[Federal Register Volume 79, Number 79 (Thursday, April 24, 2014)]
[Notices]
[Pages 22820-22822]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-09354]


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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.

Use of Antihistamine Compounds for the Treatment of Hepatitis C Virus

    Description of Technology: The vast majority of people infected 
with Hepatitis C Virus (HCV) will have chronic infection. Over decades, 
this can lead to liver disease and liver cancer. In fact, HCV infection 
is the leading cause of liver transplants in the U.S. Several new drugs 
have recently come into the market that will likely change the HCV 
treatment paradigm. However, the effectiveness of these new drugs can 
vary depending on the HCV genotype. Thus, there is still the need for 
additional new therapeutics against HCV.
    The subject technology are small molecule compounds identified 
using a novel cell-based high throughput assay of HCV infection. The 
compounds are antihistamines that show potent antiviral properties 
against HCV. One advantage of these compounds is that they are already 
on the market for the treatment of allergic reactions and, thus, have 
been used extensively in humans and have excellent safety profiles with 
known pharmaceutical properties. The subject technology can also 
potentially be used in combination with other HCV therapeutics.
    Potential Commercial Applications: Prevention or treatment of HCV 
infection.
    Competitive Advantages: These compounds are already on the market 
and, thus, have known safety profiles and pharmaceutical properties.

Development Stage

 Early-stage
 In vitro data available
    Inventors: Jake Tsanyang Liang (NIDDK), Juan Jose Marugan (NCATS), 
Noel Terrance Southhall (NCATS), Xin Hu (NCATS), Jingbo Xiao (NCATS), 
Shanshan He (NIDDK), Marc Ferrer (NCATS), Zongyi Hu (NIDDK), Wei Zhang 
(NCATS)
    Intellectual Property: HHS Reference No. E-011-2014/0--US 
Provisional Patent Application No. 61/909,414 filed 27 Nov 2013
    Licensing Contact: Kevin W. Chang, Ph.D.; 301-435-5018; 
[email protected]

Intranasal Nebulizer With Disposable Drug Cartridge for Improved 
Delivery of Vaccines and Therapeutics

    Description of Technology: Intranasal delivery is a simple, 
inexpensive and needle-free route for administration of vaccines and 
therapeutics. This intranasal delivery technology, developed with 
Creare LLC, includes low-cost, disposable drug cartridges (DDCs) that 
mate with a durable hand-held device. The rechargeable-battery-powered 
device transmits ultrasonic energy to the DDC to aerosolize the drug 
and is capable of performing for eight hours at 120 vaccinations per 
hour. Potential applications for this platform technology include 
intranasal vaccination (e.g. seasonal or pandemic influenza vaccines) 
and intranasal delivery of locally active (e.g. antihistamines, 
steroids) or systemically active (e.g. pain medications, sedatives) 
pharmaceuticals.
    The DDCs themselves offer two unique benefits. First, all 
components that contact the active agent or the patient may be easily 
disposed of, which reduces the risk of patient cross-contamination and 
minimizes cleaning and maintenance requirements of the hand-held 
device. Second, DDCs provide a low-cost and simple method to package 
and distribute individual doses.
    This technology also allows for significant dose-sparing. 
Preliminary studies have shown robust immune responses when this 
technology is used to delivery significantly reduced doses of Live 
Attenuated Influenza Vaccine in animal models. The intranasal nebulizer 
produces droplets sized for optimum depositioning in the nasal airway. 
The small nebulizer droplets essentially ``spray paint'' the internal 
nasal airway, resulting in an increased tissue surface coverage that 
may enable a significant dose reduction. In contrast, currently 
available nasal delivery devices, such as nasal sprays and droppers, do 
not provide efficient intranasal delivery in humans because the large 
droplets they generate fail to coat a significant portion of the nasal 
airway. Large droplets also tend to drip out of the nose or down the 
throat, which can be unpleasant for the patient in addition to wasting 
a sizable portion of the active agent.

Potential Commercial Applications

 Intranasal delivery of vaccines and therapeutics
 Childhood vaccination programs, mass immunization campaigns, 
or response to epidemics

Competitive Advantages

 Safe, needle-less delivery
 No patient-to-patient contamination
 Long-life, rechargeable battery
 Consistent delivery and dose-sparing
 Nasal delivery of live-attenuated vaccines may be more 
effective than traditional injected vaccines
 Cost-effective
 Reduces biohazard waste
 May be administered by personnel with minimal medical training
 Easy means of delivery to children with fear of needles

Development Stage

 Prototype
 In vitro data available
 In vivo data available (animal)

    Inventors: Mark J. Papania (CDC), et al.
    Publication: Smith JH, et al. Nebulized live-attenuated influenza

[[Page 22821]]

vaccine provides protection in ferrets at a reduced dose. Vaccine. 2012 
Apr 19;30(19):3026-33. [PMID 22075083]

Intellectual Property

 HHS Reference No. E-308-2013/0--
--PCT Application No. PCT/US2011/039020 filed on 03 Jun 2011, which 
published as WO 2011/153406 on 08 Dec 2011
--US Patent Application No. 13/701,992 filed 04 Dec 2012
--Various international pending patents

 HHS Reference No. E-323-2013/0--
--PCT Application No. PCT/US2002/007973 filed 13 Mar 2002, which 
published as WO 2002/074372 on 26 Sep 2002
--US Patent No. 7,225,807 issued 05 Jun 2007
--US Patent No. 8,544,462 issued 01 Oct 2013
--Various international issued patents

 HHS Reference No. E-324-2013/0--
--PCT Application No. PCT/US2005/011086 filed 01 Apr 2005, which 
published as WO 2006/006963 on 19 Jan 2006
--US Patent No. 7,954,486 issued 07 Jun 2011
--US Patent No. 8,656,908 issued 25 Feb 2014
--Various international issued patents

 HHS Reference No. E-564-2013/0--US Provisional Application No. 
61/808,547 filed 04 Apr 2013
    Licensing Contact: Whitney Blair, J.D., M.P.H.; 301-435-4937; 
[email protected]

Silica Exposure Safety: Mini-Baghouse Systems and Methods for 
Controlling Particulate Release From Large Sand Transfer Equipment

    Description of Technology: CDC/NIOSH scientists have developed an 
effective point-source control for silica-containing dusts that can be 
generated from machinery on sites where hydraulic fracturing is 
occurring. The CDC/NIOSH mini-baghouse retrofit assembly is a bolt-on 
control designed to contain silica-containing respirable dusts 
generated during refill operations of sand movers during hydraulic 
fracturing.
    In the U.S., most new oil and gas wells are hydraulically fractured 
to enhance well production. Most hydraulic fracturing operations have 
2-5 sand movers on-site which transfer thousands to millions of pounds 
of silica sand during each stage of fracturing. While a variety of 
passive and active controls are currently available (or have been 
proposed) to limit release of silica-containing dusts, the CDC/NIOSH 
mini-baghouse retrofit assembly was designed to fill a unique need for 
a control. The retrofit to equipment can be made in the field, uses 
existing energy inherent in the system and is relatively simple and 
effective. CDC/NIOSH field research has shown that risks for exposure 
to respirable silica arise from at least 8 points of dust generation 
and that a variety of controls (engineering, administrative and 
personal protective equipment) are needed to control exposures. Use of 
the mini-baghouse retrofit technology is intended to limit release of 
respirable silica from thief hatches on top of the sand movers, 
enhancing workplace health and safety.

Potential Commercial Applications

 Controlling occupational exposure to respirable crystalline 
silica, particularly during work involving transfer of sand into sand 
movers on hydraulic fracturing sites
 In-field retrofits of currently operating heavy equipment 
(e.g., sand movers)
 Limiting visible dust emissions from sand moving equipment
 Reducing respirable crystalline silica dust emissions to 
enhance compliance with OSHA PEL for silica

Competitive Advantages

 Designed for in-field retrofitting ``thief hatches'' of 
existing machinery
 Uses energy inherent in the pneumatic transfer of sand
 Provides a passive sand-mover-mounted control for silica 
release at hydraulic fracturing operations

Development Stage

 In situ data available (on-site)
 Prototype

    Inventors: Eric J. Esswein, Michael Breitenstein, John E. Snawder, 
Michael G. Gressel, Jerry L. Kratzer (all of CDC)
    Publication: Esswein EJ, et al. Occupational exposures to 
respirable crystalline silica during hydraulic fracturing. JJ Occup 
Environ Hyg. 2013;10(7):347-56. [PMID 23679563]
    Intellectual Property: HHS Reference No. E-291-2013/0--US 
Application No. 13/802,265 filed 13 Mar 2013
    Licensing Contact: Whitney Blair, J.D., M.P.H.; 301-435-4937; 
[email protected]

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.
    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)

[[Page 22822]]

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

 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 No. 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; [email protected]

    Dated: April 21, 2014.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2014-09354 Filed 4-23-14; 8:45 am]
BILLING CODE 4140-01-P