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`13895111
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`S. George Kotlayil
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`Juergen Regenold, et al.
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`Pettersson, et al.
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`2013-07-16
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`Liebert, et al.
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`INFORMATION DISCLOSURE
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`|NS10763P00101US
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`Copy of lnt‘| Preliminary Report on Patentability from related |nt'| Application No. PCTIUSOB/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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`Examination Report for corresponding Australian Patent Application No. 2008282743, mailed on February 9, 2011
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`Smyth, et al., 2003, AAPS PharmSciTech 2003; 4 (3):1—11.
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`Examination Report for corresponding Australian Patent Application No. 2008282743, mailed on November 1, 2012
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`EXAMINER SIGNATURE
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`Examiner Signature
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`11,l1'6/2013
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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.
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`/Robert Lal‘l(}Sii13:’l/
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`Date Considered
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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 CONSIDERED EXCEPT WHERE LINED THROUGH.
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`13895111
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`2013-05-15
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`3. George Kotlayil
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`20020055496
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`McCoy et al.
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`Dugger, III
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`Dugger, III
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`Dugger, III, et al.
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`Dugger, III
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`20030082107
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`Dugger, III
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`Dugger, Ill
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`EFS Web 2.1.17
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`ALL REFERENCES CONSIDERED EXCEPT WE-*lEElE LINED THROUGH.
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`2003-10-09
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`Dugger, III
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`INFORMATION DISCLOSURE
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`STATEMENT BY APPLICANT
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`EFS We” “"7
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`13895111
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`2013-05-15
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`3. George Kotiayil
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`2003-10-09
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`WO 2004/075877
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`WO 2004/016243
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`2004-02-26
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`RU2232580
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`WO 2004/080382
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`W0 00l’47203
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`W0 90/07333
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`WO 2007/087431
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`2004-07-20
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`Generex
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`Pharmaceuticals, Inc,
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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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`EFS Web 2.1.17
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`ALL REFERENCES C20llS|DERED EXCEPT WHERE LINED THROUGH.
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`U.S.PATENTS
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`Juergen Regenold, et al.
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`5958379
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`8486972
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`6946150
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`1999-09-28
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`1993-06-15
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`Liebert, et al.
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`E’.“'?"“,l“e’ Cite No
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`20020055496
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`Dugger, Ill
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`EFS We” “"7
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`Generex
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`Pharmaceuticals, Inc,
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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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`Examination Report for corresponding European Patent Application No. 077625499, mailed on September 30, 2010
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`STATEMENT BY APPLICANT
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`13895111
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`2013-05-15
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`3. George Kotlayil
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`|NS10763POO101US
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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"
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`121-124, esp. p. 123, Figure 1
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`Copy of International Preliminary Report on Patentability dated August 26, 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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`EFS Web 2.1.17
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`ALL REFERENCES C20llS|DERED EXCEPT WHERE LINED THROUGH.
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`/R.l_./
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`INFORMATION DISCLOSURE
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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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`13895111
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`2013-05-15
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`3. George Kotlayil
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`| 1015
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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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`LEJUS, et aI., versus sufentanilz plasma concentrations during continuous epidural postoperative infusion in
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`children," British Journal Volume 85, Issue 4, October 2000, pp. 515-617
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`Examination Report for corresponding Australia Application No. 2008282743, mailed on February 9, 2011
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`Smyth, et al._ 2003, AAPS PharmSciTech 2003; 4 (3):1—11.
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`Examination Report for corresponding Australian Patent Application No. 2008282743, mailed on Novembe ''
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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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