[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]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Government-Owned Inventions; Availability for Licensing

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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SUMMARY: The inventions listed below are owned by an agency of the U.S. 
Government and are available for licensing in the U.S. in accordance 
with 35 U.S.C. 209 and 37 CFR part 404 to achieve expeditious 
commercialization of results of federally-funded research and 
development. Foreign patent applications are filed on selected 
inventions to extend market coverage for companies and may also be 
available for licensing.

FOR FURTHER INFORMATION CONTACT: Licensing information and copies of 
the U.S. patent applications listed below may be obtained by writing to 
the indicated licensing contact at the Office of Technology Transfer, 
National Institutes of Health, 6011 Executive Boulevard, Suite 325, 
Rockville, Maryland 20852-3804; telephone: 301-496-7057; fax: 301-402-
0220. A signed Confidential Disclosure Agreement will be required to 
receive copies of the patent applications.

SUPPLEMENTARY INFORMATION: Technology descriptions follow.

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