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Filed on Behalf of Ethicon, Inc. Paper No Filed on behalf of Ethicon, Inc. Paper No. ___ By: Dianne B. Elderkin ([email protected]) Date Filed: March 26, 2015 Steven D. Maslowski ([email protected]) AKIN GUMP STRAUSS HAUER & FELD LLP Two Commerce Square 2001 Market Street, Suite 4100 Philadelphia, PA 19103 Tel: (215) 965-1200 Fax: (215) 965-1210 UNITED STATES PATENT AND TRADEMARK OFFICE ________________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ________________ ETHICON, INC. Petitioner v. BAXTER INTERNATIONAL INC. AND BAXTER HEALTHCARE S.A. Patent Owners ________________ Case IPR: Unassigned ________________ PETITION FOR INTER PARTES REVIEW OF UNITED STATES PATENT NO. 6,066,325 TABLE OF CONTENTS I. MANDATORY NOTICES UNDER 37 C.F.R § 42.8(a)(1) ........................... 1 A. Real Party-In-Interest Under 37 C.F.R. § 42.8(b)(1) ................................ 1 B. Related Matters Under 37 C.F.R. § 42.8(b)(2) ......................................... 1 C. Lead and Back-Up Counsel and Service Information .............................. 1 II. PAYMENT OF FEES – 37 C.F.R. § 42.103 ................................................... 2 III. REQUIREMENTS FOR IPR UNDER 37 C.F.R. § 42.104 ............................ 2 A. Grounds for Standing Under § 42.104(a) ................................................. 2 B. Challenge Under § 42.104(b) and Relief Requested ................................ 2 IV. SUMMARY OF THE ’325 PATENT ............................................................. 4 A. Brief Description ....................................................................................... 4 B. Summary of the Prosecution History of the ’325 Patent .......................... 5 C. State of the Art at the Time of the Alleged Invention Claimed in the ’325 Patent ................................................................................................ 5 V. CLAIM CONSTRUCTION UNDER 37 C.F.R. §§ 42.104(b)(3) .................. 7 A. “Fragmented” (claims 1-8) ....................................................................... 7 B. “Hydrogel,” “gel” (claims 1-8) ................................................................. 8 C. “Partially hydrated” and “fully hydrated” (claims 1-8) ............................ 9 D. “Substantially free from an aqueous phase” (claims 1-8) ..................... 10 E. “Subunit size in the range from 0.01 mm to 5 mm when fully hydrated” (claims 1-8) ............................................................................................. 11 F. “Equilibrium swell” (claims 1-8) ........................................................... 12 G. “Active agent” (claims 3-8) .................................................................... 13 VI. EVERY CLAIM OF THE ’325 PATENT FOR WHICH IPR IS REQUESTED IS UNPATENTABLE ........................................................... 14 A. Ground 1: Ikada Anticipates Claims 1-3, and 6 ..................................... 15 1. Ikada Anticipates Claim 1 ............................................................. 19 2. Ikada Anticipates Claim 2 ............................................................. 26 3. Ikada Anticipates Claim 3 ............................................................. 26 4. Ikada Anticipates Claim 6 ............................................................. 27 B. Ground 2: Sakamoto in View of Schramm Renders Obvious Claims 1-8 27 1. Motivation to Combine Sakamoto and Schramm ......................... 31 2. Sakamoto in View of Schramm Renders Claim 1 Obvious .......... 34 3. Sakamoto in View of Schramm Renders Claim 2 Obvious .......... 41 i 4. Sakamoto in View of Schramm Renders Claims 3, 4, and 5 Obvious ......................................................................................... 42 5. Sakamoto in View of Schramm Renders Claim 6 Obvious .......... 43 6. Sakamoto in View of Schramm Renders Claim 7 Obvious .......... 43 7. Sakamoto in View of Schramm Renders Claim 8 Obvious .......... 44 C. Ground 3: Ikada in view of Sakamoto Renders Obvious Claims 1-8 .... 45 1. Motivation to Combine Ikada and Sakamoto ................................ 45 1. Ikada in View of Sakamoto Renders Claim 1 Obvious ................ 47 2. Ikada in View of Sakamoto Renders Claim 2 Obvious ................ 53 3. Ikada in View of Sakamoto Renders Claim 3 Obvious ................ 53 4. Ikada in View of Sakamoto Renders Claims 4 and 5 Obvious ..... 54 5. Ikada in View of Sakamoto Renders Claim 6 Obvious ................ 55 6. Ikada in View of Sakamoto Renders Claim 7 Obvious ................ 56 7. Ikada in View of Sakamoto Renders Claim 8 Obvious ................ 56 VII. SECONDARY CONSIDERATIONS ........................................................... 57 VIII. CONCLUSION .............................................................................................. 60 ii LIST OF EXHIBITS Ethicon Exhibit Description No. Ex. 1001 U.S. Patent Number 6,066,325 to Wallace et al. (the “’325 Patent”) Ex. 1002 Excerpts from the Prosecution History of the ’325 Patent (the “Prosecution History”) Ex. 1003 Declaration of Dr. David J. Mooney Ex. 1004 Curriculum Vitae of Dr. David J. Mooney Ex. 1005 U.S. Patent Number 6,831,058 to Ikada et al. (“Ikada”) Ex. 1006 EP Publication No. EP 0 172 710 to Sakamoto et al. (“Sakamoto”) Ex. 1007 Schramm, V.L., Lavorato, A. S., Gelfoam Paste Injec- tion for Vocal Cord Paralysis: Temporary Rehabilitation of Glottic Incompetence, The Laryngoscope 88:1978 (“Schramm”) Ex. 1008 Cantor and Reynolds, Gelfoam and Thrombin in Gas- troduodenal Bleeding, J. Lab. Clinical Medicine 35:890- 893 (1950) (“Cantor”) Ex. 1009 Krill et al., Topical Thorombin and Powered Gelfoam: An Efficient Hemostatic Treatment for Surgery, Journal of Tennesee Dental Association 66(2):26-27 (1986) (“Krill”) Ex. 1010 Guinto, Preparation of Gelfoam Particles Using and Or- thopedic Rasp, Radiology 153:260 (1984) (“Guinto”) Ex. 1011 U.S. Patent Number 3,896,815 to Fettel et al. (the “’815 Patent) Ex. 1012 Peppas and Barr-Howell, Chapter 2: Characterization of the Cross-Linked Structure of Hydrogels, from Hydro- gels in Medicine and Pharmacy, Vol. I: Fundamentals, 1987 (“Peppas”) Ex. 1013 Lewis et al., Comparison of Two Gelatin and Thrombin Combination Hemostats in a Porcine Liver Abrasion Model, Journal of Investigative Surgery, Early Online 2013 (“Lewis”) iii Ex. 1014 Sakurabayashi. S. et al., Clinical Evaluation of a New Hemostatic Agent for Liver Biopsy, Fourth Dept. of In- ternal Medicine Tokyo Medical College, 30(10):2249- 2256 (1988) (in English (“Sakurabayashi”) Ex. 1015 Sakurabayashi. S. et al., Clinical Evaluation of a New Hemostatic Agent for Liver Biopsy, Fourth Dept. of In- ternal Medicine Tokyo Medical College, 30(10):2249- 2256 (1988) (in Japanese) (“Sakurabayashi”) Ex. 1016 Flory, P., “Phase Equilibria,” Principles of Polymer Chemistry, Cornell University Press, (1953) (“Flory”) Ex. 1017 Gelfoam® Plus - Powder Hemostasis Kit Instructions for Use Ex. 1018 Herndon, J., et al. Compression of the Brain and Spinal Cord Following Use of Gelfoam, Archives of Surgery, Vol. 104:107 (Jan. 1972) (“Herndon”) Ex. 1019 Antalek, B. Magnetic Resonance Imaging Studies of the Behavior of Fluids in Gelatin and Other Porous Ma- terials. Thesis. Submitted to the Graduate School of the Rochester Institute of Technology, Rochester, NY (Feb. 1991) Ex. 1020 Franks, F., ed., Water, a Comprehensive Treatise, Vol- ume 1, Introduction. (Plenum Press, NY 1972) Ex. 1021 Notice of a Lawsuit and Waiver of Summons executed by Ethicon Inc. in the matter of Baxter International Inc., et al. v. Johnson & Johnson, et al., Civil Action No. 1:14cv00498, N.D. Ill. Ex. 1022 Notice of a Lawsuit and Waiver of Summons executed by Johnson & Johnson in the matter of Baxter Interna- tional Inc., et al. v. Johnson & Johnson, et al., Civil Ac- tion No. 1:14cv00498, N.D. Ill. Ex. 1023 Notice of Institution of ITC Investigation, 337-TA-913 Ex. 1024 Complaint of Baxter International Inc., Baxter Healthcare Corporation, and Baxter Healthcare SA Un- der Section 337 of the Tariff Act of 1930, As Amended, 337-TA-913 iv Ethicon, Inc. (“Petitioner” or “Ethicon”) petitions for Inter Partes Review (“IPR”) under 35 U.S.C. §§ 311–319 and 37 C.F.R. § 42 of claims 1-8 (“the Chal- lenged Claims”) of U.S. Patent No. 6,066,325 (the “’325 Patent”). As explained below, there exists a reasonable likelihood that Petitioner will prevail in demon- strating unpatentability of at least one Challenged Claim based on teachings set forth in the references presented in this petition. I. MANDATORY NOTICES UNDER 37 C.F.R § 42.8(a)(1) A. Real Party-In-Interest Under 37 C.F.R. § 42.8(b)(1) Ethicon is a real party-in-interest. Ethicon is a wholly-owned subsidiary of Johnson & Johnson (“J&J”), which is also a real party-in-interest. B. Related Matters Under 37 C.F.R. § 42.8(b)(2) Petitioner is not aware of any disclaimers, reexamination certificates or peti- tions for IPR for the ’325 Patent. The ’325 Patent is the subject of Civil Action Number 1:14-cv-00498 (N.D. Ill.) filed on January 23, 2014 (the “District Court Action”) (currently stayed), and U.S. International Trade Commission Investiga- tion No. 337-TA-913 filed on February 28, 2014 (the “ITC Action”). C. Lead and Back-Up Counsel and Service Information Petitioner designates Dianne B. Elderkin, Reg. No. 28,598, as Lead Counsel and Steven D. Maslowski, Reg. No. 46,905, as Backup Counsel, both available at Two Commerce Square, 2001 Market Street, Suite 4100, Philadelphia, PA 19103 (T: 215.965.1200; F: 215.965.1210), or electronically by email at ETHI- 1 [email protected]. II. PAYMENT OF
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