`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria, Vi
`'nia 22313-1450
`www.uspto.go
`
`NOTICE OF ALLOWANCE AND FEE(S) DUE
`
`27777
`
`7590
`
`10/25/2013
`
`PHILIP S. JOHNSON
`JOHNSON & JOHNSON
`ONE JOHNSON & JOHNSON PLAZA
`NEW BRUNSWICK, NJ 08933-7003
`
`EXAMINER
`
`HUI, SAN MING R
`
`1629
`
`DATE MAILED: 10/25/2013
`
`APPLICATION NO.
`
`FILING DATE
`
`F {ST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
`
`Alan H. Auerbach
`02/24/2011
`13/034,340
`TITLE OF INVENTION: METHODS AND COMPOSITIONS FOR TREATING CANCER
`
`CGR5001USCNT1
`
`1597
`
`APPLN. TYPE
`
`ENTITY STATUS
`
`ISSUE FEE DUE
`
`PUBLICATION FEE DUE
`
`PREV. PAID ISSUE FEE
`
`TOTAL FEE(S) DUE
`
`DATE DUE
`
`nonprovisional
`
`UNDISCOUNTED
`
`$1780
`
`$300
`
`$0
`
`$2080
`
`01/27/2014
`
`THE APPLICATION IDENTIFIED ABOVE HAS BEEN EXAMINED AND IS ALLOWED FOR ISSUANCE AS A PATENT.
`PROSECUTION ON THE MERITS IS CLOSED. THIS NOTICE OF ALLOWANCE 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.
`
`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
`STATUTORY PERIOD CANNOT 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 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 shown above. If the ENTITY STATUS is shown as SMALL or MICRO, verify Whether entitlement to that
`entity status still applies.
`
`If the ENTITY STATUS is the same as shown above, pay the TOTAL FEE(S) DUE shown above.
`
`If the ENTITY STATUS is changed from that shown above, on PART B - FEE(S) TRANSMITTAL, complete section number 5 titled
`"Change in Entity Status (from status indicated above)".
`
`For purposes of this notice, small entity fees are 1/2 the amount of undiscounted fees, and micro entity fees are 1/2 the amount of small entity
`fees.
`
`II. 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 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 number. Please direct all communications prior to issuance to
`Mail Stop ISSUE FEE 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.
`
`PTOL—85 (Rev. 02/11)
`
`Page 1 of 4
`
`MYLAN PHARMS. INC. EXHIBIT 1014 PAGE 1
`
`
`
`PART B - 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 1 (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
`_ap ropriate. All further correspondence including the Patent, advance orders and notification of maintenance fees will be mailed to the current correspondence address as
`1n icated 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 1 for any Change Ofaddress)
`
`7590
`27777
`PHILIP J
`&
`ONE JOHNSON & JOHNSON PLAZA
`
`10/25/2013
`
`NEW BRUNSWICK, NJ 08933-7003
`
`Note: A certificate of mailin can only be used for domestic mailings of the
`Fee(s) Transmittal. This certi icate cannot be used for any other accompanying
`fiapers. 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.
`
`(Date)
`
`‘”°P°S“°"S(Sigznature)
`
`APPLICATION NO.
`
`FILING DATE
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
`
`Alan H. Auerbach
`02/24/2011
`13/034,340
`TITLE OF INVENTION: METHODS AND COMPOSITIONS FOR TREATING CANCER
`
`CGR5001USCNT1
`
`1597
`
`APPLN. TYPE
`
`ENTITY STATUS
`
`ISSUE FEE DUE
`
`PUBLICATION FEE DUE
`
`PREV. PAID ISSUE FEE
`
`TOTAL FEE(S) DUE
`
`DATE DUE
`
`nonprovisional
`
`UNDISCOUNTED
`
`EXAMINER
`
`HUI, SAN MING R
`
`$1780
`
`ART UNIT
`
`1629
`
`$300
`
`$0
`
`$2080
`
`01/27/2014
`
`CLASS-SUB CLASS
`
`514- 170000
`
`1. Change of correspondence address or indication of "Fee Address" (37
`CFR 1.363).
`
`3 Chan e of correspondence address (or Change of Correspondence
`Address orm PTO/SB/ 122) attached.
`
`3 "Fee Address" indication (or "Fee Address" Indication form
`PTO/SB/47; Rev 03-02 or more recent) attached. Use of a Customer
`Number is required.
`
`
`
`2. For printing on the patent front page, list
`(1) the names of up to 3 registered patent attorneys
`or agents OR, alternatively,
`(2) 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.
`
`3
`
`3. ASSIGNEE NAME AND RESIDENCE DATA TO BE PRINTED ON THE PATENT (print or type)
`PLEASE NOTE: Unless an assignee is identified below, no assignee data will appear on the patent. If an assignee is identified below, the document has been filed for
`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) : D Individual D Corporation or other private group entity D Government
`
`4a. The following fee(s) are submitted:
`3 Issue Fee
`
`4b. Payment of Fee(s): (Please first reapply any previously paid issue fee shown above)
`3 A check is enclosed.
`
`3 Publication Fee (No small entity discount permitted)
`3 Advance Order _ # of Copies
`
`3 Payment by credit card. Form PTO—2038 is attached.
`3 The Director is hereby authorized to charge the required fee(s), any deficiency, or credit_ any
`overpayment, to Deposit Account Number
`(enclose an extra copy of this form).
`
`PTOL—85 (Rev. 02/11)
`
`Page 2 of 4
`
`MYLAN PHARMS. INC. EXHIBIT 1014 PAGE 2
`
`
`
`5. Change in Entity Status (from status indicated above)
`3 Applicant certifying micro entity status. See 37 CFR 1.29
`
`3 Applicant asserting small entity status. See 37 CFR 1.27
`
`3 Applicant changing to regular undiscounted fee status.
`
`NO"E: Absent a valid certification of Micro Entity Status (see form PTO/SB/ 15A and 15B), issue
`fee payment in the micro entity amount will not be accepted at the risk of application abandonment.
`NO"E: If the application was previously under micro entity status, checking this box will be taken
`to be a notification of loss of entitlenient to micro entity status.
`NO"E: Checking this box will be taken to be a notification of loss of entitlement to small or micro
`entity status, as applicable.
`
`NOTE: The Issue Fee and Publication Fee (if required) will not be accepted from anyone other than the applicant; a registered attorney or agent; or the assignee or other party in
`interest as shown b the records of the United States Patent and Trademark Office.
`
`Authorized Signature
`
`Typed or printed name
`
`Date
`
`Registration No.
`
`This collection of information is required by 37 CFR 1.311. The information is re uired 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. T is collection is estimated to take 12 minutes to complete, including gathering, preparing, and
`submitting the completed application form to the USPTO. Time will v
`de endin upon the individual case. Any comments on the amount of time you require to complete
`this form and/or su gestions for reducing this burden, should be sent to
`e C ief In ormation Officer, U.S. Patent and Trademark Office, U.S. Department of Commerce, P.O.
`Box 1450, Alexan ria, Virginia 22313-1450. DO NOT SEND FEES OR COMPLETED FORMS TO THIS ADDRESS. SEND TO: Commissioner for Patents, P.(). Box 1450,
`Alexandria, Virginia 223 13— 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.
`
`PTO1.—85 (Rev. 02/] 1) Approved for use through 08/31/2013.
`
`OMB 0651 -0033
`
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OE COMMERCE
`
`Page 3 of 4
`
`MYLAN PHARMS. INC. EXHIBIT 1014 PAGE 3
`
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`UNITED STATES DEPARTMENT OF COIVLVIERCE
`United States Patent and Tradelllark Office
`Address: COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`www.uspto.gov
`
`APPLICATION NO.
`
`FILING DATE
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
`
`13/034,340
`
`02/24/2011
`
`Alan H. Auerbach
`
`CGR5001USCNT1
`
`1597
`
`PHILIP S. JOHNSON
`JOIINSON & JOIINSON
`ONE JOHNSON & JOHNSON PLAZA
`NEW BRUNSWICK, NJ 08933-7003
`
`HUI. SAN MINGR
`
`1629
`
`DATE MAILED: 10/25/2013
`
`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 0 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 0 day(s).
`
`If a Continued Prosecution Application (CPA) was filed in the ab0Ve—identified 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.g0V).
`
`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 4 of 4
`
`MYLAN PHARMS. INC. EXHIBIT 1014 PAGE 4
`
`
`
`Privacy Act Statement
`
`The Privacy Act of 1974 (P.L. 93-579) requires that you be given certain information in connection with
`your submission of the attached forn1 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.S.C. 2(b)(2); (2) furnishing of the information solicited is voluntary; and (3) the
`principal purpose for which the information is used by the U.S. Patent and Trademark Office is to process
`and/or examine your submission related to a patent application or patent. If you do not furnish the
`requested information, the U.S. Patent and Trademark Office may not be able to process and/or examine
`your submission, which may result in termination of proceedings or abandonment of the application or
`expiration of 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 by the Freedom of Information Act.
`A record from this system of records may be disclosed, as a routine use, in 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
`submitting a request involving an individual, to whom the record pertains, when the individual has
`requested assistance fro111 the Member with respect to the subject matter of the record.
`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).
`. 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.
`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)).
`to the Administrator,
`. A record from this system of records may be disclosed, as a routine use,
`General Services, or his/her designee, during an inspection of records conducted by GSA as part of
`that agency's responsibility to recommend 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.
`
`. 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. 122(b) or issuance of a 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.
`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 of a violation or potential violation of law or
`regulation.
`
`MYLAN PHARMS. INC. EXHIBIT 1014 PAGE 5
`
`
`
`Notices of Allowance and Fee(s) Due mailed between October 1, 2013 and
`December 31, 2013
`
`(Addendum to PTOL—85)
`
`If the “Notice of Allowance and Fee(s) Due” has a mailing date on or after October 1, 2013 and before
`January 1, 2014, the following information is applicable to this application.
`
`If the issue fee is being timely paid on or after January 1, 2014, the amount due is the issue fee and
`publication fee in effect January 1, 2014. On January 1, 2014, the issue fees set forth in 37 CFR 1.18
`decrease significantly and the publication fee set forth in 37 CFR 1.18(d)(1) decreases to $0.
`
`If an issue fee or publication fee has been previously paid in this application, applicant is not entitled to a
`refund of the difference between the amount paid and the amount in effect on January 1, 2014.
`
`MYLAN PHARMS. INC. EXHIBIT 1014 PAGE 6
`
`
`
`Notice of Allowability
`
`Application No.
`13/034,340
`
`HUI
`
`App|icant(s)
`AUERBACH ET AL.
`fg‘2;’““
`§i'{:,‘§I;iLL""°"‘°"°
`No
`
`-- The MAILING 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. I:I This communication is responsive to
`
`I] A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/were 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 restriction
`
`3. E The allowed c|aim(s) is/are 37-56. As a result of the allowed c|aim(s), 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
`§'iilI'i/1'Vv"JVV\.'.LiS‘t0. ow atents/'init events/r
`it/ir1ct'e;»<.’s orsend an inquiry to PPH1“'eedbacka>us lI0.CfO\i.
`
`4. I:I Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)—(d) or (f).
`
`Certified copies:
`
`a) [I All
`
`b) I] Some
`
`*c) I:I None of the:
`
`1. El Certified copies of the priority documents have been received.
`
`2. I:I 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. I:I CORRECTED DRAWINGS ( as “replacement sheets”) must be submitted.
`
`I:I
`
`including changes required by the attached Examiner’s Amendment / Comment or 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 drawings in the from (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 and/or INFORMATION about the deposit of BIOLOGICAL MATERIAL must be submitted. Note the
`attached Examiner’s comment regarding REQUIREMENT FOR THE DEPOSIT OF BIOLOGICAL MATERIAL.
`
`Attachment(s)
`1. El Notice of References Cited (PTO—892)
`
`2. IXI Information Disclosure Statements (PTO/SB/08),
`Paper No./Mail Date
`3. I:I Examiner’s Comment Regarding Requirement for Deposit
`of Biological Material
`4. D Interview Summary (PTO—413),
`Paper No./Mail Date
`
`/San—ming Hui/
`Primary Examiner, Art Unit 1629
`
`5. El Examiner's Amendment/Comment
`
`6. IXI Examiner's Statement of Reasons for Allowance
`
`7. I:I Other
`
`.
`
`U.S. Patent and Trademark Office
`PTOL-37 (Rev. 08-13)
`
`Notice of Allowability
`
`Part of Paper No./Mail Date 20131021
`
`MYLAN PHARMS. INC. EXHIBIT 1014 PAGE 7
`
`
`
`Application/Control Number: 13/034,340
`
`Page 2
`
`Art Unit: 1629
`
`The present application is being examined under the pre-AIA first to invent
`
`provisions.
`
`DETAILED ACTION
`
`Continued Examination Under 37 CFR 1.114
`
`A request for continued examination under 37 CFR 1.114, including the fee set
`
`forth in 37 CFR 1.17(e), was filed in this application after allowance or after an Office
`
`action under Ex Parte Quayle, 25 USPQ 74, 453 O.G. 213 (Comm'r Pat. 1935). Since
`
`this application is eligible for continued examination under 37 CFR 1.114, and the fee
`
`set forth in 37 CFR 1.17(e) has been timely paid, prosecution in this application has
`
`been reopened pursuant to 37 CFR 1.114. Applicant's submission filed on 10/3/2013
`
`has been entered.
`
`Claims 37-56 are pending.
`
`The following is an examiner’s statement of reasons for allowance: essentially
`
`the same reason of allowance as previous communicated in the previous notice of
`
`allowance.
`
`Any inquiry concerning this communication or earlier communications from the
`
`examiner should be directed to SAN-MING HUI whose telephone number is (571)272-
`
`0626. The examiner can normally be reached on Mon - Fri from 9:00 to 5:00.
`
`If attempts to reach the examiner by telephone are unsuccessful, the examiner’s
`
`supervisor, Melenie McCormick can be reached on (571) 272-8037. The fax phone
`
`number for the organization where this application or proceeding is assigned is 571 -
`
`273-8300.
`
`MYLAN PHARMS. INC. EXHIBIT 1014 PAGE 8
`
`
`
`Application/Control Number: 13/034,340
`
`Page 3
`
`Art Unit: 1629
`
`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 (toII—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) or 571-272-1000.
`
`San-ming Hui
`Primary Examiner
`Art Unit 1629
`
`/San-ming Hui/
`Primary Examiner, Art Unit 1629
`
`MYLAN PHARMS. INC. EXHIBIT 1014 PAGE 9
`
`
`
`Application/Control No.
`
`Index Of Claims
`
`13034340
`
`Applicant(s)/Patent Under
`Reexamination
`
`AUERBACH ET AL.
`
` Rejected I Cancelled
`
`Examiner
`
`SAN—M|NG HUI
`
`A” Unit
`
`1629
`
`Allowed
`
`a Non-Elected I Appeal
`Restricted l a Objected
`
`El Claims renumbered in the same order as presented by applicant
`
`El CPA
`
`|:I T.D.
`
`El R.1.47
`
`CLAIM
`
`Final
`
`Original
`
`DATE
`11/21/2011 01/27/2012 09/05/2012 02/25/2013 06/28/2013 10/21/2013
`
`_; OD
`_; -l>
`_; U1
`.5 O’)
`
`_; O0
`_; (0
`l\)O
`l\J _.
`
`N(0—nol\)\l
`
`N00
`N-B
`N01
`NO’)
`[U \l
`N00
`
`00l\)
`0000
`
`000)U1-l>
`000’)
`
`US. Patent and Trademark Office
`
`Part of Paper No.
`
`‘ 20131021
`
`MYLAN PHARMS. INC. EXHIBIT 1014 PAGE 10
`
`
`
`Application/Control No.
`
`Index Of Claims
`
`13034340
`
`Applicant(s)/Patent Under
`Reexamination
`
`AUERBACH ET AL.
`
`a Non-Elected I Appeal Rejected I Cancelled
`
`Examiner
`
`SAN—M|NG HUI
`
`A” Unit
`
`1629
`
`Allowed
`
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`US. Patent and Trademark Office
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`Part of Paper No.
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`‘ 20131021
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`MYLAN PHARMS. INC. EXHIBIT 1014 PAGE 11
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`MYLAN PHARMS. INC. EXHIBIT 1014 PAGE 12
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`Application Number
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`13034340
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`2011-02-24
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`ALAN H. AUERBACH
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`1
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`ASCO CANCER FOUNDATION, Poster Session F: Hormone Refractory, ASCO, 2005, —, —
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`BRUNO ET AL, Targeting cytochrome P450 enzymes: A new approach in anti-cancer drug development, Elsevier,
`2007, pages 5047-5060, vol. 15
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`CANNELL, 100th Annual Meeting of the American Association for Cancer Research, Los Angeles, CA, USA;, http://
`oncology.thelancet.com, 2007, pp 471, Volume 8
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`Collins, et al. “A Systematic Review of the effectiveness of Docetaxel and Mitoxantrone for the Treatement of
`Metastatic Hormone—Refractory Prostate Cancer”, British J. of Cancer, 95, pp 457-462 (2006)
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`COUGAR BIOTECHNOLOGY, Cougar Biotechnology Announces Initiation of Phase I/II Trial for CB7630 (Arbiraterone
`Acetate), Cougar Biotechnology, 12-14-2004, —, —
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`COUGAR BIOTECHNOLOGY, Cougar Biotechnology Announces Presentation of Positive CB7630 Clinical Data at
`AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics, Cougar Biotechnology,
`10-2007, -, -
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`COUGAR BIOTECHNOLOGY, Cougar Biotechnology Announces Presentation of Positive CB7630 Clinical Data at
`ESMO Conference, Drugs.com, 7-2007, —, —
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`COUGAR BIOTECHNOLOGY, Cougar Biotechnology announces presentation of positive phase I and phase II data at
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`COUGAR BIOTECHNOLOGY, Cougar Biotechnology presents CB7630 Phase I clinical data at the 2005 Prostate
`Cancer Symposium, A||Business, 2005, —, —
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`COUGAR BIOTECHNOLOGY, Cougar Biotechnology presents positive CB7630 Clinical Data at AACR Annual
`Meeting Late-Breaking Clinical Trials Session, Cougar Biotechnology, 04-17-2007, -, -
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`COUGAR BIOTECHNOLOGY, Cougar Technology Announces Presentation of Positive CB7630 Clinical Data at
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`MYLAN PHARMS. INC. EXHIBIT 1014 PAGE 13
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`Am“
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`First Named Inventor
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`ALAN H. AUERBACH
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`12
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`Q)
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`DE BONO ET AL, Inhibition of CYP450c17 by abiraterone administered once daily to castrate patients with prostate
`cancer resistant to LHRH analogues, anti—androgens and steriod therapy is well tolerated..., The institute of Cancer
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`DE COSTER, ET AL., Effects of High—Dose Ketoconazole and Dexamethason on ACTH-Stimulated Adrenal
`Steriodogenesis in Orchiectomized Prostatic Cancer Patients, Acta Endocrinologica (Copenh), 1987, pp 265-271,
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`_\ -l>
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`A_\4©CI)\lCD
`
`_\
`
`A
`
`DUC ET AL, In Vitro and in vivo models for the evaluation of potent inhibitors of male rat 17 —hydroxy|ase/C—|yase,
`Pergamon, 2003, pages 537-542, vol. 84
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`ENDOCRINOLOGY, Inhibition of Androgen Synthesis in Human Testicular and Prostatic Microsomes and in Male Rats
`by Novel Steroidal Compounds, Endocrinology, 1999, pages 2891-2897, vol. 140 No. 6
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`FOSSA, ET AL., Weekly Docetaxel and Prednisone Versus Prednisolone Alone in Androgen-Independent Prostate
`Cancer: A Randomized Phase II Study, European Urology, 2007, pp 1691-1699, Volume 52
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`GERBER, ET AL., Prostate Specific Antigen for Assessing Response to Ketoconazole and Prednisone in Patients with
`Hormone Refractory Metastatic Prostate Cancer, The Journal of Urology, 1990, pp 1177-1179, Volume 144, Number 5
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`HAKKI ET AL, CYP17- and CYP11B-dependent steriod hydroxylases as drug development targets, Elsevier, 2006,
`pages 27-52, vol. 11
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`HARRIS, ET AL., Low Dose Ketoconazole with Replacement Doses of Hydrocortisone in Patients with Progressive
`Androgen Independent Prostate Cancer, The Journal of Urology, 2002, pp 542-545, Volume 168
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`MOREIRA ET AL, Synthesis and evaluation of novel 17-indazole androstene derivatives designed as CYP17
`inhibitors, Elsevier, 2007, pages 939-948, vol. 72
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`NEWELL ET AL, The Cancer Research UK experience of pre-clinical toxicology studies to support early clinical trials
`with novel cancer therapies, Elsevier, 2004, pages 899-906, vol. 40
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`PETRYLAK, ET AL., Future Directions in the Treatment of Androgen-Independent Prostate Cancer, Urology, 2005, pp
`8-13, Volume 65, Supplement 6A
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`MYLAN PHARMS. INC. EXHIBIT 1014 PAGE 14
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`13034340
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`Am“
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`First Named Inventor
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`ALAN H. AUERBACH
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`Attorney Docket Number
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`CGR5001USCNT1
`EflfiD
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`SCHOLZ, ET AL., Long-Term Outcome for Men with Androgen Independent Prostate Cancer Treated with
`Ketoconazole and Hydrocortisone, The Journal of Urology, 2005, pp 1947-1952, Volume 173
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`SMALL ET AL, The Case for Socondary Hormaonal Therapies in the Chemotherapy Age, The Journal of Urology,
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`MYLAN PHARMS. INC. EXHIBIT 1014 PAGE 15
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`Issue Classification 13034340
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`AUERBACH ET AL.
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`Issue Classification 13034340
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`MYLAN PHARMS. INC. EXHIBIT 1014 PAGE 17
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`Issue Classification 13034340
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`AUERBACH ET AL.
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