UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD. BIODELIVERY SCIENCES INTERNATIONAL, INC.

Transcription

1 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 IPR / Case IPR / Case IPR 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.

2 LIST OF EXHIBITS Exhibit Ex Ex Ex Ex Ex Ex 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 (EDNC) Corrected Declaration of Edward Cohen, Ph.D. (Cohen Dec.) Ex Ex Ex Ex Ex Ex [*There are three different Exhibit 1007s. IPR , IPR , and IPR 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, (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 Excerpts from MERRIAM-WEBSTER S COLLEGIATE DICTIONARY, (10 th ed. 2000) Ex Excerpt from PHYSICIANS DESK REFERENCE (56 th ed. 2002) Ex Excerpt from Ferry, J. D., VISCOELASTIC PROPERTIES OF POLYMERS, John Wiley & Sons, Inc. (3rd ed. 1980) Ex December 31, 2013 Amendment and Response, Excerpt from File History of 167 patent ( 167 History, Amendment and Response 12/31/13) 2

3 Exhibit Ex Case Nos. IPR , IPR , IPR November 19, 2013 Interview Summary, Excerpt from File History of 167 patent ( 167 History, Interview Summary 11/19/13) Ex July 31, 2013 Office Action, Excerpt from File History of 167 patent ( 167 History, Office Action 7/31/13) Ex July 8, 2013 Reply to Office Action, Excerpt from File History 167 patent ( 167 History, Reply 7/8/13) Ex April 8, 2013 Office Action, Excerpt from File History of 167 patent ( 167 History, Office Action 4/8/13) Ex May 2, 2012 Amendment and Response, Excerpt from File History 167 patent ( 167 History, Amendment and Response 5/2/12) Ex November 2, 2011 Office Action, Excerpt from File History of 167 Ex Ex Ex Ex 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 ( 588 Decision) Ex Excerpt from June 24, 2013 Patent Owner Appeal Brief, 588 patent reexamination, Control No. 95/001,753 Ex Jan. 23, 2013 Right of Appeal Notice, 588 patent reexamination, Control No. 95/001,753 ( 588 History, RAN) Ex US Patent No. 7,897,080 (the 080 patent) Ex July 31, 2013 Action Closing Prosecution, 080 patent reexamination, Control No. 95/002,170 ( 080 History, ACP) Ex December 6, 2013, Right of Appeal Notice, 080 patent reexamination, Control No. 95/002,170 ( 080 History, RAN) Ex US Patent No. 7,666,337 (the 337 patent) Ex December 17, 2013 Right of Appeal Notice, 337 patent reexamination, Control No. 95/002,171 ( 337 History, RAN) Ex US Patent No. 7,425,292 (the 292 patent) Ex Ex Parte Reexamination Certificate for US Patent No. 7,425,292 Ex US Patent No. 7,357,891 (the 891 patent) Ex Ex Parte Reexamination Certificate for US Patent No. 7,357,891 Ex US Patent No. 8,652,378 (the 378 patent) 3

4 Exhibit Ex Transcript of Mar. 26, 2014 Oral Hearing on Appeal of 588 patent reexamination, Control No. 95/001,753, Appeal ( 588 History, Hearing Transcript) Ex Electronic Comparison of Specifications of the 167 Patent and the 588 Patent Ex Trademark Registration No. 1,107,737 for VICODIN Ex Status of Trademark Registration No. 1,107,737 for VICODIN (2008) Ex Package Insert for VICODIN (2014) Ex Coating Technology Handbook, D. Satas (ed.), Marcel Dekker, Inc. (1991) ( Coating Technology ) Ex U.S. Patent No. 2,681,294 issued June 15, 1954 (the 1954 Kodak patent ) Ex Corrected Declaration of Maureen Reitman, Sc.D. (Reitman Dec.) Ex Affidavit Of Ms. Wyley S. Proctor in Support of Motion for Pro Hac Vice Admission Ex Mil to Micron (mil to µm) Length or Distance Conversion Table, downloaded from < on October 23, 2015 and marked as Deposition Exhibit No in October 26, 2015 Deposition of Dr. Joseph W. Wyse Ex 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 and also marked as Deposition Exhibit No in October 29, 2015 Deposition of Mr. Garry Myers Ex Garry Myers LinkedIn Profile, downloaded from < on September 28, 2015 and marked as Deposition Exhibit No in October 29, 2015 Deposition of Mr. Garry Myers Ex US Patent No. 4,136,145 (Fuchs) Ex Mr. Garry Myers Deposition Transcript dated October 29, 2015 Ex Dr. Joseph W. Wyse Deposition Transcript dated October 26, 2015 Ex Sigma-Aldrich Estradiol Product Information Ex Mar. 27, 2015 Decision on Appeal of 080 patent inter partes reexamination, Control No. 95/002,170 ( 080 Decision) Ex Mar. 27, 2015 Decision on Appeal of 337 patent inter partes reexamination, Control No. 95/002,171 ( 337 Decision) Ex Declaration of Edith Mathiowitz, Ph.D. (Mathiowitz Dec.) 4

5 Exhibit Ex Curriculum Vitae of Edith Mathiowitz, Ph.D. Ex Declaration of Philip T. Lavin, Ph.D. (Lavin Dec.) Ex Curriculum Vitae of Philip T. Lavin, Ph.D. Ex US Patent No. 8,663,687 (the 687 Patent) Ex US Patent No. 5,629,003 (Horstmann) Ex US Patent No. 5,948,430 (Zerbe) Ex US Patent No. 4,849,246 (Schmidt) Ex Transcript of Teleconference held October 29, 2015 Ex Testimony of Robert Langer, November 4, 2015 (excerpts) Ex Expunged Ex 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

6 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 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 dscola@hbiplaw.com mchakansky@hbiplaw.com 165ipr@hbiplaw.com By: /Danielle L. Herritt/ Danielle L. Herritt Registration No. 43,670 Attorney for Petitioner 6