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
`AlexiUldria, Virginia 22313-1450
`www.uspto.gov
`
`~~-A_P_P_LI_C_A_TI_o_N_N_o_. __ L----F-IL_m_a_o_A_T_E ____ 4--------F-IR_sr_N_A_M_E_D_m __ vE_N_T_o_R ________ ._ATT __ O_RN __ EY __ o_oc_K_E_T_N_o_ . .__c_o_N_FI-RM--AT_I_ON __ N_o_. ~
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`10/525,021
`
`02/18/2005
`
`Mitsutaka Nakamura
`
`0020-5041PUS2
`
`3141
`
`12117/2007
`7590
`2292
`BIRCH STEW ART KOLASCH & BIRCH
`POBOX 747
`FALLS CHURCH, VA 22040-0747
`
`EXAM mER
`
`HUYNH, CARLIC K
`
`ART UNIT
`
`1617
`
`PAPER NUMBER
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`NOTIFICATION DATE
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`DELIVERY MODE
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`12/17/2007
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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):
`mailroom@bskb.com
`
`PTOL-90A (Rev. 04/07)
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`Page 1 of 10
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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
`
`NAKAMURA ET AL.
`
`Art Unit
`
`Garlic K. Huynh
`1617
`-- 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 J 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 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).
`Status
`
`1)1Z! Responsive to communication(s) filed on 01 October 2007.
`2a)0 This action is FINAL.
`2b)IZ! 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 parle Quayle, 1935 C.D. 11, 453 O.G. 213.
`
`Disposition of Claims
`
`4)1:8J Claim(s) 1·19 is/are pending in the application.
`4a) Of the above claim(s) 14·19 is/are withdrawn from consideration.
`5)0 Claim(s) __ is/are allowed.
`6)1Z! Claim(s) 1-13 is/are rejected.
`7)0 Claim(s) __ is/are objected to.
`8)0 Claim(s) __ are subject to restriction and/or election requirement.
`
`Application Papers
`
`9)[gl The specification is objected to by the Examiner.
`10)[gl The drawing(s) filed on 18 February 2005 is/are: a)IZ! 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.
`
`Priority under 35 U.S.C. § 119
`
`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) [gl Notice of References Cited (PT0-892)
`2) 0 Notice of Draftsperson's Patent Drawing Review (PT0-948)
`3) IZ!Information Disclosure Statement(s) (PTO/SB/08)
`Paper No(s)/Mail Date 18 Februarv 2005.
`
`4) 0
`
`Interview Summary (PT0413)
`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
`
`Part of Paper No./Mail Date 20071130
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`Application/Control Number: 10/525,021
`Art Unit: 161 7
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`Page 2
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`DETAILED ACTION
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`Status of the Claims
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`1.
`
`Claims 1-19 are pending in the application, with claims 14-19 having been withdrawn, in
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`response to the restriction requirement submitted on August 29, 2007. Accordingly, claims 1-13
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`are being examined on the merits herein.
`
`Election/Restrictions
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`2.
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`Applicant's election ofthe claims of Group I, namely claims 1-13, in the reply filed on
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`October 1, 2007 is acknowledged. Because Applicants did not distinctly and specifically point
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`out the supposed errors in the restriction requirement, the election has been treated as an election
`
`without traverse (MPEP § 818.03(a)).
`
`Claims 14-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as
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`being drawn to a nonelected invention, there being no allowable generic or linking claim.
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`Election was made without traverse in the reply filed on October 1, 2007.
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`Accordingly, claims 1-13 are examined on the merits herein.
`
`The election/restriction requirement is deemed proper and is made FINAL.
`
`Information Disclosure Statement
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`The Information Disclosure Statement submitted on February 18, 2005, is acknowledged.
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`Application/Control Number: 10/525,021
`Art Unit: 1617
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`Page 3
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`Specification
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`3.
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`Applicant is reminded of the proper language and format for an abstract of the disclosure.
`
`The abstract should be in narrative form and generally limited to a single paragraph on a
`separate sheet within the range of 50 to 150 words. It is important that the abstract not exceed
`150 words in length since the space provided for the abstract on the computer tape used by the
`printer is limited. The form and legal phraseology often used in patent claims, such as "means"
`and "said," should be avoided. The abstract should describe the disclosure sufficiently to assist
`readers in deciding whether there is a need for consulting the full patent text for details.
`
`The language should be clear and concise and should not repeat information given in the
`title. It should avoid using phrases which can be implied, such as, "The disclosure concerns,"
`"The disclosure defined by this invention," "The disclosure describes," etc.
`
`The abstract contains legal phraseology, namely "said". Appropriate correction is
`
`required. See MPEP 37 CFR § 1.72 (b).
`
`Claim Rejections- 35 USC§ 103
`
`The following is a quotation of35 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.
`
`4.
`
`Claims 1-13 are rejected under 35 U.S.C. 103(a) as being unpatentable over Sommerville
`
`et al. (WO 03/066039 A1) in view of Wong et al. (US 6,964,962).
`
`It is noted that (1R,2S,3R,4S)-N-[(1R,2R)-2-[4-(l ,2-benzoisothiazol-3-yl)-1-piperazinyl-
`
`methyl]-l-cyclohexylmethyl]-2,3-bicyclo[2.2.1 ]heptanedicarboximide hydrochloride is known in
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`the art as SM-13496 (see page 7, lines 5-8 ofthe specipcation). Thus, SM-13496 is the
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`Application/Control Number: 10/525,021
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`hydrochloride salt of (1 R,2S,3R,4S)-N-[ (1 R,2R)-2-[ 4-( 1 ,2-benzoisothiazol-3-yl)-1-piperazinyl-
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`methyl]-1-cyclohexylmethyl]-2,3-bicyclo[2.2.1 ]heptanedicarboximide.
`
`Sommerville et al. teach a method of treating schizophrenia comprising atypical
`
`antipsychotics, namely SM-13496 (abstract; and page 5, line 35). Sommerville et al. further
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`teaches positive and negative symptoms are often increased during the acute phase, or the florid
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`psychotic phase, of schizophrinia and that the method of Sommerville et al. is aime~ at treatment
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`during the acute phase of schizophrenia (page 4, lines 16-23).
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`Sommerville et al. do not explicitly teach the dose of SM-13496 (see page 7, lines 23-25).
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`Wong et al. teach 0.05 to 7500 mg/day/patient ofSM-13496 can be used to schizophrenia
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`(see column 4, lines 51-58; and Table in column 8, line 16), which details the daily dose of SM-
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`13496 that can be given to the patient and thus may be a once a day administration.
`
`Moreover, Wong et al. teach 0.05 to 7500 mg/day/patient ofSM-13496 can be used to
`
`schizophrenia (column 4, lines 51-58; and Table in column 8, line 16). Thus it would be obvious
`
`to one skilled in the art that the amount of(IR,2S,3R,4S)-N-[(1R,2R)-2-[4-(1,2-benzoisothiazol-
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`3-yl)-1-piperazinyl-methyl]-1-cyclohexylmethyl]-2,3-bicyclo[2.2.1 ]heptanedicarboximide
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`hydrochloride may be optimized to be administered at 5 to 120, 20 to 80, 5 to 80, or 10 to 40 mg
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`once a day. It is 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 Aller, 220 F.2d 454, 456, 105 USPQ 223, 235 (CCPA 1955).
`
`Accordingly, absence the showing of unexpected results, it would have been obvious to a
`
`person of skill in the art. at the time of the invention to employ the composition of Sommerville et
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`al. to contain 0.05 to 7500 mg/day/patient ofSM-13496 because the composition of Wong et al.
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`Application/Control Number: 10/525,021
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`contains 0.05 to 7500 mg/day/patient of SM-13496 and according to Wong et al., 0.05 to 7500
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`mg/day/patient of SM-13496 can be used to treat schizophrenia.
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`The motivation to combine the compounds of Sommerville et al. to the compounds of
`
`Wong et al. is that the compositions of Wong et al. are SM-13496 compositions and that such
`
`compositions treat schizophrenia.
`
`It is noted that "It is obvious to combine individual compositions taught to have the same
`
`utility to form a new composition for the very same purpose" and "It is obvious to combine two
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`compositions taught by the prior art to be useful for the same purpose to form a third
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`composition that is to be used for the very same purpose". In re Kerkhoven, 626 F.2d 846, 205
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`U.S.P.Q. 1069 (C.C.P.A. 1980).
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`5.
`
`No claims are allowable.
`
`Conclusion
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`Any inquiry concerning this communication or earlier communications from the
`
`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 supervisor,
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`Sreenivasan Padmanabhan can be reached on 571-272-0629. The fax phone number for the
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`organization where this application or proceeding is assigned is 571-273~8300.
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`Application/Control Number: 10/525,021
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`Infonnation regarding the status of an application may be obtained from the Patent
`
`Application Infonnation Retrieval (PAIR) system. Status infonnation for published applications
`
`may be obtained from either Private PAIR or Public PAIR. Status infonnation for unpublished
`
`applications is available through Private PAIR only. For more infonnation about the PAIR
`
`system, see http://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
`
`infonnation system, callS00-786-9199 (IN USA OR CANADA) or 571-272-1000.
`
`ckh
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`• •
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`I
`.;,.'(
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`19
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`CLAIMS
`
`1.
`
`A method for treatment of schizophrenia without being
`accompanied by any extrapyramidal symptoms, which comprises orally
`administering a daily dose of 5 mg to 120 mg of the active compound:
`( 1 R,2S,3R,4S)-N-(( 1 R,2R)-2-[4-( 1 ,2-benzoisothiazol-3-yl)-1-piperazinyl(cid:173)
`methyl)-1-cyclohexylmethyl) -2,3-bicyclo[2 .2 .1 )heptanedicarboximide of
`
`the formula (1):
`
`(1)
`
`or a pharmaceutically acceptable salt thereof to a patient suffering from
`schizophrenia once a day.
`The method for treatment according to claim 1, wherein the
`2.
`active compound is ( 1R,2S,3R,4S)-N-[( 1R,2R)-2-[4-( 1,2-benzoisothiazol-
`3-yl) -1-piperazinylmethyl]-1-cyclohexylmethyl)-2 ,3-bicyclo[2 .2 .1]-
`heptanedicarboximide hydrochloride.
`The method for treatment according to claim 1 or claim 2, which
`3.
`improves the negative symptoms of schizophrenia.
`The method for treatment according to claim 1 or claim 2, which·
`4.
`improves the positive and negative symptoms of schizophrenia.
`5.
`The method for treatment according to claim 1 or claim 2, which
`comprises orally administering the active compound: (1R,2S,3R,4S)-N(cid:173)
`I( 1 R,2R)-2-[4-( 1,2-benzoisothiazol-3-yl)-1-piperazinylmethyl)-1-cyclo(cid:173)
`hexylmethyl)-2,3-bicyclo(2.2.1]heptanedicarboximide hydrochloride at a
`daily dose of 20 mg to 80 mg once a day.
`The method according to claim 5, which improves the negative
`6.
`symptoms of schizophrenia.
`
`5
`
`10
`
`15
`
`20
`
`25
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`20
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`7.
`
`The method according to claim 5, which improves the positive
`
`and negative symptoms of schizophrenia.
`
`8.
`
`The method for treatment of schizophrenia in the chronic stage
`
`according to claim 1 or claim 2, which improves schizophrenia without
`
`5
`
`being accompanied by any extrapyramidal symptoms by orally
`
`administering the active compound: (1R,2S,3R,4S)-N-[(1R,2R)-2-[4-(1,2-
`
`benzoisothiazol-3-yl)-1-piperazinylmethyl)-1-cyclohexylmethyl) -2,3-
`
`bicyclo [2.2.1]heptanedicarboximide hydrochloride at a daily dose of 5
`mg to 80 mg once a day.
`
`10
`
`9.
`
`The method for treatment according to claim 8, which improves
`
`the negative symptoms of schizophrenia.
`
`10.
`
`The method for treatment according to claim 8, which improves
`
`the positive and negative symptoms of schizophrenia.
`
`11.
`
`The method for treatment according to claim 8, which comprises
`
`15
`
`orally administering the active compound: (1R,2S,3R,4S)-N-[(1R,2R)-2-
`[4-( 1 ,2-benzoisothiazol-3-yl)-1-piperazinylmethyl]-1-cyclohexylmethyl)-
`
`20
`
`2,3-bicyclo[2.2.1)heptanedicarboximide hydrochloride at a daily dose of
`10 mg to 40 mg once a day.
`
`12.
`
`The method for treatment according to claim 11, which improves
`
`the negative symptoms of schizophrenia.
`13.
`The method for treatment according to claim 11, which improves
`th~ positive and negative symptoms of schizophrenia.
`An agent for treatment of schizophrenia, which comprises as an
`14.
`
`active compound ( 1R,2S,3R,4S)-N-(( 1R,2R)-2-(4-( 1 ,2-benzoisothiazol-3-
`
`25
`
`yl)-1-piperazinylmethyl)-1-cyclohexylmethyl]-2,3-bicyclo (2.2.1)heptane(cid:173)
`
`dicarboximide of the formula (1):
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`21
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`~ H 0
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`. .:.
`.:.Ho
`H
`
`HH
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`\__/
`
`.
`
`-
`~ A
`
`(1)
`
`or a pharmaceutically acceptable salt thereof in an amount of 5 mg to
`
`120 mg as a daily dose for oral administration once a day.
`The agent according to claim 14, wherein the active compound is
`15.
`( 1 R,2S,3R,4S)-N-[( 1R,2R)-2-[4-( 1,2-benzoisothiazol-3-yl)-1-
`
`piperazinylmethyl]-1-cyclohex:ylmethyl)-2,3-bicyclo [2. 2. 1] heptane(cid:173)
`
`dicarboximide hydrochloride.
`
`16.
`The agent according to claim 14 or claim 15, wherein the content
`of the active compound is in the range of 20 mg to 80 mg.
`A use of ( 1 R,2S,3R,4S)-N-[( 1 R,2R)-2-I4-( 1 ,2-benzoisothiazol-3-
`17.
`yl)-1-piperazinylmethyl)-1-cycloheXy-lmethyl]-2,3-bicyclo [2.2.1 )heptane(cid:173)
`
`dicarboximide of the formula ( 1):
`
`or a pharmaceutically acceptable salt thereof in the preparation of an
`agent for treatment of schizophrenia.
`
`The use according to claim 17, wherein the active compound is
`18.
`( 1 R,2S,3R,4S)-N-[( 1 R,2R)-2-[4-( 1 ,2-benzoisothiazol-3-yl)-1-piperazinyl(cid:173)
`
`methyl]-1-cyclohex:ylmethyl)-2 ,3-bicyclo 12 .2.1 )heptanedicarboximide
`hydrochloride.
`
`19.
`The use according to claim 17 or claim 18, wherein the agent for
`treatment of schizophrenia contains the active compound in an amount
`of 5 mg to 120 mg as a daily dose for oral administration once a day.
`
`5
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`10
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`15
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`20
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