Paper No. Filed July 25, 2016 UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD BIODELIVERY SCIENCES INTERNATIONAL, INC., Petitioner v. MONOSOL RX, LLC Patent Owner Case IPR2015-00165 / Case IPR2015-00168 / Case IPR2015-00169 US 1 PETITIONER S SIXTH UPDATED EXHIBIT LIST 1 Per Scheduling Order, Paper 7, fn. 1, Petitioner hereby attests that the word-forword identical paper is filed in each proceeding identified in the heading.
LIST OF EXHIBITS Exhibit Ex. 1001 Ex. 1002 Ex. 1003 Ex. 1004 Ex. 1005 Ex. 1006 Ex. 1007* US (the 167 patent) WO 00/42992 to Chen et al. (Chen) WO 99/55312 to Tapolsky et al. (Tapolsky) US Patent No. 5,393,528 (Staab) WO 00/18365 to Leung et al. (Leung) Complaint, BioDelivery Sciences International, Inc. v. Reckitt Benckiser Pharmaceuticals, Inc., et al., 5:14-cv-00529 (EDNC) Corrected Declaration of Edward Cohen, Ph.D. (Cohen Dec.) Ex. 1008 Ex. 1009 Ex. 1010 Ex. 1011 Ex. 1012 Ex. 1013 [*There are three different Exhibit 1007s. IPR2015-00165, IPR2015-00168, and IPR2015-00169 each include a different Exhibit 1007.] US Patent No. 370,110, entitled Process of Coating Photographic Paper and assigned to Eastman Dry Plate & Film Co. on Sept. 20, 1887 (the 1887 patent) Excerpts from MODERN COATING AND DRYING TECHNOLOGY, Cohen, E. and Gutoff, E., eds., John Wiley & Sons, Inc. (1992) (MODERN COATING) Cohen, E. & Gutoff, E., Coating Processes, Survey, ENCYCLOPEDIA OF CHEMICAL TECHNOLOGY, Vol. 6, Wiley (1993) Gelderblom, H., et al., Cremophor EL: the drawbacks and advantages of vehicle selection for drug formulation, EUROPEAN J. OF CANCER, Vol. 37, 1590-98 (2001) Excerpts from HANDBOOK OF PHARMACEUTICAL EXCIPIENTS, Pharmaceutical Press (3 rd ed. 2000) (HANDBOOK) Excerpts from Ansel, H., PHARMACEUTICAL DOSAGE FORMS AND DRUG DELIVERY SYSTEMS (7 th ed. 1999) (PHARMACEUTICAL DOSAGE FORMS) Ex. 1014 Excerpts from MERRIAM-WEBSTER S COLLEGIATE DICTIONARY, (10 th ed. 2000) Ex. 1015 Excerpt from PHYSICIANS DESK REFERENCE (56 th ed. 2002) Ex. 1016 Excerpt from Ferry, J. D., VISCOELASTIC PROPERTIES OF POLYMERS, John Wiley & Sons, Inc. (3rd ed. 1980) Ex. 1017 December 31, 2013 Amendment and Response, Excerpt from File History of 167 patent ( 167 History, Amendment and Response 12/31/13) 2
Exhibit Ex. 1018 Case Nos. IPR2015-00165, IPR2015-00168, IPR2015-00169 November 19, 2013 Interview Summary, Excerpt from File History of 167 patent ( 167 History, Interview Summary 11/19/13) Ex. 1019 July 31, 2013 Office Action, Excerpt from File History of 167 patent ( 167 History, Office Action 7/31/13) Ex. 1020 July 8, 2013 Reply to Office Action, Excerpt from File History 167 patent ( 167 History, Reply 7/8/13) Ex. 1021 April 8, 2013 Office Action, Excerpt from File History of 167 patent ( 167 History, Office Action 4/8/13) Ex. 1022 May 2, 2012 Amendment and Response, Excerpt from File History 167 patent ( 167 History, Amendment and Response 5/2/12) Ex. 1023 November 2, 2011 Office Action, Excerpt from File History of 167 Ex. 1024 Ex. 1025 Ex. 1026 Ex. 1027 patent ( 167 History, Office Action 11/2/11) February 19, 2010 Amendment and Response, Excerpt from File History of 167 patent ( 167 History, Amendment and Response 2/19/10) Partial Patent Family Tree US Patent No. 7,824,588 (the 588 patent) Apr. 17, 2014 Decision on Appeal of 588 inter partes patent reexamination, Control No. 95/001,753, Appeal 2014-000547 ( 588 Decision) Ex. 1028 Excerpt from June 24, 2013 Patent Owner Appeal Brief, 588 patent reexamination, Control No. 95/001,753 Ex. 1029 Jan. 23, 2013 Right of Appeal Notice, 588 patent reexamination, Control No. 95/001,753 ( 588 History, RAN) Ex. 1030 US Patent No. 7,897,080 (the 080 patent) Ex. 1031 July 31, 2013 Action Closing Prosecution, 080 patent reexamination, Control No. 95/002,170 ( 080 History, ACP) Ex. 1032 December 6, 2013, Right of Appeal Notice, 080 patent reexamination, Control No. 95/002,170 ( 080 History, RAN) Ex. 1033 US Patent No. 7,666,337 (the 337 patent) Ex. 1034 December 17, 2013 Right of Appeal Notice, 337 patent reexamination, Control No. 95/002,171 ( 337 History, RAN) Ex. 1035 US Patent No. 7,425,292 (the 292 patent) Ex. 1036 Ex Parte Reexamination Certificate for US Patent No. 7,425,292 Ex. 1037 US Patent No. 7,357,891 (the 891 patent) Ex. 1038 Ex Parte Reexamination Certificate for US Patent No. 7,357,891 Ex. 1039 US Patent No. 8,652,378 (the 378 patent) 3
Exhibit Ex. 1040 Transcript of Mar. 26, 2014 Oral Hearing on Appeal of 588 patent reexamination, Control No. 95/001,753, Appeal 2014-000547 ( 588 History, Hearing Transcript) Ex. 1041 Electronic Comparison of Specifications of the 167 Patent and the 588 Patent Ex. 1042 Trademark Registration No. 1,107,737 for VICODIN Ex. 1043 Status of Trademark Registration No. 1,107,737 for VICODIN (2008) Ex. 1044 Package Insert for VICODIN (2014) Ex. 1045 Coating Technology Handbook, D. Satas (ed.), Marcel Dekker, Inc. (1991) ( Coating Technology ) Ex. 1046 U.S. Patent No. 2,681,294 issued June 15, 1954 (the 1954 Kodak patent ) Ex. 1047 Corrected Declaration of Maureen Reitman, Sc.D. (Reitman Dec.) Ex. 1048 Affidavit Of Ms. Wyley S. Proctor in Support of Motion for Pro Hac Vice Admission Ex. 1049 Mil to Micron (mil to µm) Length or Distance Conversion Table, downloaded from <http://www.aqua-calc.com/convert/length/milto-micron> on October 23, 2015 and marked as Deposition Exhibit No. 1049 in October 26, 2015 Deposition of Dr. Joseph W. Wyse Ex. 1050 Combined Declaration and Power of Attorney, marked by the USPTO as received with respect to App. No. 10/074,272 (later issued as 292 patent) on June 11. 2002 and also marked as Deposition Exhibit No. 1050 in October 29, 2015 Deposition of Mr. Garry Myers Ex. 1051 Garry Myers LinkedIn Profile, downloaded from <https://www.linkedin.com> on September 28, 2015 and marked as Deposition Exhibit No. 1051 in October 29, 2015 Deposition of Mr. Garry Myers Ex. 1052 US Patent No. 4,136,145 (Fuchs) Ex. 1053 Mr. Garry Myers Deposition Transcript dated October 29, 2015 Ex. 1054 Dr. Joseph W. Wyse Deposition Transcript dated October 26, 2015 Ex. 1055 Sigma-Aldrich Estradiol Product Information Ex. 1056 Mar. 27, 2015 Decision on Appeal of 080 patent inter partes reexamination, Control No. 95/002,170 ( 080 Decision) Ex. 1057 Mar. 27, 2015 Decision on Appeal of 337 patent inter partes reexamination, Control No. 95/002,171 ( 337 Decision) Ex. 1058 Declaration of Edith Mathiowitz, Ph.D. (Mathiowitz Dec.) 4
Exhibit Ex. 1059 Curriculum Vitae of Edith Mathiowitz, Ph.D. Ex. 1060 Declaration of Philip T. Lavin, Ph.D. (Lavin Dec.) Ex. 1061 Curriculum Vitae of Philip T. Lavin, Ph.D. Ex. 1062 US Patent No. 8,663,687 (the 687 Patent) Ex. 1063 US Patent No. 5,629,003 (Horstmann) Ex. 1064 US Patent No. 5,948,430 (Zerbe) Ex. 1065 US Patent No. 4,849,246 (Schmidt) Ex. 1066 Transcript of Teleconference held October 29, 2015 Ex. 1067 Testimony of Robert Langer, November 4, 2015 (excerpts) Ex. 1068 Expunged Ex. 1069 Jan. 27, 2016 Decision on Request for Rehearing of 337 patent inter partes reexamination, Control No. 95/002,171 Respectfully submitted, Dated: July 25, 2016 By: /Danielle L. Herritt/ Danielle L. Herritt (Reg. No. 43,670) Attorney for the Petitioner 5
CERTIFICATE OF SERVICE The undersigned hereby certifies that a copy of the foregoing Petitioner s Sixth Updated Exhibit List, including this Certificate of Service, was served via email on July 25, 2016, on attorneys for Patent Owner: Daniel A. Scola, Jr. Michael I. Chakansky Hoffmann & Baron LLP 6 Campus Drive Parsippany, New Jersey 07054 dscola@hbiplaw.com mchakansky@hbiplaw.com 165ipr@hbiplaw.com By: /Danielle L. Herritt/ Danielle L. Herritt Registration No. 43,670 Attorney for Petitioner 6