`Attorney Docket No. 05273.0127-01
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`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
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`!n re Application of:
`
`Mitsutaka Nakamura et al.
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`Application No.: To be assigned
`(Continuation of App. No. 10/525,021)
`
`Filed: Herewith
`
`For: AGENT FOR TREATMENT OF
`SCHIZOPHRENIA
`
`)
`)
`) Parent Group Art Unit 1612
`)
`) Parent Examiner: Snigdha MAEWALL
`)
`)
`)
`)
`)
`)
`
`VIA EFS-WEB
`
`Commissioner for Patents
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`Sir:
`
`PRELIMINARY AMENDMENT
`
`Please amend the above-identified patent application as follows:
`
`Amendments to the Specification begin on page 2.
`
`Remarks follow the Amendments section, beginning on page 3.
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`Page 1 of 6
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`SLAYBACK EXHIBIT 1020
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`
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`Attorney Docket No. 05273.0127-0100
`Continuation of App. No. 10/525,021
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`Page 2 of 6
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`AMENDMENT TO THE SPECIFICATIOfi
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`Please amend this application on page 1, line 1, by inserting the following new
`
`paragraph:
`
`This is a continuation application of Application No. 10/525,021, filed
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`February 18, 2005, which is a national stage application of PCT/JP2003/010490, filed
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`August 20, 2003, and claims priority to U.S. Provisional Application 60/404,927, filed
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`August 22, 2002, the contents of which are incorporated herein by reference.
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`2
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`Page 2 of 6
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`SLAYBACK EXHIBIT 1020
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`Attorney Docket No. 05273.0127-0100
`Continuation of App. No. 10/525,021
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`Page 3 of 6
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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. (New) A method for treating schizophrenia in a patient, without causing clinically
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`significant body weight gain in the patient, the method comprising administering to the
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`patient a dose of 5 mg to 120 mg of the active compound: (1 R,2S,3R,4S)-N-[(1 R,2R)-
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`2-[4-( 1,2-benzoisothiazol-3-yl)-1-piperazinylmethyl]-1-cyclohexylmethyl]-2, 3-
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`bicyclo[2 .2.1 ]heptanedicarboximide or a pharmaceutically acceptable salt thereof.
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`21.
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`(New) The method of claim 20, wherein said active compound is
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`(1 R,2S,3R,4S)-N-[(1 R,2R)-2-[4-(1,2-benzoisothiazol-3-yl)-1-piperaziny!methyl]-1-
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`cyclohexylmethyl]-2, 3-bicyclo[2. 2 .1 ]heptaned icarboxim ide hydrochloride.
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`22.
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`(New) The method of claim 20, wherein 20 mg to 120 mg of said active
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`compound is administered to said patient
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`23.
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`(New) The method of claim 20, wherein said active compound is administered to
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`said patient orally.
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`3
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`Page 3 of 6
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`SLAYBACK EXHIBIT 1020
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`Attorney Docket No. 05273.0127-0100
`Continuation of App. No. 10/525,021
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`Page 4 of 6
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`24.
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`(New) The method of eiaim 20, wherein said active compound is administered to
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`said patient without concurrently administering another antipsychotic medication.
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`25.
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`(New) The method of claim 20, wherein said active compound is administered to
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`said patient for a period of at least six weeks.
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`26.
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`(New) The method of claim 20, wherein said patient has a BPRS score of at
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`least 42 and wherein the patient's BPRS score is significantly reduced from a baseline
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`measurement prior to the administering of said active compound.
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`27.
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`(New) The method of claim 20, wherein said active compound is administered
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`once daily.
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`4
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`Page 4 of 6
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`SLAYBACK EXHIBIT 1020
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`Attorney Docket No. 05273.0127-0100
`Continuation of App. No. 10/525,021
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`Page 5 of 6
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`~EMARKS
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`The specification ls amended to insert the proper priority information. Original
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`claims 1-19 are cancelled without prejudice or disclaimer. New claims 20-27 find
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`support in the published application of parent application 10/525,021 (US
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`2006/0025422), as follows:
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`Claim 20 - claim 1 and paragraph [0036] of US2006/0025422;
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`Claim 21 - claim 2 of US2006/0025422;
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`Claim 22 - paragraphs [0014] and [0016] of US2006/0025422;
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`Claim 23 - paragraphs [0016] and [0017] of US2006/0025422;
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`Claim 24 - paragraph [0029] (TABLE1: Combined Drug and Combination
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`Therapy, 1 )) in US2006/0025422A 1;
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`Claim 25 - paragraphs [0011] and [0029] of US2006/0025422; and
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`Claim 26 - paragraph [0029] (TABLE1: Subjects Selection criteria, 2)),
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`[0030];TABLE 2 and [0032]; FIG 1 in US2006/0025422A 1;
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`Claim 27 - paragraph [0008] of US2006/0025422.
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`Accordingly, no new matter is added.
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`5
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`Page 5 of 6
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`SLAYBACK EXHIBIT 1020
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`Attorney Docket No. 05273.0127-0100
`Continuation of App. No. 10/525,021
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`Page 6 of 6
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`Please grant any extensions of time required to enter this paper and charge any
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`additional required fees to Deposit Account No, 06-0916.
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`Respectfully submitted,
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`FINNEGAN, HENDERSON, FARABOW,
`GARRETT & DUNNER, L.L.P.
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`Dated: August 28, 2014
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`6
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`Page 6 of 6
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`SLAYBACK EXHIBIT 1020
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