Docket No. 17618CON6B(AP)
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`Applicant: Acheampong,etal.
`
`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
`
`DearSir:
`
`Prior to examining the above-referenced application, please amend the
`
`specification as described on page 2 of this paper, and please amendthe claims as
`
`described on pages3-6 of this paper. Remarks follow on page7.
`
`TEVA - EXHIBIT 1024 (PART 1 OF 4) 0001
`
`0001
`
`TEVA - EXHIBIT 1024 (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 claimedthe benefit
`
`of U.S. Provisional Application No. 60/503,137 filed September 15, 2003, which-s are
`
`incorporated in #s 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 methodsare useful in treating any suitable condition whichis
`
`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 conditionsare,
`
`without limitation, dry eye syndrome, phacoanaphy lactic 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 foundas effective in treating immune mediated keratoconjunctivitis sicca (KCS
`
`
`or dry
`eye disease)
`in a patient suffering therefrom. The activity of cyclosporinsis as an
`
`immunosuppressant and in the enhancementor restoring of lacrimal gland tearing. Other
`
`conditions that can be treated with cyclosporin components include an absolute or partial
`
`deficiency in aqueoustear production (keratoconjunctivitis sicca, or KCS). Topical
`
`administration to a patient's 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.
`
`0002
`
`0002
`
`

`

`Docket No. 17618CON6B(AP)
`
`Amendmentsto 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 amountof 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 componentis 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.
`
`0003
`
`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 humanin an effective amount in
`
`treating KCS, the blood of the humanhassubstantially 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 amountof 1.25% by
`
`weight.
`
`50. (New) The topical ophthalmic emulsion of Claim 37, wherein the topical ophthalmic
`
`emulsion achievesat least as much therapeutic effectiveness as an emulsion comprising
`
`cyclosporin A in an amount of 0.1% by weight and castor oil in an amountof 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
`
`0004
`
`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 muchcastoroil.
`
`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 amountof
`
`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
`
`includeside 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 amountof about 1.0% by weight;
`
`Pemulen in an amount of about 0.05% by weight;
`
`a tonicity componentor a demulcent componentin an amountof 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) Thetopical ophthalmic emulsion of Claim 54, wherein the tonicity component
`
`or the demulcent componentis glycerine.
`
`0005
`
`0005
`
`

`

`Docket No. 17618CON6B(AP)
`
`57. (New) The topical ophthalmic emulsion of Claim 54, wherein, whenthe topical
`
`ophthalmic emulsion is administered to an eye of a human in an effective amountto
`
`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) Thetopical 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 amountof 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 emulsionis 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.
`
`0006
`
`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 amendmentto 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 amendmentcontains 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 Amendmentfiled 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.
`
`Respectfully submitted,
`
`/Laura L. Wine/
`Date: August 14, 2013
`Laura L. Wine
`Attorney of Record
`Registration Number 68,681
`
`0007
`
`0007
`
`

`

`Docket No. 17618CON6B(AP)
`
`Please direct all inquiries and correspondenceto:
`Laura L. Wine, Esq.
`Allergan, Inc.
`2525 Dupont Drive, T2-7H
`Irvine, California 92612
`Tel: (714) 246-6996 Fax: (714) 246-4249
`
`0008
`
`0008
`
`

`

`PTO/AIA/O1 (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 persans are required to respond to 4 collection of information unless it displays a valid OMB 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
`
`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.
`
`Invention|]COMPONENTS
`Docket No.: 17618CON6(AP)
`
`As the below named Inventor, | hereby declare that:
`
`(77
`This declaration
`The attached application, or
`|_|
`is directedto:
`[x United States application or PCT international application number_13/961, 828
`filed on 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 a claimed invention in the application.
`
`| 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 thanfive (5) years, or both.
`
`WARNING:
`
`
`LEGAL NAME OF INVENTOR
`
`Inventor:
`
` Andrew Acheampong
`
`Date (Optional) :
`
`Note: An application data sheet (PTO/AIA/14 or equivalent), including naming the entire inventive entity, must accompanythis form.
`Use an additional PTO/SB/AIA01 form for each additional inventor.
`
`This collection of information is required by 35 U.S.C. 145 and 37 CFR 1.63. The information is required to obtain or retain a benefit bythe public whichIs fo file (and
`by the USPTO to process) an application. Confidentiality is governed by 35 U.S.C. 122 and 37 CFR 7.11 and 1.14. This collection is estimated to lake 1 minute to
`complete, including gathering, preparing, and submitting the completed application form to the USPTO. Time will vary depending upon the individual case. Any
`comments onthe atnount of time you require to complete this form and/or suggestions for reducing thie burden, should be sent to the Chief Information Officer, U.S.
`Patent and Tradernark Office, U.S. Department of Commerce, P.O. Box 1450, Alexandria, VA 22313-1450. DO NOT SEND FEES OR COMPLETED FORMS TO
`THIS ADDRESS. SEND TO: Commissioner for Patents, P.O. Box 1450, Alexandria, VA 22313-1450.
`ifyou need assistance in completing the form, call 1-800-PTO-0198 and select option 2.
`
`O O O 9
`
`eareeesesonngntnonnnisnnsitan
`
`0009
`
`

`

`PTOIAIAION (06-12)
`Approved for use through 01/31/2014. OMB 0651-)0a2
`US. Patent and Trademark Office; U.S, DEPARTMENT OF COMMERCE
`Underthe Paperwork Reduction Act of1995._nopersonsare requiredtorespondto8 collectionof informationunlessifdisplaysavalidOMBcontrolnumber.
`_ DECLARATION(37 CFR 1.63) FOR UTILITY OR DESIGN APPLICATION USING AN
`APPLICATION DATA SHEET(87 CFR 1.76) _
`METHODS OFPROVIDING THERAPEUTIIC EFFECTSustNG CYCLOSPORIN
`| invention | COMPONENTS
`
`{Docket No.: 17618CON6(AP)
`
`| As the below named inventor, | hereby declare that:
`
`| This declaration
`
`is directed to:
`
`|
`
`’
`
`«ott
`
`.
`‘a The attached application, or
`United States application or PCT intemational application number 13/961, 828
`8/7/2013
`
`fled on
`
`| The above-identified application was made or authorized to be made by me.
`
`i | belleve that | am the original inventor or an original joint inventor of a claimed invention in the application.
`
`_ hereby acknowledge that any willful faise staterment made in this declaration is punishable under 18 U.S.C. 100%
`| by fine or imprisonment of not more than five (5) years, or both.
`
`WARNING:
`
`| Peiitioner/applicant is cautioned to avoid submitting personal information in docurnents 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 formn PTO-2038 submitted for payrnent purposes) is never required by the USPTO!
`| fo support a petition or an application.
`If this type of personal information is included in documents subrnitied to the USPTO,
`i
`| petitioners/applicants should consider redacting such personal information from the documents before submitting them to the
`LUSPTO. Petitioner/applicant is advised that the record of a patent application is available to the public after publication of the
`i 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 io the public ifthe application is
`referenced in a published application or an Issued patent (see 37 CFR 1.744). Checks and credit card authorization forme
`| PTO-2038 submitied for payment purposes are not retained in the application fle and therefore are not publicly available.
`
`LEGAL NAME GF INVENTOR
`
`inventor. DIANE TANG-LIU Cate (Optional) «
`
`| Use an additional PTO/SS/AIA01 fomn for each additional inventor.
`
`_ Note: An application deta sheet (PTO/AIA/14 or equivalent), including naming the entire inventive entity, musi accompeny this form.
`
`SeoeneeteCoes4148and37CFR1.63.“TheinformationIsrequired&«shiaoe= Sin abenefitbythepublicoheon cal
`application. Cor is governed by 36 U.S.C. 122 and 37 CFR 1.11 and 1.14. This collection fs estimatedto take 1 minute to
`
`
` ‘ ‘ enolate ions for reducing this burden1, should be sent fo the Chief information Officer, Us.
`
`
`Patent and Trademwk Offinw, U3. Denetnent afGoereren, P.O. Box 1450, Alexandria, VA 22313-1480. DONOT SEND FEES OR COMPLETED FORMETO
`THIS ADORESS. SEND TO: Commissioner for Patentia, P.O. Gox 1450, Alewandria, VA 22573-4469.
`ifyou need aseistance in completing the form, call 1-800-PTO-G108 end select aption 2
`
`
`
`_sveaetonsaeonuustrannnsnninns
`
`0010
`
`0010
`
`

`

`PTO/AIA/O1 (06-12)
`Approved for use through 01/21/2014. OMB 0657-0032
`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 OMB control number.
`
`DECLARATION(37 CFR 1.63) FOR UTILITY OR DESIGN APPLICATION USING AN APPLICATION DATA SHEET(37 CFR1.76)
`
`Tittle of|METHODS OF PROVIDING THERAPEUTIC EFFECTS USING CYCLOSPORIN
`Invention|COMPONENTS
`
`This declaration
`is directed to-
`
`_—
`[7]
`The attached application, or
`_.
`“ati
`ing
`«ati
`1
`| United States application or PCT international application number __
`filed on 8/7/2013
`
`13/961, 828
`
`The above-identified application was made or authorized to be made by me.
`
`| believe that | arn the original inventor or an originaljoint inventor of a claimed invention in the application.
`
`| hereby acknowledge that anywillful false statement madein this declaration is punishable under 18 U.S.C. 1001
`by fine or imprisonment of not more than five (5) years, or both.
`
`Docket No.: 17618CON6(AP) As the below named inventor, | hereby declare that:
`
`WARNING:
`
`Petitioner/applicant is cautioned to avoid submitting personal information in documentsfiled in a patent application that may
`contribute fo 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.
`
`Date (Optional) ; g-
`
`Note: An application data sheet (PTO/AIA/14 or equivalent), including naming the entire inventive entity. must accompany this forrn.
`Use an additional PTO/SB/AIAQ1 form for each additional invertor.
`
`This collection of information ie required by 25 U.S.C. 115 and 37 CFR 1.63. The information is required tp obtain or retain a benelit by the public which is te fe (and
`by the USPTOfo process) an application. Confidentiality is governed by 36 U.S.C. 122 and 37 CFR 7.11 and 1.14. This collection is estimated to take 1 minute to
`corrplel, inching gatherng, preparing, ar] sulenitiing the compelec application form to the USPTO. Time wil vary depending upon the incwidual case. Any
`comments on the arnount of time you require to complete this form and/or suggestions for reducing this burden, snould be sent t the Chief information Officer, U.S.
`Patent and Trademark (fice, US. Department of Commerce, FO. Box 1480, Alexandria, VA 22515-1480. 20 NOT SEND FEES OR COMPLETED FORMS TO
`THIS ADDRESS. SEND TO: Commissioner for Patents, P.O. Gox 1450, Alexandria, VA 22373-1480.
`if you need assistance in cornpleting the form, call 1-800-PTO-9198 and sevect option2.
`
`0011
`
`0011
`
`

`

`Doc code: Oath
`Document Description: Oath or declaration fled
`
`PTOVAIAO2 (06-12)
`Agproved far TenEaiaenn, ORB 0881-OR2
`U.S. Patent end Trademark Ofc: U.S, DEPARTMENT OF COMMERCE
`Underos PaperRetatonActof1088,noperearareroguesorespondtoacobainofomniuesapayeawkdONDcorte.
`
`
`
`United States application or PCT intemational application number
`
`
`
` SUBSTITUTE STATEMENT IN LIEU OF AN OATH OR DECLARATION FOR UTILITY
`OR DESIGN PATENT APPLICATION 35 U.S.C.MSta) AND 37 CFR 7$4)
`,Taeot
`| Methods of Providing Therapeutic Effects UsingCyclosporintComponents
`
`
`| invention“Pocket No.: 17618CONG(AP)
`
` his statement is directed to:
`
`
`
`13/961,828 8-7-13
`
`Eg. GivenName(first and middie (fany!) and Family Name or Suman)
`
`James N. Chang
`
`
`
`
`
`
`
`
`
`bytre USPTO fprnozeg}anapplontar,Somheolabyi serted ip36Oeaaeoa retails2 Desvedtbythe pukewhiitofe (and
`
`Rdentably is govemed by 36 U.S.C. 122 and 37 CFR 1.11 and 1.44. This cotection Is extimeted to teke 4 minus to
`complete,
`preparing,
`sompieled eoptcetion
`upon
`. Arey
`comments on the amaunt of ten you require te compiate this forn andfor sungestions for reducing this burden, should be sentto the Chief information Officer, U8.
`
`Patentand Tradamerk Offices, U.S. DepartmentofCommerce, P.O. Box 1486, Almandriz, VA 22313-1450. 80 NOT SEND FEESFEES OR COMPLETED FORMSTO
`
`THIS ADDRESS. BENG To: Comuniesioner for Patents, P.O. Box 1458, Alomamiria, VA 22949-4486,
`Ifyouneedesalstarcein completing theform, esl $-200-P70-8109andsateoption 2
`
`
`
`0012
`
`
`
`i beleve the above-named inventor or joint inventor to be the original inventor or an original joint Inventor of a claimed Invention
`f
`inthe apgication.
`
` entified application was made or au
`
` thorized to be made by me.
`
`The shove-dd
`
`
`
`
`i hereby acknowledge that any willful falee stalement made In this statement is sunishable under 76 U.S.C. 1064 by fins or
`imprisonment of not more than five () years, or both.
` ip to the inventorto whom this substitute statement applies:
`[| Legal Representative (for deceased or legally incapacitated inventoronly),
`
`Ea} Assignee,
`[| Personto whom the inventor fe underan obligation to assign,
`C] Person who othenvise shows a aufficiant proprietary interest in the matter (petition under 37 CFR 1.48 Is required), or
`[| Joint invertor.
`
`*
`
`
`
`0012
`
`

`

`PTO/SBIAIAN2 (06-12)
`Approved far 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 unfess it displays a valid OMB control number.
`
`SUBSTITUTE STATEMENT
`
`
` Circumstances permitting execution of this substitute statement:
`
`
`
`[J Inventor is deceased,
`[_] Inventoris under legal incapacity,
`
`
`[_] tnventor cannotbe foundor reached after diligent effort, or
`fm 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/AIA/14 or equivalent) naming the entire inventive entity has been
`or is currently submitted.
`
`
`
`OR
`
`
`[__] An application data shest under 37 CFR 1.76 (PTO/AIA/14or 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 appilcation 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 madein 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:
`
`4 SEI C7RO” SETIETRKY
`
`
`na, Debra D. Condino 777264Aiccneanne
` CASE SLSE?
`
`
`
`
` [Residence (uniée = provided nyanplication data sheet, PTO/AIA/14 orequivalent):
`
`
`
`
`
`
`bawCA492612
`Irvine
`oy
`
`
`Note: Use an additional PTO/AIA/02 form for each inventor who is deceased,legally incapacitated, cannot be found or
`reached afterer diligent effort, or has refused to execute the oath or declaration under 37 CFR 1.63.
`[Page2of 2)
`
`MananaAddress(unlessprovidedinanapplicationdataonSOMATAorsane
`12525 Dupont Drive-T2-7H
`
`0013
`
`0013
`
`

`

`Privacy Act Statement
`
`The Privacy Act of 1874 (P.L. 93-879) requires that you be given certain information In connection
`
`with your submission of the atlachedform related te a patent application or patent. Accordingly,
`pursuant t the requirements of the Act, please be advised that (4) the general authority for the
`collection of this information is 35 U.S.C. 2(}(2}; (2) furnishing of the information solicited is voluntary;
`and (3) the principal purpose for which the information is used by the U.S. Patent and Trademark
`Offices is © process and/or exarnine your submission related to a patent application or patent. f you do
`not furnish the requested information, the U.S. Patent and Trademark Office may not be able to
`
`process and/or examine your submission, which may result in termination of proceedings or
`sbhandonment of the ssplcation or expiration of the patent.
`
`The information provided by you in this form will be subject to the following routine uses:
`
`1. The information on this fonm will be treated confidentially to the extent allowed under the
`Freedom of information Act (6 U.S.C. 2)and the Privacy Act (6 U.S.C 5522). Records from
`
`disclosure ofthese records is required bythe Freedom of information Act.
`this system of reconis may be disclosed to
`the Department of Justice to detenmine whether
`A record from this system of records may be disclosed, as a routine use, in the course of
`presenting evidence to a court, magistrate, or administrative tribunal, including disclosures to
`opposing counsel in the course of settlement negotiations.
`A record in this system of records may be disclosed, as s routine use, fo a Member of
`Congress submitting a request involving an individual, to whom the record pertains, when the
`individual has requested assistance from the Member with reepect to the subject matter of the
`record.
`A record in this system of records may be disclosed, as a routine use, to a contractor of the
`Agency having need for the information in order te perform a contract. Recipients of
`information shall be required to comply with the requirements of the Privacy Act of 1974, as
`amended, pursuant to 5 U.S.C, §52Za(m).
`A record related to an Intemational Application filed under the Patent Cooperation Treaty in
`this system of records may be disclosed, as a routine use, to the Intemational Bureau of the
`World intellectual Property Organization, pursuant to the Patent Cooperation Treaty.
`
`A record in this syetem of records may be disclosed, as a routine use, fo another federal
`agency for purposes of National Seourlty review QsU.S.C. 181} and for review pursuant to
`the Atomic Eneray Act (42 U.S.C. 278i{c}).
`A record from this system of records may be disclosed, as a routine use, to the Administrator,
`General Serviess, or his/her designee, during an inspection of records conducted by GSA as
`partof that agency's responsibility to recommend improvements in records management
`practices and programs, under authority of 44 U.S.C. 2904 and 2806. Such disclosure shail
`
`be mada in accordance with the GSA regulations governing inspection of records for this
`purpose, and any other relevant (1e., GSA or Gommerce) directive. Such disclosure shall not
`be used to make determinations about individuals.
`A record from this system of records may be disclosed, as a routine use, to the public after
`elther publicetion of the application pursuant to 35 U.S.C. 4220) or iesuance of a patent
`pursuant fo 35 U.S.C. 151. Further, a record may be disclosed, subject to the limitations of 37
`CFR 1.14, a8 a routine use, to the public # the record was filed in an application which
`became abandoned or in which the proceedings were terminated and which applicationis
`referenced by either a published application, an application open to public inspection or an
`issued patent.
`A record from this system of records may be disclosed, as e routine use, to a Federal, State,
`of local law enforcement agency,if the USPTO becomes aware of a violation or potential
`violation of law or reguiation.
`
`0014
`
`0014
`
`

`

`PTO/AIAB28(07-12)
`Approved for use through 11/30/2074. OMB 0651-0035
`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 OMB contro! number.
`
`POWER OF ATTORNEYBY APPLICANT
`
`| hereby revoke all previous powers of attorney given in the application identified in the attached transmittalletter.
`
`| 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
`
`_
`
`_
`
`Pl [hereby appoint Practitioner(s) named below 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):
`
`Number pe Number
`
`Name
`
`Registration
`
`Name
`
`Registration
`
`Please recognize or change the correspondence addressfor the application identified in the attached
`transmittal letter to:
`The address associated with the above-mentioned Customer Number.
`
`OR[| The address associated with Customer Number: [
`
`|
`
`OR
`|
`Firm or
`| ON
`IndividualName!
`
`Address
`
`Zip
`
`state |
`
`City
`Country _
`'
`Telephone
`_ Lema
`|
`I
`
`am the Applicant:
`
`
`[| Inventor or Joint Inventor
`
`[|Legal Representative of a Deceased or Legally incapacitated Inventor
`
`
`[x |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
`;
`;
`
`
`Signature
`ICA 2
`Date09/20/2012
`;
`.
`Name ;
`“Condino,"Re No. 34,007
`oSTelephone 714-246-2988
`[Bebra
`
`Title and Comepan
`[Assistant Secretary, Allergan,inc.
` certifications. Submit