Receipt date: 03/21/2015
`
`Substitute for form 1449/PTO
`
`FIRST SUPPLEMENTAL
`
`INFORMATION DISCLOSURE
`
`Eouivalent Of Form PTO/SB/OBb 7-09
`
`Cam I lete i Known
`
`Application Number
`l4/500,409
`Filing Date
`September 29, 2014
`
`
`ArtUnit
`STATEMENT BY APPLICANT
`1628
`
`(USE as many sheets as necessary)
`Examiner Name
`Ricci, Craig D
`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
`
`ALVAREZ-FUENTES, J., et al., "Effectiveness of repeated administration of a new oral
`naltrexone controlled-release system on morphine analgesia," J Pharm Pharmacol
`53 : 1201-1205, Pharmaceutical Society of Great Britain, England (2001)
`
`ALVAREZ-FUENTES, J., et al., "Preclinical Study of an Oral Controlled Release
`Naltrexone Complex in Mice," J Pharm Pharmacol 52:659-663, Pharmaceutical Society
`of Great Britain, England (2000)
`
`AMASS, L., et al., "Efficacy of daily and alternate-day dosing regimens with the
`combination buprenorphine-naloxone tablet," Drug and Alcohol Dependence 58: 143-
`152, Elsevier Science Ireland Ltd., Ireland (2000)
`
`ARCHER, S., "Historical Perspective on the Chemistry and Development of
`Naltrexone," NIDA Res Monogr 2633-10, National Institute on Drug Abuse, United
`States (1981)
`
`BASHAW, E.D., et al., "Relative bioavailability of controlled-release oral morphine
`sulfate during naltrexone blockade," Int J Clin Pharmacol Ther 33(9):524-529, Dustri-
`Verlag Dr. K. Feistle, Germany (1995)
`
`N
`
`
`BALS-KUBIK, R., et al., "Evidence that the aversive effects of opioid antagonists and
`K-agonists are centrally mediated," Phychopharmacology 98:203 -206, Springer-Verlag,
`Germany (1989)
`
`BIGELOW, G.E., et al., "Abuse Liability Assessment of Buprenorphine-Naloxone
`Combinations," Department of Psychiatry and Behavioral Sciences, The Johns Hopkins
`University School of Medicine
`
`BLOOM, W.A., et al., "Clinical Studies with Naloxone/Methadone in a Ratio of 1:20,"
`5th National Conference on Methadone Treatment, March 17-19, 1973, Volume Two:
`Pages 811 to 1504, 9 pages
`
`Co-pending Application, US. Application No. 14/470,662 (UNPUBLISHED)
`
`CARUSO, F.S., et al., "Methadone and Naloxone in Combination (Naldone) for the
`Treatment of Heroin Addicts," Proc Natl ConfMethadone Treat 2: 1336-1341, National
`Association For The Prevention Of Addiction To Narcotics, United States (1973)
`
`Examiner
`Signature
`
`/Craig RiCCi/
`
`Date
`Considered
`
`03/22/2015
`
`*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 CONSIEEREE EXCEPT WHERE LINES THROUGH.
`
`/C.E./’
`
`

`

`Receipt date: 03/21/2015
`
`Substitute for form 1449/PTO
`
`FIRST SUPPLEMENTAL
`
`INFORMATION DISCLOSURE
`
`Eouivalent Of Form PTO/SB/OBb 7-09
`
`Cam I lete i Known
`
`Application Number
`14/500,409
`Filing Date
`September 29, 2014
`
`
`ArtUnit
`STATEMENT BY APPLICANT
`1628
`
`(USE as many sheets as necessary)
`Examiner Name
`Ricci, Craig D
`Attorney Docket Number
`1861.2700001/JMC/MSB
`
`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
`
`CHERNY, N.I., "Opioid Analgesics Comparative Features and Prescribing Guidelines,’
`Drugs 51(5):7l3-737, Adis International United, New Zealand (1996)
`
`CHIANG, C.N., et al., "Pharmacokinetics of the combination tablet of buprenorphine
`and naloxone," Drug and Alcohol Dependence 70:S39-S47, Elsevier Science Ireland
`Ltd., Ireland (2003)
`
`CHIANGE, C.N., et al., "Kinetics of a naltrexone sustained-release preparation,"
`Clinicalpharmacology and therapeutics 35:704-708, Wiley, United States (1984)
`
`N
`
`CHIANGE, C.N., et al., "Clinical Evaluation of aNaltrexone Sustained-Release
`Preparation," Drug and Alcohol Dependence 16:1-8, Elsevier Scientific Publishers
`Ireland Ltd., Ireland (1985)
`
`CICCOCIOPPO, R., et al., "Effect of nociceptin/orphanin FQ on the rewarding
`properties of morphine," European Journal ofPharmacology 4 04 :153-159, Elsevier
`Science B.V., Netherlands (2000)
`
`COMER, S.D., et al., "Depot naltrexone: long-lasting antagonism of the effects of
`heroin in humans," Psychopharmacology 1 5 9351-3 60, Springer-Verlag, Germany
`(2002)
`
`CRABTREE, B.L., "Review of naltrexone, a long-acting opiate antagonist," Clinical
`Pharmacy 3 :273-280, American Society of Hospital Pharmacists, United States (1984)
`
`CRAIN, S.M., et al., "Antagonists of excitatory opioid receptor functions enhance
`morphine's analgesic potency and attenuate opioid tolerance/dependence liability," Pain
`82:1-11, Elsevier Science B.V., Netherland (1999)
`
`CRAIN, S.M., et al., "Ultra-low concentrations of naloxone selectively antagonize
`excitatory effect of morphine on sensory neurons, thereby increasing its antinociceptive
`potency and attenuating tolerance/ dependence during chronic cotreatment," Proc Natl
`
`Acad Sci USA 92:10540-10544, United States National Academy of Sciences (1995)
`CRAIN, SM. and SHEN, K-F., "Acute thermal hyperalgesia elicited by low-dose
`morphine in normal mice is blocked by ultra-low dose naltrexone, unmasking potent
`opioid analgesia," Brain Research 888:75-82, Elsevier Science B.V., Netherlands
`
`Examiner
`
`Signature
`
`_
`
`V
`
`.
`
`'CCii
`
`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.
`ALL REFERENCES CONSIEEREE EXCEPT WHERE LINES THRQUQH.
`
`lCEJ’
`
`

`

`Receipt date: 03/21/2015
`
`Substitute for form 1449/PTO
`
`FIRST SUPPLEMENTAL
`
`INFORMATION DISCLOSURE
`
`Eouivalent Of Form PTO/SB/OBb 7-09
`
`Cam I lete i Known
`
`Application Number
`14/500,409
`Filing Date
`September 29, 2014
`
`
`ArtUnit
`STATEMENT BY APPLICANT
`1628
`
`(USE as many sheets as necessary)
`Examiner Name
`Ricci, Craig D
`Attorney Docket Number
`1861.2700001/JMC/MSB
`
`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
`
`N
`
`DATA SHEET "SUBOXONE" (buprenorphine + naloxone), March 2006, 11 pages
`
`EISSENBERG, T., et al., "Buprenorphine's Physical Dependence Potential: Antagonist-
`Precipitated Withdrawal in Humans," J Pharmacol Exp Ther 2 76(2):449-459, Williams
`& Wilkins, United States (1996)
`
`ELKADER, A. and SPROULE, B., "Buprenorphine Clinical Pharmacokinetics in the
`Treatment of Opioid Dependence," Clin Pharmacokinet 44 (7):661-680, Adis Data
`Information B.V., New Zealand (2005)
`
`FINK, M., et al., "Naloxone in heroin dependence," Clin Pharmacol Ther 9(5):568-577,
`Wiley, United States (1968)
`
`FISHMAN, J., et al., "Disposition of Naloxone-7-8-H in Normal and Narcotic-
`Dependent Men," The Journal ofPharmacology and Experimental Therapeutics
`187(3):575-580, The Williams & Wilkins Co., United States (1973)
`
`FUDALA, P.J., et al., "Effects of buprenorphine and naloxone in morphine-stabilized
`opioid addicts," Drug and Alcohol Dependence 50: 1-8, ElseVier Science Ireland Ltd.,
`Ireland (1998)
`
`GERRA, G., et al., "Clonidine and Opiate Receptor Antagonists in the Treatment of
`Heroin Addiction," Journal ofSubstance Abuse Treatment 12(1):35-41, ElseVier
`Science Ltd., England (1995)
`
`GONZALEZ, JP. and BRODAEN, R.N., "Naltrexone A Review of its
`Pharmacodynamic and Pharmacokinetic Properties and Therapeutic Efficacy in the
`Management of Opioid Dependence," Drug 35: 192-213, ADIS Press Limited, New
`
`GREENWALD, M.K., et al., "Comparative Clinical Pharmacology of Short-Acting Mu
`Opioids in Drug Abusers ," The Journal ofPharmacology and Experimental
`Therapeutics 2 77: 1228-123 6, The American Society for Pharmacology and
`Ex 0 erimental Thera. eutics, United States 1996
`
`HARRIS, D.S., et al., "Buprenorphine and naloxone co-administration in opiate-
`dependent patients stabilized on sublingual buprenorphine," Drug and Alcohol
`Dependence 61:85-94, ElseVier Science Ireland Ltd., Ireland (2000)
`
`Examiner
`Signature
`
`’
`
`'
`
`[CCE
`
`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 CONSIEEREE EXCEPT WHERE LINES THRQUQH.
`
`lCEJ’
`
`

`

`Receipt date: 03/21/2015
`
`Substitute for form 1449/PTO
`
`FIRST SUPPLEMENTAL
`
`INFORMATION DISCLOSURE
`
`Eouivalent Of Form PTO/SB/OBb 7-09
`
`Cam I lete i Known
`
`Application Number
`14/500,409
`Filing Date
`September 29, 2014
`
`
`ArtUnit
`STATEMENT BY APPLICANT
`1628
`
`(USE as many sheets as necessary)
`Examiner Name
`Ricci, Craig D
`Attorney Docket Number
`1861.2700001/JMC/MSB
`
`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
`
`HUSSAIN, M.A., et al., "Buccal and oral bioavailability of naloxone and naltrexone in
`rats," International Journal ofPharaceutics 36: 127-130, Elsevier B.V., Netherlands
`(1987)
`
`JOHNSON R.E., et al., "Buprenorphine and Naloxone for Heroin Dependence,"
`Current Psychiatry Reports 2:519-526, Current Sciences Inc., United States (2000)
`
`KOSTEN, T.R., et al., "Opioid antagonist challenges in buprenorphine maintained
`patients," Drug and Alcohol Dependence 25 :73-78, Elsevier Scientific Publishers
`Ireland Inc., Ireland (1990)
`
`KUHLMAN, J.J., et al., "Human Pharmacokinetics of Intravenous, Sublingual, and
`Buccal Buprenorphine," Journal ofAnalytical Toxicology 20:369-378, Oxford
`University Press, United States (1996)
`
`N
`
`LEHMANN, K.A., et al., "Influence of Naloxone on the Postoperative Analgesic and
`Respiratory Effects of Buprenorphine," EurJ Clin Pharmacol 34:343-352, Springer-
`Verlag, Germany (1988)
`
`MENDELSON, J., et al., "Bioavailability of Sublingual Buprenorphine," J Clin
`Pharmacol 3 7:3 1-37, Hall Associates, England (1997)
`
`MENDELSON, J., et al., "Buprenorphine and naloxone combinations: the effects of
`three dose ratios in morphine-stabilized, opiate-dependent volunteers,"
`Psychopharmacology 141:37-46, Springer-Verlag, Germany (1999)
`
`MENDLESON, J., et al. "Buprenorphine and naloxone interactions in opiate-dependent
`volunteers," Clin Pharmacol Ther 60: 105-1 14, Wiley, United States (1996)
`
`MENDLESON, J., et al., "Buprenorphine and Naloxone Interactions in Methadone
`Maintenance Patients," Biol Psychiatry 41:1095-1101, Society of Biological Psychiatry,
`Elsevier, United States (1997)
`
`PARWATIKAR, S.D., et al., "Methadone-naloxone in combination for the treatment of
`heroin addicts," Clin Pharmacol Ther 14(6):941-948, Wiley, United States (1973)
`
`Examiner
`Signature
`
`“n.-
`.h 5/
`luialg REIGN
`
`Date
`
`I
`i
`03/22/2015
`
`*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 CONSIEEREE EXCEPT WHERE LINES THRQUQH.
`
`lCEJ’
`
`

`

`Receipt date: 03/21/2015
`
`Substitute for form 1449/PTO
`
`FIRST SUPPLEMENTAL
`
`INFORMATION DISCLOSURE
`
`Eouivalent Of Form PTO/SB/OBb 7-09
`
`Cam I lete i Known
`
`Application Number
`14/500,409
`Filing Date
`September 29, 2014
`
`
`ArtUnit
`STATEMENT BY APPLICANT
`1628
`
`(USE as many sheets as necessary)
`Examiner Name
`Ricci, Craig D
`Attorney Docket Number
`1861.2700001/JMC/MSB
`
`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
`
`PRESTON, K.L., et al., "Buprenorphine and naloxone alone and in combination in
`opioid-dependent humans," Psychopharmacology 94 :484-490, Springer-Verlag,
`Germany (1988)
`
`PRESTON, K.L., et al., "Effects of sublingually given naloxone in opioid-dependent
`human volunteers," Drug and Alcohol Dependence 25 :27-34, Elsevier Scientific
`Publishers Ireland Ltd., Ireland (1990)
`
`ROBINSON, S.E., "Buprenorphine: An Analgesic with an Expanding Role in the
`Treatment of Opioid Addiction," CNS Drug Reviews 8(4):377-390, Neva Press, United
`States (2002)
`
`SCHUH, K.J., et al., "Onset, magnitude and duration of opioid blockade produced by
`buprenorphine and naltrexone in humans," Psychopharmacology 145:162-174,
`Springer-Verlag, Germany (1999)
`
`SHOJAEI, A.H., "Buccal Mucosa As A Route For Systemic Drug Delivery: A Review,"
`JPlzarm Pharm Sci 1(1):15-30, The Society, Canada (1998)
`
`STOLLER, K.B., et al, "Effects of buprenorphine/ naloxone in opioid-dependent
`humans," Psychopharmacology 154:230-242, Springer-Verlag, Germany (2001)
`
`STRAIN, E.C., et al, "Effects of burprenorphine versus buprenorphine/naloxone tablets
`in non-dependent opioid abusers," Psychopharmacology [48374-3 83, Springer-Verlag,
`Germany (2000)
`
`N
`
`Suboxone (CIII) buprenorphine HCl and naloxone HCl dihydrate sublingual tablets
`insert, September 2006, 4 pages
`
`WEINHOLD, L.L., et al., "Buprenorphine alone and in combination with naloxone in
`non-dependent humans," Drugs and Alcohol Dependence 3 0263-274, Elsevier
`Scientific Publishers Ireland Ltd., Ireland (1992)
`
`"Suboxone : EPAR - Scientific Discussion," published by EMEA on October 19, 2006,
`42 pages
`
`1955045_1
`
`Examiner
`
`"
`
`:
`-
`m -
`lcrai RlCCI/
`
`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 CONSIEEREE EXCEPT WHERE LINES THROUGH.
`
`lCEJ’
`
`