`Attorney Docket No. 05273.0127-01
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`lN THE UNITED STATES PATENT AND TRADEMARK OFF!CE
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`l n re Application of:
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`Mitsutaka Nakamura et a!.
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`Application No.: 14/471,919
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`Filed: August 28, 2014
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`For: AGENT FOR TREATMENT OF
`SCH IZOPH REN IA
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`)
`)
`) Group Art Unit 1612
`)
`} Examiner: Snigdha MAEWALL
`)
`) VIA EFS-WEB
`)
`)
`)
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`Commissioner for Patents
`P.O. Box 1450
`Alexandria, VA 22313-1450
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`Commissioner:
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`PRELIMINARY AMENDMENT
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`Further to the Preliminary Amendment filed August 28, 2014, please amend the
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`above-identified application as follows:
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`Amendments to the Claims begin at page 2.
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`Remarks/Arguments follow the amendment section of this paper.
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`Page 1 of 4
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`SLAYBACK EXHIBIT 1006
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`Application No.: 14/471,919
`Attorney Docket No.: 05273,0127-01
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`AMENDMENTS TO THE CLAIMS:
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`This listing of claims will replace all prior versions and listings of claims in the
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`application:
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`Claims 1-19 (Cancelled)
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`20. (Currently Amended) A method for treating schizophrenia or manic depressive
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`psychoses in a patient, without causing clinically significant body weight gain in the
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`patient, the method comprising administering to the patient a dose of 5 mg to 120 mg of
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`the active compound: (1 R,2S,3R,4S)-N-[(1 R,2R)-2-[4-(1,2-benzoisothiazol-3-yl)-1-
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`piperazinylmethyl]-1-cyc!ohexylmethyl]-2,3-bicyc!o[2.2.1 ]heptanedicarboximide or a
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`pharmaceutically acceptable salt thereof.
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`21.
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`(Previously Presented) The method of claim 20, wherein said active compound
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`is (1 R,2S,3R,4S}-N-[(1 R,2R)-2-[4-(1,2-benzoisothiazol-3-y!)-1-piperazinylmethy!]-1-
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`cyclohexylmethyl]-2, 3-bicyclo[2 .2, 1 ]heptaned icarboximide hydrochloride.
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`22.
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`(Previously Presented)
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`The method of claim 20, wherein 20 mg to 120 mg of
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`said active compound is administered to said patient
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`23.
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`(Previously Presented)
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`The method of claim 20, wherein said active
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`compound is administered to said patient orally.
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`Page 2 of 4
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`SLAYBACK EXHIBIT 1006
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`
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`Application No,: 14/471,919
`Attorney Docket No.: 05273.0127-01
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`24.
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`(Previously Presented)
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`The method of claim 20, wherein said active
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`compound is administered to said patient without concurrently administering another
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`antipsychotic medication.
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`25.
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`(Previously Presented)
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`The method of claim 20, wherein said active
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`compound is administered to said patient for a period of at least six weeks.
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`26.
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`(Previously Presented)
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`The method of claim 20, wherein said patient has a
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`BPRS score of at !east 42 and wherein the patient's BPRS score is significantly reduced
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`from a baseline measurement prior to the administering of said active compound.
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`27.
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`(Previously Presented)
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`The method of claim 20, wherein said active
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`compound is administered once daily.
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`28.
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`(New) The method of claim 20, wherein the method is for treating manic
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`depressive psychoses.
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`,-3-
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`Page 3 of 4
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`SLAYBACK EXHIBIT 1006
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`Application No.: 14/471,919
`Attorney Docket No,: 05273.0127-01
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`REMARKS
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`Claims 20-27 are pending. Claim 20 is amended and daim 28 is added herein.
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`Written description support for the amendments can be found, for example, at page 2,
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`lines 26-30 of the as-filed specification (paragraph [0007] of the published application,
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`U.S. Patent Application Publication No. 2014/0371236). Accordingly, no new matter is
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`added, and entry of the Amendment is respectfully requested,
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`Please grant any extensions of time required to enter this response and charge
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`any additional required fees to Deposit Account No. 06-0916.
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`Dated: October 5, 2015
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`Respectfully submitted,
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`FINNEGAN, HENDERSON, FARABOW,
`GARRETT & DUNNER, L.L.P.
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`By:_:<:~};'.>Lt J·Ll-i?t '· .. (\< _ _,,·s: .. =~r=_:-~f_~~~;:._
`.. __ _
`(/ Jennife(·H. Gupta
`Reg. No. 54,257
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`-4-
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`Page 4 of 4
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`SLAYBACK EXHIBIT 1006
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