`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`WWW,USplo.gov
`
`NOTICE OF ALLOWANCE AND FEE(S) DUE
`
`84802
`
`7590
`
`0122014
`
`JONES DAYfor Celgene Corporation
`222 FE. 41ST. STREET
`NEW YORK, NY 10017
`
`EXAMINER
`
`ANDERSON, JAMES D
`
`1629
`
`DATE MAILED: 01/22/2014
`
` APPLICATION NO,
`
`FILING DATE
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO,
`
`9516-904-999
`Jerome B. Zeldis
`11/19/2009
`12/621 ,502
`TITLE OF INVENTION: METHODS USING 3-(4-AMINO-1-OXO-1,3-DIHYDRO-ISOINDOL-2-Y1.)-PIPERIDINE-2,6-DIONE FOR TREATMENT OF
`MANTLE CELL LYMPHOMAS
`
`2588
`
`
`
`
`
`
`
`APPLN. TYPE PUBLICATIONFEE DUE|PREV. PAID ISSUE FEEENTITY STATUS ISSUE FEE DUE TOTAL FEE(S) DUE DATE DUE
`
`
`
`
`
`
`
`nonprovisional
`
`UNDISCOUNTED
`
`$960
`
`04/22/2014
`
`THE APPLICATION IDENTIFIED ABOVE HAS BEEN EXAMINED AND IS ALLOWED FOR ISSUANCE AS A PATENT,
`PROSECUTION ON THE MERITS IS CLOSED. THIS NOTICE OF ALLOWANCEIS NOT A GRANT OF PATENTRIGHTS.
`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 MPEP1308.
`
`THE ISSUE FEE AND PUBLICATION FEE (IF REQUIRED) MUST BE PAID WITHIN THREE MONTHS FROM THE
`MAILING DATE OF THIS NOTICE OR THIS APPLICATION SHALL BE REGARDED AS ABANDONED.
`THIS
`TBE 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 THIS APPLICATION.
`IF AN ISSUE FEE HAS
`PREVIOUSLY BEEN PAID IN THIS APPLICATION (AS SHOWN ABOVE), THE RETURN OF PART B OF THIS FORM
`WILL BE CONSIDERED A REQUEST TO REAPPLY THE PREVIOUSLY PAID ISSUE FEE TOWARD THE ISSUE FEE NOW
`DUE.
`
`HOW TO REPLY TO THIS NOTICE:
`
`I. Review the ENTITY STATUS shownabove. If the ENTITY STATUS is shown as SMALL or MICRO,verify whether entitlement to that
`entity status still applies.
`If the ENTITY STATUSis the same as shown above, pay theTOTAL FEE(S) DUE shownabove.
`If the ENTITY STATUSis changed fromthat shown above, on PART B - FEE(S) TRANSMITTAL, complete section number5 titled
`"Change in Entity Status (fromstatus indicated above)".
`For purposesofthis notice, small entity fees are 1/2 the amount of undiscounted fees, and micro entity fees are 1/2 the amount ofsmallentity
`fees.
`
`Il. PART B - FEE(S) TRANSMITTAL,or its equivalent, must be completed and returned to the United States Patent and Trademark Office
`(USPTO) with your ISSUE FEE and PUBLICATION FEE(if required). If you are charging the fee(s) to your deposit account, section "4b"
`of Part B - Fee(s) Transmittal should be completed and an extra copy ofthe 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 dueto the difficulty in recognizing
`the paper as an equivalent ofPart B.
`
`I. All communications regarding this application must give the application number, Please direct all communications prior to issuance to
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`IMPORTANT REMINDER: Utility patents issuing on applications filed on or after Dec. 12, 1980 may require payment of
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`
`PTOL-85 (Rev. 02/11)
`
`Page | of 3
`
`Apotex Ex. 1009, p. 1
`
`Apotex Ex. 1009, p. 1
`
`

`

`PARTB - FEE(S) TRANSMITTAL
`
`Complete and send this form, together with applicable fee(s), to: Mail Mail Stop ISSUE FEE
`Commissioner for Patents
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`or Fax (571)-273-2885
`through 5 should be completed where
`INSTRUCTIONS: This form should be used for transmitting the ISSUE FEE and PUBLICATION FEE (if required). Blocks 1
`appropriate. All further correspondence including the Patent. advance orders and notification of maintenance fees will be mailed to the current correspondence address as
`indicated unless corrected below or directed otherwise in Block 1, by (a) specifying a new correspondence address; and/or (b) indicating a separate “FEE ADDRESS"for
`maintenance fee notifications.
`
`CURRENT CORRESPONDENCE ADDRESS(Note: Use Block | for any change of address)
`
`. 01/22/20 4
`. 7520
`84802
`JONES DAY for Celgene Corporation
`222 F. 41ST. STREET
`ee
`
`Note: A certificate of mailing can only be used for domestic mailings of the
`Fee(s) Transmittal. This certificate cannot be used for any other accompanying
`papers. Each additional paper, such as an assignment or formal drawing, must
`ave its own certificate of mailing or transmission.
`Certificate of Mailing or Transmission
`I hereby certify that this Fee(s) Transmittal is being deposited with the United
`States
`Postal Service with sufficient postage for first class mail in an envelope
`addressed to the Mail Stop
`ISSUE FEE address above, or being facsimile
`transmitted to the USPTO (571) 273-2885, on the date indicated below.
`
`NEW YORK, NY 10017
`
`APPLICATION NO,
`
`FILING DATE
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO,
`
`95 16-904-999
`Jerome B. Zeldis
`11/19/2009
`12/621,502
`TITLE OF INVENTION: METHODS USING3-(4-AMINO-1-OXO-|,3-DIHYDRO-ISOINDOL-2-¥YL)-PIPERIDINE- 2,6-DIONE FOR TREATMENT OF
`MANTLE CELL LYMPHOMAS
`
`2588
`
`
`
`
`
`
`APPLN. TYPE PUBLICATION FEE DUE|PREV. PAID ISSUE FEEENTITY STATUS ISSUE FEE DUE TOTAL FEE(S) DUE DATE DUE
`
`
`
`nonprovisional
`UNDISCOUNTED
`$960
`$960
`04/22/2014
`
`
`ANDERSON, JAMES D
`
`1629
`
`514-183000
`
`1. Change of correspondence address or indication of "Fee Address" (37
`a
` LJ "Pee Address" indication (or "Fee Address" Indication form
`Lj poanee ofcorrespondence address (or Change ofCorrespondence
`Address form PTO/SB/122) attached.
`
`PTO/SB/47, Rev 03-02 or more recent) attached. Use of a Customer
`Numberis required.
`
`2. For printing on the patent front page, list
`(1) The names ofup to 3 registered patent attorneys
`or agents OR,alternatively,
`2
`(2) The name of a single firm (having as amembera
`==
`registered attorney or agent) and the names of up to
`2 registered patent altorneys or agents. Ifnonameis
`listed, no name will be printed.
`
`3
`ss
`
`
`
` J Applicant changing to regular undiscounted fee status.
`
`3. ASSIGNEE NAME AND RESIDENCE DATA TO BE PRINTED ON THE PATENT(print or type)
`If an assignee is identified below, the document has been filed for
`PLEASE NOTE:Unless an sepa is identified below, no assignee data will appear on the patent.
`recordation as set forth in 37 CFR
`3.11. Completion of this form is NOT a substitute for filing an assignment.
`(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) :
`
`individual O Corporation orother private group entity (J Government
`
`4a. The following fee(s) are submitted:
`LI} Issue Fee
`4) Publication Fee (No small entity discount permitted)
`LJ Advance Order - # of Copies
`
`4b. Payment of Fee(s): (Please first reapply any previously paid issue fee shown above)
`LI A check is enclosed.
`| Payment by credit card. Form PTO-2038is attached.
`[J The Director is hereby authorized to charge the required fee(s), any deficiency, or credits any _
`overpayment, to Deposit Account Number
`(enclose an extra copy ofthis form).
`
`
`
`5. Change in Entity Status (fromstatus indicated above)
`| Applicant certifying microentity status. See 37 CFR 1.29
`
`| Applicant asserting small entity status. See 37 CFR 1.27
`
`
`NOTE: Absent a valid certification of Micro Entity Status (see forms PTO/SB/15A and 15B), issue
`fee paymentin the micro entity amount will not be accepted at the risk of application abandonment.
`NOTE:If the 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 be a notification ofloss of entitlement to small or micro
`enlily status, as applicable.
`NOTE:This form must be signed in accordance with 37 CFR 1.31 and 1.33. See 37 CFR 14 for signature requirements and certifications.
`
`
`
`
`Authorized Signature
`
`Typed or printed name
`
`Date
`
`Registration No.
`
`Page 2 of 3
`
`PTOL-85 Part B (10-13) Approved for use through 10/31/2013.
`
`OMB 0651-0033
`
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`
`Apotex Ex. 1009, p. 2
`
`Apotex Ex. 1009, p. 2
`
`

`

`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`WWW,USplo.gov
`
`APPLICATION NO.
`
`FILING DATE
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO,
`
`
`
`12/621,502
`
`11/19/2009
`
`JeromeB. Zeldis
`
`9516-904-999
`
`2588
`
`84802
`
`7590
`
`0122014
`
`JONES DAYfor Celgene Corporation
`222 E. 41ST. STREET
`NEW YORK, NY 10017
`
`ANDERSON, JAMES D
`
`1629
`
`DATE MAILED: 01/22/2014
`
`Determination of Patent Term Adjustment under 35 U.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) wasfiled in the above-identified application, the filing date that
`determines Patent Term Adjustmentis 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) WEBsite (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 1-(888)-786-0101 or (571)-272-4200.
`
`PTOL-85 (Rev. 02/11)
`
`Page 3 of 3
`
`Apotex Ex. 1009, p. 3
`
`Apotex Ex. 1009, p. 3
`
`

`

`OMB Clearance and PRA 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 most types of information from the public. When OMB approves an agency
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`1320.5(b).
`
`The information collected by PTOL-85 Part B is required by 37 CFR 1.311. The informationis required to obtain
`or retain a benefit by the public which is to file (and by the USPTO 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
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`The Privacy Act of 1974 (P.L. 93-579) requires that you be given certain information in connection with your
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`related to a patent application or patent. If you do not furnish the requested information, the U.S. Patent and
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`proceedings or abandonmentofthe application or expirationof the patent.
`
`The information provided by you in this form 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 U.S.C 552a). Records from this system of records
`may be disclosed to the Department of Justice to determine whether disclosure of these records is required
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`2. Arecord from this system of records may be disclosed, as a routine use, in the course of presenting evidence
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`5. A record related to an International Application filed under the Patent Cooperation Treaty in 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 his/her designee, during an inspection of records conducted by GSA as part of that agency's
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`Suchdisclosure shall not be used to make determinations about individuals,
`8. A record fromthis system of records may be disclosed, as a routine use, to the public after either publication
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`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 oran issued patent.
`9, A record from this system of records may be disclosed, as a routine use, to a Federal, State, or local law
`enforcement agency, if the USPTO becomes aware ofa violation or potential violation of law or regulation.
`
`Apotex Ex. 1009, p. 4
`
`Apotex Ex. 1009, p. 4
`
`

`

`
`Application No.
`Applicant(s)
`
` 12/621 502 ZELDIS, JEROME B.
`j
`i
`AIA (First Inventor to
`“
`ape
`Notice of Allowability So.|File) Statusee apnea
`
`
`No
`
`-- The MAILING DATEof 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 GRANTOF PATENTRIGHTS.This application is subject to withdrawal from issueat the initiative
`of the Office or upon petition by the applicant. See 37 CFR 1.313 and MPEP 1308.
`
`1. 4] This communication is responsive to Amendmentsfiled 12/18/2013.
`(CA declaration (s)/affidavit(s) under 37 CFR 1.130(b) was/werefiled on
`
`2. (1 An election was madebythe applicant in response to a restriction requirement set forth during the interview on
`requirement and election have been incorporatedinto this action.
`
`; the restriction
`
`3. 4 The allowed claim(s)is/are 1,3-10 and 13-27. As a result of the allowed claim(s), you may beeligible to benefit from the Patent
`Prosecution Highway program ata participating intellectual property office for the corresponding application. For more information,
`please see hitp:/
`AUspio,
`nit_events
`ex.jiso
`or send an inquiry to PPHieedbacke
`
`4, (J Acknowledgmentis made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
`Certified copies:
`a)O All
`b)[)Some *c) [J Noneofthe:
`1. ( Certified copies of the priority documents have been received.
`2. (J Certified copies of the priority documents have been received in Application No.
`3. CJ Copies ofthe certified copies of the priority documents have been receivedin 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 communicationto file a reply complying with the requirements
`noted below. Failure to timely comply will result in ABANDONMENTofthis application.
`THIS THREE-MONTH PERIOD IS NOT EXTENDABLE.
`
`5. (] CORRECTED DRAWINGS ( as “replacement sheets”) must be submitted.
`
`C1
`
`including changes required by the attached Examiner's Amendment / Commentor in the Office action of
`Paper No./Mail Date
`Identifying indicia such as the application number (see 37 CFR 1.84(c)) should be written on the drawingsin 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. (J DEPOSIT OFand/or INFORMATIONaboutthe deposit of BIOLOGICAL MATERIAL must be submitted. Note the
`attached Examiner's comment regarding REQUIREMENT FOR THE DEPOSIT OF BIOLOGICAL MATERIAL.
`
`Attachment(s)
`1. [] Notice of References Cited (PTO-892)
`2. XJ Information Disclosure Statements (PTO/SB/08),
`Paper No./Mail Date See Continuation Sheet
`3. [] Examiner's Comment Regarding Requirement for Deposit
`of Biological Material
`4. [] Interview Summary (PTO-413),
`Paper No./Mail Date
`/JAMES D ANDERSON/
`Primary Examiner, Art Unit 1629
`
`5. (] Examiner's Amendment/Comment
`6. ] Examiner's Statement of Reasonsfor Allowance
`
`7. Other
`
`
`U.S, Patent and Trademark Office
`PTOL-37 (Rev. 08-13)
`
`Part of Paper No./Mail Date 20140102
`
`Notice of Allowability
`
`Apotex Ex. 1009, p. 5
`
`Apotex Ex. 1009, p. 5
`
`

`

`Continuation Sheet (PTOL-37)
`
`Application No. 12/621,502
`
`Continuation of Attachment(s) 2. Information Disclosure Statements (PTO/SB/08), Paper No./Mail Date: 9/30/2013 and 12/18/2013.
`
`Apotex Ex. 1009, p. 6
`
`Apotex Ex. 1009, p. 6
`
`

`

`Application/Control Number: 12/621,502
`
`Art Unit: 1629
`
`Page 2
`
`Information Disclosure Statement
`
`The information disclosure statements (IDS) submitted on 9/30/2013 and
`
`12/18/2013 were filed after the mailing date of the Final Office Action on 9/19/2018.
`
`The submissions are in compliance with the provisions of 87 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 to conventional therapy comprising administration of lenalidomide in the
`
`dosing regimen presently claimed. Specifically, as set forth in the Declaration filed
`
`12/18/2013, prior to June 2013 there was only one drug approved by the FDAfor 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 cell 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: 12/621,502
`
`Art Unit: 1629
`
`Page 3
`
`that lenalidomideelicits 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
`
`accompanythe issue fee. Such submissions should be clearly labeled “Comments on
`
`Statement of Reasons for Allowance.”
`
`Conclusion
`
`Any inquiry concerning this communication or earlier communications from
`
`the examiner should be directed to JAMES D. ANDERSON whose telephone
`
`numberis (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 numberfor 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: 12/621,502
`
`Art 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://pair-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 lke
`
`assistance from a USPTO Customer Service Representative or access to the
`
`automated information system, call 800-786-9199 (IN USA OR CANADA)or 571-
`
`272-1000.
`
`/JAMES D ANDERSON/
`Primary Examiner, Art Unit 1629
`
`Apotex Ex. 1009, p. 9
`
`Apotex Ex. 1009, p. 9
`
`