Docket No.: 085199-0034
`
`PATENT
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`In re Application of:
`Amir SHOJAEI
`
`Application No.: 11/383,066
`Filed: May 12, 2006
`
`:
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`Customer Number: 20277
`Confirmation Number: 7083
`
`Group Art Unit: 1618
`Examiner: Micah Paul YOUNG
`
`For:
`
`CONTROLLED DOSE DRUG DELIVERY SYSTEM
`
`AMENDMENT
`
`Mail Stop Amendment
`Commissioner for Patents
`
`P.O. Box 1450
`
`Alexandria, VA 22313 -1 450
`
`Sir:
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`INTRODUCTION
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`This is in response to the non-final Office Action mailed October 2, 2009.
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`A petition for a One-Month Extension of Time accompanies this response.
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`Amendments to the Specification begin on page 2 of this paper.
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`Amendments to the Claims are reflected in the listing of the claims beginning on page 3
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`of this paper.
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`Remarksmrguments begin on page 7 of this paper.
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`Amerigen Ex. 1008, p. 1
`Amerigen Ex. 1008, p.
`1
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`

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`Application No.:
`
`l1!383,066
`
`Docket No.: 085199-0034
`
`Amendments to the Specification
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`Please replace the paragraph beginning at page 16, line 7 with the following paragraph:
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`“Immediate” and “delayed” release refer to the onset of release in relationship to
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`administration of the drug. “Immediate” means that the release of drug begins very soon,
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`within a relatively short time afier administration, e.g. a few minutes or less. “Delayed”
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`means that the release of drug is postponed, and begins or is triggered some period of
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`time after administration (e.g., the lag time), typically a relatively long period of time,
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`e.g- more than one hour.
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`2
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`Amerigen Ex. 1008, p. 2
`Amerigen Ex. 1008, p. 2
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`

`

`Application No.:
`
`ll)'383,066
`
`Docket No.: 085199-0034
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`Amendments to the Claims
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`1.
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`(Original) A pharmaceutical composition comprising: (a) an immediate release
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`bead comprising at least one amphetamine salt; (b) a first delayed release bead comprising at
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`least one amphetamine salt; and (c) a second delayed release bead comprising at least one
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`amphetamine salt; wherein the first delayed release bead provides pulsed release of the at least
`
`one amphetamine salt and the second delayed release bead provides sustained release of the at
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`least one 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
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`coating is 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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`7.
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`(Canceled)
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`(Original) The pharmaceutical composition of claim 1, wherein administration of
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`a 37.5 mg dose of the pharmaceutical composition to a human patient results in a d-amphetamine
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`Cm” of about 50 ng/ml.
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`8.
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`(Original) The pharmaceutical composition of claim 1, wherein the d-
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`amphetamine area under the curve from time 0 to the last measured time (AUCo.|a5;) after
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`administration of a 37.5 mg dose of the pharmaceutical composition to a human patient is about
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`1058 nghr/ml.
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`9.
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`(Original) The pharmaceutical composition of claim 1, wherein the d-
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`amphetamine area under the curve from time 0 to time infinity (AUCg-;,,f) after administration of
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`a 37.5 mg dose of the pharmaceutical composition to a human patient is about 1035 nghr/ml.
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`3
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`Amerigen Ex. 1008, p. 3
`Amerigen Ex. 1008, p. 3
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`

`

`Application No.:
`
`ll!383,066
`
`Docket No.: 085199-0034
`
`10.
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`(Original) The pharmaceutical composition of claim 1, wherein the d-
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`amphetamine Tm,‘
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`is about 8.2 hours after administration of a 37.5 mg dose of the
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`pharmaceutical composition to a human patient.
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`11.
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`(Original) The pharmaceutical composition of claim 1, wherein the 1-
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`arnphetamine Cm-ax after administration of a 37.5 mg dose of the pharmaceutical composition to a
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`human patient is about 15 ng/ml.
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`12.
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`(Original) The pharmaceutical composition of claim 1, wherei.n the
`
`l—
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`amphetamine area under the curve from time 0 to the last measured time (AUCo-1a5.) after
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`administration of a 37.5 mg dose of the pharmaceutical composition to a human patient is about
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`354 nghr/ml.
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`13.
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`(Original) The pharmaceutical composition of claim 1, wherein the
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`l-
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`arnphetamine area under the curve from time 0 to time infinity (AUCo-[nf) after administration of
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`a 37.5 mg dose of the pharmaceutical composition to a human patient is about 373 nghr/ml.
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`14.
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`(Original) The pharmaceutical
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`composition of claim 1, wherein the 1-
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`amphetamine Tmx is about 8.4 hours after administration of a 37.5 mg dose of the
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`pharmaceutical composition to 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 head are present on different cores.
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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 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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`4
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`Amerigen Ex. 1008, p. 4
`Amerigen Ex. 1008, p. 4
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`

`

`Application No.:
`
`ll!383,066
`
`Docket No.: 035199-0034
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`20.
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`(Original) The pharmaceutical composition of claim 2, which fiirther 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 least one
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`amphetamine salt
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`is 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 is a mixture of dextroamphetamine sulfate, dextroamphetamjne 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
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`does not exhibit a food effect.
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`24.
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`(Currently amended) The composition of claim [6] 1, wherein the amount of at
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`least one amphetamine salt is about 12.5 mg.
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`25.
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`(Currently amended) The composition of claim [6] _I_, wherein the amount of at
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`least one amphetamine salt is about 18.75 mg.
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`26.
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`(Currently amended) The composition of claim [6] 1, wherein the amount of at
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`least one amphetamine salt is about 25 mg.
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`27.
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`(Currently amended) The composition of claim [6] 1, wherein the amount of at
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`least one amphetamine salt is about 31.25 mg.
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`28.
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`(Currently amended) The composition of claim [6] 1, wherein the amount of at
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`least one amphetamine salt is about 37.5 mg.
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`29.
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`(Currently amended) The composition of claim [6] 1, wherein the amount of at
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`least one amphetamine salt is about 43.75 mg.
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`30.
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`(Currently amended) The composition of claim [6] L, wherein the amount of at
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`least one amphetamine salt is about 50 mg.
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`5
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`Amerigen Ex. 1008, p. 5
`Amerigen Ex. 1008, p. 5
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`

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`Application No.: 11/383,066
`
`Docket No.: 085199-0034
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`31.
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`(Currently amended) The composition of claim [6] 1, wherein the amount of at
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`least one amphetamine salt is about 62.5 mg.
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`32.
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`(Currently amended) The composition of claim [6] 1, wherein the amount of at
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`least one amphetamine salt is about 75 mg.
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`33-61 . (Canceled)
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`5
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`Amerigen Ex. 1008, p. 6
`Amerigen Ex. 1008, p. 6
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`

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`Application No.: 11/333,066
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`Docket No.: 085199-0034
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`Remarksllargyments
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`Claims 1-32 and 59-61 were pending before this amendment. Claims 6 and 59-61 have
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`been canceled. Claims 24-32 have been amended to depend from claim 1 instead of claim 6.
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`Amendments to the Specification
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`The paragraph beginning at page 16, line 7 includes a typographical error, i.e., an extra
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`quotation mark: “’Immediate’ and ‘delayed’ release’ refer to . . .” The typographical error has
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`been corrected by amending the specification to delete the quotation mark after “release.”
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`The rejection under 35 U.S.C. § 112, second paragraph
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`Claims 6 and 59-61 have been rejected under 35 U.S.C. § 112, second paragraph. This
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`rejection is rendered moot by the cancellation of claims 6 and 59-61.
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`The rejection under 35 U.S.C. § 102(b)
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`Claims 1-23, 25, 26 and 59-61 have been rejected under 35 U.S.C. § 102(b) as anticipated
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`by U.S. Patent No. 6,605,300. According to the Examiner, the ‘300 patent discloses an oral
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`pulsed release formulation comprising a combination of immediate release and delayed release
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`amphetamine beads. Office Action, p. 3. Further, according to the Examiner, the ‘300 patent
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`discloses the instantly claimed enteric coating, enteric polymers, bead structure, amphetamine
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`salt mixture, and pharmacokinetic parameters. Office Action, p. 3-4.
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`Applicants respectfiilly traverse this rejection. The cancellation of claims 6 and 59-61
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`renders the rejection moot as to these claims. Claim 1, the only remaining independent claim,
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`requires:
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`(a) an immediate release bead comprising at least one amphetamine salt;
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`(b) a first delayed release bead comprising at least one amphetamine salt wherein
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`the first delayed release bead provides pulsed release of the at
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`least one
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`amphetamine salt; and
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`7
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`Amerigen Ex. 1008, p. 7
`Amerigen Ex. 1008, p. 7
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`

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`Application No.: 1 1/383,066
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`Docket No.: 085199-0034
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`(c) a second delayed release bead comprising at least one amphetamine salt,
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`wherein second delayed release bead provides sustained release of the at least one
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`amphetamine salt.
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`"A claim is anticipated only if each and every element as set forth in the claim is found,
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`either expressly or inherently described, in a single prior art reference." MPEP 2131 (quoting
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`Verdegaa! Bros. v. Union 01’! Co. 0fCahfornia, 814 F.2d 628, 631, 2 USPQ2d 1051, 1053 (Fed.
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`Cir. 1937)).
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`Claim 1 and the claims dependent thereon are not anticipated for at least the reasons that
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`the ‘300 patent does not disclose the claim elements of: (1) a 3-bead composition (immediate
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`release bead, delayed pulsed release bead, and sustained release bead), and (2) a bead providing
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`sustained release. The ‘300 patent discloses immediate release beads and delayed pulsed release
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`beads, but not sustained release beads. Sustained release is not the same as delayed pulsed
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`release. For example, the ‘300 patent states that: “[p]ulsed dose delivery systems
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`have been
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`studied to address the aforementioned problematic areas for sustained release preparations." ‘300
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`patent, col. 1,
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`l. 64 » col. 2, l. 1. Thus, a pulsed dose delivery system is not the same as a
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`sustained release formulation but, according to the ‘300 patent, is something to be used in place
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`of a sustained release preparation. The diiference between pulsed release and sustained release
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`is that, upon initiation of release, a delayed pulsed release formulation releases the drug rapidly
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`and completely, “i.e., the entire dose is released within about 30-60 minutes ...” ‘300 patent, col.
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`4, 11. 4-10.
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`In contrast, sustained release means that the delivery of drug goes on for an extended
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`period of time after initial onset, typically for more than one hour. Specification, p. 16, 11. 17-19.
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`For the reasons stated above, the ‘300 patent does not disclose every element of the instant
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`claims. Thus, this rejection should be withdrawn.
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`The rejection under 35 U.S.C. § 103(a)
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`Claims 1-32 and 59-61 have been rejected under 35 U.S.C. § 103(a) as obvious over the
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`‘300 patent. According to the Examiner, in the ‘30O patent: “[t]he general conditions of the
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`claim have been met, namely a pharmaceutical dosage fonn comprising immediate release and
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`sustained release beads ...” Ofiice Action, p. 5. Applicants respectfully disagree and traverse
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`this rejection.
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`3
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`Amerigen Ex. 1008, p. 8
`Amerigen Ex. 1008, p. 8
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`

`

`Application No.: 11f383,066
`
`Docket No.: 085199-0034
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`The cancellation of claims 6 and 59-61 renders the rejection moot as to these claims. The
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`remaining claims include claim 1 and claims dependent thereon.
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`Claim 1 requires:
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`(a) an immediate release bead comprising at least one amphetamine salt;
`
`(b) a first delayed release bead comprising at least one amphetamine salt wherein
`
`the first delayed release bead provides pulsed release of the at
`
`least one
`
`amphetamine salt; and
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`(c) a second delayed release bead comprising at least one amphetamine salt,
`
`wherein second delayed release bead provides sustained release of the at least one
`
`amphetamine salt.
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`The ‘300 patent does not disclose a sustained release bead. The delayed pulsed release
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`beads disclosed in the ‘300 patent are not the same as a sustained release bead for the reasons set
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`forth above. Further, the ‘300 patent does not disclose a pharmaceutical composition comprising
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`3-beads, i.e., an immediate release head, a delayed pulsed release bead, and a sustained release
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`bead. Further yet, the ‘300 patent does not provide any teaching, suggestion, or motivation that
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`would have led one of ordinary skill to modify the ‘300 patent to add a sustained release bead
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`and arrive at the claimed invention. Even if such suggestion or motivation was provided (it was
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`not), the results would not have been predictable because the ‘300 patent teaches that sustained
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`release do not work for amphetamines. The ‘300 patent discloses that there were problems with
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`sustained release amphetamine formulations and that “[p]ulsed dose delivery systems
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`have
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`been studied to address the aforementioned problematic areas for sustained release preparations.”
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`‘300 patent, col. 1, l. 64 —- col. 2, 1. 1.
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`The ‘300 patent teaches that pulsed dose delivery systems can be used in place of
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`sustained release preparations. The ‘300 patent does not provide any teaching or suggestion for
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`including both pulsed dose and sustained release formulations in the same composition. The
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`‘300 patent teaches that sustained release amphetamine formulations are problematic and that
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`delayed pulsed release formulations can be used instead. Thus, the ‘300 patent teaches (1) not to
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`use sustained release amphetamine fonnulations and (2) to use a delayed pulsed release
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`formulation instead. In view of this teaching, one of ordinary skill in the art would not have used
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`9
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`Amerigen Ex. 1008, p. 9
`Amerigen Ex. 1008, p. 9
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`

`

`Application No.:
`
`llf383,066
`
`Docket No.: 085199-0034
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`a sustained release formulation, nor used a sustained release formulation along with a delayed
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`pulsed release formulation (instead of as an alternative to a delayed pulsed release formulation).
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`Thus, for the reasons stated above, this rejection should be withdrawn.
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`Conclusion
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`This application is believed to be in condition for allowance.
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`If any issues remain that
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`can be addressed by a supplemental or Exarninefs amendment, the Examiner is respectfully
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`requested to contact the undersigned.
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`To the extent necessary, a petition for an extension of time under 37 C.F.R. 1.136 is
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`hereby made. Please charge any shortage in fees due in connection with the filing of this paper,
`
`including extension of time fees, to Deposit Account 5004]? and please credit any excess fees to
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`such deposit account.
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`Respectfully submitted,
`
`MCDERMOTT WILL & EMERY LLP
`
`/A///W
`
`Paul M. Zagar
`Registration No. 52,392
`
`Please recognize our Customer No. 2027'?‘
`as our correspondence address.
`
`Attention: Patent Docketing Dept.
`600 13"‘ Street, N.W.
`Washington, DC 20005-3096
`Phone: 212.547.5400 PMZ:MWE
`
`Facsimile: 202.756.8087
`
`Date: January 29, 2010
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`10
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`Amerigen Ex. 1008, p. 10
`Amerigen Ex. 1008, p. 10
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