UNI] 1:1) S IA] 135 P/\ll:N1 AND TRADEMARK OH~lCl:
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`I.‘-\'ITl'-I1’) STATES DEPARTMENT OF COMMERCE
`United States Patent and '1‘ratIen1ark Ofliee
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`Amir shojaci
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`085199-0034
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`30277
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`600 13TH S'l'RJ:]]:"l', N.W.
`WASHINGTON, DC.‘ 20005-3096
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`Y0‘—WG- MICAII PM-TL
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`_ M
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`AIL DATE
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`DELIVERY MODE
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`Please find below andlor attached an Office communication concerning this application or proceeding.
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`The time period for reply, if any, is set in the attached communication.
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`1011212010
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`PAPER
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`[,T0,J__(,{,A (RW_04,m,
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`Amerigen Ex. 1011, p. 1
`Amerigen Ex. 1011, p.
`1
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`

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`Office Action Summary
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`Application No.
`
`AppIicant(s)
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`‘I‘Ii383,066
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`SHOJAEI ET AL.
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`Examine,
`
`MICAH-PAUL YOUNG
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`Art Unit
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`1618 -
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`- The MAILING DA TE of this communication appears on the cover sheet with the correspondence address -
`Period for Reply
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`A SHORTENED STATUTORY PERIOD FOR REPLY IS SET TO EXPIRE § MONTH(S) OR THIRTY (30) DAYS,
`WHICHEVER IS LONGER, FROM THE MAILING DATE OF THIS COMMUNICATION.
`- Extensions of time may be available under the provisions of 3? CFR 1.136(a).
`In no event. however. may a reply be timely filed
`after SIX (6) MONTHS from the mailing date of this communication.
`If NO period for reply is specified above, the maximum statutory period will apply and will expire six (6) MONTHS from the mailing date of this communication.
`—
`- Failure to reply within the set or extended period for reply will. by statute. cause the application to become ABANDONED (35 U.S.C. § 133).
`Any reply received by the Office later than three months after the mailing date of this communication. even if timely filed. may reduce any
`earned patent term adjustment. see 37 CFR 1_Tl]4(l:i)_
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`Statu s
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`1) Responsive to communication(s) filed on 28 Juiy 2010.
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`2a)E This action is FINAL.
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`2b)|:| This action is non-final.
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`3)I:I Since this application is in condition for allowance except for formal matters, prosecution as to the merits is
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`closed in accordance with the practice under Ex parte Quayie, 1935 CD. 11, 453 O6. 213.
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`Disposition of Claims
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`4)X C|aim(s) 1-5 and 7-32 isiare pending in the application.
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`4a) Of the above claim(s)
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`isiare withdrawn from consideration.
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`5)I:I C|aim(s)
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`isiare allowed.
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`6)X C|aim(s) 1-5 and 7-32 isiare rejected.
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`7)[:l C|aim(s)j isiare objected to.
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`8)I:I C|aim(s)j are subject to restriction andior election requirement.
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`Application Papers
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`9)I:I The specification is objected to by the Examiner.
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`10)I:I The drawing(s) filed on
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`isiare: a)I:| accepted or b)I:| objected to by the Examiner.
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`Applicant may not request that any objection to the drawing(s) be held in abeyance. See 37 CFR 1.85(a).
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`Replacement drawing sheet(s) including the correction is required if the drawing(s} is objected to. See 37 CFR 1.121(d).
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`11)I:I The oath or declaration is objected to by the Examiner. Note the attached Office Action or form PTO-152.
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`Priority under 35 U.S.C. § 119
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`12)I:I Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
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`a)I:I All
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`b)I:I Some * c)I:I None of:
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`1.I:I Certified copies of the priority documents have been received.
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`2.[:l Certified copies of the priority documents have been received in Application No.
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`3.I:I Copies of the certified copies of the priority documents have been received in this National Stage
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`application from the International Bureau (PCT Rule 17.2(a)).
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`* See the attached detailed Office action for a list of the certified copies not received.
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`Attachme-nt(s}
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`Notice of References Cited (PTO-892}
`1)
`2) El Notice of Draftsperson’s Patent Drawing Review [PTO-948)
`3) E Information Disclosure Statementls) [PTOiSB.’08)
`Paper No(s).’Mai| Date 9/14x10.
`U.S. Patent and Trademark Ofiice
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`4) El Interview Summary [PTO-413)
`Paper N0(5)"M3II D313 T-
`5} I:I NOIICE‘ 07 I"f0|TT13I Patent APPIICGIIOI1
`6) El Other:
`_
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`PTOL-326 (Rev. 08-06)
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`Office Action Summary
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`Part of Pa er No_.’MaiI Date 20100930
`Amerigen Ex. 1011, p. 2
`Amerigen x. 1011, p. 2
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`

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`Application/Control Number: l1f383,066
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`Page 2
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`Art Unit: 1618
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`DETAILED ACTION
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`Continued Examination Under 3 7 CFR I. I M
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`A request for continued examination under 3'? CFR 1.114, including the fee set forth in
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`3? CFR 1.17(e), was filed in this application after final rejection. Since this application is
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`eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR l.l'}’(e)
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`has been timely paid, the finality of the previous Office action has been withdrawn pursuant to
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`3'? CFR 1.114. Applicant's submission filed on 7f28f10 has been entered.
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`Claim Rejections - 35 USC § 102
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`The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the
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`basis for the rejections under this section made in this Office action:
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`A p-erson shall be entitled to a patent unless
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`{b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on
`sale in this country, more than one year prior to the date of application for patent in the United States.
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`Claims 1-5, 7-23, 25, and 26 are rejected under 35 U.S.C. 102(b) as being anticipated by
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`Burnside et al (USPN 6,605,300 hereafier ‘300).
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`The ‘300 patent teaches an oral pulsed release formulation comprising a combination of
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`immediate release and delayed release amphetamine beads (abstract). The formulation can
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`comprise a coated core comprising an immediate release portion of the amphetamine salts, along
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`with an enterically coated delayed release bead (claim 1). The enteric polymers include pH
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`dependent enteric polymers (col. 8, lin. 43 -68). The formulation further comprises a protective
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`coating to the core between the drug layers, or at the enteric layer (col. 8, lin. 10-30). The
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`amphetamine is coated to an inert seed material (Example 1). This coated seed is then coated
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`with Various polymers, forming a core with the amphetamine incorporated (Examples 2 and 3).
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`Amerigen Ex. 1011, p. 3
`Amerigen Ex. 1011, p. 3
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`

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`Application/Control Number: l1f383,066
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`Page 3
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`Art Unit: 1618
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`The formulation can comprise multiple coated delayed core comprises different enteric polymers
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`or the same polymers such as Eudragit L or 41 10D (Examples 1-4). The formulation comprises
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`a combination of immediate release beads and controlled release beads (Example 4). The
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`formulation can comprise up to 20 mg ofa mixture of amphetamine salts including
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`dextroamphetamine saccharate and amphetamine sulfate (claim 1). A single immediate release
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`bead can be coated with a delayed release bead coating solution and combined with a second
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`delayed release formulation so that the immediate and delayed release portions are present in the
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`same bead and on different beads (Example 4).
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`Regarding the bioequivalence of the formulation to that of ADDERALL XL, and the
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`other physiological effects of the instant dosage form (food, Tmax, AUC and Cmax values) it is
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`the position of the Examiner that these limitations are merely functional limitations that are the
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`result of the instant compositional components. These functional limitations are inherent
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`properties of the composition and are dependent from the composition components, since a
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`compound and its properties cannot be separated. The same compositions, comprising the same
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`components and compounds must have the same properties. As such, since the formulation of
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`the ‘300 patent comprises the same immediate release and delayed release beads, comprising the
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`same polymers and arrangement the formulation of the ‘300 patent must also have the same
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`bioequivalence, and blood plasma concentrations.
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`Further specifically regarding the potential Tmax, Cmax and AUC of a 37.5 mg close, it is
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`the position of the Examiner that these limitation merely recite a future intended use for the
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`composition. These Values are based on a theoretical future dosage form that has the same
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`Amerigen Ex. 1011, p. 4
`Amerigen Ex. 1011, p. 4
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`

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`Application/Control Number: l1f383,066
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`Page 4
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`Art Unit: 1618
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`fundamental structure and components as the ‘300 formulation. As such if the same components
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`are applied to the theoretical model they would inherently result in the same in vivo results.
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`For these reasons the claims are anticipated.
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`Claim Rejections - 35 USC § 103
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`The following is a quotation of 35 U.S.C. 1U3(a) which forms the basis for all
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`obviousness rejections set forth in this Office action:
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`(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in
`section 102 of this title, it‘ the differences between the subject matter sought to be patented and the prior art are
`such that the subject matter as a whole would have been obviotis at the time the invention was made to a person
`having ordinary skill in the art to which said subject matter pertains. Patentability shall 11ot be negativcd by the
`manner in which the invention was made.
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`The factual inquiries set forth in Graham V. John‘. Deere Co., 383 U.S. l, 148 USPQ 459
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`(1966), that are applied for establishing a background for determining obviousness under 35
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`U.S.C. 103(3) are summarized as follows:
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`:P-.°~’!*9.—
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`Determining the scope and contents of the prior art.
`Ascertaining the differences between the prior art and the claims at issue.
`Resolving the level of ordinary skill in the pertinent art.
`Considering objective evidence present in the application indicating obviousness
`or nonobviousness.
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`Claims 1-5, and 7-32 are rejected under 35 U.S.C. 103(3) as being unpatentable over the
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`disclosures of Burnside et al (USPN 6,605,300 hereafter ‘30[}).
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`As discussed above the ‘300 patent discloses a controlled release dosage form comprising
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`immediate release bead sand delayed release beads where the delayed release beads comprise
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`enter polymers and protective coating. The beads comprise a mixture of amphetamine salts and
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`are disclosed at a concentration of at least 20 mg (claims). The reference is silent to a higher
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`dosage, however concentration however increasing the dosage of a well known pharmaceutical
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`Amerigen Ex. 1011, p. 5
`Amerigen Ex. 1011, p. 5
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`Application/Control Number: l1f383,066
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`Page 5
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`Art Unit: 1618
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`dependent on the patient is well within the limits of one of ordinary skill and would be an
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`obvious modification. Since dosing concentrations are based on patient need an increase or
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`decrease in the potency of a dosage form would be an obvious modification to provide the result
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`effective variable to increase or decrease the effectiveness of the dosage form. The general
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`conditions of the claim have been met, namely a pharmaceutical dosage form comprising
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`immediate release and sustained release beads coated with enteric polymers. Applicant is
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`reminded that where the general conditions of a claim are disclosed in the prior art, it is not
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`inventive to discover the optimum or workable ranges by routine experimentation. See In re
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`Aller, 220 F.2d 454 105 USPQ 233, 235 (CCPA 1955).
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`Furthermore the claims differ from the reference by reciting various concentrations of the
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`active ingredient(s). However, the preparation of various pharmaceutical compositions having
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`various amounts of the active is within the level of skill ofone having ordinary skill in the art at
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`the time of the invention.
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`It has also been held that the mere selection of proportions and ranges
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`is not patentable absent a showing of criticality. See In re Russell, 439 F.2d 1228 169 USPQ 426
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`(CCPA 1971).
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`With these things in mind it would have been obvious to modify the concentration of the
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`active amphetamine salt mixture in order to accommodate each individual patient.
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`It would have
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`been obvious to adjust the dosage in order to provide more precise care for the patient. One of
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`ordinary skill in the art would have been motivated to optimize and modify the concentrations of
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`the active components with an expected result of tailored dosage form useful in treating ADHD.
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`Response to Arguments
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`Amerigen Ex. 1011, p. 6
`Amerigen Ex. 1011, p. 6
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`

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`Application/Control Number: l1f383,066
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`Page 6
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`Art Unit: 1618
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`Applicant's arguments filed 1/29/10 have been fully considered but they are not
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`persuasive. Applicant argues that;
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`1) The ‘300 patent does not anticipate the instant claims since it does not disclose or
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`teach (a) an immediate release bead; (b) first delayed release bead; and (C) second delayed
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`release bead as described in the instant claims.
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`2) The ‘300 patent does not obviate the instant claims since it does not disclose the “3-
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`bead” system of the instant claims.
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`Regarding argument I) it remains the position of the Examiner that the '300 patent
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`continues to anticipate the instant claims. The '300 patent teaches a controlled release dosage
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`form comprising a plurality of beads. The beads include immediate release beads and coated
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`controlled release beads (abstract). The instant claims recite that the coated second and third
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`beads are both coated with cnteric polymers. Further the instant claims recite that the enteric
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`polymers are the same. As such the coated beads of the ‘300 patent would act as the second and
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`third beads, since their only difference is the intended use of a pulse release or a sustained
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`release. Since the coating materials would be the same, the collection of enteric coated
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`controlled released beads found in the ‘300 patent would meet this limitations. The claims do
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`not further distinguish the second and third beads, by polymer type, , disposition, or amount.
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`The claims actually recite that they are the same polymers. Since the ‘300 patent disclose
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`multiple beads, both immediate release uncoated beads and cnteric coated as described in the
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`instant claims, the claims remain fully anticipated. Regarding the specific pharmokinetic
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`properties of the instant claims it remains the position of the Examiner that these limitations are
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`functional limitations fully dependent from the compositional components of the instant claims.
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`Amerigen Ex. 1011, p. 7
`Amerigen Ex. 1011, p. 7
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`

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`Application/Control Number: l1f383,066
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`Page 7
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`Art Unit: 1618
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`Since the ‘300 patent meet the compositional components of the instant claims and since the
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`same compounds must have the same properties it remains the position of the Examiner that the
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`'3 00 patent would inherently have the same pharmokinetic properties.
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`Regarding argument 2) it remains the position of the Examiner that the ‘.300 patent
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`continues to obviate the instant claims. Applicant argues that the ‘300 patent teaches tat pulsed
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`and sustained release formulation cannot be used together. However the release of the beads in
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`merely an intended use that does not distinguish over the art since the compositional components
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`of the head is identical. The same Compounds regardless of their intended use will have the same
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`properties. As such the enteric coated beads of the ‘300 patent that act as the second and third
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`beads will meet the compositional limitations of the instant claims since they are both coated
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`with enteric polymers a11d even have the same enteric polymers. Further regarding the
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`difficulties of sustained release formulations disclosed in the ‘300 patent, applicant is directed to
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`Fig 3, where a sustained release of amphetamine is achieved through the use of enteric polymer
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`coatings and protective coatings. The problems disclosed in the background of the invention are
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`solved by applying the techniques of the ‘300 patent. The patent acknowledges the shortcomings
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`of the art in order to overcome them through the practice of the invention. It remains obvious to
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`optimize the coating disposition and concentration in order to provide an optimal release profile.
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`This would have been obtained through routine experimentation. For these reasons the claims
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`remain obviated.
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`Conclusion
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`Amerigen Ex. 1011, p. 8
`Amerigen Ex. 1011, p. 8
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`

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`Application/Control Number: l1f383,066
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`Page 8
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`Art Unit: 1618
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`This is a continuation of applicant's earlier Application No. 1 1383066. All claims are
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`drawn to the same invention claimed in the earlier application and could have been finally
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`rejected on the grounds and art of record in the next Office action if they had been entered in the
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`earlier application. Accordingly, THIS ACTION IS MADE FINAL even though it is a first
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`action in this case. See MPEP § '}’06.0?'(b). Applicant is reminded of the extension of time
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`policy as set forth in 37 CFR l.l36(a).
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`A shortened statutory period for reply to this final action is set to expire THREE
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`MONTHS from the mailing date of this action.
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`In the event a first reply is filed within TWO
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`MONTHS of the mailing date of this final action and the advisory action is not mailed until after
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`the end of the THREE-MONTH shortened statutory period, then the shortened statutory period
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`will expire on the date the advisory action is mailed, and any extension fee pursuant to 37
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`CFR l.l36(a) will be calculated from the mailing date of the advisory action.
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`In no, however,
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`event will the statutory period for reply expire later than SIX MONTHS from the mailing date of
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`this final action.
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`Correspondence
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`Any inquiry concerning this communication or earlier communications from the
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`examiner should be directed to MICAH-PAUL YOUNG whose telephone number is (571)272-
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`0608. The examiner can normally be reached on Monday-Friday 8:00-5:30; every other Friday
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`off.
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`If attempts to reach the examiner by telephone are unsuccessful, the examiner’s
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`supervisor, Michael G. Hartley can be reached on 5?l-2?'2-0616. The fax phone number for the
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`organization where this application or proceeding is assigned is 571-273-8300.
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`Amerigen Ex. 1011, p. 9
`Amerigen Ex. 1011, p. 9
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`

`
`Application/Control Number: l1f383,066
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`Page 9
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`Art Unit: 1618
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`Information regarding the status of an application may be obtained from the Patent
`
`Application Information Retrieval (PAIR) system. Status information for published applications
`
`may be obtained from either Private PAIR or Public PAIR. Status information for unpublished
`
`applications is available through Private PAIR only. For more information about the PAIR
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`system, see http:r’fpair-direct.uspto.gov. Should you have questions on access to the Private PAIR
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`system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would
`
`like assistance from a USPTO Customer Service Representative or access to the automated
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`information system, call 800-'x'86-9199 (IN USA OR CANADA) or 5';'l-272-I000.
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`x’Michae| G. Hartleyf
`Supervisory Patent Examiner, Art Unit 1618
`
`/MICAH-PAUL YOUNG}
`
`Examiner, Art Unit 1618
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`Amerigen Ex. 1011, p. 10
`Amerigen Ex. 1011, p. 10