Receipt date:
`
`t wee/2014
`
`Substitute for form 1449/PTO
`
`
`Complete IfKnown
`
`INFORMATION DISCLOSURE
`
`Application Number
`
`14/500,409
`
`Equivalent of Form PTO/SB/08b (7-09)
`
`STATEMENT BY APPLICANT
`(Use as many sheets as necessary)
`
`1628
`
`Attorney Docket Number
`
`1861 .2700001/JMC/MSB
`
`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
`
`N
`
`Dialog File 351, Accession No. 1709997, Derwent WPI English language abstract for
`DE 2746414 A (listed as document FP1 on accompanying form PTO/SB/08A)
`
`"Australian Public Assessment Report for Buprenorphine/Naloxone - Propriety Product
`Name: Suboxone Sublingual Film - Sponsor: Reckitt Benckiser (Australia) Pty Ltd,"
`PM-2009-01902-3-1, Commonwealth of Australia, 72 pages, Australia (March 2011)
`
`English language Abstract of Japanese Patent Publication No. 08-291070, Japanese
`Patent Office, Patent Abstract of Japan (1996) (listed as document FP9 on the
`accompanying form PTO/SB/0 8A)
`
`
`
`English language translation (unverified, machine generated) of German Patent
`Publication No. 27 46 414, European Patent Office, espacenet database — Worldwide,
`(2012) (listed as document FP5 on the accompanying form PTO/SB/08A)
`
`International Search Report for International Application No. PCT/EP2007/058978,
`European Patent Office, Netherlands, mailed on October 5, 2007
`
`RB Pharmaceuticals Limited, "Package Leaflet: Information for the User - Subutex 0.4
`mg, 2 mg and 8 mg Sublingual Tablets - Buprenorphine hydrochloride," 5 pages,
`Reckitt Benckiser Healthcare (September 2010)
`
`STRAIN, E. C., et al., "Relative bioavailability of different buprenorphine formulations
`under chronic closing conditions," Drug Alcohol Depend. 74 (1):37-43, ElseVier Ireland
`Ltd., Ireland (April 2004)
`
`Leaflet entitled 'Ondansetron RLTM Zydis ® Wafers’ (April 8, 2005)
`
`Office Action mailed August 18, 201 1, in United States Patent Application No.
`12/439,410, Oksche, A., et al., filed November 9, 2009
`
`Examiner
`Signature
`
`.
`
`,
`
`*
`
`I
`
`Date
`Considered
`
`03/22/201 5
`
`*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.
`
`ALL REFERENCES CONSIQEEED EXCEPT WHERE LiNEi} THEOUQE.
`
`/C.E./’
`
`

`

`Receipt date:
`
`t 3/20/2014
`
`Substitute for form 1449/PTO
`
`
`Complete IfKnown
`
`INFORMATION DISCLOSURE
`
`Application Number
`
`14/500,409
`
`Equivalent of Form PTO/SB/08b (7-09)
`
`STATEMENT BY APPLICANT
`(Use as many sheets as necessary)
`
`1628
`
`NON PATENT LITERATURE DOCUMENTS
`
`
`Attorney Docket Number
`
`1861.2700001/JMC/MSB
`
`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
`
`Office Action mailed May 22, 2012, in United States Patent Application No.
`12/439,410, Oksche, A., et al., filed November 9, 2009
`
`
`
`
`SUBOXONE Package Insert, Buprenorphine HCl and naloxone HCl dehydrate
`sublingual tablets, Reckitt Benckiser Healthcare Ltd., 4 pages, published at least as early
`as July 27, 2006 as evidenced by the Internet Archive Report, accessed at
`WWW.naabt.org/documents/packageinsertpdf , accessed on October 9, 2014 through the
`Wa back Machine
`
`PVP Polyvinylpyrrolidone Polymers in Performance Enhancing Products as cited by the
`USPTO in US. Application No. 12/439,410, 15 pages (no publication date available)
`
`
`"Pharmacology" in Kare/2’s Pathology ofDrug Abuse Fourth Edition by Steven B.
`Karch, page 436 (2009)
`
`Office Action mailed October 15, 2014, in United States Patent Application No.
`12/439,410, Oksche, A., et al., filed November 9, 2009
`
`1904159_1
`
`
`Examiner
`-/
`i
`m ;
`Signature
`mralg RCCI/
`
`03/225301?)
`
`Date
`
`*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.
`
`ALL REFERENCES CONSIQEEED EXCEPT WHERE LiNEi} THEOUQE.
`
`/C.E./
`
`