Prospective Grant of Start-Up Exclusive Evaluation License: Live Attenuated Codon-Deoptimized Respiratory Syncytial Virus Vaccines, 12696 [2014-04929]
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Federal Register / Vol. 79, No. 44 / Thursday, March 6, 2014 / Notices
comments may be seen in the Division
of Dockets Management between 9 a.m.
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will be posted to the docket at https://
www.regulations.gov.
Dated: February 28, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of Start-Up
Exclusive Evaluation License: Live
Attenuated Codon-Deoptimized
Respiratory Syncytial Virus Vaccines
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 worldwide exclusive
evaluation option license to practice the
inventions embodied in: HHS Ref. No.
E–080–2013/0 and /1, ‘‘Attenuation Of
Human Respiratory Syncytial Virus By
Genome Scale Codon-Pair
Deoptimization,’’ US Provisional Patent
Applications 61/762,768 filed February
8, 2013 and 61/794,155 filed March 15,
2013, and PCT/US2014/015274 filed
February 7, 2014, to Codagenix, Inc.,
having its principle place of business in
Stony Brook, New York.
The United States of America is an
assignee to the patent rights of these
inventions.
The contemplated exclusive license
may be limited to a live attenuated
codon-deoptimized respiratory syncytial
virus vaccine. Upon the expiration or
termination of the start-up exclusive
evaluation license, Codagenix will have
the right to execute a start-up exclusive
patent commercialization license with
no greater field of use and territory than
granted in the evaluation license.
DATES: Only written comments and/or
applications for a license that are
received by the NIH Office of
Technology Transfer on or before March
21, 2014 will be considered.
ADDRESSES: Requests for a copy of the
patent application, inquiries, comments
and other materials relating to the
contemplated license should be directed
to: Michael Shmilovich, Esq., Senior
Licensing and Patent Manager, Office of
Technology Transfer, National Institutes
tkelley on DSK3SPTVN1PROD with NOTICES6
SUMMARY:
VerDate Mar<15>2010
17:07 Mar 05, 2014
Jkt 232001
The
invention pertains to live attenuated
respiratory syncytial viruses that can be
used in prophylactic vaccines. The
viruses are generated using codon-pair
deoptimization techniques, resulting in
attenuation based on hundreds or
thousands of nucleotide substitutions
with no differences at the amino acid
level. The most notable strain has
mutations in the NS1, NS2, N, P, M, SH,
G, F, or L genes and referenced by the
designation RSV MinFLC (SEQ ID No: 5
in the patent application). Experimental
growth data for representative viruses in
mice and in African Green Monkeys
demonstrated in vivo growth
attenuation.
The prospective exclusive evaluation
option 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 404. The
prospective exclusive evaluation option
license, and a subsequent exclusive
patent commercialization 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 404.
Properly filed competing applications
for a license filed in response to this
notice will be treated as objections to
the contemplated license. Comments
and objections submitted in response 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:
[FR Doc. 2014–04930 Filed 3–5–14; 8:45 am]
AGENCY:
of Health, 6011 Executive Boulevard,
Suite 325, Rockville, MD 20852–3804;
Telephone: (301) 435–5019; Facsimile:
(301) 402–0220; Email: shmilovm@
mail.nih.gov.
Dated: March 3, 2014.
Richard Rodriguez,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. 2014–04929 Filed 3–5–14; 8:45 am]
BILLING CODE 4140–01–P
PO 00000
Frm 00011
Fmt 4703
Sfmt 4703
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of Start-Up
Exclusive Evaluation License: CavalAortic Devices for Aortic Valve
Replacement
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 worldwide exclusive
evaluation option license to practice the
inventions embodied in: HHS Ref. No.
E–553–2013/0, U.S. Provisional Patent
Application No. 61/863,071, filed
August 7, 2013; International Patent
Application PCT/US2013/072344 filed
November 27, 2013 entitled
‘‘Transvascular And Transcameral
Device Access And Closure,’’ to Mehr
Medical LLC, having its principle place
of business in Andover Massachusetts.
The contemplated exclusive license
may be limited to caval-aortic devices
for aortic valve replacement. Upon the
expiration or termination of the start-up
exclusive evaluation license, Mehr will
have the right to execute a start-up
exclusive patent commercialization
license with no greater field of use and
territory than granted in the evaluation
license.
DATES: Only written comments and/or
applications for a license that are
received by the NIH Office of
Technology Transfer on or before March
21, 2014 will be considered.
ADDRESSES: Requests for a copy of the
patent application, inquiries, comments
and other materials relating to the
contemplated license should be directed
to: Michael Shmilovich, Esq. Senior
Licensing and Patent Manager, Office of
Technology Transfer, National Institutes
of Health, 6011 Executive Boulevard,
Suite 325, Rockville, MD 20852–3804;
Telephone: (301) 435–5019; Facsimile:
(301) 402–0220; Email: shmilovm@
mail.nih.gov.
SUPPLEMENTARY INFORMATION: The
invention pertains to devices and
methods for transcatheter correction of
cardiovascular abnormalities and most
specifically for the delivery of prosthetic
valves to the heart. Featured is a device
implant for closing a caval-aortic
iatrogenic fistula created by the
introduction of a transcatheter device
from the inferior vena cava into the
abdominal aorta. The occlusion device
SUMMARY:
E:\FR\FM\06MRN1.SGM
06MRN1
]]>Agencies
[Federal Register Volume 79, Number 44 (Thursday, March 6, 2014)]
[Notices]
[Page 12696]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-04929]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of Start-Up Exclusive Evaluation License: Live
Attenuated Codon-Deoptimized Respiratory Syncytial Virus Vaccines
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 (NIH), Department of Health
and Human Services (HHS), is contemplating the grant of a worldwide
exclusive evaluation option license to practice the inventions embodied
in: HHS Ref. No. E-080-2013/0 and /1, ``Attenuation Of Human
Respiratory Syncytial Virus By Genome Scale Codon-Pair
Deoptimization,'' US Provisional Patent Applications 61/762,768 filed
February 8, 2013 and 61/794,155 filed March 15, 2013, and PCT/US2014/
015274 filed February 7, 2014, to Codagenix, Inc., having its principle
place of business in Stony Brook, New York.
The United States of America is an assignee to the patent rights of
these inventions.
The contemplated exclusive license may be limited to a live
attenuated codon-deoptimized respiratory syncytial virus vaccine. Upon
the expiration or termination of the start-up exclusive evaluation
license, Codagenix will have the right to execute a start-up exclusive
patent commercialization license with no greater field of use and
territory than granted in the evaluation license.
DATES: Only written comments and/or applications for a license that are
received by the NIH Office of Technology Transfer on or before March
21, 2014 will be considered.
ADDRESSES: Requests for a copy of the patent application, inquiries,
comments and other materials relating to the contemplated license
should be directed to: Michael Shmilovich, Esq., Senior Licensing and
Patent Manager, Office of Technology Transfer, National Institutes of
Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852-3804;
Telephone: (301) 435-5019; Facsimile: (301) 402-0220; Email:
shmilovm@mail.nih.gov.
SUPPLEMENTARY INFORMATION: The invention pertains to live attenuated
respiratory syncytial viruses that can be used in prophylactic
vaccines. The viruses are generated using codon-pair deoptimization
techniques, resulting in attenuation based on hundreds or thousands of
nucleotide substitutions with no differences at the amino acid level.
The most notable strain has mutations in the NS1, NS2, N, P, M, SH, G,
F, or L genes and referenced by the designation RSV MinFLC (SEQ ID No:
5 in the patent application). Experimental growth data for
representative viruses in mice and in African Green Monkeys
demonstrated in vivo growth attenuation.
The prospective exclusive evaluation option 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 404. The prospective exclusive evaluation option license, and a
subsequent exclusive patent commercialization 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 404.
Properly filed competing applications for a license filed in
response to this notice will be treated as objections to the
contemplated license. Comments and objections submitted in response 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 3, 2014.
Richard Rodriguez,
Director, Division of Technology Development and Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. 2014-04929 Filed 3-5-14; 8:45 am]
BILLING CODE 4140-01-P
