[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]


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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.

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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