Merck Sharp & Dohme LLC - PGR2025-00087

Primakoff et al., “Fully effective contraception in male and....(1988)

Errata and Acknowledgement to Dr. Michael Hecht's 8/26/2025 Deposition

Errata and Acknowledgement to Dr. Sheldon Park's 8/21/2025 Deposition

Errata and Acknowledgement to Dr. Sheldon Park's 8/7/2025 Deposition

Transcript of 8/21/2025 Deposition of Dr. Sheldon Park

Transcript of 8/7/2025 Deposition of Dr. Sheldon Park

Transcript of 8/26/2025 Deposition of Dr. Michael Hecht

U.S. Publication 2010/0143457

Vembar & Brodsky, “One Step at a Time: Endoplasmic Reticulum-....(2008)

Goldberg, Protein Degradation and Protection (2003)

Bookbinder, A Recombinant Human Enzyme for Enhanced Interstitial Transport

Hunnicutt, Sperm Surface Protein PH-20 Is Bifunctional (1996)

Swiss Model Printout of PH20 Model with E324R Mutation

Swiss Model Printout of PH20 Model with E324N Mutation

Swiss Model Printout of PH20 Model with E324D Mutation

Swiss Model Printout of PH20 Model

Collection of PyMol Webpages from the Internet Archive

Collection of SWISS-MODEL Webpages from the Internet Archive

Collection of Clustal Omega Webpages from the Internet Archive

Collection of BLAST Webpages from the Internet Archive

Rosengren, Clinical Immunogenicity of rHuPH20 (2015)

US Patent No. 12,371,685

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

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

Ph20_pre2011 Alignment html

Ph20_pre2011.aln-clustal_num

Hom_pre2011.fasta

Hom_pre2011_header_clean

Hom_pre2011_header

File History of US Patent No. 12,371,685 Part 1

Hom_pre2011

File History of US Patent No. 12,371,685 Part 2

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

File History of US Patent No. 12,371,685 Part 3

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

Pace & Scholtz, A Helix Propensity Scale (1998)

KEGG, DRUG: Hyaluronidase (human recombinant)

Hayden, Key Protein-Design Papers Challenged (2009)

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

Declaration of Dr. Sheldon Park

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

US Patent No. US7,767,429

Redline Comparison of the ’731 and ’685 Specifications

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)

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

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)

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

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

Table Associating ’685 Patent to Corresponding ’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 Based on Recombinant Mouse Sperm

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

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

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

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

2024 Chemistry Nobel Prize Background

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

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

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

Sills, “Retraction,” Science, 319:569 (2008)

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

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

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)

Declaration of Jeffrey P. Kushan

Petition for Post Grant Review

Petitioner's Power of Attorney

Declaration of Dr. Michael Hecht

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