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Patent Owner

Halozyme, Inc.

Petitioner

Merck Sharp & Dohme LLC

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Merck Sharp & Dohme LLC v. Halozyme, Inc.

PGR2025-00030 | Patent Trial and Appeal Board

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Filed Feb. 4, 2025

Case Type Post Grant Review

Status Pending

Challenged Patent 18/66,960

Patent No. 12,054,758 assignments

Tech Center 1600

Art Unit 1656

Inventors Ge WEI, H. Michael Shepard, Qiping Zhao, Robert James Connor

Last Updated: 15 minutes ago

Filing Date	#	Filing and Exhibits
Entries matching. Show All.
3/4/2025	03-04-2025-Patent_Owner	Patent Owner Notice: Updated Mandatory Notice 5: Patent Owner's Updated Mandatory Notices
2/18/2025	02-18-2025-Patent_Owner	Patent Owner Notice: Mandatory Notice 3: Patent Owner's Mandatory Notice Patent Owner Notice: Power of Attorney 4: Patent Owner's Power of Attorney
2/4/2025	02-04-2025-Petitioner	Petitioner Petition: as filed 1: Petition for Post Grant Review of U.S. Patent No. 12,054,758 Petitioner Notice: Power of Attorney 2: Petitioner's Power of Attorney Petitioner Exhibit 1001: U.S. Patent No. 12,054,758 Petitioner Exhibit 1002: File History of U.S. Patent No. 12,054,758 Part 1 Petitioner Exhibit 1002: File History of U.S. Patent No. 12,054,758 Part 2 Petitioner Exhibit 1003: Declaration of Dr. Michael Hecht Petitioner Exhibit 1004: Declaration of Dr. Sheldon Park Petitioner Exhibit 1005: U.S. Patent No. 7,767,429 Petitioner Exhibit 1006: Chao, Structure of Human Hyaluronidase-1 (2007) Petitioner Exhibit 1007: WO/2010/077297, published July 8, 2010 Petitioner Exhibit 1008: Stern, The Hyaluronidases: Their Genomics, Structures, & Mechanisms (2006) Petitioner Exhibit 1009: Jedzrejas, Structures of Vertebrate Hyaluronidases (2005) Petitioner Exhibit 1010: Zhang, Hyaluronidase Activity of Human Hyal1 (2009) Petitioner Exhibit 1011: Arming, In vitro Mutagenesis of PH-20 Hyaluronidase from Human Sperm (1997) Petitioner Exhibit 1012: Bordoli, Protein Structure Homology Modeling Using SWISSMODEL (2008) Petitioner Exhibit 1013: Frost, Recombinant Human Hyaluronidase (rHuPH20) (2007) Petitioner Exhibit 1014: Brandon & Tooze, Introduction to Protein Structure (1999) Part 1 Petitioner Exhibit 1014: Brandon & Tooze, Introduction to Protein Structure (1999) Part 2 Petitioner Exhibit 1015: Table Associating ’758 Patent to Corresponding ’731 Application Petitioner Exhibit 1016: Steipe, Consensus-Based Engineering of Protein Stability (2004) Petitioner Exhibit 1017: Green, Computer Graphics, Homology Modeling, and Bioinformatics (2010) Petitioner Exhibit 1018: Chica, Semi-rational Approaches to Engineering Enzyme Activity (2005) Petitioner Exhibit 1019: Hardy, Assessment of Contraceptive Vaccines Based on Recombinant Mouse Sper Petitioner Exhibit 1020: Pomering, Restricted Entry of IgG (2002) Petitioner Exhibit 1021: Baba, Mouse Sperm Lacking Cell Surface Hyaluronidase PH-20 (2002) Petitioner Exhibit 1022: Primakoff, Reversible Contraceptive Effect of PH-20 Immunization (1997) Petitioner Exhibit 1023: Tung, Mechanism of Infertility in Male Guinea Pigs Immunized with Sperm Petitioner Exhibit 1024: Rosengren, Recombinant Human PH20 (2018) Petitioner Exhibit 1025: U.S. Patent No. 9,447,401 Petitioner Exhibit 1026: U.S. Patent Application No. 13/694,731 Petitioner Exhibit 1029: Gmachl, The Human Sperm Protein PH-20 Has Hyaluronidase Activity (1993) Petitioner Exhibit 1030: Sills, "Retraction," Science, 319:569 (2008) Petitioner Exhibit 1031: Yue, Loss of Protein Structure Stability as a Major Causative Factor (2005) Petitioner Exhibit 1032: Wang & Moult, SNPs, Protein Structure, and Disease (2001) Petitioner Exhibit 1033: Marković-Housley, Crystal Structure of Hyaluronidase (2000) Petitioner Exhibit 1034: "Negative Results," Nature: Editorials, 453:258 (2008) Petitioner Exhibit 1035: Lins, Analysis of Accessible Surface of Residues in Proteins (2003) Petitioner Exhibit 1036: Hayden, Chemistry: Designer Debacle (2008) Petitioner Exhibit 1037: Benkert, Toward the Estimation of the Absolute Quality (2010) Petitioner Exhibit 1038: Schwede, SWISS-MODEL: An Automated Protein Homology-Modeling Server (2003) Petitioner Exhibit 1039: Alberts, Molecular Biology of the Cell, Chapter 3 (2007) Petitioner Exhibit 1040: He, NMR Structures of Two Designed Proteins with High Sequence Identity Petitioner Exhibit 1041: Alexander, A Minimal Sequence Code for Switching Protein Structure (2009) Petitioner Exhibit 1042: Ruan, Design & Characterization of a Protein Fold Switching Network (2023) Petitioner Exhibit 1043: Sievers, Fast, Scalable Generation of High-Quality Protein (2011) Petitioner Exhibit 1044: Mihel, PSAIA – Protein Structure and Interaction Analyzer (2008) Petitioner Exhibit 1045: Redline Comparison of the ’731 and ’758 Specifications Petitioner Exhibit 1046: Beasley & Hecht, Protein Design: The Choice of de Novo Sequences (1997) Petitioner Exhibit 1047: Xiong, Periodicity of Polar and Nonpolar Amino Acids (1995) Petitioner Exhibit 1048: Hayden, Key Protein-Design Papers Challenged (2009) Petitioner Exhibit 1049: KEGG, DRUG: Hyaluronidase (human recombinant) Petitioner Exhibit 1050: Pace & Scholtz, A Helix Propensity Scale (1998) Petitioner Exhibit 1051: U.S. Patent Application No. 61/631,313 Petitioner Exhibit 1052: U.S. Patent Application No. 61/796,208 Petitioner Exhibit 1053: Hom_pre2011 Petitioner Exhibit 1054: Hom_pre2011_header Petitioner Exhibit 1055: Hom_pre2011_header_clean Petitioner Exhibit 1056: Hom_pre2011.fasta Petitioner Exhibit 1057: Ph20_pre2011.aln-clustal_num Petitioner Exhibit 1058: Ph20_pre2011 Alignment html Petitioner Exhibit 1059: Leisola & Turunen, Protein Engineering: Opportunities and Challenges 2007 Petitioner Exhibit 1060: Hecht, De Novo Proteins from Designed Combinatorial Libraries (2004) Petitioner Exhibit 1061: Rosengren, Clinical Immunogenicity of rHuPH20 (2015) Petitioner Exhibit 1064: Collection of BLAST Webpages from the Internet Archive Petitioner Exhibit 1065: Collection of Clustal Omega Webpages from the Internet Archive Petitioner Exhibit 1066: Collection of SWISS-MODEL Webpages from the Internet Archive Petitioner Exhibit 1067: Collection of PyMol Webpages from the Internet Archive Petitioner Exhibit 1068: Declaration of Jeffrey P. Kushan Petitioner Exhibit 1069: Swiss Model Printout of PH20 Model Petitioner Exhibit 1070: Swiss Model Printout of PH20 Model with L317Q Mutation Petitioner Exhibit 1071: Swiss Model Printout of PH20 Model with L317R Mutation Petitioner Exhibit 1072: Swiss Model Printout of PH20 Model with L317M Mutation Petitioner Exhibit 1074: Swiss Model Printout of PH20 Model with L317I Mutation

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Merck Sharp & Dohme LLC v. Halozyme, Inc.

PGR2025-00030 | Patent Trial and Appeal Board

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