UN111:1) S'l‘A'I‘l;S PA’l‘l;N 1‘ AND TRADEMARK OI~H(.‘h
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`UNI'l‘El._) STATES DEPAR’I'.\-IILVT OF COMMERCE
`Unlto.-d States Patent and Trudetnurk Olflee
`Addrcss, ('(JMMlSSl()Nl{R FOR I’A'l'liNl'S
`PO Box I450
`Alexandria. Vixyilnia Z2313-I450
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`n wunttspto gt
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`NOTICE OF ALLOWANCE AND FEE(S) DUE
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`513
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`04/21/2014
`75w
`WENDEROTH, LIND & PONACK. I..I..P.
`I030 l5tl1 Street, N.W.,
`Suite 400 East
`Washington, DC 20005-1503
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`EXAMINER
`SOROU$H.LAYLA
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`1637
`DATE MAILEI): 0-I/2|/20]-I
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` "“‘“' -"*‘““” “‘’““'‘°‘‘
`‘“'‘'°‘*‘” ”"“‘“"‘ -“°-
`14/105.970
`OI/Z8/2014
`Shiruu sAw,-\
`2014-0075
`4523
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`'l'I'I'l.H OF lNVl~'.N'I'lON: AQI IHOI IS |.|Ql'lI) PREP/\RA'l'l()N (‘ON’l'Al.\'lN(i 2-/\MIN()»3»(~l-I<IR()VI()P.l£NlOYl .)l’HE.\'Y| .A(Tl:"|'I(‘ /\(‘I|)
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`:\PPL.\'. TYPE
`ENTITY STATUS
`ISSUE HEE DUE
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`I N DISCOI INTED
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`TIIE APPLICATION IDENTIFIED ABOVE IIAS BEEN EXAMINED AND IS ALLOWED FOR ISSUANCE AS A PATENT.
`PROSECUTION ON THE MERITS IS CLOSED. THIS NOTICE OF ALLOWANCE IS NOT A GRANT OF PATENT RIGHTS.
`THIS APPLICATION IS SUB.IECT TO WITHDRAWAL FROM ISSUE AT THE INITIATIVE OF THE OFFICE OR UPON
`PETITION BY THE APPLICANT. SEE 37 CFR 1.313 AND MPEP 1308.
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`TIIE ISSUE FEE AND PUBLICATION FEE (IF REQUIRED) MUST BE PAID WITIIIN TIIREE MONTIIS FROM TIIE
`MAILING DATE OF THIS NOTICE OR THIS APPLICATION SHALL BE REGARDED AS ABANDONED.
`Ifllfi
`,§'|‘A'|‘g1[|gg[gy [[3 [gm]; QANNQH fit‘ bx | hM)|:,‘|).
`SEE 35 U.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 IIAS
`PREVIOUSLY BEEN PAID IN THIS APPLICATION (AS SHOWN ABOVE), TIIE RETURN OF PART B OF THIS FORM
`WILL BE CONSIDERED A REQUEST TO REAPPLY TIIE PREVIOUSLY PAID ISSUE FEE TOWARD TIIE ISSUE FEE NOW
`DUE.
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`HOW’ TO REPLY T0 THIS NOTICE:
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`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 EN'l‘I'l‘Y S'l‘A'l'US is the same as shown above, pay the 'l‘O'l'AL FEE(S) DUE shown above.
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`II" the EN'l‘l'l‘Y S'l'A'l'US is ehzmged from that shown above. on PART B - FEE(S) 'l'RANSMI'l'I‘AL, complete section number 5 tilled
`"Change i11 Emily Status (from slams indicated above)".
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`For purposes of this notice, small e11tity fees are 1/2 tl1e a1nou11t of undiscounted fees, and micro entity fees are 1/2 the amou11t of small e11IiIy
`fees.
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`ll. PART B - FEE(S) TRANSMITTAL, or its equivalent, must be completed and retur11ed to the United States Patent and Trademark Office
`(USPTO) with your ISSUE
`and PUBLICATION
`(if required). If you are charging the fee(s) to your deposit account. section "4b"
`of Part B - Feets) Transmittal should be eo1npletcd and an extra copy of the fomi should be submitted. If an equivalent of Part B is filed. a
`request to reapply a previously paid issue fee 1nust be clearly made, and delays i11 processing may occur due to the difficulty in recognizing
`the paper as a11 equivale11t of Part B.
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`Ill. All communications regarding this application must give the application number. Please direct all cotntnunications prior to issuance to
`Mail Stop ISSUE FEE unless advised to the contrary.
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`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.
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`I"I‘OL-85 (Rev. 02/1 11
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`PAGE 1 OF 10
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`Page I of 3
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`SENJU EXHIBIT 2257
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`LUPIN v SENJU
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`IPR2015—01l05
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`PART B - FEE(S) TRANSMITTAL
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`Complete and send this form, together with applicable fee(s), to: Mail Mail Stop ISSUE FEE
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`Commissioner for Patents
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`Alexandria, Virginia 22313-1450
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`or @ (571)-273-2885
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`through 5 should be completed where
`INSTRUCTIONS: This form should be used for transmitting the ISSUE FEE and PUBLICATION FEE (if required). Blocks 1
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`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
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`Fee(s) Transmittal. This certi icate cannot be used for any other accompanying
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`Certificate of Mailing or Transmission
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`States Postal Service with sufficient postage for first class mail in an envelope
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`addressed to the Mail Stop ISSUE FEE address above, or being facsimile
`transmitted to the USPTO (571) 273-2885, on the date indicated below.
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`CURRENT CORRESPONDENCE ADDRESS (Note: Use Block 1101 any 0116113: 01 adtllcbst
`513
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`7590
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`WENDEROTH, LIND &
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`logo 15th Street N W
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`Suite 400 East
`wasimlgm, Dc 200050503
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`14/165.976
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`01/28/2014
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`Shirou SAWA
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`TITLE OF INVENTION: AQUEOUS LIQUID PREPARATION CONTAINING 2—AMlNO—3—(4—BROMOBENZOYL)PHENYLACETIC ACID
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`2014—0075
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`PUBLICATION FEE DUE
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`CLASS-SUB CLASS
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`DATE DUE
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`ENTITY STATUS
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`UNDISCOUNTED
`nonprovisional
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`EXAMINER
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`ISSUE FEE DUE
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`$960
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`SOROUS H, LAYLA
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`1. Change of correspondence address or indication of "Fee Address" (37
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`3 Change of correspondence address (or Change of Correspondence
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`Addrcss ("rm PTO/SB/122) attached‘
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`3 "Fee Address" indication (or "Fee Address" Indication form
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`>TO/SB/47; Rev 03-02 or more i-ecem) attached. Use of a Customer
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`Number is required,
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`ART UNIT
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`1627
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`514—619000
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`2. For printing on the patent front page, list
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`(1) The names of up to 3 registered patent attorneys
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`registered 31101116)’ 01' 339111) 31111 1111‘ 11311155 (‘£1113 1_0
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`Zrcgistcred patent attorneys or agents. If no name is
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`listed, no name will be printed.
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`3. ASSIGNE3 NAME AND RESIDENCE DATA TO BE PRINTED ON THE PATENT (print or type)
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`If an assignee is identified below. the document has been filed for
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`recordation as set forth in 37 CFR 3.11. Completion of this form is NOT a substitute for filing an assignment.
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`(A) NAME OF ASSIGNEE
`(B) RESIDENCE: (CITY and STATE OR COUNTRY)
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`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
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`4b. Payment of Fee(s): (Please first reapply any previously paid issue fee shown above)
`4a. The following fee(s) are submitted:
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`3 A check is enclosed.
`3 Issue Fee
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`3 Payment by credit card. Form PTO—2038 is attached.
`3 Publication Fee (No small entity discount permitted)
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`3 The Director is hereby authorized to charge the required fee(s), any deficiency, or credits any
`3 Advance Order — # of Copies
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`overpayment, lo Deposit Account Number
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`5. Change in Entity Status (from status indicated above)
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`3 Applicant certifying micro entity status. See 37 CFR 1.29
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`3 Applicant asserting small entity status. See 37 CFR 1.27
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`3 Applicant changing to regular undiscounted fee status.
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`NOTE: Absent a valid certification of Micro Entity Status (see forms PTO/SB/15A and 15B), issue
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`fee payment in the micro entity amount will not be accepted at the risk of application abandonment.
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`NOTE: If the application was previously under micro entity status, checking this box will be taken
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`to be a notification of loss of entitlement to micro entity status.
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`NOTE: Checking this box will be taken to be a notification of loss of entitlement to small or micro
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`entity status, as applicable.
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`NOTE: This form must be signed in accordance with 37 CFR 131 and 1.33. See 37 CFR 1.4 for signature reguirements and certifications.
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`Authorized Signature
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`l'TOL—85 Part B (10-13) Approved for use through 10/31/2013.
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`Page 2 of 3
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`OMB 0651-0033
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`US. Patent and Trademark Office; US. DEPARTMENT OF C0.\/JMERCE
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`OMB Clearance and PRA Burden Statement for PTOL—85 Part B
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`The Paperwork Reduction Act (PRA) of 1995 requires Federal agencies to obtain Office of Management and
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`agency to inform the public about the OMB Control Number’s legal significance i11 accordance with 5 CFR
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`l320.5(b).
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`The information collected by PTOL—85 Part B is required by 37 CFR 1.311. The information is required to obtain
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`and/or suggestions for reducing this burden, should be sent to the Chief lnformation Officer, U.S. Patent and
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`Trademark Office, U.S. Department of Commerce, P.O. Box 1450, Alexandria, Virginia 22313-1450. DO NOT
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`SEND FEES OR COMPLETED FORMS TO THIS ADDRESS. SEND TO: Commissioner for Patents, P.O. Box
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`1450, Alexandria, Virginia 22313-1450. Under the Paperwork Reduction Act of 1995, no persons are required to
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`Privacy Act Statement
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`The Privacy Act of 1974 (P.L. 93-579) requires that you be given certain information in connection with your
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`submission of the attached form related to a patent application or patent. Accordingly, pursuant
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`requirements of the Act, please be advised that: (1) the general authority for the collection of this information is
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`35 U .S.C. 2(b)(2); (2) furnishing of the information solicited is voluntary; and (3) the principal purpose for which
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`proceedings or abandonment of the application or expiration of the patent.
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`The information provided by you in this form will be subject to the following routine uses:
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`1. The information on this form will be treated confidentially to the extent allowed under the Freedom of
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`lnfor1natio11 Act (5 U.S.C. 552) and the Privacy Act (5 U.S.C 552a). Records from this system of records
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`settlement negotiations.
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`request involving an individual, to whom the record pertains, when the individual has requested assistance
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`from the Member with respect to the subject matter of the record.
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`need for the information in order to perform a contract. Recipients of information shall be required to
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`comply with the requirements of the Privacy Act of 1974, as amended, pursuant to 5 U.S.C. 552a(m).
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`. A record related to a11 lnternational Application filed under the Pate11t Cooperation Treaty i11 this system of
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`records may be disclosed, as a routine use, to the International Bureau of the World I11tellectual Property
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`Organization, pursuant to the Patent Cooperation Treaty.
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`. A record in this system of records may be disclosed, as a routine use, to another federal agency for purposes
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`of National Security review (35 U.S.C. 181) and for review pursuant to the Atomic Energy Act (42 U.S.C.
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`218(c)).
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`Services, or his/her designee, during an inspection of records conducted by GSA as part of that agency's
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`responsibility to recommend improvements in records management practices and programs, u11der authority
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`of 44 U.S.C. 2904 and 2906. Such disclosure shall be made in accordance with the GSA regulations
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`governing inspection of records for this purpose, and any other relevant (i.e., GSA or Commerce) directive.
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`Such disclosure shall not be used to make determinations about individuals.
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`. A record from this system of records may be disclosed, as a routine use, to the public after either publication
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`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
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`record may be disclosed, subject to the limitations of 37 CPR 1.14, as a routine use, to the public if the
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`record was filed in an application which became abandoned or in which the proceedings were terminated
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`and which application is referenced by either a published application, an application open to public
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`inspection or a11 issued patent.
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`. A record from this system of records may be disclosed, as a routine use, to a Federal, State, or local law
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`enforcement agency, if the USPTO becomes aware of a violation or potential violation of law or regulation.
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`PAGE 4 OF 10
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`Notice of Allowabrlrty
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`Application No.
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`14/165,976
`Examiner
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`LAYLA SOROUSH
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`App|icant(s)
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`SAWA ET AL.
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`-- The MAILING DA TE of this communication appears on the cover sheet with the correspondence address--
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`All claims being allowable, PROSECUTION ON THE MERITS IS (OR REMAINS) CLOSED in this application.
`If not included
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`herewith (or previously mailed). a Notice of Allowance (PTOL—85) or other appropriate communication will be mailed in due course. THIS
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`NOTICE OF ALLOWABILITY IS NOT A GRANT OF PATENT RIGHTS. This application is subject to withdrawal from issue at the initiative
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`of the Office or upon petition by the applicant. See 37 CFR 1.313 and MPEP 1308.
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`1. IX This communication is responsive to the arguments filed on 3/20/14.
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`2. E] An election was made by the applicant in response to a restriction requirement set forth during the interview on
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`requirement and election have been incorporated into this action.
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`3. IX The allowed c|aim(s) is/are 19-48.
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`4. IX Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
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`b) I:I Some*
`c) E] None
`of the:
`a) E All
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`1. El Certified copies of the priority documents have been received.
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`2. IXI Certified copies of the priority documents have been received in Application No. 10/525 006.
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`3. El Copies of the certified copies of the priority documents have been received in this national stage application from the
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`International Bureau (PCT Rule 17.2(a)).
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`* Certified copies not received:
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`Applicant has THREE MONTHS FROM THE “MAILING DATE” of this communication to file a reply complying with the requirements
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`noted below. Failure to timely comply will result in ABANDONMENT of this application.
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`THIS THREE-MONTH PERIOD IS NOT EXTENDABLE.
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`5. E] A SUBSTITUTE OATH OR DECLARATION must be submitted. Note the attached EXAMINER’S AMENDMENT or NOTICE OF
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`INFORMAL PATENT APPLICATION (PTO—152) which gives reason(s) why the oath or declaration is deficient.
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`; the restriction
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`6. El CORRECTED DRAWINGS (as “replacement sheets”) must be submitted.
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`(a) El including changes required by the Notice of Draftsperson’s Patent Drawing Review ( PTO-948) attached
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`1) D hereto or 2) I] to Paper No./Mail Date
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`(b) E] including changes required by the attached Examiner’s Amendment / Comment or in the Office action of
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`Paper No./Mail Date
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`Identifying indicia such as the application number (see 37 CFR 1.84(c)) should be written on the drawings in the from (not the back) at
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`each sheet. Replacement sheet(s) should be labeled as such in the header according to 37 CFR 1.121(d).
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`7. |:I DEPOSIT OF and/or INFORMATION about the deposit of BIOLOGICAL MATERIAL must be submitted. Note the
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`attached Examiner’s comment regarding REQUIREMENT FOR THE DEPOSIT OF BIOLOGICAL MATERIAL.
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`Attachment(s)
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`1. El Notice of References Cited (PTO—892)
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`2. El Notice of Draftperson‘s Patent Drawing Review (PTO-948)
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`3. El Information Disclosure Statements (PTO/SB/O8),
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`Paper No./Mail Date
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`4. El Examiner’s Comment Regarding Requirement for Deposit
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`of Biological Material
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`5. El Notice of Informal Patent Application
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`6. El Interview Summary (PTO-413),
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`Paper No./Mail Date
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`Examiner’s Amendment/Comment
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`7.
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`Examiner’s Statement of Reasons for Allowance
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`8.
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`9. El Other
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`/LAYLA SOROUSH/
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`Primary Examiner, Art Unit 1627
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`US. Patent and Trademark Olfice
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`PTOL-37 (Rev. 03-11)
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`Notice 01 Allowability
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`Part of Paper No./Mail Date 20140409
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`PAGE 5 OF 10
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`Application/Control Number: 14/165,976
`Art Unit: 1627
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`Page 2
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`The present application is being examined under the pre-AIA first to invent
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`provisions.
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`Acknowledgement of Receipt
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`Applicant's response filed on 3/20/2014 to the Office Action mailed on
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`03/13/2014 is acknowledged.
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`Claim Status
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`Claims 19-48 are pending.
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`Claims 19-48 are allowed.
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`Withdrawn Rejections
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`The Double Patenting rejections over U.S. Patent No. 8129431, 8497304, and
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`8669290 is withdrawn in view of the TD’s filed on 3/20/2014.
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`Reasons for Allowance
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`The following is an examiner’s statement of reasons for allowance:
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`The composition as claimed are found to be patentable over the prior art
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`because the prior art does not teach or fairly suggest a stable aqueous liquid
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`preparation comprising: (a) a first component; and (b) a second component; wherein the
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`first component is 2—amino-3-(4-bromobenzoyl)phenylacetic acid or a pharmacologically
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`acceptable salt thereof or a hydrate thereof; wherein the hydrate is at least one selected
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`from a 1/2 hydrate, 1 hydrate, and 3/2 hydrate; the first component is the sole
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`pharmaceutical active ingredient contained in the preparation and is present in the
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`PAGE 6 OF 10
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`Application/Control Number: 14/165,976
`Art Unit: 1627
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`Page 3
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`preparation at a concentration from about 0.05 w/v °/o to about 0.2 w/v %; the second
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`component is tyloxapol and is present in said liquid preparation in an amount sufficient
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`to stabilize said first component; and wherein said stable liquid preparation is formulated
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`for ophthalmic administration.
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`The closest prior arts of record, namely Chen et al. (US 6383471), teach a
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`pharmaceutical composition including a hydrophobic therapeutic agent having at least
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`one ionizable functional group, and a carrier. The carrier includes an ionizing agent
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`capable of ionizing the functional group, a surfactant, and optionally solubilizers,
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`triglycerides, and neutralizing agents (abstract). The reference teaches a hydrophobic
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`therapeutic agent to include bromfenac (2—amino—3—(4—bromobenzoy|)phenalyacetic
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`acid)(see claim 4). The hydrophobic therapeutic agent is used in less than about 1% by
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`weight, and typically less than about 0.1% or 0.01% by weight (see col 4 lines 58-60)
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`(renders obvious the limitation of claims 8 and 24). The reference further teaches
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`surfactants inclusive of polyethylene glycol fatty acid esters and additionally teaches
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`polyethylene glycol fatty acid monoesters such as peg—1 5 stearate, etc (see claims 21-
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`22 24 and 27). The surfactants are selected from the group consisting of alcohols;
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`polyoxyethylene alkylethers; fatty acids; glycerol fatty acid esters; acetylated glycerol
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`fatty acid esters; lower alcohol fatty acids esters; polyethylene glycol fatty acids esters;
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`polyethylene glycol glycerol fatty acid esters; polypropylene glycol fatty acid esters;
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`polyoxyethylene glycerides; lactic acid derivatives of mono/diglycerides; propylene
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`glycol diglycerides; sorbitan fatty acid esters; polyoxyethylene sorbitan fatty acid esters;
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`polyoxyethylene-polyoxypropylene block copolymers; transesterified vegetable oils;
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`PAGE 7 OF 10
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`Application/Control Number: 14/165,976
`Art Unit: 1627
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`Page 4
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`sterols; sterol derivatives; sugar esters; sugar ethers; sucroglycerides; polyoxyethylene
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`vegetable oils; and polyoxyethylene hydrogenated vegetable oils. The pharmaceutical
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`compositions of the present invention can be provided in the form of a solution
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`preconcentrate; i.e., a composition as described above, and intended to be dispersed
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`with water, either prior to administration, in the form of a drink, or dispersed in vivo (col
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`34 lines 63-68) (reads on an aqueous liquid preparation). The reference also teaches
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`preservatives (see claim 64). Although formulations specifically suited to oral
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`administration are presently preferred, the compositions of the present invention can
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`also be formulated for topical, transdermal, ocular, pulmonary, vaginal, rectal,
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`transmucosal or parenteral administration (col 35 lines 9-20). Chen et al. further
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`teaches components that can be incorporated into the composition include inorganic
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`acids inclusive of boric acid (col 46, line 6), solubilizer such as polyvinylpyrrolidone
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`(claim 49), exemplifications of carriers comprising Edetate Disodium (col 4 table 20
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`formulations 65 and 66), and ionizing agents that deprotonate the acidic functional
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`groups of the therapeutic agent are pharmaceutically acceptable organic or inorganic
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`bases, inclusive of sodium hydroxide (col 11 lines 12-13) (reads on the limitations of
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`claim 22).
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`However, Applicant presents excellent effects are clearly demonstrated by
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`Experiments 1 to 3 of the present specification. Experiment 1 —— Stability of sodium 2-
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`amino-3—(4—bromobenzoyl)phenyl acetate was evaluated. Namely, two eye drops of
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`sodium 2—amino—3—(4—bromobenzoyl) phenylacetate comprising the components as
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`shown in Table 1 were prepared, filled respectively into a polypropylene container and
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`PAGE 8 OF 10
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`Application/Control Number: 14/165,976
`Art Unit: 1627
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`subjected to a stability test at 60 °C for 4 weeks. As is apparent from Table 1, the
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`stability test was carried out under the conditions of pH 7.0 at 60°C for 4 weeks. Table 1
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`clearly shows that sodium 2-amino-3- (4-bromobenzoyl)phenylacetate in polyoxyl 40
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`stearate—containing preparation was more stable than that in polysorbate 80- containing
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`preparation. As is apparent from Table 2, the remaining rate of sodium 2-amino-3-(4-
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`bromobenzoyl)pheny|acetate in the compositions A—07 and A—08 containing 0.02 w/v °/3
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`and 0.05 w/v % of polyoxyl 40 stearate is not less than 90 % after storage at 60°C for 4
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`weeks. Table 2 clearly shows that the compositions containing 0.02 w/v % and 0.05 w/v
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`°/o of polyoxyl 40 stearate have sufficient stability for eye drops. The arguments are
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`persuasive.
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`The composition as claimed are found to be patentable over the prior art
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`because the prior art does not teach or fairly suggest a stable aqueous liquid
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`preparation comprising: (a) a first component; and (b) a second component; wherein the
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`first component is 2-amino-3-(4-bromobenzoyl)phenylacetic acid or a pharmacologically
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`acceptable salt thereof or a hydrate thereof; wherein the hydrate is at least one selected
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`from a 1/2 hydrate, 1 hydrate, and 3/2 hydrate; the first component is the sole
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`pharmaceutical active ingredient contained in the preparation and is present in the
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`preparation at a concentration from about 0.05 w/v % to about 0.2 w/v %; the second
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`component is tyloxapol and is present in said liquid preparation in an amount sufficient
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`to stabilize said first component; and wherein said stable liquid preparation is formulated
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`for ophthalmic administration.
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`PAGE 9 OF 10
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`Application/Control Number: 14/165,976
`Art Unit: 1627
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`Page 6
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`Any comments considered necessary by applicant must be submitted no later
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`than the payment of the issue fee and, to avoid processing delays, should preferably
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`accompany the issue fee. Such submissions should be clearly labeled “Comments on
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`Statement of Reasons for Allowance.”
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`Any inquiry concerning this communication or earlier communications from the
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`examiner should be directed to LAYLA SOROUSH whose telephone number is
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`(571)272-5008. The examiner can normally be reached on 8:30a.m.-5:O0p.m..
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`If attempts to reach the examiner by telephone are unsuccessful, the examiner’s
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`supervisor, Sreenivasan Padmanabhan can be reached on (571)272-0629. The fax
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`phone number for the organization where this application or proceeding is assigned is
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`571-273-8300.
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`Information regarding the status of an application may be obtained from the
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`Patent Application Information Retrieval (PAIR) system. Status information for
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`published applications may be obtained from either Private PAIR or Public PAIR.
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`Status information for unpublished applications is available through Private PAIR only.
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`For more information about the PAIR system, see http://pair-direct.uspto.gov. Should
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`you have questions on access to the Private PAIR system, contact the Electronic
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`Business Center (EBC) at 866-217-9197 (toII—free).
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`If you would like assistance from a
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