Prospective Grant of Start-Up Exclusive Evaluation License: Caval-Aortic Devices for Aortic Valve Replacement, 12696-12697 [2014-04928]
Download as PDF
<![CDATA[
12696
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.
and 4 p.m., Monday through Friday, and
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
Federal Register / Vol. 79, No. 44 / Thursday, March 6, 2014 / Notices
includes an expandable transvascular
implant with an elastomeric surface
capable of extending between a vein and
artery which conforms to the boundaries
of an arteriovenous fistula tract between
the artery and vein. A guidewire
channel is disposed within the
occlusion device wherein the channel
also has elastomeric wall surfaces that
conform or can be expanded to the area
so that it occludes the channel when the
guidewire is not present. The implant is
resiliently deformable into a radially
compressed configuration for delivery
through the catheter but when not
deformed into the radially compressed
configuration at least the distal end of
the device is radially enlarged relative
to the intermediate neck whereby the
distal end forms an enlarged distal skirt,
such as a disk or button shaped
member. A polymer coating on the
radially enlarged distal end conforms to
the endoluminal aortic wall for
deployment against an internal wall of
the artery.
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.
tkelley on DSK3SPTVN1PROD with NOTICES6
Dated: March 3, 2014.
Richard Rodriguez,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. 2014–04928 Filed 3–5–14; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Diabetes and
Digestive and Kidney Diseases; Notice
of Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Diabetes and Digestive and Kidney Diseases
Special Emphasis Panel, NIDDK Ancillary
Studies.
Date: March 24, 2014
Time: 12 p.m. to 1 p.m.
Agenda: To review and evaluate grant
applications
Place: National Institutes of Health, Two
Democracy Plaza, 6707 Democracy
Boulevard, Bethesda, MD 20892, (Telephone
Conference Call).
Contact Person: Elena Sanovich, Ph.D.
Scientific Review Officer, Review Branch,
DEA, NIDDK, National Institutes Of Health,
Room 750, 6707 Democracy Boulevard,
Bethesda, MD 20892–2542, 301–594–8886,
sanoviche@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.847, Diabetes,
Endocrinology and Metabolic Research;
93.848, Digestive Diseases and Nutrition
Research; 93.849, Kidney Diseases, Urology
and Hematology Research, National Institutes
of Health, HHS)
Dated: February 28, 2014.
David Clary,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2014–04877 Filed 3–5–14; 8:45 am]
12697
PubMed Central National Advisory
Committee.
The meeting will be open to the
public as indicated below, with
attendance limited to space available.
Individuals who plan to attend and
need special assistance, such as sign
language interpretation or other
reasonable accommodations, should
notify the Contact Person listed below
in advance of the meeting.
Name of Committee: PubMed Central
National Advisory Committee.
Date: June 10, 2014.
Time: 9:30 a.m. to 3:00 p.m.
Agenda: Review and Analysis of Systems.
Place: National Library of Medicine,
Building 38, 2nd Floor, Board Room, 8600
Rockville Pike, Bethesda, MD 20892.
Contact Person: David J. Lipman, MD,
Director, National Center for Biotechnology
Information, National Library of Medicine,
Building 38, Room 8N805, Bethesda, MD
20894, 301–435–5985, dlipman@
mail.nih.gov.
Any interested person may file written
comments with the committee by forwarding
the statement to the Contact Person listed on
this notice. The statement should include the
name, address, telephone number and when
applicable, the business or professional
affiliation of the interested person.
In the interest of security, NIH has
instituted stringent procedures for entrance
onto the NIH campus. All visitor vehicles,
including taxicabs, hotel, and airport shuttles
will be inspected before being allowed on
campus. Visitors will be asked to show one
form of identification (for example, a
government-issued photo ID, driver’s license,
or passport) and to state the purpose of their
visit.
Information is also available on the
Institute’s/Center’s home page: https://
www.pubmed.central.nih.gov/about/nac/
html, where an agenda and any additional
information for the meeting will be posted
when available.
(Catalogue of Federal Domestic Assistance
Program No. 93.879, Medical Library
Assistance, National Institutes of Health,
HHS)
Dated: February 28, 2014.
Michelle Trout,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2014–04873 Filed 3–5–14; 8:45 am]
BILLING CODE 4140–01–P
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institutes of Health
National Library of Medicine; Notice of
Meeting
VerDate Mar<15>2010
17:07 Mar 05, 2014
Jkt 232001
National Institute of Diabetes and
Digestive and Kidney Diseases Notice
of Closed Meeting
Pursuant to section 10(a) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App), notice is
hereby given of a meeting of the
BILLING CODE 4140–01–P
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
PO 00000
Frm 00012
Fmt 4703
Sfmt 4703
E:\FR\FM\06MRN1.SGM
06MRN1
]]>Agencies
[Federal Register Volume 79, Number 44 (Thursday, March 6, 2014)]
[Notices]
[Pages 12696-12697]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-04928]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of Start-Up Exclusive Evaluation License:
Caval-Aortic Devices for Aortic Valve Replacement
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-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
[[Page 12697]]
includes an expandable transvascular implant with an elastomeric
surface capable of extending between a vein and artery which conforms
to the boundaries of an arteriovenous fistula tract between the artery
and vein. A guidewire channel is disposed within the occlusion device
wherein the channel also has elastomeric wall surfaces that conform or
can be expanded to the area so that it occludes the channel when the
guidewire is not present. The implant is resiliently deformable into a
radially compressed configuration for delivery through the catheter but
when not deformed into the radially compressed configuration at least
the distal end of the device is radially enlarged relative to the
intermediate neck whereby the distal end forms an enlarged distal
skirt, such as a disk or button shaped member. A polymer coating on the
radially enlarged distal end conforms to the endoluminal aortic wall
for deployment against an internal wall of the artery.
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. 2014-04928 Filed 3-5-14; 8:45 am]
BILLING CODE 4140-01-P
