`
`
`UNITED STATES DEPARTMENT OF CONDIERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATIENTS
`1’ 0 Box 1450
`Alcxandt’im Virginia 32313—1450
`www uspto gov
`
`NOTICE OF ALLOWANCE AND FEE(S) DUE
`
`02/11/2014
`
`,.
`7590
`277/7
`PHILIP S. JOHNSON
`JOHNSON & JOHNSON
`ONE JOHNSON & JOHNSON PLAZA
`NEW BRUNSWICK, NJ 08933-7003
`
`APPLICATION NO.
`
`FILING DATE
`
`FIRST NAMED INVENTOR
`
`
`
`Alan ll. AUerbach
`02/14/2011
`13/034,340
`TITLE OF INVENTION: METHODS AND COMPOSITIONS FOR TREATING CANCER
`
`EXAMINER
`
`IIUI, SAN MING R
`
`
`
`m
`DATE MAILED: 02/1 1/2014
`
`ATTORNEY DOCKP1NO.
`
`CURSOOI I.'S(‘,\’T1
`
`("ONEIRMAT ION NO.
`
`1597
`
`
`
`
`
`APPLN. TYPE
`ENTITY STATUS
`ISSUE FEE DUE
`PUBLR 'ATION FEL DITE
`PREV. PAID ISSUE FEE
`'I UTAI. l-IiL'ISI DUE
`DATE DUE
`
`nonprovisional
`UNDISCOUNTED
`$960
`$0
`$0
`$900
`()5/12/20l4
`
`TIIE APPLICATION IDENTIFIED ABOVE HAS BEEN EXAMINED AND IS ALLOWED FOR ISSUANCE AS A PATENT.
`PROSECUTII IN 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
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`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
`TAT
`Y P *R
`T
`t
`4
`t
`t
`.
`SEE 35 U.S.C. 151. TIIE ISSUE FEE DUE INDICATED ABOVE DOES
`NOT REFLECT A CREDIT FOR ANY PREVIOUSLY PAID ISSUE FEE IN THIS APPLICATION.
`IF AN ISSUE FEE HAS
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`11. PART B — PEE(S) TRANSMITTAL, or its equivalent, must be completed and returned to the United States Patent and Trademark Office
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`P'I‘OL-ss (Rev. 02/11)
`
`Page 1 of 3
`
`JANSSEN EXHIBIT 2165
`
`Wockhardt v. Janssen |PR2016-01582
`
`JANSSEN EXHIBIT 2165
`Wockhardt v. Janssen IPR2016-01582
`
`

`

`PART B - FEE(S) TRANSMITTAL
`
`Complete and send this form, together with applicable fee(s), to: Mail Mail Stop ISSUE FEE
`Commissioner for Patents
`I’,0. Box 1450
`Alexandria, Virginia 22313-1450
`or flag (571)-273-2885
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`
`
`
`
`
`through 5 should be completed where
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`ap ropriate. All further correspondence including the Patent, advance orders and notification of maintenance lees will be mailed to the current corres ondence address as
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`maintenance fee notifications,
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`CURRENT CORRESPONDENCE ADDRESSWOIC= USO Block ! forany Change oiaddrcss)
`
`7590
`27777
`,
`PI IILIP S. JOHNSON
`JOHNSON & JOHNSON
`ONE JOHNSON & JOHNSON PLAZA
`NEW BRUNSWICK, NJ 08933-7003
`
`02/11/2014
`
`Note: A certificate of mailing can only be used for domestic mailings of the
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`ISSUE FEE address above, or being facsimile
`transmitted to the USPTO (. 71) 27372885, on the date indicated below.
`
`
`
`
`(Signature)
`
`
`
`
`
`
`FIRST NAMED INVENTOR
`
`
`CONFIRMATION NO.
`FILING DATE
`APPLICATION NO.
`1597
`Alan ll. Aucrbach
`02/24/2011
`13/034,340
`CGRSOOIUSCNTI
`TITLE OF INVENTION: METHODS AND COMPOSITIONS FOR TREATING CANCER
`
`APPLN. TYPE
`
`nonprovi sional
`
`
`
`
`
`
`
`
`
`
`
`
`PUBLICATION lilili DUE
`PREV. PAID ISSUE 11;];
`TOTAL FEMS) DUE
`ISSUE ILE DUE
`EN’I'I'I'Y STATUS
`DATE DUI:
`
`UNDISCOUNTED
`$960
`$0
`$0
`$960
`05/12/2014
`ART ITNIT
`CLASS-SUB CLASS
`
`HUI, SAN MING R
`1621
`514470000
`
`
`
`1. Change of correspondence address or indication of "Fe
`CPR 1.363),
`
`2. For printing on the patent front page, list
`0 Address" (37
`(i) The names of up to 3 registered patent attorneys
`3 Chan e of correspondence address (or Change of Correspondence
`
`
`or agents OR. alternatively.
`Address orm PTO/SB/IZZ') attached.
`(2) The name of a single firm (having as a member a
`3 "Fee Address” indication (or "Fee Address” Indication form
`
`registered attorney or agent) and the names of up to
`PTO/SW47; Rev O3~OZ or more recent) attached. Use of a Customer
`Number is required.
`3
`2 registered patent attorneys or agents. II no name is
`
` listed. no name will be printed. ’ W'mmwiw'fi‘riwi“ rim ..,.__ "m
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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 assignce 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)
`
`l
`
`..
`
`777777
`
`W...
`
`..
`
`.
`
`
`
`
`
`Please check the appropriate assignee category or categories (will not be printed on the patent) 7 Cl Individual D Corporation or other private group entity D Government
`
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`
`4a. The following fee-(s) are submitted:
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`jThc Director is hereby authorized to charge the required fce(s), any deficiency, or credits any
`3 Advance Order — # of Copies
`overpayment, to Deposit Account Number
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`5. Change in Entity Status (from status indicated above)
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`NOTE: Checking this box will be taken to be a notification of loss of entitlement to small or micro
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`
`NOTE: This form must be si ned in accordance with 37 CFR 131 and 1.33. See 37 CPR 1.4 for SI nature re uircments and certifications.
`
`
`
`
`Authorized Signature w
`Typed or printed name
`
`Date
`
`Registration No.
`
`Page 2 of 3
`
`PTOL~85 Part B (10—13) Approved for use through 10/31/2013.
`
`OMB 0651-0033
`
`U.S. Patent and Trademark Office; US, DEPARTMENT OF COMMERCE
`
`
`
`

`

`
`
`UNITED STATES PATENT AND TRADEMARK OIHCE
`
`UNITED STATES DEPARTMENT OF COMMER('TE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`P O. Box [450
`Alexandria Virginia 233134450
`www usplo gov
`
`
`
`APPLICATION NO.
`
`13/034,340
`
`
`
`FILING DATE
`
`02/24/2011
`
`
`
`FIRST NAMED IN V ‘ZNTOR
`
`Alan II. Auerbach
`
`
`
`ATTORNEY DOCKET NO.
`
`CURSOOIUSCNTI
`
`
`
`CONFIRMATION NO.
`
`1597
`
`
`
`PHILIP S. JOHNSON
`JOHNSON & JOHNSON
`ONE JOHNSON & JOHNSON PLAZA
`NEW BRUNSWICK, NJ 08933-7003
`
`HUI, SAN MINO R
`
`1.521
`DATE MAILED: 02/1 1/2014
`
`Determination of Patent Term Adjustment under 35 U.S.C. 154 (b)
`(application filed on or after May 29, 2000)
`
`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 above—identified application,
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`the filing date that
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`PTOL~85 (Rev. 02/11)
`
`Page 3 Of 3
`
`
`
`

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`OMB Clearance and PRA Burden Statement for PTOL-85 Part B
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`

`

`'—
`
`if not included
`All claims being allowable, PROSECUTION ON THE MERITS IS (OR REMAlNS) CLOSED in this application.
`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.
`
`
`
`
`Application No.
`Applicant(s)
`
` 13/034,340 AUERBACH ET AL.
`-
`'
`NA (First Inventor to
`
`.
`
`.
`
`.
`
`No
`
`
`i File)Status
`$23”!
`Emma; HUI
`Notice ofAllowablllty
`- The MAILING DATE of this communication appears on the coversheet with the correspondence address—-
`
`
`
`1. E This communication is responsive to 1/10/2014.
`[Z] A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/were 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
`
`8. E The allowed claim(s) is/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
`tatt' :il't’wwwus' to. ov/ atents/init events/pphilndestp or send an inquiry to PPeredback us toqov .
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`
`
`
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`4. E] Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)—(d) or (f).
`Certified copies:
`
`’c) I] None of the:
`b) [:1 Some
`a) [I All
`1. [:l Certified copies of the priority documents have been received.
`2. El Certified copies of the priority documents have been received in Application No.
`3. E] 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
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`THIS THREE-MONTH PERIOD IS NOT EXTENDABLE.
`
`5. [:1 CORRECTED DRAWINGS ( as “replacement sheets") must be submitted.
`
`E]
`
`including changes required by the attached Examiner’s Amendment / Comment or in the Office action of
`Paper No./Mai| 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. E] 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.
`
`5. E] Examiner's Amendment/Comment
`6. E Examiner's Statement of Reasons for Allowance
`
`7, [:1 Other
`
`Attachment(s)
`1. D Notice of References Cited (PTO-892)
`2. K information Disclosure Statements (PTO/SB/OB).
`Paper No./Mai| Date
`3. D Examiner's Comment Regarding Requirement for Deposit
`of Biological Material
`4. 1:] Interview Summary (PTO-413),
`Paper No./Mai| Date
`
`/SAN-MING HUI/
`Primary Examiner, Art Unit 1621
`
`
`
` U 8 Patent and Trademark Office
`
`PTOLv37 (Rev. 08-13)
`
`, Notice of Allowabiiity
`
`Part of Paper No/Mail Date 20140128
`
`
`
`

`

`Application/Control Number: 13/034,340
`Art Unit: 1621
`
`Page 2
`
`The present application is being examined under the pre—AlA first to invent
`
`provisions.
`
`DETAILED ACTION
`
`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 Quay/e, 25 USPQ 74, 453 0.6. 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 1/10/2014
`
`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 7/30/2013. 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 comments considered necessary by applicant must be submitted no later
`
`than the payment of the issue fee and, to avoid processing delays, should preferably
`
`accompany the issue fee. Such submissions should be clearly labeled “Comments on
`
`Statement of Reasons for Allowance.”
`
`

`

`Application/Control Number: 13/034,340
`Art Unit: 1621
`
`Page 3
`
`Any inquiry concerning this communication or earlier communications from the
`
`examiner should be directed to SAN-MING HUI whose telephone number is (571 )272—
`
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`
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`
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`
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`
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`
`information regarding the status of an application may be obtained from the
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`
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`
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`
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`
`/SAN—MING HUl/
`
`Primary Examiner, Art Unit 1621
`
`San~ming Hui
`Primary Examiner
`Art Unit 1621
`
`

`

`PTO/SBIOSA (0800)
`Approved for use through 10/31/2002 OMB 0651-0031
`US. Patent and Trademark Office: US. DEPARTMENT OF COMMERCE
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`
`
`
`13/034,340
`February 24, 2011
`Alan H. Auerbach
`‘629
`San Ming R. Hui
`CGR5001USCNT1
`
`SUbStitme ‘0’ mm “WA/PTO
`
`Application Number
`Filing Date
`First Named inventor
`INFORMATION DISCLOSU RE
`STATEMENT BY APPLICANT WW“
`Examiner Name
`(use as many she“ as messa’vl
`Attorney Docket Number
`Sheet 1 of 2
`U.S. PATENT DOCUMENTS
`
`US. Patent Document
`
`Examiner
`initials
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`Kind Code
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`(if known)
`
`Name of Patentee or Applicant
`of Cited Document
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`Date of Publication
`of Cited Document
`mm—ddsyyyy
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`Pages, Columns, Lines.
`where relevant passages or
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`
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`
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` Foreign Patent Document
`W... ___W Name of patentee or
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`ApplicantotCited Document
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`Officea Number“
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`KindCode“
`
`Date of Publication
`of Cited Document
`mm-dd—yyyy
`
`Pages, Columns, Lines.
`where relevant
`passages or relevant
`.
`figures appear
`
`T
`
`a
`
`
`
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`Examiner
`initials
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`Cite
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`'EXAMlNER: initial it reference considered, whether or not citation is in conformance with MPEP 609. Draw line through citation if not ln conformance
`and not considered, Include copy of this form with next communication to applicant,
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`1 Unique citation designation number, 2 See attached Kinds of US. Patent Documents, 3 Enter Office that issued the document. by the twovletter
`code (WIPO Standard 8T3). 4 For Japanese patent documents, the indication of the year of the reign of the Emperor must precede the serial
`number ofthe patent document. sKind of document by the appropriate symbols as indicated on the document under WlPO Standard ST. 16 if
`possible. aApplicant is to place a check mark here it English language Translation :5 attached.
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`Burden Hour Statement: This form is estimated to take 2.0 hours to complete. Time will vary depending upon the needs otthe indivtdual case. Any
`comments on the amount of time you are required to complete this form should be sent to the Chief Information Officer, U. 8. Patent and Trademark
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`ALL REFERENCES CONS/DERED EXCEPT WHERE LINED THROUGH.
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`PTO/SB/OBA (0800)
`Approved for use lhrough10/31/2002 OMB 06510031
`US Patent and Trademark Office: U S, DEPARTMENT OF COMMERCE
`Under the Pariwoik Reduction Act of 1995, no ersons are re-uired to resund to a collection oi information unless it dis- a s a valid OMB control number
`
`
`Substitute for form 1449A/PTO
`Agplication Number
`13/034340
`FilingDate
`February 24, 2011
`First Named Inventor
`Alan H, Auerbach
`
`Egfign’,
`8,, MW,
`
`Attorney Docket Number
`CGR5001 U SCNTt
`
`IN FORMAT'ON DISCLOSURE
`STATEMENT BY APPLICANT
`(“59 as "my 51‘9““ 8‘ "9““an
`Sheet 2 of 2
`
`
`OTHER PRIOR ART - NON PATENT LITERATURE DOCUMENTS
`
`
`Examiner‘s
`lnitials"
`
`Cite
`‘I No.‘
`
`__fl__
`The Journal ofUrology 2002Lpages 2439-2443, Volume 168.
`_l
`_r Chang, Ching-Yi, ct a1. Glucocorticoids Manifest Androgcnic Activity in a Cell Derived from
`r a Metastatic Prostate Cancer, Cancer Research, 2001, pages 8712—8717, Volume 61.
`
`
`
`include name of the author (in CAPITAL LETTERS), title of the article (when appropriate), title of the item T— ,
`(book, magazine, journal, serial. symposium, catalog, etc), date, page(s), volume—issue number(s),
`T’
`publisher, city and/or country where published
`Berry, W, et al. Phase III Study ofMitoxantrone Plus Low Dose Prednisone Versus Low
`Dose Prcdnisonc Alone in Patients with Asymptomatic Hormone Retractory Prostate Cancer,
`
`*1
`
`_,_
`
`4
`
`__]
`
`
`
`Dorff, TB, Crawford, ED. Management and challenges ot‘corticosteroid therapy in men with
`metastatic castrate~resistant prostate cancer, Annals ol‘ Oncology, 2013, pages 31 ~8, Volume
`240).
`Efstathiou, Eleni, et al. Effects ofAbiraterone Acetate on Androgen Signaling in Castraten
`Resistant Prostate Cancer in Bone, American Society of Clinical Oncology, Joumal of
`Clinical Oncolog, 2011, pages 1—8,
`Huggins, Charles, et a1. Studies on Prostatic Cancer]. The Effect ot‘Castration, ot‘Estrogen
`and of Androgen Injection on Serum Phosphatascs in Metastatic Carcinoma of the Prostate,
`
`Cancer Research, 1941, pages 293—297, Volume 1.
`l_
`Mostaghel, EA. et al. Molecular Pathways: Targeting resistance in the androgen receptor for
` therapeutic benefit, Clin Cancer Res, 2013 Dec 4. Ewahead of priflL
`Nishimura, Kazuo, et a1. Potential Mechanism for the Effects ol’Dcxamethasone on Growth
`of Androgen—Independent Prostate Cancer, Journal of the National Cancer Institute, 2001,
`
`'i
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`T
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`4
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`Examiner
`/San Miri- Hui/
`”EXAMINER: initial it reference considered. whether or nul citation is in conformance with MPEP 609. Drawl
`next mmmminmnn tn appiimm
`1 Unique motion dasognauon number. 2 Applicant is In place a streak mark here it English language Translation 18 attached
`Burden Hoiir Statement This form is estimated to lake 2 0 hours It) mniplete. Time will vary depending upon the needs at the Indivrdual ease Any comments on the anouii cl time you are requred to
`complete this form should be senl to the Chief lnlormation Officer, U 8 Patent and Trademark Oifice. Washington, DC 20231.
`DO NOT SEND FEES OR COMPLETED FORMS TO THIS ADDRESS. SEND TO‘ Comrmssionor for Patents, P O Box 1450, Alexandria, VA 2231134450
`
`.
`1,0 I,
`Date
`outs/2014
`ine through citation it not in mntorinanoe and not considered include copy at this term with
`
`
`
`ALL REFERENCES CONSlDERED EXCEPT WHERE LINED THROUGH.
`
`/S.H,/
`
`
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`L __l 1pages 1739-1746, Volume 93. __L
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`f
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`Oudar, Stephane, et a1. Actualite dans le cancer de la prostate, Synthese, Bull Cancer 2005',
`
`92 (10), pgs. 865~873 (relevance in English abstract)
`Petrylak, et a1. Docetaxel and Estramustine Compared with Mitoxantrone and Prednisone
`I
`for Advanced Refractory Prostate Cancer, The New [England Journal ol‘ Medicine, 2004,
`pages 151320, Volume 351,
`Ryan, et a1., Aberaterone Acetate in Metastatic Prostate C anccr Without Previous
`~r_ChcmothcrapL The Ncw England Journal ol‘ Medicine, 2013, 368:138—148,
`Sartor, et al, Ahirateroric Prolongs Survival in Metastatic Prostate (farmer, Nature Reviews
`Clinical Oncology 20E 1, pages SIS—l6, Volume 8,
`Tannock, IF, et a1. Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced
`prostate cancer, The New England Journal of Medicine, 2004, pages 1502-1512, Volume
`351(15).
`
`

`

`
`Application/Control No.
`
`Applicant(s)/Patent Under
`Reexamination
`
`Index of Claims
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`SANvMING HUI
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`13034340
`AUERBACH ET AL,
`
`Examiner
`Art Unit
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`’1
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` Rejected
`Cancelled
`-
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`IFN 1 Non-Elected
`Allowed
`Restricted I l I1+ Interference Objected
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`E] Claims renumbered in the same order as presented by applicant r—
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`CLAIM
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`Final
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`E] CPA
`I: TD.
`[3 R.1.47 J
`
`DATE
`1 01/27/2012
`09/05/2012 02/25/2013 06/28/2013 10/21/2013 01/29/2014
`r
`Original
`11/21/201 I
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`U 8 Patent and ‘ rademark Office
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`: 20140128
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`1
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`
`Application/Control No.
`Applicant(s)/Patent Under
`Reexamination
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`Index 01' Claims
`t "m It
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`H
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`13034340
`Examiner
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`SAN—MING HUI
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`AUERBACH ET AL.
`Art Unit
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`1629
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`‘J
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`CLAIM —[
`DATE
`
`Final
`Original 117/21/2011 01/27/2012TE9705/2012L02/25/20133528/25?10/21/2013 01/29/2014
`
`37
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`US. Patent and Trademark Office
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`Part of Paper No . 20140128
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`Application/Control No.
`Applicant(s)/Patent Under
`Reexamination
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`Search Notes
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`13034340
`AUEHBACH ET AL.
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`Examiner
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`1628
`SAN-MING HUI
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`Application/Control No.
`Issue CIaSSIflcatlon 13034340
`
`Applicant(s)/Patent Under Reexamination
`AUERBACH ET AL.
`
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`3:17;;
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`(Assistant Examiner)
`/SAN-M|NG HUI/
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`Primary ExaminerAn Unit 1621
`
`Total Claims Allowed:
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`20
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`01/29/2014
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`0 G. Prim Ciaim(s)
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`0G. Prim Figure (Primary Examiner)
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`1(Date) 1
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`Application/Control No.
`Applicant(s)/Patent Under Reexamination
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`Issue Classification
`AUERBACH ET AL,
`13034340
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