UNITED STATES PATENT AND TRADEMARK OFFICE
`
`UNITE) STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Oflice
`Address: COMMISSIONER K)R PATENTS
`PO. Box 1450
`Alexandria. Virginia 22313-1450
`www.usplo.goN
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`NOTICE OF ALLOWANCE AND FEE(S) DUE
`
`BERNARD F. PLANTZ
`JOHNSON & JOHNSON
`ONE JOHNSON & JOHNSON PLAZA
`NEW BRUNSWICK, NJ 08933-7003
`
`HUI. SAN MINGR
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`PAPER NUMBER
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`1621
`
`DATE MAILED: 06/02./2014
`
`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
`
`CGRSOOIUSCNTI
`
`I 597
`
`nonprovisional
`
`UNDISCOUNTED
`
`ISSUE FEE DUE
`$960
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`PUBLICATION FEE DUE
`$0
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`PREV. PAID ISSUE FEE
`$0
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`TOTAL FEE(S) DUE
`$960
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`DATE DUE
`09/02/2014
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`THE APPLICATION IDENTIFIED ABOVE HAS BEEN EXAMINED AND IS ALLOWED FOR ISSUANCE AS A PATENT.
` . 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
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`THE ISSUE FEE AND PUBLICATION FEE (IF REQUIRED) MUST BE PAID WITHIN THREE MONTHS FROM THE
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`IMPORTANT REMINDER: Utility patents issuing on applications filed on or alter Dec. 12, 1980 may require payment of
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`"°L'85‘R°“°2""
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`ARGENTUM EX1016
`ARGENTUM EX1016
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`Page 1
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`Page 1
`
`

`
`PART B - FEE(S) TRANSMITTAL
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`Complete and send this form, together with applicable fee(s), to: Mail Mail Stop ISSUE FEE
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`or 1 (571)-273-2885
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`through 5 should be completed where
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`appropriate. All further correspondence including the Patent, advance orders and notification of maintenance fees will be mailed to the current correspondence address as
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`CURRENT CORRESPONDENCE ADDRESS (Note: Use Block 1 for any Change Ofaddress)
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`Certificate of Mailing or Transmission
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`
`(Date)
`
`‘D°P°S“°"S W)
`(Signature)
`
`27777
`
`7590
`
`06/02/2014
`
`F.
`JOHNSON & JOHNSON
`ONE JOHNSON & JOHNSON PLAZA
`
`NEW BRUNSWICK, NJ 08933-7003
`
`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
`
`HUI, SAN MING R
`
`$960
`
`1621
`
`$0
`
`$0
`
`$960
`
`09/02/2014
`
`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
`Vumber is required.
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`
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`2. For printing on the patent front page, list
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`(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
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`2
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`3
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`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 assignee 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)
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`Please check the appropriate assignee category or categories (will not be printed on the patent) :
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`5. Change in Entity Status (from status indicated above)
`3 Applicant certifying micro entity status. See 37 CFR 1.29
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`3 Applicant asserting small entity status. See 37 CFR 1.27
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`3 Applicant changing to regular undiscounted fee status.
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`\IOTE: Absent a valid certification of Micro Entity Status (see forms PTO/SB/ 15A and 15B), issue
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`Authorized Signature
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`Typed or printed name
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`Date
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`Registration No.
`
`PTOL-85 Part B (10-13) Approved for use through 10/31/2013.
`
`Page 2 of 3
`OMB 0651-0033
`
`Page 2
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`
`Page 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.uspto.gov
`
`APPLICATION NO.
`
`FILING DATE
`
`F {ST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
`
`13/034,340
`
`02/24/2011
`
`Alan H. Auerbach
`
`CGR5001USCNT1
`
`1597
`
`BERNARD F. PLANTZ
`JOHNSON & JOHNSON
`ONE JOHNSON & JOHNSON PLAZA
`NEW BRUNSWICK, NJ 08933-7003
`
`HUI, SAN MING R
`
`1621
`
`DATE MAILED: 06/02/2014
`
`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 1(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 determination with the notice of allowance. See
`Revisions to Patent Term Adjustment, 78 Fed. Reg. 19416, 19417 (Apr. 1, 2013). Therefore, the Office is no longer
`providing an initial patent term 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 37 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)-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
`
`Page 3 of 3
`
`Page 3
`
`

`
`OMB Clearance and PRA Burden Statement for PTOL-85 Part B
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`The Paperwork Reduction Act (PRA) of 1995 requires Federal agencies to obtain Office of Management and
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`
`Page 4
`
`Page 4
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`

`
`Notice of Allowability
`
`Application No.
`13/034,340
`gmjihi/136 HUI
`
`App|icant(s)
`AUERBACH ET AL.
`fgtzyn"
`’F‘:{;,<;‘,;S,‘,,',""°"‘°"°
`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. IX This communication is responsive to 5/9/2014.
`
`D A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/were filed on
`
`2. I:l 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. IX The allowed cIaim(s) is/are 37-56. As a result of the allowed cIaim(s), you may be eligible to benefit from the Patent Prosecution
`in.
`Highway program at a participating intellectual property office for the corresponding application. For more information, please see
`hit’ :/'/wwwusrto. ov/ atents/'init events/'
`I1/ir1ciex.'s' or send an inquiry to r'PHfeedback us today.
`
`4. I:l Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)—(d) or (f).
`
`Certified copies:
`
`a) I:l All
`
`b) D 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.
`
`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.
`
`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 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. 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. I] Notice of References Cited (PTO—892)
`
`2. I] Information Disclosure Statements (PTO/SB/08),
`Paper No./Mail Date
`3. I] Examiner’s Comment Regarding Requirement for Deposit
`of Biological Material
`4. I] Interview Summary (PTO—413),
`Paper No./Mail Date
`
`/SAN—MING HUI/
`
`Primary Examiner, Art Unit 1621
`
`5. El Examiner’s Amendment/Comment
`
`6. IX 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 20140519
`
`Page 5
`
`Page 5
`
`

`
`Application/Control Number: 13/034,340
`
`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 CFR 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 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 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 2/11/2014. 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
`
`Page 6
`
`Page 6
`
`

`
`Application/Control Number: 13/034,340
`
`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
`
`/SAN—MING HUI/
`
`Primary Examiner, Art Unit 1621
`
`Page 7
`
`Page 7
`
`

`
`Application/Control No.
`
`Search NOTES
`
`13034340
`
`Applicant(s)/Patent Under
`Reexamination
`
`AUERBACH ET AL.
`
`
`
`Examiner
`
`SAN-MING HUI
`
`
`
`Art Unit
`
`1323
`
`CPC- SEARCHED
`
`US CLASSIFICATION SEARCHED
`
`170,182
`170,182
`
`1/29/14
`5/19/14
`
`SEARCH NOTES
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`2
`EAST search and inventor search in PALM
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`INTERFERENCE SEARCH
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`: 20 40519
`Part of Pape No.
`8 e
`
`Page 8
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`

`
`5/19/2014
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`US Classl
`CPC Symbol
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`514
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`170, 182
`170,182
`170,182
`170,182
`
`INTERFERENCE SEARCH
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`SH
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`
`EAST Search History
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`EAST Search History
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`EAST Search History (Prior Art)
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`Default
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`Plurals Time
`
`§abiraterone
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`§US~PGPUB; USPAT; EPO; JPO;
`ERWENT;
`|BM_TDB
`
`§prdnisone
`5
`
`§USrPGPUB; USPAT; EPO; JPO;
`§DERWENT;
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`§prednisone
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`‘ SPGPUB; USPAT; EPO; JPO;
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`C:\ Users\ shui\ Documents\ EAST\ Workspaces\ 13-034340.wsp
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`P ag e 1 O
`file:///CI/Users/shui/Documents/e—Red%2OF01der/13034340/EASTSearchHist0ry.13034340_Accessib1eVersi0n.htm[5/19/2014 1:42:20 PM]
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`§NFQRMAT§QN §ES$i“'$SURE
`STATEMW-u BY AQWCANT
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`Apptication Number
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`13034340
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`Firing Date
`First Named inventor
`
`2011-02-24
`Aian H. Auerbach
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`(gap Ming P Hm
`
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`U.S.PATENTS
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`24:rs9o7
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`2012-07-25
`
`Cougar Biotecnnoiogy,
`inc.
`
`§2«:>o6<>272ee
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`‘
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`......................
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`:——
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`Nitec Pharma AG
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`ENWRMATKEN m$m“‘Q$URE
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`Appiicretion Nuinber
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`1
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`Fiiing Date
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`2011-02-24
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`Examiner Name
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`'1
`San Ming R. Hui
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`Attorney Docket Number
`
`.
`._
`inotude name of the author {in C/-\F-‘ETAL LETTERS), titte of the articie (when appropriate), titie of the item
`Examiner: Cite i
`.
`.
`.
`V
`,
`.
`iniiiaw No
`i (book, rnagaaine, journai, senai, symposium, cateiog, etc), date. pagesrs), V€)iUiYi9—iSSSU9 nurntraerisi,
`pubiisher, city andfor country where pubiisned.
`
`5.
`i
`; To
`
`Assessment Report for Zytiga (abiraterone) pubiished 2011 by the CHMP of the EMA
`
`AUCHUS, R.J., "The genetics, netnophysioiogy, and the management
`Ctiin North Am (2001), '30, p.101-1 19
`
`human deficiencies ofPz‘-.55(3r:17", Endoerinoi
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`AYUB, M. "inhibition oftesticuiar 1 '7a—h3/droxyiase and 1'.7,2O—iyase but not 3-Bmyoroxysteroid dehyorogenase—
`ieomerese or 178--nydroxysteroid oxioor‘eda;ctase by keimzonazoie and other irnidezoie dings, Journai oi’ Steroid
`Bioctiernietry (1987) 28(5), p.521—53‘:
`
`Cainptaeii-\i’VeEsii Uioiogy, Ninth Edition, S-EiLii1Ci'-3i”S, \/oi. 3, Cthepiters 104 and ‘E05
`
`Cecil Textbook of Medicine, Wyngaarden & Smith 18th edition; Chapter on "$3-iucocoiticosteroid Therapy",
`Wyngearden & €~3rnii:n
`“:8ti~. eciition, (1988) p.128-“:31
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`ei., "Pherrneooixirieti-;:s and Pnerrriacodynarnics of Systerniceiiy Adininieitered Giut.:ocoi'tiooio'e“,
`CZOCK,
`Pharmacokinet (2005), 44(1), p.61—98
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`ERGUN—LQNGi‘viiRE, Benin, et at, "Two Novei Mutations Found in a Patient with 17a~Hydroxyiase Enzyme
`Deficiency", The Journei of Ciinioai Endoorinoiogy -33¢ i\/ietaboiisrn{12L‘-0(5), 91(‘iO), p.41'7§3~!:-182
`
`FAKEH, et ai., Uroiogy
`
`et ei., "Sup:ni‘es3ion oiadrenai function by iow--dose precinisone: assessineni: with 24-hour urinary
`Patrick
`steroid noi'rnc~ne profiies-A review of five c.e:3e:3",
`Medicine Review (2006), 11(1)
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`ENWRMATKEN m$m“‘Q$URE
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`Appiicratinn Nuinber
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`1
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`Fiiing Date
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`2011-02-24
`
`Examiner Name
`
`'0
`San Ming R. Hui
`
`information -:oncer’ning Zytiga (afoiraterore acetate) from http;//vv'ww.i1ontpendEurn.cn.I’pi'od/prir/‘i183238/de?
`Piatt'orm=Desktop as of March 25, 2014
`
`internet artiste: http:!/ciinicaitriais.gov/ci:2!sshc>w/‘sttidy/NCTOO485303?sec==X5()“i
`
`MOSTAQ-JHEL, E./’~\.. ".Abirai:erene in the treatment of metastatic castration-r‘esistant prostate cancer", Cancer
`Management Res, (2014) 0, p.39--5‘!
`
`OSAE-3:’-\., E23,, et ai., "Heaitn-Retai:ed Qiiaiity of Life in Men with Metastatic i3rosi:ai:e Cancer Treated with Prednisene
`aione or iviitoxartrone and Prect'nisone", J. Ctin. Oncoi. (1999), 17(6), p.‘i654—‘i663
`
`PETRYLAK, [}.P., "New Paradigms for Advanced Prostate Cancer", Rev. Uroi. (2007), 9, Suppl. 2, S3—S‘i2
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`Prostate i13ancerPrincipies and Practice, Taylor & Francis (2006) Chapter 93
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`REED, A., et ai., "Annais of Oncology", Educationai and Abstract Book eftne E-I-I53i‘v’i() Conference Lugane (ECLU).
`(2007), ‘i8(Suppiernent Si), ix1?3—ixi7-4. Abstract SOPD
`
`REMENGTON, "The Science and Practice of Pharmacy, 20th Edition (2000), p/i303—‘i3'r‘O
`
`ai., "Pr'irtci_oi-as of ii/ioiecuiar i\.Iiedic.ine; Second edition; (2006) i--iurnana Press inc. ESESN:
`RUNGE, Marsciiaii 3.,
`‘:—58829—202—9. pgs.365-3.76 and 4824484
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`et ai., "’:.7a—nydroxyiase deficiency in a genetic rnaie and fernaie sibiing pair", int. J. Gynaecoi. Obsteni
`SiLLS, irene
`(1981). ‘i9, p.473—4'."0
`'
`
`EFS‘v’\.’e'u2.1.1.7
`
`ALL REFERENCES COi\iSi{I}EREi3 EXCEPT WHERE i_iNE{) Ti-=g%Qi,gGi-=-i.
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`/S.i--i./"
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`ENWRMATKEN m$m“‘Q$URE
`STATEMEN? BY AEPEJCANT
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`2011-02-24
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`San Ming R. Hui
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`Attorney Docket Number
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`CGR500tUSCi\lT1
`
`Summary of Product Characteristics for Zytiga 250mg tablets (i6Jan20ir-‘i)
`
`TAl\lNOCK., et al., "Docetaxei Pius Prednisone or li/iitexantrene Plus Predniscne for Advanced Prostate Cancer",
`Journal of Uroiogy (2005). 1173(2). p.456
`
`i
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`The reply of applicant (ie. the Proprietor of herein opposed patent) dated June -4-, 2013
`US201'l/01!:-40'l6A’i US proceedings.
`
`relation to the cerreeponciingi
`i D
`
`WAi\lG. (3., et al., "Hypertension due to ’l7’a--Hydroxylase deficiency", Australian and New Zealand Journai of Medicine E
`1978), 3(3), 9295-299
`E
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`YANG, I-\., et at. "Giiicocoriicoids Sunmess Tumor Angiogensis and in vivo Growth of Prostate Cancer Cells", Cilin.
`Cancer (2006) 12, 3GO3~3GO9
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`Confirmation Number
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`13/034340
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`1621
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