[Federal Register Volume 78, Number 148 (Thursday, August 1, 2013)]
[Notices]
[Page 46594]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-18449]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Start-up Exclusive License: Topical 
Antibiotic With Immune Stimulating Oligodeoxynucleotide Molecules To 
Speed Wound Healing; and Use of CpG Oligodeoxynucleotides To Induce 
Epithelial Cell Growth

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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SUMMARY: This is notice, in accordance with 35 U.S.C. 209 and 37 CFR 
part 404, that the National Institutes of Health (NIH), Department of 
Health and Human Services, is contemplating the grant of a start-up 
exclusive license to practice the inventions embodied in: US 
provisional Applications 61/639,688 (E-294-2011/0-US-01) filed April 
27, 2012 and PCT application PCT/US2013034639 (E-294-2011/0-PCT-02) 
filed March 29, 2013, each entitled ``Topical Antibiotic with Immune 
Stimulating oligodeoxynucleotide Molecules to Speed Wound Healing'' and 
US application 12/205,756 (E-328-2001/1-US-01) filed September 2008 and 
issued as US patent 8,466,116, each entitled ``Use of CpG 
Oligodeoxynucleotides to Induce Epithelial Cell Growth'' to Tollgene 
having a place of business at 2429 Ginny Way, Lafayette, CO 80026. The 
patent rights in these inventions have been assigned to the United 
States of America.

DATES: Only written comments and/or application for a license that are 
received by the NIH Office of Technology Transfer on or before August 
16, 2013 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: Tedd Fenn, Office of Technology Transfer, 
National Institutes of Health, 6011 Executive Boulevard, Suite 325, 
Rockville, MD 20852-3804; Email: [email protected]; Telephone: 
424-500-2005; Facsimile: 301-402-0220.

SUPPLEMENTARY INFORMATION: The prospective start-up 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 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 part 404.
    These technologies relate to relate to use of CpG 
oligodeoxynucleotides (ODNs) to accelerate wound healing. The E-294-
2011/0, technology relates to an antibiotic composition containing the 
toll-like receptor-7 (TLR7) ligand (imidazoquinoline) and an 
immunostimulatory K ODN. There is evidence that this formulation may 
produce more rapid wound healing versus standard antibiotic 
formulations. Because standard antibiotics eliminate bacteria at a 
wound site, they also eliminate the molecular signals present in 
bacterial DNA that stimulate the immune system's wound healing 
processes. The ODN and imidazoquinoline act as artificial immune 
stimulants that mimic the bacterial signals to improve healing rates. 
The E-328-2001/1 technology relates to a method of inducing epithelial 
cell growth by administration of immunostimulatory ODNs. The 
stimulation of epithelial cell growth also promotes wound healing.
    The proposed field of exclusivity may be limited to human and 
veterinary therapeutics for treatment of wounds.
    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: July 26, 2013.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2013-18449 Filed 7-31-13; 8:45 am]
BILLING CODE 4140-01-P