Substitute for form 1449/PTO
`THIRD SUPPLEMENTAL
`
`Complete ifKnown
`
`Application Number
`14/500,409
`
`Filing Date
`September 29, 2014
`
`First Named Inventor
`Alexander OKSCHE
`INFORMATION DISCLOSURE
`
`Art Unit
`1628
`STATEMENT BY APPLICANT
`
`(Use as many sheets as necessary)
`Examiner Name
`Craig D. RICCI
`Attorney Docket Number
`18 61 .2700001/JMC/MSB
`
`E-uivalent of Form PTO/SB/O8b 7-09
`
`NON PATENT LITERATURE DOCUMENTS
`
`Examiner
`Initials *
`
`Include name of the author (in CAPITAL LETTERS), title of the article (when
`appropriate), title of the item (book, magazine, journal, serial, symposium, catalog, etc.),
`date, page(s), volume-issue number(s), publisher, city and/or country Where published
`
`MATHARU, R.P., et al., "Development and Stability Assessment of Buprenorphine
`Sublingual Tablets for the Treatment of Opiate Addiction," Pharmaceutical Research
`9(10):S128, Plenum Press, United States (1992) (Abstract Number PT 6056)
`
`"Pharmaceutical Technical Procedures," in European Pharmacopoeia Fourth Edition
`Supplement 4. 1, pp.106-107 and 194-197, Counsel of Europe, France (2001)
`
`"Pharmaceutical Technical Procedures," in European Pharmacopoeia Third Edition, pp.
`127-131, Counsel of Europe, France (1997)
`
`Drugs@FDA: FDA Approved Drug Products, "Suboxone" FDA Application No. (NDA)
`020733, 26 pages
`
`RB Pharmaceuticals Limited, "Temgesic 200 microgram Sublingual tablets," 6 pages,
`Rechick Benckiser Healthcare (October 2013)
`
`RB Pharmaceuticals Limited, "Temgesic 400 microgram Sublingual tablets," 7 pages,
`Rechick Benckiser Healthcare (October 2013)
`
`JENKINSON, RA, et al., "Buprenorphine diversion and injection in Melbourne,
`Australia: an emerging issue?" Addiction 100:197-205, Society for the Study of
`Addiction, Australia (2004)
`
`Patent and Exclusivity Search Results "Orange Book: Approved Drug Products with
`Therapeutic Equivalence Evaluations," 3 pages, accessed on January 8, 2013
`
`
`
`
`
`"Ondansetron-RLTM Zydis ® Wafers," Consumer Medicine Information Leaflet, 5
`pages, accessed on February 19, 2013
`
`"Test of disintegration time for buprenorphine tablets," Document ID PID 2013-302, 8
`pages, dated December 12, 2013
`
`Examiner
`
`Signature
`
`Date
`
`Considered
`
`*EXAMINER: Initial if reference considered, Whether or not citation is in conformance with MPEP 609. Draw line through citation if not in conformance
`and not considered. Include copy of this form with next communication to applicant.
`1 Applicant’s unique citation designation number (optional). 2 Applicant is to place a check mark here if English language Translation is attached.
`
`
`
`Substitute for form 1449/PTO
`
`THIRD SUPPLEMENTAL
`
`INFORMATION DISCLOSURE
`
`E-uivalent of Form PTO/SB/O8b 7-09
`
`Complete ifKnown
`
`14/500,409
`Application Number
`
`September 29, 2014
`Filing Date
`
`Alexander OKSCHE
`First Named Inventor
`
`1628
`Art Unit
`STATEMENT BY APPLICANT
`
`(Use as many sheets as necessary)
`Examiner Name
`Craig D. RICCI
`18 61 .2700001/JMC/MSB
`
`Attorney Docket Number
`
` N
`For Heroin Treatment, 1 page, accessed on December 26, 2013
`
`NON PATENT LITERATURE DOCUMENTS
`
`Include name of the author (in CAPITAL LETTERS), title of the article (when
`Examiner
`appropriate), title of the item (book, magazine, journal, serial, symposium, catalog,
`Initials *
`etc.), date, page(s), volume number, publisher, city and/or country where published
`
`"Suboxone (CIII) (buprenorphine HCL and naloxone HCL dihydrate sublingual tablets)
`and Subtex (CIII) (buprenorphine HCl sublingual tablets)" Prescribing Information, 48
`pages
`
`BREDENBERG, S., et al., "In vitro and in vivo evaluation of a new sublingual tablet
`system for rapid oromucosal absorption using fentanyl citrate as the active substance,"
`European Journal ofPharmaceutical Sciences 20:327-334, Elsevier B.V., Netherlands
`
`(2003)
`
`GUO, J-H, "Bioadhesive Polymer Buccal Patches for Buprenorphine Controlled
`Delivery Formulation, In-vitro Adhesion and Release Properties," Drug Development
`and Industrial Pharmacy 20(18):2809-2821, Marcel Dekker, Inc., United States (1994)
`
`"Pharmacology of Buprenorphine,"
`in The Treatment of Opioid Dependence, Strain,
`EC. and Stitzer, M.L., eds., pp. 216-219, Johns Hopkins University Press, United States
`(2006)
`
`CHAWARSKI, M.C., et al., "Plasma concentrations of buprenorphine 24 to 72 hours
`after dosing," Drug and Alcohol Dependence 5 5 :157-163, Elsevier Science Ireland Ltd.,
`Ireland (1999)
`
`SCHUH, K]. and JOHANSON, C-E., "Pharmacokinetic comparison of the
`buprenorphine sublingual liquid and tablet," Drug and Alcohol Dependence 5 6:55-60,
`Elsevier Science Ireland Ltd., Ireland (1999)
`
`VIDAL 2002, "Extrait du Vidal 2002, pages du SUBUTEX,”
`Le Dictionnaire, 3 pages
`
`Suboxone Prescribing Information, revised December 2011, 21 pages
`
`UNKNOWN AUTHOR "Reckitt Benckiser Pharma Voluntarily Withdraws Suboxone
`
`"Background Information on the Procedure, Suboxone buprenorphine/ naloxone, 2
`pages accessed on December 20, 2013
`
`
`
`_xaminerS1gnature
`
`
`
`D_te_onsidered
`
`*EXAMINER: Initial if reference considered, whether or not citation is in conformance with MPEP 609. Draw line through citation if not in conformance
`and not considered. Include copy of this form with next communication to applicant.
`1 Applicant’s unique citation designation number (optional). 2 Applicant is to place a check mark here if English language Translation is attached.
`
`
`
`Substitute for form 1449/PTO
`THIRD SUPPLEMENTAL
`
`Complete ifKnown
`
`Application Number
`14/500,409
`
`Filing Date
`September 29, 2014
`
`First Named Inventor
`Alexander OKSCHE
`INFORMATION DISCLOSURE
`
`Art Unit
`1628
`STATEMENT BY APPLICANT
`
`(Use as many sheets as necessary)
`Examiner Name
`Craig D. RICCI
`Attorney Docket Number
`18 61 .2700001/JMC/MSB
`
`E-uivalent of Form PTO/SB/O8b 7-09
`
`Iq(HVILATHENWTLJTTHLATTHREII)CK:UDJEPWFS
`
`Examiner
`Initials *
`
`Include name of the author (in CAPITAL LETTERS), title of the article (when
`appropriate), title of the item (book, magazine, journal, serial, symposium, catalog, etc.),
`date, page(s), volume-issue number(s), publisher, city and/or country Where published
`
`Notice of Opposition to European Patent 2059243 B1, Opponent Hexal AG, 23 pages,
`December 17, 2013
`
`Notice of Opposition to European Patent 2059243 B1, Opponent Orexo AB, 235 pages,
`December 19, 2013
`
`Notice of Opposition to European Patent 2059243 B1, Opponent Alison Gallafent, 150
`pages, December 21, 2013
`
`Notice of Opposition to European Patent 2059243 B1, Opponent Ethypharm, 85 pages,
`December 26, 2013
`
`
`
`
`
`English translation of the Notice of Opposition to European Patent 2059243 B1,
`Opponent Ethypharm, 24 pages, December 26, 2013
`
`Proprietor's Response to Notices of Opposition During Opposition Procedure in
`European Patent 2059243 B1, 45 pages, August 22, 2014
`
`l981237_l
`
`Examiner
`
`Signature
`
`Date
`
`Considered
`
`*EXAMINER: Initial if reference considered, Whether or not citation is in conformance with MPEP 609. Draw line through citation if not in conformance
`and not considered. Include copy of this form with next communication to applicant.
`1 Applicant’s unique citation designation number (optional). 2 Applicant is to place a check mark here if English language Translation is attached.
`
`
