Prospective Grant of Exclusive License: Secreted Frizzled Related Protein-1 (sFRP-1) and derivatives thereof and their Use In Therapeutic Applications, 63316-63317 [2011-26343]

Download as PDF 63316 Federal Register / Vol. 76, No. 197 / Wednesday, October 12, 2011 / Notices and Hematology Research, National Institutes of Health, HHS) DEPARTMENT OF HEALTH AND HUMAN SERVICES Dated: October 4, 2011. Jennifer S. Spaeth, Director, Office of Federal Advisory Committee Policy. 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 [FR Doc. 2011–26215 Filed 10–11–11; 8:45 am] BILLING CODE 4140–01–P National Institutes of Health, Public Health Service, HHS. ACTION: Notice. AGENCY: This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR SUMMARY: Filing date or international filing date Status Publication or patent number Abandoned ......................................................... Abandoned ......................................................... Issued ................................................................ Issued ................................................................ Expired ............................................................... Issued ................................................................ Issued ................................................................ Issued ................................................................ Pending .............................................................. Abandoned ......................................................... Expired ............................................................... Issued ................................................................ Pending .............................................................. Issued ................................................................ Pending .............................................................. Pending .............................................................. Issued ................................................................ Issued ................................................................ Issued ................................................................ N/A N/A 6,479,255 7,183,377 WO 98/54325 6,600,018 7,223,853 7,947,651 N/A N/A WO 02/055547 7,488,710 20080145884 A1 2002241859 2,434,672 1387854 A2 4029041 4248583 4248600 Country 60/050,417 ......................................................... 60/050,495 ......................................................... 09/087,031 ......................................................... 10/138,434 ......................................................... PCT/US98/10974 ............................................... 09/546,043 ......................................................... 10/425,586 ......................................................... 11/748,872 ......................................................... 13/031,060 ......................................................... 60/260,908 ......................................................... PCT/US02/00869 ............................................... 10/466,136 ......................................................... 12/019,567 ......................................................... 2002241859 ....................................................... 2,434,672 ........................................................... 02 707454.1 ....................................................... 2002–556615 ..................................................... 2007–120533 ..................................................... 2008–169716 ..................................................... jlentini on DSK4TPTVN1PROD with NOTICES Patent application number US ...... US ...... US ...... US ...... PCT .... US ...... US ...... US ...... US ...... US ...... PCT .... US ...... US ...... AU ...... CA ...... EP ...... JP ....... JP ....... JP ....... 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: ruckersu@mail.nih.gov. VerDate Mar<15>2010 17:43 Oct 11, 2011 Jkt 226001 5/29/1997 6/23/1997 5/29/1998 5/3/2002 5/29/1998 4/10/2000 4/28/2003 5/15/2007 2/18/2011 1/10/2001 1/10/2002 7/10/2003 1/24/2008 1/10/2002 1/10/2002 1/10/2002 1/10/2002 1/10/2002 1/10/2002 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 SUPPLEMENTARY INFORMATION: PO 00000 Frm 00039 Fmt 4703 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: Sfmt 4703 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. E:\FR\FM\12OCN1.SGM 12OCN1 Federal Register / Vol. 76, No. 197 / Wednesday, October 12, 2011 / Notices 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 National Institutes of Health Prospective Grant of Exclusive License: The Development of Human Anti-Mesothelin Monoclonal Antibodies for the Treatment of Human Cancers National Institutes of Health, Public Health Service, HHS. ACTION: Notice. AGENCY: 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 U.S. Patent Application 61/040,005 entitled ‘‘Human Monoclonal Antibodies Specific for Mesothelin’’ [HHS Ref. E–079–2008/0– US–01], PCT Application PCT/US2009/ 038228 entitled ‘‘Human Monoclonal Antibody Against Mesothelin’’ [HHS Ref. E–079–2008/0–PCT–02], Australian patent application AU 2009228361 entitled ‘‘Human Monoclonal Antibody Against Mesothelin’’ [HHS Ref. E–079– 2008/0–AU–03], Canadian patent application CA 2718321 entitled ‘‘Human Anti-Mesothelin Monoclonal Antibodies’’ [HHS Ref. E–079–2008/0– CA–04], European patent application EP 09726082.2 entitled ‘‘Human Monoclonal Antibody Against Mesothelin’’ [HHS Ref. E–079–2008/0– EP–05], U.S. patent application 12/934,060 entitled ‘‘Human AntiMesothelin Monoclonal Antibodies ’’ [HHS Ref. E–079–2008/0–US–06], and all related continuing and foreign patents/patent applications for the technology family, to Sanomab, Ltd. The patent rights in these inventions have been assigned to and/or exclusively licensed to the Government of the United States of America. The prospective exclusive license territory may be worldwide, and the field of use may be limited to: jlentini on DSK4TPTVN1PROD with NOTICES The use of the monoclonal antibody m912 (SM–101) as an antibody therapy for the treatment of pancreatic cancer, ovarian cancer, lung cancer, mesothelioma, and stomach/gastric cancer. The Licensed Field of Use explicitly excludes the use of the Jkt 226001 Requests for copies of the patent application, inquiries, comments, and other materials relating to the contemplated exclusive license should be directed to: David A. Lambertson, Ph.D., Senior Licensing and Patenting Manager, Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852–3804; Telephone: (301) 435–4632; Facsimile: (301) 402– 0220; E-mail: lambertsond@od.nih.gov. This invention concerns a monoclonal antibody and methods of using the antibody for the treatment of mesothelin-expressing cancers, including mesothelioma, lung cancer, stomach/gastric cancer, ovarian cancer and pancreatic cancer. The specific antibody covered by this technology is designated m912 (SM–101), which is a fully human monoclonal antibody against mesothelin. Mesothelin is a cell surface antigen that is preferentially expressed on certain types of cancer cells. The m912 antibody can selectively bind to these cancer cells and induce cell death while leaving healthy, essential cells unharmed. This can result in an effective therapeutic strategy with fewer side effects due to less non-specific killing of cells.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 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 within thirty (30) days from the date of this published notice. Complete 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. SUPPLEMENTARY INFORMATION: SUMMARY: 17:43 Oct 11, 2011 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. DATES: Dated: October 4, 2011. Richard U. Rodriguez, Director, Division of Technology Development & Transfer, Office of Technology Transfer, National Institutes of Health. [FR Doc. 2011–26342 Filed 10–11–11; 8:45 am] BILLING CODE 4140–01–P ADDRESSES: DEPARTMENT OF HEALTH AND HUMAN SERVICES VerDate Mar<15>2010 antibody in the form of an immunoconjugate, including, but not limited to, immunotoxins. 63317 PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 DEPARTMENT OF HOMELAND SECURITY Federal Emergency Management Agency [Internal Agency Docket No. FEMA–4031– DR; Docket ID FEMA–2011–0001] New York; Major Disaster and Related Determinations Federal Emergency Management Agency, DHS. ACTION: Notice. AGENCY: This is a notice of the Presidential declaration of a major disaster for the State of New York (FEMA–4031–DR), dated September 13, 2011, and related determinations. DATES: Effective Date: September 13, 2011. FOR FURTHER INFORMATION CONTACT: Peggy Miller, Office of Response and Recovery, Federal Emergency Management Agency, 500 C Street, SW., Washington, DC 20472, (202) 646–3886. SUPPLEMENTARY INFORMATION: Notice is hereby given that, in a letter dated September 13, 2011, the President issued a major disaster declaration under the authority of the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121 et seq. (the ‘‘Stafford Act’’), as follows: SUMMARY: I have determined that the damage in certain areas of the State of New York resulting from the Remnants of Tropical Storm Lee beginning on September 7, 2011, and continuing, is of sufficient severity and magnitude to warrant a major disaster declaration under the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121 et seq. (the ‘‘Stafford Act’’). Therefore, I declare that such a major disaster exists in the State of New York. In order to provide Federal assistance, you are hereby authorized to allocate from funds available for these purposes such amounts as you find necessary for Federal disaster assistance and administrative expenses. You are authorized to provide Individual Assistance in the designated areas and Hazard Mitigation throughout the State. Consistent with the requirement that Federal assistance is supplemental, any Federal funds provided under the Stafford Act for Hazard Mitigation and Other Needs Assistance will be limited to 75 percent of the total eligible costs. Further, you are authorized to make changes to this declaration for the approved E:\FR\FM\12OCN1.SGM 12OCN1

Agencies

[Federal Register Volume 76, Number 197 (Wednesday, October 12, 2011)]
[Notices]
[Pages 63316-63317]
From the Federal Register Online via the Government Printing 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.

-----------------------------------------------------------------------

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: ruckersu@mail.nih.gov.

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

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