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Extract from the Register of European Patents

EP About this file: EP3285756

EP3285756 - FORMULATIONS OF L-ORNITHINE PHENYLACETATE [Right-click to bookmark this link]
StatusNo opposition filed within time limit
Status updated on  29.12.2023
Database last updated on 03.10.2024
FormerThe patent has been granted
Status updated on  20.01.2023
FormerGrant of patent is intended
Status updated on  14.09.2022
FormerExamination is in progress
Status updated on  22.01.2021
FormerRequest for examination was made
Status updated on  26.01.2018
FormerThe international publication has been made
Status updated on  02.11.2016
Most recent event   Tooltip09.02.2024Lapse of the patent in a contracting state
New state(s): SI		published on 13.03.2024  [2024/11]
Applicant(s)For all designated states
Ocera Therapeutics, Inc.
675 McDonnell Blvd.
Hazelwood, MO 63042 / US
[2023/27]
Former [2023/08]For all designated states
Ocera Therapeutics, Inc.
555 Twin Dolphin Drive, Suite 615
Redwood City, CA 94065 / US
Former [2018/09]For all designated states
Ocera Therapeutics, Inc.
555 Twin Dolphin Drive, Suite 615
Redwood City, CA 94065 / US
Inventor(s)01 / RUETTIMANN, Kenneth
7104 Pebble Gate Drive
Raleigh, NC 27612 / US
02 / COFFIN, Mark
5001 South Miami Boulevard
Suite 300
Durham, NC 27703 / US
03 / BERNSTEIN, James
7413 Six Forks Road 312
Raleigh, NC 27615 / US
04 / GOODSON, Gary
7413 Six Forks Road 312
Raleigh, NC 27615 / US
05 / WANG, Laurene
512 Booth Road
Chapel Hill, NC 27516 / US
 [2018/09]
Representative(s)Jones, Nicholas Andrew
Withers & Rogers LLP
2 London Bridge
London SE1 9RA / GB
[2023/08]
Former [2018/09]J A Kemp
14 South Square
Gray's Inn
London WC1R 5JJ / GB
Application number, filing date16783692.319.04.2016
[2018/09]
WO2016US28298
Priority number, dateUS201562150238P20.04.2015         Original published format: US 201562150238 P
US201562150676P21.04.2015         Original published format: US 201562150676 P
US201562211619P28.08.2015         Original published format: US 201562211619 P
US201562255300P13.11.2015         Original published format: US 201562255300 P
US201662276754P08.01.2016         Original published format: US 201662276754 P
[2018/09]
Filing languageEN
Procedural languageEN
PublicationType: A1 Application with search report
No.:WO2016172112
Date:27.10.2016
Language:EN
[2016/43]
Type: A1 Application with search report 
No.:EP3285756
Date:28.02.2018
Language:EN
The application published by WIPO in one of the EPO official languages on 27.10.2016 takes the place of the publication of the European patent application.
[2018/09]
Type: B1 Patent specification 
No.:EP3285756
Date:22.02.2023
Language:EN
[2023/08]
Search report(s)International search report - published on:AU27.10.2016
(Supplementary) European search report - dispatched on:EP20.12.2018
ClassificationIPC:A61K31/195, A61K31/192, A61P1/16, A61K9/08
[2022/33]
CPC:
A61K31/198 (EP,CN,KR,RU,US); A61K9/0053 (CN,KR,US); A61K31/222 (EP,KR,US);
A61K9/5026 (KR,US); A61K9/5047 (KR,US); A61K9/5089 (KR,US);
A61P1/16 (EP,CN,RU); A61P25/00 (CN); A61P3/00 (EP,CN);
A61P7/00 (EP,CN); A61P9/12 (CN); A61K2300/00 (KR) (-)
C-Set:
A61K31/198, A61K2300/00 (US,EP);
A61K31/222, A61K2300/00 (EP,US)
Former IPC [2018/09]A61K31/198, A61K31/192, A61K31/195, A61P1/16, C07C57/32
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 [2018/09]
Extension statesBANot yet paid
MENot yet paid
Validation statesMANot yet paid
MDNot yet paid
TitleGerman:FORMULIERUNGEN VON L-ORNITHIN-PHENYLACETAT[2018/09]
English:FORMULATIONS OF L-ORNITHINE PHENYLACETATE[2018/09]
French:FORMULATIONS DE PHÉNYLACÉTATE DE L-ORNITHINE[2018/09]
Entry into regional phase18.10.2017National basic fee paid 
18.10.2017Search fee paid 
18.10.2017Designation fee(s) paid 
18.10.2017Examination fee paid 
Examination procedure18.10.2017Examination requested  [2018/09]
18.10.2017Date on which the examining division has become responsible
26.08.2019Despatch of communication that the application is deemed to be withdrawn, reason: reply to the Extended European Search Report/Written Opinion of the International Searching Authority/International Preliminary Examination Report/Supplementary international search report not received in time
25.10.2019Amendment by applicant (claims and/or description)
25.01.2021Despatch of a communication from the examining division (Time limit: M06)
03.08.2021Reply to a communication from the examining division
13.12.2021Despatch of a communication from the examining division (Time limit: M04)
23.03.2022Reply to a communication from the examining division
15.09.2022Communication of intention to grant the patent
13.01.2023Fee for grant paid
13.01.2023Fee for publishing/printing paid
13.01.2023Receipt of the translation of the claim(s)
31.01.2023Request for correction of the decision to grant filed
Divisional application(s)EP23157390.8  / EP4205735
Opposition(s)23.11.2023No opposition filed within time limit [2024/05]
Request for further processing for:The application is deemed to be withdrawn due to failure to reply to the Extended European Search Report/Written Opinion of the International Searching Authority/International Preliminary Examination Report/Supplementary international search report/Supplementary European search report
25.10.2019Request for further processing filed
25.10.2019Full payment received (date of receipt of payment)
Request granted
05.11.2019Decision despatched
Fees paidRenewal fee
11.04.2018Renewal fee patent year 03
15.04.2019Renewal fee patent year 04
27.04.2020Renewal fee patent year 05
27.04.2021Renewal fee patent year 06
27.04.2022Renewal fee patent year 07
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  TooltipCZ22.02.2023
EE22.02.2023
FI22.02.2023
HR22.02.2023
LT22.02.2023
LV22.02.2023
MC22.02.2023
PL22.02.2023
RO22.02.2023
RS22.02.2023
SI22.02.2023
SK22.02.2023
SM22.02.2023
GR23.05.2023
IS22.06.2023
PT22.06.2023
[2024/11]
Former [2024/08]CZ22.02.2023
EE22.02.2023
FI22.02.2023
HR22.02.2023
LT22.02.2023
LV22.02.2023
MC22.02.2023
PL22.02.2023
RO22.02.2023
RS22.02.2023
SK22.02.2023
SM22.02.2023
GR23.05.2023
IS22.06.2023
PT22.06.2023
Former [2023/50]CZ22.02.2023
EE22.02.2023
FI22.02.2023
HR22.02.2023
LT22.02.2023
LV22.02.2023
PL22.02.2023
RO22.02.2023
RS22.02.2023
SK22.02.2023
SM22.02.2023
GR23.05.2023
IS22.06.2023
PT22.06.2023
Former [2023/49]CZ22.02.2023
EE22.02.2023
FI22.02.2023
HR22.02.2023
LT22.02.2023
LV22.02.2023
PL22.02.2023
RO22.02.2023
RS22.02.2023
SM22.02.2023
GR23.05.2023
IS22.06.2023
PT22.06.2023
Former [2023/48]EE22.02.2023
FI22.02.2023
HR22.02.2023
LT22.02.2023
LV22.02.2023
PL22.02.2023
RS22.02.2023
SM22.02.2023
GR23.05.2023
IS22.06.2023
PT22.06.2023
Former [2023/46]FI22.02.2023
HR22.02.2023
LT22.02.2023
LV22.02.2023
PL22.02.2023
RS22.02.2023
SM22.02.2023
GR23.05.2023
IS22.06.2023
PT22.06.2023
Former [2023/39]FI22.02.2023
HR22.02.2023
LT22.02.2023
LV22.02.2023
PL22.02.2023
RS22.02.2023
GR23.05.2023
IS22.06.2023
PT22.06.2023
Former [2023/38]FI22.02.2023
HR22.02.2023
LT22.02.2023
LV22.02.2023
PL22.02.2023
RS22.02.2023
GR23.05.2023
PT22.06.2023
Former [2023/37]FI22.02.2023
HR22.02.2023
LT22.02.2023
LV22.02.2023
RS22.02.2023
GR23.05.2023
PT22.06.2023
Former [2023/36]FI22.02.2023
HR22.02.2023
LT22.02.2023
LV22.02.2023
RS22.02.2023
PT22.06.2023
Former [2023/35]HR22.02.2023
LT22.02.2023
RS22.02.2023
PT22.06.2023
Former [2023/34]LT22.02.2023
RS22.02.2023
PT22.06.2023
Former [2023/33]LT22.02.2023
Documents cited:Search[X]WO2006056794  (UCL BIOMEDICA PLC [GB], et al) [X] 1-15 * the whole document * * page 3, lines 15-17; figure 10 * * page 11, line 20 - page 12, line 21 * * page 13, line 18 - page 17, line 20; example 13 * * page 36, lines 25-27; claims 1-11,15 *;
 [X]WO2010144498  (UCL BUSINESS PLC [GB], et al) [X] 1-15 * the whole document * * paragraph [0092] * * paragraphs [0144] - [0146]; examples 1-6 *;
 [I]  - VENTURA-COTS MERITXELL ET AL, "Safety of Ornithine Phenylacetate in Cirrhotic Decompensated Patients : An Open-label, Dose-escalating, Single-cohort Study", vol. 47, no. 10, doi:10.1097/MCG.0B013E318299C789, ISSN 0192-0790, (20130101), pages 881 - 887, JOURNAL OF CLINICAL GASTROENTEROLOGY, RAVEN PRESS LTD., NEW YORK, NY, US, URL: http://content.wkhealth.com/linkback/openurl?sid=WKPTLP:landingpage&an=00004836-201311000-00013, XP009507196 [I] 1-15 * abstract *

DOI:   http://dx.doi.org/10.1097/MCG.0b013e318299c789
 [I]  - JALAN R ET AL, "l-Ornithine phenylacetate (OP): A novel treatment for hyperammonemia and hepatic encephalopathy", MEDICAL HYPOTHESES, EDEN PRESS, PENRITH, US, (20070427), vol. 69, no. 5, doi:10.1016/J.MEHY.2006.12.061, ISSN 0306-9877, pages 1064 - 1069, XP029096478 [I] 1-15 * abstract *

DOI:   http://dx.doi.org/10.1016/j.mehy.2006.12.061
 [I]  - YTREBO LARS MARIUS ET AL, "L-ornithine phenylacetate attenuates increased arterial and extracellular brain ammonia and prevents intracranial hypertension in pigs with acute liver failure", HEPATOLOGY, JOHN WILEY & SONS, INC, US, vol. 50, no. 1, doi:10.1002/HEP.22917, ISSN 0270-9139, (20090701), pages 165 - 174, (20090218), XP009164051 [I] 1-15 * abstract *

DOI:   http://dx.doi.org/10.1002/hep.22917
 [X]  - Rune Gangsøy Kristiansen ET AL, "L-Ornithine phenylacetate reduces ammonia in pigs with acute liver failure through phenylacetylglycine formation: a novel ammonia-lowering pathway", American journal of physiology. Gastrointestinal and liver physiology, United States, doi:10.1152/ajpgi.00244.2014, (20141115), pages G1024 - G1031, URL: https://www.physiology.org/doi/full/10.1152/ajpgi.00244.2014, XP055532599 [X] 1-15 * the whole document *

DOI:   http://dx.doi.org/10.1152/ajpgi.00244.2014
 [X]  - VAIRAPPAN BALASUBRAMANIYAN ET AL, "Ammonia reduction with ornithine phenylacetate restores brain eNOS activity via the DDAH-ADMA pathway in bile duct-ligated cirrhotic rats", AMERICAN JOURNAL OF PHYSIOLOGY - GASTROINTESTINAL AND LIVER PHYSIOLOGY, US, (20120101), vol. 302, no. 1, doi:10.1152/ajpgi.00097.2011, ISSN 0193-1857, pages G145 - G152, XP055532625 [X] 1-15 * abstract *

DOI:   http://dx.doi.org/10.1152/ajpgi.00097.2011
International search[X]WO2006056794  (UCL BIOMEDICA PLC [GB], et al) [X] 1-57 * See abstract, page 2, lines 4-6, page 9, lines 12-14, page 10, lines 16-17, page 11, lines 21-33, page 1, line 33-page 12, line 5, page 14, lines 17-26, page 17, lines 4-7 and lines 18-20. *;
 [X]WO2010115055  (OCERA THERAPEUTICS INC [US], et al) [X] 1-57 * See [0034], [0035], [0092], [0102], [0103], [0106], [0151], [0157], [0158]. *;
 [XY]WO2010144498  (UCL BUSINESS PLC [GB], et al) [X] 1-57 * See abstract, [0005], [0033], [0034], [0043], [0061], [0071], [0086], [0087], [0090], [0107]. As above. * [Y] 34-40, 42, 44, 45 and 54-56;
 [XY]WO2012048043  (OCERA THERAPEUTICS INC [US], et al) [X] 1-33, 41, 43, 46-53 and 57 * See [0003], [0005], [0102], [0103], [0113], [0114], [0117]. As above. * [Y] 34-40, 42, 44, 45 and 54-56;
 [XY]AU2014250643  (OCERA THERAPEUTICS INC, et al) [X] 1-57 * See abstract, [0005], [0033], [0034], [0043], [0061], [0071], [0086], [0087], [0090], [0107]. As above. * [Y] 34-40, 42, 44, 45 and 54-56;
 [PX]AU2015221466  (OCERA THERAPEUTICS INC) [PX] 1-57* See [0034], [0035], [0092], [0102], [0103], [0106], [0151], [0157], [0158]. *;
 [A]  - VENTURA-COTS, M. et al., "Safety of ornithine phenylacetate in cirrhotic decompensated patients: an open-label, dose-escalating, single-cohort study", Journal of Clinical Gastroenterology., (20130000), vol. 47, no. 10, pages 881 - 887, XP009507196 [A] 28-33 * See abstract. *

DOI:   http://dx.doi.org/10.1097/MCG.0b013e318299c789
 [A]  - JALAN, R. et al., "L-Ornithine phenylacetate (OP): a novel treatment for hyperammonemia and hepatic encephalopathy", Medical Hypotheses., (20070000), vol. 69, no. 5, pages 1064 - 1069, XP 029096478 [A] 28-33 * See abstract, Figure 5. *
 [A]  - JOVER-COBOS, M. et al., "Ornithine phenylacetate revisited", Metabolic Brain Disease., (20130000), vol. 28, no. 2, pages 327 - 331, XP 055324717 [A] 28-33 * See abstract, subheading 'Clinical Studies'. *
Examination   - M. MOKHTARANI ET AL, "Urinary phenylacetylglutamine as dosing biomarker for patients with urea cycle disorders", MOLECULAR GENETICS AND METABOLISM, (20121101), vol. 107, no. 3, doi:10.1016/j.ymgme.2012.08.006, ISSN 1096-7192, pages 308 - 314, XP055202395

DOI:   http://dx.doi.org/10.1016/j.ymgme.2012.08.006
by applicantWO8705297
 US2008119554
 WO2010115055
 US2010280119
 US2013211135
    - BATSHAW, M. L. et al., "Alternative pathway therapy for urea cycle disorders: twenty years later", J. Pediatr., (20010000), vol. 138, doi:10.1067/mpd.2001.111836, pages S46 - S55, XP002623143

DOI:   http://dx.doi.org/10.1067/mpd.2001.111836
    - ROCKEY D. et al., "Randomized, Double-Blind, Controlled Study of Glycerol Phenylbutyrate in Hepatic Encephalopathy", Hepatology, (20140000), vol. 59, no. 3, pages 1073 - 1083
    - JALAN et al., "L-Ornithine phenylacetate (OP): a novel treatment for hyperammonemia and hepatic encephalopathy", Med Hypotheses, (20070000), vol. 69, no. 5, doi:10.1016/j.mehy.2006.12.061, pages 1064 - 69, XP029096478

DOI:   http://dx.doi.org/10.1016/j.mehy.2006.12.061
The EPO accepts no responsibility for the accuracy of data originating from other authorities; in particular, it does not guarantee that it is complete, up to date or fit for specific purposes.