Baxter Healthcare Corp. et al. vs Millenium Biologix, LLC

Decision - Petitioner's Request for Rehearing - 37 CFR 42.71

Petitioners Motion for Hearing

Decision - Denying Institution of Inter Partes Review 37 C.F.R. 42.108

Patent Owner's Preliminary Response

Exhibit

Exhibit

Exhibit

Exhibit

Exhibit

Exhibit

Exhibit

Exhibit

Exhibit

Exhibit

Exhibit

Exhibit

Exhibit

Exhibit

Exhibit

Exhibit

Exhibit

Exhibit 2018 pt 1

Exhibit 2018 pt 2

Power of Attorney

Related Matters

Notice of Filing Date Accorded to Petition

Petition for Inter Partes Review

Exhibit List

Power of Attorney

Declaration of Antonios Mikos

Ohgushi, H., et al., Bone formation process in porous calcium carbonate and hydroxyapatite

Ohgushi, H., et al., Repair of bone defects with marrow cells and porous ceramic

Ohgushi, H., et al., Heterotopic Osteogenesis in Porous Ceramics Induced by Marrow Cells

Uchida, A., et al., Growth of bone marrow cells on porous ceramics in vitro

Yoshikawa, T., Self-setting hydroxyapatite cement as a carrier for bone-forming cells

Grundel, R.E., et al., Autogeneic Bone Marrow and Porous Biphasic Calcium Phosphate Ceramic for Segmental Bone Defects in the Canine Ulna

Chaki, T., et al., Densification and strengthening of silver-reinforced hydroxyapatite-matrix composite prepared by sintering

U.S. Patent No. 5,204,319

EP 0353476

U.S. Patent No. 6,585,992

U.S. Patent No. 6,585,992 File History

Curriculum Vitae of Dr. Antonios Mikos

WEBSTER’S THIRD NEW INTERNATIONAL DICTIONARY

U.S. Patent No. RE41,251

U.S. Patent No. RE41,251 File Wrapper

U.S. Patent No. 6,323,146

U.S. Patent No. 6,323,146 File Wrapper

M. Jarcho et al., Hydroxylapatite synthesis and characterization in dense polycrystalline form

A.J. Ruys, A Feasibility Study of Silicon Doping of Hydroxyapatite,

A.J. Ruys & E.R. McCartney, Progress in Developing High-Strength Resorbable Bone Implants

K.S. Leshkivich & E.A. Monroe, Synthetic silicate sulphate apatite: mechanical properties and biocompatibility testing

A.J. Ruys, Silicon-Doped Hydroxyapatite

PCT WO 94/26872

Q. Qiu et al., Bone Growth on Sol-Gel Calcium Phosphate Thin Films in Vitro

PCT WO 97/09286

P. Layrolle et al., Sol-gel synthesis of zinc containing calcium phosphate biomaterials

A. Bigi et al., Isomorphous substitutions in ß-tricalcium phosphate: the different effects of zinc and strontium

L. Hench, Bioactive Ceramics: Theory And Clinical Applications

AN INTRODUCTION TO BIOCERAMICS

E. White & E. Shors, Biomaterial Aspects of Interpore-200 Porous Hydroxyapetite

F.H. Lin et al., Fabrication and biocompatibility of a porous bioglass ceramic in a Na2O-CaO-SiO2-P2O5 system

European Patent Application No. EP 0 267 624 A2

PCT WO 98/08773

U.S. Patent No. 5,306,303

U. Heise et al., Hydroxapatite ceramic as a bone substitute

M. Akao et al., Mechanical properties of sintered hydroxyapatite for prosthetic applications

M. Baslé et al., Osteoclastic Resorption of Ca-P Biomaterials Implanted in Rabbit Bone

A. Bigi et al., Chemical and Structural Characterization of the Mineral Phase from Cortical and Trabecular Bone

N.C. Blumenthal et al., Effect of Carbonate and Biological Macromolecules on Formation and Properties of Hydroxyapatite

L. Boyer, J. Carpena & J.L. Lacout, Synthesis of phosphate-silicate apatites at atmospheric pressure

H.U. Cameron, Tricalcium Phosphate as a Bone Graft Substitute

W. Cao & L.L. Hench, Bioactive Materials

E.M. Carlisle, Silicon: A Possible Factor in Bone Calcification

E.M. Carlisle, Silicon: A Requirement in Bone Formation Independent of Vitamin D1

A.G. Cockbain, The Crystal chemisty of the apatites

J.D. de Bruijn et al., Structural arrangements at the interface between plasma sprayed calcium phosphates and bone

H. Denissen, Ceramic hydroxyapatite implants for the release of bisphosphonate

B. Dickens & W.E. Brown, The Crystal Structure of Ca5(PO4)2SiO4 (Silico-Carnotite)

T.D. Driskell et al., Calcium Phosphate Resorbable Ceramics: A Potential Alternative to Bone Grafting & Current Status of High Density Alumins Ceramic Tooth Root Structures

J.C. Elliott, STRUCTURE AND CHEMISTRY OF THE APATITES AND OTHER CALCIUM ORTHOPHOSPHATES

K. Gomi et al., Resorption of sintered synthetic hydroxyapatite by osteoclasts in vitro

K.A. Hing et al., Mechanical Assessment of Porous Hydroxyapatite Implants Before and After Osseointegration

R. Holmes et al., A Coralline Hydroxyapatite Bone Graft Substitute. Preliminary Report

M. Hott et al., Proliferation and Differentiation of human trabecular osteoblastic cells on hydroxyapatite

M. Jarcho, Calcium Phophate Ceramics as Hard Tissue Prosthetics

L.J. Jha et al., Preparation and characterization of fluoride-substituted apatites

Z. Jianguo & Z. Xingdong, The early host and material response of hydroxyapatite/ß-tricalciumphosphate porous ceramics after implantation into the femur rats

J.J. Klawitter & S.F. Hulbert, Application of Porous Ceramics for the Attachment of Load Bearing Internal Orthopedic Applications

J.J. Klawitter et al., An Evaluation of Bone Growth into Porous High Density Polyethylene

C.P.A.T. Klein et al., A comparative study of different ß-whitlockite ceramics in rabbit cortical bone with regard to their biodegradation behaviour

T. Kobayashi et al., Chin Augmentation with Porous Hydroxyapatite Blocks

T. Kokubo, Surface Chemistry of Bioactive Glass-Ceramics

J.H. Kuhne et al., Bone formation in coralline hydroxyapatite. Effects of pore size studied in rabbits

W.J. Landis et al., Detection and Localization of Silicon and Associated Elements in Vertebrate Bone Tissue by Imaging Ion Microscopy

S. Langstaff et al., Resorbable bioceramics based on stabilized calcium phosphates. Part I: rational design, sample preparation and material characterization

S. Langstaff et al., Resorbable bioceramics based on stabilized calcium phosphates. Part II: evaluation of biological response

R.Z. Legeros et al., Formation and Stability of Apatites: Effects of some Cationic Substituents

R.Z. Legeros & J.P. Legeros, Phosphate Minerals in Human Tissues

R.Z. Legeros et al., Significance of the Porosity and Physical Chemistry of Calcium Phosphate Ceramics. Biodegradation-Bioresorption

R.Z. Legeros et al., Transformation of Calcium Carbonates and Calcium Phosphates to Carbonate Apatites: Possible Mechanism for Phosphorite Formation

J. Lemons, Ceramics: Past, Present, And Future

K.S. Leshkivich & E.A. Monroe, Solubility characteristics of synthetic silicate sulphate apatites

P. Li et al., The role of hydrated silica, titania, and alumina in inducing apatite on implants

R.B. Martin et al., Bone ingrowth and mechanical properties of coralline hydroxyapatite 1 yr after implantation

D. McConnell, The Substitution of SiO4- And SO4-Groups For PO4-Groups in The Apatite Structure; Ellestadite, The End-Member

C.E. Misch & F. Dietsh, Bone-Grafting Materials in Implant Dentistry

M. Miyake et al., Synthesis of Silicon- and Manganese-Substituted Hydroxyapatites and Their Efficacy as Fertilizers

E.A. Monroe et al., New Calcium Phosphate Ceramic Material for Bone and Tooth Implants

C.M. Muller-Mai, Incorporation and Degradation of Hydroxyapatite Implants of Different Surface Roughness and Surface Structure in Bone

G.N. Nancollas, The involvement of calcium phosphates in biological mineralization and demineralization processes

H. Ohgushi, M. Okumura, S. Tamai, E.C. Shors & A.I. Caplan, Marrow cell induced osteogenesis in porous hydroxyapatite and tricalcium phosphate: A comparative histomorphometric study of ectopic bone formation

M. Okumura et al., Osteoblastic Phenotype Expression On The Surface Of Hydroxyapatite Ceramics

S. Ozawa & S. Kasugai, Evaluation of implant materials (hydroxyapatite, glass-ceramics, titanium) in rat bone marrow stromal cell culture

W. Rao & R. Boehm, A Study of Sintered Apatites,

R. Rawlings, Review Paper. Bioactive Glasses and Glass-Ceramics

R. Rouse & P. Dunn, A contribution to the crystal chemistry of ellestadite and the silicate sulfate apatites

P.A. Rubin et al., Comparison of Fibrovascular Ingrowth into Hydroxyapatite and Porous Polyethylene Orbital Implants

A.J. Ruys et al., Sintering effects on the strength of hydroxyapatite

J.D. Santos et al., Liquid phase sintering of hydroxyapatite by phosphate and silicate glass additions: structure and properties of the composites

W. Suchanek et al., Hydroxyapatite ceramics with selected sintering additives

K. Sugiyama & T. Suzuki, Bactericidal Activity of Silicate-containing hydroxyapatite

K. Sugiyama et al., Synthesis and Cation-exchange Characteristics of Silicate-containing Hydroxyapatites

Y. Tanizawa & T. Suzuki, X-Ray Photoelectron Spectroscopy Study on Silicate-Containing Apatite

A.J. Tofe et al., Solution and Cell Mediated Resorption of Grafting Materials

CHARACTERIZATION AND PERFORMANCE OF CALCIUM PHOSPHATE COATINGS FOR IMPLANTS

B.C. Tofield et al., Novel phosphosilicate

A. Uchida et al., The Use of Calcium Hydroxyapatite Ceramic in Bone Tumour Surgery

Z. Yang et al., Osteogenic responses to extraskeletally implanted synthetic porous calcium phosphate ceramics: an early stage histomorphological study in dogs

U.S. Patent No. 4,698,375

U.S. Patent No. 4,097,935

U.S. Patent No. 4,871,578

U.S. Patent No. 4,983,182

U.S. Patent No. 4,988,362

U.S. Patent No. 4,990,163

U.S. Patent No. 4,842,603

U.S. Patent No. 4,869,906

U.S. Patent No. 4,717,556

U.S. Patent No. 4,612,053

U.S. Patent No. 4,629,464

U.S. Patent No. 5,011,495

U.S. Patent No. 5,034,352

U.S. Patent No. 5,149,368

Japanese Patent No. JPH 06277673A

Japanese Patent No. JP 07008550

Japanese Patent No. JP 8165216

Japanese Patent No. JPS 63218580

European Patent Application No. EP 0 360 244 A1

Excerpt of U.S. Provisional Patent Application No. 60/003,157 File Wrapper

Excerpt of U.S. Patent Application. No. 09/601,028 File Wrapper

Excerpt of U.S. Patent Application No. 08/576,238 File Wrapper

Excerpt of U.S. Patent Application No. 09/029,872 File Wrapper

Excerpt of PCT/CA98/00046 File Wrapper

Excerpt of PCT/CA96/00585 File Wrapper

BIOMINERALS

CRC HANDBOOK OF BIOACTIVE CERAMICS VOLUME II CALCIUM PHOSPHATE AND HYDROXYLAPATITE CERAMICS

CHAMBER’S TECHNICAL DICTIONARY

M. Sayer, et al., Structure and Composition of Silicon-Stablized Tricalcium Phosphate

E. Piccinini et al., Ceramic Materials Lead to Underestimated DNA Quantifications: A Method for Reliable Measurements

Stellar Int’l Inc., Annual Report (Form 10-KSB)

STEADMAN’S MEDICAL DICTIONARY

Complaint, Millenium Biologix, LLC v. Baxter Healthcare, et al., 1:13-CV-3084 (USDC for the Northern District of Illinois)