Prospective Grant of Exclusive License: The Development of Human Anti-CD22 Monoclonal Antibodies for the Treatment of Human Cancers and Autoimmune Disease, 9678-9679 [2012-3829]
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Federal Register / Vol. 77, No. 33 / Friday, February 17, 2012 / Notices
Patent and Trademark Office or the
World Intellectual Property
Organization.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
The
present technology provides a novel
method for cancer therapy which may
offer improved specificity and
sensitivity in cancer treatment. The
method is based on molecular targeting.
More specifically, it is based on
photoimmunotherapy (PIT). The
therapeutic agent is a targeted
photosensitizer composed of a tumor
specific antibody conjugated to IR700
dye, where the dye is sensitive to a near
infrared light. Upon administration of
the conjugated antibody to a subject, it
specifically binds to the targeted
cancerous tissue. Upon subsequent
irradiation with a near infrared light, the
dye releases energy that leads to the
killing of the targeted cells. The concept
was proven by the inventors in vitro and
in vivo with mouse models, using
humanized anti-HER1 (Panitumumab,
for colon cancer), anti-HER2
(Trastuzumab, for breast cancer) and
anti-PSMA antibody (huJ591, for
prostate cancer). Targeted cells were
completely killed while normal cells
were not noticeably affected. The
technology provides also for wearable
LED systems that can be used to
irradiate the photosensitizer.
The prospective exclusive evaluation
option license will comply with the
terms and conditions of 35 U.S.C. 209
and 37 CFR 404.7. The prospective
exclusive evaluation option license may
be granted unless, within fifteen (15)
days from the date of this published
notice, 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 404.7.
Properly filed competing applications
for a license filed in response to this
notice will be treated as objections to
the contemplated license. Comments
and objections submitted in response 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.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
SUPPLEMENTARY INFORMATION:
Prospective Grant of Exclusive
License: Photosensitizing AntibodyFluorophore Conjugates for PhotoImmunotherapy
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
404.7(a)(1)(i), that the National
Institutes of Health (NIH), Department
of Health and Human Services (HHS), is
contemplating the grant of a worldwide
exclusive evaluation option license, to
practice the inventions embodied in US
patent application 13/180,111, filed July
11, 2011 (HHS Reference# E–205–2010/
0–US–02), originated from provisional
application 61/363,079 filed July 09,
2010, and entitled ‘‘Photosensitizing
Antibody Fluorophore Conjugates for
Photo-Immunotherapy’’ to Aspyrian
Therapeutics, Inc., a company
incorporated under the laws of the State
of Delaware, having its headquarters in
San Diego, California. The United States
of America is the assignee of the rights
of the above inventions.
The field of use may be limited to
‘‘use of photosensitizing antibodyfluorophore conjugate for imaging and
photo-immunotherapy of cancer’’ and
may be further limited to certain types
of cancer and/or specific platforms.
Upon the expiration or termination of
the exclusive evaluation option license,
Aspyrian Therapeutics, Inc. will have
the right to execute an exclusive
worldwide patent commercialization
license which will supersede and
replace the exclusive evaluation option
license with the same field of use.
DATES: Only written comments and/or
applications for a license received by
the NIH Office of Technology Transfer
on or before March 5, 2012 will be
considered.
ADDRESSES: Requests for a copy of the
patent application, inquiries, comments
and other materials relating to the
contemplated license should be directed
to: Uri Reichman, Ph.D., M.B.A., Office
of Technology Transfer, National
Institutes of Health, 6011 Executive
Boulevard, Suite 325, Rockville, MD
20852–3804; Telephone: (301) 435–
4616; Facsimile: (301) 402–0220; Email:
Reichmau@mail.nih.gov. A signed
confidentiality nondisclosure agreement
will be required to receive copies of any
patent applications that have not been
published or issued by the United States
mstockstill on DSK4VPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
19:08 Feb 16, 2012
Jkt 226001
Dated: February 13, 2012.
Richard U. Rodriguez,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. 2012–3828 Filed 2–16–12; 8:45 am]
BILLING CODE 4140–01–P
PO 00000
Frm 00059
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Prospective Grant of Exclusive
License: The Development of Human
Anti-CD22 Monoclonal Antibodies for
the Treatment of Human Cancers and
Autoimmune Disease
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
404.7(a)(1)(i), that the National
Institutes of Health, Department of
Health and Human Services, is
contemplating the grant of an exclusive
evaluation option license to practice the
inventions embodied in U.S. Patent
Application 61/042,239 entitled
‘‘Human Monoclonal Antibodies
Specific for CD22’’ [HHS Ref. E–080–
2008/0–US–01], PCT Application PCT/
US2009/124109 entitled ‘‘Human and
Improved Murine Monoclonal
Antibodies Against CD22’’ [HHS Ref. E–
080–2008/0–PCT–02], U.S. patent
application 12/934,214 entitled ‘‘Human
Monoclonal Antibodies Specific for
CD22’’ [HHS Ref. E–080–2008/0–US–
03], 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 evaluation
option license territory may be
worldwide, and the field of use may be
limited to:
SUMMARY:
The use of the m971 and m972 (SMB–002)
monoclonal antibodies as therapies for the
treatment of B cell cancers and autoimmune
disease. The Licensed Field of Use includes
the use of the antibodies in the form of an
immunoconjugate, including immunotoxins.
Upon the expiration or termination of
the exclusive evaluation option license,
Sanomab, Ltd. will have the exclusive
right to execute an exclusive
commercialization license which will
supersede and replace the exclusive
evaluation option license with no
greater field of use and territory than
granted in the exclusive evaluation
option license.
DATES: Only written comments and/or
applications for a license which are
received by the NIH Office of
Technology Transfer on or before March
5, 2012 will be considered.
ADDRESSES: Requests for copies of the
patent application, inquiries, comments,
and other materials relating to the
E:\FR\FM\17FEN1.SGM
17FEN1
Federal Register / Vol. 77, No. 33 / Friday, February 17, 2012 / Notices
contemplated exclusive evaluation
option 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; Email:
lambertsond@od.nih.gov.
This
invention concerns monoclonal
antibodies against CD22 and methods of
using the antibodies for the treatment of
CD22-expressing cancers, including
hematological malignancies such as
hairy cell leukemia, chronic
lymphocytic leukemia and pediatric
acute lymphoblastic leukemia, and
autoimmune disease such as lupus and
Sjogren’s syndrome. The specific
antibodies covered by this technology
are designated m971 and m972 (SMB–
002; applicant designation).
CD22 is a cell surface antigen that is
preferentially expressed on certain types
of cancer cells, and is involved in the
modulation of the immune system. The
m971 and m972 antibodies can
selectively bind to diseased 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 evaluation
option license is being considered under
the small business initiative launched
on 1 October 2011, and will comply
with the terms and conditions of 35
U.S.C. 209 and 37 CFR 404.7. The
prospective exclusive evaluation option
license, and a subsequent exclusive
commercialization 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 404.7 within
fifteen (15) 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
evaluation option 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.
mstockstill on DSK4VPTVN1PROD with NOTICES
SUPPLEMENTARY INFORMATION:
VerDate Mar<15>2010
19:08 Feb 16, 2012
Jkt 226001
Dated: February 13, 2012.
Richard U. Rodriguez,
Director, Division of Technology Development
& Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. 2012–3829 Filed 2–16–12; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Substance Abuse and Mental Health
Services Administration
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Periodically, the Substance Abuse and
Mental Health Services Administration
(SAMHSA) will publish a summary of
information collection requests under
OMB review, in compliance with the
Paperwork Reduction Act (44 U.S.C.
Chapter 35). To request a copy of these
documents, call the SAMHSA Reports
Clearance Officer on (240) 276–1243.
Proposed Project: Toolkit Protocol for
the Crisis Counseling Assistance and
Training Program (CCP)—Revision
The Substance Abuse and Mental
Health Services Administration’s
(SAMHSA) Center for Mental Health
Services (CMHS) will create a toolkit to
be used for the purposes of collecting
data on the Crisis Counseling Assistance
and Training Program (CCP). The CCP
provides supplemental funding to states
and territories for individual and
community crisis intervention services
during a Federal disaster.
The CCP has provided disaster mental
health services to millions of disaster
survivors since its inception and, as a
result of 30 years of accumulated
expertise, it has become an important
model for Federal response to a variety
of catastrophic events. State CCPs, such
as the recent 2009 Project A’apa Atu (for
the Tsunami in American Samoa), 2010
Tennessee Recovery Project (following
devastating flooding), Healing Joplin
and Project Rebound (following the
2011 tornadoes in Joplin, Missouri and
Alabama), and most recently the
multiple CCPs that resulted from 2011
Hurricane Irene, and flooding
throughout the summer of 2011 have
primarily addressed the short-term
mental health needs of communities
through (a) Outreach and public
education, (b) individual and group
counseling, and (c) referral. Outreach
and public education serve primarily to
normalize reactions and to engage
people who might need further care.
Crisis counseling assists survivors to
cope with current stress and symptoms
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9679
in order to return to predisaster
functioning. Crisis counseling relies
largely on ‘‘active listening,’’ and crisis
counselors also provide psychoeducation (especially about the nature
of responses to trauma) and help clients
build coping skills. Crisis counseling
typically continues no more than a few
times. Because crisis counseling is timelimited, referral is the third important
functions of CCPs. Counselors are
expected to refer clients to formal
treatment if the person has developed
more serious psychiatric problems.
Data about services delivered and
users of services will be collected
throughout the program period. The
data will be collected via the use of a
toolkit that relies on standardized forms.
At the program level, the data will be
entered quickly and easily into a
cumulative database to yield summary
tables for quarterly and final reports for
the program. We have confirmed the
feasibility of using scanable forms for
most purposes. Because the data will be
collected in a consistent way from all
programs, they can be uploaded into an
ongoing national database that likewise
provides CMHS with a way of
producing summary reports of services
provided across all programs funded.
The components of the tool kit are
listed and described below:
• Encounter Logs. These forms
document all services provided.
Completion of these logs is required by
the crisis counselors. There are three
types of encounter logs: (1) Individual/
Family Crisis Counseling Services
Encounter Log; (2) Group Encounter
Log; and (3) Weekly Tally Sheet.
Æ Individual/Family Crisis
Counseling Services Encounter Log.
Crisis counseling is defined as an
interaction that lasts at least 15 minutes
and involves participant disclosure.
This form is completed by the Crisis
Counselor for each service recipient or
family, defined as the person or persons
who actively participated in the session
(e.g., by verbally participating), not
someone who is merely present. For
families, complete only one form to
capture all family members who are
actively engaged in the visit.
Information collected includes
demographics, service characteristics,
risk factors, and referral data.
Æ Group Encounter Log. This form is
used to identify either a group crisis
counseling encounter or a group public
education encounter. A check at the top
identifies the class of activities (i.e.,
counseling or education). Information
collected includes services
characteristics, group identity and
characteristics, and group activities.
E:\FR\FM\17FEN1.SGM
17FEN1
]]>Agencies
[Federal Register Volume 77, Number 33 (Friday, February 17, 2012)]
[Notices]
[Pages 9678-9679]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-3829]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive License: The Development of Human
Anti-CD22 Monoclonal Antibodies for the Treatment of Human Cancers and
Autoimmune Disease
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 404.7(a)(1)(i), that the National Institutes of Health, Department
of Health and Human Services, is contemplating the grant of an
exclusive evaluation option license to practice the inventions embodied
in U.S. Patent Application 61/042,239 entitled ``Human Monoclonal
Antibodies Specific for CD22'' [HHS Ref. E-080-2008/0-US-01], PCT
Application PCT/US2009/124109 entitled ``Human and Improved Murine
Monoclonal Antibodies Against CD22'' [HHS Ref. E-080-2008/0-PCT-02],
U.S. patent application 12/934,214 entitled ``Human Monoclonal
Antibodies Specific for CD22'' [HHS Ref. E-080-2008/0-US-03], 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 evaluation option license territory may
be worldwide, and the field of use may be limited to:
The use of the m971 and m972 (SMB-002) monoclonal antibodies as
therapies for the treatment of B cell cancers and autoimmune
disease. The Licensed Field of Use includes the use of the
antibodies in the form of an immunoconjugate, including
immunotoxins.
Upon the expiration or termination of the exclusive evaluation
option license, Sanomab, Ltd. will have the exclusive right to execute
an exclusive commercialization license which will supersede and replace
the exclusive evaluation option license with no greater field of use
and territory than granted in the exclusive evaluation option license.
DATES: Only written comments and/or applications for a license which
are received by the NIH Office of Technology Transfer on or before
March 5, 2012 will be considered.
ADDRESSES: Requests for copies of the patent application, inquiries,
comments, and other materials relating to the
[[Page 9679]]
contemplated exclusive evaluation option 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; Email:
lambertsond@od.nih.gov.
SUPPLEMENTARY INFORMATION: This invention concerns monoclonal
antibodies against CD22 and methods of using the antibodies for the
treatment of CD22-expressing cancers, including hematological
malignancies such as hairy cell leukemia, chronic lymphocytic leukemia
and pediatric acute lymphoblastic leukemia, and autoimmune disease such
as lupus and Sjogren's syndrome. The specific antibodies covered by
this technology are designated m971 and m972 (SMB-002; applicant
designation).
CD22 is a cell surface antigen that is preferentially expressed on
certain types of cancer cells, and is involved in the modulation of the
immune system. The m971 and m972 antibodies can selectively bind to
diseased 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 evaluation option license is being
considered under the small business initiative launched on 1 October
2011, and will comply with the terms and conditions of 35 U.S.C. 209
and 37 CFR 404.7. The prospective exclusive evaluation option license,
and a subsequent exclusive commercialization 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 404.7 within fifteen (15) 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 evaluation option 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: February 13, 2012.
Richard U. Rodriguez,
Director, Division of Technology Development & Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. 2012-3829 Filed 2-16-12; 8:45 am]
BILLING CODE 4140-01-P
