Prospective Grant of Exclusive License: Miniature Serial Sectioning Microtome for Block-Face Imaging, 59796-59797 [2015-24994]
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59796
Federal Register / Vol. 80, No. 191 / Friday, October 2, 2015 / Notices
Computerized Contingency
Management, Ecological Momentary
Assessment, and a Protocol Workflow
System,’’ Drug and Alcohol Review,
28(1):3–11, January 2009.
Intellectual Property: HHS Reference
No. E–266–2014/0—Software. No patent
protection is being sought.
Contact Information: Vio Conley,
M.S.; NCI Technology Transfer Center;
Phone: 240–276–5531; Email: conleyv@
mail.nih.gov.
Keywords: Software, Clinical
Information System, Research
Information System, Medical Decision
Support System (DSS), Electronic
Hospital Records (EHR), Physicians
Order Entry (POE), Pharmacy
Information System, Laboratory
Information Management (LIM),
Biospecimen Tracking System,
Substance abuse, Drug addiction,
Mental health, mPAL, HuRIS.
mstockstill on DSK4VPTVN1PROD with NOTICES
Optimized Gene Therapy Vector for the
Treatment of Glycogen Storage Disease
Type Ia
Description of Technology: NIH
researchers have developed an adenoassociated viral (AAV) vector for the
treatment of glycogen storage disease
type Ia (GSD-Ia). GSD-Ia is an inherited
disorder of metabolism associated with
life-threatening hypoglycemia, hepatic
malignancy, and renal failure caused by
the deficiency of glucose-6-phosphatasealpha (G6Pase-alpha or G6PC). This new
AAV vector that expresses human
G6Pase-alpha directed by the tissuespecific human G6PC promoter/
enhancer incorporates two
improvements: (1) It expresses a variant
of G6Pase-alpha with enhanced
enzymatic activity; (2) it is codon
optimized to achieve higher enzyme
expression levels and enhanced
enzymatic activity.
Current therapy, which primarily
consists of dietary modification, fails to
prevent long-term complications in
many patients, including growth failure,
gout, pulmonary hypertension, renal
dysfunction, osteoporosis, and
hepatocellular adenomas (HCA). Gene
therapy-based techniques, which
directly address the underlying genetic
deficiency driving the disorder, offer the
prospect of long-term remission in
patients with GSD-Ia.
Potential Commercial Applications:
Gene therapy vector for the treatment of
GSD-Ia.
Competitive Advantages:
• Protein coding sequence modified
for enhanced enzymatic activity.
• Codon optimized for increased
enzyme expression in target organs.
Inventor: Janice J. Chou (NICHD)
VerDate Sep<11>2014
20:43 Oct 01, 2015
Jkt 238001
Development Stage: In vivo data
available (animal).
Publications:
1. Lee YM et al. Prevention of
hepatocellular adenoma and correction
of metabolic abnormalities in murine
glycogen storage disease type Ia by gene
therapy. Hepatology 2012
Nov;56(5):1719–29. [PMID 22422504].
2. Lee YM, et al. The upstream
enhancer elements of the G6PC
promoter are critical for optimal G6PC
expression in murine glycogen storage
disease type Ia. Mol Genet Metab. 2013
Nov;110(3):275–80. [PMID 23856420].
Intellectual Property: HHS Reference
No. E–039–2015/0–US–01—US
Provisional Patent Application 62/
096,400 filed December 23, 2014.
Related Technologies: HHS Reference
No. E–552–2013/0—US Provisional
Patent Application No. 61/908,861 filed
November 26, 2013; PCT Application
No. PCT/US2014/067415 filed
November 25, 2014.
Licensing Contact: Surekha Vathyam,
Ph.D.; 301–435–4076; vathyams@
mail.nih.gov.
Collaborative Research Opportunity:
The National Institute of Child Health
and Human Development is seeking
statements of capability or interest from
parties interested in collaborative
research to further develop, evaluate, or
commercialize gene therapy vectors for
the treatment of glycogen storage
disease type Ia. For collaboration
opportunities, please contact Joseph M.
Conrad, III, Ph.D., J.D. at jmconrad@
mail.nih.gov.
Dated: September 25, 2015.
Richard U. Rodriguez,
Acting Director, Office of Technology
Transfer, National Institutes of Health.
[FR Doc. 2015–24987 Filed 10–1–15; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive
License: Miniature Serial Sectioning
Microtome for Block-Face Imaging
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
This is notice, in accordance
with 35 U.S.C. 209 and 37 CFR part 404,
that the National Institutes of Health
(NIH), Department of Health and Human
Services, is contemplating the grant of
an exclusive license to Carl Zeiss
Microscopy GmbH, which is located in
Germany, to practice the inventions
SUMMARY:
PO 00000
Frm 00077
Fmt 4703
Sfmt 4703
embodied in the following patent
applications:
1. US Provisional Application 61/
991,929, filed May 12, 2014 (E–
121–2014/0–US–01)
2. PCT Application PCT/US2015/
030359, filed May 12, 2015 (E–121–
2014/0–PCT–02)
The patent rights in these inventions
have been assigned to the United States
of America.
The prospective start-up exclusive
license territory may be worldwide and
the field of use may be limited to
microtomes for scanning electron
microscopes (SEMs) or light
microscopes for life science
applications.
Only written comments and/or
applications for a license which are
received by the NIH Office of
Technology Transfer on or before
November 2, 2015 will be considered.
ADDRESSES: Requests for copies of the
patent application, inquiries, comments,
and other materials relating to the
contemplated exclusive license should
be directed to: Susan Ano, Ph.D., NINDS
Technology Transfer and Development
Branch, 31 Center Drive, Suite 8A52,
MS2540, Bethesda, MD 20892;
Telephone: (301) 435–5515; Email:
anos@mail.nih.gov.
SUPPLEMENTARY INFORMATION: A
microtome device is used in a variety of
microcopy techniques to remove very
thin (e.g., in the tens of nanometers
range) portions from the top of a sample
between successive images. This
technology discloses a design for a
microtome device that offers several
unique features and advantages over
commercially available microtomes. A
prototype of the microtome has been
built and demonstrated to work with a
serial block-face scanning electron
microscopy in order to serially collect
ultrathin sections from plastic
embedded biological tissues. This
microtome design allows for a sample to
be cut at a location removed from the
electron beam axis, reducing
interference from debris and allowing
imaging at a greater range of working
distances. This microtome device is
lightweight and easy to install utilizing
the built-in stage of existing
microscopes such that a sample’s
position and orientation can be
controlled along three-axes of rectilinear
translation and two axes of rotation.
This microtome design utilizes a
diamond blade coupled to both the base
plate and an actuator to control the
movement of the blade in a direction
perpendicular to the exposed surface of
the pedestal, while producing an output
DATES:
E:\FR\FM\02OCN1.SGM
02OCN1
Federal Register / Vol. 80, No. 191 / Friday, October 2, 2015 / Notices
signal that indicates the blade location
with respect to the base plate.
Advantageously, this allows for a stage
coupled pedestal to be moved
accurately from an imaging location on
the beam axis to a cutting location off
the beam axis.
The prospective start-up exclusive
license may be granted unless within
thirty (30) days from the date of this
published notice, the NIH receives
written evidence and argument that
establishes that the grant of the license
would not be consistent with the
requirements of 35 U.S.C. 209 and 37
CFR part 404.
Complete applications for a license in
the field of use filed in response to this
notice will be treated as objections to
the grant of the contemplated start-up
exclusive license. Comments and
objections submitted to this notice will
not be made available for public
inspection and, to the extent permitted
by law, will not be released under the
Freedom of Information Act, 5 U.S.C.
552.
Dated: September 28, 2015.
Richard U. Rodriguez,
Acting Director, Office of Technology
Transfer, National Institutes of Health.
[FR Doc. 2015–24994 Filed 10–1–15; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of a Start-up
Exclusive Commercial License
Agreement: Development of MHC
Class II Restricted T Cell Epitopes
From the Cancer Antigen, NY ESO–1,
for the Treatment of Human Cancers
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
This is notice, in accordance
with 35 U.S.C. 209 and 37 CFR part
404.7, that the National Institutes of
Health, Department of Health and
Human Services, is contemplating the
grant of an start-up exclusive
commercial license to Immunova
Therapeutics, Inc., which is located in
Houston, Texas, to practice the
inventions embodied in the following
patent applications and applications
claiming priority to these applications:
mstockstill on DSK4VPTVN1PROD with NOTICES
SUMMARY:
E–090–2000
1. U.S. Provisional Patent Application No.
61/179,004 filed January 28, 2000
entitled ‘‘MHC Class II Restricted T Cell
Epitopes from the Cancer Antigen, NY
ESO–1’’ (HHS Ref No. E–090–2000/0–
VerDate Sep<11>2014
20:43 Oct 01, 2015
Jkt 238001
US–01);
2. U.S. Provisional Patent Application No.
60/237,107 filed September 29, 2000
entitled ‘‘HLA–DP Restricted CD4+ T
Cell Epitopes from the Cancer Antigen,
NY ESO–1’’ (HHS Ref No. E–227–2000/
0–US–01 was combined with E–090–
2000/0–US–01 at the PCT stage, creating
the E–090–2000/1 technology family and
associated applications);
3. PCT Application No. PCT/US01/02765
filed January 26, 2001 entitled ‘‘MHC
Class II Restricted T Cell Epitopes from
the Cancer Antigen, NY ESO–1’’ (HHS
Ref No. E–090–2000/1–PCT–01);
4. Canadian Patent No. 2398743 issued June
23, 2015 entitled ‘‘MHC Class II
Restricted T Cell Epitopes from the
Cancer Antigen, NY ESO–1’’ (HHS Ref
No. E–090–2000/1–CA–02);
5. Australian Patent No. 785151 issued
January 18, 2007 entitled ‘‘MHC Class II
Restricted T Cell Epitopes from the
Cancer Antigen, NY ESO–1’’ (HHS Ref
No. E–090–2000/1–AU–03);
6. Japanese Patent No. 5588363 issued
August 1, 2014 entitled ‘‘MHC Class II
Restricted T Cell Epitopes from the
Cancer Antigen, NY ESO–1’’ (HHS Ref
No. E–090–2000/1–JP–12);
7. U.S. Patent No. 7,619,057 issued
November 17, 2009 entitled ‘‘MHC Class
II Restricted T Cell Epitopes from the
Cancer Antigen, NY ESO–1’’ (HHS Ref
No. E–090–2000/1–US–06);
8. U.S. Patent No. 8,754,046 issued June 17,
2014 entitled ‘‘MHC Class II Restricted T
Cell Epitopes from the Cancer Antigen,
NY ESO–1’’ (HHS Ref No. E–090–2000/
1–US–07);
9. U.S. Patent Application No. 12/568,134
filed September 28, 2009 entitled ‘‘MHC
Class II Restricted T Cell Epitopes from
the Cancer Antigen, NY ESO–1’’ (HHS
Ref No. E–090–2000/1–US–013);
10. European Patent Application No.
10010354.8 filed January 26, 2001
entitled ‘‘MHC Class II Restricted T Cell
Epitopes from the Cancer Antigen, NY
ESO–1’’ (HHS Ref No. E–090–2000/1–
EP–10);
The patent rights in these inventions
have been assigned to the Government
of the United States of America. The
prospective start-up exclusive
commercial license territory may be
worldwide and the field of use may be
limited to the use of the Licensed Patent
Rights to develop, manufacture,
distribute, sell and use NY–ESO–1
based vaccines and cell therapy
products for the treatment of NY–ESO–
1-positive cancers.
DATES: Only written comments and/or
applications for a license which are
received by the NIH Office of
Technology Transfer on or before
October 19, 2015 will be considered.
ADDRESSES: Requests for copies of the
patent applications, inquiries,
comments, and other materials relating
to the contemplated exclusive
evaluation option license should be
PO 00000
Frm 00078
Fmt 4703
Sfmt 4703
59797
directed to: Sabarni K. Chatterjee, Ph.D.,
M.B.A., Senior Licensing and Patenting
Manager, NCI Technology Transfer
Center, 9609 Medical Center Drive, RM
1E530 MSC 9702, Bethesda, MD 20892–
9702 (for business mail), Rockville, MD
20850–9702; Telephone: (240) 276–
5530; Facsimile: (240) 276–5504; Email:
chatterjeesa@mail.nih.gov.
SUPPLEMENTARY INFORMATION: NY–ESO–
1 is a known tumor antigen which is
expressed on a broad range of tumor
types, including melanoma, breast,
bladder, ovarian, prostate, head and
neck cancers, neuroblastoma, and small
cell lung cancer. The above-referenced
inventions embody the identification of
a number of novel immunogenic
peptide epitopes, and analogs thereof,
which are derived from the NY–ESO–1
tumor antigen. Specifically, this
technology describes novel MHC Class
II restricted epitopes of NY–ESO–1
which are recognized by CD4+ T cells.
It also embodies the identification of
two additional immunogenic peptide
epitopes of NY–ESO–1. The latter two
epitopes are presented by HLA–DP4, a
prevalent MHC Class II allele present in
43–70% of Caucasians. The inventors
also determined that the DP allele is
highly associated with the NY–ESO–1
antibody production. In addition, one of
these epitopes has dual HLA A2 and
DP4 specificity, thereby it has the
potential to generate both CD4+ and
CD8+ tumor specific T cells. These
epitopes may be of great value as
prophylactic and/or therapeutic cancer
vaccines or cell therapy products for use
against a number of common cancers.
The prospective start-up exclusive
commercial license is being considered
under the small business initiative
launched on October 1, 2011 and will
comply with the terms and conditions
of 35 U.S.C. 209 and 37 CFR part 404.7.
The prospective start-up exclusive
commercial license may be granted
unless within fifteen (15) days from the
date of this published notice, the NIH
receives written evidence and argument
that establishes that the grant of the
license would not be consistent with the
requirements of 35 U.S.C. 209 and 37
CFR part 404.7.
Any additional, properly filed, and
complete applications for a license in
the field of use filed in response to this
notice will be treated as objections to
the grant of the contemplated exclusive
commercial license. Comments and
objections submitted to this notice will
not be made available for public
inspection and, to the extent permitted
by law, will not be released under the
Freedom of Information Act, 5 U.S.C.
552.
E:\FR\FM\02OCN1.SGM
02OCN1
]]>Agencies
[Federal Register Volume 80, Number 191 (Friday, October 2, 2015)]
[Notices]
[Pages 59796-59797]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-24994]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive License: Miniature Serial
Sectioning Microtome for Block-Face Imaging
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This is notice, in accordance with 35 U.S.C. 209 and 37 CFR
part 404, that the National Institutes of Health (NIH), Department of
Health and Human Services, is contemplating the grant of an exclusive
license to Carl Zeiss Microscopy GmbH, which is located in Germany, to
practice the inventions embodied in the following patent applications:
1. US Provisional Application 61/991,929, filed May 12, 2014 (E-121-
2014/0-US-01)
2. PCT Application PCT/US2015/030359, filed May 12, 2015 (E-121-2014/0-
PCT-02)
The patent rights in these inventions have been assigned to the
United States of America.
The prospective start-up exclusive license territory may be
worldwide and the field of use may be limited to microtomes for
scanning electron microscopes (SEMs) or light microscopes for life
science applications.
DATES: Only written comments and/or applications for a license which
are received by the NIH Office of Technology Transfer on or before
November 2, 2015 will be considered.
ADDRESSES: Requests for copies of the patent application, inquiries,
comments, and other materials relating to the contemplated exclusive
license should be directed to: Susan Ano, Ph.D., NINDS Technology
Transfer and Development Branch, 31 Center Drive, Suite 8A52, MS2540,
Bethesda, MD 20892; Telephone: (301) 435-5515; Email:
anos@mail.nih.gov.
SUPPLEMENTARY INFORMATION: A microtome device is used in a variety of
microcopy techniques to remove very thin (e.g., in the tens of
nanometers range) portions from the top of a sample between successive
images. This technology discloses a design for a microtome device that
offers several unique features and advantages over commercially
available microtomes. A prototype of the microtome has been built and
demonstrated to work with a serial block-face scanning electron
microscopy in order to serially collect ultrathin sections from plastic
embedded biological tissues. This microtome design allows for a sample
to be cut at a location removed from the electron beam axis, reducing
interference from debris and allowing imaging at a greater range of
working distances. This microtome device is lightweight and easy to
install utilizing the built-in stage of existing microscopes such that
a sample's position and orientation can be controlled along three-axes
of rectilinear translation and two axes of rotation. This microtome
design utilizes a diamond blade coupled to both the base plate and an
actuator to control the movement of the blade in a direction
perpendicular to the exposed surface of the pedestal, while producing
an output
[[Page 59797]]
signal that indicates the blade location with respect to the base
plate. Advantageously, this allows for a stage coupled pedestal to be
moved accurately from an imaging location on the beam axis to a cutting
location off the beam axis.
The prospective start-up exclusive license may be granted unless
within thirty (30) days from the date of this published notice, the NIH
receives written evidence and argument that establishes that the grant
of the license would not be consistent with the requirements of 35
U.S.C. 209 and 37 CFR part 404.
Complete applications for a license in the field of use filed in
response to this notice will be treated as objections to the grant of
the contemplated start-up exclusive license. Comments and objections
submitted to this notice will not be made available for public
inspection and, to the extent permitted by law, will not be released
under the Freedom of Information Act, 5 U.S.C. 552.
Dated: September 28, 2015.
Richard U. Rodriguez,
Acting Director, Office of Technology Transfer, National Institutes of
Health.
[FR Doc. 2015-24994 Filed 10-1-15; 8:45 am]
BILLING CODE 4140-01-P
