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

Patent Owner's Notice of Park Deposition

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Granting Petitioner’s Motion for Pro Hac Vice Admission of Leif E. Peterson, II 37 C.F.R. § 42.10

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

Declaration of Leif E. Peterson, II

Patent Owner Preliminary Response

EX2001 - Triggs-Raine Declaration

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EX2008 - Recombinant Drugs - Smithsonian Institution

EX2009 - Naz 2011

EX2010 - Primakoff 1988

EX2011 - Guinea Pig - Merriam-Webster 2010

EX2012 - Nature 2012

EX2013 - Lin 1993

EX2015 - USP7872107 File History (Part 1 of 3)

EX2015 - USP7872107 File History (Part 2 of 3)

EX2015 - USP7872107 File History (Part 3 of 3)

EX2016 - Pils 2005

EX2018 - Duterme 2009

EX2019 - Atmuri 2008

EX2020 - Hemming 2008

EX2021 - Miller 2008

EX2022 - Kaneiwa 2010

EX2023 - PGR2025-00003 Petition

EX2024 - PGR2025-00006 Petition

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EX2026 - PGR2025-00017 Petition

EX2027 - PGR2025-00030 Petition

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EX2029 - PGR2025-00003 EX1003 - Hecht Declaration

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EX2033 - PGR2025-00030 EX1003 - Hecht Declaration

EX2034 - PGR2025-00024 EX1003 - Hecht Declaration

EX2035 - Lokeshwar 2002

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EX2017 - EP0953574A1

Patent Owner's Updated Mandatory Notices

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U.S. Patent No. 12,018,298

File History of U.S. Patent No. 12,018,298 Pt. 1

File History of U.S. Patent No. 12,018,298 Pt. 2

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

Chao et al., “Structure of Human Hyaluronidase-1 (2007)

WO 2010/077297, published 8 July 2010

Stern The Hyaluronidases Their Genomics, Structures, and 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 SWISS-MODEL (2008)

Frost, Recombinant human hyaluronidase (rHuPH20) (2007)

Brandon & Tooze, “Introduction to Protein Structure" (1999) Pt. 1

Brandon & Tooze, “Introduction to Protein Structure" (1999) Pt. 2

Table Associating Citations from the ’298 Patent to '731 Application

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 (2004)

Pomering “Restricted Entry of IgG into Male and Female Rabbit" (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" (1997)

Rosengren Recombinant Human PH20 Baseline Analysis of the Reactivity (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,” Nature, 453:275-278 (2008)

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

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

Alberts, “Molecular Biology of the Cell,” Fifth Edition, Chapter 3 (2007)

He “NMR Structures of Two Designed Proteins with High Sequence" (2008)

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

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

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

Mihel, Protein Structure and Interaction Analyzer,” BMC Structural (2008)

Redline Comparison of the ’731 and ’298 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,” Nature, 461:859 (2009)

KEGG, DRUG: Hyaluronidase (human recombinant)

Pace Scholtz A Helix Propensity Scale Based on Experimental Studies (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 M313K Mutation

Swiss Model Printout of PH20 Model with M313A Mutation

Swiss Model Printout of PH20 Model with M313R Mutation

Swiss Model Printout of PH20 Model with M313Y Mutation

Swiss Model Printout of PH20 Model with M313P Mutation

Swiss Model Printout of PH20 Model with M313L Mutation

Declaration of Jeffrey P. Kushan

Declaration of Dr. Michael Hecht

Declaration of Dr. Sheldon Park

EXPUNGED

Petitioner's Power of Attorney (298)