`
`UNITED STATES PA'I‘EN'I‘ AND TRADEMARK OFFICE
`
`UNITED STATES DEPARTMENT OF COMIHERCE
`United States Patent and Trademark ()Ifice
`Address; COMMISSIONER FOR PA'I'IEN'I'S
`PD. Boat 1-1-50
`Alexandria, V i Igi I1i:| 2 2.1.13 - I 450
`w ww . nsplnguv
`
`NOTICE OF ALLOWANCE AND FEE(S) DUE
`
`2????
`
`"£590
`
`UfiftflflIII-I
`
`BERNARD l". PLANTZ
`JOHNSON 8; JOHNSON
`ONF, JOHNSON 8; JOHNSON PLAZA
`NEW BRUNSWICK. NJ 03933—J003
`
`EXAMINER
`
`IIULSAN MING R
`
`162.
`
`DATE MAILED: WOEIEDH
`
`APPLICATION NO.
`
`FILING DA'I'Ii
`
`FIRST NAMED INVIENTOR
`
`ATTORNEY DOCKI‘I'I' NO.
`
`('ONI‘IRNIA'I'ION NO.
`
`Alan H. Auerhach
`DEEMED] I
`l3f0.I4,340
`TITLE OF INVENTION: METHODS AND COMPOSITIONS FOR TREATING CANCER
`
`CGRSOOIIJ'SCNTI
`
`|59T
`
`APPLN. TYPE
`ENTITY STATUS
`ISSUE FEE DUE
`PUBLICATION FEE DUE
`PREV. PAID ISSUE FEE
`TOTAL FEELS] DUE
`DATE DUE
`
`$960
`SI)
`SI)
`$960
`DWOZJ'EDH
`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 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 SHALL BE REGARDED AS ABANDONED.
`THIS
`TAT T RY PERI D A
`T 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
`DUE.
`
`HOW TO REPLY TO TIIIS NOTICE:
`
`1. 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 FEEt’S) DUE shown above.
`
`If the ENTITY _S'I‘ATI J S is changed from that shown above, on PART B - FEEt’S) TRANSMI'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 of undiscounted fees. and micro entity fees are U2 the amount of small entity
`fees.
`
`[1. PART B - FEE(S) 'I'RANSMI'I‘TAL, or its equivalent. must be completed and returned to the United States Patent and 'I‘rademark Office
`(USPTO) with your ISSUE FEE and PUBLICA'I'ION FEE (if requined). If you are charging the t‘eet’s} to your deposit account, section "4b"
`of Part B - Feets) '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 number. Please direct all conununicalions prior to issuance to
`Mail Stop ISSUE
`unless advised to the contrzu‘y.
`
`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.
`
`PTOI.—85 (Rev. 02;” I)
`
`Fag“ ' "[3
`
`JANSSEN EXHIBIT 2166
`Wockhardt v. Janssen |PR2016-01582
`
`JANSSEN EXHIBIT 2166
`Wockhardt v. Janssen IPR2016-01582
`
`
`
`PART B - FEELS) TRANSMITTAL
`
`Complete and send this form, together with applicable l‘ee(s), to: Mg'l Mail Stop ISSUE FEE
`Commissioner for Patents
`P.0. Bax 1450
`Alexandria, Virginia 22313-1450
`(571)-273-2885
`
`or Ea;
`
`through 5 should be completed where
`INSTRUCTIONS: This form should be used for transmitting the ISSUE [lit] and PUBLICATION l-'EE (it required]. Blocks 1
`ap ropriate. All further correspondence including the Patent. advance orders and notification of maintenance fees will be mailed to the current corres ondence address as
`in
`icated unless corrected below or directed otherwise in Block 1. by (a) specifying a new correspondence address: andior tb} indicating a separate “ - -'E ADDRESS“ for
`maintenance fee notifications.
`
`(.‘lYRRl-INI'CORRESPONDI-INCIEAIJDRIESSLNote: use lilock | melycltimgeofarldress]
`
`27???
`
`7590
`
`owomOH
`
`&
`ONE JOHNSON & JOHNSON PLAZA
`
`Note: A certificate of_maitir_to can only be used for domestic mailings ot‘ the
`l-cets) Transmittal. This certificate cannot be used for any other accompanying
`Eng-m Each additional paper! such as an assigflmcm o,- fol-mat drawing" mus;
`ave its own certificate ot‘ mailing or transmisston.
`
`Certificate of Mailing or Transmission
`I hereh ' certify that this Fee(s] Transmittal is being deposited with the United
`States Rostal Service with sufficient postage for first class mail in an envelope
`addressed to the Mail Sto
`ISSUE FEE address above, or being facsimile
`transmitted to the USPTO (_ 71) 273—2385. on the date indicated below.
`
`NEWBmmmxfimggnsom
`
` AI’I’IJCA'I'ION N0.
`
`Alan H. Auerhach
`0324201 1
`1330114340
`TITLE 01" INVENTION: ME'l'I IODS AND COMl-USI'I'ION S FOR TREATING CANCER
`
`CGRSOO I USCNTI
`
`159?
`
`FILING DATE
`
`FIRST NANIIED INVI'IN'I‘OR
`
`A'l"l'(JRN|iY DIIXIKIE'I' N0.
`
`t.'()N'l-'IRMA'1'1()N N0.
`
`APPI TYPE
`
`I'INTI'I'Y S'l'A'I'liS
`
`ISSUE I'lili DI IE
`
`Elf-1:11.II1.'A'I‘III)E\r 1"1‘21'2 DUE
`
`PR1 EV. PAID ISSUE l"IiE
`
`'I‘O'I'AI. 1"1'21 its) DUE
`
`DATE DUE
`
`nonprovisional
`
`UND ISCOI iNTED
`
`EXAMINER
`
`111.71. SAN MING R
`
`$960
`
`ART l..‘-N1T
`
`1621
`
`CLASS-S UB CLASS
`
`514—170000
`
`$0
`
`$960
`
`mmmm 4
`
`
` |
`
`. Change of correspondence address or indication ol‘ "Fee Address" (37"
`CFR 1.363].
`:l Change of correspondence address (or Change of Correspondence
`Address orm P'l't'Ji'.‘:i|3.Ir 122} attached.
`3 "Fee Address" indication (or "Fee Address" Indication form
`I’TOISBHT: Rev 03—02 or more recent} attached. list: of a Customer
`Number is required.
`
`
`
`
`
`2. For printing on the patent front page. list
`(l) The names of up to 3 registered patent attorneys
`I
`or agents 0R. alternatively.
`('3) The name of a single lirrn (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 NANlE AND RESIDENCE DATA TO BE PRINTED ON THE PATENT t print or type}
`
`PLEASE NOTE: Unless an assignee is identified below, no assignee data will appear on the patent.
`11' an assignee is identified below, the document has been filed For
`recordation as set forth in 3"." CF 3.] 1. Completion of this form is NOT a substitute for filing an assignment.
`(A) NAME OF ASSIGNEF.
`(B) RESIDENCE: (CITY and STATE OR COUNTRY)
`
`Please check the appropriate assignee category or categories i will not be printed on the patent] : El Individual El Corporation or other private group entity 1] Government
`
`4a. The following feet 5} are submitted:
`3 Issue Fee
`
`4b. Payment ot‘liectsj: (Please first reapply any previously paid issue fee shown above)
`3 A check is enclosed.
`
`
`
`:l Payment by credit card. l-‘orm PTO—2038 is attached.
`jThe Director is hereby authorised to charge the required l'ee(s], any deficiency, or credits any
`overpayment, to Deposit Account Number
`(enclose an extra copy of this form).
`
`NOTE: Absent a valid certification of Micro Entity Status (see l‘orms PTOISRHSA and 15B], issue
`fee payment in the micro entity amount will not be accepted at the risk of application abandonment.
`NOTE: [fthc 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.
`
`:l Publication l-‘ee {No small entity discount permitted}
`3 Advance Order — # ot‘Copjcs
`
`5. Change in Entity Status (from status indicated above]
`3 Applicant certifying micro entity status. See .37 CFR I .29
`
`:l Applicant asserting small entity status. See 3? CPR 1.2".Ir
`
`
`
`3 Applicant changing to regular undisoounted l‘ee status.
`
`NOTE: Checking this box will be taken to he a notification of loss of entitlement to small or micro
`entity status, as applicable.
`NOTE: This form must he signed in accordance with 37 CPR 1.31 and 1.33. See 37" CPR [.4 for si nature re uirements and certifications.
`
`
`
`Authorized Signature
`
`Typed or printed name
`
`Date
`
`Registration No.
`
`Page 2 of 3
`
`P'l'OL—SS Part B { |tJ~ [3] Approved for use through 1013112013.
`
`OMB 0651—0033
`
`US. Patent and 'l'rademark Office: U .8. DEPARTMENT 01" COMMERCE
`
`
`
`
`
`UNITED STATES PA'I‘EN'I‘ AND TRADEMARK OFFICE
`
`UNITED STATES DEPARTMENT OF COAIMERCE
`United States Patent and Trademark Olfiue
`Address: COMMISSIONER FOR I’A'I'IEN'I'S
`PD. Bout 1-1-50
`Alexamlrizl, Virginia 231134-150
`www.|lspln.guv
`
`APPLICATION NO.
`
`FILING DATE
`
`FERST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
`
`13I034.340
`
`03241201]
`
`Alan II. Aucrbach
`
`CGRSOU] USCN'J']
`
`159?
`
`BERNARD 1". PLANTZ
`JOHNSON & JOHNSON
`ONE JOHNSON & JOHNSON PLAZA
`NEW BRUNSWICK. NJ 08933-7003
`
`IIUI. SAN MING R
`
`162]
`
`DATE MAILED: WOEIEOH
`
`Determination of Patent Term Adjustment under 35 U.S.C. 154 (b)
`
`(Applications filed on or after May 29, 2000)
`
`The Office has discontinued providing a Patent Term Adjustment (PTA) calculation with the Notice of Allowance.
`
`to eliminate the
`Section l(h)(2) of the AIA Technical Corrections Act amended 35 U.S.C. 154(b)(3)(B)(i)
`requirement
`that
`the Office provide a patent term adjustment deteimination with the notice of allowance. See
`Revisions to Patent Term Adjustment, 78 Fed. Reg. I9416, 194]? (Apr. 1, 2013). Therefore, the Office is no longer
`providing an initial patent temi 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 3? 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)-2?2-7?02. 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)—736—0101 or (571)—272—4200.
`
`PTO].—85 (Rev. DUI I)
`
`Page 3 of 3
`
`
`
`OMB Clearance and PRA Burden Statement for PTOL-35 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
`request to collect information from 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 in accordance with 5 CFR
`1320.5(b).
`
`The 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} 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. Any comments on the amount of time you require to complete this form
`andfor suggestions for reducing this burden, should be sent to the Chief Infomiation Officer, US. Patent and
`Trademark Office, US. Department of Commerce, P.O. Box 1450, Alexandria, Virginia 22313-1450. DO NOT
`SEND FEES OR COMPLETED FORMS TO THIS ADDRESS. SEND '10: Commissioner for Patents, PO. 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: (I) 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 information is used by the U.S. Patent and Trademark Ollice is to process andr‘or examine your submission
`related to a patent application or patent. If you do not furnish the requested information, the [1.3. Patent and
`Trademark Office may not 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.
`
`w
`
`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 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, 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
`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 ill 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 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 I 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 hislher 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.
`
`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. 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.
`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 of a violation or potential violation of law or regulation.
`
`
`
`
`
`.
`.
`.
`Notice of Aiiowabiiity
`
`Applicantis)
`Application No.
`
` 13.034340 AUERBACH ET AL.
`-
`'
`AIA (First Inventor to
`HUI
`$512?“
`H...) 3.31....
`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. E This communication is responsive to 5/9/2014.
`
`El A declaration (s)iaffidavit(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) isr‘are 37—56. As a result of the allowed claim(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
`:ix‘wwwus to.
`atentsiinit events!“
`hiindex.'s’ or send an inquiry to PF’I-Ifeedbacka us' tooov .
`
`4. 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] 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.
`
`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] 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 NojMaiI Date
`Identifying indicia such as the application number (see 3? CFR 1 34th should be written on the drawings in the trout (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. El DEPOSIT OF andior 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. I] Notice of References Cited (PTO-892)
`
`2. [:I Information Disclosure Statements (PTOISBIOB),
`Paper No.iMaiI Date
`3. El Examiners Comment Regarding Requirement for Deposit
`of Biological Material
`4. I] Interview Summary (PTO-413),
`Paper NoJMaiI Date
`
`iSAN-MING HUI!
`
`Primary Examiner, Art Unit 1621
`
`5. El Examiner‘s AmendmentiComment
`
`6. E Examiner's Statement of Reasons for Allowance
`
`7. El Other
`
`US. Patenl and Trademark Office
`
`PTOL—S? (Rev. 08—13)
`
`Notice 01 Allowability
`
`Part of Paper NoJMail Date 20140519
`
`
`
`Application/Control Number: 13034340
`
`Page 2
`
`Art Unit: 1621
`
`The present application is being examined under the pre-AIA first to invent
`
`provisions.
`
`DETAILED ACTION
`
`Continued Examination Under 37 OFF? 1. 1' 14
`
`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 Parie 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 5/9/2014 has
`
`been entered.
`
`REASONS FOR ALLOWANCE
`
`The following is an examiner’s statement of reasons for allowance: the herein
`
`claimed method of treating prostate cancer is essentially the same as the notice of
`
`allowance mailed 2i11i2014. The commercial success of the combination of prednisone
`
`and abiraterone to treat prostate cancer obviate the rejection under 35 USC 103(a).
`
`Claims 37-56 are allowed.
`
`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
`
`
`
`Application/Control Number: 13034340
`
`Page 3
`
`Art Unit: 1621
`
`number for the organization where this application or 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://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 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 1621
`
`ISAN-MING HUI/
`
`Primary Examiner, Art Unit 1621
`
`
`
`
`
`ApplicationIControl No.
`
`SearCh Notes
`
`13034340
`
`Applicant(s)r’Patent Under
`Reexamination
`
`AUERBACH ET AL.
`
`
`
`
`
`
`SAN-MING HUI
`
`Examiner
`
`CPC- SEARCHED
`
`Examiner
`
`CPC COMBINATION SETS - SEARCHED
`
`Examiner
`
`US CLASSIFICATION SEARCHED
`
`
`Subclass
`
`Date
`
`Examiner
`
`
`
`
`514
`514
`
`1127711
`170,182
`91'51’12
`170, 182
`2125113
`170, 182
`6128113
`170, 182
`10121113
`170.182
`
`170,182
`112914
`514
`SH
`514
`170,182
`51’191’14
`SH
`
`SH
`SH
`H
`3
`SH
`
`SEARCH NOTES
`
`Search Notes
`EAST search and inventor search in PALM
`EAST search and inventor search in PALM
`EAST search and inventor search in PALM
`
`Examiner
`
`Date
`1127;11
`95112
`225113
`
`SH
`SH
`SH
`
`EAST search and inventor search in PALM
`EAST search and inventor search in PALM
`SH
`1129114
`EAST search and inventor search in PALM
`
`EAST search and inventor search in PALM SH 51119314
`
`
`INTERFERENCE SEARCH
`
`Examiner
`Date
`US Subclass ! CPC Group
`US Class!
`
`CPC Symbol
`
`
`
`US. Paleni and Trademark Office
`
`Part of Paper No.
`
`'. 20140519
`
`
`
`
`
`INTERFERENCE SEARCH
`
`US Subclass I CPC Group
`
`Date
`
`Examiner
`
`6f28f13
`10321;“13
`112914
`5f19f2014
`
`SH
`SH
`SH
`
`
`
`
`
`US Class!
`CPC Symbol
`514
`514
`514
`
`170, 182
`170,182
`170,182
`170,182
`
`
`
`US. Paleni and Trademark Office
`
`Part of Paper No.
`
`'. 20140519
`
`
`
`EAST Search IIislory
`
`EAST Search History
`
`‘
`
`
`
`Siprdnisone
`§=
`
`EAST Search History (Prior Art)
`
`EESearch
`E
`................
`gaabiraterone
`. “uuuu‘. unu.uuuuuu~u.uu.u“uuuuuuuuuuu
`
`
`Plurals Time
`:
`
`........
`..............
`....
`rrrrrr
`.........................................................................
`
`
`EUSPGDUB;USPAT;EPO;.JPO;
`E2014f05f19§
`. ‘.uu.uu.uu.uu.uu.uu.uu.uu.uu.uu.uu.uu.uuuuuuu.: uu.u“uuuuuuuuuu: .uuuuuuuuux
`“uuuuuuuuuuu‘
`EDERWENT;
`|BM_TDB
`:13:4o
`‘
`
`SUSPGPUB; USPAT; EPO; .JPO;
`
`DERWENT;
`|BM_TDB
`
`5
`
`01410519;
`13:40
`‘
`
`
`
`
`
`
`
`USPGPUB; USPAT; EPO; JPO;
`DERWENT;
`|BM_TDB
`
`
`
`
`
`2014105119;
`13:40
`‘
`E2014105f19§
`‘
`‘
`
`E2014105f19§
`USPGPUB; USPAT; EPO; JPO;
`DERWENT;
`|BM_TDB
`‘
`‘
`
`
`EUS—PGPUB; USPAT; EPO; JPO;
`014105119;
`i3514f170.ccls.
`5:12:22:
`.
`
`5w;_é,é:.é&.;...ug US PGPUB; USPAT; EPO;
`
`£2222:
`
`
`cancer
`
`DERWENT;
`|BM_TDB
`
`
`
`
`
`L5 and L13
`
`
`
`
`
`
`
`U3 PGPUB; USPAT; EPO; JPO;
`DERWENT;
`|BM_TDB
`
`S—PGF'UB; USF'AT; EPO; JF’O;
`E'L5 same L13
`rum-"7"“
`
`9320097 .pn.
`
`
`
`
`
`
`
`
`
`E0999903; USPAT; EPO; JPO;
`2014105!
`‘
`.EBYEE'HIE.,.'§M:IPR,““,.
`“1‘19",”
`‘
`
`E SPGPUB; USPAT; EPO;
`
`DERWENT;
`|BM_TDB
`
`
`
`5091
`
`
`
`
` EUS-PGPUB; USPATE E2014105119 13:40:
`
`
`E2014105119 13:40 USPGPUB; USPAT
`5! 1912014 1 :42:17 PM
`
`
`
`C:\ Users\ shui\ Documents\ EASTK Workspaoes\ 1 3 -034340 .1111 sp
`
`fileflIClrUserslshuifDocumentsle— Red‘I’r-ZOFolderfl 30343402EASTSearch History. 1 3034340_Acce 3311bleVe.-rsion.htm[5,Jr 1920 14 1:4 2:20 PM]
`
`'91222222222?’12:...-
`
`
`
`PTOI'SBa‘Oaa {01-10}
`Doc code: 303
`fipproveo for use through aroma-:2. 0MB {35351-0031
`..
`.
`_
`_
`_
`.
`_
`h _
`I
`_
`_
`A
`n
`i
`=
`c1 r
`_
`.
`_
`-
`H
`..
`inr- .,
`,
`i a
`11-.
`,p‘
`Us Pammnd “we ‘ fl mm; U5 DEM} MEN} m COMMERCE
`Doc oescripirou. information ..'iisciosuro oteterrent (Filo) F..ed
`Under the Paperwork Reduction Act oi 1.995. no persons are required in respond to a coll-adieu of information urriees i1 ooiiiairie a valid OMB eoniro! number.
`
`
`SNFQRMA‘E‘SQN QESCLQSSRE
`
`STfiiEMEN"? BY APPLiCANT
`
`{ Not for submission under 3? CFR 1.99)
`
`Application Number
`
`13034340
`
`Fiiing Date
`
`2611-02—24
`
`First Named invenier
`
`Afar: H. Auerbach
`
`CGRSGO‘: USCNT'i
`
`Ari Unit
`
`Examiner Name
`
`Ming R. Hui
`
`Attorney Dooket Number
`
`
`
`U.S.PATENT3
`
`
`
`Name of Pateriiee or Aopiicarit
`of cited fiocument
`
`Pagesfioiumnsiines where
`Relevant Passages or Reievarr?
`Figures Appear
`
`
`Exernineri Cite
`Patten? Number
`{find
`issue Date
`bode1
`initiai“
`No
`
`
`
`
`
`
`
`
`you wish to arid additionei US. Patent citation information piease oiiek the Add bulion.
`U.S.PATENT APPLECATSGN PUBLECATiONS
`
`Pages,Coiumris,i_ines where
`Merrie oi Pateriiee or Aopiioarit
`Pubiioation
`.
`Examiner;
`. Cite No
`Relevant Passages or Reievant
`of cited flooument
`Number
`initiai"
`Figures Appear
`
`
`Kind
`
`Pooiioetion
`
`I
`
`20060630608
`
`:
`
`2006—02-09
`
`Nelson. et at.
`
`
`
`if you wish to add additional US. Pubiisheo Appiioatiori citation iniormatioi‘. pieaee oiiok the Add button.
`
`FGREEGN PATENT QGCUMEN?S
`
`Pages,Coiumns,Lines
`T5
`fiagiigétiffgze m where Relevant
`Purification
`Kind
`Country
`Examiner; Cite Foreign Document
`BEBE-mam '
`Paeeages or Reievant
`Code“1 Date
`Code2i
`initiai“
`No
`iiiuiriber3
`Figures Appear
`
`1
`
`2:1?8907
`
`EP
`
`29‘2‘0745
`
`Cougar Biotechnology,
`inc.
`
`I:
`
`E2008027286
`
`Ewe)
`
`2006-03—16
`
`Niiec Pharma Are
`
`3:}
`
`if you wish to add additionai Foreign Patent Document citation informaiion piease eiiok ihe Add button
`
`NONnFATENT LETERATURE EQCUREENTS
`
`EFSWeb211?
`
`ALL REFERENCES CONSiDERED EXCEPT WHERE LiNED THROUGH. fSJ-if
`
`
`
`Application Number
`
`130343d0
`
`Fiiing Gate
`
`20‘: 1—02—24
`
`iNFGRMATiQN BESCLGSERE
`
`
`First Named inventor Nan H. Auerbach
`
`STfiiEMENT BY APPLiCANT
`
`(_ Not for submission under 3? CFR 1.99)
`
`An Unit
`
`Examiner Name
`
`Sen Ming R. Hui
`
`Attorney Docket Number
`
`CGRSGGE USCNTt
`
`
`
`.
`.
`Examiner; Cite :
`initiate’
`No
`
`inciucie name of the author {in CAPETAL LETTERS}, titie of the enioie {when appropriate}, title of the item
`(book. magazine, journal. seriei, symposium, cataiog; etc), date. pagesie}. voiume—iesue numberis},
`pubiisher. city andior country where published.
`
`Assessment Report for Zytiga (abiraterone) published 2011 by the CHMP of the EMA
`
`AUCHUS, R..i., “The genetics, pathophyeioicgy‘ and the management
`Meiab C—iin Netti: Am (2091), 3'23, {1101-119
`
`human deficiencies of P45iioi7", Endocrine-i
`
`AYUES, M" “inhibition of testicular ‘i'FB—iiyciroxyiese and 1?,20—iyase but not 38—hydroxysteroid dehydrogenaee-
`isomeraee or 1?B--hydroxyeieroid oxidoredociaee 'oy ketooonezoie and oiher imidazoie drugs. Journei c-t Steroid
`Biochemistry {198.7} 28(5), 9521-53“:
`
`Tii
`
`‘
`
`:
`
`Campbeii-Weish Uioiogy, Ninth Edition, Saundeie, Voi. 3. Chapters 104 and 16-5
`
`iii-iii?"
`
`Cecil Textbook of Medicine, Wyngaaiden & Smith 18th edition; Chapter on “Giuoooortioosteroid Therapy“.
`Wyngeerden 8: Smith 18th editionr (1988} 33.1284 31
`
`Cougar Biotechnoiogy inc. with the US. Securities and Exchange Commission, Form iii—C1388
`
`SEWE-
`
`---------------------
`
`5
`
`6
`
`D
`
`[:l
`
`=i et, "Pitearrneaoohiiietios and Phaimawciynamice of Systemicaiiy Administered Giuoooeiticoide",
`CZOCK,
`Li
`Pharmaookinet {2005}, 44(1} 961—93
`7’
`
`
`ERGUN—LONGMIRE Berrin, et 35., " we Novel Mutations Found in a Patient with Wa—i-iydmxyiase Enzyme
`Beficienoy", The Journei of
`Endocrinology & Metaboiism {2008), 91(10): 941794182
`
`8
`
`D
`
`FAKEH, at at, Uroiogy {2002} 60, {1553—561
`
`steioid hormone profiiee-A (eview of five cases". Aiiei'native Medicine Review (2006}, 11(1)-
`
`f-‘RiEL, Patrick hi. et at, "Suppression of ednenei function by tow-dose precinieone: assessment with 24-hour urinary
`
`EFSWebZd 1.7
`
`ALL REFERENCES CONSiDERED EXCEPT WHERE LiNED THROUGH. iSJ-if
`
`
`
`Applicatien Number
`
`130343d0
`
`Fiiing Gate
`
`20‘: 1—02—24
`
`CGRSGGE USCNTi
`
`iNFGRMATiQN BESCLGSERE
`
`Aian H. Auerbach
`First Named inventor
`
`
`STA?EMENT BY APPLiCANT
`
`(_ Not for submission under 3? CFR 1.99)
`
`Art Unit
`
`Examiner Name
`
`San Ming R. Hui
`
`Attorney Becket Number
`
`:11
`
`iintemeiarticie: htipzflciinicaitriaEs.gow’arehiveiNCTG04-85353i2007_{3§_1i
`
`---------------------
`
`E
`
`12
`
`infermatican cenceming Zytiga (abiratercne acetate} fiern iittpzir‘wvmitempenditirnchipi'wipnri'i183238i’de"?
`Piatform=Desktop as of Marci: 25‘ 2014
`
`fl
`
`U
`
`13
`
`iintetneiarticie:
`
`iitipLIICiinicaiEi'iais.gnviciiéiahcwi‘eiudyiNC't'00485303?3ec=)§501
`
`'LZtit-fi
`
`a M
`
`GSTAGHEL, EA. “Abiraiercne in the treatment of metastatic castration-resistant prostate cancer“, Cancer
`Management Res. (2014315, peg—51
`
`1:;
`
`OSABA. 0., at at. "Heaiih-Reiated Quality of Life in Men with Metastatic Prostate Cancer Treated Witi‘. Piednicone
`aiane er Mitcxantrone and Precinisane". J. Ciin. Oncoi. {1999), 1?(6), {3.165446%
`
`:
`
`D
`
`PETRYLAK, DR. “New Paradigms for Advanced Prostate Cancer“, Rev. Uroi. {290?}, 9, Suppl. 2, 813-312
`
`-
`
`D
`
`14
`
`15
`
`---------------------
`
`Prostate Cancer Principles and Practice, Taylor 8: Francis {2008) Chapter 93
`
`E
`
`1?
`
`18
`
`‘
`
`i'tEit), It. etat, "Armais of Oncology", Educationai and Abstract Boa-k of the ESMO (icnference Luganc- (ii-LCLU}.
`{250?}, 18(Siippieinent9}, ix173-ix174. Abstract EOPD
`
`D
`
`:
`
`REMENGTON, "The Scienoe and Praeiice of Pharmacy. 20th Edition {2006). {3.138343%
`
`U
`
`———————————-i——————-t————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————i-—————-
`
`RUN-13E, Marsctiaii 8., ei at, “Principles; of Meiecuiar Medicine; Seccand ediiieii; (2096} Humana Press inc. ZSBN:
`1—58829—202—9. pga.365—3i’6 and 4824184
`
`E
`
`SiLLS, irene ii, et aL, "iffa—hydroxyiase deficiency in a genetic maie and female sibiing pair‘fl int. J. Gynaecol. Obsteti
`{1961}. 19, paw—m}
`
`i3
`
`21
`
`
`
`era-wan 1.7
`
`ALL REFERENCES CONSiDERED EXCEPT WHERE LiNED THROUGH. iSJ-if
`
`
`
`Application Number
`
`13034310
`
`Fiiing Gate
`
`20‘: 1—02—24
`
`iNFGRMATiQN BESCLGSERE
`
`Aian H. Aoerbach
`First Named inventor
`
`
`STfiiEMENT BY APPLiCANT
`
`(_ Not for submission under 3? CFR 1.99)
`
`Art Unit
`
`CGRSGoi USCNTi
`
`Examiner Name
`
`San Ming R. Hui
`
`Attorney Docket Number
`
`22
`
`Summary of Product Characteristics for Zytiga 250mg tablets (1633512014)
`
`fl
`
`---------------------
`
`23
`
`TANNOCK., at at, "Docetaxei Pins Preo'nieone or itiitoxaritrone Pius Prednisone for Advanced Prostate Cancer",
`Journal of Urology (2005). ’i?3(
`). p.458
`
`The reply- of appiicant (ie. the Proprietor of herein opposed patent} dated June 4, 2013
`USQOi'if-fi‘iziaifi'lfim U3 proceedings.
`
`reiation to the corresponding:
`‘
`
`i3
`
`i231
`
`
`
`25
`
`‘
`
`WANG. C.‘ et ai.. "Hypertension one to 1?a--i-iydroxyiaee deficiency", Australian and New Zeaiand Journal of Medicine B
`(1.978}. air-3‘, 9295-299
`=
`
`retro, A, et at. "Giemcoriicoide Suppress Tumor Angiogeneie and in vivo Growth of Prostate Cancer Ceiis", Ciin.
`Cancer Rea, {2006) 12, 3093-3099
`
`E
`i D
`
`26
`
`it you wish to add additionai non—patent iiterature document citation information piease click tile Add button
`
`EXAMENER $EGNATURE
`
` Examiner Signature
`{San Ming Hui] 0531332014 Date Considered
`
`
`
`*EXAMINER: initiei if reference considered, whether or not citation is in conformance with MPEP 809. {Fraw tine through a
`citation if not in conformance and not considered.
`incincie copy of this: form with next communication to appiicant.
`
`
`
`a indication iihe yearoi the reign of the Emperor must precede the aeriei numberoi the patent document.
`'5 For Japanese patent documents,
`Standard 8T3).
`‘5 Kin-:i of document by the apnrorariate symbols as indicated on the docu