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Extract from the Register of European Patents

EP About this file: EP3004388

EP3004388 - DETECTION AND QUANTIFICATION OF DONOR CELL-FREE DNA IN THE CIRCULATION OF ORGAN TRANSPLANT RECIPIENTS [Right-click to bookmark this link]
StatusPatent maintained as amended
Status updated on  28.04.2023
Database last updated on 03.10.2024
FormerThe patent has been granted
Status updated on  28.09.2018
FormerGrant of patent is intended
Status updated on  13.05.2018
FormerExamination is in progress
Status updated on  15.09.2017
Most recent event   Tooltip10.11.2023Change - lapse in a contracting state
State(s) deleted from list of lapses: GR		published on 13.12.2023  [2023/50]
Applicant(s)For all designated states
Chronix Biomedical
5941 Optical Court, Suite 203E
San Jose, California 95138 / US
[2016/15]
Inventor(s)01 / SCHUTZ, Ekkehard
Rottenanger 30
Gottingen 37077 / DE
02 / BECK, Julia
Riemannstrasse 2
Gottingen 37083 / DE
 [2016/15]
Representative(s)J A Kemp LLP
80 Turnmill Street
London EC1M 5QU / GB
[2023/22]
Former [2018/44]J A Kemp
14 South Square
Gray's Inn
London WC1R 5JJ / GB
Former [2016/15]Campbell, Patrick John Henry
J A Kemp
14 South Square
Gray's Inn
London WC1R 5JJ / GB
Application number, filing date14804474.629.05.2014
[2016/15]
WO2014US40055
Priority number, dateUS201361828553P29.05.2013         Original published format: US 201361828553 P
[2016/15]
Filing languageEN
Procedural languageEN
PublicationType: A2 Application without search report
No.:WO2014194113
Date:04.12.2014
Language:EN
[2014/49]
Type: A2 Application without search report 
No.:EP3004388
Date:13.04.2016
Language:EN
The application published by WIPO in one of the EPO official languages on 04.12.2014 takes the place of the publication of the European patent application.
[2016/15]
Type: B1 Patent specification 
No.:EP3004388
Date:31.10.2018
Language:EN
[2018/44]
Type: B2 New European patent specification 
No.:EP3004388
Date:31.05.2023
Language:EN
[2023/22]
Search report(s)International search report - published on:US22.01.2015
(Supplementary) European search report - dispatched on:EP13.12.2016
ClassificationIPC:C12Q1/6883, C12Q1/6881, G01N33/68
[2022/38]
CPC:
C12Q1/6883 (EP,US); C12Q1/6881 (EP,US); G01N33/6854 (EP,US);
C12Q2600/106 (US); C12Q2600/156 (EP,US); C12Q2600/16 (US);
C12Q2600/172 (US); G01N2800/245 (EP,US) (-)
Former IPC [2018/21]C12Q1/6883, C12Q1/6881
Former IPC [2016/15]C12Q1/68, C40B20/08, G06F19/22
Designated contracting statesAL,   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 [2016/15]
TitleGerman:NACHWEIS UND QUANTIFIZIERUNG VON DONATORZELLENFREIER DNA IM BLUTKREISLAUF VON ORGANTRANSPLANTATEMPFÄNGERN[2016/15]
English:DETECTION AND QUANTIFICATION OF DONOR CELL-FREE DNA IN THE CIRCULATION OF ORGAN TRANSPLANT RECIPIENTS[2016/15]
French:DÉTECTION ET QUANTIFICATION D'ADN LIBRE EN PROVENANCE DE CELLULES DU DONNEUR DANS LA CIRCULATION SANGUINE DE BÉNÉFICIAIRES D'UNE GREFFE D'ORGANE[2016/15]
Entry into regional phase16.12.2015National basic fee paid 
16.12.2015Search fee paid 
16.12.2015Designation fee(s) paid 
16.12.2015Examination fee paid 
Examination procedure16.12.2015Examination requested  [2016/15]
19.07.2017Amendment by applicant (claims and/or description)
13.09.2017Despatch of a communication from the examining division (Time limit: M04)
22.01.2018Reply to a communication from the examining division
14.05.2018Communication of intention to grant the patent
24.09.2018Fee for grant paid
24.09.2018Fee for publishing/printing paid
24.09.2018Receipt of the translation of the claim(s)
Opposition(s)Opponent(s)01  31.07.2019    ADMISSIBLE
Gillard, Richard Edward
Elkington and Fife LLP
Thavies Inn House
3-4 Holborn Circus
London EC1N 2HA / GB
Opponent's representative
Elkington and Fife LLP
Prospect House
8 Pembroke Road
Sevenoaks, Kent TN13 1XR / GB
 [2019/36]
12.08.2019Invitation to proprietor to file observations on the notice of opposition
20.12.2019Reply of patent proprietor to notice(s) of opposition
12.05.2020Despatch of a communication from the opposition division (Time limit: M04)
02.09.2020Reply to a communication from the opposition division
24.08.2021Cancellation of oral proceeding that was planned for 25.01.2022
05.01.2022Despatch of a communication from the opposition division (Time limit: M02)
25.01.2022Date of oral proceedings
22.08.2022Reply to a communication from the opposition division
28.09.2022Despatch of interlocutory decision in opposition
09.10.2022Legal effect of interlocutory decision in opposition
26.01.2023Despatch of communication that the patent will be maintained as amended
17.04.2023Fee for printing new specification paid
Fees paidRenewal fee
10.05.2016Renewal fee patent year 03
10.05.2017Renewal fee patent year 04
11.05.2018Renewal fee patent year 05
Opt-out from the exclusive  Tooltip
competence of the Unified
Patent Court		 See the Register of the Unified Patent Court for opt-out data
Responsibility for the accuracy, completeness or quality of the data displayed under the link provided lies entirely with the Unified Patent Court.
Lapses during opposition  TooltipEE31.10.2018
FI31.10.2018
MK31.10.2018
RS31.10.2018
SK31.10.2018
SM31.10.2018
TR31.10.2018
BG31.01.2019
[2023/50]
Former [2022/31]EE31.10.2018
FI31.10.2018
MK31.10.2018
RS31.10.2018
SK31.10.2018
SM31.10.2018
TR31.10.2018
BG31.01.2019
GR05.12.2019
Former [2020/17]EE31.10.2018
FI31.10.2018
RS31.10.2018
SK31.10.2018
SM31.10.2018
TR31.10.2018
BG31.01.2019
GR05.12.2019
Former [2020/12]EE31.10.2018
FI31.10.2018
RS31.10.2018
SK31.10.2018
SM31.10.2018
BG31.01.2019
GR05.12.2019
Former [2019/40]EE31.10.2018
FI31.10.2018
RS31.10.2018
SK31.10.2018
SM31.10.2018
BG31.01.2019
Former [2019/37]EE31.10.2018
FI31.10.2018
RS31.10.2018
SM31.10.2018
BG31.01.2019
Former [2019/25]FI31.10.2018
RS31.10.2018
BG31.01.2019
Former [2019/22]FI31.10.2018
BG31.01.2019
Former [2019/21]FI31.10.2018
Documents cited:Search[X]WO2012115851  (HOPE CITY [US], et al) [X] 1,3-5,10,12 * page 2, [0011]; page 3, [0013]; page 4, [0017] - page 5, [0018]; page 14, [0059]; table 2; examples; claims *;
 [E]WO2015138997  (CAREDX INC [US]) [E] 1-5 * claims; example 1 *;
 [XY]  - YING LI ET AL, "Ready Detection of Donor-Specific Single-Nucleotide Polymorphisms in the Urine of Renal Transplant Recipients by Matrix-Assisted Laser Desorption/Ionization Time-of-Flight Mass Spectrometry", CLINICAL CHEMISTRY, (20050101), vol. 51, no. 10, doi:10.1373/clinchem.2005.055038, pages 1903 - 1904, XP055325501 [X] 4,5,12 * table 1 * [Y] 1-15

DOI:   http://dx.doi.org/10.1373/clinchem.2005.055038
 [XP]  - J. BECK ET AL, "Digital Droplet PCR for Rapid Quantification of Donor DNA in the Circulation of Transplant Recipients as a Potential Universal Biomarker of Graft Injury", CLINICAL CHEMISTRY, (20131201), vol. 59, no. 12, doi:10.1373/clinchem.2013.210328, ISSN 0009-9147, pages 1732 - 1741, XP055214461 [XP] 1-15 * pages 1733-1734, "Material and methods" *

DOI:   http://dx.doi.org/10.1373/clinchem.2013.210328
 [Y]  - T. M. SNYDER ET AL, "Universal noninvasive detection of solid organ transplant rejection", PROCEEDINGS OF THE NATIONAL ACADEMY OF SCIENCES, (20110328), vol. 108, no. 15, doi:10.1073/pnas.1013924108, ISSN 0027-8424, pages 6229 - 6234, XP055129832 [Y] 1-15 * Figure 1 *

DOI:   http://dx.doi.org/10.1073/pnas.1013924108
International search[Y]EP1325963  (HOLZGREVE WOLFGANG PROF [CH], et al);
 [Y]US2010209926  (ALAOUI HICHAM [US], et al);
 [Y]US2012115737  (EHRICH MATHIAS [US], et al)
by applicantWO9208800
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 US5750343
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 US5844106
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 US6001611
 US6440706
 US6753147
 US7824889
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    - LO, Clin Chem, (20110000), vol. 57, pages 941 - 942
    - BECK et al., Clin Chem, (20090000), vol. 55, pages 730 - 738
    - LO et al., Sci Transl Med, (20100000), vol. 2, page 61ra91
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    - OELLERICH et al., Ther Dug Monit, (20140000), vol. 36, pages 136 - 140
OppositionWO2008098142
 US2012115737
 WO2012115851
 WO2013159035
    - LI et al., "Ready Detection of Donor-Specific Single Nucleotide Polymorphisms in the Urine of Renal Transplant Recipients by Matrix-Assisted Laser Desorption/lonization Time-of-Flight Mass Spectroscopy", Clinical Chemistry, (20050101), vol. 51, no. 10, pages 1903 - 1904, XP055325501

DOI:   http://dx.doi.org/10.1373/clinchem.2005.055038
    - BECK et al., "Digital Droplet PCR for Rapid Quantification of Donor DNA in the Circulation of Transplant Recipients as a Potential Universal Biomarker of Graft Injury", Clinical Chemistry, (20131201), vol. 59, no. 1 2, pages 1732 - 1741, XP055214461

DOI:   http://dx.doi.org/10.1373/clinchem.2013.210328
    - SNYDER et al., "Universal noninvasive detection of solid organ transplant rejection", Proceedings of the National Academy of Sciences, (20110308), vol. 108, no. 15, pages 6229 - 6234, XP055129832

DOI:   http://dx.doi.org/10.1073/pnas.1013924108
    - HIDESTRAND et al., "254 Highly Sensitive Transplant Rejection Surveillance Using Targeted Detection of Donor Specific Cell Free DNA", The Journal of Heart and Lung Transplantation, (20120400), vol. 31, no. 4S, XP028911538

DOI:   http://dx.doi.org/10.1016/j.healun.2012.01.261
    - SPARKS et al., "Noninvasive prenatal detection and selective analysis of cell-free DNA obtained from maternal blood: evaluation for trisomy 21 and trisomy 18", American Journal of Obstetrics & Gynecology, (20120400), vol. 206, no. 4, pages 319.e1 - 319.e9, XP055024123

DOI:   http://dx.doi.org/10.1016/j.ajog.2012.01.030
    - GINEIKIENE et al., "Single Nucleotide Polymorphism-Based System Improves the Applicability of Quantitative PCR for Chimerism Monitoring", Journal of Molecular Diagnostics, (20090100), vol. 11, no. 1, doi:10.2353/jmoldx.2009.080039, XP055046105

DOI:   http://dx.doi.org/10.2353/jmoldx.2009.080039
    - LI et al., "Ready Detection of Donor-Specific Single Nucleotide Polymorphisms in the Urine of Renal Transplant Recipients by Matrix-Assisted Laser Desorption/lonization Time-of-Flight Mass Spectroscopy", Clinical Chemistry, (20050101), vol. 51, no. 10, pages 1903 - 1904
    - HIDESTRAND et al., "254 Highly Sensitive Transplant Rejection Surveillance Using Targeted Detection of Donor Specific Cell Free DNA", The Journal of Heart and Lung Transplantation, (20120400), vol. 31, no. 4S
    - SPARKS et al., "Noninvasive prenatal detection and selective analysis of cell-free DNA obtained from maternal blood: evaluation for trisomy 21 and trisomy 18", American Journal of Obstetrics & Gynecology, (20120400), vol. 206, no. 4, pages 319.e1 - 319.e9
    - GINEIKIENE et al., "Single Nucleotide Polymorphism-Based System Improves the Applicability of Quantitative PCR for Chimerism Monitoring", Journal of Molecular Diagnostics, (20090100), vol. 11, no. 1, doi:10.2353/jmoldx.2009.080039
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