IPR2018-00717
`Patent No. 9,492,393
`Declaration of Hossein Omidian, Ph.D.
`Attorney Docket No. KASHIV 7.1R-005
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`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________________________
`
`KASHIV PHARMA, LLC,
`
`Petitioner,
`
`v.
`
`PURDUE PHARMA L.P., and
`PURDUE PHARMACEUTICALS L.P.,
`Patent Owners.
`
`Patent No. 9,492,393 to McKenna et al.
`Issue Date: November 15, 2016
`Title: TAMPER RESISTANT DOSAGE FORMS
`____________________________
`
`Inter Partes Review No. IPR2018-00717
`
`
`__________________________________________________________________
`(Exhibit 1030)
`
`DECLARATION OF HOSSEIN OMIDIAN, Ph.D. IN SUPPORT
`OF INTER PARTES REVIEW OF U.S. PATENT NO. 9,492,393
`
`
`5341326_1.docx
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`KASHIV1030
`IPR of Patent No. 9,492,393
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`
`Patent No. 9,492,393
`Declaration of Hossein Omidian, Ph.D.
`Attorney Docket No. KASHIV 7.1R-005
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________________________
`
`KASHIV PHARMA, LLC,
`
`Petitioner,
`
`v.
`
`PURDUE PHARMA L.P., and
`PURDUE PHARMACEUTICALS L.P.,
`Patent Owners.
`
`Patent No. 9,492,393 to McKenna et al.
`Issue Date: November 15, 2016
`Title: TAMPER RESISTANT DOSAGE FORMS
`____________________________
`
`Inter Partes Review No. IPR2018-00717
`
`
`__________________________________________________________________
`(Exhibit 1030)
`
`DECLARATION OF HOSSEIN OMIDIAN, Ph.D. IN SUPPORT
`OF INTER PARTES REVIEW OF U.S. PATENT NO. 9,492,393
`
`
`5341326_1.docx
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`KASHIV1030
`IPR of Patent No. 9,492,393
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`IPR2018-00717 (Patent No. 9,492,393)
`Declaration of Hossein Omidian, Ph.D.
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`TABLE OF CONTENTS
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`Page
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`INTRODUCTION ........................................................................................... 1
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`I.
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`II. MY BACKGROUND AND QUALIFICATIONS ......................................... 1
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`III. THE ’393 PATENT ......................................................................................... 5
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`IV. PERTINENT PROSECUTION HISTORY OF THE ’393 PATENT ...........12
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`V. A PERSON OF ORDINARY SKILL IN THE ART ....................................15
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`VI. CLAIM CONSTRUCTION ..........................................................................17
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`A. “Compression Shaped” And “Compression” .........................................18
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`B. “Air Cured” And “Curing” .....................................................................18
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`C. “Optionally” ............................................................................................19
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`D. “Total Combined Weight Of Said High And Low Molecular Weight
`PEO” .......................................................................................................19
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`E. Rheological Measurements And Units ...................................................20
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`F. Product-By-Process Limitations .............................................................20
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`VII. TECHNICAL BACKGROUND AND STATE OF THE ART ....................22
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`A. Polymer Matrix Extended-Release Strategy ...........................................24
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`B. Bartholomaus ..........................................................................................34
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`C. McGinity .................................................................................................36
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`D. SDNY II Decision ...................................................................................37
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`E. Wright .....................................................................................................39
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`F. Oshlack 2 ................................................................................................42
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`G. Oshlack 3 ................................................................................................44
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`H. Royce ......................................................................................................45
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`I. Moroni .....................................................................................................45
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`J. Shao .........................................................................................................46
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`K. Zhou ........................................................................................................48
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`VIII. DENSITY ......................................................................................................48
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`A. The Data Does Not Reliably Show Density Decrease ...........................49
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`B. Purdue Mentions No Advantage Of A Decrease In Density And None
`Would Be Apparent To A POSA ............................................................55
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`C. Even The Art Relied On By The Examiner In Connection With Density
`Is Inconsistent With A Conclusion That A Density Change Would Be
`Superior ...................................................................................................56
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`IX. GROUND 1 ...................................................................................................59
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`X. GROUND 2 ...................................................................................................74
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`XI. CONCLUSION ..............................................................................................86
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`IPR2018-00717 (Patent No. 9,492,393)
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`I, HOSSEIN OMIDIAN, declare and state as follows:
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`I.
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`INTRODUCTION
`I am a U.S. citizen and a resident of the State of Florida.
`1.
`
`2.
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`I have been retained by Lerner, David, Littenberg, Krumholz &
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`Mentlik, LLP (“counsel”) to provide my opinions in the field of pharmaceutical
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`formulation for purposes of this petition for Inter Partes Review (“IPR”). I have
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`read and understand U.S. Patent No. 9,492,393 (“the ’393 Patent”) (Ex. 1001) as
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`well as all other references discussed in this declaration. I am being compensated
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`for my time in an amount consistent with my customary consulting fee, and my
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`compensation is not contingent on my opinion or the outcome of this proceeding. I
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`have provided a declaration in connection with IPR2018-00625 filed February 27,
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`2018, seeking cancellation of claims of a related patent, U.S. Patent No. 9,492,392.
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`II. MY BACKGROUND AND QUALIFICATIONS
`I have about 30 years of experience in both academia and industry.
`3.
`
`4.
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`I received my B.Sc. in Chemical Engineering in 1987 and M.Sc. in
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`Polymer Engineering in 1990 from Tehran Polytechnic University in Tehran, Iran.
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`I received my Ph.D. in Polymer Engineering and Science in 1998 from the Brunel
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`University in London, UK. The title of my dissertation was “Improved
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`Superabsorbent Polymers.” Throughout my career, my research interests have
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`included polymer synthesis and characterization, scale up of polymer products,
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`in vitro and in vivo preclinical and clinical testing of polymer-based products for
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`pharmaceutical
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`applications,
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`pharmaceutical
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`formulations,
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`advanced
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`pharmaceutical dosage forms for oral targeted drug delivery, abuse deterrent
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`formulations, polymers for pharmaceutical and biomedical applications, immediate
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`and extended-release dosage forms, and developing polymer-based products for
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`hygiene and other industrial applications.
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`5.
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`I’m currently a full professor of pharmaceutical sciences at the
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`College of Pharmacy of Nova Southeastern University. In this position, I teach
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`several core and elective courses in the professional Pharm.D., Masters, and Ph.D.
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`programs. The courses I teach, or coordinate, include Pharmaceutics I ____ this
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`course is about utilizing physical chemical principles of materials in developing
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`pharmaceutical dosage forms, Advanced Physical Pharmacy, Pharmaceutical
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`Polymers, Research Techniques and Instrumentation, and Advanced Topics in
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`Pharmaceutical Sciences. Moreover, my lab is conducting research in the area of
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`novel pharmaceutical formulations, in particular, abuse-deterrent dosage forms
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`capable of deterring abuse by injection, insufflation, and oral ingestion. I currently
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`train and supervise several Pharm.D. and Ph.D. students.
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`6.
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`From 2011-2015, I was an Associate Professor of Pharmaceutical
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`Sciences at the College of Pharmacy of Nova Southeastern University. I taught and
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`coordinated several core and elective pharmacy and pharmaceutical courses
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`including Pharmaceutics I, Advanced Physical Pharmacy, Pharmaceutical
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`Polymers, Research Techniques and Instrumentations, Pharmaceutical Formulation
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`and Development, and Drug Delivery. I also conducted research in the area of
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`novel drug delivery systems, in particular abuse-deterrent formulations. I
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`supervised two Ph.D. students in this period.
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`7.
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`From 2007-2011, I was an Assistant Professor of Pharmaceutical
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`Sciences at the College of Pharmacy of Nova Southeastern University. I primarily
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`taught Physical Pharmacy to the professional Pharm.D. program and taught
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`Advanced Physical Pharmacy to the Ph.D. program.
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`8.
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`From 2006-2007, I worked as a Principal Scientist for Abbott
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`Laboratories. My main responsibility was to finalize the intellectual properties that
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`my lab developed on polymer-based advanced diet platforms to treat obesity. I was
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`the primary inventor of those intellectual properties.
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`9.
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`From 2002-2006, I worked as a Senior Scientist, Research Manager,
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`and Principal Scientist for Kos Pharmaceuticals. My main responsibility was to
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`develop a polymer-based swellable gastro-retentive platform and a polymer-based
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`swellable platform to treat obesity.
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`10. From 2001-2002, I was a Postdoctoral Fellow at the Department of
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`Industrial and Physical Pharmacy at Purdue University. I was in charge of
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`developing mechanically strong polymer-based superporous hydrogels for
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`pharmaceutical applications.
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`11.
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`I am the primary inventor of three issued U.S. Patents, over 30 U.S.
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`and World Patent Applications, 28 Invention Disclosures, primary author,
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`co-author of 80 Peer-Reviewed Journal Publications, 135 presentations, 25 book
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`chapters and books, supervised seven graduates, and currently have two PhD
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`students. I have co-authored 13 scientific book chapters and textbook chapters in
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`the areas of drug delivery, hydrogels, and pharmaceutical polymers, including
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`chapters on “Drug Delivery Systems and Targeting,” “Commercial Oral Controlled
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`Release Solid Dosage Forms,” “Oral Controlled Delivery Mechanisms and
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`Technologies,” “Oral Targeted Drug Delivery Systems,” “Pharmaceutical
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`Polymers,” and “Polymers in Oral Drug Delivery.” I have also served as consulting
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`expert and testifying expert in several patent litigation cases.
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`12. Accordingly, I believe I am an expert in the field of pharmaceutical
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`formulations,
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`including
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`controlled-release
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`polymer-based
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`pharmaceutical
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`formulations, and I have been an expert in this field since prior to August 25, 2006.
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`Additional details of my education, experience, and credentials are set forth in my
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`curriculum vitae. (Ex. 1031.) I also believe that, because of my education,
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`experience, and interactions with students at all levels (undergraduate, Master,
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`Pharm.D., and PhD) and scientists, researchers, and administrators at all levels in
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`this field, both in academia and industry, I understand who a person of ordinary
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`skill in the art was as of August 25, 2006, and what such a person would know.
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`III. THE ’393 PATENT
`I understand from the face of the ’393 Patent (Ex. 1001) that it issued
`13.
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`on November 15, 2016, from U.S. Application Serial No. 14/729,660 (“the
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`’660 Application”) (Ex. 1033), which was filed on June 3, 2015. The ’393 Patent
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`states on its face that it is a continuation of several earlier family members all
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`claiming the benefit of U.S. Provisional Application No. 60/840,244, filed
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`August 25, 2006 (“the Provisional Application”) (Ex. 1032). I have been advised
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`by counsel that the earliest possible effective filing date for the ’393 Patent is
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`August 25, 2006.
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`14. The specification of the ’393 Patent discloses tamper-resistant dosage
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`forms that include opioid analgesics. It teaches that an abuser may seek to
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`circumvent the sustained release features of an opioid dosage form to achieve an
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`immediate “high” by crushing the tablet or dissolving a tablet in solvents such as
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`ethanol. (Ex. 1001, 1:23-41.) The specification suggests that there is a need in the
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`art to provide a tablet that is resistant to crushing. (Id. 1:38-41.) In some
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`embodiments, the dosage form is resistant to alcohol extraction and dose dumping
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`when used concomitantly with or in contact with alcohol. (Id. 1:54-58.) I note that
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`PEO, while soluble in water, is generally insoluble in alcohol. (Ex. 1047,
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`at 399-400.)
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`15. The ’393 Patent claims a method of treating pain by administering to a
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`patient in pain a specific pharmaceutical tablet that provides a dosage form for
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`twice-daily extended-release administration of oxycodone or its salt. The tablet is a
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`cured shaped pharmaceutical tablet that includes: a compression shaped matrix,
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`which is subsequently heated to at least 62ºC for at least five minutes to “cure.”
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`This “curing” step is to be done without compression. The tablet also includes PEO
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`having a molecular weight of 4,000,000; 7,000,000; or combinations thereof, and
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`requires the PEO to be present in at least 79% or 65% by weight of the tablet,
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`depending on the dose. The tablet may optionally include low molecular weight
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`PEO in the matrix, a coating, and a second air-cured matrix that includes a low
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`molecular weight PEO.
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`16. The specification describes various embodiments to achieve this goal.
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`In some embodiments, the dosage form is resistant to alcohol extraction and dose
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`dumping when used concomitantly with or in contact with alcohol. (Ex. 1001,
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`1:56-58.) In some embodiments, the dosage form can be flattened without
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`breaking. (Id. 1:59-64.) The specification also describes flattening, indentation,
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`breaking strength, resistant to crushing, and resistant to alcohol tests that can be
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`used to determine the strength of the tablets. (Id. 9:13-11:16.)
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`17. The specification includes a discussion of the process for creating the
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`tablets, which includes a “curing” step. I note that what the art often refers to as
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`“curing” in pharmaceutical formulation and development would more properly be
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`called “annealing” that is followed by either a slow or a fast cooling process
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`“quenching,” to solidify the heated product, but a POSA reading this art would
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`understand its meaning. The term “curing” is widely used in polymer industries
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`when a “chemical crosslinking” process is utilized to enhance mechanical or
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`chemical properties of a polymer or a polymer-based product, for instance curing
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`natural rubber with sulfur in tire manufacturing where natural rubber and sulfur are
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`heated up to its curing temperature while pressed. However, the term “curing” in
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`pharmaceutical
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`industry refers
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`to a cycle(s) of heating and cooling a
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`pharmaceutical composition, which is associated with some changes in physical
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`properties of the composition. This understanding is supported by the ’393 Patent’s
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`description of “curing,” which is described in various ways, e.g., at least partially
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`melting the PEO (id. 17:42-45), as subjecting the formulation to elevated
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`temperatures (id. 17:55-58), or heating the PEO to its softening temperature (id.
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`17:58-66). The specification describes various curing and temperature profiles and
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`mentions curing devices that may be used for this purpose. (Id. 18:41-19:67.)
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`18. The specification includes numerous tables and examples, two of
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`which (Examples 13, 22) were relied upon by Purdue and the Examiner in
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`allowing the patent.
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`19. Although claim 1 stated that at least 79% of PEO would be needed for
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`10, 15, 20, and 30% active concentrations, in the patent itself, in Example 8.1 of
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`Example 8 (Ex. 1001, 63:54-64:10), the inventors used 74.5% PEO for a tablet
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`preparation containing 25% active. Clearly 74.5% PEO is less than the minimum
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`requirement of 79% as stated in claim 1 for lower range of active concentration.
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`This confirms what a POSA would have expected to be the case, that there is no
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`“magic” to 79% PEO or 65%. A POSA well knows that the ultimate tablet
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`properties (e.g., physical, drug release, deterrence capability, and the like) is a
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`function of numerous factors. And among them is the PEO concentration in the
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`composition. (See, e.g., Exs. 1025, 3:57-67; 1029, at 253; 1049, at 83-90.)
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`20.
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`Indeed, the PEO used in preparation of abuse-deterrent compositions
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`plays multiple roles in that tablet. First, it controls the release of the active over an
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`extended period of time. (Exs. 1017 ¶¶ [0049], [0150]; 1024 ¶¶ [0009], [0102];
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`1025 Abstract; 1062 ¶¶ [0045], [0046]; 1049; 1029, at 253; 1027, 3:3-56.) Second,
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`it imparts crush resistance properties to the tablet if mechanically manipulated.
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`(Exs. 1024 Abstract; 1029, at 250, 253.) Last it imparts extraction resistance
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`properties if chemically manipulated. (Ex. 1017.) A POSA knows well that an
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`abuse-deterrent formulation must provide a drug release profile similar to the
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`nondeterrent version of a same active, to be bioequivalent. Therefore, the actual
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`amounts of the PEO used in that tablet (if no other controlled release polymers are
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`used) will be dependent on many factors including the intended extent of release,
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`extent of deterrence, and so on. A POSA can hardly find a rationale for what has
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`been stated in claim 1 of the ’393 Patent regarding the minimum amounts of PEO
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`required for a certain percentage of the active used in those preparations, although
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`there is a large overlap between the two. If the tablet weight is fixed, a POSA
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`knows that the weight of the tablet is also another factor in determining how much
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`of PEO can be used in that tablet. In the ’393 Patent, Example 13’s preparations
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`illustrate this principle by using different amounts of PEO for different
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`concentrations of the drug while maintaining the tablet weight at 150 mg.
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`21. Example 13 describes five different oxycodone formulations, which
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`were made with various amounts of 4,000,000 MW PEO. (Id. 70:11-77:67.)
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`Example 13 describes how the tablets are manufactured and describes testing
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`protocol for breaking strength and density. Table 13.6 compares the density of
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`uncured tablets and those cured for 30, 60, and 90 minutes. (Id. 77:55-67.) In each
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`instance, the density is reported to be lower after curing. (Id.) However, this
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`purported phenomenon is not supported by a solid trend. For instance, in
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`Example 13.1, the density of the tablets cured for 30 minutes is less than that of the
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`uncured tablet, however, the densities reported for the tablets cured 60 and 90
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`minutes are equal to or slightly higher (not significant though) than those of the
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`30 minute cured tablets. There are similar inconsistencies with all of the examples
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`in Table 13.6 for these preparations. Although many details were provided in the
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`’393 Patent, i.e., Ex. 1001, 70:10-72:45, I could not find a discussion or teaching of
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`how much force (the tableting force, the compression force) has been applied
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`during tablet manufacturing. A POSA well knows that the apparent density of a
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`tablet is closely related to the compression force applied during the tableting.
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`Although very dependent on the compaction properties of the mix and
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`compactability of the excipients, in general, the greater the compression force, the
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`denser the tablet would be. Tablets containing such a high percentage of a very soft
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`polymer possessing high plasticity (PEO) would be more sensitive to the
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`compression force applied during the tableting process. The ’393 Patent stated the
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`compression forces in Tables 17.2.2 and 18.1.2 for Examples 17.2 and 18.1,
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`respectively, however this critical information is missing for the preparation of
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`Examples 13 and 14.
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`22. Similarly, Example 14 describes five formulations similar to those
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`used in Example 13, but prepared in a larger batch size. This example includes a
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`table to compare the density of uncured and cured tablets. (Id. Table 14.6, 95:40-
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`55.) Table 14.6 compares the uncured, cured, and cured then coated tablets.
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`Density was measured by the process described in Example 13. (Id. 72:15-45.) In
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`each instance, the density is reported to be lower after curing, and lower still after
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`coating. (Id. Table 14.6, 95:40-55.)
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`23. Comparative Example 22 describes five formulations and also
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`includes a table to compare the density. But in this example, the comparison is
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`between unmolded and molded tablets. (Id. 128:60-130:15.) The density of the
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`“unmolded” tablet is described as corresponding to the density of the “uncured”
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`tablet of Example 13. The difference between the process of Example 13 and
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`Example 22 is that the tablets of Example 22 were “subjected to a molding step
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`instead of a curing step.” (Id. 128:60-67.) This “molding step” is defined in step 7
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`as placing the compressed tablets “between two heated plates which were
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`preheated to 120ºC. and then compressed at a pressured setting of 1000 kg and
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`held for 3 minutes.” (Id. 129:33-38.) It’s my understanding that Purdue used
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`Example 22 to show that density would increase if heat was applied with
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`compression. (Ex. 1035, at 10-12.) This is a thoroughly unremarkable conclusion.
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`Indeed that is what would generally be expected because combined application of
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`heat and pressure can significantly enhance plastic deformation of the tablet, more
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`air will be removed from the tablet, and the solid fraction of the tablet increases,
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`which would all resulting in an increased tablet density. More importantly, it is not
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`relevant to density behavior when curing without compression.
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`IV. PERTINENT PROSECUTION HISTORY OF THE ’393 PATENT
`I am an inventor and have been involved in patent prosecution and
`24.
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`litigation and therefore I have an understanding of the patent prosecution process.
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`However, when I review a prosecution history, I do so as a technical expert. I
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`understand that in response to a nonfinal office action (Ex. 1034), Purdue filed
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`amendments and arguments on December 11, 2015 (Ex. 1035), and a declaration
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`under 37 C.F.R. § 1.132 by Richard O. Mannion (the “Mannion Declaration”)
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`(Ex. 1036). In the response, Purdue argued that “[c]ombining Wright with
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`Bartholomaus does not provide the compression shaped and then air cured tablets
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`of the invention and does not provide the surprising decrease in density.”
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`(Ex. 1035, at 10.) Purdue also filed a supplemental amendment on February 16,
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`2016 (Ex. 1037).
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`25.
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`I understand that in response to a final office action mailed on April 8,
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`2016, Purdue filed an after final amendment to include the term “without
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`compression” to the claims, based on the Examiner’s suggestion that Bartholomaus
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`required curing with compression and that a decrease in density after curing was
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`unexpected. (Exs. 1038; 1039.) The Examiner then issued a Notice of Allowability
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`on June 29, 2016. (Ex. 1040.) The Notice of Allowability made clear that she
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`believed that Bartholomaus required curing with compression and that a drop in
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`density was unexpected. (Id.)
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`26. Based on the Mannion Declaration, Examples 13 and 22 of the
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`’393 Patent, and three references Mai (Ex. 1041), AlKhatib (Ex. 1042), and Mpofu
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`IPR2018-00717 (Patent No. 9,492,393)
`Declaration of Hossein Omidian, Ph.D.
`
`
`(Ex. 1043) (collectively referred to herein as the “Density Publications”), the
`
`Examiner determined that “Applicant has surprisingly demonstrated a decrease in
`
`density which does not appear to be a predictable or expected result.” (Ex. 1040,
`
`at 4.) I do not agree that these references establish that a POSA would expect a
`
`density increase for PEO. Moreover, while the Examiner suggested that the prior
`
`art did not teach curing without compression to overcome Bartholomaus (the
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`reasoning behind the Examiner’s suggested amendment), I believe a POSA would
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`find that Bartholomaus actually did teach heating without compression. The
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`Examiner also failed to appreciate that the Mannion Declaration and Examples 13
`
`and 22 do not prove that curing without compression lead to a decrease in
`
`density ____ because a POSA would have little faith in the data contained in the
`
`’393 Patent. I also find it curious that density was selected as a basis for arguing
`
`unexpected results. While not claimed in claim 1, the specification talks of a great
`
`deal of abuse deterrence by, amongst other things, crushing. One would expect that
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`one of the other physical parameters such as breaking strength or indentation
`
`would have been the subject of Purdue’s argument. These parameters, the testing
`
`methods used, and the reported values in the specification are all conventional. But
`
`at least an argument can be made that they are consequential. Purdue has offered
`
`no explanation of why the density decrease should matter in this regard.
`
`14
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`KASHIV1030
`IPR of Patent No. 9,492,393
`
`
`
`IPR2018-00717 (Patent No. 9,492,393)
`Declaration of Hossein Omidian, Ph.D.
`
`V. A PERSON OF ORDINARY SKILL IN THE ART
`I understand from my own experiences and from counsel that patents
`27.
`
`are read by, and are to be read in light of the knowledge of, a person of ordinary
`
`skill in the art (“POSA”) as of the earliest effective filing date of the patent. I have
`
`been told by counsel to assume that the earliest effective filing date is August 25,
`
`2006, for purposes of this declaration. All of the prior art relied on in my
`
`declaration was published more than a year before the earliest effective filing date
`
`or was filed in the United States before the earliest effective filing date of the
`
`’393 Patent.
`
`28.
`
`It was explained to me by counsel that a POSA is a hypothetical
`
`person who is deemed to be aware of all relevant prior art. A POSA is also a
`
`person of ordinary creativity, not an automaton.
`
`29.
`
`I am further told by counsel that factors relevant to determining the
`
`level of skill in the art include: the educational level of the inventors, the types of
`
`problems encountered in the art, prior art solutions to those problems, the rapidity
`
`with which innovations are made, the sophistication of the technology, and the
`
`educational level of active workers in the field. I understand from counsel that a
`
`POSA may be a composite of different types of individuals.
`
`30.
`
`I understand from counsel that Kashiv has proposed the following
`
`definition for a POSA:
`
`15
`
`KASHIV1030
`IPR of Patent No. 9,492,393
`
`
`
`IPR2018-00717 (Patent No. 9,492,393)
`Declaration of Hossein Omidian, Ph.D.
`
`
`One of ordinary skill in the art would have a Ph.D., Pharm.D, or M.D.
`
`degree in a relevant field (such as polymer chemistry, pharmaceuticals,
`
`pharmaceutical
`
`chemistry,
`
`pharmaceutical
`
`formulation,
`
`chemical
`
`engineering or materials science, pharmacy, pharmaceutical science,
`
`pharmaceuticals, medical chemistry, chemical engineering, or medicine)
`
`with at least three years of post-doctoral experience in those fields, or a
`
`Master's degree in said field with at least six years of experience,
`
`particularly experience with controlled-release formulations.
`
`31.
`
`In comparison, Purdue has advocated:
`
`One of ordinary skill in the art would have had a degree in one or more
`
`fields of medicine, chemical engineering, chemistry, pharmaceutical
`
`science, polymer chemistry, pharmaceutics, pharmaceutical technology,
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`pharmacokinetics, and/or pharmacology, and/or a number of years of
`
`industry training or experience in one or more of those fields.
`
`32. Having reviewed both proposed definitions, I would modify both in
`
`minor respects. For example, I think the level of experience and education of a
`
`POSA might actually be lower than that proposed by either party to the related
`
`litigation.
`
`16
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`KASHIV1030
`IPR of Patent No. 9,492,393
`
`
`
`IPR2018-00717 (Patent No. 9,492,393)
`Declaration of Hossein Omidian, Ph.D.
`
`
`33.
`
`I can accept either of the proposed definitions. In my opinion, the
`
`result of my analysis of what a POSA would conclude would be unchanged no
`
`matter which of these standards is applied. Therefore I accept Petitioner’s proposed
`
`language, with the understanding that I see little practical difference between the
`
`proposed standards. Both standards reflect scientists with a high level of education
`
`and/or experience and the concepts key to this analysis is one well within the
`
`education and/or experience of all of the above.
`
`34. As of the relevant date of August 2006, I believe I was a POSA under
`
`any of these definitions. I understand who a person of ordinary skill in the art was
`
`as of August 25, 2006, and what such a person would know.
`
`VI. CLAIM CONSTRUCTION
`I understand that it is often desirable to construe the meaning of a
`35.
`
`claim’s terms to eliminate ambiguity when possible. I also understand from
`
`counsel that the claims in an IPR are to be given their broadest reasonable
`
`interpretation (“BRI”) unless they are specifically defined otherwise. My
`
`understanding of broadest reasonable interpretation is that the definition must be
`
`consistent with the understanding of a POSA in the field and with the specification
`
`and statements made during prosecution, but it is not limited to only those items
`
`discussed in the specification. Terms that can be given a more inclusive meaning
`
`are given that meaning.
`
`17
`
`KASHIV1030
`IPR of Patent No. 9,492,393
`
`
`
`IPR2018-00717 (Patent No. 9,492,393)
`Declaration of Hossein Omidian, Ph.D.
`
`
`“Compression Shaped” And “Compression”
`A.
`36. Claim 1 recites a “compression shaped” tablet that is cured without
`
`“compression.” The ’393 Patent does not define these terms and the prosecution
`
`history offers no further explicit insight. But I believe a POSA would understand
`
`this to mean applying pressure to compact materials into a tablet. The patent does
`
`define “direct compression,” which is described as forming a tablet by dry
`
`blending followed by compressing the dry blend. (Ex. 1001, 8:64-9:5.) But both
`
`the use of the qualifier “direct,” and the way the ’393 Patent recognizes that there
`
`are other types of compressive tablet forming techniques (see id. 17:32-41)
`
`necessarily means to a POSA that the terms in question are broader than direct
`
`compression. This establishes that the term “compression” is not synonymous with
`
`direct compression; indeed it is broader. Therefore, the broadest reasonable
`
`interpretation of “compression” and “compression shaped,” in the context of the
`
`claims, means any compaction step where pressure is applied to a material to form
`
`a shaped tablet. This includes direct compression, but also other compaction
`
`processes, such as dry granulation and wet granulation. A POSA would understand
`
`“without compression” to mean without such application of pressure.
`
`“Air Cured” And “Curing”
`B.
`37. The claims of the ’393 Patent require an “air cured” matrix, wherein
`
`the “curing” is accomplished without compression. The ’393 Patent does not
`
`18
`
`KASHIV1030
`IPR of Patent No. 9,492,393
`
`
`
`IPR2018-00717 (Patent No. 9,492,393)
`Declaration of Hossein Omidian, Ph.D.
`
`
`define these terms and the prosecution history offers no further insight. A POSA
`
`would read the term “curing” in light of the specification to mean partially melting
`
`the PEO or subjecting the formulation to an elevated temperature that is at least as
`
`high as the softening temperature of the PE
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