Prospective Grant of Exclusive License: Development of PANVACTM, 31864-31866 [2012-13006]
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31864
Federal Register / Vol. 77, No. 104 / Wednesday, May 30, 2012 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive
License: Development of PANVACTM
and Tumor Associated Antigens as
Colorectal Cancer Vaccine
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 the following U.S. Patents
and Patent Applications to Bavarian
Nordic Immunotherapeutics (‘‘BNIT’’)
located in Mountain View, CA, USA.
SUMMARY:
srobinson on DSK4SPTVN1PROD with NOTICES
Intellectual Property
Group I—Exclusive Licensed Patent
Rights
1. U.S. Patent Application No. 60/
061,589 filed October 10, 1997 as well
as all issued and pending foreign
counterparts [HHS Ref. No. E–099–
1996/0–US–01];
2. PCT Patent Application No. PCT/
US1998/19794 filed September 22, 1998
as well as all issued and pending foreign
counterparts [HHS Ref. No. E–099–
1996/0–PCT–02];
3. U.S. Patent No. 6,756,038 issued
June 29, 2004 as well as issued and
pending foreign counterparts [HHS Ref.
No. E–099–1996/0–US–07];
4. U.S. Patent No. 7,723,096 issued
May 25, 2010 as well as continuation
and divisional applications, and issued
and pending foreign counterparts [HHS
Ref. No. E–099–1996/0–US–08];
5. European Patent No. lOI7810 [HHS
Ref. No. E–099–1996/0–EP–05], and all
European contracting states in which
this patent is validated;
6. European Patent Application No.
04011673.3 (now EP Patent No.
1447414) [HHS Ref. No. E–099–1996/0–
EP–17], and all European contracting
states in which this patent is validated,
Japan Patent Application No. 2000–
516030 (now JP Patent No. 4291508)
[HHS Ref. No. E–099–1996/0–JP–06],
and all continuations and divisional
applications claiming priority to this
application;
7. Australia Patent No. 745863 [HHS
Ref. No. E–099–1996/0–AU–03], and all
continuations and divisional
applications claiming priority to this
application;
8. Canada Patent No. 2308127 [HHS
Ref. No. E–099–1996/0–CA–04], and all
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continuations and divisional
applications claiming priority to this
application;
9. PCT Patent Application No. PCT/
US1992/03843 filed May 6, 1992 as well
as all issued and pending foreign
counterparts [HHS Ref. No. E–200–
1990/2–PCT–01];
10. U.S. Patent No. 5,698,530 issued
December 6, 1997 as well as issued and
pending foreign counterparts [HHS Ref.
No. E–200–1990/1–US–02];
11. Australian Patent No. 674492
issued April 22, 1997 [HHS Ref. No. E–
200–1990/2–AU–02]; Europe Patent No.
0584266 issued September 3, 2003 [HHS
Ref. No. E–200–1990/2–EP–04]; Japan
Patent No. 3399943 issued February 21,
2003 [HHS Ref. No. E–200–1990/2–JP–
05]; and Canada Patent No. 2102623
issued April 22, 2003 [HHS Ref. No. E–
200–1990/2–CA–03];
12. U.S. Patent No. 6,001,349 issued
14 Dec. 1999 as well as issued and
pending foreign counterparts [HHS Ref.
No. E–200–1990/3–US–01];
13. U.S. Patent Application No. 60/
519,354 filed November 12, 2003 as well
as all issued and pending foreign
counterparts [HHS Ref. No. E–087–
2005/0–US–01];
14. U.S. Patent Application No. 10/
579,025 filed May 11, 2006 as well as
all continuation and divisional
applications, and issued and pending
foreign counterparts [E–0872005/0–US–
03];
15. U.S. Patent Application No. 60/
519,427 filed November 12, 2003 as well
as all issued and pending foreign
counterparts [HHS Ref. No. E–088–
2005/0–US–01];
16. U.S. Patent Application No. 10/
579,007 filed May 11, 2006 as well as
all continuation and divisional
applications, and issued and pending
foreign counterparts [HHS Ref. No. E–
088–2005/0–US–03];
17. U.S. Patent Application No. 60/
038,253 filed February 24, 1997 as well
as all issued and pending foreign
counterparts [HHS Ref. No. E–154–
1998/0–US–01];
18. PCT Patent Application No. PCT/
US1998/03693 filed February 24, 1998
as well as all issued and pending foreign
counterparts [HHS Ref. No. E–154–
1998/0–PCT–02];
19. U.S. Patent No. 7,118,738 issued
October 10, 2006 as well as all
continuations and divisional
applications, and issued and pending
foreign counterparts [HHS Ref. No. E–
154–1998/0–US–07];
20. PCT Patent Application No. PCT/
US1995/12638 filed October 2, 1995 as
well as all issued and pending foreign
counterparts [HHS Ref. No. E–259–
1994/2–PCT–01];
PO 00000
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21. PCT Patent Application No. PCT/
US1997/12203 filed July 15, 1997 as
well as all issued and pending foreign
counterparts [HHS Ref. No. E–259–
1994/3–PCT–02];
22. U.S. Patent Application No. 08/
686,280 filed July 25, 1996 as well as all
issued and pending foreign counterparts
[HHS Ref. No. E–259–1994/3–US–01];
23. U.S. Patent No. 7,410,644 issued
August 12, 2008 as well as all
continuation and divisional
applications, and issued and pending
foreign counterparts [HHS Ref. No. E–
259–1994/3–US–08];
24. PCT Patent Application No. PCT/
US1995/12624 filed October 2, 1995 as
well all issued and pending foreign
counterparts [HHS Ref. No. E–260–
1994/2–PCT–01];
25. U.S. Patent Nos. 6,893,869,
6,548,068 and 6,045,802 issued May 17,
2005, April 15, 2003 and April 4, 2000
respectively, as well as issued and
pending foreign counterparts [HHS Ref.
Nos. E–260–1994/1–US–03, US–02, US–
01]; U.S. Patent No. 7,368,116 issued
May 6, 2008 and U.S. Patent
Application No. 12/112,819, as well as
all continuation and divisional
applications [HHS Ref. Nos. E–260–
1994/1–US–04 and US–05];
26. Europe Patent Application No.
00102998.2 filed October 2, 1995,
Europe Patent No. 0784483 issued
November 29, 2001, Europe Patent
Application No. 09013495.8 filed
October 26, 2009, as well as all
continuation, and divisional
applications [HHS Ref. Nos. E–260–
1994/2–EP–15, EP–16 and EP–27]; Japan
Patent Application No. 512100/96 filed
October 2, 1995; Japan Patent No.
4078319 issued February 8, 2008 [HHS
Ref. No. E–260–1994/2–JP–25]; and
Japan Patent No. 4160612 issued July
25, 2008, as well as all continuation and
divisional applications; [HHS Ref. No.
E–260–1994/2–JP–21, JP–25 and JP–26];
Australia Patent No. 688606 issued July
2, 1998 [HHS Ref. No. E–260–1994/2–
AU–11]; Canada Patent No. 2201587
issued June 25, 2002 [HHS Ref. No. E–
260–1994/2–CA–12];
27. U.S. Patent Application No. 60/
211,717 filed June 15, 2000 as well as
all continuation and divisional
applications, and issued and pending
foreign counterparts [HHS Ref. No. E–
187–2000/0–US–01];
28. PCT Patent Application No. PCT/
US2001/19201 filed June 15, 2001 as
well all issued and pending foreign
counterparts [HHS Ref. No. E–187–
2000/0–PCT–02];
29. Canada Patent Application No.
2,412,050 filed June 15, 2001 [HHS Ref.
No. E–187–2000/0–CA–05]; Australia
Patent No. 2001268452 issued
E:\FR\FM\30MYN1.SGM
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srobinson on DSK4SPTVN1PROD with NOTICES
Federal Register / Vol. 77, No. 104 / Wednesday, May 30, 2012 / Notices
November 30, 2006 [HHS Ref. No. E–
187–2000/0–AU–06]; Japan Patent
Application No. 2002–510097 filed June
15, 2001 [HHS Ref. No. E–187–2000/0–
JP–07]; Hong Kong Patent Application
No. 03105975.5 filed June 15, 2001
[HHS Ref. No. E–187–2000/0–HK–08];
as well as all continuation and
divisional applications;
30. U.S. Patent Application No. 60/
776,506 filed February 24, 2006 as well
as all continuation and divisional
applications, and issued and pending
foreign counterparts [HHS Ref. No. E–
104–2006/0–US–01];
31. PCT Patent Application No. PCT/
US2007/004603 filed February 27, 2007
as well all issued and pending foreign
counterparts [HHS Ref. No. E–104–
2006/0–PCT–02];
32. U.S. Patent Application No. 12/
280,534 filed February 21, 2007 [HHS
Ref. No. E–104–2006/0–US–06];
Australia Patent Application No.
2007221255 filed February 21, 2007
[HHS Ref. No. E–104–2006/0–AU–03];
Europe Patent Application No.
07751371.1 filed February 21, 2007
[HHS Ref. No. E–104–2006/0–US–06];
filed February 21, 2007 [HHS Ref. No.
E–104–2006/0–EP–05]; Canada Patent
Application No. 2642994 filed February
21, 2007 [HHS Ref. No. E–104–2006/0–
CA–04]; as well as all continuation and
divisional applications.
33. U.S. Patent Application No. 60/
904,236 filed February 28, 2007 as well
as all continuation and divisional
applications, and issued and pending
foreign counterparts [HHS Ref. No. E–
074–2007/0–US–01];
34. PCT Patent Application No. PCT/
US2008/055185 filed February 28, 2008
as well all issued and pending foreign
counterparts [HHS Ref. No. E–074–
2007/0–PCT–02];
35. U.S. Patent Application No. 12/
528,796 filed August 26, 2009 [HHS Ref.
No. E–074–2007/0–US–07]; Australia
Patent Application No. 2008221383
filed February 27, 2008 [HHS Ref. No.
E–074–2007/0–AU–03]; Europe Patent
Application No. 08743578.0 filed
February 27, 2008 [HHS Ref. No. E–074–
2007/0–EP–05]; Canada Patent
Application No. 2,678,404 filed
February 27, 2008 [HHS Ref. No. E–074–
2007/0–CA–04]; Japan Patent
Application No. not yet assigned filed
February 27, 2008 [HHS Ref. No. E–074–
2007/0–JP–06] as well as all
continuation, divisional and pending
foreign counterpart applications.
Group II—Nonexclusive Licensed Patent
Rights
1. U.S. Patent Application No. 60/
111,582 filed December 9, 1998 as well
as all continuation and divisional
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applications, and issued and pending
foreign counterparts [HHS Ref. No. E–
256–1998/0–US–01];
2. PCT Patent Application No. PCT/
US1999/26866 filed November 12, 1999
as well all issued and pending foreign
counterparts [HHS Ref. No. E–256–
1998/0–PCT–02];
3. U.S. Patent No. 6,969,609 issued
November 29, 2005; U.S. Patent No.
7,211,432 issued May 1, 2007; U.S.
Patent Application No. 11/723,666 filed
March 21, 2007; as well as all
continuation and divisional
applications, and issued and pending
foreign counterparts [HHS Ref. No. E–
256–1998/0, 1];
4. U.S. Patent Application No. 60/
448,591 filed February 20, 2003 as well
as all continuation and divisional
applications, and issued and pending
foreign counterparts [HHS Ref. No. E–
028–2007/0–US–01];
5. PCT Patent Application No. PCT/
US2004/005077 filed February 20, 2004
as well all issued and pending foreign
counterparts [HHS Ref. No. E–028–
2007/0–PCT–02];
6. U.S. Patent Application Nos. 60/
448,591 and 10/543,944 filed February
20, 2003 and February 20, 2004
respectively, as well as all continuation
and divisional applications, and issued
and pending foreign counterparts [HHS
Ref. No. E–028–2007/0];
7. PCT Patent Application No. PCT/
US1998/003032 filed September 2, 1998
as well all issued and pending foreign
counterparts [HHS Ref. No. E–134–
2007/0–PCT–02];
8. U.S. Patent No. 6,699,475 issued
March 2, 2004, as well as all
continuation and divisional
applications, and issued and pending
foreign counterparts [HHS Ref. No. E–
134–2007/0];
9. PCT Patent Application No. PCT/
US1989/03701 filed August 25, 1989 as
well all issued and pending foreign
counterparts [HHS Ref. No. E–135–
2007/0–PCT–02];
10. U.S. Patent No. 5,093,258 issued
March 3, 1992, as well as all
continuation and divisional
applications, and issued and pending
foreign counterparts [HHS Ref. No. E–
135–2007/0];
11. PCT Patent Application No. PCT/
US1989/02486 filed June 7, 1989 as well
all issued and pending foreign
counterparts [HHS Ref. No. E–136–
2007/0–PCT–02];
12. U.S. Patent Application No. 07/
205,189 filed June 10, 1988, as well as
all continuation and divisional
applications, and issued and pending
foreign counterparts [HHS Ref. No. E–
136–2007];
PO 00000
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31865
13. U.S. Patent Application No. 60/
625,321 filed November 5, 2004 as well
as all continuation and divisional
applications, and issued and pending
foreign counterparts [HHS Ref. No. E–
138–2007/0–US–01];
14. PCT Patent Application No. PCT/
US2005/040170 filed November 4, 2005
as well all issued and pending foreign
counterparts [HHS Ref. No. E–138–
2007/0–PCT–02];
15. U.S. Patent Application No. 60/
625,321 filed November 5, 2004, as well
as all continuation and divisional
applications, and issued and pending
foreign counterparts [HHS Ref. No. E–
138–2007];
16. U.S. Patent Application No. 60/
678,329 filed May 5, 2005 as well as all
continuation and divisional
applications, and issued and pending
foreign counterparts [HHS Ref. No. E–
139–2007/0–US–01];
17. PCT Patent Application No. PCT/
US2006/017765 filed May 5, 2006 as
well all issued and pending foreign
counterparts [HHS Ref. No. E–139–
2007/0–PCT–02];
18. U.S. Patent Application No. 60/
678,329 filed May 5, 2005, as well as all
continuation and divisional
applications, and issued and pending
foreign counterparts [HHS Ref. No. E–
139–2007/0]; and
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 limited to the use
of Licensed Patent Rights for
development of therapeutics for human
colorectal cancer in all geographic
territories.’’ For the avoidance of doubt,
delivery formulations shall specifically
exclude canary poxvirus vectors,
NYVAC, non-viral eukaryotic
expression vectors and recombinant
yeast vectors.’’
DATES: Only written comments and/or
applications for a license which are
received by the NIH Office of
Technology Transfer on or before June
29, 2012 will be considered.
FOR FURTHER INFORMATION CONTACT:
Requests for copies of the patent
application, inquiries, and 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:
chatterjeesa@od.nih.gov.
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31866
Federal Register / Vol. 77, No. 104 / Wednesday, May 30, 2012 / Notices
Cancer
immunotherapy is a recent approach
where tumor associated antigens
(TAAs), which are primarily expressed
in human tumor cells, and not
expressed or minimally expressed in
normal tissues, are employed to
generate a tumor-specific immune
response. Specifically, these antigens
serve as targets for the host immune
system and elicit responses that result
in tumor destruction.
The initiation of an effective T-cell
immune response to antigens requires
two signals. The first one is antigenspecific via the peptide/major
histocompatibility complex and the
second or ‘‘costimulatory’’ signal is
required for cytokine production,
proliferation, and other aspects of T-cell
activation.
The patents and patent applications
describe a vaccine technology, TRICOM,
in conjunction with tumor associated
antigens (TAAs). The TRICOM
technology employs avirulent
poxviruses to present a combination of
costimulatory signaling molecules with
tumor-associated antigens (TAAs) to
activate T-cells and break the immune
systems tolerance towards cancer cells.
This is achieved using recombinant
poxvirus DNA vectors that encode both
T-cell costimulatory molecules and
TAAs. The combination of the three (3)
costimulatory molecules B7.1, ICAM–1
and LFA–3, hence the name TRICOM,
has been shown to have more than the
additive effect of each costimulatory
molecule when used individually to
optimally activate both CD4+ and CD8+
T cells. When a TRICOM based vaccine
expressing TAAs is administered it
greatly enhances the immune response
against the malignant cells expressing
those TAAs. The addition of the two
well-known TAAs, carcinoembryonic
antigen (CEA) and MUC–1 to the
TRICOM vector results in the PANVAC
vaccine, which is used in a prime and
boost vaccine strategy. It is well
established that the over-expression of
these two (2) TAAs are associated with
the presence of a variety of carcinomas;
including colorectal cancer and
therefore PANVAC can potentially be an
effective cancer vaccine for colorectal
cancer. Additionally, new tumor
associated antigens can also be used
with TRICOM to develop novel
vaccines. For example, Brachyury, well
known for its role in developmental cell
biology and recently been implicated in
tumor cell invasion and metastasis, has
been shown to be aberrantly expressed
in several tumors including colorectal
tumors. As a result, Brachyury is being
used as a tumor associated antigen along
with TRICOM and has potential as a
srobinson on DSK4SPTVN1PROD with NOTICES
SUPPLEMENTARY INFORMATION:
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cancer immunotherapeutic vaccine for
the treatment of several tumors
including colorectal 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 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: May 23, 2012.
Richard U. Rodriguez,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. 2012–13006 Filed 5–29–12; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HOMELAND
SECURITY
Transportation Security Administration
Intent To Request Approval From OMB
of One New Public Collection of
Information: Baseline Assessment for
Security Enhancement (BASE)
Program for Public Transportation
Systems
Transportation Security
Administration, DHS.
ACTION: 60-day Notice.
AGENCY:
The Transportation Security
Administration (TSA) invites public
comment on a new Information
Collection Request (ICR) abstracted
below that we will submit to the Office
of Management and Budget (OMB) for
approval in compliance with the
Paperwork Reduction Act (PRA). The
ICR describes the nature of the
information collection and its expected
burden. This voluntary collection
allows TSA to conduct transportation
security-related assessments during site
visits with security and operating
officials of transit agencies.
DATES: Send your comments by July 30,
2012.
ADDRESSES: Comments may be emailed
to TSAPRA@dhs.gov or delivered to the
SUMMARY:
PO 00000
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TSA PRA Officer, Office of Information
Technology (OIT), TSA–11,
Transportation Security Administration,
601 South 12th Street, Arlington, VA
20598–6011.
FOR FURTHER INFORMATION CONTACT:
Susan Perkins at the above address, or
by telephone (571) 227–3398.
SUPPLEMENTARY INFORMATION:
Comments Invited
In accordance with the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501
et seq.), an agency may not conduct or
sponsor, and a person is not required to
respond to, a collection of information
unless it displays a valid OMB control
number. The ICR documentation is
available at www.reginfo.gov. Therefore,
in preparation for OMB review and
approval of the following information
collection, TSA is soliciting comments
to—
(1) Evaluate whether the proposed
information requirement is necessary for
the proper performance of the functions
of the agency, including whether the
information will have practical utility;
(2) Evaluate the accuracy of the
agency’s estimate of the burden;
(3) Enhance the quality, utility, and
clarity of the information to be
collected; and
(4) Minimize the burden of the
collection of information on those who
are to respond, including using
appropriate automated, electronic,
mechanical, or other technological
collection techniques or other forms of
information technology.
Information Collection Requirement
Purpose of Data Collection
Approximately 6,000 transit service
providers, commuter railroads, and long
distance passenger railroad providers
operate in the United States.1 Mass
transit and passenger rail systems
provide transportation services through
buses, rail transit, commuter rail, longdistance rail, and other, less common
types of service (cable cars, inclined
planes, funiculars, and automated
guideway systems). These systems can
also include ‘‘demand response
services’’ for seniors and persons with
disabilities, as well as vanpool/
rideshare programs and taxi services
operated under contract with a public
transportation agency.
TSA is required to ‘‘assess the
security of each surface transportation
mode and evaluate the effectiveness and
efficiency of current Federal
Government surface transportation
1 TSA, ‘‘Transportation Sector-Specific Plan Mass
Transit Modal Annex’’, page 4 (May 2007).
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]]>Agencies
[Federal Register Volume 77, Number 104 (Wednesday, May 30, 2012)]
[Notices]
[Pages 31864-31866]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-13006]
[[Page 31864]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive License: Development of
PANVACTM and Tumor Associated Antigens as Colorectal Cancer
Vaccine
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 Bavarian Nordic
Immunotherapeutics (``BNIT'') located in Mountain View, CA, USA.
Intellectual Property
Group I--Exclusive Licensed Patent Rights
1. U.S. Patent Application No. 60/061,589 filed October 10, 1997 as
well as all issued and pending foreign counterparts [HHS Ref. No. E-
099-1996/0-US-01];
2. PCT Patent Application No. PCT/US1998/19794 filed September 22,
1998 as well as all issued and pending foreign counterparts [HHS Ref.
No. E-099-1996/0-PCT-02];
3. U.S. Patent No. 6,756,038 issued June 29, 2004 as well as issued
and pending foreign counterparts [HHS Ref. No. E-099-1996/0-US-07];
4. U.S. Patent No. 7,723,096 issued May 25, 2010 as well as
continuation and divisional applications, and issued and pending
foreign counterparts [HHS Ref. No. E-099-1996/0-US-08];
5. European Patent No. lOI7810 [HHS Ref. No. E-099-1996/0-EP-05],
and all European contracting states in which this patent is validated;
6. European Patent Application No. 04011673.3 (now EP Patent No.
1447414) [HHS Ref. No. E-099-1996/0-EP-17], and all European
contracting states in which this patent is validated, Japan Patent
Application No. 2000-516030 (now JP Patent No. 4291508) [HHS Ref. No.
E-099-1996/0-JP-06], and all continuations and divisional applications
claiming priority to this application;
7. Australia Patent No. 745863 [HHS Ref. No. E-099-1996/0-AU-03],
and all continuations and divisional applications claiming priority to
this application;
8. Canada Patent No. 2308127 [HHS Ref. No. E-099-1996/0-CA-04], and
all continuations and divisional applications claiming priority to this
application;
9. PCT Patent Application No. PCT/US1992/03843 filed May 6, 1992 as
well as all issued and pending foreign counterparts [HHS Ref. No. E-
200-1990/2-PCT-01];
10. U.S. Patent No. 5,698,530 issued December 6, 1997 as well as
issued and pending foreign counterparts [HHS Ref. No. E-200-1990/1-US-
02];
11. Australian Patent No. 674492 issued April 22, 1997 [HHS Ref.
No. E-200-1990/2-AU-02]; Europe Patent No. 0584266 issued September 3,
2003 [HHS Ref. No. E-200-1990/2-EP-04]; Japan Patent No. 3399943 issued
February 21, 2003 [HHS Ref. No. E-200-1990/2-JP-05]; and Canada Patent
No. 2102623 issued April 22, 2003 [HHS Ref. No. E-200-1990/2-CA-03];
12. U.S. Patent No. 6,001,349 issued 14 Dec. 1999 as well as issued
and pending foreign counterparts [HHS Ref. No. E-200-1990/3-US-01];
13. U.S. Patent Application No. 60/519,354 filed November 12, 2003
as well as all issued and pending foreign counterparts [HHS Ref. No. E-
087-2005/0-US-01];
14. U.S. Patent Application No. 10/579,025 filed May 11, 2006 as
well as all continuation and divisional applications, and issued and
pending foreign counterparts [E-0872005/0-US-03];
15. U.S. Patent Application No. 60/519,427 filed November 12, 2003
as well as all issued and pending foreign counterparts [HHS Ref. No. E-
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16. U.S. Patent Application No. 10/579,007 filed May 11, 2006 as
well as all continuation and divisional applications, and issued and
pending foreign counterparts [HHS Ref. No. E-088-2005/0-US-03];
17. U.S. Patent Application No. 60/038,253 filed February 24, 1997
as well as all issued and pending foreign counterparts [HHS Ref. No. E-
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18. PCT Patent Application No. PCT/US1998/03693 filed February 24,
1998 as well as all issued and pending foreign counterparts [HHS Ref.
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19. U.S. Patent No. 7,118,738 issued October 10, 2006 as well as
all continuations and divisional applications, and issued and pending
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20. PCT Patent Application No. PCT/US1995/12638 filed October 2,
1995 as well as all issued and pending foreign counterparts [HHS Ref.
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21. PCT Patent Application No. PCT/US1997/12203 filed July 15, 1997
as well as all issued and pending foreign counterparts [HHS Ref. No. E-
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well as all issued and pending foreign counterparts [HHS Ref. No. E-
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23. U.S. Patent No. 7,410,644 issued August 12, 2008 as well as all
continuation and divisional applications, and issued and pending
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24. PCT Patent Application No. PCT/US1995/12624 filed October 2,
1995 as well all issued and pending foreign counterparts [HHS Ref. No.
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25. U.S. Patent Nos. 6,893,869, 6,548,068 and 6,045,802 issued May
17, 2005, April 15, 2003 and April 4, 2000 respectively, as well as
issued and pending foreign counterparts [HHS Ref. Nos. E-260-1994/1-US-
03, US-02, US-01]; U.S. Patent No. 7,368,116 issued May 6, 2008 and
U.S. Patent Application No. 12/112,819, as well as all continuation and
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26. Europe Patent Application No. 00102998.2 filed October 2, 1995,
Europe Patent No. 0784483 issued November 29, 2001, Europe Patent
Application No. 09013495.8 filed October 26, 2009, as well as all
continuation, and divisional applications [HHS Ref. Nos. E-260-1994/2-
EP-15, EP-16 and EP-27]; Japan Patent Application No. 512100/96 filed
October 2, 1995; Japan Patent No. 4078319 issued February 8, 2008 [HHS
Ref. No. E-260-1994/2-JP-25]; and Japan Patent No. 4160612 issued July
25, 2008, as well as all continuation and divisional applications; [HHS
Ref. No. E-260-1994/2-JP-21, JP-25 and JP-26]; Australia Patent No.
688606 issued July 2, 1998 [HHS Ref. No. E-260-1994/2-AU-11]; Canada
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27. U.S. Patent Application No. 60/211,717 filed June 15, 2000 as
well as all continuation and divisional applications, and issued and
pending foreign counterparts [HHS Ref. No. E-187-2000/0-US-01];
28. PCT Patent Application No. PCT/US2001/19201 filed June 15, 2001
as well all issued and pending foreign counterparts [HHS Ref. No. E-
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[[Page 31865]]
November 30, 2006 [HHS Ref. No. E-187-2000/0-AU-06]; Japan Patent
Application No. 2002-510097 filed June 15, 2001 [HHS Ref. No. E-187-
2000/0-JP-07]; Hong Kong Patent Application No. 03105975.5 filed June
15, 2001 [HHS Ref. No. E-187-2000/0-HK-08]; as well as all continuation
and divisional applications;
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as well as all continuation and divisional applications, and issued and
pending foreign counterparts [HHS Ref. No. E-104-2006/0-US-01];
31. PCT Patent Application No. PCT/US2007/004603 filed February 27,
2007 as well all issued and pending foreign counterparts [HHS Ref. No.
E-104-2006/0-PCT-02];
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[HHS Ref. No. E-104-2006/0-US-06]; Australia Patent Application No.
2007221255 filed February 21, 2007 [HHS Ref. No. E-104-2006/0-AU-03];
Europe Patent Application No. 07751371.1 filed February 21, 2007 [HHS
Ref. No. E-104-2006/0-US-06]; filed February 21, 2007 [HHS Ref. No. E-
104-2006/0-EP-05]; Canada Patent Application No. 2642994 filed February
21, 2007 [HHS Ref. No. E-104-2006/0-CA-04]; as well as all continuation
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as well as all continuation and divisional applications, and issued and
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Application No. not yet assigned filed February 27, 2008 [HHS Ref. No.
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Group II--Nonexclusive Licensed Patent Rights
1. U.S. Patent Application No. 60/111,582 filed December 9, 1998 as
well as all continuation and divisional applications, and issued and
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well as all continuation and divisional applications, and issued and
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as well as all continuation and divisional applications, and issued and
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as well as all continuation and divisional applications, and issued and
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well as all continuation and divisional applications, and issued and
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well as all continuation and divisional applications, and issued and
pending foreign counterparts [HHS Ref. No. E-139-2007/0]; and
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 limited to the use of Licensed Patent Rights
for development of therapeutics for human colorectal cancer in all
geographic territories.'' For the avoidance of doubt, delivery
formulations shall specifically exclude canary poxvirus vectors, NYVAC,
non-viral eukaryotic expression vectors and recombinant yeast
vectors.''
DATES: Only written comments and/or applications for a license which
are received by the NIH Office of Technology Transfer on or before June
29, 2012 will be considered.
FOR FURTHER INFORMATION CONTACT: Requests for copies of the patent
application, inquiries, and 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: chatterjeesa@od.nih.gov.
[[Page 31866]]
SUPPLEMENTARY INFORMATION: Cancer immunotherapy is a recent approach
where tumor associated antigens (TAAs), which are primarily expressed
in human tumor cells, and not expressed or minimally expressed in
normal tissues, are employed to generate a tumor-specific immune
response. Specifically, these antigens serve as targets for the host
immune system and elicit responses that result in tumor destruction.
The initiation of an effective T-cell immune response to antigens
requires two signals. The first one is antigen-specific via the
peptide/major histocompatibility complex and the second or
``costimulatory'' signal is required for cytokine production,
proliferation, and other aspects of T-cell activation.
The patents and patent applications describe a vaccine technology,
TRICOM, in conjunction with tumor associated antigens (TAAs). The
TRICOM technology employs avirulent poxviruses to present a combination
of costimulatory signaling molecules with tumor-associated antigens
(TAAs) to activate T-cells and break the immune systems tolerance
towards cancer cells. This is achieved using recombinant poxvirus DNA
vectors that encode both T-cell costimulatory molecules and TAAs. The
combination of the three (3) costimulatory molecules B7.1, ICAM-1 and
LFA-3, hence the name TRICOM, has been shown to have more than the
additive effect of each costimulatory molecule when used individually
to optimally activate both CD4+ and CD8+ T cells. When a TRICOM based
vaccine expressing TAAs is administered it greatly enhances the immune
response against the malignant cells expressing those TAAs. The
addition of the two well-known TAAs, carcinoembryonic antigen (CEA) and
MUC-1 to the TRICOM vector results in the PANVAC vaccine, which is used
in a prime and boost vaccine strategy. It is well established that the
over-expression of these two (2) TAAs are associated with the presence
of a variety of carcinomas; including colorectal cancer and therefore
PANVAC can potentially be an effective cancer vaccine for colorectal
cancer. Additionally, new tumor associated antigens can also be used
with TRICOM to develop novel vaccines. For example, Brachyury, well
known for its role in developmental cell biology and recently been
implicated in tumor cell invasion and metastasis, has been shown to be
aberrantly expressed in several tumors including colorectal tumors. As
a result, Brachyury is being used as a tumor associated antigen along
with TRICOM and has potential as a cancer immunotherapeutic vaccine for
the treatment of several tumors including colorectal 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 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: May 23, 2012.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. 2012-13006 Filed 5-29-12; 8:45 am]
BILLING CODE 4140-01-P
