[Federal Register Volume 78, Number 178 (Friday, September 13, 2013)]
[Notices]
[Pages 56720-56722]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-22264]


-----------------------------------------------------------------------

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.

Aortic Access From Vena Cava for Large Caliber Transcatheter 
Cardiovascular Interventions

    Description of Technology: The invention pertains to a device and 
method for transcatheter correction of cardiovascular abnormalities, 
such as the delivery of prosthetic valves to the heart. Featured is a 
device implant for closing a caval-aortic iatrogenic fistula created by 
the introduction of a transcatheter device from the inferior vena cava 
into the abdominal aorta. The occlusion device includes an expandable 
transvascular implant with an elastomeric surface capable of extending 
between a vein and artery which conforms to the boundaries of an 
arteriovenous fistula tract between the artery and vein. A guidewire 
channel is disposed within the occlusion device where the channel also 
has elastomeric wall surfaces that conform or can be expanded to the 
area so that it occludes the channel when the guidewire is not present. 
The implant is resiliently deformable into a radially compressed 
configuration for delivery through the catheter. When not deformed into 
the radially compressed configuration, the distal end of the device is 
radially enlarged, relative to the intermediate neck, whereby the 
distal end forms an enlarged distal skirt, such as a disk or button 
shaped member. A polymer coating on the radially enlarged distal end 
conforms to the endoluminal aortic wall for deployment against an 
internal wall of the artery.
    Potential Commercial Applications:

 cardiovascular surgery.
 heart valve implantation.
 valve-repair.
    Competitive Advantages:
 closure of the caval-aortic iatrogenic fistula.
 vascular access.
    Development Stage:
 Prototype.
 In vivo data available (animal).
 In vivo data available (human).
    Inventors: Robert Lederman and Ozgur Kocaturk (NHLBI).
    Publications:

1. Kodali SK, et al. Two-year outcomes after transcatheter or surgical 
aortic-valve replacement. N Engl J Med. 2012 May 3;366(18):1686-95. 
[PMID 22443479]
2. Makkar RR, et al. Transcatheter aortic-valve replacement for 
inoperable severe aortic stenosis. N Engl J Med. 2012 May 
3;366(18):1696-704. [PMID 22443478]
3. Smith CR, et al. Transcatheter versus surgical aortic-valve 
replacement in high-risk patients. N Engl J Med. 2011 Jun 
9;364(23):2187-98. [PMID 21639811]

    Intellectual Property: HHS Reference No. E-553-2013/0--U.S. 
Provisional Patent Application 61/863,071 filed August 7, 2013.
    Related Technologies:

 HHS Reference No. E-115-2013/0--U.S. Provisional Patent 
Application No. 61/834,357 filed June 12, 2013.
 HHS Reference No. E-027-2013/0--U.S. Provisional Patent 
Application No. 61/785,652 filed March 14, 2013.
    Licensing Contact: Michael Shmilovich; 301-435-5019; 
shmilovm@mail.nih.gov.
    Collaborative Research Opportunity: The National Heart Lung & Blood

[[Page 56721]]

Institute is seeking statements of capability or interest from parties 
interested in collaborative research to further develop, evaluate or 
commercialize Transcatheter Cardiovascular Interventions. For 
collaboration opportunities, please contact Ms. Peg Koelble at 
koelblep@mail.nih.gov or 301-402-5579.

Photoactivatable Nanoparticles for Targeted Drug Delivery

    Description of Technology: The invention relates to novel lipid-
based nanoparticles (liposomes) for use in targeted drug delivery. The 
particles include a wall surrounding a cavity, wherein the wall 
includes (i) a lipid bilayer comprising 1,2-bis(tricosa-10,12-diynoyl)-
sn-glycero-3-phosphocholine (DC8,9PC), and 
dipalmitoylphosphatidylcholine (DPPC), and (ii) a tetrapyrollic 
photosensitizer, such as 2-[1-hexyloxyethyl]-2-devinyl 
pyropheophorbide-a (HPPH) within the lipid bilayer. The lipid bilayer 
may include one or more segregated regions, or pockets, of DC8,9PC with 
the HPPH being preferentially located within the DC8,9PC pockets. The 
nanoparticles include at least one therapeutic agent within the cavity. 
Upon a targeted application of light in the near-infrared range, the 
particles are disrupted and can release the therapeutic agent at a 
targeted site. The concurrent release of the photosensitizing agent 
HPPH may be advantageous in the treatment of certain cancers, since 
this agent has shown to possess therapeutic ability on its own right.
    Potential Commercial Applications: The nanoparticles can be used 
for targeted drug delivery.
    Competitive Advantages:
 The particles are stable and can be activated upon demand to 
release the therapeutic agent at the desired site.
 The concurrent release of the photosensitizing agent HPPH may 
be advantageous in the treatment of certain types of cancer, since this 
agent has shown to possess therapeutic ability on its own right.
    Development Stage: In vivo data available (animal).
    Inventors: Anu Puri (NCI) et al.
    Publications:

1. Yavlovich A, et al. Design of liposomes containing 
photopolymerizable phospholipids for triggered release of contents. J 
Therm Anal Calorim. 2009 Oct1;98(1):97-104. [PMID 20160877]
2. Yavlovich A, et al. A novel class of photo-triggerable liposomes 
containing DPPC:DC(8,9)PC as vehicles for delivery of doxorubicin to 
cells. Biochim Biophys Acta. 2011 Jan;1808(1):117-26. [PMID 20691151]
3. Puri A, Blumenthal R. Polymeric lipid assemblies as novel 
theranostic tools. Acc Chem Res. 2011 Oct 18;44(10):1071-9. [PMID 
21919465]
4. Puri A, et al. Material properties of matrix lipids determine the 
conformation and intermolecular reactivity of diacetylenic 
phosphatidylcholine in the lipid bilayer. Langmuir. 2011 Dec 
20;27(24):15120-8. [PMID 22053903]

    Intellectual Property: HHS Reference No. E-482-2013/0--U.S. 
Application No. 61/845,861 filed July 12, 2013.
    Related Technologies:

1. Fabrication of phototriggerable liposomes.
2. Loading of a drug into the cavity and HPPH in the lipid bilayer of 
liposomes.
3. Laser-triggered release in vitro and in tumors.
    Licensing Contact: Uri Reichman, Ph.D., MBA; 301-435-4616; 
ur7a@nih.gov.
    Collaborative Research Opportunity: The National Cancer Institute 
is seeking statements of capability or interest from parties interested 
in collaborative research to further develop, evaluate or commercialize 
photoactivable nanoparticles for drug delivery. For collaboration 
opportunities, please contact John D. Hewes, Ph.D. at 
hewesj@mail.nih.gov.

Signatures of Genetic Control in Digestive and Liver Disorders

    Description of Technology: Our technology describes unique genetic 
signatures in patients with digestive diseases and liver disorders. 
Using comprehensive analysis of 735 microRNAs and 19,000 mRNAs, we have 
identified a unique set of microRNAs and/or mRNAs which predict disease 
phenotypes in patients with digestive and liver disorders. The 
identification of such point-of-care genetic signatures is significant 
for both personalized biomarkers and novel targeted biotherapeutics. 
These microRNAs and mRNAs function either together or separately thus 
modulating protein expressions in one or more signaling pathways. A 
particular noteworthy signature of genetic control includes miR-150, 
which is known to modulate target proteins within the Akt signaling 
pathways implicated in inflammatory processes as well as processes 
affecting cancer cell proliferation and/or survival.
    Potential Commercial Applications:
 Personalized biomarkers.
 Novel targeted biotherapeutic.
    Competitive Advantages:
 Point-of-care signatures from minimally invasive samples.
 Protocol streamlined for high-throughput analysis.
 Quantitative molecular diagnostics.
 Unique microRNAs and/or mRNAs reveal biological targets within 
synergistic cellular pathways.
    Development Stage:
 Pilot.
 Early-stage.
 Pre-clinical.
 In vitro data available.
    Inventors: Wendy A. Henderson, Ralph M. Peace, Nicolaas H. Fourie, 
Sarah K. Abey (NINR).
    Intellectual Property:
 HHS Reference No. E-349-2013/0--U.S. Provisional Patent 
Application No. 61/825,154 filed May 20, 2013.
 HHS Reference No. E-349-2013/1--U.S. Provisional Patent 
Application No. 61/825,489 filed May 20, 2013.
    Licensing Contact: Suryanarayana (Sury) Vepa, Ph.D., J.D.; 301-435-
5020; vepas@mail.nih.gov.

Histone Deacteylase (HDAC) Inhibitors That Enhance Chemotherapy

    Description of Technology: In cancers with KRAS-mutations, such as 
leukemias, colon cancer, pancreatic cancer, and lung cancer, 
researchers at the NCI have observed that administration of the HDAC 
inhibitor romidepsin in combination with certain MAPK pathway and PI3K 
pathway inhibitors resulted in significant cytotoxicity, regardless of 
the type of cancer. Further, the researchers have achieved this effect 
at clinically relevant dosages and time periods.
    Available for licensing are methods that employ these findings to 
treat cancers or induce cell death in tumor cells.
    Potential Commercial Applications: Development of therapeutics for 
cancers with a high instance of KRAS mutations such as leukemias, colon 
cancer, pancreatic cancer, and lung cancer.
    Competitive Advantages: The synergistic combination of agents 
induces cytotoxicity better than any of the agents alone.
    Development Stage: Early-stage.
    Inventors: Susan E. Bates, et al. (NCI).
    Intellectual Property: HHS Reference No. E-097-2013/0--U.S. 
Application No. 61/807,574 filed April 2, 2013.
    Licensing Contact: Patrick McCue, Ph.D.; 301-435-5560; 
mccuepat@mail.nih.gov.

[[Page 56722]]

Dipicolylamine-based Nanoparticles for Delivery of Ligands

    Description of Technology: Many potential nucleic acid therapeutics 
have not transitioned from the research laboratory to clinical 
application in large part because delivery technologies for these 
therapies are not effective. Most nucleic acid delivery technologies 
are lipid-based or positively charged and require chemical or physical 
conjugation with the nucleic acid. These delivery systems are often 
therapeutically unacceptable due to toxicity or immune system 
reactivity. The present technology is a nanoparticle complex, 
containing a polymer substrate, such as a hyaluronic acid, and 
Zn2\+\-dipicolylamine (Zn-DPA), that associates selectively 
with the nucleic acid phosphodiester groups. This complex functions as 
a simple, easy to scale-up, cost effective, low toxicity delivery 
system for potential nucleic acid therapeutics, such as siRNA 
molecules. It may also be capable of co-delivering other small molecule 
drugs.
    Potential Commercial Applications:
 Drug delivery.
 Gene therapy.
    Competitive Advantages:
 Efficient.
 Easy to scale-up.
 Cost effective
 Low toxicity
    Development Stage:

 Early-stage
 In vivo data available (animal)
    Inventors: Xiaoyuan Chen (NIBIB), Seulki Lee (NIBIB), KiYoung Choi 
(NIBIB), Gang Liu (North Sichuan Medical College, China).
    Publication: Liu G, et al. Sticky nanoparticles: a platform for 
siRNA delivery by bis(zinc(ll) dipolyamine)-functionalized, self-
assembled nanoconjugate. Angew Chem lnt Ed Engl. 2012 Jan 9;51(2):445-
9. [PMID 22110006].
    Intellectual Property: HHS Reference No. E-066-2012/0--U.S. 
Provisional Application No. 61/729,159 filed November 21, 2012
    Licensing Contact: Edward (Tedd) Fenn; 424-500-2005; 
tedd.fenn@nih.gov.
    Collaborative Research Opportunity: The National Institute of 
Biomedical Imaging and Bioengineering 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 Henry S. Eden, M.D., 
Ph.D. at edenh@mail.nih.gov.

Norovirus-Neutralizing Monoclonal Antibodies

    Description of Technology: Vaccines and therapies to prevent and 
treat Norovirus infections do not exist, despite the worldwide 
prevalence of Norovirus infections. Outbreaks of human gastroenteritis 
attributable to Norovirus commonly occur in group setting, such as 
hospitals, nursing homes, schools, dormitories, cruise ships and 
military barracks.
    This technology relates to monoclonal antibodies, which 
specifically bind to Norovirus and have therapeutic potential. In a 
primate model, these antibodies stimulated a strong adaptive immune 
response which may produce a protective effect. These Norovirus 
antibodies may have application as immunoprophylaxis to protect 
individuals from infections or as a possible treatment for infected 
individuals.
    Potential Commercial Applications:
 Therapeutic
 Vaccine
    Competitive Advantages: Currently, no vaccines or therapies exist 
to prevent and treat Norovirus infections.
    Development Stage:
 Early-stage
 In vivo data available (animal)
    Inventors: Zhaochun Chen, Robert H. Purcell, Lisbeth Kim Green, 
Stanislav Sosnovtsev, Karin Bok (all of NIAID).
    Publication: Chen Z, et al. Development of Norwalk virus-specific 
monoclonal antibodies with therapeutic potential for the treatment of 
Norwalk virus gastroenteritis. J Virol. 2013 Sep;87(17):9547-57. [PMID 
23785216].
    Intellectual Property: HHS Reference No. E-226-2011/0--U.S. 
Provisional Application No. 61/763,879 filed February 2, 2013.
    Licensing Contact: Edward (Tedd) Fenn; 424-500-2005; 
tedd.fenn@nih.gov.
    Collaborative Research Opportunity: The National Institute of 
Allergy and Infectious Diseases 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 Maryann Puglielli, Ph.D., J.D. at 
pugliellim@mail.nih.gov.

    Dated: September 9, 2013.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2013-22264 Filed 9-12-13; 8:45 am]
BILLING CODE 4140-01-P