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`Attorney Docket No. 2004__1016A
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`Serial No. 10/500,354
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`Filed June 30, 2004
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`AQUEOUS LIQUID PREPARATIONS AND
`LIGHT-STABILIZED AQUEOUS LIQUID
`PREPARATIONS
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`Group Art Unit 1614
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`Examiner Charlesworth E. Rae
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`Mail Stop: Amendment
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`SUPPLEMENTAL AMENDMENT
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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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`Further to Applicants’ Response dated October 9, 2007, please amend the above-
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`identified application as follows:
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`MYLAN EX. 1020, Page 1
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`MYLAN Ex. 1020, Page 1
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`Amendments to the Specification
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`Page 10, lines 5-17, please rewrite as follows:
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`The appearance after light irradiation did not change from that immediately after
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`preparation and was pale yellow and clear for Formulation 10 (pH 4) and Formulation 11 (pH
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`8.5) comprising sodium chloride. In addition, the appearance did not change from gag
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`immediately after preparation and was colorless and clear for Formulation 12 having a
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`bepotastine besilate concentration of 0.1 w/v%. These results and the results of Formulation 7
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`(pH 6.8) in Experimental Example 2 indicate that addition of sodium chloride, which is a water-
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`soluble metal chloride, improves light stability of bepotastine besilate at pH 4-8.5. In addition,
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`they indicate that the light-stability of bepotastine besilate is improved in the concentration range
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`of 0.1 w/v% - 1.5 w/v%.
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`MYLAN EX. 1020, Page 2
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`MYLAN Ex. 1020, Page 2
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`Amendments to the Claims
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`1. (Currently amended)
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`An aqueous liquid preparation comprising (+)—(S)—4—[4-[(4-
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`chlorophenyl)(2-pyridyl)methoxy]piperidino]butyric acid or a pharmacologically acceptable acid
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`addition salt thereof, and a water-soluble metal chloride in an agueous solution.
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`2. (Original)
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`The aqueous liquid preparation of claim 1, wherein the metal chloride has
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`a concentration selected from the range of a lower limit concentration of 0.15 w/v% and an upper
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`limit concentration of 1.5 w/v%.
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`3. (Previously presented)
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`The aqueous liquid preparation of claim 1, wherein the metal
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`chloride is at least one kind selected from sodium chloride, potassium chloride and calcium
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`chloride.
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`4. (Previously presented)
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`The aqueous liquid preparation of claim 1, wherein the (+)-(S)-4-
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`[4-[(4—chlorophenyl)(2-pyridyl)methoxy]piperidino]butyric acid or the pharmacologically
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`acceptable acid addition salt thereof has a concentration selected from the range of a lower limit
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`concentration of 0.1 w/v% and an upper limit concentration of 2.0 w/v%.
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`5. (Previously presented)
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`The aqueous liquid preparation of claim 1, which is an acid
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`addition salt of (+)-(S)-4-[4-[(4-chlorophenyl)(2-pyridyl)methoxy]piperidino]butyric acid.
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`6. (Original)
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`The aqueous liquid preparation of claim 5, wherein the acid addition salt is
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`monobenzenesulfonate.
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`7. (Previously presented)
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`The aqueous liquid preparation of claim 1, wherein the aqueous
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`liquid preparation has a pH in the range of 4-8.5.
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`8. (Previously presented)
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`The aqueous liquid preparation of claim 1, which is an eye drop.
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`9. (Previously presented)
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`The aqueous liquid preparation of claim 1, which is a nasal drop.
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`MYLAN EX. 1020, Page 3
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`MYLAN Ex. 1020, Page 3
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`
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`10. (Currently amended)
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`An aqueous eye drop comprising (+)-(S)-4-[4-[(4-
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`chloropheny1)(2-pyridyl)methoxy]piperidino]butyric acid monobenzenesulfonate and sodium
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`chloride at not less than 0.2 w/v% and not more than 0.8 w/v% in an agueous solution.
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`11. (Original)
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`A method of light-stabilizing (+)-(S)-4-[4-[(4-ch1orophenyl)(2-
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`pyridyl)methoxy]piperidino]butyric acid in an aqueous solution, which comprises adding a
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`water-soluble metal chloride to an aqueous solution comprising (+)-(S)-4-[4-[(4-
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`chlorophenyl)(2-pyridyl)methoxy]piperidino]butyric acid or a pharmacologically acceptable acid
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`addition salt thereof.
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`MYLAN EX. 1020, Page 4
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`MYLAN Ex. 1020, Page 4
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`REMARKS
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`A further editorial change has been effected to the paragraph appearing on page 10, line
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`Claims 1 and 10 have been further amended to specify that the preparation is “in an
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`aqueous solution”. This is responsive to the Examiner’s statement on page 4, lines 3-4 of the
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`Action that no patentable weight is given to the preamble of the former claims.
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`In addition, there is submitted herewith an executed Rule 132 Declaration of Dr.
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`Higashiyama. The Declaration sets forth the experiments of Experimental Examples 1-4 of the
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`specification. As discussed in Applicants’ response of October 9, 2007, these experiments show
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`the unexpected effect of this invention.
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`In view of the foregoing, favorable consideration and allowance is solicited.
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`Respectfully submitted,
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`Masayo HIGASHIYAMA
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`Bygai
`Warren M. Cheek
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`Registration No. 33,367
`Attorney for Applicant
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`WMC/dlk
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`Washington, D.C. 20006-1021
`Telephone (202) 721-8200
`Facsimile (202) 721-8250
`November 13, 2007
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`MYLAN EX. 1020, Page 5
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`MYLAN Ex. 1020, Page 5
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