Government-Owned Inventions; Availability for Licensing, 25018-25019 [E8-9871]
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25018
Federal Register / Vol. 73, No. 88 / Tuesday, May 6, 2008 / Notices
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
No. of
Respondents
Reporting Activity
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
Total Hours
Designation Request
64
1.28
77
60
4,620
Premeeting Packages
54
1.11
60
100
6,000
Total
10,620
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Please note that on January 15, 2008,
the FDA Division of Dockets
Management Web site transitioned to
the Federal Dockets Management
System (FDMS). FDMS is a
Government-wide, electronic docket
management system. Electronic
comments or submissions will be
accepted by FDA only through FDMS at
https://www.regulations.gov.
Dated: April 29, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–9882 Filed 5–5–08; 8:45 am]
BILLING CODE 4160–01–S
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.
rwilkins on PROD1PC63 with NOTICES
ADDRESSES:
VerDate Aug<31>2005
17:11 May 05, 2008
Jkt 214001
Human Papillomavirus microRNA
Diagnostics and Therapeutics
Description of Technology: Available
for licensing and commercial
development are patent rights that cover
the uses of a p53 specific microRNA
(miRNA). It has been reported that the
tumor suppressive mRNA miR–34a (a
downstream target of p53) is
downregulated in HPV-infected primary
keratinocytes. miR–34a arrests the cell
cycle at G2 phase and promotes
apoptosis. Therapeutic restoration of
normal expression levels of miR–34a
and/or simultaneous stabilization of p53
(inhibited by HPV E6) induces miR–34a
accumulation in G0/G1 phase and can
arrest tumor growth. Neoplasia and
cancer cell progression has also been
associated with p18Ink4c
overexpression which can be regulated
with the introduction of a therapeutic
amount of miR–34a. Tumor reduction/
suppression by down regulating
p18Ink4c is also a therapeutic benefit
provided by this invention.
Applications: Cervical cancer; Human
papillomavirus; Therapeutics.
Inventors: Zhi-Ming Zheng and
Xiaohong Wang (NCI).
Publications:
1. WO Lui et al. Patterns of known
and novel small RNAs in human
cervical cancer. Cancer Res. 2007 Jul
1;67(13):6031–6043.
2. I Martinez et al. Human
papillomavirus type 16 reduces the
expression of microRNA–218 in cervical
carcinoma cells. Oncogene 2007 Nov 12;
Advance online publication,
doi:10.1038/sj.onc.1210919.
Patent Status:
U.S. Provisional Application No. 60/
983,368 filed 29 Oct 2007 (HHS
Reference No. E–029–2008/0–US–01).
U.S. Provisional Application No. 61/
041,842 filed 02 Apr 2008 (HHS
Reference No. E–029–2008/1–US–01).
Licensing Status: Available for
licensing.
Licensing Contact: Michael A.
Shmilovich, Esq.; 301–435–5019;
shmilovm@mail.nih.gov.
Collaborative Research Opportunity:
The National Cancer Institute HIV and
AIDS Malignancy Branch is seeking
PO 00000
Frm 00081
Fmt 4703
Sfmt 4703
statements of capability or interest from
parties interested in collaborative
research to further develop, evaluate, or
commercialize HPV-induced aberrant
expression of microRNAs for cervical
cancer diagnostics and therapeutics.
Please contact John D. Hewes, PhD at
301–435–3121 or hewesj@mail.nih.gov
for more information.
Microarray Binding Sensors Using
Carbon Nanotube Transistors
Description of Technology: Available
for licensing and commercial
development are: (a) An apparatus
containing microarray binding sensors
having biological probe materials and
carbon nanotube transistors (CNTs) and
(b) various methods of using the highly
sensitive CNTs for the electronic
detection of nucleic acid hybridization
for performing microarray gene
expression experiments and detection of
DNA–DNA, DNA–RNA, Peptide Nucleic
Acid (PNA) –DNA, PNA–RNA, DNAprotein or PNA-protein binding. By
analogy to the microarray concept, each
transistor is associated with a distinct
probe oligonucleotide. Each transistor is
operated as a field effect transistor (FET)
and the transconductance between the
source and drain electrodes is measured
before and after a hybridization event.
The expected advantages are, besides
higher sensitivity and ease of use, the
elimination of chemical labeling and
enzymatic manipulation and the further
miniaturization. The unique distinction
of this design over other CNT-based
biomolecular sensing schemes is the
complete isolation of the CNTs from
chemical reactions concomitant with
probe immobilization and target
capture, and the CNTs functioning only
as charge sensors. In contrast, current
methods rely on enzymatic
amplification of nucleic acids,
fluorescent labeled targets,
hybridization, amplification of signal
and detection by optical scanners,
which are time consuming and have
limited sensitivity.
Applications: The apparatus and
method can be used for numerous
applications, among them: Highthroughput monitoring of genome-wide
E:\FR\FM\06MYN1.SGM
06MYN1
Federal Register / Vol. 73, No. 88 / Tuesday, May 6, 2008 / Notices
rwilkins on PROD1PC63 with NOTICES
DNA, mRNA copy number changes;
sequencing of DNA; miRNA levels in
cancer; or identifying targets of
transcription factors.
Furthermore, given the intensity of
effort in linking gene expression with
diseases, it is only a matter of time
before diagnosis and prognosis of
certain ailments can be performed on
the basis of gene expression. At the
present, most such analyses require
costly apparatus and labor-intensive
laboratory procedures.
Development Status: In the process of
developing prototypes.
Inventors: Javed Khan (NCI) et al.
Publications:
1. H Pandana, KH Aschenbach, D
Lenski, M Fuhrer, J Khan, RD Gomez. A
versatile biomolecular charge based
sensor using oxide-gated carbon
nanotube transistor arrays. IEEE Sens J.,
Special Issue, July 2008, in press.
2. K Aschenbach, H Pandana, J Lee, J
Khan, M Fuhrer, D Lenski, RD Gomez.
Detection of nucleic acid hybridization
via oxide gated carbon nanotube field
effect transistors (invited). Proceedings
of SPIE MEMS and Nanotechnologies,
Volume 6959 (2008), in press.
Patent Status:
U.S. Patent Application No. 60/
743,524 filed 17 Mar 2006 (HHS
Reference No. E–056–2007/0–US–01).
PCT Application No. PCT/US2007/
06809 filed 19 Mar 2007, which
published as WO 2007/109228 on 27
Sep 2007 (HHS Reference No. E–056–
2007/0–PCT–02).
U.S. Patent Application No. 11/
723,369 filed 19 Mar 2007 (HHS
Reference No. E–056–2007/0–US–03).
Licensing Status: Available for nonexclusive or exclusive licensing.
Licensing Contact: Cristina
Thalhammer-Reyero, Ph.D., M.B.A.;
301–435–4507; thalhamc@mail.nih.gov.
Collaborative Research Opportunity:
The Oncogenomics Section, Center for
Cancer Research, National Cancer
Institute, is seeking statements of
capability or interest from parties
interested in collaborative research to
further develop, evaluate, or
commercialize electrical detection of
nucleic acid and protein levels. Please
contact Javed Khan, M.D. at 301–435–
2937 or khanjav@mail.nih.gov for more
information.
Segmenting Colon Wall Via Level Set
Techniques
Description of Technology: Virtual
Colonoscopy (VC) has become a more
prevalent and accepted method of
colorectal cancer diagnosis. An essential
element for detecting cancerous polyps
using VC, in conjunction with
computer-aided detection, is the
VerDate Aug<31>2005
17:11 May 05, 2008
Jkt 214001
accurate segmentation of the colon wall.
While the inner boundary of the colon
wall, the lumen-mucosal boundary, has
often been the focus of previous
segmentation work, detection of the
outer wall, the serosal tissue boundary,
allows for the segmentation of the colon
wall, which is useful in determining
potential polyps, muscular hypertrophy,
and diverticulitis of the colon.
Unfortunately, automatic determination
of the outer colon wall position often is
difficult due to the low contrast between
CT attenuation values of the colon wall
and the surrounding fat tissue. This
invention is a level set based method to
determine, from a CT colonography
(CTC) scan, the location of the colon
serosal tissue boundary. After
determining this location, the algorithm
segments the entire colon wall at
subvoxel accurate precision.
In this algorithm, the loops in the
colon caused by over-distention are
detected and removed when the
centerline calculation is performed.
Also, a newly developed method for the
detection and segmentation of the outer
wall of the colon is used to connect
collapsed portions where the lumen
segmentation failed to produce a
connected centerline. These two
methods allow for a complete and
accurate centerline to be calculated in
uniformly distended colons as well as
colons containing segments which are
over and/or under-distended.
Applications: Diagnostics.
Inventors: Robert L. Van Uitert,
Ronald M. Summers, Ingmar Bitter (CC).
Publications:
1. R Van Uitert, I Bitter. Subvoxel
precise skeletons of volumetric data
based on fast marching methods. Med
Phys. 2007 Feb;34(2):627–638.
2. RL Van Uitert, RM Summers.
Automatic correction of level set based
subvoxel precise centerlines for virtual
colonoscopy using the colon outer wall.
IEEE Trans Med Imaging. 2007
Aug;26(8):1069–1078.
3. RM Summers, J Yao, PJ Pickhardt,
M Franaszek, I Bitter, D Brickman, V
Krishna, JR Choi. Computed
tomographic virtual colonoscopy
computer-aided polyp detection in a
screening population. Gastroenterology.
2005 Dec;129(6):1832–1844.
4. R Van Uitert, I Bitter, RM Summers,
JR Choi, PJ Pickhardt. Quantitative
assessment of colon distention for polyp
detection in CT virtual colonoscopy.
Proc SPIE Int Soc Opt Eng. (2006)
6143,61431B:451–457; published online
13 Mar 2006, doi 10.1117/12.653205.
5. R Van Uitert, I Bitter, RM Summers.
Detection of colon wall outer boundary
and segmentation of the colon wall
based on level set methods. Conf Proc
PO 00000
Frm 00082
Fmt 4703
Sfmt 4703
25019
IEEE Eng Med Biol Soc. 2006;1:3017–
3020.
6. G Iordanescu, RM Summers.
Benefits of centerline analysis for CT
colonography computer-aided polyp
detection. Proc SPIE Int Soc Opt Eng.
(2003) 5031:388–397; published online
02 May 2003, doi:10.1117/12.485797.
7. G Iordanescu, RM Summers.
Automated centerline for computed
tomography colonography. Acad Radiol.
2003 Nov;10(11):1291–1301.
Patent Status: U.S. Patent Application
No. 11/810,704 filed 05 Jun 2007 (HHS
Reference No. E–298–2006/0–US–01).
Licensing Status: Available for
licensing.
Licensing Contact: Michael A.
Shmilovich, Esq.; 301–435–5019;
shmilovm@mail.nih.gov.
Dated: April 28, 2008.
Steven M. Ferguson,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. E8–9871 Filed 5–5–08; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Cancer Institute; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2), notice
is hereby given of the following
meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Cancer
Institute Special Emphasis Panel; The Colon
Cancer Family Registry.
Date: May 29, 2008.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: Marriott Courtyard Gaithersburg
Washingtonian Ctr, 204 Boardwalk Place,
Gaithersburg, MD 20878.
Contact Person: Gerald G. Lovinger, PhD,
Scientific Review Officer, Special Review
and Logistics Branch, Division of Extramural
Activities, National Cancer Institute, 6116
Executive Blvd., Room 8101, Bethesda, MD
E:\FR\FM\06MYN1.SGM
06MYN1
Agencies
[Federal Register Volume 73, Number 88 (Tuesday, May 6, 2008)]
[Notices]
[Pages 25018-25019]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-9871]
-----------------------------------------------------------------------
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.
Human Papillomavirus microRNA Diagnostics and Therapeutics
Description of Technology: Available for licensing and commercial
development are patent rights that cover the uses of a p53 specific
microRNA (miRNA). It has been reported that the tumor suppressive mRNA
miR-34a (a downstream target of p53) is downregulated in HPV-infected
primary keratinocytes. miR-34a arrests the cell cycle at G2 phase and
promotes apoptosis. Therapeutic restoration of normal expression levels
of miR-34a and/or simultaneous stabilization of p53 (inhibited by HPV
E6) induces miR-34a accumulation in G0/G1 phase and can arrest tumor
growth. Neoplasia and cancer cell progression has also been associated
with p18Ink4c overexpression which can be regulated with the
introduction of a therapeutic amount of miR-34a. Tumor reduction/
suppression by down regulating p18Ink4c is also a therapeutic benefit
provided by this invention.
Applications: Cervical cancer; Human papillomavirus; Therapeutics.
Inventors: Zhi-Ming Zheng and Xiaohong Wang (NCI).
Publications:
1. WO Lui et al. Patterns of known and novel small RNAs in human
cervical cancer. Cancer Res. 2007 Jul 1;67(13):6031-6043.
2. I Martinez et al. Human papillomavirus type 16 reduces the
expression of microRNA-218 in cervical carcinoma cells. Oncogene 2007
Nov 12; Advance online publication, doi:10.1038/sj.onc.1210919.
Patent Status:
U.S. Provisional Application No. 60/983,368 filed 29 Oct 2007 (HHS
Reference No. E-029-2008/0-US-01).
U.S. Provisional Application No. 61/041,842 filed 02 Apr 2008 (HHS
Reference No. E-029-2008/1-US-01).
Licensing Status: Available for licensing.
Licensing Contact: Michael A. Shmilovich, Esq.; 301-435-5019;
shmilovm@mail.nih.gov.
Collaborative Research Opportunity: The National Cancer Institute
HIV and AIDS Malignancy Branch is seeking statements of capability or
interest from parties interested in collaborative research to further
develop, evaluate, or commercialize HPV-induced aberrant expression of
microRNAs for cervical cancer diagnostics and therapeutics. Please
contact John D. Hewes, PhD at 301-435-3121 or hewesj@mail.nih.gov for
more information.
Microarray Binding Sensors Using Carbon Nanotube Transistors
Description of Technology: Available for licensing and commercial
development are: (a) An apparatus containing microarray binding sensors
having biological probe materials and carbon nanotube transistors
(CNTs) and (b) various methods of using the highly sensitive CNTs for
the electronic detection of nucleic acid hybridization for performing
microarray gene expression experiments and detection of DNA-DNA, DNA-
RNA, Peptide Nucleic Acid (PNA) -DNA, PNA-RNA, DNA-protein or PNA-
protein binding. By analogy to the microarray concept, each transistor
is associated with a distinct probe oligonucleotide. Each transistor is
operated as a field effect transistor (FET) and the transconductance
between the source and drain electrodes is measured before and after a
hybridization event. The expected advantages are, besides higher
sensitivity and ease of use, the elimination of chemical labeling and
enzymatic manipulation and the further miniaturization. The unique
distinction of this design over other CNT-based biomolecular sensing
schemes is the complete isolation of the CNTs from chemical reactions
concomitant with probe immobilization and target capture, and the CNTs
functioning only as charge sensors. In contrast, current methods rely
on enzymatic amplification of nucleic acids, fluorescent labeled
targets, hybridization, amplification of signal and detection by
optical scanners, which are time consuming and have limited
sensitivity.
Applications: The apparatus and method can be used for numerous
applications, among them: High-throughput monitoring of genome-wide
[[Page 25019]]
DNA, mRNA copy number changes; sequencing of DNA; miRNA levels in
cancer; or identifying targets of transcription factors.
Furthermore, given the intensity of effort in linking gene
expression with diseases, it is only a matter of time before diagnosis
and prognosis of certain ailments can be performed on the basis of gene
expression. At the present, most such analyses require costly apparatus
and labor-intensive laboratory procedures.
Development Status: In the process of developing prototypes.
Inventors: Javed Khan (NCI) et al.
Publications:
1. H Pandana, KH Aschenbach, D Lenski, M Fuhrer, J Khan, RD Gomez.
A versatile biomolecular charge based sensor using oxide-gated carbon
nanotube transistor arrays. IEEE Sens J., Special Issue, July 2008, in
press.
2. K Aschenbach, H Pandana, J Lee, J Khan, M Fuhrer, D Lenski, RD
Gomez. Detection of nucleic acid hybridization via oxide gated carbon
nanotube field effect transistors (invited). Proceedings of SPIE MEMS
and Nanotechnologies, Volume 6959 (2008), in press.
Patent Status:
U.S. Patent Application No. 60/743,524 filed 17 Mar 2006 (HHS
Reference No. E-056-2007/0-US-01).
PCT Application No. PCT/US2007/06809 filed 19 Mar 2007, which
published as WO 2007/109228 on 27 Sep 2007 (HHS Reference No. E-056-
2007/0-PCT-02).
U.S. Patent Application No. 11/723,369 filed 19 Mar 2007 (HHS
Reference No. E-056-2007/0-US-03).
Licensing Status: Available for non-exclusive or exclusive
licensing.
Licensing Contact: Cristina Thalhammer-Reyero, Ph.D., M.B.A.; 301-
435-4507; thalhamc@mail.nih.gov.
Collaborative Research Opportunity: The Oncogenomics Section,
Center for Cancer Research, National Cancer Institute, is seeking
statements of capability or interest from parties interested in
collaborative research to further develop, evaluate, or commercialize
electrical detection of nucleic acid and protein levels. Please contact
Javed Khan, M.D. at 301-435-2937 or khanjav@mail.nih.gov for more
information.
Segmenting Colon Wall Via Level Set Techniques
Description of Technology: Virtual Colonoscopy (VC) has become a
more prevalent and accepted method of colorectal cancer diagnosis. An
essential element for detecting cancerous polyps using VC, in
conjunction with computer-aided detection, is the accurate segmentation
of the colon wall. While the inner boundary of the colon wall, the
lumen-mucosal boundary, has often been the focus of previous
segmentation work, detection of the outer wall, the serosal tissue
boundary, allows for the segmentation of the colon wall, which is
useful in determining potential polyps, muscular hypertrophy, and
diverticulitis of the colon. Unfortunately, automatic determination of
the outer colon wall position often is difficult due to the low
contrast between CT attenuation values of the colon wall and the
surrounding fat tissue. This invention is a level set based method to
determine, from a CT colonography (CTC) scan, the location of the colon
serosal tissue boundary. After determining this location, the algorithm
segments the entire colon wall at subvoxel accurate precision.
In this algorithm, the loops in the colon caused by over-distention
are detected and removed when the centerline calculation is performed.
Also, a newly developed method for the detection and segmentation of
the outer wall of the colon is used to connect collapsed portions where
the lumen segmentation failed to produce a connected centerline. These
two methods allow for a complete and accurate centerline to be
calculated in uniformly distended colons as well as colons containing
segments which are over and/or under-distended.
Applications: Diagnostics.
Inventors: Robert L. Van Uitert, Ronald M. Summers, Ingmar Bitter
(CC).
Publications:
1. R Van Uitert, I Bitter. Subvoxel precise skeletons of volumetric
data based on fast marching methods. Med Phys. 2007 Feb;34(2):627-638.
2. RL Van Uitert, RM Summers. Automatic correction of level set
based subvoxel precise centerlines for virtual colonoscopy using the
colon outer wall. IEEE Trans Med Imaging. 2007 Aug;26(8):1069-1078.
3. RM Summers, J Yao, PJ Pickhardt, M Franaszek, I Bitter, D
Brickman, V Krishna, JR Choi. Computed tomographic virtual colonoscopy
computer-aided polyp detection in a screening population.
Gastroenterology. 2005 Dec;129(6):1832-1844.
4. R Van Uitert, I Bitter, RM Summers, JR Choi, PJ Pickhardt.
Quantitative assessment of colon distention for polyp detection in CT
virtual colonoscopy. Proc SPIE Int Soc Opt Eng. (2006) 6143,61431B:451-
457; published online 13 Mar 2006, doi 10.1117/12.653205.
5. R Van Uitert, I Bitter, RM Summers. Detection of colon wall
outer boundary and segmentation of the colon wall based on level set
methods. Conf Proc IEEE Eng Med Biol Soc. 2006;1:3017-3020.
6. G Iordanescu, RM Summers. Benefits of centerline analysis for CT
colonography computer-aided polyp detection. Proc SPIE Int Soc Opt Eng.
(2003) 5031:388-397; published online 02 May 2003, doi:10.1117/
12.485797.
7. G Iordanescu, RM Summers. Automated centerline for computed
tomography colonography. Acad Radiol. 2003 Nov;10(11):1291-1301.
Patent Status: U.S. Patent Application No. 11/810,704 filed 05 Jun
2007 (HHS Reference No. E-298-2006/0-US-01).
Licensing Status: Available for licensing.
Licensing Contact: Michael A. Shmilovich, Esq.; 301-435-5019;
shmilovm@mail.nih.gov.
Dated: April 28, 2008.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. E8-9871 Filed 5-5-08; 8:45 am]
BILLING CODE 4140-01-P