Docket No. 17618CON6B (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 22313-1450
`
`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.
`
`1
`
`0001
`
` EXHIBIT 1004 (Part 1 of 4)
`
`

`
`Docket No. 17618CON6B (AP)
`
`Amendments to the Specification
`
`Please replace page 1, lines 5-10 of the specification filed herewith with the following
`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
`of U.S. Provisional Application No. 60/503,137 filed September 15, 2003, which-4s 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
`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 a human or animal. Included among such conditions are,
`without limitation, dry eye syndrome, phacoanaphylactic 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
`has been found as effective in treating immune mediated keratoconiunctivitis sicca (KCS
`or dry eve disease) in a 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 (keratoconiunctivitis sicca, or KCS). Topical
`administration to a patient's tear deficient eve can increase tear production in the eve. 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.
`
`2
`
`0002
`
`

`
`Docket No. 17618CON6B (AP)
`
`Amendments to the claims
`
`The following list of claims will replace all previous versions of claims presented
`in this application:
`
`1. -36. (Canceled)
`37. (New) A topical ophthalmic emulsion for treating an eye of a human having KCS,
`wherein the topical ophthalmic emulsion comprises cyclosporin A in an amount of about
`0.05% by 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 a tonicity agent or a 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 a 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 a 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.
`
`3
`
`0003
`
`

`
`Docket No. 17618CON6B (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 a
`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
`ophthalmic emulsion is administered to an eye of a human in an effective amount in
`treating KCS, the blood of the human has substantially no detectable concentration of
`cyclosporin A.
`
`48. (New) The topical ophthalmic emulsion of Claim 42, wherein the topical ophthalmic
`emulsion has a 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 A 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 A 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 a human, once administered to the eye
`
`4
`
`0004
`
`

`
`Docket No. 17618CON6B (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 a human, demonstrates a reduction in adverse
`events in the human, relative to an emulsion comprising cyclosporin A in an amount of
`0.1% by weight and castor oil in an amount of 1.25% by weight.
`
`53. (New) The topical ophthalmic emulsion of Claim 52, wherein the adverse events
`include side effects.
`
`54. (New) A topical ophthalmic emulsion for treating an eye of a human, wherein the
`topical ophthalmic emulsion increases tear production in the eye of a human, and wherein
`the topical ophthalmic 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;
`a tonicity component or a demulcent component in an amount of about 2.2% by
`weight;
`a 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.
`
`5
`
`0005
`
`

`
`Docket No. 17618CON6B (AP)
`
`57. (New) The topical ophthalmic emulsion of Claim 54, wherein, when the topical
`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.
`
`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.
`
`59. (New) The topical ophthalmic emulsion of Claim 54, wherein the topical ophthalmic
`emulsion is effective in treating KCS.
`
`60. (New) A topical ophthalmic emulsion for treating an eye of a human, the topical
`ophthalmic 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;
`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 a pH in the range of about 7.2 to about 7.6.
`
`6
`
`0006
`
`

`
`Docket No. 17618CON6B (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 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
`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
`Registration Number 68,681
`
`7
`
`0007
`
`

`
`Docket No. 17618CON6B (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
`
`8
`
`0008
`
`

`
`PTO/AIA/01 (06-12)
`Approved for use through 01/31/2014. OMB 0651-0032
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`DECLARATION (37 CFR 1.63) FOR UTILITY OR DESIGN APPLICATION USING AN
`APPLICATION DATA SHEET (37 CFR 1,76)
`
`Title of
`Invention
`
`METHODS OF PROVIDING THERAPEUTIC EFFECTS USING CYCLOSPORIN
`COMPONENTS
`Docket No,; 17618CON6(AP)
`
`As the below named inventor, I hereby declare that:
`
`This declaration
`is directed to:
`
`1
`
`(
`The attached application, or
`| If United States application or PCT international application number 1 3 / 9 6 1 , 8 2 8
`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.
`
`I hereby acknowledge that any willful false statement made in this declaration is punishable under 18 U.S.C. 1001
`by fine or imprisonment of not more than five (5) years, or both.
`
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`LEGAL NAME OF INVENTOR
`
`Inventor
`
`Andrew Acheampong
`
`Signature:
`
`A r £
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`-•
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`' ^2
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`If
`
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`0009
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`Til# of METHODS OF PROVIDING THERAPEUTIC EFFECTS USING CYCLOSPORIN
`(nvwrtton COMPONENTS
`Docket No.: 17618CON6(AP)
`
`As the below named inventor, I hereby dedare that:
`
`This declaration
`Is directed to:
`
`( | The attached application,
`or
`1 3 / 9 6 1 , 8 2 8
`[xj United States application or PCT international applcafion number
`8 / 7 / 2 0 1 3
`
`filed on
`
`The above-identified application was made or authorized to be made by me.
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`DIANE TANG-LIU
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`Patent and Trademark OOce. U.S. Oapaitmam of Commaroo, P.O. Box 1450. Atoxandria. VA 22313-1450. 00 M
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`U.S. Patent and Trademark Office; U.S. DEPARTMENT Of COMMERCE
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`DECLARATION (37 CFR 1.63) FOR UTILITY OR DESIGN APPLICATION USING AN
`APPLICATION DATA SHEET (37 CFR 1.76)
`
`Title of
`Invention
`
`METHODS OF PROVIDING THERAPEUTIC EFFECTS USING CYCLOSPORIN
`COMPONENTS
`Docket No.i 17618CON6(AP)
`
`As the below named inventor, I hereby declare that;
`
`This declaration
`is directed to:
`
`[ |
`
`The attached application, or
`
`p^J United States application or PCT international application number
`8 / 7 / 2 0 1 3
`
`filed on
`
`1 3 / 9 6 1 , 8 2 8
`
`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.
`
`I hereby acknowledge that any willful false statement made in this declaration is punishable under 18 U S C. 1001
`by fine or imprisonment of not more than five (5) years, or both.
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`

`
`PTO/SB/AIA02 (06-12)
`Approved far use through 01/31/2014. OMB 0851-0032
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`Under the Paperwork Reduction Act of 1895, no persons are required to respond to a collection of information unless it displays a valid OMB control number.
`MAM
`
`)
`
`SUBSTITUTE STATEMENT
`
`Circumstances permitting execution of this substitute statement
`| | inventor is deceased,
`| | Inventor is under legal incapacity,
`[
`] Inventor cannot be found or reached after diligent effort, or
`
`m 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;
`B An application data sheet under 37 CFR 1.76 (PTO/AIA/14 or equivalent) naming the entire inventive entity has been
`or is currently submitted.
`
`OR
`| | An application data sheet under 37 CFR 1.76 (PTO/AIA/14 or equivalent) has not been submitted. Thus, a Substitute
`Statement Supplemental Sheet (PTO/AIA/11 or equivalent) naming the entire inventive entity and providing inventor
`information is attached. See 37 CFR 1.64(b).
`WARNING:
`Petitioner/applicant is cautioned to avoid submitting personal information In documents filed In a patent application that may
`contribute to identity theft. Personal Information such as social security numbers, bank account numbers, or credit card numbers
`(other than a check or credit card authorization form PTO-2038 submitted for payment purposes) is never required by the USPTO
`to support a petition or an application. If this type of personal information is included In documents submitted to the USPTO,
`petitioners/applicants should consider redacting such personal Information from the documents before submitting them to the
`USPTO. Petitioner/applicant Is advised that the record of a patent application is available to the public after publication of the
`application (unless a non-publication request in compliance with 37 CFR 1.213(a) is made In the application) or issuance of a
`patent Furthermore, the record from an abandoned application may also be available to the public if the application is
`referenced in a published application or an issued patent (see 37 CFR 1.14). Checks and credit card authorization forms
`PTO-2038 submitted for payment purposes are not retained in the application file and therefore are not publicly available.
`PERSON EXECUTING THIS SUBSTITUTE STATEMENT:
`
`Debra D.
`
`Name:
`
`- j f /(
`Sia nature:
`provided In an application data sheet, PTO/AIA/14 or equivalent):
`Residence (unl
`
`Irvine
`
`City
`Country
`State
`Mailing Address (unless provided in an application data sheet, PTO/AIA/14 or equivalent)
`2525 Dupont Drive-T2-7H
`
`CA
`
`US
`
`Irvine
`
`City
`Country
`Zip
`State
`Note: Use an additional PTO/AIA/D2 form for each inventor who is deceased, legally Incapacitated, cannot be found or
`reached after diligent effort, or has refused to execute the oath or declaration under 37 CFR 1.63.
`
`CA
`
`92612
`
`US
`
`page 2 of 2]
`
`0013
`
`

`
`Privacy Art Statement
`
`The Frtvae^ Ast ®ff 1i?4 CF,L, S3-S7t) requires that you bs gfvsn certain iWorrrsatten in connedion
`with your
`of the attached form miated to a patent appjiGatson or pstsrst Accordingly,
`pursumt to tie rsquframents of the Ad, pleasa be advssed tsat (1) ths gertorai aulho$% for the
`ssSSesHon ©f this infbrmsfion la 35 U.S.C, 2(bK2); (2) furnishing erf tha information solicited is vdurttery;
`and (3) ths pdndpai purpose for whidi the irsfbn-naiisn Is used by tie U.S. Patent and Trademark
`OfHee is to process and/or sxamlm yowr submi^lon mM&d to a patent apptaffsn or patent If you do
`not furnish the requested infomiation, th© U.S. Paterst and Trad®mrk OfScs msy net be able to
`procass and/or examln© your submission, which may rssult In terminal"on of proceedings or
`abandonment of th© applfsatlen or expiraHon of ths patent.
`
`TSi© informafen provided by you in this form will be sub|sct to Iho feliowsrsg rouUna uses:
`
`1. The Information on this form wfif b§ treated con^dentialy to th® extsrst aik^ad under th©
`Fmedm! of informaBon Act (5 U.S.C. 552) and tie Privacy Act (5 U.S.C 552a). Rsosrds from
`this system of records may be disdosad to the Department of Juste to determine whether
`dtsefosur® of these reeerds is respired by tie Freedom of fnformatlors Act
`2. A record fmm this system of rooords may ba disclosed, as a routine use, in the course of
`presenting evidence to a court, magistrate, or administrative tribunal, irsduding disclosures to
`opposing eounset In it© course of settiement negotlafions.
`A rseord in tils system of records may be disciesed, as s routine use, to a Member of
`Congress submitting a request involving an Sndlvlduai, to whom the reeord pertains, when th®
`Individual has requested sssistarsee torn the yamber with respect to th® subfect matter of tie
`record.
`4. A resord in this system of records may be disclosed, as a routine use, to a eontraetorofihe
`Agency having need for the information in order to perform a esnfract. Reeiplente of
`informaion shaii be required to eomply with the raquiraments of the Privacy Act of 1974, as
`amended, pursuant to 511.8.0.5§2a(m}.
`5. A record reiated to an intematienai Application iiad under the Patent Cooperation Treaty in
`this system of records may be disdosad, as a routine use, to the intemaiJona! Bureau of tie
`World Inteffeetusf Property Organization, pursuant to tre Patent Cosparation Tnsafy.
`6. A record in this system of records may be disdosad, as a routine use, to another fsderai
`agency for purposes of Nafional Security review (35 U.S.C. 181) and for review pursuant to
`the Atomic Energy Act (42 U.S.C. 218(c)).
`7. A racopd from this system of records may be disdosad, as a routine use, to the Administrator,
`General Services, or his/her designee, during en fnspeetien of records conducted by GSA as
`part of feat agency's responsifeiHty to racommand improvements in records management
`pracSees and programs, under authority of 44 U.S.C. 2904 and 2906. Such disdosure shall
`be made in accordance with the GSA reguiations governing inspection of records for this
`purpose, and any other relevant (La., GSA or Commerce) directive. Such disclosure shall not
`be used to make determinations about individuals.
`S. A record from this system erf reeonte may be disdosad, as a routine use, to the public after
`either publication of the application pursuant to 35 U.S.C. 122(b) or Issuance of a patent
`pursuant to 3§ U.S.C. 151. Further, a meord may be dlsdosed, subject to the limitations of 37
`CFR1.14, as a routine use, to the public If She record was filed in an appfieafion which
`became abandoned or in which fee proceedings were terminated and which application is
`referenced by either a published application, an application open to pubic inspection or an
`issued patent.
`9. A record ten this system of nseords may be disclosed, as a routine use, to a Federal, State,
`or local law enforcement agency, if the USPTO becomes swam of a violation or potontiai
`violation of law or reguiation.
`
`0014
`
`

`
`PTO/AIA/82B<07-12)
`Approved for use through 11/30/2014, OMB 0851-0035
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`Under the Papewortt Reduction Act of 199S, no persons are required to respond to a collection of information unless it displays a valid OMB control number.
`
`POWER OF ATTORNEY BY APPLICANT
`
`I hereby revoke all previous powers of attorney given in the application identified in the attached transmittal letter.
`ra I hereby appoint Practitioner(s) associated with the following Customer Number as my/our attorney(s) or agent(s), and to
`'—' transact all business in the United States Patent and Trademark Office connected therewith for the application referenced
`in the attached transmittal letter (form PTO/AIA/82A or equivalent):
`51957
`
`OR
`j I hereby appoint Practltioner(s) named below as my/our attomey(s) or agent(s), and to transact all business in the
`1
`'— United States Patent and Trademark Office connected therewith for the application referenced in the attached
`transmittal letter (form PTO/AIA/82A or equivalent):
`
`Name
`
`Registration
`Number
`
`Name
`
`Registration
`Number
`
`Please recognize or change the correspondence address for the application identified in the attached
`transmittal letter to:
`fx] The address associated with the above-mentioned Customer Number.
`OR
`'
`"
`'
`| The address associated with Customer Number:
`OR
`Firm or
`Individual Name
`Address
`
`•
`
`[
`
`T State
`
`1 Email
`
`Zip
`
`City
`Country
`Telephone
`I am the Applicant:
`• Inventor or Joint Inventor
`|
`| Legal Representative of a Deceased or Legally Incapacitated Inventor
`fy] Assignee or Person to Whom the Inventor is Under an Obligation to Assign
`'Person Who Otherwise Shows Sufficient Proprietary Interest (e.g., a petition under 37 CFR 1.46(b)(2) was
`granted in the application or is concurrently being filed with this document)
`SIGNATURE of Applicant for Patent
`
`4-~i
`
`Signature
`Name
`OebfaO Condino, Reg. No. 31,007
`Title and Company Agsislant Secretary. Allergan. inc
`NOTE: StgnatutB - This form must be signed by the applicant in accordance with 37 CFR 1.33. See 37 CFR 1.4 tor signature requirements and
`certrflcatiom. Submit multiple farms for more than one signature, see below *.
`
`Date
`Telephone
`
`09/20/2012
`714-246-2388
`
`forms are submitted.
`
`Total of
`This oolecSon of intamatlon is requiwd by 37 CFR 1.31,1.32 and 1.33. Trie infonnatien is re^urrsd to obtain