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1. WO2020109365 - PROCÉDÉS DE FABRICATION D'UN ADJUVANT


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INTERNATIONAL SEARCH REPORT (ISR)
Part 1:  1  2  3  4  5  6          Part 2:  A  B  C  D  E 
International application No. Applicant's or agent's file reference
PCT/EP2019/082689 VB66688 WO
International filing date (day/month/year) (Earliest) Priority Date (day/month/year)
27 November 2019 29 November 2018
Applicant
GLAXOSMITHKLINE BIOLOGICALS SA
FOR FURTHER ACTION: See Form PCT/ISA/220 as well as, where applicable, item 5 below.
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.
It is also accompanied by a copy of each prior art document cited 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 which it was filed.
a translation of the international application into                                          which is the language of a translation furnished for the purposes of international search (Rules 12.3(a) and 23.1(b)).
b.
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.
1. With regard to any nucleotide and/or amino acid sequence disclosed in the international application, the international search was carried out on the basis of a sequence listing:
a. forming part of the international application as filed:
in the form of an Annex C/ST.25 text file.
on paper or in the form of an image file.
b. 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. 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 13ter.1(a)).
on paper or in the form of an image file (Rule 13ter.1(b) and Administrative Instructions, Section 713).
2.
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.
3.
Additional comments:
2. Certain claims were found unsearchable
3. Unity of invention is lacking
This International Searching Authority found multiple inventions in this international application, as follows:
1. claims: 1-16, 23(completely); 24-43(partially)
Method for manufacturing a liposomal adjuvant comprising AGP or GLA using a microfluidic device; liposomal adjuvant produced by the method
2. claims: 17, 18(completely); 24-43(partially)
Solution comprising a solvent, an AGP or GLA and 100-170 mg/ml lipid, herein the solvent comprises 70-90% ethanol and 10-30% isopropyl alcohol
3. claims: 19-22(completely); 24-43(partially)
Method for the preparation of a solution comprising a solvent, lipid, cholesterol and AGP or GLA comprising preparing a suspension of AGP or GLA in at least a portion of the solvent, combining with phosphatidylcholine lipid an cholesterol, adding further solvent an mixing; liposome obtained by the method
1.
As all required additional search fees were timely paid by the applicant, this international search report covers all searchable claims.
2.
As all searchable claims could be searched without effort justifying additional fees, this Authority did not invite payment of additional fees.
3.
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.
No required additional search fees were timely paid by the applicant. Consequently, this international search report is restricted to the invention first mentioned in the claims; it is covered by claims Nos.:
Remark on Protest
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.
No protest accompanied the payment of additional search fees.
4. Title of the invention
The text is approved as submitted by the applicant.
The text has been established by this Authority to read as follows:
METHODS FOR MANUFACTURING AN ADJUVANT

5. 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. Drawings
a.
The figure of the drawings to be published with the abstract is Figure No. ____________
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.
b.
none of the figures is to be published with the abstract.

A. CLASSIFICATION OF SUBJECT MATTER

     A61K 39/39 (2006.01)i
According to International Patent Classification (IPC) or to both national classification and IPC

B. FIELDS SEARCHED

Minimum documentation searched (classification system followed by classification symbols):
     A61K
Documentation searched other than minimum documentation to the extent that such documents are included in the fields searched:
Electronic data base consulted during the international search (name of data base and, where practicable, search terms used):
EPO-Internal, WPI Data, BIOSIS

C. DOCUMENTS CONSIDERED TO BE RELEVANT

Category* Citation of document, with indication, where appropriate, of the relevant passages Relevant to claim No.
(1)
X
US 2016361411 A1 (GINDY MARIAN [US] ET AL) 15 December 2016 (2016-12-15)
1-16,23-43
Y
page 1, paragraph 0007
17,18
page 17, paragraph 0107 - paragraph 0108
page 18, paragraph 0127 - paragraph 0131; example 1.3
page 24; example 2
(2)
X
HW MILLIE FUNG ET AL, "Optimizing manufacturing and composition of a TLR4 nanosuspension: physicochemical stability and vaccine adjuvant activity", JOURNAL OF NANOBIOTECHNOLOGY, BIOMED CENTRAL, GB,Vol. 11, No. 1, 21 December 2013 (2013-12-21), page 43,
XP021172581
10,14,16,19-22,24-43
Y
page 1, right-hand column, paragraph 2 - page 3, left-hand column, paragraph 1; tables 1, 3
17,18,24-43
A
page 8, right-hand column, paragraph 2 - page 11, left-hand column, paragraph 1; table 4
1-9
page 12, left-hand column, paragraph 1
(3)
Y
CN 102133186 A (HAINAN MEIDA PHARMACEUTICAL CO) 27 July 2011 (2011-07-27)
17,18,24-43
page 3, paragraph 26 - paragraph 28; examples 1-3
(4)
Y
ANDREAS JAHN ET AL, "Microfluidic Directed Formation of Liposomes of Controlled Size", LANGMUIR,Vol. 23, No. 11, 01 May 2007 (2007-05-01), page 6289-6293,
XP055036503
17,18,24-43
abstract
page 6290, right-hand column, paragraph 3 - paragraph 4
page 6293, right-hand column, paragraph 3
(5)
A
WO 2017097783 A1 (GLAXOSMITHKLINE BIOLOGICALS SA [BE]) 15 June 2017 (2017-06-15)
1-16,23-29
page 1, paragraph 6 - page 2, paragraph 2
page 3, paragraph 7 - page 8, paragraph 1
page 11, paragraph 4 - paragraph 5
page 13, paragraph 6; examples 1, 2, 5
(6)
A
US 2016324783 A1 (FOX CHRISTOPHER B [US] ET AL) 10 November 2016 (2016-11-10)
1-10,14-18,23-43
page 3, paragraph 0044 - paragraph 0046
page 15, paragraph 0179
page 17, paragraph 0192 - page 19, paragraph 0209
page 33, paragraphs 0321, 0325
(7)
A
WO 2017200957 A1 (INFECTIOUS DISEASE RES INSTITUTE [US] ET AL.) 23 November 2017 (2017-11-23)
1-10,14-16
page 3, paragraph 0009 - page 5, paragraph 0011
page 20, paragraph 0084
page 27, paragraph 0112 - page 30, paragraph 0128
page 48, paragraph 0220 - paragraph 0222
page 62, paragraph 0288
(8)
A
JOSHI SAMEER ET AL, "Microfluidics based manufacture of liposomes simultaneously entrapping hydrophilic and lipophilic drugs", INTERNATIONAL JOURNAL OF PHARMACEUTICS, ELSEVIER, NL,Vol. 514, No. 1, 15 November 2016 (2016-11-15), page 160-168,
XP029809143
17,18,24-43
abstract
page 161, right-hand column, paragraph 3 - page 162, left-hand column, paragraph 1
page 163, right-hand column, paragraph 1 - page 164, left-hand column, paragraph 1
page 165, right-hand column, paragraph 2 - page 166, right-hand column, paragraph 2
page 167, left-hand column, last paragraph
(9)
X,P
WO 2018219521 A1 (GLAXOSMITHKLINE BIOLOGICALS SA [BE]) 06 December 2018 (2018-12-06)
1-43
page 2, line 22 - page 4, line 5
page 10, line 27 - page 12, line 22
page 13, line 9 - page 14, line 37
page 16, line 5 - line 16
page 16, line 30 - line 37
page 18, line 25 - page 19, line 9
page 19, line 16 - line 20
page 20, line 25 - line 29
page 23, line 30 - page 24, line 3; examples
(10)
A
US 2017071967 A1 (DUTTA NUPUR [US] ET AL) 16 March 2017 (2017-03-16)
19-22,24-43
page 1, paragraph 0014
page 7, paragraph 0111 - paragraph 0115; example 1
*
Special categories of cited documents:
"A"
document defining the general state of the art which is not considered to be of particular relevance
"D"
document cited by the applicant in the international application
"E"
earlier application or patent but published on or after the international filing date
"L"
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)
"O"
document referring to an oral disclosure, use, exhibition or other means
"P"
document published prior to the international filing date but later than the priority date claimed
"T"
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
"X"
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
"Y"
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

D. INFORMATION ON PATENT FAMILY MEMBERS

Patent document cited in search report Publication date
(day/month/year)
Patent family member(s) Publication date
(day/month/year)
US 2016361411 A1
15 December 2016
EP 3110401 A2
EP 3556353 A2
US 2016361411 A1
WO 2015130584 A2
04 January 2017
23 October 2019
15 December 2016
03 September 2015
CN 102133186 A
27 July 2011
NONE
WO 2017097783 A1
15 June 2017
BE 1024228 A1
EP 3386540 A1
US 2018318415 A1
WO 2017097783 A1
15 December 2017
17 October 2018
08 November 2018
15 June 2017
US 2016324783 A1
10 November 2016
AU 2014373928 A1
BR 112016015422 A2
CA 2935620 A1
CN 106163551 A
EA 201691348 A1
EP 3089754 A2
JP 2017502962 A
KR 20160133413 A
US 2016324783 A1
WO 2015103167 A2
ZA 201604498 B
21 July 2016
24 October 2017
09 July 2015
23 November 2016
30 November 2016
09 November 2016
26 January 2017
22 November 2016
10 November 2016
09 July 2015
30 October 2019
WO 2017200957 A1
23 November 2017
AU 2017268175 A1
BR 112018073676 A2
CA 3023672 A1
CN 109562057 A
EP 3458028 A1
JP 2019518739 A
KR 20190025822 A
WO 2017200957 A1
ZA 201807128 B
15 November 2018
26 February 2019
23 November 2017
02 April 2019
27 March 2019
04 July 2019
12 March 2019
23 November 2017
26 June 2019
WO 2018219521 A1
06 December 2018
CA 3063954 A1
CN 111032080 A
DE 112018002827 T5
EP 3630176 A1
FR 3066920 A1
GB 2577232 A
WO 2018219521 A1
06 December 2018
17 April 2020
09 April 2020
08 April 2020
07 December 2018
18 March 2020
06 December 2018
US 2017071967 A1
16 March 2017
AU 2015228387 A1
CA 2942235 A1
CN 106456545 A
EP 3116480 A1
JP 2017511802 A
KR 20160127828 A
US 2017071967 A1
WO 2015136480 A1
27 October 2016
17 September 2015
22 February 2017
18 January 2017
27 April 2017
04 November 2016
16 March 2017
17 September 2015
Name and mailing address of the ISA/:
European Patent Office
P.B. 5818, Patentlaan 2, 2280 HV Rijswijk,
Netherlands
Telephone No. (+31-70)340-2040
Facsimile No. (+31-70)340-3016
Date of the actual completion of the international search:
28 April 2020
Date of mailing of the international search report:
12 May 2020
Authorized officer:
Montero Lopez, B
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