Docket No 176 18CON6B 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 18CON6B 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
`
`13/961828 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 18CON6B 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
`
`topical ophthalmic emulsion for treating an eye of
`
`human having KCS
`
`wherein the topical ophthalmic 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 therapeutically effective in treating
`
`KCS
`
`38 New The topical ophthalmic emulsion of Claim 37 wherein the topical ophthalmic
`
`emulsion further comprises
`
`tonicity agent or
`
`demulcent component
`
`39 New The topical ophthalmic emulsion of Claim 38 wherein the tonicity agent or the
`
`demulcent component
`
`is glycerine
`
`40 New The topical ophthalmic emulsion of Claim 37 wherein the topical ophthalmic
`
`emulsion further comprises
`
`buffer
`
`41 New The topical ophthalmic emulsion of Claim 40 wherein the buffer is sodium
`
`hydroxide
`
`42 New The topical ophthalmic emulsion of Claim 37 wherein the topical ophthalmic
`
`emulsion further comprises glycerine and buffer
`
`43 New The topical ophthalmic emulsion of Claim 37 wherein the topical ophthalmic
`
`emulsion comprises polysorbate 80 in an amount of about 1.0% by weight
`
`FAMY CARE - EXHIBIT 1004-0003
`
`

`

`Docket No 176 18CON6B AP
`
`44 New The topical ophthalmic emulsion of Claim 37 wherein the topical ophthalmic
`
`emulsion comprises Pemulen in an amount of about 0.05% by weight
`
`45 New The topical ophthalmic emulsion of Claim 37 wherein the topical ophthalmic
`
`emulsion further comprises glycerine in an amount of about 2.2% by weight water and
`
`buffer
`
`46 New The topical ophthalmic emulsion of Claim 45 wherein the buffer is sodium
`
`hydroxide
`
`47 New The topical ophthalmic emulsion of Claim 37 wherein when the topical
`human in an effective amount
`
`in
`
`ophthalmic emulsion is administered to an eye of
`treating KC the blood of the human has substantially no detectable
`
`concentration of
`
`cyclosporin
`
`48 New The topical ophthalmic emulsion of Claim 42 wherein the topical ophthalmic
`
`emulsion has
`
`pH in the range of about 7.2 to about 7.6
`
`49 New The topical ophthalmic emulsion of Claim 37 wherein the topical ophthalmic
`
`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 topical ophthalmic emulsion of Claim 37 wherein the topical ophthalmic
`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 topical ophthalmic emulsion of Claim 37 wherein the topical ophthalmic
`emulsion breaks down more quickly in the eye of human once administered to the eye
`
`FAMY CARE - EXHIBIT 1004-0004
`
`

`

`Docket No 176 18CON6B AP
`
`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 topical ophthalmic emulsion of Claim 37 wherein the topical ophthalmic
`emulsion when administered to the eye of human demonstrates
`
`reduction in adverse
`
`events in the human relative to an 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 topical ophthalmic emulsion of Claim 52 wherein the adverse events
`
`include side effects
`
`54 New
`
`topical ophthalmic emulsion for treating an eye of human wherein the
`
`topical ophthalmic emulsion increases tear production in the eye of human and wherein
`
`the topical ophthalmic 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
`
`tonicity component or
`
`demulcent component
`
`in an amount of about 2.2% by
`
`weight
`
`buffer and
`
`water
`
`55 New The topical ophthalmic emulsion of Claim 54 wherein the buffer is sodium
`
`hydroxide
`
`56 New The topical ophthalmic emulsion of Claim 54 wherein the tonicity component
`
`or the demulcent component
`
`is glycerine
`
`FAMY CARE - EXHIBIT 1004-0005
`
`

`

`Docket No 176 18CON6B AP
`
`57 New The topical ophthalmic emulsion of Claim 54 wherein when the topical
`human in an effective amount to
`
`ophthalmic emulsion is administered to an eye of
`
`increase tear production the blood of the human has substantially no detectable
`
`concentration of the cyclosporin
`
`58 New The topical ophthalmic emulsion of Claim 54 wherein the topical ophthalmic
`
`emulsion has
`
`pH in the range of about 7.2 to about 7.6
`
`59 New The topical ophthalmic emulsion of Claim 54 wherein the topical ophthalmic
`emulsion is effective in treating KCS
`
`60 New
`
`topical ophthalmic emulsion for treating an eye of human the topical
`
`ophthalmic 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
`
`glycerine in an amount of about 2.2% by weight
`
`sodium hydroxide and
`
`water
`wherein the emulsion is effective in treating KCS
`
`61 New The topical ophthalmic emulsion of Claim 60 wherein the topical ophthalmic
`
`emulsion has
`
`pH in the range of about 7.2 to about 7.6
`
`FAMY CARE - EXHIBIT 1004-0006
`
`

`

`Docket No 176 18CON6B AP
`
`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
`
`and at least at page
`
`line 25
`
`page
`
`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
`
`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
`Registration Number 68681
`
`FAMY CARE - EXHIBIT 1004-0007
`
`

`

`Docket No 176 18CON6B 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
`
`FAMY CARE - EXHIBIT 1004-0008
`
`

`

`0642
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`
`Title of
`
`METHODS OF PROVIDING THERAPEUTIC EFFECTS USING CYCLOSPORIN
`Invention COMPONENTS
`Docket NoW 17618CON6AP
`
`As the below named inventor
`
`hereby declare that
`
`This declaration
`is directed to
`
`The attached application or
`
`United States application or PCT international application number
`
`13/ 961 82
`
`filedon
`
`8/7/2013
`
`The above-identified
`
`application was made or authorized to be made by me
`
`believe that
`
`am the original
`
`inventor or an original
`
`joint
`
`inventor of
`
`claimed invention in the application
`
`hereby acknowledge that any willful false statement made in this declaration is punishable under 18 U.S.C 1001
`years or both
`by fine or imprisonment of not more than five
`
`WARNING
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`is cautioned to avoid submitting personal
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`FAMY CARE - EXHIBIT 1004-0009
`
`

`

`PTOFAINO
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`r37CFR1RUTJLIRDESGPPLtCATiON USING AN
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`USN
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`CLOSF FN
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`As the below named inventor
`
`hereby declare that
`
`This declaratIon
`
`Isdirectedtcr
`
`The attached application or
`
`United States application or PCI international application number3 /961 828
`8/7/2013
`
`filed on
`
`The aboveadentifled
`
`application was made or authorized to be made by me
`
`behave that
`
`am the original
`
`inventor or an original joint
`
`inventor of
`
`dairrec nvention in the application
`
`raise statement made in this declaratIon is punishable under
`hereby acknowledge that any willful
`by fine or imprisonment of not more than five
`years or both
`
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`form ror
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`civ
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`ci
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`ci
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`3$
`ommIsIo
`
`FAMY CARE - EXHIBIT 1004-0010
`
`

`

`Ui dec the Paperwork Reductorn
`
`of 1995
`
`persona
`
`cv requ ed to respond
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`oolie icr jf nforrrwt on unless
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`PlO AA01 06
`0MB 1651
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`OP COMMER
`DEPARTMEN
`vaiid 0MB coritroi nuo her
`spiava
`
`DECLARATION 37 CFR t63 FOR UTILITY OR DESIGN APPLICATION USING AN
`APPLICATION DATA SHEET 37 CFR J6
`
`Title
`
`Invention
`
`METHODS OF PROVIDING THERAPEUTtC EFFECTS USfNG CYCLOSPORIN
`COMPONENTS
`Docket No 17618C0N6AP
`
`As the below named inventor
`
`hereby declare that
`
`This declaration
`
`is directed to
`
`The attached application or
`
`United States apphcation or PCT international application number
`8/7/2013
`
`ifiedon
`
`13/961828
`
`The aboveadentifled application was made or authorized to be made by me
`
`believe that am the original
`
`inventor or an original joint inventor of
`
`claimed invention in the appbcation
`
`false statement made in this declaration is punishable under 18
`hereby acknowledge that any willful
`by fine or impnsonment of not more than five
`years or both
`
`1001
`
`WARNING
`
`patent application that may
`information in documents filed in
`is cautioned to avoid submitting personal
`Petitioner/appbcant
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`contribute to identity theft Personal
`is never required by the USPTO
`check or credit card authonzation form PTO-2038 submitted for payment purposes
`other than
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`
`LEGAL NAME OF INVENTOR
`
`frventor DAvtp
`
`Date Opt onal
`
`Sgnature
`_____________________
`
`S__________________________________________
`
`fir
`
`at ndatasleet FTOAIAI4o equi alert
`app
`seas ant cia PIT SBAA If
`rcifor aclaoditi ciii
`
`rcu ngnamrgtberiireirvePtivoentit
`verto
`
`tsJ mparett 51
`
`Stilt
`
`dl
`
`SEND TO
`
`stir
`
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`
`ter for Patents
`
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`
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`
`FAMY CARE - EXHIBIT 1004-0011
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`0MB 0661-0032
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`
`--
`
`Title
`Invention
`
`Methods of Providing Therapeutic Effects Using Cydospotin Components
`No 17618C0N6AP
`
`rocket
`
`This statement Is directed to
`
`ii The attached application
`
`LEGAL NAME of Inventor to whom this substitute statement applies
`E.g Given Name first and middle If any and Family Name or Surname
`James
`Chang
`deceased or legally incapacitated
`
`Residence
`
`except
`
`for
`
`Inventor
`
`-------------
`jus
`
`Newport Beach
`
`LCA
`
`36 Cervantes -a ---.--
`Newport Beach CA
`
`Mating Address except
`
`for
`
`deceased or legally Incapacitated
`
`lnventor
`
`--
`
`believe the above-named Inventor or joint inventor to be the original
`in the application
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`Inventor or an original joint Inventor of
`
`claimed Invention
`
`The above-Identified
`
`application was made or authorized to be made by me
`
`that any wIlld false statemant made In this statement Is punishable under 18 U.s.C 1001 by fine or
`hereby acknowledge
`hoprisonment of not more than fIve
`years or both
`
`Relationship to the Inventor
`
`to whom this substitute statement applies
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`fl
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`Legal Representative for deceased or legally Incapacitated
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`inventor only
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`
`Is under an obligation to assIgn
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`Person who othenaeise shows
`
`sufficient proprietary Interest In the matter petition under 37 CFR 1.46 Is required or
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`JoInt Inventor
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`incapacity
`
`Inventor cannot be found or reached after diligent effort or
`
`Inventor has refused to execute the oath or declaration under 37 CFR 1.63
`
`If there are Joint Inventors please check the appropriate box below
`
`An application data sheet under 37 CFR 1.76 PTO/AINI4 or equivalent naming the entire Inventive entity has bean
`or is currently submitted
`
`OR
`
`An application data sheet under 37 CFR 1.76 PTO/AINI4 or equivalent has not been submitted Thus
`Substitute
`or equivalent naming the entire Inventive entity and providing Inventor
`Statement Supplemental Sheet P10/AlA/I
`InformatIon Is attached See 37 CFR 1.64b
`WARNING
`Is cautioned to avoid submitting personal Information In documents filed In
`patent application that may
`Petitioner/applicant
`Information such as social security numbers bank account numbers or credit card numbers
`contribute to Identity thefL Personal
`check or credit card authorization form P10-2038 submitted for payment purposes Is never requIred by the USPTO
`other than
`In documents submitted to the USPTO
`petition or an application
`Information Is Included
`If this type of personal
`to support
`redactlng such personal Information from the documents before submitting them to the
`should consider
`petftioners/appllcants
`USPTO Petitioner/applicant
`Is advised that the record of
`patent application Is available to the public after publication of the
`non-publication request In compliance wIth 37 CFR 1213a Is made In the application or Issuance of
`application unless
`patent Furthermore the record from an abandoned application may also be available to the public if the applicatIon Is
`published application or an Issued patent see 37 CFR 1.14 Checks and credit card authorization forms
`referenced In
`PTO-2038 submitted for payment purposes are not retained in the application file and therefore are not publidy available
`
`ERSON EXECUTING ThIS SUBSTITUTE STATEMENT
`
`Name LeLra
`
`LOflUIflOON
`
`Slanature
`
`Residence uns provided In an application data sheet PTO/AIAI14 or equivalent
`CA
`countri US
`
`Irvine
`
`IState
`
`tailing Address unless provided In an application data sheet PTO/AINI4
`2525 Dupont Drive-T2-7H
`
`or equivalent
`
`Irvine
`
`CA
`
`92612 L0
`
`form for each inventor who Is deceased
`legally Incapacitated cannot be found or
`Note Use an additional PTO/hJA102
`reached after diligent effort or has refused to execute the oath or declaration under 37 CFR 1.63
`
`Page
`
`of
`
`FAMY CARE - EXHIBIT 1004-0013
`
`

`

`Pilvacy Act Statement
`
`The Privacy Act 11074 P.L fl.570 requires that you be given certain information In connection
`with your submIssion of the attached form related to
`patent application or patent Acordingly
`pursuant to the requirements of the Act please be advised that
`the general authority for the
`collection of this information Is 35 U.S.C 2b2
`furnishing of the Information solicited Is vduntary
`the principal purpose for which the information is used by the IS Patent and Trademark
`and
`Office is to process and/or examine your submission related to
`If you do
`patent application or patent
`not fUrnish the requested Information the U.S Patent and Trademark Office may not be able to
`process andor examine your submission which may result in termination of proceedings or
`abandonment of the application or expiration of the patent
`
`The Information provided by you In this form will be subject to the following routine uses
`
`The Information on this form will be treated confidentially to the extent allowed under the
`U.S.C 552a Records from
`Freedom of Information Act
`U.S.C 552 and the Privacy Act
`this system of records may be disclosed to the Department of Justice to determine whether
`disclosure of these records is required by the Freedom of Information Act
`record from this system of records may be disclosed as
`routine use In the course of
`presenting evidence to
`court magistrate or administrative tribunal
`including disclosures to
`opposing counsel
`In the course of settiement negotiations
`routine use to Member of
`record In this system of records may be disclosed as
`to whom the record pertains when the
`request lnvoMng an lndMdual
`Congress submitting
`individual has requested assistance from the Member with respect
`to the subject matter of the
`record
`record In this system of records may be disclosed as
`routine use to
`contractor of the
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`information shall be required to comply with the requirements of the Privacy Act of 1974 as
`amended pursuant to U.S.C 552am
`record related to an International Application filed under the Patent Cooperation Treaty in
`this system of records may be disclosed as
`routine use to the International Bureau of the
`World lnteiiectuai Property Organization pursuant to the Patent Cooperation Treaty
`Arecordinthissystemofrecords maybedisclosed asaroutineusetoanotherfederai
`agency for purposes of National Security review 35 U.S.C 181 and for review pursuant to
`the Atomic Energy Act 42 U.S.C 218c
`record from this system of records may be disclosed as
`routine use to the Administrator
`General Services or hislher designee during an Inspection of records conducted by GSA as
`part of that agencs responsibility to recommend improvements in records management
`practices and programs under authority of 44 U.S.C 2904 and 2908 Such dlscloeure shall
`be marie In accordance with the GSA regulations governing Inspection of records for this
`I.e GSA or Commerce directive Such disclosure shall not
`purpose and any other relevant
`be used to make determinations about
`Individuals
`record from this system of records may be disclosed ass routine use to the public after
`either publication of the application pursuant to 35 U.S.C 122b or issuance of
`patent
`pursuant to 35 U.S.C 151 Further
`record may be disclosed subject
`to the limitations of 37
`CFR 1.14 as
`routine use to the public if the record was filed in an application which
`became abandoned or In which the proceedings were terminated and which application is
`referenced by either
`published application an application open to public inspection or an
`issued patent
`record from this system of records may be disclosed as
`routine use to Federal State
`law enforcement agency if the USPTO becomes aware of
`or local
`violation or potential
`violation of law or regulation
`
`FAMY CARE - EXHIBIT 1004-0014
`
`

`

`ide ifs aperwoik Reduct on Act of 199h
`
`ro persons are reqjired to respond to
`
`PlO AiA82B 712
`30 2814 0MB 0651 8835
`Approved for use through
`DEPARTMENT OF COMMERCE
`Patert and Trademaric OffIce
`valid 0MB contro number
`thsplas
`
`ection of information unless
`
`POWER OF ATTORNEY BY APPLICANT
`
`hereby revoke all previous powers of attorney given in the application identified in the attached transmittal
`
`letter
`
`hereby appoint Practitioners associated with the foflowing Customer Number as my/Our attorneys or agents and to
`transact all business in the United States Patent and Trademark Office connected
`therewith for the application referenced
`letter form PTO/AIA/82A
`
`or equivalent/
`
`51957
`
`in the attached
`
`transmittal
`
`OR
`
`hereby appoint Practitioners named below as my/our attorneys or agents and to transact all business in the
`United States Patent and Trademark Office connected
`therewith for the application referenced in the attached
`letter form PTO/AIA/82A
`
`or equivalent
`
`transmittal
`
`Name
`
`Registration
`Number
`
`Name
`
`Registration
`Number
`
`Please recognize or change the correspondence adess for the application identified in the attached
`letter to
`
`transmittal
`
`LXI
`
`The address associated with the abovementioned Customer Number
`OR
`The address associated with Customer Number
`OR
`
`Firmor
`Individual Name
`Address
`
`City
`
`Country
`
`Telephone
`am the Apphcant
`
`Inventor or Joint
`
`lnventor
`
`rstate
`
`Email
`
`JZipJ
`
`jLegal Representative of Deceased or Legally Incapacitated Inventor
`or Person to Whom the Inventor
`is Under an Obligation to Assign
`Person Who Otherwise Shows Sufficient Proprietary Interest eg petition under 37 CFR A6b2 was
`being filed with this document
`granted in the application or is concurrently
`lGNATURE of Applicant for Patent
`
`Signature
`Name
`
`Debra5
`
`lino Req No
`
`87
`
`Date
`
`09/20/2012
`
`leephone
`
`4623
`
`Title and CompanyiAsscttnt
`tig Signature
`in accordance with 37 CER 33
`This form must be signed by the applicant
`certifications Submit multip
`forms for more than one signature see below
`
`reosy
`
`erg
`
`See 37 CFR
`
`for signature requirements and
`
`Tota of
`
`forms are subm tted
`
`iiet
`
`PT
`
`luding gather rig
`tfe nuuni
`adararfr
`
`tare
`
`5y
`
`ocriaeaostan
`
`Ui
`
`is requ red to obta
`FR
`32 and
`equ ed be 37
`rrraion
`so
`and 114
`onds tia ty
`Ill
`122 ar
`goier ed by 35
`pr ass an april ab
`ropleted appl at
`se wit vary deper
`the JSPTO
`repa ng and submitt eq the
`rndoung 9s
`mpe9 ifs
`sf 3d tie artt
`nn aido
`requ ci
`der
`ref
`gqesii
`EN FF1
`Ceyrreroc P0
`231 149
`ffoo US Depsrtrrent
`1458 Aex ijri
`lEcS SEND TO Commissioner for Patents PO aox 1450 Alexandria VA 223131450
`riP sfrg tre ctr uS 88O4 TO 3199 mo
`
`33 Ire foviat
`
`or eta
`
`barf
`
`ry the pub
`
`wni
`
`ci
`
`by
`
`ic
`
`up
`
`ftc
`
`if
`
`rd due
`
`rCa at
`
`atari
`
`take
`
`TpCie
`asr Ary ct mae its
`OffLer
`Patert
`RM
`
`TD
`
`rd
`
`FAMY CARE - EXHIBIT 1004-0015
`
`

`

`Doc Code TRACKI.REQ
`Document Description TrackOne Request
`
`PTO/A1N424 03-13
`
`CERTIFICATION AND REQUEST FOR PRIORITIZED EXAMINATION
`UNDER 37 CFR 1.102e Page
`
`of
`
`Andrew Acheampong
`
`onFDrvisional
`
`Application Number
`
`if
`
`METHODS OF PROVIDING THERAPEUTIC EFFECTS USING CYCLOSPORIN COMPONENTS
`
`ron
`APPLICANT HEREBY CERTIFIES THE FOLLOWING AND REQUESTS PRIORITIZED EXAMINATION FOR
`THE ABOVE-IDENTIFIED APPLICATION
`
`The processing fee set forth in 37 CFR 1.1 7i1 the prioritized examination fee set forth in
`37 CFR 1.17c and if not already paid the publication fee set forth in 37 CFR 1.18d have
`been filed with the request The basic filing fee search fee examination fee and any required
`excess claims and application size fees are filed with the request or have been already been
`paid
`
`The application contains or is amended to contain no more than four independent claims and no
`more than thirty total claims and no multiple dependent claims
`
`The applicable box is checked below
`
`El Original Application Track One Prioritized Examination under 1.102e1
`
`utility application filed under 35 U.S.C iii
`The application is an original nonprovisional
`is being filed with the utility application via EF5-Web
`This certification and request
`---0 R--
`The application is an original nonprovisional plant application filed under 35 U.S.C iii
`This certification and request
`is being filed with the plant application in paper
`
`ii
`
`The executed inventors oath or declaration is filed with the application 37 CFR .63 and
`
`.64
`
`II
`
`LII Request for Continued Examination Prioritized Examination under 1.102e2
`
`ii
`
`iii
`
`request for continued examination has been filed with or prior to this form
`is being filed via EF5-Web
`this certification and request
`If the application is
`utility ap