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Application No.: 12/285,887
`Attorney Docket No.: 11285.0056-00000
`
`AMENDMENTS TO THE CLAIMS
`
`Please amend claims 24, 32, 34, 36, 44, and 46. Please add new claims 54-57.
`
`Please cancel claims 25, 28, 31, 33, 37, 40, 43, 45, and 48-53 without prejudice or
`
`disclaimer. This listing of claims will replace all prior versions and listings of claims in
`
`the application.
`
`Claims 1-23 (Cancelled)
`
`24.
`
`(Currently amended) A method for treating a hormonal dependent benign or
`
`malignant disease of the breast or reproductive tract comprising administering"
`
`intramuscularly to a human in need of such treatment a formulation comprising:
`
` 4
`
`.
`
`H ¥EoE,E||H III‘;
`
`
`
`°;
`
`about 50 mgml" of fulvestrant;
`
`about 10% w/v of ethanol;
`
`about 10% w/v of benzyl alcohol;
`
`about 15% w/v of benzyl benzoate; and -
`
`a sufficient amount of castor oil vehicle;
`
`wherein the method achieves a therapeutically significant blood plasma
`
`fulvestrant concentration of atleast 2.5 ngml" for at least twefour weeks.
`
`25.
`
`(Cancelled)
`
`

`
`Application No.: 12/285,887
`Attorney Docket No.: 11285.0056-00000
`
`26.
`
`27.
`
`(Previously presented) The method of claim 24, wherein the therapeutically
`
`significant blood plasma fulvestrant concentration is at least 8.5 ngml“.
`
`(Previously presented) The method of claim 24, wherein the hormonal
`
`dependent benign or malignant disease of the breast or reproductive tract is
`
`breast cancer.
`
`28.
`
`I
`
`(Cancelled)
`
`29.
`
`(Previously presented) The method of claim 24, wherein the method comprises
`
`administering intramuscularly to a human in need of such treatment 5 mL of the
`
`formulation.
`
`30.
`
`31.
`
`32.
`
`(Previously presented) The method of claim 24, wherein the method further
`
`comprises once monthly administration of the formulation.
`
`(Cancelled)
`
`(Currently amended) The method of+:-laim—34 claim 26, wherein the hormonal
`
`dependent benign or malignant disease of the breast or reproductive tract is
`
`breast cancer.
`
`33.
`
`(Cancelled)
`
`34.
`
`(Currently amended) The method of—elaim—33 claim 32, wherein the method
`
`comprises administering intramuscularly to a human in need of such treatment 5
`
`mL of the formulation.
`
`

`
`Application No.: 12/285,887
`Attorney Docket No.: 11285.0056-00000
`
`35.
`
`36.
`
`(Previously presented) The method of claim 34, wherein the method further
`
`comprises once monthly administration of the formulation.
`
`(Currently amended) A method for treating a hormonal dependent benign or
`
`malignant disease of the breast or reproductive tract comprising administering
`
`intramuscularly to a human in need of such treatment a formulation consisting
`
`essentially of:
`
` 4
`
`about 50 mgml" of fulvestrant;
`
`about 10% w/v of ethanol;
`
`about 10% w/v of benzyl alcohol;
`
`about 15% w/v of benzyl benzoate; and
`
`wherein the method achieves a therapeutically significant blood plasma
`
`'
`
`fulvestrant concentration of at least 2.5 ngml“ for at least twefour weeks.
`
`37.
`
`(Cancelled)
`
`38.
`
`(Previously presented) The method of claim 36, wherein the therapeutically
`
`significant blood plasma fulvestrant concentration is at least 8.5 ngml“.
`
`

`
`Application No.: 12/285,887
`Attorney Docket No.: 11285.0056-00000
`
`39.
`
`(Previously presented) The method of claim 36, wherein the hormonal
`
`dependent benign or malignant disease of the breast or reproductive tract is
`
`40.
`
`41.
`
`breast cancer.
`
`(Cancelled)
`
`(Previously presented) The method of claim 36, wherein the method comprises
`
`administering intramuscularly to a human in need of such treatment 5 mL of the
`
`formulation.
`
`42.
`
`(Previously presented) The method of claim 36, wherein the method further
`
`comprises once monthly administration of the formulation.
`
`.43.
`
`44.
`
`(Cancelled)
`
`(Currently amended) The method of—elaim-43 claim 38, wherein the hormonal
`
`dependent benign or malignant ‘disease of the breast or reproductive tract is
`
`breast cancer.
`
`45.
`
`(Cancelled)
`
`46.
`
`(Currently amended) The method of4;laim—45 claim 44, wherein the method I
`
`comprises administering intramuscularly to a human in need of such treatment 5
`
`mL of the formulation.
`
`47.
`
`(Previously presented) The method of claim 46, wherein the method further
`
`comprises once monthly administration of the formulation.
`
`

`
`Application No.: 12/285,887
`Attorney Docket No.: 11285.0056-00000
`
`Claims 48-53 (Cancelled)
`
`54.
`
`(New) The method according to claim 24, wherein the formulation is administered
`
`in a divided dose.
`
`55.
`
`(New) The method according to claim 35, wherein the formulation is administered
`
`in a divided dose.
`
`56.
`
`(New) The method according to claim 36, wherein the formulation is administered
`
`in a divided dose.
`
`57.
`
`(New) The method according to claim 47, wherein the formulation is administered
`
`in a divided dose.

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