Docket No.: 120140-001 10
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`(PATENT)
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`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
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`
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`In re Utility Application of:
`Andreas Bathe et al.
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`Application No.: Not Yet Assigned
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`Confirmation No.: N/A
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`Filed: Concurrently Herewith
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`Art Unit: N/A
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`For: POLYMORPHIC FORMS OF l—[4—(5—
`CYANOINDOL—3—YL)BUTYL—4— (2—
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`CARBAMOYLBENZOFURAN—S—YL)
`PIPERAZINE HYDROCHLORIDE
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`Examiner: Not Yet Assigned
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`MS Amendment
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`Commissioner for Patents
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`PO. Box 1450
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`Alexandria, VA 22313—1450
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`PRELIMINARY AMENDMENT UNDER 37 C.F.R. 1.115
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`Dear Madam:
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`Prior to examination on the merits, please amend the above—identified US patent
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`application as follows:
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`Amendments to the Specification begin at page 2 of this paper.
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`Amendments to the Claims are reflected in the listing of claims which begins at page 3 of
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`this paper.
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`Remarks/Arguments begin at page 6 of this paper.
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`MEI 16433226V.1
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`Merck 2012
`Merck 2012
`Argentum v. Merck
`Argentum V. Merck
`IPR2018-00423
`IPR2018-00423
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`

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`Application No. Not Yet Assigned
`Preliminary Amendment dated September 16, 2013
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`Docket N0.: 120140-001 10
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`AMENDMENTS TO THE SPECIFICATION
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`Please insert the following new paragraph after the Title of the invention on page 1, line 3:
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`RELATED APPLICATIONS
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`This application is a continuation application of US. Patent Application No. 13/658,088,
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`filed on October 23, 2012, which is a continuation of US. Patent Application No. 13/085,117, filed
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`April 12, 2011, now US. Patent No. 8,318,744, issued November 27, 2012, which is a continuation
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`application of US. Patent Application No. 12/566,835, filed September 25, 2009, now US. Patent
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`No. 7,981,894, issued July 19, 2011, which is a divisional application of US. Patent Application
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`No. 12/110,704, filed April 28, 2008, now US. Patent No. 7,834,020, issued November 16, 2010,
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`which is a divisional application of US. Patent Application No. 10/481,270, filed December 19,
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`2003, now US. Patent No. 7,381,726, issued June 3, 2008, which is a national phase application of
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`International Application No. PCT/EP2002/006153, filed June 5, 2002, which claims priority to
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`European Patent Application No. 011136470, filed June 19, 2001. The entire contents of each of
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`the foregoing applications and patents are hereby incorporated by reference.
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`MEl 16433226v.1
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`Application No. Not Yet Assigned
`Preliminary Amendment dated September 16, 2013
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`Docket N0.: 120140-001 10
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`AMENDMENTS TO THE CLAIMS
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`This listing of the claims will replace all prior versions and listings of claims in the
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`application.
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`Listing of Claims:
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`l.— 55. (Cancelled)
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`56. (New) A compound which is l—[4—(5—cyanoindol—3—yl)butyl]—4—(2—carbamoyl—
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`benzofuran—5—yl)—piperazine hydrochloride in its crystalline modification, wherein the compound is
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`an anhydrate, hydrate, solvate or dihydrochloride.
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`57. (New) The compound of claim 56, wherein the compound is an anhydrate in crystalline
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`modification III.
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`58. (New) The compound of claim 56, wherein the compound is an anhydrate in crystalline
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`modification VII.
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`59. (New) The compound of claim 56, wherein the compound is a solvate in crystalline
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`modification XI.
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`60. (New) A pharmaceutical composition comprising l—[4—(5—cyanoindol—3—yl)butyl]—4—(2—
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`carbamoyl—benzofuran—S—yl)—piperazine hydrochloride anhydrate in its crystalline modification IV
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`and one or more hydrated forms of l—[4—(5—cyanoindol—3—yl)butyl]—4—(2—carbamoyl—benzofuran—S—
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`yl)—piperazine hydrochloride.
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`61. (New) A pharmaceutical composition according to claim 60, wherein the composition
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`comprises l—[4—(5—cyanoindol—3—yl)butyl]—4—(2—carbamoyl—benzofuran—5—yl)—piperazine
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`hydrochloride monohydrate in its crystalline modification Form V.
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`MEl 16433226V.1
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`Application No. Not Yet Assigned
`Preliminary Amendment dated September 16, 2013
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`Docket N0.: 120140-001 10
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`62. (New) A pharmaceutical composition according to claim 61, wherein Form IV and Form
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`V are in a molar ratio of about 100 to l to 10 to l.
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`63. (New) A pharmaceutical composition according to claim 61 comprising an active
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`ingredient consisting essentially of a mixture of Form IV and Form V.
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`64. (New) A pharmaceutical composition according to claim 63, wherein Form IV and Form
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`V are in a molar ratio of about 100 to l to 10 to l.
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`65. (New) A method of treating a patient suffering from a depressive disorder, an anxiety
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`disorder, a bipolar disorder, mania, dementia, a substance—related disorder, a sexual dysfunction, an
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`eating disorder, obesity, fibromyalgia, a sleeping disorder, a psychiatric disorder, cerebral infarct,
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`tension, side—effects in the treatment of hypertension, a cerebral disorder, chronic pain, acromegaly,
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`hypogonadism, secondary amenorrhea, premenstrual syndrome and undesired puerperal lactation, or
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`combinations thereof, comprising administering to the patient in need thereof the pharmaceutical
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`composition of claim 61.
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`66. (New) A pharmaceutical composition comprising a compound which is l—[4—(5—
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`cyanoindol—3—yl)butyl]—4—(2—carbamoyl—benzofuran—5—yl)—piperazine hydrochloride anhydrate in its
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`crystalline modification IV, and one or more conventional auxiliary substances and /or carriers.
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`67. (New) A method of treating a patient suffering from a depressive disorder, an anxiety
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`disorder, a bipolar disorder, mania, dementia, a substance—related disorder, a sexual dysfunction, an
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`eating disorder, obesity, fibromyalgia, a sleeping disorder, a psychiatric disorder, cerebral infarct,
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`tension, side—effects in the treatment of hypertension, a cerebral disorder, chronic pain, acromegaly,
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`hypogonadism, secondary amenorrhea, premenstrual syndrome and undesired puerperal lactation, or
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`combinations thereof, comprising administering to the patient in need thereof the pharmaceutical
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`composition of claim 66.
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`MEI 16433226v.1
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`Application No. Not Yet Assigned
`Preliminary Amendment dated September 16, 2013
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`Docket N0.: 120140-001 10
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`68. (New) A method of treating a patient suffering from a depressive disorder, an anxiety
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`disorder, a bipolar disorder, mania, dementia, a substance—related disorder, a sexual dysfunction, an
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`eating disorder, obesity, fibromyalgia, a sleeping disorder, a psychiatric disorder, cerebral infarct,
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`tension, side—effects in the treatment of hypertension, a cerebral disorder, chronic pain, acromegaly,
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`hypogonadism, secondary amenorrhea, premenstrual syndrome and undesired puerperal lactation, or
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`combinations thereof, comprising administering to the patient in need thereof an effective amount of
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`a compound, wherein the compound is l—[4—(5—cyanoindol—3—yl)butyl]—4—(2—carbamoyl—benzofuran—
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`5—yl)—piperazine hydrochloride monohydrate in its crystalline modification (V).
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`69. (New) A method of treating a patient suffering from a depressive disorder, an anxiety
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`disorder, a bipolar disorder, mania, dementia, a substance—related disorder, a sexual dysfunction, an
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`eating disorder, obesity, fibromyalgia, a sleeping disorder, a psychiatric disorder, cerebral infarct,
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`tension, side—effects in the treatment of hypertension, a cerebral disorder, chronic pain, acromegaly,
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`hypogonadism, secondary amenorrhea, premenstrual syndrome and undesired puerperal lactation, or
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`combinations thereof, comprising administering to the patient in need thereof an effective amount of
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`a compound of claim 56.
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`70. (New) A pharmaceutical composition comprising a compound according to claim 56,
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`and one or more conventional auxiliary substances and/or carriers.
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`MEl 16433226v.1
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`Application No. Not Yet Assigned
`Preliminary Amendment dated September 16, 2013
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`Docket N0.: 120140-001 10
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`REMARKS
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`Pursuant to 37 CPR. §1.78(a), the specification has been amended to include a cross
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`reference to the Related Applications. No new matter has been added.
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`Claims 1—55 are canceled. Claims 56—70 are new. Support for claims 56—70 is found in the
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`specification and in the claims as originally filed. Upon entry of the claim amendments set forth
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`above, claims 56—70 will be pending in the application. No new matter has been added.
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`Claims 60—64 are similar to claims 58—62 of abandoned application 12/945,260 (published as
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`US. 2011/0183994) filed on November 12, 2010. Applicants respectfully point out that claims 58—
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`62 of patent application 12/945,260 were indicated as allowable during prosecution, prior to
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`abandonment of the application. See, Non-Final Oflice Action ofApplication N0.: 12/945,260,
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`mailed August I 7, 2011, at page I 7, second paragraph, thereof. In view of the foregoing,
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`allowance of the subject claims is respectfully requested.
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`If a telephone conversation with Applicants’ attorney would help expedite the prosecution of
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`the instant application, the Examiner is urged to call Applicants’ attomey/agent at (617) 449—6500.
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`The Commissioner is hereby authorized to charge any fees associated with the filing of this
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`communication to our Deposit Account No. 50—4876, under Order No. 120140—001 10 from which
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`the undersigned is authorized to draw.
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`Dated: September 19, 2013
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`Respectfully submitted,
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`Electronic signature:
`Danielle L. Herritt
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`/Danielle L. Herritt/
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`Registration N0.: 43,670
`MCCARTER & ENGLISH, LLP
`265 Franklin Street
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`Boston, Massachusetts 02110
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`(617) 449—6500
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`(617) 607-9200 (Fax)
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`Attomey/Agent For Applicant
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`MEl 16433226v.1
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