Multi-layered polymer based thin film structure for medical grade products

EP 0 680 401 B1 1/1999 EP 0 709 105 B1 12/2001 FR 2688511 9/1993 GB 2 131 739 A 6/1984 GB 2 177 974 A 2/1987 JP 03-095286 4/1991 JP 05-277154 10/1993 JP 11-071554 3/1999 WO 83/00158 A1 1/1983 WO 86/07010 A1 1/1986 WO 93/23093 A1 11/1993 WO 97/08054 A1 3/1997 WO 98/27926 A1 7/1998 WO 98/44043 A1 10/1998 WO 99/15289 A2 4/1999 WO 99/48990 A1 9/1999

OTHER PUBLICATIONS

Irvine Scientific, Data Sheet: “Tissue Culture Products, Media Manager® Product Line”, 1 pg., undated. Mediatech, Inc., Brochure: “Mediatech Flexible Packaging Systems. Media Bags—Cellgro®”, 8 pgs., undated. Mediatech, Inc., website printout: “Cellgro® Flexible Packaging by Mediatech, Inc.: Mediatech Flexible Packaging Systems, Media Bags, Taking Bags to the 21“ Century”, wvvw.cellgro.com/cellgro13.cfm, 2 pgs., Feb. 10, 2000. Mediatech, Inc., website printout: “Cellgro® Antibiotics by Mediatech, Inc.: Cellgro® Flexible Collection Containers and Totes”, wvvw.cellgro.com/cellgro9.cfm, 1 pg., Feb. 10, 2000.

JRH Biosciences, Inc., Brochure “When it comes to bulk liquid customization, Nobody configures better.” Aug. 1999, 4 pgs.

BioWhittaker, Inc., Brochure “The UltraPakTM Liquid Transfer System”, May 1997, 4 pgs.

Sigma-Aldrich, Brochure “Bulk Liquid Packaging”, 4 pgs., undated.

Sigma-Aldrich, Brochure “Custom Product Capabilities”, 4 pgs., undated.

Wave Biotech LLC, Catalog “Wave Bioreactor® System 20” and price list, 10 pgs., Jan. 2000.

Genetic Engineering News, “BioProcess Tutorial, Novel Disposable Bioreactor”, vol. 19, No. 5, Mar. 1, 1999, 4 pgs. Wave Biotech LLC, “Disposable Cell Culture Technology: Wave Bioreactor”, 4 pgs., undated.

Wave Biotech LLC, datasheets/website printouts, Jan. 6, 2000, 10 pgs.

American Fluoroseal Corporation, website printouts, wvvw. teflonbag.com, Feb. 11, 2000, 11 pgs.

Ethox Corp., Datasheet, “Etho-Guard: High Gas Barrier Media Bag”, 5 pgs., undated.

Ethox Corp., catalog “Contract Manufacturing, Sterilization, & Microbiology Services”, 8 pgs., undated.

Ethox Corp., website printouts, wvvw.ethoxcorp.com, EthoGuardTM High Gas Barrir Media Bag (1 pg.); “SteriCell® Culture Containers” (1 pg.); Ethox Corp. Home Page (1 pg.). Nexell Inc., website printout, wvvw.nexellinc.com, “Innovative Programs to Secure Nexell’s Future”, Jan. 27, 2000, 2 pgs.

FMI, Inc. Datasheets “Integrated Biotech Systems Design” (1 pg.); “Flexible Barrier Containers” (1 pg.); “IntaseptTM Superior Aseptic Transfer Technology” (1 pg.); “Manufacturing & Assembly Clean Room Facility” (1 pg.); Aug. 1997.

FMI, Inc., website printouts, www.fmi-inc.com, 3 pgs. Feb. 7, 2000.

Newport Biosystems Inc., catalog “Cleanroom in a Bag!”, 2 pgs., undated.

Newport Biosystem Inc., website printout wvvw.bioweb.net., “Biobag Product List”, 2 pgs., Feb. 3, 2000.

Charter Medical, Ltd., website printouts www.chartermed. com, Biopharmaceutical Products Division, 14 pgs., Jan. 29, 2000.

TC Tech Corporation, Catalog “Single Use Containers for Fluid Storage”, 8 pgs., undated.

TC Tech Corporation, Catalog “SiCulture: The New Cell Culture Alternative”, 4 pgs., Mar. 1999.

TC Tech Corporation Flyer #1.1 “Silicon Bag For Production-Scale Inoculations” (1 pg.); Tech Flyer #1.2 “Bag Comparison Study” (1 pg.); Tech Flyer #2.1 “Silicone Bag for Recombinant Protein Production” (1 pg.); Tech Flyer #3.0 “Cost to Produce Analysis using the SiCultureTM Silicone Bag”(1 pg.); Tech Flyer #4.0 “Cell Attachment Study with Surface-Modified SiCulture Bags” (1 pg.); undated. TC Tech Corporation Product Insert “SiCultureTM Silicone Cell Culture Growth Bag”, 2 pgs., undated.

TC Tech Corporation, website printouts, www.tc-tech.com “SiCultureTM Cell culture bags” (2 pgs.), “Nalgene Tank Liners” (3 pgs.); Company profile (1 pg.); Flexible Media Storage Bags (1 pg.); “Cell Culture Media Bags” (2 pgs.); Jan. 24, 2000.

HyClone, catalog “Bioprocess Container Systems: Standard and Custom Engineering”, 8 pgs., undated.

HyClone, advertisement “Introducing the clear _”, 3 pgs., undated.

HyClone “Complete Mixing Resuspension System”, 4 pgs., undated.

HyClone “Liquid Media: Solutions in Large and Small Volume Liquid Media”, 12 pgs., undated.

HyClone, website printout www.hyclone.com, “Bioprocess Containers”, 9 pgs., undated.

Aastrom Biosciences Inc., advertisement “Pioneering Clinical Systems for Cell Therapy”, 1 pg. undated.

LJL Biosystems, advertisement, 1 pg. undated.

Stedim, advertisement, “From Drug Discovery to Drug Delivery”, 4 pgs. undated.

Stedim datasheet “Stedim 30 Film Flexel Tank Liners”, 2 pgs. undated.

Stedim, website printout www.stedim.com, “Biopharmaceutical Products” (1 pg.); Flexel 3-D Bag Customization (2 pgs.); Product Reference Sheet: Palletank (1 pg.); Flexboy Customization (2 pgs.); Jan. 1, 2000.

Stedim catalog “Flexel Tank Liners”, 6 pg. undated. Stedim catalog “The FLEXBOY System”, 8 pgs. undated. Stedim, catalog “The FLEXEL 3-D System”, 22 pgs., undated.

Stedim catalog “A new Generation of Bio-Compatible Containers”, 14 pgs., 2000.

Stedim catalog “Your Quality Resource for Standard and Custom I.V. Component Parts”, 15 pg. 2000.

Stedim Contract Manufacturing “Advance Technologies for I.V. Drug Delivery”, 11 pgs., 1998.