Government-Owned Inventions; Availability for Licensing, 46840-46843 [2014-18853]
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46840
Federal Register / Vol. 79, No. 154 / Monday, August 11, 2014 / Notices
Based on the number of
manufacturers that would be covered by
the guidance, we estimate that
approximately 5,000 firms will add the
following to their COOP: (1) Instructions
for reporting adverse events; and (2) a
plan for submitting stored reports that
were not submitted within regulatory
timeframes. We estimate that each firm
will take approximately 50 hours to
prepare the adverse event reporting plan
for its COOP.
We estimate that approximately 500
firms will be unable to fulfill normal
adverse event reporting requirements
because of conditions caused by an
influenza pandemic and that these firms
will notify the appropriate FDA
organizational unit responsible for
adverse event reporting compliance
when the conditions exist. Although we
do not anticipate such pandemic
influenza conditions to occur every
year, for purposes of the PRA, we
estimate that each of these firms will
notify FDA approximately once each
year, and that each notification will take
approximately 8 hours to prepare and
submit.
Concerning the recommendation in
the guidance that firms unable to fulfill
normal adverse event reporting
requirements maintain documentation
of the conditions that prevent them from
meeting these requirements and also
maintain records to identify what
adverse event reports have been stored
and when the reporting process is
restored, we estimate that
approximately 500 firms will each need
approximately 8 hours to maintain the
documentation and that approximately
500 firms will each need approximately
8 hours to maintain the records.
Therefore, the total recordkeeping
burden that would result from the
guidance would be 258,000 hours.
The guidance also refers to previously
approved collections of information
found in FDA’s adverse event reporting
requirements in 21 CFR 310.305, 314.80,
314.98, 600.80, 606.170, 640.73,
1271.350, and part 803. These
regulations contain collections of
information that are subject to review by
OMB under the PRA (44 U.S.C. 3501–
3520) and are approved under OMB
control numbers 0910–0116, 0910–0291,
0910–0230, 0910–0308, 0910–0437, and
0910–0543. In addition, the guidance
also refers to adverse event reports for
nonprescription human drug products
marketed without an approved
application and dietary supplements
required under sections 760 and 761 of
the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 379aa and 379aa–1),
which include collections of
information approved under OMB
control numbers 0910–0636 and 0910–
0635.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Type of reporting
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
Notify FDA when normal reporting is not feasible ...............
500
1
500
8
4,000
Average
burden per
recordkeeper
Total hours
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
Type of recordkeeping
Add adverse event reporting plan to COOP .......................
Maintain documentation of influenza pandemic conditions
and resultant high absenteeism .......................................
Maintain records to identify what reports have been stored
and when the reporting process was restored ................
Number of
records per
recordkeeper
Total annual
records
[FR Doc. 2014–18944 Filed 8–8–14; 8:45 am]
BILLING CODE 4164–01–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
National Institutes of Health,
HHS.
ACTION:
5,000
50
250,000
500
1
500
8
4,000
500
1
500
8
4,000
........................
........................
........................
258,000
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: August 5, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
AGENCY:
1
........................
1 There
5,000
Notice.
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17:35 Aug 08, 2014
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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
SUMMARY:
PO 00000
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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
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Federal Register / Vol. 79, No. 154 / Monday, August 11, 2014 / Notices
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
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• 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;
shmilovm@mail.nih.gov.
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 colee@cc.nih.gov or 301–451–4430.
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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;
shmilovm@mail.nih.gov.
Collaborative Research Opportunity:
The National Institutes of Health
Clinical Center is seeking statements of
capability or interest from parties
interested in collaborative research to
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46841
further develop, evaluate or
commercialize conduction assisted stent
removal. For collaboration
opportunities, please contact Ken Rose,
Ph.D., JD at rosek@mail.nih.gov or 240–
276–5509.
Cancer Immunotherapy Using VirusLike 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).
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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; vince.contreras@
nih.gov.
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 hewesj@mail.nih.gov.
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
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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).
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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; hus@
mail.nih.gov.
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; tongb@
mail.nih.gov.
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
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contact Marguerite J. Miller at
Marguerite.Miller@nih.gov or 301–496–
9003.
AAV-Vectors for Treatment of Glycogen
Storage Disorders
Description of Technology: AdenoAssociated 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-a (G6Pase-a 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 ssAAVG6PC-GPE. The expression of G6Pase-a
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 ssAAVG6PC-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 ssAAVG6PC-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-a.
Competitive Advantages: Comparative
studies showed that the ssAAV-G6PaseGPE 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
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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;
vepas@mail.nih.gov.
Novel Epstein-Barr Virus Vaccines
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Description of Technology: EpsteinBarr 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 selfassembly 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).
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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; changke@
mail.nih.gov.
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 selfrenewal 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).
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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; mccuepat@
mail.nih.gov.
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Office of the Director, National
Institutes of Health; Notice of Meeting
Pursuant to section 10(a) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of a meeting of the
Advisory Committee to the Director,
National Institutes of Health.
The meeting will be open to the
public, the attendance limited to space
available. Individuals who plan to
attend and need special assistance, such
as sign language interpretation or other
reasonable accommodations, should
notify the Contact Person listed below
in advance of the meeting.
Name of Committee: Advisory Committee
to the Director, National Institutes of Health.
Date: September 5, 2014.
Time: 3:00 p.m. to 4:00 p.m.
Agenda: To review and evaluate reports
from the HeLa Genome Data Access and the
Stem Cell working groups.
Place: National Institutes of Health
(Telephone Conference Call), Dial in 800–
779–9282, Passcode: ACD Teleconference.
Contact Person: Gretchen Wood, Staff
Assistant, National Institutes of Health Office
of the Director, One Center Drive, Building 1,
Room 126, Bethesda, MD 20892, 301–496–
4272, woodgs@od.nih.gov.
Any member of the public interested in
presenting oral comments to the committee
must notify the Contact Person listed on this
notice at least 10 days in advance of the
meeting. Interested individuals and
representatives of organizations must submit
a letter of intent, a brief description of the
organization represented, and a short
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]]>Agencies
[Federal Register Volume 79, Number 154 (Monday, August 11, 2014)]
[Notices]
[Pages 46840-46843]
From the Federal Register Online via the Government Printing 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;
shmilovm@mail.nih.gov.
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 colee@cc.nih.gov 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;
shmilovm@mail.nih.gov.
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
rosek@mail.nih.gov 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;
vince.contreras@nih.gov.
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
hewesj@mail.nih.gov.
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;
hus@mail.nih.gov.
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;
tongb@mail.nih.gov.
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 Marguerite.Miller@nih.gov 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;
vepas@mail.nih.gov.
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;
changke@mail.nih.gov.
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;
mccuepat@mail.nih.gov.
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]
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