`
`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
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`APPLICATION NO.
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`FILING DATE
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`FIRST NAMED INVENTOR
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`ATTORNEY DOCKET NO.
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`CONFIRMATION NO.
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`13/034,340
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`02/24/2011
`
`Alan H. Auerbach
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`CGR5001USCNT1
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`1597
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`09/11/2012
`
`27777
`7590
`PHILIPS. JOHNSON
`JOHNSON & JOHNSON
`ONE JOHNSON & JOHNSON PLAZA
`NEW BRUNSWICK, NJ 08933-7003
`
`EXAMINER
`
`HUI, SAN MING R
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`ART UNIT
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`PAPER NUMBER
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`1628
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`NOTIFICATION DATE
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`DELIVERY MODE
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`09/1112012
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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):
`jnjuspatent@corus.jnj.com
`lhowd @its.jnj .com
`gsanche @its.jnj .com
`
`PTOL-90A (Rev. 04/07)
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`ACTAVIS, AMNEAL, DR. REDDY’S LABORATORIES, SUN, TEVA, WEST-WARD
`IPR2017-00853 - Ex. 1070, p. 1 of 7
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`
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`Office Action Summary
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`Application No.
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`Applicant(s)
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`13/034,340
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`Examiner
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`AUERBACH ET AL.
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`Art Unit
`
`SAN-MING HUI
`1628
`-- The MAILING DATE of this communication appears on the cover sheet with the correspondence address -(cid:173)
`Period for Reply
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`A SHORTENED STATUTORY PERIOD FOR REPLY IS SET TO EXPIRE ;2 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 CFR t. t 36(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. § t33).
`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 t .704(b).
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`Status
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`1 )IZ! Responsive to communication(s) filed on 03 Jutv 2012.
`2a)IZ! This action is FINAL.
`2b)0 This action is non-final.
`3)0 An election was made by the applicant in response to a restriction requirement set forth during the interview on
`__ ;the restriction requirement and election have been incorporated into this action.
`4)0 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 Quayle, 1935 C. D. 11, 453 O.G. 213.
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`Disposition of Claims
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`5)[8J Claim(s) 37-56 is/are pending in the application.
`5a) Of the above claim(s) __ is/are withdrawn from consideration.
`6)0 Claim(s) __ is/are allowed.
`7)[8J Claim(s) 37-56 is/are rejected.
`8)0 Claim(s) __ is/are objected to.
`9)0 Claim(s) __ are subject to restriction and/or election requirement.
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`Application Papers
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`1 0)0 The specification is objected to by the Examiner.
`11 )0 The drawing(s) filed on __ is/are: a)O accepted or b)O objected to by the Examiner.
`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).
`12)0 The oath or declaration is objected to by the Examiner. Note the attached Office Action or form PT0-152.
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`Priority under 35 U.S.C. § 119
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`13)0 Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
`a)O All b)O Some * c)O None of:
`1.0 Certified copies of the priority documents have been received.
`2.0 Certified copies of the priority documents have been received in Application No. __ .
`3.0 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.
`
`Attachment{s)
`1) 0 Notice of References Cited (PT0-892)
`2) 0 Notice of Draftsperson's Patent Drawing Review (PT0-948)
`3) 0 Information Disclosure Statement(s) (PTO/SB/08)
`Paper No(s)/Mail Date __ .
`
`4) 0 Interview Summary (PT0-413)
`Paper No(s)/Mail Date. __ .
`5) 0 Notice of Informal Patent Application
`6) 0 Other: __ .
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`U.S. Patent and Trademark Off1ce
`PTOL-326 (Rev. 03-11)
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`Office Action Summary
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`Part of Paper No./Mail Date 20120905
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`ACTAVIS, AMNEAL, DR. REDDY’S LABORATORIES, SUN, TEVA, WEST-WARD
`IPR2017-00853 - Ex. 1070, p. 2 of 7
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`Application/Control Number: 13/034,340
`Art Unit: 1628
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`Page 2
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`DETAILED ACTION
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`Applicant's response filed 7/3/2012 has been entered.
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`Claims 37-56 are pending.
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`The provisional double patenting rejection is withdrawn in view of the conflicting
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`patent application being abandoned.
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`Claim Rejections - 35 USC § 103
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`The following is a quotation of 35 U.S.C. 1 03(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 1 02 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. 1 03(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. Oneal., 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 17a-
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`hydroxylase/C17,20-Iyase, which can be used to suppress testosterone level in
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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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`ACTAVIS, AMNEAL, DR. REDDY’S LABORATORIES, SUN, TEVA, WEST-WARD
`IPR2017-00853 - Ex. 1070, p. 3 of 7
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`Application/Control Number: 13/034,340
`Art Unit: 1628
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`Page 3
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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 1 Omg of prednisone in combination with other an it-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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`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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`ACTAVIS, AMNEAL, DR. REDDY’S LABORATORIES, SUN, TEVA, WEST-WARD
`IPR2017-00853 - Ex. 1070, p. 4 of 7
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`Application/Control Number: 13/034,340
`Art Unit: 1628
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`Page 4
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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. 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 experimentation."
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`In re Aller, 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 7/3/2012 averring the presence of unexpected results
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`because abiraterine plus prednisone being more effective than prednisone alone have
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`been fully considered but they are not persuasive. The examiner notes that it is
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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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`Applicant's arguments filed 7/3/2012 averring the presence of commercial
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`success have been considered, but are not found persuasive. The examiner notes that
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`applicant bears the burden to provide evidence of commercial success. Furthermore,
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`gross sales figures do not show commercial success absent evidence as to market
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`share, Cable Electric Products, Inc. v. Genmark, Inc., 770 F.2d 1015, 226 USPQ 881
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`(Fed. Cir. 1985), or as to the time period during which the product was sold, or as to
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`ACTAVIS, AMNEAL, DR. REDDY’S LABORATORIES, SUN, TEVA, WEST-WARD
`IPR2017-00853 - Ex. 1070, p. 5 of 7
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`Application/Control Number: 13/034,340
`Art Unit: 1628
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`Page 5
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`what sales would normally be expected in the market, Ex parte Standish, 10 USPQ2d
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`1454 (Bd. Pat. App. & Inter. 1988). In the instant case, there is no evidence of
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`commercial success was provided. Therefore, possessing the teachings of the cited
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`prior art, one of ordinary skill in the art would employ the herein claimed agents into a
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`single method of treating refractory prostate cancer.
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`No claims are allowed.
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`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).
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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. 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. 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
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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 Man - 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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`ACTAVIS, AMNEAL, DR. REDDY’S LABORATORIES, SUN, TEVA, WEST-WARD
`IPR2017-00853 - Ex. 1070, p. 6 of 7
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`Application/Control Number: 13/034,340
`Art Unit: 1628
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`Page 6
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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 1628
`
`/San-ming Hui/
`Primary Examiner, Art Unit 1628
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`ACTAVIS, AMNEAL, DR. REDDY’S LABORATORIES, SUN, TEVA, WEST-WARD
`IPR2017-00853 - Ex. 1070, p. 7 of 7
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