2011-26343. 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.

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:

Patent application number	Country	Filing date or international filing date	Status	Publication or patent 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: [phone]; Facsimile: [phone]; E-mail: [e-mail].

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 s ecreted F rizzled R elated P rotein-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.

Dated: October 4, 2011.

Richard U. Rodriguez,

Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health.