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`Refiuest
`or
`Continued Examination (RCE)
`Transmittal
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`Address to:
`Mail Stop RCE
`Com mlssloner for Parents
`P.O. E011-I$5'|J
`Alexandria. vi: 2231 3.1450
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`A Iication Number
`F""‘ “'19
`First Named Inventor
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`Art Unit
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`111383.066
`Ma
`'2» 2°05
`Arnir Sho'aei
`
`Examiner Name
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`Attome Docket Number
`
`Micah Pam Y°“"' '
`
`085199-0034
`This is a Request for Continued Examination {ROE} under 37 CFR 1.114 of the above-identified application.
`Request for Continued Examination (ROE) practice under 37 CFR 1.114 does not apply to any utility or plant application filed prlorto June
`8, 1995. or to a ny design eppl icalion.
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`
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`1- 3|-|bmi35i°|'| Tefiuired Under 37 CFR 1-1 14 Note: If the RCE is proper, any previously filed unentered amen dmenls and
`amendments enclosed with the ROE will be entered in the order in which they were filed unless appiicant instructs otherwise.
`If
`applicant does not wish to he ve any previously tiled unentered arnendmentisl entered, applicant must req uest non-entry oi such
`amendrnentis).
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`a_
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`If a final Oflice action is outstanding. any amendments filed afier the final Offioe action
`Previously submitted.
`may be considered as a submission even if this box is not checked.
`i. Cl Consider the arguments in the Appeal Brief or Reply Brief previously tiled on
`
`ii. Bother
`l:-.E| Enclosed
`i.
`IE AmendrnentlReply
`ii.
`i:|Aflidavit(s)r‘Dec|aration(s)
`2. Miscellaneous
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`iii. El information Disclosure Statement (IDS)
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`iv.
`|:]0ther
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`a. D Suspension of action on the above-identified application is requested under 3? CFR 1.103(c) for a
`period of
`months. (Period of suspension shall not exceed 3 months; Fee under 37 CFR 1_17(i} required)
`
`b. E‘ Other
`The act: tee under 37 CFR 1.17(e) is required by 37 CFR 1.114 when the RCE is filed.
`The Director is hereby authorized to charge the following fees. any underpayment of fees. or credit any
`overpayments to Deposit Account No.
`50-0417
`.
`I have enclosed a duplicate copy of this sheet.
`i. El RCE fee required under 3'.-' CFR 1.17{e)
`ii. El Extension of time fee (37 CFR1.136 and1.1‘i']
`
`iii. El Other
`b. [:| Check in the amount of S
`c. a Payment by credit card (Form PTO-2038 enclosed)
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`ICA T, ATTORNEY, OR AGENT REQUIRED
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`3.
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`a.
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`enclosed
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`M.
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`NYK13?‘i"283-1.D55199.0Cl34
`
`Amerigen Ex. 1012, p. 1
`Amerigen Ex. 1012, p.
`1
`
`
`
`Docket N0.: 08.5199-0034
`
`PATENT
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`In re Application of
`Amir SHOJAEI
`1 l{3'83,066
`Application No.:
`Filed: May 12, 2006
`
`:
`
`Customer Number: 20277
`Confirmation Number: 7083
`Group Art Unit: 1618
`Examiner: Micah Paul YOUNG
`
`For:
`
`CONTROLLED DOSE DRUG DELITIERY SYSTEM
`
`AMENDMENT
`
`Mail Stop AF
`Commissioner for Patents
`
`P.O. Box 1450
`
`Alexandria, VA 22313-1450
`
`Sir:
`
`This is in response to the final Office Action mailed October 12, 2010. A Request for
`
`Continued Examination (RCE) and the required fee accompany this response.
`
`Amendments to the claims are reflected in the listing of the claims beginning on page 2
`
`of this paper.
`
`Renlarksiarguments begin on page 7 of this paper.
`
`To the extent necessary, a petition for an extension of time under 37 C.F.R. 1.136 is
`
`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
`
`such deposit account.
`
`Amerigen Ex. 1012, p. 2
`Amerigen Ex. 1012, p. 2
`
`
`
`Application No.:
`
`llJ'383,I}66
`
`Listing of the Claims
`
`1.
`
`(Currently amended) A pharmaceutical composition comprising: (a) an immediate
`
`release bead comprising at
`
`least one amphetamine salt;
`
`(b) a first delayed release bead
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`-comprising at least one amphetamine salt; and (c) a second 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 the second delayed release bead provides sustained release of
`
`the at least one amphetamine salt;
`
`wherein the second delayed release bead comprises at least one amphetamine salt layered
`
`onto or inco1_'porated into a core; a delayed release coating layered onto the amphetamine core;
`
`and a sustained release coating layered onto the delayed release coating.
`
`2.
`
`(Original) The pharmaceutical composition of claim 1, wherein the first delayed
`
`release bead and the second delayed release bead comprise an enteric coating.
`
`3.
`
`(Original) The pharmaceutical composition of claim 2, wherein the enteric
`
`coating is pH dependent.
`
`4.
`
`(Original) The pharmaceutical composition of claim 2, wherein the first delayed
`
`release bead and the second delayed release bead comprise different enteric coatings.
`
`5.
`
`(Original) The pharmaceutical composition of claim 2, wherein the first delayed
`
`release bead and the second delayed release bead comprise the same enteric coating.
`
`6.
`
`(Canceled)
`
`Amerigen Ex. 1012, p. 3
`Amerigen Ex. 1012, p. 3
`
`
`
`Application No.: 11/383,066
`
`7.
`
`(Original) The pharmaceutical composition of claim 1, wherein administration of
`
`a 37.5 mg dose of the pharmaceutical composition to a human patient results in a d-amphetamine
`
`Cm,‘ of about 50 ng/ml.
`
`8.
`
`(Original) The pharmaceutical composition of claim 1, wherein the d-
`
`amphetamine area under the curve from time 0 to the last measured time (AUCo.1a31) after
`
`administration of a 37.5 mg dose of the pharmaceutical composition to a human patient is about
`
`1058 nghr/'ml.
`
`9.
`
`(Original) The pharmaceutical composition of claim 1, wherein the d-
`
`amphetamine area under the curve from time 0 to time infinity (AUCO-jnf) after administration of
`
`a 37.5 mg dose of the pharmaceutical composition to a human patient is about 1085 nghrfml.
`
`10.
`
`(Original) The pharmaceutical composition of claim 1, wherein the d-
`
`amphetamine Tmax
`
`is about 8.2 hours after administration of a 37.5 mg dose of the
`
`pharmaceutical composition to a human patient.
`
`1 1.
`
`(Original) The pharmaceutical
`
`composition of claim 1, wherein the
`
`[-
`
`amphetamine Cmx after administration of a 37.5 mg dose of the pharmaceutical composition to a
`
`human patient is about 15 ng/ml.
`
`12.
`
`(Original) The pharmaceutical composition of claim 1, wherein the
`
`1-
`
`amphetamine area under the curve from time 0 to the last measured time (AUC()_]as[) 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 nghrfml.
`
`Amerigen Ex. 1012, p. 4
`Amerigen Ex. 1012, p. 4
`
`
`
`Application No.:
`
`ll!'383,066
`
`13.
`
`(Original) The pharmaceutical
`
`composition of claim 1, wherein the
`
`1-
`
`amphetamine area under the curve from time 0 to time infinity (AUCg.;,,f) after administration of
`
`a 37.5 mg dose of the pharmaceutical composition to a human patient is about 373 nghr/ml.
`
`14.
`
`(Original) The pharmaceutical
`
`composition of claim 1, wherein the
`
`l-
`
`amphetarnine Tm.
`
`is about 8.4 hours after administration of a 37.5 mg dose of the
`
`pharmaceutical composition to a human patient.
`
`15.
`
`(Original) The pharmaceutical composition of claim 1, wherein the immediate
`
`release bead and at least one delayed release bead are present on a single core.
`
`16.
`
`(Original) The pharmaceutical composition of claim 1, wherein the immediate
`
`release bead and at least one delayed release bead are present on different cores.
`
`1?.
`
`(Original) The pharmaceutical composition of claim 1, wherein the at least one
`
`amphetamine salt is coated onto a core.
`
`18.
`
`(Original) The pharmaceutical composition of claim 1, wherein the at least one
`
`amphetamine salt is incorporated into a core.
`
`19.
`
`(Original) The pharmaceutical composition of claim 2, which further comprises a
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`protective layer over at least one enteric coating.
`
`20.
`
`(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.
`
`21.
`
`(Original) The pharmaceutical composition of claim 1, wherein the at least one
`
`amphetamine salt
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`is selected from the group consisting of dextroamphetamine sulfate,
`
`Amerigen Ex. 1012, p. 5
`Amerigen Ex. 1012, p. 5
`
`
`
`Application No.:
`
`l12‘383,066
`
`dextroamphetamine saccharate, amphetamine aspartate monohydrate, amphetamine suifate, and
`
`mixtures thereof.
`
`22.
`
`(Original) The pharmaceutical composition of claim 21, wherein the at least one
`
`amphetamine salt is a mixture of dextroamphetamine sulfate, dextroamphetamine saccharate,
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`amphetamine aspartate monohydrate, and amphetamine sulfate.
`
`23.
`
`(Original) The pharmaceutical composition of claim 1, wherein the composition
`
`does not exhibit a food effect.
`
`24.
`
`(Previously presented) The composition of claim I, wherein the amount of at least
`
`one amphetamine salt is about 12.5 mg.
`
`25.
`
`(Previously presented) The composition of claim 1, wherein the amount of at least
`
`one amphetamine salt is about 18.75 mg.
`
`26.
`
`(Previously presented) The composition of claim I, wherein the amount of at least
`
`one amphetamine salt is about 25 mg.
`
`27.
`
`(Previously presented) The composition of claim 1, wherein the amount of at least
`
`one amphetamine salt is about 31.25 mg.
`
`28.
`
`(Previously presented) The composition of claim 1, wherein the amount of at least
`
`one amphetamine salt is about 37.5 mg.
`
`29.
`
`(Previously presented) The composition of claim 1, wherein the amount of at least
`
`one amphetamine salt is about 43.75 mg.
`
`Amerigen Ex. 1012, p. 6
`Amerigen Ex. 1012, p. 6
`
`
`
`Application No.: 11:‘383,066
`
`30.
`
`(Previously presented) The composition of claim I, wherein the amount of at least
`
`one amphetamine salt is about 50 mg.
`
`31.
`
`(Previously presented) The composition of claim 1, wherein the amount of at least
`
`one amphetarnine salt is about 62.5 mg.
`
`32.
`
`(Previously presented) The composition of claim 1, wherein the amount of at least
`
`one amphetamine salt is about 75 mg.
`
`33-61 . (Canceled)
`
`62.
`
`(New) The pharmaceutical composition of claim 1, wherein a protective coating
`
`is layered between the delayed release coating and the sustained release coating.
`
`Amerigen Ex. 1012, p. 7
`Amerigen Ex. 1012, p. 7
`
`
`
`Application No.: 11/383,066
`
`Remarks
`
`Claims 1-5, 7-32, and 62 are pending. Claim 1 has been amended to recite that the
`
`second delayed release bead comprises at
`
`least one amphetamine salt
`
`layered onto or
`
`incorporated into a core; a delayed release coating layered onto the amphetamine core; and a
`
`sustained release coating layered onto the delayed release coating. Support for the claim 1
`
`amendment and new claim 62 can be found in the specification at paragraphs 23-24.
`
`Reection under 35 U.S.C.
`
`102
`
`Claims 1-5, 'i'—23, 25, and 26 have been rejected under 35 U.S.C. § l02(b) as anticipated
`
`by U.S. Patent No. 6,605,300. According to the Examiner, the ‘300 patent teaches “an oral
`
`pulsed release formulation comprising a combination of immediate release and delayed release
`
`amphetamine beads.” Office Action, p. 2 (emphasis added).
`
`The Examiner states that the ‘300 patent anticipates the instant claims because the beads
`
`according to the ‘300 patent, and the instantly claimed first and second delayed pulsed release
`beads can include the same enteric polymer. Office Action, p. 6. According to the Examiner,
`
`claiming pulsed release and sustained release amounts to reciting intended uses, and not
`
`structural differences. Id.
`
`Applicants respectfully traverse this rejection. The Examiner does not take into account
`
`that materials may be used or structured in different ways to achieve different results. One of
`
`ordinary skill
`
`in the art would have looked to the specification for guidance and, from the
`
`specification, ascertained that the second delayed release head has an atypical construction, i.e.,
`
`an atypical layering of the materials. Such a construction is neither disclosed nor suggested in
`
`the prior art. Typically, a delayed, sustained release bead is constructed with a delayed release
`
`Amerigen Ex. 1012, p. 8
`Amerigen Ex. 1012, p. 8
`
`
`
`Application No.:
`
`ll;’383,066
`
`coating overlaying a sustained release coating. Specification, paragraph 23.
`
`This typical
`
`construction results in a Tmax occurring too early, with the consequence that a patient’s longer-
`
`day requirements for ADHD treatment are not met. Id.
`
`In order to expedite prosecution, claim 1 has been amended to recite that the second
`
`delayed release bead comprises at least one amphetamine salt layered onto or incorporated into a
`
`core; a delayed release coating layered onto the amphetamine core; and a sustained release
`
`coating layered onto the delayed release coating. This construction is counterintuitive and
`
`unexpectedly provides drug release that
`
`to meet a patient’s longer day ADHD treatment
`
`requirements, when administered with an immediate release bead and a first delayed release bead
`
`according to the present invention.
`
`The ‘300 patent teaches delayed release beads having a drug—containing core coated with
`
`an enteric polymer (Examples 2 and 3), and delayed release beads having a drugvcontaining core
`
`coated with an enteric polymer which, in turn, is coated with SURELEASE. Thus, 300 patent
`
`Examples 2 and 3 disclose a bead with one coating, and do not disclose a bead comprising a
`
`delayed release coating and a sustained release coating. Example 4 of the ‘300 patent discloses a
`
`head with layers in a “typical” construction.
`
`Thus,
`
`the ‘30O patent does not disclose a
`
`pharmaceutical composition comprised of the instantly claimed three beads. Accordingly, this
`
`rejection should be withdrawn.
`
`Re'ection under 35 U.S.C.
`
`103 a
`
`Claims 1-5 and 7-32 have been rejected under 35 U.S.C. § 103(a) as obvious over the
`
`‘300 patent. According to the Examiner, the ‘300 patent discloses beads comprising a mixture of
`
`amphetamine salts having a concentration of at least 20 mgs. The Examiner acknowledges that
`
`Amerigen Ex. 1012, p. 9
`Amerigen Ex. 1012, p. 9
`
`
`
`Application No.: 11/383,066
`
`the instant claims “differ from the reference by reciting various concentrations of the active
`
`ingredient(s).” Office Action, p. 5. The Examiner states that the preparation of pharmaceutical
`
`compositions having various amounts of the active ingredient is “within the level of skill of one
`
`having ordinary skill in the art.” Id.
`
`As stated above, the instant claims require a second delayed release bead that provides
`
`sustained release and having a construction wherein a delayed release ‘coating is layered onto the
`
`amphetamine core; and a sustained release coating is layered onto the delayed release coating.
`
`The ‘300 patent neither discloses nor suggests such a construction. The instantly claimed second
`
`delayed release bead postpones release of the drug after administration and then releases the drug
`
`for an extended period of time.
`
`Intuitively, such a head would be expected to have a delayed
`
`release coating external
`
`to the sustained release coating because the delayed release occurs
`
`before the sustained release. Such a construction, however, does not provide a release to meet
`
`the longer day needs for ADHD treatment because the Trnax occurs too soon. Surprisingly the
`
`instantly claimed, counterintuitive construction does work.
`
`Thus,
`
`this rejection should be
`
`withdrawn.
`
`Amerigen Ex. 1012, p. 10
`Amerigen Ex. 1012, p. 10
`
`
`
`Application No.: 11:’383,066
`
`Conclusion
`
`This application is believed to be in condition for allowance. If any issues remain which
`
`may be addressed by an Exan1iner’s amendment or a supplemental amendment, the Examiner is
`
`respectfully requested to contact the undersigned.
`
`Respectfully submitted,
`
`M7RMOTI'
`
`LL & EMERY LLP
`
`Paul M. Zagar
`Registration No. 52,392
`
`Please recognize our Customer No. 20277
`as our correspondence address.
`
`600 13th Street, N.W.
`Washington, DC 20005-3096
`Phone: 212.547.5400 PMZ:MWE
`
`Facsimile: 202.756.8087
`
`Date: January 12, 2011
`
`10
`
`Amerigen Ex. 1012, p. 11
`Amerigen Ex. 1012, p. 11