13/04/3003 17=45
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`ST*PN
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`Data
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`Your rafaranca
`
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`Our rufurunca
`
`Ourlutlar dated
`
`Contact
`Dr Slowasser
`
`:j;“§j‘f'_;_;9_259g
`TE,“
`+49 241 569-2655
`E-Mall
`
`ggfljanthaljcum
`
`GFIUNENTHAL GMBH
`
`Griinenlhal GmbH - 52099 Aachen — Germany
`
`Europaisches Patentamt
`Erhardtstrafle 27
`
`Munchen
`
`.
`
`T
`
`—
`
`Patent Application No. 05 770 026.2 - 2103
`Our reference: GRA 3111-EP I ST-PN I RS-KN
`
`Reply to the communicationaccording Article 96(2) EPC
`
`reply to the communication according Article 96(2) EPC an
`In
`amended claim set is provided on a separate sheet. We are confident
`that the examiner's objections with respect to the formal issues 1.1,
`1.2, 1.3. and 2 of the office action have been overcome by the
`amendments. Regarding the formal objections 1.1, we would like to
`emphasis that claim 2, 3 and 4 are dependent claims of claim 1 and
`that is stated in the description on page 2, line 19-25, that crystalline
`form A is best and sufficient described by the parameters recited in
`claim 1.
`
`Regarding 3:
`The subject matter of the present claims are regarded as being novel
`by the examination division.
`
`Regarding 4:
`The applicant provides with the enclosed “experiment 1" data that the
`novel crystalline form A is inventive over the prior art: The crystalline
`form B disclosed in D1 has the disadvantage that under the influence
`of pressure (which occurs e.g.
`in the manufacturing process for the
`drug tablet) polymorph B (crystalline form of D1) is transformed in a
`mixture of the crystalline forms A and B.
`-
`
`The underlined problems can be defined in view of D1 to find a
`crystalline form which can be used in a manufacturing process of drug
`tablets. Surprisingly and shown by the data enclosed in Table 1
`the
`.;«"**=g,
`crystalline form A claimed in the pending application shows stability
`regarding high pressure. There can be no mixture of polymorphs A W
`and B detected up to the limit of quantification (LOQ) with the starting
`material B. The experiment shows clear evidence for a changein the
`
`EMA5
`Verified Environmental
`Management, D-101-00034
`
`VEr0s?t|;g':9 érglbcipl.-Psych. Wolfgang Becker, Dipl,-Kim. Stefan Genlen, Prof. Dr. Eric-Paul Péques,
`Diplxlng. Sebastian Wirtz Sitz der Gesellschaft Aachen Flegislergericl-it: A:-nisgsrichl Aachen, HFIB Nr. 3546 ust.-ID NAT]: DE121737755 St.Nr. 202 5804 D019
`Eankvarbindungen: Sparkasse Aachen, BLZ 390 500 O0, Kto 181 B0 04, BlI3 AACSDE33. IBAN DEZO 3905 D000 DOD1 8180 D4 ABN AMRO Bank N.V.. BLZ 502 304 O0.
`K10 16 67 27 00 01, Eli} ABNADEFFFHA. IBAN DE30 5023 D400 1667 2700 O1 Lieteranschrift: Zieglerslrafie 6, 52078 Aachen. Te|.: +49 241 5690. Fax: +49 241 56943300
`eived at the E’l5°C3°5‘i'i'7iE)rfJ"1ri§‘f"§'6b5§21g? :"s°l?is.??”‘f5E‘e'i**§.“la”1“t*if“‘l*‘“‘““"°°”
`
`
`
`
`
`0238011086001582
`
`ReC)
`
`RS 1004 - 000001
`
`

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`13/04/3003 17=47
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`ST*PN
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`iFAX)+49 241 5592555
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`p.002/our
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`_.(l_
`GRUNENTHALT
`
`modification of all form B batches exposed to pressure of 2 tons within
`only 60 seconds. All form A batches remain unchanged.
`
`In the case the amended claim set enclosed are considered to be not
`allowable by the examination division, a further official communication
`or, as an auxiliary request, oral proceedings are requested before any
`decision is taken other than the grant of the patent.
`
`Furthermore the applicant asks to postpone the amendments of the
`description until
`the examination division agreed on the amended
`claim set.
`
`Yours sincerely,
`Grtinenthal GmbH
`
`. Dr. Hellfel
`
`t
`
`I. V. Dr. Stowasse
`
`Enclosures:
`
`- Table 1 with experimental data
`o
`amended claim set
`
`0
`
`self-addressed envelope (by mail only)
`
`6D3WJOB.CJ4 F:\Pn\Patente\KOR\Gra31 1 1\G RA 3111 EP_Cl8Cl22'1_KN_dDc
`2
`
`Received at the EPO on Apr 18, 2008 17:51 :57. Page 2 of 7
`
`RS 1004 - 000002