UNITED S'I‘A'IES PA'I'EN'I‘ AND TRADEMARK OFFICE
`
`
`
`UNITED STATES DEPARTMENT OF CODLA‘IERCE
`United States Patent and "Trademark ()lfiee
`Address: COMMISSIONER FOR PA'I‘IEN'I'S
`P0. Bout I450
`Alexandria, Virginia 211134451!
`wwalsplixguw
`
`NOTICE OF ALLOWANCE AND FEE(S) DUE
`
`84802
`
`159"]
`
`EJIIEE’ZIIl—I
`
`JONES DAY for Cclgcne Corporation
`222 E. 418T. STREET
`anvomwnoo
`
`EXAMINER
`
`ANDERSON. JAMESD
`
`1629
`
`DATE MAII .ED: 01032014
`
`APPLICATION NO.
`FILING DATI'.
`FIRST NAMED INVI-IN'I‘OR
`ATTORNEY DOIIIKI‘I'I' NO.
`('().'\'1"IRMA'I'I()N NO.
`
`[2}621502
`I IIIGIZOOG
`Jerome B. Zeldis
`95 | 6904—999
`7538
`TITLE OF INVENTION: METHODS USING 3-(4—AMINO—l-0XO- l.3—DIHYDRO—ISOINDOI.—l—YI.]-PIPERIDINF-2.6—DION'E FOR TREATMENT OF
`MAN'I‘LE CELL LYM PIIOmS
`
`APPLE TYPE
`
`ENTITY STATI‘3
`
`ISSUE FEE DUE
`
`PI'BLILATION FEE DI‘IE
`
`PREV PAID ISSUE FEE
`
`TOTAL FEELS] DUE
`
`DATE DI‘IE
`
`nonprovisional
`
`UNDISCOI INTED
`
`3960
`
`04123.10] 4
`
`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 WITIIDRAWAL 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 SIIALI. BE REGARDED AS ABANDONED.
`TIIIS
`' ‘
`'
`T BE EXTENDED. SEE 35 U.S.C. 151. THE ISSUE FEE DUE INDICATED ABOVE DOES
`
`NOT REFI ECT 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 REAPPI.Y TIIE PREVIOUSLY PAID ISSUE FEE TOWARD TIIE ISSUE FEE NOW
`DUE.
`
`IIOW TO REPLY TO TIIIS NOTICE:
`
`I. Review the ENTITY STATUS shown above. If the ENTITY S'I‘A’I‘US is shown as SMALL or MICRO, verify whether entitlement to that
`entity status still applies.
`If the ENTITY STA'I‘US is the same as shown above. pay the TOTAL FEE(S) DUE shown above.
`
`If the ENTITY _S'J‘A'I‘US is changed from that shown above. on PART B - FEELS) 'I'RANSMI'I'I'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 ot'undiscounted fees, and micro entity fees are 1/2 the amount of small entity
`fees.
`
`[1. PART B - FEELS) 'I'RANSMITTAL, or its equivalent. must be completed and returned to the United States Patent and Trademark Office
`(USPI'O) with your ISSUE FEE and PUBLICATION FEE ( if required). If you are charging the feets} to your deposit account. section "4b"
`of Part B - Fee(s) 'l‘ransmittal 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 must be clearly made, and delays in processing may occur due to the difficulty in recognizing
`the paper as an equivalent of Part B.
`
`III. All communications regarding this application must give the application mlmber. Please direct all communications prior to issuance to
`Mail Stop ISSUE FFE unless advised to the contrary.
`
`IMPORTANT REMINDER: Utility patents issuing on applications filed on or after Dec. 12, 1980 may require payment of
`maintenance fees. It is patentee‘s responsibility to ensure timely payment of maintenance fees when due.
`
`I‘TOI.-85 (Rev. 02” I)
`
`Page I of 3
`
`Apotex EX. 1009, p. 1
`
`Apotex Ex. 1009, p. 1
`
`

`

`PART B - FEEtS) TRANSMITTAL
`
`Complete and send this form, together with applicable feets), to: Mg'l Mail Stop ISSUE FEE
`Commissioner for Patents
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`(571)-273-2885
`
`or Ea;
`
`through 5 should be completed where
`INS'I‘RUC'J'IONS: This form should be used for transmitting the ISSUE. l-Elj and PUBLICAZI‘ION l-'L-‘.lj {it"roquiredj. Blocks 1
`ap ropriate. All further correspondence including the Patent. advance orders and notification of maintenance tees will be mailed to the ctirrent cones ondence address as
`in
`icated unless con‘eeted below or directed otherwise in Block 1. by ta} specifying a new correspondence address: andror tb} indicating a separate “ -
`-'L-; ADDRESS“ for
`maintenance fee notifications.
`
`(IIYRRI-Nt‘titmkt‘SPONm-NtlliAIJDRIESSLNote- Use Illnekl Inirailyclizmgenfarlrlress]
`
`‘ mam“?
`. 75901
`84802‘
`JONES DAY [01' Lelgcne (.(‘prOl'flthl’l
`-
`u ~
`-
`.. .
`.
`22213. 4151.51Rbbl
`NEW YORK. NY 10017
`
`Note: A certificate ofrmailino can only be used For domestic mailings of the
`l-eets} transmittal. This certificate cannot be used for an}r other accompanying
`fiapfls' Each additional paper. such as an assignment 0,- t‘orniat drawing. "lust
`ave its own certificate ot‘ mailing or transmisston.
`Certificate at" Mailing or Transmission
`[ hereh ' certify that this Fee(sj Transmittal is being deposited with the United
`States ostal Service with sufficient postage for first class mail in an envelope
`'ddressed to the Mail Sto
`ISSUE FEE address above or hein
`facsimile
`'1
`’
`g
`transmitted to the USPTO (_ 7] } 273-2385, on the date indicated below.
`llkpoetilur's mum
`(Signature!
`
`
`
`APPLIt‘A'I'IUN N0.
`FILING DA'I‘I';
`FIRST smut-:1) INVI-ZN'I‘OR
`A'I'TURNILY DIIXIKIE'I' N0.
`(.'()N'1-'IRMA'I'1()N N0.
`
`[36.21.5091
`I It IWZOO")
`Jerome B. 7eldis
`95 | 6904999
`2538
`'l‘l'l'LL'L 01’ INVLLN'I'ION: MHI'IIODS USING 3-[4—AerNO-t-0XU-l.3—DIIIYDRO-[SOINDUL—l-YLl-PIPLLRIDINLi-l.6-DIONE I‘OR 'I‘RLA'I'MENI' 01‘
`MANTLJJ CELL LYMPIIOWS
`
`APPLN. I'Yl’l'.
`IiN'I'I I'Y S'I'AI IFS
`ISSUI'I I'I'JLI)UI'I
`I’l.'I:II.It'i't't‘IUEMr l'IiIi DUI;
`PHI-N. I’AII) ISSIJI'I ['1']:
`It) I'AI. I'I'IIitSI DUI-I
`DAI'I'; DUI;
`
`
`
`
` $960 3960UNDISCOI INTI-"2D 043212014 nonprovisional
`
`MINER
`ART l_.‘-'NlT
`CLASS-SUB CLASS
`
` I
`
`ANDERSON. UltMIIJLS D
`
`l (.129
`
`514483000
`
`. Change of correspondence address or indication ol‘ "Fee Address" t3?
`CFR 1.363].
`
`
`
`3 Change ofcorrespondence address [or Change ot‘t‘orrespondence
`Address orm P't‘OfSBf 122} attached.
`3 "Fee Address" indication (or "Fee Address" Indication Form
`I’TOJ‘SBMW Rev 03‘02 or more recent) attached list- of a Customer
`Number is required.
`
`2, For printing on the patent from page. list
`[1) The names of up to 3 registered patent attorneys
`or agents OR. alternatively.
`(3') The name of a single firm (having as a member a
`registered attorney or agent) and the names ol‘ up to
`2 registered patent attorneys or agents. Il' no name is
`listed, no name will be printed.
`
`I
`Id
`
`3
`'
`
`
`
`3. ASSIGNLLLL NANIt-L AND RESIDENCE DA'I‘A TO BE PRIN'I‘L-LD 0N 'l'ltli t-‘A'I'L’NT (print or type)
`
`reoordation as set l‘orlh in 37' CF 3.] J. Completion of this form is NOT a substitute for filing an assignment.
`PLEASE NOTE: Unless an assirgnee is identified below, no assignee data will appear on the patent.
`If an assignee is identified below the document has been filed l'or
`(A) NAME OF ASSIGNEE
`(B) RESIDENCE: (CITY and STATE OR COUNTRY)
`
`Please check the appropriate assignee category or categories (will not be printed on the patent] : El Individual El Corporation or other private group entity '3 Government
`
`4a. The Following feets) are submitted:
`3 Issue Fee
`:l Publication 1-'ec {No small entity discount permitted}
`D Advance- Ordcr 7 if ot‘Copjcs
`
`4b. Payment oft-eels]: [Please first reapply any previously paid issue fee shown above)
`3 A check is enclosed.
`:l Payment b 'credil card. 1-‘orm PTO-203$ is attached.
`jThe Director is hereby authorimed to charge the required l'eets)‘ any deficiency, or credits any _
`overpayment, to Deposit Account Number
`(enclose an extra copy ol‘ this form).
`
`
`
`5. Change in Entity Status l'l‘rom status indicated above]
`3 Applicant certifying micro entity status. See .37 CFR I29
`
`
`
`NOTE: Absent a valid certification of Micro Entity Status (see l‘orms PTOISRIHA and 153], issue
`lee payment in the micro entity amount will not be accepted at the rislc of application abandonment.
`NO't'li: [fthe application was previously under micro entity status. checking this box will be taken
`to be a notification of loss of entitlement to micro entity status.
`NOTE: Checking this box will be taken to he a notification ol'loss of entitlement to small or micro
`entity status‘ as applicable.
`NO'I‘L-Z: This form must be signed in accordance with 3'." CI‘R 1.31 and 1.33. See 3? Cl-‘R 1.4 t‘orsi nature re tiirements and certifications.
`
`
`:l Applicant asserting small entity status. See 37 (Tt’R 1.2'.Ir
`
`3 Applicant changing to regular undiscounted l‘ee status.
`
`
`
`Authorized Signature
`
`Typed or printed name
`
`Date
`
`Registration No.
`
`Page 2 of 3
`
`P't‘OLitiS Part B {1043] Approved for use through 1013112013.
`
`OMB 005170033
`
`US. Patent and 't'raden'iark Office: U .S. DLLPAR'I'MEN'I' 01" COMMERCE
`
`Apotex EX. 1009, p. 2
`
`Apotex Ex. 1009, p. 2
`
`

`

`wwalspmgov
`
`UNITED STATES DEPARTMENT OF CONLMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR I’A'I‘IEN'I'S
`P0. Bout
`t-l-SO
`Alexandria, Virginia 21.11344le
`
`
`121621.502
`111192009
`Jerome 13. Zeldis
`951o9o+999
`2588
`
`84802
`
`159"]
`
`EJIIZZI'leI—‘l
`
`J ONES DAY for Cclgcnc Corporation
`222 fi. 41 ST. STREET
`anvomwnoo
`
`ANDERSON. JAMESD
`
`1629
`
`DATF. MAI] ED: 010332014
`
`Determination of Patent Term Adjustment under 35 [l.S.C. 154 (b)
`(application filed on or after May 29, 2000)
`
`The Patent Term Adjustment to date is 429 day(s). If the issue fee is paid on the date that is three months after the
`mailing date of this notice and the patent issues on the Tuesday before the date that is 28 weeks (six and a half
`months) after the mailing date of this notice, the Patent Term Adjustment will be 429 day(s).
`
`If a Continued Prosecution Application (CPA) was filed in the aboveiidentifled application, the filing date that
`determines Patent Term Adjustment is the filing date of the most recent CPA.
`
`Applicant will be able to obtain more detailed information by accessing the Patent Application Information Retrieval
`(PAIR) WEB site (http://pair.uspto .gov).
`
`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)-786-0101 or (571)-272-4200.
`
`PTOl.-85 (Rev, {ml l)
`
`Page 3 of 3
`
`Apotex EX. 1009, p. 3
`
`Apotex Ex. 1009, p. 3
`
`

`

`0MB Clearance and PFtA Burden Statement for PTOL-85 Part B
`
`The Paperwork Reduction Act (PRA) of 1995 requires Federal agencies to obtain Office of Management and
`Budget approval before requesting tnost types of information frotn the public. When OMB approves an agency
`request to collect information frotn the public, OMB (i) provides a valid OMB Control Number 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 inform the public about the OMB Control Number's legal significance ill accordance with 5 CFR
`1320.5(b).
`
`The inl'omtation collected by PTOIFSS 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 USP’I‘O to process} an 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. Ally comments on the amount of time you require to complete this fortn
`andfor suggestions for reducing this burden, should be sent to the Chief Information Officer, US. Patent and
`Trademark Office, U.S. Department of Commerce, P.O. Box 1450, Alexandria, Virginia 22313-1450. DO NOT
`SEND FEES OR COMPLETED FORMS TO THIS ADDRESS. SEND TO: Commissioner for Patents, 13.0. Box
`1450, Alexandria, Virginia 2231371450. Under the Paperwork Redttetiotl Act of 1995, no persons are required to
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`
`P rivacy 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: (l) the general authority for the collection of this information is
`35 USC. 2(b)(2); (2) furnishing of the information solicited is voluntary; and (3) the principal purpose for which
`the information is used by the US. Patent and Trademark Office is to process andlor examine your submission
`related to a patent application or patent. If you do not furnish the requested information, the [1.8. Patent attd
`Trademark Office may 1101 be able to process andfor examine your submission, which may result in termination of
`proceedings or abandonment of the application or expiration of the patent.
`
`'9)
`
`The information provided by you in this fortn will be subject to the following routine uses:
`1. The information on this form will be treated confidentially to the extent allowed under the Freedom of
`Information Act (5 U.S.C. 552) and the Privacy Act (5 USE 552a). Records from this system of records
`may be disclosed to the Department of Justice to determine whether disclosure of these records is required
`by the Freedom of Information Act.
`2. A record froln this system of records may be disclosed, as a routine use, ill the course of presenting evidence
`to a court, magistrate, or administrative tribunal, including disclosures to opposing counsel in the course of
`settlement negotiations.
`A record in this system of records may be disclosed, as a routine use, to a Member of Congress snbtnitting 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 in order to perform a contract. Recipients of information shall be required to
`comply with the requirements of the Privacy Act of 1974, as amended, pursuant to 5 U.S.C. 552a(m).
`5. A record related to an lntematiotlal Application filed under the Patent Cooperation Treaty itt 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 Energy Act (42 U.S.C.
`218(c}}.
`7. A record from this system of records may be disclosed, as a routine use, to the Administrator, General
`Services, or hisiher designee, during all inspection of records Conducted by GSA as part of that agency's
`responsibility to reeolntnetld improvements in 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 not be used to make determinations about individuals.
`
`8. A record front dlis 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. 122(b) or issuance ofa patent pursuant to 35 U.S.C. 151. Further, 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 in which the proceedings were terminated
`and which application is referenced by either a published application, an application open to public
`inspection or an issued patent.
`9. A record frotn this system of records may be disclosed, as a routine use, to a Federal, State, or local law
`enforcement agency, if the USP’I‘O becomes aware of a violation or potential violation of law or regulation.
`
`Apotex EX. 1009, p. 4
`
`Apotex Ex. 1009, p. 4
`
`

`

`
`
`.
`.
`.
`Notice of Allowabrirty
`
`Application No. Applicant(s)
`
`121621502
`zanrs, JEROME B.
`'
`'
`NA (First Inventor to
`Elfin??? ANDERSON
`$923“
`Fire, status
`No
`
`-- The MAiLtNG DA TE 01‘ 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. E This communication is responsive to Amendments fiieo' 12/18/2013.
`
`El A declaration (s)r’aflidavit(s) under 37 CFR 1.130(b) wasiwere filed on
`
`2. [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 restriction
`
`3. E The allowed claim(s) isIare 1 3—10 and 13—27. As a result of the allowed claimIs), 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 b:
`:."«‘wrvw.us '-tc. 0v! atenlsr'init events"
`hiirrdexIS' or send an inquiry to RPHi'eed'oackr us'tooov.
`
`4. El Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or If).
`Certified copies:
`
`*0) El None of the:
`b) [I Some
`a) [I All
`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.
`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 172(3)).
`" 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.
`
`El
`
`including changes required by the attached Examiner's Amendment I Comment or in the Office action of
`Paper No.1Mail Date
`.
`Identifying indicia such as the application number (see 3? CFR 1 .B4(c)) should be written on the drawings in the from (not the back) of
`each sheet. Replacement sheet(s) should be labeled as such in the header according to 37 CFFl 1.121 (d).
`
`6. El DEPOSIT OF andfor INFORMATION about the deposit of BIOLOGICAL MATERIAL must be submitted. Note the
`attached Examiner's comment regarding REQUIREMENT FOR THE DEPOSIT OF BIOLOGICAL MATERIAL.
`
`Attachmentts)
`1. El Notice of References Cited (PTO-692)
`2. E Information Disclosure Statements (PTOISBIDB),
`Paper NoJMail Date See Continuation Sheet
`3. [:l Examiners Comment Regarding Requirement for Deposit
`of Biological Material
`4. El Interview Summary (PTO-413),
`Paper NoJMail Date
`NAMES D ANDERSONI
`Primary Examiner, Art Unit 1629
`
`5. El Examiner‘s Amendmentr'Comment
`6. E Examiner‘s Statement of Reasons for Allowance
`
`7. El Other
`
`.
`
`
`U 5 Patent and Trademark Office
`PTOL-S? (Rev. 08—13)
`
`Part of Paper Noflv'lail Date 20140102
`
`Notice 01 Nlowability
`
`Apotex EX. 1009, p. 5
`
`Apotex Ex. 1009, p. 5
`
`

`

`Continuation Sheet (PTOL-37)
`
`Application No. 121621502
`
`Continuation of Attachment(s) 2. Information Disclosure Statements (PTO/SBIOS), Paper NoJMail Date: 9/30/2013 and 12/18/2013.
`
`Apotex EX. 1009, p. 6
`
`Apotex Ex. 1009, p. 6
`
`

`

`ApplicationfControl Number: 12/62 1,502
`
`An Unit: 1629
`
`Page 2
`
`Information Disclosure Statement
`
`The information disclosure statements (IDS) submitted on 9/30/2013 and
`
`12l18f2013 were filed after the mailing date of the Final Office Action on 9z‘19l2013.
`
`The submissions are in compliance with the provisions of 37 CFR 1.97. Accordingly,
`
`the information disclosure statements are being considered by the examiner.
`
`REASONS FOR ALLOWANCE
`
`The following is an examiner’s statement of reasons for allowance: The
`
`Examiner is persuaded by Applicant's argument of unexpected results as it pertains
`
`to the treatment of mantle cell lymphoma relapsed, refractory, or relapsed and
`
`refractOry t0 COnventional therapy comprising administration of lenalidomide in the
`
`dOsing regimen presently claimed. Specifically, as set forth in the Declaration filed
`
`12/1812013, prior to June 2013 there was only one drug approved by the FDA for the
`
`treatment of patients with relapsed or refractory MCL (bortezomib). Surprisingly,
`
`Applicant demonstrated that lenalidomide administered in the claimed dosing
`
`regimen was effective in treating heavily pretreated MCL patients,
`
`including
`
`patients previously treated with bortezomib.
`
`Given the extremely poor prognosis of mantle cefl
`
`lymphoma patients
`
`relapsed, refractory, or relapsed and refractory to conventional therapy and the lack
`
`of available effective therapies for such patients, it is surprising and unexpected
`
`Apotex EX. 1009, p. 7
`
`Apotex Ex. 1009, p. 7
`
`

`

`Application/Control Number: 13621502
`
`An Unit: 1629
`
`Page 3
`
`that lenalidomide elicits an overall respOnse rate of 28% in heavily pretreated MCL
`
`patients.
`
`Any COmments considered necessary by applicant must be submitted no later
`
`than the payment of the issue fee and, to avoid processing delays, should preferably
`
`accompany the issue fee. Such submissions should be clearly labeled “Comments on
`
`Statement of Reasons for Allowance."
`
`Conclusion
`
`Any inquiry concerning this communication or earlier communications fr0m
`
`the examiner shOuld be directed to JAMES D. ANDERSON whose telephone
`
`number is (571)272-9038. The examiner can normally be reached on MON-FRI 9:00
`
`am - 5:00 pm EST (Telework MOndays and Fridays).
`
`If attempts to reach the examiner by telephone are unsuccessful,
`
`the
`
`examiner’s supervisor, Jeffrey Lundgren can be reached on 571-272-5541. The fax
`
`phone number for the organization where this application or proceeding is assigned
`
`is 571-273-8300.
`
`Apotex EX. 1009, p. 8
`
`Apotex Ex. 1009, p. 8
`
`

`

`Application/Control Number: 12/62 1,502
`
`An Unit: 1629
`
`Page 4
`
`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:l/pair-directusptogov.
`
`Should you have questions on access to the Private PAIR system, contact the
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`Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like
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`assistance from a USPTO Customer Service Representative or access to the
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`autOmated information system, call 800-786-9199 (IN USA OR CANADA) or 571-
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`272-1000.
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`IJAMES D ANDERSON!
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`Primary Examiner, Art Unit 1629
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`Apotex EX. 1009, p. 9
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`Apotex Ex. 1009, p. 9
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`