(12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT)
`(19) World Intellectual Property
`Organization
`International Bureau
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`(43) International Publication Date
`27 June 2013 (27.06.2013)
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`WI P O I P C T
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`é\
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`(10) International Publication Number
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`WO 2013/096811 A3
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`(51)
`
`International Patent Classification:
`AéIK 9/70 (2006.01)
`
`(21)
`
`International Application Number:
`
`(22)
`
`International Filing Date:
`
`PCT/US2012/071330
`
`(25)
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`(26)
`
`(30)
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`(71)
`
`(72)
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`(74)
`
`(81)
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`21 December 2012 (21.12.2012)
`English
`
`Filing Language:
`
`Publication Language:
`
`English
`
`US
`
`Priority Data:
`61/578,755
`21 December 2011 (21.12.2011)
`
`Applicant: BIODELIVERY SCIENCES INTERNA-
`TIONAL, INC.
`[US/US]; 801 Corporate Center Drive,
`Suite #210, Raleigh, NC 27607 (US).
`
`3104 Raymond Street,
`Inventors: FINN, Andrew;
`Raleigh, NC 27607 (US). VASISHT, Niraj; 230 Shillings
`Chase Drive, Cary, NC 27518 (US).
`
`Agents: HERRITT, Danielle, L. et a1.; McCarter & Eng-
`lish, LLP, 265 Franklin Street, Boston, MA 021 10 (US).
`
`Designated States (unless otherwise indicated, for every
`kind of national protection available): AE, AG, AL, AM,
`AO, AT, AU, AZ, BA, BB, BG, BH, BN, BR, BW, BY,
`BZ, CA, CH, CL, CN, CO, CR, CU, CZ, DE, DK, DM,
`DO, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT,
`HN, HR, HU, ID, IL, 1N, IS, JP, KE, KG, KM, KN, KP,
`
`KR, KZ, LA, LC, LK, LR, LS, LT, LU, LY, MA, MD,
`ME, MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI,
`NO, NZ, OM, PA, PE, PG, PH, PL, PT, QA, RO, RS, RU,
`RW, SC, SD, SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ,
`TM, TN, TR, TT, Tz, UA, UG, US, UZ, VC, VN, ZA,
`ZM, ZW.
`
`(84)
`
`Designated States (unless otherwise indicated, for every
`kind of regional protection available): ARIPO (BW, GH,
`GM, KE, LR, LS, MW, MZ, NA, RW, SD, SL, SZ, TZ,
`UG, ZM, ZW), Eurasian (AM, AZ, BY, KG, KZ, RU, TJ,
`TM), European (AL, AT, BE, BG, CH, CY, CZ, DE, DK,
`EE, ES, FI, FR, GB, GR, HR, HU, IE, IS, IT, LT, LU, LV,
`lVlC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SI, SK, SlVl,
`TR), OAPI (BF, BJ, CF, CG, CI, CM, GA, GN, GQ, GW,
`ML, MR, NE, SN, TD, TG).
`Declarations under Rule 4.17:
`
`as to applicant’s entitlement to apply for and be granted a
`patent (Rule 4.17(ii))
`
`as to the applicant’s entitlement to claim the priority ofthe
`earlier application (Rule 4.1 7(iii))
`Published:
`
`with international search report (Art. 21(3))
`
`(88)
`
`Date of publication of the international search report:
`24 July 2014
`
`(54) Title: TRANSMUCOSAL DRUG DELIVERY DEVICES FOR USE IN CHRONIC PAIN RELIEF
`
`Study Design Schematic
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`Figure 1.
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`(57) Abstract: Provided herein are methods for treating chronic pain by administering low doses of buprenorphine twice daily (or
`once daily) via a trarismucosal drug delivery device. The methods and devices efficiently treat chronic pain without significant side
`effects. In one embodiment, the buprenorphine delivery device comprises a bioerodable mucoadhesive layer comprising a therapeut —
`ically effective amount of buprenorphine disposed in a buffered polymeric diffusion environment, wherein the polymeric diffusion
`environment is a buffered environment having a p11 of between about 4 and about 6.
`
`RB Ex. 2044
`BDSI V. RB PHARMACEUTICALS LTD
`IPR2014—00325
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`Page 1
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`RB Ex. 2044
`BDSI v. RB PHARMACEUTICALS LTD
`IPR2014-00325
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`

`

`INTERNATIONAL SEARCH REPORT
`
`international application No.
`PCT/USZD12/071330
`
`CLASSIFICATION OF SUBJECT MATTER
`A.
`|PC(8) . A61K 9/70 (2013.01)
`USPC - 424/435
`According to International Patent Classification (lPC) or to both national classification and lPC
`B.
`FIELDS SEARCHED
`
`Minimum documentation searched (classification system followed by classification symbols)
`IPC(8) - A61 K 9H0, 31/44, 31/485; A61 P 25/04, 25/30 (2013.01)
`USPC - 424/422, 434. 435, 444; 5141279, 282
`
`Documentation searched other than minimum documentation to the extent that such documents are included in the fields searched
`CFC Class/Subclass(es): A61 K 910053. 91006
`
`Electronic data base consulted during the international search (name otdata base and, where practicable, search terms used)
`PatBase. Google Patents. Pubmed
`
`' P
`
`C. DOCUMENTS CONSIDERED TO BE RELEVANT
`
`Citation of document, with indication, where appropriate, of the relevant passages
`
`. Relevant to claim No.
`
`US 201110262522 A1 (FINN et al) 27 October 2011 (27.10.2011) entire document
`
`1-3. 14-19
`
`US 201 “0189259 A1 (VASlSHT et al) 04 August 2011 (04.08.2011) entire document
`
`7
`
`1-3. 14-19 ,
`
`US 2004/0024003 A1 (ASMUSSEN et al) 05 February 2004 (05.02.2004) entire document
`
`1-3. 14-19
`
`US 2009/0270438 A1 (BOOLES et al) 29 October 2009 (29.10.2009) entire document
`
`1-3. 14-19 1
`
`D Further documents are listed in the continuation ofBox C. D
`51’9”." “mam-i“ of the" documents:
`“T"
`later document published otter Ihc international filing date or rioriry
`document defining the general state aid»: anwhieh is normnsidcred
`date and not in conflict With the ap ligation but cited to u
`rstand
`to be of particular relevance
`the prmctplt: or theory underlying l c invention
`earlier application or patent but published on orat’lcr theintcmational
`“X" document of particular relevance; the claimed invention cannot‘bc
`filing d3":
`considered novel or cannot be consulcrcd lo involve an inventive
`document which may throw doubts on priOrity claim(s)_ or which is
`SWP when ""3 document IS taken 510110
`citcd 1" “WW5“ ”"3 Whliwti‘m mm" 0f ““01"" “mm" 0' 0m” “Y“ document of particular relevance; the claimed invention cannot be
`51mm ”“50“” ‘Pfi‘fic‘n
`considered to involve an inventive Step when the document is
`document referring to an oral disulosurC, use, exhibition or other
`combined wilhoncormoreothersuchdocuments,suchcombmatton
`means
`being obvious to a person skilled in the an
`document published prior to the international filing date but later than “8:" documcnl member of the same patent family
`the priority date claimed
`-
`Date of the actual completion of the international Search
`11 February 2013
`Name and mailing address of the ISA/US
`Mail Stop PCT, Attn: ISNUS, Commissioner for Patents
`PO. Box 1450. Aloxandna. Virglrua 22313-1450
`Facsimile No.
`571-273-3201
`
`Date of mailing of the international search report
`2 2‘; F E B 2013
`Authorized officer:
`*
`Blaine R. Copenheaver
`Pcr Haws“: 571-21243”
`PCT 089: 511-272-7114
`
`Form PCTllSA/ZIO (second sheet) (July 2009)
`
`age 2
`
`Page 2
`
`

`

`This international search report has not been established in respect of certain claims under Article l7(2)(a) for the following reasons:
`l.
`Claims Nosr:
`because they relate to subject matter not required to be searched by this Authority, namely:
`
`
`INTERNATIONAL SEARCH REPORT
`[mgr-national application No,
`PCT/U82012/071330
`
`
` Box No. II Observations where certain claims were found unsearchnble (Continuation of item 2 of first sheen}
`
`
`
`
` 2. D ClaimsNos.:
`
`
`because they relate to parts of the international application that do not comply with the prescribed requirements to such an
`extent that no meaningful international search can be can-ied out, specifically:
`
`
`
`
`This International Searching Authority found multiple inventions in this international application, as follows:
`
`
`
`
`
`
`3. E Claims Nos: 4-13, 20
`because they are dependent claims and are not drafted in accordance with the second and third sentences of Rule 6.4(a).
`
`
`Box No. In Observations where unity oflnvention is lacking (Continuation ofitem 3 of first sheet)
`
`I. D As all required additional search fees were timely paid by the applicant, this international search report covers all searehable
`claims.
`'
`
`As all searchable claims could be searched without effort justifying additional fees, this Authority did not invite payment of
`additional ees.
`
`As only some of the required additional search fees were timely paid by the applicant, this international search report covers
`only those claims for which fees were paid, specifically claims Nos:
`
`
`
`
`
`
`
`
`4. D No required additional search fees were timely paid by the applicant. Consequently, this international search report is
`restricted to the invention first mentioned in the claims;
`it is covered by claims Nos.:
`
`Remark on Protest
`
`
`D The additional search fees were accompanied by the applicant’s protest and, where applicable. the
`payment ofa protest fee.
`
`
`E] The additional Search fees were accompanied by the applicant’s protest but the applicable protest
`
`
`fee was not paid within the time limit specified in the invitation.
`No protest accompanied the payment of additional search fees.
`
`Form PCT/ISAIZ l0 (continuation of first sheet (2)) (July 2009)
`
`Page 3
`
`Page 3
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