Prospective Grant of Evaluation Option Exclusive License: Development of a Diagnostic and Prognostic for Breast and Prostate Cancer Using Spatial Genome Organization, 40119-40120 [2014-16268]
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Federal Register / Vol. 79, No. 133 / Friday, July 11, 2014 / Notices
Only written comments and/or
applications for a license which are
received by the NIH Office of
Technology Transfer on or before July
28, 2014 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: Whitney A. Hastings,
Ph.D., Licensing and Patenting Manager,
Office of Technology Transfer, National
Institutes of Health, 6011 Executive
Boulevard, Suite 325, Rockville, MD
20852–3804; Telephone: (301) 451–
7337; Facsimile: (301) 402–0220; Email:
hastingw@mail.nih.gov.
SUPPLEMENTARY INFORMATION:
Granulysin is a cytolytic and
proinflammatory molecule expressed by
activated human cytotoxic T
lymphocytes (CTLs) and natural killer
(NK) cells when they are attached to
disease cells including infection, cancer,
transplantation, autoimmunity, skin and
reproductive maladies. Granulysin is
made in a 15-kDa form that is cleaved
into a 9-kDa form at both the amino and
the carboxy termini. Granulysin is
broadly cytolytic against tumors and
microbes. It has been implicated in
many of diseases and studies suggest
that granulysin may be a useful
therapeutic directly contributing to
immunity against foreign molecules for
a wide variety of diseases.
This technology describes the use of
15 kD granulysin for enhancing immune
responses.
Investigators at the NIH have
discovered that 15 kD granulysin
activates monocytes and induces them
to differentiate into mature dendritic
cells and activates allospecific T cells.
The proof of this principle was
demonstrated by mice expressing
granulysin in vivo showing markedly
improved anti-tumor responses, with
increased numbers of activated
dendritic cells and cytokine-producing
T cells. Furthermore, current data
suggest that dendritic cells matured
with 15 kD granulysin are superior to
the well-established GM–CSF induction.
There appears to be a significant market
opportunity for use of the 15 kD
granulysin for the ex vivo dendritic cell
maturation and adoptive
immunotherapy.
The prospective exclusive evaluation
option license, and a subsequent
exclusive commercialization license,
may be granted unless 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
tkelley on DSK3SPTVN1PROD with NOTICES
DATES:
VerDate Mar<15>2010
20:23 Jul 10, 2014
Jkt 232001
CFR part 404 within fifteen (15) days
from the date of this published notice.
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
evaluation option 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: July 10, 2014.
Richard U. Rodriguez,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. 2014–16267 Filed 7–10–14; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of Evaluation Option
Exclusive License: Development of a
Diagnostic and Prognostic for Breast
and Prostate Cancer Using Spatial
Genome Organization
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
This is notice, in accordance
with 35 U.S.C. 209 and 37 CFR 404, that
the National Institutes of Health,
Department of Health and Human
Services, is contemplating the grant of
an exclusive evaluation option license
to practice the inventions embodied in
U.S. Provisional Application 61/094,318
filed September 4, 2008 entitled
‘‘Method for detection of cancer based
on spatial genome organization’’ (HHS
Ref No. E–283–2008/0–US–01);
International Application PCT/US2009/
055857 filed September 3, 2009 entitled
‘‘Method for detection of cancer based
on spatial genome organization’’ (HHS
Ref No. E–283–2008/0–PCT–02); U.S.
Patent Application 13/062,247 filed
March 4, 2011 entitled ‘‘Method for
detection of cancer based on spatial
genome organization’’ (HHS Ref No. E–
283–2008/0–US–0; and foreign
equivalents thereof to Radial Genomics,
Ltd. (‘‘RG’’), a company located in
Cambridge, U.K. The patent rights in
these inventions have been assigned to
the United States of America.
The prospective exclusive evaluation
option license territory may be
worldwide and the field of use may be
limited to the use of the Licensed Patent
SUMMARY:
PO 00000
Frm 00062
Fmt 4703
Sfmt 4703
40119
Rights for the diagnosis, prognosis, and
prediction of cancer.
Upon the expiration or termination of
the exclusive evaluation option license,
RG will have the exclusive right to
execute an exclusive commercialization
license which will supersede and
replace the exclusive evaluation option
license with no greater field of use and
territory than granted in the exclusive
evaluation option license.
DATES: Only written comments and/or
applications for a license which are
received by the NIH Office of
Technology Transfer on or before July
28, 2014 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: Whitney A. Hastings,
Ph.D., Licensing and Patenting Manager,
Office of Technology Transfer, National
Institutes of Health, 6011 Executive
Boulevard, Suite 325, Rockville, MD
20852–3804; Telephone: (301) 451–
7337; Facsimile: (301) 402–0220; Email:
hastingw@mail.nih.gov.
SUPPLEMENTARY INFORMATION: The
successful treatment of cancer is
correlated with the early detection of
the cancerous cells. Conventional
cancer diagnosis is largely based on
qualitative morphological criteria, but
more accurate quantitative tests could
greatly increase early detection of
malignant cells. It has been observed
that the spatial arrangement of DNA in
the nucleus is altered in cancer cells in
comparison to normal cells. Therefore,
it is possible to distinguish malignant
cells by mapping the position of labeled
marker genes in the nucleus. This NIH
invention provides methods of detecting
abnormal cells in a sample using the
spatial position of one or more genes
within the nucleus of a cell, as well as
a kit for detecting abnormal cells using
such methods. It also provides methods
of identifying gene markers for
abnormal cells using the spatial position
of one or more genes within the nucleus
of a cell. Therefore, this invention could
be used as a very effective cancer
diagnostic from tumor biopsies after
non-invasive techniques such as a
mammogram or PSA assay have
suggested cancer.
The primary product arising from this
technology would be a diagnostic for
cancer using tumor biopsies after noninvasive techniques such as a
mammogram or PSA assay have
suggested the presence of cancer. This
novel in vitro diagnostic test for cancer
has use in oncology laboratories of
hospitals and commercial clinical
laboratories. It has several advantages
E:\FR\FM\11JYN1.SGM
11JYN1
40120
Federal Register / Vol. 79, No. 133 / Friday, July 11, 2014 / Notices
over other diagnostics including
sensitive cancer detection, small sample
size (100–200 cells), probes to all
genomic regions are available, and it
does not require mitotic chromosomes.
Additionally, it is applicable to both
solid tumors and blood cancers, allows
analysis of subpopulations from biopsy,
measures metastatic potential of cancer
cells, determines tumor type, and can be
alternative to or complementary to
conventional diagnostics.
The prospective exclusive evaluation
option license, and a subsequent
exclusive commercialization license,
may be granted unless 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 within fifteen (15) days
from the date of this published notice.
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
evaluation option 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: July 10, 2014.
Richard U. Rodriguez,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. 2014–16268 Filed 7–10–14; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive
License: Development of MolecularBased Cancer Diagnostic and
Prognostic
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
This is notice, in accordance
with 35 U.S.C. 209 and 37 CFR 404, that
the National Institutes of Health,
Department of Health and Human
Services, is contemplating the grant of
an exclusive patent license to Heragen,
Inc., which is located in Benicia,
California to practice the inventions
embodied in the following patent
applications:
tkelley on DSK3SPTVN1PROD with NOTICES
SUMMARY:
1. U.S. Provisional Application 61/152,597
filed February 13, 2009 entitled ‘‘MolecularBased Method of Cancer Diagnosis and
VerDate Mar<15>2010
20:23 Jul 10, 2014
Jkt 232001
Prognosis’’ (HHS Ref No. E–023–2009/0–US–
01).
2. International Application PCT/US2010/
024026 filed February 12, 2010 entitled
‘‘Molecular-Based Method of Cancer
Diagnosis and Prognosis’’ (HHS Ref No. E–
023–2009/0–PCT–02).
3. U.S. Patent No. 8,715,928 issued May 6,
2014 entitled ‘‘Molecular-Based Method of
Cancer Diagnosis and Prognosis’’ (HHS Ref
No. E–023–2009/0–US–03).
4. U.S. Patent Application No. 14/215,574,
filed March 17, 2014 entitled ‘‘MolecularBased Method of Cancer Diagnosis and
Prognosis’’ (HHS Ref No. E–023–2009/0–US–
04).
The patent rights in these inventions
have been assigned to the United States
of America.
The prospective exclusive license
territory may be worldwide and the
field of use may be limited to the use
of the Licensed Patent Rights to develop
FDA approved and/or 510K cleared tests
and kits for the diagnosis and prognosis
of breast and lung cancer.
DATES: Only written comments and/or
applications for a license which are
received by the NIH Office of
Technology Transfer on or before
August 11, 2014 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: Whitney A. Hastings,
Ph.D., Licensing and Patenting Manager,
Office of Technology Transfer, National
Institutes of Health, 6011 Executive
Boulevard, Suite 325, Rockville, MD
20852–3804; Telephone: (301) 451–
7337; Facsimile: (301) 402–0220; Email:
hastingw@mail.nih.gov.
SUPPLEMENTARY INFORMATION: Molecular
profiling with high throughput assays
has gained utility in the management of
select cancer patients and several gene
expression-based assays are now
marketed for improved prognostic
accuracy for patients with cancer.
This technology describes a genomics
based diagnostic assay for the diagnosis
and prognosis of cancer patients. Using
a mouse model of breast cancer, the
inventors identified a gene expression
signature that can predict the outcome
for human breast cancer patients with as
few as six genes. The gene signature
includes a total of 79 cancer survival
factor-associated genes and was
validated using available genomic test
sets that were based on previously
conducted human clinical trials. More
recently, the six-gene-model was
validated for cancers other than breast
using multiple, independent, publiclyavailable human lung cancer data sets.
In addition to predicting the outcome of
cancer patients, this technology could
PO 00000
Frm 00063
Fmt 4703
Sfmt 4703
also be used to stratify patients for
further therapy and treat patients by
administering therapeutic agents that
alter the activity of one of the
aforementioned cancer survival factorassociated genes.
The prospective exclusive license will
be royalty bearing and will comply with
the terms and conditions of 35 U.S.C.
209 and 37 CFR part 404. The
prospective 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.
Any additional 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 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: July 10, 2014.
Richard U. Rodriguez,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. 2014–16266 Filed 7–10–14; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
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:
E:\FR\FM\11JYN1.SGM
11JYN1
]]>Agencies
[Federal Register Volume 79, Number 133 (Friday, July 11, 2014)]
[Notices]
[Pages 40119-40120]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-16268]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of Evaluation Option Exclusive License:
Development of a Diagnostic and Prognostic for Breast and Prostate
Cancer Using Spatial Genome Organization
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This is notice, in accordance with 35 U.S.C. 209 and 37 CFR
404, that the National Institutes of Health, Department of Health and
Human Services, is contemplating the grant of an exclusive evaluation
option license to practice the inventions embodied in U.S. Provisional
Application 61/094,318 filed September 4, 2008 entitled ``Method for
detection of cancer based on spatial genome organization'' (HHS Ref No.
E-283-2008/0-US-01); International Application PCT/US2009/055857 filed
September 3, 2009 entitled ``Method for detection of cancer based on
spatial genome organization'' (HHS Ref No. E-283-2008/0-PCT-02); U.S.
Patent Application 13/062,247 filed March 4, 2011 entitled ``Method for
detection of cancer based on spatial genome organization'' (HHS Ref No.
E-283-2008/0-US-0; and foreign equivalents thereof to Radial Genomics,
Ltd. (``RG''), a company located in Cambridge, U.K. The patent rights
in these inventions have been assigned to the United States of America.
The prospective exclusive evaluation option license territory may
be worldwide and the field of use may be limited to the use of the
Licensed Patent Rights for the diagnosis, prognosis, and prediction of
cancer.
Upon the expiration or termination of the exclusive evaluation
option license, RG will have the exclusive right to execute an
exclusive commercialization license which will supersede and replace
the exclusive evaluation option license with no greater field of use
and territory than granted in the exclusive evaluation option license.
DATES: Only written comments and/or applications for a license which
are received by the NIH Office of Technology Transfer on or before July
28, 2014 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: Whitney A. Hastings, Ph.D., Licensing
and Patenting Manager, Office of Technology Transfer, National
Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville,
MD 20852-3804; Telephone: (301) 451-7337; Facsimile: (301) 402-0220;
Email: hastingw@mail.nih.gov.
SUPPLEMENTARY INFORMATION: The successful treatment of cancer is
correlated with the early detection of the cancerous cells.
Conventional cancer diagnosis is largely based on qualitative
morphological criteria, but more accurate quantitative tests could
greatly increase early detection of malignant cells. It has been
observed that the spatial arrangement of DNA in the nucleus is altered
in cancer cells in comparison to normal cells. Therefore, it is
possible to distinguish malignant cells by mapping the position of
labeled marker genes in the nucleus. This NIH invention provides
methods of detecting abnormal cells in a sample using the spatial
position of one or more genes within the nucleus of a cell, as well as
a kit for detecting abnormal cells using such methods. It also provides
methods of identifying gene markers for abnormal cells using the
spatial position of one or more genes within the nucleus of a cell.
Therefore, this invention could be used as a very effective cancer
diagnostic from tumor biopsies after non-invasive techniques such as a
mammogram or PSA assay have suggested cancer.
The primary product arising from this technology would be a
diagnostic for cancer using tumor biopsies after non-invasive
techniques such as a mammogram or PSA assay have suggested the presence
of cancer. This novel in vitro diagnostic test for cancer has use in
oncology laboratories of hospitals and commercial clinical
laboratories. It has several advantages
[[Page 40120]]
over other diagnostics including sensitive cancer detection, small
sample size (100-200 cells), probes to all genomic regions are
available, and it does not require mitotic chromosomes. Additionally,
it is applicable to both solid tumors and blood cancers, allows
analysis of subpopulations from biopsy, measures metastatic potential
of cancer cells, determines tumor type, and can be alternative to or
complementary to conventional diagnostics.
The prospective exclusive evaluation option license, and a
subsequent exclusive commercialization license, may be granted unless
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 within fifteen (15) days from the
date of this published notice.
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 evaluation option 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: July 10, 2014.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. 2014-16268 Filed 7-10-14; 8:45 am]
BILLING CODE 4140-01-P
