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
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`iiilmmorfi1233. 1 & pMpi£‘3F’f‘i'%
`'l'he McDer1nott Building
`500 North Capitol Street, N.W.
`WASHINGTON, DC 2000]
`
`Y0WG- MICA11 PAUL
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`
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`NOTIFICATION DATE
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`DELIVERY MODE
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`lU!07".I'2Ul 3
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`I_'Il-L".C'l'RON [C
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`Please find below andfor 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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`Notice of the Office communication was sent electronically on above—indicated "Notification Date" to the
`following e-mail address(es):
`
`mwcipdockcl@n1wc.co1n
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`m,J_9(,A (RW_04,m,
`
`Amerigen Ex. 1013, p. 1
`Amerigen Ex. 1013, p.
`1
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`

`
`Application No.
`1 1883.066
`
`Applicantis)
`SHOJAEI ET AL.
`
`Office Action Summary
`
`AIA (First Inventor to may
`A" Unit
`Examine,
`:|‘;‘“3
`1618
`M|CAH—PAUL YOUNG
`— The MMLING 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 § 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(aj.
`In no event. however. may a reply be timely filed
`afler SIX (6) MDNTHS 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 ollhis communication.
`—
`— Failure to reply within the set or extended period for reply will, by statute. cause the application to become ABANDONED (35 U_S.G_ § 133}.
`Any reply received by the Dfiice later than three months afterthe mailing date of this communication. even if timely filed. may reduce any
`earned patent term adjustment. See 3? CFR 1.?Cl4(b}.
`
`Status
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`1)|:| Responsive to communication(s) filed on
`E] A declaration(s)faffidavit(s) under 37 CFR 1.130(b) wasiwere filed on
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`2b)E This action is non—final.
`2a)|:| 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)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 Quayle, 1935 CD. 11, 453 O.G. 213.
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`Disposition of Claims
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`5) Claim(s) 1-5 7-32 and 62 isiare pending in the application.
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`5a) Of the above claim(s)
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`isiare withdrawn from consideration.
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`isiare allowed.
`6)I:i Claimts)
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`HE C|aim(s) i -5 7-32 and 62 isiare rejected.
`8)I:I C|aim(s)
`isiare objected to.
`9)I:I C|aim(s)
`are subject to restriction andior election requirement.
`‘ If any claims have been determined allowable, you may be eligible to benefit from the Patent Prosecution Highway program at a
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`participating intellectual property office for the corresponding application. For more information, please see
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`htt Jiwv.rvi.usr3to. ovi atentsfi nit eveattsi
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`hiindaxjs or send an inquiry to PPI-ifeedbackgtfiuspto.gov.
`
`Application Papers
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`10)|:I The specification is objected to by the Examiner.
`11)|:I The drawing(s) filed on
`isiare: a)I:I accepted or b)I:I objected to by the Examiner.
`Applicant may not request that any objection to the drawingisj 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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`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).
`Certified copies:
`a)I:| All
`b)I:l Some * c)|:| None of the:
`1.|:I Certified copies of the priority documents have been received.
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`2.|:I Certified copies of the priority documents have been received in Application No.
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`.
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`3.|: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 Flule 17.2(a)).
`* See the attached detailed Office action for a list of the certified copies not received.
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`Attachment(s)
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`1} E Notice of References Cited {PTO—892j
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`2}
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`Information Disclosure Statementnisj (PTOiSBi0Bj
`Paper No(s]iMail Date 12/6/10. 10/12/12.
`U.S. Patenl and Trademark Office
`
`PTDL—326 (Rev. 08- 1 3)
`
`Office Action Summary
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`3} El jmewiew summary (pT0.413)
`P
`N
`EM "I D t
`.
`.
`al
`a e
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`0(5)
`aper
`43 D Om" :-
`Amerigen Ex. 1013, p. 2
`A m e r g éan oEaper
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`001
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`

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`Application1'Control Number: ll;’383,066
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`Page 2
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`Art Unit: 1618
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`The present application is being examined unde1' the pre-AIA first to invent provisions.
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`DETAILED ACTION
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`Continued Examination Under 37 CFR 1.114
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`A request for continued examination under 37 CFR 1.1 14, including the fee set forth in
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`37 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 l.l 14, and the fee set forth in 37 CFR l.17(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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`37 CFR 1.1 14. Applicant's submission filed on lfl2.r"l 1 has been entered.
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`Claim Rejections - 35 USC § 103
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`The following is a quotation of p1'e—AIA 35 USC. l03(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 a1't are such that the subject matter as a whole would have bcc11 obvious at the time the
`invention was made to a person having ordinary skill in the an to which said subject matter pertains.
`Patentability shall not be negativecl by the manner in which the invention was made.
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`The factual inquiries set forth in Graham 12. John Deere C0., 383 U.S. 1, 148 USPQ 459
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`(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. Determining 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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`nonobviousne ss.
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`Amerigen Ex. 1013, p. 3
`Amerigen Ex. 1013, p. 3
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`

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`Application1'Control Number: ll;’383,066
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`Page 3
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`Art Unit: 1618
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`Claims 1-5, 17, 18, and 23 a1'e rejected under pre-AIA 35 U.S.C. lO3(a) as being
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`unpatentable over the combined disclosures of Percel et al ("US 200330157173 hereafter ‘l73) in
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`view of Odidi et al (US 2003;’0050620 hereafter ‘620).
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`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 d1'ug 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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`coating over the delayed release csustained0l4-0016]. 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 or
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`different cores as the sustained or delayed release beads [0025]. The beads are collected into
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`capsules or compressed into tablets [003 l].
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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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`'620 publication.
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`The 620 publication discloses a controlled release formulation where various active
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`agents a1'e differentially released including propranolol 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 [0037]. The granules or beads are collected into capsules of compressed into tablets
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`[Examples]. It would have been obvious to substitute the amphetamine of the 620 for the
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`p1'opranolol of the l?3 publication as they a1'e both used for differential release of active agents.
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`Amerigen Ex. 1013, p. 4
`Amerigen Ex. 1013, p. 4
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`

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`Application1'Control Number: ll;’383,066
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`Page 4
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`Art Unit: 1618
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`With these aspects in mind it would have been obvious to combine the prior a1't with an
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`expected result of a stable drug useful in maintain wakefulness. It would have been obvious to
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`substitute the active agents from the 620 into the 173 publication since they both 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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`Claims 1, 7-32 and 62 are rejected unde1' pre-AIA 35 U.S.C. l03(a) as being unpatentable
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`over the combined disclosures of Percel et al (US 200330157173 hereafter ‘l73) and Odidi et al
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`(US 2003130050620 hereafter ‘620) in view of Burnside et al (US 6,605,300 hereafter ‘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 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, Iin. 43—68). The formulation further comprises a protective
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`coating to the core between the drug laye1's, 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 co1'e with the amphetamine incorporated ("Examples 2 and 3).
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`Amerigen Ex. 1013, p. 5
`Amerigen Ex. 1013, p. 5
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`

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`Application1'Control Number: ll;’383,066
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`Page 5
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`Art Unit: 1618
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`The formulation can comprise multiple coated delayed co1'e comprises different enteric polymers
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`or the same polymers such as Eud1'agit L or 41 10D (Examples l—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 saccha1'ate and amphetamine sulfate (claim 1). A single immediate 1'elease-
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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 a1'e 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 from 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 form (food, Tmax, AUC and Cmax values) it is
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`the position of the Examiner that these limitations a1'e merely functional limitations that are the
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`result of the instant compositional components. These functional limitations a1'e 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 ‘3{)(} 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 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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`Amerigen Ex. 1013, p. 6
`Amerigen Ex. 1013, p. 6
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`

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`Applicatiom'Contro1 Number: ll;’383,066
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`Page 6
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`Art Unit: 1618
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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 of a 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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`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 or 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 comprising 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 or 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 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 of one 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 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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`Amerigen Ex. 1013, p. 7
`Amerigen Ex. 1013, p. 7
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`

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`Application1'Contro1 Number: ll;’383,066
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`Page 7
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`Art Unit: 1618
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`to protect the cores f1'om cracking and deg1'ading or prematurely releasing. 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 comp1'ising bead and enteric polymers. 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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`Applicant’s arguments with respect to claims 1-5, 7-32 and 62 have been considered but
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`are moot because the arguments do not apply to any of the references being used in the current
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`rejection.
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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 MlCAH—PAUL YOUNG whose telephone number is (571)272-
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`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 examiner’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. 1013, p. 8
`Amerigen Ex. 1013, p. 8
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`

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`Application1'Control Number: ll;’383,066
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`Page 8
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`Art Unit: 1618
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`Info1'mation regarding the status of an application may be obtained from the Patent
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`Application Information Retrieval (PAIR) system. Status infonnation for published applications
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`may be obtained f1'om either Private PAIR or Public PAIR. Status information fo1' unpublished
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`applications is available through Private PAIR only. For more information about the PAIR
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`system, see http:;’fpair-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
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`like assistance f1'om 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.
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`IMICAH-PAUL YOUNG!
`
`Examiner, Art Unit 1618
`
`:"Michael G. Hartleyf
`Supervisory Patent Examiner, Art Unit 1618
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`Amerigen Ex. 1013, p. 9
`Amerigen Ex. 1013, p. 9