Vifor (International) AG et al. vs Biofer, S.p.A.

Institution Decision: DECISION Denying Institution of Inter Partes Review 35 U.S.C. § 314

Patent Owner's Preliminary Response

Ex. 2001 2022.10.06 (DKT 027) Biofer v Vifor - Rule 26f Report Filing

Ex. 2002 2022.09.21 (DKT 025) Letter to Judge Donnelly re Status update pursuant to Courts Request at the 8-31-2022 Hearing Minutes

Ex. 2003 2022.11.04 Response to Vifor's 1st set of RFPs (Nos 1-56)

Ex. 2004 2022.11.04 Response to Vifor's 1st set of Rogs (Nos 1-6)

Ex. 2005 2022-11-03 Vifor Objections and Responses to Biofer 1st RFPs (Nos. 1-2)

Ex. 2006 2022-11-03 Vifor's Objections and Responses to Biofer First Set of Rogs (Nos. 1-4)

Ex. 2007 2022-11-03 Vifor Objections and Responses to Biofer First Set of RFAs (Nos. 1-3)

Ex. 2008 2023.01.12 Biofer Second Set of RFPs (Nos. 3-50)

Ex. 2009 2022.12.02 [DKT 033] Biofer Letter MOTION to Compel (EDNY 22-cv-02180)

Ex. 2010 2022.08.31 Biofer v Vifor - Proceeding Transcript (Minu)

Notice: acceptance corrected petition

Exhibit 3001

Petitioner's Certificate of Service of (Corrected) Exhibits to Petition

U.S. Patent No. 8,759,320 to Sacchi et al.

Declaration of Jeffrey D. Winkler, Ph.D.

Curriculum Vitae of Dr. Jeffrey D. Winkler

Certified Prosecution History of the ’320 Patent

PCT Application No. WO 2004/037865

PCT Application No. WO 2004/037865 (certified translation)

U.S. Patent No. 1,648,368 to Stoll et al.

Canadian Patent Application No. 2,195,283

G. MARC LOUDON, ORGANIC CHEMISTRY (3d ed. 1995)

PCT App. No. WO 97/17,377 to Monte et al.

U.S. Patent No. 5,326,864 to Besemer et al.

Arie C. Besemer et al., Dicarboxy-Starch by Sodium Hypochlorite/Bromide Oxidation and its Calcium Binding Properties, 46 STARCH 95 (1994)

Arie C. Besemer et al., The Catalytic Effect of Bromide in the Hypochlorite Oxidation of Linear Dextrins and Inulin, 46 STARCH 101 (1994)

U.S. Patent No. 3,821,192 to Montgomery et al.

U.S. Patent No. 7,612,109 to Geisser et al.

Ray Yip, Iron Deficiency: Contemporary Scientific Issues and International Programmatic Approaches, 124 (8 Supp.) J. NUTRITION 1479S (1994)

Bo G. Danielson, Structure, Chemistry, and Pharmacokinetics of Intravenous Iron Agents, 15 J. AM. SOC. NEPHROL. S93 (2004)

Bo G. Danielson et al., Pharmacokinetics of Iron(III)-Hydroxide Sucrose Complex after a Single Intravenous Dose in Healthy Volunteers, 46 ARZNEIM.-FORSCH./DRUG RES. 615 (1996)

Sodium Hypochlorite, ENCYCLOPEDIA OF REAGENTS FOR ORGANIC SYNTHESIS 4580 (Leo A. Paquette ed., 7th ed. 1995)

HAWLEY’S CONDENSED CHEMICAL DICTIONARY (Richard J. Lewis ed., 13th ed. 1997)

LAURENCE M. HARWOOD ET AL., EXPERIMENTAL ORGANIC CHEMISTRY (1st ed. 1989)

Ladislaus Farkas et al., Analysis of Hypochlorite-Hypobromite Solutions, 19 ANAL. CHEM. 662 (1947)

Christopher S. Foote et al., Chemistry of Singlet Oxygen, 46 TETRAHEDRON LETTERS 4111 (1965)

Bromine Material Data Safety Sheet (Rev. Nov. 2001)

I. Ziderman, Variations in the Composition of Bromine Water During Oxidation Reactions, 11 (1) ISR. J. CHEM. 7 (1973)

Complaint, Biofer S.p.A. v. Vifor (International) AG., C.A. No. 1:22-cv-02180-AMD-SJB, D.I. 1 (E.D.N.Y. Apr. 15, 2022)

Josefinal Palou, Oxidation of Some Organic Compounds by Aqueous Bromine Solutions, 5 CHEM. SOC. REV. 357 (1994)

Table N/A—U.S. District Courts–Combined Civil and Criminal Federal Court Management Statistics (June 30, 2022), UNITED STATES COURTS,

Vifor’s Letter Request for Pre-Motion Conference, Biofer S.p.A. v. Vifor (International) AG., C.A. No. 1:22-cv-02180-AMD-SJB, D.I. 12 (E.D.N.Y. July 12, 2022)

Biofer’s Opposition Letter to Request for Pre-Motion Conference, Biofer S.p.A. v. Vifor (International) AG., C.A. No. 1:22-cv-02180-AMD-SJB, D.I. 16 (E.D.N.Y. July 19, 2022)

Order Granting Motion for Pre-Motion Conference, Biofer S.p.A. v. Vifor (International) AG., C.A. No. 1:22-cv-02180-AMD-SJB, (E.D.N.Y. July 27, 2022)

Motion Pursuant to Articles 696 bis Civil Procedure Code and 128 IP Code, Biofer S.p.A. v. Vifor International AG et al., Docket No. 22680/2022 (Court of Milan July 25, 2022) (certified translation)

U.S. Patent App. Pub. No. 2003/0136941 A1

Gadi Rothernberg et al., Vanadium-Catalysed Oxidative Bromination Using Dilute Mineral Acids and Hydrogen Peroxide:  An Option for Recycling Waste Acid Streams, 4 ORG. PROC. RES. DEV. 270 (2000)

Mario G. Clerici et al., Oxidation reactions with in situ generated oxidants, 41 CATALYSIS TODAY 351 (1998)

Alan D. McNaught, IUPAC Nomenclature of Carbohydrates, 68 PURE & APPL. CHEM. 1919 (1996)

G.P. Moss et al., Glossary of Class Names of Organic Compounds and Reactive Intermediates Based on Structure, 67 PURE & APPL. CHEM. 1307 (1995)

FRANK BARRESI ET AL., Maltooligosaccharides from corn, in OLIGOSACCHARIDES IN FOOD AND AGRICULTURE 182 (ACS Symposium Series, 2003)

Matthew J. Mollan et al., Maltodextrin, 24 ANAL. PROFILES OF DRUG SUBSTANCES & EXCIPIENTS 307 (1996)

Herbert H. Bunzel et al., The Mechanism of the Oxidation of Glucose by Bromine in Neutral and Acid Solutions, 31 J. AM. CHEM. SOC. 464 (1909)

Herbert H. Bunzel et al., The Mechanism of the Oxidation of Glucose by Bromine, 7 J. BIOL. CHEM. 157 (1910)

Clinton M. Kelley et al., On the System: Bromine-Water, 78 J. AM. CHEM. SOC. 5752 (1956)

RALPH J. FESSENDEN ET AL., ORGANIC CHEMISTRY 923 (Keith Dodson ed., 6th ed. 2008)

ROBERT T. MORRISON ET AL., ORGANIC CHEMISTRY 982 (2d ed. 1966)

Ernest Dorko et al., Heat effects occurring during the reactions between gaseous chlorine and strong aqueous bases, 2702 SPIE 349 (1996)

Notice: defective petition

Notice : Mandatory Notice

Notice : Power of Attorney

Petition for Inter Partes Review of U.S. Patent No. 8,759,320

Petitioner's Power of Attorney

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