Blood separating device

The American Journal of Surgery, vol. 168, pp. 120-122, Aug. 1994, Roy L. Tawes, Jr., M.D., et al., “Autologous Fibrin Glue: The Last Step in Operative Hemostatis”.

The American Surgeon, vol. 55, pp. 166-168, Mar. 1989, William D. Spotnitz, M.D., et al., “Successful Use ofFibrin Glue During 2Years of Surgery at a University Medical Center”.

VortechTM Concentration System, “Do you want a sticky gel to improve the handling of your bone graft?, Platelet Rich Plasma Concentrate, High Volume in 5 Minutes,” Biomet Biologics, Inc., Aug. 2005.

Vox Sanquinis, vol. 68: 82-89, 02/95, Boomgaard Et. al, Pooled Platelet Concentration Prepred by the . . . .

Weis-Fogh, U. S. “Fibrinogen prepared from small blood samples for autologous use in a tissue adhesive system.” Eur Surg Res 20 (5-6 1988): 381-9.

Wiseman, David M., David T. Rovee, and Oscar M. Alverez. “Wound Dressings: Design and Use.” In Wound Healing.‘ Biochemical & Clinical Aspects,ed. I. Kelman Cohen, Robert F. Diegelmann, and William J. Lindblad. 562-580. 1st ed., Vol. Philadelphia: W. B. Saunders Company, 1992).

International Search Report and Written Opinion for PCT/US2006/ 003599 mailed Aug. 21, 2006.

International Search Report and Written Opinion for PCT/US2006/ 003597 mailed Feb. 6, 2006.

“Cell Isolation Techniques, Methods and Materials, Working with Enzymes,” (2004) (9 pages) Worthington Biochemical Corp.

“Cell Isolation Theory, Tissue Types,” (2004) (5 pages) Worthington Biochemical Corp.

“Cytori Celution Cell Concentrate Device,” Exhibit 14, 510(k) Summary, FDA approval K060482 (Sep. 28, 2006).

“Frequently Asked Questions, 1. Kits, 2. Engzymes,” (2003) 3 pages Worthington Biochemical Corp.

“Sefar Solutions for the Healthcare Industry,” brochure (2003) 9 pages Sefar Medifab®.

“Trypsinization of Adherent Cells,” (undated) 2 pages.

DeUgarte, M.D., Daniel A., et al., “Future of Fat as Raw Material for Tissue Regneration,” (2007) pp. 215-219, Lippincott Williams & Wilkins, Inc.

DiMuzio, Paul et al., “Development of a Tissue-Engineered Bypass Graft Seeded with Stem Cells,” Vasucular, vol. 14, No. 6, (2006) pp. 338-342, BC Decker, Inc.

Frasier, John K., et al ., “Plasticity of human adipose stem cells toward endotl1elial cells and cardiomyocytes,” Nature Clinical Practice Cardiovascular Medicine, vol. 3, Supplement 1 (Mar. 2006) pp. S33-S37. Gimble, Jeffrey M., “Adipose-Derived Stem Cells for Regenerative Medicine,” Circulation Research (2007) pp. 1249-1260, American Heart Association, Inc.

Gomillion, Cheryl T., et al., “Stem cells and adipose tissue engineering,” Biomaterials 27, Science Direct (2006) pp. 6052-6063, Elsevier.

GPS® III System, GPS® III Platelet Separation System, Leadership through Technology, brochure, Jul. 2007 (8 sheets) .

GPS® System, “GPS® Platelet Concentrate System,” Cell Factor Technologies, Inc., Biomet Orthopaedics, Inc., (2004) (9 pages). GPS® System, “Shoulder Recovery with the GPS® Platelet Concentrate System, Rotator Cuff Surgical Techniques,” brochure, Cell Factor Technologies, Inc., Biomet Orthopaedics, Inc., (2004) 6 pages. GPS® System, “Shoulder Recovery with the GPS® Platelet Concentrate System, Rotator Cuff Surgical Techniques,” Cell Factor Technologies, Inc., Biomet Orthopaedics, Inc., (2004) 3 pages, http:// www.cellfactortech.com/globaliproductscfm, printed Sep. 16, 2005.

GPS® II System, Gravitational Platelet Separation System, “Accelerating the Body’s Natural Healing Process,” Cell Factor Technologies, Inc., Biomet Europe (2005) 16 pages, http://www. cellfactortech.com/globaliproductscfm, printed Sep. 16, 2005. GPS® II System, Gravitational Platelet Separation System, “User Manual,” Cell Factor Technologies, Inc., Biomet Europe [date unknown] 13 pages, http://www.cellfactortech.com/globaliproducts.cfm, printed Sep. 16, 2005.

Guilak, Frank, et al., “Adipose-derived adult stem cells for cartilage tissue engineering,” Biorheology 41 (2004) pp. 389-399, IOS Press.

Hattori, et al., “Osteogenic Potential of Human Adipose TissueDerived Stromal Cells as an Alternative Stem Cell Source,” Cells Tissues Organs (2004) 178:2-12 Karger.

International Search Report and Written Opinion mailed Jul. 3, 2009 for PCT/US2009/035564 claiming benefit of U.S. Appl. No. 61/078,178, filed Jul. 3, 2008.

Lendeckel, Stefan, et al., “Autologous stem cells (adipose) and fibrin glue used to treat widespread traumatic calvarial defects: case report,” Journal of Cranio-Maxillofacial Surgery (2004) European Association for Cranio-Maxillofacial Surgery.

MarrowstimTM Concentration System, (2008) 20 pages Biomet Biologics, Inc.

Nakagami, Hironori, et al., “Novel Autologous Cell Tehrapy in Ischemic Limb Disease Through Growth Factor Secretion by Cultured Adipose Tissue-Derived Stromal Cells,” Angiogenesis by Adipose Tissue-Derived Cells, (2005) pp. 2542-2547, American Heart Association, Inc.

Nathan, Suresh et al., “Cell-Based Therapy in the Repair of Osteochondral Defects: A Novel Use for Adipose Tissue,” Tissue Engineering, vol. 9, No. 4 (2003) pp. 733-744 MaryAnn Liebert, Inc. Parker, Anna M., et al., Adipose-derived stem cells for the regeneration of damaged tissues, Expert Opinion, Cell- & Tissue-based Therapy, Expert Opin. Biol. Ther. (2006) pp. 567-578 Informa UK Ltd.

Planat-Bénard, V., et al., “Spontaneous Cardiomyocyte Differentiation From Adipose Tissue Stroma Cells,” Adipose-Derived Cell Cardiomyocyte (2004) pp. 223 -229 American Heart Association, Inc. PlasmaxTM Plasma Concentrate, brochure (2006) 5 pages Biomet Biologics, Inc.

Rangappa, Sunil, M.D., “Transformation of Adult Mesenchyrnal Stem Cells Isolated From the Fatty Tissue Into Cardiomyocytes,” Adult Stem Cells Transformed into Cardiomyoctyes, (2003) pp. 775779 Ann Thorac Surg.

Rigotti, M.D., et al, “Clinical Treatment of Radiotherapy Tissue Damage by Lipoaspirate Transplant: A Healing Process Mediated by Adipose-Derived Adult Stem Cells,” Plastic and Reconstructive Surgery, Breast, PRS Journal vol. 119, No. 5, Stem Cell Therapy for Angiogenesis, (Pub. 2005) pp. 1409-1422.

Rubin, M.D., et al, “Clinical Treatment of Radiotherapy Tissue Damage by Lipoaspirate Transplant: A Healing Process Mediated by Adipose-Derived Adult Stem Cells,” Plastic and Reconstructive Surgery, Discussion vol. 119, No. 5, Stem Cell Therapy for Angiogenesis, (2007) pp. 1423-1424.

Schaffler, Andreas, et al., “Concise Review: Adipose Tissue-Derived Stromal CellsiBasic and Clinical Implications for Novel CellBased Therapies,” Tissue-Specific Stem Cells, Stem Cells® (2007) pp. 818-827 AlphaMed Press.

Sigma-Aldrich® Alkaline Phosphatase (Procedure No. 85), drug fact sheet, (2003) pp. 1-2, Sigma-Aldrich, Inc.

Takahashi, Kazutoshi et al., “Induction of Pluripotent Stem Cells from Adult Human Fibroblasts by Defined Factors,” Cell, (2007) pp. 1-12, Elsevier Inc.

Yoon, Eulsik, M.D., Ph.D., et al., “In Vivo Osteogenic Potential of Human Adipo se-Derived Stem Cells/ Poly Lactide-Co -Glycolic Acid Constructs for Bone Regneration in a Rat Critical-Sized Calvarial Defect Model,” Tissue Engineering, vol. 13, No. 3 (2007) pp. 619627 Mary Ann Liebert, Inc.

Zhang, Duan-zhen, et al., “Transplantation of autologous adiposederived stem cells ameliorates cardiac function in rabbits with myocardial infarction,” Chinese Medical Journal, vol. 120, No. 4 (2007) pp. 300-307 General Hospital of Shenyang Military Region, Shenyang, China.

Zuk, Patricia A., Ph.D., “Multilineage Cells from Human Adipose Tissue: Implications for Cell-Based Therapies,” Tissue Engineering, vol. 7, No. 2, (2001) pp. 211-228 MaryAnn Liebert, Inc.

* cited by examiner

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