Prospective Grant of Exclusive License: Implants for Sustained Ocular Therapeutic Agent Delivery, 77420-77421 [E5-8120]
Download as PDF
<![CDATA[
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
Federal Register / Vol. 70, No. 250 / Friday, December 30, 2005 / Notices
Dated: December 21, 2005.
Steven M. Ferguson,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. E5–8120 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: Fusion Proteins Comprising
Circularly Permuted Ligands
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, Department of
Health and Human Services, is
contemplating the grant of an exclusive
patent license to practice the inventions
embodied in United States Patent No.
4,892,827, issued on January 9, 1990,
entitled ‘‘Recombinant Pseudomonas
Exotoxin: Construction Of An Active
Immunotoxin With Low Side Effects’’
[E–385–1986/0–US–01]; U.S. Patent No.
5,635,599, issued on June 3, 1997,
entitled ‘‘Fusion Proteins Comprising
Circularly Permuted Ligands’’ [E–047–
1994/0–US–01]; PCT Patent Application
No. PCT/US95/04468, filed April 6,
1995, entitled ‘‘Fusion Proteins
Comprising Circularly Permuted
Ligands’’ [E–047–1994/0–PCT–02];
Switzerland Patent No. 0754192, issued
on January 29, 2003, entitled ‘‘Fusion
Proteins Comprising Circularly
Permuted Ligands’’ [E–047–1994/0–CH–
03]; Spain Patent No. 0754192, issued
on January 29, 2003, entitled ‘‘Fusion
Proteins Comprising Circularly
Permuted Ligands’’ [E–047–1994/0–ES–
04]; United Kingdom Patent No.
0754192, issued on January 29, 2003,
entitled ‘‘Fusion Proteins Comprising
Circularly Permuted Ligands’’ [E–047–
1994/0–GB–05]; Italy Patent No.
0754192, issued on January 29, 2003,
entitled ‘‘Fusion Proteins Comprising
Circularly Permuted Ligands’’ [E–047–
1994/0–IT–06]; Luxembourg Patent No.
0754192, issued on January 29, 2003,
entitled ‘‘Fusion Proteins Comprising
Circularly Permuted Ligands’’ [E–047–
1994/0–LU–07]; Netherlands Patent No.
0754192, issued on January 29, 2003,
entitled ‘‘Fusion Proteins Comprising
Circularly Permuted Ligands’’ [E–047–
1994/0–NL–09]; German Patent No.
0754192, issued on January 29, 2003,
entitled ‘‘Fusion Proteins Comprising
VerDate Aug<31>2005
18:16 Dec 29, 2005
Jkt 208001
Circularly Permuted Ligands’’ [E–047–
1994/0–DE–10]; Austria Patent No.
0754192, issued on January 29, 2003,
entitled ‘‘Fusion Proteins Comprising
Circularly Permuted Ligands’’ [E–047–
1994/0–AT–11]; Australia Patent No.
694211, issued on November 5, 1998,
entitled ‘‘Fusion Proteins Comprising
Circularly Permuted Ligands’’ [E–047–
1994/0–AU–12]; Belgium Patent No.
0754192, issued on January 29, 2003,
entitled ‘‘Fusion Proteins Comprising
Circularly Permuted Ligands’’ [E–047–
1994/0–BE–13]; Canada Patent No.
2187283, filed on April 6, 1995, entitled
‘‘Fusion Proteins Comprising Circularly
Permuted Ligands’’ [E–047–1994/0–CA–
14]; European Patent No. 0754192,
issued on January 29, 2003, entitled
‘‘Fusion Proteins Comprising Circularly
Permuted Ligands’’ [E–047–1994/0–EP–
15]; France Patent No. 0754192, issued
on January 29, 2003, entitled ‘‘Fusion
Proteins Comprising Circularly
Permuted Ligands’’ [E–047–1994/0–FR–
16]; Ireland Patent No. 0754192, issued
on January 29, 2003, entitled ‘‘Fusion
Proteins Comprising Circularly
Permuted Ligands’’ [E–047–1994/0–IE–
17]; Liechtenstein Patent No. 0754192,
issued on January 29, 2003, entitled
‘‘Fusion Proteins Comprising Circularly
Permuted Ligands’’ [E–047–1994/0–LI–
18]; and U.S. Patent No. 6,011,002,
issued on January 4, 2000, entitled
‘‘Circularly Permutated Ligands And
Circularly Permuted Chimeric
Molecules’’ [E–047–1994/1–US–01] to
Protox Therapeutics, Inc., which has
offices in Vancouver, British Columbia,
Canada. 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 Interleukin-4/cytotoxin fusion
proteins for the treatment of cancer.
DATES: Only written comments and/or
applications for a license which are
received by the NIH Office of
Technology Transfer on or before
February 28, 2006 will be considered.
ADDRESSES: Requests for copies of the
patent application, inquiries, comments,
and other materials relating to the
contemplated exclusive license should
be directed to: Jesse S. Kindra, J.D.,
M.S., Technology Licensing Specialist,
Office of Technology Transfer, National
Institutes of Health, 6011 Executive
Boulevard, Suite 325, Rockville, MD
20852–3804; Telephone: (301) 435–
5559; Facsimile: (301) 402–0220; E-mail:
kindraj@mail.nih.gov.
SUPPLEMENTARY INFORMATION: The
technology relates to circularly
permuted ligands having the ability to
PO 00000
Frm 00050
Fmt 4703
Sfmt 4703
77421
change the conformation of certain
proteins so that they can be more
effectively used as therapeutics.
Specifically, growth factors such as IL–
4 can be used in fusion proteins to target
cell surface receptors. Accordingly,
these growth factors can be used, when
linked with cytotoxic moieties (i.e.,
Pseudomonas Exotoxin), to target and
then kill desired cells. These circularly
permuted molecules are advantageous
over prior molecules in that they allow
greater binding specificity of an
immunotoxin to the targeted cell. This
change in conformation is a result of the
production of new carboxyl and amino
termini. The new termini are located
away from the active binding site and
hence cause less steric hindrance
between the active site and the fused
protein. Hence, the targeting moiety is
closer to its native conformation.
Without such a conformational change,
binding specificity for the immunotoxin
is greatly reduced. Therefore, these
circularly permuted molecules allow for
greater binding specificity without
retarding the cytotoxicity of the toxin to
which they are bound.
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, 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.
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: December 14, 2005.
Steven M. Ferguson,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. E5–8131 Filed 12–29–05; 8:45 am]
BILLING CODE 4140–01–P
E:\FR\FM\30DEN1.SGM
30DEN1
]]>Agencies
[Federal Register Volume 70, Number 250 (Friday, December 30, 2005)]
[Notices]
[Pages 77420-77421]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E5-8120]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive License: Implants for Sustained
Ocular Therapeutic Agent Delivery
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-
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 Sj[ouml]gren'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
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.
[[Page 77421]]
Dated: December 21, 2005.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. E5-8120 Filed 12-29-05; 8:45 am]
BILLING CODE 4140-01-P
