. PATENT COOPERATION TREATY From the IRIN cmoNAL seARCHING AUTHORITY WECD 26 4 UG 2009 fa Tas v.comnaan PC Hen See ec ee mae orien tae NEWYORK NY louse WRITTEN OPINION OF THE INTERNATIONAL SEARCHING AUTHORITY (PCT Rule 436is.1) Tae ara 5 ; (asiontijeer) 24 AUG 03 oes a a rermormear Me 153082005 vey 0 p92) International Patent Classification (IPC) or both national classification and TPC IPCC): AGIK 6/00, 928; AOIN 25/34 and US CL: 424/401, 408, 441 ‘Applicant ‘SOLAPHARM, INC. |. This opinion contains indications relating to the following items: Box No.! Basis ofthe opinion BoxNoll Priority [7] Boxe. mt Non-stbistment of opinion with fegard to novelty, inventive step and indus applicability BoxNo IV Lack of wit ofinvention Box No. V _Reasoned statement under Rule 4bis.1(a)() with regard to novelty, inventive step or industrial applicability; citations and explanations supporting such statement Box No. VI Certain documents cited Box No. VII Certain deftets in the international epplicstion Box No, VIII Certain observations on the international application 2. FURTHER ACTION {fe demand for istermational preliminary examination is mede, this opinion will be considered to be a written opinion of the Interational Preliminary Examining Authority ("IPEA") excapt that this does not apply where the applicant cheoses an ‘Authority other than this one tobe the [PEA. and the chosen IPEA has notified the Intemational Bureau under Rule 66.161(8) ‘hat written opinions ofthis International Searching Authority wil not be so considered. If this opinion is, as provided above, considered to be a written opinion ofthe IPEA, the applicant is invited to submit to the PEA a written reply together, where appropriate, with amendments, before the expiration of 3 months from the date of mailing of Form PCT/ISA/220 or before the expiration of22 months from the priority dato, Whichever expire ater For further options, see Form PCTASA/220. 3. For further details, see note to Form PCTISA/220, J Name and mailing dikes of he ISAT US Auhories Chie Mal Stop PCT, Ate: ISA/US CCommstioner for Patents David 0, Box 450. Alesana, Virginie 22313-1450 Facsimile No. (571) 273-8300, Form PCTVISA/237 (eover shel) January 3008) ‘Telephone No. (571) 272.3108Tilematonal application No. WRITTEN OPINION OF THE INTERNATIONAL SEARCHING AUTHORITY PCT/USOS/18638 Box No.1 Basis of this opinion |. With rege to the language, this opinion has been established on the basis ofthe international application in the language in which it ‘was filed, unless otherwise indicated under this item, (C1 tis opinion has been established onthe basis ofa translation from the eriginal language ino the following language, ‘ich isthe language ofa translation furnished for the purposes of international search (under Rules 123 and 23.1(0). 2. With regard to any nucleotide and/or amino acid sequence disclosed in the international application and necessary tothe elaied Jnventon, this opinion has been established on the bass of a. type of material 1 a sequence listing tet reed othe segs iting fat of materi 1 invweiten format (C1 incomparable frm © time of iting/fumishing 1 contsined internat nal application as led. [7 ited together with the international application in computer readable form. Cerise subsequent ois Autor or te poses of seach 3.[1] tn addition, inthe case that more than one version or copy of a sequence listing andor table relating thereto has been filed or furnished, the required stalements thatthe information inthe subsequent or additional copies is identical to tha inthe application a filed or does not go beyond the application s filed, as appropriate, were farished 4. Additional comments Form PCTASAII37(Box No. 1) Ganvary 2004)Tnterational application No, WRITTEN OPINION OF THE PCrvUsos/14e58 INTERNATIONAL SEARCHING AUTHORITY Box No. V Reasoned statement under Rule 43 bis.1(a)() with regard to novelty, inventive step or industrial applicability; citations and explanations supporting such statement 1. Statement Novelty (N) Claims NONE. yes Claims yg NO Inventive step (IS) Claims NONE YES Claims 1-19. NO Industrial applicability (A) Claims Jeg YES Claims NONE. NO 2, Citations and explanations: (Claims 1-18 lack novelty under PCT Artle-33(2) as being anticipated by US 5,756,124 (124), “124 disclose solid pharmaceutical tablets comprising a multiplicity of scores tha fecilitate tablet breakage (abstract), Based on the particular application, the tablet ean be divide iro sections of 1, 1/4, 38, 1/2, 578, 3/4, ot 78 (Figures 1-12 and colurm 4 ines 37= 43), Depending onthe dosage sought, the tablets advanced by ‘124 can be administered a variety of different ways (Figures 1-12 and columa 4, lines 37-43). Like the instantapplication, the tablets comprise bottom and top sections and, depending on how the tablet is ented, the scores are either vertical or horizontal (abstract). Like the instant application the tablets can be engraved with indicia, indicating required dosage (column 3, ine 64-67). I desired the tablet sections ean also be colored o reflect particular dosage unis (column 4, lines 1). It shouldbe noted tet the open claim language Yeomprising” allows fr the presence of elements beyend the cones claimed, Ciaims 1-2, 5-8, 18 lack novelty under PCT Article 33(2) as being anticipated by US 3,927,194 (194), “194 disclose deeply gooved or scored inblets that facilitate breaking (abstract and Figures 1-5). Tho tablets comprise two separate paris divided by ascore (column 1, lines 15-18). Depending on how the tablet is oriented, the scores are either vertzal or horizontal (Figures 1-5). Claims 1-18 lack novelty under PCT Anite 3(2) as being anticipated by US 4,258,027 (027). "027 disclose mali-factonable pharmaceutical tablets (strat). Divided by a multitude of scores, the tablets advanced by ‘027 are «easly broken into haves or thirds (abstract; column 2 ines 25-32; and Figures A-Y). As many a ix mull-ractue dosages may be configured (column 4, tines 20-31 and column 4, lines 55-62). Depending on tke dosage sought, the tablets advanced by 124 an be administered a variety of different ways (Figures A-Y), Like the instant aplication, the tablets advanced by “027 ean be colored and ‘nay additionally comprise a logo (columa 6 ines 38-52). It should be noted tat the open claim language “comprising” allows forthe presence ofelements beyond the ones claimed, Cle 19 lacks an inventive step under PCT Article 33(3) as being cbvicus over US 4,258,027 (027). Since the tablet advanced by 027 is designed to disperse pharmaceutical agents, one of skill in the art would have the ability to imcorporate a variety of dosage forms into the tablet, including pain-related drugs (column 6, lines 41-45). Claims 1-19 meet the criteria set out in PCT Article 33(4), and thus have industrial applicebilisy beeause the subject mater claimed can ‘be made or used in industry Form PCTASAVR31 (Box No, V) Gamuary 2004)