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`n re application of
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`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
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`Confirmation No. 1756
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`Shirou SAWA et al.
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`Attorney Docket No. 2005__0232A
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`Serial No. 10/525,006
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`Group Art Unit 1615
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`Filed March 28, 2005
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`Examiner Not Yet Assigned
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`AQUEOUS LIQUID PREPARATION
`CONTAINING 2-AMINO-3-(4-
`BROMOBENZOYL)PI-IENYLACETIC ACID
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`Mail Stop: Amendment
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`THE C0l.lMlSS|0NER IS AUTHORIZED
`TO CHARGE ANY DEFICIENCY IN THE
`TEE FOR THIS PAPER T0 DEPOSIT
`HP-
`SUPPLEMENTAL PRELIMINARY AMENf)i\§1‘iz1~l’1“°-23‘0975-
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`Commissioner for Patents
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`P.O. Box 1450
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`Alexandria, VA 22313-1450
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`Sir:
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`Please amend the above-identified application as follows:
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`Page 1 of 6
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`SENJU EXHIBIT 2083
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`LUPIN v. SENJU
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`IPR2015—01l00
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`Amendments to the Claims
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`1-18. (Cancelled)
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`19. (New)
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`An aqueous liquid preparation comprising 2-amino-3—(4-
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`bromobenzoyl)phenylacetic acid or a pharmacologically acceptable salt thereof or a hydrate
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`thereof, and an alkyl aryl polyether alcohol type polymer or a polyethylene glycol fatty acid
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`ester.
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`20. (New)
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`The aqueous liquid preparation according to claim 19, wherein the
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`alkyl aryl polyether alcohol type polymer is tyloxapol;
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`wherein the concentration of the tyloxapol is selected from a range of about 0.01 w/v %
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`to about 0.5 w/v %; and
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`wherein the concentration of the 2-amino-3-(4-bromobenzoyl)phenylacetic acid or a
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`‘pharrnacologically acceptable salt thereof or a hydrate thereof is selected from a range of about
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`0.01 to about 0.5 w/v %.
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`21. (New)
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`The aqueous liquid preparation according to claim 20, wherein the
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`pharmacologically acceptable salt of 2—amino—3—(4—brornobenzoyl)phenylacetic acid is a sodium
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`salt.
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`22. (New)
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`The aqueous liquid preparation according to claim 21, wherein the
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`concentration of the 2~amino—3-(4-bromobenzoyl)phenylacetic acid sodium salt is selected from
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`a range of about 0.05 to about 0.2 w/v %.
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`23. (New)
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`The aqueous liquid preparation according to claim 22, wherein the
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`concentration of the tyloxapol is selected from a range of about 0.01 w/v % to about 0.3 w/v %.
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`24. (New)
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`The aqueous liquid preparation according to claim 23, wherein the
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`concentration of the 2-amino-3—(4-bromobenzoyl)pheny1acetic acid sodium salt is about
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`0.1 w/v %.
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`Page 2 of 6
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`Page 2 of 6
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`25. (New)
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`The aqueous liquid preparation according to claim 24, wherein the
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`concentration of the tyloxapol is about 0.02 w/v %.
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`26. (New)
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`The aqueous liquid preparation according to claim 25, wherein the
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`formulation further includes one or more additives selected from the group consisting of a
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`preservative, buffer, thickener, stabilizer, chelating agent, and pH controlling agent.
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`27. (New)
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`The aqueous liquid preparation according to claim 26, wherein said
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`preservative is benzalkonium chloride; wherein said buffer is boric acid and/or sodium borate;
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`wherein said thickener is polyvinylpyrrolidone; wherein said stabilizer is sodium sulfite; wherein
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`said chelating agent is sodium edetate; and wherein said pH controlling agent is sodium
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`hydroxide.
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`28. (New)
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`The aqueous liquid preparation according to claim 27, wherein the pH is
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`from about 7 to about 9.
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`29. (New)
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`The aqueous liquid preparation according to claim 28, wherein the pH is
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`from about 7.5 to about 8.5.
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`30. (New)
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`The aqueous liquid preparation according to claim 27, wherein said liquid
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`preparation is in the form of an eye drop.
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`31. (New)
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`The aqueous liquid preparation according to claim 23, wherein the
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`concentration of the 2-amino—3~(4—bromobenzoy1)phenylacetic acid sodium salt is about 0.2 w/v
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`%.
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`32. (New)
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`The aqueous liquid preparation according to claim 31, wherein the
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`concentration of the tyloxapol is about 0.3 w/v %.
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`Page 3 of 6
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`Page 3 of 6
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`33. (New)
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`The aqueous liquid preparation according to claim 32, wherein the
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`formulation further includes one or more additives selected from the group consisting of a
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`preservative, buffer, thickener, stabilizer, chelating agent, and pH controlling agent.
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`34. (New)
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`The aqueous liquid preparation according to claim 33, wherein said
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`preservative is benzalkonium chloride; wherein said buffer is boric acid and/or sodium borate;
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`wherein said thickener is polyvinylpyrrolidone; wherein said stabilizer is sodium sulfite; wherein
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`said chelating agent is sodium edetate; and wherein said pH controlling agent is sodium
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`hydroxide.
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`35. (New)
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`The aqueous liquid preparation according to claim 34, wherein said liquid
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`preparation is in the form of an eye drop.
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`36. (New)
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`The aqueous liquid preparation according to claim 31, wherein the
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`concentration of the tyloxapol is about 0.02 w/v %.
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`37. (New)
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`The aqueous liquid according to claim 36, wherein the formulation further
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`includes one or more additives selected from the group consisting of a preservative, buffer,
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`thickener, stabilizer, chelating agent, and pH controlling agent.
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`38. (New)
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`The aqueous liquid preparation according to claim 37, wherein said
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`preservative is benzalkonium chloride; wherein said buffer is boric acid and/or sodium borate;
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`wherein said thickener is polyvinylpyrrolidone; wherein said chelating agent is sodium edetate;
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`and wherein said pH controlling agent is sodium hydroxide.
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`39. (New)
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`A method for stabilizing 2-amino~3-(4-bromobenzoyl)phenylacetic acid or
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`a pharmacologically acceptable salt thereof or a hydrate thereof in an aqueous liquid preparation,
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`which comprises incorporating tyloxapol or polyethylene glycol monostearate into an aqueous
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`liquid preparation containing 2—amino-3—(4—brornobenzoyl)pheny1acetic acid or a
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`pharmacologically acceptable salt thereof or a hydrate thereof.
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`Page 4 of 6
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`Page 4 of 6
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`40. (New)
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`A method for inhibiting decrease in preservative effect of a preservative in
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`an aqueous liquid preparation of 2-amino-3-(4-bromobenzoyl)phenylacetic acid or a
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`pharmacologically acceptable salt thereof or a hydrate thereof, which comprises incorporating
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`tyloxapol or polyethylene glycol monostearate into an aqueous liquid preparation containing 2-
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`amino-3-(4-bromobenzoyl)phenylacetic acid or a pharmacologically acceptable salt thereof or a
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`hydrate thereof and a preservative.
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`Page 5 of 6
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`Page 5 of 6
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`REMARKS
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`Claims 1-18 are cancelled without prejudice and new claims 19-40 are added. The new
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`claims are supported by the original claims and the disclosure of the specification.
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`Favorable action on the merits is solicited.
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`Respectfully submitted,
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`Shirou SAWA et al.
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`Warren M. Cheek, Jr.
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`Registration No. 33,367
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`Attorney for Applicants
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`WMC/dlk
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`Washington, D.C. 20006-1021
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`Telephone (202) 721—8200
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`Facsimile (202) 721-8250
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`March 20, 2007
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`Page 6 of 6
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`Page 6 of 6