Postdoctoral Scientist—Exit Survey (online survey) .......................................
Postdoctoral Scientist—Post-exit 2-year Follow-up Survey (online survey) ...
Principal Investigators—Annual Interview (phone—end of each year of
award ) .........................................................................................................
Dated: August 20, 2014.
Lawrence A. Tabak,
Deputy Director, National Institutes of Health.
[FR Doc. 2014–20268 Filed 8–25–14; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
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.
tkelley on DSK3SPTVN1PROD with NOTICES
SUMMARY:
A Rabbit Anti-pT1989 ATR Monoclonal
Antibody for Use in Immunoassays
Description of Technology: This
technology concerns a novel
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Average
burden per
response
(in hours)
Annual hour
burden
5,901
14,753
3,934
1
1
1
45/60
20/60
20/60
4,426
4,918
1,311
3,934
3,777
2,518
2,518
1
1
1
1
20/60
45/60
20/60
20/60
1,311
2,833
839
839
25
1
1
25
monoclonal antibody for selecting new
anti-cancer compounds.
The active form of ATR (ataxia
telangiectasia-mutated and Rad3related) kinase is phosphorylated at
Threonine 1989 site (T1989). The
monoclonal antibody binds the
phosphorylated Threonine 1989
(T1989). The phosphorylated ATR
senses DNA damage response and leads
to cell cycle arrest. Targeting at ATR,
anti-cancer drugs may induce cancer
cell death.
This technology can be applied into
stable and immunoassays on multiple
platforms for measuring ATR activation
and inhibition and may inform
therapeutic decisions for cancer
treatment.
Potential Commercial Applications:
• Antibody specifically against
phosphorylated ATR (at T1989 site).
• Application in assays to develop
personalized medicine for pT1989 ATRrelated disease.
• Application in assays for selecting
measuring ATR modulation.
• Application in assays for selecting
ATR inhibitors.
Competitive Advantages:
• Novel antibody against ATR
phosphorylated at T1989.
• Possibility to establish stable and
effective immunoassays to select drugs
specifically targeting ATR.
• Works in western blot and IFA
applications on crude (unenriched) cell
lysates.
• Works in standard processed
clinical and preclinical samples.
• Can be used to report drug activity.
Development Stage:
• In vitro data available.
• In vivo data available (animal).
• Prototype.
Inventors: Thomas D. Pfister (SAICFrederick), Allison M. Marrero (SAICFrederick), Ralph E. Parchment (SAICFrederick), James H. Doroshow (NCI).
Intellectual Property: HHS Reference
No. E–001–2014/0—US Provisional
PO 00000
Frequency of
response
Application No. 61/893,070 filed 18 Oct
2013.
Licensing Contact: Surekha Vathyam,
Ph.D.; 301–435–4076;
vathyams@mail.nih.gov.
Monitoring the Effects of Sleep
Deprivation Using Neuronal
Avalanches
Description of Technology:
Investigators at the National Institute of
Mental Health have discovered a novel
method for monitoring the effects of
sleep deprivation on brain activity.
Sleep deprivation has been known to
adversely affect basic cognitive abilities,
such as object recognition and decision
making, even leading to hallucinations
and epileptic seizures. This invention
measures the degree of sleep
deprivation and decrease in behavioral
performance directly from resting brain
activity. A deviation from optimal
avalanche parameters correlates with
duration of wakefulness and decrease in
performance.
Potential Commercial Applications:
• Monitor wakefulness, reaction time.
• Potential application for monitoring
sleep-deprived first-responders (e.g.,
military, EMT, etc.)
Competitive Advantages:
• Continuously monitors brain
activity.
• Non-invasive.
Development Stage:
• In vivo data available (human).
• Prototype.
Inventors: Dietmar Plenz (NIMH),
Oren Shriki (NIMH), Christian Meisel
(NIMH), Giulio Tononi (Univ.
Wisconsin).
Publication: Meisel C, et al. Fading
signatures of critical brain dynamics
during sustained wakefulness in
humans. J Neurosci. 2013 Oct
30;33(44):17363–72. [PMID 24174669].
Intellectual Property: HHS Reference
No. E–345–2013/0—US Application No.
61/866,962 filed 16 Aug 2013.
Related Technologies: HHS Reference
No. E–294–2005/1–
E:\FR\FM\26AUN1.SGM
26AUN1
Federal Register / Vol. 79, No. 165 / Tuesday, August 26, 2014 / Notices
• US Application No. 11/990,419
filed 14 Aug 2006, which issued as US
Patent No. 8,548,786 on 01 Oct 2013.
• CA Application No. 2,618,933 filed
14 Aug 2006.
• AU Application No. 2006279572
filed 14 Aug 2006.
• EP Application No. 06813476.6
filed 14 Aug 2006.
• JP Application No. 2008–526298
filed 14 Aug 2006.
• AU Application No. 2013201187
filed 14 Aug 2006.
Licensing Contact: Charlene Maddox,
Ph.D.; 301–435–4689;
maddoxcs@mail.nih.gov.
Collaborative Research Opportunity:
The National Institute of Mental Health
is seeking statements of capability or
interest from parties interested in
collaborative research to further
develop, evaluate or commercialize this
technology. For collaboration
opportunities, please contact Suzanne
Winfield, Ph.D. at
winfiels@mail.nih.gov.
tkelley on DSK3SPTVN1PROD with NOTICES
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.
Potential Commercial Applications:
• Pathogen detection.
• Biomarker targeted diagnostics.
• Point-of-care.
• Food allergens.
Competitive Advantages:
• Easy to assemble.
• Detection of multiple analytes.
• Digital signal amplification.
• Stable shelf-life.
Development Stage:
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21:48 Aug 25, 2014
Jkt 232001
• In vitro data available.
• Prototype.
Inventors: Avraham Rasooly (NCI),
Minghui Yang (Univ. of Maryland,
Baltimore), Yordan Kostov (Univ. of
Maryland, Baltimore), Hugh Brock
(Univ. of Maryland, College Park).
Publications:
1. Qu F, et al. Electrochemical
biosensing platform using hydrogel
prepared from ferrocene modified
amino acid as highly efficient
immobilization matrix. Anal Chem.
2014 Jan 21;86(2):973–6. [PMID
24383679].
2. Herold KE, Rasooly A. Editorial for
‘‘biosensor technologies’’. Methods.
2013 Oct;63(3):201. [PMID 24139786].
3. Bruck HA, et al. Electrical
percolation based biosensors. Methods.
2013 Oct;63(3):282–9. [PMID 24041756].
4. Balsam J, et al. Thousand-fold
fluorescent signal amplification for
mHealth diagnostics. Biosens
Bioelectron. 2014 Jan 15;51:1–7. [PMID
23928092].
5. Rasooly A, et al. An ELISA Lab-ona-Chip (ELISA–LOC). Methods Mol Biol.
2013;949:451–71. [PMID 23329460].
Intellectual Property: HHS Reference
No. E–040–2009/0–
• US Patent No. 8,614,466 issued 24
Dec 2013.
• Pending European Patent
Application 09828144.7.
Licensing Contact: Michael
Shmilovich, JD; 301–435–5019;
shmilovm@mail.nih.gov.
Viral Like Particles Based Chikungunya
Vaccines
Description of Technology:
Chikungunya virus (CHIKV) is
mosquito-borne alphavirus endemic in
Africa, India, and Southeast Asia. In
2013 CHIKV infection has also emerged
in the Caribbean and a pandemic of
CHIKV has re-emerged in the
Philippines following Typhoon Haiyan.
Currently, there is no vaccine available
for the prevention of CHIKV infection
and no specific therapy exists to treat
the illness. Researchers at the Vaccine
Research Center (VRC) of the National
Institute of Allergy and Infectious
Diseases (NIAID) have developed a
CHIKV Viral Like Particle (CHIKV VLP)
vaccine based on plasmid expression
vectors encoding structural proteins of
the CHIKV virus, which gave rise to
CHIKV VLPs in transfected cells. The
CHIKV VLPs consist of the core, E1 and
E2 proteins and are similar in buoyant
density and morphology to replicationcompetent CHIKV virus. Immunization
with CHIKV VLPs elicited neutralizing
antibodies against envelope proteins
from different CHIKV strains in mouse
and nonhuman primate (NHP) models.
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50923
Monkeys immunized with CHIKV VLPs
produced high titer neutralizing
antibodies that protected against
viremia after high dose challenge. The
selected CHIKV VLP vaccine candidate,
VRC–CHKVLP059–00–VP, composed of
the E1, E2, and capsid proteins from the
CHIKV strain 37997, was recently
evaluated by the VRC at the NIH
Clinical Center for safety, tolerability
and immunogenicity in the clinical
protocol VRC 311 (ClinicalTrials.gov #
NCT01489358), a Phase I, open-label,
dose escalation clinical trial. The VRC–
CHKVLP059–00–VP vaccine was highly
immunogenic, safe, and well-tolerated.
VRC researchers have also developed
the transient transfection manufacturing
process for CHIKV and other
alphaviruses, such as Western, Eastern
and Venezuelan Equine Encephalitis
(WEVEE) viruses. Pre-clinical in vivo
mouse and NHP data, Phase 1 clinical
trial data and manufacturing data are
available.
NIH will evaluate a license
applicant’s capabilities and experience
in advancing similar technologies
through the regulatory process. This
technology is not eligible for the NIH’s
start-up license program.
Potential Commercial Applications:
Chikungunya vaccines based on viral
like particles.
Competitive Advantages:
• There is currently no CHIKV
vaccine on the market.
• VRC–CHKVLP059–00–VP vaccine
candidate is highly immunogenic, safe,
and well-tolerated.
• Minimal containment requirements
for CHIKV VLP manufacturing because
live virus production is not required.
Development Stage:
• In vitro data available.
• In vivo data available (animal).
• In vivo data available (human).
Inventors: Gary J. Nabel, Wataru
Akahata, Srinivas S. Rao (all of VRC/
NIAID).
Publications:
1. Akahata W, et al. A virus-like
particle vaccine for epidemic
Chikungunya virus protects non-human
primates against infection. Nat Med.
2010 Mar;16(3):334–8. [PMID
20111039].
2. Akahata W, Nabel GJ. A specific
domain of the Chikungunya virus E2
protein regulates particle formation in
human cells: implications for alphavirus
vaccine design. J Virol. 2012
Aug;86(16):8879–83. [PMID 22647698].
3. Chang et al. Chikungunya VirusLike Particle Vaccine Elicits
Neutralizing Antibodies in Healthy
Adults in a Phase I Clinical Trial;
manuscript submitted.
Intellectual Property:
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26AUN1
50924
Federal Register / Vol. 79, No. 165 / Tuesday, August 26, 2014 / Notices
HHS Reference Nos. E–004–2009/0/1/
2–
• US Provisional Application No. 61/
118,206 filed 26 Nov 2008.
• US Provisional Application No. 61/
201,118 filed 05 Dec 2008.
• International Application No. PCT/
US2009/006294 (WO 2010/062396) filed
24 Nov 2009.
• and corresponding filings in the US,
Europe, China, Australia, Brazil, India,
Malaysia, South Africa, Singapore,
Indonesia, Philippines and Vietnam.
HHS Reference Nos. E–057–2011/0/1/
2–
• US Provisional Application No. 61/
438,236 filed 31 Jan 2011.
• International Application No. PCT/
US2012/023361 (WO 2012/106356) filed
31 Jan 2012.
• and corresponding filings in the US
and India.
Licensing Contact: Cristina
Thalhammer-Reyero, Ph.D., MBA; 301–
435–4507; ThalhamC@mail.nih.gov.
Dated: August 20, 2014.
Richard U. Rodriguez,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. 2014–20183 Filed 8–25–14; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
tkelley on DSK3SPTVN1PROD with NOTICES
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 meetings.
The meetings 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: Center for Scientific
Review Special Emphasis Panel, PAR–14–
073 Shared Instrumentation: Confocal
Microscopy and Imaging.
Date: September 18, 2014.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Washington Marriott Georgetown,
1221 22nd Street NW., Washington, DC
20037.
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21:48 Aug 25, 2014
Jkt 232001
Contact Person: Maqsood A Wani, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 2114,
MSC 7814, Bethesda, MD 20892, 301–435–
2270, wanimaqs@csr.nih.gov.
Name of Committee: Risk, Prevention and
Health Behavior Integrated Review Group,
Psychosocial Risk and Disease Prevention
Study Section.
Date: September 29–30, 2014.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Residence Inn Bethesda, 7335
Wisconsin Avenue, Bethesda, MD 20814.
Contact Person: Stacey FitzSimmons,
Ph.D., MPH, Scientific Review Officer, Center
for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3114,
MSC 7808, Bethesda, MD 20892, (301) 451–
9956, fitzsimmonss@csr.nih.gov.
Name of Committee: Digestive, Kidney and
Urological Systems Integrated Review Group,
Clinical, Integrative and Molecular
Gastroenterology Study Section.
Date: September 29, 2014.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Doubletree Hotel Bethesda,
(Formerly Holiday Inn Select), 8120
Wisconsin Avenue, Bethesda, MD 20814.
Contact Person: Mushtaq A Khan, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 2176,
MSC 7818, Bethesda, MD 20892, 301–435–
1778, khanm@csr.nih.gov.
Name of Committee: Healthcare Delivery
and Methodologies Integrated Review Group,
Health Services Organization and Delivery
Study Section.
Date: September 29–30, 2014.
Time: 8:30 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Embassy Suites at the Chevy Chase
Pavilion, 4300 Military Road NW.,
Washington, DC 20015.
Contact Person: Jacinta Bronte-Tinkew,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3164,
MSC 7770, Bethesda, MD 20892, (301) 806–
0009, brontetinkewjm@csr.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
Dated: August 20, 2014.
David Clary,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2014–20179 Filed 8–25–14; 8:45 am]
BILLING CODE 4140–01–P
PO 00000
Frm 00041
Fmt 4703
Sfmt 4703
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and
Infectious 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
Allergy and Infectious Diseases Special
Emphasis Panel, NIAID Clinical Trial
Implementation Cooperative Agreement
(U01) and Program Application (P01).
Date: October 15, 2014.
Time: 10 a.m. to 1 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, Room
3137, 6700B Rockledge Drive, Bethesda, MD
20817, (Telephone Conference Call).
Contact Person: Quirijn Vos, Ph.D.,
Scientific Review Officer, Scientific Review
Program, Division of Extramural Activities,
DHHS/NIH/NIAID, 6700B Rockledge Drive,
MSC 7616, Bethesda, MD 20892, 301–451–
2666, qvos@niaid.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.855, Allergy, Immunology,
and Transplantation Research; 93.856,
Microbiology and Infectious Diseases
Research, National Institutes of Health, HHS)
Dated: August 20, 2014.
David Clary,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2014–20181 Filed 8–25–14; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Dental &
Craniofacial Research; Notice of
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of a meeting of the
National Advisory Dental and
Craniofacial Research Council.
E:\FR\FM\26AUN1.SGM
26AUN1
]]>Agencies
[Federal Register Volume 79, Number 165 (Tuesday, August 26, 2014)]
[Notices]
[Pages 50922-50924]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-20183]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions; Availability for Licensing
AGENCY: National Institutes of Health, 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. 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.
A Rabbit Anti-pT1989 ATR Monoclonal Antibody for Use in Immunoassays
Description of Technology: This technology concerns a novel
monoclonal antibody for selecting new anti-cancer compounds.
The active form of ATR (ataxia telangiectasia-mutated and Rad3-
related) kinase is phosphorylated at Threonine 1989 site (T1989). The
monoclonal antibody binds the phosphorylated Threonine 1989 (T1989).
The phosphorylated ATR senses DNA damage response and leads to cell
cycle arrest. Targeting at ATR, anti-cancer drugs may induce cancer
cell death.
This technology can be applied into stable and immunoassays on
multiple platforms for measuring ATR activation and inhibition and may
inform therapeutic decisions for cancer treatment.
Potential Commercial Applications:
Antibody specifically against phosphorylated ATR (at T1989
site).
Application in assays to develop personalized medicine for
pT1989 ATR-related disease.
Application in assays for selecting measuring ATR
modulation.
Application in assays for selecting ATR inhibitors.
Competitive Advantages:
Novel antibody against ATR phosphorylated at T1989.
Possibility to establish stable and effective immunoassays
to select drugs specifically targeting ATR.
Works in western blot and IFA applications on crude
(unenriched) cell lysates.
Works in standard processed clinical and preclinical
samples.
Can be used to report drug activity.
Development Stage:
In vitro data available.
In vivo data available (animal).
Prototype.
Inventors: Thomas D. Pfister (SAIC-Frederick), Allison M. Marrero
(SAIC-Frederick), Ralph E. Parchment (SAIC-Frederick), James H.
Doroshow (NCI).
Intellectual Property: HHS Reference No. E-001-2014/0--US
Provisional Application No. 61/893,070 filed 18 Oct 2013.
Licensing Contact: Surekha Vathyam, Ph.D.; 301-435-4076;
vathyams@mail.nih.gov.
Monitoring the Effects of Sleep Deprivation Using Neuronal Avalanches
Description of Technology: Investigators at the National Institute
of Mental Health have discovered a novel method for monitoring the
effects of sleep deprivation on brain activity. Sleep deprivation has
been known to adversely affect basic cognitive abilities, such as
object recognition and decision making, even leading to hallucinations
and epileptic seizures. This invention measures the degree of sleep
deprivation and decrease in behavioral performance directly from
resting brain activity. A deviation from optimal avalanche parameters
correlates with duration of wakefulness and decrease in performance.
Potential Commercial Applications:
Monitor wakefulness, reaction time.
Potential application for monitoring sleep-deprived first-
responders (e.g., military, EMT, etc.)
Competitive Advantages:
Continuously monitors brain activity.
Non-invasive.
Development Stage:
In vivo data available (human).
Prototype.
Inventors: Dietmar Plenz (NIMH), Oren Shriki (NIMH), Christian
Meisel (NIMH), Giulio Tononi (Univ. Wisconsin).
Publication: Meisel C, et al. Fading signatures of critical brain
dynamics during sustained wakefulness in humans. J Neurosci. 2013 Oct
30;33(44):17363-72. [PMID 24174669].
Intellectual Property: HHS Reference No. E-345-2013/0--US
Application No. 61/866,962 filed 16 Aug 2013.
Related Technologies: HHS Reference No. E-294-2005/1-
[[Page 50923]]
US Application No. 11/990,419 filed 14 Aug 2006, which
issued as US Patent No. 8,548,786 on 01 Oct 2013.
CA Application No. 2,618,933 filed 14 Aug 2006.
AU Application No. 2006279572 filed 14 Aug 2006.
EP Application No. 06813476.6 filed 14 Aug 2006.
JP Application No. 2008-526298 filed 14 Aug 2006.
AU Application No. 2013201187 filed 14 Aug 2006.
Licensing Contact: Charlene Maddox, Ph.D.; 301-435-4689;
maddoxcs@mail.nih.gov.
Collaborative Research Opportunity: The National Institute of
Mental Health is seeking statements of capability or interest from
parties interested in collaborative research to further develop,
evaluate or commercialize this technology. For collaboration
opportunities, please contact Suzanne Winfield, Ph.D. at
winfiels@mail.nih.gov.
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.
Potential Commercial Applications:
Pathogen detection.
Biomarker targeted diagnostics.
Point-of-care.
Food allergens.
Competitive Advantages:
Easy to assemble.
Detection of multiple analytes.
Digital signal amplification.
Stable shelf-life.
Development Stage:
In vitro data available.
Prototype.
Inventors: Avraham Rasooly (NCI), Minghui Yang (Univ. of Maryland,
Baltimore), Yordan Kostov (Univ. of Maryland, Baltimore), Hugh Brock
(Univ. of Maryland, College Park).
Publications:
1. Qu F, et al. Electrochemical biosensing platform using hydrogel
prepared from ferrocene modified amino acid as highly efficient
immobilization matrix. Anal Chem. 2014 Jan 21;86(2):973-6. [PMID
24383679].
2. Herold KE, Rasooly A. Editorial for ``biosensor technologies''.
Methods. 2013 Oct;63(3):201. [PMID 24139786].
3. Bruck HA, et al. Electrical percolation based biosensors.
Methods. 2013 Oct;63(3):282-9. [PMID 24041756].
4. Balsam J, et al. Thousand-fold fluorescent signal amplification
for mHealth diagnostics. Biosens Bioelectron. 2014 Jan 15;51:1-7. [PMID
23928092].
5. Rasooly A, et al. An ELISA Lab-on-a-Chip (ELISA-LOC). Methods
Mol Biol. 2013;949:451-71. [PMID 23329460].
Intellectual Property: HHS Reference No. E-040-2009/0-
US Patent No. 8,614,466 issued 24 Dec 2013.
Pending European Patent Application 09828144.7.
Licensing Contact: Michael Shmilovich, JD; 301-435-5019;
shmilovm@mail.nih.gov.
Viral Like Particles Based Chikungunya Vaccines
Description of Technology: Chikungunya virus (CHIKV) is mosquito-
borne alphavirus endemic in Africa, India, and Southeast Asia. In 2013
CHIKV infection has also emerged in the Caribbean and a pandemic of
CHIKV has re-emerged in the Philippines following Typhoon Haiyan.
Currently, there is no vaccine available for the prevention of CHIKV
infection and no specific therapy exists to treat the illness.
Researchers at the Vaccine Research Center (VRC) of the National
Institute of Allergy and Infectious Diseases (NIAID) have developed a
CHIKV Viral Like Particle (CHIKV VLP) vaccine based on plasmid
expression vectors encoding structural proteins of the CHIKV virus,
which gave rise to CHIKV VLPs in transfected cells. The CHIKV VLPs
consist of the core, E1 and E2 proteins and are similar in buoyant
density and morphology to replication-competent CHIKV virus.
Immunization with CHIKV VLPs elicited neutralizing antibodies against
envelope proteins from different CHIKV strains in mouse and nonhuman
primate (NHP) models. Monkeys immunized with CHIKV VLPs produced high
titer neutralizing antibodies that protected against viremia after high
dose challenge. The selected CHIKV VLP vaccine candidate, VRC-
CHKVLP059-00-VP, composed of the E1, E2, and capsid proteins from the
CHIKV strain 37997, was recently evaluated by the VRC at the NIH
Clinical Center for safety, tolerability and immunogenicity in the
clinical protocol VRC 311 (ClinicalTrials.gov NCT01489358), a
Phase I, open-label, dose escalation clinical trial. The VRC-CHKVLP059-
00-VP vaccine was highly immunogenic, safe, and well-tolerated. VRC
researchers have also developed the transient transfection
manufacturing process for CHIKV and other alphaviruses, such as
Western, Eastern and Venezuelan Equine Encephalitis (WEVEE) viruses.
Pre-clinical in vivo mouse and NHP data, Phase 1 clinical trial data
and manufacturing data are available.
NIH will evaluate a license applicant's capabilities and experience
in advancing similar technologies through the regulatory process. This
technology is not eligible for the NIH's start-up license program.
Potential Commercial Applications: Chikungunya vaccines based on
viral like particles.
Competitive Advantages:
There is currently no CHIKV vaccine on the market.
VRC-CHKVLP059-00-VP vaccine candidate is highly
immunogenic, safe, and well-tolerated.
Minimal containment requirements for CHIKV VLP
manufacturing because live virus production is not required.
Development Stage:
In vitro data available.
In vivo data available (animal).
In vivo data available (human).
Inventors: Gary J. Nabel, Wataru Akahata, Srinivas S. Rao (all of
VRC/NIAID).
Publications:
1. Akahata W, et al. A virus-like particle vaccine for epidemic
Chikungunya virus protects non-human primates against infection. Nat
Med. 2010 Mar;16(3):334-8. [PMID 20111039].
2. Akahata W, Nabel GJ. A specific domain of the Chikungunya virus
E2 protein regulates particle formation in human cells: implications
for alphavirus vaccine design. J Virol. 2012 Aug;86(16):8879-83. [PMID
22647698].
3. Chang et al. Chikungunya Virus-Like Particle Vaccine Elicits
Neutralizing Antibodies in Healthy Adults in a Phase I Clinical Trial;
manuscript submitted.
Intellectual Property:
[[Page 50924]]
HHS Reference Nos. E-004-2009/0/1/2-
US Provisional Application No. 61/118,206 filed 26 Nov
2008.
US Provisional Application No. 61/201,118 filed 05 Dec
2008.
International Application No. PCT/US2009/006294 (WO 2010/
062396) filed 24 Nov 2009.
and corresponding filings in the US, Europe, China,
Australia, Brazil, India, Malaysia, South Africa, Singapore, Indonesia,
Philippines and Vietnam.
HHS Reference Nos. E-057-2011/0/1/2-
US Provisional Application No. 61/438,236 filed 31 Jan
2011.
International Application No. PCT/US2012/023361 (WO 2012/
106356) filed 31 Jan 2012.
and corresponding filings in the US and India.
Licensing Contact: Cristina Thalhammer-Reyero, Ph.D., MBA; 301-435-
4507; ThalhamC@mail.nih.gov.
Dated: August 20, 2014.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. 2014-20183 Filed 8-25-14; 8:45 am]
BILLING CODE 4140-01-P
