UNITED STA 1ES p A 1ENT 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
`
`APPLICATION NO.
`
`FILING DATE
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
`
`10/525,021
`
`02/18/2005
`
`Mitsutaka Nakamura
`
`0020-5041PUS2
`
`3141
`
`06112/2009
`7590
`2292
`BIRCH STEW ART KOLASCH & BIRCH
`POBOX747
`FALLS CHURCH, VA 22040-0747
`
`EXAMINER
`
`MAEW ALL, SNIGDHA
`
`ART UNIT
`
`PAPER NUMBER
`
`1612
`
`NOTIFICATION DATE
`
`DELIVERY MODE
`
`06/12/2009
`
`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 12
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`Office Action Summary
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`Application No.
`
`Applicant(s)
`
`10/525,021
`
`Examiner
`
`NAKAMURA ET AL.
`
`Art Unit
`
`1612
`Snigdha Maewall
`-- 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~ 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 )IZ! Responsive to communication(s) filed on 16 March 2009.
`2a)0 This action is FINAL.
`2b)[8J 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
`
`4)[8J Claim(s) 1.2.5.8. 11 and 20 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)[8J Claim(s) 1-2. 5. 8. 11 and 20 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)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.
`
`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) [8J Notice of References Cited (PT0-892)
`2) 0 Notice of Draftsperson's Patent Drawing Review (PT0-948)
`3) 0 Information Disclosure Statement(s) (PTO/SB/08)
`Paper No(s)/Mail Date __ .
`
`4) 0 Interview Summary (PT0-413)
`Paper No(s)/Mail Date. __ .
`5) 0 Notice of Informal Patent Application
`6) 0 Other: __ .
`
`U.S. Patent and Trademark Off1ce
`PTOL-326 (Rev. 08-06)
`
`Office Action Summary
`
`Part of Paper No./Mail Date 20090407
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`Application/Control Number: 10/525,021
`Art Unit: 1612
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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.
`
`Receipt of Applicants arguments/Remarks and RCE filed on 03/16/09 are
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`acknowledged.
`
`Claims 3-4, 6-7, 9-10, 12-19 and 21 have been canceled.
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`Claim 1 has been amended.
`
`Accordingly, claims 1-2, 5, 8, 11 and 20 are being examined on the merits herein.
`
`Claim Rejections- 35 USC§ 102
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`2.
`
`The following is a quotation of the appropriate paragraphs of 35
`
`U.S.C. 102 that form the basis for the rejections under this section made in this
`
`Office action:
`
`A person shall be entitled to a patent unless-
`(a) the invention was known or used by others in this country, or patented or described in a printed publication in this
`or a foreign country, before the invention thereof by the applicant for a patent.
`
`(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on
`sale in this country, more than one year prior to the date of application for patent in the United States.
`
`(e) the invention was described in (1) an application for patent, published under section 122(b), by another filed
`in the United States before the invention by the applicant for patent or (2) a patent granted on an application for
`patent by another filed in the United States before the invention by the applicant for patent, except that an
`international application filed under the treaty defined in section 351 (a) shall have the effects for purposes of
`this subsection of an application filed in the United States only if the international application designated the
`United States and was published under Article 21 (2) of such treaty in the English language.
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`Application/Control Number: 10/525,021
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`Page 3
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`3.
`
`Claims 1-2, 5, 8, 11 and 20 are rejected under 35 U .S.C. 1 02(b) as being
`
`anticipated by EP 464846 by Saji et al.
`
`Saji teaches a method of treatment of schizophrenia (see page 3, lines 1-4 and
`
`page 15). Saji et al. teaches oral preparations of the claimed compound, see page 33.
`
`The reference teaches dosage for adult daily dose to be from about 1 mg to 1000 mg,
`
`preferably from about 5 to 1 00 mg and in case of oral dosage to be from about 0.1 mg
`
`to 100 mg, preferably from about 0.3 mg to 50 mg, (see page 13, lines 25-30). The
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`reference teaches in Table 4, the amount of compound 101, an antipsychotic, which is
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`same as the instant claimed compound to be 1 0.3 mg/kg and similar antipsychotic
`
`compound to be 26.5 mg/kg on page 15.
`
`Claim Rejections - 35 USC § 103
`
`4.
`
`The following is a quotation of 35 U.S.C. 1 03(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.
`
`5.
`
`Claims 1-2, 5, 8, 11 and 20 are rejected under 35 U.S.C. 103(a) as being
`
`unpatentable over EP 464846 by Saji et al.
`
`Saji et al. teaches oral preparations of the claimed compound, see page 33. The
`
`reference teaches dosage for adult daily dose to be from about 1 mg to 1000 mg,
`
`preferably from about 5 to 1 00 mg and in case of oral dosage to be from about 0.1 mg
`
`to 100 mg, preferably from about 0.3 mg to 50 mg, (see page 13, lines 25-30). The
`
`reference teaches in Table 4, the amount of compound 101, an antipsychotic, which is
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`Application/Control Number: 10/525,021
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`Page 4
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`same as the instant claimed compound to be 1 0.3 mg/kg and similar antipsychotic
`
`compound to be 26.5 mg/kg on page 15.
`
`Although the reference does not teach exactly the same range 5 mg to 120 mg,
`
`however, the reference also teaches that the dosage of the imide compound or its
`
`pharmaceutically acceptable salt varies greatly with the symptom, age and weight of the
`
`patient, the dosage form and the administration mode, see page 13, lines 25-30.
`
`It would have been obvious to one of ordinary skill in the art at the time the
`
`invention was made to optimize the amount of drug and arrive at the optimum dosage
`
`level by doing experimental manipulations with minimum side effects. It is to be 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) absent evidence to the
`
`contrary
`
`6.
`
`Claims 1-2, 5, 8, 11 and 20 are rejected under 35 U.S.C. 103(a) as being
`
`unpatentable over Sommerville et al. (WO 03/066039 A 1) in view of Wong et al. (US
`
`6,964,962) by itself or in view of EP 464846 by Saji et al.
`
`It is noted that (1 R,2S,3R,4S)-N-[(1 R,2R)-2-[4-(1 ,2-benzoisothiazol-3-yl)-1-
`
`piperazinyl-methyl]-1-cyclohexylmethyl]-2,3-bicyclo[2.2.1] heptanedicarboximide
`
`hydrochloride is known in the art as SM-13496 (see page 7, lines 5-8 of the
`
`specification). Thus, SM-13496 is the hydrochloride salt of (1 R,2S,3R,4S)-N-[(1 R,2R)-
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`Application/Control Number: 10/525,021
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`Page 5
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`2-[4-( 1 ,2-benzoisoth iazol-3-yl )-1-piperazinyl-methyl]-1-cyclohexylmethyl]-2,3-
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`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.
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`further teaches positive and negative symptoms are often increased during the acute
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`phase, or the florid psychotic phase, of schizophrinia and that the method of
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`Sommerville et al. is aimed at treatment during the acute phase of schizophrenia (page
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`4, lines 16-23).
`
`Sommerville et al. do not explicitly teach the dose of SM-13496 (see page 7, lines 23-
`
`25).
`
`Wong et al. teach 0.05 to 7500 mg/day/patient of SM-13496 can be used to treat
`
`schizophrenia (see column 4, lines 51-58; and Table in column 8, line 16), which details
`
`the daily dose of SM-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 of SM-
`
`13496 can be used to schizophrenia (column 4, lines 51-58; and Table in column 8, line
`
`16). It would have been obvious too one of ordinary skill in the art to utilize the claimed
`
`amounts of 40 and 120 mg of he claimed compound for treating schizophrenia since
`
`Wong teaches the same compound for the same disease in a broad range.
`
`While Wong et al. teach wide range of dosage, Saji et al. disclose specific ranges
`
`of dosage to treat schizophrenia.
`
`Saji et al. teaches oral preparations of the claimed compound, see page 33. The
`
`reference teaches in Table 4, the amount of compound 101 an antipsychotic, which is
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`Application/Control Number: 10/525,021
`Art Unit: 1612
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`Page 6
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`same as the instant claimed compound to be 1 0.3 mg/kg and similar antipsychotic
`
`compound to be 26.5 mg/kg on page 15. The reference teaches dosage for adult daily
`
`dose to be from about 1 mg to 1000 mg, preferably from about 5 to 100 mg and in case
`
`of oral dosage to be from about 0.1 mg to 100 mg, preferably from about 0.3 mg to 50
`
`mg, (see page 13, lines 25-30).
`
`The reference also teaches that the dosage of the imide compound or its
`
`pharmaceutically acceptable salt varies greatly with the symptom, age and weight of the
`
`patient, the dosage form and the administration mode, see page 13, lines 25-30.
`
`It would have been obvious to one of ordinary skill in the art to optimize the
`
`dosage range of the claimed drug in order to obtain the most efficacious dosage range
`
`by doing experimental manipulations. Based on the teachings of Wong et al. and Saji et
`
`al. one would have been motivated to perform experimental manipulations with the
`
`dosage range in order to treat schizophrenia in a most efficacious dosage amount as
`
`taught by Sommerville et al. It is to be 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) absent evidence to the contrary.
`
`Response to Arguments
`
`7.
`
`Applicant's arguments filed 03/16/09 have been fully considered but they are not
`
`persuasive.
`
`Applicants argue that:
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`Page 7
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`"Applicants submit that Saji does not remedy the deficiencies of the combination of
`Wong and Sommerville to establish prima facie obviousness because the difference
`between the range is not minor. Saji discloses an extremely broad range of compounds
`(almost 200 compounds), which it claims have "significant" anti-psychotic activity (See
`col. 12, lines 25-28; and col. 2 lines 9-15 and 64-65). In contrast to the Examiner's
`assertions, Saji discloses that any one of this broad range of compounds could be
`administered in "a dose of from about 1 to 1,000 mg, preferably from about 5 to 100 mg,
`in case of oral administration and at a daily dose of from about 0.1 to 1000 rag,
`preferably from about 0.3 to 50 mg, in case of intravenous injection." (Saji, col. 12, lines
`19-23). Furthermore, the in vivo methods disclosed in Saji merely disclose "a
`designated amount of the test compound is orally administered." (Saji, col. 13, lines 30-
`31 ). Thus, Applicants submit that one of skill would not be able to determine which
`particular compound would be effective at any particular dose range from the disclosure
`in Saji."
`Applicants arguments are not persuasive because Saji does disclose the claimed
`
`range, thus one of ordinary skill would envision based on the given dosage range of
`
`1 mg to 1 000 mg of the claimed compound of prior art that any given amount that falls
`
`within the disclosed amount would work based on the teachings of the prior art.
`
`Applicants argue that Saji does not speak to the negative symptoms of
`
`Schizophrenia. Applicant's arguments are not persuasive. Saji teaches the claimed
`
`amounts and it would have been within the purview of a skilled artisan to come to the
`
`optimum amount to treat schizophrenia. There is nothing in the Saji's reference which
`
`describes that negative symptoms were still prevailing while treating schizophrenia with
`
`the claimed compound. Patent office is not equipped with laboratory to teat the
`
`compounds. Hence the burden is on Applicant to provide the statistical analysis of the
`
`prior art and the claimed invention to present unexpected result. Since prior art
`
`discloses the same amount as claimed instantly, one of ordinary would have expected
`
`the treatment of schizophrenia with no negative side effects. Applicant argues that the
`
`declaration provided the comparison, however, it is the position of the Examiner that
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`Application/Control Number: 10/525,021
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`Page 8
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`the declaration and the study of maximum tolerated dose of SM-13496 is not sufficient
`
`to overcome the rejection based on the prior art since applicants have not shown
`
`comparative analysis of the prior art versus the claimed invention. Additionally, the
`
`reference by Saji et al. disclose the dosage range of the claimed compound which can
`
`be in the range of 10 mg, 20 mg and 40 mg, which overlap with the claimed dosage
`
`range of the claimed compound. The declaration fails to provide unexpected results with
`
`respect to the claimed dosage ranges to treat all the aspects of schizophrenia such as
`
`positive and negative. The declaration does not compare the Saji reference with the
`
`claimed amounts. Saji teaches the claimed amounts. Furthermore, the declaration is not
`
`supported by in vivo data to show the comparative analysis and unexpected results.
`
`8.
`
`Claims 1-2, 5, 8, 11 and 20 are rejected under 35 U.S.C. 103(a) as being
`
`unpatentable over Wong et al. (US 6,964,962) by itself or in view of EP 464846 by Saji
`
`et al.
`
`Wong et al. teach 0.05 to 7500 mg/day/patient of SM-13496 can be used to treat
`
`schizophrenia (see column 4, lines 51-58; and Table in column 8, line 16), which details
`
`the daily dose of SM-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 of SM-
`
`13496 can be used to schizophrenia (column 4, lines 51-58; and Table in column 8, line
`
`16). It would have been obvious too one of ordinary skill in the art to utilize the claimed
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`Application/Control Number: 10/525,021
`Art Unit: 1612
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`Page 9
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`amounts of 40 and 120 mg of he claimed compound for treating schizophrenia since
`
`Wong teaches the same compound for the same disease in a broad range.
`
`It would have been obvious too one of ordinary skill in the art to utilize the
`
`claimed amounts of 40 and 120 mg of he claimed compound for treating schizophrenia
`
`since Wong teaches the same compound for the same disease in a broad range.
`
`While Wong et al. teach wide range of dosage, Saji et al. disclose specific ranges
`
`of dosage to treat schizophrenia. Since Wong teaches the treatment of schizophrenia
`
`in combination and discloses a wide rage of dosage amount and teaches that the
`
`selection of the dosage of the first component is that which provides relief to the patient,
`
`the dosage of this component depends on several factors such as potency of the
`
`selected specific compound, the mode of administration, the age and weight of the
`
`patient, the severuity of the condition to be treated and this is considered to be within
`
`the skill of the artisan and one can review the existing literature on the components to
`
`determine optimal dosing (see column 6, lines 49-57) and Saji teaches the claimed drug
`
`alone in smaller dosage amounts in treating schizophrenia, one would have been
`
`motivated to optimize the amount to achieve best possible dosage amount with
`
`minimum side effects.
`
`It would have been obvious to one of ordinary skill in the art to optimize the
`
`dosage range of the claimed drug in order to obtain the most efficacious dosage range
`
`by doing experimental manipulations. Based on the teachings of Wong et al. and Saji et
`
`al. one would have been motivated to perform experimental manipulations with the
`
`dosage range in order to treat schizophrenia in a most efficacious dosage amount. It is
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`Application/Control Number: 10/525,021
`Art Unit: 1612
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`Page 10
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`to be 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)
`
`absent evidence to the contrary.
`
`9.
`
`Any inquiry concerning this communication or earlier communications from the
`
`examiner should be directed to Snigdha Maewall whose telephone number is (571 )-
`
`272-6197. The examiner can normally be reached on Monday to Friday; 8:30a.m. to
`
`5:00p.m. EST.
`
`If attempts to reach the examiner by telephone are unsuccessful, the examiner's
`
`supervisor, Frederick Krass can be reached on (571) 272-0580. The fax phone number
`
`for the organization where this application or proceeding is assigned is 571-273-0580.
`
`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 applications is available through Private PAIR only. For
`
`more information 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
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`Application/Control Number: 10/525,021
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`Page 11
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`Customer Service Representative or access to the automated information system, call
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`800-786-9199 (IN USA OR CANADA) or 571-272-1000.
`
`/Snigdha Maewall/
`
`Examiner, Art Unit 1612
`
`/Gollamudi S Kishore/
`
`Primary Examiner, Art Unit 1612
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