Prospective Grant of Exclusive License: Software for Predicting Molecular Properties and Pathogen Detection, 77419-77420 [E5-8133]
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Federal Register / Vol. 70, No. 250 / Friday, December 30, 2005 / Notices
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 404.7. The prospective
exclusive license may be granted unless,
within 60 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.
Dated: December 22, 2005.
Steven M. Ferguson,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. E5–8139 Filed 12–29–05; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive
License: Software for Predicting
Molecular Properties and Pathogen
Detection
National Institutes of Health,
Public Health Service, HHS.
ACTION: Notice.
wwhite on PROD1PC61 with NOTICES
AGENCY:
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 (NIH), Department
of Health and Human Services, is
contemplating the grant of an exclusive
worldwide license to practice the
invention embodied in E–169–2000/0
‘‘Drift Compensation Method for
Fingerprint Spectra,’’ U.S. Patent
Application No. 09/975,530 filed
October 10, 2001; E–297–2001/0
‘‘Methods For Predicting Properties of
Molecules,’’ U.S. Patent Application No.
10/383,602 filed March 7, 2003; and E–
017–2003/0 ‘‘Improved Pattern
Recognition Of Whole Cell Mass Spectra
Via Separation Of Specific Charge
States,’’ U.S. Patent Application No. 10/
863,745 filed June 7, 2004; to Litmus,
LLC an Arkansas corporation having its
headquarters in Little Rock, Arkansas.
The United States of America is the
assignee of the patent rights of the above
inventions.
VerDate Aug<31>2005
18:16 Dec 29, 2005
Jkt 208001
The contemplated exclusive license
may be granted in the field of providing
software solutions for pathogen
detection and for predicting molecular
properties.
DATES: Only written comments and/or
applications for a license received by
the NIH Office of Technology Transfer
on or before February 28, 2006 will be
considered.
ADDRESSES: Requests for a copy of the
patent applications, inquiries,
comments and other materials relating
to the contemplated license should be
directed to: Michael A. Shmilovich,
Esq., Office of Technology Transfer,
National Institutes of Health, 6011
Executive Boulevard, Suite 325,
Rockville, MD 20852–3804; Telephone:
(301) 435–5019; Facsimile: (301) 402–
0220; E-mail: shmilovm@mail.nih.gov.
A signed confidentiality nondisclosure
agreement may be required to receive
copies of the patent applications.
SUPPLEMENTARY INFORMATION: The patent
applications intended for licensure
disclose and/or cover the following:
E–297–2001 ‘‘Methods For Predicting
Properties of Molecules’’ Quantitative
Spectral data-activity relationships
(QSDAR)
The invention relates to methods for
predicting the biological, chemical, and
physical properties of molecules from
their chemical shift through bond and
through spatial distance connectivity
patterns. This invention is related to E–
209–1999 (related to the SDAR patent
that could use chemical shift through
bond correlated data); however, here
predicted NMR chemical shift data is
used that has already been structurally
assigned. The invention uses the carbon
or other heteronuclear molecular
skeleton atom to atom connectivity of
the molecule instead of proton to proton
or proton to carbon connectivity that
can be obtained from NMR experimental
spectra of unlabeled molecules. This
allows a model to be built using a
complete molecular connectivity pattern
instead of a pattern developed from a set
of individual 2 or 3 atom pieces of a
molecule. A 2D through bond
connectivity spectrum is produced with
a cross peak bin ‘‘hit’’ occurring when
there is an atom to atom bond
connection. Only half of the spectrum is
used because the spectrum is
symmetrical. A 2D through space
connectivity spectrum is simulated is
produced with a cross peak bin ‘‘hit’’
occurring when there is a atom to atom
distance r is within a certain specified
range.
The through bond and through space
spectra can be reduced to principal
PO 00000
Frm 00048
Fmt 4703
Sfmt 4703
77419
components. The biological, chemical,
and physical endpoints are added to the
connectivity patterns and multiple
linear regression (OVILS) or artificial
neural networks (ANN) methods are
applied to produce and validate the
model. This provides a very rapid,
reliable ability to model many different
compounds. The model uses the
structurally assigned chemical shifts
from predicted NMR spectra. The
through bond and through space
connectivity patterns uses the structural
assignment of the chemical shifts. The
through bond connectivity pattern gives
a local description of the atoms and the
through space connectivity pattern gives
a non-local description of the atoms.
The combination of the through bond
and through space molecular
connectivity pattern provides a very
precise pattern that can be used by
pattern recognition software to produce
a model. All parts of this model can be
completely computerized. The ideas
used in this model may be able to
produce the highest cross-validated
models of ‘‘endpoints’’ that are
important to the public health service.
E–169–2000 ‘‘Microbial Identification
Databases’’
The invention is a method for, based
on an assembled coherent database,
containing an essentially unlimited
number of pyrolysis mass spectra to
enable rapid chemotaxonomy of
unknown microbial samples. The
invention corrects for short- and longterm drift of microbial pyrolysis mass
spectra by using spectra of similar
microbes as internal standards. The
invention provides a way to assemble a
coherent database containing an
essentially unlimited number of
pyrolysis mass spectra or other
instrumental ‘‘fingerprints,’’ where one
or more is representative of each
relevant strain, and representative of
additional strains as they are added to
the pool of microbial agents.
Microorganisms can be identified using
the invention from their fingerprint
spectra regardless of the growth medium
used to culture the bacteria. This is a
result of the discovery that corrections
made to the fingerprint spectrum of one
type of bacterium to compensate for
changes in growth medium may be
applied successfully to metabolically
similar bacteria. Fingerprint spectra to
which the method of the invention may
be applied include pyrolysis MALDI or
other types of mass spectra, infrared
spectra, chromatograms, NMR spectra
and ion-mobility spectra. The present
invention is especially useful for the
rapid identification of microorganisms,
including human pathogens.
E:\FR\FM\30DEN1.SGM
30DEN1
77420
Federal Register / Vol. 70, No. 250 / Friday, December 30, 2005 / Notices
E–017–2003 ‘‘Pattern Recognition of
Whole Cell Mass Spectra’’
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
This invention analyzes mass spectra
(MALDI, SELDI) from a plurality of
microorganism sources and biological
agents. The invention is useful for
diagnosing disease, anticipating
epidemic outbreaks, monitoring food
supplies for contamination, regulating
bio-processing operations, and is
especially useful for detecting agents of
war. The invention dramatically
improves spectral analysis through
deconvolution of complex spectra by
collapsing multiple peaks showing
different molecular mass originating
from the same molecular fragment into
a single peak. The differences in
molecular mass are apparent differences
caused by different charge states of the
fragment and/or different metal ion
adducts of one or more of the charge
states. The deconvoluted spectrum is
compared to a library of mass spectra
acquired from samples of known
identity to unambiguously determine
the identity of one or more components
of the sample undergoing analysis.
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 404.7. The prospective
exclusive license may be granted unless,
within sixty (60) 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.
National Institutes of Health
Dated: December 14, 2005.
Steven M. Ferguson,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. E5–8133 Filed 12–29–05; 8:45 am]
wwhite on PROD1PC61 with NOTICES
BILLING CODE 4140–01–P
VerDate Aug<31>2005
18:16 Dec 29, 2005
Jkt 208001
Prospective Grant of Exclusive
License: Implants for Sustained Ocular
Therapeutic Agent Delivery
National Institutes of Health,
Public Health Service, HHS.
ACTION: Notice.
AGENCY:
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 (NIH), Department
of Health and Human Services, is
contemplating the grant of an exclusive
worldwide license to practice the
invention embodied in E–241–1999/0,
‘‘Ocular Therapeutic Agent Delivery
Devices And Methods For Making And
Using Such Devices;’’ U.S. Patent
6,713,081 issued March 30, 2004 and
expires March 15, 2021; U.S. Patent
Application 10/471,468 filed September
12, 2004; and European Patent
Application 02723446.7 filed March 14,
2002; to Lux Biosciences, a Delaware
corporation having a principle place of
business in Jersey City, New Jersey. The
United States of America is the assignee
of the patent rights of the above
inventions.
The contemplated exclusive license
may be granted in the field of ocular
cyclosporine A delivery for the
treatment of graft-versus-host-disease¨
associated dry eye and Sjogren’s
Syndrome.
DATES: Only written comments and/or
applications for a license received by
the NIH Office of Technology Transfer
on or before February 28, 2006 will be
considered.
ADDRESSES: Requests for a copy of the
patent applications, inquiries,
comments and other materials relating
to the contemplated license should be
directed to: Michael A. Shmilovich,
Esq., Office of Technology Transfer,
National Institutes of Health, 6011
Executive Boulevard, Suite 325,
Rockville, MD 20852–3804; Telephone:
(301) 435–5019; Facsimile: (301) 402–
0220; E-mail: shmilovm@mail.nih.gov.
A signed confidentiality nondisclosure
agreement may be required to receive
copies of the patent applications.
SUPPLEMENTARY INFORMATION: The patent
applications intended for licensure
disclose and/or cover the following: E–
241–1999/0, ‘‘Ocular Therapeutic Agent
Delivery Devices And Methods For
Making And Using Such Devices.’’ The
invention is a method and apparatus for
delivering a precisely controlled amount
of drug to the eye on a sustained basis
PO 00000
Frm 00049
Fmt 4703
Sfmt 4703
using an implantable polymer cylinder
containing a drug pellet. In this method,
the thickness of the polymer around the
drug pellet is precisely controlled to
provide a predictable release rate of the
drug to the eye. Drug pellets made using
a modified press are placed in a teflon
tube having a silicone base, the top of
the tube is filled with wet silicone and
the pellet is spun down and centered in
the teflon tubing. The teflon tubing is
removed and the top and bottom ends
of the silicone cylinder surrounding the
pellet are trimmed. Thus, an annulus of
uniform thickness surrounds the drug
pellet, resulting in a uniform and
predictable release rate. The invention
also comprises a method, apparatus and
implant design developed for surgical
subconjunctival implantation to deliver
an initial bolus of drug to the eye
compartments followed by slow release
of drug from the polymer matrix of the
implant. A pellet of drug (e.g.,
cyclosporine) is imbedded between two
saucer or disk shaped polyvinyl alcohol
(PVA) components, forming a ‘‘wafer’’
shaped implant. The drug is also mixed
into the matrix of the PVA itself at a
nominal 10% concentration. Soon after
implantation, a high level of drug is
delivered to the eye for the first month
and, thereafter, the embedded pellet
sustains a continuous release of the
drug.
The invention has also been described
along with preclinical data in a recent
publication by Kim et al. (2005) IOVS
46(2):655–662, ‘‘Preclinical Evaluation
of a Novel Episcleral Cyclosporine
Implant for Ocular Graft-Versus-Host
Disease.’’
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 404.7. The prospective
exclusive license may be granted unless,
within sixty (60) 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.
E:\FR\FM\30DEN1.SGM
30DEN1
]]>Agencies
[Federal Register Volume 70, Number 250 (Friday, December 30, 2005)]
[Notices]
[Pages 77419-77420]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E5-8133]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive License: Software for Predicting
Molecular Properties and Pathogen Detection
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 (NIH),
Department of Health and Human Services, is contemplating the grant of
an exclusive worldwide license to practice the invention embodied in E-
169-2000/0 ``Drift Compensation Method for Fingerprint Spectra,'' U.S.
Patent Application No. 09/975,530 filed October 10, 2001; E-297-2001/0
``Methods For Predicting Properties of Molecules,'' U.S. Patent
Application No. 10/383,602 filed March 7, 2003; and E-017-2003/0
``Improved Pattern Recognition Of Whole Cell Mass Spectra Via
Separation Of Specific Charge States,'' U.S. Patent Application No. 10/
863,745 filed June 7, 2004; to Litmus, LLC an Arkansas corporation
having its headquarters in Little Rock, Arkansas. The United States of
America is the assignee of the patent rights of the above inventions.
The contemplated exclusive license may be granted in the field of
providing software solutions for pathogen detection and for predicting
molecular properties.
DATES: Only written comments and/or applications for a license received
by the NIH Office of Technology Transfer on or before February 28, 2006
will be considered.
ADDRESSES: Requests for a copy of the patent applications, inquiries,
comments and other materials relating to the contemplated license
should be directed to: Michael A. Shmilovich, Esq., Office of
Technology Transfer, National Institutes of Health, 6011 Executive
Boulevard, Suite 325, Rockville, MD 20852-3804; Telephone: (301) 435-
5019; Facsimile: (301) 402-0220; E-mail: shmilovm@mail.nih.gov. A
signed confidentiality nondisclosure agreement may be required to
receive copies of the patent applications.
SUPPLEMENTARY INFORMATION: The patent applications intended for
licensure disclose and/or cover the following:
E-297-2001 ``Methods For Predicting Properties of Molecules''
Quantitative Spectral data-activity relationships (QSDAR)
The invention relates to methods for predicting the biological,
chemical, and physical properties of molecules from their chemical
shift through bond and through spatial distance connectivity patterns.
This invention is related to E-209-1999 (related to the SDAR patent
that could use chemical shift through bond correlated data); however,
here predicted NMR chemical shift data is used that has already been
structurally assigned. The invention uses the carbon or other
heteronuclear molecular skeleton atom to atom connectivity of the
molecule instead of proton to proton or proton to carbon connectivity
that can be obtained from NMR experimental spectra of unlabeled
molecules. This allows a model to be built using a complete molecular
connectivity pattern instead of a pattern developed from a set of
individual 2 or 3 atom pieces of a molecule. A 2D through bond
connectivity spectrum is produced with a cross peak bin ``hit''
occurring when there is an atom to atom bond connection. Only half of
the spectrum is used because the spectrum is symmetrical. A 2D through
space connectivity spectrum is simulated is produced with a cross peak
bin ``hit'' occurring when there is a atom to atom distance r is within
a certain specified range.
The through bond and through space spectra can be reduced to
principal components. The biological, chemical, and physical endpoints
are added to the connectivity patterns and multiple linear regression
(OVILS) or artificial neural networks (ANN) methods are applied to
produce and validate the model. This provides a very rapid, reliable
ability to model many different compounds. The model uses the
structurally assigned chemical shifts from predicted NMR spectra. The
through bond and through space connectivity patterns uses the
structural assignment of the chemical shifts. The through bond
connectivity pattern gives a local description of the atoms and the
through space connectivity pattern gives a non-local description of the
atoms. The combination of the through bond and through space molecular
connectivity pattern provides a very precise pattern that can be used
by pattern recognition software to produce a model. All parts of this
model can be completely computerized. The ideas used in this model may
be able to produce the highest cross-validated models of ``endpoints''
that are important to the public health service.
E-169-2000 ``Microbial Identification Databases''
The invention is a method for, based on an assembled coherent
database, containing an essentially unlimited number of pyrolysis mass
spectra to enable rapid chemotaxonomy of unknown microbial samples. The
invention corrects for short- and long-term drift of microbial
pyrolysis mass spectra by using spectra of similar microbes as internal
standards. The invention provides a way to assemble a coherent database
containing an essentially unlimited number of pyrolysis mass spectra or
other instrumental ``fingerprints,'' where one or more is
representative of each relevant strain, and representative of
additional strains as they are added to the pool of microbial agents.
Microorganisms can be identified using the invention from their
fingerprint spectra regardless of the growth medium used to culture the
bacteria. This is a result of the discovery that corrections made to
the fingerprint spectrum of one type of bacterium to compensate for
changes in growth medium may be applied successfully to metabolically
similar bacteria. Fingerprint spectra to which the method of the
invention may be applied include pyrolysis MALDI or other types of mass
spectra, infrared spectra, chromatograms, NMR spectra and ion-mobility
spectra. The present invention is especially useful for the rapid
identification of microorganisms, including human pathogens.
[[Page 77420]]
E-017-2003 ``Pattern Recognition of Whole Cell Mass Spectra''
This invention analyzes mass spectra (MALDI, SELDI) from a
plurality of microorganism sources and biological agents. The invention
is useful for diagnosing disease, anticipating epidemic outbreaks,
monitoring food supplies for contamination, regulating bio-processing
operations, and is especially useful for detecting agents of war. The
invention dramatically improves spectral analysis through deconvolution
of complex spectra by collapsing multiple peaks showing different
molecular mass originating from the same molecular fragment into a
single peak. The differences in molecular mass are apparent differences
caused by different charge states of the fragment and/or different
metal ion adducts of one or more of the charge states. The deconvoluted
spectrum is compared to a library of mass spectra acquired from samples
of known identity to unambiguously determine the identity of one or
more components of the sample undergoing analysis.
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 404.7.
The prospective exclusive license may be granted unless, within sixty
(60) 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.
Dated: December 14, 2005.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. E5-8133 Filed 12-29-05; 8:45 am]
BILLING CODE 4140-01-P
