82 FR 47757 - Prospective Grant of Exclusive Patent License: Devices and Systems For Treating Valvular Regurgitation

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 82, Issue 197 (October 13, 2017)

Page Range		47757-47758
FR Document		2017-22157

The National Heart, Lung and Blood Institute (NHLBI), National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an Exclusive Patent License to Cook Medical Technologies, LLC, located in Bloomington, Indiana, to practice the inventions embodied in the patent applications listed in the Supplementary Information section of this notice.

Federal Register, Volume 82 Issue 197 (Friday, October 13, 2017)

[Federal Register Volume 82, Number 197 (Friday, October 13, 2017)]
[Notices]
[Pages 47757-47758]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-22157]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive Patent License: Devices and 
Systems For Treating Valvular Regurgitation

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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SUMMARY: The National Heart, Lung and Blood Institute (NHLBI), National 
Institutes of Health, Department of Health and Human Services, is 
contemplating the grant of an Exclusive Patent License to Cook Medical 
Technologies, LLC, located in Bloomington, Indiana, to practice the 
inventions embodied in the patent applications listed in the 
Supplementary Information section of this notice.

DATES: Only written comments and/or applications for a license which 
are received by the NHLBI Office of Technology Transfer and Development 
October 30, 2017 will be considered.

ADDRESSES: Requests for copies of the patent applications, inquiries, 
and comments relating to the contemplated exclusive patent license 
should be directed to: Michael Shmilovich, Esq., Senior Licensing and 
Patent Manager, 31 Center Drive Room 4A29, MSC2479, Bethesda, MD 20892-
2479, phone number 301-435-5019, or [email protected].

SUPPLEMENTARY INFORMATION: The following and all continuing U.S. and 
foreign patents/patent applications thereof are the intellectual 
properties to be licensed under the prospective agreement to Cook 
Medical Technologies, LLC: NIH Ref. No. E-027-2013/0 ``Devices And 
Methods for Treating Functional Triscupid Valve Regurgitation'' U.S. 
Provisional Patent Application 61/785,652 filed March 14, 2013, 
International Patent Application PCT/US2014/025300 filed under the 
Patent Cooperation Treaty on March 13, 2014, European Patent 
Application 14723540.2 having an international filing date of March 13, 
2014, and U.S. Patent Application 14/776,488 also having an 
international filing date of March 13, 2014. NIH Ref. No. E-115-2013/0 
``Encircling Suture Delivery System For Flexible Circumferential 
Suture,'' U.S. Provisional Patent Application 61/834,357 filed June 12, 
2013, International Patent Application PCT/US2014/040716 filed under 
the Patent Cooperation Treaty on June 3, 2014, European Patent 
Application 14735030.0 having an international filing date of June 3, 
2014 and U.S. Patent Application 14/898,020 also having an 
international filing date of June 3, 2014. The patent rights in these 
inventions have been assigned to the Government of the United States of 
America. The prospective exclusive patent License territory may be 
worldwide and a field of use limited to valvular regurgitation.
    The invention embodied in NIH Ref. No. E-027-2013/0 relates to 
devices and methods for treating functional tricuspid valve 
regurgitation and related conditions. The devices are adapted for 
applying force to an area of a patient's heart along or near the 
atrioventricular groove and can include a tensioning element configured 
to be delivered by a flexible member guided through a catheter and 
positioned generally along or near the atrioventricular groove, and a 
compression member that can be positioned along the tensioning element 
and over a desired segment of the atrioventricular groove to develop 
force to be applied to an adjacent area of the heart by selective 
tensioning of the tensioning element.
    The invention embodied in NIH Ref No. E-115-2013/0 relates to 
devices for delivering encircling implants that can include two 
separate limbs held together at a distal articulation by the implant 
being delivered. The implant can comprise a suture and/or a braided

[[Page 47758]]

tube. The implant can extend through or over the limbs. The implant and 
at least a distal portion of the limbs can be compressible into a 
delivery shape that allows for advancement through the lumen of a 
delivery catheter. When the distal portion of the limbs move out of the 
delivery catheter, the limbs and implant can resiliently assume a loop 
shape that is complementary to a shape of a target around which the 
encircling implant is to be placed. The limbs are then retracted from 
along the implant to leave the implant in the desired delivery 
position. The delivery device can be used to place encircling implants 
around the heart or other targets, and the implant can be tightened to 
exert compressive force on the target.
    This notice is made in accordance with 35 U.S.C. 209 and 37 CFR 
part 404. The prospective exclusive patent license will be royalty 
bearing and may be granted unless within fifteen (15) days from the 
date of this published notice, the NHLBI 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.
    Complete applications for a license in the prospective field of use 
that are timely filed in response to this notice will be treated as 
objections to the grant of the contemplated exclusive patent 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: September 22, 2017.
Michael Shmilovich,
Senior Licensing and Patenting Manager, National Heart, Lung, and Blood 
Institute, Office of Technology Transfer and Development.
[FR Doc. 2017-22157 Filed 10-12-17; 8:45 am]
 BILLING CODE 4140-01-P

Federal Register / Vol. 82, No. 197 / Friday, October 13, 2017 / Notices 47757

ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Average
Number of
Number of burden per Total
Type of respondent Form name responses per
respondents response burden hours
respondent (in hours)

State Government ....................................................... 20 1 5/60 2
Federal Government .................................................... 10 1 5/60 1

Total ...................................................................... 250 250 ........................ 105

Dated: October 6, 2017. Dated: October 6, 2017. Regurgitation’’ U.S. Provisional Patent
Karla Bailey, Michelle Trout, Application 61/785,652 filed March 14,
Project Clearance Liaison, National Cancer Program Analyst, Office of Federal Advisory 2013, International Patent Application
Institute, National Institutes of Health. Committee Policy. PCT/US2014/025300 filed under the
[FR Doc. 2017–22156 Filed 10–12–17; 8:45 am] [FR Doc. 2017–22141 Filed 10–12–17; 8:45 am] Patent Cooperation Treaty on March 13,
BILLING CODE 4140–01–P BILLING CODE 4140–01–P 2014, European Patent Application
14723540.2 having an international
filing date of March 13, 2014, and U.S.
DEPARTMENT OF HEALTH AND DEPARTMENT OF HEALTH AND Patent Application 14/776,488 also
HUMAN SERVICES HUMAN SERVICES having an international filing date of
March 13, 2014. NIH Ref. No. E–115–
National Institutes of Health 2013/0 ‘‘Encircling Suture Delivery
National Institutes of Health
System For Flexible Circumferential
Prospective Grant of Exclusive Patent
National Heart, Lung, and Blood Suture,’’ U.S. Provisional Patent
License: Devices and Systems For
Institute; Notice of Closed Meeting Application 61/834,357 filed June 12,
Treating Valvular Regurgitation
2013, International Patent Application
Pursuant to section 10(d) of the AGENCY: National Institutes of Health, PCT/US2014/040716 filed under the
Federal Advisory Committee Act, as HHS. Patent Cooperation Treaty on June 3,
amended, notice is hereby given of the ACTION: Notice. 2014, European Patent Application
NHLBI Special Emphasis Panel. 14735030.0 having an international
SUMMARY: The National Heart, Lung and filing date of June 3, 2014 and U.S.
The meeting will be closed to the Blood Institute (NHLBI), National
public in accordance with the Patent Application 14/898,020 also
Institutes of Health, Department of having an international filing date of
provisions set forth in sections Health and Human Services, is
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., June 3, 2014. The patent rights in these
contemplating the grant of an Exclusive inventions have been assigned to the
as amended. The grant applications and Patent License to Cook Medical
the discussions could disclose Government of the United States of
Technologies, LLC, located in America. The prospective exclusive
confidential trade secrets or commercial Bloomington, Indiana, to practice the
property such as patentable material, patent License territory may be
inventions embodied in the patent worldwide and a field of use limited to
and personal information concerning applications listed in the
individuals associated with the grant valvular regurgitation.
Supplementary Information section of The invention embodied in NIH Ref.
applications, the disclosure of which this notice.
would constitute a clearly unwarranted No. E–027–2013/0 relates to devices and
DATES: Only written comments and/or methods for treating functional
invasion of personal privacy. applications for a license which are tricuspid valve regurgitation and related
Name of Committee: National Heart, Lung, received by the NHLBI Office of conditions. The devices are adapted for
and Blood Institute Special Emphasis Panel; Technology Transfer and Development applying force to an area of a patient’s
NHLBI Single Site CLTR Review. October 30, 2017 will be considered. heart along or near the atrioventricular
Date: November 6, 2017. ADDRESSES: Requests for copies of the groove and can include a tensioning
Time: 8:00 a.m. to 3:00 p.m. patent applications, inquiries, and
Agenda: To review and evaluate grant
element configured to be delivered by a
comments relating to the contemplated flexible member guided through a
applications. exclusive patent license should be
Place: Hyatt Regency Bethesda, One catheter and positioned generally along
directed to: Michael Shmilovich, Esq., or near the atrioventricular groove, and
Bethesda Metro Center, 7400 Wisconsin
Senior Licensing and Patent Manager, a compression member that can be
Avenue, Bethesda, MD 20814.
31 Center Drive Room 4A29, MSC2479, positioned along the tensioning element
Contact Person: Chang Sook Kim, Ph.D.,
Bethesda, MD 20892–2479, phone and over a desired segment of the
Scientific Review Officer, Office of Scientific
number 301–435–5019, or shmilovm@ atrioventricular groove to develop force
Review/DERA, National Heart, Lung, and
Blood Institute, 6701 Rockledge Drive, Room
mail.nih.gov. to be applied to an adjacent area of the
heart by selective tensioning of the
asabaliauskas on DSKBBXCHB2PROD with NOTICES

7188, Bethesda, MD 20892–7924, 301–827– SUPPLEMENTARY INFORMATION: The
7940, carolko@mail.nih.gov. following and all continuing U.S. and tensioning element.
(Catalogue of Federal Domestic Assistance foreign patents/patent applications The invention embodied in NIH Ref
Program Nos. 93.233, National Center for thereof are the intellectual properties to No. E–115–2013/0 relates to devices for
Sleep Disorders Research; 93.837, Heart and be licensed under the prospective delivering encircling implants that can
Vascular Diseases Research; 93.838, Lung agreement to Cook Medical include two separate limbs held
Diseases Research; 93.839, Blood Diseases Technologies, LLC: NIH Ref. No. E–027– together at a distal articulation by the
and Resources Research, National Institutes 2013/0 ‘‘Devices And Methods for implant being delivered. The implant
of Health, HHS) Treating Functional Triscupid Valve can comprise a suture and/or a braided

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Document Created: 2017-10-13 04:34:01
Document Modified: 2017-10-13 04:34:01

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		Only written comments and/or applications for a license which are received by the NHLBI Office of Technology Transfer and Development October 30, 2017 will be considered.
FR Citation		82 FR 47757

82 FR 47757 - Prospective Grant of Exclusive Patent License: Devices and Systems For Treating Valvular Regurgitation

DEPARTMENT OF HEALTH AND HUMAN SERVICESNational Institutes of Health

Federal Register Volume 82, Issue 197 (October 13, 2017)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health