[Federal Register Volume 78, Number 89 (Wednesday, May 8, 2013)]
[Notices]
[Pages 26794-26795]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-10859]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Start-Up Exclusive Evaluation Option License 
Agreement: Gene Therapy and Cell-Based Therapy for Cardiac Arrhythmias

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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SUMMARY: This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 
CFR 404.7(a)(1)(i), that the National Institutes of Health, Department 
of Health and Human Services, is contemplating the grant of a Start-Up 
Exclusive Evaluation Option License Agreement to Pace Biologics, LLC, a 
company having a place of business in Elkridge, Maryland, to practice 
the inventions embodied in U.S. Provisional Patent Application No. 61/
180,491, filed May 22, 2009 (HHS Ref. No. E-134-2009/0-US-01), PCT 
Patent Application No. PCT/US2010/035823, filed May 21, 2010 (HHS Ref. 
No. E-134-2009/0-PCT-02), and U.S. Patent Application No. 13/322,066, 
filed November 22, 2011 (HHS Ref. No. E-134-2009/0-US-03), all entitled 
``Engineered Biological Pacemakers.'' The patent rights in these 
inventions have been assigned to the Government of the United States of 
America. The territory of the prospective Start-Up Exclusive Evaluation 
Option License Agreement may be worldwide, and the field of use may be 
limited to ``Gene therapy and cell-based therapy for cardiac 
arrhythmias in humans.''
    Upon the expiration or termination of the Start-up Exclusive 
Evaluation Option License Agreement, Pace Biologics will have the 
exclusive right to execute a Start-Up Exclusive Patent

[[Page 26795]]

License Agreement which will supersede and replace the Start-up 
Exclusive Evaluation Option License Agreement, with no greater field of 
use and territory than granted in the Start-up Exclusive Evaluation 
Option License Agreement.

DATES: Only written comments and/or applications for a license which 
are received by the NIH Office of Technology Transfer on or before May 
23, 2013 will be considered.

ADDRESSES: Requests for copies of the patent application(s), inquiries, 
comments and other materials relating to the contemplated Start-Up 
Exclusive Evaluation Option License Agreement should be directed to: 
Tara L. Kirby, Ph.D., 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-
4426; Facsimile: (301) 402-0220; Email: [email protected]. A signed 
confidentiality nondisclosure agreement will be required to receive 
copies of any patent applications that have not been published or 
issued by the United States Patent and Trademark Office or the World 
Intellectual Property Organization.

SUPPLEMENTARY INFORMATION: This invention consists of biological 
pacemakers engineered to treat arrhythmia by generating a normal heart 
rhythm. These pacemakers include viral vectors suitable for gene 
therapy that incorporate Ca\2+\-activated adenylyl cyclase, as well as 
cardiac cells or cardiac-like cells derived from embryonic stem cells 
or mesenchymal stem cells, which are suitable for cell-based therapy.
    In contrast to implantable artificial pacemakers, these biological 
pacemakers are not externally powered, are not subject to interference 
from other devices, and have a lower risk of infection. They would be 
particularly appropriate for patients who are not candidates for 
artificial pacemakers, such as children or those who have had an 
implantable pacemaker removed due to complications or other problems.
    The prospective Start-Up Exclusive Evaluation Option License 
Agreement 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 404.7. The prospective Start-Up 
Exclusive Evaluation Option License Agreement and a subsequent Start-Up 
Exclusive Patent License Agreement may be granted unless the NIH 
receives written evidence and argument, within fifteen (15) days from 
the date of this published notice that establishes, that the grant of 
the contemplated Start-Up Exclusive Evaluation Option License Agreement 
would not be consistent with the requirements of 35 U.S.C. 209 and 37 
CFR 404.7.
    Complete applications for a license in the prospective field of use 
that are filed in response to this notice will be treated as objections 
to the grant of the contemplated Start-Up Exclusive Evaluation Option 
License Agreement. 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: May 2, 2013.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2013-10859 Filed 5-7-13; 8:45 am]
BILLING CODE 4140-01-P