Docket No. 17618CON6 (AP)
`Docket No. 17618CON6 (AP)
`Docket No. 17618CON6 (AP)
`
`IN THE UNITED STATES PATENT
`AND
`TRADEMARK
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`OFFICE
`
`Applicant: Acheampong, et al.
`Applicant: Acheampong, et al.
`Applicant: Acheampong, et al.
`
`Examiner: TBA
`Examiner: TBA
`Examiner: TBA
`
`Serial No.: TBA
`Serial No.: TBA
`Serial No.: TBA
`
`Filed: Herewith
`Filed: Herewith
`Filed: Herewith
`
`For: METHODS OF PROVIDING
`For: METHODS OF PROVIDING
`For: METHODS OF PROVIDING
`THERAPEUTIC EFFECTS USING
`THERAPEUTIC EFFECTS USING
`THERAPEUTIC EFFECTS USING
`CYCLOSPORIN COMPONENTS
`CYCLOSPORIN COMPONENTS
`CYCLOSPORIN COMPONENTS
`
`Group Art Unit: TBA
`Group Art Unit: TBA
`Group Art Unit: TBA
`
`Confirmation No. TBA
`Confirmation No. TBA
`Confirmation No. TBA
`
`Customer No.: 51957
`Customer No.: 51957
`Customer No.: 51957
`
`PRELIMINARY AMENDMENT
`PRELIMINARY AMENDMENT
`PRELIMINARY AMENDMENT
`
`Commissioner for Patents
`Commissioner for Patents
`Commissioner for Patents
`P.O. Box 1450
`P.O. Box 1450
`P.O. Box 1450
`Alexandria, VA 22313-1450
`Alexandria, VA 22313-1450
`Alexandria, VA 22313-1450
`
`Dear Sir:
`Dear Sir:
`Dear Sir:
`
`Prior to examining the above-referenced application, please amend the specification as
`Prior to examining the above-referenced application, please amend the specification as
`Prior to examining the above-referenced application, please amend the specification as
`
`described on page 2 of this paper, and please amend the claims as described on pages 3-6 of this
`described on page 2 of this paper, and please amend the claims as described on pages 3-6 of this
`described on page 2 of this paper, and please amend the claims as described on pages 3-6 of this
`paper. Remarks follow on page 7.
`paper. Remarks follow on page 7.
`paper. Remarks follow on page 7.
`
`1
`1
`1
`
`FAMY CARE - EXHIBIT 1004-0001
`
`

`
`Docket No. 17618CON6 (AP)
`
`Docket No. 17618CON6 (AP) Docket No. 17618CON6 (AP)
`
`Amendments to the Specification
`
`Amendments to the Specification Amendments to the Specification
`
`Please replace page 1, lines 5-10 of
`the
`specification
`filed herewith with
`the
`Please replace page 1, lines 5-10 of the specification filed herewith with the following amended Please replace page 1, lines 5-10 of the specification filed herewith with the following amended
`
`paragraph:
`
`paragraph: paragraph:
`
`following
`
`This application is a continuation of copending U.S. Application Serial No. 11/897.177.
`
`This application is a continuation of copending U.S. Application Serial No. 11/897,177, This application is a continuation of copending U.S. Application Serial No. 11/897,177,
`filed August 28. 2007. which is a continuation of U.S. Application Serial No. 10/927,857, filed
`
`filed August 28, 2007, which is a continuation of U.S. Application Serial No. 10/927,857, filed 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
`the
`benefit
`of
`U.S.
`Provisional
`August 27, 2004, now abandoned, which claimed the benefit of U.S. Provisional Application No. August 27, 2004, now abandoned, which claimed the benefit of U.S. Provisional Application No.
`
`60/503,137 filed September 15, 2003, which-4s are incorporated in its their entirety herein by
`60/503,137 filed September 15, 2003, which—is are incorporated in its their entirety herein by 60/503,137 filed September 15, 2003, which—is are incorporated in its their entirety herein by
`
`reference.
`
`reference. reference.
`
`Application
`
`
`Please replace page 4, line 25 - page 5, line 3 of the specification
`filed herewith with
`Please replace page 4, line 25 — page 5, line 3 of the specification filed herewith with the Please replace page 4, line 25 — page 5, line 3 of the specification filed herewith with the
`
`following amended paragraph:
`
`following amended paragraph: following amended paragraph:
`
`the
`
`The present methods are useful
`in
`
`treating suitable condition which any
`
`is
`therapeutically
`
`The present methods are useful in treating any suitable condition which is therapeutically The present methods are useful in treating any suitable condition which is therapeutically
`sensitive to or treatable with cyclosporin components. Such
`
`conditions preferably are ophthalmic
`
`sensitive to or treatable with cyclosporin components. Such conditions preferably are ophthalmic sensitive to or treatable with cyclosporin components. Such conditions preferably are ophthalmic
`or ocular conditions, that is relating to or having to do with one or more parts of an eye of a
`or ocular conditions, that is relating to or having to do with one or more parts of an eye of a 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 such conditions are, without limitation, dry eye syndrome,
`
`human or animal. Included among such conditions are, without limitation, dry eye syndrome, human or animal. Included among such conditions are, without limitation, dry eye syndrome,
`phacoanaphylactic endophthalmitis, uveitis, vernal conjunctivitis, atopic keratoconjunctivitis,
`
`phacoanaphy 1 actic endophthalmitis, uveitis, vernal conjunctivitis, atopic keratoconjunctivitis, phacoanaphy 1 actic endophthalmitis, uveitis, vernal conjunctivitis, atopic keratoconjunctivitis,
`corneal graft rejection and the like conditions. The present invention is particularly effective in
`
`corneal graft rejection and the like conditions. The present invention is particularly effective in corneal graft rejection and the like conditions. The present invention is particularly effective in
`treating dry eye syndrome. Cyclosporin has been found as effective in treating immune
`
`treating dry eye syndrome. Cyclosporin has been found as effective in treating immune treating dry eye syndrome. Cyclosporin has been found as effective in treating immune
`medicated keratoconiunctivitis sicca (KCS or dry eve disease) in a patient suffering therefrom.
`
`medicated keratoconjunctivitis sicca (KCS or dry eye disease) in a patient suffering therefrom. medicated keratoconjunctivitis sicca (KCS or dry eye disease) in a patient suffering therefrom.
`The activity of cyclosporins is as an immunosuppressant and in the enhancement or restoring of
`
`The activity of cyclosporins is as an immunosuppressant and in the enhancement or restoring of The activity of cyclosporins is as an immunosuppressant and in the enhancement or restoring of
`lacrimal gland tearing. Other conditions that can be treated with cyclosporin components include
`
`lacrimal gland tearing. Other conditions that can be treated with cyclosporin components include lacrimal gland tearing. Other conditions that can be treated with cyclosporin components include
`an absolute or partial deficiency in aqueous tear production (keratoconiunctivitis sicca, or KCS).
`
`an absolute or partial deficiency in aqueous tear production (keratoconjunctivitis sicca, or KCS). an absolute or partial 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.
`
`Topical administration to a patient's tear deficient eye can increase tear production in the eye. Topical 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 exacerbated by tear
`
`The treatment can further serve to correct corneal and conjunctival disorders exacerbated by tear The treatment can further serve to correct corneal and conjunctival disorders exacerbated by tear
`deficiency and KCS. such as corneal scarring, corneal ulceration, inflammation of the cornea or
`
`deficiency and KCS, such as corneal scarring, corneal ulceration, inflammation of the cornea or deficiency and KCS, such as corneal scarring, corneal ulceration, inflammation of the cornea or
`conjunctiva, filamentary keratisis. mucopurulent discharge and vascularization
`of
`the
`
`conjunctiva, filamentary keratisis, mucopurulent discharge and vascularization of the cornea. conjunctiva, filamentary keratisis, mucopurulent discharge and vascularization of the cornea.
`
`cornea.
`
`2
`2 2
`
`
`FAMY CARE - EXHIBIT 1004-0002
`
`

`
`Docket No. 17618CON6 (AP)
`
`Docket No. 17618CON6 (AP) Docket No. 17618CON6 (AP)
`
`Amendments to the claims
`
`Amendments to the claims Amendments to the claims
`
`The following list of claims will replace all previous versions of claims presented in this
`The following list of claims will replace all previous versions of claims presented in this The following list of claims will replace all previous versions of claims presented in this
`
`application:
`
`application: application:
`
`1. -36. (Canceled)
`
`1. — 36. (Canceled) 1. — 36. (Canceled)
`
`(New) A topical ophthalmic emulsion for treating an eye of
`a human having KCS, wherein
`37.
`
`
`37. 37.
`(New) A topical ophthalmic emulsion for treating an eye of a human having KCS, wherein (New) A topical ophthalmic emulsion for treating an eye of a human having KCS, wherein
`the topical ophthalmic emulsion comprises cyclosporin A in an amount of about 0.05% by
`
`the topical ophthalmic emulsion comprises cyclosporin A in an amount of about 0.05% by the topical ophthalmic emulsion comprises cyclosporin A in an amount of about 0.05% by
`weight, polysorbate 80, Pemulen, water, and castor oil in an amount of about 1.25% by weight;
`
`weight, polysorbate 80, Pemulen, water, and castor oil in an amount of about 1.25% by weight; weight, polysorbate 80, Pemulen, water, and castor oil in an amount of about 1.25% by weight;
`and
`and and
`
`
`
`
`is wherein the topical ophthalmic emulsion therapeutically effective in
`treating KCS.
`
`wherein the topical ophthalmic emulsion is therapeutically effective in treating KCS. wherein the topical ophthalmic emulsion is therapeutically effective in treating KCS.
`
`(New) The topical ophthalmic emulsion of Claim 37, wherein the topical ophthalmic
`38.
`
`(New) The topical ophthalmic emulsion of Claim 37, wherein the topical ophthalmic (New) The topical ophthalmic emulsion of Claim 37, wherein the topical ophthalmic
`
`38. 38.
`emulsion further comprises a tonicity agent or
`a demulcent
`component.
`emulsion further comprises a tonicity agent or a demulcent component. emulsion further comprises a tonicity agent or a demulcent component.
`
`
`(New) The topical ophthalmic emulsion of Claim 38, wherein the tonicity agent or the
`39.
`
`(New) The topical ophthalmic emulsion of Claim 38, wherein the tonicity agent or the (New) The topical ophthalmic emulsion of Claim 38, wherein the tonicity agent or the
`
`39. 39.
`demulcent component is glycerine.
`
`demulcent component is glycerine. demulcent component is glycerine.
`
`(New) The topical ophthalmic emulsion of Claim 37, wherein the topical ophthalmic
`40.
`
`(New) The topical ophthalmic emulsion of Claim 37, wherein the topical ophthalmic (New) The topical ophthalmic emulsion of Claim 37, wherein the topical ophthalmic
`
`40. 40.
`emulsion further comprises a buffer.
`
`emulsion further comprises a buffer. emulsion further comprises a buffer.
`
`(New) The topical ophthalmic emulsion of Claim 40, wherein the buffer is sodium
`41.
`
`
`41. 41.
`(New) The topical ophthalmic emulsion of Claim 40, wherein the buffer is sodium (New) The topical ophthalmic emulsion of Claim 40, wherein the buffer is sodium
`hydroxide.
`
`hydroxide. hydroxide.
`
`(New) The topical ophthalmic emulsion of Claim 37, wherein the topical ophthalmic
`42.
`
`
`42. 42.
`(New) The topical ophthalmic emulsion of Claim 37, wherein the topical ophthalmic (New) The topical ophthalmic emulsion of Claim 37, wherein the topical ophthalmic
`emulsion further comprises glycerine and a buffer.
`
`emulsion further comprises glycerine and a buffer. emulsion further comprises glycerine and a buffer.
`
`(New) The topical ophthalmic emulsion of Claim 37, wherein the topical ophthalmic
`43.
`
`(New) The topical ophthalmic emulsion of Claim 37, wherein the topical ophthalmic (New) The topical ophthalmic emulsion of Claim 37, wherein the topical ophthalmic
`
`43. 43.
`emulsion comprises polysorbate 80
`in
`an amount of
`about 1.0%
`by
`
`emulsion comprises polysorbate 80 in an amount of about 1.0% by weight. emulsion comprises polysorbate 80 in an amount of about 1.0% by weight.
`
`weight.
`
`3
`
`3 3
`
`FAMY CARE - EXHIBIT 1004-0003
`
`

`
`Docket No. 17618CON6 (AP)
`
`Docket No. 17618CON6 (AP) Docket No. 17618CON6 (AP)
`
`(New) The topical ophthalmic emulsion of Claim 37, wherein the topical ophthalmic
`44.
`
`
`44. 44.
`(New) The topical ophthalmic emulsion of Claim 37, wherein the topical ophthalmic (New) The topical ophthalmic emulsion of Claim 37, wherein the topical ophthalmic
`emulsion comprises Pemulen in
`an amount of
`about 0.05%
`by
`weight.
`
`emulsion comprises Pemulen in an amount of about 0.05% by weight. emulsion comprises Pemulen in an amount of about 0.05% by weight.
`
`(New) The topical ophthalmic emulsion of Claim 37, wherein the topical ophthalmic
`45.
`
`(New) The topical ophthalmic emulsion of Claim 37, wherein the topical ophthalmic (New) The topical ophthalmic emulsion of Claim 37, wherein the topical ophthalmic
`
`45. 45.
`emulsion further comprises glycerine
`in
`an amount of
`about
`2.2%
`by
`weight,
`
`emulsion further comprises glycerine in an amount of about 2.2% by weight, water, and a buffer. emulsion further comprises glycerine in an amount of about 2.2% by weight, water, and a buffer.
`
`water,
`
`(New) The topical ophthalmic emulsion of Claim 45, wherein the buffer is sodium
`46.
`46. 46.
`
`
`(New) The topical ophthalmic emulsion of Claim 45, wherein the buffer is sodium (New) The topical ophthalmic emulsion of Claim 45, wherein the buffer is sodium
`hydroxide.
`
`hydroxide. hydroxide.
`
`(New) The topical ophthalmic emulsion of Claim 37, wherein, when the topical
`47.
`47. 47.
`
`
`(New) The topical ophthalmic emulsion of Claim 37, wherein, when the topical (New) The topical ophthalmic emulsion of Claim 37, wherein, when the topical
`ophthalmic emulsion is administered to an eye of a human in an effective amount in treating
`ophthalmic emulsion is administered to an eye of a human in an effective amount in treating ophthalmic emulsion is administered to an eye of a human in an effective amount in treating
`
`KCS, the blood of the human has
`
`substantially no detectable concentration of cyclosporin A.
`
`KCS, the blood of the human has substantially no detectable concentration of cyclosporin A. KCS, the blood of the human has substantially no detectable concentration of cyclosporin A.
`
`(New) The topical ophthalmic emulsion of Claim 42, wherein the topical ophthalmic
`48.
`48. 48.
`
`
`(New) The topical ophthalmic emulsion of Claim 42, wherein the topical ophthalmic (New) The topical ophthalmic emulsion of Claim 42, wherein the topical ophthalmic
`emulsion has a pH in
`the
`range of
`
`about 7.2 7.6.
`to
`about
`emulsion has a pH in the range of about 7.2 to about 7.6. emulsion has a pH in the range of about 7.2 to about 7.6.
`
`
`(New) The topical ophthalmic emulsion of Claim 37, wherein the topical ophthalmic
`49.
`
`(New) The topical ophthalmic emulsion of Claim 37, wherein the topical ophthalmic (New) The topical ophthalmic emulsion of Claim 37, wherein the topical ophthalmic
`49. 49.
`
`emulsion is as substantially
`therapeutically
`effective
`as
`an
`emulsion
`
`comprising in
`
`emulsion is as substantially therapeutically effective as an emulsion comprising cyclosporin A in emulsion is as substantially 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.
`
`an amount of 0.1% by weight and castor oil in an amount of 1.25% by weight. an amount of 0.1% by weight and castor oil in an amount of 1.25% by weight.
`
`cyclosporin
`
`(New) The topical ophthalmic emulsion of Claim 37, wherein the topical ophthalmic
`50.
`
`(New) The topical ophthalmic emulsion of Claim 37, wherein the topical ophthalmic (New) The topical ophthalmic emulsion of Claim 37, wherein the topical ophthalmic
`50. 50.
`
`emulsion achieves at least as much therapeutic effectiveness as an emulsion comprising
`
`emulsion achieves at least as much therapeutic effectiveness as an emulsion comprising emulsion achieves at least as much 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.
`
`cyclosporin A in an amount of 0.1% by weight and castor oil in an amount of 1.25% by weight. cyclosporin A in an amount of 0.1% by weight and castor oil in an amount of 1.25% by weight.
`
`(New) The topical ophthalmic emulsion of Claim 37, wherein the topical ophthalmic
`51.
`
`(New) The topical ophthalmic emulsion of Claim 37, wherein the topical ophthalmic (New) The topical ophthalmic emulsion of Claim 37, wherein the topical ophthalmic
`51. 51.
`
`emulsion breaks down more quickly in the eye of a human, once administered to the eye of the
`
`emulsion breaks down more quickly in the eye of a human, once administered to the eye of the emulsion breaks down more quickly in 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 emulsion
`
`human, thereby reducing vision distortion in the eye of the human as compared to an emulsion human, thereby reducing vision distortion in the eye of the human as compared to an emulsion
`that contains only 50%) as much castor oil.
`
`that contains only 50% as much castor oil. that contains only 50% as much castor oil.
`
`(New) The topical ophthalmic emulsion of Claim 37, wherein the topical ophthalmic
`52.
`
`(New) The topical ophthalmic emulsion of Claim 37, wherein the topical ophthalmic (New) The topical ophthalmic emulsion of Claim 37, wherein the topical ophthalmic
`
`52. 52.
`emulsion, when administered to the eye of a human, demonstrates a reduction in adverse events
`
`emulsion, when administered to the eye of a human, demonstrates a reduction in adverse events emulsion, when administered to the eye of a human, demonstrates a reduction in adverse events
`
`4
`4 4
`
`
`FAMY CARE - EXHIBIT 1004-0004
`
`

`
`Docket No. 17618CON6 (AP)
`
`Docket No. 17618CON6 (AP) Docket No. 17618CON6 (AP)
`
`in the human, relative to an emulsion comprising cyclosporin A
`in an amount of 0.1% by weight
`
`in the human, relative to an emulsion comprising cyclosporin A in an amount of 0.1% by weight in the human, relative to an emulsion comprising cyclosporin A in an amount of 0.1% by weight
`and castor oil in an amount of 1.25% by weight.
`
`and castor oil in an amount of 1.25% by weight. and castor oil in an amount of 1.25% by weight.
`
`(New) The topical ophthalmic emulsion of Claim 52, wherein the adverse events include
`53.
`
`
`53. 53.
`(New) The topical ophthalmic emulsion of Claim 52, wherein the adverse events include (New) The topical ophthalmic emulsion of Claim 52, wherein the adverse events include
`side effects.
`
`side effects. side effects.
`
`(New) A topical ophthalmic emulsion for treating an eye of a human, wherein the topical
`54.
`(New) A topical ophthalmic emulsion for treating an eye of a human, wherein the topical (New) A topical ophthalmic emulsion for treating an eye of a human, wherein the topical
`54. 54.
`
`
`ophthalmic emulsion increases tear production in the eye of a human, and wherein the topical
`
`ophthalmic emulsion increases tear production in the eye of a human, and wherein the topical ophthalmic emulsion increases tear production in the eye of a human, and wherein the topical
`ophthalmic emulsion comprises:
`
`ophthalmic emulsion comprises: ophthalmic emulsion comprises:
`cyclosporin A in an amount of
`
`about 0.05%) by weight;
`
`cyclosporin A in an amount of about 0.05% by weight; 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; castor oil in an amount of about 1.25% by weight;
`
`weight;
`polysorbate 80 in an amount of
`about 1.0%
`
`polysorbate 80 in an amount of about 1.0% by weight; 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; Pemulen in an amount of about 0.05% by weight;
`a tonicity component or a demulcent component
`in
`an
`
`of amount 2.2% by weight;
`
`
`a tonicity component or a demulcent component in an amount of about 2.2% by weight; a tonicity component or a demulcent component in an amount of about 2.2% by weight;
`a buffer; and
`a buffer; and a buffer; and
`
`water.
`
`water. water.
`
`by
`
`about
`
`(New) The topical ophthalmic emulsion of Claim 54, wherein the buffer is sodium
`55.
`
`
`55. 55.
`(New) The topical ophthalmic emulsion of Claim 54, wherein the buffer is sodium (New) The topical ophthalmic emulsion of Claim 54, wherein the buffer is sodium
`hydroxide.
`
`hydroxide. hydroxide.
`
`(New) The topical ophthalmic emulsion of Claim 54, wherein the tonicity component or
`56.
`
`(New) The topical ophthalmic emulsion of Claim 54, wherein the tonicity component or (New) The topical ophthalmic emulsion of Claim 54, wherein the tonicity component or
`
`56. 56.
`the demulcent component is glycerine.
`
`the demulcent component is glycerine. the demulcent component is glycerine.
`
`(New) The topical ophthalmic emulsion of Claim 54, wherein, when the topical
`57.
`
`(New) The topical ophthalmic emulsion of Claim 54, wherein, when the topical (New) The topical ophthalmic emulsion of Claim 54, wherein, when the topical
`
`57. 57.
`ophthalmic emulsion is administered
`to
`an eye
`of
`a human
`in
`an
`effective
`
`ophthalmic emulsion is administered to an eye of a human in an effective amount to increase tear ophthalmic emulsion is administered to an eye of a human in an effective amount to increase tear
`production, the blood of the human has substantially no detectable concentration of the
`
`production, the blood of the human has substantially no detectable concentration of the production, the blood of the human has substantially no detectable concentration of the
`cyclosporin A.
`
`cyclosporin A. cyclosporin A.
`
`amount
`
`(New) The topical ophthalmic emulsion of Claim 54, wherein the topical ophthalmic
`58.
`
`(New) The topical ophthalmic emulsion of Claim 54, wherein the topical ophthalmic (New) The topical ophthalmic emulsion of Claim 54, wherein the topical ophthalmic
`
`58. 58.
`emulsion has a pH in
`the
`range of
`
`about 7.2 to about 7.6.
`
`emulsion has a pH in the range of about 7.2 to about 7.6. emulsion has a pH in the range of about 7.2 to about 7.6.
`
`5
`
`5 5
`
`FAMY CARE - EXHIBIT 1004-0005
`
`

`
`Docket No. 17618CON6 (AP)
`Docket No. 17618CON6 (AP)
`Docket No. 17618CON6 (AP)
`
`(New) The topical ophthalmic emulsion of Claim 54, wherein the topical ophthalmic
`59.
`(New) The topical ophthalmic emulsion of Claim 54, wherein the topical ophthalmic
`(New) The topical ophthalmic emulsion of Claim 54, wherein the topical ophthalmic
`59.
`59.
`emulsion is effective in
`treating KCS.
`emulsion is effective in treating KCS.
`emulsion is effective in treating KCS.
`
`(New) A topical ophthalmic emulsion for treating an eye of a human, the topical
`60.
`(New) A topical ophthalmic emulsion for treating an eye of a human, the topical
`(New) A topical ophthalmic emulsion for treating an eye of a human, the topical
`60.
`60.
`ophthalmic emulsion comprising:
`ophthalmic emulsion comprising:
`ophthalmic emulsion comprising:
`cyclosporin A in an amount of
`about 0.05% by weight;
`cyclosporin A in an amount of about 0.05% by weight;
`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;
`castor oil in an amount of about 1.25% by weight;
`weight;
`polysorbate 80 in an amount of
`about 1.0%
`polysorbate 80 in an amount of about 1.0% by weight;
`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;
`Pemulen in an amount of about 0.05% by weight;
`glycerine in an amount of about 2.2% by weight;
`glycerine in an amount of about 2.2% by weight;
`glycerine in an amount of about 2.2% by weight;
`sodium hydroxide; and
`sodium hydroxide; and
`sodium hydroxide; and
`water;
`water;
`water;
`wherein the emulsion is effective
`in
`
`treating KCS.
`wherein the emulsion is effective in treating KCS.
`wherein the emulsion is effective in treating KCS.
`
`by
`
`(New) The topical ophthalmic emulsion of Claim 60, wherein the topical ophthalmic
`61.
`(New) The topical ophthalmic emulsion of Claim 60, wherein the topical ophthalmic
`(New) The topical ophthalmic emulsion of Claim 60, wherein the topical ophthalmic
`61.
`61.
`emulsion has a pH in
`the
`range of
`
`about 7.2 to about 7.6.
`emulsion has a pH in the range of about 7.2 to about 7.6.
`emulsion has a pH in the range of about 7.2 to about 7.6.
`
`6
`6
`6
`
`FAMY CARE - EXHIBIT 1004-0006
`
`

`
`incorporated
`
`Docket No. 17618CON6 (AP)
`Docket No. 17618CON6 (AP)
`Docket No. 17618CON6 (AP)
`
`REMARKS
`REMARKS
`REMARKS
`The applicants have canceled claims 1-36 and have added claims 37-61. Support for the
`The applicants have canceled claims 1-36 and have added claims 37-61. Support for the
`The applicants have canceled claims 1-36 and have added claims 37-61. Support for the
`limitations recited in the new claims may be found throughout the specification, and at least at
`limitations recited in the new claims may be found throughout the specification, and at least at
`limitations recited in the new claims may be found throughout the specification, and at least at
`page 5, line 14, page 26, lines 5-19, and page 27, lines 4-31 of the application
`page 4, line 25
`page 4, line 25 — page 5, line 14, page 26, lines 5-19, and page 27, lines 4-31 of the application
`page 4, line 25 — page 5, line 14, page 26, lines 5-19, and page 27, lines 4-31 of the application
`specification filed herewith.
`specification filed herewith.
`specification filed herewith.
`Support for the amendment to the specification at page 4, line 25 - page 5, line 3 may be
`Support for the amendment to the specification at page 4, line 25 — page 5, line 3 may be
`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
`previously
`found, at least, in U.S. Patent Nos. 5,474,979 and 6,254,860, which were previously incorporated
`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, lines 18-21. The amendment
`by reference in the present application specification at page 1, lines 18-21. The amendment
`by reference in the present application specification at page 1, lines 18-21. The amendment
`contains no new matter.
`contains no new matter.
`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
`The claims of the present application may vary in scope from the claims pursued in the
`parent applications. To the extent any prior amendments or characterizations of the scope of any
`parent applications. To the extent any prior amendments or characterizations of the scope of any
`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 any subject
`claim, or the specification, or referenced art could be construed as a disclaimer of any subject
`claim, or the specification, or referenced art could be construed as a disclaimer of any subject
`matter supported by the present disclosure, the Applicants hereby rescind and retract such
`matter supported by the present disclosure, the Applicants hereby rescind and retract such
`matter supported by the present disclosure, the Applicants hereby rescind and retract such
`disclaimer.
`disclaimer.
`disclaimer.
`Specifically, the Applicants would like to bring to the Examiner's attention comments
`Specifically, the Applicants would like to bring to the Examiner's attention comments
`Specifically, the Applicants would like to bring to the Examiner's attention comments
`made in the Response filed on June 15, 2009 in U.S. Patent Application Serial No. 10/927,857
`made in the Response filed on June 15, 2009 in U.S. Patent Application Serial No. 10/927,857
`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 15, 2009 in U.S. Patent
`(now abandoned) and comments made in the Amendment filed on June 15, 2009 in U.S. Patent
`(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 U.S. Patent No. 5,474,979 and
`Application Serial No. 11/897,177 (currently pending) regarding U.S. Patent No. 5,474,979 and
`Application Serial No. 11/897,177 (currently pending) regarding U.S. Patent No. 5,474,979 and
`the present application specification. Since these comments have been filed, the Applicants have
`the present application specification. Since these comments have been filed, the Applicants have
`the present application specification. Since these comments have been filed, the Applicants have
`collected evidence that supports
`
`the patentability of the pending claims.
`collected evidence that supports the patentability of the pending claims.
`collected evidence that supports the patentability of the pending claims.
`The Commissioner is hereby authorized to charge any fees required or necessary for the
`The Commissioner is hereby authorized to charge any fees required or necessary for the
`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 refund any
`filing, processing or entering of this paper or any of the enclosed papers, and to refund any
`filing, processing or entering of this paper or any of the enclosed papers, and to refund any
`overpayment, to deposit account 01-0885.
`overpayment, to deposit account 01-0885.
`overpayment, to deposit account 01-0885.
`
`Respectfully submitted,
`Respectfully submitted,
`Respectfully submitted,
`
`/Laura L. Wine/
`/Laura L. Wine/
`/Laura L. Wine/
`
`Laura L. Wine
`Laura L. Wine
`Laura L. Wine
`Attorney of Record
`Attorney of Record
`Attorney of Record
`Registration Number 68,681
`Registration Number 68,681
`Registration Number 68,681
`to:
`
`Date: August 7, 2013
`Date: August 7, 2013
`Date: August 7, 2013
`
`Please direct all inquiries and correspondence
`Please direct all inquiries and correspondence to:
`Please direct all inquiries and correspondence to:
`Laura L. Wine, Esq., Allergan, Inc.
`Laura L. Wine, Esq., Allergan, Inc.
`Laura L. Wine, Esq., Allergan, Inc.
`2525 Dupont Drive, T2-7H
`2525 Dupont Drive, T2-7H
`2525 Dupont Drive, T2-7H
`Irvine, California 92612
`Irvine, California 92612
`Irvine, California 92612
`Tel: (714) 246-6996 Fax: (714)246-4249
`Tel: (714) 246-6996 Fax: (714) 246-4249
`Tel: (714) 246-6996 Fax: (714) 246-4249
`
`7
`7
`7
`
`FAMY CARE - EXHIBIT 1004-0007
`
`

`
`Electronic Patent Application Fee Transmittal
`Electronic Patent Application Fee Transmittal
`Electronic Patent Application Fee Transmittal
`
`Application Number:
`Application Number:
`Application Number:
`
`Filing Date:
`Filing Date:
`Filing Date:
`
`Title of Invention:
`Title of Invention:
`Title of Invention:
`
`METHODS OF PROVIDING
`THERAPEUTIC EFFECTS USING
`CYCLOSPORIN
`METHODS OF PROVIDING THERAPEUTIC EFFECTS USING CYCLOSPORIN
`METHODS OF PROVIDING THERAPEUTIC EFFECTS USING CYCLOSPORIN
`COMPONENTS
`COMPONENTS
`COMPONENTS
`
`First Named Inventor/Applicant
`Name:
`First Named Inventor/Applicant Name:
`First Named Inventor/Applicant Name:
`
`Andrew Ancheampong
`Andrew Ancheampong
`Andrew Ancheampong
`
`Filer:
`Filer:
`Filer:
`
`Laura Lee Wine/Lauren
`Barberena
`Laura Lee Wine/Lauren Barberena
`Laura Lee Wine/Lauren Barberena
`
`Attorney Docket
`Number:
`Attorney Docket Number:
`Attorney Docket Number:
`
`17618CON6
`(AP)
`17618CON6 (AP)
`17618CON6 (AP)
`
`Filed as Large Entity
`Filed as Large Entity
`Filed as Large Entity
`
`Utility under
`35 USC 111 (a) Filing Fees
`Utility under 35 USC 111(a) Filing Fees
`Utility under 35 USC 111(a) Fil