UNITED STATES PATENT AND TRADEMARK OFFICE
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Otflee
`Addtes: COMMISSIONER FOR PATENTS
`P.0. Box 1450
`Alexandria. Virginia Z23l3- I450
`www.usplo.gav
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`13/034,340
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`02/24/2011
`
`Alan H. Auerbach
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`CGRSOOIUSCNTI
`
`1597
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`03/04f20l3
`
`27777
`7590
`PHILJPSJOHNSON
`JOHNSON & JOHNSON
`ONE JOHNSON & JOHNSON PLAZA
`Nawsaunswxcx, NJ 08933-7003
`
`**-Wm
`HUI. SAN MING R
`
`.-O\to‘O
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`NOTIFICATION DATE
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`DELIVERY MODE
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`03/04/2013
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`ELECTRONIC
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`Please find below and/or attached an Office communication concerning this application or proceeding.
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`The time period for reply, if any, is set in the attached communication.
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`Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
`following e-mail address(es):
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`jnjuspatent@corus.jnj.com
`1howd@its.jnj .com
`gsanche@its.jnj.com
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`PTOL-90A (Rev. 04/07)
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`ARGENTUM EX1011
`ARGENTUM EX1011
`Page 1
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`Page 1
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`Office Action Summary
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`Application No.
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`App|icant(s)
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`13/034,340
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`Examiner
`SANAMNGHUI
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`AUERBACH ET AL.
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`A“ Unit
`1629
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`-- The MAILING DA TE of this communication appears on the cover sheet with the correspondence address --
`Period for Reply
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`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 of 37 CFR1.136(a).
`In no event, however, may a reply be timely filed
`after SIX (6) MONTHS from the mailing date of this communication.
`If 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 for reply will, by statute, cause the application to become ABANDONED (35 U.S.C. § 133).
`Any reply received by the Office later than three months after the mailing date of this communication, even if timely filed, may reduce any
`earned patent term adjustment. See 37 CFR 1.704(b).
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`Status
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`1)IXl Responsive to communication(s) filed on 11 January 2013.
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`2a)IXl This action is FINAL.
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`2b)I:I This action is non—final.
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`3)I:l An election was made by the applicant in response to a restriction requirement set forth during the interview on
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`; the restriction requirement and election have been incorporated into this action.
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`4)I:l 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 Exparte Quayle, 1935 C.D. 11, 453 O.G. 213.
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`Disposition of Claims
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`5)IZl Claim(s) 1% is/are pending in the application.
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`5a) Of the above claim(s)
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`is/are withdrawn from consideration.
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`)
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`8 I:l Claim s)
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`is/are objected to.
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`9)I:l Claim(s)
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`are subject to restriction and/or election requirement.
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`* If any claims have been determined allowable, 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
`ht‘:
`://www.us to. ov./Watents/init events/bah/index.'s or send an inquiry to PPHfeedba<:i< usr*to.L ev.
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`Application Papers
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`10)I:I The specification is objected to by the Examiner.
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`11)|:| The drawing(s) filed on j is/are: a)I:I accepted or b)I:l objected to by the Examiner.
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`Applicant may not request that any objection to the drawing(s) be held in abeyance. See 37 CFR 1.85(a).
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`Replacement drawing sheet(s) including the correction is required if the drawing(s) is objected to. See 37 CFR 1.121 (d).
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`Priority under 35 U.S.C. § 119
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`12)I:| Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
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`a)|:I All
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`b)I:l Some * c)I:I None of:
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`1.|:I Certified copies of the priority documents have been received.
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`2.|:I Certified copies of the priority documents have been received in Application No. _.
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`3.|:I Copies of the certified copies of the priority documents have been received in this National Stage
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`application from the International Bureau (PCT Rule 17.2(a)).
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`* See the attached detailed Office action for a list of the certified copies not received.
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`Attachment(s)
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`1) El Notice of References Cited (PTO-892)
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`2) D Information Disclosure Statement(s) (PTO/SB/08)
`Paper No(s)/Mail Date
`.
`U.S. Patent and Trademark Office
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`3) El Interview Summary (PTO-413)
`Paper No(s)/Mail Date.
`4) D Other:
`.
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`PTOL-326 (Rev. 09-12)
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`Office Action Summary
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`Part of Paper No./Mail Date 20130225
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`Page 2
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`Page 2
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`

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`Application/Control Number: 13/034,340
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`Page 2
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`Art Unit: 1629
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`DETAILED ACTION
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`Continued Examination Under 37 CFR 1. 1 14
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`A request for continued examination under 37 CFR 1.114, including the fee set
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`forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this
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`application is eligible for continued examination under 37 CFR 1.114, and the fee set
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`forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action
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`has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on
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`1/11/2013 has been entered.
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`Claims 37-56 are pending.
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`The outstanding rejection under 35 USC 103(a) is maintained.
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`Claim Rejections - 35 USC § 103
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`The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all
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`obviousness rejections set forth in this Office action:
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`(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.
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`Claims 37-56 are rejected under 35 U.S.C. 103(a) as being unpatentable over
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`O’Donnell et al., British Journal of Cancer, 2004;90:2317—2325 in view of Tannock et al.,
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`J. Clin. Oncol., 1996;14:1756-1764. All of the references are of record in the parent
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`application.
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`O’Donnell et al. teaches abiraterone acetate is known to be an inhibitor of 170(-
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`hydroxylase/C17,20—lyase , which can be used to suppress testosterone level in
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`Application/Control Number: 13/034,340
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`Page 3
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`Art Unit: 1629
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`prostate cancer patients (see the abstract for example). O'Donnell et al. teaches 800mg
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`of abiraterone acetate as useful in suppressing the serum testosterone level (See the
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`abstract for example). O'Donnell et al. also teaches that cocomitant glucocorticoid
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`therapy may be needed for continuous use of abiraterone acetate (See the abstract and
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`page 2323, col.2 for example).
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`O’Donnell et al. does not expressly teach the use of prednisone in the method of
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`treating prostate cancer. O’Donnell et al. does not expressly teach the use of the herein
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`claimed dosage and regimen for prednisone and abiraterone acetate.
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`Tannock et al. teaches 10mg of prednisone in combination with other anit-cancer
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`drug as effective in treating refractory hormonal-resistance prostate cancer.
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`It would have been obvious to one of ordinary skill in the art at the time the
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`invention was made to employ both prednisone and abiraterone acetate, in the dosage
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`herein claimed, together in a method of treating prostate cancer, including refractory
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`prostate cancer.
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`One of ordinary skill in the art would have been motivated to employ both
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`prednisone and abiraterone acetate, in the dosage herein claimed, together in a method
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`of treating prostate cancer, including refractory prostate cancer. Since abiraterone
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`acetate provide a new mechanism of action in treating prostate cancer and prednisone
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`is known to be useful in treating refractory prostate cancer, concomitant employment of
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`both compounds into a single method useful for the very same purpose, treating
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`prostate cancer, would be considered prima facie obvious (See In re Kerkhoven 205
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`USPQ 1069 (CCPA 1980)). Treating refractory prostate cancer with abiraterone
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`Application/Control Number: 13/034,340
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`Art Unit: 1629
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`acetate would be reasonably expected to be effective since abiraterone provides a new
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`mechanism of action against prostate cancer. O'donnell et al. provides an additional
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`motivation to concomitantly employ prednisone since employing replacement
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`glucocorticoid such as prednisone would ensure the safety and effectiveness of
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`abiraterone acetate.
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`Furthermore, the optimization of result effect parameters (e.g., dosage range,
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`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
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`in the competence level of an ordinary skilled artisan in pharmaceutical science,
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`involving merely routine skill in the art.
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`It has been held that it is within the skill in the art
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`to select optimal parameters, such as amounts of ingredients, in a composition in order
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`to achieve a beneficial effect. See In re Boesch, 205 USPQ 215 (CCPA 1980). It is also
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`noted that “[W]here the general conditions of a claim are disclosed in the prior art, it is
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`not inventive to discover the optimum or workable ranges by routine
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`experimentation.” In re A//er, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
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`Response to Arguments
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`Applicant's arguments filed 1/11/2013 averring the presence of unexpected
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`results because abiraterine plus prednisone being more effective than prednisone
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`alone, by citing Ryan et al., have been fully considered but they are not persuasive. The
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`examiner notes that the superior results of using abiraterone and prednisone together is
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`Application/Control Number: 13/034,340
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`expected because abiraterone and prednisone are known to be individually effective in
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`treating prostate cancer. At least additive effective is expected.
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`This is an RCE of instant application. All claims are drawn to the same invention
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`claimed in the earlier application and could have been finally rejected on the grounds
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`and art of record in the next Office action if they had been entered in the earlier
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`application. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action
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`in this case. See MPEP § 706.07(b). Applicant is reminded of the extension of time
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`policy as set forth in 37 CFR 1.136(a).
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`A shortened statutory period for reply to this final action is set to expire THREE
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`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
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`mailed until after the end of the THREE-MONTH 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
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`the advisory action.
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`In no, however, event 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
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`examiner should be directed to SAN-MING HUI whose telephone number is (571)272-
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`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, Melenie McCormick can be reached on (571) 272-8037. The fax phone
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`Application/Control Number: 13/034,340
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`Page 6
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`Art Unit: 1629
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`number for the organization where this application or proceeding is assigned is 571 —
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`273-8300.
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`Information regarding the status of an application may be obtained from the
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`Patent Application Information Retrieval (PAIR) system. Status information for
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`published applications may be obtained from either Private PAIR or Public PAIR.
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`Status information for unpublished applications is available through Private PAIR only.
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`For more information about the PAIR system, see http://pair-direct.uspto.gov. Should
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`you have questions on access to the Private PAIR system, contact the Electronic
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`Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a
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`USPTO Customer Service Representative or access to the automated information
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`system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
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`San—ming Hui
`Primary Examiner
`Art Unit 1629
`
`/San—ming Hui/
`Primary Examiner, Art Unit 1629
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`Page 7
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