UNITED STA TES p A TENT 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.
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`FILING DATE
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`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
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`14/471,919
`
`08/28/2014
`
`Mitsutaka Nakamura
`
`472340US40CONT
`
`1054
`
`10/19/2016
`7590
`22850
`0BL0N, MCCLELLAND, MAIER & NEUSTADT, L.L.P.
`1940 DUKE STREET
`ALEXANDRIA, VA 22314
`
`EXAMINER
`
`MAEWALL, SNIGDHA
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`ART UNIT
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`PAPER NUMBER
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`1612
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`NOTIFICATION DATE
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`DELIVERY MODE
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`10/19/2016
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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):
`patentdocket@oblon.com
`oblonpat@oblon.com
`ahudgens@oblon.com
`
`PTOL-90A (Rev. 04/07)
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`Page 1 of 9
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`

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`Application No.
`14/471,919
`
`Applicant(s)
`NAKAMURA ET AL.
`
`Office Action Summary
`
`AIA (First Inventor to File)
`Status
`No
`-- The MAILING DA TE of this communication appears on the cover sheet with the correspondence address -(cid:173)
`Period for Reply
`
`Examiner
`SNIGDHA MAEWALL
`
`Art Unit
`1612
`
`A SHORTENED STATUTORY PERIOD FOR REPLY IS SET TO EXPIRE ;J. MONTHS 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 )~ Responsive to communication(s) filed on 4/8/16.
`0 A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/were filed on __ .
`2a)0 This action is FINAL.
`2b)~ This action is non-final.
`3)0 An election was made by the applicant in response to a restriction requirement set forth during the interview on
`__ ; the restriction requirement and election have been incorporated into this action.
`4)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*
`5)~ Claim(s) 20-28 is/are pending in the application.
`5a) Of the above claim(s) __ is/are withdrawn from consideration.
`6)0 Claim(s) __ is/are allowed.
`7)~ Claim(s) 20-28 is/are rejected.
`8)0 Claim(s) __ is/are objected to.
`9)0 Claim(s) __ are subject to restriction and/or election requirement.
`* If any claims have been determined allowable, you may be eligible to benefit from the Patent Prosecution Highway program at a
`participating intellectual property office for the corresponding application. For more information, please see
`http:ilwww.usoto.gov/patents/init events/pph/index.isp or send an inquiry to PPHfeedback(wuspto.aov.
`
`Application Papers
`10)0 The specification is objected to by the Examiner.
`11 )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).
`
`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).
`Certified copies:
`a)O All b)O Some** c)O None of the:
`Certified copies of the priority documents have been received.
`1.0
`Certified copies of the priority documents have been received in Application No. __ .
`2.0
`Copies of the certified copies of the priority documents have been received in this National Stage
`3.0
`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) ~ Notice of References Cited (PTO-892)
`
`2) ~ Information Disclosure Statement(s) (PTO/SB/08a and/or PTO/SB/08b)
`Paper No(s)/Mail Date __ .
`
`3) 0 Interview Summary (PTO-413)
`Paper No(s)/Mail Date. __ .
`4) 0 Other: __ .
`
`U.S. Patent and Trademark Office
`PTOL-326 (Rev. 11-13)
`
`Office Action Summary
`
`Part of Paper No./Mail Date 20161013
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`Application/Control Number: 14/471,919
`Art Unit: 1612
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`Page 2
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`The present application is being examined under the pre-AIA first to invent
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`provisions.
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`Detailed Action
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`Restriction/Election
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`Applicant's arguments regarding prosecuting all the claims is considered. Claims
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`20-28 are pending and are included in the prosecution.
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`Claim Rejections - 35 USC § 103
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`The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis
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`for all obviousness rejections set forth in this Office action:
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`(a) A patent may not be obtained though the invention is not identically disclosed or described
`as set forth in section 102, 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.
`
`Claims 20-28 are rejected under 35 U.S.C. 103(a) as being unpatentable
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`over Wong et al. (US 6,964,962); as evidenced by Pozuelo et al. (US PG pub.
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`2001/0047010 A1).
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`Wong et al. teach 0.05 to 7500 mg/day/patient of SM-13496 (Instant compound)
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`can be used to treat schizophrenia (see column 4, lines 51-58; column 7, lines 37-38
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`and Table in column 8, line 16), which details the daily dose of SM-13496 (instant
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`compound) that can be given to the patient and thus may be a once a day
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`administration. Moreover, Wong et al. teaches 0.05 to 7500 mg/day/patient of SM-
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`13496 can be used to treat schizophrenia (column 4, lines 51-58; and Table in column
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`8, line 16). The amount disclosed overlaps with the claimed amount and thus creates
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`case of obviousness. The prior art does not disclose the exact claimed values, but does
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`Application/Control Number: 14/471,919
`Art Unit: 1612
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`Page 3
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`overlap: in such instances even a slight overlap in range establishes a prima facie case
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`of obviousness. In re Peterson, 65 USPQ2d 1379, 1382 (Fed. Cir. 2003). The reference
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`discloses that the common side effects associated with treatment of schizophrenia is
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`weight gain and sleepiness, however the object of the invention is to provide an
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`effective treatment of schizophrenia with reduced side effects that are known, see
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`column 4, lines 25-27 and column 5, lines 4-5., column 10, lines 13-15. The reference
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`teaches diseases that are treated are schizophrenia and bipolar disorder, see column 9,
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`lines 55-56).
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`The prior art discloses compositions containing SM-13496 in column 7, lines 37-
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`38 along with other antisychotic agents such as ariprazole, ziprasidone, sertindole etc
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`and treatment of schizophrenia, bipolar disorder and several other diseases and
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`disorders as disclosed in column 9, lines 35-65. The prior art is not anticipatory insofar
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`as the antipsychotic agent, SM-13496 as claimed and the disease to be to be treated
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`must be selected from various lists/locations in the reference in an amount that overlaps
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`with the claimed amount. It would have been obvious, however, to utilize SM-13496
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`from among various agents taught by the reference for treating schizophrenia or bipolar
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`disorder since each agent is taught as being useful in treating schizophrenia or bipolar
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`disorder in prior art.
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`Since this modification of the prior art represents nothing more than "the
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`predictable use of prior art elements according to their established functions" a prima
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`facie case of obviousness exists. See KSR v. Teleflex, 82 USPQ2d 1385, 1396 (2007).
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`See also Ex parte Perrier, Appeal 2012-003888 (PTAB (2014)) (USSN 11/174,414)
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`Application/Control Number: 14/471,919
`Art Unit: 1612
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`Page 4
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`(applying the KSR standard of obviousness to selection of xanthan polymer and
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`chloride of sebacic acid as polymer and crosslinker for forming prior art polymer
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`networks since "this combination is merely a predictable used of prior art elements
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`according to their established functions" - see fifth page of the decision). Wong et al.
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`does not explicitly teach treating manic depressive psychosis. Pozuelo et al. teaches
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`that manic depressive psychosis is typically referred to as bipolar illness, see [0005].
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`Therefore based on the teachings of Pozuelo et al. it would appear reasonable to
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`conclude that treatment of bipolar illness by using the instantly claimed compound as
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`taught by Wong et al. would include treatment of manic depressive psychosis as
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`claimed because Pozuelo et al. teaches that manic depressive psychosis is typically
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`referred to as bipolar illness, see [0005].
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`Nonstatutory double patenting rejection
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`The nonstatutory double patenting rejection is based on a judicially created
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`doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the
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`unjustified or improper timewise extension of the "right to exclude" granted by a patent
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`and to prevent possible harassment by multiple assignees. A nonstatutory double
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`patenting rejection is appropriate where the claims at issue are not identical, but at least
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`one examined application claim is not patentably distinct from the reference claim(s)
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`because the examined application claim is either anticipated by, or would have been
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`obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d
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`1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir.
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`Application/Control Number: 14/471,919
`Art Unit: 1612
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`Page 5
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`1993); In re Langi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum,
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`686 F.2d 937,214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438,164 USPQ 619
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`(CCPA 1970); and In re Thorington, 418 F.2d 528,163 USPQ 644 (CCPA 1969).
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`A timely filed terminal disclaimer in compliance with 37 CFR 1.321 (c) or 1.321 (d)
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`may be used to overcome an actual or provisional rejection based on a nonstatutory
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`double patenting ground provided the reference application or patent either is shown to
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`be commonly owned with this application, or claims an invention made as a result of
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`activities undertaken within the scope of a joint research agreement. A terminal
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`disclaimer must be signed in compliance with 37 CFR 1.321 (b).
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`The USPTO internet Web site contains terminal disclaimer forms which may be
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`used. Please visit http://www.uspto.gov/forms/. The filing date of the application will
`
`determine what form should be used. A web-based eTerminal Disclaimer may be filled
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`out completely online using web-screens. An eTerminal Disclaimer that meets all
`
`requirements is auto-processed and approved immediately upon submission. For more
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`information about eTerminal Disclaimers, refer to http://www.uspto.gov/patents/proc
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`Claims 20-28 are rejected on the ground of nonstatutory double patenting as
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`being unpatentable over claims 1-11 of (USP 9,174,975) in view of Wong et al. (US
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`6,964,962); as evidenced by Pozuelo et al. (US PG pub. 2001/0047010 A1).
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`Although the claims at issue are not identical, they are not patentably distinct
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`from each other because the instant claims recite a method for treating schizophrenia in
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`a patient, without causing clinically significant body weight gain in the patient, the
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`method comprising administering to the patient a dose of 5 mg to 120 mg of the active
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`Application/Control Number: 14/471,919
`Art Unit: 1612
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`Page 6
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`compound: (1 R,2S,3R,4S)-N-[(1 R,2R)- 2-[4-(1,2-benzoisothiazol-3-yl)-I-
`
`piperazinylmethyl]-1-cyclohexylmethyl]-2,3- bicyclo[2.2.1 ]heptanedicarboximide or a
`
`pharmaceutically acceptable salt thereof. The patented claims recite a method for
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`treating the negative symptoms of schizophrenia and/or the cognitive dysfunction of
`
`schizophrenia in a patient, which comprises orally administering a once 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-3myl)-I piperazinylmethyl]-I -cyclohexylmethyn]-2,3-
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`bicyclo[2.2.1 ]heptanedicarboxyimide of the formula (1 ): or a pharmaceutically
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`acceptable salt thereof to a patient suffering from negative symptoms of schizophrenia
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`and/or cognitive dysfunction of schizophrenia. The instant claims recite a method for
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`treating schizophrenia in a patient, without causing clinically significant body weight gain
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`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)(cid:173)
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`l-piperazinylmethyl]-1-cyclohexylmethyl]-2,3- bicyclo[2.2.1 ]heptanedicarboximide or a
`
`pharmaceutically acceptable salt thereof.
`
`The patented claims do not teach treating manic depressive psychosis. However
`
`Wong as discussed above teaches use of the (1 R,2S,3R,4S)-N[(1 R,2R)-2-[4-(1,2-
`
`benzoisothiazol-3myl)-I piperazinylmethyl]-I -cyclohexylmethyn]-2,3-
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`bicyclo[2.2.1 ]heptanedicarboxyimide of the formula (1) (Lurasidone) in treating bipolar
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`illnesses and Pozuelo teaches that bipolar illnesses are typically known as manic
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`depressive psychosis. Therefore it would have been obvious to one of ordinary skill in
`
`the art at the time the invention was made to have utilized the compound taught in
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`Application/Control Number: 14/471,919
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`patented claims to treat manic depressive disorder motivated by the teachings of Wong
`
`et al. and Pozuelo et al.
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`Correspondence
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`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; 8:30 a.m.
`
`to 5:00 p.m. EST. If attempts to reach the examiner by telephone are unsuccessful, the
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`examiner's supervisor, Frederick Krass can be reached on (571) 272-0580. The fax
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`phone number for the organization where this application or proceeding is assigned is
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`571-273-8300.
`
`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 Customer Service Representative or access to the automated information
`
`system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
`
`/SNIGDHA MAEWALL/
`Primary Examiner, Art Unit 1612
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`Application/Control Number: 14/471,919
`Art Unit: 1612
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