Prospective Grant of Exclusive License: Development of V-ATPase Inhibitor Compounds for the Treatment of Human Cancers and Osteoclastic Bone Diseases Excluding Rheumatoid Arthritis and Other Osteo-Specific Auto-Immune Diseases, 1798-1799 [2010-420]
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1798
Federal Register / Vol. 75, No. 8 / Wednesday, January 13, 2010 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive
License: Development of V–ATPase
Inhibitor Compounds for the Treatment
of Human Cancers and Osteoclastic
Bone Diseases Excluding Rheumatoid
Arthritis and Other Osteo-Specific
Auto-Immune Diseases
AGENCY: National Institutes of Health,
Public Health Service, HHS.
ACTION: Notice.
srobinson on DSKHWCL6B1PROD with NOTICES
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 following U.S. Patents
and Patent Applications to the
Australian Institute of Marine Science
(‘‘AIMS’’) located in Townsville,
Queensland, Australia.
Intellectual Property
• U.S. Provisional Patent Application
No. 60/398,092 filed July 24, 2002
entitled ‘‘Chondropsin-Class Antitumor
V–ATPase Inhibitor Compounds,
Compositions and Methods of Use
Thereof’’ [HHS Ref. No. E–191–2002/0–
US–01];
• International Patent Application
No. PCT/US03/23290 filed July 24, 2003
entitled ‘‘Chondropsin-Class Antitumor
V–ATPase Inhibitor Compounds,
Compositions and Methods of Use
Thereof’’ [HHS Ref. No. E–191–2002/0–
PCT–02];
• U.S. Patent Application No. 10/
521,930 filed April 18, 2005 entitled
‘‘Chondropsin-Class Antitumor V–
ATPase Inhibitor Compounds,
Compositions and Methods of Use
Thereof’’ [HHS Ref. No. E–191–2002/0–
US–03];
• European Patent Application No.
03751813.1 filed February 16, 2005
entitled ‘‘Chondropsin-Class Antitumor
V–ATPase Inhibitor Compounds,
Compositions and Methods of Use
Thereof’’ [HHS Ref. No. E–191–2002/0–
EP–04];
• Australian Patent Application No.
2003269924 filed February 4, 2005
entitled ‘‘Chondropsin-Class Antitumor
V–ATPase Inhibitor Compounds,
Compositions and Methods of Use
Thereof’’ [HHS Ref. No. E–191–2002/0–
AU–05];
• Canadian Patent Application No.
2493821 filed January 24, 2005 entitled
‘‘Chondropsin-Class Antitumor V–
ATPase Inhibitor Compounds,
VerDate Nov<24>2008
16:51 Jan 12, 2010
Jkt 220001
Compositions and Methods of Use
Thereof’’ [HHS Ref. No. E–191–2002/0–
CA–06];
• U.S. Patent No. 7,521,475 issued
April 21, 2009 entitled ‘‘ChondropsinClass Antitumor V–ATPase Inhibitor
Compounds, Compositions and
Methods of Use Thereof’’ [HHS Ref. No.
E–191–2002/0–US–07];
• U.S. Patent Application No. 12/
402,560 filed March 12, 2009 entitled
‘‘Chondropsin-Class Antitumor V–
ATPase Inhibitor Compounds,
Compositions and Methods of Use
Thereof’’ [HHS Ref. No. E–191–2002/0–
US–08];
• U.S. Provisional Patent Application
No. 60/220,270 filed July 24, 2000
entitled ‘‘Biologically Active Macrolides,
Compositions, and Uses Thereof’’ [HHS
Ref. No. E–203–2000/0–US–01];
• International Patent Application
No. PCT/US01/23633 filed July 24, 2001
entitled ‘‘Biologically Active Macrolides,
Compositions, and Uses Thereof’’ [HHS
Ref. No. E–203–2000/0–PCT–02];
• US Patent No. 7,144,918 issued
December 5, 2006 entitled ‘‘Biologically
Active Macrolides, Compositions, and
Uses Thereof’’ [HHS Ref. No. E–203–
2000/0–US–04];
• US Patent Application No. 11/
435,189 filed May 16, 2006 entitled
‘‘Biologically Active Macrolides,
Compositions, and Uses Thereof’’ [HHS
Ref. No. E–203–2000/0–US–08];
• Australian Patent No. 200112808
issued November 30, 2006 entitled
‘‘Biologically Active Macrolides,
Compositions, and Uses Thereof’’ [HHS
Ref. No. E–203–2000/0–US–03];
• European Patent Application No.
01959257.5 filed July 24, 2001 entitled
‘‘Biologically Active Macrolides,
Compositions, and Uses Thereof’’ [HHS
Ref. No. E–203–2000/0–EP–05];
• Canadian Patent Application No.
2415611 filed July 24, 2001 entitled
‘‘Biologically Active Macrolides,
Compositions, and Uses Thereof’’ [HHS
Ref. No. E–203–2000/0–CA–06]; and
• Japanese Patent Application No.
514137/2002 filed July 24, 2001 entitled
‘‘Biologically Active Macrolides,
Compositions, and Uses Thereof’’ [HHS
Ref. No. E–203–2000/0–JP–07].
The patent rights in these inventions
have been assigned to the United States
of America.
The prospective exclusive license
territory may be worldwide and the
field of use may be for ‘‘use of Licensed
Patent Rights for use and development
of pharmaceutically suitable V–ATPase
Inhibitor compounds for the treatment
of human cancers, including
osteosarcoma, and osteoclastic bone
diseases, such as osteoporosis,
osteopenia and Paget’s disease, ’’ in ‘‘all’’
PO 00000
Frm 00051
Fmt 4703
Sfmt 4703
geographic territories. For avoidance of
doubt, the field of use will specifically
exclude rheumatoid arthritis and other
osteo-specific autoimmune diseases.
DATES: Only written comments and/or
applications for a license which are
received by the NIH Office of
Technology Transfer on or before
February 12, 2010 will be considered.
ADDRESSES: Requests for copies of the
patent application, inquiries, comments,
and other materials relating to the
contemplated exclusive license should
be directed to: Sabarni K. Chatterjee,
PhD Licensing and Patenting Associate,
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; e-mail: chatterjeesa@od.nih.gov.
SUPPLEMENTARY INFORMATION: The
technology describes the class of
Chondropsin compounds and its
derivatives. The compounds can be
potentially developed into new
therapeutics for cancer, osteoporosis,
and Alzheimer’s diseases.
Briefly, vacuolar type (H+) ATPase
(V–ATPase) has been described as ‘‘a
universal proton pump of eukaryotes’’.
V–ATPase is responsible for
maintaining internal acidity and is
important in myriad of physiological
functions, such as sorting of membrane
proteins, proinsulin conversion,
neurotransmitter uptake, and cellular
degradation process. This technology
describes a new chondropsin,
Poecillastrin-A, a cytotoxic, 33-member
ring, macrolide lactam, isolated from the
sponge Poecillastra sp. It is structurally
related to the chondropsin class of
macrolide lactams. However, it
possesses unique patterns of
methylation and oxygenation, and it is
the first member of this family of
polyketide derivatives with a 33membered macrocyclic ring. The in
vitro anti-tumor activity of the
compound is comparable to that of the
chondropsins, however the new
structural features found in
Poecillastrin-A broaden the known
structural diversity of this family of
potent anti-proliferative and cytotoxic
macrolide lantams. The chondropsins
and poecillastrin A produce a
distinctive pattern of differential
cytotoxicity in the NCI’s 60 cell
antitumor screen that directly correlates
with selective V–ATPase inhibitors.
This class of compounds and its’
derivatives have the potential of being
used as a therapeutics against several
cancer types and may have applicability
as highly selective anti-cancer small
molecule inhibitors. Additionally, it has
E:\FR\FM\13JAN1.SGM
13JAN1
Federal Register / Vol. 75, No. 8 / Wednesday, January 13, 2010 / Notices
the potential of being used for the
treatment of several other diseases such
as osteoporosis, and Alzheimer’s
diseases.
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: December 29, 2009.
Richard U. Rodriguez,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. 2010–420 Filed 1–12–10; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HOMELAND
SECURITY
U.S. Customs and Border Protection
Agency Information Collection
Activities: Accreditation of Commercial
Laboratories and Approval of
Commercial Gaugers
U.S. Customs and Border
Protection, Department of Homeland
Security.
ACTION: 30-Day notice and request for
comments; Extension of an existing
information collection: 1651–0053.
srobinson on DSKHWCL6B1PROD with NOTICES
AGENCY:
SUMMARY: U.S. Customs and Border
Protection (CBP) of the Department of
Homeland Security has submitted the
following information collection request
to the Office of Management and Budget
(OMB) for review and approval in
accordance with the Paperwork
Reduction Act: Accreditation of
Commercial Laboratories and Approval
of Commercial Gaugers. This is a
proposed extension of an information
collection that was previously
approved. CBP is proposing that this
information collection be extended with
no change to the burden hours. This
document is published to obtain
comments from the public and affected
VerDate Nov<24>2008
16:51 Jan 12, 2010
Jkt 220001
agencies. This proposed information
collection was previously published in
the Federal Register (74 FR 58036) on
November 10, 2009, allowing for a 60day comment period. This notice allows
for an additional 30 days for public
comments. This process is conducted in
accordance with 5 CFR 1320.10.
DATES: Written comments should be
received on or before February 12, 2010.
ADDRESSES: Interested persons are
invited to submit written comments on
this proposed information collection to
the Office of Information and Regulatory
Affairs, Office of Management and
Budget. Comments should be addressed
to the OMB Desk Officer for Customs
and Border Protection, Department of
Homeland Security, and sent via
electronic mail to
oira_submission@omb.eop.gov or faxed
to (202) 395–5806.
SUPPLEMENTARY INFORMATION: U.S.
Customs and Border Protection (CBP)
encourages the general public and
affected Federal agencies to submit
written comments and suggestions on
proposed and/or continuing information
collection requests pursuant to the
Paperwork Reduction Act (Pub. L. 104–
13). Your comments should address one
of the following four points:
(1) Evaluate whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency/component,
including whether the information will
have practical utility;
(2) Evaluate the accuracy of the
agencies/components estimate of the
burden of The proposed collection of
information, including the validity of
the methodology and assumptions used;
(3) Enhance the quality, utility, and
clarity of the information to be
collected; and
(4) Minimize the burden of the
collections of information on those who
are to respond, including the use of
appropriate automated, electronic,
mechanical, or other technological
techniques or other forms of
information.
Title: Accreditation of Commercial
Laboratories and Approval of
Commercial Gaugers.
OMB Number: 1651–0053.
Form Number: None.
Abstract: Commercial gaugers and
laboratories seeking accreditation or
approval must provide the information
specified in 19 CFR 151.12 and/or 19
CFR 151.13 to CBP. CBP uses this
information in deciding whether to
approve individuals or businesses
desiring to measure bulk products or to
analyze importations
Current Actions: There are no changes
to the information collection. This
PO 00000
Frm 00052
Fmt 4703
Sfmt 4703
1799
submission is being made to extend the
expiration date.
Type of Review: Extension (without
change).
Affected Public: Businesses,
Individuals.
Reporting
Estimated Number of Respondents:
200.
Estimated Number of Responses per
Respondent: 1.
Estimated Number of Total
Responses: 200.
Estimated Time per Response: 75
minutes.
Estimated Total Burden Hours: 250.
Recordkeeping
Estimated Number of Recordkeepers:
200.
Estimated Time per Recordkeeper: 60
minutes.
Estimated Total Burden Hours: 200.
If additional information is required
contact: Tracey Denning, U.S. Customs
and Border Protection, Office of
Regulations and Rulings, 799 9th Street,
NW., 7th Floor, Washington, DC 20229–
1177, at 202–325–0265.
Dated: January 7, 2009.
Tracey Denning,
Agency Clearance Officer, U.S. Customs and
Border Protection.
[FR Doc. 2010–464 Filed 1–12–10; 8:45 am]
BILLING CODE 9111–14–P
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
[Docket No. USCG–2009–0299]
Terminate Long Range Aids to
Navigation (Loran-C) Signal
U.S. Coast Guard, DHS.
Notice; correction.
AGENCY:
ACTION:
SUMMARY: The Coast Guard is correcting
a notice that appeared in the Federal
Register of January 7, 2010 (75 FR 998).
The document announced termination
of the Long Range Aids to Navigation
(Loran-C) Signal commencing on or
about February 8, 2010. The document
had an incorrect word in the DATES
section.
DATES:
Effective January 13, 2010.
If
you have questions on this notice,
contact Mr. Mike Sollosi, U.S. Coast
Guard, Department of Homeland
Security, telephone (202) 372–1545,
Mike.M.Sollosi@uscg.mil.
FOR FURTHER INFORMATION CONTACT:
In the
Federal Register of January 7, 2010, in
SUPPLEMENTARY INFORMATION:
E:\FR\FM\13JAN1.SGM
13JAN1
]]>Agencies
[Federal Register Volume 75, Number 8 (Wednesday, January 13, 2010)]
[Notices]
[Pages 1798-1799]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-420]
[[Page 1798]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive License: Development of V-ATPase
Inhibitor Compounds for the Treatment of Human Cancers and Osteoclastic
Bone Diseases Excluding Rheumatoid Arthritis and Other Osteo-Specific
Auto-Immune Diseases
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
following U.S. Patents and Patent Applications to the Australian
Institute of Marine Science (``AIMS'') located in Townsville,
Queensland, Australia.
Intellectual Property
U.S. Provisional Patent Application No. 60/398,092 filed
July 24, 2002 entitled ``Chondropsin-Class Antitumor V-ATPase Inhibitor
Compounds, Compositions and Methods of Use Thereof'' [HHS Ref. No. E-
191-2002/0-US-01];
International Patent Application No. PCT/US03/23290 filed
July 24, 2003 entitled ``Chondropsin-Class Antitumor V-ATPase Inhibitor
Compounds, Compositions and Methods of Use Thereof'' [HHS Ref. No. E-
191-2002/0-PCT-02];
U.S. Patent Application No. 10/521,930 filed April 18,
2005 entitled ``Chondropsin-Class Antitumor V-ATPase Inhibitor
Compounds, Compositions and Methods of Use Thereof'' [HHS Ref. No. E-
191-2002/0-US-03];
European Patent Application No. 03751813.1 filed February
16, 2005 entitled ``Chondropsin-Class Antitumor V-ATPase Inhibitor
Compounds, Compositions and Methods of Use Thereof'' [HHS Ref. No. E-
191-2002/0-EP-04];
Australian Patent Application No. 2003269924 filed
February 4, 2005 entitled ``Chondropsin-Class Antitumor V-ATPase
Inhibitor Compounds, Compositions and Methods of Use Thereof'' [HHS
Ref. No. E-191-2002/0-AU-05];
Canadian Patent Application No. 2493821 filed January 24,
2005 entitled ``Chondropsin-Class Antitumor V-ATPase Inhibitor
Compounds, Compositions and Methods of Use Thereof'' [HHS Ref. No. E-
191-2002/0-CA-06];
U.S. Patent No. 7,521,475 issued April 21, 2009 entitled
``Chondropsin-Class Antitumor V-ATPase Inhibitor Compounds,
Compositions and Methods of Use Thereof'' [HHS Ref. No. E-191-2002/0-
US-07];
U.S. Patent Application No. 12/402,560 filed March 12,
2009 entitled ``Chondropsin-Class Antitumor V-ATPase Inhibitor
Compounds, Compositions and Methods of Use Thereof'' [HHS Ref. No. E-
191-2002/0-US-08];
U.S. Provisional Patent Application No. 60/220,270 filed
July 24, 2000 entitled ``Biologically Active Macrolides, Compositions,
and Uses Thereof'' [HHS Ref. No. E-203-2000/0-US-01];
International Patent Application No. PCT/US01/23633 filed
July 24, 2001 entitled ``Biologically Active Macrolides, Compositions,
and Uses Thereof'' [HHS Ref. No. E-203-2000/0-PCT-02];
US Patent No. 7,144,918 issued December 5, 2006 entitled
``Biologically Active Macrolides, Compositions, and Uses Thereof'' [HHS
Ref. No. E-203-2000/0-US-04];
US Patent Application No. 11/435,189 filed May 16, 2006
entitled ``Biologically Active Macrolides, Compositions, and Uses
Thereof'' [HHS Ref. No. E-203-2000/0-US-08];
Australian Patent No. 200112808 issued November 30, 2006
entitled ``Biologically Active Macrolides, Compositions, and Uses
Thereof'' [HHS Ref. No. E-203-2000/0-US-03];
European Patent Application No. 01959257.5 filed July 24,
2001 entitled ``Biologically Active Macrolides, Compositions, and Uses
Thereof'' [HHS Ref. No. E-203-2000/0-EP-05];
Canadian Patent Application No. 2415611 filed July 24,
2001 entitled ``Biologically Active Macrolides, Compositions, and Uses
Thereof'' [HHS Ref. No. E-203-2000/0-CA-06]; and
Japanese Patent Application No. 514137/2002 filed July 24,
2001 entitled ``Biologically Active Macrolides, Compositions, and Uses
Thereof'' [HHS Ref. No. E-203-2000/0-JP-07].
The patent rights in these inventions have been assigned to the
United States of America.
The prospective exclusive license territory may be worldwide and
the field of use may be for ``use of Licensed Patent Rights for use and
development of pharmaceutically suitable V-ATPase Inhibitor compounds
for the treatment of human cancers, including osteosarcoma, and
osteoclastic bone diseases, such as osteoporosis, osteopenia and
Paget's disease, '' in ``all'' geographic territories. For avoidance of
doubt, the field of use will specifically exclude rheumatoid arthritis
and other osteo-specific autoimmune diseases.
DATES: Only written comments and/or applications for a license which
are received by the NIH Office of Technology Transfer on or before
February 12, 2010 will be considered.
ADDRESSES: Requests for copies of the patent application, inquiries,
comments, and other materials relating to the contemplated exclusive
license should be directed to: Sabarni K. Chatterjee, PhD Licensing and
Patenting Associate, 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; e-mail: chatterjeesa@od.nih.gov.
SUPPLEMENTARY INFORMATION: The technology describes the class of
Chondropsin compounds and its derivatives. The compounds can be
potentially developed into new therapeutics for cancer, osteoporosis,
and Alzheimer's diseases.
Briefly, vacuolar type (H+) ATPase (V-ATPase) has been described as
``a universal proton pump of eukaryotes''. V-ATPase is responsible for
maintaining internal acidity and is important in myriad of
physiological functions, such as sorting of membrane proteins,
proinsulin conversion, neurotransmitter uptake, and cellular
degradation process. This technology describes a new chondropsin,
Poecillastrin-A, a cytotoxic, 33-member ring, macrolide lactam,
isolated from the sponge Poecillastra sp. It is structurally related to
the chondropsin class of macrolide lactams. However, it possesses
unique patterns of methylation and oxygenation, and it is the first
member of this family of polyketide derivatives with a 33-membered
macrocyclic ring. The in vitro anti-tumor activity of the compound is
comparable to that of the chondropsins, however the new structural
features found in Poecillastrin-A broaden the known structural
diversity of this family of potent anti-proliferative and cytotoxic
macrolide lantams. The chondropsins and poecillastrin A produce a
distinctive pattern of differential cytotoxicity in the NCI's 60 cell
antitumor screen that directly correlates with selective V-ATPase
inhibitors.
This class of compounds and its' derivatives have the potential of
being used as a therapeutics against several cancer types and may have
applicability as highly selective anti-cancer small molecule
inhibitors. Additionally, it has
[[Page 1799]]
the potential of being used for the treatment of several other diseases
such as osteoporosis, and Alzheimer's diseases.
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: December 29, 2009.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. 2010-420 Filed 1-12-10; 8:45 am]
BILLING CODE 4140-01-P
