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PATENT
`Attorney Docket No. 05273.0127-01
`
`lN THE UNITED STATES PATENT AND TRADEMARK OFF!CE
`
`l n re Application of:
`
`Mitsutaka Nakamura et a!.
`
`Application No.: 14/471,919
`
`Filed: August 28, 2014
`
`For: AGENT FOR TREATMENT OF
`SCH IZOPH REN IA
`
`)
`)
`) Group Art Unit 1612
`)
`} Examiner: Snigdha MAEWALL
`)
`) VIA EFS-WEB
`)
`)
`)
`
`Commissioner for Patents
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`Commissioner:
`
`PRELIMINARY AMENDMENT
`
`Further to the Preliminary Amendment filed August 28, 2014, please amend the
`
`above-identified application as follows:
`
`Amendments to the Claims begin at page 2.
`
`Remarks/Arguments follow the amendment section of this paper.
`
`Page 1 of 4
`
`SLAYBACK EXHIBIT 1006
`
`

`

`Application No.: 14/471,919
`Attorney Docket No.: 05273,0127-01
`
`AMENDMENTS TO THE CLAIMS:
`
`This listing of claims will replace all prior versions and listings of claims in the
`
`application:
`
`Claims 1-19 (Cancelled)
`
`20. (Currently Amended) A method for treating schizophrenia or manic depressive
`
`psychoses in a patient, without causing clinically significant body weight gain in the
`
`patient, the method comprising administering to the patient a 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-
`
`piperazinylmethyl]-1-cyc!ohexylmethyl]-2,3-bicyc!o[2.2.1 ]heptanedicarboximide or a
`
`pharmaceutically acceptable salt thereof.
`
`21.
`
`(Previously Presented) The method of claim 20, wherein said active compound
`
`is (1 R,2S,3R,4S}-N-[(1 R,2R)-2-[4-(1,2-benzoisothiazol-3-y!)-1-piperazinylmethy!]-1-
`
`cyclohexylmethyl]-2, 3-bicyclo[2 .2, 1 ]heptaned icarboximide hydrochloride.
`
`22.
`
`(Previously Presented)
`
`The method of claim 20, wherein 20 mg to 120 mg of
`
`said active compound is administered to said patient
`
`23.
`
`(Previously Presented)
`
`The method of claim 20, wherein said active
`
`compound is administered to said patient orally.
`
`Page 2 of 4
`
`SLAYBACK EXHIBIT 1006
`
`

`

`Application No,: 14/471,919
`Attorney Docket No.: 05273.0127-01
`
`24.
`
`(Previously Presented)
`
`The method of claim 20, wherein said active
`
`compound is administered to said patient without concurrently administering another
`
`antipsychotic medication.
`
`25.
`
`(Previously Presented)
`
`The method of claim 20, wherein said active
`
`compound is administered to said patient for a period of at least six weeks.
`
`26.
`
`(Previously Presented)
`
`The method of claim 20, wherein said patient has a
`
`BPRS score of at !east 42 and wherein the patient's BPRS score is significantly reduced
`
`from a baseline measurement prior to the administering of said active compound.
`
`27.
`
`(Previously Presented)
`
`The method of claim 20, wherein said active
`
`compound is administered once daily.
`
`28.
`
`(New) The method of claim 20, wherein the method is for treating manic
`
`depressive psychoses.
`
`,-3-
`
`Page 3 of 4
`
`SLAYBACK EXHIBIT 1006
`
`

`

`Application No.: 14/471,919
`Attorney Docket No,: 05273.0127-01
`
`REMARKS
`
`Claims 20-27 are pending. Claim 20 is amended and daim 28 is added herein.
`
`Written description support for the amendments can be found, for example, at page 2,
`
`lines 26-30 of the as-filed specification (paragraph [0007] of the published application,
`
`U.S. Patent Application Publication No. 2014/0371236). Accordingly, no new matter is
`
`added, and entry of the Amendment is respectfully requested,
`
`Please grant any extensions of time required to enter this response and charge
`
`any additional required fees to Deposit Account No. 06-0916.
`
`Dated: October 5, 2015
`
`Respectfully submitted,
`
`FINNEGAN, HENDERSON, FARABOW,
`GARRETT & DUNNER, L.L.P.
`
`By:_:<:~};'.>Lt J·Ll-i?t '· .. (\< _ _,,·s: .. =~r=_:-~f_~~~;:._
`.. __ _
`(/ Jennife(·H. Gupta
`Reg. No. 54,257
`
`-4-
`
`Page 4 of 4
`
`SLAYBACK EXHIBIT 1006
`
`

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