Docket No 176 18CON7B AP
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`Applicant Acheampong et at
`
`Examiner TBA
`
`Serial No TBA
`
`Filed Herewith
`
`For METHODS OF PROVIDNG
`THERAPEUTIC EFFECTS USING
`CYCLOSPORN COMPONENTS
`
`Group Art Unit TBA
`
`Confirmation No TBA
`
`Customer No 51957
`
`PRELIMINARY AMENDMENT
`
`Commissioner for Patents
`P.O Box 1450
`Alexandria VA 223 13-1450
`
`Dear Sir
`
`Prior to examining the above-referenced application please amend the
`
`specification as described on page
`
`of this paper and please amend the claims as
`
`described on pages 3-6 of this paper Remarks follow on page
`
`FAMY CARE - EXHIBIT 1004-0001
`
`

`

`Docket No 176 18CON7B AP
`
`Amendments to the Specification
`
`Please replace page
`
`lines 5-10 of the specification filed herewith with the following
`
`amended paragraph
`
`This application is
`
`continuation of copending U.S Application Serial No
`
`13/961835 filed August
`
`2013 which is
`
`continuation of copending U.S Application
`
`Serial No 11/897177
`
`filed August 28 2007 which is
`
`continuation of U.S Application
`
`Serial No 10/927857
`
`filed August 27 2004 now abandoned which claimed the benefit
`of U.S Provisional Application No 60/503137 filed September 15 2003 which-is are
`
`incorporated in i4s their entirety herein by reference
`
`Please replace page
`
`line 25
`
`page
`
`line
`
`of the specification filed herewith with the
`
`following amended paragraph
`
`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 or ocular conditions that is relating to or having to do with one
`
`or more parts of an eye of human or animal
`
`Included among such conditions are
`
`without limitation dry eye syndrome phacoanaphyl actic endophthalmitis uveitis vernal
`
`conjunctivitis atopic keratoconjunctivitis corneal graft rejection and the like conditions
`
`The present invention is particularly effective in treating dry eye syndrome Cyclosporin
`sicca KCS
`
`has been found as effective in treating immune mediated keratoconjunctivitis
`
`or dry eye disease in patient suffering therefrom 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 an absolute or partial
`deficiency in aqueous tear production keratoconjunctivitis sicca or KCS Topical
`
`administration to
`
`patients tear deficient eye can increase tear production in the eye 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 conjunctiva
`
`filamentary keratisis mucopurulent discharge and
`
`vascularization of the cornea
`
`FAMY CARE - EXHIBIT 1004-0002
`
`

`

`Docket No 176 18CON7B AP
`
`Amendments to the claims
`
`The following list of claims will replace all previous versions of claims presented
`
`in this application
`
`36 Canceled
`
`37 New
`comprising topically administering to the eye of the human an emulsion at
`
`method of increasing tear production in the eye of human the method
`
`frequency of
`
`twice
`
`day wherein the emulsion comprises cyclosporin
`
`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
`
`wherein the topical ophthalmic emulsion is effective in increasing tear production
`
`38 New The method of Claim 37 wherein the emulsion further comprises
`
`tonicity
`
`agent or
`
`demulcent component
`
`39 New The method of Claim 38 wherein the tonicity agent or the demulcent
`
`component
`
`is glycerine
`
`40 New The method of Claim 37 wherein the emulsion further comprises
`
`buffer
`
`41 New The method of Claim 40 wherein the buffer is sodium hydroxide
`
`42 New The method of Claim 37 wherein the topical ophthalmic emulsion further
`
`comprises glycerine and buffer
`
`43 New The method of Claim 37 wherein the emulsion comprises polysorbate 80 in an
`
`amount of about 1.0% by weight
`
`FAMY CARE - EXHIBIT 1004-0003
`
`

`

`Docket No 176 18CON7B AP
`
`44 New The method of Claim 37 wherein the emulsion comprises Pemulen in an
`
`amount of about 0.05% by weight
`
`45 New The method of Claim 37 wherein the emulsion further comprises glycerine in
`
`an amount of about 2.2% by weight and buffer
`
`46 New The method of Claim 45 wherein the buffer is sodium hydroxide
`
`47 New The method of Claim 37 wherein when the emulsion is administered to an
`in treating KCS the blood of the human has
`eye of human in an effective amount
`
`substantially no detectable concentration of cyclosporin
`
`48 New The method of Claim 42 wherein the emulsion has
`
`pH in the range of about
`
`7.2toabout7.6
`
`49 New The method of Claim 37 wherein the emulsion is as substantially
`
`therapeutically effective as an emulsion comprising cyclosporin
`
`in an amount of 0.1%
`
`by weight and castor oil
`
`in an amount of 1.25% by weight
`
`50 New The method of Claim 37 wherein the emulsion achieves at least as much
`
`therapeutic effectiveness as an emulsion comprising cyclosporin
`
`in an amount of 0.1%
`
`by weight and castor oil
`
`in an amount of 1.25% by weight
`
`51 New The method of Claim 37 wherein the emulsion breaks down more quickly in
`
`the eye of human once administered to the eye of the human thereby reducing vision
`distortion in the eye of the human as compared to an emulsion that contains only 50% as
`
`much castor oil
`
`52 New The method of Claim 37 wherein the emulsion when administered to the eye
`
`of human demonstrates
`
`reduction in adverse events in the human relative to an
`
`FAMY CARE - EXHIBIT 1004-0004
`
`

`

`Docket No 176 18CON7B AP
`
`emulsion comprising cyclosporin
`
`in an amount of 0.1% by weight and castor oil
`
`in an
`
`amount of 1.25% by weight
`
`53 New The method of Claim 52 wherein the adverse events include side effects
`
`54 New
`administering to an eye of human an emulsion at
`
`method of treating KCS the method comprising the step of topically
`
`frequency of twice
`
`day the
`
`emulsion comprising
`
`cyclosporin
`
`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
`
`tonicity component or
`
`demulcent component
`
`in an amount of about 2.2% by
`
`weight
`
`buffer and
`
`water
`wherein the emulsion is effective in treating KCS
`
`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 the demulcent
`
`component
`
`is glycerine
`
`57 New The method of Claim 54 wherein when the emulsion is administered to the
`in treating KCS the blood of the human has
`eye of human in an effective amount
`
`substantially no detectable concentration of the cyclosporin
`
`58 New The method of Claim 54 wherein the emulsion has
`
`pH in the range of about
`
`7.2toabout7.6
`
`FAMY CARE - EXHIBIT 1004-0005
`
`

`

`Docket No 176 18CON7B AP
`
`59 New
`method comprising
`administering an emulsion topically to the eye of human having KCS wherein
`
`the emulsion comprises
`
`cyclosporin
`
`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
`
`pH in the range of about
`
`7.2toabout7.6
`
`FAMY CARE - EXHIBIT 1004-0006
`
`

`

`Docket No 176 18CON7B 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
`
`line 25
`
`page
`
`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
`
`line 25
`
`page
`
`line
`
`may be found at
`
`least
`
`in U.S Patent Nos 5474979 and 6254860 which were
`
`previously incorporated by reference in the present application specification at page
`
`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
`
`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 Examiners attention
`
`comments made in the Response filed on June 15 2009 in U.S Patent Application Serial
`No 10/927857 now abandoned and comments made in the Amendment
`filed on June
`15 2009 in U.S Patent Application Serial No 11/897177 currently pending regarding
`U.S Patent No 5474979
`
`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
`
`1-0885
`
`Date August 14 2013
`
`Respectfully submitted
`
`/Laura
`
`Wine/
`
`______________________
`Laura Wine
`Attorney of Record
`
`FAMY CARE - EXHIBIT 1004-0007
`
`

`

`Docket No 176 18CON7B AP
`
`inquiries and correspondence to
`Please direct all
`Laura Wine Esq
`Allergan Inc
`2525 Dupont Drive T2-7H
`Irvine California 92612
`Tel 714 246-6996 Fax 714 246-4249
`
`Registration Number 68681
`
`FAMY CARE - EXHIBIT 1004-0008
`
`

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`inventor or inventors who are also the applicant should be
`inventors then the joint
`proprietary interest
`identified in this section
`
`Clear
`
`Assignee
`
`Legal Representative
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`under 35 U.S.C 117
`
`Joint Inventor
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`Person to whom the inventor is obligated to assign
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`Person who shows sufficient proprietary interest
`
`If applicant
`
`is the legal representative
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`indicate the authority to file the patent application the inventor is
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`Name of the Deceased or Legally Incapacitated Inventor ________________________________________________
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`If the Applicant
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`is an Organization check here
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`Organization Name
`
`Allergan Inc
`
`Mailing Address Information
`
`Address
`
`Address
`
`city
`
`country
`
`US
`
`Phone Number
`
`2525 Dupont Drive
`
`Irvine
`
`State/Province
`
`Postal Code
`
`Fax Number
`
`CA
`
`92612
`
`FAMY CARE - EXHIBIT 1004-0013
`
`

`

`Under the Paperwork Reduction Act of 1995 no persons are required to respond to
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`PTOIAIAI14 03-13
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`U.S Patent and Trademark Office U.S DEPARTMENT OF COMMERCE
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`Application Data Sheet 37 CFR 1.76
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`Attorney Docket Number
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`17618C0N7B AP
`
`Application Number
`
`Title of Invention
`
`METHODS OF PROVIDING THERAPEUTIC EFFECTS USING CYCLOSPORIN COMPONENTS
`
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`patent_ipallergan .Com
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`Signature
`NOTE This form must be signed in accordance with 37 CFR 1.33 See 37 CFR .4 for signature requirements and
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`Signature
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`/Laura Wine
`
`Date YYYY-MM-DD
`
`2013-08-14
`
`First Name
`
`Laura
`
`Last Name
`
`Wine
`
`Registration Number
`
`68681
`
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`EF5 web 2.2.7
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`FAMY CARE - EXHIBIT 1004-0014
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`Under the Paperwork Reduction Act of 1995 no persons are required to respond to
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`
`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
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`FAMY CARE - EXHIBIT 1004-0015
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`Privacy Act Statement
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`The Privacy Act 011914 AL 93-519 requires that you be given certain information in connection with your submission 01 the attached form related to
`to the requirements of the Act please be advised that
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`furnishing of the information solicited is voluntary and 3the principal purpose for which the information is
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`furnish the requested information the u.s Patent and Trademark Office may not be able to process and/or examine your submission which may
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`record from this system of records may be disclosed as
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`to 35 U.S.C 122b or issuance of
`to 35 U.S.C 151 Further
`to the limitations of 37
`record may be disclosed subject
`patent pursuant
`CFR 1.14 as
`the record was filed in an application which became abandoned or in which the proceedings were
`routine use to the public if
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`patent
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`Federal State or local
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`EFS Web 2.2.7
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`FAMY CARE - EXHIBIT 1004-0016
`
`

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`Under
`
`the Paperwork Reduchon Act of 1995 no persons are reqwred to respond to
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`PTO/AtA/01
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`Appoved for use through 01/312014
`DEPARTMENT OF COMMERCE
`Patent and Trademark Office
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`unless it rasplays
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`
`DECLARATION 37 CFR 1.63 FOR UTILITY OR DESIGN APPLICATION USING AN
`APPLICATION DATA SHEET 37 CFR 1.76
`
`Title
`
`METHODS OF PROVIDING THERAPEUTIC EFFECTS USING CYCLOSPORIN
`tnvention COMPONENTS
`Docket No 17618C0N7AP
`
`As the below named inventor
`
`hereby dedare that
`
`This declaration
`
`ts dtrected to
`
`The attached application or
`
`13/961835
`Untted States appltcatton or PCT internattonal appltcatton number _____________________
`8/7/2013
`
`filed on
`
`The above-identified
`
`appltcation was made or authorized to be made by me
`
`believe that
`
`am the ortginal
`
`inventor or an original
`
`jotnt
`
`inventor of
`
`claimed invention in the application
`
`false statement made in this declaration is punishable under 18 USC 1001
`hereby acknowledge that any willful
`by fine or imprisonment of not more than five
`years or both
`
`Petitioner/applicant
`
`WARNING
`information in documents filed in
`is cautioned to avoid submitting personal
`patent application that may
`information such as social security numbers bank account numbers or credit card numbers
`contribute to identity theft Personal
`form P10-2038 submitted for payment purposes is never required by the USPTO
`check or credit card authorization
`other than
`information is included in documents submitted to the USPTO
`petition or an application If this type of personal
`to support
`redacting such personal
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`should consider
`USPTO Petitioneriappltcant
`is advised that
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`in compliance with 37 CFR 1213a is made in the application or issuance of
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`patent Furthermore the record from an abandoned application may also be available to the public if
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`
`petitioners/applicants
`
`LEGAL NAME OF INVENTOR
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`Date Opttonal
`
`Note Ar app icahon data sheet PlO AIA/14 or equtvalentl
`tnclud ng iamtng the ent re inventive entity must acCompany this form
`Use an add tiona PlO SB AIAU1 form for eacH addttional
`inventor
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`TI
`
`collect on of nforrnat on is reqj rei by 35
`cc
`at
`
`i/c
`
`15
`
`FR
`
`TI
`
`Talc
`
`ae tak
`
`II
`
`II
`
`at
`rI
`
`des
`
`Far
`
`pt
`
`tc
`
`urtanct
`
`HI
`
`patIo
`
`Pt
`
`ctcrrarsff
`
`ftrg
`
`app
`
`pt
`rd
`et
`ip1 to thi
`Rx
`nr rs
`Decanot
`Rio SEND TO Commissionerfor Patents PO Box 1450 AlexandrIa VA 22313-1450
`If you ned ass/stance ir completing
`80 PTO 9/PP ani se/c
`
`SI
`
`rp
`
`IC
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`vtv
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`At
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`
`FAMY CARE - EXHIBIT 1004-0017
`
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`Under the Papeiwork Reductior Act of 995 to pomona are eqwred to ospond to
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`
`Paleut and
`
`O/AIM1 812
`ue thr ugh
`31 2014 0MB 08600
`Apnsd
`DEPAR ML if OF
`rademark Office
`YaV 0MB onL
`Staptays
`
`formation untess
`
`t4
`
`cATONTASHEETc3lcFRl6j
`
`AN
`
`USING CYCLOSPORIN
`
`As the below named inventor
`
`hereby declare that
`
`The declaration
`is directed to
`
`The attached application or
`
`1J
`
`UntIed States application or PCI international a