UN1'l‘l:‘.D S'l‘A'l'J:'S PA'rEN'r AND TRADl:‘.MARK OFFICE
`
`UNITED STATES DI:‘.I’ARTMENT OF COM.MER(_‘.E
`United States Patent and Trademark Olfiue
`Address-. (IOMMISS|()N}ER I"()R l’:\'|'I£N'1'S
`PD. Bout
`l-1-50
`Alx:x:t1|(lri:|, \-"'
`'ni:I 22.'l.l3—I-I-5IJ
`www.usplu.gt
`
`NOTICE OF ALLOWANCE AND FEE(S) DUE
`
`21137?
`
`T591]
`
`EJTHJTQII I -4
`
`MCDL-‘RMO’l'l' WILL & EMERY LLP
`
`The MeDerInott Building
`500 No11I1 Capitol Street, N.W.
`WASIIINCITON, DC ZUUUI
`
`EXANIINER
`
`YOUNG. MICAIIPALIL
`
`1513
`
`DATE MAILED: OTIDTIEOI4
`
`;\l’PI.I(‘.w\'|'|()N NO.
`
`1"lI.|N(i l)A'l'Ii
`
`|"|RS'l' NAMISI) |N\«"I-INTOR
`
`.*\'|"I'OR.\7|iY 1)O(IKI€'l' NO.
`
`('()N1"lRNI.4\'|'|()N NO.
`
`05! I 29.006
`l |.I'333,066
`TITLE OF INVENTION: C‘ONTROI.l.F.D DOSE DRUG DELIVERY SYSTEM
`
`Amir Shojaei
`
`O35] 9‘}—0034
`
`T033
`
`APPLN. TYPE
`ENTITY STATUS
`ISSUE FEE DUE
`PUBLICATION FEE DUE
`PREV. PAID ISSUE FEE
`TOTAL FEELS] DUE
`DATE DIJE
`
`$960
`$0
`$0
`$960
`I DID?!20] -1
`nonprovisional
`UNT) ISCOUNTED
`
`THE APPLICATION IDENTIFIED ABOVE HAS BEEN EXAMINED AND IS ALLOWED FOR ISSUANCE AS A PATENT.
`PROSECUTION ON THE MERITS IS CLOSED. THIS NOTICE OF ALLOWANCE IS NOT A GRANT OF PATENT RIGHTS.
`TIIIS APPLICATION IS SUBJECT TO WITIIDRAWAI. FROM ISSUE AT TIIE INITIATIVE OF TIIE OFFICE OR UPON
`PETITION BY THE APPLICANT. SEE 37 CFR 1.313 AND MPEP 1308.
`
`THE ISSUE FEE AND PUBLICATION FEE (IF REQUIRED) MUST BE PAID WITHIN THREE MONTHS FROM THE
`MAILING DATE OF TIIIS NOTICE OR TIIIS APPLICATION SHALL BE REGARDED AS ABANDONED.
`TIIIS
`TAT T RY PERI D A
`'I‘ BE EXTENDED. SEE 35 U.S.C. 151. THE ISSUE FEE DUE INDICATED ABOVE DOES
`
`
`NOT REFLECT A CREDIT FOR ANY PREVIOUSLY PAID ISSUE FEE IN TIIIS APPLICATION.
`IF AN ISSUE FEE IIAS
`PREVIOUSLY BEEN PAID IN THIS APPLICATION (AS SHOWN ABOVE), THE RETURN OF PART B OF THIS FORM
`WILL BE CONSIDERED A REQUEST TO REAPPLY TIIE PREVIOUSLY PAID ISSUE FEE TOWARD TIIE ISSUE FEE NOW
`DI E.
`
`IIOW TO REPLY TO TIIIS NOTICE:
`
`1. Review the l:]N'I‘I'l‘Y S'l‘A'l‘US shown above. If tl1e l:‘NTl'l'Y S'I"A'l‘US is sl1owt1 as SMALL or MICRO, verify whether et1tit|e1nent to tl1at
`entity status still applies.
`
`If the l:‘.N'l‘l'l'Y S'1‘A'l‘US is the same as shown above, pay the TOTAL F]:'l:](S) DUE shown above.
`
`If the l:‘.N:l‘l'l'Y _S'l'A'l‘I J S is changed from that shown above, ot1 PART B - Fl:'l:]t’S) 'l'RANSMl'l'l‘AL, complete section number 5 titled
`"Change in Entity Status (from status 1nd1cated above)".
`
`For purposes of this notice, small entity fees are U2 the amount of undiscounted fees, and micro entity fees are U2 the amount of small entity
`fees.
`
`ll. PART B - Fl:II:'(S) 'l'RANSMI'I"l"AL, or its equivalent, must be completed and returned to the United States Patent and Tradeniark Office
`(USPTO) with your ISSUE FEE and PUBL1(_‘A'l'lON FEE (if required). If you are charging the feels} to your deposit account, section "4b"
`of Part B - Fee( s) Transmittal should be completed and an extra copy of the form should be submitted. If an equivalent of Part B is filed, a
`request to reapply a previously paid issue fee t11ust be clearly t11ade, and delays in processing may occur due to the difficulty in recognizing
`the paper as an equivalent of Part B.
`
`III. All communications regarding lI1is application must give the application number. Please direct all eo1n1n1II1icatioI1s prior to issuance to
`Mail Stop ISSUE
`unless advised to the eontrary.
`
`IMPORTANT REMINDER: Utility patents issuing on applications filed on or after Dec. 12, 1980 may require payment of
`maintenance fees. It is palentee‘s responsibility to ensure timely payment of maintenance fees when due.
`
`PTOl.—85 (Rev. OZII I)
`
`Page I "[3
`
`Amerigen Ex. 1017, p. 1
`Amerigen Ex. 1017, p.
`1
`
`

`
`PART B - FEE(S) TRANSMITTAL
`
`Complete and send this form, together with applicable l‘ee{s), to: Mg'l Mail Stop ISSUE. FEE
`Commissioner for Patents
`PO. Box 1450
`Alexandria, Virginia 22313-1450
`(571)-273-2885
`
`or Ea;
`
`through 5 should be completed where
`tit‘ required]. Blocks 1
`lNS'I‘RUC’l'[0NS: This form should be used for transmitting the ISSULL I-I.-‘.1.-I and PLI'l5LICA'l‘[0N 1-"L-'.|_i
`tip ropriate. All further correspondence including the Patent. advance orders and notification of maintenance fees will be mailed to the c1ii'reiit corres ondence address as
`in
`icated unless corrected below or directed otherwise in Block I. by ta} specifying a new correspondence address: andfor tb} indicating a separate “ -
`-"L-L At)DR]_-'.SS“ for
`maintenance fee notifications.
`
`(.'l7RRl{.7\t_l' CURRl{Sl’()Nl)l{N[.'lE ADDRESS (Note: Use lilock I For any clizmge olatltiressy
`
`Eoyq
`
`7590
`
`. &
`The Nlcljennon Building
`500 North Capitol Street, N.W.
`
`O7’f0?Q0l4
`
`J)
`
`.|\_lote: A certificate of_maitir_i0 can only be used for domestic mailings of the
`1-eets} transmittal. 'l'his certificate cannot be used for any othei' accompanying
`glpg-[g_
`addiljgnal pap(_~['__ such as an assignfnc-n[ of fofnjal drawing‘ I-nus;
`liave its own certificate ot‘ mailing or transmission.
`(Ierlilicale til" Mailing or Trurismissitin
`[ hereh ' certiliy that this Fee(s] Transmittal is heing deposited with the United
`States ostal Service _with suITiciei:t postage For first class mail in an envelope
`addressed to the Mail Sto
`ISSI.-F. FFF: address above, or being facsimile
`transmitted to the USP'T'0 (_ 7]) 273-2385. on the date indicated below.
`Il)cpiisiIor's iizuiicl
`
`WAS HINGTON. DC 20001
`
`A|’1’l.l(TA'I'|()N N0.
`
`1"|l.|N(i ])A'l'|'i
`
`|"|RS'l' NA.i\'l]il'.‘.' |NVI'IN'l'0R
`
`,4‘\'|"l'(JR.V|iY ])II}t'IKI5'|' N0.
`
`(.'()N'l"|RMA'l'I()N NO.
`
`05! I EJZDO6
`I [£383,066
`'l'l'l'LL'L 01" lNVl_-'.N'l'lON: CON'l'l{0LL|_'LD DOSLL DRUG Dl_'}LlV]_-LRY SYS'l'L".l\«'I
`
`Amir Shoiaei
`
`085 I 99—003=l
`
`"F033
`
`APPI 'l'Yl’|£
`
`1'IN'l'I'l'Y S'l'A'|'l.'!S
`
`ISSI.‘-1'2 |"|L|L DI Ili
`
`Pl.‘-13I.I(.'A'l'I()N 1"l€1'I DUIL
`
`l’Rl'I\-'. PAI1) ISSIJTI l"Ii|i
`
`'l'()'l'AI. 1'15] '15?) l)IJ'1'I
`
`DA'l'1'I DUIL
`
`nonprovisional
`
`UND ISCOI ‘NTF.D
`
`EXAMINER
`
`YOUNG. MICAJI PAUL
`
`$960
`
`ART UNIT
`
`1618
`
`Cl_.ASS—S UB CLASS
`
`-I2-l—490'000
`
`S0
`
`5960
`
`I DID?!201 4
`
`
` I
`
`. Change of correspondence address or indication oi‘ "Fee Address" (3?
`CFR L363").
`:l Change of correspondence address (or Change ot‘(_‘.orrespondence
`Address orm P'l'(Ji'.‘:‘t|3i' 122} attached.
`3 "Fee Address" indication (or "Fee Address" [ndication Form
`l’TO.I'SB.I'4'?': Rev 03-02 or more recent} attached. Ilse til" in Customer
`Number is required.
`
`
`
`2. For printing on the patent front page. list
`(1) 'l'he names of up to 3 registered patent attorneys
`or agents OR. alternatively.
`(3) The name of a single firm (having as a member a
`registered attorney or agent) and the names of up to
`2 registered patent attorneys or agents. if no name is
`listed, no name will be printed.
`
`I
`
`3
`'
`
`3. ASSlGNL'L|_'L NAB-".ll_'L AND Rl_'LSIDL'LN(_‘.l_-L DATA TO Blj PRIi\"l‘|_'LD ON 'l'lIl;' I-‘A'l'L'Li\"l‘ I print or type}
`
`l’l.F,ASF. NOTE: Unless an 21S5li%]'It‘t‘ is identified below, no assignee data will appear on the patent.
`ll" an assignee is identified helow, the document has been filed fill’
`rectirdation as set forth in 37 CF 3.] l. C‘omplelion of this Ihrm is NOT a substitute Ilir filing an assignment.
`(A) NAME OF ASSIGNEF.
`(B) RF.Sll)F.NCF.: (CITY and STATE OR C0l.TN’I'RY}
`
`Please check the appi'opi'iate assignee category or categories {will not be printed on the patent] : El Individual El Corporation or other private group entity D Government
`
`-la. The following feets} are submitted:
`3 Issue Fee
`
`4b. Payment ot‘l-'ee[sJ: (Please first reapply any previously paid issue fee shown above)
`3 A check is enclosed.
`
`:l Publication I-'ee {No small entity discount permitted}
`3 Advance Order — # ot‘Co[-tics
`
`:l Payment by credit card. 1-‘orm Pl‘O—2038 is attached.
`jThe Director is hereby authoriried to charge the required l'ee[s], any deficiency, or credits any _
`overpayment, to Deposit Account Number
`(enclose an extra copy oi this l'on1't}.
`
`5. Change in Enlily Status Ilirom status indicated above]
`3 Applicant certifying micro entity status. See 37 CFR I .29
`
`:l Applicant asserting small entity status. See 3?’ (.‘.l"R 1.27
`
`NOTE: Absent a valid certilication of Micro Fntity Status (see forms P"l‘O.I'SRi'l5A and I513], issue
`fee payment in the micro entity amount will not be accepted at the risk of application abandonment.
`]\’0't‘1£: [fthe application was previously undei' micro entity status. checking this box will be taken
`to be a notification of loss of entitlement to micro entity status.
`
`3 Applicant changing to regular undiseounted Iiee status.
`
`NOTF: Checking this box will he taken to he a notilication of loss of entitlement to small or micro
`entity status, as applicable.
`N0'I‘l'_-'.: This form must he signed in accordance with 3? Cl-"R 1.3] and 1.33. See 37" Cl-"R [.4 for si nature re tiirements and certifications.
`
`
`
`Authorized Signature
`
`Typed or printed name
`
`Date
`
`Registration No.
`
`P'l'0L—8S Part B I I0 I3) Approved for use through 1013112013.
`
`Pagc20f3
`OMB 0651-0033
`
`Amerigen Ex. 1017, p. 2
`Amerigen Ex. 1017, p. 2
`US. Patent and Trademark Office: U .S. DI_£PAR'l'Ml_iN'l' 01" COMM].-LRCL-I
`
`

`
`CON'F[RMATION NO.
`
`UNl'l‘l:‘.D S'l‘A'l'J:'S PA'n£N'r AND TRADl:‘.MARK OFFICE
`
`UNITED STATES DI:‘.l’ARTMl:lNT OF CO1\L\1]i‘.R(_‘.l:I
`United States Patent and 'l‘r:1dcmark Olfiuc
`Adrln.-ss: (IOMMlSS|()N}ER I"()R |’a'\'|'I£N'1'S
`PO. BOX [450
`Alrxarltlrizl, Virginia 2 2.113 — I -150
`wwu-.||splu.guv
`
`APPl_.ICATION NO.
`
`FILING DATE
`
`F IRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`I 1.683.066
`
`05! 1272006
`
`Amir Shojaci
`
`(J85 I99-0-034
`
`7083
`
`MCDL£RMO'l'l‘ WILL & EMERY LLP
`
`YOUNG. MICAIIPALIL
`
`The McDcrInoI1 Building
`500 Noun Capitol su-ecu, N.w.
`WAS] IINGTON, DC 20'U0|
`
`1513
`
`DATE MAILED: l')7!07a'20l4
`
`Determination of Patent Term Adjustment under 35 U.S.C. 154 (b)
`
`(Applications filed on or afte1' May 29, 2000)
`
`The Office has discontinued providing a Patent Term Adjustment (PTA) calculation with the Notice of Allowance.
`
`to eliminate the
`l54(b)('3)(B)(i)
`Section l(h)(2) of the AIA Technical Corrections Act amended 35 U.S.C.
`requirement
`that
`the Office provide a patent term adjustment determination with the notice of allowance. See
`Revisions to Patent Term Adjustment, 78 Fed. Reg. I94l6, 19417 (Apr. 1, 2013). Therefore, the Office is no longer
`providing an initial patent term adjustment determination with the notice of allowance. The Office will continue to
`provide a patent
`term adjustment determination with the Issue Notification Letter that
`is mailed to applicant
`approximately three weeks prior to the issue date of the patent, and will include the patent term adjustment on the
`patent. Any request for reconsideration of the patent term adjustment determination (or reinstatement of patent term
`adjustment) should follow the process outlined in 37 CFR 1.705.
`
`Any questions regarding the Patent Term Extension or Adjustment determination should be directed to the Office of
`Patent Legal Administration at (571)-272-7702. Questions relating to issue and publication fee payments should be
`directed to the Customer Service Center of the Office of Patent Publication at l—(888)—786—0l01 or (571)-272-4200.
`
`I,mI‘_8__;(RW_mn
`
`Page 3 of3
`
`.
`Amerigen Ex. 1017, p. 3
`Amerlgen Ex. 1017, p. 3
`
`

`
`OMB Clearance and PRA Burden Statement for PTOL-B5 Part B
`
`T|1e Paperwork Reduction Act (PRA} of 1995 requires Federal agencies to obtain Office of Management and
`Budget approval before requesting tnost types of infortnation frot11 tl1e public. Wl1eI1 OMB approves an agency
`request to collect information from the public, OMB (i) provides a valid OMB Control Nutnber and expiration
`date for the agency to display on the instrument that will be used to collect the information and (ii) requires the
`agency to infortn the public about the OMB Control Number's legal significance in accordance with 5 CPR
`l320.5(b).
`
`T|1e infomiation collected by PTOl,—85 Part B is required by 37 CFR 1.311. The information is required to obtain
`or retain a benefit by the public which is to file {and by the USPTO to process} all application. Confidentiality is
`governed by 35 U.S.C. 122 and 37 CFR 1.14. This collection is estimated to take 12 minutes to complete,
`including gathering, preparing, and submitting the completed application form to the USPTO. Time will vary
`depending upon the individual case. Any comments on the amount of time you require to complete this fortn
`andfor suggestions for reducing this burden, should be sent to the Chief Infomiation Officer, U.S. Patent and
`'frade1nark Office, US. Department of Commerce, P.O. Box 1450, Alexandria, Virginia 22313-1450. DO NOT
`SEND FEES OR COMPL.l:Z'l'l:'lD FORMS 'TO THIS ADDRESS. SEN D TO: Commissioner for Patents, P.O. Box
`1450, Alexandria, Virginia 22313-1450. Under the Paperwork Reduction Act of 1995, no persons are required to
`respond to a collection of information unless it displays a valid OMB control number.
`
`Privacy Act Statement
`
`The Privacy Act of 1974 (PL. 93-579) requires that you be given certain information in connection with your
`submission of the attached form related to a patent application or patent. Accordingly, pursuant
`to the
`requirements of the Act, please be advised that: (1) the general authority for the collection of this information is
`35 U 2(b)(2}; (2) furnishing of the information solicited is voluntary; and (3) the principal purpose for which
`the infomtation is used by the U8. Patent and Trademark Office is to process andfor examine your submission
`related to a patent application or patent. If you do t1ot furnish the requested information, the U8. Patent and
`Trademark Oflice may not be able to process andfor examine your submission, which may result it1 termination of
`proceedings or abandonment of the application or expiration of the patent.
`
`but
`
`The infonnation provided by you in this forI11 will be subject to the following routine uses:
`1. The information on this form will be treated conlidentially to the extent allowed under the Freedom of
`Information Act (5 U.S.C. 552} and the Privacy Act (5 U.S.C 552a). Records from this systetn of records
`may be disclosed to the Department of Justice to determine whether disclosure of these records is required
`by the Freedom of lnfomtation Act.
`2. A record from this system of records may be disclosed, as a routine use, it1 the course of presenting evidence
`to a court, magistrate, or administrative tribunal, including disclosures to opposing counsel it1 the course of
`settlement negotiations.
`A record it1 this system of records may be disclosed, as a routine use, to a Member of Congress submitting a
`request involving an individual, to whom the record pertains, when the individual has requested assistance
`from the Member with respect to the subject matter of the record.
`4. A record in this system of records may be disclosed, as a routine use, to a contractor of the Agency having
`need for the information it1 order to perform a contract. Recipients of information shall be required to
`comply with the requirements of the Privacy Act of 1974, as amended, pursttant to 5 U.S.C. 552a(m).
`5. A record related to an Intemational Application filed under the Patent Cooperation Treaty it1 this system of
`records may be disclosed, as a routine use, to the International Bureau of the World Intellectual Property
`Organization, pursuant to the Patent Cooperation Treaty.
`6. A record in this system of records may be disclosed, as a routine use, to another federal agency for purposes
`of National Security review (35 U.S.C. 181) and for review pursuant to the Atomic F-.nergy Act ( 42 U.S.C.
`2l8(t:}}.
`7. A record from this system of records may be disclosed, as a routine use, to the Administrator, General
`Services, or hislher designee, during an inspection of records conducted by GSA as part of that agency's
`responsibility to reco11u11et1d improvements it1 records management practices and programs, under authority
`of 44 U.S.C. 2904 and 2906. Such disclosure shall be made in accordance with the GSA regulations
`governing inspection of records for this purpose, and any other relevant (i.e., GSA or Commerce) directive.
`Such disclosure shall I1ot be used to make determinations about individuals.
`
`8. A record from this system of records may be disclosed, as a routine use, to the public after either publication
`of the application pursuant to 35 U.S.C. l22(b) or issuance of a patent pursuant to 35 U.S.C. 151. Furtlter, a
`record may be disclosed, subject to the limitations of 37 CFR 1.14, as a routine use, to the public if the
`record was filed in an application which became abandoned or it1 which the proceedings were terminated
`attd which application is referenced by either a published application, at1 application open to public
`inspection or an issued patent.
`9. A record from this system of records may be disclosed, as a routine use, to a Federal, State, or local law
`Amerigen Ex. 1017, p. 4
`enforcement agency, if the USPTO becomes aware of a violation or poteAtF%l‘
`oélgzw 5rrCfig?lat6)n.4
`.
`,
`.
`
`

`
`Notice of Aiiowabiiity
`
`Application No.
`11i383,066
`f1’|‘g:‘:j:';wL YOUNG
`
`Applicant(s)
`SHOJAEI ET AL.
`*1‘; 'é'""
`,‘§§;:,‘§};3t‘uL,[‘“°“‘°"°
`No
`
`-- The MAii_iNG DA TE of this communication appears on the cover sheet with the correspondence address--
`All claims being allowable, PROSECUTION ON THE MERITS IS {OR REMAINS) CLOSED in this application.
`If not included
`herewith (or previously mailed), a Notice of Allowance (PTOL-85) or other appropriate communication will be mailed in due course. THIS
`NOTICE OF ALLOWABILITY IS NOT A GRANT OF PATENT RIGHTS. This application is subject to withdrawal from issue at the initiative
`of the Office or upon petition by the applicant. See 37 CFR 1.313 and MPEP 1308.
`
`1.
`
`This communication is responsive to interview dated 6/26/14.
`
`D A declaration(s)iaffidavit(s) under 37 CFR 1.130(b) wasiwere filed on
`
`2. I:I An election was made by the applicant in response to a restriction requirement set forth during the interview on
`requirement and election have been incorporated into this action.
`
`The allowed claimls) isiare 1' 3-5 7-32 and 62. As a result of the allowed claimls). 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 hit
`:#v.rww.Lis ‘-to. ow‘ atentsiinit events?
`hiirisziexfis or send an inquiry to PPH§eeclé9ack§5)us;;to.oov.
`
`; the restriction
`
`3.
`
`4. I:I Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 1 19(a)-(d) or (f).
`
`Certified copies:
`
`a) D All
`
`b) I:] Some
`
`"c) I:I None of the:
`
`1. El Certified copies of the priority documents have been received.
`
`2. El Certified copies of the priority documents have been received in Application No. j
`
`3. El Copies of the certified copies of the priority documents have been received in this national stage application from the
`International Bureau (PCT Rule 17.2(a}).
`
`" Certified copies not received:
`
`Applicant has THREE MONTHS FROM THE “MAILING DATE" of this communication to file a reply complying with the requirements
`noted below. Failure to timely comply will result in ABANDONMENT of this application.
`THIS THREE-MONTH PERIOD IS NOT EXTENDABLE.
`
`5. El CORRECTED DRAWINGS ( as “replacement sheets") must be submitted.
`
`I:I
`
`including changes required by the attached Examiner's Amendment i Comment or in the Office action of
`Paper No.iMail Date
`ldentitying indicia such as the application number (see 37 CFR 1.84(c)) should be written on the drawings in the front {not the back} of
`each sheet. Replacement sheet(s) should be labeled as such in the header according to 37 CFR 1.121{d).
`
`6. I:I DEPOSIT OF andior INFORMATION about the deposit of BIOLOGICAL MATERIAL must be submitted. Note the
`attached Examiner’:-3 comment regarding REQUIREMENT FOR THE DEPOSIT OF BIOLOGICAL MATERIAL.
`
`Attachmentis)
`1. El Notice of References Cited {PTO-892)
`
`2. E Information Disclosure Statements (PTOiSBi08),
`Paper No.iMai| Date 5i16i14
`3. [:I Examiner's Comment Regarding Requirement for Deposit
`of Biological Material
`4. E Interview Summary (PTO4-I13),
`Paper No.iMai| Date 6/24/14 .
`
`tMICAH—PAUL YOUNG!
`Examiner, Art Unit 1618
`
`5.
`
`Examiner's AmendmentiComment
`
`6. D Examiners Statement of Reasons for Allowance
`
`
`7. X Other bib data sheet After iinaizflmendment.
`
`US Patent and Trademark Otiice
`PTOL-37 (Rev. 08-13]
`
`Notice of Allowability
`
`Part of Paper No.iMai| Date 20140626
`
`Amerigen Ex. 1017, p. 5
`Amerigen Ex. 1017, p. 5
`
`

`
`Application.r"Control Number: I l.r"383,066
`
`Art Unit: 1618
`
`Page 2
`
`The present application is being examined under the pre—AIA first to invent provisions.
`
`EXAMlNER’S AMENDMENT
`
`An cxaminer’s amendment to the record appears below. Should the changes andfor
`
`additions be unacceptable to applicant, an amendment may be filed as provided by 37 CFR
`
`1.312. To ensure consideration of such an amendment, it MUST be submitted no later than the
`
`payment of the issue fee.
`
`Authorization for this examiner’s amendment was given in a telephone interview with
`
`Paul Zaga1' on 6J'26;’l4.
`
`The application has been amended as follows:
`
`1.
`
`A pharmaceutical composition comprising:
`
`(a) an immediate release bead
`
`comprising at least one amphetamine salt; (b) a first delayed release bead comprising at least one
`
`amphetamine salt; and (c) a second delayed release bead comprising at least one amphetamine
`
`salt; wherein the first delayed release bead provides pulsed release of the at
`
`least one
`
`amphetamine salt and the second delayed release bead provides sustained release of the at least
`
`one amphetamine salt;
`
`wherein the second delayed release bead comp1'ises at least one amphetamine salt laye1'ed
`
`onto or incorporated into a core; a delayed release coating layered onto the amphetamine core;
`
`and a sustained release coating laye1'ed onto the delayed release coating, wherein the sustained
`
`release coating is pH—independent; and
`
`wherein the first delayed release bead and the second delayed release bead comprise an
`
`enteric coating.
`
`Amerigen Ex. 1017, p. 6
`Amerigen Ex. 1017, p. 6
`
`

`
`Application.r"Control Number: I l.r"383,066
`
`Art Unit: 1618
`
`Page 3
`
`Any inquiry concerning this communication or earlier communications from the
`
`examiner should be directed to MICAH-PAUL YOUNG whose telephone number is (571)272-
`
`0608. The examiner can normally be reached on Monday—Thursday 7:00-5:30; every Friday off.
`
`If attempts to reach the examiner by telephone are unsuccessful, the exami11er’s
`
`supervisor, Michael G. Hartley can be reached on 571-272-0616. The fax phone number for the
`
`organization where this application 01' proceeding is assigned is 571-273-8300.
`
`Information regarding the status of an application may be obtained from the Patent
`
`Application Information Retrieval (PAIR) system. Status information for published applications
`
`may be obtained from either Private PAIR or Public PAIR. Status information for unpublished
`
`applications is available through Private PAIR only. For more information about the PAIR
`
`system, see http::’!'pai1'—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
`
`information system, call 800-786-9199 (IN USA OR CANADA) 01' 571-272-1000.
`
`:"MICAH—PAUL YOUNG!’
`
`Examiner, Art Unit 1618
`
`:"Nissa Westerberg/
`Primary Examiner, Art Unit 1613
`
`Amerigen Ex. 1017, p. 7
`Amerigen Ex. 1017, p. 7