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`PHILIP 5. J0] INSON
`JOHNSON & JOHNSON
`'1'--‘L SAN WNG R
`ONE JOHNSON & JOHNSON PLAZA
`NEW Bl{UNSWIC'K. NJ 08933-7003
`
`1023
`
`
`
`NOTIFICATION DATE
`
`DEIJVERY MODE
`
`()9! I
`
`I I20] 2
`
`I_"1-L'LC'l'RON [C
`
`Please find below andlor attached an Office communication concerning this application or proceeding.
`
`The time period for reply, if any, is set in the attached communication.
`
`Notice of the Office communication was sent electronically on above—indicated "Notification Date" to the
`following e-mail address(es):
`
`jn lISp2IlL:l1l @ corus.jn .c01n
`Ihowd @ ils.j11 .c01n
`gsalicllc €13 ils.11 .c0m
`
`PT0l.—9fIA (Rev. D-H0?)
`
`MYLAN PHARMS. INC. EXHIBIT 1039 PAGE 1
`
`
`
`Office Action Summary
`
`Application No-
`
`Applicantts)
`
`13io34,34o
`
`Examiner
`SAN—MlNG HUI
`
`AUERBACH ET AL.
`
`A“ Unit
`1628
`
`-- The MAtLlNG DA TE of this communication appears on the cover sheet with the correspondence address --
`Period for Reply
`
`A SHORTENED STATUTORY PERIOD FOR REPLY IS SET TO EXPIRE § MONTH(S) OR THIRTY (30) DAYS,
`WHICHEVER IS LONGER, FROM THE MA|L|NG DATE OF THIS COMMUNICATION.
`- Extensions of time may be available under the provisions ol 3? CFR 1.136(a).
`In no event. however. may a reply be timely filed
`after SIX (6) MONTHS from the mailing date of this communication.
`ll NO period for reply is specified above. the maximum statutory period will apply and will expire SIX (6) MONTHS from the mailing date of this communication.
`—
`— Failure to reply within the set or extended period [or reply will. by statute. cause the application to become ABAN DDNED (35 U.S.C. § 133).
`Any reply received by the Otlice later than three months after the mailing date ol this communication. even if timely filed. may reduce any
`earned patent term adjustment. See 37 CFR 1.?04(b).
`
`Status
`
`1) Responsive to communication(s) filed on 03 Jury 2012.
`
`2a) This action is FINAL.
`
`2b)I:I This action is non-final.
`
`3)|:I An election was made by the applicant in response to a restriction requirement set forth during the interview on
`
`j; the restriction requirement and election have been incorporated into this action.
`
`4)I:I Since this application is in condition for allowance except for formal matters, prosecution as to the merits is
`
`closed in accordance with the practice under Ex parte Ouayfe, 1935 CD. 1 1, 453 O.G. 213.
`
`Disposition of Claims
`
`5)E Claim(s) 37-56 islare pending in the application.
`5a) Of the above cIaim(s)
`isfare withdrawn from consideration.
`
`6)|:I C|aim(s) _ isiare allowed.
`
`7) Claim(s) Mi is/are rejected.
`
`( (
`
`8)|:l Claim s
`
`I:
`
`isiare objected to.
`
`9)|:I Claim s)
`
`are subject to restriction andior election requirement.
`
`Application Papers
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`10)I:I The specification is objected to by the Examiner.
`
`11)|:I The drawing(s) filed on
`
`isfare: a)[:I accepted or b)|:I objected to by the Examiner.
`
`Applicant may not request that any objection to the drawingtsj be held in abeyance. See 37 CFR 1.85(a).
`
`Replacement drawing sheettsj including the correction is required if the drawing(s) is objected to. See 37 CFR 1.121 (d).
`
`12)I:I The oath or declaration is objected to by the Examiner. Note the attached Office Action or form PTO—152.
`
`Priority under 35 U.S.C. § 119
`
`13)I:I Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)—(d) or (f).
`
`a)I:| All
`
`b)I:I Some * c)I:I None of:
`
`1.I:I Certified copies of the priority documents have been received.
`
`2.I:I Certified copies of the priority documents have been received in Application No. j.
`
`3.I:I 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)).
`
`* See the attached detailed Office action for a list of the certified copies not received.
`
`Atlachn1ent(s)
`
`1) El Notice of References Cited (PTO—892)
`2) El Notice of Draflsperson's Patent Drawing Review (PTO—948]i
`3) El Information Disclosure Statementts) (PTOISBIOS)
`Paper No(s)i'Mai| Date
`.
`US. Patent and Trademark Office
`PTOL-326 (Rev. 03-11]
`
`4) El lnteniiew Summary (PTO—413j
`_
`P3P_9l N0(5li'M3" 9319-
`_-
`5) l:l N01|C9 07 Informal F‘-’=1T9nTAPPI|C31|0n
`6) El Other:
`,
`
`Office Action Summary
`
`Part of Paper No.fMai| Date 20120905
`
`MYLAN PHARMS. INC. EXHIBIT 1039 PAGE 2
`
`
`
`Applicationlcontrol Number: 13l034,34O
`
`Page 2
`
`Art Unit: 1628
`
`DETAILED ACTION
`
`Applicant's response filed 7/3/2012 has been entered.
`
`Claims 37-56 are pending.
`
`The provisional double patenting rejection is withdrawn in view of the conflicting
`
`patent application being abandoned.
`
`Claim Rejections - 35 USC § 103
`
`The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all
`
`obviousness rejections set forth in this Office action:
`
`(a) A patent may not be obtained though the invention is not identically disclosed or described as set
`lorth in section 102 oi this title, if the differences between the subject matter sought to be patented and
`the prior art are such that the subject matter as a whole would have been obvious at the time the
`invention was made to a person having ordinary skill in the an to which said subject matter pertains.
`Patentability shall not be negatived by the manner in which the invention was made.
`
`Claims 37-56 are rejected under 35 U.S.C. 103(a) as being unpatentable over
`
`O'Donnell et al., British Journal of Cancer, 2004;90:2317—2325 in view of Tannock et al.,
`
`J. Clin. Oncol., 1996;14:1?'56—1764. All of the references are of record in the parent
`
`application.
`
`O’Donne|l et al. teaches abiraterone acetate is known to be an inhibitor of 170:-
`
`hydroxylase/C17,20—lyase , which can be used to suppress testosterone level in
`
`prostate cancer patients (see the abstract for example). O'Donnell et al. teaches 800mg
`
`of abiraterone acetate as useful in suppressing the serum testosterone level (See the
`
`abstract for example). O'Donnell et al. also teaches that cocomitant glucocorticoid
`
`therapy may be needed for continuous use of abiraterone acetate (See the abstract and
`
`page 2323, col.2 for example).
`
`MYLAN PHARMS. INC. EXHIBIT 1039 PAGE 3
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`
`
`Applicationlcontrol Number: 13f034,34O
`
`Page 3
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`Art Unit: 1628
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`O’Donnell et al. does not expressly teach the use of prednisone in the method of
`
`treating prostate cancer. O'Donnell et al. does not expressly teach the use of the herein
`
`claimed dosage and regimen for prednisone and abiraterone acetate.
`
`Tannock et al. teaches 10mg of prednisone in combination with other anit—cancer
`
`drug as effective in treating refractory hormonal-resistance prostate cancer.
`
`It would have been obvious to one of ordinary skill in the art at the time the
`
`invention was made to employ both prednisone and abiraterone acetate, in the dosage
`
`herein claimed, together in a method of treating prostate cancer, including refractory
`
`prostate cancer.
`
`One of ordinary skill in the art would have been motivated to employ both
`
`prednisone and abiraterone acetate, in the dosage herein claimed, together in a method
`
`of treating prostate cancer, including refractory prostate cancer. Since abiraterone
`
`acetate provide a new mechanism of action in treating prostate cancer and prednisone
`
`is known to be useful in treating refractory prostate cancer, concomitant employment of
`
`both compounds into a single method useful for the very same purpose, treating
`
`prostate cancer, would be considered prima facie obvious (See in re Kerkhoven 205
`
`USPQ 1069 (CCPA 1980)). Treating refractory prostate cancer with abiraterone
`
`acetate would be reasonably expected to be effective since abiraterone provides a new
`
`mechanism of action against prostate cancer. O'donnell et al. provides an additional
`
`motivation to concomitantly employ prednisone since employing replacement
`
`glucocorticoid such as prednisone would ensure the safety and effectiveness of
`
`abiraterone acetate.
`
`MYLAN PHARMS. INC. EXHIBIT 1039 PAGE 4
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`
`
`Applicationlcontrol Number: 13f034,34O
`
`Page 4
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`Art Unit: 1628
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`Furthermore, the optimization of result effect parameters (eg, dosage range,
`
`dosing regimens) is obvious as being within the skill of the artisan. The optimization of
`
`known effective amounts of known active agents to be administered, is considered well
`
`in the competence level of an ordinary skilled artisan in pharmaceutical science,
`
`involving merely routine skill in the art.
`
`It has been held that it is within the skill in the art
`
`to select optimal parameters, such as amounts of ingredients, in a composition in order
`
`to achieve a beneficial effect. See in re Boesch, 205 USPQ 215 (CCPA 1980). It is also
`
`noted that “[W]here the general conditions of a claim are disclosed in the prior art, it is
`
`not inventive to discover the optimum or workable ranges by routine experimentation."
`
`in re Alter, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
`
`Response to Arguments
`
`Applicant's arguments filed 7/3/2012 averring the presence of unexpected results
`
`because abiraterine plus prednisone being more effective than prednisone alone have
`
`been fully considered but they are not persuasive. The examiner notes that it is
`
`expected because abiraterone and prednisone are known to be individually effective in
`
`treating prostate cancer. At least additive effective is expected.
`
`Applicant's arguments filed 7!3!2012 averring the presence of commercial
`
`success have been considered, but are not found persuasive. The examiner notes that
`
`applicant bears the burden to provide evidence of commercial success. Furthermore,
`
`gross sales figures do not show commercial success absent evidence as to market
`
`share, Cable Electric Products, inc. v. Genmark, inc, 770 F.2d 1015, 226 USPQ 881
`
`(Fed. Cir. 1985), or as to the time period during which the product was sold, or as to
`
`MYLAN PHARMS. INC. EXHIBIT 1039 PAGE 5
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`
`
`Applicationlcontrol Number: 13i034,340
`
`Page 5
`
`Art Unit: 1628
`
`what sales would normally be expected in the market, Ex parte Standish, 10 USPO2d
`
`1454 (Bd.Pat. App. 8. Inter. 1988).
`
`In the instant case, there is no evidence of
`
`commercial success was provided. Therefore, possessing the teachings of the cited
`
`prior art, one of ordinary skill in the art would employ the herein claimed agents into a
`
`single method of treating refractory prostate cancer.
`
`No claims are allowed.
`
`THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time
`
`policy as set forth in 37 CFR 1.136(a).
`
`A shortened statutory period for reply to this final action is set to expire THREE
`
`MONTHS from the mailing date of this action.
`
`In the event a first reply is filed within
`
`TWO MONTHS of the mailing date of this final action and the advisory action is not
`
`mailed until after the end of the THREE-MONTH shortened statutory period, then the
`
`shortened statutory period will expire on the date the advisory action is mailed, and any
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`extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of
`
`the advisory action.
`
`In no event, however, will the statutory period for reply expire later
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`than SIX MONTHS from the mailing date of this final action.
`
`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, Brandon Fetterolf can be reached on (571) 272-2919. The fax phone
`
`MYLAN PHARMS. INC. EXHIBIT 1039 PAGE 6
`
`
`
`Application!Control Number: 13f034,34O
`
`Page 6
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`Art Unit: 1628
`
`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 httpzltpair-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 1628
`
`rSan—ming Hui/
`Primary Examiner, Art Unit 1628
`
`MYLAN PHARMS. INC. EXHIBIT 1039 PAGE 7
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`
`
`Applicalionlcontrol No.
`
`Search N01‘-95
`
`13034340
`
`AppIicanl(s)a'Patenl Under
`Reexamination
`
`AUERBACH ET AL.
`
`|
`
`
`Examiner
`
`
`SAN-MING HUI
`
`SH
`
`SEARCHED
`
`Subclass
`
`170, 182
`170, 182
`
`Examiner
`
`SH
`
`SEARCH NOTES
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`Search Notes
`EAST Search and inventor Search in PALM
`EAST Search and inventor Search in PALM
`
`Date
`1f27.F11
`95} 12
`
`SH
`SH
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`Examiner
`
`INTERFERENCE SEARCH
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`
`
`U.S. Patent and Trademark Office
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`Pan of Paper No.
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`. 20120905
`
`MYLAN PHARMS. INC. EXHIBIT 1039 PAGE 8
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`
`
`EAST Search Ilislory
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`EAST Search History
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`EAST Search History (Prior Art)
`
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`MYLAN PHARMS. INC. EXHIBIT 1039 PAGE 9
`
`
`
`Applicationlcontrol No.
`
`Index Of Claims
`
`13034340
`
`AppIicant(s)lPalent Under
`Reexamination
`
`AUERBACH ET AL.
`
`M Unit
`
`1628
`
`N
`
`I
`
`Non-Elected
`
`Interference
`
`A
`
`O
`
`Appeal
`
`Obiected
`
`Examiner
` Reiected
`
`Allowed
`
`:
`
`Restricted
`
`SAN—M|NG HUI
`
`Cancelled
`
`|:| Claims renumbered in the same order as presented by applicant
`
`I:I CPA
`
`|:| T.D.
`
`|:| H.111?
`
`CLAIM
`
`DATE
`
`Final
`
`Original
`
`11a’21!2011 01I2?a’2012 09f05.i2()12
`
`|'\J
`
`O\U‘|-l’-‘~03
`
`'\.|
`
`10
`11
`
`12
`13
`14
`15
`16
`
`17
`18
`19
`20
`21
`
`22
`
`-2222“),
`24
`25
`25
`2?
`23
`29
`30
`31
`32
`33
`34
`35
`36
`
`US. Patent and Trademark Ollice
`
`Pan of Paper No.
`
`: 20120905
`
`MYLAN PHARMS. INC. EXHIBIT 1039 PAGE 10
`
`
`
`Applicationlcontrol No.
`
`Index Of Claims
`
`13034340
`
`AppIicant(s)lPalent Under
`Reexamination
`
`AUERBACH ET AL.
`
`M Unit
`
`1628
`
`N
`
`I
`
`Non-Elected
`
`Interference
`
`A
`
`O
`
`Appeal
`
`Obiected
`
`Examiner
` Reiected
`
`SAN—M|NG HUI
`
`Cancelled
`
`Allowed
`
`:
`
`Restricted
`
`|:| Claims renumbered in the same order as presented by applicant
`
`I:I CPA
`
`|:| T.D.
`
`|:| H.111?
`
`CLAIM
`
`DATE
`
`Final
`
`Original
`37
`38
`
`39
`40
`41
`
`11f21!2011 01I2?'a’2012 O9f05f2()12
`«K
`‘K
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`‘x
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`44
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`45
`46
`4?
`
`RR
`
`‘KS
`
`48
`49
`50
`51
`52
`
`53
`54
`55
`56
`
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`‘\K‘\
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`
`RR
`
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`‘\K‘\
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`
`RR
`
`U.S. Patent and Trademark Ollice
`
`Pan of Paper No.
`
`3 20120905
`
`MYLAN PHARMS. INC. EXHIBIT 1039 PAGE 11