[Federal Register Volume 85, Number 205 (Thursday, October 22, 2020)]
[Notices]
[Page 67363]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-23385]



[[Page 67363]]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of an Exclusive Patent License: Development of 
a Topical Ointment Containing Immunostimulatory CpG 
Oligodeoxynucleotides (ODN) for Dermatological Wound Healing

AGENCY: National Institutes of Health, HHS

ACTION: Notice.

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

SUMMARY: The National Cancer Institute, an institute of the National 
Institutes of Health, Department of Health and Human Services, is 
contemplating the grant of an Exclusive Patent License to practice the 
inventions embodied in the Patents and Patent Applications listed in 
the Supplementary Information section of this notice to Six 
Therapeutics Technologies Holdings Group. (``Six Therapeutics'') 
located in New Jersey.

DATES: Only written comments and/or applications for a license which 
are received by the National Cancer Institute's Technology Transfer 
Center on or before November 6, 2020 will be considered.

ADDRESSES: Requests for copies of the patent application, inquiries, 
and comments relating to the contemplated an Exclusive Patent License 
should be directed to: *** Rose. M. Freel, Ph.D., Senior Licensing and 
Patenting Manager, NCI Technology Transfer Center at (301) 624-8775 or 
Email: [email protected].

SUPPLEMENTARY INFORMATION:

Intellectual Property

    United States Provisional Patent Application No. 61/639,688, filed 
April 27, 2012 and entitled ``Use of CPG oligonucleotides co-formulated 
with an antibiotic to accelerate wound healing'' [HHS Reference No. E-
294-2011/0-US-01];
    PCT Patent Application PCT/US2013/034639, filed March 29, 2013 and 
entitled ``Use of CPG oligonucleotides co-formulated with an antibiotic 
to accelerate wound healing'' [HHS Reference No. E-294-2011/0-PCT-02];
    Australian Patent No. 2013252785, filed March 29, 2013, issued 
August 24, 2017, and entitled ``Use of CPG oligonucleotides co-
formulated with an antibiotic to accelerate wound healing'' [HHS 
Reference No. E-294-2011/0-AU-03];
    Canadian Patent Application No. 2871490, filed March 29, 2013, and 
entitled ``Use of CPG oligonucleotides co-formulated with an antibiotic 
to accelerate wound healing'' [HHS Reference No. E-294-2011/0-CA-04];
    U.S. Patent No. 10,076,535, filed October 24, 2014, issued 
September 18, 2018, and entitled ``Use of CPG oligonucleotides co-
formulated with an antibiotic to accelerate wound healing'' [HHS 
Reference No. E-294-2011/0-US-05]; and
    U.S. Patent No. 8,466,116, filed September 5, 2008, issued June 18, 
2013, and entitled ``Use Of CpG Oligodeoxynucleotides To Induce 
Epithelial Cell Growth'' [HHS Reference No. E-328-2001/1-US-01].
    The patent rights in these inventions have been assigned and/or 
exclusively licensed to the government of the United States of America.
    The prospective exclusive license territory may be worldwide and 
the field of use may be limited to: ``Topical ointment containing K-
type CpG oligodeoxynucleotides that activate Toll-like receptor 9 to 
induce angiogenesis and epithelial cell growth, alone or in combination 
with other agents, for dermatological wound healing.''
    This technology discloses the 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.
    This notice is made in accordance with 35 U.S.C. 209 and 37 CFR 
part 404. The prospective exclusive license will be royalty bearing, 
and the prospective exclusive license may be granted unless within 
fifteen (15) days from the date of this published notice, the National 
Cancer Institute 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.
    In response to this Notice, the public may file comments or 
objections. Comments and objections, other than those in the form of a 
license application, will not be treated confidentially, and may be 
made publicly available.
    License applications submitted in response to this Notice will be 
presumed to contain business confidential information and any release 
of information in these license applications will be made only as 
required and upon a request under the Freedom of Information Act, 5 
U.S.C. 552.

    Dated: October 15, 2020.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer 
Institute.
[FR Doc. 2020-23385 Filed 10-21-20; 8:45 am]
BILLING CODE 4140-01-P