Case 1:15—cv—O0O87-UNA Document 4 Filed 01/26/15 Page 1 of 1 PageID #: 74
`A0 120 Rev. 08/10
`
`T0:
`
`Mail Stop 3
`Director of the U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`REPORT ON THE
`FILING OR DETERMINATION OF AN
`ACTION REGARDING A PATENT OR
`TRADEMARK
`
`In Compliance with 35 U.S.C. § 290 and/or 15 U.S.C. 9‘ I116 you are hereby advised that a court action has been
`filed in the U.S. District Court
`for the District of Delaware
`on the following
`
`I: Trademarks or
`
`[Z Patents.
`
`( E] the patent action involves 35 U.S.C. § 292.):
`
`DOCKET NO.
`
`PLAINTIFF
`
`
`
`
`DATE FILED
`1/26/2015
`
`U.S. DISTRICT COURT
`for the District of Delaware
`
`DEFENDANT
`
`
`
`
`SENJU PHARMACEUTICAL CO., LTD., et al.
`
`
`
`PADDOCK LABORATORIES, LLC, et al.
`
`
`
`
`
`%AJ%§;FD‘;*:}:EE£
`
`
`
`
`
`
`
`
`
`
`DATE INCLUDED
`
`In the aboVe—entitled case, the following patent(s)/ trademark(s) have been included:
`INCLUDED BY
`
`TR:g;]§4IEl;{%RNO
`
`HOLDER OF PATENT OR TRADEMARK
`
`D Amendment
`
`[I Answer
`
`l:I Cross Bill
`
`D Other Pleading
`
`——
`——
`——
`——
`
`In the above—entitled case, the following decision has been rendered or judgement issued:
`DECISION/JUDGEMENT
`
` (BY) DEPUTY CLERK
`
`DATE
`
`Copy 1—Upon initiation of action, mail this copy to Director Copy 3——Upon termination of action, mail this copy to Director
`Copy 2—Upon filing document adding patent(s), mail this copy to Director Copy 4—Case file copy
`
`P8991 of 281
`
`LUPIN EX 1045
`
`LUPIN EX 1045
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`Page 1 of 281
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`Case 1:14—cv-06893—JBS-KMW Document 4 Filed 11/03/14 Page 1 of 1 Page|D: 64
`
`
`
`
`
`OF AN
`FILING
`ACTION REGARDING A PATENT OR
`TRADEMARK
`
`
`
`
`Mail Stop 8
`
`Director ofthe U.S(.)1f’t2_:$nt and Trademark
`1, O Box 1450
`Alexandria, VA 22313-1450
`
`
`
`In Compliance with 35 U.S.C. § 290 and/or 15 U.S.C. § 1116 you are hereby advised that a court action has been
`filed in the U.S. District Court for the District of New Jersey on the following:
`Trademarks or X Patents. (
`the patent action involves 35 U.S.C. § 292.)
`
`
`
` U.S. DISTRICT COURT
`CAMDEN NJ
`
`DEFENDANT
`
`INNOPHARMA LICENSING, INC.
`
`
`
`DATE FILED
`DOCKET NO.
`l:l4—cv-06893-JBS-KMW 11/3/2014
`PLAINTIFF
`SENJU PHARMACEUTICAL CO., LTD.
`
`
`
`
`
`
`
`
`HOLDER OF PATENT OR TRADEMARK
`
`
`
`
`
`
`
`
`DATE INCLUDED
`
`n the above--entitled case the followin atent s / trademark s have been included:
`
`
`INCLUDED BY
`
`
`
`
`— I
`
`
`
`
` bJi\)*—‘
`
`PATENT OR
`TRADEMARK NO.
`
`DATE OF PATENT
`OR TRADEMARK
`
`HOLDER OF PATENT OR TRADEMARK
`
`Amendment
`
`Answer _ Cross Bill
`
`__ Other Pleading
`
`U1-5
`
`
`
`
`
`In the above-—entitled case the followin decision has been rendered or udement issued:
`DECISION/IUDGEMENT
`
` CLERK
`
`William T. Walsh
`
`(BY) DEPUTY CLERK
`s/ Nicholas Zotti
`
`DATE
`ll/3/2014
`
`
`
`
`
`Copy 1—Upon initiation of action, mail this copy to Director Copy 3~—Upon termination of action, mail this copy to Director
`Copy 2—Upon filing document adding patent(s), mail this copy to Director Copy 4—Case file copy
`
`Page 2 of 281
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`Page 2 of 281
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`TRADEMARK
`
`TO:
`
`Mail Stop 8
`Director of the U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`REPORT ON THE
`FILING OR DETERMINATION OF AN
`ACTION REGARDING A PATENT OR
`
`In Compliance with 35 U.S.C. § 290 and/or 15 U.S.C. § 1116 you are hereby advised that a court action has been
`filed in the U.S. District Court
`Eastern District Of North Carolina
`on the following
`
`I:l Trademarks or
`
`IZPatents.
`
`( E! the patent action involves 35 U.S.C. § 292.):
`
`DOCKET NO.
`U.S. DISTRICT COURT
`
`
`4:14-CV-141-BO
`Eastern District of North Carolina
`PLAINTIFF
`DEFENDANT
`
`Senju Pharmaceutical Co., Ltd., et al
`Metrics, |nc., et al
`
`DATE FILED
`8/8/2014
`
`
`
`
`
`
`
`——
`5 ——
`
`
`DATE INCLUDED
`
`INCLUDED BY
`
`In the above——entitled case, the following patent(s)/ trademark(s) have been included:
`
`
`
`MJCJ
`
`
`
`
`
`
`
`[I Answer
`
`El Cross Bill
`
`[:I Other Pleading
`
`l_—_I Amendment
`PATENT OR
`DATE OF PATENT
`TRADEMARK NO.
`OR TRADEMARK
`HOLDER OF PATENT OR TRADEMARK
`_——
`——
`——
`_—
`——
`
`In the above——entitled case, the following decision has been rendered or judgement issued:
`DECISION/JUDGEMENT
`
`(BY) DEPUTY CLERK
`
`Copy 1—Upon initiation of action, mail this copy to Director Copy 3—Upon termination of action, mail this copy to Director
`Copy 2——Upon filing document adding patent(s), mail this copy to Director Copy 4—Case file copy
`Page 3 of 281
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`Page 3 of 281
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`

`Case 1:14-cv-O4964—JBS Document 4 Filed 08/07/14 Page 1 of 1 PagelD: 52
`
`0120 Rev. 08/10
`
`Ma“ S‘°P 8
`Director of the U.S(.)lf’iatent and Trademark
`ice
`P.O. Box 1450
`Alexandria, VA 22313—1450
`
`REPORT ON THE
`FILING OR DETERMINATION OF AN
`ACTION REGARDING A PATENT OR
`TRADEMARK
`
`In Compliance with 35 U.S.C. § 290 and/or 15 U.S.C. § 1116 you are hereby advised that a court action has been
`filed in the U.S. District Court for the District of New Jersey on the following:
`Trademarks or X Patents. (
`the patent action involves 35 U.S.C. § 292.)
`
`DOCKET NO.
`1:14—cv-04964*JBS
`
`DATE FILED
`8/7/2014
`
`PLAINTIFF
`SENJU PHARMACEUTICAL CO., LTD.
`
`U.S. DISTRICT COURT
`CAMDEN NJ
`
`DEFENDANT
`METRICS, INC.
`
`TT
`
`—
`INCLUDED BY
`In the above-—entitled case the followin atent s / trademark s have been included:
`DATE INCLUDED
`
`
`
`
`"# Amendment _ Answer _ Cross Bill _ Other Pleading
`
`PATENT OR
`TRADEMARK NO.
`
`DATE OF PATENT
`OR TRADEMARK
`
`HOLDER OF PATENT OR TRADEMARK
`
`-¥>-LrJl\)
`
`U1
`
`
`
`
`
`In the above-—entitled case the followin decision has been rendered or 'udement issued:
`DECISION/JUDGEMENT
`
`
`
`CLERK
`William T. Walsh
`
`(BY) DEPUTY CLERK
`3/ Brian D. Kemner
`
`DATE
`8/7/2014
`
`
`
`Copy 1--Upon initiation of action, mail this copy to Director Copy 3-—Upon termination of action, mail this copy to Director
`Copy 2—Upon filing document adding patent(s), mail this copy to Director Copy 4-—Case file copy
`
`Page 4 of 281
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`Page 4 of 281
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`

`

`Case 1:14-cv—04149-JBS-KMW Document 4 Filed 06/26/14 Page 1 of 1 Page|D: 25
`
`‘ 0120 Rev. 08/10
`
`
`REPORT ON THE
`FILING OR DETERMINATION OF AN
`ACTION REGARDING A PATENT OR
`TRADEMARK
`
`
`
`
`
`Ma“ St”? 3
`Director of the U.S.Olf’i2_::£‘:nt and Trademark
`R0 Box 1450
`Alexandria, VA 22313-1450
`
`In Compliance with 35 U.S.C. § 290 and/or 15 U.S.C. § 1116 you are hereby advised that a court action has been
`filed in the U.S. District Court for the District of New Jersey on the following:
`Trademarks or X Patents. (
`the patent action involves 35 U.S.C. § 292.)
`
`U.S. DISTRICT COURT
`CAMDEN NJ
`
`DEFENDANT
`LUPIN, LTD.
`
`
`
`
`
`DATE FILED
`DOCKET NO.
`l:l4-cv-04149-JBS—KMW 6/26/2014
`
`PLAINTIFF
`SENJU PHARMACEUTICAL CO., LTD.
`
`
`
`
`
`
`
`
`
`HOLDER OF PATENT OR TRADEMARK
`smu
`
`
`———— I
`
`
`
`
`
`DATE INCLUDED
`
`n the above-—entitled case the followin atent s / trademark s have been included:
`INCLUDED BY
`
`
`
`__ Amendment __ Answer
`
`__ Cross Bill _ Other Pleading
`
`
` -l§L»Jl\)
` kl!
`
`DATE OF PATENT
`PATENT OR
`OR TRADEMARK
`TRADEMARK NO.
`—
`
`HOLDER OF PATENT OR TRADEMARK
`
`In the above--entitled case the followin decision has been rendered or 'udement issued:
`DECISION/JUDGEMENT
`
`CLERK
`William T. Walsh
`
`
`
`(BY) DEPUTY CLERK
`s/ Nicholas Zotti
`
`
`
`DATE
`6/26/2014
`
`
`
`Copy 1—Upon initiation of action, mail this copy to Director Copy 3-Upon termination of action, mail this copy to Director
`Copy 2——Upon filing document adding patent(s), mail this copy to Director Copy 4--Case file copy
`
`Page 5 of 281
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`Page 5 of 281
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`

`

`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`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.
`
`13/687,242
`
`ISSUE DATE
`
`03/11/2014
`
`PATENT NO.
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
`
`8669290
`
`2012_5420
`
`1577
`
`513
`
`7590
`
`02/19/2014
`
`WENDEROTH, LIND & PONACK, L.L.P.
`1030 15th Street, N.W.,
`Suite 400 East
`
`Washington, DC 20005-1503
`
`The projected patent number and issue date are specified above.
`
`ISSUE NOTIFICATION
`
`Determination of Patent Term Adjustment under 35 U.S.C. 154 (b)
`(application filed on or after May 29, 2000)
`
`The Patent Term Adjustment is 0 day(s). Any patent to issue from the above—identified application will include
`an indication of the adjustment on the front page.
`
`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 Application Assistance Unit (AAU) of the Office of Data Management
`(ODM) at (571)-272-4200.
`
`APPLICANT(S) (Please see PAIR WEB site http://pair.uspto. gov for additional applicants):
`
`Shirou SAWA, Hyogo, JAPAN;
`Shuhei FUJITA, Hyogo, JAPAN;
`SENJU PHARMACEUTICAL CO., LTD., Osaka, JAPAN
`
`The United States represents the largest, most dynamic marketplace in the world and is an unparalleled location
`for business investment, innovation, and commercialization of new technologies. The USA offers tremendous
`resources and advantages for those who invest and manufacture goods here. Through SelectUSA, our nation
`works to encourage and facilitate business investment. To learn more about why the USA is the best country in
`the world to develop technology, manufacture products, and grow your business, visit SelectUSA.gov.
`
`Pa e 6 of 281
`IR103 (Rev.
`/09)
`
`Page 6 of 281
`
`

`

`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`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.
`
`F ING DATE
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`CONF {MATION NO.
`
`13/687,242
`
`11/28/2012
`
`Shirou SAWA
`
`2012_5420
`
`1577
`
`WENDEROTH,LIND&PONACK,L.L.P.
`103015th Street, N.W.,
`Suite
`East
`
`SOROUSH, LAYLA
`PAPER \1Ul\/IBER
`
`ART UNIT
`1627
`
`02/1 1/2014
`
`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 @Wender0th.c0m
`e0a@ Wender0th.c0m
`
`Page 7 of 281
`PTOL—90A ( ev. 04/07)
`
`Page 7 of 281
`
`

`

`Of
`
`Application No.
`
`13/687,242
`Examiner
`
`App|icant(s)
`
`SAWA ET AL.
`Art Unit
`
`LAYLA SOROUSH
`
`1627
`
`-- 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. IX This communication is responsive to the amendments made on 10/22/13.
`
`2. I:I 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 19-48.
`
`4. IX Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119( )—(d) or (f).
`a) X All
`b) I:I Some*
`c) I:I None
`of the:
`
`1. I:I Certified copies of the priority documents have been received.
`
`2. E Certified copies of the priority documents have been received in Application No. 10/525 006.
`
`3. I:I 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” of this 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. |:I A SUBSTITUTE OATH OR DECLARATION must be submitted. Note the attached EXAMINER’S AMENDMENT or NOTICE OF
`INFORMAL PATENT APPLICATION (PTO—152) which gives reason(s) why the oath or declaration is deficient.
`
`6. I:I CORRECTED DRAWINGS (as “replacement sheets”) must be submitted.
`
`(a) I] including changes required by the Notice of Draftsperson’s Patent Drawing Review ( PTO—948) attached
`
`1) I:| hereto or 2) I] to Paper No./Mail Date
`
`(b) I] 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 1.121(d).
`
`7. 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. El Notice of References Cited (PTO—892)
`
`2. El Notice of Draftperson‘s Patent Drawing Review (PTO—948)
`
`3. IX Information Disclosure Statements (PTO/SB/08),
`Paper No./Mail Date 1/15/141/17114
`4. I:I Examiner’s Comment Regarding Requirement for Deposit
`of Biological Material
`
`5. I:I Notice of Informal Patent Application
`
`6. I:I Interview Summary (PTO—413),
`Paper No./Mail Date
`.
`7. IX Examiner’s Amendment/Comment
`
`8. E Examiner’s Statement of Reasons for Allowance
`
`9. I:| Other
`
`U.S. Patent and Trademark Office
`
`PTOL-37 (Rev. 03-11)
`
`Page 8 of 281
`
`Notice of Allowability
`
`Part of Paper No./Mail Date 20140206
`
`Page 8 of 281
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`

`

`Application/Control Number: 13/687,242
`
`Page 2
`
`Art Unit: 1627
`
`The present application is being examined under the pre-AIA first to invent
`
`provisions.
`
`Acknowledgement of Receipt
`
`Applicant's response filed on 10/22/2013 to the Office Action mailed on
`
`08/01/2013 is acknowledged.
`
`Claim Status
`
`Claims 19-48 are pending.
`
`Claims 19-48 are allowed.
`
`Withdrawn Rejections
`
`The rejection of claims 44-48 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA),
`
`second paragraph is withdrawn in view of the amendments made to the claims.
`
`The rejection of claims 19, 21-24, 26, 28-30, 32, 34-36, 38, 40-42, and 44-48
`
`under 35 U.S.C. 103(a) as being unpatentable over Gamache, et al. (WO 01/15677 A2;
`
`03/2001) is withdrawn in view of the amendments made to the claims.
`
`The rejection of claims 20, 27, 33, and 39 under 35 U.S.C. 103(a) as being
`
`unpatentable over Gamache, et al. (WO 01/15677 A2; 03/2001), as applied to claims
`
`19, 21-24, 26, 28-30, 32, 34-36, 38, 40-42, and 44-48 and further in view of Desai, et al.
`
`(5558876) is withdrawn in view of the amendments made to the claims.
`
`The rejection of claims 25, 31, 37, and 43 under 35 U.S.C. 103(a) as being
`
`unpatentable over Gamache, et al. (WO 01/15677 A2; 03/2001), as applied to claims
`
`19, 21-24, 26, 28-30, 32, 34-36, 38, 40-42, and 44-48 and further in view of Ogawa, et
`
`Page 9 of 281
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`Page 9 of 281
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`

`

`Application/Control Number: 13/687,242
`
`Page 3
`
`Art Unit: 1627
`
`al. (US 4910225 A) and De Bruiju et al. (US 6162393 A) is withdrawn in view of the
`
`amendments made to the claims.
`
`The Double Patenting rejections over U.S. Patent No. 7829544, U.S. Patent No.
`
`8129431, copending Application No. 13353653 is withdrawn in view of the TD’s filed on
`
`11/2/13.
`
`The Double Patenting rejections over copending Application No. 11755662 is
`
`withdrawn in view of the abandonment of the case.
`
`EXAM|NER’S AMENDMENT
`
`An examiner’s amendment to the record appears below. Should the changes
`
`and/or additions be unacceptable to applicant, an amendment may be filed as provided
`
`by 37 CFR 1.312. To ensure consideration of such an amendment, it MUST be
`
`submitted no later than the payment of the issue fee.
`
`Authorization for this examiner’s amendment was given in a telephone interview
`
`with Warren M. Cheek on 1/8/14.
`
`The application has been amended as follows:
`
`In claim 26 line 5 after hydrate; insert “the first component is the sole
`
`pharmaceutical active ingredient contained in the preparation;”
`
`In claim 27 lines 2-3 after salt delete —, and wherein the first component is the
`
`sole pharmaceutical active ingredient contained in the preparation -- .
`
`Page 10 of 281
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`Page 10 of 281
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`

`

`Application/Control Number: 13/687,242
`
`Page 4
`
`Art Unit: 1627
`
`Reasons for Allowance
`
`The following is an examiner’s statement of reasons for allowance:
`
`The composition as claimed are found to be patentable over the prior art
`
`because the prior art does not teach or fairly suggest 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.
`
`The closest prior arts of record, namely Chen et al. (US 6383471), teach a
`
`pharmaceutical composition including a hydrophobic therapeutic agent having at least
`
`one ionizable functional group, and a carrier. The carrier includes an ionizing agent
`
`capable of ionizing the functional group, a surfactant, and optionally solubilizers,
`
`triglycerides, and neutralizing agents (abstract). The reference teaches a hydrophobic
`
`therapeutic agent to include bromfenac (2-amino-3-(4-bromobenzoyl)phenalyacetic
`
`acid)(see claim 4). The hydrophobic therapeutic agent is used in less than about 1% by
`
`weight, and typically less than about 0.1% or 0.01% by weight (see col 4 lines 58-60)
`
`(renders obvious the limitation of claims 8 and 24). The reference further teaches
`
`surfactants inclusive of polyethylene glycol fatty acid esters and additionally teaches
`
`Page 11 of 281
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`Page 11 of 281
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`

`

`Application/Control Number: 13/687,242
`
`Page 5
`
`Art Unit: 1627
`
`polyethylene glycol fatty acid monoesters such as peg-15 stearate, etc (see claims 21 —
`
`22 24 and 27). The surfactants are selected from the group consisting of alcohols;
`
`polyoxyethylene alkylethers; fatty acids; glycerol fatty acid esters; acetylated glycerol
`
`fatty acid esters; lower alcohol fatty acids esters; polyethylene glycol fatty acids esters;
`
`polyethylene glycol glycerol fatty acid esters; polypropylene glycol fatty acid esters;
`
`polyoxyethylene glycerides; lactic acid derivatives of mono/diglycerides; propylene
`
`glycol diglycerides; sorbitan fatty acid esters; polyoxyethylene sorbitan fatty acid esters;
`
`polyoxyethylene-polyoxypropylene block copolymers; transesterified vegetable oils;
`
`sterols; sterol derivatives; sugar esters; sugar ethers; sucroglycerides; polyoxyethylene
`
`vegetable oils; and polyoxyethylene hydrogenated vegetable oils. The pharmaceutical
`
`compositions of the present invention can be provided in the form of a solution
`
`preconcentrate; i.e., a composition as described above, and intended to be dispersed
`
`with water, either prior to administration, in the form of a drink, or dispersed in vivo (col
`
`34 lines 63-68) (reads on an aqueous liquid preparation). The reference also teaches
`
`preservatives (see claim 64). Although formulations specifically suited to oral
`
`administration are presently preferred, the compositions of the present invention can
`
`also be formulated for topical, transdermal, ocular, pulmonary, vaginal, rectal,
`
`transmucosal or parenteral administration (col 35 lines 9-20). Chen et al. further
`
`teaches components that can be incorporated into the composition include inorganic
`
`acids inclusive of boric acid (col 46, line 6), solubilizer such as polyvinylpyrrolidone
`
`(claim 49), exemplifications of carriers comprising Edetate Disodium (col 4 table 20
`
`formulations 65 and 66), and ionizing agents that deprotonate the acidic functional
`
`Page 12 of 281
`
`Page 12 of 281
`
`

`

`Application/Control Number: 13/687,242
`
`Page 6
`
`Art Unit: 1627
`
`groups of the therapeutic agent are pharmaceutically acceptable organic or inorganic
`
`bases, inclusive of sodium hydroxide (col 11 lines 12-13) (reads on the limitations of
`
`claim 22).
`
`However, Applicant presents excellent effects are clearly demonstrated by
`
`Experiments 1 to 3 of the present specification. Experiment 1 -- Stability of sodium 2-
`
`amino-3-(4-bromobenzoyl)phenyl acetate was evaluated. Namely, two eye drops of
`
`sodium 2—amino-3-(4-bromobenzoyl) phenylacetate comprising the components as
`
`shown in Table 1 were prepared, filled respectively into a polypropylene container and
`
`subjected to a stability test at 60°C for 4 weeks. As is apparent from Table 1, the
`
`stability test was carried out under the conditions of pH 7.0 at 60 °C for 4 weeks. Table 1
`
`clearly shows that sodium 2-amino-3- (4-bromobenzoyl)phenylacetate in polyoxyl 40
`
`stearate-containing preparation was more stable than that in polysorbate 80- containing
`
`preparation. As is apparent from Table 2, the remaining rate of sodium 2—amino-3-(4-
`
`bromobenzoyl)phenylacetate in the compositions A-07 and A—08 containing 0.02 w/v °/o
`
`and 0.05 w/v °/o of polyoxyl 40 stearate is not less than 90 °/o after storage at 60 °C for 4
`
`weeks. Table 2 clearly shows that the compositions containing 0.02 w/v °/o and 0.05 w/v
`
`°/o of polyoxyl 40 stearate have sufficient stability for eye drops. The arguments are
`
`persuasive.
`
`The composition as claimed are found to be patentable over the prior art
`
`because the prior art does not teach or fairly suggest 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
`
`Page 13 of 281
`
`Page 13 of 281
`
`

`

`Application/Control Number: 13/687,242
`
`Page 7
`
`Art Unit: 1627
`
`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.
`
`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.”
`
`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 8:30a.m.-5:00p.m..
`
`If attempts to reach the examiner by telephone are unsuccessful, the examiner’s
`
`supervisor, Sreenivasan Padmanabhan can be reached on (571)272-0629. The fax
`
`phone 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
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`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
`
`Page 14 of 281
`
`Page 14 of 281
`
`

`

`Application/Control Number: 13/687,242
`
`Page 8
`
`Art Unit: 1627
`
`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). If you would like assistance from a
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`USPTO Customer Service Representative or access to the automated information
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`system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
`
`/Layla Soroush/
`
`Examiner, Art Unit 1627
`
`Page 15 of 281
`
`Page 15 of 281
`
`

`

`Search Notes
`
`Application/Control No.
`
`App|icant(s)/Patent under
`Reexamination
`
`13/687,242
`
`SAWA ET AL.
`
`1627‘
`
`LAYLA SOROUSH
`
`SEARCHED
`
`619
`
`1/8/14
`
`1/8/14
`
`1/8/14
`
`SEARCH NOTES
`(INCLUDING SEARCH STRATEGY)
`‘
`
`STIC (See 13535653); and npl
`
`1/8/14
`
`odp:SAWA, SHIROU and FUJITA,
`SHUHEI
`
`1/8/14
`
`INTERFERENCE SEARCHED
`
`U.S. Patent and Trademark Office
`
`Page 16 of 281
`
`Par1 of Paper No. 20140206
`
`Page 16 of 281
`
`

`

`Sheet 1 Of 1
`
`INFORMATION DISCLOSURE STATEMENT
`
`FORM PTO/SB/08 A&B (modified)
`U.S. DEPARTMENT OF COMMERCE
`PATENT AND TRADEMARK OFFICE
`
`LIST OF REFERENCES CITED BY APPLICANT(S)
`(Use several sheets ifnecessary)
`
`Date Submitted to PTO: January 15, 2014
`
`‘SOTSEEECKET N0‘
`
`FIRST NAMED INVENTOR
`Shirou SAWA
`
`FILING DATE
`
`November 28> 2012
`U.S. PATENT DOCUMENTS
`
`fig/2‘8L;‘;‘41;l°'
`
`*EXAMINER
`INITIAL
`
`DOCUMENT
`NUMBER
`
`DATE
`
`NAME
`
`CLASS
`
`SUBCLASS
`
`FILING DATE
`IF APPROPRIATE
`
`4,910,225
`
`3/1990
`
`Ogawa et al.
`
`6,274,609
`
`8/2001
`
`Yasueda et al.
`
`HEEEE
`
`U3 U3
`
`U3 0
`
`D1H
`
`DOCUMENT
`NUMBER
`
`0 306 984
`
`DATE
`
`3/1989
`
`FOREIGN PATENT DOCUMENTS
`
`COUNTRY
`
`CLASS
`
`SUBCLASS
`
`TRANSLATION
`
`’-<U1:12
`
`ZO
`
`EP
`
`OTHER DOCUMENT(S) (Including Author, Title, Date, Pertinent Pages, Etc.)
`
`H. Scott et al., "Comparing the Surface Chemical Properties and the Effect of Salts on the Cloud Point of a Conventional
`Nonionic Surfactant, Octoxynol 9 (Triton X-100), and of its Oligomer, Tyloxapol (Triton WR-1339)", Journal of Colloid and
`Interface Science, Vol. 205, pp. 496-502, 1998.
`
`EXAMINER
`
`/Layla SOTO
`
`I
`
`'
`
`DATE CONSIDERED
`
`P%7tlifiarf 2z8z1tial reference considered, whether or not citation is in conformance with MPEP 609; draw line through
`citation ifnot in conformance and not considered. Include copy ofthisform with next communication to applicant.
`
`Page 17 of 281
`
`

`

`Sheet 1 of 1
`
`INFORMATION DISCLOSURE STATEMENT
`
`FORM PTO/SB/08 A&B (modified)
`U.S. DEPARTMENT OF COMMERCE
`PATENT AND TRADEMARK OFFICE
`
`LIST OF REFERENCES CITED BY APPLICANT(S)
`(Use several sheets ifnecessary)
`
`Date Submitted to PTO: January 17, 2014
`
`*EXAMINER
`INITIAL
`
`""‘
`
`3/
`
`"
`
`DOCUMENT
`NUMBER
`
`4,910,225
`
`DATE
`
`3/1990
`
`8/2001
`
`‘
`
`fig/2‘8L;‘;‘41;l°'
`
`‘SOTSEEECKET N0‘
`
`FIRST NAMED INVENTOR
`Shirou SAWA
`
`FILING DATE
`
`November 28> 2012
`U.S. PATENT DOCUMENTS
`
`NAME
`
`CLASS
`
`SUBCLASS
`
`FILING DATE
`IF APPROPRIATE
`
`Ogawa et al.
`
`Yasueda et al.
`
`Eflrflfl
`
`H
`
`U3 U3
`
`U3 0
`
`D1H
`
`DOCUMENT
`NUMBER
`
`0 306 984
`
`DATE
`
`3/1989
`
`FOREIGN PATENT DOCUMENTS
`
`COUNTRY
`
`CLASS
`
`SUBCLASS
`
`TRANSLATION
`
`’-<U1:12
`
`ZO
`
`EP
`
`OTHER DOCUMENT(S) (Including Author, Title, Date, Pertinent Pages, Etc.)
`
`H. Scott et al., "Comparing the Surface Chemical Properties and the Effect of Salts on the Cloud Point of a Conventional
`Nonionic Surfactant, Octoxynol 9 (Triton X-100), and of its Oligomer, Tyloxapol (Triton WR-1339)", Journal of Colloid and
`Interface Science, Vol. 205, pp. 496-502, 1998.
`
`
`
`P%7i|iBa)’f 2z8z1tial reference considered, whether or not citation is in conformance with MPEP 609; draw line through
`citation ifnot in conformance and not considered. Include copy ofthisform with next communication to applicant.
`
`Page 18 of 281
`
`

`

`Issue Classification
`
`Application/Control No.
`13/687,242
`
`HSU0RrOeSmmV:mAEL
`
`App|icant(s)/Patent under
`Reexamination
`LA_I
`EtAi
`SA1
`wmm
`A..hnO
`
`ORIGINAL
`
`ISSUE CLASSIFICATION
`INTERNATIONAL CLASSIFICATION
`DEMAI.cNON
`
`MAI.C
`
`/
`
`/
`
`ma
`NII
`13J16J
`
`8H
`
`561/
`
`SSAI.
`I
`
`BUS
`SSAI.
`I
`
`CROSS REFERENCES
`
`CLASS
`
`SUBCLASS (ONE SUBCLASS PER BLOCK)
`
`A55I5‘a“‘ Examine’
`
`/Layla SorouSh/ 2/6/14
`
`(Legal Instruments Examiner)
`
`(Date)
`
`(Primary Examiner)
`
`D Claims renumbered in the same order as presented by applicant
`
`AD:C
`
`Total Claims Allowed: 30
`
`O.G.
`Print C|aim(s)
`
`_mc_m__o123457mnmmmwmnmmmmamm
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`U.S. Patent and Trademark Office
`
`Part of Paper No. 20140206
`
`Page 19 of 281
`
`

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`

`

`Electronic Patent Application Fee Transmittal
`
`T'tIe °f I'“’e"t'°"‘
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`AQUEOUS LIQUID PREPARATION CONTAINING 2-AM|NO-3-(4-
`BROMOBENZOYL)PHENYLACETIC ACID
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`AQUEOUS LIQUID PREPARATION CONTAINING 2-AM|NO-3-(4-
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