[Federal Register Volume 79, Number 154 (Monday, August 11, 2014)]
[Notices]
[Pages 46840-46843]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-18853]
-----------------------------------------------------------------------
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.
Web Application for Managing the Request Process for Order Set
Development Within an Electronic Health Record
Description of Technology: Technology to empower clinical staff in
requesting and designing order sets can be transformative for hospitals
and other health care organizations. This software is proving itself
vital in building greater
[[Page 46841]]
order set development efficiencies and in communication among key
stakeholders responsible for certain aspects of an order set within an
organization. By providing end users the necessary tools (e.g.,
ordering items off of an available ``menu'' of orderable items within
an EHR) to build order sets on their own time and under their own
accord has been met with critical acclaim. This empowerment to the end
user and the deprecation of any manual process has been a primary goal
of this software.
With less time spent translating and managing order sets from the
conceptual stage to release, organizational staff can now spend more
time working through more pressing clinical issues with their
customers; and since this software can standardize and manage the
process by which order sets are developed, less error-prone and more
timely stages of an order set request with clinical and organizational
staff become the norm. Most importantly, this software enables all of
those end-users targeted communication pathways in which to operate and
end users can now gleam a greater picture of the entire order set
development needs and direction--bringing concept to release a quicker
pathway than what was available for them in the past.
Potential Commercial Applications: Electronic Health Records.
Competitive Advantages
Web-based Application
Platform for development of Order Sets
Customizable for extension to EHR of choice
Facilitation of workflow process and approval sign-off
Development Stage: Prototype.
Inventors: Christopher Siwy, Josanne Revoir, Jon McKeeby (all of
NIHCC).
Intellectual Property: HHS Reference No. E-187-2014/0--Software.
Patent protection is not being pursued for this technology.
Licensing Contact: Michael Shmilovich, Esq., CLP; 301-435-5019;
[email protected].
Collaborative Research Opportunity: The National Institutes of
Health Clinical Center is seeking statements of capability or interest
from parties interested in collaborative research to further develop,
evaluate or commercialize Electronic Health Records. For collaboration
opportunities, please contact Eric Cole at [email protected] or 301-451-
4430.
Implantable Medical Devices With Electric Current Retrieval Assist
Description of Technology: Implantable devices, such as filters and
stents, typically include structures that anchor to surrounding tissue.
To prevent blood clots from reaching the heart, an IVC filter may be
implanted into the patient. While generally effective at preventing
movement of post-implantation, traditional anchors present challenges
when attempting to remove the device from the subject. In particular,
the tissue to which the device is anchored may grow around the anchors
making removal difficult. The invention pertains to an implantable
device (e.g., an IVC filter) with a plurality of expandable members
each having a portion that comes into contact with the tissue of a
subject when expanded. A force is then provided to the retrieval
portion to collapse the implantable device. An electrical current
(approx. 0.2 and 0.55 Amps) is also provided to the portions of the
expandable members that come into contact with the tissue of the
subject via the retrieval apparatus by way of a conductive snare in one
or more of the expandable members.
Potential Commercial Applications
Blood clot prevention
Stent removal
Implantation
Competitive Advantages: Ease of removal from subject tissue.
Development Stage
Early-stage
In vitro data available
In vivo data available (animal)
Inventors: Bradford Wood and Hayet Amalou (NIHCC).
Publication: Amalou H, et al. Electrically conductive catheter
inhibits bacterial colonization. J Vasc Interv Radiol. 2014
May;25(5):797-802. [PMID 24745908].
Intellectual Property: HHS Reference No. E-088-2014/0--U.S.
Provisional Patent Application 61/968,757 filed March 21, 2014.
Related Technologies: HHS Reference No. E-244-2000/1--U.S. Patent
Nos. 6,676,657, issued January 13, 2004, and 7,122,033, issued October
17, 2006 (Endoluminal Radiofrequency Cauterization System).
Licensing Contact: Michael Shmilovich, Esq., CLP; 301-435-5019;
[email protected].
Collaborative Research Opportunity: The National Institutes of
Health Clinical Center is seeking statements of capability or interest
from parties interested in collaborative research to further develop,
evaluate or commercialize conduction assisted stent removal. For
collaboration opportunities, please contact Ken Rose, Ph.D., JD at
[email protected] or 240-276-5509.
Cancer Immunotherapy Using Virus-Like Particle Containing Alphavirus
Replicons Coding for Therapeutic Proteins
Description of Technology: One major challenge in development of
effective cancer therapies is a lack of universal, cancer specific
markers in target cells. Current cancer therapies heavily rely on
surgery, chemotherapy, and radiation therapy. Such treatments, although
successful in some limited cases, are less effective long term and
often result in highly resistant populations of cancer cells that are
less susceptible to successive applications of chemotherapy and
radiation. Additionally, the systemic application of these therapies
and lack of specificity can lead to adverse side effects. Considerable
effort has thus been devoted to finding new ways of identifying and
specifically targeting extracellular cancer markers using antibody
based therapies. However, diminished access to new cancer cell surface
markers has limited the development of corresponding antibodies.
Investigators at the National Cancer Institute have discovered a novel
method employing presentation of intracellular cancer antigens on the
cell surface to convert a tumor into induced antigen presenting cells
(APCs). The technology utilizes virus-like particle (VLP) mediated RNA
delivery of therapeutic proteins, HLA II and CD80, to directly convert
cancer cells into APCs to activate helper and cytotoxic T cells against
the tumor. This immunotherapy has the potential to induce tumor
specific responses with minimal toxicity to neighboring healthy cells.
Potential Commercial Applications
Cancer immunotherapy
Cancer vaccine
Competitive Advantages
Targeted delivery
Therapy is effective for any cancer antigen, known or unknown
Simple procedure
More robust immune response
Development Stage
In vitro data available
In vivo data available (animal)
Prototype
Inventors: Stanislaw J. Kaczmarczyk and Deb K. Chatterjee (NCI/
Leidos).
[[Page 46842]]
Intellectual Property: HHS Reference No. E-050-2014/0--U.S.
Provisional Application No. 61/916,384 filed December 16, 2013.
Related Technology: HHS Reference No. E-264-2011/0--PCT Application
No. PCT/US2013/031876 filed March 15, 2013.
Licensing Contact: Vince Contreras, Ph.D.; 301-435-4711;
[email protected].
Collaborative Research Opportunity: The NCI Technology Transfer
Center is seeking statements of capability or interest from parties
interested in collaborative research to further develop, evaluate, or
commercialize Cancer Immunotherapy Using Virus-like Particles. For
collaboration opportunities, please contact John D. Hewes, Ph.D. at
[email protected].
Novel Anti-HIV Compounds (Peptides or Peptide Mimetics)
Description of Technology: The subject invention describes a new
class of compounds (such as peptides or mimetics) that target viral
RNAs and inhibit viral life cycle through blocking the viral
recognition process. More specifically, these compounds are the first
against an RNA Target as currently there is no clinical drug against
any RNA targets in treatment of any types of human disease. Moreover,
in contrast to all market available anti-HIV drugs that are complicated
by the development of resistance and substantial side-effect, these
compounds would unlikely develop any side effects because of its very
high specificity against only viral RNA. In addition, these compounds
may be further linked to a detectable label. Thus, these compounds have
the potential to be used as a new class of systemic drug for the
treatment of HIV infection and to be developed to diagnostic kit/
devices.
Potential Commercial Applications
HIV therapeutics
Diagnostic
Competitive Advantages
No current anti-HIV drug targets against the viral nuclear
export activity.
High binding affinity.
Permeability of cell membrane because they are positively
charged.
No side effects because of its very high specificity only to
viral RNAs.
Development Stage
Early-stage
In vitro data available
Prototype
Inventors: Yun-Xing Wang, Liu Yu, Ping Yu, Ina O'Carroll (all of
NCI).
Publication: Fang X, et al. An unusual topological structure of the
HIV-1 Rev response element. Cell. 2013 Oct 24;155(3):594-605. [PMID
24243017].
Intellectual Property: HHS Reference No. E-019-2014/0--U.S.
Provisional Patent Application No. 61/894,849 filed October 23, 2013.
Licensing Contact: Sally H. Hu, Ph.D., M.B.A.; 301-435-5606;
[email protected].
A3 Adenosine Receptor Agonists for Treating Chronic Neuropathic Pain
Description of Technology: Chronic neuropathic pain (NP) is a
widespread condition that is often associated with diabetes, cancer,
injury as well as a variety of other diseases. Current therapies for NP
are not always effective and patients suffer from serious side effects,
such as liver toxicity and addiction. Opioids, while effective against
acute pain, are not the first line of treatment for chronic NP because
of their addictive qualities and low efficacy. Thus, there is an unmet
need for chronic neuropathic pain treatment that operates on a
different mechanism.
The current invention describes selective A3 Adenosine Receptor
agonists and their in vivo activity reducing or preventing development
of chronic neuropathic pain in an animal model.
Potential Commercial Applications: New treatment for chronic
neuropathic pain associated with diabetes, cancer, injury, etc.
Competitive Advantages: The compounds are consistently highly
selective and have smaller molecular weight, thus greater oral
bioavailability is possible.
Development Stage
Early-stage
In vitro data available
In vivo data available (animal)
Inventors: Dr. Kenneth A. Jacobson (NIDDK), Dr. Dilip K. Tosh
(NIDDK), Daniela Salvemini (Saint Louis University).
Intellectual Property: HHS Reference No. E-742-2013/0--U.S.
Provisional Patent Application No. 61/909,742 filed November 27, 2013.
Licensing Contact: Betty B. Tong, Ph.D.; 301-594-6565;
[email protected].
Collaborative Research Opportunity: The National Institute of
Diabetes and Digestive and Kidney Diseases is seeking statements of
capability or interest from parties interested in collaborative
research to further develop, evaluate or commercialize small molecules
for neuropathic pain. For collaboration opportunities, please contact
Marguerite J. Miller at [email protected] or 301-496-9003.
AAV-Vectors for Treatment of Glycogen Storage Disorders
Description of Technology: Adeno-Associated Virus Vectors for the
treatment of glycogen storage disease, particularly glycogen storage
disease type Ia, are disclosed. Glycogen storage disease type Ia (GSD-
Ia or von Gierke disease) is caused by a deficiency in glucose-6-
phosphatase-[alpha] (G6Pase-[alpha] or G6PC). Patients affected by GSD-
Ia are unable to maintain glucose homeostasis and present with fasting
hypoglycemia, growth retardation, hepatomegaly, nephromegaly,
hyperlipidemia, hyperuricemia, and lactic academia. There is currently
no cure for GSD-Ia deficiency disorder. NIH investigators have
constructed a novel gene therapy vector by placing the G6PC gene in a
novel virus-based vector, named ssAAV-G6PC-GPE. The expression of
G6Pase-[alpha] in ssAAV-G6PC-GPE is directed by the human G6PC
promoter/enhancer at nucleotides -2864 to -1 (GPE) and this vector also
contains an intron. The G6pc-/- mice treated with ssAAV-G6PC-GPE vector
exhibited normal levels of blood glucose, blood metabolites, hepatic
glycogen, and hepatic fat. This vector was compared with a dsAAV-G6Pase
vector which differed from the NIH vector that it is double stranded
and contained much smaller G6PC promoter. The results showed that the
ssAAV-G6PC-GPE vector directed significantly higher expression of
G6Pase-alpha and achieved greater reduction in hepatic glycogen storage
while better tolerating fasting conditions. The results also showed
that the enhancer elements upstream the human G6PC minimal promoter
contained within the ssAAV-G6PC-GPE vector are responsible for the
increased efficacy in treating GSD-Ia mice.
Potential Commercial Applications: Gene therapy for glycogen
storage disorders, specifically caused by the deficiency of G6Pase-
[alpha].
Competitive Advantages: Comparative studies showed that the ssAAV-
G6Pase-GPE vector is more efficacious than other candidate therapy
vectors.
Development Stage
In vitro data available
In vivo data available (animal)
Inventors: Drs. Janice Y. Chou (NICHD) and Barry J. Byrne (Univ. of
Florida).
Publication: Lee YM, et al. The upstream enhancer elements of the
G6PC promoter are critical for optimal
[[Page 46843]]
G6PC expression in murine glycogen storage disease type Ia. Mol Genet
Metab. 2013;110(3):275-80. [PMID 23856420].
Intellectual Property: HHS Reference No. E-552-2013/0--U.S.
Provisional Patent Application No. 61/908,861 filed November 26, 2013.
Licensing Contact: Suryanarayana Vepa, Ph.D., J.D.; 301-435-5020;
[email protected].
Novel Epstein-Barr Virus Vaccines
Description of Technology: Epstein-Barr Virus (EBV) is the
causative agent of infectious mononucleosis and is associated with
certain types of cancers, such as Hodgkin's lymphoma, Burkitt's
lymphoma, gastric carcinoma, and nasopharyngeal carcinoma. There are
currently no vaccines against EBV on the market and there is only
supportive treatment available for EBV infection.
The subject technologies are novel vaccine candidates against EBV
that employ fusion proteins consisting of immunogenic portions of the
EBV envelope glycoproteins (i.e. gp350, gH/gL, etc.) that are found on
the surface of the virus fused with a self-assembling protein such as
ferritin. The fusion proteins multimerize and the resulting
nanoparticles serve as the antigens in the vaccine. In mice, these
vaccine candidates were able to elicit neutralizing antibodies that
were significantly higher than vaccination with only soluble forms of
the EBV envelope glycoproteins lacking the self-assembly domains. In
some cases, the fusion protein vaccine candidates were able to elicit
neutralizing antibodies while vaccination with the corresponding
soluble versions elicited primarily non-neutralizing antibodies. These
neutralizing antibody titers in immunized mice were substantially
higher than those seen in humans naturally infected with EBV.
Potential Commercial Applications: Vaccines against EBV.
Competitive Advantages: The subject technologies are novel vaccine
candidates against EBV that were able to elicit significantly higher
levels of neutralizing antibodies than vaccines based solely on soluble
forms of the EBV envelope glycoproteins lacking self-assembly domains.
Development Stage
Early-stage
In vitro data available
In vivo data available (animal)
Inventors: Masaru Kanekiyo, Wei Bu, Jeffrey Cohen (all of NIAID).
Intellectual Property
HHS Reference No. E-531-2013/0-US-01--U.S. Provisional Patent
Application No. 61/889,840 filed 11 Oct 2013
HHS Reference No. E-531-2013/1-US-01--U.S. Provisional Patent
Application No. 61/921,284 filed 27 Dec. 2013
Licensing Contact: Kevin W. Chang, Ph.D.; 301-435-5018;
[email protected].
Lentiviral Vectors To Modulate p53 Function in Human Stem Cells
Description of Technology: The tumor suppressor protein p53
regulates the self-renewal and pluripotency of normal and cancer stems
cells, as well as the efficiency of reprogramming normal cells into
induced pluripotent stem cells (iPSC). Natural human p53 isoforms
delta133p53 and p53beta are the physiological inhibitor and enhancer,
respectively. Researchers at the National Cancer Institute, NIH, have
discovered that human embryonic stem cells (hESC) express delta133p53
protein much more abundantly than normal human fibroblasts or cancer
cell lines.
Available for licensing are lentiviral vectors for constitutive
over-expression of the p53 isoforms delta133p53 and p53beta, inducible
over-expression of delta133p53, and inducible shRNA knock-down of
delta133p53.
Potential Commercial Applications
Stem cell-based regenerative medicine for the treatment of
age-related degenerative diseases.
Targeting of cancer stem cells for treatment of cancer.
Development of compounds that mimic the effects of the p53
isoforms on hESC and iPSC.
Development of compounds that act in p53 isoform-dependent
manners to regulate self-renewing vs. asymmetric cell divisions in
cancer stem cells.
Competitive Advantages
Enhanced expression of delta133p53 for efficient hESC
self-renewal and pluripotency without genome instability.
Enhanced expression of delta133p53 for efficient
reprogramming to iPSC without genome instability.
Enhanced expression of p53beta and/or knockdown of
delta133p53 for efficient induction of hESC/iPSC differentiation
without unwanted cell death.
Development Stage: In vitro data available.
Inventors: Curtis C. Harris, et al. (NCI).
Publication: Fujita K, et al. Positive feedback between p53 and
TRF2 during telomere-damage signalling and cellular senescence. Nat
Cell Biol. 2010 Dec;12(12):1205-12. [PMID 21057505].
Intellectual Property: HHS Reference No. E-137-2010/0--Research
Tool. Patent protection is not being pursued for this technology.
Related Technology: HHS Reference No. E-239-2010/0--Retroviral and
Lentiviral Vectors to Increase Efficiency of Inducible Pluripotent Stem
Cell (iPSC) Production.
Licensing Contact: Patrick P. McCue, Ph.D.; 301-435-5560;
[email protected].
Dated: August 6, 2014.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. 2014-18853 Filed 8-8-14; 8:45 am]
BILLING CODE 4140-01-P