Prospective Grant of Exclusive License: Use of Oligodeoxynucleotide as Neuroprotectants in Cerebral and Other Ischemic Injury, 26794 [2013-10858]

Download as PDF 26794 Federal Register / Vol. 78, No. 89 / Wednesday, May 8, 2013 / Notices on Aging, Gateway Building, 7201 Wisconsin Avenue, Suite 2C212, Bethesda, MD 20892, 301–402–7705, JOHNSONJ9@NIA.NIH.GOV. Name of Committee: National Institute on Aging Special Emphasis Panel; Mild Cognitive Impairment. Date: June 5, 2013. Time: 1:00 p.m. to 4:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institute on Aging, Gateway Building, Suite 2C212, 7201 Wisconsin Avenue Bethesda, MD 20892 (Telephone Conference Call). Contact Person: William Cruce, Ph.D., Scientific Review Branch, National Institute on Aging, Gateway Building, 7201 Wisconsin Avenue, Suite 2C212, Bethesda, MD 20892, 301–402–7704, crucew@nia.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.866, Aging Research, National Institutes of Health, HHS) Dated: May 1, 2013. Melanie J. Gray, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2013–10854 Filed 5–7–13; 8:45 am] BILLING CODE 4140–01–P 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. 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 mstockstill on DSK4VPTVN1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 17:56 May 07, 2013 Jkt 229001 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: fennea@mail.nih.gov; 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. PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Prospective Grant of Start-Up Exclusive Evaluation Option License Agreement: Gene Therapy and CellBased Therapy for Cardiac Arrhythmias AGENCY: National Institutes of Health, HHS. ACTION: Notice. 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 SUMMARY: E:\FR\FM\08MYN1.SGM 08MYN1

Agencies

[Federal Register Volume 78, Number 89 (Wednesday, May 8, 2013)]
[Notices]
[Page 26794]
From the Federal Register Online via the Government Printing 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.

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

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: fennea@mail.nih.gov; 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
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