IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`Inventors: T0 Be Assigned
`
`Confirmation No.: T0 Be Assigned
`
`Applicant: Rhodes Pharmaceuticals LP.
`
`Art Unit: T0 Be Assigned
`
`Application No.: T0 Be Assigned
`
`Examiner: T0 Be Assigned
`
`Filing Date: To Be Assigned
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`Atty. Docket: 1861.2700006/JMC/MSB/SBL
`
`Title: Buprenorphine Wafer For Drug Substitution Therapy
`
`Information Disclosure Statement
`
`Mail Stop Amendment
`
`Commissioner for Patents
`
`PO Box 1450
`
`Alexandria, VA 22313-1450
`
`Commissioner:
`
`Listed on accompanying forms 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. §l.56. These documents are being provided to the USPTO in compliance with the duty of
`
`disclosure requirements of 37 C.F.R. §§ 1.97 and 1.98.
`
`Where the publication date of a listed document does not provide a month of publication, the
`
`year of publication of the listed document is sufficiently earlier than the effective U.S. filing date
`
`and any foreign priority date so that the month of publication is not in issue. Applicant has listed
`
`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 may not be prior art,
`
`and/or to prove that this information may not be enabling for the teachings purportedly offered.
`
`
`
`Inventors: T0 Be Assigned
`
`Confirmation No.: T0 Be Assigned
`
`Applicant: Rhodes Pharmaceuticals LP.
`
`Art Unit: T0 Be Assigned
`
`Application No.: T0 Be Assigned
`
`Examiner: T0 Be Assigned
`
`Filing Date: To Be Assigned
`
`Atty. Docket: 1861.2700006/JMC/MSB/SBL
`
`Title: Buprenorphine Wafer For Drug Substitution Therapy
`
`Information Disclosure Statement
`
`Mail Stop Amendment
`
`Commissioner for Patents
`
`PO Box 1450
`
`Alexandria, VA 22313-1450
`
`Commissioner:
`
`Listed on accompanying forms 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. §l.56. These documents are being provided to the USPTO in compliance with the duty of
`
`disclosure requirements of 37 C.F.R. §§ 1.97 and 1.98.
`
`Where the publication date of a listed document does not provide a month of publication, the
`
`year of publication of the listed document is sufficiently earlier than the effective U.S. filing date
`
`and any foreign priority date so that the month of publication is not in issue. Applicant has listed
`
`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 may not be prior art,
`
`and/or to prove that this information may not be enabling for the teachings purportedly offered.
`
`
`
`- 2 -
`
`Rhodes Pharmaceuticals L.P.
`
`Application No. T0 Be Assigned
`
`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 Examiner is specifically requested not to rely solely on the material submitted herewith.
`
`This Information Disclosure Statement is 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. § l.98(a)(3).
`
`Document FP4, DEl9652188, is in a foreign language. Document FPZ, CA-22749lO-C, is
`
`believed to be an English language equivalent of document FP4.
`
`Document FPS, DE2138593A1, is in a foreign language. Document US1, U.S.3,773,955,
`
`is
`
`an English language equivalent of document FPS.
`
`Document FP6, DE2222039A1, is in a foreign language. Document FP15, GB-l390772-A,
`
`is believe to be an English language equivalent of document FP6.
`
`Document FP7, DE2746414, is in a foreign language. Document NPL30 is believed to be
`
`an English language Abstract of document FP7 .
`
`Document FP11, EP-O460588-Al, is in a foreign language. An unverified English language
`
`abstract is provided on the first page of document FP11.
`
`Document FP14, E82214649T3, is in a foreign language. Document FPZ, CA-22749lO-C,
`
`is believed to be an English language equivalent of document FP14.
`
`Document FP18, IP2001506640A, is in a foreign language. Document FPSZ, WO-9826780-
`
`A2, includes an unverified English language abstract of document FP18.
`
`Atty. Dkt. No. 1861.2700006/JlVlC/MSB/SBL
`
`
`
`- 3 -
`
`Rhodes Pharmaceuticals L.P.
`
`Application No. T0 Be Assigned
`
`Document FP19, IP2001513549A, is in a foreign language. Document FP54, WO-9909962-
`
`Al, is believed to be an English language equivalent of document FP19.
`
`Document FP20, IP2005517722A, is in a foreign language. Document FP35, W0-
`
`03 O70227-Al, includes an unverified English language abstract of document FP20.
`
`Document FP21, JP 08-291070, is in a foreign language. Document NPL31 is believed to
`
`be an English language abstract of document FP21.
`
`Document FP22, JPS6l l9l6l3A, is in a foreign language. Document FPS, EP-0185472-Al,
`
`is believed to be an English language equivalent of document FP22.
`
`Document FP39, WO 2006/087160 Al, is in a foreign language. An English language
`
`abstract is included on the first page of document FP39.
`
`Document FP43, WO 2007/144085 Al, is in a foreign language. An English language
`
`abstract is included on the first page of document FP43.
`
`Document FP47, W09312769Al, is in a foreign language. An unverified English language
`
`abstract is included on the first page of document FP47.
`
`Document FPSZ, WO 98/26780 A2, is in a foreign language. An unverified English
`
`language abstract is provided on the first page of document FP52.
`
`Document NPL56 is in a foreign language. An unverified English language translation of
`
`document NPL56 is cited as document NPL32.
`
`NPL91 is an entry for SubuteX® tablets copied from the French version of the Physician’s
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`Desk Reference. SubuteX® is a buprenorphine only sublingual tablet. NPL91 is believed to be
`
`relevant in view of its discussion of the formulation, pharmacokinetic parameters, and
`
`Atty. Dkt. No. 1861.2700006/JlVlC/MSB/SBL
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`
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`- 4 -
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`Rhodes Pharmaceuticals L.P.
`
`Application No. T0 Be Assigned
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`pharmacodynamics of the Subutex® dosage form. Applicant will provide the Examiner with a
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`translation of NPL91, upon request, should the Examiner believe further analysis of this document
`
`is warranted.
`
`In accordance with 37 C.F.R. § 1.98(a)(2)(ii), no copies of US. patents and patent
`
`application publications cited as documents US1-US90 have been submitted.
`
`Copies of FPl-FP58 and NPLl-NPL96 were cited by or submitted to the Office in an IDS
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`that complies with 37 C.F.R. § 1.98(a)-(c) in Application Nos. 12/439,410, filed November 9, 2009
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`(now U. S. Patent No. 9,101,625, issued August 11, 2015) and 14/800,270, filed July 15, 2015 (now
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`US. Patent No. 9,370,512) which is relied upon for an earlier filing date under 35 U.S.C. § 120.
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`Thus, copies of these documents are not attached. 37 C.F.R. § l.98(d).
`
`It is expected that the examiner will review the prosecution and cited art in the parent
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`Application Nos. 12/439,410, 14/800,270, and 15/135,794 in accordance with MPEP 2001 .06(b),
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`and indicate in the next communication from the office that the art cited in the earlier prosecution
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`history has been reviewed in connection with the present application.
`
`It is respectfully requested that the Examiner initial and return a copy of the enclosed forms
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`and indicate in the official file wrapper of this patent application that the documents have been
`
`considered.
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`Atty. Dkt. No. 1861.2700006/J1VlC/MSB/SBL
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`
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`- 5 -
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`Rhodes Pharmaceuticals L.P.
`
`Application No. T0 Be Assigned
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`The US. Patent and Trademark Office is hereby authorized to charge any fee deficiency, or
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`credit any overpayment, to our Deposit Account No. 19-0036.
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`Respectfully submitted,
`
`STERNE, KESSLER, GOLDSTEIN & FOX P.L.L.C.
`
`/Matthew S. Bodenstein/
`
`Matthew S. Bodenstein
`
`Attorney for Applicants
`Registration No. 58,885
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`Date:
`
`September 19, 2017
`
`l 100 New York Avenue, NW.
`Washington, DC. 20005-3934
`(202) 371-2600
`
`825755671
`
`Atty. Dkt. No. l86l.2700006/]lVlC/MSB/SBL
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`
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