Prospective Grant of Exclusive License: The Development of Therapeutic Agents for the Treatment of Metastatic Breast Cancer and T-cell Lymphoma, 62521 [2012-25170]
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Federal Register / Vol. 77, No. 199 / Monday, October 15, 2012 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive
License: The Development of
Therapeutic Agents for the Treatment
of Metastatic Breast Cancer and T-cell
Lymphoma
National Institutes of Health,
Public Health Service, HHS.
ACTION: Notice.
AGENCY:
This is notice, in accordance
with 35 U.S.C. 209(c)(1) and 37 CFR
Part 404.7(a)(1)(i), that the National
Institutes of Health, Department of
Health and Human Services, is
contemplating the grant to Birich
Technologies, Inc., of an exclusive
evaluation option license to practice the
inventions embodied in the following
U.S. Patent Applications (and all
continuing applications and foreign
counterparts): Serial No. 61/045,088
entitled, ‘‘COMPOSITIONS AND
METHODS FOR DELIVERING
INHIBITORY OLIGONUCLEOTIDES’’
[HHS Ref. E–051–2008/0–US–01]; Serial
No. 61/333,512 entitled, ‘‘Peptide
Inhibitors of Interferon Gamma and
Interleukin 10 Signaling’’ [HHS Ref. E–
167–2010/0–US–01]; and Serial No. 60/
987,340 entitled, ‘‘Diagnostic and
Therapeutic Applications of a p53
Isoform in Regenerative Medicine,
Aging and Cancer’’ [HHS Ref. E–033–
2008/0–US–01]. The patent rights in
these inventions have been assigned or
exclusively licensed to the Government
of the United States of America.
The prospective exclusive evaluation
option license territory may be
worldwide, and the field of use may be
limited to:
SUMMARY:
erowe on DSK2VPTVN1PROD with
The use in humans of the peptide-based
antisense delivery technology (ChemoArp) in
conjunction with either (i) a peptide-based
interleukin-10 (IL–10) inhibitor as a dualbiologic therapy to treat metastatic breast
cancer, or ii) incorporating a p53 isoform
antisense oligonucleotide as a single biologic
therapy to treat T-cell lymphoma.
Upon the expiration or termination of
the exclusive evaluation option license,
Birich Technologies, Inc. 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 or
applications for a license (or both)
which are received by the NIH Office of
VerDate Mar<15>2010
15:21 Oct 12, 2012
Jkt 229001
Technology Transfer on or before
October 30, 2012 will be considered.
ADDRESSES: Requests for copies of the
patent application, inquiries, comments,
and other materials relating to the
contemplated exclusive evaluation
option license should be directed to:
Patrick McCue, 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) 435–5560; Facsimile:
(301) 402–0220; Email:
mccuepat@mail.nih.gov.
These
inventions concern i) compositions and
methods for targeted delivery of
inhibitory nucleic acids to cells using a
cell surface receptor ligand targeting
domain and an inhibitory
oligonucleotide-binding domain to
efficiently deliver the antisense nucleic
acid to cells that expresses the cell
surface receptor that binds the ligand, ii)
compositions that potently and
selectively interfere with dimerization
of interleukin-10 and binding of this
protein to its receptor, and iii)
compositions that inhibit delta133p53, a
natural variant nucleic acid of tumor
suppressor protein 53 (p53) that inhibits
p53-dependent cell senescence.
The prospective exclusive evaluation
option license is being considered under
the small business initiative launched
on 1 October 2011, and will comply
with the terms and conditions of 35
U.S.C. 209 and 37 CFR Part 404.7. 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 404.7
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.
SUPPLEMENTARY INFORMATION:
Dated: October 9, 2012.
Richard U. Rodriguez,
Director, Division of Technology Development
& Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. 2012–25170 Filed 10–12–12; 8:45 am]
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62521
DEPARTMENT OF HOMELAND
SECURITY
[Docket No. DHS–2012–0056]
National Infrastructure Advisory
Council
National Protection and
Programs Directorate, DHS.
ACTION: Committee Management; Notice
of an open Federal Advisory Committee
Meeting.
AGENCY:
The National Infrastructure
Advisory Council (NIAC) will meet
Tuesday, October 16, 2012, at the
United States Access Board, 1331 F
Street NW., Suite 800, Washington, DC
20004. The meeting will be open to the
public.
DATES: The NIAC will meet Tuesday,
October 16, 2012, from 1:30 p.m. to 4:30
p.m. The meeting may close early if the
committee has completed its business.
For additional information, please
consult the NIAC Web site,
www.dhs.gov/NIAC, or contact the NIAC
Secretariat by phone at (703) 235–2888
or by email at NIAC@hq.dhs.gov.
ADDRESSES: United States Access Board,
1331 F Street NW., Suite 800,
Washington, DC 20004.
For information on facilities or
services for individuals with disabilities
or to request special assistance at the
meeting, contact the person listed under
FOR FURTHER INFORMATION CONTACT,
below as soon as possible.
To facilitate public participation, we
are inviting public comment on the
issues to be considered by the Council
as listed in the SUMMARY section below.
Comments must be submitted in writing
no later than October 11, 2012, and
must be identified by ‘‘DHS–2012–
0056’’ and may be submitted by any one
of the following methods:
• Federal eRulemaking Portal:
www.regulations.gov. Follow the
instructions for submitting written
comments.
• Email: NIAC@hq.dhs.gov. Include
the docket number in the subject line of
the message.
• Fax: (703) 603–5098.
• Mail: Nancy Wong, National
Protection and Programs Directorate,
Department of Homeland Security, 245
Murray Lane SW., Mail Stop 0607,
Arlington, VA 20598–0607.
Instructions: All written submissions
received must include the words
‘‘Department of Homeland Security’’
and the docket number for this action.
Written comments received will be
posted without alteration at
www.regulations.gov, including any
personal information provided.
SUMMARY:
E:\FR\FM\15OCN1.SGM
15OCN1
]]>Agencies
[Federal Register Volume 77, Number 199 (Monday, October 15, 2012)]
[Notices]
[Page 62521]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-25170]
[[Page 62521]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive License: The Development of
Therapeutic Agents for the Treatment of Metastatic Breast Cancer and T-
cell Lymphoma
AGENCY: National Institutes of Health, Public Health Service, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37
CFR Part 404.7(a)(1)(i), that the National Institutes of Health,
Department of Health and Human Services, is contemplating the grant to
Birich Technologies, Inc., of an exclusive evaluation option license to
practice the inventions embodied in the following U.S. Patent
Applications (and all continuing applications and foreign
counterparts): Serial No. 61/045,088 entitled, ``COMPOSITIONS AND
METHODS FOR DELIVERING INHIBITORY OLIGONUCLEOTIDES'' [HHS Ref. E-051-
2008/0-US-01]; Serial No. 61/333,512 entitled, ``Peptide Inhibitors of
Interferon Gamma and Interleukin 10 Signaling'' [HHS Ref. E-167-2010/0-
US-01]; and Serial No. 60/987,340 entitled, ``Diagnostic and
Therapeutic Applications of a p53 Isoform in Regenerative Medicine,
Aging and Cancer'' [HHS Ref. E-033-2008/0-US-01]. The patent rights in
these inventions have been assigned or exclusively licensed to the
Government of 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 in humans of the peptide-based antisense delivery
technology (ChemoArp) in conjunction with either (i) a peptide-based
interleukin-10 (IL-10) inhibitor as a dual-biologic therapy to treat
metastatic breast cancer, or ii) incorporating a p53 isoform
antisense oligonucleotide as a single biologic therapy to treat T-
cell lymphoma.
Upon the expiration or termination of the exclusive evaluation
option license, Birich Technologies, Inc. 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 or applications for a license (or both)
which are received by the NIH Office of Technology Transfer on or
before October 30, 2012 will be considered.
ADDRESSES: Requests for copies of the patent application, inquiries,
comments, and other materials relating to the contemplated exclusive
evaluation option license should be directed to: Patrick McCue, 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) 435-5560; Facsimile: (301)
402-0220; Email: mccuepat@mail.nih.gov.
SUPPLEMENTARY INFORMATION: These inventions concern i) compositions and
methods for targeted delivery of inhibitory nucleic acids to cells
using a cell surface receptor ligand targeting domain and an inhibitory
oligonucleotide-binding domain to efficiently deliver the antisense
nucleic acid to cells that expresses the cell surface receptor that
binds the ligand, ii) compositions that potently and selectively
interfere with dimerization of interleukin-10 and binding of this
protein to its receptor, and iii) compositions that inhibit
delta133p53, a natural variant nucleic acid of tumor suppressor protein
53 (p53) that inhibits p53-dependent cell senescence.
The prospective exclusive evaluation option license is being
considered under the small business initiative launched on 1 October
2011, and will comply with the terms and conditions of 35 U.S.C. 209
and 37 CFR Part 404.7. 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 404.7 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: October 9, 2012.
Richard U. Rodriguez,
Director, Division of Technology Development & Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. 2012-25170 Filed 10-12-12; 8:45 am]
BILLING CODE 4140-01-P
