94304
`
`
`PATENT COOPERATION TREATY
`
`PCT/US2022/015092
`
`PCT
`
`NOTIFICATION OF TRANSMITTAL OF
`THE INTERNATIONAL SEARCH REPORT AND
`THE WRITTEN OPINION OF THE INTERNATIONAL
`SEARCHING AUTHORITY, OR THE DECLARATION
`
`(PCT Rule 44.1)
`
`Applicant
`
`
`From the INTERNATIONAL SEARCHING AUTHORITY
`
` To:
`
`
`ALVAREZ-MALO,Ciara
` WILSON SONSINIT650 Page Mill Road Palo Alto, California
`USA
`
`
`
`
`
`Applicant's or agent's file reference
`
`
`46682-710601
` FOR FURTHER ACTION|See paragraphs 1 and 4 below
`
`
`
`International filing date
`International application No.
`daw
`th/vear
`
`(day/monthivedr)
`9% February 2022 (03.02.2022)
`
`PCT/US2022/015092
`
`
`
`
`SYDNEXIS, INC.
`
`
`
`
`
`
`1.
`
`The applicant is hereby notified that the international search report and the written opinion of the International Searching
`Authority have been established and are transmitted herewith.
`Filing of amendments and statement under Article 19:
`The applicantis entitled, if he so wishes, to amend the claims of the international application (see Rule 46):
`When? The timelimit 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 WIPOpreferably 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 PCT Applicant's Guide, International Phase, paragraphs 9.004 . 9-011.
`
`2. [| 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.
`
`3. [| With regard to any protest against payment of (an) additional fee(s) under Rule 40.2, the applicantis 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 madeyet 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. These comments will be made available to the public after international publication. The International
`Bureau will send a copy of such comments to all designated Offices unless an international preliminary examination report has
`been oris to be established.
`
`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 monthsfrom the priority date, but only in respect of some designated Offices, a demand for international preliminary
`examination mustbe filed if the applicant wishes to postpone the entry into the national phase until 30 months fromthe priority date
`Cin some Offices evenlater); otherwise, the applicant must, within 20 months fromthe 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 demandis filed within 19 months. For details about the applicable time limits, Office by Office, see
`www.wipo.int/pct/en/texts/time_limits.html and the PCT Applicant's Guide, National Chapters.
`
`Within 22 months from the priority date, the applicant may request that 4 supplementary international search be carried out by a
`different International Searching Authority, that offers this service (Rule 455/s.1). The procedure for requesting supplementary
`international search is described in the PCT Applicant's Guide, International Phase, paragraphs 8.006-8.032.
`
` Nameand mailing address of the ISA/KR
`International Application Division
`
`
`
`
`Korean Intellectual Property Office
` 189 Cheongsa-ro, Sco-gu, Dacjcon, 35208, Republic of Korea
`
`
`
`
`
`
`
`
`
`
`
`Facsimile No. 82-42-48 1-8578 Telephone No, 82-42-48 1-8109
`Form PCT/ISA/220 (July 2017)
`
`Authorized officer
`
`COMMISSIONER
`
`
`
`

`

` Notes to Form PCT/ISA/220 (July 2014)
` * Attention
`
`Inquiries related to PCT International Search Report or Written Opinion prepared by KIPO asan International
`Searching 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.
`
`Homepage: http://www.ipkcenter.com
`
`Email: ipkc@ipkcenter.com
`
`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 : 2022.11.30
`) from the date of
`mailing of the international search report.
`
`http:/Avww.kipo.go.kr/en/ => PCT ISA Portal => PCT Status
`
`ID: PCT international application number
`
`PW : 7L26578B%
`
`

`

`PATENT COOPERATION TREATY
`
`PCT
`
`INTERNATIONAL SEARCH REPORT
`
`(PCT Article 18 and Rules 43 and 44)
`
`FOR FURTHER ACTION
`Applicant's or agent's file reference
`see Form PCT/ISA/220 as well as,
`46682-710601
`whereapplicable, item 5 below.
`
`International application No.
`PCT/US2022/015092
`
`Appli
`Ppucan
`
`t
`
`International filing date (day/month/year)
`03 February 2022
`SYDNEXIS, INC.
`
`(Earliest) Priority Date (day/month/year)
`04 February 2021
`
`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 atotalof_ 6___sheets.
`
`[| It is also accompanied by a copy ofeach prior art documentcited in this report.
`
`1. 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 whichit was filed.
`[] a translation of the international application into which is the language of a
`translation furnished for the purposes ofinternational search (Rules 12.3(a) and 23.1(b)).
`b. [| This international search report has been established taking into accountthe rectification ofan obvious mistake authorized
`by or notified to this Authority under Rule 91 (Rule 43.6bis(a)).
`Cc.[| With regard to any nucleotide and/or amino acid sequence disclosed in the international application, see Box No. L.
`
`b.[] noneof the figures is to be published with the abstract.
`
`Certain claims were found unsearchable (see Box No.II).
`
`[| Unity of invention is lacking (see Box No. IID.
`
`4. With regard to the title,
`
`the text is approved as submitted by the applicant.
`[| the text has been established by this Authority to read as follows:
`
`5. With regard to the abstract,
`
`the text is approved as submitted by the applicant.
`[| 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. 1_
`
`as suggested by the applicant.
`[] as selected by this Authority, because the applicant failed to suggest a figure.
`[| as selected by this Authority, because this figure better characterizes the invention.
`
`Form PCT/ISA/210 (first sheet) (July 2019)
`
`

`

`INTERNATIONAL SEARCH REPORT
`
`International application No.
`PCT/US2022/015092
`
`
`
`Box No. I Observations where certain claims were found unsearchable (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. [| Claims Nos.:
`because they relate to subject matter not required to be searched by this Authority, namely:
`
`2.
`
`Claims Nos.: 30-31, 33, 35, 37, 39, 41, 45-46, 48, 50, 56, 59, 61, 89-90, 92, 94, 96, 98, 100, 103-104, 106, 108, 114, 117,
`119, 131-132, 134, 136, 138, 141-142, 144, 146, 152, 155, 157, 167-168, 170, 172, 174, 177-178, 180, 182, 188, 191, 193,
`221-222, 224, 232, 236-237, 239, 241, 247, 250, 252
`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:
`
`because they are dependent claims and are not drafted in accordance with the second and third sentences of Rule 6.4(a).
`
`Claims 30-31, 33, 35, 37, 39, 41, 45-46, 48, 50, 56, 59, 61, 89-90, 92, 94, 96, 98, 100, 103-104, 106, 108,
`114, 117, 119, 131-132, 134, 136, 138, 141-142, 144, 146, 152, 155, 157, 167-168, 170, 172, 174, 177-178,
`180, 182, 188, 191, 193, 221-222, 224, 232, 236-237, 239, 241, 247, 250, 252 refer to a claim which is not
`drafted in accordance with the third sentence of Rule 6.4(a).
`
`Claims Nos.: 19-29, 32, 34, 36, 38, 40, 42-44, 47, 49, 51-55, 57-58, 60, 62-63, 81-88, 91, 93, 95, 97, 99, 101-102, 105,
`107, 109-113, 115-116, 118, 120-121, 126-130, 133, 135, 137, 139-140, 143, 145, 147-151, 153-154, 156, 158-159, 163-
`166, 169, 171, 173, 175-176, 179, 181, 183-187, 189-190, 192, 194-195, 217-220, 223, 231, 233-235, 238, 240, 242-246,
`248-249, 251, 253-255
`
`Form PCT/SA/210 (continuation of first sheet) July 2019)
`
`

`

`INTERNATIONAL SEARCH REPORT
`
`International application No.
`PCT/US2022/015092
`
`A.
`
`CLASSIFICATION OF SUBJECT MATTER
`
`AG61K 31/439(2006.01)i; A61K 9/00(2006.01)i; AGIK 31/4178(2006.01)i; AG1K 31/4409(2006.01)i; A6LK 47/02(2006.01)i;
`A61K 47/18(2006.01)i; A61P 27/00(2006.01)i1; A61P 27/10(2006.01)i
`
`Accordingto International Patent Classification (IPC) or to both national classification and IPC
`
`B. FIELDS SEARCHED
`
`Minimum documentation searched (classification system followed by classification symbols)
`
`AG61K 31/439(2006.01); A61K 31/245(2006.01); A61K 31/417(2006.01); A61K 3 1/4178(2006.01); A61K 31/46(2006.01);
`A61K 31/765(2006.01); A61K 47/00(2006.01); A61K 9/00(2006.01); A61P 27/14(2006.01)
`Documentation searched other than minimum documentation to the extent that such documents are included in the fields searched
`
`eKOMPASS(KIPOinternal) & Keywords: ophthalmic composition, pilocarpine, aceclidine, tropicamide
`
`
`
`Cc. DOCUMENTS CONSIDERED TO BE RELEVANT
`
`
`
`Citation of document, with indication, where appropriate, of the relevant passagesCategory * Relevant to claim No.
`
`
`
`Koreanutility 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)
`
`
`
`WO2020-087021 Al (OCUPHIRE PHARMA,INC.) 30 April 2020 (2020-04-30)
`abstract; claims 1, 12-13, 77-83, 125; paragraphs [0023], [0058]-[0059], [0112]
`
`US 2020-0222369 Al (ORASIS PHARMACEUTICALS LTD.) 16 Tuly 2020 (2020-07-16)
`claims 1, 71, 73, 84; paragraph [0269]
`
`1-3,160-162
`
`4-18,68-70,75-8
`0,198-199,208-2
`09,215,225-226
`
`64-67,71-74, 122-125,
`196-197,200-207,
`210-214,216,227-230
`
`4-7,12-18,68-80,200-
`202,214,227-228
`
`
`
`
`
`Further documents are listed in the continuation of Box C. See patent family annex.
`
`“—D”
`
`*—Special categories of cited documents: “T” later document published after the international filing date or priority
`
`
`
`“a” document defining the generalstate of the art which is not considered
`date and not in conflict with the application but cited to understand the
`to be of particular relevance
`principle or theory underlying the invention
`documentcited by the applicant in the international application
`document of particular relevance; the claimed invention cannot be
`earlier application or patent but published onorafter the international
`considered novel or cannot be considered to involve an inventive step
`filing date
`when the documentis taken alone
`document which may throw doubts on priority claim(s) or which is
`document of particular relevance; the claimed invention cannot be
`cited to establish the publication date of another citation or other
`considered to involve an inventive step when the documentis
`special reason (as specified)
`combined with one or more othersuch documents, such combination
`documentreferring to an oral disclosure, use, exhibition or other
`being obvious to a person skilled in the art
`means
`“& document memberof the same patent family
`document published priorto the internationalfiling date butlater than
`the priority date claimed
`Date of the actual completion of the international search
`Date of mailing of the international search report
`
`30 May 2022
`
`30 May 2022
`
`Name and mailing address of the ISA/KR
`
`Authorized officer
`
`Korean Intellectual Property Office
`189 Cheongsa-ro, Seo-gu, Daejeon
`35208, Republic of Korea
`
`Facsimile No. +82-42-481-8578
`Form PCT/ISA/210 (second sheet) (July 2019)
`
`HEO, Joo Hyung
`
`Telephone No. +82-42-481-5373
`
`
`
`

`

`INTERNATIONAL SEARCH REPORT
`
`International application No.
`PCT/US2022/015092
`
`Cc.
`
`DOCUMENTS CONSIDERED TO BE RELEVANT
`
`Category *
`Citation of document, with indication, where appropriate, of the relevant passages
`Relevant to claim No.
` WO 2015-200361 Al (SYDNEXIS, INC.) 30 December 2015 (2015-12-30)
`abstract; claims 1-2, 8, 17, 22-23, 30; paragraphs [0017], [0021], [0049]
`122-125,196-197
`,203-207,210-21
`3,216,229-230
`
`
`
`US 5710182 A (REUNAMAKI,T.et al.) 20 January 1998 (1998-01-20)
`the entire document
`
`US 2012-0064123 Al (SAWAYA, A. S.) 15 March 2012 (2012-03-15)
`the entire document
`
`8-18,71-80, 198-
`202,208-209,214
`~215,225-228
`
`1-18,64-80, 122-
`125,160-162,196
`~216,225-230
`
`1-18,64-80, 122-
`125,160-162,196
`~216,225-230
`
`Form PCT/ISA/210 (second sheet) (July 2019)
`
`

`

`Publication date
`Publication date
`Patent document
`Patent family member(s)
`cited in search report (day/month/year) (day/month/year)
`
`A
`WoO
`113164452
`3870170
`Al
`10-2021 -0096096
`11202104094
`10993932
`2020-0246310
`2020-0253931
`2021-0346349
`
`12 July 2018
`
`23 July 2021
`01 September 2021
`04 August 2021
`28 May 2021
`04 May 2021
`06 August 2020
`13 August 2020
`11 November 2021
`
`14 February 2019
`14 May 2019
`22 February 2018
`24 May 2019
`26 June 2019
`25 March 2020
`
`05 September 2019
`21 September 2020
`22 December 2020
`
`05 May 2020
`28 September 2021
`26 July 2018
`08 November 2018
`
`16 January 2018
`22 February 2018
`29 March 2018
`
`17 July 2018
`30 December2015
`
`19 April 2017
`08 November 2019
`
`03 January 2020
`03 May 2017
`05 August 2020
`10 August 2017
`25 June 2020
`
`08 April 2020
`20 February 2017
`06 January 2020
`27 September 2021
`24 November 2020
`
`12 January 2021
`09 March 2021
`23 March 2021
`
`18 September 2018
`12 February 2019
`27 October 2020
`15 December 2020
`24 December 2015
`
`14 January 2016
`24 November 2016
`
`15 February 2018
`
`A A
`
`B2
`Al
`Al
`
`CN
`EP
`KR
`
`2017-311636
`112019002967
`3031370
`109803652
`3500255
`3500255
`2019-524826
`2019107585
`2019107585
`10639297
`1129812
`2018-0207136
`2018-0318264
`9867810
`2018-033792
`2018-033792
`
`112016030368
`2953363
`106572998
`106572998
`110638749
`3160471
`3689350
`2017-522292
`2020-097599
`
`6678362
`10-2017-0018962
`10-2020-0001612
`10-2021-0116688
`0842787
`0888557
`0940145
`0953002
`
`10076515
`10201534
`10813923
`
`10864208
`2015-0366854
`2016-0009705
`2016-0339007
`2018-0042911
`
`2018-0193326
`
`KR
`KR
`KR
`US
`US
`US
`US
`US
`
`US
`US
`US
`US
`US
`US
`US
`
`INTERNATIONAL SEARCH REPORT
`Information on patent family members
`
`International application No.
`
`PCT/US2022/015092
`
`
`
`2020-087021
`
`Al
`
`30 April 2020
`
`SG
`US
`US
`
`2020-0222369
`
`Al
`
`16 July 2020
`
`2015-200361
`
`Al
`
`30 December 2015
`
`Form PCT/SA/210 (patent family annex) (July 2019)
`
`

`

`INTERNATIONAL SEARCH REPORT
`Information on patent family members
`
`International application No.
`
`PCT/US2022/015092
`
`
`
`
`
`Publication date
`Publication date
`Patent document
`Patent family member(s)
`cited in search report (day/month/year) (day/month/year)
`US
`2019-009 1213
`Al
`28 March 2019
`US
`2019-0298707
`Al
`03 October 2019
`US
`2020-00858 13
`Al
`19 March 2020
`US
`2020-297712
`Al
`24 September 2020
`US
`2020-297713
`Al
`24 September 2020
`US
`2020-297714
`Al
`24 September 2020
`
`
`US 2020-306239=Al O01 October 2020
`US
`2020-316052
`Al
`08 October 2020
`US
`2020-338060
`Al
`29 October 2020
`
`US 2021-0059998=Al
`04 March 2021
`US
`9421199
`B2
`US
`9770447
`B2
`2016-172712
`2016-172712
`
`15 March 2012
`
`23 August 2016
`26 September 2017
`27 October 2016
`01 December 2016
`
`12 October 1995
`05 March 1997
`05 March 1997
`
`15 January 1997
`11 July 2001
`31 March 1998
`
`16 April 2003
`12 October 1995
`
`15 March 2012
`02 December 2014
`
`07 May 2014
`30 January 2014
`10 September 2013
`14 April 2015
`
`2186734
`1144477
`1144477
`0752847
`0752847
`10-503470
`10-0365914
`95-26711
`
`2810537
`2810537
`2726082
`2014-0030337
`8530449
`9006214
`2012-033811
`
`WO
`
`5710182
`
`A
`
`20 January 1998
`
`2012-0064123
`
`Al
`
`15 March 2012
`
`Form PCT/SA/210 (patent family annex) (July 2019)
`
`

`

`From the INTERNATIONAL SEARCHING AUTHORITY
`
`PATENT COOPERATION TREATY
`
`ALVAREZ-MALO,Ciara
`
`WILSON SONSINI 650 Page Mill Road
`Palo Alto, California 94304
`USA
`
`PCT
`
`WRITTEN OPINION OF THE
`INTERNATIONAL SEARCHING AUTHORITY
`
`(PCT Rule 43bis.1)
`
`
`
`Date of mailing
`
`
`
`(day/month/year)
`30 May 2022
`FOR FURTHER ACTION
` Applicant's or agent's file reference
`
`
`
` 46682-710601
`
`
`See paragraph 2 below
`
`
`
`Priority date (day/month/year)
`International application No.
`International filing date (day/montl/vear)
`
`PCT/US2022/015092
`03 February 2022
`04 February 2021
`
`
`International Patent Classification (IPC) or both national classification and IPC
`
`
`A61K 31/439(2006.01)i; A61K 9/00(2006.01)i; A61K 31/4178(2006.01)i; A61K 31/4409(2006.01)i;
`AG1K47/02(2006.01)i;AGIK47/18(2006.01)i;A61P27/00(2006.01)i;AGIP27/10(2006.01i
` Applicant
`
`
`SYDNEXIS, INC.
`
`
`1. This opinion contains indicationsrelating to the following items:
`Box No
`mae
`Basis of the opinion
`il
`[] Box No.
`Priority
`Box No.
`iil
`Non-establishment of opinion with regard to novelty, inventive step and industrial applicability
`[| Box No.
`Box No.
`
`IV
`
`Vv
`
`Lack of unity of invention
`
`HEO, Joo Hyung Facsimile No. +82-42-481-8578
`
`[| Box No.
`Box No.
`[| Box No
`FURTHER ACTION
`
`Reasonedstatement under Rule 43bis. 1(a)(i) with regard to novelty, inventive step and industrial applicability;
`citations and explanations supporting such statement
`Certain documents cited
`
`VI
`
`Vil
`
`Certain defects in the international application
`
`- Vill
`
`Certain observations on the international application
`
`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 International Bureau under Rule 66.1bis(b) that written
`opinions of this International Searching Authority will not be so considered.
`
`If this opinion is, as provided above, considered to be a written opinion of the IPEA,the applicantis 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/AISA/220 or before the expiration of 22 months from the priority date, whichever expireslater.
`
`For further options, see Form PCT/AISA/220.
`
`Nameand mailing address of the ISA/KR
`
`Date of completion of this opinion
`
`Authorized officer
`
`Korean Intellectual Property Office
`:
`189 Cheongsa-ro, Seo-gu, Daejeon,
`35208
`
`30M.
`
`ay 2022
`
`Form PCT/TSA/237 (Coversheet) (revised January 2019)
`
`Telephone No. +82-42-481-5373
`
`

`

`WRITTEN OPINION OF THE
`INTERNATIONAL SEARCHING AUTHORITY
`
`International application No.
`PCT/US2022/015092
`
`
`
`Box No. I Basis of the opinion
`
`1. With regard to the language, this opinion has been established on the basis of:
`
`the international application in the language in whichit was filed.
`a translation of the international application into. which is the language of a translation
`furnished for the purposesofinternational search (Rules 12.3(a) and 23.1(b)).
`
`5. Additional comments:
`
`[|
`
`2. [| This opinion has been established taking into accountthe rectification of an obvious mistake authorized by or notified to
`this Authority under Rule 91 (Rule 43dis.1(b)).
`
`3. [| 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 sequencelisting:
`
`a.[] forming part of the international application as filed:
`[] in the form of an Annex C/ST.25 text file.
`[] on paperor in the form of an imagefile.
`b.[] furnished together with the international application under PCT Rule 13zer.1(a) for the purposes of international search
`only in the form of an Annex C/ST.25 textfile.
`Cc.[| furnished subsequent to the international filing date for the purposes of international search only:
`[|
`in the form of an Annex C/ST.25 text file (Rule 13zer.1(a)).
`[] on paperor in the form of an imagefile (Rule 13ter.1(b) and Administrative Instructions, Section 713).
`
`4,[| In addition, in the case that more than one version or copy of a sequencelisting 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.
`
`Form PCT/ISA/237 (Box No. D (revised January 2019)
`
`

`

`the description, claims or drawings (indicate particular elements below) or said claims Nos._30-31, 33, 35, 37, 39, 41, 45-
`46, 48, 50, 56, 59, 61, 89-90, 92, 94, 96, 98, 100, 103-104, 106, 108, 114, 117, 119, 131-132, 134, 136, 138, 141-142, 144,
`146, 152, 155, 157, 167-168, 170, 172, 174, 177-178, 180, 182, 188, 191, 193, 221-222, 224, 232, 236-237, 239, 241, 247,
`250,252
`are so unclear that no meaningful opinion could be formed(specify):
`
`Claims 30-31, 33, 35, 37, 39, 41, 45-46, 48, 50, 56, 59, 61, 89-90, 92, 94, 96, 98, 100, 103-104, 106, 108,
`114, 117, 119, 131-132, 134, 136, 138, 141-142, 144, 146, 152, 155, 157, 167-168, 170, 172, 174, 177-178,
`180, 182, 188, 191, 193, 221-222, 224, 232, 236-237, 239, 241, 247, 250, 252 are regarded to be unclear
`becausethey refer to a claim which docs not comply with PCT Rulc 6.4(a).
`[| the claims, or said claims Nos.
`the description that no meaningful opinion could be formed (specify):
`
`are so inadequately supported by
`
`no international search report has been established for said claims Nos._19-63, 81-121, 126-159, 163-195, 217-224, 231-255
`
`WRITTEN OPINION OF THE
`INTERNATIONAL SEARCHING AUTHORITY
`
`International application No.
`PCT/US2022/015092
`
`Box No. III
`
`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 examinedin respect of:
`[| the entire international application.
`claims Nos.
`19-63, 81-121, 126-159, 163-195, 217-224, 231-255
`
`because:
`
` [| the said international application, or the said claims Nos.
`
`relate to the following
`
`subject matter which does not require an international search (specify):
`
`C] See Supplemental Box for furtherdetails.
`
`[| a meaningful opinion could not be formed without the sequencelisting; the applicant did not, within the prescribed time limit:
`furnish a sequencelisting in the form of an Annex C/ST.25 textfile, 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 sequencelisting in responseto an invitation under Rule |3ter.1(a)
`or (b).
`
`Form PCT/TS A/237 (Box No. ITT) (revised January 2019)
`
`

`

`WRITTEN OPINION OF THE
`INTERNATIONAL SEARCHING AUTHORITY
`
`International application No.
`PCT/US2022/015092
`
`Box No. V
`
`Reasoned statement under Rule 43d/s.1(a)(i) with regard to novelty, inventive step and industrial applicability;
`oy
`gs
`:
`:
`citations and explanations supporting such statement
`
`1. Statement
`
`Novelty (N)
`
`Inventive step (IS)
`
`Industrial applicability ([A)
`
`Claims
`Claims
`
`1-18,64-80,122-125, 160-162,196-216,225-230
`NONE
`
`Claims
`Claims
`
`Claims
`Claims
`
`NONE
`
`1-18,64-80, 122-125, 160-162, 196-2 16,225-230
`
`1-18,64-80,122- 125, 160-162,196-216,225-230
`NONE
`
`2. Citations and explanations :
`
`Reference is madeto the following documents:
`
`D1: WO 2020-087021 Al (OCUPHIRE PHARMA,INC.) 30 April 2020
`D2: US 2020-0222369 Al (ORASIS PHARMACEUTICALSLTD.) 16 July 2020
`D3: WO 2015-200361 Al (SYDNEXIS, INC.) 30 December 2015
`
`* These written opinion and international search report have been made on the presumption that claims 210-213
`tefers to claim 196.
`
`I. Novelty and Inventive Step(PCT Article 33(2) and (3))
`
`1. Claims 1-18
`
`pharmaceutical composition consisting of pilocarpine or a pharmaceutically acceptable salt thereof at a
`
`D1 discloses compositions for treatment of a presbyopia further comprising administering to said eye of the
`paticnt an additional agent and a pharmaccutically acccptable carricr, whercin the additional agent is aceclidine
`or a pharmaccutically acccptable salt thercof, and wherein the pharmaccutically acceptable carricr comprises
`water and buffered solution(see abstract; claims 1, 12-13; paragraph [0023]).
`
`Claim 1 differs from D1 in an ophthalmic composition comprising deuterated water.
`
`However,the different feature would be derived by a person skilled in the art from D1 in an ophthalmic
`solution containing water(see paragraph [0023]).
`
`The additional features of claims 2-3 would be easily modified or optimized by a person skilled in the art
`through repeated experimentation which does not require a technical burden.
`
`Therefore, claims 1-3 are novel but lack an inventive step as being obvious over D1.
`
`The additional features of claims 4-7 would be derived by a person skilled in the art from D2 in an
`ophthalmic pharmaceutical composition consisting of pilocarpine or a pharmaceutically acceptable salt
`thereof(see claims 71, 73, 84).
`
`Therefore, claims 4-7 are novel but lack an inventive step as being obvious over D1 in view of D2.
`
`The additional features of claims 8-11 would be derived by a person skilled in the art from D3 in an
`ophthalmic composition comprising a muscarinic antagonist, wherein the muscarinic antagonist comprises
`tropicamide(see claims 1, 2).
`
`Therefore, claims 8-11 are novel but lack an inventive step as being obvious over D1 in view of D3.
`
`The additional feature of claim 12 would be derived by a person skilled in the art from D2 in an ophthalmic
`
`Form PCT/TS A/237 (Box No. V) (revised January 2019)
`
`

`

`WRITTEN OPINION OF THE
`INTERNATIONAL SEARCHING AUTHORITY
`
`International application No.
`PCT/US2022/015092
`
`Box No. V
`
`Reasoned statement under Rule 43d/s.1(a)(i) with regard to novelty, inventive step and industrial applicability;
`oy
`gs
`:
`:
`citations and explanations supporting such statement
`
`concentration of about 0.01% (w/w) to about 0.45%(w/w)(see claims 71, 73, 84) and from D3 in an ophthalmic
`composition comprising from about 0.001 wt% to about 0.05 wt% of a muscarinic antagonist, wherein the
`muscarinic antagonist comprises tropicamide(see claims 1, 2).
`
`The additional features of claims 13-15 would be easily modified or optimized by a person skilled in the art
`through repeated experimentation which does not require a technical burden considering a concentration of
`about 0.01 %(w/w) to about 0.45%(w/w) in D2(see claim 1).
`
`The additional features of claims 16-18 would be easily modified or optimized by a person skilled in the art
`through repeated experimentation which does not require a technical burden considering that the tropicamide is
`present in the composition at a concentration of about 0.001 wt% to about 0.025 in D3(see claims 1, 2,8).
`
`Therefore, claims 12-18 are novel but lack an inventive step as being obvious over D1 in view of D2 and D3.
`
`2. Claims 64-80
`
`D2 discloses an ophthalmic pharmaceutical composition consisting of pilocarpine or a pharmaceutically
`acceptable salt thereof at a concentration of about 0.01 %(w/w)to about 0.45% (w/w); a pH agent, water and one
`or more pharmaceutically acceptable carriers(see claims 71,73, 84).
`
`Claim 64 differs from D2 in an ophthalmic composition comprising about 0.001wt% to about 3wt%
`pilocarpine(different feature 1) and a buffering agent to provide a pH ofabout 4.2 to about 7.9(different feature
`2).
`
`However, the different feature 1 would be easily modified or optimized by a person skilled in the art through
`repeated experimentation which does not require a technical burden considering a concentration of about
`0.01%(w/w) to about 0.45%(w/w) in D2(see claim 1).
`
`The different feature 2 1s considered to be either a matter a person skilled in the art can appropriately select in
`accordance with circumstances, or a physical property measured under a certain condition which is determined
`by the material.
`
`The additional features of claims 65-67 would be easily modified or optimized by a person skilled in the art
`through repeated experimentation which does not require a technical burden considering a concentration of
`about 0.01 %(w/w) to about 0.45%(w/w) in D2(see claim 1).
`
`Therefore, claims 64-67 are novel but lack an inventive step as being obvious over D2.
`
`The additional feature of claim 68 would be derived by a person skilled in the art from D1 in a compositions
`for treatment of a ocular disorders further comprising administering to said eye of the patient an additional
`agent, wherein the additional agent is aceclidine or a pharmaceutically acceptable salt thereof(see abstract;
`claims 1, 12-13).
`
`present in the composition at a concentration of about 0.001 wt% to about 0.025 in D3(see claims 1, 2, 8).
`
`The additional features of claims 69-70 would be easily modified or optimized by a person skilled in the art
`through repeated experimentation which does not require a technical burden considering the ocular formulation
`comprising aceclidine hydrochloride in an amount of about 0.01%, 0.1%, 0.25%, 0.5%, 1%, 1.5%, 2%, 3%, or
`4% w/w in D1(see paragraphs [0058]-[0059]).
`
`Therefore, claims 68-70 are novel but lack an inventive step as being obvious over D1-D2.
`
`The additional feature of claim 71 would be derived by a person skilled in the art from D3 in an ophthalmic
`composition comprising from about 0.001 wt% to about 0.05 wt% of a muscarinic antagonist, whercin the
`muscarinic antagonist comprises tropicamide in D3(sce claims 1, 2).
`
`The additional features of claims 72-74 would be easily modified or optimized by a person skilled in the art
`through repeated experimentation which does not require a technical burden considering that the tropicamide is
`
`Form PCT/TS A/237 (Box No. V) (revised January 2019)
`
`

`

`WRITTEN OPINION OF THE
`INTERNATIONAL SEARCHING AUTHORITY
`
`International application No.
`PCT/US2022/015092
`
`Box No. V
`
`Reasoned statement under Rule 43d/s.1(a)(i) with regard to novelty, inventive step and industrial applicability;
`oy
`gs
`:
`:
`citations and explanations supporting such statement
`
`Therefore, claims 71-74 are novel but lack an inventive step as being obvious over D2-D3.
`
`The additional feature of claim 75 would be derived by a person skilled in the art from D1 in a composition
`for treatment of ocular disorders further comprising administering to said eye of the patient an additional agent,
`wherein the additional agent is aceclidine or a pharmaceutically acceptable salt thereof(see abstract; claims 1,
`12-13) and from D3 in an ophthalmic composition comprising from about 0.001 wt% to about 0.05 wt% of a
`muscarinic antagonist, wherein the muscarinic antagonist comprises tropicamide(see claims 1, 2).
`
`repeated experimentation which does not require a technical burden.
`
`The additional features of claims 76-77 would be easily modified or optimized by a person skilled in the
`art through repeated experimen