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 22313-14 50
`
`Dear Sir:
`
`Prior to examining the above-referenced application, please amend the
`
`specification as described on page 2 of this paper, and please amend the claims as
`
`described on pages 3-6 of this paper. Remarks follow on page 7.
`
`1
`
`APOTEX 1019, pg. 1
`
`

`
`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 ofU.S. Application
`
`Serial No. 10/927,857, filed August 27, 2004, now abandoned, which claimed the benefit
`
`ofU.S. Provisional Application No. 60/503,137 filed September 15, 2003, which-is are
`
`incorporated in its their entirety herein by reference.
`
`Please replace page 4, line 25- page 5, line 3 of the specification filed herewith with the
`
`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, phacoanaphy 1 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
`
`has been found as effective in treating immune mediated keratoconjunctivitis sicca (KCS
`
`or dry eye 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 (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.
`
`2
`
`APOTEX 1019, pg. 2
`
`

`
`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
`
`APOTEX 1019, pg. 3
`
`

`
`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
`
`APOTEX 1019, pg. 4
`
`

`
`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
`
`APOTEX 1019, pg. 5
`
`

`
`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
`
`APOTEX 1019, pg. 6
`
`

`
`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
`
`APOTEX 1019, pg. 7
`
`

`
`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
`
`APOTEX 1019, pg. 8
`
`

`
`PTOIAIA/01 (06-12)
`Approved for use through 0113112014" 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 lo respond to a col!ection of information unless it displays a valid OMB control numbec
`
`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:
`
`The attached application, or
`
`United States application or PCT international application number - - - ' - - - - - ' - - - (cid:173)
`8 I 7 I 2 0 13
`
`filed on
`
`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.
`
`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 PT0-2038 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
`PT0-2038 submitted for payment purposes are not retained in the application file and therefore are not publicly available.
`
`LEGAL NAME OF INVENTOR
`
`Inventor:
`
`Signature
`
`Note: An apJ:)iica1t1on
`Use an adclitic•nal
`
`Date (Optional)·--~------~
`
`including naming the entire inventive entity, must accompany this form.
`
`DO NOT SEND FEES OR COMPLETED FORMS TO
`Box
`THIS ADDRESS. SEND TO: Commissioner for Patents, P.O. Box 1450, Alexandria, VA 22313-1450.
`If you need assistance
`completing the
`
`APOTEX 1019, pg. 9
`
`

`
`This declaration
`directed
`
`or PCT lntarn.:rnnn<>l a:,pli<::atlc>n
`United States
`8/7/2013
`filed on--~---------~·
`
`3/961,828
`
`inventor or an
`
`inventor
`
`ac~<•OO\IV!ei'2ae that any wilfful false statement made
`imrori'!U"'"""nt of not more thgn five
`years,
`
`WARNING:
`
`LEGAL
`
`OF INVENTOR
`
`APOTEX 1019, pg. 10
`
`

`
`Under the PaperwrJfk Reduction
`
`of 1995, no parsons
`
`DECLARATION (37 CFR 1.63) FOR UTILITY OR DESIGN APPLICATION USING AN
`APPLICATION DATA SHEET (37 CFR 1. 76)
`
`Title of METHODS OF PROVIDING THERAPEUTIC EFFECTS USING CYCLOSPORIN
`Invention COMPONENTS
`Docket No .. 17618CON6(AP)
`
`As the below named inventor, I
`
`declare that
`
`This declaration
`is directed to:
`
`The attached application, or
`
`United States
`filed on 8 I 7 I 2 0 13
`
`131961,828
`or PCT international ap~)licaticm number -~~~---~-~
`
`The above-identified application was made or authorized to be made by me.
`
`I believe that I am the original inventor or an
`
`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$.C. 1001
`fine or imprisonment of not more than five (5) years, or both.
`
`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 PT0-2038 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,
`pel·itionet·sfaiPPIIicants should consider redacting such personal information from the documents before
`them to the
`Petitic>ner/aiDDiicant is advised that the record of a patent application is available to the
`of the
`application (unless a
`request
`compliance with 37 CFR 1
`is made in the
`or issuance of a
`patent Furthermore, the record from an abandoned
`may also be
`to the
`the application is
`referenced in a
`or an issued patent
`37 CFR 1
`Checks and credit card authorization forms
`PT0-2038 submitted for payment purposes are not retained in the
`file and therefore are not
`available.
`
`after
`
`LEGAL NAME OF INVENTOR
`
`APOTEX 1019, pg. 11
`
`

`
`Coo oode: Oalh
`l'.)ocument ~lion: Oath Of dedal'lli!tion filed
`
`l"TTOA~Mll! (Qe.12)
`~for Ulllillilloog!l 01131.12014. Ot.m 0061-0032
`U.S. Pa!imiaooT~ Offk:e; U.S. OEP~OF ~ERCE
`~'IIIII ~~Actaf100!S,rm~llll'!ll~~~!olll~of~ulllil!lslt~e'lddOMBOI3i!lroll'll!!!!bsr.
`
`SUBSTITUTE STATEMENT IN UIEU OF AN OATH OR DECLARATION FOR UTILITY
`OR DESIGN PATENT APPLICATION (35 U.S.C.115(d) AND 37 CFR 1.64)
`
`~of Methods of Providing Therapeutic Effects Using Cyclosponn Components
`an~ on pocket No.: 17618CON8(AP)
`
`This s~t 16 direded to:
`
`D The attached a~.
`!II United S~ applk:ation or PCT International app!lcatloo number 13/961 ,828 filed on 8-7-13
`
`OR
`
`lEGAL NAME of Inventor to wham I'll& eulbstiWts ~nt applies:
`(E.g., Giver! Name (first and middle (If any)} end Family Name or Sul'l"'ame)
`James N. Chang
`R~ {except fora deooased or legally I~ in~):
`
`btv Newport Beach
`
`SweCA
`
`Mailing~{~ for a~ or I~ lnoopa~ lmlentor):
`36 Cervantes
`
`...... us
`
`~ Newport Beach
`
`~16 CA
`
`~D92660 Country us
`
`1 OOJ!ew the above-named inventor or joint inventor to be the original in\IIEII'Itor or an original joint Inventor of a claimed Invention
`in the applimlioo.
`
`The a~oo appllcmioo wu made or~ to be made by me.
`
`1 hereby acknowledge that any wilful false ~ent made In tills~ Is punishable under 18 U.S.C. 1001 by tine or
`lmprioomnent of not mom than five (5) years, or bolh.
`
`~ to the inventor to whom this substitute mtement applies:
`0 legal R~nllidive (ford~ or legally incap~ inventor only),
`iiJ Assignee,
`0 Person to whom tile Inventor is under an obligation to assign,
`0 Person who ~ si'lows a S!Jfflclent proprietary lnte~t In the I'!'IBtter (petition ooder 37 CFR 1.46 18 required), or
`0 Joint Inventor.
`
`[Page 1 of2J
`Th!:!l ~ afi~IIB ~by 36 U.S.C.115lllllld 37 CfR 1.53. Tilll>~ !II~ 11!1 aililalll arl'etlll!la ~bylliil ~~ll!olliB (ill!!d
`by!MUSPTOiQ~)IIIII~~IIsgi'MIII'Ile!:lby35U.S.C.1228003"/'CFR1.11-.!1.14.Thls~ls~loillllia1mlmi!&!o
`~. ~~~.-.! wbmi!llng'hl~~ l'l:irmiQIMUSFI"O. Tlmilo1Aii8W~ry~llp(llll:he~~.AIIy
`oomm81FU oo 'IIIII ~ofilmll you mqi!lr& 1D ~ !ti!sbm arnlfor ~fer~ !tl!a ~~be 81!1!lin ihll Ctllilflnfoomslloo ~.U.S.
`Pai!limtlll!'ld T~ Ollloi8, U.S. ~at~. P.O. !lim: 1450, ~. VA22313-1400. 00 NOT SENO FEES OR~ FORMS iO
`THIS A.OORESS.SEND TO: ~for~ P.O. Box 1451. ~VA 22313-1410.
`")'®l'lllli!llds~ltl~tMfMn.. ed 1~19!ilsoo~~2.
`
`APOTEX 1019, pg. 12
`
`

`
`PTOISBIAIAD2 (06-12)
`Approved for use through 0113112014. OMS 0651-0032
`U.S. Patent and Trademark Oftlce; U.S. DEPARTMENT OF COMMERCE
`
`Circumstances penniUfng execution of this substitute statement
`
`0 Inventor Is deceased,
`0 Inventor Is under legal Incapacity,
`0 Inventor cannot be found or reached after dUigent effort, or
`IIJ Inventor has refused to execute the oath or declaration under 37 CFR 1.63.
`If there are joint Inventors, please chedc the appropriate box below:
`IIJ An appDcatlon data sheet under 37 CFR 1.76 (PTO/AIA/14 or equivalent) naming the entire Inventive entity has been
`or is currently submitted.
`OR
`0 An appllcatlon 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:
`Petltioner/appDcant Is cautioned to avoid submiWng personal Information In documents flied In a patent application that may
`contribute to Identity theft Peraonallnformation such as social security number&, bank account numbers, or credit card numbers
`(other than a check or credit card authorization form PT0-2038 submitted for payment purposes) Is never required by the USPTO
`to support a petition or an application. If this type of personal infonnatlon Is Included In documents submitted to the USPTO,
`petitionelslappllcants should consider radactlng such peraonallnformadon from the documents before submitting them to the
`USPTO. Petitioner/applicant Is advised that the record of a patent appDcatlon Is available to the public after publication of the
`application (unless a non-publlcadon 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 appHcatlon 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
`PT0-2038 submitted for payment purposes are not retained In the application file and therefore are not pubUcly available .
`
`.. ERSON EXECunNG THIS SUBSTITUTE STATEMENT:
`D C d"
`TJrt.E:I'1~1C"711Alr Stztl.FT111t ~
`. on lnOC~HfllAIV: AL.u:f/'{6,4..U, ;'A)~.
`Name: Debra
`-~ ~S~'fi:£.)
`,
`ate
`nal:
`r., .... -,
`,...,
`,J!
`I l _,.
`'>..
`.. .. ,
`..... ! ./iJ "i (.- v./1-· '-f.J
`Signature:
`,1/'
`Residence (un'ths provided In an application data sheet. PTO/AJA/14 or equivalent):
`city Irvine
`State CA
`
`Country us
`
`Mailing Address (unless provided In an applicaton data sheet, PTO/AIA/14 or equivalent)
`2525 Dupont Drive-T2-7H
`
`City Irvine
`state CA
`~p92612 Country US
`Note: Use an additional PTO/AIA/02 fonn 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.
`
`[Page 2 of2]
`
`APOTEX 1019, pg. 13
`
`

`
`Privacy Act Statement
`
`The Privacy Act of 1974 (P.L. 93-579) requires that you be given certain information In connection
`with your submission of the attached form related to a patent application or patent Accordingly,
`pursuant to the requirements of the Act, please be advised that ( 1) the general authority for the
`collection of this information Is 35 U.S.C. 2(b)(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
`Office is to process and/or examine your submission related to a patent application or patent. If 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 tennination 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 follmv!ng routine uses:
`
`1. The information on this form w!!l be treated confidenl:lafty to the extent allowed under the
`Freedom of lnfoonation Act (5 U.S.C. 552) and the Privacy N.zt (5 U.S.C 552a). Records from
`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
`2. 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 adminls1mtlve tribunal, including disclosures to
`opposing counsel In the course of settlement negotiations.
`3. A record In this system of records may be disclosed, as a routine use, to a Member of
`Congress submitting a request lnvoMng an indMdual, to whom the record pertains, when the
`individual has requested assistance from the Member with respect to the subject matter of the
`record.
`4. A record In this system of records may be disclosed, as a routine use, to a contractor of the
`Agency having need for the infonnation in order to perform a contract. Recipients of
`information shall be required to comply with the requirements of the Privacy Ad of 1974, as
`amended, pursuant to 5 U.S.C. 552a(m).
`5. A record related to an International Application filed under the Patent Cooperation Treaty ln
`this system of records may be disclosed, as a routine use, to the International Bureau of the
`World Intellectual Property Organization, pursuant to the Patent Cooperation Treaty.
`6. A record ln this system of records may be disclosed, as a routine use, to another federal
`agency for purposes of National Security revle\v (35 U.S. C. 181) and for review pursuant to
`the Atomic Energy N.zt (42 U.S.C. 218{c)).
`7. A record from this system of records may be disclosed, as a routine use, to the Administrator,
`General Servloas, or hisiher designee, during an Inspection of records conducted by GSA as
`part of that agency's responsibility to recommend Improvements in records management
`practices and programs, under authority of 44 U.S.C. 2904 and 2006. SUch disclosure shaD
`be mads In accordance with the GSA regulations governing inspection of records for this
`purpose, and any other relevant (i.e., GSA or Commerce) directive. Such disclosure shal not
`be used to make determinations about Individuals.
`8. A record from this system of records may be disclosed, 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 35 U.S.C. 151. Further, a record may be disclosed, subject to the limitations of 37
`CFR 1.14, as a 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 a published application, an application open to public inspection or an
`issued patent.
`9. A record from this system of records may be disclosed, as a routine use, to a Federal, State,
`or local law enforcement agency, if the USPTO becomes aware of a violation or potential
`violation of law or regulation.
`
`APOTEX 1019, pg. 14
`
`

`
`[
`
`Approved lor use through 11/30/2014. OMB
`US. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`Under the Papei'NCrk Reduction Act of 1995, no persons are required to respond to a collection of Information unless it displays a valid OMB control number.
`
`POWER OF ATTORNEY BY APPLICANT
`
`in the application identified in the attached transmittal letter.
`
`l
`
`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
`referenced
`in the attached transmittal letter (form PTO/AIA/82A or equivalent):
`
`OR
`
`I hereby appoint Practitioner(s) named below as my/our attomey(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/AlAI82A 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:
`!]t] The address associated with the above-mentioned Customer Number.
`OR
`
`.-----~~~--~--~----·--~·~
`
`The address associated with Customer Number:
`OR
`
`Zip
`
`Inventor or Joint Inventor
`
`0Legal Representative of a Deceased or Legally Incapacitated Inventor
`@Assignee or Person to Whom the Inventor is Under an Obligation to Assign
`Who Otherwise Shows Sufficient Proprietary Interest (e.g., a petition under 37 CFR 1 A6(b)(2) was
`ranted in the ap lication or is concurrent! bein
`filed with this
`
`See 37 CFR 1 A for signature requirements and
`
`NOT
`rn-~~,,~A P.O. Box
`"'u'J"""'"'· SEND TO: Commissioner for Patents, P.O. Box 1450, Alexandria, VA 22313-1450.
`1·800-PT0·9199
`
`APOTEX 1019, pg. 15
`
`

`
`Doc Code: TRACK1.REQ
`Document Description: TrackOne Request
`
`PTO/AIA/424 (03-13)
`
`CERTIFICATION AND REQUEST FOR PRIORITIZED EXAMINATION
`UNDER 37 CFR 1.102(e) (Page 1 of 1)
`
`Andrew Acheampong
`
`I Nonprovisional Application Number (if I
`
`known):
`
`METHODS OF PROVIDING THERAPEUTIC EFFECTS USING CYCLOSPORIN COMPONENTS
`
`First Named
`Inventor:
`Title of
`Invention:
`
`APPLICANT HEREBY CERTIFIES THE FOLLOWING AND REQUESTS PRIORITIZED EXAMINATION FOR
`THE ABOVE-IDENTIFIED APPLICATION.
`
`1. The processing fee set forth in 37 CFR 1.17(i)(1 ), the prioritized examination fee set forth in
`37 CFR 1.17(c), and if not already paid, the publication fee set forth in 37 CFR 1.18(d) 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.
`
`2. 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.
`
`3. The applicable box is checked below:
`0 Original Application (Track One)- Prioritized Examination under§ 1.102(e)(1)
`
`I.
`
`i.
`
`(a) The application is an original nonprovisional utility application filed under 35 U.S.C. 111 (a).
`This certification and request is being filed with the utility application via EFS-Web.
`---OR---
`( b) The application is an original nonprovisional plant application filed under 35 U.S.C. 111 (a).
`This certification and request is being filed with the plant application in paper.
`
`ii. The executed inventor's oath or declaration is filed with the application. (37 CFR 1.63 and 1.64)
`0 Request for Continued Examination - Prioritized Examination under§ 1.1 02(e)(2)
`
`II.
`
`i. A request for continued examination has been filed with, or prior to, this form.
`ii.
`If the application is a utility application, this certification and request is being filed via EFS-Web.
`iii. The application is an original nonprovisional utility application filed under 35 U.S.C. 111 (a), or is
`a national stage entry under 35 U.S.C. 371.
`iv. This certification and request is being filed prior to the mailing of a first Office action responsive
`to the request for continued examination.
`v. No prior request for continued examination has been granted prioritized examination status
`under 37 CFR 1.1 02( e )(2).
`
`Siqnature/Laura L. Wine/
`~p~~~Typed) Laura L. Wine
`
`~~Augu~ 14,2013
`68681
`
`Practitioner
`Registration Number
`
`Note: This form must be signed in accordance with 37 CFR 1.33. See 37 CFR 1.4(d) for signature requirements and certifications.
`Submit multiple forms if more than one signature is required.*
`
`tJ *Total of
`
`1
`
`forms are submitted.
`
`APOTEX 1019, pg. 16
`
`

`
`Privacy Act Statement
`
`The Privacy Act of 1974 (P.L. 93-579) requires that you be given certain information in connection with your
`submission of the attached form related to a patent application or patent. Accordingly, pursuant to the requirements of
`the Act, please be advised that: (1) the general authority for the collection of this information is 35 U.S.C. 2(b)(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 Office is to process and/or examine your submission related to a patent application or
`patent. If 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 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:
`
`1. The information on this form will be treated confidentially to the extent allowed under the Freedom of
`Information Act (5 U.S.C. 552) and the Privacy Act (5 U.S.C 552a). Records from 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.
`2. 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.
`3. A record in this system of records may be disclosed, as a routine use, to 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 respect to the subject matter of the record.
`4. 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 to 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. 552a(m).
`5. A record related to an International Application filed under the Patent Cooperation Treaty in this system of
`records may be disclosed, as a routine use, to the International Bureau of the World Intellectual Property
`Organization, pursuant to the Patent Cooperation Treaty.
`6. A record in this system of records may be disclosed, as a routine use, to another fed