[Federal Register Volume 78, Number 60 (Thursday, March 28, 2013)]
[Page 18999]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-07166]



National Institutes of Health

Prospective Grant of Start-Up Exclusive License: Photosensitizing 
Antibody-Fluorophore Conjugates for Photoimmunotherapy

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 404.7(a)(1)(i), that the National Institutes of Health (NIH), 
Department of Health and Human Services (HHS), is contemplating the 
grant of a worldwide exclusive patent license, to practice the 
inventions embodied in PCT patent application PCT/US2012/044421, filed 
June 27, 2012 (HHS Reference E-205-2010/2-PCT-01), which is a 
continuation-in-part of U.S. Application No. 13/180,111 (E-205-2010/1-
US-01) which claims priority to U.S. provisional application No. 61/
363,079 (E-205-2010/0-US-01), and entitled ``Photosensitizing Antibody-
Fluorophore Conjugates,'' to Aspyrian Therapeutics, Inc., a company 
incorporated under the laws of the State of Delaware, having its 
headquarters in San Diego, California.
    The United States of America is the assignee of the rights of the 
above invention.
    The field of use may be limited to ``use of photosensitizing 
antibody-fluorophore conjugate by itself for Photoimmunotherapy (PIT), 
or in combination with cancer therapeutic agents, to treat cancer or 
pre-cancerous hyperplasia'', and may be further limited to certain 
types of cancer and/or specific platforms.
    The license will include the priority case US 13/180,111, which is 
currently licensed to Aspyrian under an exclusive evaluation option 
license. The exclusive commercialization license proposed in this 
notice will supersede and replace the exclusive evaluation option 

DATES: Only written comments and/or applications for a license received 
by the NIH Office of Technology Transfer on or before April 12, 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: Uri Reichman, Ph.D., M.B.A, Office of Technology 
Transfer, National Institutes of Health, 6011 Executive Boulevard, 
Suite 325, Rockville, MD 20852-3804; Telephone: (301) 435-4616; 
Facsimile: (301) 402-0220; Email: [email protected]. 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: The invention is in the field of 
Photoimmunotherapy (PIT). More specifically, the invention relates to 
antibody-fluorophore conjugates where the antibody is specific for 
cancer cells and the fluorophore is IR700 dye. Binding of such 
conjugates to targeted cancer cells followed by irradiation with near 
infrared light (NIR) was shown to kill cancer cells in a highly 
specific manner. Furthermore, the invention discloses that the 
therapeutic effect of the PIT conjugate is significantly enhanced by 
the administration of one or more anti-cancer agents following the 
irradiation step. This is achieved by the markedly rapid accumulation 
of the therapeutic agent in the PIT-treated tissue. Also provided in 
the invention are wearable devices that incorporate NIR light emitting 
diodes (LEDs) and can be used to activate the PIT conjugates.
    The prospective exclusive license 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.
    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 22, 2013.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2013-07166 Filed 3-27-13; 8:45 am]