Declaration of Maureen Reitman, Sc.D.
`US Patent No. 8,475,832
`
`Attorney Docket No. 117744-00041
`
`Paper No._______
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
`
` BIODELIVERY SCIENCES INTERNATIONAL, INC.
`Petitioner
`
`v.
`
`RB PHARMACEUTICALS LIMITED
`Patent Owner
`
`US Patent No. 8,475,832
`Issue Date: July 2, 2013
`
`Title: SUBLINGUAL AND BUCCAL FILM COMPOSITIONS
`_______________
`
`Inter Partes Review No. Unassigned
`
`DECLARATION BY MAUREEN REITMAN, SC.D.
`UNDER 37 CFR § 1.132
`
`Sir/Madam:
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`Declaration of Maureen Reitman, Sc.D.
`US Patent No. 8,475,832
`
`Attorney Docket No. 117744-00041
`
`
`
`I, Maureen Reitman, do hereby make the following declaration:
`
`1.
`
`I am a Principal and the Director of the Polymer Science and
`
`Materials Chemistry Practice at Exponent. I hold two academic
`
`degrees: (1) a Bachelor of Science in Materials Science and
`
`Engineering from the Massachusetts Institute of Technology (MIT),
`
`and (2) a Doctor of Science in Materials Science and Engineering,
`
`with a thesis in the field of polymers, from MIT. I have been
`
`practicing in the field of polymer science and engineering for more
`
`than 20 years as a researcher at MIT, in a variety of technical roles at
`
`the 3M Company, and as a consultant with Exponent. I provide
`
`consulting engineering services in all aspects of polymer science and
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`engineering including, but not limited to material selection, product
`
`design and development, mechanical and chemical testing, failure
`
`analysis, polymer chemistry, polymer physics, and polymer
`
`processing. My specialties include formulation, processing and
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`performance evaluation of polymeric materials, including films,
`
`coatings, adhesives and transdermal drug delivery systems. I have
`
`been directly involved in product development, product line
`
`extensions, transfer of new products to manufacturing, qualification of
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`Declaration of Maureen Reitman, Sc.D.
`US Patent No. 8,475,832
`
`Attorney Docket No. 117744-00041
`
`
`
`alternative materials and manufacturing equipment, evaluating field
`
`performance, and assessing intellectual property. I am a past
`
`chairman and continue to serve as a member of the board of directors
`
`of the Medical Plastics Division of the Society of Plastics Engineers.
`
`My curriculum vitae is provided in Appendix A.
`
`2. While Exponent is being paid for my time, I am not an employee of,
`
`nor do I have any financial interest in, BioDelivery Sciences
`
`International, Inc.
`
`3.
`
`I have been asked to measure the pH of Suboxone® tablets.
`
`4. Materials/Methods. 8 mg Suboxone® tablets were used in this
`
`experiment. An EL20 pH meter from Mettler Toledo was used
`
`according to manufacturer instructions to measure the pH of the
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`Suboxone ® tablets in deionized water.
`
`5.
`
`pH of Suboxone® tablets. In order to measure the pH of the 8 mg
`
`Suboxone® tablets, the tablets were dissolved in both 1.5 mL and 3
`
`mL of deionized water. The pH of the 8 mg tablets was measured to
`
`be 3.5 in both 1.5 mL and 3 mL of deionized water.
`
`6.
`
`I hereby declare that all statements made herein of my own
`
`knowledge are true and that all statements made on information and
`
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`Declaration of Maureen Reitman, Sc.D.
`US Patent No. 8,475,832
`
`Attorney Docket No. 117744-00041
`
`belief are believed to be true; and further that these statements were
`
`made with the knowledge that willful false statements and the like so
`
`made are punishable by fine, or imprisonment, or both, under section
`
`1001 of Title 18 of the United States Code, and that such willful
`
`statements may jeopardize the validity of the application or any
`
`patents issued thereon.
`
`
`
`Dated: January 6, 2014
`
`Maureen Reitman, Sc.D.
`
`
`
`
`
`
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`
`Maureen T. F. Reitman, Sc.D.
`Principal and Practice Director
`
`Professional Profile
`
`Dr. Maureen Reitman is a Principal and the Director of Exponent’s Polymer Science and
`Material Chemistry practice. Her expertise includes polymer and composite technology,
`mechanics of materials, adhesion science, fiber mechanics, history and technology of plastics,
`and material failure analysis. She is skilled in the development and use of testing tools and
`methods and has applied them to plastic, rubber, textile, metal, glass, ceramic, and composite
`materials and systems. She is experienced in major aspects of product development, including
`materials selection, formulation, scale-up, end-use testing, failure analysis, certification
`procedures and issues related to intellectual property.
`
`Dr. Reitman has conducted research in the areas of packaging and barrier materials; paints and
`coatings; plastic pipes; transdermal drug delivery; adhesives, sealants, and encapsulants;
`molding compounds; high temperature resins; nanoparticles; fibers and textiles; protective
`coatings and finishes; polymer chemical resistance; plastic insulation; connectors and splices;
`plastic packaging; medical devices; environmental effects on durability; and product aging. She
`has used her expertise to solve a broad range of problems related to coatings, fibers, films, and
`extruded and molded products, and their use in the telecom, electronics, electrical,
`transportation, construction, fire protection, medical, and consumer products markets.
`
`Dr. Reitman is a member of the Board of Directors of the Medical Plastics Division of the
`Society of Plastics Engineers and an active member of two Underwriters Laboratories Standard
`Technical Panels, addressing Polymeric Materials (UL 94, UL 746, UL 1694) and Appliance
`Wiring (UL758).
`
`Prior to joining Exponent, Dr. Reitman worked for the 3M Company in both research and
`management roles. Her activities included technology identification, materials selection and
`qualification, product development, customer support, program management, acquisition
`integration, intellectual property analysis, and patent litigation support.
`
`Academic Credentials and Professional Honors
`
`Sc.D., Materials Science and Engineering/ Program in Polymer Science and Technology,
`Massachusetts Institute of Technology, 1993
`B.S., Materials Science and Engineering, Massachusetts Institute of Technology, 1990
`
`National Academy of Engineering Frontiers of Engineering, 2009; Tau Beta Pi; Sigma Xi
`John Wulff Award; Carl Loeb Fellowship; NCAA Postgraduate Scholarship;
`Malcolm G. Kispert Award; GTE Academic All-American
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`Patents
`
`Patent 6,311,524: Accelerated Method for Increasing the Photosensitivity of a Glassy Material,
`issued November 6, 2001.
`
`European Patent EP0830428: Tackified Polydiorganosiloxane Polyurea Segmented
`Copolymers and a Process for Making Same, published March 25, 1998.
`
`Patent 5,371,051: Fiber Optic Fusion Splice Protector Sleeve, issued March 24, 1998.
`
`Publications
`
`Kurtz S, Siskey R, Reitman M. Accelerated aging, natural aging, and small punch testing of
`gamma-air sterilized polycarbonate urethane acetabular components. Journal of Biomedical
`Materials Research Part B: Applied Biomaterials 2010 May; 93B(2):422–447.
`
`Hoffman JM, Reitman M, Donthu S, Ledwith P. Complimentary failure analysis methods and
`their application to CPVC pipe. Proceedings, ANTEC 2010, Society of Plastics Engineers,
`Orlando, FL, May 2010.
`
`Hoffman JM, Reitman M, Donthu S, Ledwith P, Wills D. Microscopic characterization of
`CPVC failure modes. Proceedings, ANTEC 2009, Society of Plastics Engineers, Chicago, IL,
`June 2009. Best Paper Award in Failure Analysis & Prevention.
`
`Kurtz SM, Ebert M, Siskey R, Ciccarelli L, Reitman M, Harper ML, Chan FW. Natural and
`accelerated aging of polyurethanes in the Bryan cervical disc. Poster No. P158. Transactions of
`Spineweek 2008, Geneva, Switzerland, May 26–31, 2008.
`
`Reitman M, Ledwith P, Hoffman M, Moalli J, Xu T. Environmentally driven changes in nylon.
`Proceedings, ANTEC 2008, Milwaukee, WI, Society of Plastics Engineers, May 2008.
`
`Hoffman JM, Reitman M, Ledwith P. Characterization of manufacturing defects in medical
`balloons. Proceedings, ANTEC 2008, Milwaukee, WI, Society of Plastics Engineers, May
`2008.
`
`Reitman, MTF, Moalli JE. Polymeric coatings for medical device. Medical Device and
`Manufacturing Technology, Touch Briefings, pp. 28–30, 2006.
`
`Moalli JE, Moore CD, Robertson C, Reitman MTF. Failure analysis of nitrile radiant heating
`tubing. Proceedings, ANTEC 2006, Society of Plastic Engineers, Charlotte, NC, May 2006.
`
`Reitman M, McPeak J. Protective coatings for implantable medical devices. Proceedings,
`ANTEC 2005, Society of Plastic Engineers, Boston MA, May 2005.
`
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`McPeak J, Reitman M, Moalli J. Determination of in-service exposure temperature of
`thermoformed PVC via TMA. Proceedings, 31st Annual North American Thermal Analysis
`Society Conference, Williamsburg, VA, 2004.
`
`Reitman MTF, Moalli JE. Product development and standards organizations: Listings and
`certifications for plastic products. 8th Annual International Conference on Industrial
`Engineering Theory, Applications and Practice, Las Vegas, NV, 2003.
`
`Potdar YK, Reitman MTF. The role of engineering consultants in failure analysis and product
`development. 8th Annual International Conference on Industrial Engineering Theory,
`Applications and Practice, Las Vegas, NV, 2003.
`
`Ezekoye OA, Lowman CD, Hulme-Lowe AG, Fahey MT. Polymer weld strength predictions
`using a thermal and polymer chain diffusion analysis. Polymer Engineering and Science 1998;
`38(6):976–991, June.
`
`Fahey MT. Nonlinear and anisotropic properties of high performance fibers. MIT Thesis,
`1993.
`
`Fahey MT. Mechanical property characterization and enhancement of rigid rod polymer fibers.
`MIT Thesis, 1990.
`
`Book Contributions
`
`Reitman M, Liu D, Rehkopf J. Chapter 38. Mechanical properties of polymers. In: Handbook
`of Measurement in Science and Engineering. Volume 2. Kutz, M (ed), John Wiley & Sons,
`Hoboken NJ, 2013. ISBN- 978-1-118-38464-0.
`
`Reitman M, Jaekel D, Siskey R, Kurtz S. Morphology and crystalline architecture of
`polyarylketones, pp. 49-60. In: PEEK Biomaterials Handbook. Kurtz SM (ed), Elsevier
`William Andrews, Kidlington, Oxford, UK, 2012. ISBN 13:978-1-4377-4463-7
`
`Tsuji JS, Mowat FS, Donthu S, Reitman M. Application of toxicology studies in assessing the
`health risks of nanomaterials in consumer products, pp. 543-580. In: Nanotoxicity: From In
`Vivo and In Vitro Models to Health Risks. Sahu S, and Casciano D. (eds), John Wiley & Sons,
`Chicester, West Sussex, UK, 2009. ISBN 978-0-470-74137-5.
`
`Reitman MTF. The Plastics Revolution. In: Research and Discovery: Landmarks and Pioneers
`in American Science. Lawson RM (ed), Armonk NY: Sharpe Reference 2008. ISBN 978-0-
`7656-8073-0.
`
`Klein SM. Mid-century plastic jewelry. Schiffer Publishing, Atglen, PA, 2005. (Technical
`advisor to author).
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`Selected Invited Presentations
`
`Reitman MTF. Failure analysis tools. Workshop on Future Needs for Service Life Prediction of
`Polymeric Materials. NIST and Underwriters Laboratories, Gaithersburg, MD, October 2012.
`
`Hoffman J, MacLean S, Ralston B, Reitman M, Ledwith P. Fractography of unfilled
`thermoplastic materials experiencing common mechanical failure modes. Materials Science &
`Technology 2012 Conference, Pittsburgh PA, October 2012.
`
`Hoffman J, Reitman M, Ledwith P. Microscopic characterization of CPVC failure. Materials
`Science & Technology 2012 Conference, Pittsburgh PA, October 2012.
`
`Reitman MTF. Polymer material properties for next generation medical devices. Invited
`Speaker: MedTech Polymers, UBM Canon, Chicago, IL, September 2012.
`
`Reitman MTF. Polymers for medical applications. Fundamentals and Fellows Forum, ANTEC
`2012, Orlando FL, April 2012.
`
`Reitman MTF. Plastic and composite product failures. Invited lecture in Failure Analysis of
`Emerging Technologies. Stanford University Department of Materials Science and
`Engineering, Menlo Park, CA October 2009.
`
`Reitman MTF. Factors for success: Plastics in injection molded medical devices. Part of
`Injection Molding Works for Medical Design, Design News Webcast, October 2008.
`
`Reitman MTF. Plastic and composite product failures. Keynote Speaker: Third International
`Conference on Engineering Failure Analysis (ICEFA III), Elsevier, Sitges Spain, July 2008.
`
`Reitman MTF. Multiphase materials for medical device applications, an overview. Medical
`Device and Manufacturing (MDM), Canon Communications, various locations, January- June
`2008.
`
`Reitman MTF. Nanotechnology and plastics for medical devices. Capitalizing on Nanoplastics,
`Intertek PIRA San Antonio TX, February 2008.
`
`Reitman MTF. Nano additives in composites and coatings for medical device applications.
`Medical Device and Manufacturing Minneapolis, Canon Communications, Minneapolis MN,
`October 2007.
`
`Reitman MTF, Swanger LA. Practical tips on how to manage your technical expert in patent
`disputes. Ropes & Gray IP Master Class, Live Teleconference, June 2007.
`
`Reitman MTF, Kennedy E. Root cause failure analysis and accident investigation. Lorman
`Educational Services, Live Teleconference, November 2007.
`
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`Reitman MTF. Plastics failure analysis: Case studies. Baltimore/ Washington Chapter of
`SAMPE, October 2006.
`
`Reitman MTF. Plastics failure analysis. Baxter Global Plastics Processing Conference 2005,
`Schaumburg IL, 2005.
`
`Fahey MT. Fiber mechanics, corrosion, sealants: Tales of a 3M materials scientist. Class of
`1960's Scholars Program, Williams College, 1999.
`
`Fahey MT. Adhesives and sealants for the telecommunications industry. Riverwood V
`Conference, St. Paul MN, 1998.
`
`Current Professional Appointments
`
`
` Underwriter’s Laboratory Standards Technical Panel STP 746 (Polymeric Materials,
`includes UL94, UL 746 and UL1694)
` Underwriter’s Laboratory Standards Technical Panel STP 758 (Appliance Wires/
`UL758)
` Medical Plastics Division Board of Directors, Society of Plastics Engineers
`
`
`Committee and Review Activities
`
`
` UL Forum on Initiatives to Improve the Long Term Aging Program, LTTA Tools
`Working Groups, Underwriters Laboratories
` Research and Engineering Technology Award Committee, Society of Plastics Engineers
` Reviewer, Medical Plastics Technical Program Committee, Society of Plastics Engineers
` Reviewer, Failure Analysis and Prevention Technical Program Committee, Society of
`Plastics Engineers
` Reviewer, various book proposals and submissions related to polymer science, ASM
`International, Elsevier, John Wiley
`
`
`Professional Affiliations
`
`
` American Association for the Advancement of Science (member)
` American Association of Textile Chemists and Colorists—AATCC (senior member)
` American Chemical Society (member)
` ASTM International (member)
` Society for the Advancement of Material and Process Engineering (member)
` Society of Plastics Engineers (senior member)
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