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1. (WO2016196621) MANGANESE SUPPLEMENTATION FOR CONTROL OF GLYCOSYLATION IN MAMMALIAN CELL CULTURE PROCESS



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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/US2016/035250 2159452PC01
International filing date (day/month/year) (Earliest) Priority Date (day/month/year)
01 June 2016 01 June 2015
Applicant
BIOGEN MA INC.
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: 1-24
Production of anti-.alpha.4.integrin antibody with a predetermined glycosylation profile.
2. claims: 25-53
Production of interferon .beta.1a with a predetermined glycosylation profile.
3. claims: 54-77
Production of recombinant factor VIII with a predetermined glycosylation profile.
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.: 1-24
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:
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

     C12N 5/00 (2006.01)i; C12P 21/00 (2006.01)i; C07K 16/28 (2006.01)n; C07K 14/565 (2006.01)n; C07K 14/755 (2006.01)n
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):
     C12N; C07K; C12P
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, EMBASE, BIOSIS

C. DOCUMENTS CONSIDERED TO BE RELEVANT

Category* Citation of document, with indication, where appropriate, of the relevant passages Relevant to claim No.
(1)
A
CROWELL C K ET AL, "Amino acid and manganese supplementation modulates the glycosylation state of erythropoietin in a CHO culture system", 15 February 2007 (2007-02-15), Vol. 96, No. 3, page 538-549,
XP002457773
[retrieved on  2006-08-25]
1-24
(2)
A
US 2007161084 A1 (CROWELL CHRISTOPHER K [US] ET AL) 12 July 2007 (2007-07-12)
1-24
(3)
X
GRAMER M J ET AL, "Modulation of Antibody Galactosylation Through Feeding of Uridine, Manganese Chloride, and Galactose", July 2011 (2011-07), Vol. 108, No. 7, page 1591-1602,
XP002688515
[retrieved on  2011-02-15]
1-24
the whole document
(4)
X
GRAINGER R K ET AL, "CHO cell line specific prediction and control of recombinant monoclonal antibody N -glycosylation", November 2013 (2013-11), Vol. 110, No. 11, page 2970-2983,
XP055298829
[retrieved on  2013-06-06]
1-24
the whole document
(5)
X
THARMALINGAM T ET AL, "A framework for real-time glycosylation monitoring (RT-GM) in mammalian cell culture", June 2015 (2015-06), Vol. 112, No. 6, page 1146-1154,
XP055298833
[retrieved on  2015-04-17]
1-24
the whole document
*
Special categories of cited documents:
"A"
document defining the general state of the art which is not considered to be of particular relevance
"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 2007161084 A1
12 July 2007
AU 2006324163 A1
CA 2630811 A1
EP 1957630 A2
EP 2495308 A1
EP 3026109 A1
ES 2564790 T3
SI 1957630 T1
US 2007161084 A1
US 2011287483 A1
US 2014088294 A1
US 2016222075 A1
WO 2007070315 A2
21 June 2007
21 June 2007
20 August 2008
05 September 2012
01 June 2016
29 March 2016
30 June 2016
12 July 2007
24 November 2011
27 March 2014
04 August 2016
21 June 2007
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:
31 August 2016
Date of mailing of the international search report:
31 October 2016
Authorized officer:
Teyssier, Bertrand
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