IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`Inventors: OKSCHE ef al.
`
`Confirmation No.: 7842
`
`Applicant: Rhodes Pharmaceuticals L.P.
`
`Art Unit: 1615
`
`Application No.: 15/998,868
`
`Examiner: To Be Assigned
`
`Filing Date: August 17, 2018
`
`Atty. Docket: 1861.2700007/JMC/MSB
`
`Title:BUPRENORPHINE-WAFER FOR DRUG SUBSTITUTION THERAPY
`
`Information Disclosure Statement
`
`Mail Stop Amendment
`
`Commissionerfor Patents
`PO Box 1450
`Alexandria, VA 22313-1450
`
`Commissioner:
`
`Listed on accompanying form equivalent to forms PTO/SB/08a and PTO/SB/08b are
`
`documents that may be considered material to the patentability of this application as defined in 37
`
`C.F.R. §1.56. This IDS is being filed in compliance with the duty of disclosure requirements of 37
`
`C.F.R. §§ 1.97 and 1.98.
`
`Applicant haslisted publication dates on the attached forms based on information presently
`
`available to the undersigned. However, the listed publication dates should not be construed as an
`
`admission that the information was actually published on the date indicated.
`
`Applicant reserves the right to establish the patentability of the claimed invention over any
`
`of the information provided herewith, and/or to prove that this information maynotbe priorart,
`
`and/or to prove that this information may not be enabling for the teachings purportedly offered.
`
`This statement should not be construed as a representation that a search has been made, or
`
`that information more material to the examination of the present patent application does not exist.
`
`The Examineris specifically requested not to rely solely on the material submitted herewith.
`
`
`
`Inventors: OKSCHE ef al.
`
`Confirmation No.: 7842
`
`Applicant: Rhodes Pharmaceuticals L.P.
`
`Art Unit: 1615
`
`Application No.: 15/998,868
`
`Examiner: To Be Assigned
`
`Filing Date: August 17, 2018
`
`Atty. Docket: 1861.2700007/JMC/MSB
`
`Title:BUPRENORPHINE-WAFER FOR DRUG SUBSTITUTION THERAPY
`
`Information Disclosure Statement
`
`Mail Stop Amendment
`
`Commissionerfor Patents
`PO Box 1450
`Alexandria, VA 22313-1450
`
`Commissioner:
`
`Listed on accompanying form equivalent to forms PTO/SB/08a and PTO/SB/08b are
`
`documents that may be considered material to the patentability of this application as defined in 37
`
`C.F.R. §1.56. This IDS is being filed in compliance with the duty of disclosure requirements of 37
`
`C.F.R. §§ 1.97 and 1.98.
`
`Applicant haslisted publication dates on the attached forms based on information presently
`
`available to the undersigned. However, the listed publication dates should not be construed as an
`
`admission that the information was actually published on the date indicated.
`
`Applicant reserves the right to establish the patentability of the claimed invention over any
`
`of the information provided herewith, and/or to prove that this information maynotbe priorart,
`
`and/or to prove that this information may not be enabling for the teachings purportedly offered.
`
`This statement should not be construed as a representation that a search has been made, or
`
`that information more material to the examination of the present patent application does not exist.
`
`The Examineris specifically requested not to rely solely on the material submitted herewith.
`
`
`
`-2-
`
`Rhodes Pharmaceuticals L.P.
`Application No. 15/998,868
`
`This Information Disclosure Statementis being filed before the mailing date of a first Office
`
`Action on the merits. No statement or fee is required.
`
`A concise explanation of the relevance of the non-English language documents appears
`
`below in accordance with 37 C.F.R. § 1.98(a)(3).
`
`Document FP4, DE19652188, is in a foreign language. Document FP2, CA-2274910-C,is
`
`believed to be an English language equivalent of document FP4.
`
`Document FP5, DE2138593A1, is in a foreign language. Document US1, U.S.3,773,955,
`
`is
`
`an English language equivalent of document FPS5.
`
`Document FP6, DE2222039A1, is in a foreign language. Document FP15, GB-1390772-A,
`
`is believed to be an English language equivalent of document FP6.
`
`Document FP7, DE2746414A1, is in a foreign language. Document NPL271s believed to
`
`be an English language Abstract of document FP7.
`
`Document FP11, EP-0460588-A1, is in a foreign language. An unverified English language
`
`abstract is provided on the first page of document FP11.
`
`Document FP14, ES2214649T3, is in a foreign language. Document FP2, CA-2274910-C,
`
`is believed to be an English language equivalent of document FP14.
`
`Document FP18, JP-H10-506409, is in a foreign language. Document FP50, WO-9626720-
`
`A1, is believed to be an English language equivalent of document FP18.
`
`Document FP19, JP2001506640A,is in a foreign language. Document FP53, WO-9826780-
`
`A2, includes an unverified English language abstract of document FP19.
`
`Atty. Dkt. No. 1861.2700007/JMC/MSB
`
`
`
`-3-
`
`Rhodes Pharmaceuticals L.P.
`Application No. 15/998,868
`
`Document FP20, JP2001513549A,is in a foreign language. Document FP55, WO-9909962-
`
`A1, is believed to be an English language equivalent of document FP20.
`
`Document FP21, JP2005517722A,is in a foreign language. Document FP36, WO-
`
`03070227-A1, includes an unverified English language abstract of document FP21.
`
`Document FP22, JP H08-291070, is in a foreign language. Document NPL32is believed to
`
`be an English language abstract of document FP22.
`
`Document FP23, JPS61191613A,is in a foreign language. Document FP8, EP-0185472-A1,
`
`is believed to be an English language equivalent of document FP23.
`
`Document FP40, WO 2006/087160 A1, is in a foreign language. An English language
`
`abstract is included on thefirst page of document FP40.
`
`Document FP44, WO 2007/144085 A1, is in a foreign language. An English language
`
`abstract is included on thefirst page of document FP44.
`
`Document FP48, WO9312769A1, is in a foreign language. An unverified English language
`
`abstract is included onthefirst page of document FP48.
`
`Document FP53, WO 98/26780 A2,is in a foreign language. An unverified English
`
`language abstract is provided on the first page of document FP53.
`
`Document NPL64 is in a foreign language. An unverified English languagetranslation of
`
`document NPL64 is cited as document NPL33.
`
`NPL102is an entry for Subutex® tablets copied from the French version of the Physician’s
`
`Desk Reference. Subutex® is a buprenorphine only sublingual tablet. NPL102 is believed to be
`
`relevant in view ofits discussion of the formulation, pharmacokinetic parameters, and
`
`Atty. Dkt. No. 1861.2700007/JMC/MSB
`
`
`
`-4-
`
`Rhodes Pharmaceuticals L.P.
`Application No. 15/998,868
`
`pharmacodynamicsof the Subutex® dosage form. Applicant will provide the Examiner with a
`
`translation of NPL102, upon request, should the Examinerbelieve further analysis of this document
`
`is warranted.
`
`In accordance with 37 C.F.R. § 1.98(a)(2)(ii), no copies of U.S. patents and patent
`
`application publications cited as documents US1-US894 have been submitted.
`
`Copies of documents FP18 and NPL104 are submitted herewith.
`
`Copies of FP1-FP17 and FP19-FP59 and NPL1-NPL103 were cited by or submitted to the
`
`Office in an IDS that complies with 37 C.F.R. § 1.98(a)-(c) in Application Nos. 12/439,410,filed
`
`November9, 2009 (now U.S. Patent No. 9,101,625, issued August 11, 2015), 14/800,270, filed July
`
`15, 2015 (now U.S. Patent No. 9,370,512), 15/135,794, filed April 22, 2016 (now U’S. Patent No.
`
`9,861,628), and 15/708,991, filed September 19, 2017, which are relied upon for an earlier filing
`
`date under 35 U.S.C. § 120. Thus, copies of these documents are not attached. 37 C.F.R. § 1.98(d).
`
`It is expected that the examiner will review the prosecution and cited art in the parent
`
`Application Nos. 12/439,410, 14/800,270, 15/135,794, and 15/708,991 in accordance with MPEP
`
`2001.06(b), and indicate in the next communication from the office that the art cited in the earlier
`
`prosecution history has been reviewed in connection with the present application.
`
`It is respectfully requested that the Examinerinitial and return a copy of the enclosed forms
`
`and indicate in the official file wrapper of this patent application that the documents have been
`
`considered.
`
`Atty. Dkt. No. 1861.2700007/JMC/MSB
`
`
`
`-5-
`
`Rhodes Pharmaceuticals L.P.
`Application No. 15/998,868
`
`The U.S. Patent and Trademark Office is hereby authorized to charge any fee deficiency, or
`
`credit any overpayment, to our Deposit Account No. 19-0036.
`
`Respectfully submitted,
`
`STERNE, KESSLER, GOLDSTEIN & FOX P.L.L.C.
`
`/Matthew S. Bodenstein/
`
`Matthew S. Bodenstein
`Attorney for Applicants
`Registration No. 58,885
`
`Date:
`
`October 23, 2018
`
`1100 New York Avenue, N.W.
`Washington, D.C. 20005-3934
`(202) 371-2600
`
`101029441
`
`Atty. Dkt. No. 1861.2700007/JMC/MSB
`
`
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