UNITED STATES PATENT 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
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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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`10/525,021
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`02/18/2005
`
`Mitsutaka Nakamura
`
`0020-5041 PUS2
`
`3141
`
`08129/2007
`7590
`2292
`BIRCH STEW ART KOLASCH & BIRCH
`POBOX747
`FALLS CHURCH, VA 22040-0747
`
`EXAMINER
`
`HUYNH, CARLIC K
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`ART UNIT
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`PAPER NUMBER
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`1617
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`NOTIFICATION DATE
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`DELIVERY MODE
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`08/29/2007
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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):
`mailroom@bskb.com
`
`PTOL-90A (Rev. 04/07)
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`Page 1 of 6
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`Office Action Summary
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`Application No.
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`Applicant(s)
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`10/525,021
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`Examiner
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`NAKAMURA ET AL.
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`Art Unit
`
`1617
`Garlic K. Huynh
`- The MAILING DATE 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 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 1.136(a). In no event, however, may a reply be timely filed
`after SIX (6) MONTHS from the mailing date ofthis 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).
`Status
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`1 }0 Responsive to communication(s) filed on __ .
`2a)0 This action is FINAL.
`2b)[gl This action is non-final.
`3)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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`4)[gl Claim(s) 1-19 is/are pending in the application.
`4a) Of the above claim(s) __ is/are withdrawn from consideration.
`5)0 Claim(s) __ is/are allowed.
`6)0 Claim(s) __ is/are rejected.
`7)0 Claim(s) __ is/are objected to.
`8)[gl Claim(s} 1-19 are subject to restriction and/or election requirement.
`
`Application Papers
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`9)0 The specification is objected to by the Examiner.
`10)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).
`11 )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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`12)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} D Notice of References Cited (PT0-892}
`2) D Notice of Draftsperson's Patent Drawing Review (PT0-948}
`3) 0 Information Disclosure Statement(s) (PTO/SB/08)
`Paper No(s}/Mail Date __ .
`
`4} D Interview Summary (PT0-413)
`Paper No(s)/Mail Date. __ .
`5) 0 Notice of Informal Patent Application
`6) 0 Other: __ .
`
`U.S. Patent and Trademark Office
`PTOL-326 (Rev. 08-06)
`
`Office Action Summary
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`Part of Paper No./Mail Date 20070809
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`Application/Control Number: 10/525,021
`Art Unit: 1617
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`Page 2
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`DETAILED ACTION
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`Election/Restrictions
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`1.
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`Restriction is required under 35 U.S.C. 121 and 372.
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`This application contains the following inventions or group of inventions which are not
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`so linked as to form a single general inventive concept under PCT Rule 13.1.
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`In accordance with 37 CFR 1.499, applicant is required, in reply to this action, to elect a
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`single invention to which the claims must be restricted.
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`I.
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`Claims 1-13, drawn to a method for treating schizophrenia comprising
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`administering (1R,2S,3R,4S)-N-[(1 R,2R)-2-[ 4-(1 ,2-benzoisothiazol-3-yl)-1-
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`piperazinylmethyl]-1-cyclohexylmethyl]-2,3-bicyclo[2.2.1 ]heptanedicarboximide
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`of formula (I).
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`II.
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`Claims 14-16, drawn to agent for treatment of schizophrenia comprising
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`(1R,2S,3R,4S)-N-[(1R,2R)-2-[4-(1,2-benzoisothiazol-3-yl)-1-piperazinylmethyl]-
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`1-cyclohexylmethyl]-2,3-bicyclo[2.2.1 ]heptanedicarboximide of formula (I).
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`III.
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`Claims 17-19, drawn to a method for the preparation of an agent for treatment of ·
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`schizophrenia comprising ( 1 R,2S,3 R, 4S )-N -[ ( 1 R,2R )-2-[ 4-( 1 ,2-benzoisothiazol-
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`3-yl)-1-piperazinylmethyl]-1-cyclohexylmethyl]-2,3-
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`bicyclo[2.2.1 ]heptanedicarboximide of formula (1).
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`2.
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`The inventions listed as Groups I, II, and III do not relate to a single general inventive
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`concept under PCT Rule 13.1 because, under PCT Rule 13 .2, they lack the same or
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`corresponding special technical features.
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`Application/Control Number: 10/525,021
`Art Unit: 1617
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`Page 3
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`An international application should relate to only one invention or, if there is more than
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`one invention, the inclusion of those inventions in one international application is only permitted
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`if all inventions are so linked as to form a single general inventive concept (PCT Rule 13.1 ).
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`With respect to a group of inventions claimed in an international application, unity of invention
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`exists only when there is a technical relationship among the claimed inventions involving one or
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`more of the same or corresponding special technical features.
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`The expression "special technical features" is defined in PCT Rule 13.2 as meaning those
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`technical features that define a contribution which each of the inventions, considered as a whole,
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`makes over the prior art. The determination is made on the contents of the claims as interpreted
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`in light of the description and drawings (if any). Whether or not any particular technical feature
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`makes a "contribution" over the prior art, and therefore constitutes a "special technical feature,"
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`should be considered with respect to novelty and inventive step.
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`The common technical feature in all groups is an agent comprising (1R,2S,3R,4S)-N-
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`[(1 R,2R)-2-[ 4-(1 ,2-benzoisothiazol-3-yl)-1-piperazinylmethyl]-1-cyclohexylmethyl]-2,3-
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`bicyclo[2.2.1 ]heptanedicarboximide of formula (1). The element cannot be a special technical
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`feature under PCT Rule 13.2 because the element is shown in the prior art.
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`In this case, Fujihara et al. (WO 02/24166 A 1 as cited in the IDS) disclose the compound
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`of formula:
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`Application/Control Number: 10/525,021
`Art Unit: 1617
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`Page4
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`which is the (1R,2S,3R,4S)-N-[(1R,2R)-2-[4-(1 ,2-benzoisothiazol-3-yl)-1-piperazinylmethyl]-1-
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`cyclohexylmethyl]-2,3-bicyclo[2.2.1 ]heptanedicarboximide compound of formula (I) of the
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`instant application (page 7, line 1).
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`Should applicant traverse on the ground that the inventions or species are not patentably
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`distinct, applicant should submit evidence or identify such evidence now of record showing the
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`inventions or species to be obvious variants or clearly admit on the record that this is the case. In
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`either instance, if the examiner finds one of the inventions unpatentable over the prior art, the
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`evidence or admission may be used in a rejection under 35 U.S.C.103(a) ofthe other invention.
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`Applicant is reminded that upon the cancellation of claims to a non-elected invention, the
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`inventorship must be amended in compliance with 3 7 CFR 1.48(b) if one or more of the
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`currently named inventors is no longer an inventor of at least one claim remaining in the
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`application. Any amendment of inventorship must be accompanied by a request under 37 CFR
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`1.48(b) and by the fee required under 37 CFR 1.17(i).
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`A telephone call to the attorney is not required where: 1) the restriction requirement is
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`complex, 2) the application is being prosecuted prose, or 3) the examiner knows from past
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`experience that a telephone election will not be made (MPEP § 812.01). Therefore, since this
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`restriction requirement is considered complex, a call to the attorney for telephone election was
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`not made.
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`Application/Control Number: 10/525,021
`Art Unit: 1617
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`Page 5
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`Conclusion
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`3.
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`Any inquiry concerning this communication or earlier communications from the
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`examiner should be directed to Carlic K. Huynh whose telephone number is 571-272-5574. The
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`examiner can normally be reached on Monday to Friday, 8:30AM to 5:00PM.
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`If attempts to reach the examiner by telephone are unsuccessful, the examiner's
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`supervisor, Sreenivasan Padmanabhan can be reached on 571-272-0629. The fax phone number
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`for the organization where this application or proceeding is assigned is 571-273-8300.
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`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
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`applications is available through Private PAIR only. For more information about the PAIR
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`system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR
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`system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would
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`like assistance from a USPTO Customer Service Representative or access to the automated
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`information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
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`ckh
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