Prospective Grant of Exclusive License: Papilloma Pseudovirus and Virus-Like Particles as a Delivery System for Human Cancer Therapeutics and Diagnostics, 18359-18360 [2013-06837]

Download as PDF Federal Register / Vol. 78, No. 58 / Tuesday, March 26, 2013 / Notices Place: National Institutes of Health, Two Democracy Plaza, 6707 Democracy Boulevard, Bethesda, MD 20892, (Telephone Conference Call). Contact Person: Carol J. Goter-Robinson, Ph.D., Scientific Review Officer, Review Branch, DEA, NIDDK, National Institutes Of Health, Room 748, 6707 Democracy Boulevard, Bethesda, MD 20892–5452, (301) 594–7791, goterrobinsonc@extra.niddk.nih.gov. This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. Name of Committee: National Institute of Diabetes and Digestive and Kidney Diseases Special Emphasis Panel; Review of U34 Clinical Trial Planning Grant. Date: April 12, 2013. Time: 3:00 p.m. to 4:30 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Two Democracy Plaza, 6707 Democracy Boulevard, Bethesda, MD 20892, (Telephone Conference Call). Contact Person: John F. Connaughton, Ph.D., Chief, Chartered Committees Section, Review Branch, DEA, NIDDK, National Institutes of Health, Room 753, 6707 Democracy Boulevard, Bethesda, MD 20892– 5452, (301) 594–7797, connaughtonj@extra.niddk.nih.gov. This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. (Catalogue of Federal Domestic Assistance Program Nos. 93.847, Diabetes, Endocrinology and Metabolic Research; 93.848, Digestive Diseases and Nutrition Research; 93.849, Kidney Diseases, Urology and Hematology Research, National Institutes of Health, HHS) Dated: March 20, 2013. David Clary, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2013–06804 Filed 3–25–13; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health srobinson on DSK4SPTVN1PROD with NOTICES National Institute of Environmental Health Sciences; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The contract proposals and the discussions could disclose confidential trade secrets or commercial VerDate Mar<15>2010 19:07 Mar 25, 2013 Jkt 229001 property such as patentable material, and personal information concerning individuals associated with the contract proposals, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute of Environmental Health Sciences Special Emphasis Panel; Loan Repayment Program. Date: April 25, 2013. Time: 8:00 a.m. to 5:00 p.m. Agenda: To review and evaluate contract proposals. Place: NIEHS, Keystone Building, 530 Davis Drive, Research Triangle Park, NC 27709, (Virtual Meeting). Contact Person: RoseAnne M McGee, Associate Scientific Review Administrator, Scientific Review Branch, Division of Extramural Research and Training, Nat. Institute of Environmental Health Sciences, P.O. Box 12233, MD EC–30, Research Triangle Park, NC 27709, (919) 541–0752, mcgee1@niehs.nih.gov. Name of Committee: National Institute of Environmental Health Sciences Special Emphasis Panel; Research Careers in Emerging Technologies. Date: April 30, 2013. Time: 1:00 p.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: Nat. Inst. of Environmental Health Sciences, Keystone, 530 Davis Drive, Research Triangle Park, NC 27709, (Telephone Conference Call). Contact Person: Linda K Bass, Scientific Review Officer, Scientific Review Branch, Division of Extramural Research and Training, Nat. Institute Environmental Health Sciences, P. O. Box 12233, MD EC–30, Research Triangle Park, NC 27709, (919) 541– 1307, bass@niehs.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.115, Biometry and Risk Estimation—Health Risks from Environmental Exposures; 93.142, NIEHS Hazardous Waste Worker Health and Safety Training; 93.143, NIEHS Superfund Hazardous Substances—Basic Research and Education; 93.894, Resources and Manpower Development in the Environmental Health Sciences; 93.113, Biological Response to Environmental Health Hazards; 93.114, Applied Toxicological Research and Testing, National Institutes of Health, HHS) Dated: March 20, 2013. Carolyn Baum, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2013–06812 Filed 3–25–13; 8:45 am] BILLING CODE 4140–01–P PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 18359 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Prospective Grant of Exclusive License: Papilloma Pseudovirus and Virus-Like Particles as a Delivery System for Human Cancer Therapeutics and Diagnostics National Institutes of Health, Public Health Service, HHS. ACTION: Notice. AGENCY: SUMMARY: This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR Part 404.7(a)(1)(i), that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive license to Aura BioSciences to practice the inventions embodied in U.S. Provisional Patent Application No. 60/ 928,495 entitled, ‘‘Papillomavirus Pseudoviruses for Detection and Therapy of Tumors’’ filed May 8, 2007 [HHS Ref. No. E–186–2007/0–US–01], U.S. Provisional Patent Application No. 61/065,897 entitled ‘‘Papillomavirus Pseudoviruses for Detection and Therapy of Tumors’’ filed February 14, 2008 [HHS Ref. No. E–186–2007/1–US– 01], PCT Application No. PCT/US2008/ 062296 ‘‘Papillomavirus Pseudoviruses for Detection and Therapy of Tumors’’ filed May 1, 2008 [HHS Ref. No. E–186– 2007/2–PCT–01], Australian Patent Application No. 2008251615 entitled ‘‘Papillomavirus Pseudoviruses for Detection and Therapy of Tumors’’ filed May 1, 2008 [HHS Ref. No. E–186–2007/ 2–AU–02], Canadian Patent Application No. 2,686,990 entitled ‘‘Papillomavirus Pseudoviruses for Detection and Therapy of Tumors’’ filed May 1, 2008 [HHS Ref. No. E–186–2007/2–CA–03], European Patent Application No. 08747407.8 entitled ‘‘Papillomavirus Pseudoviruses for Detection and Therapy of Tumors’’ filed May 1, 2008 [HHS Ref. No. E–186–2007/2–EP–04], U.S. Patent Application No. 12/598,684 entitled, ‘‘Papillomavirus Pseudoviruses for Detection and Therapy of Tumors’’ filed February 8, 2010 [HHS Ref. No. E–186–2007/2–US–05], and US Patent Application No. 13/763,365 entitled, ‘‘Papilloma Pseudovirus for Detection and Therapy of Tumors’’ filed February 8, 2013 [HHS Ref. No. E–186–2007/2– US–06] and all continuing applications and foreign counterparts. The patent rights in these inventions have been assigned to the United States of America. The prospective exclusive license territory may be worldwide and the field of use may be limited to the E:\FR\FM\26MRN1.SGM 26MRN1 srobinson on DSK4SPTVN1PROD with NOTICES 18360 Federal Register / Vol. 78, No. 58 / Tuesday, March 26, 2013 / Notices development and use of the Licensed Patent Rights in combination with Licensee’s proprietary nanosphere encapsulation technology for the treatment, diagnosis and imaging of cancer tumors and metastases as well as their respective pre-cursor dysplasia states. Licensee’s proprietary nanosphere encapsulation technology is understood to consist of: (1) Methods for manipulating the outer proteins of human papillomavirus-derived nanoparticles to create particles targeted to solid tumors and distant metastases; and (2) enhancements for the delivery of particles created by Licensee’s proprietary technology. DATES: Only written comments and/or applications for a license which are received by the NIH Office of Technology Transfer on or before April 25, 2013 will be considered. ADDRESSES: Requests for copies of the patent application, inquiries, comments, and other materials relating to the contemplated exclusive license should be directed to: Jennifer Wong, M.S., Senior Licensing and Patenting Manager, Cancer Branch, Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852–3804; Telephone: (301) 435–4633; Facsimile: (301) 402–0220; Email: wongje@mail.nih.gov. SUPPLEMENTARY INFORMATION: There is extensive literature on the use of viral vectors, particularly those based on the adenovirus, to increase the potency of anti-tumor gene therapy. However, these approaches have had limited success because of limited anti-tumor effects and unacceptable toxicity. This invention describes the use of human papillomavirus pseudoviruses (PsV) as a cancer diagnostic and therapeutic. Preliminary studies showed that PsVs bind to ovarian tumor cells while normal tissues were not affected. PsVs does not infect several other normal intact tissues but continues to selectively infect additional cancer cells. This technology could be an effective anti-tumor therapy because it has shown increased infection of cancer cells with an inability to infect normal cells thereby reducing potential toxicity to patients. In addition to a potential anti-cancer therapeutic, this technology could also be used as a diagnostic tool in the detection of tumor masses. Detection can be achieved through the use of fluorescent dye coupled particles of PsVs that have preferential binding to tumor tissues and not normal tissues. The prospective exclusive license will be royalty bearing and will comply with the terms and conditions of 35 U.S.C. VerDate Mar<15>2010 19:07 Mar 25, 2013 Jkt 229001 209 and 37 CFR Part 404.7. The prospective exclusive license may be granted unless within thirty (30) days from the date of this published notice, the 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 Part 404.7. Applications for a license in the field of use filed in response to this notice will be treated as objections to the grant of the contemplated exclusive license. 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: March 18, 2013. Richard U. Rodriguez, Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health. [FR Doc. 2013–06837 Filed 3–25–13; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Prospective Grant of Start-Up Exclusive License: Manual Device for Constructing Tissue Micro Arrays and Methods for Making Cryo Arrays for Use in Association With the Device National Institutes of Health, Public Health Service, HHS. ACTION: Notice. AGENCY: 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 a start-up exclusive license to practice the inventions embodied in U.S. Patent No. 7,854,899, (E–098–2004/0) filed 08/26/2004 and issued 12/20/2010 entitled ‘‘Template Methods and Device for Preparing Sample Arrays’’; by Hewitt et al. (NCI); and U.S. Patent No. 6,951,761 9 (E–064–2001/0) filed 08/30/ 2002 and issued 11/04/2005 ‘‘Measurements of Multiple Molecules Using a Cryoarray’’ by Star et al. (NIDDK) to Micatu, Inc. having a place of business at 231 West Water Street, Elmira, NY 14901. 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 PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 Technology Transfer on or before April 10, 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 fifteen (15) 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 patents relate to a device for tissue microarray construction having a block of embedding medium, a platform configured to retain the block, a templates secured to the platform and aligned to guide needles into the embedding block; and methods of making a block containing liquid biological samples that can be frozen and sectioned to make tissue microarray. The field of use may be limited to the field of devices for construction of tissue microarrays. 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: March 18, 2013. Richard U. Rodriguez, Director, Division of Technology Development & Transfer, Office of Technology Transfer, National Institutes of Health. [FR Doc. 2013–06835 Filed 3–25–13; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Substance Abuse and Mental Health Services Administration Fiscal Year (FY) 2013 Funding Opportunity Substance Abuse and Mental Health Services Administration, HHS. AGENCY: E:\FR\FM\26MRN1.SGM 26MRN1

Agencies

[Federal Register Volume 78, Number 58 (Tuesday, March 26, 2013)]
[Notices]
[Pages 18359-18360]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-06837]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: Papilloma Pseudovirus and 
Virus-Like Particles as a Delivery System for Human Cancer Therapeutics 
and Diagnostics

AGENCY: National Institutes of Health, Public Health Service, HHS.

ACTION: Notice.

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

SUMMARY: This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 
CFR Part 404.7(a)(1)(i), that the National Institutes of Health, 
Department of Health and Human Services, is contemplating the grant of 
an exclusive license to Aura BioSciences to practice the inventions 
embodied in U.S. Provisional Patent Application No. 60/928,495 
entitled, ``Papillomavirus Pseudoviruses for Detection and Therapy of 
Tumors'' filed May 8, 2007 [HHS Ref. No. E-186-2007/0-US-01], U.S. 
Provisional Patent Application No. 61/065,897 entitled ``Papillomavirus 
Pseudoviruses for Detection and Therapy of Tumors'' filed February 14, 
2008 [HHS Ref. No. E-186-2007/1-US-01], PCT Application No. PCT/US2008/
062296 ``Papillomavirus Pseudoviruses for Detection and Therapy of 
Tumors'' filed May 1, 2008 [HHS Ref. No. E-186-2007/2-PCT-01], 
Australian Patent Application No. 2008251615 entitled ``Papillomavirus 
Pseudoviruses for Detection and Therapy of Tumors'' filed May 1, 2008 
[HHS Ref. No. E-186-2007/2-AU-02], Canadian Patent Application No. 
2,686,990 entitled ``Papillomavirus Pseudoviruses for Detection and 
Therapy of Tumors'' filed May 1, 2008 [HHS Ref. No. E-186-2007/2-CA-
03], European Patent Application No. 08747407.8 entitled 
``Papillomavirus Pseudoviruses for Detection and Therapy of Tumors'' 
filed May 1, 2008 [HHS Ref. No. E-186-2007/2-EP-04], U.S. Patent 
Application No. 12/598,684 entitled, ``Papillomavirus Pseudoviruses for 
Detection and Therapy of Tumors'' filed February 8, 2010 [HHS Ref. No. 
E-186-2007/2-US-05], and US Patent Application No. 13/763,365 entitled, 
``Papilloma Pseudovirus for Detection and Therapy of Tumors'' filed 
February 8, 2013 [HHS Ref. No. E-186-2007/2-US-06] and all continuing 
applications and foreign counterparts. The patent rights in these 
inventions have been assigned to the United States of America.
    The prospective exclusive license territory may be worldwide and 
the field of use may be limited to the

[[Page 18360]]

development and use of the Licensed Patent Rights in combination with 
Licensee's proprietary nanosphere encapsulation technology for the 
treatment, diagnosis and imaging of cancer tumors and metastases as 
well as their respective pre-cursor dysplasia states. Licensee's 
proprietary nanosphere encapsulation technology is understood to 
consist of: (1) Methods for manipulating the outer proteins of human 
papillomavirus-derived nanoparticles to create particles targeted to 
solid tumors and distant metastases; and (2) enhancements for the 
delivery of particles created by Licensee's proprietary technology.

DATES: Only written comments and/or applications for a license which 
are received by the NIH Office of Technology Transfer on or before 
April 25, 2013 will be considered.

ADDRESSES: Requests for copies of the patent application, inquiries, 
comments, and other materials relating to the contemplated exclusive 
license should be directed to: Jennifer Wong, M.S., Senior Licensing 
and Patenting Manager, Cancer Branch, Office of Technology Transfer, 
National Institutes of Health, 6011 Executive Boulevard, Suite 325, 
Rockville, MD 20852-3804; Telephone: (301) 435-4633; Facsimile: (301) 
402-0220; Email: wongje@mail.nih.gov.

SUPPLEMENTARY INFORMATION: There is extensive literature on the use of 
viral vectors, particularly those based on the adenovirus, to increase 
the potency of anti-tumor gene therapy. However, these approaches have 
had limited success because of limited anti-tumor effects and 
unacceptable toxicity. This invention describes the use of human 
papillomavirus pseudoviruses (PsV) as a cancer diagnostic and 
therapeutic. Preliminary studies showed that PsVs bind to ovarian tumor 
cells while normal tissues were not affected. PsVs does not infect 
several other normal intact tissues but continues to selectively infect 
additional cancer cells. This technology could be an effective anti-
tumor therapy because it has shown increased infection of cancer cells 
with an inability to infect normal cells thereby reducing potential 
toxicity to patients. In addition to a potential anti-cancer 
therapeutic, this technology could also be used as a diagnostic tool in 
the detection of tumor masses. Detection can be achieved through the 
use of fluorescent dye coupled particles of PsVs that have preferential 
binding to tumor tissues and not normal tissues.
    The prospective exclusive license will be royalty bearing and will 
comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR Part 
404.7. The prospective exclusive license may be granted unless within 
thirty (30) days from the date of this published notice, the 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 Part 404.7.
    Applications for a license in the field of use filed in response to 
this notice will be treated as objections to the grant of the 
contemplated exclusive license. 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: March 18, 2013.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2013-06837 Filed 3-25-13; 8:45 am]
BILLING CODE 4140-01-P

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