Docket No.: 120140-00110
`(PATENT)
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`In re Utility Application of:
`AndreasBatheetal.
`
`Application No.: Not Yet Assigned
`
`Confirmation No.: N/A
`
`Filed: Concurrently Herewith
`
`Art Unit: N/A
`
`Examiner: Not Yet Assigned
`
`For: POLYMORPHIC FORMSOF1-[4-(5-
`CYANOINDOL-3-YL)BUTYL-4-(2-
`CARBAMOYLBENZOFURAN-5-YL)
`PIPERAZINE HYDROCHLORIDE
`
`MS Amendment
`Commissionerfor Patents
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`PRELIMINARY AMENDMENT UNDER 37 C.F.R. 1.115
`
`Dear Madam:
`
`Prior to examination on the merits, please amend the above-identified U.S. patent
`
`application as follows:
`
`Amendments to the Specification begin at page 2 of this paper.
`
`Amendments to the Claimsare reflected in the listing of claims which beginsat page 3 of
`
`this paper.
`
`Remarks/Arguments begin at page 6 of this paper.
`
`MEI 16433226v.1
`
`Merck 2012
`Merck 2012
`Argentum v. Merck
`Argentum v. Merck
`IPR2018-00423
`IPR2018-00423
`
`
`(PATENT)
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`In re Utility Application of:
`AndreasBatheetal.
`
`Application No.: Not Yet Assigned
`
`Confirmation No.: N/A
`
`Filed: Concurrently Herewith
`
`Art Unit: N/A
`
`Examiner: Not Yet Assigned
`
`For: POLYMORPHIC FORMSOF1-[4-(5-
`CYANOINDOL-3-YL)BUTYL-4-(2-
`CARBAMOYLBENZOFURAN-5-YL)
`PIPERAZINE HYDROCHLORIDE
`
`MS Amendment
`Commissionerfor Patents
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`PRELIMINARY AMENDMENT UNDER 37 C.F.R. 1.115
`
`Dear Madam:
`
`Prior to examination on the merits, please amend the above-identified U.S. patent
`
`application as follows:
`
`Amendments to the Specification begin at page 2 of this paper.
`
`Amendments to the Claimsare reflected in the listing of claims which beginsat page 3 of
`
`this paper.
`
`Remarks/Arguments begin at page 6 of this paper.
`
`MEI 16433226v.1
`
`Merck 2012
`Merck 2012
`Argentum v. Merck
`Argentum v. Merck
`IPR2018-00423
`IPR2018-00423
`
`
`
`Application No. Not Yet Assigned
`Preliminary Amendment dated September 16, 2013
`
`Docket No.: 120140-00110
`
`AMENDMENTS TO THE SPECIFICATION
`
`Please insert the following new paragraph after the Title of the invention on page 1, line 3:
`
`RELATED APPLICATIONS
`
`This application is a continuation application of U.S. Patent Application No. 13/658.088.
`
`filed on October 23, 2012, which is a continuation of U.S. Patent Application No. 13/085,117, filed
`
`April 12, 2011, now U.S. Patent No. 8.318.744, issued November 27, 2012, which is a continuation
`
`application of U.S. Patent Application No. 12/566,835, filed September 25, 2009, now U.S. Patent
`
`No. 7,981,894, issued July 19, 2011, which is a divisional application of U.S. Patent Application
`
`No. 12/110,704, filed April 28, 2008, now U.S. Patent No. 7,834,020, issued November16, 2010,
`
`whichis a divisional application of U.S. Patent Application No. 10/481,270, filed December 19,
`
`2003, now U.S. Patent No. 7,381,726, issued June 3, 2008, which is a national phase application of
`
`International Application No. PCT/EP2002/006153, filed June 5, 2002, which claims priority to
`
`European Patent Application No. 01113647.0, filed June 19, 2001. The entire contents of each of
`
`the foregoing applications and patents are hereby incorporated by reference.
`
`ME! 16433226v.1
`
`
`
`Application No. Not Yet Assigned
`Preliminary Amendment dated September 16, 2013
`
`Docket No.: 120140-00110
`
`AMENDMENTS TO THE CLAIMS
`
`This listing of the claims will replace all prior versions andlistings of claims in the
`
`application.
`
`Listing of Claims:
`
`1.- 55. (Cancelled)
`
`56. (New) A compound whichis 1-[4-(5-cyanoindol-3-yl)butyl]-4-(2-carbamoyl-
`
`benzofuran-5-yl)-piperazine hydrochloride in its crystalline modification, wherein the compoundis
`
`an anhydrate, hydrate, solvate or dihydrochloride.
`
`57. (New) The compoundof claim 56, wherein the compoundis an anhydrate in crystalline
`
`modification II.
`
`58. (New) The compoundof claim 56, wherein the compoundis an anhydrate in crystalline
`
`modification VII.
`
`59. (New) The compoundof claim 56, wherein the compoundis a solvate in crystalline
`
`modification XI.
`
`60. (New) A pharmaceutical composition comprising 1-[4-(5-cyanoindol-3-yl)butyl]-4-(2-
`
`carbamoyl-benzofuran-5-yl)-piperazine hydrochloride anhydrate in its crystalline modification IV
`
`and one or more hydrated formsof 1-[4-(5-cyanoindol-3-yl)butyl]-4-(2-carbamoyl-benzofuran-5-
`
`yl)-piperazine hydrochloride.
`
`61. (New) A pharmaceutical composition according to claim 60, wherein the composition
`
`comprises |-[4-(5-cyanoindol-3-yl)butyl]-4-(2-carbamoyl-benzofuran-5-yl)-piperazine
`
`hydrochloride monohydrate in its crystalline modification Form V.
`
`ME! 16433226v.1
`
`
`
`Application No. Not Yet Assigned
`Preliminary Amendment dated September 16, 2013
`
`Docket No.: 120140-00110
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`62. (New) A pharmaceutical composition according to claim 61, wherein Form IV and Form
`
`V are in a molar ratio of about 100 to 1 to 10 to 1.
`
`63. (New) A pharmaceutical composition according to claim 61 comprising an active
`
`ingredient consisting essentially of a mixture of Form IV and Form V.
`
`64. (New) A pharmaceutical composition according to claim 63, wherein Form IV and Form
`
`V are in a molar ratio of about 100 to 1 to 10 to 1.
`
`65. (New) A methodoftreating a patient suffering from a depressive disorder, an anxiety
`
`disorder, a bipolar disorder, mania, dementia, a substance-related disorder, a sexual dysfunction, an
`
`eating disorder, obesity, fibromyalgia, a sleeping disorder, a psychiatric disorder, cerebral infarct,
`
`tension, side-effects in the treatment of hypertension, a cerebral disorder, chronic pain, acromegaly,
`
`hypogonadism, secondary amenorrhea, premenstrual syndrome and undesired puerperal lactation, or
`
`combinationsthereof, comprising administering to the patient in need thereof the pharmaceutical
`
`composition of claim 61.
`
`66. (New) A pharmaceutical composition comprising a compound whichis 1-[4-(5-
`
`cyanoindol-3-yl)butyl]-4-(2-carbamoyl-benzofuran-5-yl)-piperazine hydrochloride anhydrate in its
`
`crystalline modification IV, and one or more conventional auxiliary substancesand/or carriers.
`
`67. (New) A methodoftreating a patient suffering from a depressive disorder, an anxiety
`
`disorder, a bipolar disorder, mania, dementia, a substance-related disorder, a sexual dysfunction, an
`
`eating disorder, obesity, fibromyalgia, a sleeping disorder, a psychiatric disorder, cerebral infarct,
`
`tension, side-effects in the treatment of hypertension, a cerebral disorder, chronic pain, acromegaly,
`
`hypogonadism, secondary amenorrhea, premenstrual syndrome and undesired puerperal lactation, or
`
`combinationsthereof, comprising administering to the patient in need thereof the pharmaceutical
`
`composition of claim 66.
`
`ME! 16433226v.1
`
`
`
`Application No. Not Yet Assigned
`Preliminary Amendment dated September 16, 2013
`
`Docket No.: 120140-00110
`
`68. (New) A methodoftreating a patient suffering from a depressive disorder, an anxiety
`
`disorder, a bipolar disorder, mania, dementia, a substance-related disorder, a sexual dysfunction, an
`
`eating disorder, obesity, fibromyalgia, a sleeping disorder, a psychiatric disorder, cerebral infarct,
`
`tension, side-effects in the treatment of hypertension, a cerebral disorder, chronic pain, acromegaly,
`
`hypogonadism, secondary amenorrhea, premenstrual syndrome and undesired puerperal lactation, or
`
`combinations thereof, comprising administering to the patient in need thereof an effective amount of
`
`a compound, wherein the compoundis 1-[4-(5-cyanoindol-3-yl)butyl]-4-(2-carbamoyl-benzofuran-
`
`5-yl)-piperazine hydrochloride monohydratein its crystalline modification (V).
`
`69. (New) A methodoftreating a patient suffering from a depressive disorder, an anxiety
`
`disorder, a bipolar disorder, mania, dementia, a substance-related disorder, a sexual dysfunction, an
`
`eating disorder, obesity, fibromyalgia, a sleeping disorder, a psychiatric disorder, cerebral infarct,
`
`tension, side-effects in the treatment of hypertension, a cerebral disorder, chronic pain, acromegaly,
`
`hypogonadism, secondary amenorrhea, premenstrual syndrome and undesired puerperal lactation, or
`
`combinations thereof, comprising administering to the patient in need thereof an effective amount of
`
`a compoundof claim 56.
`
`70. (New) A pharmaceutical composition comprising a compound accordingto claim 56,
`
`and one or more conventional auxiliary substances and/orcarriers.
`
`ME! 16433226v.1
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`
`
`Application No. Not Yet Assigned
`Preliminary Amendment dated September 16, 2013
`
`Docket No.: 120140-00110
`
`REMARKS
`
`Pursuant to 37 C.F.R. §1.78(a), the specification has been amended to include a cross
`
`reference to the Related Applications. No new matter has been added.
`
`Claims 1-55 are canceled. Claims 56-70 are new. Support for claims 56-70 is foundin the
`
`specification and in the claimsas originally filed. Upon entry of the claim amendmentsset forth
`
`above, claims 56-70 will be pending in the application. No new matter has been added.
`
`Claims 60-64 are similar to claims 58-62 of abandonedapplication 12/945,260 (published as
`
`U.S. 2011/0183994) filed on November 12, 2010. Applicants respectfully point out that claims 58-
`
`62 of patent application 12/945,260 were indicated as allowable during prosecution, prior to
`
`abandonmentof the application. See, Non-Final Office Action ofApplication No.: 12/945,260,
`
`mailed August 17, 2011, at page 17, second paragraph, thereof. In view of the foregoing,
`
`allowance of the subject claims is respectfully requested.
`
`If a telephone conversation with Applicants’ attorney would help expedite the prosecution of
`
`the instant application, the Examineris urged to call Applicants’ attorney/agent at (617) 449-6500.
`
`The Commissioneris hereby authorized to charge any fees associated with the filing of this
`
`communication to our Deposit Account No. 50-4876, under Order No. 120140-00110 from which
`
`the undersigned is authorized to draw.
`
`Dated: September 19, 2013
`
`Respectfully submitted,
`
`/Danielle L. Herritt/
`
`Electronic signature:
`Danielle L. Herritt
`Registration No.: 43,670
`MCCARTER & ENGLISH, LLP
`265 Franklin Street
`Boston, Massachusetts 02110
`(617) 449-6500
`(617) 607-9200 (Fax)
`Attorney/Agent For Applicant
`
`ME! 16433226v.1
`
`
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