Prospective Grant of an Exclusive Patent License for Commercialization: Cerclage Annuloplasty Devices for Treating Mitral Valve Regurgitation, 15363-15364 [2017-06036]

Download as PDF Federal Register / Vol. 82, No. 58 / Tuesday, March 28, 2017 / Notices Name of Committee: National Cancer Institute Special Emphasis Panel; Feb2017 Cycle 25 NExT SEP Committee Meeting. Date: April 19, 2017. Time: 8:30 a.m. to 4:30 p.m. Agenda: To evaluate the NCI Experimental Therapeutics Program Portfolio. Place: National Institutes of Health, 9000 Rockville Pike, Building 31, Wing C; 6th Floor, Conference Room 10, Bethesda, MD 20892. Contact Person: Barbara Mroczkowski, Ph.D., Executive Secretary, Discovery Experimental Therapeutics Program, National Cancer Institute, NIH, 31 Center Drive, Room 3A44, Bethesda, MD 20817, (301) 496–4291, mroczkoskib@mail.nih.gov. Toby Hecht, Ph.D., Executive Secretary, Development Experimental Therapeutics Program, National Cancer Institute, NIH, 9609 Medical Center Drive, Room 3W110, NIH Ref. No. Rockville, MD 20850, (240) 276–5683, toby.hecht2@nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.392, Cancer Construction; 93.393, Cancer Cause and Prevention Research; 93.394, Cancer Detection and Diagnosis Research; 93.395, Cancer Treatment Research; 93.396, Cancer Biology Research; 93.397, Cancer Centers Support; 93.398, Cancer Research Manpower; 93.399, Cancer Control, National Institutes of Health, HHS) DEPARTMENT OF HEALTH AND HUMAN SERVICES Dated: March 22, 2017. Melanie J. Pantoja, Program Analyst, Office of Federal Advisory Committee Policy. ACTION: [FR Doc. 2017–06040 Filed 3–27–17; 8:45 am] BILLING CODE 4140–01–P Patent No. or application No. E–249–2006/1–US–01 .......... E–249–2006/2–PCT–01 ....... E–249–2006/2–EP–02 .......... 60/932,611 PCT/US2007/023876 07861997.0 May 31, 2006. November 13, 2007. November 13, 2007 ............. E–249–2006/2–US–03 .......... E–249–2006/2–US–04 .......... E–249–2006/3–US–01 .......... 8,211,171 9,271,833 15/056,599 November 13, 2007. November 13, 2007. February 29, 2016 ............... sradovich on DSK3GMQ082PROD with NOTICES VerDate Sep<11>2014 17:14 Mar 27, 2017 Jkt 241001 National Institutes of Health, HHS. Notice. The National Institutes of Health (NIH), Department of Health and Human Services, is contemplating the grant of a worldwide exclusive license to practice the inventions embodied in: SUMMARY: Transcatheter Coronary Sinus Mitral Valve Annuloplasty Procedure And Coronary Artery And Myocardial Protection Device. Transcatheter Coronary Sinus Mitral Valve Annuloplasty Procedure and Coronary Artery and Myocardial Protection Device with ‘‘Landing Zone’’. disorders, with an estimated prevalence of approximately 1.7% in the United States, increasing with age to approximately 9.3% in those over the age of 75. MR is classified as primary (also known as ‘‘organic’’) when principally due to a structural or degenerative abnormality of the mitral valve (MV), whether of the leaflets, chordae tendineae, papillary muscles, or mitral annulus. Secondary (also known as functional) MR occurs in the absence of organic MV disease, usually from left ventricular (LV) dysfunction. It is more common than primary MR and is associated with a worse prognosis (compounded by the underlying cardiomyopathy), and (in contrast to primary MR) the benefits of MV surgery are uncertain. The MV consists of two leaflets (anterior and posterior) sitting within the annulus (see picture below). The posterior mitral leaflet originates from the left atrial (LA) endocardium. A subvalvular apparatus, comprising two papillary muscles (anterolateral and posteromedial) arising from the LV myocardium and the chordae tendineae, supports the leaflets. LV dilation due to ischemic or nonischemic cardiomyopathy secondarily impairs leaflet coaptation of a structurally PO 00000 AGENCY: A Device To Protect Coronary Arteries Against Compression During Transcatheter Mitral Valve Annuloplasty (PMVA). November 14, 2006 ............. Only written comments and/or applications for a license that are received by NIH at the address indicated below on or before April 12, 2017 will be considered. ADDRESSES: Requests for a copy of any unpublished patent application, inquiries, objections to this notice, comments and other requests relating to the contemplated license should be directed to: Michael Shmilovich, Esq., CLP, Senior Licensing and Patent Manager, 31 Center Drive Room 4A29, MSC2479, Bethesda, MD 20892–2479, phone number 301–435–5019, or shmilovm@mail.nih.gov. SUPPLEMENTARY INFORMATION: This notice is published in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i). Mitral regurgitation (MR) is amongst the most common valvular heart Prospective Grant of an Exclusive Patent License for Commercialization: Cerclage Annuloplasty Devices for Treating Mitral Valve Regurgitation Title 60/858,716 DATES: National Institutes of Health Filing date E–249–2006/0–US–01 .......... to Transmural Systems, LLC, a limited liability company incorporated under the laws of the State of Massachusetts and having its principle place of business in Andover, Massachusetts. The contemplated exclusive license may be limited to cerclage annuloplasty devices for treating mitral valve regurgitation. 15363 Frm 00050 Fmt 4703 Sfmt 4703 normal MV, resulting in secondary MR. Specifically, LV dysfunction and remodeling lead to apical and lateral papillary muscle displacement, resulting in leaflet tethering, dilation and flattening of the mitral annulus, and reduced valve closing forces. The subject mitral repair system devices are primarily intended to treat secondary mitral regurgitation. The proposed mitral cerclage with coronary artery protection is an approach capable of overcoming many of the problems that exist with existing devices namely allowing a larger subset of patients to be treated compared to other coronary sinus devices, providing a full annuloplasty type device which is flexible enough to preserve annular motion, reduce hospitalization costs and shorten recovery time. The associated method closely resembles the surgical placement of a full annuloplasty ring. E–249–2009/0–2 Catheter-based mitral valve regurgitation treatments that use coronary sinus trajectory or coronary sinus implant can have unwanted effects because the coronary sinus and its branches have been found to cross the outer diameter of major coronary E:\FR\FM\28MRN1.SGM 28MRN1 15364 Federal Register / Vol. 82, No. 58 / Tuesday, March 28, 2017 / Notices sradovich on DSK3GMQ082PROD with NOTICES arteries in a majority of humans. As a result, pressure applied by any prosthetic device in the coronary sinus (such as tension on the annuloplasty device) can compress the underlying coronary artery and induce myocardial ischemia or infarction. This invention pertains to devices and methods that avoid constricting coronary artery branches during coronary sinus-based annuloplasty. These devices and methods protect coronary artery branches from constriction during transsinus mitral annuloplasty. The device protects a coronary vessel from compression during mitral annuloplasty by extending an annuloplasty element, such as a tensioning device, at least partially through the coronary sinus over a coronary artery. The device is a surgically sterile bridge configured for placement within the coronary sinus at a location where the coronary sinus passes over a coronary artery, so that the protection device provides a support for a mitral annuloplasty element, such as a compressive prosthesis, including a tension element when it is placed under tension. The protection device has an arch of sufficient rigidity and dimensions to support the tensioning element over the coronary artery, redistribute tension away from an underlying coronary artery, and inhibit application of pressure to the underlying artery, for example when an annuloplasty tension element is placed under tension during mitral annuloplasty. In particular, the protective device can be a support interposed in the coronary sinus between the annuloplasty device and the coronary artery. The device may be substantially tubular so that the tensioning element is contained within the protective device and supported in spaced relationship to the coronary artery. An arch may be configured to extend between a proximal end and a distal end that are substantially collinear with one another so that the ends form stabilizing members such as feet that retain the bridge in position over the coronary artery. E–249–2009/3 Another embodiment of the cerclage protection device is a combination with a cerclage tension element that can be used to facilitate transcatheter mitral valve implantation. The transcatheter strategy includes a ‘‘valve-in-ring’’ wherein a cerclage annuloplasty is first performed. During the same session or during a separate procedure, a transcatheter mitral valve implantation could be performed that would take advantage of the cerclage annuloplasty system to serve as a visual and a VerDate Sep<11>2014 17:14 Mar 27, 2017 Jkt 241001 mechanical ‘‘landing zone’’ for mitral valve implantation. A cerclage annuloplasty ring would allow outward expansion of the mitral valve to achieve fixation. However, without the cerclage protection device in place, such a strategy would cause compression of an entrapped coronary artery. This new embodiment of the protection device protects coronary arteries not from extrinsic compression but from ‘‘insideout’’ compression, thereby allowing cerclage to be the first step for transcatheter mitral valve implantation. It also allows the latter to be employed as second-stage adjunct or bailout for inadequate cerclage mitral valve annuoplasty. The prospective exclusive license will be royalty bearing and will comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR 404.7. The prospective exclusive license may be granted unless, within fifteen (15) days from the date of this published notice, 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 404.7. 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 17, 2017. Michael Shmilovich, Senior Licensing and Patenting Manager, Office of Technology Transfer and Development, National Heart, Lung, and Blood Institute. [FR Doc. 2017–06036 Filed 3–27–17; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Submission for OMB Review; 30-Day Comment Request; Early Career Reviewer Program Application and Vetting System (EAVS) (Center for Scientific Review) AGENCY: National Institutes of Health, HHS. ACTION: Notice. In compliance with the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management SUMMARY: PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on December 29, 2016, page 96020 (Vol. 81, No. 250) and allowed 60 days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. DATES: Comments regarding this information collection are best assured of having their full effect if received within 30-days of the date of this publication. ADDRESSES: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, OIRA_submission@omb.eop.gov or by fax to 202–395–6974, Attention: Desk Officer for NIH. FOR FURTHER INFORMATION CONTACT: To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact: Dr. Mary Ann Guadagno, Project Clearance Liaison, Center for Scientific Review, NIH, Room 3182, 6701 Rockledge Drive, Bethesda, MD 20892 or call non-toll-free number (301) 435–1251 or Email your request, including your address to: guadagma@ csr.nih.gov. SUPPLEMENTARY INFORMATION: The Center for Scientific Review (CSR), National Institutes of Health, may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. Proposed Collection: Early Career Reviewer Program Application and Vetting System (EAVS) OMB #0925– 0695, Expiration Date: 04/30/2017, Extension, Center for Scientific Review (CSR), National Institutes of Health (NIH). Need and Use of Information Collection: The Center for Scientific Review (CSR) is the portal for NIH grant applications and their review for scientific merit. Our mission is to see that NIH grant applications receive fair, E:\FR\FM\28MRN1.SGM 28MRN1

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[Federal Register Volume 82, Number 58 (Tuesday, March 28, 2017)]
[Notices]
[Pages 15363-15364]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-06036]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of an Exclusive Patent License for 
Commercialization: Cerclage Annuloplasty Devices for Treating Mitral 
Valve Regurgitation

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The National Institutes of Health (NIH), Department of Health 
and Human Services, is contemplating the grant of a worldwide exclusive 
license to practice the inventions embodied in:

----------------------------------------------------------------------------------------------------------------
           NIH Ref. No.             Patent No. or application No.      Filing date                Title
----------------------------------------------------------------------------------------------------------------
E-249-2006/0-US-01...............  60/858,716                      November 14, 2006..  A Device To Protect
                                                                                         Coronary Arteries
                                                                                         Against Compression
                                                                                         During Transcatheter
                                                                                         Mitral Valve
                                                                                         Annuloplasty (PMVA).
E-249-2006/1-US-01...............  60/932,611                      May 31, 2006.......
E-249-2006/2-PCT-01..............  PCT/US2007/023876               November 13, 2007..
E-249-2006/2-EP-02...............  07861997.0                      November 13, 2007..  Transcatheter Coronary
                                                                                         Sinus Mitral Valve
                                                                                         Annuloplasty Procedure
                                                                                         And Coronary Artery And
                                                                                         Myocardial Protection
                                                                                         Device.
E-249-2006/2-US-03...............  8,211,171                       November 13, 2007..
E-249-2006/2-US-04...............  9,271,833                       November 13, 2007..
E-249-2006/3-US-01...............  15/056,599                      February 29, 2016..  Transcatheter Coronary
                                                                                         Sinus Mitral Valve
                                                                                         Annuloplasty Procedure
                                                                                         and Coronary Artery and
                                                                                         Myocardial Protection
                                                                                         Device with ``Landing
                                                                                         Zone''.
----------------------------------------------------------------------------------------------------------------

to Transmural Systems, LLC, a limited liability company incorporated 
under the laws of the State of Massachusetts and having its principle 
place of business in Andover, Massachusetts. The contemplated exclusive 
license may be limited to cerclage annuloplasty devices for treating 
mitral valve regurgitation.

DATES: Only written comments and/or applications for a license that are 
received by NIH at the address indicated below on or before April 12, 
2017 will be considered.

ADDRESSES: Requests for a copy of any unpublished patent application, 
inquiries, objections to this notice, comments and other requests 
relating to the contemplated license should be directed to: Michael 
Shmilovich, Esq., CLP, Senior Licensing and Patent Manager, 31 Center 
Drive Room 4A29, MSC2479, Bethesda, MD 20892-2479, phone number 301-
435-5019, or shmilovm@mail.nih.gov.

SUPPLEMENTARY INFORMATION: This notice is published in accordance with 
35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i).
    Mitral regurgitation (MR) is amongst the most common valvular heart 
disorders, with an estimated prevalence of approximately 1.7% in the 
United States, increasing with age to approximately 9.3% in those over 
the age of 75. MR is classified as primary (also known as ``organic'') 
when principally due to a structural or degenerative abnormality of the 
mitral valve (MV), whether of the leaflets, chordae tendineae, 
papillary muscles, or mitral annulus. Secondary (also known as 
functional) MR occurs in the absence of organic MV disease, usually 
from left ventricular (LV) dysfunction. It is more common than primary 
MR and is associated with a worse prognosis (compounded by the 
underlying cardiomyopathy), and (in contrast to primary MR) the 
benefits of MV surgery are uncertain. The MV consists of two leaflets 
(anterior and posterior) sitting within the annulus (see picture 
below). The posterior mitral leaflet originates from the left atrial 
(LA) endocardium. A subvalvular apparatus, comprising two papillary 
muscles (anterolateral and posteromedial) arising from the LV 
myocardium and the chordae tendineae, supports the leaflets. LV 
dilation due to ischemic or nonischemic cardiomyopathy secondarily 
impairs leaflet coaptation of a structurally normal MV, resulting in 
secondary MR. Specifically, LV dysfunction and remodeling lead to 
apical and lateral papillary muscle displacement, resulting in leaflet 
tethering, dilation and flattening of the mitral annulus, and reduced 
valve closing forces.
    The subject mitral repair system devices are primarily intended to 
treat secondary mitral regurgitation. The proposed mitral cerclage with 
coronary artery protection is an approach capable of overcoming many of 
the problems that exist with existing devices namely allowing a larger 
subset of patients to be treated compared to other coronary sinus 
devices, providing a full annuloplasty type device which is flexible 
enough to preserve annular motion, reduce hospitalization costs and 
shorten recovery time. The associated method closely resembles the 
surgical placement of a full annuloplasty ring.

E-249-2009/0-2

    Catheter-based mitral valve regurgitation treatments that use 
coronary sinus trajectory or coronary sinus implant can have unwanted 
effects because the coronary sinus and its branches have been found to 
cross the outer diameter of major coronary

[[Page 15364]]

arteries in a majority of humans. As a result, pressure applied by any 
prosthetic device in the coronary sinus (such as tension on the 
annuloplasty device) can compress the underlying coronary artery and 
induce myocardial ischemia or infarction. This invention pertains to 
devices and methods that avoid constricting coronary artery branches 
during coronary sinus-based annuloplasty. These devices and methods 
protect coronary artery branches from constriction during trans-sinus 
mitral annuloplasty. The device protects a coronary vessel from 
compression during mitral annuloplasty by extending an annuloplasty 
element, such as a tensioning device, at least partially through the 
coronary sinus over a coronary artery. The device is a surgically 
sterile bridge configured for placement within the coronary sinus at a 
location where the coronary sinus passes over a coronary artery, so 
that the protection device provides a support for a mitral annuloplasty 
element, such as a compressive prosthesis, including a tension element 
when it is placed under tension. The protection device has an arch of 
sufficient rigidity and dimensions to support the tensioning element 
over the coronary artery, redistribute tension away from an underlying 
coronary artery, and inhibit application of pressure to the underlying 
artery, for example when an annuloplasty tension element is placed 
under tension during mitral annuloplasty. In particular, the protective 
device can be a support interposed in the coronary sinus between the 
annuloplasty device and the coronary artery. The device may be 
substantially tubular so that the tensioning element is contained 
within the protective device and supported in spaced relationship to 
the coronary artery. An arch may be configured to extend between a 
proximal end and a distal end that are substantially collinear with one 
another so that the ends form stabilizing members such as feet that 
retain the bridge in position over the coronary artery.

E-249-2009/3

    Another embodiment of the cerclage protection device is a 
combination with a cerclage tension element that can be used to 
facilitate transcatheter mitral valve implantation. The transcatheter 
strategy includes a ``valve-in-ring'' wherein a cerclage annuloplasty 
is first performed. During the same session or during a separate 
procedure, a transcatheter mitral valve implantation could be performed 
that would take advantage of the cerclage annuloplasty system to serve 
as a visual and a mechanical ``landing zone'' for mitral valve 
implantation. A cerclage annuloplasty ring would allow outward 
expansion of the mitral valve to achieve fixation. However, without the 
cerclage protection device in place, such a strategy would cause 
compression of an entrapped coronary artery. This new embodiment of the 
protection device protects coronary arteries not from extrinsic 
compression but from ``inside-out'' compression, thereby allowing 
cerclage to be the first step for transcatheter mitral valve 
implantation. It also allows the latter to be employed as second-stage 
adjunct or bailout for inadequate cerclage mitral valve annuoplasty.
    The prospective exclusive license will be royalty bearing and will 
comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR 404.7. 
The prospective exclusive license may be granted unless, within fifteen 
(15) days from the date of this published notice, 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 404.7.
    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 17, 2017.
Michael Shmilovich,
Senior Licensing and Patenting Manager, Office of Technology Transfer 
and Development, National Heart, Lung, and Blood Institute.
[FR Doc. 2017-06036 Filed 3-27-17; 8:45 am]
 BILLING CODE 4140-01-P