UNITED STATES PATENT AND TRADEMARK OFFICE
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`UNITED STATES DEPARTNIENT OF CO3/HVIERCE
`United States Patent and Trademark Office
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`ALLERGAN, INC_
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`EXAIVIINER
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`CORDERO GARCIA, MARCELA M
`
`1676
`
`DATE MAILED: 01/28/2014
`
`APPLICATION NO.
`
`FILING DATE
`
`FIRST NAIVIED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
`
`1761 SCON6 (AP)
`Andrew Acheanipoiig
`08/07/2013
`13/961,828
`TITLE OF INVENTION: METHODS OF PROVIDING THERAPEUTIC EFFECTS USING CYCLOSPORIN COMPONENTS
`
`9904
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`PTOL-85 (Rev. 02/11)
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`1
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`ALL 2008
`APOTEX V. ALLERGAN
`IPR2015-01283
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`PART B - FEE(S) TRANSMITTAL
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`fle1rvi\c/E:
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`first glass mailbin an pnvelorie
`a
`esse
`to
`e . ai
`‘top
`‘
`‘
`'
`'
`'
`‘ a
`ress a ove. or
`einn ‘acsimi e
`transmitted to the USPTO (571) 273-2885. on the date indicated belgw.
`(Llepositors Amine)
`
`APPLICATION NO.
`
`FILING DATE
`
`FIRST NAIVIED [NVENTOR
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
`
`17618CON6 (AP)
`Andrew Acheampong
`08/07/2013
`13/961,828
`TITLE OF INVENTION: IVETHODS OF PROVIDING THERAPEUTIC EFFECTS USING CYCLOS PORIN COMPONENTS
`
`APPLN. TYPE
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`ENTITY STATUS
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`ISSUE FEE DUE
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`UNDISCOI .'NTED
`nonprovi sional
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`CORDERO GARCIA, MARCELA M
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`ART UNIT
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`1676
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`DATE DUE
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`04/28/2014
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`514-020500
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`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMM
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`2
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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`UNITED STATES DEPARTMENT OF COIWVIERCE
`United States Patent and Trademark Office
`Address: COMIVIISSIONER FOR PATENTS
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`APPLICATION NO.
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`FILING DATE
`
`FIRST NAIVIED [NVENTOR
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
`
`08/07/2013
`
`Andrew Acheampong
`
`I 761 8CON6 (AP)
`
`9904
`
`51957
`
`7590
`
`01/28/2014
`
`ALLERGAN, INC.
`2525 DUPONT DRIVE, T2-7H
`IRVINE. CA 92612-1599
`
`CORDERO GARCIA, MARCELA M
`
`1 676
`
`DATE MAILED: 01/28/2014
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`Determination of Patent Term Adjustment under 35 U.S.C. 154 (b)
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`PTOI.—S5 (Rev. 02/1 1)
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`Page 3 of 3
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`3
`
`

`
`_
`_
`_
`Notzce Requzrmg Invent0r’s Oath or
`Declaration
`
`13/961,828
`
`ndrew Acheampong
`
`'xaminer
`.ORDERO GARCIA,
`I ARCELAM
`
`rl Unjl
`1676
`
`This notice is an attachment to the Notice of Allowability (PTOI.-37), or the Notice of Allowability For A Design
`Application (PTOL—37D).
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`An inventor’s oath or declaration in compliance with 37 CFR 1.63 or 1.64 executed by or with respect to eacl1
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`An oath or declaration in compliance with 37 CFR 1.63, or a substitute statement in compliance with 37 CFR
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`A properly executed inventor’s oath to declaration has not been received for the following inventor(s):
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`If applicant previously filed one or more oaths, declarations, or substitute statements, applicant may have received
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`The following deficiencies are noted:
`INFORMAL ACTION PROBLEMS
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`0 A properly executed inventors oath or declaration has not been received for the following inventor(s): Diane
`D. Tang-Liu.
`Applicant may submit the inventors oath or declaration at any time before the Notice of Allowance and
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`U.S. Patent and Trademark Office
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`PTOQ306 (01-13)
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`Notice Requiring Invent0r’s Oath or Declaration
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`4
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`

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`OMB Clearance and PRA Burden Statement for PTOL-85 Part B
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`
`5
`
`

`
`Notice of Allowability
`
`Application No.
`13/961,828
`
`App|icant(s)
`ACHEAMPONG ET AL.
`
`E/l)Aal=rIT(]')irEER M. CORDE RO
`GARCIA
`
`tAgt7gnit
`
`é'l':’(:i*:LlSnvent°r to
`N0
`
`— The MAILING DA TE of this communication appears on the cover sheet with the correspondence address--
`All claims being allowable. PROSECUTION ON THE MERITS IS (OR REMAINS) CLOSED in this application.
`If not included
`herewith (or previously mailed), a Notice of Allowance (PTOL-85) or other appropriate communication will be mailed in due course. THIS
`NOTICE OF ALLOWABILITY IS NOT A GRANT OF PATENT RIGHTS. This application is subject to withdrawal from issue at the initiative
`of the Office or upon petition by the applicant. See 37 CFR 1.313 and MPEP 1308.
`
`1. E This communication is responsive to 12/2/2013 12/5/2013 12/20/2013.
`D A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/were filed on
`
`2. El An election was made by the applicant in response to a restriction requirement set forth during the interview on
`requirement and election have been incorporated into this action.
`
`; the restriction
`
`3. IX The allowed cIaim(s) is/are 37-48 and 62-85. As a result of the allowed c|aim(s), you may be eligible to benefit from the Patent
`Prosecution Highway program at a participating intellectual property office for the corresponding application. For more information,
`please see .i:1_ii:.t2_:_/';Z:xrr_~_I_v::J»_:_s:-L.=s
`l;1lJ_/_lt1_@Ls_>;<_-_I:»:l;2.orsend an inquiry to
`
`4. El Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119( )-(d) or (f).
`Certified copies:
`*c) D None of the:
`a) El All
`b) D Some
`1. El Certified copies of the priority documents have been received.
`2. El Certified copies of the priority documents have been received in Application No. j
`3. El Copies of the certified copies of the priority documents have been received in this national stage application from the
`International Bureau (PCT Rule 17.2( )).
`* Certified copies not received:
`
`Applicant has THREE MONTHS FROM THE “MAILING DATE" ofthis communication to file a reply complying with the requirements
`noted below. Failure to timely comply will result in ABANDONMENT of this application.
`THIS THREE-MONTH PERIOD IS NOT EXTENDABLE.
`
`5. El CORRECTED DRAWINGS ( as “replacement sheets") must be submitted.
`
`El
`
`including changes required by the attached Examiner’s Amendment / Comment or in the Office action of
`Paper No./Mail Date
`Identifying indicia such as the application number (see 37 CFR 1.84(c)) should be written on the drawings in the front (not the back) of
`each sheet. Replacement sheet(s) should be labeled as such in the header according to 37 CFR 1 .1 21 (d).
`
`6. El DEPOSIT OF and/or INFORMATION about the deposit of BIOLOGICAL MATERIAL must be submitted. Note the
`attached Examiner’s comment regarding REQUIREMENT FOR THE DEPOSIT OF BIOLOGICAL MATERIAL.
`
`Attachment(s)
`1. E Notice of References Cited (PTO—892)
`2. IE Information Disclosure Statements (PTO/SB/O8),
`Paper No./Mail Date 9/5/2013 9/25/2013
`3. El Examiner’s Comment Regarding Requirement for Deposit
`of Biological Material
`4. El Interview Summary (PTO-413),
`Paper No./Mail Date 20131220.
`/MARCELA M CORDERO GARCIA/
`Primary Examiner, Art Unit 1676
`
`5. IX Examiner's AmendmenUComment
`6. IX! Examiner's Statement of Reasons for Allowance
`
`7. El Other
`
`.
`
`U.S. Patent and Trademark Office
`PTOL—37 (Rev. 08-13)
`
`Notice of Allowability
`
`Part of Paper No./Mail Date 20131220
`
`6
`
`

`
`Application/Control Number: 13/961,828
`Art Unit: 1676
`
`DETAILED ACTION
`
`1.
`
`The present application is being examined under the pre-AIA first to invent
`
`provisions. This Office Action is in response to the replies received on 12/2/2013,
`
`12/5/2013 and 12/20/2013.
`
`Election/Restrictions
`
`2.
`
`Applicant’s election without traverse of the species wherein the tonicity or
`
`demulcent component is “glycerin” and the buffer is “sodium hydroxide” in the reply filed
`
`on 12/02/2013 is acknowledged. Upon reconsideration, the election of species mailed
`
`on 10/25/2013 is herein withdrawn and all species are being examined.
`
`Status of the claims
`
`3.
`
`Claims 37-61 were pending. Claim 49 was cancelled. Claims 62-85 are new
`
`claims. Claims 37 and 44 have been amended. Claims 37-48 and 62-85 are now
`
`pending. Claims 37-48 and 62-85 are presented for examination on the merits.
`
`Declarations under 37 CF}? 1. 132
`
`4.
`
`The declaration under 37 CFR 1.132 by Rhett M. Schiffman filed on 12/5/2013
`
`(EXHIBIT 1 comprising EXHIBITS A-F) is deemed sufficient to overcome a potential 103
`
`rejection of claims 37-48 and 62-85 based upon Ding et al. (US 5,474,979, cited in the
`
`IDS dated 9/5/2013) because: After carefully reviewing exhibits A-F, which compare the
`
`instantly claimed embodiment having 0.05%/1.25% castor oil with embodiments E and
`
`F of Ding et al. (0.10°/o/1.25% castor oil and 0.05/.625°/o cyclosporin/castor oil ratios),
`
`Examiner is persuaded that, unexpectedly, the claimed formulation (0.05°/o cyclosporin
`
`A/1.25% castor oil) demonstrated an 8-fold increase in relative efficacy for the Schirmer
`
`7
`
`

`
`Application/Control Number: 13/961,828
`Art Unit: 1676
`
`Page 3
`
`Tear Test score in the first study of Phase 3 trials compared to the relative efficacy for
`
`the 0.05% by weight cyclosporin A/0.625% by weight castor oil formulation disclosed in
`
`Example 1E of Ding, tested in Phase 2 trials. The data represents a comparison of the
`
`subpopulation of Phase 2 patients using compositions with the same reductions in tear
`
`production (5 mm/5 min) as those enrolled in the Phase 3 studies. EXHIBIT 1 at
`
`paragraph 8. All of the cyclosporin A—containing formulations as well as the vehicle also
`
`included 2.2% by weight glycerine, 1.0% by weight polysorbate, 0.05% Pemulen,
`
`sodium hydroxide, and water (see paragraph 6, page 2 of EXHIBIT 1).
`
`Exhibits E and F also illustrate that the claimed formulations comprising 0.05%
`
`cyclosporin A/1.25% castor oil also demonstrated a 4-fold improvement in the relative
`
`efficacy for the Schirmer Tear Test score for the second study of Phase 3 and a 4-fold
`
`increase in relative efficacy for decrease in corneal staining score in both of the Phase 3
`
`studies compared to the 0.05% by weight cyclosporin A/0.625% by weight castor oil
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`formulation tested in Phase 2 and disclosed in Ding (Ding 1E). The excipients were the
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`same in the compared compositions. Given that the compositions comprise the same
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`amount of active agent (0.05 % cyclosporin A) as Ding 1 E, the improvements are
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`surprising, unexpected and commensurate in scope with the claimed invention.
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`The declaration under 37 CFB 1.132 by Mayssa Attar, filed on 12/5/2013
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`(EXHIBIT 2, comprising EXHIBITS A—D) is deemed sufficient to overcome the rejection
`
`of claims 37-61 based upon Ding et al. (US 5,474,979, cited in the IDS dated 9/12/2013)
`
`as set forth in the last Office action because: EXHIBITS A—D were carefully reviewed.
`
`As described in paragraph 7 of the EXHIBIT 2, the chart in EXHIBIT B shows that the
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`Application/Control Number: 13/961,828
`Art Unit: 1676
`
`Page 4
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`amount of cyclosporin A that reaches the cornea and conjunctiva, ocular tissues that
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`are highly relevant for the treatment of dry eye or keratoconjunctivis sicca, is higher for
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`the formulation containing 0.05% by weight cyclosporin A and 0.625% by weight castor
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`oil (Ding et al. 1E) than the formulation containing 0.05% by weight cyclosporin A and
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`1.25% by weight castor oil (the claimed formulation) relative to the formulation
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`containing 0.1% by weight cyclosporin A and 1.25% by weight castor oil (Ding et al. 1D).
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`According to Dr. Attar, this data teaches that the formulation containing 0.05% by weight
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`cyclosporin A and 1.25% by weight castor oil would be less therapeutically effective
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`than the formulation containing 0.05% by weight cyclosporin A and 0.625% by weight
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`castor oil or the formulation containing 0.10% by weight cyclosporin A and 1.25% by
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`weight castor oil. EXHIBIT A, paragraph 8. Therefore it would be unexpected that the
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`composition with lower uptake in cornea and conjunctiva would have significantly
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`improved activity.
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`Taking the results of the studies and data presented in the EXHIBITS 1 and 2
`
`together, it is clear that the specific combination of 0.05% by weight cyclosporin A with
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`1.25% by weight castor oil is surprisingly critical for therapeutic effectiveness in the
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`treatment of dry eye or keratoconjunctivitis sicca.
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`Accordingly, the Declarations in EXHIBIT 1 and EXHIBIT 2, together with the
`
`data presented in those declarations, provide clear and convincing objective evidence
`
`that establishes that the claimed formulations, including 0.05% by weight cyclosporin A
`
`and 1.25% by weight castor oil, demonstrate surprising and unexpected results,
`
`including improved Schirmer Tear Test scores and corneal staining scores (key
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`Application/Control Number: 13/961,828
`Art Unit: 1676
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`Page 5
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`objective measures of efficacy for dry eye or keratoconjunctivitis sicca) and improved
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`visual blurring and reduced artificial tear use as compared to the prior art, for example,
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`emulsion formulations disclosed in Ding et al., including formulations with 0.05% by
`
`weight cyclosporin A and 0.625% by weight castor oil (Ding et al. 1 E) and formulations
`
`with 0.10% by weight cyclosporin A and 1.25% by weight Castor oil (Ding et al. 1D)
`
`which are the closest prior art formulations. The unexpected results are commensurate
`
`in scope with the claims (MPEP 716.02(d)).
`
`Thus, a potential obviousness rejection in view of Ding et al. is rendered moot.
`
`Declaration under 37 CFR 1.131
`
`5.
`
`The 37 CFR 1.131 declaration filed on 12/5/2013 has been reviewed and
`
`accepted, thus obviating the need for a potential 102(e) rejection over US 6,984,628
`
`(corresponding to US 2005/0014691, cited in the IDS dated 9/5/2013).
`
`Double Parenting
`
`6.
`
`A potential ODP rejection over Ding et al. (US 5,474,979, cited in the IDS dated
`
`9/5/2013) is rendered moot for the reasons set forth in section 4 above.
`
`Terminal disclaimers
`
`7.
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`Terminal disclaimers for 12/035,698; 13/649,287; 13/967,168; 13/967,179;
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`13/967,189; 13/967,163; 11/897,177 were received and accepted on 12/20/2013.
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`Therefore, potential ODP rejections for these applications are rendered moot.
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`10
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`

`
`Application/Control Number: 13/961,828
`Art Unit: 1676
`
`Claims 37-48 and 62-85 are allowed.
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`Conclusion
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`The prior art made of record and not relied upon is considered pertinent to
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`applicant's disclosure.
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`REASONS FOR ALLOWANCE
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`9.
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`The following is an examiner’s statement of reasons for allowance: The closest
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`prior art is that of Ding et al. (US 5,474,979, cited in the IDS dated 9/5/2013), which
`
`would necessitate a potential 103 rejection and Bakhit et al. (US 6,984,628,
`
`corresponding to US 2005/0014691, cited in the IDS dated 9/5/2013) which would
`
`necessitate a potential 102(e) rejection. However, these potential rejections have been
`
`obviated in view of declarations under 1.132 and 1.131 as described in detail in
`
`paragraphs 4 and 5 above.
`
`.Any comments considered necessary by applicant must be submitted no later
`
`than the payment of the issue fee and, to avoid processing delays, should preferably
`
`accompany the issue fee. Such submissions should be clearly labeled “Comments on
`
`Statement of Reasons for Allowance.”
`
`10.
`
`Any inquiry concerning this communication or earlier communications from the
`
`examiner should be directed to MARCELA M. CORDERO GARCIA whose telephone
`
`number is (571)272-2939. The examiner can normally be reached on M—F 8:30-5:00.
`
`If attempts to reach the examiner by telephone are unsuccessful, the examiner’s
`
`supervisor, Karlheinz R. Skowronek can be reached on (571)-272-9047. The fax phone
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`11
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`Application/Control Number: 13/961,828
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`Page 7
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`Art Unit: 1676
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`number for the organization where this application or proceeding is assigned is 571 —
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`273-8300.
`
`Information regarding the status of an application may be obtained from the
`
`Patent Application Information Retrieval (PAIR) system. Status information for
`
`published applications may be obtained from either Private PAIR or Public PAIR.
`
`Status information for unpublished applications is available through Private PAIR only.
`
`For more information about the PAIR system, see http://pair-direct.uspto.gov. Should
`
`you have questions on access to the Private PAIR system, contact the Electronic
`
`Business Center (EBC) at 866-217-9197 (toll—free).
`
`If you would like assistance from a
`
`USPTO Customer Service Representative or access to the automated information
`
`system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
`
`/MARCELA M CORDERO GARCIA/
`
`Primary Examiner, Art Unit 1676
`
`MMCG 12/2013
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`12
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`

`
`Docket No. 17618CON6 (AP)
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`Applicant: Acheampong, et al.
`
`Examiner: Marcela M Cordero Garcia
`
`Serial No.: 13/961,828
`
`Group Art Unit: 1658
`
`Filed: August 7, 2013
`
`Confirmation No. 9904
`
`PROVIDING Customer No.: 51957
`METHODS OF
`For:
`THERAPEUTIC
`EFFECTS
`USING
`CYCLOSPORIN COMPONENTS
`
`INTERVIEW SUMMARY, PRELIMINARY AMENDMENT, AND REMARKS
`
`Commissioner for Patents
`P.O. Box 1450
`
`Alexandria, VA 22313 -1450
`
`Dear Sir:
`
`Attached please find an interview summary, preliminary amendment to the claims, and
`
`accompanying remarks.
`
`Amendments to the Claims begin at page 2;
`
`Summary of the Interview begins at page 7;
`
`Remarks follow on page 8.
`
`13
`
`13
`
`

`
`Docket No. 17618CON6 (AP)
`
`AMENDMENTS TO THE CLAIMS
`
`The following claims replace all prior versions of claims submitted in this application.
`
`Only those claims being amended herein show their changes in highlighted form, where
`
`insertions appear as underlined text (e.g., insertions) while deletions appear as strikethrough or
`
`surrounded by double brackets (e.g. deletions or [[deletions]]).
`
`1- 36. (Canceled)
`
`37. (Currently Amended) A topical ophthalmic emulsion for treating an eye of a human having
`
`Késkeratoconjunctivitis sicca, wherein the topical ophthalmic emulsion comprises cyclosporin
`
`A in an amount of about 0.05% by weight, polysorbate 80, Pemu-len acrylate/C10—30 alkyl
`
`acglate cross-polymer, water, and castor oil in an amount of about 1.25% by weight; and
`
`wherein the topical ophthalmic
`
`emulsion is
`
`therapeutically effective in treating
`
`lééskeratoconjunctivitis sicca.
`
`38. (Previously Presented) The topical ophthalmic emulsion of Claim 37, wherein the topical
`
`ophthalmic emulsion further comprises a tonicity agent or a demulcent component.
`
`39. (Previously Presented) The topical ophthalmic emulsion of Claim 38, wherein the tonicity
`
`agent or the dcmulccnt component is glyccrinc.
`
`40. (Previously Presented) The topical ophthalmic emulsion of Claim 37, wherein the topical
`
`ophthalmic emulsion further comprises a buffer.
`
`41. (Previously Presented) The topical ophthalmic emulsion of Claim 40, wherein the buffer is
`
`sodium hydroxide.
`
`42. (Previously Presented) The topical ophthalmic emulsion of Claim 37, wherein the topical
`
`ophthalmic emulsion further comprises glycerine and a buffer.
`
`14
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`

`
`Docket No. 17618CON6 (AP)
`
`43. (Previously Presented) The topical ophthalmic emulsion of Claim 37, wherein the topical
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`ophthalmic emulsion comprises polysorbate 80 in an amount of about 1.0% by weight.
`
`44. (Currently Amended) The topical ophthalmic emulsion of Claim 37, wherein the topical
`
`ophthalmic emulsion comprises Pemulen acglate/C10—30 alkyl acrylate cross—polymer in an
`
`amount of about 0.05% by weight.
`
`45.