81_FR_69738 81 FR 69544 - Prospective Grant of Exclusive Patent License: Development of a NANOG-Based Therapeutic for Cancer

81 FR 69544 - Prospective Grant of Exclusive Patent License: Development of a NANOG-Based Therapeutic for Cancer

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 81, Issue 194 (October 6, 2016)

Page Range69544-69545
FR Document2016-24133

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 U.S. Patents and Patent Applications listed in the Summary Information section of this notice to Inova Health System located in Falls Church, VA.

Federal Register, Volume 81 Issue 194 (Thursday, October 6, 2016) 
[Federal Register Volume 81, Number 194 (Thursday, October 6, 2016)]
[Notices]
[Pages 69544-69545]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-24133]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive Patent License: Development of a 
NANOG-Based Therapeutic for Cancer

AGENCY: National Institutes of Health.

ACTION: Notice.

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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 U.S. Patents and Patent Applications listed 
in the Summary Information section of this notice to Inova Health 
System located in Falls Church, VA.

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 October 21, 2016 will be considered.

ADDRESSES: Requests for copies of the patent application, inquiries, 
and comments relating to the contemplated exclusive license should be 
directed to: Kevin W. Chang, Ph.D., Senior Licensing and Patenting 
Manager, NCI Technology Transfer Center, 9609 Medical Center Drive, RM 
1E530 MSC 9702, Bethesda, MD 20892-9702 (for business mail), Rockville, 
MD 20850-9702 Telephone: (240) 276-6910; Facsimile: (240) 276-5504 
Email: [email protected].

SUPPLEMENTARY INFORMATION: 

Intellectual Property

    United States Provisional Patent Application No. No. 61/420,214, 
filed December 6, 2010, entitled ``Allele Specific shRNAs For NANOG, 
Pharmaceutical Composition Comprising The shRNA, And Its Method of Use 
to Treat Cancer'' [HHS Reference No. E-294-2010/0-US-01]; International 
PCT Application No. PCT/US2011/063451, filed December 6, 2011, entitled 
``Pharmaceutical Composition Comprising NANOG shRNA, and Method of 
Using NANOG shRNA to Treat Cancer'' [HHS Reference No. E-294-2010/0-
PCT-02]; United States Patent No. 9,163,236, issued October 20, 2015, 
entitled ``Pharmaceutical Composition Comprising NANOG shRNA, and 
Method of Using NANOG shRNA to Treat Cancer'' [HHS Ref. No. E-294-2010/
0-US-03]; and United States Patent Application No. 14/886,970 filed 
October 19, 2015, entitled, ``Pharmaceutical Composition Comprising 
NANOG shRNA, and Method of Using NANOG shRNA to Treat Cancer'' [HHS 
Ref. No. E-294-2010/0-US-04].
    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 the use of Licensed Patent Rights 
for the following: ``Treatment or prevention of colorectal cancer in 
humans.''
    The subject technologies are short hair-pin RNAs which inhibit 
NANOG or NANOGP8 for the treatment of cancer and viral vectors that 
encode the RNAs. The first generation of these vectors were non-
replicating lentiviral based vectors that were introduced into cancer 
cells as a standard form of RNA inhibition, blocking the expression of 
NANOG or NANOGP8 protein. The most current version of the subject 
technology utilizes conditionally replicating, oncolytic adenovirus 
vectors. These adenovirus-based vectors grow in cells that express 
NANOGP8 but not in cells that lack NANOGP8 or where the shRNA has 
inhibited NANOGP8 expression. The vectors have been constructed to 
directly kill tumors and to inhibit the NANOGs to block cancer stem 
cell function in the tumors.
    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.
    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 Exclusive Patent 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.


[[Page 69545]]


    Dated: September 29, 2016.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer 
Institute.
[FR Doc. 2016-24133 Filed 10-5-16; 8:45 am]
BILLING CODE 4140-01-P

69544 Federal Register / Vol. 81, No. 194 / Thursday, October 6, 2016 / Notices Contact Person: Jian Cao, MD. Dated: September 29, 2016. ‘‘Pharmaceutical Composition Name of Committee: Center for Scientific Carolyn Baum, Comprising NANOG shRNA, and Review Special Emphasis Panel; Member Program Analyst, Office of Federal Advisory Method of Using NANOG shRNA to Conflict: Vascular Biology and Pathobiology. Committee Policy. Treat Cancer’’ [HHS Ref. No. E–294– Date: November 3–4, 2016. [FR Doc. 2016–24124 Filed 10–5–16; 8:45 am] 2010/0–US–03]; and United States Time: 10:00 a.m. to 6:00 p.m. BILLING CODE 4140–01–P Patent Application No. 14/886,970 filed Agenda: To review and evaluate grant October 19, 2015, entitled, applications. ‘‘Pharmaceutical Composition Place: National Institutes of Health, 6705 DEPARTMENT OF HEALTH AND Comprising NANOG shRNA, and Rockledge Drive, Bethesda, MD 20817, (Virtual Meeting). HUMAN SERVICES Method of Using NANOG shRNA to Contact Person: Ai-Ping Zou, MD, Ph.D., Treat Cancer’’ [HHS Ref. No. E–294– Scientific Review Officer, Center for National Institutes of Health 2010/0–US–04]. Scientific Review, National Institutes of The patent rights in these inventions Prospective Grant of Exclusive Patent Health, 6701 Rockledge Drive, Room 4118, have been assigned and/or exclusively MSC 7814, Bethesda, MD 20892, 301–408– License: Development of a NANOG- 9497, zouai@csr.nih.gov. Based Therapeutic for Cancer licensed to the government of the United States of America. Name of Committee: Center for Scientific AGENCY: National Institutes of Health. Review Special Emphasis Panel; Member ACTION: Notice. The prospective exclusive license Conflict: Bioengineering Sciences #3. territory may be worldwide and the Date: November 3, 2016. SUMMARY: The National Cancer Institute, field of use may be limited to the use Time: 2:00 p.m. to 4:00 p.m. an institute of the National Institutes of of Licensed Patent Rights for the Agenda: To review and evaluate grant Health, Department of Health and following: ‘‘Treatment or prevention of applications. Human Services, is contemplating the colorectal cancer in humans.’’ Place: National Institutes of Health, 6701 grant of an exclusive patent license to Rockledge Drive, Bethesda, MD 20892, The subject technologies are short practice the inventions embodied in the hair-pin RNAs which inhibit NANOG or (Telephone Conference Call). Contact Person: Joseph Thomas Peterson, U.S. Patents and Patent Applications NANOGP8 for the treatment of cancer Ph.D., Scientific Review Officer, Center for listed in the Summary Information and viral vectors that encode the RNAs. Scientific Review, National Institutes of section of this notice to Inova Health The first generation of these vectors Health, 6701 Rockledge Drive, Room 4118, System located in Falls Church, VA. were non-replicating lentiviral based MSC 7814, Bethesda, MD 20892, 301–408– DATES: Only written comments and/or vectors that were introduced into cancer 9694, petersonjt@csr.nih.gov. applications for a license which are cells as a standard form of RNA Name of Committee: Center for Scientific received by the National Cancer inhibition, blocking the expression of Review Special Emphasis Panel; Cell and Institute’s Technology Transfer Center NANOG or NANOGP8 protein. The Tissue Engineering and Analysis using on or before October 21, 2016 will be Microfluidics, Bioprinting, and Bioreactors. most current version of the subject considered. technology utilizes conditionally Date: November 4, 2016. Time: 8:00 a.m. to 6:00 p.m. ADDRESSES: Requests for copies of the replicating, oncolytic adenovirus Agenda: To review and evaluate grant patent application, inquiries, and vectors. These adenovirus-based vectors applications. comments relating to the contemplated grow in cells that express NANOGP8 Place: Residence Inn Capital View, 2850 exclusive license should be directed to: but not in cells that lack NANOGP8 or South Potomac Avenue, Arlington, VA Kevin W. Chang, Ph.D., Senior where the shRNA has inhibited 22202. Licensing and Patenting Manager, NCI NANOGP8 expression. The vectors have Contact Person: Wenchi Liang, Ph.D., Technology Transfer Center, 9609 been constructed to directly kill tumors Scientific Review Officer, Center for Medical Center Drive, RM 1E530 MSC and to inhibit the NANOGs to block Scientific Review, National Institutes of 9702, Bethesda, MD 20892–9702 (for cancer stem cell function in the tumors. Health, 6701 Rockledge Drive, Room 3150, business mail), Rockville, MD 20850– This notice is made in accordance MSC 7770, Bethesda, MD 20892, 301–435– 0681, liangw3@csr.nih.gov. 9702 Telephone: (240) 276–6910; with 35 U.S.C. 209 and 37 CFR part 404. Facsimile: (240) 276–5504 Email: The prospective exclusive license will Name of Committee: Center for Scientific Review Special Emphasis Panel; PAR: changke@mail.nih.gov. be royalty bearing, and the prospective Development of Pediatric Formulations and SUPPLEMENTARY INFORMATION: exclusive license may be granted unless Drug Delivery Systems. Intellectual Property within fifteen (15) days from the date of Date: November 4, 2016. this published notice, the National Time: 11:00 a.m. to 1:00 p.m. United States Provisional Patent Cancer Institute receives written Agenda: To review and evaluate grant Application No. No. 61/420,214, filed evidence and argument that establishes applications. December 6, 2010, entitled ‘‘Allele Place: National Institutes of Health, 6701 that the grant of the license would not Specific shRNAs For NANOG, Rockledge Drive, Bethesda, MD 20892, Pharmaceutical Composition be consistent with the requirements of (Telephone Conference Call). Comprising The shRNA, And Its 35 U.S.C. 209 and 37 CFR part 404. Contact Person: Sharon S Low, Ph.D., Method of Use to Treat Cancer’’ [HHS Complete applications for a license in Scientific Review Officer, Center for Reference No. E–294–2010/0–US–01]; the prospective field of use that are filed Scientific Review, National Institutes of in response to this notice will be treated Health, 6701 Rockledge Drive, Room 5104, International PCT Application No. PCT/ US2011/063451, filed December 6, as objections to the grant of the sradovich on DSK3GMQ082PROD with NOTICES MSC 5104, Bethesda, MD 20892–5104, 301– 237–1487, lowss@csr.nih.gov. 2011, entitled ‘‘Pharmaceutical contemplated Exclusive Patent License Composition Comprising NANOG Agreement. Comments and objections (Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; shRNA, and Method of Using NANOG submitted to this notice will not be 93.333, Clinical Research, 93.306, 93.333, shRNA to Treat Cancer’’ [HHS Reference made available for public inspection 93.337, 93.393–93.396, 93.837–93.844, No. E–294–2010/0–PCT–02]; United and, to the extent permitted by law, will 93.846– 93.878, 93.892, 93.893, National States Patent No. 9,163,236, issued not be released under the Freedom of Institutes of Health, HHS). October 20, 2015, entitled Information Act, 5 U.S.C. 552. VerDate Sep<11>2014 18:46 Oct 05, 2016 Jkt 241001 PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 E:\FR\FM\06OCN1.SGM 06OCN1

Federal Register / Vol. 81, No. 194 / Thursday, October 6, 2016 / Notices 69545 Dated: September 29, 2016. DEPARTMENT OF THE INTERIOR the AIARMA and include the specific Richard U. Rodriguez, information collection requirements. Associate Director, Technology Transfer Bureau of Indian Affairs This information collection allows Center, National Cancer Institute. BIA to obtain the information necessary [FR Doc. 2016–24133 Filed 10–5–16; 8:45 am] [178A2100DD/AAKC001030/ to determine whether an applicant is A0A501010.999900 253G] eligible to acquire, modify, or assign a BILLING CODE 4140–01–P grazing permit on trust or restricted Renewal of Agency Information lands and to allow a successful Collection for Grazing Permits applicant to meet bonding requirements. Some of this information is collected on DEPARTMENT OF THE INTERIOR AGENCY: Bureau of Indian Affairs, forms. The burden hours for this Interior. Geological Survey continued collection of information are ACTION: Notice of submission to OMB. reflected in the Estimated Total Annual SUMMARY: In compliance with the Hour Burden in this notice. [GX17GG00995TR00] Paperwork Reduction Act of 1995, the II. Request for Comments Announcement of Scientific Bureau of Indian Affairs (BIA) has The BIA requests your comments on Earthquake Studies Advisory submitted to the Office of Management this collection concerning: (a) The Committee Meeting and Budget (OMB) a request for renewal necessity of this information collection of the collection of information for for the proper performance of the AGENCY:U.S. Geological Survey, Grazing Permits authorized by OMB functions of the agency, including Department of the Interior. Control Number 1076–0157. This whether the information will have information collection expires October practical utility; (b) The accuracy of the ACTION: Notice of meeting. 31, 2016. agency’s estimate of the burden (hours DATES: Interested persons are invited to and cost) of the collection of SUMMARY: The Scientific Earthquake submit comments on or before information, including the validity of Studies Advisory Committee (SESAC) November 7, 2016. the methodology and assumptions used; will hold its next meeting in the Mesa Room of the Golden Hotel at 800 11th ADDRESSES: Please submit your (c) Ways we could enhance the quality, Street, Golden, Colorado. The comments to the Desk Officer for the utility, and clarity of the information to Committee is comprised of members Department of the Interior at the Office be collected; and (d) Ways we could from academia, industry, and State of Management and Budget, by facsimile minimize the burden of the collection of government. The Committee shall to (202) 395–5806 or you may send an the information on the respondents. email to: OIRA_Submission@ Please note that an agency may not advise the Director of the U.S. omb.eop.gov. Also please send a copy of conduct or sponsor and an individual Geological Survey (USGS) on matters your comments to David Edington, need not respond to, a collection of relating to the USGS’s participation in Office of Trust Services, 1849 C Street information unless it displays a valid the National Earthquake Hazards NW., Mail Stop 4637 MIB, Washington, OMB Control Number. Reduction Program. The Committee will It is our policy to make all comments receive reports on the status of activities DC 20240; facsimile: (202) 219–0006; email: David.Edington@bia.gov. available to the public for review at the of the Program and progress toward location listed in the ADDRESSES section. Program goals and objectives. The FOR FURTHER INFORMATION CONTACT: David Edington, Office of Trust Before including your address, phone Committee will assess this information number, email address or other personal and provide guidance on the future Services, 1849 C Street NW., Mail Stop 4637 MIB, Washington, DC 20240; identifying information in your undertakings and direction of the comment, you should be aware that Earthquake Hazards Program. Focus facsimile: (202) 219–0006; email: David.Edington@bia.gov. You may your entire comment—including your topics for this meeting include a personal identifying information—may program review and strategic planning review the information collection request online at http:// be made publicly available at any time. for 2016–2018. While you can ask us in your comment www.reginfo.gov. Follow the DATES: The meeting will be held from instructions to review Department of the to withhold your personal identifying 9:00 a.m. to 5:00 p.m. on November 7– Interior collections under review by information from public review, we 8, 2016. OMB. cannot guarantee that we will be able to do so. FOR FURTHER INFORMATION CONTACT: Dr. SUPPLEMENTARY INFORMATION: William Leith, U.S. Geological Survey, III. Data I. Abstract MS 905, 12201 Sunrise Valley Drive, OMB Control Number: 1076–0157. Reston, Virginia 20192, (703) 648–6786, The ‘‘American Indian Agricultural Title: Grazing Permits, 25 CFR 166. wleith@usgs.gov. Resource Management Act,’’ (AIARMA), Brief Description of Collection: 25 U.S.C. 3701 et seq., authorizes the Submission of this information allows SUPPLEMENTARY INFORMATION: Meetings Secretary of the Interior, in participation individuals or organizations to acquire of the Scientific Earthquake Studies with the beneficial owner of the land, to or modify a grazing permit on Tribal Advisory Committee are open to the manage Indian agricultural lands in a land, individually-owned Indian land, public. manner consistent with identified Tribal or government land and to meet sradovich on DSK3GMQ082PROD with NOTICES Authority: Public Law 106–503. goals and priorities for conservation, bonding requirements. Some of this multiple use, sustained yield, and information is collected on the William Leith, consistent with trust responsibilities, following forms: Form 5–5423— Senior Science Advisor for Earthquake and related to grazing on Tribal land, Performance Bond, Form 5–5514—Bid Geologic Hazards. individually-owned Indian land, or for Grazing Privileges, 5–5515 Grazing [FR Doc. 2016–24226 Filed 10–5–16; 8:45 am] government land. The regulations at 25 Permit, Form 5–5516—Grazing Permit BILLING CODE 4338–11–P CFR 166, Grazing Permits, implement for Organized Tribes, Form 5–5517— VerDate Sep<11>2014 18:46 Oct 05, 2016 Jkt 241001 PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 E:\FR\FM\06OCN1.SGM 06OCN1


Document Created: 2016-10-06 02:38:00
Document Modified: 2016-10-06 02:38:00
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesOnly written comments and/or applications for a license which are received by the National Cancer Institute's Technology Transfer Center on or before October 21, 2016 will be considered.
FR Citation81 FR 69544 
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