UNl'l‘l;‘D S'l‘A'l‘l;‘S PA’l‘l:'N'l‘ AND TRADEMARK OI-'l<‘l(.‘l;‘
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`UNITED STATF.S DEPARTMENT OF (‘.0MM'ER(‘E
`United Slzles Patent and Trademark Olfce
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`Alcumlna, V
`www nspm go
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`FOR PATENTS
`nin _‘2\l ‘~- I-F4)
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`APPl.l("r\TI(')N NO.
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`Fl'l JNG T)I\TE
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`FIRST N.’\Ml7D l‘.\'VF.NTOR
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`/\'i'l'0R.\l'F.Y DOCKET NO.
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`(‘0NFlRM.I\TlO\' NO.
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`14/105.970
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`01/28/2014
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`Shirou s.~\w.~\
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`2014-0075
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`4523
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`513
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`Wl:‘NDl:‘R0’1‘H LlND&PON/’\(.‘K)L.L.P.
`I030 15th Street, N.W.,
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`Suite 400 Pam
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`N( )'I'IFI( ‘A'l'I().V l)A'l‘l€
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`I)liI.lVl£RY M()I)l~L
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`ELECTRON IC
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`Please find below and/or attached an Office communication concerning this application or proceeding.
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`The time period for reply, if any. is set in the attached communication.
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`Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
`following e—mail address(es):
`ddalecki @ wenderolli .com
`eoa@ wendemthcom
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`l’l'0L-90A (Rev. 04/07)
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`Page 1 of 8
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`SENJU EXI-I[BIT 2255
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`LUPW V. SENJU
`IPR20l5—0l 100
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`Office Action Summary
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`Application No.
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`14/165,976
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`App|icant(s)
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`SAWA ET AL.
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`Art unit
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`AIA (First lnventorto File)
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`1627
`LAYLA SOROUSH
`§‘3*”3
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`-- The MAILING DA TE of this communication appears on the cover sheet with the correspondence address --
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`Period for Reply
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`THIS COMMUNICATION.
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`In no event, however may a reply be timely filed
`Extensions of time may be available under the provisions of 37 CFR 1.136(a)
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`after SIX (6) MONTHS from the mailing date of this communication.
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`If NO period for reply is specified above, the maximum statutory period will apply and will expire SIX (6) MONTHS from the mailing date of this communication.
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`Failure to reply within the set or extended period for reply will. by statute. cause the application to become ABANDONED (35 U.S.C. § 133).
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`Any reply received bythe Office later than three months after the mailing date of this communication, even if timely filed, may reduce any
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`earned patent term adjustment. See 37 CFR 1.704(b).
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`Status
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`1)|XI Responsive to communication(s) filed on 1/28/14.
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`I] A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/were filed on
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`2a)|:l This action is FINAL.
`2b) This action is non-final.
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`3)I:I An election was made by the applicant in response to a restriction requirement set forth during the interview on
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`_; the restriction requirement and election have been incorporated into this action.
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`4)|:| Since this application is in condition for allowance except for formal matters, prosecution as to the merits is
`closed in accordance with the practice under Ex parte Quayle, 1935 C.D. 11, 453 O.G. 213.
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`Disposition of Claims*
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`5)XI Claim(s) O3 is/are pending in the application.
`5a) Of the above claim(s) _ is/are withdrawn from consideration.
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`_ is/are allowed.
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`s) 1.<9;z1¢‘3is/are rejected.
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`) _ is/are objected to.
`) j are subject to restriction and/or election requirement.
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`* If any claims have been determined allowable, you may be eligible to benefit from the Patent Prosecution Highway program at a
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`participating intellectual property office for the corresponding application. For more information, please see
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`://www.usoto.ciov/ atents/init events/. E‘:/'inde><.'s , or send an inquiry to PPl--lfee<ibacK@usjgtooov.
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`Application Papers
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`10)I:I The specification is objected to by the Examiner.
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`11)|:| The drawing(s) filed on j is/are: a)I:l accepted or b)I:I objected to by the Examiner.
`Applicant may not request that any objection to the drawing(s) be held in abeyance. See 37 CFR 1.85( ).
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`Replacement drawing sheet(s) including the correction is required if the drawing(s) is objected to. See 37 CFR 1.121 (d).
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`Priority under 35 U.S.C. § 119
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`12)lZ| Acknowledgment is made of a claim for foreign priority under 35 U.S.C.§119(a)—(d) or ( ).
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`Certified copies:
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`a)lXl All
`b)I:| Some” c)I:I None of the:
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`1.|:I Certified copies of the priority documents have been received.
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`2.XI Certified copies of the priority documents have been received in Application No. 10/525,006.
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`3.l:l Copies of the certified copies of the priority documents have been received in this National Stage
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`application from the International Bureau (PCT Rule 17.2( )).
`** See the attached detailed Office action for a list of the certified copies not received.
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`Attachment(s)
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`1) D Notice of References Cited (PTO-892)
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`2) IX Information Disclosure Statement(s) (PTO/SB/08a and/or PTO/SB/08b)
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`Paper No(s)/Mail Date 1/28/14.
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`U 8 Patent and Trademark Office
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`PTOL-326 (Rev. 11-18)
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`Office Action Summary
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`3) El jmervjew summary (PTQ.413)
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`Paper No(s)/Mail Date.
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`Part of Paper No./Mail Date 20140307
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`Page 2 of 8
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`Application/Control Number: 14/165,976
`Art Unit: 1627
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`DETAILED ACTION
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`The following is in response to the Preliminary amendments filed on 1/28/2014.
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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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`Double Patenting
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`The nonstatutory double patenting rejection is based on a judicially created
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`doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the
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`unjustified or improper time wise extension of the “right to exclude" granted by a patent
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`and to prevent possible harassment by multiple assignees. A nonstatutory double
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`patenting rejection is appropriate where the claims at issue are not identical, but at least
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`one examined application claim is not patentably distinct from the reference claim(s)
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`because the examined application claim is either anticipated by, or would have been
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`obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d
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`1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir.
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`1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum,
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`686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619
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`(CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
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`A timely filed terminal disclaimer in compliance with 37 CFR 1.321 (c) or 1.321 (cl)
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`may be used to overcome an actual or provisional rejection based on a nonstatutory
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`double patenting ground provided the reference application or patent either is shown to
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`be commonly owned with this application, or claims an invention made as a result of
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`Page 3 of 8
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`Application/Control Number: 14/165,976
`Art Unit: 1627
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`activities undertaken within the scope of a joint research agreement. A terminal
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`disclaimer must be signed in compliance with 37 CFR 1.321 (b).
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`The USPTO internet Web site contains terminal disclaimer forms which may be
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`used. Please visit http://www.uspto.gov/forms/. The filing date of the application will
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`determine what form should be used. A web-based eTerminal Disclaimer may be filled
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`out completely online using web—screens. An eTermina| Disclaimer that meets all
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`requirements is auto—processed and approved immediately upon submission. For more
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`information about eTerminal Disclaimers, refer to
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`Claims 19-48 are rejected on the ground of nonstatutory double patenting as
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`being unpatentable over claims 1-22 of U.S. Patent No. 8129431. Although the claims
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`at issue are not identical, they are not patentably distinct from each other because the
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`claims in the patent are drawn to an aqueous liquid preparation consisting essentially of
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`the following two components, wherein the first component is 2—amino—3—(4—
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`bromobenzoyl)phenylaceticacid or a pharmacologically acceptable salt thereof or a
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`hydrate thereof, wherein the hydrate is at least one selected from a 1/2 hydrate, 1
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`hydrate, and 3/2 hydrate and the second component is tyloxapol wherein said liquid
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`preparation is formulated for ophthalmic administration, and wherein when a quaternary
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`ammonium compound is included in said liquid preparation, the quaternary ammonium
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`compound is benzalkonium chloride whereas the claims herein are drawn to a stable
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`aqueous liquid preparation comprising: (a) a first component; and (b) a second
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`Application/Control Number: 14/165,976
`Art Unit: 1627
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`Page 4
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`component; wherein the first component is 2-amino-3-(4-bromobenzoyl)phenylacetic
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`acid or a pharmacologically acceptable salt thereof or a hydrate thereof; wherein the
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`hydrate is at least one selected from a 1/2 hydrate, 1 hydrate, and 3/2 hydrate; the first
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`component is the sole pharmaceutical active ingredient contained in the preparation and
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`is present in the preparation at a concentration from about 0.05 w/v % to about 0.2 w/v
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`°/o; the second component is tyloxapol and is present in said liquid preparation in an
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`amount sufficient to stabilize said first component; and wherein said stable liquid
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`preparation is formulated for ophthalmic administration.
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`Claims 19-48 are rejected on the ground of nonstatutory double patenting as
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`being unpatentable over claims 1-17 of U.S. Patent No. 8497304. Although the claims
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`at issue are not identical, they are not patentably distinct from each other because the
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`claims in the copending application are drawn to an aqueous liquid preparation
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`comprising 2-amino-3—(4— bromobenzoyl)phenylacetic acid sodium salt thereof or a
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`hydrate thereof, and polyoxyl 40 stearate, wherein the concentration of the polyoxyl 40
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`stearate is selected from a range of a minimum concentration of 0.02 w/v % to a
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`maximum concentration of O.
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`1 w/v% whereas the claims herein are drawn to a stable
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`aqueous liquid preparation comprising: (a) a first component; and (b) a second
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`component; wherein the first component is 2-amino-3-(4—bromobenzoyl)phenylacetic
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`acid or a pharmacologically acceptable salt thereof or a hydrate thereof; wherein the
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`hydrate is at least one selected from a 1/2 hydrate, 1 hydrate, and 3/2 hydrate; the first
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`component is the sole pharmaceutical active ingredient contained in the preparation and
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`is present in the preparation at a concentration from about 0.05 w/v °/o to about 0.2 w/v
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`Application/Control Number: 14/165,976
`Art Unit: 1627
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`°/o; the second component is tyloxapol and is present in said liquid preparation in an
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`amount sufficient to stabilize said first component; and wherein said stable liquid
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`preparation is formulated for ophthalmic administration.
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`Claims 19-48 are rejected on the ground of nonstatutory double patenting as
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`being unpatentable over claims 1-30 of U.S. Patent No. 8669290. Although the claims
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`at issue are not identical, they are not patentably distinct from each other because the
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`claims in the copending application are drawn to a stable aqueous liquid preparation
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`comprising: (a) a first component; and (b) a second component; wherein the first
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`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; the second component is
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`tyloxapol and is present in said liquid preparation in an amount sufficient to stabilize
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`said first component; and wherein said stable liquid preparation is formulated for
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`ophthalmic administration whereas the claims herein are drawn to a stable aqueous
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`liquid preparation comprising: (a) a first component; and (b) a second component;
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`wherein the first component is 2—amino—3—(4—bromobenzoyl)phenylacetic acid or a
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`pharmacologically acceptable salt thereof or a hydrate thereof; wherein the hydrate is at
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`least one selected from a 1/2 hydrate, 1 hydrate, and 3/2 hydrate; the first component is
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`the sole pharmaceutical active ingredient contained in the preparation and is present in
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`the preparation at a concentration from about 0.05 w/v °/o to about 0.2 w/v °/o; the
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`second component is tyloxapol and is present in said liquid preparation in an amount
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`Page 6 of 8
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`Application/Control Number: 14/165,976
`Art Unit: 1627
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`Page 6
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`sufficient to stabilize said first component; and wherein said stable liquid preparation is
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`formulated for ophthalmic administration.
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`No claims allowed.
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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 (571 )272—
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`5008. The examiner can normally be reached on Monday through Friday from 8:30
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`a.m. to 5:00 p.m.
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`If attempts to reach the examiner by telephone are unsuccessful, the examiners
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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 (toll-free).
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`/Layla Soroushl
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`Examiner, Art Unit 1627
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`Page 7 of 8
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`Application/Control Number: 14/165,976
`Art Unit: 1627
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`Page 8 of 8