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EP2638152
European procedure
Extract from the Register of European Patents
EP About this file: EP2638152
| EP2638152 - VARIANT, RECOMBINANT BETA-GLUCOCEREBROSIDASE PROTEINS WITH INCREASED STABILITY AND INCREASED RETAINED CATALYTIC ACTIVITY [Right-click to bookmark this link] | Status | No opposition filed within time limit Status updated on 07.07.2017 Database last updated on 03.08.2024 | Most recent event Tooltip | 07.07.2017 | No opposition filed within time limit | published on 09.08.2017 [2017/32] | Applicant(s) | For all designated states Amicus Therapeutics, Inc. 1 Cedar Brook Drive Cranbury, NJ 08512 / US | [2014/51] |
| Former [2013/38] | For all designated states Callidus Biopharma, Inc. 3805 Old Easton Road Doylestown, PA 18902 / US | Inventor(s) | 01 /
DO, Hung 819 Yearling Drive New Hope, PA 18938 / US | [2013/38] | Representative(s) | Miller Sturt Kenyon 9 John Street London WC1N 2ES / GB | [2014/07] |
| Former [2013/38] | Carpmaels & Ransford LLP One Southampton Row London WC1B 5HA / GB | Application number, filing date | 11839428.7 | 08.11.2011 | [2016/35] | WO2011US59731 | Priority number, date | US20100411331P | 08.11.2010 Original published format: US 411331 P | US20100412180P | 10.11.2010 Original published format: US 412180 P | [2013/38] | Filing language | EN | Procedural language | EN | Publication | Type: | A2 Application without search report | No.: | WO2012064709 | Date: | 18.05.2012 | Language: | EN | [2012/20] | Type: | A2 Application without search report | No.: | EP2638152 | Date: | 18.09.2013 | Language: | EN | The application published by WIPO in one of the EPO official languages on 18.05.2012 takes the place of the publication of the European patent application. | [2013/38] | Type: | B1 Patent specification | No.: | EP2638152 | Date: | 31.08.2016 | Language: | EN | [2016/35] | Search report(s) | International search report - published on: | US | 02.08.2012 | (Supplementary) European search report - dispatched on: | EP | 10.03.2014 | Classification | IPC: | C12N9/26 | [2013/38] | CPC: |
A61K38/47 (EP,US);
C12N15/52 (KR);
C12Y302/01045 (EP,CN,US);
A61K31/445 (EP,US);
A61P3/00 (EP);
A61P3/06 (EP);
A61P43/00 (EP);
C12N9/24 (KR);
C12N9/2402 (EP,CN,US);
A61K38/00 (CN)
(-)
| Designated contracting states | AL, AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IS, IT, LI, LT, LU, LV, MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SI, SK, SM, TR [2013/38] | Extension states | BA | Not yet paid | ME | Not yet paid | Title | German: | VARIANTE UND REKOMBINANTE BETA-GLUCOCEREBROSIDASE-PROTEINE MIT ERHÖHTER STABILITÄT UND ERHÖHTER ZURÜCKGEHALTENER KATALYTISCHER AKTIVITÄT | [2013/38] | English: | VARIANT, RECOMBINANT BETA-GLUCOCEREBROSIDASE PROTEINS WITH INCREASED STABILITY AND INCREASED RETAINED CATALYTIC ACTIVITY | [2013/38] | French: | PROTÉINES BÊTA-GLUCOCÉRÉBROSIDASE RECOMBINANTES, VARIANTES, AYANT UNE STABILITÉ ACCRUE ET UNE ACTIVITÉ CATALYTIQUE RÉSIDUELLE ACCRUE | [2013/38] | Entry into regional phase | 04.06.2013 | National basic fee paid | 04.06.2013 | Search fee paid | 04.06.2013 | Designation fee(s) paid | 04.06.2013 | Examination fee paid | Examination procedure | 07.09.2012 | Request for preliminary examination filed International Preliminary Examining Authority: US | 04.06.2013 | Examination requested [2013/38] | 03.10.2014 | Amendment by applicant (claims and/or description) | 04.02.2015 | Despatch of a communication from the examining division (Time limit: M04) | 02.06.2015 | Reply to a communication from the examining division | 19.10.2015 | Despatch of a communication from the examining division (Time limit: M02) | 08.12.2015 | Reply to a communication from the examining division | 02.03.2016 | Communication of intention to grant the patent | 01.07.2016 | Disapproval of the communication of intention to grant the patent by the applicant or resumption of examination proceedings by the EPO | 06.07.2016 | Fee for grant paid | 06.07.2016 | Fee for publishing/printing paid | 26.07.2016 | Information about intention to grant a patent | 26.07.2016 | Receipt of the translation of the claim(s) | Divisional application(s) | EP16178095.2 / EP3144386 | The date of the Examining Division's first communication in respect of the earliest application for which a communication has been issued is 04.02.2015 | Opposition(s) | 01.06.2017 | No opposition filed within time limit [2017/32] | Fees paid | Renewal fee | 09.10.2013 | Renewal fee patent year 03 | 10.11.2014 | Renewal fee patent year 04 | 10.11.2015 | Renewal fee patent year 05 |
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| Responsibility for the accuracy, completeness or quality of the data displayed under the link provided lies entirely with the Unified Patent Court. | Documents cited: | Search | [X]WO0149830 (MAXYGEN APS [DK]) [X] 1,11-13 * the whole document, in particular p.22-24, Example 6 Table 3, p.65/66), p.76/77 and claims, especially claims 20, 21, 24, 25 *; | [ ] - "Human glucocerebrosidase, GCB, mutant K321N.", Geneseq, (20011024), Database accession no. AAU05680, URL: EBI, XP002720873 [ ] * sequence . * | [ ] - "Human glucocerebrosidase, GCB, mutant K321N/T323S.", Geneseq, (20011024), Database accession no. AAU05681, URL: EBI, XP002720874 [ ] * sequence . * | [X] - B. LIOU, "Analyses of Variant Acid beta-Glucosidases: EFFECTS OF GAUCHER DISEASE MUTATIONS", JOURNAL OF BIOLOGICAL CHEMISTRY, (20060103), vol. 281, no. 7, doi:10.1074/jbc.M511110200, ISSN 0021-9258, pages 4242 - 4253, XP055104212 [X] 1,11,12 * the whole document, in particular Fig. 8 * DOI: http://dx.doi.org/10.1074/jbc.M511110200 | [X] - O' Neill ET AL, "Comparison of the chromosomal localization of murine and humanglucocerebrosidase genes and of the deduced amino acid sequences", Genetics, vol. 86, (19890701), pages 5049 - 5053, URL: http://www.pnas.org/content/86/13/5049.full.pdf, (20140225), XP055104183 [X] 1,11,12 * the whole document, in particular Fig. 2 * | [ ] - "RecName: Full=Glucosylceramidase; EC=3.2.1.45; AltName: Full=Acid beta-glucosidase; AltName: Full=Beta-glucocerebrosidase; AltName: Full=D-glucosyl-N-acylsphingosine glucohydrolase; Flags: Precursor;", UniProt, (19900801), Database accession no. P17439, URL: EBI, XP002720875 [ ] * sequence . * | [X] - "RecName: Full=Glucosylceramidase; EC=3.2.1.45; AltName: Full=Acid beta-glucosidase; AltName: Full=Beta-glucocerebrosidase; AltName: Full=D-glucosyl-N-acylsphingosine glucohydrolase; Flags: Precursor;", UniProt, (20060307), Database accession no. Q2KHZ8, URL: EBI, XP002720876 [X] 1,11,12 * sequence . * | [X] - ANTONIN STRATIL ET AL, "Comparative and genetic analysis of the porcine glucocerebrosidase (GBA) gene", COMPARATIVE BIOCHEMISTRY AND PHYSIOLOGY PART B: BIOCHEMISTRY AND MOLECULAR BIOLOGY, (20040801), vol. 138, no. 4, doi:10.1016/j.cbpc.2004.04.021, ISSN 1096-4959, pages 377 - 383, XP055104176 [X] 1,11,12 * the whole document * DOI: http://dx.doi.org/10.1016/j.cbpc.2004.04.021 | [ ] - "RecName: Full=Glucosylceramidase; EC=3.2.1.45; AltName: Full=Acid beta-glucosidase; AltName: Full=Beta-glucocerebrosidase; AltName: Full=D-glucosyl-N-acylsphingosine glucohydrolase; Flags: Precursor;", UniProt, (20040705), Database accession no. Q70KH2, URL: EBI, XP002720877 [ ] * sequence . * | [A] - RICHARD A STEET ET AL, "The iminosugar isofagomine increases the activity of N370S mutant acid beta glucosidase in Gaucher fibroblasts by several mechanisms", PROCEEDINGS OF THE NATIONAL ACADEMY OF SCIENCES, NATIONAL ACADEMY OF SCIENCES, US, (20060101), vol. 103, no. 37, doi:10.1073/PNAS.0605928103, ISSN 0027-8424, pages 13813 - 13818, XP008129303 [A] 1-13 DOI: http://dx.doi.org/10.1073/pnas.0605928103 | [A] - STEET ET AL, "Selective action of the iminosugar isofagomine, a pharmacological chaperone for mutant forms of acid-beta-glucosidase", BIOCHEMICAL PHARMACOLOGY, ELSEVIER, US, (20070324), vol. 73, no. 9, doi:10.1016/J.BCP.2006.12.015, ISSN 0006-2952, pages 1376 - 1383, XP022000198 [A] 1-13 DOI: http://dx.doi.org/10.1016/j.bcp.2006.12.015 | [A] - WUSTMAN B A ET AL, "Pharmacological chaperone therapy for the treatment of Gaucher disease: AT2101 increases beta-glucocerebrosidase levels in cells, mice and healthy human volunteers", JOURNAL OF INHERITED METABOLIC DISEASE, KLUWER, DORDRECHT, NL, (20070801), vol. 30, no. Suppl. 1, ISSN 0141-8955, page 120, XP009124537 [A] 1-13 | [A] - WEINREB NEAL J ET AL, "Pharmacological chaperone therapy for the treatment of Gaucher disease: Results of phase 1 clinical trials and a clinical ex vivo response study with a survey of blood markers for 53 Gaucher patients", BLOOD, AMERICAN SOCIETY OF HEMATOLOGY, US, (20071101), vol. 110, no. 11, Part 1, ISSN 0006-4971, page 709A, XP009130375 [A] 1-13 | International search | [X]US2007166813 (FUTERMAN ANTHONY [IL], et al); | [X]US2003215435 (BERENT SUSAN L [US]); | [Y]US2010041151 (YEW NELSON S [US], et al); | [Y]US2005265988 (CHOI BYUNG-KWON [US], et al); | [X]US2002127219 (OKKELS JENS SIGURD [DK], et al) | [X] - GRACE ET AL., "Analysis of human acid beta-glucosidase by site-directed mutagenesis and heterologous expression.", J BIOL CHEM., (19940121), vol. 269, no. 3, pages 2283 - 91, XP055103953 | [Y] - LOPEZ-CAMACHO ET AL., "Amino acid substitutions enhancing thermostability of Bacillus polymyxa b-glucosidase A", BIOCHEM. J., (1996), vol. 314, pages 833 - 838, XP008164558 DOI: http://dx.doi.org/10.1042/bj3140833 | [A] - MAEGAWA ET AL., "Identification and Characterization of Ambroxol as an Enzyme Enhancement Agent for Gaucher Disease.", THE JOURNAL OF BIOLOGICAL CHEMISTRY, (20090828), vol. 284, pages 23502 - 23516, XP055103959 DOI: http://dx.doi.org/10.1074/jbc.M109.012393 | by applicant | WO0149830 | US2002127219 | - STATIL ET AL., COMPARATIVE BIOCHEMISTRY AND PHYSIOLOGY, (2004), vol. 138, pages 377 - 383 | - O'NEILL ET AL., PROC. NATL. ACAD. SCI. USA, (2009), vol. 86, pages 5049 - 5053 | - LIOU ET AL., J. BIOL. CHEM., (2006), vol. 281, pages 4242 - 4253 |