[Federal Register Volume 78, Number 89 (Wednesday, May 8, 2013)]
[Notices]
[Page 26794]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-10858]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: Use of 
Oligodeoxynucleotide as Neuroprotectants in Cerebral and Other Ischemic 
Injury

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 (NIH), 
Department of Health and Human Services, is contemplating the grant of 
an exclusive license to practice the inventions embodied in U.S. 
provisional patent application No. 60/176/115 (E-078-2000/0-US-01) 
filed 1/14/2000; PCT application No. PCT/US01/01122 (E-078-2000/0-PCT-
02) filed 1/12/2001; U.S. patent No. 7,521,063 (E-078-2000/1-US-01) 
filed 07/12/2002 and issued 04/21/2009; U.S. patent No. 7,919,477 (E-
078-2000/1-US-02) filed 05/10/2007and issued 04/05/2011; U.S. patent 
No. 8,232,259 (E-078-2000/1-US-03) filed 02/11/2011 and issued 07/31/
2012; E.U. patent No. 1322655 (E-078-2000/0-EP-03) filed 1/12/2001 and 
issued 11/14/2007 and validated in AT, GB, and IE (E-078-2000/0-AT-05, 
E-078-2000/0-GB-07, & E-078-2000/0-IE-08) and issued 12/13/2007 as 
patent No. 6031430 and validated in Germany (E-078-2000/0-DE-06); and 
E.U. patent application No. 07021557.9 (E-078-2000/0-EP-04) filed 11/
05/2007; each entitled ``Oligodeoxynucleotide and Its Use to Induce an 
Immune Response''; by Klinman et al. (FDA) to Oregon Health Sciences 
University having a place of business at 3181 SW. Sam Jackson Park Rd. 
Portland, Oregon 97239. The patent rights in this invention 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 June 7, 
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: 301-
435-5031; Facsimile: 301-402-0220.

SUPPLEMENTARY INFORMATION: The prospective worldwide 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 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 404.7.
    The subject patents relate to compositions and methods of use of 
oligodeoxynucleotides (ODNs) expressing CpG motifs to induce immune 
responses. These ODNs mimic signals of invading pathogens. ODN motifs 
trigger immune system responses via Toll-like receptor 9 (TLR9). They 
also mediate inflammatory responses to tissue injury, such as those 
responses following ischemic damage to the central nervous system. 
Structural differences between various ODNs may stimulate distinct cell 
populations, allowing selective targeting of immune responses for 
therapeutic purposes. Non-human primate and animal models using 
specific ODNs for pharmacological preconditioning have shown that ODNs 
may act therapeutically as neuroprotectants from ischemic damage. These 
TLR ligands as may be useful therapeutically as neuroprotectants in 
cerebral ischemic injury.
    The field of use may be limited to pharmacological preconditioning 
against excitotoxic injury, ischemia and/or hypoxia.
    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: May 2, 2013.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2013-10858 Filed 5-7-13; 8:45 am]
BILLING CODE 4140-01-P