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`UNITED STATES DEPARTMENT OF COMMERCE
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`NOTICE OF ALLOWANCE AND FEE(S) DUE
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`513
`7590
`04/21/2014
`WENDEROTH, LIND & PONACK, L.L.P.
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`EXAMINER
`
`SOROUSH, LA YLA
`
`ART UNIT
`
`PAPER NUMBER
`
`1627
`
`DATE MAILED: 04/2112014
`
`APPLICATION NO.
`
`FILING DATE
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
`
`14/165,976
`
`01128/2014
`
`ShirouSAWA
`
`2014-0075
`
`4523
`
`TITLE OF INVENTION: AQUEOUS LIQUID PREPARATION CONTAINING 2-AMIN0-3-(4-BROMOBENZOYL)PHENYLACETIC ACID
`
`APPLN. TYPE
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`ENTITY STATUS
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`DATE DUE
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`07/2112014
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`PTOL-85 (Rev. 02/11)
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`SENJU EXHIBIT 2257
`LUPIN v. SENJU
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`ATTORNEY DOCKET NO.
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`CONFIRMATION NO.
`
`14/165,976
`
`01128/2014
`
`ShirouSAWA
`
`2014-0075
`
`4523
`
`TITLE OF INVENTION: AQUEOUS LIQUID PREPARATION CONTAINING 2-AMIN0-3-(4-BROMOBENZOYL)PHENYLACETIC ACID
`
`APPLN. TYPE
`
`ENTITY STATUS
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`ISSUE FEE DUE
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`PUBLICATION FEE DUE PREV. PAID ISSUE FEE
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`TOTAL FEE(S) DUE
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`DATE DUE
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`nonprovisional
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`UNDISCOUNTED
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`$960
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`$0
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`07/2112014
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`EXAMINER
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`ART UNIT
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`CLASS-SUBCLASS
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`SOROUSH, LA YLA
`
`1627
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`514-619000
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`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
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`UNITED STA 1ES p A 1ENT AND TRADEMARK OFFICE
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`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`P.O. Box 1450
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`
`APPLICATION NO.
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`FILING DATE
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`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
`
`14/165,976
`
`01128/2014
`
`ShirouSAWA
`
`2014-0075
`
`4523
`
`513
`7590
`04/21/2014
`WENDEROTH, LIND & PONACK, LLP.
`1030 15th Street, N.W.,
`Suite 400 East
`Washington, DC 20005-1503
`
`EXAMINER
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`SOROUSH, LA YLA
`
`ART UNIT
`
`PAPER NUMBER
`
`1627
`
`DATE MAILED: 04/2112014
`
`Determination of Patent Term Adjustment under 35 U.S.C. 154 (b)
`(application filed on or after May 29, 2000)
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`The Patent Term Adjustment to date is 0 day(s). If the issue fee is paid on the date that is three months after the
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`Page 4 of 10
`
`
`
`Notice of Allowability
`
`Application No.
`
`14/165,976
`Examiner
`
`Applicant(s)
`
`SAWA ET AL.
`Art Unit
`
`LAYLA SOROUSH
`
`1627
`
`-- The MAILING DATE of this communication appears on the cover sheet with the correspondence address-(cid:173)
`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 ALLOW ABILITY 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. [8] This communication is responsive to the arguments filed on 3/20114.
`2. D 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.
`3. [8] The allowed claim(s) is/are 19-48.
`4. [8] Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
`b) D Some*
`c) D None
`a) [8] All
`of the:
`1. D Certified copies of the priority documents have been received.
`2. [8] Certified copies of the priority documents have been received in Application No. 101525.006.
`3. D 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(a)).
`* 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. 0 A SUBSTITUTE OATH OR DECLARATION must be submitted. Note the attached EXAMINER'S AMENDMENT or NOTICE OF
`INFORMAL PATENT APPLICATION (PT0-152) which gives reason(s) why the oath or declaration is deficient.
`6. D CORRECTED DRAWINGS (as "replacement sheets") must be submitted.
`(a) D including changes required by the Notice of Draftsperson's Patent Drawing Review ( PT0-948) attached
`1) D hereto or 2) D to Paper No./Mail Date __ .
`(b) D including changes required by the attached Examiner's Amendment I 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. 0 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. D Notice of References Cited (PT0-892)
`2. D Notice of Draftperson's Patent Drawing Review (PT0-948)
`3. D Information Disclosure Statements (PTO/SB/08),
`Paper No./Mail Date __
`4. D Examiner's Comment Regarding Requirement for Deposit
`of Biological Material
`
`/LAYLA SOROUSH/
`Primary Examiner, Art Unit 1627
`
`5. D Notice of Informal Patent Application
`6. D Interview Summary (PT0-413),
`Paper No./Mail Date __ .
`7. [8] Examiner's Amendment/Comment
`
`8. [8] Examiner's Statement of Reasons for Allowance
`9. D Other __ .
`
`U.S. Patent and Trademark Off1ce
`PTOL-37 (Rev. 03·11)
`
`Notice of Allowability
`
`Part of Paper No./Mail Date 20140409
`
`Page 5 of 10
`
`
`
`Application/Control Number: 14/165,976
`Art Unit: 1627
`
`Page 2
`
`The present application is being examined under the pre-AlA first to invent
`
`provisions.
`
`Acknowledgement of Receipt
`
`Applicant's response filed on 3/20/2014 to the Office Action mailed on
`
`03/13/2014 is acknowledged.
`
`Claim Status
`
`Claims 19-48 are pending.
`
`Claims 19-48 are allowed.
`
`Withdrawn Rejections
`
`The Double Patenting rejections over U.S. Patent No. 8129431, 8497304, and
`
`8669290 is withdrawn in view of the TO's filed on 3/20/2014.
`
`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 and is present in the
`
`Page 6 of 10
`
`
`
`Application/Control Number: 14/165,976
`Art Unit: 1627
`
`Page 3
`
`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.
`
`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
`
`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;
`
`Page 7 of 10
`
`
`
`Application/Control Number: 14/165,976
`Art Unit: 1627
`
`Page 4
`
`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
`
`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
`
`Page 8 of 10
`
`
`
`Application/Control Number: 14/165,976
`Art Unit: 1627
`
`Page 5
`
`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
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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)phenylacetate in the compositions A-07 and A-08 containing 0.02 w/v %
`and 0.05 w/v % of polyoxyl 40 stearate is not less than 90 % after storage at 60 oc 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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`%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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`
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`Application/Control Number: 14/165,976
`Art Unit: 1627
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`Page 6
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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.-5:00p.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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`/Layla Soroush/
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`Examiner, Art Unit 1627
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`Page 10 of 10