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.
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`F ING DATE
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`CONF {MATION NO.
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`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
`
`PTOL_90A (RW04/07)
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`Metrics EX1015, Page 1
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`Metrics EX1015, Page 1
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`

`
`Of
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`Application No.
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`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.
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`3. I:I 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( )).
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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
`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)
`
`Notice of Allowability
`
`Part of Paper No./Mail Date 20140206
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`Metrics EX1015, Page 2
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`Metrics EX1015, Page 2
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`

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`Application/Control Number: 13/687,242
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`Page 2
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`Art Unit: 1627
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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 10/22/2013 to the Office Action mailed on
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`08/01/2013 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 rejection of claims 44-48 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA),
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`second paragraph is withdrawn in view of the amendments made to the claims.
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`The rejection of claims 19, 21-24, 26, 28-30, 32, 34-36, 38, 40-42, and 44-48
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`under 35 U.S.C. 103(a) as being unpatentable over Gamache, et al. (WO 01/15677 A2;
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`03/2001) is withdrawn in view of the amendments made to the claims.
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`The rejection of claims 20, 27, 33, and 39 under 35 U.S.C. 103(a) as being
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`unpatentable over Gamache, et al. (WO 01/15677 A2; 03/2001), as applied to claims
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`19, 21-24, 26, 28-30, 32, 34-36, 38, 40-42, and 44-48 and further in view of Desai, et al.
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`(5558876) is withdrawn in view of the amendments made to the claims.
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`The rejection of claims 25, 31, 37, and 43 under 35 U.S.C. 103(a) as being
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`unpatentable over Gamache, et al. (WO 01/15677 A2; 03/2001), as applied to claims
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`19, 21-24, 26, 28-30, 32, 34-36, 38, 40-42, and 44-48 and further in view of Ogawa, et
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`Metrics EX1015, Page 3
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`Metrics EX1015, Page 3
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`Application/Control Number: 13/687,242
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`Page 3
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`Art Unit: 1627
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`al. (US 4910225 A) and De Bruiju et al. (US 6162393 A) is withdrawn in view of the
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`amendments made to the claims.
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`The Double Patenting rejections over U.S. Patent No. 7829544, U.S. Patent No.
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`8129431, copending Application No. 13353653 is withdrawn in view of the TD’s filed on
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`11/2/13.
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`The Double Patenting rejections over copending Application No. 11755662 is
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`withdrawn in view of the abandonment of the case.
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`EXAM|NER’S AMENDMENT
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`An examiner’s amendment to the record appears below. Should the changes
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`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
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`submitted no later than the payment of the issue fee.
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`Authorization for this examiner’s amendment was given in a telephone interview
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`with Warren M. Cheek on 1/8/14.
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`The application has been amended as follows:
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`In claim 26 line 5 after hydrate; insert “the first component is the sole
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`pharmaceutical active ingredient contained in the preparation;”
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`In claim 27 lines 2-3 after salt delete —, and wherein the first component is the
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`sole pharmaceutical active ingredient contained in the preparation -- .
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`Metrics EX1015, Page 4
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`Metrics EX1015, Page 4
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`Application/Control Number: 13/687,242
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`Page 4
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`Art Unit: 1627
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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
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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; 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-bromobenzoyl)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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`Metrics EX1015, Page 5
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`Metrics EX1015, Page 5
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`Application/Control Number: 13/687,242
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`Page 5
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`Art Unit: 1627
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`polyethylene glycol fatty acid monoesters such as peg-15 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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`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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`Metrics EX1015, Page 6
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`Metrics EX1015, Page 6
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`Application/Control Number: 13/687,242
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`Page 6
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`Art Unit: 1627
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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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`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)phenylacetate in the compositions A-07 and A—08 containing 0.02 w/v °/o
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`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
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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
`
`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
`
`Metrics EX1015, Page 7
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`Metrics EX1015, Page 7
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`Application/Control Number: 13/687,242
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`Page 7
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`Art Unit: 1627
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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
`
`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
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`for ophthalmic administration.
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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
`
`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.-5:00p.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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`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.
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`For more information about the PAIR system, see http://pair-direct.uspto.gov. Should
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`Metrics EX1015, Page 8
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`Metrics EX1015, Page 8
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`Application/Control Number: 13/687,242
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`Page 8
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`Art Unit: 1627
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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). If you would like assistance from a
`
`USPTO Customer Service Representative or access to the automated information
`
`system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
`
`/Layla Soroush/
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`Examiner, Art Unit 1627
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`Metrics EX1015, Page 9
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`Metrics EX1015, Page 9