PATENT COOPERATION TREATY
`
`PC T/U82015/037249
`
`From the INTERNATIONAL SEARCHING AUTHORITY
`
`WILSON SONSINI GOODRICH & ROSATI 650 PAGE MILL
`ROAD PALO ALTO CA 94304 USA
`
`To:
`
`HOSTETLER, MICHAEL J.
`
`
`
`
`International application No.
`PCT/US2015/0372 49
`
`Applicant
`
`Authority have been established and are transmitted herewith.
`Filing of amendments and statement under Article 19:
`The applicant is entitled, if he so wishes, to amend the claims of the international application (see Rule 46):
`When? The time limit for filing such amendments is normally two months from the date of transmittal of the
`international search report.
`How? Directly to the International Bureau of WIPO preferably through ePCT or on paper to, 34 chemin des
`Colombettes 1211 Geneva 20, Switzerland, Facsimile No.: +41 22 338 82 70
`
`For more detailed instructions, see PCTApplicant’s Guide, International Phase, paragraphs 9.004 . 9-011.
`
`The applicant is hereby notified that no international search report will be established and that the declaration under
`Article 17(2)(a) to that effect and the written opinion of the International Searching Authority are transmitted herewith.
`
`With regard to any protest against payment of (an) additional fee(s) under Rule 40.2, the applicant is notified that:
`the protest together with the decision thereon has been transmitted to the International Bureau together with any
`request to forward the texts of both the protest and the decision thereon to the designated Offices.
`
`|:| no decision has been made yet on the protest; the applicant will be notified as soon as a decision is made.
`4. Reminders
`
`The applicant may submit comments on an informal basis on the written opinion of the International Searching Authority to the
`International Bureau. The International Bureau Will send a copy of such comments to all deSIgnated Offices unless an International
`preliminary examination report has been or is to be established. Following the expiration of 30 months from the priority date, these
`comments will also be made available to the public.
`
`Shortly after the expiration of 18 months from the priority date, the international application will be published by the International
`Bureau. If the applicant wishes to avoid or postpone publication, a notice of withdrawal of the international application, or of the
`priority claim, must reach the International Bureau before the completion of the technical preparations for international publication
`(Rules 90bis.1 and 90bis.3).
`
`Within 19 months from the priority date, but only in respect of some designated Offices, a demand for international preliminaiy
`examination must be filed if the applicant wishes to postpone the entry into the national phase until 30 months from the priority date
`(in some Offices even later); otherwise, the applicant must, within 20 months from the priority date, perform the prescribed acts for
`entry into the national phase before those designated Offices. In respect of other designated Offices, the time limit of 30 months (or
`later) will apply even if no demand is filed within 19 months. For details about the applicable time limits, Office by Office, see
`www.wipo.int/chen/texts/time_limits.html and the PCTApp/icanl's Guide, National Chapters.
`
`Within 19 months from the priority date, the applicant may request that a supplementary international search be carried out by an
`International Searching Authority, that offers this service (Rule 45bis.1). The procedure for requesting supplementary international
`search is described in the PCT Applicant’s Guide, International Phase, paragraphs 8006-8032.
`
`Name and mailing address of the ISA/KR
`.
`-
`International Application Division
`' § Korean Intellectual Property Office
`, 189 Cheongsa-ro, Seo-gu, Daejeon Metropolitan City, 35208,
`Republic of Korea
`Facsimile No. 82-42-472-7140
`Form PCT/ISA/220 (July 2014)
`
`Authorized officer
`
`COMMIS SIONER
`
`Telephone No. 82-42-481-5875
`
`P C T
`
`,
`NOTIFICATION OF TRAN SMlTTAL OF
`THE INTERNATIONAL SEARCH REPORT AND
`THE WRITTEN OPINION OF THE INTERNATIONAL
`SEARCHING AUTHORITY, OR THE DECLARATION
`
`(PCT Rule 44.1)
`
`Date of mailing
`(day/monlh/year)
`
`30 September 2015 (30.09.2015)
`
`FOR FURTHER ACTION See paragraphs 1 and 4 below
`
`International filing date
`(day/WWW)
`23 June 2015 (23.06.2015)
`
`
`
`Applicant's or agent's file reference
`46682-70160]
`
`SYDNEXIS, INC. The applicant is hereby notified that the international search report and the written opinion of the international Searching
`
`

`

`Email: ipkc@ipkcenter.com
`
`Inquiries related to PCT International Search Report or Written Opinion prepared by KIPO as an International
`Searchng Authority can be answered not only by KIPO but also through IPKC (Intellectual Property Korea
`Center), located in Vienna, VA, which functions as a PCT Help Desk for PCT applicants.
`
`* Attention
`
`Copies of the documents cited in the international search report can be searched in the following Korean
`Intellectual Property Office English website for six months(expire date : 2016.03.30
`) from the date of
`mailing of the international search report.
`
`http://wwwtkipotgotkr/en/ => PCT SCl‘ViCCS =\ PCT SCI‘ViCCS
`
`ID : PCT international application number
`PW : P324W86Q
`
`Homepage: http://www.ipkcentercom
`
`Notes to Form PCT/ISA/220 (July 2014)
`
`

`

`PATENT COOPERATION TREATY
`
`PCT
`INTERNATIONAL SEARCH REPORT
`
`(PCT Article 18 and Rules 43 and 44)
`
`PCT/US2015/037249
`
`Applicant 5 or agent 5 file reference
`46682-701601
`
`FOR FURTHER
`ACTION
`
`see Form PCT/lSA/220
`as well as. where applicable. item 5 below.
`
`International application No.
`
`International filing date (day/mnnth/year)
`
`(Earliest) Priority Date (day/monIh/year)
`
`PCT/U S2015/037249
`
`23 June 2015 (23.06.2015)
`
`24 June 2014 (24.06.2014)
`
`Applicant
`
`SYDNEXIS, INC.
`
`This International search report has been prepared by this International Searching Authority and is transmitted to the applicant according
`to Article 18. A copy is being transmitted to the International Bureau.
`
`This international search report consists of a total of
`
`4
`
`sheets
`
`D It is also accompanied by a copy of each prior art document cited in this report.
`
`Basis of the report
`a. With regard to the language, the international search was carried out on the basis of :
`
`the international application in the language in which it was filed
`
`, which is the language of a
`a translation of the international application into
`translation furnished for the purposes of international search (Rules 12.3(a) and 23.1(b))
`b. D This international search report has been established taking into account the rectification of an obvious mistake
`authorized by or notified to this Authority under Rule 91 (Rule 43.6bis(a)).
`c. D With regard to any nucleotide and/0r amino acid sequence disclosed in the international application, see Box No. I.
`
`
`
`X] Certain claims were found unsearchable (See Box No. II)
`
`D Unity of invention is lacking (See Box No. III)
`
`With regard to the title,
`IX] the text is approved as submitted by the applicant.
`D the text has been established by this Authority to read as follows:
`
`With regard to the abstract,
`
`X] the text is approved as submitted by the applicant.
`D the text has been established. according to Rule 38.2. by this Authority as it appears in Box No. IV. The applicant
`may, within one month from the date of mailing of this international search report, submit comments to this Authority.
`
`6. With regard to the drawings,
`
`a.
`
`the figure of the drawings to be published with the abstract is Figure No.
`as suggested by the applicant.
`
`10
`
`El as selected by this Authority, because the applicant failed to suggest a figure.
`D as selected by this Authority, because this figure better characterizes the invention.
`b. D none of the figures is to be published with the abstract.
`
`Form PCT/ISA/210 (first sheet) (January 2015)
`
`

`

`INTERNATIONAL SEARCH REPORT
`
`International application No.
`PCT/US2015/037249
`
`Box No. II Observations where certain claims were found unsearchahle (Continuation of item 2 of first sheet)
`
`This international search report has not been established in respect of certain claims under Article 17(2) (a) for the following reasons:
`
`1.
`
`2.
`
`3.
`
`Claims Nos: 19-21
`because they relate to subject matter not required to be searched by this Authority, namely:
`Claims 19-21 pertain to methods for treatment of the human body by therapy, and thus relate to a subject matter which this
`International Searching Authority is not required, under PCT Article l7(2)(a)(i) and PCT Rule 39.1(iv), to search.
`
`’1‘ Claims Nos: 13, 20
`’
`because they relate to parts of the international application that do not comply with the prescribed requirements to such an
`extent that no meaningful international search can be carried out, specifically:
`Claims 13 and 20 are unclear, since they refer to one of claims which are not drafted in accordance with PCT Rule 6.4(a) (PCT
`Article 6).
`
`Claims Nos: 5—12, 14-19, 21, 25-30
`because they are dependent claims and are not drafted in accordance with the second and third sentences of Rule 6.4(a).
`
`
`
`Box No. “I Observations where unity of invention is lacking (Continuation of item 3 of first sheet)
`
`This International Searching Authority found multiple inventions in this international application, as follows:
`
`1. D As all required addtional search fees were timely paid by the applicant, this international search report covers all searchable
`claims.
`
`2. D As all searchable claims could be searched without effort justifying an additional fees, this Authority did not invite payment
`of any additional fees
`
`3. D As only some of the required additional search fees were timely paid by the applicant, this international search report covers
`only those claims for which fees were paid, specifically claims Nos:
`
`4. D No required additional search fees were timely paid by the applicant. Consequently,
`restricted to the invention first mentioned in the Claims;
`it is covered by Claims Nos:
`
`this international search report is
`
`Remark on Protest D The additional search fees were accompanied by the applicant's protest and, where applicable, the
`payment of a protest fee.
`The additional search fees were accompanied by the applicant's protest but the applicable protest
`fee was not paid within the time limit specified in the invitation.
`D No protest accompanied the payment of additional search fees.
`
`Form PCT/ISA/210 (continuation of first sheet (2)) (January 20 15)
`
`

`

`INTERNATIONAL SEARCH REPORT
`
`International application No.
`PCT/US2015/037249
`
`A.
`
`CLASSIFICATION OF SUBJECT MATTER
`
`A61K 31/46(2006.01)i, A61K 31/245(2006.01)i, A61K 9/08(2006.01)i, A61P 27/02(2006.01)i
`
`According to International Patent Classification (IPC) or to both national classification and [PC
`FIELDS SEARCHED
`
`Minimum documentation searched (classification system followed by classification symbols)
`A61K 31/46; A61K 31/135; A61P 29/00; A61K 31/55; A61K 31/505; A61K 9/50; A61K 47/32; A61K 47/38; A61K 47/42; A61K 38/13;
`C07D 401/14; A61K 31/245; A61K 9/08; A61P 27/02
`
`Documentation searched other than minimum documentation to the extent that such documents are included in the fields searched
`Korean utility models and applications for utility models
`Japanese utility models and applications for utility models
`
`Electronic data base consulted during the international search (name of data base and, where practicable, search terms used)
`eKOlVIPASS(KIPO internal) & Keywords: ophthalmic composition, muscarinic antagonist, deuterated water, shelf life, stability
`
`C. DOCUMENTS CONSIDERED TO BE RELEVANT
`
`Category*
`
`Citation of document, with indication, where appropriate, of the relevant passages
`
`Relevant to claim No.
`
`US 5716952 A (WOLDEMUSSIE, E. et al.) 10 February 1998
`See columns 2, 4; and table 1.
`
`W0 97716192 A1 (MERCK & C0,,
`See pages 2’4, 12.
`
`INC.) 09 May 1997
`
`US 2012’0015035 A1 (WILDSOET, C. F. et a1.) 19 January 2012
`See paragraphs [0030],
`[0031],
`[0075]; and claims 1, 13, 14.
`
`W0 20117019940 A2 (SEROS MEDICAL, LLC) 17 February 2011
`See the whole document.
`
`
`
`US 201270028910 A1 (COMBAL, JrP. et a1.) 02 February 2012
`See the whole document.
`
`
`
`
`
`
`
`
`
`*
`"A"
`
`"E"
`
`"L"
`
`El Further documents are listed in the continuation of Box C.
`Special categories of cited documents:
`document defining the general state ofthe art which iS not considered
`to be of particular relevance
`earlier application or patent but published on or after the international
`filing date
`document which may throw doubts on priority claim(s) or which is
`cited to establish the publication date of another Citation or other
`special reason (as specified)
`document referring to an oral disclosure, use, exhibition or other
`means
`document published prior to the international filing date but later
`than the priority date claimed
`
`"T"
`
`See patent family annex.
`later document published after the international filing date or priority
`date and not in conflict with the application but cited to understand
`the principle or theory underlying the invention
`document of particular relevance; the claimed invention cannot be
`considered novel or cannot be considered to involve an inventive
`step when the document is taken alone
`document of particular relevance; the claimed invention cannot be
`considered to involve an inventive step when the document is
`combined with one or more other such documents,such combination
`being obvious to a person skilled in the art
`"&" document member of the same patent family
`
`Date of the actual completion of the international search
`
`Date of mailing of the international search report
`
`30 September 2015 (30.09.2015)
`
`30 September 2015 (30.09.2015)
`
`Name and mailing address of the ISA/KR
`International Application Division
`\
`\ Korean Intellectual Property Office
`189 Chcongsa—ro, Sco—gu, Dacjcon Metropolitan City, 35208,
`Republic of Korea
`
`Authorized officer
`
`LEE’ Jeong A
`
`Facsimile No. +82-42-472-7140
`
`Telephone No. +82-42-481-8740
`
`Form PCT/ISA/210 (second sheet) (January 2015)
`
`

`

`INTERNATIONAL SEARCH REPORT
`
`Information on patent family members
`
`International application No.
`
`PCT/U520 15/037249
`
`Pmentdocunmnt
`cited in search report
`
`PubHcafion
`date
`
`Pamntfinnfly
`member(s)
`
`PubHcafion
`date
`
`2132007 C
`0634932 A1
`0634932 B1
`93-18772 A1
`
`7528696 A
`
`8883214 B2
`2010-083129 A2
`2010-083129 A9
`
`2464387 A2
`2464387 A4
`2012-0203161 A1
`2011-019940 A3
`
`2008-309923 A1
`2008-309923 B2
`P10819081 A2
`2702082 A1
`101820917 A
`101820917 B
`019867 B1
`201000441 A1
`2195033 A1
`1147937 A1
`2010-540671 A
`5640207 B2
`2010003774 A
`584275 A
`2009-046967 A1
`
`18/07/2006
`04/10/2001
`19/06/2002
`30/09/1993
`
`22/05/1997
`
`11/11/2014
`22/07/2010
`09/12/2010
`
`20/06/2012
`15/05/2013
`09/08/2012
`16/06/2011
`
`16/04/2009
`03/04/2014
`22/04/2015
`16/04/2009
`01/09/2010
`02/01/2013
`30/06/2014
`29/10/2010
`16/06/2010
`13/09/2013
`24/12/2010
`17/12/2014
`27/04/2010
`29/06/2012
`
`16/04/2009
`
`US 5716952 A
`
`10/02/1998
`
`W0 97-16192 A1
`
`IE 2012-0015035 A1
`
`09/05/1997
`
`19/01/2012
`
`W0 2011*019940 A2
`
`17/02/2011
`
`US 2012-0028910 A1
`
`02/02/2012
`
`Form PCT/ISA/210 (patent family annex) (January 2015)
`
`

`

`From the
`INTERNATIONAL SEARCHING AUTHORITY
`
`PATENT COOPERATION TREATY
`
`PCT/US2015/037249
`
`THOSTETLER, MICHAEL J.
`WILSON SONSINI GOODRICH & ROSATI 650 PAGE
`
`MILL ROAD PALO ALTO CA 94304 USA
`
`PC T
`
`WRITTEN OPINION OF THE
`INTERNATIONAL SEARCHING AUTHORITY
`
`(PCT Rule 43bis.1)
`
`
`
`
`
`
`
`
`
`Date of mailing—daV/monflz/Vear)30_eptember2015 (30.09.2015)
`
`
`
`Applicant's or agent's file reference
`
`FOR FURTHER ACTION
`
`23 June 2015 (23.06.2015)
`PCT/USZOIS/037249
`International Patent Classification (IPC) or both national classification and [PC
`
`24 June 2014 (24.06.2014)
`
`A61K 31/460006. 01)i, A61K 31/245(2006. 01)i, A61K 9/08(2006. 01)i, A61P27/02(2006. 01)i
`
`Applicant
`SYDNEXIS, INC.
`
`1, This opinion contains indications relating to the following items:
`
`Box \0. I
`
`Basis of the opinion
`
`
`
`Box \ 0. II
`
`Box \0. III
`
`Box \0. IV
`
`Box \0. V
`
`Box \o. VI
`
`Box \o, VII
`
`
`
`
`
`Priority
`
`Non-establishment of opinion with regard to novelty, inventive step and industrial applicability
`
`Lack ofunity of invention
`
`Reasoned statement under Rule 43bis.1(a)(i) with regard to novelty, inventive step and industrial applicability;
`Citations and explanations supporting such statement
`Certain documents cited
`
`Certain defects in the international application
`
`Box \o, VIII Certain observations 011 the international application
`
`FURTHER ACTION
`
`If a demand for international preliminary examination is made, this opinion will be considered to be a written opinion of the
`International Preliminary Examining Authority ("IPEA") except that this does not apply where the applicant chooses an Authority
`other than this one to be the IPEA and the chosen IPEA has notified the lntemational Bureau under Rule 66.1bis(b) that written
`opinions of this International Searching Authority will not be so considered.
`
`Ifthis opinion is, as provided above, considered to be a written opinion of the IPEA, the applicant is invited to submit to the
`IPEA 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 of 22 months from the priority date, whichever expires later.
`For further options, see Form PCT/ISA/ZZO,
`
`Name and mailing address of the ISA/KR
`~
`Internatlonal Application Division
`\nKorean Intellectual Property Office
`>189 Chcongsa-ro, Sco-gu, Dacicon
`Metropolitan City, 35208, Republic of Korea
`Facsimile No.
`|82-42-472-7140
`
`Form PCT/ISA/237 (cover sheet) (January 2015)
`
`Date of completion of this opinion Authorized officer
`
`30 Septe111be1’2015 (3009,2015)
`
`LEE, Jeong A
`
`Telephone No. +82-42-481-8740
`
`

`

`WRITTEN OPINION OF THE
`INTERNATIONAL SEARCHING AUTHORITY
`
`ti N .
`1'
`1
`ti
`1 t
`“em 011a app m on 0
`P C T/ U 820 1 5/037249
`
`Box No. I Basis of this opinion
`
`1. With regard to the language, this opinion has been established on the basis of :
`
`E the international application in the language in which it was filed
`
`which is the language of a
`El a translation of the international application into
`translation furnished for the purposes of international search (Rules 12.3(a) and 23.1(b))
`
`2. El This opinion has been established taking into account the rectification of an obvious mistake authorized by or notified
`to this Authority under Rule 9] (Rule 43bis. 1(a))
`
`3. El With regard to any nucleotide and/or amino acid sequence disclosed in the international application, this opinion has
`been established on the basis of a sequence listing:
`
`a. El forming part of the international application as filed:
`CI in the form of an Annex C/ST.25 text file.
`D on paper or in the form of an image file.
`
`
`
`b. D furnished together with the international application under PCT Rule 13ter. 1(a) for the purposes of international
`search only in the form of an Annex C/ST.25 text file.
`
`c. El furnished subsequent to the international filing date for the purposes of international search only:
`CI in the form of an Annex C/ST.25 text file (Rule 131w. 1(a)).
`El on paper or in the form of an image file (Rule l3ter.1(b) and Administrative Instructions, Section 713).
`
`4. El In addition, in the case that more than one version or copy of a sequence listing has been filed or furnished, the required
`statements that the information in the subsequent or additional copies is identical to that forming part of the application as
`filed or does not go beyond the application as filed, as appropriate, were furnished.
`
`5. Additional comments:
`
`Form PCT/lSA/237 (Box No. l)( January 2015)
`
`

`

`WRITTEN OPINION OF THE
`INTERNATIONAL SEARCHING AUTHORITY
`
`International application No.
`PCT/US2015/037249
`
`Box No. 111 Non-establishment of opinion with regard to novelty, inventive step and industrial applicability
`
`The questions whether the claimed invention appears to be novel, to involve an inventive step (to be non obvious), or to be
`industrially applicable have not been examined in respect of:
`
`D the entire international application
`XI claims Nos. 5-21, 25-30
`
`because:
`
`El the said international application, or the said claims Nos. 19-21
`relate to the following subject matter which does not require an international search (51166034):
`
`The subject matter of claims 19-21 relates to a method for treatment of the human body by therapy (PCT Rule 43bis. i(b),
`Rule 67.1(iv)).
`
`XI the description, claims or drawings (indicate particular elements below) or said claims Nos.
`are so unclear that no meaningful opinion could be formed (spew/31):
`
`13> 20
`
`Claims 13 and 20 are unclear since they refer to one of the claims which are not drafted in accordance with PCT Rule 6.4(a)
`(PCT Article 6).
`
`D the claims, or said claims Nos.
`by the description that no meaningful opinion could be formed (Speclfid:
`
`are so inadequately supported
`
`D See Supplemental Box for further details.
`
`XI no international search report has been established for said claims Nos. 5'21: 25'30
`
`D a meaningful opinion could not be formed without the sequence listing; the applicant did not, within the prescribed time limit:
`
`|:| furnish a sequence listing in the form of an Annex C/ST.25 text file, and such listing was not available to the
`International Searching Authority in the form and manner acceptable to it; or the sequence listing furnished did not
`comply with the standard provided for in Annex C of the Administrative instructions.
`
`|:| furnish a sequence listing on paper or in the form of an image file complying with the standard provided for in Annex
`C of the Administrative instructions, and such listing was not available to the international Searching Authority in the
`form and manner acceptable to it; or the sequence listing furnished did not comply with the standard provided for in
`Annex C of the Administrative Instructions.
`
`pay the required late furnishing fee for the furnishing of a sequence listing in response to an invitation under Rule
`lSter.l(a) 01' (b).
`
`Form PCT/ISA/237 (Box No. III) (January 2015)
`
`

`

`WRITTEN OPINION OF THE
`INTERNATIONAL SEARCHING AUTHORITY
`
`International application No.
`PCT/USZO 1 5/037249
`
`Box No. V Reasoned statement under Rule 43bis.l(a)(i) with regard to novelty, inventive step or industrial applicability;
`citations and explanations supporting such statement
`
`1. Statement
`
`Novelty (N)
`
`Claims
`Claims
`
`1-4,22-24
`NONE
`
`Inventive step (IS)
`
`Claims
`
`1'4
`
`Industrial applicability (IA)
`
`Claims
`
`22—24
`
`Claims
`
`Claims
`
`1-4,22-24
`
`NONE
`
`2. Citations and explanations :
`
`
`
`>'<' The word “pirenzapine” of claims 2 and 23 is considered to be a typo for “pirenzepine”.
`
`Reference is made to the following documents:
`
`D1: US 5716952 A (WOLDEMUSSIE, E. et a1.) 10 February 1998
`
`D2: W0 97-16192 A1 (MERCK & CO.,
`
`lNC.) 09 May 1997
`
`D3: US 2012-0015035 A1 (VVILDSOET, C. F. et a1.) 19 January 2012
`
`D4: W0 2011—019940 A2 (SEROS MEDICAL, LLC) 17 February 2011
`
`D5: US 2012-0028910 A1 (COMBAL, J.-P. et al.) 02 February 2012
`
`2.1. Novelty and Inventive Step
`
`2.1.1. Claim 1
`
`Claim 1
`
`relates to an ophthalmic composition comprising from about 0.001 wt% to about 0.05
`
`wt% of a muscarinic antagonist and deuterated water, at a pD of from about 4.2 to about 7.9.
`
`D], which is considered to be the closest prior art
`
`to the subject matter of claim 1, discloses
`
`an ophthalmic formulation comprising about 0.0001 to about 0.1 %W/V of a muscarinic
`
`antagonist compound, pH adjuster, and purified water (see column 2,
`
`lines 50, 51; column 4,
`
`lines 50-54, and table l
`
`in Dl).
`
`Claim 1 differs from D1 in that
`
`the ophthalmic composition comprises deuterated water, and
`
`said difference is not disclosed in any other available prior art documents D2-D5. Furthermore,
`
`the applicant has shown that
`
`the ophthalmic composition comprising deuterated water in the
`
`present claim provides a more stabilized ophthalmic composition with extended shelf life upon
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`Continued on Supplemental Box
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`Form PCT/ISA/237 (Box No. V) (January 2015)
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`

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`WRITTEN OPINION OF THE
`INTERNATIONAL SEARCHING AUTHORITY
`
`I
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`' N .
`1'
`1
`'
`memuom applcauon 0
`PCT/U $201 5/037249
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`Box No. VII Certain defects in the international application
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`The following defects in the form or contents of the international application have been noted:
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`Claims 5-12, 14-19, 21 and 25-30 do not comply with PCT Rule 6.4(a) because multiple dependent claims shall not serve as a basis
`for any other multiple dependent claim.
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`alternative.
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`Claim 19 does not comply with PCT Rule 6.4(a) because the multiple dependent claim does not refer to other claims in the
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`Form PCT/ISA/237 (Box No. VII) (January 2015)
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`

`

`WRITTEN OPINION OF THE
`
`International application No.
`
`INTERNATIONAL SEARCHING AUTHORITY
`
`PCT/U S201 5/037249
`
`Supplemental Box
`
`In case the space in any of the preceding boxes is not sufficient.
`Continuation of : Box No. V
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`
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`storage, compared to an ophthalmic composition comprising regular water. Accordingly, claim 1
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`is not anticipated by any of the documents D1-D5, nor
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`is
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`it obvious from the documents,
`
`taken individually or in any combination. Therefore, claim 1
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`is novel and involves an inventive
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`stcp undcr PCT Article 33(2) and (3).
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`2.1.2. Claims 2-4
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`Claims 2-4 are essentially dependent on claim 1 and therefore meet
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`the requirements of PCT
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`Article 33(2) and (3).
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`2.1.3. Claim 22
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`Claim 22 relates to an ophthalmic composition comprising from about 0.001 wt% to about 0.05
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`wt% of a muscarinic antagonist and water, at a pH of from about 3.8 to about 7.5.
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`D1, which is considered to be the closest prior art to the subject matter of claim 22, discloses
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`an ophthalmic formulation comprising about 0.0001 to about 0.1 %W/V of a muscarinic
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`antagonist compound, a pH adjustor, and purified water (see column 2,
`
`lines 50, 51, column 4,
`
`lines 50-54; and table 1
`
`in D1).
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`Claim 22 differs from D1 in the ranges of the amount of the muscarinic antagonist and pH.
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`However, said differences appear to come within the scope of the customary practice followed
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`by a person skilled in the art. Moreover,
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`the applicant has not shown that
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`the ranges of
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`amount and pH defined in the present claim produce an unexpected beneficial effect compared
`
`to those in D1. Therefore, claim 22 lacks an inventive step under PCT Article 33(3) as being
`obvious over Dl.
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`2.1.4. Claim 23
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`Claim 23, dependent on claim 22, defines the sort of muscarinic antagonist. As Dl discloses
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`pirenzepine as
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`the muscarinic antagonist compound (see column 2,
`
`lines 50, 51 in D1),
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`it
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`would have been obvious for a person skilled in the art to arrive at the invention of claim 23.
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`Therefore, claim 23 lacks an inventive step under PCT Article 33(3) as being obvious over Dl.
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`Continued on The Next Page
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`Form PCT/ISA/237 (Supplemental Box) (January 2015)
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`Claim 24, dependent on claim 22 or 23, defines the ophthalmic composition as comprising at
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`least about 80% of the muscarinic antagonist based on initial concentration after extended
`
`period of time under storage condition. Although D1 does not disclose the additional feature of
`
`claim 24, said feature is merely a property of the composition, and a person skilled in the art
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`would easily arrive at the claimed invention by general experimentation alone Without exercising
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`2.2. Industrial Applicability
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`Claims 1-4 and 22-24 are industrially applicable under PCT Article 33(4).
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`WRITTEN OPINION OF THE
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`International applie ation No.
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`INTERNATIONAL SEARCHING AUTHORITY
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`PCT/U S201 5/037249
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`Supplemental Box
`
`In case the space in any of the preceding boxes is not sufficient.
`Continuation of : Previous Page
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`2.1.5. Claim 24
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`any ingenuity. Therefore, claim 24 lacks an inventive step under PCT Article 33(3) as being
`obvious over Dl.
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`
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`Form PCT/ISA/237 (Supplemental Box) (January 2015)
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`