Docket No. l76l8CON6B (AP)
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`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`Applicant: Acheampong, et al.
`
`Examiner: TBA
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`Serial No.: TBA
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`Filed: Herewith
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`Group Art Unit: TBA
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`Confirmation No. TBA
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`For: METHODS OF PROVIDING
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`Customer No.: 51957
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`THERAPEUTIC EFFECTS USING
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`CYCLOSPORIN COMPONENTS
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`PRELIMINARY AMENDMENT
`
`Commissioner for Patents
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`P.O. Box l450
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`Alexandria, VA 22313-1450
`
`Dear Sir:
`
`Prior to examining the above-referenced application, please amend the
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`specification as described on page 2 of this paper, and please amend the claims as
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`described on pages 3-6 of this paper. Remarks follow on page 7.
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`ARGENTUM - EX. 1004, p. 001
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`ARGENTUM - EX. 1004, p. 001
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`

`
`Docket No. 17618CON6B (AP)
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`Amendments to the Specification
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`Please replace page 1, lines 5-10 of the specification filed herewith with the following
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`amended paragraph:
`
`This application is a continuation of copending U.S. Application Serial No.
`
`13/961,828 filed August 7, 2013, which 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 August 27, 2004, now abandoned, which claimed the benefit
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`of U.S. Provisional Application No. 60/503,137 filed September 15, 2003, which—is Q
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`incorporated in its their entirety herein by reference.
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`Please replace page 4, line 25 — page 5, line 3 of the specification filed herewith with the
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`following amended paragraph:
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`The present methods are useful in treating any suitable condition which is
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`therapeutically sensitive to or treatable with cyclosporin components. Such conditions
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`preferably are ophthalmic or ocular conditions, that is relating to or having to do with one
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`or more parts of an eye of a human or animal. Included among such conditions are,
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`without limitation, dry eye syndrome, phacoanaphylactic endophthalmitis, uveitis, vernal
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`conjunctivitis, atopic keratoconjunctivitis, corneal graft rejection and the like conditions.
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`The present invention is particularly effective in treating dry eye syndrome. Cyclosporin
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`has been found as effective in treatin immune mediated keratocon'unctivitis sicca KCS
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`or d
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`e e disease in a atient sufferin therefrom. The activit of c clos orins is as an
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`immunosuppressant and in the enhancement or restoring of lacrimal gland tearing. Other
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`conditions that can be treated with cyclosporin components include an absolute or partial
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`deficienc in a ueous tear
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`roduction keratoconunctivitis sicca or KCS . To ical
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`administration to a patient's tear deficient eye can increase tear production in the eye. The
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`treatment can further serve to correct corneal and conjunctival disorders exacerbated by
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`tear deficiency and KCS, such as corneal scarring, corneal ulceration, inflammation of
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`the cornea or conjunctiva, filamentapy keratisis, mucopurulent discharge and
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`vascularization of the cornea.
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`ARGENTUM - EX. 1004, p. 002
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`ARGENTUM - EX. 1004, p. 002
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`

`
`Docket No. 17618CON6B (AP)
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`Amendments to the claims
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`The following list of claims will replace all previous versions of claims presented
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`in this application:
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`1. — 36. (Canceled)
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`37. (New) A topical ophthalmic emulsion for treating an eye of a human having KCS,
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`wherein the topical ophthalmic emulsion comprises cyclosporin A in an amount of about
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`0.05% by weight, polysorbate 80, Pemulen, water, and castor oil in an amount of about
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`1.25% by weight; and
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`wherein the topical ophthalmic emulsion is therapeutically effective in treating
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`KCS.
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`38. (New) The topical ophthalmic emulsion of Claim 37, wherein the topical ophthalmic
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`emulsion further comprises a tonicity agent or a demulcent component.
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`39. (New) The topical ophthalmic emulsion of Claim 38, wherein the tonicity agent or the
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`demulcent component is glycerine.
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`40. (New) The topical ophthalmic emulsion of Claim 37, wherein the topical ophthalmic
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`emulsion further comprises a buffer.
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`41. (New) The topical ophthalmic emulsion of Claim 40, wherein the buffer is sodium
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`hydroxide.
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`42. (New) The topical ophthalmic emulsion of Claim 37, wherein the topical ophthalmic
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`emulsion further comprises glycerine and a buffer.
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`43. (New) The topical ophthalmic emulsion of Claim 37, wherein the topical ophthalmic
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`emulsion comprises polysorbate 80 in an amount of about 1.0% by weight.
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`ARGENTUM - EX. 1004, p. 003
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`ARGENTUM - EX. 1004, p. 003
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`

`
`Docket No. 17618CON6B (AP)
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`44. (New) The topical ophthalmic emulsion of Claim 37, wherein the topical ophthalmic
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`emulsion comprises Pemulen in an amount of about 0.05% by weight.
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`45. (New) The topical ophthalmic emulsion of Claim 37, wherein the topical ophthalmic
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`emulsion further comprises glycerine in an amount of about 2.2% by weight, water, and a
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`buffer.
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`46. (New) The topical ophthalmic emulsion of Claim 45, wherein the buffer is sodium
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`hydroxide.
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`47. (New) The topical ophthalmic emulsion of Claim 37, wherein, when the topical
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`ophthalmic emulsion is administered to an eye of a human in an effective amount in
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`treating KCS, the blood of the human has substantially no detectable concentration of
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`cyclosporin A.
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`48. (New) The topical ophthalmic emulsion of Claim 42, wherein the topical ophthalmic
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`emulsion has a pH in the range of about 7.2 to about 7.6.
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`49. (New) The topical ophthalmic emulsion of Claim 37, wherein the topical ophthalmic
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`emulsion is as substantially therapeutically effective as an emulsion comprising
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`cyclosporin A in an amount of 0.1% by weight and castor oil in an amount of 1.25% by
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`weight.
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`50. (New) The topical ophthalmic emulsion of Claim 37, wherein the topical ophthalmic
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`emulsion achieves at least as much therapeutic effectiveness as an emulsion comprising
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`cyclosporin A in an amount of 0.1% by weight and castor oil in an amount of 1.25% by
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`weight.
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`51. (New) The topical ophthalmic emulsion of Claim 37, wherein the topical ophthalmic
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`emulsion breaks down more quickly in the eye of a human, once administered to the eye
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`ARGENTUM - EX. 1004, p. 004
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`ARGENTUM - EX. 1004, p. 004
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`

`
`Docket No. l76l8CON6B (AP)
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`of the human, thereby reducing vision distortion in the eye of the human as compared to
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`an emulsion that contains only 50% as much castor oil.
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`52. (New) The topical ophthalmic emulsion of Claim 37, wherein the topical ophthalmic
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`emulsion, when administered to the eye of a human, demonstrates a reduction in adverse
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`events in the human, relative to an emulsion comprising cyclosporin A in an amount of
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`0. l% by weight and castor oil in an amount of 1.25% by weight.
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`53. (New) The topical ophthalmic emulsion of Claim 52, wherein the adverse events
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`include side effects.
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`54. (New) A topical ophthalmic emulsion for treating an eye of a human, wherein the
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`topical ophthalmic emulsion increases tear production in the eye of a human, and wherein
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`the topical ophthalmic emulsion comprises:
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`cyclosporin A in an amount of about 0.05% by weight;
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`castor oil in an amount of about l.25% by weight;
`
`polysorbate 80 in an amount of about 1.0% by weight;
`
`Pemulen in an amount of about 0.05% by weight;
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`a tonicity component or a demulcent component in an amount of about 2.2% by
`
`weight;
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`a buffer; and
`
`water.
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`55. (New) The topical ophthalmic emulsion of Claim 54, wherein the buffer is sodium
`
`hydroxide.
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`56. (New) The topical ophthalmic emulsion of Claim 54, wherein the tonicity component
`
`or the demulcent component is glycerine.
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`ARGENTUM - EX. 1004, p. 005
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`ARGENTUM - EX. 1004, p. 005
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`

`
`Docket No. 17618CON6B (AP)
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`57. (New) The topical ophthalmic emulsion of Claim 54, wherein, when the topical
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`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 cyclosporin A.
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`58. (New) The topical ophthalmic emulsion of Claim 54, wherein the topical ophthalmic
`
`emulsion has a pH in the range of about 7.2 to about 7.6.
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`59. (New) The topical ophthalmic emulsion of Claim 54, wherein the topical ophthalmic
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`emulsion is effective in treating KCS.
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`60. (New) A topical ophthalmic emulsion for treating an eye of a human, the topical
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`ophthalmic emulsion comprising:
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`cyclosporin A in an amount of about 0.05% by weight;
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`castor oil in an amount of about 1.25% by weight;
`
`polysorbate 80 in an amount of about 1.0% by weight;
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`Pemulen in an amount of about 0.05% by weight;
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`glycerine in an amount of about 2.2% by weight;
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`sodium hydroxide; and
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`water;
`
`wherein the emulsion is effective in treating KCS.
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`61. (New) The topical ophthalmic emulsion of Claim 60, wherein the topical ophthalmic
`
`emulsion has a pH in the range of about 7.2 to about 7.6.
`
`ARGENTUM - EX. 1004, p. 006
`
`ARGENTUM - EX. 1004, p. 006
`
`

`
`Docket No. 17618CON6B (AP)
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`REMARKS
`
`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,
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`and at least at 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.
`
`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 incorporated by reference in the present application specification at page 1,
`
`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 parent applications. To the extent any prior amendments or characterizations of the
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`scope of any 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 disclaimer.
`
`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 (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 the present application specification. Since these
`
`comments have been filed,
`
`the Applicants have collected evidence that supports the
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`patentability of the pending claims.
`
`The Commissioner is hereby authorized to charge any fees required or necessary
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`for the filing, processing or entering of this paper or any of the enclosed papers, and to
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`refund any overpayment, to deposit account 01-0885.
`
`Date: August 14, 2013
`
`Respectfully submitted,
`
`/Laura L. Wine/
`
`Laura L. Wine
`
`Attorney of Record
`Registration Number 68,681
`
`ARGENTUM - EX. 1004, p. 007
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`ARGENTUM - EX. 1004, p. 007
`
`

`
`Docket No. 17618CON6B (AP)
`
`Please direct all inquiries and correspondence to:
`Laura L. Wine, Esq.
`Allergan, Inc.
`2525 Dupont Drive, T2-7H
`Irvine, California 926l2
`Tel: (714) 246-6996 Fax: (714) 246-4249
`
`ARGENTUM - EX. 1004, p. 008
`
`ARGENTUM - EX. 1004, p. 008
`
`

`
`PTOiA!A;‘{}‘£ (0842)
`Appmvezi for 1359 through 0t.’31.z’2C?14. OMB 3553-0832
`13.8 Patent and Traciemark Office; L38. DEPARTMENT OF COMMERCE
`Urtder the Papezwsrk Reéiscticm Act of 1395, no persons are required to respand ta 2: coitectiaa of Snformatisn untess 3: disptays a vafid CW8 comtmi number.
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`
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`DECLARATION (37 CFR 1.63) FOR UTtL§TY OR DESIGN APPLKZATION USXNG AN
`APPLICATION DATA SHEET (37 CPR 1.76)
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`me of METHODS or-‘ PROWDJNG THERAPEUTH3 EFFECTS USMNEG CYCLOSPGRW
`Invention COMPONENTS
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`Docket No.: W61 8CON6(AP)
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`As the betow named invemcrg t hereby declare that:
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`This decimation
`£3 dérécted M
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`g
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`The attached application, or
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`United States apptication or PCT iretemationai appticatéon number
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`1 3 / 9 5 1 I 8 2 8
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`fitted on 8/7/2013
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`
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`The above—§dent§fted appiicatton was made or authorized to be made by me.
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`I beiieve that I am the original inventor or an origmat joint inventor of a ctaimed invention in the application.
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`I hereby acknowledge that any wiiifut faise statement made in this deciaratécsn is punishable under 18 1.3.8.8. 1001
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`LEGAL NAME OF INVENTOR
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`ARGENTUM - EX. 1004, p. 010
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`DECLARATiO¥% (37 CFR 1.63) FGR UTILITY OR DESKSN APPL§CAT¥GN 1.183148 AN
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`APPLSCATTON DATA SHEET (3? CFR 1 36)
`
`
`METHODS OF F’RC)VEBi¥\§S Ti~*§Efi§3PEUT¥C EFFECTS USING C¥"CLOSF{3R§¥‘~é
`mventiars CGMPGNENTS
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`Docket No;
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`’17’6’i8CON§{AP)
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`.115 me beiew rzameti invenior, I hereby deciars that
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`“W3 deciaratian
`gs déreded by B The attacizeii app%isa£i<m,::s.r
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`Umied Sixes applicatzm :32’ PCT mternatsonai appissatzan number W
`fiiedon 8/7/2013
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`13/961,828
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`The above-§dent§fied appiicatisn was made or auihorézed is be made by me,
`
`3 befieve that 2 am the angina? inventor or an os*ig§r:a¥ joint im='ento;* of a céaimed invention in the ap;3¥écai§o::.
`
`I hereby acknomedge thaf any wiiifui faise statement made in {his decimation is punishabiz-2 under 18 USAC. @001
`by fine at impriganmeni of not more than five {5} years, 0: boih.
`
`WARWNG:
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`?etEiiz;«ne::’ap;:s§%cant is cautiened to avoid submifiing persenaf infozmation in domsmems med 5:: a patent appiication that may
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`20 supgacrt a petition or as‘; appsication‘
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`?3’<}~2€338 submitied fer paymeni Qurpcses are mi retained in the appfistatiorz Fée and §here§oa'e are not puiniirfiy awaiéaifie.
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`ARGENTUM - EX. 1004, p. 011
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`ARGENTUM - EX. 1004, p. 011
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`ARGENTUM - EX. 1004, p. 012
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`ARGENTUM - EX. 1004, p. 012
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`

`
`PTOISBIAIA02 (06-12)
`Approved for use through 01I31I2014. OMB 0651-0032
`U.S. Patent and Trademark Office: U.S. DEPARTMENT OF COMMERCE
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`nature:
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`I
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`Petiiionerlapplicant is cautioned to avoid submitting personal lnfomiation in documents flied in a patent application that may
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`'ER8ON EXECU‘l1NG THIS suesn STTEIIENT:
`
`
`-
`77n E.-/459 rrmor St-znmm
`Nam Debra D. Condino ,_ no .gm_,,.m,,,,,¢_
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`‘ Residence (uni provided in an application data sheet. PTOIAW14 or equivalent):
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`.
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`ing Address (unless provided In an application data sheet. PTOIAIAI14 or equivalent)
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`2525 Dupont Drive-T2-7H
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`
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`.
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`Irv-ne
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`92612
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`I T[PageT2T of 2]
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`ARGENTUM - EX. 1004, p. 013
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`ARGENTUM - EX. 1004, p. 013
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`

`
`Préyeey Act Statement
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`er Eeeei iew enfemmenfi messy, if me BSPTG eewmw eemre ef e yéeiefiee er eeteuiiei
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`ARGENTUM - EX. 1004, p. 014
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`ARGENTUM - EX. 1004, p. 014
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`

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