`
`UNITED STATES PA'I‘EN'I‘ AND TRADEMARK OFFICE
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`UNITED STATES DEPARTMENT OF COMIHERCE
`United States Patent and Trademark ()Ifice
`Address; COMMISSIONER FOR PA'I'IEN'I'S
`PD. Boat 1-1-50
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`w ww . nsplnguv
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`2????
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`BERNARD l". PLANTZ
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`EXAMINER
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`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
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`TOTAL FEELS] DUE
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`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
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`NEWBmmmxfimggnsom
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` AI’I’IJCA'I'ION N0.
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`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
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`159?
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`FILING DATE
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`FIRST NANIIED INVI'IN'I‘OR
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`A'l"l'(JRN|iY DIIXIKIE'I' N0.
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`t.'()N'l-'IRMA'1'1()N N0.
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`APPI TYPE
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`I'INTI'I'Y S'l'A'I'liS
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`ISSUE I'lili DI IE
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`Elf-1:11.II1.'A'I‘III)E\r 1"1‘21'2 DUE
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`PR1 EV. PAID ISSUE l"IiE
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`'I‘O'I'AI. 1"1'21 its) DUE
`
`DATE DUE
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`nonprovisional
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`UND ISCOI iNTED
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`EXAMINER
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`111.71. SAN MING R
`
`$960
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`ART l..‘-N1T
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`1621
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`CLASS-S UB CLASS
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`514—170000
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`$0
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`$960
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`mmmm 4
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` |
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`P'l'OL—SS Part B { |tJ~ [3] Approved for use through 1013112013.
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`OMB 0651—0033
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`US. Patent and 'l'rademark Office: U .8. DEPARTMENT 01" COMMERCE
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`

`

`
`
`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)
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`(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
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`term adjustment determination with the Issue Notification Letter that
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`PTO].—85 (Rev. DUI I)
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`Page 3 of 3
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`

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`
`

`

`
`
`.
`.
`.
`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
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`SEWE-
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`San Ming R. Hui
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`iintemeiarticie: htipzflciinicaitriaEs.gow’arehiveiNCTG04-85353i2007_{3§_1i
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`Fiiing Gate
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`iNFGRMATiQN BESCLGSERE
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`San Ming R. Hui
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`22
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`Summary of Product Characteristics for Zytiga 250mg tablets (1633512014)
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`23
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