Government-Owned Inventions; Availability for Licensing, 13621-13622 [E6-3764]
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Federal Register / Vol. 71, No. 51 / Thursday, March 16, 2006 / Notices
Subject name
Address
DIRICO .....................................................................................
MOUNTAIN VISTA CHIROPRACTIC CENTER, INC ..............
ROLANDO ROZAS, MD, PA ....................................................
RURAL HEALTH NETWORKS OF FLORIDA ..........................
TWILIGHT YEARS ADULT CARE, INC ...................................
UNIVERSAL MEDICAL ASSOCIATION OF USA, INC ...........
BERKLEY, MA .........................................................................
LONGMONT, CO .....................................................................
MIAMI, FL .................................................................................
CITRA, FL ................................................................................
MINNEAPOLIS, KS ..................................................................
ROSEMEAD, CA ......................................................................
13621
Effective date
1/5/2006
3/20/2006
3/20/2006
3/20/2006
3/20/2006
3/20/2006
DEFAULT ON HEAL LOAN
COLE, MARIA ...........................................................................
DENSMORE, ROBERT ............................................................
ETIENNE, FERNANDE ............................................................
FENTON, MARK .......................................................................
FERNANDEZ, OCTAVIO ..........................................................
HUDSON, DONALD .................................................................
KEOSHIAN, CRAIG ..................................................................
KYCYNKA, DREW ....................................................................
LARA-FULLER, ADRIENNE .....................................................
Dated: March 8, 2006.
Maureen Byer,
Acting Director, Exclusions Staff, Office of
Inspector General.
[FR Doc. E6–3803 Filed 3–15–06; 8:45 am]
BILLING CODE 4152–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
National Institutes of Health,
Public Health Service, HHS.
AGENCY:
ACTION:
Notice.
SUMMARY: The inventions listed below
are owned by an agency of the U.S.
Government and are available for
licensing in the U.S. in accordance with
35 U.S.C. 207 to achieve expeditious
commercialization of results of
federally-funded research and
development. Foreign patent
applications are filed on selected
inventions to extend market coverage
for companies and may also be available
for licensing.
Licensing information and
copies of the U.S. patent applications
listed below may be obtained by writing
to the indicated licensing contact at the
Office of Technology Transfer, National
Institutes of Health, 6011 Executive
Boulevard, Suite 325, Rockville,
Maryland 20852–3804; telephone: 301/
496–7057; fax: 301/402–0220. A signed
Confidential Disclosure Agreement will
be required to receive copies of the
patent applications.
wwhite on PROD1PC61 with NOTICES
ADDRESSES:
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15:48 Mar 15, 2006
Jkt 208001
WEST PALM BEACH, FL ........................................................
TAMPA, FL ...............................................................................
ROSELLE, NJ ..........................................................................
VAN NUYS, CA ........................................................................
MIAMI, FL .................................................................................
LANSING, MI ...........................................................................
VALENCIA, CA ........................................................................
SPRING HILL, FL ....................................................................
OXNARD, CA ...........................................................................
Use of CYP1B1*3 Genotyping To
Predict Survival to Docetaxel
Treatment in Androgen-Independent
Prostate Cancer
William D. Figg et al. (NCI).
U.S. Provisional Application No. 60/
716,439 filed September 12, 2005
(HHS Reference No. E–307–2005/0–
US–01).
Licensing Contact: Mojdeh Bahar; 301/
435–2950; baharm@mail.nih.gov.
Androgen-independent prostate
cancer (AIPC) remains the second
leading cause of cancer death in men in
developed nations, and it is estimated
that one in six men will be diagnosed
with prostate cancer. The use of
docetaxel has been shown to prolong
survival rate and improve the quality of
life in patients suffering from AIPC.
Scientists at NIH have identified a
genetic marker called CYP1B1*3
(4326C>G; L432V) that can predict
survival in patients with prostate cancer
prior to treatment with docetaxel. In a
study of 25 patients suffering from
AIPC, patients that were homozygous or
heterozygous wild-type for the 4326C>G
transition had an increased mean
survival time after docetaxel treatment
when compared to patients carrying the
homozygous variant. These patients
showed a survival rate of 15.3 months
compared to 7.5 months for those
homozygous with the variant
CYP1B1*3.
This genetic marker (CYP1B1*3) can
be measured in DNA obtained from a
blood sample. This technology can be
potentially used as a diagnostic tool to
predict the patient’s propensity to
respond to docetaxel treatment when
being treated for AIPC.
In addition to licensing, the
technology is available for further
development through collaborative
research opportunities with the
inventors.
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3/20/2006
3/20/2006
3/20/2006
3/20/2006
3/20/2006
3/20/2006
3/20/2006
2/2/2006
Adoptive Immunotherapy With
Enhanced T Lymphocyte Survival
Steven A. Rosenberg et al. (NCI).
PCT Application No. PCT/US05/3640
filed October 7, 2005 (HHS Reference
No. E–340–2004/2–PCT–01);
U.S. Provisional Application No. 60/
617,340 filed October 8, 2004 (HHS
Reference No. E–340–2004/0–US–01).
Licensing Contact: Michelle A. Booden;
301/451–7337;
boodenm@mail.nih.gov.
Adoptive immunotherapy strategies
have existed for several years now and
many have proven to be highly
successful in a limited subset of
patients. This limited response rate
among a diverse patient population may
not be surprising, given the complexity
of the immune system and the
complicated evolution of a normal cell
to a immune evading malignancy. A
common observation amongst most
patients that did not respond to
adoptive therapy strategies is that the
immune response to the cancer was not
sustained.
A number of cytokines have been
shown to sustain a T-cell response when
administered systemically with
autologous isolated T-cells. However,
the systemic delivery of many
cytokines, such as IL–2, will cause
significant toxicity before the beneficial
immunologic effects of the autologous
T-cells can occur. This invention
describes a method of transfecting
isolated autologous T-Lymphocytes
with endogenous cytokines, for example
IL–7 and IL–15, to sustain an adoptive
T-lymphocyte response without
systemic toxicity. The invention also
describes a method for improving
expression of transfected cytokines via a
codon optimized IL–15 vector.
Applications of this technology beyond
cancer include the potential use of
cytokine expressing cells in treating
E:\FR\FM\16MRN1.SGM
16MRN1
13622
Federal Register / Vol. 71, No. 51 / Thursday, March 16, 2006 / Notices
wwhite on PROD1PC61 with NOTICES
infectious and autoimmune diseases
and vaccination.
This invention was developed at the
NCI Surgery Branch. The Surgery
Branch plans to initiate clinical studies
utilizing this technology and
collaborative opportunities may be
available. Publications which may
provide background information for this
technology include:
1. Hsu C, Hughes MS, Zheng Z, Bray
RB, Rosenberg SA, Morgan RA. Primary
human T lymphocytes engineered with
a codon-optimized IL–15 gene resist
cytokine withdrawal-induced apoptosis
and persist long-term in the absence of
exogenous cytokine. J Immunol. 2005
Dec 1;175(11):7226–34.
2. Rosenberg, SA and Dudley, ME.
Cancer regression in patients with
metastatic melanoma after the transfer
of autologous antitumor lymphocytes.
Proc Natl Acad Sci USA 2004 Oct 5;101
Suppl 2:14639–45. Epub 2004 Sep 20.
3. Klebanoff CA, Finkelstein SE,
Surman DR, Lichtman MK, Gattinoni L,
Theoret MR, Grewal N, Spiess PJ,
Antony PA, Palmer DC, Tagaya Y,
Rosenberg SA, Waldmann TA, Restifo
NP. IL–15 enhances the in vivo
antitumor activity of tumor-reactive
CD8+ T cells. Proc Natl Acad Sci USA
2004 Feb 17;101(7):1969–74. Epub 2004
Feb 04.
4. Dudley ME, Rosenberg SA.
Adoptive-cell-transfer therapy for the
treatment of patients with cancer. Nat
Rev Cancer. 2003 Sep;3(9):666–75.
Review.
5. Liu K, Rosenberg SA. Interleukin2-independent proliferation of human
melanoma-reactive T lymphocytes
transduced with an exogenous IL–2
gene is stimulation dependent. J
Immunother. 2003 May-Jun;26(3):190–
201.
6. Liu K, Rosenberg SA. Transduction
of an IL–2 gene into human melanomareactive lymphocytes results in their
continued growth in the absence of
exogenous IL–2 and maintenance of
specific antitumor activity. J Immunol.
2001 Dec 1;167(11):6356–65.
Gene Therapy by Administration of
Genetically Engineered CD34+
Obtained by Cord Blood
Robert M. Blaese (NCI), et al.
U.S. Patent No. 6,984,379 issued
January 10, 2006 (HHS Reference No.
E–045–1995/0–US–01).
Licensing Contact: John Stansberry,
Ph.D.; 301/435–5236;
stansbej@mail.nih.gov.
This invention provides a method of
providing a therapeutic effect in human
patients by administering to the patient
CD34+ cells obtained from umbilical
cord blood. The CD34+ cells have been
VerDate Aug<31>2005
15:48 Mar 15, 2006
Jkt 208001
engineered with at least one nucleic
acid sequence encoding a therapeutic
agent. Such CD34+ cells could be
engineered by transducing the cells with
a retroviral vector including the nucleic
acid sequence encoding the therapeutic
agent. This method has been applied in
treating new born infants suffering from
adenosine deaminase (ADA) deficiency.
This application was filed pre-GATT
and is therefore valid 17 years from
issued date of January 10, 2006.
In addition to licensing, the
technology is available for further
development through collaborative
research opportunities with the
inventors.
Dated: March 8, 2006.
Steven M. Ferguson,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. E6–3764 Filed 3–15–06; 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.
Project: Evaluation of the Policy
Academies on Chronic Homelessness—
New
The Substance Abuse and Mental
Health Services Administration’s
(SAMHSA), Center for Mental Health
Services (CMHS) and the Health
Resources and Services Administration
(HRSA) will fund an evaluation of the
Policy Academies on Chronic
Homelessness held in 2002, 2003, and
2004. These Policy Academies were
sponsored by the U.S. Department of
Human Services (HHS) in partnership
with the U.S. Department of Veterans
Affairs, U.S. Department of Labor and
the U.S. Department of Housing and
Urban Development. The Policy
Academies were 3–4 day meetings
designed to help teams of State,
Territory and local policymakers
develop Action Plans intended to
PO 00000
Frm 00057
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improve access to mainstream services
for people who are homeless.
This evaluation will assess the
effectiveness of the Policy Academies in
helping States and Territories address
the problem of chronic homelessness.
This evaluation has been
conceptualized in two parts. The
process evaluation will focus on the
activities related to conducting the
Policy Academies. The process
evaluation interviews will focus on: (1)
How the Policy Academy concept was
developed, (2) how the Federal Partners
implemented the Policy Academies, (3)
what factors influenced the
effectiveness of each step of the
intervention (i.e., pre-Academy site
visits, Policy Academy meetings, and
post-Academy technical assistance), (4)
what changes in the Policy Academy
process occurred over time, (5) what
challenges/barriers Federal Partners
faced in the development and
implementation of the Policy
Academies, and (6) how future Policy
Academies could be improved to better
meet the needs of States and Territories.
The process evaluation will include all
45 States and Territories that
participated in one of the Policy
Academies on Chronic Homelessness, as
well as the three Pacific Territories
(American Samoa, Commonwealth of
the Northern Marianas Islands, and
Guam,) that participated in a special
series of Policy Academies on
Homelessness held in American Samoa
and Guam.
The second part, the outcome
evaluation, will assess how successful
State, Territory, and local policymakers
have been in implementing the Action
Plans that were developed at the Policy
Academies. The outcome evaluation
interviews will focus on: (1) How States
and Territories put together their Policy
Academy teams, (2) the content and
overall quality of the Action Plans these
teams developed, (3) to what extent
States and Territories have been able to
increase access to coordinated housing
and mainstream services for persons
experiencing homelessness, (4) what
challenges/barriers States and
Territories faced in trying to achieve
short- and long-term goals, and (5) to
what extent relationships among the
Governor’s office, legislators, key
program administrators, and public and
private stakeholders were created or
strengthened. In order to reduce burden
on informants, the outcome evaluation
will focus on a sample of States and
Territories (the 19 States and Territories
participating in the last two Policy
Academies on Chronic Homelessness
and the three Pacific Territories).
E:\FR\FM\16MRN1.SGM
16MRN1
]]>Agencies
[Federal Register Volume 71, Number 51 (Thursday, March 16, 2006)]
[Notices]
[Pages 13621-13622]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-3764]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions; Availability for Licensing
AGENCY: National Institutes of Health, Public Health Service, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The inventions listed below are owned by an agency of the U.S.
Government and are available for licensing in the U.S. in accordance
with 35 U.S.C. 207 to achieve expeditious commercialization of results
of federally-funded research and development. Foreign patent
applications are filed on selected inventions to extend market coverage
for companies and may also be available for licensing.
ADDRESSES: Licensing information and copies of the U.S. patent
applications listed below may be obtained by writing to the indicated
licensing contact at the Office of Technology Transfer, National
Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville,
Maryland 20852-3804; telephone: 301/496-7057; fax: 301/402-0220. A
signed Confidential Disclosure Agreement will be required to receive
copies of the patent applications.
Use of CYP1B1*3 Genotyping To Predict Survival to Docetaxel Treatment
in Androgen-Independent Prostate Cancer
William D. Figg et al. (NCI).
U.S. Provisional Application No. 60/716,439 filed September 12, 2005
(HHS Reference No. E-307-2005/0-US-01).
Licensing Contact: Mojdeh Bahar; 301/435-2950; baharm@mail.nih.gov.
Androgen-independent prostate cancer (AIPC) remains the second
leading cause of cancer death in men in developed nations, and it is
estimated that one in six men will be diagnosed with prostate cancer.
The use of docetaxel has been shown to prolong survival rate and
improve the quality of life in patients suffering from AIPC.
Scientists at NIH have identified a genetic marker called CYP1B1*3
(4326C>G; L432V) that can predict survival in patients with prostate
cancer prior to treatment with docetaxel. In a study of 25 patients
suffering from AIPC, patients that were homozygous or heterozygous
wild-type for the 4326C>G transition had an increased mean survival
time after docetaxel treatment when compared to patients carrying the
homozygous variant. These patients showed a survival rate of 15.3
months compared to 7.5 months for those homozygous with the variant
CYP1B1*3.
This genetic marker (CYP1B1*3) can be measured in DNA obtained from
a blood sample. This technology can be potentially used as a diagnostic
tool to predict the patient's propensity to respond to docetaxel
treatment when being treated for AIPC.
In addition to licensing, the technology is available for further
development through collaborative research opportunities with the
inventors.
Adoptive Immunotherapy With Enhanced T Lymphocyte Survival
Steven A. Rosenberg et al. (NCI).
PCT Application No. PCT/US05/3640 filed October 7, 2005 (HHS Reference
No. E-340-2004/2-PCT-01);
U.S. Provisional Application No. 60/617,340 filed October 8, 2004 (HHS
Reference No. E-340-2004/0-US-01).
Licensing Contact: Michelle A. Booden; 301/451-7337;
boodenm@mail.nih.gov.
Adoptive immunotherapy strategies have existed for several years
now and many have proven to be highly successful in a limited subset of
patients. This limited response rate among a diverse patient population
may not be surprising, given the complexity of the immune system and
the complicated evolution of a normal cell to a immune evading
malignancy. A common observation amongst most patients that did not
respond to adoptive therapy strategies is that the immune response to
the cancer was not sustained.
A number of cytokines have been shown to sustain a T-cell response
when administered systemically with autologous isolated T-cells.
However, the systemic delivery of many cytokines, such as IL-2, will
cause significant toxicity before the beneficial immunologic effects of
the autologous T-cells can occur. This invention describes a method of
transfecting isolated autologous T-Lymphocytes with endogenous
cytokines, for example IL-7 and IL-15, to sustain an adoptive T-
lymphocyte response without systemic toxicity. The invention also
describes a method for improving expression of transfected cytokines
via a codon optimized IL-15 vector. Applications of this technology
beyond cancer include the potential use of cytokine expressing cells in
treating
[[Page 13622]]
infectious and autoimmune diseases and vaccination.
This invention was developed at the NCI Surgery Branch. The Surgery
Branch plans to initiate clinical studies utilizing this technology and
collaborative opportunities may be available. Publications which may
provide background information for this technology include:
1. Hsu C, Hughes MS, Zheng Z, Bray RB, Rosenberg SA, Morgan RA.
Primary human T lymphocytes engineered with a codon-optimized IL-15
gene resist cytokine withdrawal-induced apoptosis and persist long-term
in the absence of exogenous cytokine. J Immunol. 2005 Dec
1;175(11):7226-34.
2. Rosenberg, SA and Dudley, ME. Cancer regression in patients with
metastatic melanoma after the transfer of autologous antitumor
lymphocytes. Proc Natl Acad Sci USA 2004 Oct 5;101 Suppl 2:14639-45.
Epub 2004 Sep 20.
3. Klebanoff CA, Finkelstein SE, Surman DR, Lichtman MK, Gattinoni
L, Theoret MR, Grewal N, Spiess PJ, Antony PA, Palmer DC, Tagaya Y,
Rosenberg SA, Waldmann TA, Restifo NP. IL-15 enhances the in vivo
antitumor activity of tumor-reactive CD8+ T cells. Proc Natl Acad Sci
USA 2004 Feb 17;101(7):1969-74. Epub 2004 Feb 04.
4. Dudley ME, Rosenberg SA. Adoptive-cell-transfer therapy for the
treatment of patients with cancer. Nat Rev Cancer. 2003 Sep;3(9):666-
75. Review.
5. Liu K, Rosenberg SA. Interleukin-2-independent proliferation of
human melanoma-reactive T lymphocytes transduced with an exogenous IL-2
gene is stimulation dependent. J Immunother. 2003 May-Jun;26(3):190-
201.
6. Liu K, Rosenberg SA. Transduction of an IL-2 gene into human
melanoma-reactive lymphocytes results in their continued growth in the
absence of exogenous IL-2 and maintenance of specific antitumor
activity. J Immunol. 2001 Dec 1;167(11):6356-65.
Gene Therapy by Administration of Genetically Engineered CD34+ Obtained
by Cord Blood
Robert M. Blaese (NCI), et al.
U.S. Patent No. 6,984,379 issued January 10, 2006 (HHS Reference No. E-
045-1995/0-US-01).
Licensing Contact: John Stansberry, Ph.D.; 301/435-5236;
stansbej@mail.nih.gov.
This invention provides a method of providing a therapeutic effect
in human patients by administering to the patient CD34+ cells obtained
from umbilical cord blood. The CD34+ cells have been engineered with at
least one nucleic acid sequence encoding a therapeutic agent. Such
CD34+ cells could be engineered by transducing the cells with a
retroviral vector including the nucleic acid sequence encoding the
therapeutic agent. This method has been applied in treating new born
infants suffering from adenosine deaminase (ADA) deficiency. This
application was filed pre-GATT and is therefore valid 17 years from
issued date of January 10, 2006.
In addition to licensing, the technology is available for further
development through collaborative research opportunities with the
inventors.
Dated: March 8, 2006.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. E6-3764 Filed 3-15-06; 8:45 am]
BILLING CODE 4140-01-P
