Prospective Grant of Exclusive License: The Development of a Single Domain Human Anti-Mesothelin Monoclonal Antibody for the Treatment of Human Cancers, 18039 [2014-07022]
Download as PDF
<![CDATA[
18039
Federal Register / Vol. 79, No. 61 / Monday, March 31, 2014 / Notices
TABLE 1—ESTIMATES FOR ANNUAL BURDEN HOURS
Type of data collection
instrument
Number of
respondents
Frequency of
response
Average time
per response
Annual hour
burden
Focus Groups ..................................................................................................
Pre/Post Test ...................................................................................................
Survey ..............................................................................................................
Interview ...........................................................................................................
Tracking/Feedback Form .................................................................................
500
2,500
2,500
500
1,500
1
1
1
1
1
1
15/60
15/60
1
30/60
500
625
625
500
750
Total ..........................................................................................................
7,500
........................
........................
3,000
Dated: March 21, 2014.
Sarah L. Glavin,
Deputy Director, Office of Science Policy,
Analysis, and Communications, Eunice
Kennedy Shriver National Institute of Child
Health and Human Development, National
Institutes of Health.
[FR Doc. 2014–07105 Filed 3–28–14; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive
License: The Development of a Single
Domain Human Anti-Mesothelin
Monoclonal Antibody 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,
that the National Institutes of Health,
Department of Health and Human
Services, is contemplating the grant of
an exclusive start-up option license to
practice the inventions embodied in
U.S. Patent Application 61/706,396
entitled ‘‘Mesothelin Antibodies and
Methods for Eliciting Potent Antitumor
Activity’’ [HHS Ref. E–236–2012/0–US–
01], PCT Application PCT/US2013/
059883 entitled ‘‘Mesothelin Antibodies
and Methods for Eliciting Potent
Antitumor Activity’’ [HHS Ref. E–236–
2012/0–PCT–02], and all related
continuing and foreign patents/patent
applications for the technology family,
to H2Bio, Inc. The patent rights in these
inventions have been assigned to and/or
exclusively licensed to the Government
of the United States of America.
The prospective exclusive start-up
option licensed territory may be
worldwide, and the field of use may be
limited to:
tkelley on DSK3SPTVN1PROD with NOTICES
SUMMARY:
The use of the monoclonal antibody SD1
(and glycoengineered variants thereof) as an
antibody therapy for the treatment of
mesothelioma, pancreatic cancer, ovarian
cancer and lung adenocarcinoma. The
VerDate Mar<15>2010
18:10 Mar 28, 2014
Jkt 232001
Licensed Field of Use explicitly excludes the
use of the antibody in the form of an
immunoconjugate, including, but not limited
to, immunotoxins.
Upon the expiration or termination of
the exclusive start-up option license,
H2Bio, Inc. will have the exclusive right
to execute an exclusive
commercialization license which will
supersede and replace the exclusive
start-up option license with no greater
field of use and territory than granted in
the exclusive start-up 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 April
15, 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: David A. Lambertson,
Ph.D., Senior Licensing and Patenting
Manager, Office of Technology Transfer,
National Institutes of Health, 6011
Executive Boulevard, Suite 325,
Rockville, MD 20852–3804; Telephone:
(301) 435–4632; Facsimile: (301) 402–
0220; Email: lambertsond@mail.nih.gov.
SUPPLEMENTARY INFORMATION: This
invention concerns a monoclonal
antibody and methods of using the
antibody for the treatment of
mesothelin-expressing cancers,
including mesothelioma, lung cancer,
ovarian cancer and pancreatic cancer.
The specific antibody covered by this
technology is designated SD1, which is
a single domain, fully human
monoclonal antibody against
mesothelin.
Mesothelin is a cell surface antigen
that is preferentially expressed on
certain types of cancer cells. The SD1
antibody can selectively bind to these
cancer cells and induce cell death while
leaving healthy, essential cells
unharmed. This can result in an
effective therapeutic strategy with fewer
side effects due to less non-specific
killing of cells.
The prospective exclusive start-up
option license will be royalty bearing
and will comply with the terms and
PO 00000
Frm 00036
Fmt 4703
Sfmt 4703
conditions of 35 U.S.C. 209 and 37 CFR
part 404. The prospective exclusive
start-up option 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
start-up 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: March 27, 2014.
Richard U. Rodriguez,
Director, Division of Technology Development
& Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. 2014–07022 Filed 3–28–14; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive
License: Multivalent Vaccines for
Rabies Virus and Ebola and Marburg
(Filoviruses)
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 (NIH),
Department of Health and Human
Services (HHS), is contemplating the
grant of a an exclusive license to
practice the following invention as
embodied in the following patent
applications: E–032–2011/0, Blaney et
al., ‘‘Multivalent Vaccines for Rabies
Virus and Filoviruses,’’ U.S. Patent
Application Number 61/439,046, filed
SUMMARY:
E:\FR\FM\31MRN1.SGM
31MRN1
]]>Agencies
[Federal Register Volume 79, Number 61 (Monday, March 31, 2014)]
[Notices]
[Page 18039]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-07022]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive License: The Development of a
Single Domain Human Anti-Mesothelin Monoclonal Antibody for the
Treatment of Human Cancers
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, Department of Health
and Human Services, is contemplating the grant of an exclusive start-up
option license to practice the inventions embodied in U.S. Patent
Application 61/706,396 entitled ``Mesothelin Antibodies and Methods for
Eliciting Potent Antitumor Activity'' [HHS Ref. E-236-2012/0-US-01],
PCT Application PCT/US2013/059883 entitled ``Mesothelin Antibodies and
Methods for Eliciting Potent Antitumor Activity'' [HHS Ref. E-236-2012/
0-PCT-02], and all related continuing and foreign patents/patent
applications for the technology family, to H2Bio, Inc. The patent
rights in these inventions have been assigned to and/or exclusively
licensed to the Government of the United States of America.
The prospective exclusive start-up option licensed territory may be
worldwide, and the field of use may be limited to:
The use of the monoclonal antibody SD1 (and glycoengineered
variants thereof) as an antibody therapy for the treatment of
mesothelioma, pancreatic cancer, ovarian cancer and lung
adenocarcinoma. The Licensed Field of Use explicitly excludes the
use of the antibody in the form of an immunoconjugate, including,
but not limited to, immunotoxins.
Upon the expiration or termination of the exclusive start-up option
license, H2Bio, Inc. will have the exclusive right to execute an
exclusive commercialization license which will supersede and replace
the exclusive start-up option license with no greater field of use and
territory than granted in the exclusive start-up 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
April 15, 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: David A. Lambertson, Ph.D., Senior
Licensing and Patenting Manager, Office of Technology Transfer,
National Institutes of Health, 6011 Executive Boulevard, Suite 325,
Rockville, MD 20852-3804; Telephone: (301) 435-4632; Facsimile: (301)
402-0220; Email: lambertsond@mail.nih.gov.
SUPPLEMENTARY INFORMATION: This invention concerns a monoclonal
antibody and methods of using the antibody for the treatment of
mesothelin-expressing cancers, including mesothelioma, lung cancer,
ovarian cancer and pancreatic cancer. The specific antibody covered by
this technology is designated SD1, which is a single domain, fully
human monoclonal antibody against mesothelin.
Mesothelin is a cell surface antigen that is preferentially
expressed on certain types of cancer cells. The SD1 antibody can
selectively bind to these cancer cells and induce cell death while
leaving healthy, essential cells unharmed. This can result in an
effective therapeutic strategy with fewer side effects due to less non-
specific killing of cells.
The prospective exclusive start-up option 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 start-up option 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 start-up 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: March 27, 2014.
Richard U. Rodriguez,
Director, Division of Technology Development & Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. 2014-07022 Filed 3-28-14; 8:45 am]
BILLING CODE 4140-01-P
