Docket No.: 085199-0034
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`PATENT
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`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
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`Applicant: Amir SHOJAEI
`Application No.:
`1 1/383,066
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`Filed: May 12, 2006
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`Customer No.: 2027?
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`Confinnation No.: 7083
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`Group Art Unit:
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`1618
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`Examiner: Micah Paul YOUNG
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`Title: CONTROLLED DOSE DRUG DELIVERY SYSTEM
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`AMENDMENT UNDER 37 CFR 1.116
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`Mail Stop RCE
`Commissioner for Patents
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`P.O. Box 1450
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`Alexandria, VA 22313-1450
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`Sir:
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`This is in response to the final Office Action mailed April 30, 2010. A Request for
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`Continued Examination (RCE) accompanies this response.
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`Remarks/arguments begin on page 2 of this paper.
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`To the extent necessary, a petition for an extension of time under 3? CFR. 1.136 is
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`hereby made. Please charge any shortage in fees due in connection with the filing of this paper,
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`including extension of time fees, to Deposit Account 500417 and please credit any excess fees to
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`such deposit account.
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`NYK I 33U?3S-l .085 1 99.0034
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`Amerigen Ex. 1010, p. 1
`Amerigen Ex. 1010, p.
`1
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`

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`I lr‘383,|}66
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`Remarksfarguments
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`Claims 1-5 and 7-32 are pending.
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`I.
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`Rejection under 35 U.S.C. § 102|b[
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`Claims 1-5, 7-23, 25, and 26 have been rejected under 35 U.S.C. § 102(b) as anticipated
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`by U.S. Patent No. 6,605,300. The Examiner states that the ‘300 patent discloses a formulation
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`comprising a combination of immediate release and delayed release amphetamine beads. The
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`Examiner contends that the ‘300 discloses that: “[a] single immediate release head can be coated
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`with a delayed release bead coating solution and combined with a second delayed release
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`formulation so that the immediate and delayed release portions are present in the same bead and
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`on different beads (Example 4).” Office Action, p. 3.
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`Applicants respectfully traverse this rejection. The instant claims are directed to a 3-bead
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`pharmaceutical composition comprising (a) an immediate release bead, (b) a first delayed release
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`bead providing pulsed release, and (c) a second delayed release bead providing sustained release.
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`The ‘300 patent discloses a 2-bead pharmaceutical formulation comprising an immediate release
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`bead and a delayed pulsed release bead. Example 1 of the ‘300 patent, titled “Immediate Release
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`Formulation,” discloses an immediate release amphetamine bead. Examples 2 and 3 of the ‘300
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`patent disclose embodiments of a delayed pulsed release bead wherein the immediate release
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`bead of Example 1 was sprayed with enteric coatings. The release profile of the Example 2 bead
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`is shown in Figure 4, which illustrates a delay of 2 hours prior to a nearly complete release of
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`drug within 1 hour, i.e., delayed pulsed release. The release profile of the Example 3 bead is
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`shown in Figure 5, which illustrates a delay of 3 hours prior to a nearly complete release of drug .
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`within about 30 minutes, i.e., delayed pulsed release. The ‘300 patent teaches that the “lag time”
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`NYK l33l'J733—l_0S519'9.0034
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`Amerigen Ex. 1010, p. 2
`Amerigen Ex. 1010, p. 2
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`

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`l1:‘383,066
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`(delay until release begins) of the delayed pulsed release component can be increased by
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`applying a coating of, e. g., SURELEASE, over the enteric coating. See, ‘300 patent, col. 8, 58 —
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`col. 9,
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`l. 22. Example 4 of the ‘300 patent exemplifies this teaching by coating the delayed
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`pulsed release beads “from Example 2 or from Example 3 (2 kg of either)” with SURELEASE.
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`‘300 patent, col. ll, 1. 60 — col. 12, 1. 26 (emphasis added). Example 5 of the ‘300 patent
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`discloses a pulsatile delivery system “achieved by combining the immediate release pellets
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`[beads] (Example 1) with delayed release pellets (Example 2 or Example 3).” ‘300 patent, col.
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`12, 11. 28-48 (emphasis added). Thus, the ‘300 patent discloses a 2-bead composition comprising
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`an immediate release bead and a delayed pulsed release bead. The ‘300 patent discloses different
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`embodiments of immediate release beads and delayed pulsed release beads, but
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`the only
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`disclosure of combining beads with different release profiles is the 2-bead pulsatile delivery
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`system which includes an immediate release bead and a delayed pulsed bead. There is no
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`disclosure of a 3-bead composition.
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`In sum, the ‘3OO patent does not disclose a pharmaceutical composition comprising 3
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`beads (much less a 3-bead composition comprising an immediate release bead, a bead providing
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`delayed pulsed release, and a bead providing sustained release). Thus, this rejection should be
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`withdrawn.
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`II.
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`Rejection under 35 U.S.C. § 10312:)
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`Claims 1-5 and "F-32 have been rejected under 35 U.S.C. § l03(a) as obvious over the
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`‘300 patent. The Examiner states tha: “[t]he general conditions of the claim have been met,
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`namely a pharmaceutical dosage form comprising immediate release and sustained release beads
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`coated with enteric polymers.” Office Action p. 5. According to the Examiner, “the instant
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`NYK I330‘Ir'38—1.035|99.0034
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`Amerigen Ex. 1010, p. 3
`Amerigen Ex. 1010, p. 3
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`

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`1 1i383,l}66
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`claims recite that the enteric polymers are the sa.me. As such the coated beads of the ‘300 patent
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`would act as the second and third beads, since their only difference is the intended use of a pulse
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`release or a Sustained release. Since the coating materials would be the same, the collection of
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`enteric coated controlled release beads found in the ‘300 patent would meet this limitations
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`[sic].” Office Action, p. 6. Thus, the Examiner contends that an enteric coating may only be
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`used to create a bead with one type of profile. The ‘300 patent teaches that this profile is delayed
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`pulsed release.
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`Applicants respectfully traverse this rejection. Even if the ‘300 patent discloses the
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`instantly claimed first delayed release bead and second delayed release bead (it does not). and the
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`first and second delayed release beads have the same release profile (they do not), the ‘300
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`patent does not disclose or suggest a pharmaceutical composition comprising 3—beads. The ‘300
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`patent teaches immediate release and delayed pulsed release amphetamine beads. According to
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`the ‘300 patent, sustained release delivery is not suitable for amphetamines. See, e.g., col. 1, 11.
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`14-63; col. 4.
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`ll. 29-61. As stated in (1) above. the ‘300 patent discloses a 2-bead delivery
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`system. There would have been no motivation for one of ordinary skill in the art to include an
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`immediate release bead and two different delayed pulsed release beads in a pharmaceutical
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`delivery system, nor a reasonable expectation that such a composition would work in a
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`pharmaceutical composition according to the instant claims:
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`The addition of a second delayed pulsed release formulation. having a lag time of
`about 8 hours,
`to ADDERALL XR® cannot, as one might expect, meet
`the
`recognized need for a once—daily long-acting amphetamine composition
`A
`delayed pulsed formulation having a lag time of about 8 hours would be
`unsuitable because it would release the active agent in the distal gastrointestinal
`tract (the colon), resulting in decreased absorption of the active agent.
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`Instant specification. para. 22.
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`NYK |330T'33—l.085i99.0(J3-4
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`Amerigen Ex. 1010, p. 4
`Amerigen Ex. 1010, p. 4
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`

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`ll.r'383,066
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`Thus,
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`the ‘300 patent does not disclose or suggest the claimed 3-bead amphetamine
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`pharmaceutical composition. For the reasons stated above, this rejection should be withdrawn.
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`Conclusion
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`This application is believed to be in condition for allowance. If any issues remain which
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`may be addressed by an Examiner’s amendment of or a supplemental amendment, the Examiner
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`is respectfully requested to contact the undersigned.
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`Respectfully submitted,
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`Wmorr ILL & EMERY LLP
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`Paul M.
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`Registration No. 52,392
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`Please recognize our Customer No. 20277
`as our correspondence address.
`
`600 13"‘ Street, N.W.
`Washington, DC 20005-3096
`Phone: 212.547.5400 PMZ:MWE
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`Facsimile: 202.356.8087
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`Date: July 28, 2010
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`NYK I 330".-'38—| .035 1 99.0034
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`Amerigen Ex. 1010, p. 5
`Amerigen Ex. 1010, p. 5