80 FR 57832 - Prospective Grant of Start-Up Exclusive Evaluation Option License Agreement: Development of Diagnostic Tests and Kits for Detection of Pathological Angiogenesis in Cancer
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health Federal Register Volume 80, Issue 186 (September 25, 2015)
National Institutes of Health
Federal Register Volume 80, Issue 186 (September 25, 2015)
| Page Range | 57832-57833 | |
| FR Document | 2015-24331 |
[Federal Register Volume 80, Number 186 (Friday, September 25, 2015)] [Notices] [Pages 57832-57833] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-24331] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Prospective Grant of Start-Up Exclusive Evaluation Option License Agreement: Development of Diagnostic Tests and Kits for Detection of Pathological Angiogenesis in Cancer AGENCY: National Institutes of Health, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: This is notice, in accordance with 35 U.S.C. 209 and 37 CFR part 404, 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 Angio360 Diagnostics, LLC, a company having a place of business in Wauwatosa, Wisconsin, to practice the inventions embodied in U.S. Provisional Patent Application No. 60/ 858,068, entitled ``Differential Gene Expression in Physiological and Pathological Angiogenesis,'' filed November 9, 2006 (HHS Ref. No.: E- 285-2006/0-US-01); US Provisional Patent Application No. 60/879,457, entitled ``Organ And Tumor Associated Endothelial Markers,'' filed January 8, 2007 (HHS Ref. No. E-285-2006/1-US-01); PCT Application No. PCT/US2007/072395, entitled ``Differential Gene Expression in Physiological and Pathological Angiogenesis,'' filed June 8, 2007 (HHS Ref. No. E-285-2006/2-PCT-01); U.S. Patent Application No. 12/514,297, entitled ``Differential Gene Expression in Physiological and Pathological Angiogenesis,'' filed May 8, 2009 (HHS Ref No. E-285-2006/ 2-US-02); Australian Patent No. 2007-317753, entitled ``Differential Gene Expression in Physiological and Pathological Angiogenesis,'' filed June 28, 2007 (HHS Ref No. E-285-2006/2-AU-03); Canadian Patent Application No. 2,669,260, entitled ``Differential Gene Expression in Physiological and Pathological Angiogenesis,'' filed June 28, 2007 (HHS Ref. No. E-285-2006/2-CA-04); U.S. Patent No.: 8,440,411, entitled ``Differential Gene Expression in Physiological and Pathological Angiogenesis,'' filed March 21, 2011 (HHS Ref. No. E-285-2006/2-US-05); U.S. Patent Application No. 13/052,878, entitled ``Differential Gene Expression in Physiological and Pathological Angiogenesis,'' filed April 16, 2013 (HHS Ref. No.: E-285-2006/2-US-06); and Australian Application Patent No.: 2014-200453, entitled ``Differential Gene Expression in Physiological and Pathological Angiogenesis,'' filed January 28, 2014 (HHS Ref No. E-285-2006/2-AU-07). 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 ``Development of diagnostic tests and kits to determine or monitor pathological angiogenesis related to cancer in animals or humans.'' [[Page 57833]] Upon the expiration or termination of the Start-up Exclusive Evaluation Option License Agreement, Angio360 Diagnostics, LLC will have the exclusive right to execute a Start-Up Exclusive Patent License Agreement which will supersede and replace the Start-up Exclusive Evaluation Option License Agreement, with no greater field of use and territory than granted in the Start-up Exclusive Evaluation Option License Agreement. DATES: Only written comments and/or applications for a license which are received by the NIH Office of Technology Transfer on or before October 13, 2015 will be considered. ADDRESSES: Requests for copies of the patent application(s), inquiries, comments, and other materials relating to the contemplated Start-Up Exclusive Evaluation Option License Agreement should be directed to: Rose M. Freel, Licensing and Patenting Manager, Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852-3804; Telephone: (301) 402-9521; Facsimile: (301) 402-0220; Email: rose.freel@nih.gov. A signed confidentiality nondisclosure agreement will be required to receive copies of any patent applications that have not been published or issued by the United States Patent and Trademark Office or the World Intellectual Property Organization. SUPPLEMENTARY INFORMATION: This technology describes a method of detecting pathological angiogenesis (formation of new blood vessels) using the expression levels of certain proteins for the diagnosis of cancer or monitoring response to cancer treatment. The prospective Start-Up Exclusive Evaluation Option License Agreement is being considered under the small business initiative launched on October 1, 2011 and will comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR part 404. The prospective Start- Up Exclusive Evaluation Option License Agreement and a subsequent Start-Up Exclusive Patent License Agreement may be granted unless the NIH receives written evidence and argument, within fifteen (15) days from the date of this published notice, that establishes that the grant of the contemplated Start-Up Exclusive Evaluation Option License Agreement 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 Start-Up Exclusive Evaluation Option 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. Dated: September 21, 2015. Richard U. Rodriguez, Acting Director, Office of Technology Transfer, National Institutes of Health. [FR Doc. 2015-24331 Filed 9-24-15; 8:45 am] BILLING CODE 4140-01-P
![57832 Federal Register / Vol. 80, No. 186 / Friday, September 25, 2015 / Notices
immunization information, smoking domestic violence exposure, physical or address the toxic stress and social
cessation, oral health, as well as sexual abuse, neglectful parenting, and determinants that drive health and
parental depression, domestic violence food and housing insecurity. Findings developmental disparities for young
and substance use counseling. from the AAP national survey of children.
Pediatricians would be asked about the pediatricians, in conjunction with FOR FURTHER INFORMATION CONTACT:
frequency with which they inquire findings from other data sources and Lynn Van Pelt, DMD, Division of Child,
about, use formal screening instruments, ongoing surveys of home visitors, would Adolescent, and Family Health,
treat/manage, and refer patients for inform MCHB’s understanding of what Maternal and Child Health Bureau,
various problems/conditions. These is needed to best strengthen the home Health Resources and Services
various problems/conditions may visitors’ and pediatricians’ Administration, 5600 Fishers Lane,
include maternal depression, parental collaborations for at-risk families to Room 18W13B, Rockville, Maryland
alcohol/drug use, divorce, illiteracy, support healthy development and to 20857; lvanpelt@hrsa.gov.
FY 2015
FY 2015 estimated
Grantee/organization name Grant number State authorized supplemental
funding level funding
The American Academy of Pediatrics ....................... U04MC07853 ............................................ IL $1,176,800 $75,000
Dated: September 21, 2015. (Catalogue of Federal Domestic Assistance PCT/US2007/072395, entitled
James Macrae, Program Nos. 93.866, Aging Research, ‘‘Differential Gene Expression in
National Institutes of Health, HHS) Physiological and Pathological
Acting Administrator.
[FR Doc. 2015–24395 Filed 9–24–15; 8:45 am] Dated: September 21, 2015. Angiogenesis,’’ filed June 8, 2007 (HHS
BILLING CODE 4165–15–P Melanie J. Gray,
Ref. No. E–285–2006/2–PCT–01); U.S.
Patent Application No. 12/514,297,
Program Analyst, Office of Federal Advisory
Committee Policy.
entitled ‘‘Differential Gene Expression
DEPARTMENT OF HEALTH AND in Physiological and Pathological
[FR Doc. 2015–24322 Filed 9–24–15; 8:45 am]
HUMAN SERVICES Angiogenesis,’’ filed May 8, 2009 (HHS
BILLING CODE 4140–01–P
Ref No. E–285–2006/2–US–02);
National Institutes of Health Australian Patent No. 2007–317753,
DEPARTMENT OF HEALTH AND entitled ‘‘Differential Gene Expression
National Institute on Aging; Notice of in Physiological and Pathological
Closed Meeting HUMAN SERVICES
Angiogenesis,’’ filed June 28, 2007 (HHS
Pursuant to section 10(d) of the National Institutes of Health Ref No. E–285–2006/2–AU–03);
Federal Advisory Committee Act, as Canadian Patent Application No.
amended (5 U.S.C. App.), notice is Prospective Grant of Start-Up 2,669,260, entitled ‘‘Differential Gene
hereby given of the following meeting. Exclusive Evaluation Option License Expression in Physiological and
Agreement: Development of Pathological Angiogenesis,’’ filed June
The meeting will be closed to the Diagnostic Tests and Kits for Detection 28, 2007 (HHS Ref. No. E–285–2006/2–
public in accordance with the of Pathological Angiogenesis in CA–04); U.S. Patent No.: 8,440,411,
provisions set forth in sections Cancer entitled ‘‘Differential Gene Expression
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
AGENCY: National Institutes of Health, in Physiological and Pathological
as amended. The grant applications and
HHS. Angiogenesis,’’ filed March 21, 2011
the discussions could disclose
(HHS Ref. No. E–285–2006/2–US–05);
confidential trade secrets or commercial ACTION: Notice.
U.S. Patent Application No. 13/052,878,
property such as patentable material,
SUMMARY: This is notice, in accordance entitled ‘‘Differential Gene Expression
and personal information concerning
with 35 U.S.C. 209 and 37 CFR part 404, in Physiological and Pathological
individuals associated with the grant
that the National Institutes of Health, Angiogenesis,’’ filed April 16, 2013
applications, the disclosure of which
Department of Health and Human (HHS Ref. No.: E–285–2006/2–US–06);
would constitute a clearly unwarranted
Services, is contemplating the grant of a and Australian Application Patent No.:
invasion of personal privacy.
Start-Up Exclusive Evaluation Option 2014–200453, entitled ‘‘Differential
Name of Committee: National Institute on License Agreement to Angio360 Gene Expression in Physiological and
Aging Special Emphasis Panel; The Aging Pathological Angiogenesis,’’ filed
and Memory Project.
Diagnostics, LLC, a company having a
Date: October 26, 2015. place of business in Wauwatosa, January 28, 2014 (HHS Ref No. E–285–
Time: 10:00 a.m. to 2:00 p.m. Wisconsin, to practice the inventions 2006/2–AU–07). The patent rights in
Agenda: To review and evaluate grant embodied in U.S. Provisional Patent these inventions have been assigned to
applications. Application No. 60/858,068, entitled the Government of the United States of
Place: National Institute on Aging, ‘‘Differential Gene Expression in America. The territory of the
Gateway Building, Suite 2C212, 7201 prospective Start-Up Exclusive
mstockstill on DSK4VPTVN1PROD with NOTICES
Physiological and Pathological
Wisconsin Avenue, Bethesda, MD 20892, Angiogenesis,’’ filed November 9, 2006 Evaluation Option License Agreement
(Telephone Conference Call). (HHS Ref. No.: E–285–2006/0–US–01); may be worldwide, and the field of use
Contact Person: Kimberly Firth, Ph.D.,
National Institutes of Health, National
US Provisional Patent Application No. may be limited to ‘‘Development of
Institute on Aging, Gateway Building, 7201 60/879,457, entitled ‘‘Organ And Tumor diagnostic tests and kits to determine or
Wisconsin Avenue, Suite 2C212, Bethesda, Associated Endothelial Markers,’’ filed monitor pathological angiogenesis
MD 20892, 301–402–7702, firthkm@ January 8, 2007 (HHS Ref. No. E–285– related to cancer in animals or
mail.nih.gov. 2006/1–US–01); PCT Application No. humans.’’
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![Federal Register / Vol. 80, No. 186 / Friday, September 25, 2015 / Notices 57833
Upon the expiration or termination of Evaluation Option License Agreement. Health, 6701 Rockledge Drive, Room 6192,
the Start-up Exclusive Evaluation Comments and objections submitted to MSC 7804, Bethesda, MD 20892, 301–806–
Option License Agreement, Angio360 this notice will not be made available 2515, chatterm@csr.nih.gov.
Diagnostics, LLC will have the exclusive for public inspection and, to the extent Name of Committee: Center for Scientific
right to execute a Start-Up Exclusive permitted by law, will not be released Review Special Emphasis Panel; Cancer,
Cardiovascular and Sleep Epidemiology
Patent License Agreement which will under the Freedom of Information Act, Panel B Study Section.
supersede and replace the Start-up 5 U.S.C. 552. Date: October 19–20, 2015.
Exclusive Evaluation Option License Dated: September 21, 2015. Time: 8:30 a.m. to 3:00 p.m.
Agreement, with no greater field of use Richard U. Rodriguez, Agenda: To review and evaluate grant
and territory than granted in the Start- applications.
Acting Director, Office of Technology Place: Melrose Hotel, 2430 Pennsylvania
up Exclusive Evaluation Option License Transfer, National Institutes of Health.
Agreement. Avenue NW., Washington, DC 20037.
[FR Doc. 2015–24331 Filed 9–24–15; 8:45 am] Contact Person: Ellen K. Schwartz, EDD,
DATES: Only written comments and/or
BILLING CODE 4140–01–P Scientific Review Officer, Center for
applications for a license which are Scientific Review, National Institutes of
received by the NIH Office of Health, 6701 Rockledge Drive, Room 3144,
Technology Transfer on or before DEPARTMENT OF HEALTH AND MSC 7770, Bethesda, MD 20892, 301–828–
October 13, 2015 will be considered. HUMAN SERVICES 6146, schwarel@mail.nih.gov.
ADDRESSES: Requests for copies of the Name of Committee: Infectious Diseases
patent application(s), inquiries, National Institutes of Health and Microbiology Integrated Review Group;
comments, and other materials relating Virology—A Study Section.
Center For Scientific Review; Notice of Date: October 26–27, 2015.
to the contemplated Start-Up Exclusive
Closed Meetings Time: 8:00 a.m. to 5:00 p.m.
Evaluation Option License Agreement Agenda: To review and evaluate grant
should be directed to: Rose M. Freel, Pursuant to section 10(d) of the applications.
Licensing and Patenting Manager, Office Federal Advisory Committee Act, as Place: Renaissance Washington DC,
of Technology Transfer, National amended (5 U.S.C. App.), notice is Dupont Circle, 1143 New Hampshire Avenue
Institutes of Health, 6011 Executive NW., Washington, DC 20037.
hereby given of the following meetings. Contact Person: Kenneth M. Izumi, Ph.D.,
Boulevard, Suite 325, Rockville, MD The meetings will be closed to the
20852–3804; Telephone: (301) 402– Scientific Review Officer, Center for
public in accordance with the Scientific Review, National Institutes of
9521; Facsimile: (301) 402–0220; Email: provisions set forth in sections Health, 6701 Rockledge Drive, Room 3204,
rose.freel@nih.gov. A signed 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., MSC 7808, Bethesda, MD 20892, 301–496–
confidentiality nondisclosure agreement as amended. The grant applications and 6980, izumikm@csr.nih.gov.
will be required to receive copies of any the discussions could disclose Name of Committee: Immunology
patent applications that have not been confidential trade secrets or commercial Integrated Review Group; Innate Immunity
published or issued by the United States property such as patentable material, and Inflammation Study Section.
Patent and Trademark Office or the and personal information concerning Date: October 29–30, 2015.
World Intellectual Property Time: 8:00 a.m. to 5:00 p.m.
individuals associated with the grant Agenda: To review and evaluate grant
Organization. applications, the disclosure of which applications.
SUPPLEMENTARY INFORMATION: This would constitute a clearly unwarranted Place: Embassy Suites Alexandria-Old
technology describes a method of invasion of personal privacy. Town, 1900 Diagonal Road, Alexandria, VA
detecting pathological angiogenesis Name of Committee: Center for Scientific 22314.
(formation of new blood vessels) using Review Special Emphasis Panel; Member Contact Person: Tina McIntyre, Ph.D.,
the expression levels of certain proteins Conflict: Cell Biology. Scientific Review Officer, Center for
Date: October 14, 2015. Scientific Review, National Institutes of
for the diagnosis of cancer or monitoring Health, 6701 Rockledge Drive, Room 4202,
response to cancer treatment. Time: 1:00 p.m. to 4:00 p.m.
Agenda: To review and evaluate grant MSC 7812, Bethesda, MD 20892, 301–594–
The prospective Start-Up Exclusive 6375, mcintyrt@csr.nih.gov.
Evaluation Option License Agreement is applications.
Place: National Institutes of Health, 6701 Name of Committee: Center for Scientific
being considered under the small Rockledge Drive, Bethesda, MD 20892, Review Special Emphasis Panel; Special
business initiative launched on October (Telephone Conference Call). Topic: Development Functions and Immune
1, 2011 and will comply with the terms Contact Person: John Burch, Ph.D., Mediated Diseases.
and conditions of 35 U.S.C. 209 and 37 Scientific Review Officer, Center for Date: October 30, 2015.
CFR part 404. The prospective Start-Up Scientific Review, National Institute of Time: 8:00 a.m. to 5:00 p.m.
Exclusive Evaluation Option License Health, 6701 Rockledge Drive, Room 3213, Agenda: To review and evaluate grant
MSC 7808, Bethesda, MD 20892, 301–408– applications.
Agreement and a subsequent Start-Up
9519, burchjb@csr.nih.gov. Place: Residence Inn Capital View, 2850
Exclusive Patent License Agreement This notice is being published less than 15 South Potomac Avenue, Arlington, VA
may be granted unless the NIH receives days prior to the meeting due to the timing 22202.
written evidence and argument, within limitations imposed by the review and Contact Person: Deborah Hodge, Ph.D.,
fifteen (15) days from the date of this funding cycle. Scientific Review Officer, Center for
published notice, that establishes that Name of Committee: Oncology 2— Scientific Review, National Institutes of
the grant of the contemplated Start-Up Translational Clinical Integrated Review Health, 6701 Rockledge Drive, Room 4207
Exclusive Evaluation Option License Group; Clinical Oncology Study Section. MSC 7812, Bethesda, MD 20892, (301) 435–
1238, hodged@mail.nih.gov.
mstockstill on DSK4VPTVN1PROD with NOTICES
Agreement would not be consistent with Date: October 19, 2015.
the requirements of 35 U.S.C. 209 and Time: 8:00 a.m. to 6:00 p.m. Name of Committee: Center for Scientific
Agenda: To review and evaluate grant Review Special Emphasis Panel; PARs:
37 CFR part 404.
applications. Developing and Testing Interventions for
Complete applications for a license in Place: Sheraton Reston Hotel, 11810 Health-Enhancing Physical Activity.
the prospective field of use that are filed Sunrise Valley Drive, Reston, VA 20191. Date: October 30, 2015.
in response to this notice will be treated Contact Person: Malaya Chatterjee, Ph.D., Time: 8:30 a.m. to 5:00 p.m.
as objections to the grant of the Scientific Review Officer, Center for Agenda: To review and evaluate grant
contemplated Start-Up Exclusive Scientific Review, National Institutes of applications.
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Document Created: 2018-02-26 10:20:13
Document Modified: 2018-02-26 10:20:13
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Only written comments and/or applications for a license which are received by the NIH Office of Technology Transfer on or before October 13, 2015 will be considered. | |
| FR Citation | 80 FR 57832 |
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