Docket No. 17618CON7B (AP)
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`Applicant: Acheampong, et al.
`
`Examiner: TBA
`
`Serial No.: TBA
`
`Filed: Herewith
`
`For: METHODS OF PROVIDING
`THERAPEUTIC EFFECTS USING
`CYCLOSPORIN COMPONENTS
`
`Group Art Unit: TBA
`
`Confirmation No. TBA
`
`Customer No.: 51957
`
`PRELIMINARY AMENDMENT
`
`Commissioner for Patents
`P.O. Box 1450
`Alexandria, VA 22313-14 50
`
`Dear Sir:
`
`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 paper. Remarks follow on page 7.
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`1
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`Apotex 1019, pg. 1387
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`

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`Docket No. 17618CON7B (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.
`
`13/961,835 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 ofU.S. Application
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`Serial No. 10/927,857, filed August 27, 2004, now abandoned, which claimed the benefit
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`ofU.S. Provisional Application No. 60/503,137 filed September 15, 2003, which-is are
`
`incorporated in its their entirety herein by reference.
`
`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, phacoanaphy 1 actic 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 treating immune mediated keratoconjunctivitis sicca (KCS
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`or dry eye disease) in a patient suffering therefrom. The activity of cyclosporins 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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`deficiency in aqueous tear production (keratoconjunctivitis sicca, or KCS). Topical
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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, filamentary keratisis, mucopurulent discharge and
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`vascularization of the cornea.
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`2
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`Apotex 1019, pg. 1388
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`

`
`Docket No. 17618CON7B (AP)
`
`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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`3 7. (New) A method of increasing tear production in the eye of a human, the method
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`comprising topically administering to the eye of the human an emulsion at a frequency of
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`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 an amount of about 1.25%
`
`by weight; and
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`wherein the topical ophthalmic emulsion is effective in increasing tear production.
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`38. (New) The method of Claim 37, wherein the emulsion further comprises a tonicity
`
`agent or a demulcent component.
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`39. (New) The method of Claim 38, wherein the tonicity agent or the demulcent
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`component is glycerine.
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`40. (New) The method of Claim 37, wherein the emulsion further comprises a buffer.
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`41. (New) The method of Claim 40, wherein the buffer is sodium hydroxide.
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`42. (New) The method of Claim 37, wherein the topical ophthalmic emulsion further
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`comprises glycerine and a buffer.
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`43. (New) The method of Claim 37, wherein the emulsion comprises polysorbate 80 in an
`
`amount of about 1.0% by weight.
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`3
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`Apotex 1019, pg. 1389
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`

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`Docket No. 17618CON7B (AP)
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`44. (New) The method of Claim 37, wherein the emulsion comprises Pemulen in an
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`amount of about 0.05% by weight.
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`45. (New) The method of Claim 37, wherein the emulsion further comprises glycerine in
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`an amount of about 2.2% by weight and a buffer.
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`46. (New) The method of Claim 45, wherein the buffer is sodium hydroxide.
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`47. (New) The method of Claim 37, wherein, when the emulsion is administered to an
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`eye of a human in an effective amount in treating KCS, the blood of the human has
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`substantially no detectable concentration of cyclosporin A.
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`48. (New) The method of Claim 42, wherein the emulsion has a pH in the range of about
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`7.2 to about 7.6.
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`49. (New) The method of Claim 37, wherein the emulsion is as substantially
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`therapeutically effective as an emulsion comprising cyclosporin A in an amount of 0.1%
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`by weight and castor oil in an amount of 1.25% by weight.
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`50. (New) The method of Claim 37, wherein the emulsion achieves at least as much
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`therapeutic effectiveness as an emulsion comprising cyclosporin A in an amount of0.1%
`
`by weight and castor oil in an amount of 1.25% by weight.
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`51. (New) The method of Claim 37, wherein the emulsion breaks down more quickly in
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`the eye of a human, once administered to the eye of the human, thereby reducing vision
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`distortion in the eye of the human as compared to an emulsion that contains only 50% as
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`much castor oil.
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`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 the human, relative to an
`
`4
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`Apotex 1019, pg. 1390
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`

`
`Docket No. 17618CON7B (AP)
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`emulsion comprising cyclosporin A in an amount of 0.1% by weight and castor oil in an
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`amount of 1.25% by weight.
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`53. (New) The method of Claim 52, wherein the adverse events include side effects.
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`54. (New) A method of treating KCS, the method comprising the step of topically
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`administering to an eye of a human an emulsion at a frequency of twice a day, the
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`emulsion comprising:
`
`cyclosporin A in an amount of about 0.05% by weight;
`
`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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`a tonicity component or a demulcent component in an amount of about 2.2% by
`
`weight;
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`a buffer; and
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`water;
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`wherein the emulsion is effective in treating KCS.
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`55. (New) The method of Claim 54, wherein the buffer is sodium hydroxide.
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`56. (New) The method of Claim 54, wherein the tonicity component or the demulcent
`
`component is glycerine.
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`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 KCS, the blood of the human has
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`substantially no detectable concentration of the cyclosporin A.
`
`58. (New) The method of Claim 54, wherein the emulsion has a pH in the range of about
`
`7.2 to about 7.6.
`
`5
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`Apotex 1019, pg. 1391
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`

`
`Docket No. 17618CON7B (AP)
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`59. (New) A method comprising:
`
`administering an emulsion topically to the eye of a human having KCS, wherein
`
`the emulsion comprises:
`
`cyclosporin A in an amount of about 0.05% by weight;
`
`castor oil in an amount of about 1.25% by weight;
`
`polysorbate 80 in an amount of about 1.0% by weight;
`
`Pemulen in an amount of about 0.05% by weight;
`
`glycerine in an amount of about 2.2% by weight;
`
`sodium hydroxide; and
`
`water; and
`
`wherein the emulsion is effective in increasing tear production in the human
`
`having KCS.
`
`60. (New) The method of Claim 59, wherein the emulsion has a pH in the range of about
`
`7.2 to about 7.6.
`
`6
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`Apotex 1019, pg. 1392
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`

`
`Docket No. 17618CON7B (AP)
`
`REMARKS
`
`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,
`
`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
`
`added.
`
`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 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
`
`patentability of the pending claims.
`
`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 overpayment, to deposit account 01-0885.
`
`Date: August 14, 2013
`
`Respectfully submitted,
`
`/Laura L. Wine/
`
`Laura L. Wine
`Attorney of Record
`
`7
`
`Apotex 1019, pg. 1393
`
`

`
`Docket No. 17618CON7B (AP)
`
`Please direct all inquiries and correspondence to:
`Laura L. Wine, Esq.
`Allergan, Inc.
`2525 Dupont Drive, T2-7H
`Irvine, California 92612
`Tel: (714) 246-6996 Fax: (714) 246-4249
`
`Registration Number 68,681
`
`8
`
`Apotex 1019, pg. 1394
`
`

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`Application Data Sheet 37 CFR 1.76
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`Attorney Docket Number
`
`17618CON7B (AP)
`
`Application Number
`
`Title of Invention METHODS OF PROVIDING THERAPEUTIC EFFECTS USING CYCLOSPORIN COMPONENTS
`
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`Inventor Information:
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`1
`Inventor
`Legal Name
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`Middle Name
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`Family Name
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`Andrew
`Acheampong
`Residence Information (Select One) (!) US Residency 0 Non US Residency O Active US Military Service
`I State/Province I CA
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`Irvine
`City
`
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`
`Address 1
`Address 2
`
`City
`
`I Irvine
`Postal Code
`
`2
`Inventor
`Legal Name
`
`16 Wintergreen
`
`1 92604
`
`I State/Province
`I Country i
`1 us
`
`I CA
`
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`Tang-Liu
`D.
`Diane
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`I State/Province I NV
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`Las Vegas
`City
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`Address 1
`
`Address 2
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`3726 Las Vegas Blvd S. Unit 3303 W
`
`City
`
`I Las Vegas
`Postal Code
`
`1 89158
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`1 us
`
`I NV
`
`3
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`Legal Name
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`Chang
`James
`N.
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`EFS Web 2.2.7
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`Apotex 1019, pg. 1395
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`Application Data Sheet 37 CFR 1.76
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`Attorney Docket Number
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`17618CON7B (AP)
`
`Application Number
`
`Title of Invention METHODS OF PROVIDING THERAPEUTIC EFFECTS USING CYCLOSPORIN COMPONENTS
`
`City I Newport Beach
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`I State/Province I CA
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`I Country of Residence i I US
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`36 Cervantes
`
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`City
`
`I Newport Beach
`Postal Code
`1 92660
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`David
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`Power
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`Hubert
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`1 28539
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`202 Fox Way N
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`51957
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`patents ip@allergan.com
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`Attorney Docket Number 17618CON7B (AP)
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`METHODS OF PROVIDING THERAPEUTIC EFFECTS USING CYCLOSPORIN COMPONENTS
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`Apotex 1019, pg. 1396
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`Apotex 1019, pg. 1397
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`Title of Invention METHODS OF PROVIDING THERAPEUTIC EFFECTS USING CYCLOSPORIN COMPONENTS
`
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`Title of Invention METHODS OF PROVIDING THERAPEUTIC EFFECTS USING CYCLOSPORIN COMPONENTS
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`State/Province
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`CA
`
`Postal Code
`
`92612
`
`Fax Number
`
`Apotex 1019, pg. 1399
`
`

`
`PTO/AIN14 (03-13)
`Approved for use through 01/31/2014. OMB 0651-0032
`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.
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`Application Data Sheet 37 CFR 1.76
`
`Attorney Docket Number
`
`17618CON7B (AP)
`
`Application Number
`
`Title of Invention METHODS OF PROVIDING THERAPEUTIC EFFECTS USING CYCLOSPORIN COMPONENTS
`
`Email Address
`
`patent_ip@allergan.com
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`Add
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`Non-Applicant Assignee Information:
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`Assignee 1
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`Complete this section only if non-applicant assignee information is desired to be included on the patent application publication in
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`NOTE: This form must be signed in accordance with 37 CFR 1.33. See 37 CFR 1.4 for signature requirements and
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`Signature
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`/Laura L. Wine/
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`Date (YYYY-MM-DD) 2013-08-14
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`Laura
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`Additional Signature may be generated within this form by selecting the Add button.
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`68681
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`EFS Web 2.2. 7
`
`Apotex 1019, pg. 1400
`
`

`
`PTO/AIN14 (03-13)
`Approved for use through 01/31/2014. OMB 0651-0032
`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.
`
`Application Data Sheet 37 CFR 1.76
`
`Attorney Docket Number
`
`17618CON7B (AP)
`
`Application Number
`
`Title of Invention METHODS OF PROVIDING THERAPEUTIC EFFECTS USING CYCLOSPORIN COMPONENTS
`
`This collection of information is required by 37 CFR 1.76. The information is required to obtain or retain a benefit by the public which
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`EFS Web 2.2. 7
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`Apotex 1019, pg. 1401
`
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`Privacy Act Statement
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`EFS Web 2.2.7
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`Apotex 1019, pg. 1402
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`

`
`PTOIAIN01 (06-12)
`Approved for use through 01/31/2014. OMB 0651-0032
`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 displays a valid OMS control number.
`
`DECLARATION (37 CFR 1.63) FOR UTILITY OR DESIGN APPLICATION USING AN
`APPLICATION DATA SHEET (37 CFR 1.76)
`
`Title of METHODS OF PROVIDING THERAPEUTIC EFFECTS USING CYCLOSPORIN
`Invention COMPONENTS
`Docket No.: 17618CON7(AP)
`
`As the below named inventor, I hereby declare that:
`
`This declaration
`is directed to:
`
`The attached application, or
`
`13/961,835
`United States application or PCT international application number---------
`
`filed on __ 8_/_7_/_2_0_1_3 _ __ __ __ .
`
`The above-identified application was made or authorized to be made by me.
`
`I believe that I am the original inventor or an original joint inventor of a claimed invention in the application.
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`I hereby acknowledge that any willful false statement made in this declaration is punishable under 18 U.S.C. 1001
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`WARNING:
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