`
`UNITED STATES DEPARTNIENT OF CO3/HVIERCE
`United States Patent and Trademark Office
`Addiess: CO1‘/INIISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria. Virginia 22313—1430
`www.uspto.goV
`
`NOTICE OF ALLOWANCE AND FEE(S) DUE
`
`ALLERGAN, INC_
`2525 DUPONT DRIVE, T2—7H
`IRVINE, CA 92612-1599
`
`EXAIVIINER
`
`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
`
`APPLN. TYPE
`
`ENTITY STATUS
`
`ISSUE FEE DUE
`
`PUBLIC ATION FEE DUE
`
`PREV. PAID ISSITE FEE
`
`TOTAL FEE(S) DUE
`
`nonprovisional
`
`UNDISCOUN TED
`
`$960
`
`$0
`
`$0
`
`$960
`
`DATE DUE
`
`04/28/2014
`
`THE APPLICATION IDENTIFIED ABOVE HAS BEEN EXAMINED AND IS ALLOVVED FOR ISSUANCE AS A PATENT.
`PROSECUTION ON TIIE MERITS IS CLOSED. TIIIS NOTICE OF ALLOWANCE IS NOT A GRANT OF PATENT RIGIITS.
`THIS APPLICATION IS SUBJECT TO WITHDRAVVAL FROM ISSUE AT THE INITIATIVE OF THE OFFICE OR UPON
`PETITION BY THE APPLICANT. SEE 37 CFR 1.313 AND MPEP 1308.
`
`THE ISSUE FEE AND PUBLICATION FEE (IF REQUIRED) MUST BE PAID WITHIN THREE MONTHS FROM THE
`MAILING DATE OF THIS NOTICE OR THIS APPLICATION SHALL BE REGARDED AS ABANDONED.
`THIS
`STATUTORY PERIOD CANNOT BE EXTENDED.
`SEE 35 II.S.C. 151. THE ISSUE FEE DUE INDICATED ABOVE DOES
`NOT REFLECT A CREDIT FOR ANY PREVIOUSLY PAID ISSUE FEE IN THIS APPLICATION.
`IF AN ISSUE FEE HAS
`PREVIOUSLY BEEN PAID IN THIS APPLICATION (AS SHOWN ABOVE), THE RETURN OF PART B OF THIS FORIVI
`VVILL BE CONSIDERED A REQUEST TO REAPPLY THE PREVIOUSLY PAID ISSUE FEE TOWARD THE ISSUE FEE NOW
`DUE.
`
`HOW TO REPLY TO THIS NOTICE:
`
`I. Review the ENTITY STATUS shown above. If the ENTITY STATUS is shown as SMALL or MICRO, verify whether entitlement to that
`entity status still applies.
`
`If the ENTITY STATUS is the same as shown above, pay the TOTAL FEE(S) DUE shown above.
`
`If the ENTITY STATUS is changed from that shown above, on PART B - FEE(S) TRANSMITTAL, complete section number 5 titled
`"Change in Entity Status (from status indicated above)".
`
`For purposes of this notice, small entity fees are 1/2 the amount of iindiscounted fees, and micro entity fees are 1/2 the amount of small entity
`fees.
`
`II. PART B - FEE(S) TRANSMITTAL, or its equivalent, must be completed and returned to the United States Patent and Trademark Office
`(USPTO) with your ISSUE FEE and PUBLICATION FEE (if required). If you are charging the fee(s) to your deposit account, section "4b"
`of Part B - Fee(s) Transmittal should be completed and an extra copy of the form should be submitted. If an equivalent of Part B is filed, a
`request to reapply a previously paid issue fee must be clearly made, and delays in processing may occur due to the difficulty in recognizing
`the paper as an equivalent of Part B.
`
`III. All coiniiiunications regarding this application must give the application number. Please direct all coiiniiiiiiicatioiis prior to issuance to
`Mail Stop ISSUE FEE unless advised to the contrary.
`
`IMPORTANT REMINDER: Utility patents issuing on applications filed on or after Dec. 12, 1980 may require payment of
`maintenance fees. It is patentee's responsibility to ensure timely payment of maintenance fees when due.
`
`PTOL-85 (Rev. 02/11)
`
`Page 1 of 3
`
`1
`
`ALL 2008
`APOTEX V. ALLERGAN
`IPR2015-01283
`
`
`
`PART B - FEE(S) TRANSMITTAL
`
`Complete and send this form, together with applicable fee(s), to: Mail Mail Stop ISSUE FEE
`Commissioner for Patents
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`or @ (571)-273-2885
`through 5 should be completed where
`INSTRUCTIONS: This form should be used for transmitting the ISSUE FEE and PUBLICATION FEE (if required). Blocks 1
`ap ropriate. All further correspondence including the Patent, advance orders and notification of maintenance fees will be mailed to the current correspondence address as
`in icated unless corrected below or directed otherwise in Block 1, by (a) specifying a new correspondence address; and/or (b) indicating a separate "FEE ADDRESS" for
`maintenance fee notifications.
`
`CURRENT CORRESPONDENCE ADDRESS (Now: Um Block 1 fol any Chang: of addlm)
`
`7590
`
`51957
`ALLERGAN,
`—
`I2§€;I£]:Ul;(:N9T2P1R2lYF69T2‘7H
`,
`.
`)
`- D
`
`01/28/2014
`
`Note: A certificate of mailin _ can only be used for domestic mailings of the
`Fee(s) Transmittal. This certi icate cannot be used for any other accompanying
`ave its own certificate of maiiing or transmission.
`papers. Each additional paper, such as an assignment or formal drawing. must
`Certificate of Mailing 01' Transinission
`I hereb certif ' that this Fee(s) Transmittal is being deposited with the United
`S(tlaltres
`télstal
`fle1rvi\c/E:
`su1l1'ibc;t:LnLpi‘)Js;t:lge
`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
`
`ENTITY STATUS
`
`ISSUE FEE DUE
`
`UNDISCOI .'NTED
`nonprovi sional
`EXAMINE 2
`
`CORDERO GARCIA, MARCELA M
`
`$060
`ART UNIT
`
`1676
`
`PUBLICATION FEE DUE
`$0
`
`PREV. PAID ISSUE FEE
`$0
`
`TOTAL FEE(S) DUE
`
`S960
`
`DATE DUE
`
`04/28/2014
`
`CLASS—SUB CLASS
`
`514-020500
`
`1. Change of correspondence address or indication of "Fee Address" (37
`CFR 1363)‘
`3 Chan e of corressqpndence address (or Change of Correspondence
`Address onn PTO/
`/122) attached.
`:1 "Fee Address" indication (or "Fee Address" Indication form
`’TO/SB/47; Rev 03-02 or more recent) attached. Use of a Customer
`Number is required,
`
`2. For printing on the patent front page, list
`(1) The names of up to 3 registered patent attorneys
`or agents OR, alternatively.
`7.
`.
`.
`V.
`(-) The name of a single firm (having as a member a
`registered 'clll0FH€)’ 0F agvnl) and the Hameb 01' UP l_0
`Zreglstered paten} attorneys Or agents. If 110 flame IS
`hsted, no name Will be printed.
`
`3. ASSIGNEE NAME AND RESIDENCE DATA TO BE PRINTED ON THE PATENT (print or type)
`If an assignee is identified below, the document has been filed for
`’I.EASE NOTE: Unless an assi nee is identified below, no assignee data will appear on the patent.
`recordation as set forth in 37 C
`3.11. Completion of this form is NOT a substitute for filing an assignment.
`(A) NAME OF ASSIGNEE
`(B) RESIDENCE: (CITY and STATE OR COUNTRY)
`
`Please check the appropriate assignee category or categories (will not be printed on the patent) : D Individual D Corporation or other private group entity D Government
`4a. The following fee(s) are submitted:
`4b. Payment of Fee(s): (Please first reapply any previously paid issue fee shown above)
`:1 Issue Fee
`:1 A check is enclosed.
`:1 Publication Fee (No small entity discount permitted)
`:1 Payment by credit card. Form PTO-2038 is attached.
`:1 Advance Order — # of Copies
`:1 The Director is hereby authorized to charge the required fee(s). any deficiency. or credits any \
`overpayment. to Deposit Account Number
`(enclose an extra copy o1 this lonn).
`
`5. Change in Entity Status (from status indicated above)
`3 Applicant certifying micro entity status. See 37 CFR 1.2‘)
`
`:1 Applicant asserting small entity status. See 37 CFR 1.27
`
`NOTE: Absent a valid certification of Micro Entity Status (see forms PTO/SP;/15A and 15B), issue
`fee payment in the micro entity amount will not be accepted at the risk of application abandonment.
`NOTE: If the application was previously under micro entity status, checking this box will be taken
`to be a notification of loss of entitlement to micro entity status.
`NOTE: Checking this box will be taken to be a notification of loss of entitlement to small or micro
`:1 Applicant changing to regular undiscounted fee status.
`entity status, as applicable.
`NOTE: This form must be sinned in accordance with 37 CFR 1.31 and 1.33. See 37 CFR 1.4 for s1 nature re uirements and certifications.
`
`Authorized Signature
`
`Typed or printed name
`
`Date
`
`Registration No.
`
`PTOL-85 Part B (10-13) Approved for use through 10/31/2013.
`
`Page 2 of 3
`OMB 0651-0033
`
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMM
`
`2
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`UNITED STATES DEPARTMENT OF COIWVIERCE
`United States Patent and Trademark Office
`Address: COMIVIISSIONER FOR PATENTS
`P 0 Box l4S0
`Alexandria, Virginia 22711-1451]
`www.uspto.gov
`
`APPLICATION NO.
`
`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
`
`Determination of Patent Term Adjustment under 35 U.S.C. 154 (b)
`(application filed on or after May 29, 2000)
`
`The Patent Term Adjustment to date is 0 day(s). If the issue fee is paid on the date that is three months after the
`mailing date of this notice and the patent issues on the Tuesday before the date that is 28 weeks (six and a half
`months) after the mailing date of this notice, the Patent Term Adjustment will be 0 day(s).
`
`If a Continued Prosecution Application (CPA) was filed in the above—identified application, the filing date that
`determines Patent Term Adjustment is the filing date of the most recent CPA.
`
`Applicant will be able to obtain more detailed information by accessing the Patent Application Information Retrieval
`(PAIR) WEB site (http://pair.uspto.gov).
`
`Any questions regarding the Patent Term Extension or Adjustment determination should be directed to the Office of
`Patent Legal Administration at (571)-272-7702. Questions relating to issue and publication fee payments should be
`directed to the Customer Service Center of the Office of Patent Publication at l—(888)—786—0l0l or (571)-272-4200.
`
`PTOI.—S5 (Rev. 02/1 1)
`
`Page 3 of 3
`
`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).
`
`An inventor’s oath or declaration in compliance with 37 CFR 1.63 or 1.64 executed by or with respect to eacl1
`inventor has not yet been submitted.
`
`An oath or declaration in compliance with 37 CFR 1.63, or a substitute statement in compliance with 37 CFR
`1.64, executed by or with respect to each inventor (for any inventor for which a compliant oath, declaration, or
`substitute statement has not yet been submitted) MUST be filed no later than the date on which the issue fee is
`1% See 35 U.S.C. 115(f). Failure to timely comply will result in ABANDONMENT of this application.
`
`A properly executed inventor’s oath to declaration has not been received for the following inventor(s):
`
`If applicant previously filed one or more oaths, declarations, or substitute statements, applicant may have received
`an informational notice regarding deficiencies therein.
`
`The following deficiencies are noted:
`INFORMAL ACTION PROBLEMS
`
`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
`Fee(s) Due, PTOL-85, is mailed.
`
`Questions relating to this Notice should be directed to the Application Assistance Unit at 571-272-4200.
`
`U.S. Patent and Trademark Office
`
`PTOQ306 (01-13)
`
`Notice Requiring Invent0r’s Oath or Declaration
`
`4
`
`
`
`OMB Clearance and PRA Burden Statement for PTOL-85 Part B
`
`The Paperwork Reduction Act (PRA) of 1995 requires Federal agencies to obtain Office of Management and
`Budget approval before requesting most types of information from the public. When OMB approves an agency
`request to collect information from the public, OMB (i) provides a valid OMB Control Number and expiration
`date for the agency to display on the instrument that will be used to collect the information and (ii) requires the
`agency to inform the public about the OMB Control Number’s legal significance in accordance with 5 CFR
`1320.5(b).
`
`The information collected by PTOL-85 Part B is required by 37 CFR 1.311. The information is required to obtain
`or retain a benefit by the public which is to file (and by the USPTO to process) an application. Confidentiality is
`governed by 35 U.S.C. 122 and 37 CFR 1.14. This collection is estimated to take 12 minutes to complete,
`including gathering, preparing, and submitting the completed application form to the USPTO. Time will vary
`depending upon the individual case. Any comments on the amount of time you require to complete this form
`a11d/or suggestions for reducing this burden, should be sent to the Chief Information Officer, U.S. Patent a11d
`Trademark Office, U.S. Department of Commerce, P.O. Box 1450, Alexandria, Virginia 22313-1450. DO NOT
`SEND FEES OR COMPLETED FORMS TO THIS ADDRESS. SEND TO: Commissioner for Patents, P.O. Box
`1450, Alexandria, Virginia 22313-1450. Under tl1e Paperwork Reduction Act of 1995, no persons are required to
`respond to a collectio11 of information unless it displays a valid OMB control number.
`
`Privacy Act Statement
`
`The Privacy Act of 1974 (PL. 93-579) requires that you be given certain information in connection with your
`submission of me 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
`me 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 tl1e 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.
`. 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 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 tl1e Member with respect to tl1e subject matter of tl1e record.
`. A record in this system of records may be disclosed, as a routine use, to a contractor of tl1e Agency having
`need for tl1e information in order to perform a contract. Recipients of information shall be required to
`comply with tl1e requirements of the Privacy Act of 1974, as amended, pursuant to 5 U.S.C. 552a(1n).
`. 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
`Organi7ation, pursuant to the Patent Cooperation Treaty.
`. A record in this system of records may be disclosed, as a routine use, to another federal agency for purposes
`of National Security review (35 U.S.C. 181) and for review pursuant to the Atomic Energy Act (42 U.S.C.
`218(c)).
`. A record from this system of records may be disclosed, as a routine use, to die Administrator, General
`Services, or his/her designee, during an inspection of records co11ducted 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 2906. Such disclosure shall be made 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 shall not be used to make determinations about individuals.
`. A record fron1 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 tl1e lin1itatio11s of 37 CFR 1.14, as a routine use, to tl1e public if tl1e
`record was filed in an application which became abandoned or in which tl1e proceedings were terminated
`and which application is 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 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.
`
`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
`
`formulation tested in Phase 2 and disclosed in Ding (Ding 1E). The excipients were the
`
`same in the compared compositions. Given that the compositions comprise the same
`
`amount of active agent (0.05 % cyclosporin A) as Ding 1 E, the improvements are
`
`surprising, unexpected and commensurate in scope with the claimed invention.
`
`The declaration under 37 CFB 1.132 by Mayssa Attar, filed on 12/5/2013
`
`(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
`
`8
`
`
`
`Application/Control Number: 13/961,828
`Art Unit: 1676
`
`Page 4
`
`amount of cyclosporin A that reaches the cornea and conjunctiva, ocular tissues that
`
`are highly relevant for the treatment of dry eye or keratoconjunctivis sicca, is higher for
`
`the formulation containing 0.05% by weight cyclosporin A and 0.625% by weight castor
`
`oil (Ding et al. 1E) than the formulation containing 0.05% by weight cyclosporin A and
`
`1.25% by weight castor oil (the claimed formulation) relative to the formulation
`
`containing 0.1% by weight cyclosporin A and 1.25% by weight castor oil (Ding et al. 1D).
`
`According to Dr. Attar, this data teaches that the formulation containing 0.05% by weight
`
`cyclosporin A and 1.25% by weight castor oil would be less therapeutically effective
`
`than the formulation containing 0.05% by weight cyclosporin A and 0.625% by weight
`
`castor oil or the formulation containing 0.10% by weight cyclosporin A and 1.25% by
`
`weight castor oil. EXHIBIT A, paragraph 8. Therefore it would be unexpected that the
`
`composition with lower uptake in cornea and conjunctiva would have significantly
`
`improved activity.
`
`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
`
`1.25% by weight castor oil is surprisingly critical for therapeutic effectiveness in the
`
`treatment of dry eye or keratoconjunctivitis sicca.
`
`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
`
`9
`
`
`
`Application/Control Number: 13/961,828
`Art Unit: 1676
`
`Page 5
`
`objective measures of efficacy for dry eye or keratoconjunctivitis sicca) and improved
`
`visual blurring and reduced artificial tear use as compared to the prior art, for example,
`
`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.
`
`Terminal disclaimers for 12/035,698; 13/649,287; 13/967,168; 13/967,179;
`
`13/967,189; 13/967,163; 11/897,177 were received and accepted on 12/20/2013.
`
`Therefore, potential ODP rejections for these applications are rendered moot.
`
`10
`
`
`
`Application/Control Number: 13/961,828
`Art Unit: 1676
`
`Claims 37-48 and 62-85 are allowed.
`
`Conclusion
`
`The prior art made of record and not relied upon is considered pertinent to
`
`applicant's disclosure.
`
`REASONS FOR ALLOWANCE
`
`9.
`
`The following is an examiner’s statement of reasons for allowance: The closest
`
`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
`
`11
`
`
`
`Application/Control Number: 13/961,828
`
`Page 7
`
`Art Unit: 1676
`
`number for the organization where this application or proceeding is assigned is 571 —
`
`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
`
`12
`
`12
`
`
`
`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
`
`
`
`Docket No. 17618CON6 (AP)
`
`43. (Previously Presented) The topical ophthalmic emulsion of Claim 37, wherein the topical
`
`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.