[Federal Register Volume 78, Number 227 (Monday, November 25, 2013)]
[Pages 70308-70309]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-28119]



National Institutes of Health

Prospective Grant of Exclusive License: Development of Chitosan/
IL-12 Conjugate as Immunotherapeutic Products for Human Cancers

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 an exclusive patent 
license to practice the inventions embodied in the following U.S. 
Patents and Patent Applications to Scion Cardio-vascular (``Scion'') 
located in Miami, FL, USA.

Intellectual Property

    1. U.S. Provisional Patent Application No. 60/846,481; filed 
September 22, 2006 entitled ``Methods and Compositions for the 
Treatment of Cancer'' [HHS Ref. No. E-311-2006/0-US-01];
    2. International Patent Application No. PCT/US2007/020540 filed 
September 21, 2007 entitled ``Compositions And Methods For Chitosan 
Enhanced Immune Response'' [HHS Ref. No. E-311-2006/1-PCT-01];
    3. European Patent Application No. 07838692.7 filed September 21, 
2007 entitled ``Compositions And Methods For Chitosan Enhanced Immune 
Response'' [HHS Ref. No. E-311-2006/1-EP-02]; and
    4. U.S. Patent Application No. 12/442,483 filed March 23, 2009 
entitled ``Compositions And Methods For Chitosan Enhanced Immune 
Response'' [HHS Ref. No. E-311-2006/1-US-03].
    The patent rights in these inventions have been assigned to the 
government of the United States of America.
    The prospective exclusive license territory may be worldwide and 
the field of use will be limited to the use of Licensed Patent Rights 
for development of Chitosan/IL-12 conjugates as immunotherapeutic 
products for human cancers. Please note that the Field of Use is 
limited to the use of Chitosan with IL-12 only and does not include the 
use of the Chitosan with any other antigen. Additionally, the Field of 
Use may be limited to certain cancer indications.

DATES: Only written comments and/or applications for a license which 
are received by the NIH Office of Technology Transfer on or before 
December 26, 2013 will be considered.

ADDRESSES: Requests for copies of the patent application, inquiries, 

[[Page 70309]]

comments relating to the contemplated exclusive license should be 
directed to: Sabarni K. Chatterjee, Ph.D., M.B.A. 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) 435-5587; Facsimile: (301) 
435-4013; Email: [email protected].

SUPPLEMENTARY INFORMATION: The technology describes the use of chitosan 
depots with appropriate antigens and/or cytokines for generating an 
immune response in a subject. Such depots are made by mixing one or 
more antigens and/or cytokines with chitosan or a chitosan derivative. 
Similar compositions are described wherein chitosan or a derivative 
forms a micro- or nanoparticle, which have resulted in a more 
immunogenic presentation of antigen compared to antigen in solution. 
Using a representative antigen, the inventors showed that mice 
vaccinated with the subject depots had increased humoral and cellular 
immune responses compared to mice vaccinated with antigen alone. 
Furthermore, comparative mouse studies showed the antigen-specific 
immune response generated with chitosan depots of this invention to be 
equipotent to incomplete Freund's adjuvant (IFA) and superior to 
aluminum hydroxide, a widely used adjuvant for licensed and routinely 
administered vaccines. Thus, this technology improves upon commonly 
used adjuvant technology and is widely applicable.
    This technology is the first to show that subcutaneous 
administrations of chitosan and an appropriate antigen, with no other 
component, can be used for enhancing immune responses. In additional 
studies, the inventors showed that chitosan is able to maintain a depot 
of recombinant cytokine. A single subcutaneous injection of chitosan-
cytokine outperforms daily injections of recombinant cytokine in both 
the expansion of draining lymph nodes and in the antigen presenting 
ability of lymph node cells. This technology is the first to show that 
chitosan can maintain a depot of cytokine which results in a 
significant enhancement of the functional effects of a cytokine. This 
technology can be used for vaccines and immunotherapies against various 
infectious agents and cancer.
    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 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 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: November 18, 2013.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2013-28119 Filed 11-22-13; 8:45 am]