UNITED STA 1ES p A 1ENT AND TRADEMARK OFFICE
`
`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
`
`APPLICATION NO.
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`FILING DATE
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
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`13/034,340
`
`02/24/2011
`
`Alan H. Auerbach
`
`CGR5001USCNT1
`
`1597
`
`11/25/2011
`
`7590
`27777
`PHILIPS. JOHNSON
`JOHNSON & JOHNSON
`ONE JOHNSON & JOHNSON PLAZA
`NEW BRUNSWICK, NJ 08933-7003
`
`EXAMINER
`
`HUI, SAN MING R
`
`ART UNIT
`
`PAPER NUMBER
`
`1628
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`NOTIFICATION DATE
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`DELIVERY MODE
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`11/25/2011
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`ELECTRONIC
`
`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):
`jnjuspatent@corus.jnj.com
`lhowd @its.jnj .com
`gsanche @its.jnj .com
`
`PTOL-90A (Rev. 04/07)
`
`MYLAN PHARMS. INC. EXHIBIT 1068 PAGE 1
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`

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`Office Action Summary
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`Application No.
`
`Applicant(s)
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`13/034,340
`
`Examiner
`
`AUERBACH ET AL.
`
`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
`A SHORTENED STATUTORY PERIOD FOR REPLY IS SET TO EXPIRE 1 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).
`
`Status
`1 )0 Responsive to communication(s) filed on __ .
`2a)0 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.
`
`Disposition of Claims
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`5)~ Claim(s) 1-36 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)0 Claim(s) __ is/are rejected.
`8)0 Claim(s) __ is/are objected to.
`9)~ Claim(s) 1-36 are subject to restriction and/or election requirement.
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`Application Papers
`
`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).
`
`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: __ .
`
`U.S. Patent and Trademark Off1ce
`PTOL-326 (Rev. 03-11)
`
`Office Action Summary
`
`Part of Paper No./Mail Date 20111121
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`MYLAN PHARMS. INC. EXHIBIT 1068 PAGE 2
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`

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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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`Election/Restrictions
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`Restriction to one of the following inventions is required under 35 U.S. C. 121:
`
`I.
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`Claims 1-26, drawn to a method of treating cancer, classified in class 514,
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`subclass 182.
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`II.
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`Claims 27-36, drawn to a composition, classified in class 424, subclass
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`401+.
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`The inventions are distinct, each from the other because of the following reasons:
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`Inventions II and I are related as product and process of use. The inventions can
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`be shown to be distinct if either or both of the following can be shown: (1) the process
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`for using the product as claimed can be practiced with another materially different
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`product or (2) the product as claimed can be used in a materially different process of
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`using that product. See MPEP § 806.05(h). In the instant case the composition can be
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`used in a materially different method such as pharmacokinetic study.
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`Restriction for examination purposes as indicated is proper because all these
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`inventions listed in this action are independent or distinct for the reasons given above
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`and there would be a serious search and/or examination burden if restriction were not
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`required because at least the following reason(s) apply:
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`The search fields for the two identified patentably distinct inventions are diverse
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`and not necessarily overlapped. Searching for all of the inventions encompassed by the
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`claims would impose undue burden to the examiner.
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`MYLAN PHARMS. INC. EXHIBIT 1068 PAGE 3
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`

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`Application/Control Number: 13/034,340
`Art Unit: 1628
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`Page 3
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`Applicant is advised that the reply to this requirement to be complete must
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`include (i) an election of a invention to be examined even though the requirement
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`may be traversed (37 CFR 1 .143) and (ii) identification of the claims encompassing
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`the elected invention.
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`The election of an invention may be made with or without traverse. To reserve a
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`right to petition, the election must be made with traverse. If the reply does not distinctly
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`and specifically point out supposed errors in the restriction requirement, the election
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`shall be treated as an election without traverse. Traversal must be presented at the time
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`of election in order to be considered timely. Failure to timely traverse the requirement
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`will result in the loss of right to petition under 37 CFR 1.144. If claims are added after
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`the election, applicant must indicate which of these claims are readable upon the
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`elected invention.
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`Should applicant traverse on the ground that the inventions are not patentably
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`distinct, applicant should submit evidence or identify such evidence now of record
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`showing the inventions to be obvious variants or clearly admit on the record that this is
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`the case. In either instance, if the examiner finds one of the inventions unpatentable
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`over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C.
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`1 03(a) of the other invention.
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`Because the above restriction/election requirement is complex, a telephone call
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`to applicant's agent to request an oral election was not made. See M.P.E.P. Sec.
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`812.01.
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`MYLAN PHARMS. INC. EXHIBIT 1068 PAGE 4
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`

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`Application/Control Number: 13/034,340
`Art Unit: 1628
`
`Page 4
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`Applicant is advised that the reply to this requirement to be complete must
`
`include an election of the invention to be examined even though the requirement be
`
`traversed (37 CFR 1.143).
`
`Applicant is reminded that upon the cancellation of claims to a non-elected
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`invention, the inventorship must be amended in compliance with 37 CFR 1.48(b) if one
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`or more of the currently named inventors is no longer an inventor of at least one claim
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`remaining in the application. Any amendment of inventorship must be accompanied by
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`a request under 37 CFR 1.48(b) and by the fee required under 37 CFR 1.17(i).
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`The examiner has required restriction between product and process claims.
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`Where applicant elects claims directed to the product, and the product claims are
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`subsequently found allowable, withdrawn process claims that depend from or otherwise
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`require all the limitations of the allowable product claim will be considered for rejoinder.
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`All claims directed to a nonelected process invention must require all the limitations of
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`an allowable product claim for that process invention to be rejoined.
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`In the event of rejoinder, the requirement for restriction between the product
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`claims and the rejoined process claims will be withdrawn, and the rejoined process
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`claims will be fully examined for patentability in accordance with 37 CFR 1.1 04. Thus, to
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`be allowable, the rejoined claims must meet all criteria for patentability including the
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`requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product
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`are found allowable, an otherwise proper restriction requirement between product
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`claims and process claims may be maintained. Withdrawn process claims that are not
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`commensurate in scope with an allowable product claim will not be rejoined. See MPEP
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`MYLAN PHARMS. INC. EXHIBIT 1068 PAGE 5
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`

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`Application/Control Number: 13/034,340
`Art Unit: 1628
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`Page 5
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`§ 821.04(b). Additionally, in order to retain the right to rejoinder in accordance with the
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`above policy, applicant is advised that the process claims should be amended during
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`prosecution to require the limitations of the product claims. Failure to do so may result
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`in a loss of the right to rejoinder. Further, note that the prohibition against double
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`patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement
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`is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
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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-
`
`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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`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.
`
`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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`MYLAN PHARMS. INC. EXHIBIT 1068 PAGE 6
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`

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`Application/Control Number: 13/034,340
`Art Unit: 1628
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`Page 6
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`San-ming Hui
`Primary Examiner
`Art Unit 1628
`
`/San-ming Hui/
`Primary Examiner, Art Unit 1628
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`MYLAN PHARMS. INC. EXHIBIT 1068 PAGE 7