IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`Shirou SAW A et al.
`
`Serial No. 10/525,006
`
`Filed March 28, 2005
`
`AQUEOUS LIQUID PREPARATION
`CONTAINING 2-AMIN0-3-(4-
`BROMOBENZOYL)PHENYLACETIC ACID
`
`Confirmation No. 1756
`
`Attorney Docket No. 2005_0232A
`
`Group Art Unit 1615
`
`Examiner Not Yet Assigned
`
`Mail Stop: Amendment
`
`THE COMMISSIONER IS AUTHORIZED
`TO CHARGE ANY DEFICIENCY IN THE
`FEE FOR THIS PAPER TO DEPOSIT
`SUPPLEMENTAL PRELIMINARY AMEN{)~lfW. 23-0975.
`
`Commissioner for Patents
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`Sir:
`
`Please amend the above-identified application as follows:
`
`Page 1 of 6
`
`SENJU EXHIBIT 2083
`INNOPHARMA v. SENJU
`IPR2015-00903
`
`
`
`Shirou SAW A et al.
`
`Serial No. 10/525,006
`
`Filed March 28, 2005
`
`AQUEOUS LIQUID PREPARATION
`CONTAINING 2-AMIN0-3-(4-
`BROMOBENZOYL)PHENYLACETIC ACID
`
`Confirmation No. 1756
`
`Attorney Docket No. 2005_0232A
`
`Group Art Unit 1615
`
`Examiner Not Yet Assigned
`
`Mail Stop: Amendment
`
`THE COMMISSIONER IS AUTHORIZED
`TO CHARGE ANY DEFICIENCY IN THE
`FEE FOR THIS PAPER TO DEPOSIT
`SUPPLEMENTAL PRELIMINARY AMEN{)~lfW. 23-0975.
`
`Commissioner for Patents
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`Sir:
`
`Please amend the above-identified application as follows:
`
`Page 1 of 6
`
`SENJU EXHIBIT 2083
`INNOPHARMA v. SENJU
`IPR2015-00903
`
`
`
`Amendments to the Claims
`
`1-18. (Cancelled)
`
`19. (New)
`
`An aqueous liquid preparation comprising 2-amino-3-( 4-
`
`bromobenzoyl}phenylacetic acid or a pharmacologically acceptable salt thereof or a hydrate
`
`thereof, and an alkyl aryl polyether alcohol type polymer or a polyethylene glycol fatty acid
`
`ester.
`
`20. (New)
`
`The aqueous liquid preparation according to claim 19, wherein the
`
`alkyl aryl polyether alcohol type polymer is tyloxapol;
`
`wherein the concentration of the tyloxapol is selected from a range of about 0.01 w/v %
`
`to about 0.5 w/v %; and
`
`wherein the concentration of the 2-amino-3-(4-bromobenzoyl)phenylacetic acid or a
`
`pharmacologically acceptable salt thereof or a hydrate thereof is selected from a range of about
`
`0.01 to about 0.5 w/v %.
`
`21. (New)
`
`The aqueous liquid preparation according to claim 20, wherein the
`
`pharmacologically acceptable salt of 2-amino-3-( 4-bromobenzoyl)phenylacetic acid is a sodium
`
`salt.
`
`22. (New)
`
`The aqueous liquid preparation according to claim 21, wherein the
`
`concentration of the 2-amino-3-(4-bromobenzoyl)phenylacetic acid sodium salt is selected from
`
`a range of about 0.05 to about 0.2 w/v %.
`
`23. (New)
`
`The aqueous liquid preparation according to claim 22, wherein the
`
`concentration of the tyloxapol is selected from a range of about 0.01 w/v% to about 0.3 w/v %.
`
`24. (New)
`
`The aqueous liquid preparation according to claim 23, wherein the
`
`concentration of the 2-amino-3-(4-bromobenzoyl)phenylacetic acid sodium salt is about
`
`0.1 w/v %.
`
`2
`
`Page 2 of 6
`
`
`
`25. (New)
`
`The aqueous liquid preparation according to claim 24, wherein the
`
`concentration of the tyloxapol is about 0.02 w/v %.
`
`26. (New)
`
`The aqueous liquid preparation according to claim 25, wherein the
`
`formulation further includes one or more additives selected from the group consisting of a
`
`preservative, buffer, thickener, stabilizer, chelating agent, and pH controlling agent.
`
`27. (New)
`
`The aqueous liquid preparation according to claim 26, wherein said
`
`preservative is benzalkonium chloride; wherein said buffer is boric acid and/or sodium borate;
`
`wherein said thickener is polyvinylpyrrolidone; wherein said stabilizer is sodium sulfite; wherein
`
`said chelating agent is sodium edetate; and wherein said pH controlling agent is sodium
`
`hydroxide.
`
`28.(New)
`
`The aqueous liquid preparation according to claim 27, wherein the pH is
`
`from about 7 to about 9.
`
`29. (New)
`
`The aqueous liquid preparation according to claim 28, wherein the pH is
`
`from about 7.5 to about 8.5.
`
`30. (New)
`
`The aqueous liquid preparation according to claim 27, wherein said liquid
`
`preparation is in the form of an eye drop.
`
`31. (New)
`
`The aqueous liquid preparation according to claim 23, wherein the
`
`concentration of the 2-amino-3-(4-bromobenzoyl)phenylacetic acid sodium salt is about 0.2 w/v
`
`%.
`
`32. (New)
`
`The aqueous liquid preparation according to claim 31, wherein the
`
`concentration of the tyloxapol is about 0.3 w/v %.
`
`3
`
`Page 3 of 6
`
`
`
`. '
`
`33. (New)
`
`The aqueous liquid preparation according to claim 32, wherein the
`
`formulation further includes one or more additives selected from the group consisting of a
`
`preservative, buffer, thickener, stabilizer, chelating agent, and pH controlling agent.
`
`34. (New)
`
`The aqueous liquid preparation according to claim 33, wherein said
`
`preservative is benzalkonium chloride; wherein said buffer is boric acid and/or sodium borate;
`
`wherein said thickener is polyvinylpyrrolidone; wherein said stabilizer is sodium sulfite; wherein
`
`said chelating agent is sodium edetate; and wherein said pH controlling agent is sodium
`
`hydroxide.
`
`35. (New)
`
`The aqueous liquid preparation according to claim 34, wherein said liquid
`
`preparation is in the form of an eye drop.
`
`36. (New)
`
`The aqueous liquid preparation according to claim 31, wherein the
`
`concentration of the tyloxapol is about 0.02 w/v %.
`
`37. (New)
`
`The aqueous liquid according to claim 36, wherein the formulation further
`
`includes one or more additives selected from the group consisting of a preservative, buffer,
`
`thickener, stabilizer, chelating agent, and pH controlling agent.
`
`38.(New)
`
`The aqueous liquid preparation according to claim 3 7, wherein said
`
`preservative is benzalkonium chloride; wherein said buffer is boric acid and/or sodium borate;
`
`wherein said thickener is polyvinylpyrrolidone; wherein said chelating agent is sodium edetate;
`
`and wherein said pH controlling agent is sodium hydroxide.
`
`39. (New)
`
`A method for stabilizing 2-amino-3-(4-bromobenzoyl)phenylacetic acid or
`
`a pharmacologically acceptable salt thereof or a hydrate thereof in an aqueous liquid preparation,
`
`which comprises incorporating tyloxapol or polyethylene glycol monostearate into an aqueous
`
`liquid preparation containing 2-amino-3-( 4-bromobenzoyl)phenylacetic acid or a
`
`pharmacologically acceptable salt thereof or a hydrate thereof.
`
`4
`
`Page 4 of 6
`
`
`
`40. (New)
`
`A method for inhibiting decrease in preservative effect of a preservative in
`
`an aqueous liquid preparation of2-amino-3-(4-bromobenzoyl)phenylacetic acid or a
`
`pharmacologically acceptable salt thereof or a hydrate thereof, which comprises incorporating
`
`tyloxapol or polyethylene glycol monostearate into an aqueous liquid preparation containing 2-
`
`amino-3-( 4-bromobenzoyl)phenylacetic acid or a pharmacologically acceptable salt thereof or a
`
`hydrate thereof and a preservative.
`
`5
`
`Page 5 of 6
`
`
`
`. '
`
`REMARKS
`
`Claims 1-18 are cancelled without prejudice and new claims 19-40 are added. The new
`
`claims are supported by the original claims and the disclosure of the specification.
`
`Favorable action on the merits is solicited.
`
`Respectfully submitted,
`
`Shirou SAW A et al.
`
`By:~_L{)_~a_'-~--++--
`
`Warren M. Chdl()f:t)
`Registration No. 33,367
`Attorney for Applicants
`
`WMC/dlk
`Washington, D.C. 20006-1021
`Telephone (202) 721-8200
`Facsimile (202) 721-8250
`March 20, 2007
`
`6
`
`Page 6 of 6
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