`
`Appl. No. 15/442,231
`
`Remarks
`
`Claims 1-8 are pending in the application. Claims 1-4 and 8 are currently amended. No
`
`claims are canceled. Reconsideration is respectfully requested in View of noted amendments and
`
`following remarks.
`
`Discussion of Claim Amendments
`
`Claim 1 has been amended to recite that the dosage form does not include any of naloxone,
`
`naltrexone,
`
`nalmefene,
`
`nalorphine,
`
`nalbuphine,
`
`naloxoneazinen,
`
`methylnaltrexone,
`
`ketylcyclazocine, norbinaltorphimine, naltrindol, 6-B-naloxol, 6-B-naltrexol, or other opioid
`
`antagonist capable of inducing opioid withdrawal symptoms upon parenteral administration with
`
`buprenorphine.
`
`Support for this amendment can be found on at least the third full paragraph on page 3 of the
`
`application as filed, the third paragraph on page 10 of the application as filed, and the third full
`
`paragraph of page 21 of the application as filed. These cited passages identify that abuse-deterrent
`
`antagonists are an optional element of the disclosed dosage form such that excluding these dosage
`
`forms is proper. No new matter has been introduced by way of the present amendment and its entry
`
`is respectfully requested.
`
`Minor typographical errors have been corrected in claims 2-4 and 8.
`
`Atty. Dkt. No.:
`1861.2700005/JMC/MSB
`
`
`
`Purdue Pharma L. P.
`
`Appl. No. 15/442,231
`
`Response to 35 U.S.C. § 112, Rejection of Claims 1-8
`
`Claims 1-8 stand rejected under 35 U.S.C.
`
`§ 112, 2nd paragraph as being indefinite.
`
`According to the Examiner, the phrase "opioid antagonist" included both partial agonist/antagonists
`
`such as buprenorphine and nalbuphine, rendering the scope of the phrase "opioid antagonist"
`
`unclear. While Applicant disagrees and believes that a skilled artisan would have understood the
`
`intended scope and meaning of the rejected phrase, Applicant has amended claim 1 to specifically
`
`exclude certain specified antagonists, including nalbuphine, and any other antagonists capable of
`
`inducing opioid withdrawal upon parenteral administration with buprenorphine. This amendment is
`
`believed to render the present rejection moot.
`
`The Examiner is respectfully requested to withdraw the pending rejection and allow the
`
`pending claims.
`
`Atty. Dkt. No.:
`1861.2700005/JMC/MSB
`
`
`
`Purdue Pharma L. P.
`
`Appl. No. 15/442,231
`
`Conclusion
`
`All claims are believed to be in condition for allowance. An early action to that end is
`
`earnestly solicited. To the extent the Examiner believes it would be useful or would expedite
`
`examination, the Examiner is invited to telephone Applicant's undersigned representative.
`
`Respectfully submitted,
`
`STERNE, KESSLER, GOLDSTEIN & Fox P.L.L.C.
`
`/Matthew S. Bodenstein/
`
`Matthew S. Bodenstein
`
`Registration No. 58,885
`
`Date: August 10, 2018
`
`1100 New York Avenue, NW.
`Washington, DC. 20005-3934
`(202) 371-2600
`
`977105773
`
`7 _
`
`_
`
`Atty. Dkt. No.:
`1861.2700005/JMC/MSB
`
`
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