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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`_______________________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`_______________________
`
`AQUESTIVE THERAPEUTICS, INC.
`
`Petitioner
`
`v.
`
`HALE BIOPHARMA VENTURES, LLC
`
`Patent Owner
`
`_______________________
`
`Case: IPR2019-00450
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`U.S. Patent No. 9,763,876 B2
`
`_______________________
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`
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`DECLARATION OF NICHOLAS A. PEPPAS, Sc.D.
`
`IN SUPPORT OF PETITION FOR INTER PARTES REVIEW
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`
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`
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`OF U.S. PATENT NO. 9,763,876
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`U.S. Patent No. 9,763,876 B2
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`TABLE OF CONTENTS
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`I. PRELIMINARY STATEMENT .......................................................................... 7
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`II. BASIS FOR OPINIONS GIVEN ......................................................................... 8
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`III. BACKGROUND AND QUALIFICATIONS ....................................................15
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`IV. THE ‘876 PATENT’S FILING/PROSECUTION HISTORY .......................24
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`A. Filing History and Priority Claims .......................................................................24
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`B. Prosecution History ..............................................................................................27
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`1. Office Actions and PO’s Responses/ Arguments ............................................27
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`2. PO’s Inaccurate and Misleading Statements Regarding Sonne Generally and
`Sonne Example 11 ...........................................................................................32
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`3. PO Never Demonstrated or Evidenced Criticality or Unexpected Results With
`Respect to Claim Elements ..............................................................................37
`V. EARLIEST APPEARANCE OF CERTAIN CLAIM ELEMENTS ..................44
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`A. Claim 1 (and All Claims Dependent Therefrom) ................................................46
`
`VI. THE PERSON OF ORDINARY SKILL IN THE ART ................................47
`
`VII. OTHER RELEVANT CONSIDERATIONS ..............................................50
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`VIII. CLAIM CONSTRUCTION ........................................................................51
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`A. “Vitamin E” in Claims 1, 2, and 27-33 ................................................................52
`
`B. “Bioavailability” in Claims 34, 35, and 36 ..........................................................54
`
`C. “% (W/W)” IN CLAIMS 1, 11-14, 24-26, AND “% (W/V)” IN CLAIMS 5, 6, 8,
`15, 28, AND 30-33 ...............................................................................................57
`
`D. “About 56.47% (w/v) vitamin E” ........................................................................59
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`IX. GENERAL STATE OF THE PRIOR ART – A VERY BRIEF HISTORY .60
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`X. THE ‘876 PATENT (EXHIBIT 1001) ...............................................................64
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`XI.
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`INTRANASAL ADMINISTRATION OF PHARMACEUTICALS ............65
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`A. Brief History of Intranasal Administration ..........................................................65
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`B. BENEFITS OF INTRANASAL ADMINISTRATION ......................................66
`C. Problems Associated With Intranasal Delivery ...................................................69
`
`D. Solution #1 for Solving Permeation Problem – Increasing the Drug Solubility to
`Allow More Drug to Dissolve Per Unit Solvent/Formulation .............................72
`
`E. Solution #2 for Solving Permeation Problem – Using Penetration Enhancers to
`Increase the Permeability of the Nasal Mucosa With Respect to the Drug .........81
`
`1. Alkyl Glycosides In General ............................................................................86
`
`2. Dodecyl Maltoside In Particular ......................................................................90
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`XII.
`
`SUMMARY OF THE PRIOR ART REFERENCES .................................95
`
`A. Sonne (Exhibit 1013) ...........................................................................................96
`
`1. Problem to be Solved and Solution ..................................................................96
`
`2. Sonne’s General Teachings ..............................................................................97
`
`3. Sonne’s Example 11 as Applied to ‘876 Patent’s Claims .............................102
`B. Gwozdz (Exhibit 1014) ......................................................................................110
`
`1. Problem to be Solved and Solution ................................................................110
`
`2. Gwozdz’s General Teachings ........................................................................111
`
`3. Gwozdz as Applied to ‘876 Patent’s Claims .................................................113
`
`C. Meezan’962 (Exhibit 1011) ...............................................................................120
`
`1. Problem to be Solved and Solution ................................................................122
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`2. Meezan‘962’s (Exhibit 1011) General Teachings .........................................123
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`D. Cartt’784 (Exhibit 1015) ....................................................................................129
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`1. Problem to be Solved and Solution ................................................................129
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`2. Cartt’784’s General Teachings ......................................................................130
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`3. Cartt’784 as Applied to ‘876 Patent’s Claims 17-23 .....................................135
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`XIII. MOTIVATION TO COMBINE ................................................................137
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`XIV. THE ‘876 PATENT CLAIM CHARTS ....................................................139
`XV. GROUND 1 – CLAIMS 1-36 AS OBVIOUS OVER
`SONNE (EXHIBIT 1013) IN VIEW OF MEEZAN’962
`(EXHIBIT 1011) ...............................................................................................140
`
`A. Claim 1 ...............................................................................................................140
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`B. Claim 2 ...............................................................................................................143
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`C. Claims 3-4 ..........................................................................................................143
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`D. Claims 5-6 ..........................................................................................................143
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`E. Claim 7 ...............................................................................................................144
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`F. Claims 8 and 15..................................................................................................144
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`G. Claims 9-10 ........................................................................................................145
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`H. Claims 11-12 ......................................................................................................145
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`I. Claims 13-14 ......................................................................................................146
`J. Claim 16 .............................................................................................................146
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`K. Claims 17-18 ......................................................................................................146
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`L. Claims 19-20 ......................................................................................................147
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`M. Claims 21-22 ......................................................................................................149
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`N. Claim 23 .............................................................................................................151
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`O. Claims 24-26 ......................................................................................................152
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`P. Claims 27, 29, 30, and 31 ..................................................................................152
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`Q. Claim 28 .............................................................................................................154
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`R. Claims 32-33 ......................................................................................................158
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`S. Claims 34-36 ......................................................................................................160
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`XVI. GROUND 2 – CLAIMS 1-16 and 24-36 - AS OBVIOUS OVER
`GWOZDZ (EXHIBIT 1013) IN VIEW OF MEEZAN’962 (EXHIBIT 1011)167
`
`A. Claim 1 ...............................................................................................................167
`
`B. Claim 2 ...............................................................................................................169
`
`C. Claims 3-4 ..........................................................................................................170
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`D. Claims 5-6 ..........................................................................................................170
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`E. Claim 7 ...............................................................................................................171
`
`F. Claims 8 And 15 ................................................................................................171
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`G. Claims 9 And 10 ................................................................................................172
`H. Claims 11 and 12................................................................................................173
`
`I. Claims 13 and 14................................................................................................174
`
`J. Claim 16 .............................................................................................................175
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`K. Claims 17-23 ......................................................................................................175
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`L. Claims 24-26 ......................................................................................................175
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`M. Claims 27-33 ......................................................................................................177
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`N. Claims 34-36 ......................................................................................................182
`
`XVII. GROUND 3 – CLAIMS 17-23 – AS OBVIOUS OVER GWOZDZ
`(EXHIBIT 1013) IN VIEW OF MEEZAN’962 (EXHIBIT 1011) FURTHER IN
`VIEW OF CARTT’784 ....................................................................................189
`
`A. Claims 17 and 18................................................................................................189
`
`B. Claims 19-22 ......................................................................................................190
`C. Claim 23 .............................................................................................................194
`
`XVIII. CONCLUDING OPINION ....................................................................195
`
`XIX. APPENDIX A – CLAIMS CHART..........................................................197
`
`A. Ground 1 – Claims 1-36 – Sonne (Exhibit 1013) in View Of Meezan’962
`(Exhibit 1011) ....................................................................................................197
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`B. Ground 2 – Claims 1-16 and 24-36 – Gwozdz (Exhibit 1013) in View of
`Meezan’962 (Exhibit 1011) ...............................................................................225
`
`C. Ground 3 – Claims 17-23 – Gwozdz (Exhibit 1013) in View of Meezan’962
`(Exhibit 1011) Further in View of Cartt’784 (Exhibit 1015) ............................248
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`I.
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`I, Dr. Nicholas A. Peppas, do hereby make the following declaration:
`
`PRELIMINARY STATEMENT
`
`1.
`
`I have agreed to provide expert testimony in support of Aquestive, Inc.’s
`
`Petition for Inter Partes Review of U.S. Patent No. 9,763,876 B2, entitled
`
`“Administration of Benzodiazepine Compositions” (“the ‘876 Patent”).
`
`2.
`
`I have been asked to provide my opinion in regards to the state of
`
`technology relevant to the ‘876 Patent’s disclosure and its claims based on
`
`knowledge existing prior to March 27, 2009, prior to June 14, 2011, and
`
`prior to December 13, 2011.
`
`3.
`
`I have been asked to provide my opinion regarding whether one of ordinary
`
`skill in the art at the relevant time would have understood that certain prior
`
`art references, alone or in combination, disclose or teach each of the
`
`elements and limitations recited in the claims of the ‘876 Patent. I have also
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`been asked to provide my opinion regarding whether a person of ordinary
`
`skill in the art (a “POSITA”) would have been motivated or had a rationale
`
`or reason to modify or combine those certain prior art references to arrive at
`
`the elements recited in the claims of the ‘876 Patent. In my opinion, the
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`references discussed below disclose or teach each of the elements and
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`limitations recited in the claims of the ‘876 Patent, and a POSITA would
`
`have had a strong rationale to combine the references.
`
`4.
`
`I am being compensated for my time working on this case at my customary
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`rate of $650.00 per hour for all work performed on the case. My
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`compensation is not in any way related to the outcome of the case. I have no
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`financial interest in this proceeding, and the potential for any future financial
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`benefit is unaffected by the content of my testimony or the outcome of this
`
`proceeding. I have reviewed the ‘876 Patent and am familiar with it.
`
`
`
`II.
`
`BASIS FOR OPINIONS GIVEN
`
`5.
`
`In forming my opinion, I have relied on my own education, work
`
`experiences and knowledge and my review of the following documents:
`
`
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`EXHIBIT NO.
`
`1001
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`EXHIBIT DESCRIPTION
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`U.S. Patent No. 9,763,876, Administration Of
`Benzodiazepine Compositions, filed October 29, 2014
`(‘876 Patent)
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`8
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`AQUESTIVE EXHIBIT 1041 PAGE 0008
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`1002
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`1003
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`1004
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`1005
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`1006
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`1007
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`
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`File History for ‘876 Patent, Ser. No. 14/527,613 (‘876
`FH)
`1002 Part 1 - Pages 1-270
`1002 Part 2 - Pages 271-530
`
`U.S. Patent No. 8,895,546, Administration Of
`Benzodiazepine Compositions, filed June 13, 2012 (‘546
`Patent)
`
`File History for ‘546 Patent, Ser. No. 13/495,942 (‘546
`FH)
`1004 Part 1 – Pages 1-350
`1004 Part 2 – Pages 351-700
`1004 Part 3 – Pages 701-1050
`1004 Part 4 – Pages 1051-1400
`1004 Part 5 – Pages 1401-1750
`1004 Part 6 – Pages 1751-2100
`1004 Part 7 – Pages 2101-2450
`1004 Part 8 – Pages 2451-2681
`
`Provisional Patent Application No. 61/497,017, filed
`June 14, 2011 (‘017 Provisional)
`
`Provisional Patent Application No. 61/570,110, filed
`December 13, 2011 (‘110 Provisional)
`
`File History for Non-Provisional Patent Application
`Serial No. 12/413,439, filed March 27, 2009 (‘439 FH)
`1007 Part 1 – Pages 1-400
`1007 Part 2 – Pages 401-800
`1007 Part 3 – Pages 801-1200
`1007 Part 4 – Pages 1201-1600
`1007 Part 5 – Pages 1601-2000
`1007 Part 6 – Pages 2001-2400
`1007 Part 7 – Pages 2401-2800
`1007 Part 8 – Pages 2801-3200
`1007 Part 9 – Pages 3201-3488
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`1008
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`1009
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`1010
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`1011
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`1012
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`1013
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`1014
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`1015
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`Provisional Patent Application No. 61/040,558, filed
`March 28, 2008 (‘558 Provisional)
`
`Cartt et al., WO 2009/121039, Administration Of
`Benzodiazepine Compositions, published October 1,
`2009, International Filing Date March 27, 2009
`(PCT/US2009/038696) (Cartt‘039)
`
`U.S. Patent Application Publication No. US
`2009/0258865, Administration of Benzodiazepine
`Compositions, Serial No. 12/413,439 (Cartt‘865)
`
`Meezan et al., U.S. Patent Application Publication No.
`US 2006/0046962, Absorption Enhancers for Drug
`Administration, Serial No. 11/127,786, published March
`2, 2006 (Meezan‘962)
`
`Jamieson et al., U.S. Patent Application Publication No.
`US 2008/0070904, Pharmaceutical Compositions of
`Benzodiazepines and Method of Use Thereof, Serial No.
`11/897,028, published March 20, 2008 (Jamieson)
`
`Sonne, U.S. Patent No. 6,193,985, Tocopherol
`Compositions For Delivery Of Biologically Active
`Agents, issued February 27, 2001 (Sonne)
`
`Gwozdz et al., WO 2009/120933, Pharmaceutical
`Solutions And Method For Solubilizing Therapeutic
`Agents, published October 1, 2009, International Filing
`Date March 27, 2009 (PCT/US2009/038518) (Gwozdz)
`
`Cartt et al., U.S. Patent Application Publication No. US
`2008/0279784, Nasal Administration Of
`Benzodiazepines, Serial No. 12/116,842, published
`November 13, 2008 (Cartt‘784)
`
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`1016
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`1017
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`1018
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`1019
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`1020
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`1021
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`1022
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`1023
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`1024
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`
`Kee et al., U.S. Patent No. 5,369,095, Compositions And
`Method Comprising Substituted Glycosides As Mucus
`Membrane Permeation Enhancers, issued November 29,
`1994 (Kee)
`
`Cartt et al., WO 2008/137960, Nasal Administration Of
`Benzodiazepines, published November 13, 2008,
`International filing date May 7, 2008
`(PCT/US2008/062961) (Cartt‘960)
`
`Tenta, U.S. Patent No. 3,949,072, Seborrheic Keratosis
`Treatment, issued April 6, 1976 (Tenta)
`
`Ueda et al., U.S. Patent No. 4,657,901, Pharmaceutical
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`
`Meezan et al., U.S. Patent No. 5,661,130, Absorption
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`
`Merkus, U.S. Patent Application Publication No. US
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`
`Liversidge et al., U.S. Patent Application Publication No.
`US 2006/0198896, Serial No. 11/354,249, published
`September 7, 2006 (Liversidge)
`
`Ritschel, Handbook of Basic Pharmacokinetics, Chapter
`36 (Bioavailability and Bioequivalence), Drug
`Intelligence Publications, Illinois, 1992 (Ritschel)
`
`Osborne et al., Skin Penetration Enhancers Cited in the
`Technical Literature, Pharmaceutical Technology,
`November 1997 (Osborne)
`
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`1025
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`1026
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`Lindhardt et al., Electroencephalographic effects and
`serum concentrations after intranasal and intravenous
`administration of diazepam to healthy volunteers,
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`2001 (Lindhardt)
`
`Kibbe, editor, Handbook of Pharmaceutical Excipients,
`Third Edition (2000), American Pharmaceutical
`Association, Washington DC (Kibbe)
`
`Illum, Nasal drug delivery-possibilities, problems and
`solutions, Journal of Controlled Release 87 (2003) 187-
`198 (Illum)
`
`Ivaturi et al., Pharmacokinetics and tolerability of
`intranasal diazepam and midazolam in healthy adult
`volunteers, Acta Neurol Scand. 2009 Nov;120(5):353-7.
`doi: 10.1111/j.1600-0404.2009.01170.x. Epub 2009 May
`14 (Ivaturi)
`
`O’Dell et al., School nurses’ experience with
`administration of rectal diazepam gel for seizures, J Sch
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`
`Gizurarson et al., Intranasal Administration of Diazepam
`Aiming at the Treatment of Acute Seizures: Clinical
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`Pharmaceutical Bulletin, Volume 22 (1999) Issue 4
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`
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`Alcohol”, “Glycerin”, “Olive Oil”, “Polyethylene
`Glycol”, “Propylene Glycol”, “Sesame Oil”, and
`
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`“Triacetin”, American Pharmaceutical Association,
`Washington DC (Rowe)
`
`Edman [II] et al., Microspheres as a nasal delivery
`system for peptide drugs, Journal of Controlled Release,
`Vol. 21 (1992) 165-172 (Edman II)
`
`French et al., Pharmacopeial Standards and
`Specifications for Bulk Drugs and Solid Oral Dosage
`Forms, Journal of Pharmaceutical Sciences, December
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`
`Edman [I] et al., (D) Routes of Delivery: Case Studies -
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`
`Davis, Delivery of peptide and non-peptide drugs
`through the respiratory tract, Pharmaceutical Science &
`Technology Today, Vol. 2, No. 11 November 1999,
`pages 450-456 (Davis)
`
`Deshmukh et al., Lorazepam in the Treatment of
`Refractory Neonatal Seizures, Am J Dis Child.
`1986;140(10):1042-1044 (Deshmukh)
`
`Colombo, Mucosal Drug Delivery, Nasal, pp. 592-605,
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`(Colombo)
`
`Bara, U.S. Patent Application Publication No.
`US/2006/0178290, Serial No. 10/563,967, published
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`
`1032
`
`
`1033
`
`
`1034
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`1035
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`1036
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`1037
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`1038
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`1039
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`1040
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`1041
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`1042
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`1043
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`1044
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`1045
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`1046
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`
`
`Behl et al., Effects of physicochemical properties and
`other factors on systemic nasal drug delivery, Advanced
`Drug Delivery Reviews 29 (1998) 89–116 (Behl)
`
`File History for EP 128 01372.9, based on WO
`2012/174158 and PCT/US2012/042311
`1040 Part 1 - Pages 1-250
`1040 Part 2 - Pages 251-500
`1040 Part 3 – Pages 501-662
`
`(this Declaration)
`
`PDR 54th Edition 2000, DIASTAT® (diazepam rectal
`gel); MIACALCIN® (Calcitonin Nasal Spray);
`VALIUM® (diazepam injection), Physicians’ Desk
`Reference.
`
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`pharmacodynamics of midazolam administered as a
`concentrated intranasal spray. A study in healthy
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`
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`
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`Pharmaceutical Solutions and Method for Solubilizing
`Therapeutics Agents, filed March 28, 2008, Gwozdz,
`(Gwozdz ‘281 Provisional)
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`
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`U.S. Patent No. 9,763,876 B2
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`1047
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`1048
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`1049
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`1050
`
`Gwozdz Assignment of Provisional in Non-Provisional
`Case, dated April 21, 2008, recorded September 23, 2010
`(Gwozdz Assignment).
`
`Kagatani, et al., U.S. Patent No. 4,690,952,
`Pharmaceutical Compositions for Nasal administration
`Comprising Calcitonin and an Absorption-Promoting
`Substance, issued September 1, 1987 (Kagatani).
`
`Cartt’784 Assignment, dated March 6, 2012, recorded
`March 29, 2012 (Cartt’784 Assignment)
`
`Table of Various Diazepam Solutions Described in or
`Modified From Sonne’s Example 11 (“DS11”)
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`
`
`BACKGROUND AND QUALIFICATIONS
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`
`
`III.
`
`6.
`
`I am the Cockrell Family Regents Chair (i.e., Chaired Professor) in
`
`Engineering at the University of Texas at Austin with appointments in the
`
`Departments of Chemical Engineering, Biomedical Engineering of the
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`Cockrell College of Engineering, and the Division of Molecular
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`Pharmaceutics and Drug Delivery of the College of Pharmacy of the
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`University of Texas at Austin since January 1, 2003. I am also a tenured full
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`professor with a joint appointment in the Department of Pediatrics at the
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`Dell Medical School of the same University. From September 2009 to
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`August 2015, I was also the Chairman of the Biomedical Engineering
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`Department in the same University.
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`7.
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`Previously, I was the Showalter Distinguished Professor of Chemical and
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`Biomedical Engineering at Purdue University, in West Lafayette, Indiana,
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`with joint appointments in the School of Chemical Engineering and in the
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`Department of Biomedical Engineering. I joined Purdue University in 1976.
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`8.
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`I have degrees in chemical engineering from the National Technical
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`University of Athens, Greece (Dipl. Eng., 1971) and the Massachusetts
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`Institute of Technology - MIT (Sc.D., 1973).
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`9.
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`I did one year of postdoctoral work with Professors Clark Colton, Kenneth
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`Smith and Robert Lees at the Arteriosclerosis Center of the Massachusetts
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`Institute of Technology (1975-76).
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`10.
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`I am an elected member of the (US) National Academy of Engineering, the
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`(US) National Academy of Medicine, the American Academy of Arts and
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`Sciences, the National Academy of Inventors, the Academy of Engineering,
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`Medicine and Sciences of Texas, the Chinese Academy of Medicine, the
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`National Academy of Pharmacy of France, the Royal Academy of Pharmacy
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`of Spain, the Academy of Athens, Greece and the International Academy of
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`Medical and Biological Engineering.
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`11.
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`I have received honorary doctorate degrees from the University of Ghent,
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`Belgium (1999), the University of Parma, Italy (1999), the University of
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`Athens (2000), and the University of Ljubljana, Slovenia (2012), granted by
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`their respective Faculties of Pharmacy. The doctorate from the University of
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`Parma also carries the title “Doctor of Pharmacy”. I have also received an
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`honorary doctorate (in Chemical Engineering) from the University of Patras
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`(2015) and the National Technical University of Athens (2017).
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`12.
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`I have served as a Visiting Professor at the Faculty of Pharmacy of the
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`University of Geneva, Switzerland (Fall 1982), the Department of Chemical
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`Engineering of the California Institute of Technology (Spring 1983), the
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`Faculty of Pharmacy of the University of Paris-Sud (Fall 1986), the
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`Department of Pharmacy of the University of Parma, Italy (Fall 1987), the
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`School of Pharmacy of the Hoshi University of Tokyo, Japan (Spring 1994),
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`the School of Pharmacy of the Hebrew University of Jerusalem, Israel
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`(Spring 1994), the Departments of Pharmacy and Materials Science of the
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`University of Naples, Italy (May 1996), the Department of Pharmacy of the
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`Free University of Berlin, Germany (January-March 2001), the Department
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`of Pharmacy of the Complutense University of Madrid, Spain (March-May
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`2001) and the Department of Materials Science of the Nanyang
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`Technological Institute of Singapore (2006).
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`13. My teaching assignments at the University of Texas in the past ten years
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`have been courses on “Polymer Science and Engineering”, “Advances in
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`Biomedical Engineering”, “Advances in Biomaterials Science and
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`Engineering”, “Bionanotechnology”, “Kinetics and Reaction Engineering”,
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`and “Mass Transfer”.
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`14. Starting in 1979, I developed and taught, along with Professors Robert
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`Langer of MIT, Frank Szoka of the University of California at San Francisco
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`and others, the course “Advances in Controlled Release Technology”
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`offered every summer at MIT. This is a five-day course offered to industrial
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`and university researchers who do not have a sufficient background in the
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`preparation and characterization of drug delivery systems such as tablets,
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`films, capsules and microspheres, and related pharmaceutical systems. The
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`past summer (2018) was the 40th year I taught this course.
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`15. My research contributions have been in several areas of drug and protein
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`delivery including therapeutic agents for treatment of diabetes, cancer,
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`autoimmune diseases and cardiovascular problems, biomaterials,
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`bionanotechnology, mass transfer, kinetics and reaction engineering,
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`polymers and biomedical engineering.
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`16. Since 1979, I have also worked on the design, development and
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`investigation of the pharmaceutical and medical applications of bioadhesive
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`and mucoadhesive polymers and drug delivery formulations based on
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`mucoadhesive polymers. I have published numerous papers on the design
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`and use of mucoadhesive polymers and I have participated in the
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`development of a number of products that incorporated mucoadhesive
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`materials in order to function as adhesives.
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`17. For over forty years I have been involved with the preparation,
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`characterization and evaluation of the behavior of hydrophilic polymers and
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`their crosslinked networks known as hydrogels used in controlled release
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`devices, especially in controlled delivery of drugs, peptides and proteins. My
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`laboratory pioneered the use of these polymer carriers in drug delivery
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`applications and I have extensive experience in formulation, preparation and
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`testing of polymer formulations, including sustained release formulations. I
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`received the 2012 National Academy of Engineering Founders Award in
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`recognition of this pioneering work in the field of drug delivery. The
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`National Academy of Engineering citation for the Founders Award lists “For
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`contributions to biomedical and drug delivery applications of polymer
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`networks and hydrogels and for leadership in the bioengineering
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`community”.
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`18.
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`I am the author of approximately 1,400 publications, 450 abstracts, and
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`approximately 35 issued or pending US and international patents.
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`19.
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`I am the coauthor or coeditor of 37 books and volumes, including the three-
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`volume monograph “Hydrogels in Medicine and Pharmacy” (CRC Press,
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`1987).
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`20.
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`I am the Editor-in-Chief of “Regenerative Biomaterials”, Deputy Editor of
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`the journal “Science Advances”, the journal “Biomedical Microdevices” and
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`the Biomedical Engineering Book Series of Cambridge University Press.
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`21.
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`I sit on the editorial boards of numerous journals, including the “Journal of
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`Controlled Release”, “Advanced Drug Delivery Reviews”, “International
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`Journal of Pharmaceutics”, “Journal of Applied Polymer Science”, “Journal
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`of Biomedical Materials Research”, “Journal of Biomaterials Science”,
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`“Journal of Drug Delivery Science and Technology”, “European Journal of
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`Pharmaceutics and Biopharmaceutics”, and “Nanomedicine”.
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`22. From 2008-2016, I was the President of the 26,000-member International
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`Union of Societies of Biomaterials Science and Engineering.
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`23. Since 1981, I have been one of the leaders of the 4,000-member Controlled
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`Release Society. I guided it as its President in 1987-88, and organized the
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`1985 (Geneva) and 1993 (Washington) meetings of the Society as well as
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`many other conferences and workshops. The Controlled Release Society is
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`the world’s leading Society for technical information in the field of
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`controlled release; it is a leading group addressing controlled release and
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`bioadhesive controlled release systems. In July 2017 I received the CRS
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`Distinguished Service Award.
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`24. Since 1975 I have been also active in the Society for Biomaterials. I was
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`elected as President-elect in April 2002 and I took over as its President in
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`April 2003 by automatic succession. The Society for Biomaterials is the
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`world’s premier scientific and technical organization for the dissemination
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`of knowledge related to biomaterials for medical devices, and polymers in
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`pharmaceutical technology.
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`25.
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`I am Past Chair of the Engineering section of the American Association for
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`the Advancement of Science (AAAS).
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`26.
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`I have received numerous US and international awards that are awarded by
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`the leading world organizations of scientific and technical excellence. These
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`include the 2012 Founders Award of the National Academy of Engineering,
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`the 2010 Acta Biomaterialia Gold Medal; the 2010 Maurice-Marie Janot
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`Award, of the French and German Pharmaceutical Association