Docket No. 17618CON7B
`(AP)
`Docket No. 17618CON7B (AP)
`
`IN THE UNITED STATES PATENT
`AND
`TRADEMARK
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`OFFICE
`
`Applicant: Acheampong, et al.
`Applicant: Acheampong, et al.
`
`Examiner: TBA
`Examiner: TBA
`
`Serial No.: TBA
`Serial No.: TBA
`
`Filed: Herewith
`Filed: Herewith
`
`For: METHODS OF PROVIDING
`For: METHODS OF PROVIDING
`THERAPEUTIC EFFECTS USING
`THERAPEUTIC EFFECTS USING
`CYCLOSPORIN COMPONENTS
`CYCLOSPORIN COMPONENTS
`
`Group Art Unit: TBA
`Group Art Unit: TBA
`
`Confirmation No. TBA
`Confirmation No. TBA
`
`Customer No.: 51957
`Customer No.: 51957
`
`PRELIMINARY AMENDMENT
`PRELIMINARY AMENDMENT
`
`Commissioner for Patents
`Commissioner for Patents
`P.O. Box 1450
`P.O. Box 1450
`Alexandria, VA 22313-1450
`Alexandria, VA 22313-1450
`
`Dear Sir:
`Dear Sir:
`
`Prior to examining
`the
`above-referenced
`application,
`please
`Prior to examining the above-referenced application, please amend the
`specification as described
`on
`page
`2
`
`of please amend the claims this paper,
`
`
`specification as described on page 2 of this paper, and please amend the claims as
`described on pages 3-6
`of
`
`this Remarks follow on page paper.
`
`7.
`described on pages 3-6 of this paper. Remarks follow on page 7.
`
`amend
`and
`
`as
`
`the
`
`1
`1
`
`0001
`
`TEVA - EXHIBIT 1004 (PART 1 OF 4)
`
`

`

`Docket No. 17618CON7B
`(AP)
`Docket No. 17618CON7B (AP)
`
`Amendments to
`the Specification
`Amendments to the Specification
`
`Please replace page 1,
`lines
`5-10
`of
`the filed herewith with specification the
`
`
`
`following
`Please replace page 1, lines 5-10 of the specification filed herewith with the following
`amended paragraph:
`amended paragraph:
`This application
`is
`a continuation
`of
`copending U.S. Application Serial No.
`
`This application is a continuation of copending U.S. Application Serial No.
`
`13/961.835 filed August 7. 2013. which a continuation of copending U.S. Application is
`
`13/961,835 filed August 7, 2013, which is a continuation of copending U.S. Application
`Serial No. 11/897.177.
`
`filed August 28. 2007. which a continuation of U.S. Application is
`
`Serial No. 11/897,177, filed August 28, 2007, which is a continuation of U.S. Application
`Serial No. 10/927,857,
`filed August 27, 2004. now
`abandoned,
`which
`claimed
`Serial No. 10/927,857, filed August 27, 2004, now abandoned, which claimed the benefit
`of U.S. Provisional Application No.
`
`60/503,137 September 15, 2003, which-4s are filed
`
`of U.S. Provisional Application No. 60/503,137 filed September 15, 2003, which-is are
`incorporated in
`
`its their entirety herein by reference.
`incorporated in its their entirety herein by reference.
`
`the
`
`Please replace page 4,
`
`line page 5, line 3 of 25 -
`
`the
`
`specification herewith with filed
`
`the
`Please replace page 4, line 25 — page 5, line 3 of the specification filed herewith with the
`following amended paragraph:
`following amended paragraph:
`The present methods
`is
`are
`
`useful treating any suitable in
`
`condition which
`The present methods are useful in treating any suitable condition which is
`Such
`therapeutically sensitive to
`or
`treatable
`with
`cyclosporin
`components.
`therapeutically sensitive to or treatable with cyclosporin components. Such conditions
`one
`is relating to or having
`to
`do with
`preferably are ophthalmic
`or
`ocular
`conditions,
`that
`preferably are ophthalmic or ocular conditions, that is relating to or having to do with one
`or more parts of an eye
`of
`a
`human
`or
`animal.
`Included
`among
`or more parts of an eye of a human or animal. Included among such conditions are,
`without limitation, dry eye
`syndrome,
`phacoanaphylactic
`endophthalmitis, uveitis,
`without limitation, dry eye syndrome, phacoanaphylactic endophthalmitis, uveitis, vernal
`conjunctivitis, atopic keratoconjunctivitis,
`corneal
`graft
`rejection
`and
`conjunctivitis, atopic keratoconjunctivitis, corneal graft rejection and the like conditions.
`The present invention
`is
`particularly effective
`in
`treating dry eye syndrome. Cyclosporin
`The present invention is particularly effective in treating dry eye syndrome. Cyclosporin
`has been found as effective
`in
`
`treating mediated keratoconiunctivitis immune
`
`sicca
`(KCS
`has been found as effective in treating immune mediated keratoconjunctivitis sicca (KCS
`or dry eve disease)
`in
`
`a patient therefrom. The activity of suffering
`
`cyclosporins
`is
`or dry eye disease) in a patient suffering therefrom. The activity of cyclosporins is as an
`immunosuppressant and
`in
`the
`enhancement
`or
`restoring
`of
`immunosuppressant and in the enhancement or restoring of lacrimal gland tearing. Other
`conditions that can be
`treated with
`cyclosporin
`components
`include
`or partial
`conditions that can be treated with cyclosporin components include an absolute or partial
`deficiency in aqueous
`tear
`production
`(keratoconiunctivitis
`sicca,
`or
`deficiency in aqueous tear production (keratoconjunctivitis sicca, or KCS). Topical
`administration to a patient's
`tear
`deficient
`eve
`can increase
`tear production
`in
`the
`eve. The
`administration to a patient's tear deficient eye can increase tear production in the eye. The
`treatment can further serve
`to
`correct
`corneal
`and
`conjunctival
`disorders
`treatment can further serve to correct corneal and conjunctival disorders exacerbated by
`tear deficiency and KCS.
`such
`as corneal
`scarring,
`corneal
`ulceration,
`tear deficiency and KCS, such as corneal scarring, corneal ulceration, inflammation of
`the cornea or conjunctiva,
`filamentary
`keratisis. mucopurulent discharge
`and
`the cornea or conjunctiva, filamentary keratisis, mucopurulent discharge and
`vascularization of
`the
`cornea.
`vascularization of the cornea.
`
`the
`
`as
`lacrimal
`an
`KCS).
`
`inflammation
`
`2
`2
`
`0002
`
`

`

`Docket No. 17618CON7B
`(AP)
`Docket No. 17618CON7B (AP)
`
`Amendments to
`the
`claims
`Amendments to the claims
`
`The following
`list of
`claims will
`
`replace versions of claims presented all previous
`
`
`The following list of claims will replace all previous versions of claims presented
`in this application:
`in this application:
`1. - 36. (Canceled)
`1. — 36. (Canceled)
`
`37. (New) A method of
`
`increasing tear production
`in
`the
`eye
`of
`a method human,
`
`
`37. (New) A method of increasing tear production in the eye of a human, the method
`comprising topically
`administering
`to
`
`the human an emulsion at a eye of the
`
`
`
`frequency
`comprising topically administering to the eye of the human an emulsion at a frequency of
`twice a day, wherein
`the
`emulsion
`comprises
`cyclosporin
`A
`in
`twice a day, wherein the emulsion comprises cyclosporin A in an amount of about 0.05%
`by weight, polysorbate 80, Pemulen,
`water,
`and
`castor
`oil
`in
`by weight, polysorbate 80, Pemulen, water, and castor oil in an amount of about 1.25%
`by weight; and
`by weight; and
`wherein the
`topical ophthalmic
`emulsion
`
`is in increasing tear production. effective
`
`wherein the topical ophthalmic emulsion is effective in increasing tear production.
`
`the
`of
`
`an
`an
`
`38. (New) The method of
`Claim 37, wherein the emulsion
`
`further
`comprises
`38. (New) The method of Claim 37, wherein the emulsion further comprises a tonicity
`agent or a demulcent component.
`agent or a demulcent component.
`
`a
`
`tonicity
`
`39. (New) The method of
`Claim
`
`38, tonicity agent or wherein
`
`
`the the
`demulcent
`39. (New) The method of Claim 38, wherein the tonicity agent or the demulcent
`component is glycerine.
`component is glycerine.
`
`40. (New) The method of
`
`Claim wherein the emulsion 37,
`
`further
`comprises
`40. (New) The method of Claim 37, wherein the emulsion further comprises a buffer.
`
`a
`
`buffer.
`
`41. (New) The method of Claim
`
`40, the buffer is sodium hydroxide. wherein
`
`41. (New) The method of Claim 40, wherein the buffer is sodium hydroxide.
`
`42. (New) The method of
`Claim
`37,
`
`wherein ophthalmic emulsion the
`
`
`topical further
`42. (New) The method of Claim 37, wherein the topical ophthalmic emulsion further
`comprises glycerine and
`a buffer.
`comprises glycerine and a buffer.
`
`43. (New) The method of
`Claim
`37, the emulsion comprises polysorbate wherein
`
`
`80
`43. (New) The method of Claim 37, wherein the emulsion comprises polysorbate 80 in an
`
`amount of about 1.0% weight. by
`
`amount of about 1.0% by weight.
`
`in
`
`an
`
`3
`3
`
`0003
`
`

`

`Docket No. 17618CON7B
`(AP)
`Docket No. 17618CON7B (AP)
`
`44. (New) The method of
`Claim
`37,
`wherein
`the
`emulsion
`44. (New) The method of Claim 37, wherein the emulsion comprises Pemulen in an
`amount of about 0.05% by weight.
`amount of about 0.05% by weight.
`
`comprises
`
`45. (New) The method of
`Claim
`37, the emulsion further comprises wherein
`
`
`glycerine
`45. (New) The method of Claim 37, wherein the emulsion further comprises glycerine in
`an amount of about 2.2%
`by weight
`and
`a
`buffer.
`an amount of about 2.2% by weight and a buffer.
`
`in
`
`46. (New) The method of
`Claim
`45, the buffer is sodium hydroxide. wherein
`
`
`46. (New) The method of Claim 45, wherein the buffer is sodium hydroxide.
`
`47. (New) The method of
`Claim
`37,
`
`wherein, when emulsion is administered the
`
`to
`47. (New) The method of Claim 37, wherein, when the emulsion is administered to an
`eye of a human
`in
`an
`effective
`amount
`in
`
`treating the human has KCS,
`
`eye of a human in an effective amount in treating KCS, the blood of the human has
`substantially no detectable
`concentration
`of
`cyclosporin
`A.
`substantially no detectable concentration of cyclosporin A.
`
`an
`the
`
`blood
`
`48. (New) The method of
`Claim
`42, the emulsion has a pH wherein
`
`
`in
`the
`48. (New) The method of Claim 42, wherein the emulsion has a pH in the range of about
`7.2 to about 7.6.
`7.2 to about 7.6.
`
`range
`
`of
`
`49. (New) The method of
`Claim
`37, the emulsion is as wherein
`
`
`substantially
`49. (New) The method of Claim 37, wherein the emulsion is as substantially
`therapeutically effective
`as
`an
`emulsion comprising
`cyclosporin
`A
`therapeutically effective as an emulsion comprising cyclosporin A in an amount of 0.1%
`by weight and castor oil
`in
`an
`amount
`of
`1.25%
`by weight.
`by weight and castor oil in an amount of 1.25% by weight.
`
`in
`
`50. (New) The method of
`Claim 37, wherein the emulsion achieves
`
`at
`least as
`50. (New) The method of Claim 37, wherein the emulsion achieves at least as much
`A
`therapeutic effectiveness
`as
`an
`emulsion
`comprising
`cyclosporin
`therapeutic effectiveness as an emulsion comprising cyclosporin A in an amount of 0.1%
`by weight and castor oil
`in
`an
`amount
`of
`1.25%
`by weight.
`by weight and castor oil in an amount of 1.25% by weight.
`
`much
`
`in
`
`51. (New) The method of
`Claim 37, wherein the emulsion
`
`breaks
`down
`
`more in
`51. (New) The method of Claim 37, wherein the emulsion breaks down more quickly in
`the eye of a human, once
`administered
`
`to the human, thereby the eye
`
`
`of reducing
`
`vision
`the eye of a human, once administered to the eye of the human, thereby reducing vision
`distortion in
`the eye of
`the
`human
`as compared
`to
`an
`as
`emulsion
`distortion in the eye of the human as compared to an emulsion that contains only 50% as
`much castor oil.
`much castor oil.
`
`quickly
`
`52. (New) The method of
`Claim
`37, the emulsion, when administered wherein
`
`
`to
`52. (New) The method of Claim 37, wherein the emulsion, when administered to the eye
`of a human, demonstrates
`a
`reduction
`in
`adverse
`events
`in
`of a human, demonstrates a reduction in adverse events in the human, relative to an
`
`the eye
`the
`
`4
`4
`
`0004
`
`

`

`Docket No. 17618CON7B
`(AP)
`Docket No. 17618CON7B (AP)
`
`emulsion comprising cyclosporin A
`in
`an
`amount
`of
`0.1% in an
`emulsion comprising cyclosporin A in an amount of 0.1% by weight and castor oil in an
`amount of 1.25% by weight.
`amount of 1.25% by weight.
`
`
`
`by
`
`53. (New) The method of
`
`Claim 52, wherein the adverse events
`include
`side
`53. (New) The method of Claim 52, wherein the adverse events include side effects.
`
`effects.
`
`
`54. (New) A method of treating KCS, the method
`comprising
`the
`step
`54. (New) A method of treating KCS, the method comprising the step of topically
`administering to an eye
`of
`a
`human
`an
`emulsion
`at
`administering to an eye of a human an emulsion at a frequency of twice a day, the
`emulsion comprising:
`emulsion comprising:
`weight;
`0.05%) by
`cyclosporin A
`in
`an amount
`of
`about
`cyclosporin A in an amount of about 0.05% by weight;
`castor oil in an amount of
`about 1.25%
`by
`weight;
`castor oil in an amount of about 1.25% by weight;
`polysorbate 80 in
`an amount
`of
`
`about weight;
`1.0%
`polysorbate 80 in an amount of about 1.0% by weight;
`Pemulen in an amount of
`about 0.05%
`by
`weight;
`Pemulen in an amount of about 0.05% by weight;
`a tonicity component or
`a demulcent
`component
`in
`an
`a tonicity component or a demulcent component in an amount of about 2.2% by
`weight;
`weight;
`a buffer; and
`a buffer; and
`water;
`water;
`wherein the emulsion
`is
`effective
`in
`wherein the emulsion is effective in treating KCS.
`
`a
`
`by
`
`of
`
`topically
`frequency
`
`amount
`
`treating
`
`KCS.
`
`55. (New) The method of
`
`Claim 54, wherein the buffer
`is
`sodium
`hydroxide.
`55. (New) The method of Claim 54, wherein the buffer is sodium hydroxide.
`
`56. (New) The method of
`Claim 54, wherein the
`
`tonicity
`component
`or
`56. (New) The method of Claim 54, wherein the tonicity component or the demulcent
`component is glycerine.
`component is glycerine.
`
`the
`
`demulcent
`
`57. (New) The method of
`
`Claim 54, wherein, when
`the emulsion
`is
`administered
`57. (New) The method of Claim 54, wherein, when the emulsion is administered to the
`eye of a human
`in
`an
`effective
`amount
`in
`
`treating the human has KCS,
`
`eye of a human in an effective amount in treating KCS, the blood of the human has
`substantially no detectable
`concentration
`of
`the
`cyclosporin
`substantially no detectable concentration of the cyclosporin A.
`
`A.
`
`to
`
`the
`
`the
`blood
`
`58. (New) The method of
`
`Claim 54, wherein the emulsion has
`a
`pH
`in
`the
`58. (New) The method of Claim 54, wherein the emulsion has a pH in the range of about
`7.2 to about 7.6.
`7.2 to about 7.6.
`
`range
`
`5
`5
`
`0005
`
`

`

`Docket No. 17618CON7B
`(AP)
`Docket No. 17618CON7B (AP)
`
`a
`
`human
`
`by
`
`weight;
`
`59. (New) A method
`comprising:
`59. (New) A method comprising:
`administering an emulsion
`topically
`to
`the
`eye
`of
`administering an emulsion topically to the eye of a human having KCS, wherein
`the emulsion comprises:
`the emulsion comprises:
`cyclosporin A
`in
`an amount
`of
`about 0.05%
`cyclosporin A in an amount of about 0.05% by weight;
`
`castor oil in an amount about 1.25% by weight; of
`
`castor oil in an amount of about 1.25% by weight;
`polysorbate 80 in
`an
`amount
`of
`about
`polysorbate 80 in an amount of about 1.0% by weight;
`Pemulen in an amount of
`about
`0.05% by
`Pemulen in an amount of about 0.05% by weight;
`glycerine in an amount of
`about
`2.2%
`glycerine in an amount of about 2.2% by weight;
`sodium hydroxide; and
`sodium hydroxide; and
`water; and
`water; and
`wherein the emulsion
`is
`effective
`
`in tear production in increasing
`
`the
`human
`wherein the emulsion is effective in increasing tear production in the human
`having KCS.
`having KCS.
`
`by
`
`weight;
`
`1.0%
`weight;
`weight;
`
`by
`
`60. (New) The method of
`
`Claim 59, wherein the emulsion has
`a
`pH
`in
`the
`60. (New) The method of Claim 59, wherein the emulsion has a pH in the range of about
`7.2 to about 7.6.
`7.2 to about 7.6.
`
`range
`
`6
`6
`
`0006
`
`

`

`Docket No. 17618CON7B
`(AP)
`Docket No. 17618CON7B (AP)
`
`REMARKS
`REMARKS
`The applicants have canceled Claims 1-36 and have added Claims 37-60. Support
`The applicants have canceled Claims 1-36 and have added Claims 37-60. Support
`for the limitations recited in the new claims may be found throughout the specification,
`for the limitations recited in the new claims may be found throughout the specification,
`and at least at page 4, line 25
`page 5, line 14, page 10, lines 1-7, page 26, lines 5-19,
`and at least at page 4, line 25 — page 5, line 14, page 10, lines 1-7, page 26, lines 5-19,
`and page 27, lines 4-31 of the application specification filed herewith. No new matter is
`and page 27, lines 4-31 of the application specification filed herewith. No new matter is
`added.
`added.
`page 5, line 3
`Support for the amendment to the specification at page 4, line 25
`Support for the amendment to the specification at page 4, line 25 — page 5, line 3
`may be found, at least, in U.S. Patent Nos. 5,474,979 and 6,254,860, which were
`may be found, at least, in U.S. Patent Nos. 5,474,979 and 6,254,860, which were
`previously incorporated by reference in the present application specification at page 1,
`previously incorporated by reference in the present application specification at page 1,
`lines 18-21. The amendment contains no
`new
`matter.
`lines 18-21. The amendment contains no new matter.
`The claims of the present application may vary in scope from the claims pursued in the
`The claims of the present application may vary in scope from the claims pursued in the
`parent applications. To
`the
`
`extent prior amendments or any
`
`characterizations
`of
`parent applications. To the extent any prior amendments or characterizations of the scope
`of any claim, or the specification, or referenced art could be construed as a disclaimer of
`of any claim, or the specification, or referenced art could be construed as a disclaimer of
`any subject matter supported
`by
`
`the disclosure, the Applicants present
`
`hereby
`rescind
`any subject matter supported by the present disclosure, the Applicants hereby rescind and
`retract such disclaimer.
`retract such disclaimer.
`Specifically, the Applicants would like to bring to the Examiner's attention
`Specifically, the Applicants would like to bring to the Examiner's attention
`comments made
`in
`
`the Response on June 15, 2009 in U.S. Patent Application filed
`
`comments made in the Response filed on June 15, 2009 in U.S. Patent Application Serial
`No. 10/927,857 (now abandoned) and comments made in the Amendment filed on June
`No. 10/927,857 (now abandoned) and comments made in the Amendment filed on June
`15, 2009 in U.S. Patent Application Serial No. 11/897,177 (currently pending) regarding
`15, 2009 in U.S. Patent Application Serial No. 11/897,177 (currently pending) regarding
`U.S. Patent No. 5,474,979 and the present application specification. Since these
`U.S. Patent No. 5,474,979 and the present application specification. Since these
`comments have been filed, the Applicants have collected evidence that supports the
`comments have been filed, the Applicants have collected evidence that supports the
`patentability of
`the pending
`claims.
`patentability of the pending claims.
`The Commissioner is hereby authorized to charge any fees required or necessary
`The Commissioner is hereby authorized to charge any fees required or necessary
`for the filing, processing or entering of this paper or any of the enclosed papers, and to
`for the filing, processing or entering of this paper or any of the enclosed papers, and to
`refund any overpayment,
`to deposit account 01-0885.
`refund any overpayment, to deposit account 01-0885.
`
`Serial
`
`the
`
`scope
`
`and
`
`Date: August 14, 2013
`Date: August 14, 2013
`
`Respectfully submitted,
`Respectfully submitted,
`
`/Laura L. Wine/
`/Laura L. Wine/
`
`Laura L. Wine
`Laura L. Wine
`Attorney of Record
`Attorney of Record
`
`7
`7
`
`0007
`
`

`

`Docket No. 17618CON7B
`(AP)
`Docket No. 17618CON7B (AP)
`
`Registration Number 68,681
`Registration Number 68,681
`
`Please direct all
`inquiries
`and
`correspondence
`Please direct all inquiries and correspondence to:
`Laura L. Wine, Esq.
`Laura L. Wine, Esq.
`Allergan, Inc.
`Allergan, Inc.
`2525 Dupont Drive, T2-7H
`2525 Dupont Drive, T2-7H
`Irvine, California 92612
`Irvine, California 92612
`Tel: (714) 246-6996 Fax: (714)246-4249
`Tel: (714) 246-6996 Fax: (714) 246-4249
`
`to:
`
`8
`8
`
`0008
`
`

`

`PTO/AIA/14
`(03-13)
`PTOIAIA/14 (03-13)
`01/31/2014. OMB 0651-0032
`
`Approved
`for
`use
`through
`Approved for use through 0113112014. OMB 0651-0032
`U.S. Patent and
`Trademark
`Office;
`
`U.S. COMMERCE DEPARTMENT
`
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`respond
`no
`to
`a unless it contains collection a OMB control number.
`
`
`
`valid of
`
`
`Under the Paperwork
`Reduction
`
`Act persons are of
`
`required
`
`1995, to
`Under the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it contains a valid OMB control number.
`
`Number 17618CON7B (AP)
`Attorney Docket
`17618CON7B (AP)
`Attorney Docket Number
`Application Data Sheet 37 CFR 1.76
`Application Data Sheet 37 CFR 1.76
`Application Number
`Application Number
`
`Invention METHODS OF PROVIDING THERAPEUTIC EFFECTS USING CYCLOSPORIN COMPONENTS
`
`Title of
`Title of Invention METHODS OF PROVIDING THERAPEUTIC EFFECTS USING CYCLOSPORIN COMPONENTS
`
`application contains
`
`The application
`data sheet
`is
`part
`of
`the
`provisional
`or being submitted. The following nonprovisional
`
`
`form
`The application data sheet is part of the provisional or nonprovisional application for which it is being submitted. The following form contains the
`bibliographic data
`arranged
`in
`a
`format United States Patent specified and
`
`
`
`by Trademark
`
`the Office in 37 CFR 1.76. as
`
`
`
`outlined
`bibliographic data arranged in a format specified by the United States Patent and Trademark Office as outlined in 37 CFR 1.76.
`This document may be completed electronically and submitted to the Office in electronic
`format using the Electronic Filing System (EFS) or the
`This document may be completed electronically and submitted to the Office in electronic format using the Electronic Filing System (EFS) or the
`document may
`be
`printed
`
`and a paper included filed application.
`
`in
`
`document may be printed and included in a paper filed application.
`
`Secrecy Order 37 CFR 5.2
`Secrecy Order 37 CFR 5.2
`•
`Portions or all of
`the
`application
`associated
`with
`this
`Application may fall under
`
`a
`Data Secrecy
`
`Order pursuant
`1-7 Portions or all of the application associated with this Application Data Sheet may fall under a Secrecy Order pursuant to
`37 CFR 5.2 (Paper filers
`only.
`
`Applications fall under Secrecy that
`
`Order
`
`may filed electronically.) not
`
`be
`I—I 37 CFR 5.2 (Paper filers only. Applications that fall under Secrecy Order may not be filed electronically.)
`Inventor Information:
`Inventor Information:
`
`Inventor
`1
`Inventor 1
`Legal Name
`Legal Name
`
`Remove
`Remove
`
`Prefix Given Name
`Family Name
`Prefix Given Name
`Family Name
`Acheampong
`Andrew
`Acheampong
`Andrew
`Residence
`Information (Select One) (•) US Residency 0
`Non US Residency 0
`Active US Military Service
`Residence Information (Select One) C) US Residency (cid:9)
`0 Non US Residency 0 Active US Military Service
`City
`State/Province
`Irvine
`CA
`US
`Country of Residence
`•
`City
`State/Province
`Irvine
`CA
`Country of Residence i US
`
`Middle Name
`Middle Name
`
`Suffix
`Suffix
`
`Mailing Address
`of Inventor:
`
`Mailing Address of Inventor:
`
`1
`2
`
`Address
`Address 1
`Address
`Address 2
`City
`Irvine
`City
`Irvine
`Postal Code
`Postal Code
`
`2
`Inventor
`2
`Inventor (cid:9)
`Legal Name
`Legal Name
`
`16 Wintergreen
`16 Wintergreen
`
`92604
`92604
`
`State/Province
`State/Province
`Country i
`US
`Country i (cid:9)
`US
`
`CA
`CA
`
`Remove
`Remove
`
`Prefix Given Name
`Family Name
`Middle Name
`Middle Name
`Prefix Given Name
`Family Name
`Tang-Liu
`Diane
`D.
`Tang-Liu
`Diane
`D.
`Residence
`Information (Select One) ® US Residency 0
`Non US Residency 0
`Active US Military Service
`Residence Information (Select One) C) US Residency (cid:9)
`0 Non US Residency 0 Active US Military Service
`City
`Las Vegas
`State/Province
`NV
`US
`Country of Residence
`•
`City
`State/Province
`NV
`Las Vegas
`Country of Residence i US
`
`Suffix
`Suffix
`
`Mailing Address
`of Inventor:
`
`Mailing Address of Inventor:
`
`Address
`1
`Address 1
`2
`Address
`Address 2
`City
`Las Vegas
`City
`Las Vegas
`Postal Code
`Postal Code
`
`Inventor 3
`Inventor (cid:9)
`3
`Legal Name
`Legal Name
`
`3726 Las Vegas Blvd S. Unit 3303 W
`3726 Las Vegas Blvd S. Unit 3303 W
`
`89158
`89158
`
`State/Province
`State/Province
`Country i
`US
`Country i (cid:9)
`US
`
`NV
`NV
`
`Remove
`Remove
`
`Prefix Given Name
`Family Name
`Middle Name
`Middle Name
`Prefix Given Name
`Family Name
`Chang
`N.
`James
`Chang
`N
`James
`Information (Select One) ® US Residency 0
`Residence
`Non US Residency 0
`Active US Military Service
`Residence Information (Select One) C) US Residency (cid:9)
`0 Non US Residency 0 Active US Military Service
`
`Suffix
`Suffix
`
`EFS Web 2.2.7
`EFS Web 2.2.7
`
`0009
`
`

`

`PTO/AIA/14
`(03-13)
`PTOIAIA/14 (03-13)
`01/31/2014. OMB 0651-0032
`
`Approved
`for
`use
`through
`Approved for use through 0113112014. OMB 0651-0032
`U.S. Patent and
`Trademark
`Office;
`
`U.S. COMMERCE DEPARTMENT
`
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`respond
`no
`to
`a unless it contains collection a OMB control number.
`
`
`
`valid of
`
`
`Under the Paperwork
`Reduction
`
`Act persons are of
`
`required
`
`1995, to
`Under the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it contains a valid OMB control number.
`Number 17618CON7B (AP)
`Attorney Docket
`17618CON7B (AP)
`Attorney Docket Number
`Application Data Sheet 37 CFR 1.76
`Application Data Sheet 37 CFR 1.76
`Application Number
`Application Number
`
`Invention METHODS OF PROVIDING THERAPEUTIC EFFECTS USING CYCLOSPORIN COMPONENTS
`
`Title of
`Title of Invention METHODS OF PROVIDING THERAPEUTIC EFFECTS USING CYCLOSPORIN COMPONENTS
`
`City
`City
`
`Newport Beach
`Newport Beach
`
`State/Province
`State/Province
`
`CA
` CA
`
`US
` Country of Residence i US
`Country of Residence
`•
`
`Mailing Address
`of Inventor:
`
`Mailing Address of Inventor:
`
`36 Cervantes
`36 Cervantes
`
`1
`Address
`Address 1
`2
`Address
`Address 2
`City
`Newport Beach
`City (cid:9)
`Newport Beach (cid:9)
`Postal Code
`92660
`Postal Code
`92660
`
`Inventor 4
`Inventor (cid:9)
`4 (cid:9)
`
`Legal Name
`Legal Name
`
`State/Province
`State/Province (cid:9)
`Country i
`US
`Country i
`US
`
`CA
`CA
`
`Remove
`Remove
`
`Prefix Given Name
`Prefix Given Name
`Power
`David
`Power
`F.
`David
`Residence
`Information (Select One) ® US Residency 0
`Non US Residency 0
`Active US Military Service
`Residence Information (Select One) (cid:9) ® US Residency (cid:9) 0 (cid:9) Non US Residency (cid:9)
`0 Active US Military Service
`City
`State/Province
`Hubert
`NC
`US
`Country of Residence
`•
`City
`State/Province
`Hubert
`NC
`Country of Residence i US
`
`Middle Name
`Middle Name
`
`Family Name
`Family Name
`
`Suffix
`Suffix
`
`Mailing Address
`of Inventor:
`
`Mailing Address of Inventor:
`
`1
`2
`
`202 Fox Way N
`202 Fox Way N
`
`Address
`Address 1
`Address
`Address 2
`City
`State/Province
`Hubert
`State/Province (cid:9)
`City (cid:9)
`Hubert (cid:9)
`Country i
`Postal Code
`28539
`US
`Country i
`Postal Code
`28539
`US
`All Inventors Must Be Listed - Additional Inventor Information blocks may be
`All Inventors Must Be Listed - Additional Inventor Information blocks may be
`the Add
`generated within
`this
`form selecting
`
`by
`button.
`generated within this form by selecting the Add button.
`
`NC
`NC
`
`Add
`Add
`
`Correspondence Information:
`Correspondence Information:
`Enter either Customer
`Number
`or
`complete
`the below.
`
`Enter either Customer Number or complete the Correspondence Information section below.
`For further
`information
`see
`37
`CFR
`1.33(a).
`For further information see 37 CFR 1.33(a).
`Q An Address is being provided
`for
`the
`
`correspondence of this application.
`An Address is being provided for the correspondence Information of this application.
`
`Information
`
`Correspondence
`
`Customer Number
`Customer Number
`Email Address
`Email Address
`
`51957
`51957
`
`patents_ip@allergan.com
`patents_ip@allergan.com
`
`Add Email
`Add Email
`
`Remove Email
`Remove Email
`
`Application Information:
`Application Information:
`Title of the Invention
`METHODS OF PROVIDING THERAPEUTIC EFFECTS
`USING
`CYCLOSPORIN
`Title of the Invention
`METHODS OF PROVIDING THERAPEUTIC EFFECTS USING CYCLOSPORIN COMPONENTS
`Attorney Docket Number 17618CON7B (AP)
`Attorney Docket Number 17618CON7B (AP)
`Application Type
`Application Type
`Subject Matter
`Subject Matter
`
`Nonprovisional
`Nonprovisional
`
`Utility
`Utility
`
`Small Entity Status
`Claimed Q
`Small Entity Status Claimed
`
`Total Number of Drawing Sheets
`Total Number of Drawing Sheets (if any)
`
`(if any)
`
`Suggested
`Figure
`for
`
`Publication (if any)
`Suggested Figure for Publication (if any)
`
`EFS Web 2.2.7
`EFS Web 2.2.7
`
`COMPONENTS
`
`0010
`
`

`

`PTO/AIA/14 (03-13)
`PTOIAIA/14 (03-13)
`Approved for use through 01/31/2014. OMB 0651-0032
`Approved for use through 0113112014. OMB 0651-0032
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`Under the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it contains a valid OMB control number.
`Under the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it contains a valid OMB control number.
`Attorney Docket Number 17618CON7B (AP)
`Attorney Docket Number
`17618CON7B (AP)
`Application Number
`Application Number
`
`Application Data Sheet 37 CFR 1.76
`Application Data Sheet 37 CFR 1.76
`
`Title of Invention METHODS OF PROVIDING THERAPEUTIC EFFECTS USING CYCLOSPORIN COMPONENTS
`Title of Invention METHODS OF PROVIDING THERAPEUTIC EFFECTS USING CYCLOSPORIN COMPONENTS
`
`Publication Information:
`Publication Information:
`•
`Request
`Early
`Publication
`(Fee
`required
`at
`time
`q Request Early Publication (Fee required at time of Request 37 CFR 1.219)
`Request Not to Publish.
`Request Not to Publish. I hereby request that the attached application not be published under
`I hereby request that the attached application not be
`published
`n 35 U.S.C. 122(b) and certify that the invention disclosed in the attached application has not and will not be the
`35
`
`U.S.C. that the invention disclosed 122(b) and
`
`
`in
`
`certify the
`
`attached application has
`not
`and
`•
`will
`subject of an application
`
`
`filed in another country, or under multilateral international agreement, a
`
`that requires
`
`subject of an application filed in another country, or under a multilateral international agreement, that requires
`publication at eighteen months
`after
`filing.
`publication at eighteen months after filing.
`
`of
`
`under
`
`Representative
`Information:
`Representative Information:
`
`Representative information should be provided for all practitioners having a power of attorney in the application. Providing
`Representative information should be provided for all practitioners having a power of attorney in the application. Providing
`this information in the Application Data Sheet
`does
`not
`
`
`
`
`constitute attorney in the application a power (see 37 CFR 1.32). of
`
`this information in the Application Data Sheet does not constitute a power of attorney in the application (see 37 CFR 1.32).
`Either enter Customer Number or complete the Representative Name section below. If both sections are completed the customer
`Either enter Customer Number or complete the Representative Name section below. If both sections are completed the customer
`Number will be used
`
`for the Representative Information processing. during
`
`Number will be used for the Representative Information during processing.
`
`Please Select One:
`Please Select One:
`
`Customer Number
`Customer Number
`
`(•) Customer Number O US Patent Practitioner
`o Limited Recognition (37 CFR 11.9)
`C) (cid:9) Customer Number
`0 US Patent Practitioner 0 (cid:9) Limited Recognition (37 CFR 11.9)
`51597
`51597
`
`Domestic Benefit/National Stage Information:
`Domestic Benefit/National Stage Information:
`This section allows
`
`
`for the applicant to either claim benefit under 35
`U.S.C.
`119(e),
`
`120,121, or indicate
`This section allows for the applicant to either claim benefit under 35 U.S.C. 119(e), 120, 121, or 365(c) or indicate
`National Stage entry
`
`from a PCT application. Providing this information
`in
`the
`
`application data sheet constitutes
`National Stage entry from a PCT application. Providing this information in the application data sheet constitutes the
`specific reference
`
`required by U.S.C. 119(e) 35
`
`
`or 120, 37 CFR 1.78. and
`
`specific reference required by