`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`www.uspto.gov
`
`APPLICATION NO.
`
`FILING DATE
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
`
`141165,976
`
`01128/2014
`
`ShirouSAWA
`
`2014-0075
`
`4523
`
`03/13/2014
`7590
`513
`WENDEROTH, LIND & PONACK, L.L.P.
`1030 15th Street, N.W.,
`Suite 400 East
`Washington, DC 20005-1503
`
`EXAMINER
`
`SOROUSH, LAYLA
`
`ART UNIT
`
`PAPER NUMBER
`
`1627
`
`NOTIFICATION DATE
`
`DELIVERY MODE
`
`03/13/2014
`
`ELECTRONIC
`
`Please find below and/or attached an Office communication concerning this application or proceeding.
`
`The time period for reply, if any, is set in the attached communication.
`
`Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
`following e-mail address(es):
`ddalecki @wenderoth.com
`eoa@wenderoth.com
`
`PTOL-90A (Rev. 04/07)
`
`Page 1 of 8
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`SENJU EXHIBIT 2255
`LUPIN v. SENJU
`IPR2015-01097
`
`
`
`Application No.
`14/165,976
`
`Applicant(s)
`SAWA ET AL.
`
`Examiner
`LAYLA SOROUSH
`
`Art Unit
`1627
`
`Office Action Summary
`
`AlA (First Inventor to File)
`Status
`No
`-- The MAILING DATE of this communication appears on the cover sheet with the correspondence address -(cid:173)
`Period for Reply
`A SHORTENED STATUTORY PERIOD FOR REPLY IS SET TO EXPIRE .J. MONTHS FROM THE MAILING DATE OF
`THIS COMMUNICATION.
`Extensions of time may be available under the provisions of 37 CFR t. t 36(a). In no event, however, may a reply be timely filed
`after SIX (6) MONTHS from the mailing date of this communication.
`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.
`Failure to reply within the set or extended period for reply will, by statute, cause the application to become ABANDONED (35 U.S.C. § t33).
`Any reply received by the Office later than three months after the mailing date of this communication, even if timely filed, may reduce any
`earned patent term adjustment. See 37 CFR t .704(b).
`
`Status
`1 )~ Responsive to communication(s) filed on 1/28/14.
`0 A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/were filed on __ .
`2a)0 This action is FINAL.
`2b)~ This action is non-final.
`3)0 An election was made by the applicant in response to a restriction requirement set forth during the interview on
`__ ; the restriction requirement and election have been incorporated into this action.
`4)0 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.
`
`Disposition of Claims*
`5)~ Claim(s) 19-48 is/are pending in the application.
`5a) Of the above claim(s) __ is/are withdrawn from consideration.
`6)0 Claim(s) __ is/are allowed.
`7)~ Claim(s) 19-48 is/are rejected.
`8)0 Claim(s) __ is/are objected to.
`9)0 Claim(s) __ are subject to restriction and/or election requirement.
`* If any claims have been determined allowable, 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
`http://vvww.uspto.gov/patents/init events/pph/index.jsp or send an inquiry to P~'Hfeedback(wuspto.oov.
`
`Application Papers
`1 0)0 The specification is objected to by the Examiner.
`11 )0 The drawing(s) filed on __ is/are: a)O accepted or b)O 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(a).
`Replacement drawing sheet(s) including the correction is required if the drawing(s) is objected to. See 37 CFR 1.121 (d).
`
`Priority under 35 U.S.C. § 119
`12)~ Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
`Certified copies:
`a)~ All b)O Some** c)O None of the:
`Certified copies of the priority documents have been received.
`1.0
`Certified copies of the priority documents have been received in Application No. 10/525.006.
`2.~
`Copies of the certified copies of the priority documents have been received in this National Stage
`3.0
`application from the International Bureau (PCT Rule 17.2(a)).
`** See the attached detailed Office action for a list of the certified copies not received.
`
`Attachment{s)
`1) 0 Notice of References Cited (PT0-892)
`
`2) ~ Information Disclosure Statement(s) (PTO/SB/08a and/or PTO/SB/08b)
`Paper No(s)/Mail Date 1128114.
`U.S. Patent and Trademark Off1ce
`PTOL-326 (Rev. t t-t3)
`
`Office Action Summary
`
`3) 0 Interview Summary (PT0-413)
`Paper No(s)/Mail Date. __ .
`4) 0 Other: __ .
`
`Part of Paper No./Mail Date 20t40307
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`Page 2 of 8
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`
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`Application/Control Number: 14/165,976
`Art Unit: 1627
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`Page 2
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`DETAILED ACTION
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`The following is in response to the Preliminary amendments filed on 1/28/2014.
`
`The present application is being examined under the pre-AlA first to invent
`
`provisions.
`
`Double Patenting
`
`The nonstatutory double patenting rejection is based on a judicially created
`
`doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the
`
`unjustified or improper time wise extension of the "right to exclude" granted by a patent
`
`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
`
`one examined application claim is not patentably distinct from the reference claim(s)
`
`because the examined application claim is either anticipated by, or would have been
`
`obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d
`
`1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir.
`
`1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re VanOrnum,
`
`686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619
`
`(CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
`
`A timely filed terminal disclaimer in compliance with 37 CFR 1.321 (c) or 1.321 (d)
`
`may be used to overcome an actual or provisional rejection based on a nonstatutory
`
`double patenting ground provided the reference application or patent either is shown to
`
`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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`
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`Application/Control Number: 14/165,976
`Art Unit: 1627
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`Page 3
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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).
`
`The USPTO internet Web site contains terminal disclaimer forms which may be
`
`used. Please visit http://www.uspto.gov/forms/. The filing date of the application will
`
`determine what form should be used. A web-based eTerminal Disclaimer may be filled
`
`out completely online using web-screens. An eTerminal Disclaimer that meets all
`
`requirements is auto-processed and approved immediately upon submission. For more
`
`information about eTerminal Disclaimers, refer to
`
`http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-l.jsp.
`
`Claims 19-48 are rejected on the ground of nonstatutory double patenting as
`
`being unpatentable over claims 1-22 of U.S. Patent No. 8129431. Although the claims
`
`at issue are not identical, they are not patentably distinct from each other because the
`
`claims in the patent are drawn to an aqueous liquid preparation consisting essentially of
`
`the following two components, wherein the first component is 2-amino-3-(4-
`
`bromobenzoyl)phenylaceticacid or a pharmacologically acceptable salt thereof or a
`
`hydrate thereof, wherein the hydrate is at least one selected from a 1/2 hydrate, 1
`
`hydrate, and 3/2 hydrate and the second component is tyloxapol wherein said liquid
`
`preparation is formulated for ophthalmic administration, and wherein when a quaternary
`
`ammonium compound is included in said liquid preparation, the quaternary ammonium
`
`compound is benzalkonium chloride whereas the claims herein are drawn to a stable
`
`aqueous liquid preparation comprising: (a) a first component; and (b) a second
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`Page 4 of 8
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`
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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
`
`acid or a pharmacologically acceptable salt thereof or a hydrate thereof; wherein the
`
`hydrate is at least one selected from a 1/2 hydrate, 1 hydrate, and 3/2 hydrate; the first
`
`component is the sole pharmaceutical active ingredient contained in the preparation and
`
`is present in the preparation at a concentration from about 0.05 w/v % to about 0.2 w/v
`
`%; the second component is tyloxapol and is present in said liquid preparation in an
`
`amount sufficient to stabilize said first component; and wherein said stable liquid
`
`preparation is formulated for ophthalmic administration.
`
`Claims 19-48 are rejected on the ground of nonstatutory double patenting as
`
`being unpatentable over claims 1-17 of U.S. Patent No. 8497304. Although the claims
`
`at issue are not identical, they are not patentably distinct from each other because the
`
`claims in the copending application are drawn to an aqueous liquid preparation
`
`comprising 2-amino-3-(4- bromobenzoyl)phenylacetic acid sodium salt thereof or a
`
`hydrate thereof, and polyoxyl 40 stearate, wherein the concentration of the polyoxyl 40
`
`stearate is selected from a range of a minimum concentration of 0.02 w/v% to a
`
`maximum concentration of 0. 1 w/v% whereas the claims herein are drawn to a stable
`
`aqueous liquid preparation comprising: (a) a first component; and (b) a second
`
`component; wherein the first component is 2-amino-3-(4-bromobenzoyl)phenylacetic
`
`acid or a pharmacologically acceptable salt thereof or a hydrate thereof; wherein the
`
`hydrate is at least one selected from a 1/2 hydrate, 1 hydrate, and 3/2 hydrate; the first
`
`component is the sole pharmaceutical active ingredient contained in the preparation and
`
`is present in the preparation at a concentration from about 0.05 w/v % to about 0.2 w/v
`
`Page 5 of 8
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`
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`Application/Control Number: 14/165,976
`Art Unit: 1627
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`Page 5
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`%; the second component is tyloxapol and is present in said liquid preparation in an
`
`amount sufficient to stabilize said first component; and wherein said stable liquid
`
`preparation is formulated for ophthalmic administration.
`
`Claims 19-48 are rejected on the ground of nonstatutory double patenting as
`
`being unpatentable over claims 1-30 of U.S. Patent No. 8669290. Although the claims
`
`at issue are not identical, they are not patentably distinct from each other because the
`
`claims in the copending application are drawn to a stable aqueous liquid preparation
`
`comprising: (a) a first component; and (b) a second component; wherein the first
`
`component is 2-amino-3-(4- bromobenzoyl)phenylacetic acid or a pharmacologically
`
`acceptable salt thereof or a hydrate thereof, wherein the hydrate is at least one selected
`
`from a 1/2 hydrate, 1 hydrate, and 3/2 hydrate; the first component is the sole
`
`pharmaceutical active ingredient contained in the preparation; the second component is
`
`tyloxapol and is present in said liquid preparation in an amount sufficient to stabilize
`
`said first component; and wherein said stable liquid preparation is formulated for
`
`ophthalmic administration whereas the claims herein are drawn to a stable aqueous
`
`liquid preparation comprising: (a) a first component; and (b) a second component;
`
`wherein the first component is 2-amino-3-(4-bromobenzoyl)phenylacetic acid or a
`
`pharmacologically acceptable salt thereof or a hydrate thereof; wherein the hydrate is at
`
`least one selected from a 1/2 hydrate, 1 hydrate, and 3/2 hydrate; the first component is
`
`the sole pharmaceutical active ingredient contained in the preparation and is present in
`
`the preparation at a concentration from about 0.05 w/v % to about 0.2 w/v %; the
`
`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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`
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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
`
`formulated for ophthalmic administration.
`
`No claims allowed.
`
`Any inquiry concerning this communication or earlier communications from the
`
`examiner should be directed to Layla Soroush whose telephone number is (571 )272-
`
`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.
`
`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.
`
`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).
`
`/Layla Soroush/
`
`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 7
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`Page 8 of 8