UNITED S'1‘A'l‘]:'S P/\'l‘l:‘N'l‘ AND TRADEMARK OHHC15
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`I.‘-\'I'I‘l'-ID STATES DEPARTMENT OF COMMERCE
`United States Patent and '1‘rmIen1ark Ofliee
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`1 l!383.00(>
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`05!] 32000
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`Amir Shojaei
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`2034211202653-U38
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`"I083
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`T273
`TSQIIJ
`DARBY& DARBYPL‘.
`p_0_ Box TFO
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`Clmrch Street Station
`New York, NY looosmm
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`.,
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`]'.X \M|N|'.R
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`YOUNG. MICAII PAUL
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`MP] R V_Wml_R
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`mus
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`D1“’ER*’M°DE
`PAI-‘L-LR
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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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`[}T(')L_g.nA (RW_m,m,
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`Amerigen Ex. 1007, p. 1
`Amerigen Ex. 1007, p.
`1
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`

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`Office Action Summary
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`Application No.
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`AppIicant(s)
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`11I383,066
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`SHOJAEI ET AL.
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`Examine,
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`MICAH-PAUL YOUNG
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`M 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 slx (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 Orifice 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_?l]4(h)_
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`Statu s
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`1)I:I Responsive to communication(s) filed on
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`2a)I:| This action is FINAL.
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`2b)X 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 Quayle, 1935 CD. 11, 453 O6. 213.
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`Disposition of Claims
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`4)E C|aim(s) 1-32 and 59-61' 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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`isfare allowed.
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`6)X C|aim(s) 1-32 and 59-61 isiare rejected.
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`7)[:l C|aim(s)j isfare objected to.
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`8)I:I C|aim(s)j are subject to restriction andfor 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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`isfare: 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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`1) E Notice of References Cited (PTO-892)
`2) El Notice of Draftspersons Patent Drawing Review (PTO-948)
`3) E Information Disclosure Statementis) (PTOISBIOS)
`Paper No(s)lMail Date 10/26/01 12/7x07. 1/9/07. 3/so/07, 3/20/07, 1/to/oa_
`9/18/08.
`US. Patent and Trademark Ofiice
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`4) El Interview Summary (PTO-413)
`Paper NC-'I3IIM3II D3“? -
`5) I:I NONI-‘e of Informal Patent Appllcailon
`6) El Other:
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`PTOL-326 (Rev. 08-06)
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`0-tfice Action Summary
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`Amerigen Ex. 1007, p. 2
`Am erjagfi
`Nl1_66lfJalfi20§0929
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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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`Information Disclosure Statement
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`The information disclosure statement (IDS) submitted on l0r’26r’0'?, 12i’7f07, 1f9x’07,
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`3#'30x’07, 8,320/07, lz’l0f08 and 9f'lx’08 were filed in a timely fashion. The submission is in
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`compliance with the provisions of 37 CPR 1.97. Accordingly, the information disclosure
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`statement is being considered by the examiner.
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`Claim Rejections - 35 USC § H2
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`The following is a quotation of the second paragraph of 35 U.S.C. 1 12:
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`The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the
`subject matter which the applicant regards as his invention.
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`Claims 6 and 59-61 rejected under 35 U.S.C. 112, second paragraph, as being indefinite
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`for failing to particularly point out and distinctly claim the subject matter which applicant
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`regards as the invention.
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`Claims 6 and 59-6] contain the trademarkftrade name ADDERALL XL. Where a
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`trademark or trade name is used in a claim as a limitation to identify or describe a particular
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`material or product, the claim does not comply with the requirements of 35 U.S.C. 1 12, second
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`paragraph. See Exparte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is
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`uncertain since the trademark or trade name cannot be used properly to identify any particular
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`material or product. A trademark or trade name is used to identify a source of goods, and not the
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`goods themselves. Thus, a trademark or trade name does not identify or describe the goods
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`associated with the trademark or trade name. In the present case, the trademarkftrade name is
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`used to identifyfdescribe a commercially available mixture of amphetamine salts used in treating
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`ADHD and, accordingly, the identificationfdescription is indefinite.
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`Amerigen Ex. 1007, p. 3
`Amerigen Ex. 1007, p. 3
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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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`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 person shall be entitled to a panent unless —
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`(b) the invention was patented or described l.I.l a printed publication in this or a foreign country or in public 11se or on
`sale in this country, more than one year prior to the date olappliealioii for patent in the United States.
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`Claims 1-23, 25, 26 and 59-61 are rejected under 35 U.S.C. 102(b) as being anticipated
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`by Burnside et al (USPN 6,605,300 hereafter ‘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, Iin. 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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`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 ]0D (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 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. 1007, p. 4
`Amerigen Ex. 1007, p. 4
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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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`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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`biocquivalence, and blood plasma concentrations.
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`Further specifically regarding the potential Tmax, Cmax and AUC of a 315 mg dose, 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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`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. l03(a) which forms the basis for all
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`obviousness rejections set forth in this Office action:
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`Amerigen Ex. 1007, p. 5
`Amerigen Ex. 1007, 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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`(a) A patent may not he obtained though the invention is not identically disclosed 01' described as set forth in
`section 102 of this title, if the di1'fe1‘e11ees between the subject matter sought to be patented and the prior art are
`such that 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 negatived by the
`manner in which the invention was made.
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`The factual inquiries set forth in Graham v. John Deere C0., 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. l03(a) are summarized as follows:
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`.43"?-"’!‘-’._'
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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 1-32 and 59-6] are rejected under 35 U.S.C. l03(a) as being unpatentable over
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`the disclosures of Burnside et al (USPN 6,605,300 hereafter ‘300).
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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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`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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`Amerigen Ex. 1007, p. 6
`Amerigen Ex. 1007, p. 6
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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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`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 of one having ordinary skill in the art at
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`the time of the invention. 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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`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 (521)222-
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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 571-272-0616. The fax phone number for the
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`organization where this application or proceeding is assigned is 57]-2?'3-8300.
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`Amerigen Ex. 1007, p. 7
`Amerigen Ex. 1007, p. 7
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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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`Information regarding the status of an application may be obtained from the Patent
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`Application Information Retrieval (PAIR) system. Status information for published applications
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`may be obtained from either Private PAIR or Public PAIR. Status information for 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: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
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`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
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`/MICAH-PAUL YOUNG}
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`Examiner, Art Unit 1618
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`Amerigen Ex. 1007, p. 8
`Amerigen Ex. 1007, p. 8