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Patent Owner

Halozyme, Inc.

Petitioner

Merck Sharp & Dohme LLC

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Merck Sharp & Dohme LLC v. Halozyme, Inc.

PGR2025-00004 | Patent Trial and Appeal Board

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Filed Nov. 26, 2024

Case Type Post Grant Review

Status Pending

Challenged Patent 18/340,482

Patent No. 12,018,298 assignments

Tech Center 1600

Art Unit 1645

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

Last Updated: 1 day, 8 hours ago

Filing Date	#	Filing and Exhibits
Entries matching. Show All.
3/13/2025	03-13-2025-Patent_Owner	Event: Preliminary Response Patent Owner POPR: filed 13: Patent Owner Preliminary Response Patent Owner Exhibit 2001: EX2001 - Triggs-Raine Declaration Patent Owner Exhibit 2002: EX2002 - Triggs-Raine CV Patent Owner Exhibit 2003: EX2003 - Disclaimer Patent Owner Exhibit 2004: EX2004 - Fierce Pharma Patent Owner Exhibit 2005: EX2005 - LinkedIn Profiles Patent Owner Exhibit 2006: EX2006 - Sequence Listing Patent Owner Exhibit 2007: EX2007 - Gifre 2017 Patent Owner Exhibit 2008: EX2008 - Recombinant Drugs - Smithsonian Institution Patent Owner Exhibit 2009: EX2009 - Naz 2011 Patent Owner Exhibit 2010: EX2010 - Primakoff 1988 Patent Owner Exhibit 2011: EX2011 - Guinea Pig - Merriam-Webster 2010 Patent Owner Exhibit 2012: EX2012 - Nature 2012 Patent Owner Exhibit 2013: EX2013 - Lin 1993 Patent Owner Exhibit 2015: EX2015 - USP7872107 File History (Part 1 of 3) Patent Owner Exhibit 2015: EX2015 - USP7872107 File History (Part 2 of 3) Patent Owner Exhibit 2015: EX2015 - USP7872107 File History (Part 3 of 3) Patent Owner Exhibit 2016: EX2016 - Pils 2005 Patent Owner Exhibit 2017: EX2017 - EP0953574A1 Patent Owner Exhibit 2018: EX2018 - Duterme 2009 Patent Owner Exhibit 2019: EX2019 - Atmuri 2008 Patent Owner Exhibit 2020: EX2020 - Hemming 2008 Patent Owner Exhibit 2021: EX2021 - Miller 2008 Patent Owner Exhibit 2022: EX2022 - Kaneiwa 2010 Patent Owner Exhibit 2023: EX2023 - PGR2025-00003 Petition Patent Owner Exhibit 2024: EX2024 - PGR2025-00006 Petition Patent Owner Exhibit 2025: EX2025 - PGR2025-00009 Petition Patent Owner Exhibit 2026: EX2026 - PGR2025-00017 Petition Patent Owner Exhibit 2027: EX2027 - PGR2025-00030 Petition Patent Owner Exhibit 2028: EX2028 - PGR2025-00024 Petition Patent Owner Exhibit 2029: EX2029 - PGR2025-00003 EX1003 - Hecht Declaration Patent Owner Exhibit 2030: EX2030 - PGR2025-00006 EX1003 - Hecht Declaration Patent Owner Exhibit 2031: EX2031 - PGR2025-00009 EX1003 - Hecht Declaration Patent Owner Exhibit 2032: EX2032 - PGR2025-00017 EX1003 - Hecht Declaration Patent Owner Exhibit 2033: EX2033 - PGR2025-00030 EX1003 - Hecht Declaration Patent Owner Exhibit 2034: EX2034 - PGR2025-00024 EX1003 - Hecht Declaration Patent Owner Exhibit 2035: EX2035 - Lokeshwar 2002 Patent Owner Exhibit 2036: EX2036 - PGR2025-00033 EX1003 - Hecht Declaration Patent Owner Exhibit 2037: EX2037 - PGR2025-00033 Petition
3/4/2025	03-04-2025-Patent_Owner	Patent Owner Notice: Updated Mandatory Notice 12: Patent Owner's Updated Mandatory Notices
2/18/2025	02-18-2025-Patent_Owner	Patent Owner Notice: Updated Mandatory Notice 11: Patent Owner's Updated Mandatory Notices
2/6/2025	02-06-2025-Petitioner	Petitioner Notice: Updated Mandatory Notice 10: Petitioner's Updates to Mandatory Notices
1/29/2025	01-29-2025-Patent_Owner	Patent Owner Notice: Updated Mandatory Notice 9: Patent Owner's Updated Mandatory Notices
1/15/2025	01-15-2025-Patent_Owner	Patent Owner Notice: Updated Mandatory Notice 8: Patent Owner's Updated Mandatory Notices
12/20/2024	12-20-2024-Patent_Owner	Patent Owner Notice: Updated Mandatory Notice 7: Patent Owner's Updated Mandatory Notices
12/13/2024	12-13-2024-Board	Board Notice: Notice filing date accorded 6: Notice: Notice filing date accorded
12/3/2024	12-03-2024-Petitioner	Petitioner Petition: corrected 3: Petition: corrected
12/3/2024	12-03-2024-Patent_Owner	Patent Owner Notice: Power of Attorney 4: Patent Owner's Power of Attorney Patent Owner Notice: Mandatory Notice 5: Patent Owner's Mandatory Notices
12/3/2024	12-03-2024-Board	Board Exhibit 3001: Ex 3001 E-mail re corrected petition
11/26/2024	11-26-2024-Petitioner	Petitioner Petition: as filed 1: EXPUNGED Petitioner Notice: Power of Attorney 2: Petitioner's Power of Attorney (298) Petitioner Exhibit 1001: U.S. Patent No. 12,018,298 Petitioner Exhibit 1002: File History of U.S. Patent No. 12,018,298 Pt. 1 Petitioner Exhibit 1002: File History of U.S. Patent No. 12,018,298 Pt. 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 et al., “Structure of Human Hyaluronidase-1 (2007) Petitioner Exhibit 1007: WO 2010/077297, published 8 July 2010 Petitioner Exhibit 1008: Stern The Hyaluronidases Their Genomics, Structures, and 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 SWISS-MODEL (2008) Petitioner Exhibit 1013: Frost, Recombinant human hyaluronidase (rHuPH20) (2007) Petitioner Exhibit 1014: Brandon & Tooze, “Introduction to Protein Structure" (1999) Pt. 1 Petitioner Exhibit 1014: Brandon & Tooze, “Introduction to Protein Structure" (1999) Pt. 2 Petitioner Exhibit 1015: Table Associating Citations from the ’298 Patent to '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 (2004) Petitioner Exhibit 1020: Pomering “Restricted Entry of IgG into Male and Female Rabbit" (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" (1997) Petitioner Exhibit 1024: Rosengren Recombinant Human PH20 Baseline Analysis of the Reactivity (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,” Nature, 453:275-278 (2008) Petitioner Exhibit 1037: Benkert Toward the Estimation of the Absolute Quality of Individual (2010) Petitioner Exhibit 1038: Schwede SWISS-MODEL: An Automated Protein Homology-Modeling Server (2003) Petitioner Exhibit 1039: Alberts, “Molecular Biology of the Cell,” Fifth Edition, Chapter 3 (2007) Petitioner Exhibit 1040: He “NMR Structures of Two Designed Proteins with High Sequence" (2008) Petitioner Exhibit 1041: Alexander A Minimal Sequence Code for Switching Protein Structure (2009) Petitioner Exhibit 1042: Ruan Design and Characterization of a Protein Fold Switching Network (2023) Petitioner Exhibit 1043: Sievers Fast, Scalable Generation of High-Quality Protein (2011) Petitioner Exhibit 1044: Mihel, Protein Structure and Interaction Analyzer,” BMC Structural (2008) Petitioner Exhibit 1045: Redline Comparison of the ’731 and ’298 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,” Nature, 461:859 (2009) Petitioner Exhibit 1049: KEGG, DRUG: Hyaluronidase (human recombinant) Petitioner Exhibit 1050: Pace Scholtz A Helix Propensity Scale Based on Experimental Studies (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 M313K Mutation Petitioner Exhibit 1071: Swiss Model Printout of PH20 Model with M313A Mutation Petitioner Exhibit 1072: Swiss Model Printout of PH20 Model with M313R Mutation Petitioner Exhibit 1073: Swiss Model Printout of PH20 Model with M313Y Mutation Petitioner Exhibit 1074: Swiss Model Printout of PH20 Model with M313P Mutation Petitioner Exhibit 1075: Swiss Model Printout of PH20 Model with M313L Mutation

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Merck Sharp & Dohme LLC v. Halozyme, Inc.

PGR2025-00004 | Patent Trial and Appeal Board

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