UNIT]:-‘D S'1‘A'l‘]:'S P/\'l‘l:‘N'l‘ AND TRADl:‘.MARI( OFFICE
`
`I.‘-NITED STATES DEPARTMENT OF‘ COMMERCE
`United States Patent and '1‘ratIcn1ark Oflice
`Addrus-a: (I().i\«'1M|SS|()N]iR l"()R 1’A'l'|ii\"l'S
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`1 [£333,006
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`05!] 2120045
`
`Amir Shojaci
`
`(J8Sl99—U-U34
`
`1083
`
`iiilmmorfi1233. 1 & pMfi.3"<§”f‘i'1
`'l'he McDer1nott Building
`500 North Capitol Street, N.W.
`WASHINGTON, DC 2000]
`
`Y0WG- MICA11 PAUL
`
`
`
`NOTIFICATION DATE
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`DELIVERY MODE
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`[}4!3(J.I'2[}l 4
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`I_'Il.L".C'l'RON [C
`
`Please find below andfor attached an Office communication concerning this application or proceeding.
`
`The time period for reply, if any, is set in the attached communication.
`
`Notice of the Office communication was sent electronically on above—indicated "Notification Date" to the
`following e-mail address(es):
`
`mwcipdockcl@n1wc.co1n
`
`m,J_9(,A (RW_04,m,
`
`Amerigen Ex. 1015, p. 1
`Amerigen Ex. 1015, p.
`1
`
`

`
`Application No.
`111383.056
`
`Applicanttsj
`Shojaei, et at
`
`Office Action Summary
`
`AIA (First lnventorto File)
`Art Unit
`Examine,
`:|';‘“
`1 51 8
`Micah-Paul Young
`— The MAIUNG DATE of this communication appears on the cover sheet with the correspondence address --
`Period for Reply
`
`A SHORTENED STATUTORY PERIOD FOR REPLY IS SET TO EXPIRE § MONTHS FROM THE MAILING DATE OF
`THIS COMMUNICATION.
`Extensions of time may be available under the provisions of 37 CFR 1.136{a).
`afler SIX {6} MDNTHS from the mailing date of this communication.
`If NO period tor 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 Dffice later than three months alter the mailing date of this communication. even if timely filed. may reduce any
`earned patent term adjustment. See 3? CFR 1.‘.='04(b}.
`
`In no event. however. may a reply be timely tiled
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`Status
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`1)|Z Responsive to communication(s) filed on 1/24/14.
`
`|:I A declaration(s)faffidavit(s) under 37 CFR 1.130(b) wasiwere filed on
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`2b)I:I This action is non—fina|.
`2a)I:I This action is FINAL.
`3)I:I An election was made by the applicant in response to a restriction requirement set forth during the interview on
`; the restriction requirement and election have been incorporated into this action.
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`4)|:| 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 Quayle, 1935 C.D. 11, 453 QC. 213.
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`Disposition of Claims‘
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`5)E Claim(s) 1-5 7-32 and 62 israre pending in the application.
`5a) Of the above claim(s)
`isfare withdrawn from consideration.
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`6)I:I C|aim(s) _ isfare allowed.
`
`7)IZ Claim(s) 1-5 7-32 and 62 isfare rejected.
`8)I:I Claim(s) _ isfare objected to.
`9)I:I Claim(s)
`are subject to restriction andfor election requirement.
`‘ If any claims have been determined allowable, you may be eligible to benefit from the Patent Prosecution Highway program at a
`
`participating intellectual property office for the corresponding application. For more information, please see
`
`
`:lrwv.rw.usnto. ow’ atentsfinit eventslo i=.r'index.'s or send an inquiry to PPflfeedback-Q.usptogov.
`
`htt
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`Application Papers
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`10)|:I The specification is objected to by the Examiner.
`
`isfare: a)E] accepted or b)|:I objected to by the Examiner.
`11)|:I The drawing(s) filed on
`Applicant may not request that any objection to the drawing(s) be held in abeyance. See 37 CFR 1.85(a).
`
`Replacement drawing sheetts) including the correction is required if the drawing(s) is objected to. See 37 CFR 1.121(d).
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`Priority under 35 U.S.C. § 119
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`12)|:I Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)—(d) or (f).
`Certified copies:
`a)I:I All
`b)I:I Some“ c)I:| None of the:
`1.I:l Certified copies of the priority documents have been received.
`2.I:l Certified copies of the priority documents have been received in Application No.
`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)).
`"" See the attached detailed Office action for a list of the certified copies not received.
`
`Al'lachment(s)
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`1} D Notice of References Cited (PTO-892)
`_
`‘
`2} D Information Disclosure Statementlsj {PTO!SB!08a andfor PTOISB!tJ8bj
`Paper Norsyiviaii Date
`.
`U.S_ Patent and Trademark Ollice
`
`PTOL—326(Rev_ 11-13)
`
`Dflice Action Summary
`
`3} D jmewiew summary (pTo-413)
`Paper No(s)flvlai| Date. j
`‘II El 0"” :-
`Amerigen Ex. 1015, p. 2
`Ameriga‘1OE%t-er
`2
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`

`
`Application.r"Control Number: I l.r"383,066
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`Art Unit: 1618
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`Page 2
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`The present application is being examined under the pre—AIA first to invent provisions.
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`DETAILED ACTION
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`Acknowledgment of Papers Received: AmendmentfResponse dated l.r"24.r" l 4.
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`Claim Rejections - 35 USC § 103
`
`The following is a quotation of pre—AIA 35 U.S.C. 103(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, if the differences between the subject matter sought to be patented and
`the prior art are such mat the subject matter as a whole would have been obvious at the time the
`invention was made to a person having ordinary skill in the art to which said subject matter pertains.
`Patentability shall not be ncgativcd by the manner in which the invention was made.
`
`The factual inquiries set forth in Graham 12. John Deere C0., 383 US. 1, 148 USPQ 459
`
`(1966), that are applied for establishing a background for determining obviousness unde1' pre-
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`AIA 35 U.S.C. l03(a) are summarized as follows:
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`1. Detemiining the scope and contents of the prior art.
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`2. Ascertaining the differences between the prior art and the claims at issue.
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`3. Resolving the level of ordinary skill in the pertinent art.
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`4. Considering objective evidence present in the application indicating obviousness or
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`nonobviousness.
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`Claims 1-5, 17, 18, and 23 are rejected under pre—AIA 35 U.S.C. l03(a) as being
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`unpatentable over the combined disclosures of Pe1'cel et al (US 200310157173 hereafter ‘173) in
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`View of Odidi ct al (US 200320050620 hereafter ‘620).
`
`The 173 patent discloses a timed pulse release system comprising an immediate release
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`bead comprising an active agent, a delayed release bead comprising the drug and a coating and a
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`sustained release bead comprising the drug, a delayed release coating and a sustained release
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`Amerigen Ex. 1015, p. 3
`Amerigen Ex. 1015, p. 3
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`

`
`Application.r"Control Number: I l.r"383,066
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`Art Unit: 1618
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`Page 3
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`coating over the delayed release csustained0 1 4-00] 6]. The delayed release coatings can
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`comprise enteric polymers, pH dependent coatings [0028]. Since the beads can be coated with
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`one or more of the polymer coatings, the immediate coating may be present in the same on‘
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`different cores as the sustained or delayed release beads [0025]. The beads a1'e collected into
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`capsules or compressed into tablets [003]].
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`The reference discloses a pharmaceutical composition comprising an immediate release
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`bead, a first delayed release bead and second delayed are disclosed that provides a sustained
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`release effect. The formulation discloses a different drug fo1' differential release however. The
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`use of various active agents in a differential release formulation are well known as seen in the
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`‘(S20 publication.
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`The 620 publication discloses a controlled release formulation where various active
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`agents are differentially released including prop1'anolol and amphetamine salts are delivered to a
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`patient [abstract, 0030]. The formulation comprises coated beads coated with release controlling
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`polymers [D037]. The granules or beads are collected into capsules of compressed into tablets
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`[Examples].
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`It would have been obvious to substitute the amphetamine of the 620 for the
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`propranolol of the 1'33 publication as they a1'e both used fo1' differential release of active agents.
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`With these aspects in mind it would have been obvious to combine the prior art with an
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`expected result of a stable drug useful in maintaining wakefulness.
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`It would have been obvious
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`to substitute the active agents from the 620 into the 173 publication since they solve the same
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`problem of differential drug release, and can be used in similar controlled release formulations.
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`One of ordinary skill in the art would have been motivated to combine the prior art with an
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`expected result of a stable drug formulation.
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`Amerigen Ex. 1015, p. 4
`Amerigen Ex. 1015, p. 4
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`

`
`Application.r"Control Number: I l.r"383,066
`
`Art Unit: 1618
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`Page 4
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`Claims 1, 7—32 and 62 are rejected under pre—AIA 35 U.S.C. l03(a) as being unpatentable
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`over the combined disclosures of Percel et al (US 2003;’0 l 57 173 hereafter ‘ 173) and Odidi et al
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`(US 200330050620 hcrcaftcr ‘620) in View of Burnside ct al (US 6,605,300 hcrcaftcr ‘300).
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`As discussed above the combination of the 173 and 620 patents provide a pharmaceutical
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`composition comprising an immediate release bead, a first delayed release bead and second
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`delayed are disclosed that provides a sustained release effect. The combination is silent to the
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`specific range of amphetamine present in the controlled release formulation. This type of
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`controlled release dosing can be found in the ‘300 patent.
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`The ‘300 patent teaches an oral pulsed rclcasc 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 co1'e between the drug layers, 01' at the enteric laye1' (col. 8, lin. 10-30). The
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`amphetamine is coated to an inert seed material (Example I). This coated seed is then coated
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`with various polymers, forming a co1'e with the amphetamine incorporated (Examples 2 and 3).
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`The formulation can comprise multiple coated delayed core comprises different enteric polymers
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`01' the same polymers such as Eudragit L or 41 10D (Examples 1-4). The formulation comp1'ises
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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 of a 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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`Amerigen Ex. 1015, p. 5
`Amerigen Ex. 1015, p. 5
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`

`
`Application.r"Control Number: I l.r"383,066
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`Art Unit: 1618
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`Page 5
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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). It would have been obvious to obvious to
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`including the components of the 300 patent, including the protective layer and buffer layer in
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`order to keep the beads f1'om cracking upon packing or storage.
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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 fo1'm (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 f1'om 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 thc 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 dose, it is
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`the position of the Examiner that these limitations 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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`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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`The reference is silent to a higher dosage; however, concentration however increasing the
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`dosage ofa well—known pharmaceutical dependent on the patient is well within the limits of one
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`of ordinary skill and would be an obvious modification. Since dosing concentrations are based
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`Amerigen Ex. 1015, p. 6
`Amerigen Ex. 1015, p. 6
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`

`
`Application.r"Control Number: I l.r"383,066
`
`Art Unit: 1618
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`Page 6
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`on patient need an increase or decrease in the potency of a dosage form would be an obvious
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`modification to provide the result effective variable to increase 01' decrease the effectiveness of
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`the dosage form. The general conditions of the claim have been met, namely a pharmaceutical
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`dosage form comprisin g immediate release and sustained release beads coated with enteric
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`polymers. Applicant is reminded that where the general conditions of a claim are disclosed in
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`the prior art, it is not inventive to discover the optimum 01' workable ranges by routine
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`experimentation. See In re Aller, 220 F.2d 454 105 USPQ 233, 235 (CCPA 1955).
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`Furthermore, the claims differ f1'om the reference by reciting various concentrations of
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`the active ingredient(s). However, the preparation of VEIl'lOl1S pharmaceutical compositions
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`having various amounts of the active is within the level of skill of one having ordinary skill in
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`the art at the time of the invention.
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`It has also been held that the mere selection of proportions
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`and ranges is not patentable absent a showing of c1'iticality. See In re Russell, 439 F.2d 1228 169
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`USPQ 426 (CCPA 1971).
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`With these aspect in mind it would have been obvious to combine the prior art in order to
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`form a stable dosage form useful in promoting wakefulness.
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`It would have been obvious to
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`combine the coatings of the ‘300 patent into the combination of the 174 and 620 patents in order
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`to protect the cores from cracking and degrading or prematurely releasing.
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`It would have been
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`an obvious modification since the combination also provides a stable controlled release
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`amphetamine formulation comprising bead and enteric polymers.
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`It would have been obvious to
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`combine the prior art with an expected result of a stable formulation less likely to prematurely
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`release and promote wakefulness.
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`Response to Arguments
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`Amerigen Ex. 1015, p. 7
`Amerigen Ex. 1015, p. 7
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`

`
`Application.r"Control Number: I l.r"383,066
`
`Art Unit: 1618
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`Page 7
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`Applicant's arguments filed 1;"24:"l4 have been fully considered but they are not
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`pe1'suasive. Applicant argues that:
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`The combination of Percel and Odidi does not obviate the instant claims because the
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`combination discloses a materially different coating pellet.
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`Regarding this argument, it remains the position of the Examiner that the combination
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`continues to obviate the instant claims. Applicant argues that f1'om the inside out the second
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`pellet would comprise a core coated with a delayed release coating and a sustained release
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`coating covering the delayed release coating. However, it is the position of the Examiner that
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`Applicant is merely arguing the semantics of the coating layers, since the actual compounds
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`applied to the co1'e bead are identical to those of the instant claims. According to instant
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`Example 1, the "delayed release coating layer" is SURELEASE, an ethyl cellulose compound.
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`The "sustained release coating laye1"' is a EUDRAGIT brand polymer. Pe1'cel discloses a coated
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`bead with an inner coating of ethyl cellulose and an outer coating of pH—sensitiVe methacrylic
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`acid-methamethacrylate copolymers (EUDRAGIT polymers) [0026-0027]. Although Percel
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`designated these polymers differently than the instant claims, these polymers are identical to the
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`instantly recited Example 1, and are disposed in an identical fashion as the instant claims. As
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`such, they would function in the same manner barring evidence to the contrary. Where the
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`claimed and prior art products are identical or substantially identical in structure or composition,
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`or are produced by identical or substantially identical processes, a prima facie case of either
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`anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ
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`430, 433 (CCPA 1977). It would have been obvious to combine Percel with the teachings of
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`Odidi to arrive at the amphetamine bead of the instant claims since Odidi also discloses a coated
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`Amerigen Ex. 1015, p. 8
`Amerigen Ex. 1015, p. 8
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`

`
`Application.r"Control Number: I l.r"383,066
`
`Art Unit: 1618
`
`Page 8
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`bead comprising the same drug as Percel, compressed into tablets or capsules as seen in Percel.
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`For these reasons, the claims remain obviated.
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`The combination of Percel, Odidi and Burnside does not obviate the instant claims do
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`not meet the coating limitations of the second bead and the combination does not teach a bead
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`that meets the longer—day needs of ADHA patients.
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`Regarding this argument, as discussed above the combination of Percel and Odidi
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`provide a controlled release formulation comprises an immediate release bead, a coated bead and
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`a second coated bead. Applicant argues that Burnside does not provide a layered bead as seen in
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`the instant claims and as such cannot obviate the instant claims. As discussed above the
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`combination of Percel and Odidi teaches a coated amphetamine head as recited in the instant
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`claims by disclosing a compositionally identical bead as recited by Example 1 of the
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`specification. Burnside is relied upon to establish the level of skill in the art regarding specific
`
`ranges of amphetamine formulations. The formulation comprises a combination of immediate
`
`release beads and controlled release beads (Example 4). The formulation can comprise up to 20
`
`mg of a mixture of amphetamine salts including dextroamphetamine saccharate and
`
`amphetamine sulfate (claim 1). A single immediate release- bead can be coated with a delayed
`
`release bead coating solution and combined with a second delayed release formulation so that the
`
`immediate and delayed release portions are present in the same bead and on different beads
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`(Example 4). It would have been obvious to obvious to including the components of the 300
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`patent, including the protective laye1' and buffer layer in order to keep the beads from cracking
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`upon packing or storage. For these reasons, the claims remain obviated.
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`Conclusion
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`Amerigen Ex. 1015, p. 9
`Amerigen Ex. 1015, p. 9
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`

`
`Application.r"Control Number: I l.r"383,066
`
`Art Unit: 1618
`
`Page 9
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`THIS ACTION IS MADE FINAL. 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. 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.136(a) will be calculated f1'om the mailing date of the advisory action.
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`In no event,
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`however, will the statutory period for reply expire later than SIX MONTHS from the mailing
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`date of this final action.
`
`Correspondence
`
`Any inquiry concerning this communication o1' earlier communications from the
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`examiner should be directed to MlCAH—PAUL YOUNG Whose telephone number is (571)272-
`
`0608. The examiner can normally be reached on Monday-Thu1'sday 7:00-5:30; every Friday off.
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`If attempts to reach the examiner by telephone are unsuccessful, the cxaminer’s
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`supervisor, Michael G. Hartley can be reached on 571-272-0616. 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. 1015, p. 10
`Amerigen Ex. 1015, p. 10
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`

`
`Application.r"Control Number: I l.r"383,066
`
`Page 10
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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 Ret1'ieva1 (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
`
`system, see http:ffpair—direct.uspto.gov. Should you have questions on access to the Private PAIR
`
`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 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
`
`;"MICAH—PAUL YOUNG!’
`
`Examiner, Art Unit 1618
`
`{Michael G. Hartley.’
`
`Supervisory Patent Examiner, Art Unit 1618
`
`Amerigen Ex. 1015, p. 11
`Amerigen Ex. 1015, p. 11