IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
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`Docket No.: 2034311202653-US8
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`(PATENT)
`
`In re Patent Application of:
`Amir Shoj aei
`
`Application No.: 11!383,066
`
`Confirmation No.: 7083
`
`Filed: May 12, 2006
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`Art Unit: NIA
`
`For: CONTROLLED DOSE DRUG DELIVERY
`SYSTEM
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`Examiner: Not Yet Assigned
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`SECOND PRELIMINARY AMENDMENT
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`MS Amendment
`Commissioner for Patents
`
`P.O. Box 1450
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`Alexandria, VA 22313-1450
`
`Dear Sir:
`
`INTRODUCTORY COMIVIENTS
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`Prior to examination on the merits, please amend the above-identified U.S. patent
`
`application as follows:
`
`Amendments to the Claims are reflected in the listing of claims which begins on page 2
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`of this paper.
`
`Remarks begin on page 7 of this paper.
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`Amerigen Ex. 1006, p. 1
`Amerigen Ex. 1006, p.
`1
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`

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`Application No. 11!383,066
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`2
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`Docket No.: 20342.+'1202653-US8
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`LISTING OF CLAIMS
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`1.
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`(Original) A pharmaceutical composition comprising:
`
`(a)
`
`(b)
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`(C)
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`an immediate release bead comprising at least one amphetamine salt;
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`a first delayed release bead comprising at least one amphetamine salt; and
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`a second delayed release bead comprising at least one amphetamine salt;
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`wherein the first delayed release bead provides pulsed release of the at
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`least one
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`amphetamine salt and the second delayed release bead provides sustained release of the at least one
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`amphetamine salt.
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`2.
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`(Original) The pharmaceutical composition of claim 1, wherein the first delayed
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`release bead and the second delayed release bead comprise an enteric coating.
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`3.
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`(Original) The pharmaceutical composition of claim 2, wherein the enteric coating is
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`pH dependent.
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`4.
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`(Original) The pharmaceutical composition of claim 2, wherein the first delayed
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`release bead and the second delayed release bead comprise different enteric coatings.
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`5.
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`(Original) The pharmaceutical composition of claim 2, wherein the first delayed
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`release bead and the second delayed release bead comprise the same enteric coating.
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`6.
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`(Original) The pharmaceutical composition of claim 1, wherein the pharmaceutical
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`composition is bioequivalent to ADDERALL® XR followed by an immediate release amphetamine
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`formulation administered 8 hours after the ADDERALL® XR;
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`wherein the combined dosage of the ADDERALL® XR and the immediate release
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`formulation is equal to the dosage of the pharmaceutical composition.
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`7.
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`(Original) The pharmaceutical composition of claim 1, wherein administration of a
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`37.5 mg dose of the pharmaceutical composition to a human patient results in a d-amphetamine Cm“
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`of about 50 ng/ml.
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`Amerigen Ex. 1006, p. 2
`Amerigen Ex. 1006, p. 2
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`

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`Application No. 11!383,l}66
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`3
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`Docket No.: 2034211202653-USS
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`8.
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`(Original) The pharmaceutical composition of claim 1, wherein the d-amphetamine
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`area under the curve from time 0 to the last measured time (AUCo.1,,s,) after administration of a 37.5
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`mg dose of the pharmaceutical composition to a human patient is about 1058 ng-hrfml.
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`9.
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`(Original) The pharmaceutical composition of claim 1, wherein the d—amphetamine
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`area under the curve from time 0 to time infinity (AUCg.;.,;) after administration of a 37.5 mg dose of
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`the pharmaceutical composition to a human patient is about 1085 ng-hrfml.
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`10.
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`(Original) The pharmaceutical composition of claim 1, wherein the d-amphetamine
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`Tm, is about 8.2 hours after administration of a 37.5 mg dose of the pharmaceutical composition to
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`a human patient.
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`11.
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`(Original) The pharmaceutical composition of claim 1, wherein the I-amphetamine
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`Cum after administration of a 37.5 mg dose of the pharmaceutical composition to a human patient is
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`about 15 ng/ml.
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`12.
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`(Original) The pharmaceutical composition of claim 1, wherein the l—amphetamine
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`area under the curve from time 0 to the last measured time (AUC0_]a5;) after administration of a 37.5
`
`mg dose of the phannaceutical composition to a human patient is about 354 ng-hrfml.
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`13.
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`(Original) The pharmaceutical composition of claim 1, wherein the {amphetamine
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`area under the curve from time 0 to time infinity (AUCo.i,.f) after administration of a 37.5 mg dose of
`
`the pharmaceutical composition to a human patient is about 373 ng-hrlml.
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`14.
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`(Original) The pharmaceutical composition of claim 1, wherein the I-amphetamine
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`Tum is about 8.4 hours after administration of a 37.5 mg dose of the pharmaceutical composition to
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`a human patient.
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`15.
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`(Original) The pharmaceutical composition of claim 1, wherein the immediate
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`release bead and at least one delayed release bead are present on a single core.
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`16.
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`(Original) The pharmaceutical composition of claim 1, wherein the immediate
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`release bead and at least one delayed release bead are present on different cores.
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`Amerigen Ex. 1006, p. 3
`Amerigen Ex. 1006, p. 3
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`

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`Application No. l 1a’383,066
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`4
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`Docket No.: 203-‘-|2ll202a653-US8
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`17.
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`(Original) The pharmaceutical composition of claim 1, wherein the at least one
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`amphetamine salt is coated onto a core.
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`18.
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`(Original) The pharmaceutical composition of claim 1, wherein the at
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`least one
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`amphetamine salt is incorporated into a core.
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`19.
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`(Original) The pharmaceutical composition of claim 2, which further comprises a
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`protective layer over at least one enteric coating.
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`20.
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`(Original) The pharmaceutical composition of claim 2, which further comprises a
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`protective layer between the amphetamine salt and at least one enteric coating.
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`21.
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`(Original) The pharmaceutical composition of claim 1, wherein the at
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`least one
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`amphetamine salt
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`is
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`selected from the group consisting of dextroamphetamine sulfate,
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`dextroamphetamine saccharate, amphetamine aspartate monohydrate, amphetamine sulfate, and
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`mixtures thereof.
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`22.
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`(Original) The pharmaceutical composition of claim 21, wherein the at least one
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`amphetamine salt
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`is a mixture of dextroamphetamine sulfate, dextroamphetamine saccharate,
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`amphetamine aspartate monohydrate, and amphetamine sulfate.
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`23.
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`(Original) The pharmaceutical composition of claim 1, wherein the composition does
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`not exhibit a food effect.
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`24.
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`(Original) The composition of claim 6, wherein the amount of at
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`least one
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`amphetamine salt is about 12.5 mg.
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`25.
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`(Original) The composition of claim 6, wherein the amount of at
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`least one
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`amphetamine salt is about 18.75 mg.
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`26.
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`(Original) The composition of claim 6, wherein the amount of at
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`least one
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`amphetamine salt is about 25 mg.
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`Amerigen Ex. 1006, p. 4
`Amerigen Ex. 1006, p. 4
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`

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`Application No. lL~’383,066
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`Docket No.: 20342/1202653-US8
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`27.
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`(Original) The composition
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`of
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`claim
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`wherein
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`the
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`amount of at
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`least
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`one
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`amphetamine salt is about 31.25 mg.
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`28.
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`(Original) The composition
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`of
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`claim
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`wherein the amount of at
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`least
`
`one
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`amphetamine salt is about 37.5 mg.
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`29.
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`(Original) The composition
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`of
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`claim
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`wherein the amount of at
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`least
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`One
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`amphetamine salt is about 43.75 mg.
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`30.
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`(Original) The composition
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`of
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`claim
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`wherein the amount of at
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`least
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`0118
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`amphetamine salt is about 50 mg.
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`31.
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`(Original) The composition
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`of
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`claim
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`wherein the amount of at
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`least
`
`0116
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`amphetamine salt is about 62.5 mg.
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`32.
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`(Original)
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`The composition
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`of
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`claim
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`wherein
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`the
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`amount of at
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`least
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`0116
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`amphetamine salt is about 75 mg.
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`33-58. (Canceled)
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`59.
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`(New) A pharmaceutical composition comprising:
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`at least one amphetamine salt and a pharmaceutically acceptable carrier;
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`wherein the composition provides an about bioequivalent plasma level of amphetamine in a
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`patient compared to an equivalent amount of at least one amphetamine salt contained in the
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`combination of ADDERALL® E and an immediate release amphetamine salt composition when
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`the immediate release composition is administered to the patient about 8 hours after the
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`ADDERALL® E.
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`60.
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`(New) The composition of claim 59, wherein the composition provides an about
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`bioequivalent plasma level of d-amphetamine in the patient compared to an equivalent amount of at
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`least one amphetamine salt contained in the combination of ADDERALL® ER; and an immediate
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`release amphetamine salt composition when the immediate release composition is administered to
`
`the patient about 8 hours after the ADDERALL® Xi.
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`Amerigen Ex. 1006, p. 5
`Amerigen Ex. 1006, p. 5
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`

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`Application No. 1Lr3s3,o66
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`6
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`DucketNo.: 2.034?.+‘l202653—US8
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`6].
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`(New) The composition of claim 59, wherein the composition provides an about
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`bioequivalent plasma level of 1-amphetamine in the patient compared to an equivalent amount of at
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`least one amphetamine salt contained in the combination of ADDERALL® Q and an immediate
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`release am hetamine salt com sition when the immediate release com osition is administered to
`P
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`the patient about 8 hours after the ADDERALL® E.
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`Amerigen Ex. 1006, p. 6
`Amerigen Ex. 1006, p. 6
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`

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`Application No. 111383366
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`7
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`Docket No.: 2034211202653-US8
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`REMARKS
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`Claims 1-32 and 59-61 are pending with this amendment.
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`Claims 33-35 were
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`inadvertently canceled in the First Preliminary Amendment, filed October 24, 2006. To correct this
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`inadvertent error, original claims 33~35 are added back as new claims 59-61. To correct a
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`typographical error in original claims 33-35, new claims 59-61 recite “ADDERALL® Z(__R_.”
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`Support for this correction can be found in the specification at, for example, page 5, lines 8-10 and
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`page 34, line 21 to page 39, line 7. No new matter has been added.
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`Dated: October 26, 2006
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`Respectfully submitted,
`
`B 1
`
`. Zagar
`Paul
`Registration No.: 52,392
`DARBY & DARBY P.C.
`
`P.O. Box 5257
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`New York, New York 10150-5257
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`(212) 527-7700
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`(212) 527-7701 (Fax)
`Attorneys7AgeI1ts For Applicant
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`Amerigen Ex. 1006, p. 7
`Amerigen Ex. 1006, p. 7