80 FR 59796 - Prospective Grant of Exclusive License: Miniature Serial Sectioning Microtome for Block-Face Imaging

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 80, Issue 191 (October 2, 2015)

Page Range		59796-59797
FR Document		2015-24994

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:

Federal Register, Volume 80 Issue 191 (Friday, October 2, 2015)

[Federal Register Volume 80, Number 191 (Friday, October 2, 2015)]
[Notices]
[Pages 59796-59797]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-24994]


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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.

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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: 
[email protected].

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

59796 Federal Register / Vol. 80, No. 191 / Friday, October 2, 2015 / Notices

Computerized Contingency Development Stage: In vivo data embodied in the following patent
Management, Ecological Momentary available (animal). applications:
Assessment, and a Protocol Workflow Publications: 1. US Provisional Application 61/
System,’’ Drug and Alcohol Review, 1. Lee YM et al. Prevention of 991,929, filed May 12, 2014 (E–
28(1):3–11, January 2009. hepatocellular adenoma and correction 121–2014/0–US–01)
Intellectual Property: HHS Reference of metabolic abnormalities in murine 2. PCT Application PCT/US2015/
No. E–266–2014/0—Software. No patent glycogen storage disease type Ia by gene 030359, filed May 12, 2015 (E–121–
protection is being sought. therapy. Hepatology 2012 2014/0–PCT–02)
Contact Information: Vio Conley, Nov;56(5):1719–29. [PMID 22422504].
The patent rights in these inventions
M.S.; NCI Technology Transfer Center; 2. Lee YM, et al. The upstream
have been assigned to the United States
Phone: 240–276–5531; Email: conleyv@ enhancer elements of the G6PC
of America.
mail.nih.gov. promoter are critical for optimal G6PC
The prospective start-up exclusive
Keywords: Software, Clinical expression in murine glycogen storage
license territory may be worldwide and
Information System, Research disease type Ia. Mol Genet Metab. 2013
the field of use may be limited to
Information System, Medical Decision Nov;110(3):275–80. [PMID 23856420].
Intellectual Property: HHS Reference microtomes for scanning electron
Support System (DSS), Electronic microscopes (SEMs) or light
Hospital Records (EHR), Physicians No. E–039–2015/0–US–01—US
Provisional Patent Application 62/ microscopes for life science
Order Entry (POE), Pharmacy applications.
Information System, Laboratory 096,400 filed December 23, 2014.
Information Management (LIM), Related Technologies: HHS Reference DATES: Only written comments and/or
Biospecimen Tracking System, No. E–552–2013/0—US Provisional applications for a license which are
Substance abuse, Drug addiction, Patent Application No. 61/908,861 filed received by the NIH Office of
Mental health, mPAL, HuRIS. November 26, 2013; PCT Application Technology Transfer on or before
No. PCT/US2014/067415 filed November 2, 2015 will be considered.
Optimized Gene Therapy Vector for the November 25, 2014. ADDRESSES: Requests for copies of the
Treatment of Glycogen Storage Disease Licensing Contact: Surekha Vathyam, patent application, inquiries, comments,
Type Ia Ph.D.; 301–435–4076; vathyams@ and other materials relating to the
Description of Technology: NIH mail.nih.gov. contemplated exclusive license should
researchers have developed an adeno- Collaborative Research Opportunity: be directed to: Susan Ano, Ph.D., NINDS
associated viral (AAV) vector for the The National Institute of Child Health Technology Transfer and Development
treatment of glycogen storage disease and Human Development is seeking Branch, 31 Center Drive, Suite 8A52,
type Ia (GSD-Ia). GSD-Ia is an inherited statements of capability or interest from MS2540, Bethesda, MD 20892;
disorder of metabolism associated with parties interested in collaborative Telephone: (301) 435–5515; Email:
life-threatening hypoglycemia, hepatic research to further develop, evaluate, or anos@mail.nih.gov.
malignancy, and renal failure caused by commercialize gene therapy vectors for
SUPPLEMENTARY INFORMATION: A
the deficiency of glucose-6-phosphatase- the treatment of glycogen storage
microtome device is used in a variety of
alpha (G6Pase-alpha or G6PC). This new disease type Ia. For collaboration
microcopy techniques to remove very
AAV vector that expresses human opportunities, please contact Joseph M.
thin (e.g., in the tens of nanometers
G6Pase-alpha directed by the tissue- Conrad, III, Ph.D., J.D. at jmconrad@
range) portions from the top of a sample
specific human G6PC promoter/ mail.nih.gov.
between successive images. This
enhancer incorporates two Dated: September 25, 2015. technology discloses a design for a
improvements: (1) It expresses a variant Richard U. Rodriguez, microtome device that offers several
of G6Pase-alpha with enhanced Acting Director, Office of Technology unique features and advantages over
enzymatic activity; (2) it is codon Transfer, National Institutes of Health. commercially available microtomes. A
optimized to achieve higher enzyme [FR Doc. 2015–24987 Filed 10–1–15; 8:45 am] prototype of the microtome has been
expression levels and enhanced BILLING CODE 4140–01–P built and demonstrated to work with a
enzymatic activity. serial block-face scanning electron
Current therapy, which primarily microscopy in order to serially collect
consists of dietary modification, fails to DEPARTMENT OF HEALTH AND ultrathin sections from plastic
prevent long-term complications in HUMAN SERVICES embedded biological tissues. This
many patients, including growth failure, microtome design allows for a sample to
gout, pulmonary hypertension, renal National Institutes of Health be cut at a location removed from the
dysfunction, osteoporosis, and electron beam axis, reducing
hepatocellular adenomas (HCA). Gene Prospective Grant of Exclusive interference from debris and allowing
therapy-based techniques, which License: Miniature Serial Sectioning imaging at a greater range of working
directly address the underlying genetic Microtome for Block-Face Imaging distances. This microtome device is
deficiency driving the disorder, offer the AGENCY: National Institutes of Health, lightweight and easy to install utilizing
prospect of long-term remission in HHS. the built-in stage of existing
patients with GSD-Ia. microscopes such that a sample’s
ACTION: Notice.
Potential Commercial Applications: position and orientation can be
Gene therapy vector for the treatment of
mstockstill on DSK4VPTVN1PROD with NOTICES

SUMMARY: This is notice, in accordance controlled along three-axes of rectilinear
GSD-Ia. with 35 U.S.C. 209 and 37 CFR part 404, translation and two axes of rotation.
Competitive Advantages: that the National Institutes of Health This microtome design utilizes a
• Protein coding sequence modified (NIH), Department of Health and Human diamond blade coupled to both the base
for enhanced enzymatic activity. Services, is contemplating the grant of plate and an actuator to control the
• Codon optimized for increased an exclusive license to Carl Zeiss movement of the blade in a direction
enzyme expression in target organs. Microscopy GmbH, which is located in perpendicular to the exposed surface of
Inventor: Janice J. Chou (NICHD) Germany, to practice the inventions the pedestal, while producing an output

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Federal Register / Vol. 80, No. 191 / Friday, October 2, 2015 / Notices 59797

signal that indicates the blade location US–01); directed to: Sabarni K. Chatterjee, Ph.D.,
with respect to the base plate. 2. U.S. Provisional Patent Application No. M.B.A., Senior Licensing and Patenting
Advantageously, this allows for a stage 60/237,107 filed September 29, 2000 Manager, NCI Technology Transfer
entitled ‘‘HLA–DP Restricted CD4+ T
coupled pedestal to be moved Center, 9609 Medical Center Drive, RM
Cell Epitopes from the Cancer Antigen,
accurately from an imaging location on NY ESO–1’’ (HHS Ref No. E–227–2000/ 1E530 MSC 9702, Bethesda, MD 20892–
the beam axis to a cutting location off 0–US–01 was combined with E–090– 9702 (for business mail), Rockville, MD
the beam axis. 2000/0–US–01 at the PCT stage, creating 20850–9702; Telephone: (240) 276–
The prospective start-up exclusive the E–090–2000/1 technology family and 5530; Facsimile: (240) 276–5504; Email:
license may be granted unless within associated applications); chatterjeesa@mail.nih.gov.
thirty (30) days from the date of this 3. PCT Application No. PCT/US01/02765
SUPPLEMENTARY INFORMATION: NY–ESO–
published notice, the NIH receives filed January 26, 2001 entitled ‘‘MHC
Class II Restricted T Cell Epitopes from 1 is a known tumor antigen which is
written evidence and argument that expressed on a broad range of tumor
the Cancer Antigen, NY ESO–1’’ (HHS
establishes that the grant of the license Ref No. E–090–2000/1–PCT–01); types, including melanoma, breast,
would not be consistent with the 4. Canadian Patent No. 2398743 issued June bladder, ovarian, prostate, head and
requirements of 35 U.S.C. 209 and 37 23, 2015 entitled ‘‘MHC Class II neck cancers, neuroblastoma, and small
CFR part 404. Restricted T Cell Epitopes from the cell lung cancer. The above-referenced
Complete applications for a license in Cancer Antigen, NY ESO–1’’ (HHS Ref inventions embody the identification of
the field of use filed in response to this No. E–090–2000/1–CA–02); a number of novel immunogenic
notice will be treated as objections to 5. Australian Patent No. 785151 issued
January 18, 2007 entitled ‘‘MHC Class II peptide epitopes, and analogs thereof,
the grant of the contemplated start-up which are derived from the NY–ESO–1
exclusive license. Comments and Restricted T Cell Epitopes from the
Cancer Antigen, NY ESO–1’’ (HHS Ref tumor antigen. Specifically, this
objections submitted to this notice will No. E–090–2000/1–AU–03); technology describes novel MHC Class
not be made available for public 6. Japanese Patent No. 5588363 issued II restricted epitopes of NY–ESO–1
inspection and, to the extent permitted August 1, 2014 entitled ‘‘MHC Class II which are recognized by CD4+ T cells.
by law, will not be released under the Restricted T Cell Epitopes from the It also embodies the identification of
Freedom of Information Act, 5 U.S.C. Cancer Antigen, NY ESO–1’’ (HHS Ref two additional immunogenic peptide
552. No. E–090–2000/1–JP–12);
7. U.S. Patent No. 7,619,057 issued
epitopes of NY–ESO–1. The latter two
Dated: September 28, 2015. November 17, 2009 entitled ‘‘MHC Class epitopes are presented by HLA–DP4, a
Richard U. Rodriguez, II Restricted T Cell Epitopes from the prevalent MHC Class II allele present in
Acting Director, Office of Technology Cancer Antigen, NY ESO–1’’ (HHS Ref 43–70% of Caucasians. The inventors
Transfer, National Institutes of Health. No. E–090–2000/1–US–06); also determined that the DP allele is
[FR Doc. 2015–24994 Filed 10–1–15; 8:45 am] 8. U.S. Patent No. 8,754,046 issued June 17, highly associated with the NY–ESO–1
2014 entitled ‘‘MHC Class II Restricted T antibody production. In addition, one of
BILLING CODE 4140–01–P
Cell Epitopes from the Cancer Antigen, these epitopes has dual HLA A2 and
NY ESO–1’’ (HHS Ref No. E–090–2000/ DP4 specificity, thereby it has the
1–US–07);
DEPARTMENT OF HEALTH AND 9. U.S. Patent Application No. 12/568,134
potential to generate both CD4+ and
HUMAN SERVICES filed September 28, 2009 entitled ‘‘MHC CD8+ tumor specific T cells. These
Class II Restricted T Cell Epitopes from epitopes may be of great value as
National Institutes of Health the Cancer Antigen, NY ESO–1’’ (HHS prophylactic and/or therapeutic cancer
Ref No. E–090–2000/1–US–013); vaccines or cell therapy products for use
Prospective Grant of a Start-up 10. European Patent Application No. against a number of common cancers.
Exclusive Commercial License 10010354.8 filed January 26, 2001 The prospective start-up exclusive
Agreement: Development of MHC entitled ‘‘MHC Class II Restricted T Cell commercial license is being considered
Class II Restricted T Cell Epitopes Epitopes from the Cancer Antigen, NY under the small business initiative
From the Cancer Antigen, NY ESO–1, ESO–1’’ (HHS Ref No. E–090–2000/1–
EP–10);
launched on October 1, 2011 and will
for the Treatment of Human Cancers comply with the terms and conditions
The patent rights in these inventions of 35 U.S.C. 209 and 37 CFR part 404.7.
AGENCY: National Institutes of Health,
have been assigned to the Government The prospective start-up exclusive
HHS.
of the United States of America. The commercial license may be granted
ACTION: Notice. prospective start-up exclusive unless within fifteen (15) days from the
SUMMARY: This is notice, in accordance commercial license territory may be date of this published notice, the NIH
with 35 U.S.C. 209 and 37 CFR part worldwide and the field of use may be receives written evidence and argument
404.7, that the National Institutes of limited to the use of the Licensed Patent that establishes that the grant of the
Health, Department of Health and Rights to develop, manufacture, license would not be consistent with the
Human Services, is contemplating the distribute, sell and use NY–ESO–1 requirements of 35 U.S.C. 209 and 37
grant of an start-up exclusive based vaccines and cell therapy CFR part 404.7.
commercial license to Immunova products for the treatment of NY–ESO– Any additional, properly filed, and
Therapeutics, Inc., which is located in 1-positive cancers. complete applications for a license in
Houston, Texas, to practice the DATES: Only written comments and/or the field of use filed in response to this
inventions embodied in the following applications for a license which are notice will be treated as objections to
received by the NIH Office of
mstockstill on DSK4VPTVN1PROD with NOTICES

patent applications and applications the grant of the contemplated exclusive
claiming priority to these applications: Technology Transfer on or before commercial license. Comments and
E–090–2000
October 19, 2015 will be considered. objections submitted to this notice will
1. U.S. Provisional Patent Application No.
ADDRESSES: Requests for copies of the not be made available for public
61/179,004 filed January 28, 2000 patent applications, inquiries, inspection and, to the extent permitted
entitled ‘‘MHC Class II Restricted T Cell comments, and other materials relating by law, will not be released under the
Epitopes from the Cancer Antigen, NY to the contemplated exclusive Freedom of Information Act, 5 U.S.C.
ESO–1’’ (HHS Ref No. E–090–2000/0– evaluation option license should be 552.

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Document Created: 2015-12-15 08:44:58
Document Modified: 2015-12-15 08:44:58

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
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.
FR Citation		80 FR 59796

80 FR 59796 - Prospective Grant of Exclusive License: Miniature Serial Sectioning Microtome for Block-Face Imaging

DEPARTMENT OF HEALTH AND HUMAN SERVICESNational Institutes of Health

Federal Register Volume 80, Issue 191 (October 2, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health