80 FR 53549 - Prospective Grant of an Exclusive Patent Commercialization License: Cerclage Annuloplasty Devices for Treating Mitral Valve Regurgitation
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health Federal Register Volume 80, Issue 172 (September 4, 2015)
National Institutes of Health
Federal Register Volume 80, Issue 172 (September 4, 2015)
| Page Range | 53549-53550 | |
| FR Document | 2015-21969 |
[Federal Register Volume 80, Number 172 (Friday, September 4, 2015)] [Notices] [Pages 53549-53550] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-21969] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Prospective Grant of an Exclusive Patent Commercialization License: Cerclage Annuloplasty Devices for Treating Mitral Valve Regurgitation 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, is contemplating the grant of a worldwide exclusive license to practice the inventions embodied in: ---------------------------------------------------------------------------------------------------------------- NIH Ref No. Patent application No. Filing date Title ---------------------------------------------------------------------------------------------------------------- E-048-2009/0-US-01................. 61/157,267............. March 4, 2009......... Cerclage Locking Device And Delivery System. E-048-2009/0-PCT-02................ PCT/US2010/026245...... March 4, 2010......... Cerclage Locking Device And Delivery System. E-048-2009/0-US-03................. 13/254,160............. March 4, 2010......... Cerclage Locking Device And Delivery System. E-108-2010/0-US-01................. 61/383,061............. September 15, 2010.... Methods and Devices For Transcatheter Cerclage Annuloplasty. E-108-2010/0-PCT-02................ PCT/US2011/51748....... September 15, 2011.... Methods and Devices For Transcatheter Cerclage Annuloplasty. E-108-2010/0-EP-03................. 11760945.3............. September 15, 2011.... Methods and Devices For Transcatheter Cerclage Annuloplasty. E-108-2010/0-US-04................. 13/824,198............. March 15, 2013........ Methods and Devices For Transcatheter Cerclage Annuloplasty. ---------------------------------------------------------------------------------------------------------------- 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 the NIH Office of Technology Transfer on or before October 5, 2015 will be considered. [[Page 53550]] 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 Patenting 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: [email protected]. SUPPLEMENTARY INFORMATION: E-048-2009 The invention relates to a device that can be used to non- invasively secure surgical suture loops when combined with a percutaneous delivery system. It has been shown to be effective in correcting mitral valve regurgitation (MVR) in an animal model. During the procedure, a guidewire is percutaneously conveyed to the atrium of the heart and is used to secure the ``cerclage'' suture encircling the mitral valve annulus, which is delivered using a delivery catheter. The locking device is advanced over the suture by the delivery catheter and it permanently secures the suture and maintains the tension on the annulus once the delivery system is removed. This locking device, in combination with the percutaneous procedure, allows for more complete coaptation of the valve leaflets and correction of MVR without the need for open heart surgery and its associated risks. The locking device is also adjustable, allowing the user to vary the tension on the suture if further tightening or loosening is required. It is also MRI compatible and all follow-up studies can be performed under MRI. This invention demonstrated its ability to correct MVR in animals where the locking device was observed to maintain the correct position and tension after implantation. This device has the potential to replace the traditional loop and knot method used for surgical correction of MVR, and may also be useful for other conditions that require permanently secured suture loops. E-108-2010 The invention relates to techniques and devices for cardiovascular valve repair, particularly annuloplasty techniques and devices in which tensioning elements are positioned to treat regurgitation of the mitral valve or tricuspid valve. More specifically, the technology pertains to a new device for myocardial septal traversal (``cerclage reentry'') that also serves to capture (ensnare) and externalize the traversing guidewire. The focus of the invention is to avoid a phenomenon in cardiac surgery known as ``trabecular entrapment.'' The device features an expandable and collapsible mesh deployed in the right ventricle to simplify capture of a reentering guidewire during transcatheter cerclage annuloplasty. The wire mesh exerts pressure against trabecular-papillary elements of the tricuspid valve to displace them against the right ventricular septal wall. By abutting the right ventricular reentry site of the cerclage guidewire, trabecular entrapment is avoided. The device comprises a shaft having a distal loop which provides a target in the interventrical myocardial septum through which a catheter-delivered tensioning system is guided. The loop ensnares the catheter-delivered tensioning system as it reenters the right ventricle or right atrium. The expandable and collapsible mesh is disposed within the right ventricle such that the catheter- delivered tensioning system is directed from the ventricular septum into the right ventricular cavity through only a suitable opening in the mesh and such that the catheter delivered tensioning system is captured or ensnared within the mesh opening. 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. The prospective exclusive license may be granted unless, within thirty (30) 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. 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: September 1, 2015. Richard U. Rodriguez, Acting Director, Office of Technology Transfer, National Institutes of Health. [FR Doc. 2015-21969 Filed 9-3-15; 8:45 am] BILLING CODE 4140-01-P
![Federal Register / Vol. 80, No. 172 / Friday, September 4, 2015 / Notices 53549
Licensing Contact: Michael Potential Commercial Applications • HHS Reference E–292–2007/0
Shmilovich, Esq.; 301–435–5019; • Essential for the payload component • HHS Reference E–269–2009/0
shmilovm@mail.nih.gov of immunotoxins • HHS Reference E–174–2011/0
Collaborative Research Opportunity: • Treatment of any disease associated • HHS Reference E–263–2011/0
The National Heart, Lung and Blood with increased or preferential Licensing Contact: David A.
Institute is seeking statements of expression of a specific cell surface Lambertson, Ph.D.; 301–435–4632;
capability or interest from parties receptor lambertsond@mail.nih.gov.
interested in collaborative research to • Specific diseases include Collaborative Research Opportunity:
hematological cancers, lung cancer The National Cancer Institute is seeking
further develop, evaluate or
(including mesothelioma), ovarian statements of capability or interest from
commercialize devices for pericardial
cancer, breast cancer, and head and parties interested in collaborative
interventional procedures. For
neck cancers research to further develop, evaluate or
collaboration opportunities, please commercialize Pseudomonas Exotoxin
contact Peg Koelble at 301–594–4095 or Competitive Advantages A with Modified Furin Cleavage Site.
koelblep@nhlbi.nih.gov. • Designing specific furin cleavage sites For collaboration opportunities, please
Pseudomonas Exotoxin A With for particular immunotoxins can contact John D. Hewes, Ph.D. at
Modified Furin Cleavage Site improve cleavage and enhance toxin hewesj@mail.nih.gov.
efficacy, resulting in improved Dated: August 31, 2015.
Description of Technology: therapeutic effectiveness Richard U. Rodriguez,
Immunotoxins kill cancer cells while • Targeted therapy decreases non-
Acting Director, Office of Technology
allowing healthy, essential cells to specific killing of healthy, essential Transfer, National Institutes of Health.
survive. As a result, patients receiving cells, resulting in fewer non-specific
[FR Doc. 2015–21940 Filed 9–3–15; 8:45 am]
immunotoxins are less likely to side-effects and healthier patients
BILLING CODE 4140–01–P
experience the deleterious side-effects Development Stage: In vitro data
associated with non-specific therapies available.
such as chemotherapy. In order to make Inventors: Ira Pastan et al. (NCI). DEPARTMENT OF HEALTH AND
an effective immunotoxin, three Publications HUMAN SERVICES
components are generally required: A
targeting domain, a furin cleavage site 1. Weldon JE, et al. Designing the furin- National Institutes of Health
(FCS), and a toxic payload molecule cleavable linker in recombinant
(such as Pseudomonas exotoxin A (PE)). immunotoxins based on Pseudomonas Prospective Grant of an Exclusive
The purpose of the FCS is to allow the exotoxin A. Bioconjug Chem. 2015 Jun Patent Commercialization License:
toxin domain to be processed by the 17;26(6):1120–8. [PMID 25997032] Cerclage Annuloplasty Devices for
2. Weldon JE, et al. A protease-resistant Treating Mitral Valve Regurgitation
target cell so that it can exert its toxic immunotoxin against CD22 with greatly
effect. This technology concerns the increased activity against CLL and AGENCY: National Institutes of Health,
engineering of FCS in order to improve diminished animal toxicity’’ Blood. 2009 HHS.
the efficacy of specific immunotoxins Apr 16;113(16):3792–800. [PMID ACTION: Notice.
having distinct targeting domains. 18988862]
Several novel FCS have been generated Intellectual Property: HHS Reference SUMMARY: This is notice, in accordance
which can be substituted for the native No. E–197–2015/0–US–01—US with 35 U.S.C. 209 and 37 CFR 404, that
FCS in PE. By using specific FCS with Provisional Application No. 62/163,667 the National Institutes of Health (NIH),
different targeting moieties, it is filed May 19, 2015. Department of Health and Human
possible to engineer an immunotoxin Services, is contemplating the grant of a
that is better suited to treating specific Related Technologies worldwide exclusive license to practice
types of cancer. • HHS Reference E–262–2005/0 the inventions embodied in:
NIH Ref No. Patent application No. Filing date Title
E–048–2009/0–US–01 ................ 61/157,267 ................................ March 4, 2009 ........................... Cerclage Locking Device And Delivery
System.
E–048–2009/0–PCT–02 .............. PCT/US2010/026245 ................ March 4, 2010 ........................... Cerclage Locking Device And Delivery
System.
E–048–2009/0–US–03 ................ 13/254,160 ................................ March 4, 2010 ........................... Cerclage Locking Device And Delivery
System.
E–108–2010/0–US–01 ................ 61/383,061 ................................ September 15, 2010 ................. Methods and Devices For Transcatheter
Cerclage Annuloplasty.
E–108–2010/0–PCT–02 .............. PCT/US2011/51748 .................. September 15, 2011 ................. Methods and Devices For Transcatheter
Cerclage Annuloplasty.
E–108–2010/0–EP–03 ................ 11760945.3 ............................... September 15, 2011 ................. Methods and Devices For Transcatheter
Cerclage Annuloplasty.
E–108–2010/0–US–04 ................ 13/824,198 ................................ March 15, 2013 ......................... Methods and Devices For Transcatheter
Cerclage Annuloplasty.
mstockstill on DSK4VPTVN1PROD with NOTICES
To Transmural Systems, LLC, a limited The contemplated exclusive license DATES: Only written comments and/or
liability company incorporated under may be limited to cerclage annuloplasty applications for a license that are
the laws of the State of Massachusetts devices for treating mitral valve received by the NIH Office of
and having its principle place of regurgitation. Technology Transfer on or before
business in Andover, Massachusetts. October 5, 2015 will be considered.
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![53550 Federal Register / Vol. 80, No. 172 / Friday, September 4, 2015 / Notices
ADDRESSES: Requests for a copy of the surgery known as ‘‘trabecular DEPARTMENT OF HEALTH AND
patent application, inquiries, comments entrapment.’’ The device features an HUMAN SERVICES
and other materials relating to the expandable and collapsible mesh
contemplated license should be directed deployed in the right ventricle to National Institutes of Health
to: Michael Shmilovich, Esq. Senior simplify capture of a reentering
Licensing and Patenting Manager, Office Center for Scientific Review; Notice of
guidewire during transcatheter cerclage
of Technology Transfer, National Closed Meetings
annuloplasty. The wire mesh exerts
Institutes of Health, 6011 Executive pressure against trabecular-papillary Pursuant to section 10(d) of the
Boulevard, Suite 325, Rockville, MD elements of the tricuspid valve to Federal Advisory Committee Act, as
20852–3804; Telephone: (301) 435– amended (5 U.S.C. App.), notice is
displace them against the right
5019; Facsimile: (301) 402–0220; Email: hereby given of the following meetings.
ventricular septal wall. By abutting the
shmilovm@mail.nih.gov. The meetings will be closed to the
right ventricular reentry site of the
SUPPLEMENTARY INFORMATION: public in accordance with the
cerclage guidewire, trabecular
E–048–2009 entrapment is avoided. The device provisions set forth in sections
comprises a shaft having a distal loop 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
The invention relates to a device that as amended. The grant applications and
can be used to non-invasively secure which provides a target in the
interventrical myocardial septum the discussions could disclose
surgical suture loops when combined confidential trade secrets or commercial
with a percutaneous delivery system. It through which a catheter-delivered
property such as patentablematerial,
has been shown to be effective in tensioning system is guided. The loop
and personal information concerning
correcting mitral valve regurgitation ensnares the catheter-delivered individuals associated with the grant
(MVR) in an animal model. During the tensioning system as it reenters the right applications, the disclosure of which
procedure, a guidewire is ventricle or right atrium. The would constitute a clearly unwarranted
percutaneously conveyed to the atrium expandable and collapsible mesh is invasion of personal privacy.
of the heart and is used to secure the disposed within the right ventricle such
‘‘cerclage’’ suture encircling the mitral Name of Committee: Surgical Sciences,
that the catheter-delivered tensioning Biomedical Imaging and Bioengineering
valve annulus, which is delivered using system is directed from the ventricular
a delivery catheter. The locking device Integrated Review Group Surgery,
septum into the right ventricular cavity Anesthesiology and Trauma Study Section.
is advanced over the suture by the through only a suitable opening in the Date: October 7–8, 2015.
delivery catheter and it permanently Time: 8:00 a.m. to 5:00 p.m.
mesh and such that the catheter
secures the suture and maintains the Agenda: To review and evaluate grant
delivered tensioning system is captured
tension on the annulus once the applications.
delivery system is removed. This or ensnared within the mesh opening.
Place: Hilton Washington/Rockville, 1750
locking device, in combination with the The prospective exclusive license will Rockville Pike, Rockville, MD 20852.
percutaneous procedure, allows for be royalty bearing and will comply with Contact Person: Weihua Luo, MD, Ph.D.,
more complete coaptation of the valve the terms and conditions of 35 U.S.C. Scientific Review Officer, Center for
leaflets and correction of MVR without 209 and 37 CFR 404. The prospective Scientific Review,National Institutes of
the need for open heart surgery and its Health, 6701 Rockledge Drive, Room 5114,
exclusive license may be granted unless, MSC 7854, Bethesda, MD 20892, (301) 435–
associated risks. The locking device is within thirty (30) days from the date of 1170, luow@csr.nih.gov.
also adjustable, allowing the user to this published notice, NIH receives Name of Committee: Endocrinology,
vary the tension on the suture if further written evidence and argument that Metabolism, Nutrition and Reproductive
tightening or loosening is required. It is establishes that the grant of the license Sciences IntegratedReview Group Integrative
also MRI compatible and all follow-up would not be consistent with the Nutrition and Metabolic Processes Study
studies can be performed under MRI. requirements of 35 U.S.C. 209 and 37 Section.
This invention demonstrated its ability Date: October 8–9, 2015.
CFR 404. Properly filed competing
to correct MVR in animals where the Time: 8:00 a.m. to 1:00 p.m.
applications for a license filed in Agenda: To review and evaluate grant
locking device was observed to maintain
the correct position and tension after response to this notice will be treated as applications.
implantation. This device has the objections to the contemplated license. Place: Courtyard Long Beach, 500 E 1st
potential to replace the traditional loop Comments and objections submitted in Street, Long Beach, CA 90802.
response to this notice will not be made Contact Person: Gregory S Shelness, Ph.D.,
and knot method used for surgical Scientific Review Officer, Center for
correction of MVR, and may also be available for public inspection, and, to
Scientific Review, National Institutes of
useful for other conditions that require the extent permitted by law, will not be Health, 6701 Rockledge Dr., Room 6156,
permanently secured suture loops. released under the Freedom of Bethesda, MD 20892–7892, (301) 435–0492,
Information Act, 5 U.S.C. 552. shelnessgs@csr.nih.gov.
E–108–2010
Dated: September 1, 2015. Name of Committee: Endocrinology,
The invention relates to techniques Metabolism, Nutrition and Reproductive
and devices for cardiovascular valve Richard U. Rodriguez,
Sciences Integrated, Review Group,
repair, particularly annuloplasty Acting Director, Office of Technology Molecular and Cellular Endocrinology Study
techniques and devices in which Transfer, National Institutes of Health. Section.
tensioning elements are positioned to [FR Doc. 2015–21969 Filed 9–3–15; 8:45 am] Date: October 8–9, 2015.
Time: 8:00 a.m. to 3:00 p.m.
mstockstill on DSK4VPTVN1PROD with NOTICES
treat regurgitation of the mitral valve or BILLING CODE 4140–01–P
tricuspid valve. More specifically, the Agenda: To review and evaluate grant
technology pertains to a new device for applications.
Place: Courtyard Long Beach, 500 East
myocardial septal traversal (‘‘cerclage First Street, Long Beach, CA 90802.
reentry’’) that also serves to capture Contact Person: John Bleasdale, Ph.D.,
(ensnare) and externalize the traversing Scientific Review Officer, Center for
guidewire. The focus of the invention is Scientific Review, National Institutes of
to avoid a phenomenon in cardiac Health, 6701 Rockledge Drive, Room 6170
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Document Created: 2015-12-15 09:58:25
Document Modified: 2015-12-15 09:58:25
| 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 that are received by the NIH Office of Technology Transfer on or before October 5, 2015 will be considered. | |
| FR Citation | 80 FR 53549 |
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