`Attorney Docket No.: 11285.0056-00000
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`AMENDMENTS TO THE CLAIMS
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`Please amend claims 24, 32, 34, 36, 44, and 46. Please add new claims 54-57.
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`Please cancel claims 25, 28, 31, 33, 37, 40, 43, 45, and 48-53 without prejudice or
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`disclaimer. This listing of claims will replace all prior versions and listings of claims in
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`the application.
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`Claims 1-23 (Cancelled)
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`24.
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`(Currently amended) A method for treating a hormonal dependent benign or
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`malignant disease of the breast or reproductive tract comprising administering
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`intramuscularly to a human in need of such treatment a formulation comprising:
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`at least 45 mgmr.i. of fulvestrant;
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`a mixture of from 17 23% w/v of ethanol and benzyl aloohol;
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`12 18% w./v of benzyl benzoate; and
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`about 50 mgmr1 of fulvestrant;
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`about 10% w/v of ethanol:
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`about 10% w/v of benzyl alcohol:
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`about 15% w/v of benzyl benzoate: and ·
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`a sufficient amount of castor oil vehicle;
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`wherein the method achieves a therapeutically significant blood plasma
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`fulvestrant concentration of at.least 2.5 ngmr1 for at least twe-four weeks.
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`25.
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`(Cancelled)
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`- 2 -
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`Application No.: 12/285,887
`Attorney Docket No.: 11285.0056-00000
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`26.
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`(Previously presented) The method of claim 24, wherein the therapeutically
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`significant blood plasma fulvestrant concentration is at least 8.5 ngmr1
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`.
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`27.
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`(Previously presented) The method of claim 24, wherein the hormonal
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`dependent benign or malignant disease of the breast or reproductive tract is
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`breast cancer.
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`28.
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`(Cancelled)
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`29.
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`(Previously presented) The method of claim 24, wherein the method comprises
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`administering intramuscularly to a human in need of such treatment 5 ml of the
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`formulation.
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`30.
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`(Previously presented) The method of claim 24, wherein the method further
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`comprises once monthly administration of the formulation.
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`31.
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`(Cancelled)
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`32.
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`(Currently amended) The method of olaim J1 claim 26, wherein the hormonal
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`dependent benign or malignant disease of the breast or reproductive tract is
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`breast cancer.
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`33.
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`(Cancelled)
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`34.
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`(Currently amended) The method of olaim aa claim 32, wherein the method
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`comprises administering intramuscularly to a human in need of such treatment 5
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`ml of the formulation.
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`- 3 -
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`Application No.: 12/285,887
`Attorney Docket No.: 11285.0056-00000
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`35.
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`(Previously presented) The method of claim 34, wherein the method further
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`comprises once monthly administration of the formulation.
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`36.
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`(Currently amended) A method for treating a hormonal dependent benign or
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`malignant disease of the breast or reproductive tract comprising administering
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`intramuscularly to a human in need of such treatment a formulation consisting
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`essentially of:
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`at least 45 mgml4 of fulvestrant;
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`a mixture of from 17 2J% w/v of ethanol and benzyl alcohol;
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`12 18% \v./v of benzyl benzoate; and
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`a sufficient amount of castor oil vehicle;
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`about 50 mqmr1 of fulvestrant:
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`about 10% w/v of ethanol:
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`about 10% w/v of benzyl alcohol:
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`about 15% w/v of benzyl benzoate: and
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`wherein the method achieves a therapeutically significant blood plasma
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`fulvestrant concentration of at least 2.5 ngmr1 for at least !we-four weeks.
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`37.
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`(Cancelled)
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`38.
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`(Previously presented) The method of claim 36, wherein the therapeutically
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`significant blood plasma fulvestrant concentration is at least 8.5 ngmr1
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`.
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`- 4 -
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`
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`Application No.: 12/285,887
`Attorney Docket No.: 11285.0056-00000
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`39.
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`(Previously presented) The method of claim 36, wherein the hormonal
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`dependent benign or malignant disease of the breast or reproductive tract is
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`breast cancer.
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`40.
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`(Cancelled)
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`41.
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`(Previously presented) The method of claim 36, wherein the method comprises
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`administering intramuscularly to a human in need of such treatment 5 ml of the
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`formulation.
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`42.
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`(Previously presented) The method of claim 36, wherein the method further
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`comprises once monthly administration of the formulation.
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`43.
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`(Cancelled)
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`44.
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`(Currently amended) The method of claiFfl 4d claim 38, wherein the hormonal
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`dependent benign or malignant disease of the breast or reproductive tract is
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`breast cancer.
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`45.
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`(Cancelled)
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`46.
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`(Currently amended) The method of claiFfl 45 claim 44, wherein the method
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`comprises administering intramuscularly to a human in need of such treatment 5
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`ml of the formulation.
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`47.
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`(Previously presented) The method of claim 46, wherein the method further
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`comprises once monthly administration of the formulation.
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`- 5 -
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`Application No.: 12/285,887
`Attorney Docket No.: 11285.0056-00000
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`Claims 48-53 (Cancelled)
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`54.
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`(New) The method according to claim 24, wherein the formulation is administered
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`in a divided dose.
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`55.
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`(New) The method according to claim 35, wherein the formulation is administered
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`in a divided dose.
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`56.
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`(New) The method according to claim 36, wherein the formulation is administered
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`in a divided dose.
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`57.
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`(New) The method according to claim 47, wherein the formulation is administered
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`in a divided dose.
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`- 6 -
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