[Federal Register Volume 76, Number 197 (Wednesday, October 12, 2011)]
[Notices]
[Pages 63316-63317]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-26343]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: Secreted Frizzled Related 
Protein-1 (sFRP-1) and derivatives thereof and their Use In Therapeutic 
Applications

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 patent license to practice the inventions embodied in the 
patents and patent applications belonging to the patent families having 
HHS Reference Numbers E-160-1997/0,/1,/2 and/3; E-014-2000/0; and E-
060-2000/0, and/1. Specific details regarding the individual patents or 
patent applications which belong to these patent families are set forth 
in the table below:

----------------------------------------------------------------------------------------------------------------
                                                  Filing date or
    Patent application number         Country      international         Status          Publication or patent
                                                    filing date                                  number
----------------------------------------------------------------------------------------------------------------
60/050,417.......................  US...........       5/29/1997  Abandoned..........  N/A
60/050,495.......................  US...........       6/23/1997  Abandoned..........  N/A
09/087,031.......................  US...........       5/29/1998  Issued.............  6,479,255
10/138,434.......................  US...........        5/3/2002  Issued.............  7,183,377
PCT/US98/10974...................  PCT..........       5/29/1998  Expired............  WO 98/54325
09/546,043.......................  US...........       4/10/2000  Issued.............  6,600,018
10/425,586.......................  US...........       4/28/2003  Issued.............  7,223,853
11/748,872.......................  US...........       5/15/2007  Issued.............  7,947,651
13/031,060.......................  US...........       2/18/2011  Pending............  N/A
60/260,908.......................  US...........       1/10/2001  Abandoned..........  N/A
PCT/US02/00869...................  PCT..........       1/10/2002  Expired............  WO 02/055547
10/466,136.......................  US...........       7/10/2003  Issued.............  7,488,710
12/019,567.......................  US...........       1/24/2008  Pending............  20080145884 A1
2002241859.......................  AU...........       1/10/2002  Issued.............  2002241859
2,434,672........................  CA...........       1/10/2002  Pending............  2,434,672
02 707454.1......................  EP...........       1/10/2002  Pending............  1387854 A2
2002-556615......................  JP...........       1/10/2002  Issued.............  4029041
2007-120533......................  JP...........       1/10/2002  Issued.............  4248583
2008-169716......................  JP...........       1/10/2002  Issued.............  4248600
----------------------------------------------------------------------------------------------------------------

    to Achelois BioSciences, Inc., a Delaware corporation having a 
place of business in Lexington, Massachusetts. The patent rights in 
these inventions have been assigned to the United States of America. In 
addition, the all of the rights associated with applications 09/
546,043; 10/425,586; 11/748,872 and 13/031,060 are exclusively licensed 
to HHS by the co-owner the University of Massachusetts.
    The prospective exclusive license territory may be ``worldwide'', 
and the field of use may be limited to ``use of sFRP-1 and derivatives 
thereof in the treatment of human disease.''

DATES: Only written comments and/or applications for a license which 
are received by the NIH Office of Technology Transfer on or before 
November 14, 2011 will be considered.

ADDRESSES: Requests for copies of the patent applications, inquiries, 
comments, and other materials relating to the contemplated exclusive 
license should be directed to: Susan S. Rucker, JD, CLP, Senior Advisor 
for Intellectual Property Transactions, Office of Technology Transfer, 
National Institutes of Health, 6011 Executive Boulevard, Suite 325, 
Rockville, MD 20852-3804; Telephone: (301) 435-4478; Facsimile: (301) 
402-0220; E-mail: [email protected].

SUPPLEMENTARY INFORMATION: The technology encompassed by the patents 
and/or patent applications (IP) to be included in this exclusive 
license relates to a protein designated secreted Frizzled Related 
Protein-1 (sFRP-1). sFRP-1, also known as SARP-2 (Secreted Apoptosis 
Related Protein-2). The IP covers various sFRP-1 compositions and uses 
thereof.
    sFRP-1 is associated with Wnt signaling which has been implicated 
in a number of different processes including fibrosis (see, Hwang, I et 
al. Arch Pharm Res 32(12): 1653-62 (2009)) and bone remodeling (see, 
Hausler KD et al J Bone Miner Res 19(11) 1873-81 (Nov 2004). In 
addition, hypermethylation of the sFRP-1 promoter region, which leads 
to a loss of function and decreased sFRP-1 protein expression, has been 
linked to a number of cancers, including gastric cancer, esophageal 
adenocarcinoma, bladder cancer and head and neck squamous cell 
carcinoma (HNSCC).
    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.


[[Page 63317]]


    Dated: October 4, 2011.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2011-26343 Filed 10-11-11; 8:45 am]
BILLING CODE 4140-01-P