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`5958379
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`4244478
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`521 9083
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`6946150
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`Juergen Regenold, et al.
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`Same as RU2156126
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`2004-07-06
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`Pettersson, et al.
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`Same as RU2232580
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`1981-01-13
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`1993-06-15
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`Liebert, et al.
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`20030039680
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`2003-02-27
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`McCoy et al.
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`Dugger, III
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`20070261695
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`2007-11-15
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`WO 2004/075877
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`2004-10-09
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`WO 01797780
`
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`
`2001-12-27
`
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`Pharmaceutical
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`WO 2004/016243
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`2004-02-26
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`WO 2007/087431
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`2000-08-17
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`1990-07-12
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`Generex
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`Boots Co PLC
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`Same as US 5976504
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`Pettersson, et al.
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`Same as US 6759059
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`Sirus Pharmaceuticals Ltc
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`Riker Laboratories, Inc.
`
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`Sosei R&D Ltd.
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`lnsys Therapeutics, Inc
`
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`Examination Report for corresponding European Patent Application No. 077625499, mailed on September 30, 2010
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`Supplementary European Search Report, 2 pages, for corresponding European Patent Application No. 077625499,
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`mailed on September 30, 2010
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`Office Action on Chinese Patent Application No. 200780003555.)( dated July 9, 2010
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`Copy of the International Search Report and Written Opinion, dated July 11, 2008 from corresponding |nt'| Application
`
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`No. PCTlUS07/02163
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`MATHAR, L.E., et al. "Pulmonary administration of aerosolised fenlanyl: pharmacokinetic analysis of systemic delivery"
`
`
`
`
`
`
`
`
`
`
`
`
`
`Br. J. Clin. Pharrnacol. January 1998, Vol. 46, pp. 37-43
`
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`
`
`
`
`
`
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`
`
`MARIER, J-F., et al. "Comparative bioequivalence study between a novel matrix transdermal delivery system of
`
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`
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`
`
`
`
`
`
`fentanyl and a commercially available reservoirformulation", Br. J. Clin. Pharmacol. August 2006, Vol. 63, No.1, pp.
`
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`121-124, esp. p. 123, Figure 1
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`Copy of International Preliminary Report on Patentability dated September 4, 2008 from corresponding lnt'l Application
`
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`No. PCTlUS07l02163
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`Copy of Examination Report dated August 6, 2009 from corresponding Australian Application No. 2007208229
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`Copy of Examination Report dated May 5,2010 from corresponding Canadian Application No. 2,637,672
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`Copy of Examination Report dated March 18, 2010 from corresponding New Zealand Application No. 569949
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`An English translation of the Russian Examination Report dated August 2009 from corresponding Russian Application
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`No. 2008130763
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`Copy of ISR and Written Opinion from related |nt'| Application No. PCTIUS08/09359 dated January 9, 2009
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`STATEMENT BY APPLICANT
`(Not for submission under 37 CFR 1.99)
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`Application Number
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`Filing Date
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`13895124
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`2013-05-15
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`3. George Kottayil
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`| 1615
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`|NS10763P00091US
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`Copy of lnt‘| Preliminary Report on Patentability from related |nt'| Application No. PCTlUS08/09359 dated February 2,
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`2010
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`LEJUS, et aI., "Fentany| versus sufentanilz plasma concentrations during continuous epidural postoperative infusion in
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`children," British Journal of Anaesthesia, Volume 85, Issue 4, October 2000, pp. 515-617
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`Copy of Examination Report dated February 9, 2011 from corresponding Australian Application No. 2008282743
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`Copy of Examination Report dated November 1, 2012 from corresponding Australian Application No. 2008282743
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`Smyth, et al., 2003, AAPS PharmSclTech 2003; 4 (3)21-11.
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`If you wish to add additional non-patent literature document citation information please click the Add button Add
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`EXAMINER SIGNATURE
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`Examiner Signature
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`/‘Robert lggndsmarg/‘E
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`*EXAMlNER: Initial if reference considered, whether or not citation is in conformance with MPEP 609. Draw line through a
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`citation if not in conformance and not considered.
`Include copy of this form with next communication to applicant.
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`Date Considered
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`01/Oi/20i 4
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`1 Enter office that issued the document, by the two-letter code (WIPO
`1 See Kind Codes of USPTO Patent Documents at www.USPTO.GOV or MPEP 901.04.
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`Standard ST.3). 3 For Japanese patent documents, the indication of the year of the reign of the Emperor must precede the serial number of the patent document.
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`4 Kind ofdocument by the appropriate symbols as indicated on the document under WIPO Standard ST.1B if possible.
`5 Applicant is to place a check mark here if
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`English language translation is attached.
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`EFS Web 2.1.17
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`ALL REFERENCES CDNSEDEHED EXCEPT WHERE LiNED THROUGH.
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`/'Fl.L../‘
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`Page 7 of 7

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