Charles River Laboratories, Inc. v. Seikagaku Corporation - IPR2025-00440

Patent Owner's Response

Declaration of Brian C. Schaefer, Ph.D.

Curriculum vitae of Brian C. Schaefer, Ph.D.

Declaration of Wan-Shon Lo

Declaration of Tina Morris, Ph.D.

Curriculum vitae of Tina Morris, Ph.D.

Obst, et al., Molec Phylogenetics and Evol (2012)

Novitsky, et al., Limulus Endotoxin Test (2005)

Iwanaga, et al., Thromb Rsch (1992)

Nakamura, et al., Eur J Biochem (1986)

Tokunaga, et al., Eur J Biochem (1987)

Loverock, et al., Pharmacopeial Forum (2009)

NCBI BioProject PRJNA178587

NCBI BioProject PRJNA178588

NCBI SRA SRX202160 from BioProject PRJNA178588

NCBI SRA for Horseshoe Crab Transcriptome SRR610305

NCBI SRA entries for SRX202152 and SRX202154

NCBI BioProjects FAQ

A Brief History of NCBI’s Formation and Growth

NLM GenBank and SRA Data Processing

Marchler-Bauer, et al., Nucleic Acids Rsch (2004)

Miyata, et al., J. Biol Chem (1984)

Cheng, et al., Biochimica et Biophysica Acta (1986)

Pharmacopeial Discussion Group

Bolden, et al., PDA J Pharm Sci and Tech (2020)

FDA Guidance Pyrogen and Endotoxins Testing (June 2012)

ORCID entry for Shun-ichiro Kawabata

Schaefer, et al., Analytical Biochem (1995)

Zhu, et al., Mol Biol Rep (2008)

Kawabata, et al., Invertebrate Survival J. (2009)

Novitsky, T.J., Springer Sci Bus Media, LLC (2010)

Ding, et al., Ch. 9, 187-208 (2010)

WO2012118226A1

Tamura, H., EC Bacterio Virol Rsch (2016)

Certified English Translation of WO2008004674A1

Thorne, et al., Appl Environ Microbiol 76(15) 4988-95 (2010)

Muta, et al., J. Biol Chem. 268(28) 21384-88 (1993)

Muta, et al., J. Biol Chem. 265(36) 22426-33 (1990)

Shakhnovich, et al., Genome Rsch (2006)

Rose, et al., J Biol Chem (2002)

Clustal Alignments of Factor C

Sievers, et al., Mol Sys Bio (2011)

Dubczak, J., Charles River Laboratories PDA Letter (2018)

Iwanaga, S., Thromb Haemost 70(01) 48-55 (1993)

Nguyen, et al., J. Biol Chem (1986)

Muta, et al., J Biochem (1987)

Minetti, et al., J Biol Chem (1991)

Liu, et al., J Biol Chem (1991)

Fujii, et al., J Biol Chem (1992)

WO92020715A1

Strong, et al., Biochim Biophys Acta (1995)

Munger, et al., Invert Neurosci. (1996)

Chen, et al., J Neurochem. (1999)

Reid, et al., Life Sci (2003)

Blackburn, et al., Dev Dyn (2008)

NCBI Nucleotide search results

BLAST hits in SRR610305 transcriptome data

Opponent's Submission in Opp. to EP3530670

Predicted 3D Structure Comparisons

U.S. Patent No. 10,473,663

Yoneda, et al., J Immunol Methods (2011)

Graphical Depiction of Factor C Sequences

U.S. Pharmacopoeia, Ch. 85

European Pharmacopoeia 5.0

Japanese Pharmacopoeia-XV

Findlay, et al., Pharmeuropa Bio&SN (June 2015)

Contingent Motion to Amend

Petitioner's Opposition to Patent Owner's Motion for Additional Discovery

Transcript of November 4, 2025 Deposition of Siddhartha Jain, Ph.D., PMP

Petitioner's First Updated Mandatory Notices

Patent Owner's Motion for Additional Discovery Under 37 C.F.R. Section 42.51(b)(2)(i)

ORDER Conduct of the Proceeding 37 C.F.R. § 42.5

Patent Owner's Updated Power of Attorney

Panel Change Order

Patent Owner's Updated Mandatory Notices Adding Wan-Shon Lo, Maria E. Doukas, and Alison P. Patitucci

Declaration of Chelsea A. Loughran in Support of Admission Pro Hac Vice

Notice of Intent to Designate Chelsea A. Loughran, a Provisionally Recognized PTAB Attorney, as Back-up Counsel

Order: Granting-in-Part Patent Owner's Motion for Routine Discovery - 37 CFR 42.51

General Order: Related Matters Updates

DECISION Granting Institution of Inter Partes Review 35 U.S.C. § 314

SCHEDULING ORDER

Petitioner's Opposition to Patent Owner's Motion to Compel Routine Discovery

Email from S. McKeown RE: PGR2025-00023 and IPR2025-00440: Request for Position on Motions to Compel Routine Discovery (Jun. 25, 2025)

Patent Owner's Motion to Compel Routine Discovery

Transcript of August 1, 2025 Conference Call

Notice of Filing Transcript of August 1, 2025 Conference Call

Ex. 3002 Attorney Correspondence

Order: Authorizing Discovery

Director Discretionary Decision: Refer

Email Correspondence

Patent Owner's Preliminary Response

U.S. Patent Application Publication No. 20030054432A1

Alwis and Milton, Am. J. Indus. Med. 49 296-300 (2006)

D’Amato, et al., J. Proteome Rsch. 9 3260-3269 (2010)

U.S. Appln. No.: 17/554,128, Non-Final Office Action, Mar. 20, 2025 ("'128 App. NFR")

European Patent No. 3530670, Response to Opposition, May 9, 2025

European Patent No. 3441466, Decision on Opposition, Oct. 26, 2022

USP, General Chapter Prospectus: Use of Recombinant Reagents in Bacterial Endotoxins Test

Interim Processes for PTAB Workload Management Memo

U.S. Appln. No.: 17/554,128, Amendment, Jan. 28, 2025

European Patent No. 3530670, Notice of Opposition, Nov. 22, 2024

U.S. Appln. No.: 16/331,810, Notice of Abandonment, Mar. 14, 2023

USP Press Release

U.S. Patent Application Publication No. 2019/0241629

U.S. Appln. No.: 14/650,767, Non-Final Office Action, Sept. 16, 2016

U.S. Appln. No.: 14/650,767, Final Office Action, Apr. 13, 2017

U.S. Appln. No.: 14/650,767, Amendment, Mar. 16, 2017

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

Patent Owner's Discretionary Denial Brief

File History for U.S. Application 14 650,767 (Claims excerpt)

File History for U.S. Application 14 650,767 (Non-Final Rejection excerpt)

Webpage FAQs for Interim Processes for PTAB Workload Management

Declaration of Michael Frohman (EP 3530670)

Notice of Opposition in EP3441466

Notice of Opposition in EP33530670

Register for EP 4291648 (excerpt)

Ding et al, 1995 from EP3441466

Ding et al, 1995 from US 17650803

Ding et al, 1995 from US 18275777

Ding et al, 1995 from US 18953525

Ding et al, from Opposition to EP3530670

Wang et al, 2002 from EP3441466

Wang et al, 2002 from 17650803

Wang et al, 2002 from 18275777

Wang et al, 2002 from 18953525

Hossler et al, 2009 from EP3441466

Hossler et al, 2009 from 17650803

Hossler et al, 2009 from 18275777

Hossler et al, 2009 from 18953525

Koshiba et al, 2007 from EP3441466

Koshiba et al, 2007 from 17650803

Koshiba et al, 2007 from 18275777

Koshiba et al, 2007 from 18953525

Hashiguchi et al, 2008 from EP3441466

Hashiguchi et al, 2008 from 17650803

Hashiguchi et al, 2008 from 18275777

Hashiguchi et al, 2008 from 18953525

Tokunaga et al, 1991 from EP3441466

Tokunaga et al, 1991 from 17650803

Tokunaga et al, 1991 from 18275777

Tokunaga et al, 1991 from 18953525

D19 in Opposition to EP3441466

U.S. Patent Application Publication 20230258647A1

Notice: Notice filing date accorded

Notice: Mandatory Notice

Notice: Power of Attorney

U.S. Patent No. 11,236,318 ("the '318 patent")

Declaration of Siddhartha Jain, Ph.D., PMP ("Jain")

Curriculum Vitae of Dr. Siddhartha Jain, Ph.D., PMP

Prosecution History for U.S. Application No. 16/399,386

International Patent Publication No. WO 2018/074498 A1

U.S. Patent Application No. 14/650,767, as filed June 9, 2015

Muta et al., J Biol Chem. 1991 Apr 5; 266(10):6554-61.

Gan et al., Biophys J. 2002 Nov; 83(5):2781-91.

U.S. Patent Application Publication No. 2015/0307864

Karen McClymont, Ph.D. Thesis, University of Glasgow, March 2017

Transition Certification for U.S. Pat Appl No. 15/983,725, filed 5/31/2019

U.S. Patent No. 5,716,834

Declaration of Dr. Mary K. Bolin

U.S. Patent No. 5,858,706

International Patent Publication No. WO 2000/026366 A1

Iwanaga, Proc. Jpn. Acad., Ser. B. Phys Biol Sci. 2007 May; 83(4):110-9.

Japanese Priority Application No. JP2012-269840 (certified translation)

U.S. Application No. 14/650,767, addition to PCT specification

Higdon et al., Proc Int Symp High Perform Distrib Comput. 2010: 499–502

Tokunaga et al., J. Biochem. 1991 Jan;109(1):150-7.

Levin, Bulletin of John’s Hopkins Hospital, 1964 Sep: 115:265-74.

Walls et al., Reviews in Fisheries Science, 2002; 10(1):39-73.

Carmichael et al., "Changing Global Perspectives on Horseshoe Crab Biology"

Dwarakanath et al., Biotechnology Letters. 1997 April; 19(4):357-61.

Wang et al., Biotechnology Letters. 2001; 23:71-76.

Ding et al., Trends in Biotechnology, 2001 Aug; 19(8):277-81.

U.S. Appln. No.: 14/650,767, Declaration Under 37 C.F.R. 1.132

Barrabes et al., Electrophoresis. 2010 Sep; 31(17):2903-12.

Palomares, Methods in Molecular Biology, Vol. 267, pp. 15-51 (2004).

U.S. Patent No. 6,645,724

Mizumura, Innate Immunity. 2017 Feb; 23(2):136-146.

Ding et al., Journal of Endotoxin Research. 1997; 4(1): 33-43.

International Patent Publication No. WO 2014/092079 A1 ("the '082 PCT")

Wang et al., J Biol Chem. 2002 Sep 27; 277(39):36363-72.

Marengo-Rowe, Proc (Bayl Univ Med Cent) 2006 Jul; 19(3):239–245.

Sekiguchi and Shuster, Biology and Conservation of Horseshoe Crabs, 2009.

Hossler et al., Glycobiology. 2009 Sep; 19(9):936-4.

Power of Attorney

Petition for Inter Partes Review