Merck Sharp & Dohme LLC vs Halozyme, Inc. et al.

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Petitioner's Reply in Support of Petition for Post Grant Review

Director Discretionary Decision: Refer

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EX2007 - Gifre 2017

EX2008 - Recombinant Drugs - Smithsonian Institution

EX2009 - Naz 2011

EX2010 - Primakoff 1988

EX2011 - Guinea Pig - Merriam-Webster 2010

EX2012 - Nature 2012

EX2013 - Lin 1993

EX2016 - Pils 2005

EX2064 - PGR2025-00053 Petition

EX2065 - PGR2025-00053 EX1003 - Hecht Declaration

EX2015 - USP7872107 File History (Part 1 of 3)

EX2015 - USP7872107 File History (Part 2 of 3)

EX2015 - USP7872107 File History (Part 3 of 3)

EX2055 - Triggs-Raine Declaration

Patent Owner's Preliminary Response

Petitioner's Reply to Patent Owner's Discretionary Denial Brief

United States District Court – National Judicial Caseload Profile

Table Showing Outcomes of Disputed Motions to Stay Pending IPRs in DNJ

News Release: "Halozyme Raises 2025 Financial Guidance Ranges and Reports Strong First Quarter 2025 Results"

News Release: "Merck Breaks Ground on New $1 Billion Biologics Center of Excellence in Wilmington, Delaware"

Halozyme Therapeutics, Inc. Q1 2025 Earnings Call Transcript (May 6, 2025)

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EX2002 - Triggs-Raine CV

EX2003 - Disclaimer

EX2004 - Fierce Pharma

EX2005 - LinkedIn Profiles

EX2018 - Duterme 2009

EX2019 - Atmuri 2008

EX2020 - Hemming 2008

EX2021 - Miller 2008

EX2022 - Kaneiwa 2010

EX2023 - PGR2025-00004 Petition

EX2024 - PGR2025-00003 Petition

EX2025 - PGR2025-00009 Petition

EX2026 - PGR2025-00006 Petition

EX2027 - PGR2025-00030 Petition

EX2028 - PGR2025-00024 Petition

EX2029 - PGR2025-00004 EX1003 - Hecht Declaration

EX2030 - PGR2025-00003 EX1003 - Hecht Declaration

EX2031 - PGR2025-00009 EX1003 - Hecht Declaration

EX2032 - PGR2025-00006 EX1003 - Hecht Declaration

EX2033 - PGR2025-00030 EX1003 - Hecht Declaration

EX2034 - PGR2025-00024 EX1003 - Hecht Declaration

EX2035 - Lokeshwar 2002

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EX2037 - PGR2025-00033 Petition

EX2038 - PGR2025-00039 EX1003 - Hecht Declaration

EX2039 - PGR2025-00039 Petition

EX2046 - 2023 Pharma 50

EX2047 - Merck Financial Results

EX2048 - Products List - Merck.com

EX2050 - Merck Market Cap Nasdaq

EX2051 - Halozume Market Cap Nasdaq

EX2052 - Halozyme News Revenue

EX2053 - Halozyme - Commercial Products

EX2054 - Halozyme About Us

EX2056 - PGR2025-00042 Petition

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EX2058 - District Court Complaint

EX2059 - Alteogen announces amendment to license agreement with MSD

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Patent Owner Discretionary Denial Brief

EX2001 - Triggs-Raine Declaration ISO Patent Owner Discretionary Denial Brief

EX2006 - Sequence Listing

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Order: Granting Petitioner's Motions for Pro Hac Vice Admission of Leif E. Peterson, II - 37 CFR 42.10

Petitioner's Motion for Pro Hac Vice Admission of Leif E. Peterson, II

Declaration of Leif E. Peterson, II

Patent Owner's Updated Mandatory Notices

NOTICE OF FILING DATE ACCORDED TO PETITION AND TIME FOR FILING PATENT OWNER PRELIMINARY RESPONSE

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U.S. Patent No. 12,110,520

File History of U.S. Patent No. 12,110,520 Part 1

File History of U.S. Patent No. 12,110,520 Part 2

U.S. Patent No. 7,767,429

Chao, Structure of Human Hyaluronidase-1 (2007)

WO/2010/077297, published July 8, 2010

Stern, The Hyaluronidases: Their Genomics, Structures, & Mechanisms (2006)

Jedzrejas, Structures of Vertebrate Hyaluronidases (2005)

Zhang, Hyaluronidase Activity of Human Hyal1 (2009)

Arming, In vitro Mutagenesis of PH-20 Hyaluronidase from Human Sperm (1997)

Bordoli, Protein Structure Homology Modeling Using SWISSMODEL (2008)

Frost, Recombinant Human Hyaluronidase (rHuPH20) (2007)

Brandon & Tooze, Introduction to Protein Structure (1999) Part 1

Brandon & Tooze, Introduction to Protein Structure (1999) Part 2

Steipe, Consensus-Based Engineering of Protein Stability (2004)

Green, Computer Graphics, Homology Modeling, and Bioinformatics (2010)

Chica, Semi-rational Approaches to Engineering Enzyme Activity (2005)

Hardy, Assessment of Contraceptive Vaccines Based on Recombinant Mouse Sper

Pomering, Restricted Entry of IgG (2002)

Baba, Mouse Sperm Lacking Cell Surface Hyaluronidase PH-20 (2002)

Primakoff, Reversible Contraceptive Effect of PH-20 Immunization (1997)

Tung, Mechanism of Infertility in Male Guinea Pigs Immunized with Sperm

Rosengren, Recombinant Human PH20 (2018)

U.S. Patent No. 9,447,401

U.S. Patent Application No. 13/694,731

Gmachl, The Human Sperm Protein PH-20 Has Hyaluronidase Activity (1993)

Sills, "Retraction," Science, 319:569 (2008)

Yue, Loss of Protein Structure Stability as a Major Causative Factor (2005)

Wang & Moult, SNPs, Protein Structure, and Disease (2001)

Marković-Housley, Crystal Structure of Hyaluronidase (2000)

"Negative Results," Nature: Editorials, 453:258 (2008)

Lins, Analysis of Accessible Surface of Residues in Proteins (2003)

Hayden, Chemistry: Designer Debacle (2008)

Benkert, Toward the Estimation of the Absolute Quality (2010)

Schwede, SWISS-MODEL: An Automated Protein Homology-Modeling Server (2003)

Alberts, Molecular Biology of the Cell, Chapter 3 (2007)

He, NMR Structures of Two Designed Proteins with High Sequence Identity

Alexander, A Minimal Sequence Code for Switching Protein Structure (2009)

Ruan, Design & Characterization of a Protein Fold Switching Network (2023)

Sievers, Fast, Scalable Generation of High-Quality Protein (2011)

Mihel, PSAIA – Protein Structure and Interaction Analyzer (2008)

Redline Comparison of the ’731 and ’520 Specifications

Beasley & Hecht, Protein Design: The Choice of de Novo Sequences (1997)

Xiong, Periodicity of Polar and Nonpolar Amino Acids (1995)

Hayden, Key Protein-Design Papers Challenged (2009)

KEGG, DRUG: Hyaluronidase (human recombinant)

Pace & Scholtz, A Helix Propensity Scale (1998)

U.S. Patent Application No. 61/631,313

U.S. Patent Application No. 61/796,208

Hom_pre2011

Hom_pre2011_header

Hom_pre2011_header_clean

Hom_pre2011.fasta

Ph20_pre2011.aln-clustal_num

Ph20_pre2011 Alignment html

Leisola & Turunen, Protein Engineering: Opportunities and Challenges (2007)

Hecht, De Novo Proteins from Designed Combinatorial Libraries (2004)

Rosengren, Clinical Immunogenicity of rHuPH20 (2015)

Collection of BLAST Webpages from the Internet Archive

Collection of Clustal Omega Webpages from the Internet Archive

Collection of SWISS-MODEL Webpages from the Internet Archive

Collection of PyMol Webpages from the Internet Archive

Swiss Model Printout of PH20 Model

Swiss Model Printout of PH20 Model with E324D Mutation

Swiss Model Printout of PH20 Model with E324N Mutation

Swiss Model Printout of PH20 Model with E324R Mutation

Swiss Model Printout of PH20 Model with E324A Mutation

Swiss Model Printout of PH20 Model with E324H Mutation

Swiss Model Printout of PH20 Model with E324S Mutation

Declaration of Dr. Michael Hecht

Declaration of Dr. Sheldon Park

Table Associating ’520 Patent to Corresponding ’731 Application

Declaration of Jeffrey P. Kushan

Petition for Post Grant Review of U.S. Patent No. 12,110,520

Petitioner's Power of Attorney