UNI 1 l;D S 1/ues PA IENI AND TRADI:MARK OPTICE
`
`(JNITFD STATES DEPARTMENT OF (‘.0MMER(‘E
`United States Patent and Tradcntark Oflicc
`Addn:s.s: (,‘().VlMlSSl()Nl-R l-OR P/\'l‘l£N'I'S
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`I3/03-1.3-1()
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`02/24/20] I
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`Alan II. Aucrhach
`
`(‘(iR50()llTS(‘N'I'l
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`I597
`
`27777
`7590
`PIIII.IPS.J0llNSON
`JOHNSON & JOHNSON
`
`(‘/9/I 1/2012
`
`ONE JOHNSON & JOHNSON PLAZA
`NEW BRUNSWICK, NJ 08933-7003
`
`..
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`.
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`_.
`
`“UL SAN MING R
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`’’‘‘’’‘R M ““““‘
`I628
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`09/ l 1/2012
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`l;'Ll;'("I‘RONI(‘
`
`Please find below and/or 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):
`
`jnjuspalcnt@cOms.jnj.cOm
`lh0wd@its.jnj .cOm
`gsanchc @ iIs.jnj .cOm
`
`PTOI.-90A (Rev. 04/07)
`
`ARGENTUM EX1039
`ARGENTUM EX1039
`Page 1
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`Page 1
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`

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`Office Action Summary
`
`Application No.
`
`Applicant(s)
`
`13io34,34o
`
`Examiner
`
`SAN—MlNG HUI
`
`AUERBACH ET AL.
`
`A“ Unit
`
`1628
`
`-- The MAttJNG 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 MAILING 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) MDNTH8 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 DONED (35 U.S.C_ § 133).
`Any reply received by the Dllice later than three months alter 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 Juiy 2012.
`
`2a)lZl This action is FINAL.
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`2o)|:| This action is non-final.
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`3)|:I An election was made by the applicant in response to a restriction requirement set forth during the interview on
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`j; the restriction requirement and election have been incorporated into this action.
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`4)I:I Since this application is in condition for allowance except for formal matters, prosecution as to the merits is
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`closed in accordance with the practice under Ex parte Quayie, 1935 C.D. 11,453 O.G. 213.
`
`Disposition of Claims
`
`5)IZ CIaim(s) 37-56 isiare pending in the application.
`
`5a) Of the above cIaim(s)
`
`isiare withdrawn from consideration.
`
`6)I:I C|aim(s) _ isiare allowed.
`
`7) C|aim(s) ffli isiare rejected.
`
`8)I:l Claim(s) j isiare objected to.
`
`9)|:I CIaim(s) Z are subject to restriction andior election requirement.
`
`Application Papers
`
`10)I:I The specification is objected to by the Examiner.
`
`11)I:l The drawing(s) filed on
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`isiare: a)[:l accepted or b)I:l objected to by the Examiner.
`
`Applicant may not request that any objection to the drawingis) be held in abeyance. See 37 CFR 1.85(a).
`
`Replacement drawing sheetisj including the correction is required if the drawinglsj 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.
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`Priority under 35 U.S.C. § 1 19
`
`13)I:I Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
`
`a)I:l All
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`b)I:I Some * c)I:I None of:
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`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.
`
`Atlachment(s)
`
`4) |:I lnteniiew Summary (PTO—413}
`_
`P3P_9l N0(5li'M3" D319
`_
`5} I:I N01|C9 07 Inlormal Patent Al~'JPI|C31|0n
`6) C] Other:
`.
`
`1) El Notice of References Cited (PTO—892)
`2) D Notice of Draftsperson’s Patent Drawing Review (PTO—948]i
`3) El Information Disclosure Statementis) (PTOISBIOS)
`Paper No(s)iMai| Date
`US. Patent and Trademark Office
`PTOL-326 (Rev. 03-11}
`
`Office Action Summary
`
`Part of Paper No.i'Mai| Date 20120905
`Page 2
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`Page 2
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`

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`Application/Control Number: 13fO34,34O
`
`Page 2
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`Art Unit: 1628
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`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
`forth in section 102 of 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 art 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).
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`Page 3
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`Page 3
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`

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`Application/Control Number: 13fO34,34O
`
`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
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`glucocorticoid such as prednisone would ensure the safety and effectiveness of
`
`abiraterone acetate.
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`Page 4
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`Page 4
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`

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`Application/Control Number: 13fO34,34O
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`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
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`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 After, 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 711312012 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. 1/. 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
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`Page 5
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`Page 5
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`

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`Application/Control Number: 13i034,340
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`Page 5
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`Art Unit: 1628
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`what sales would normally be expected in the market, Ex parte Standish, 10 USPQ2d
`
`1454 (Bd.Pat. App. & 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
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`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.
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`In the event a first reply is filed within
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`TWO MONTHS of the mailing date of this final action and the advisory action is not
`
`mailed until after the end of the THREE—lvlONTH shortened statutory period, then the
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`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.
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`Any inquiry concerning this communication or earlier communications from the
`
`examiner should be directed to SAN—MlNG HUI whose telephone number is (571)272-
`
`0626. The examiner can normally be reached on Mon — Fri from 9:00 to 5:00.
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`If attempts to reach the examiner by telephone are unsuccessful, the examiner's
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`supervisor, Brandon Fetterolf can be reached on (571) 272-2919. The fax phone
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`Page 6
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`Page 6
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`

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`Application/Control Number: 13fO34,34O
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`Page 6
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`Art Unit: 1628
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`number for the organization where this application or proceeding is assigned is 571-
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`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 httpzr’/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 1628
`
`/San-ming Hui/
`Primary Examiner, Art Unit 1628
`
`Page 7
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`Page 7
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`

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`Applicalionicontrol 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
`
`Search Notes
`EAST search and inventor Search in PALM
`EAST search and inventor search in PALM
`
`Date
`1f27.F11
`995! 12
`
`SH
`SH
`
`Examiner
`
`INTERFERENCE SEARCH
`
`
`
`US. Patent and Trademark Office
`
`Pan of PapeP’ageC&0905
`
`Page 8
`
`

`
`F./\S'l‘ Search Ilislory
`
`EAST Search History
`
`EAST Search History (Prior Art}
`
`§:abiraterone
`
`giprdnisone
`
`§USPGPUB; USPAT; EPO; JPO;
`§DERWENT;
`|BM_TDB
`§U€‘rPGP|JB; USPAT; EPO; JPO;
`DERWENT;
`I BM_TDB
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`130680
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`§USPGPUB; USPAT; EPO; JPO;
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`;956
`5
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`§2012x09r05§
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`§2012f09I05§
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`EUSPGPUB; USPAT; EPO; JPO;
`§DEFiWENT;
`|BM_TDB
`§§514f170.cc|s. EUS-PGPUB; USPAT; EPO; JFO;
`5
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`
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`‘L1 and L9
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`DEHWENT;
`|BM_TDB
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`§DERWENT;
`|BM_TDB
`§'US-PGPUB; USPAT; EPO; JPO;
`§DEFiWENT;
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`9509178".pn. gus PGPUB; USPAT; EPO; JPO;
`§DERWENT;
`|BM_TDB
`
`‘
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`=
`
`EAST Search History (I nterferenoe)
`
`<This Search hisiory is empty»
`
`9;‘ 5! 2012 9:31 :48 PM
`
`C:\ Users\ sI1ui\ Documents\ EA5T\ Work:-.paces\ 1 3-034340.wsp
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`Page 9
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`Page 9
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`

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`Applicationfcontrol No.
`
`Index 01' Claims
`
`13034340
`
`AppIicant(s).*Palent Under
`Reexamination
`
`AUERBACH ET AL.
`
`Examiner
`
`SAN—M|NG HUI
`
`Art Unil
`
`1323
`
` Reiected
`
`Cancelled
`
`N
`
`I
`
`Non-Elected
`
`Interference
`
`A
`
`O
`
`Appeal
`
`Obiected
`
`Allowed
`
`:
`
`Restricted
`
`|:| Claims renumbered in the same order as presented by applicant
`
`El CPA
`
`|:| T.D.
`
`|:|
`
`Fl.1 .4?
`
`CLAIM
`
`DATE
`
`Final
`
`Original
`
`11f21!2011 01r’2?f2012 09r'05.i2()12
`
`|'\J
`
`G301-DLQ)
`
`'\.|
`
`10
`11
`
`12
`13
`14
`
`15
`16
`
`17
`18
`
`19
`20
`21
`
`22
`
`-2222)“,
`24
`25
`
`25
`2?
`
`28
`29
`30
`
`31
`32
`
`33
`34
`
`35
`36
`
`US. Patent and Trademark Ollice
`
`Part of Paper No. : 20120905
`
`Page 10
`
`Page 10
`
`

`
`Applicationfcontrol No.
`
`Index 01' Claims
`
`13034340
`
`AppIicant(s).*Palent Under
`Reexamination
`
`AUERBACH ET AL.
`
`Examiner
`
`SAN—M|NG HUI
`
`Art Unil
`
`1323
`
` Reiected
`
`Allowed
`
`:
`
`Restricted
`
`Cancelled
`
`N
`
`I
`
`Non-Elected
`
`Interference
`
`A
`
`O
`
`Appeal
`
`Obiected
`
`|:| Claims renumbered in the same order as presented by applicant
`
`El CPA
`
`|:| T.D.
`
`|:|
`
`Fl.1 .4?
`
`CLAIM
`
`DATE
`
`Final
`
`Original
`37
`38
`
`11f21!2011 01r’2?f2012 09r'05.i2()12
`sf
`sf
`K
`K
`
`39
`40
`41
`
`KK
`
`‘KK
`
`42
`
`KK
`‘KK
`K
`K
`-2222)“,
`44
`K‘‘\
`K‘‘\
`45
`
`46
`4?
`
`48
`49
`50
`
`51
`52
`
`53
`54
`
`55
`56
`
`KK
`
`‘KK
`KKK
`KK
`
`‘KK
`
`‘KK
`
`’\K
`KKK
`KK
`
`‘KK
`
`US. Patent and Trademark Ollice
`
`Part of Paper No. : 20120905
`
`Page 11
`
`Page 11