Bonerge Lifescience (Hunan) Co., Ltd. v. Nanjing Nutrabuilding Bio-Tech Co., Ltd. - IPR2025-01593

Patent Owner Preliminary Response

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King, A.J.F. The use of animal models in diabetes research

Koepsell, H. Glucose transporters in the small intestine in health and disease

Kola, I. and Landis, J. Can the pharmaceutical industry reduce attrition rates?

Kowalski, G.M. and Bruce, C.R. The regulation of glucose metabolism: implications and considerations for the assessment of glucose homeostasis in rodents

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Nair, A.B. and Jacob, S. A simple practice guide for dose conversion between animals and human

Nguyen, T.L.A. et al. How informative is the mouse for human gut microbiota research?

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Pellizzon, M.A. and Ricci, M.R. Choice of laboratory rodent diet may confound data interpretation and reproducibility

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Petersen, M.C., Vatner, D.F. and Shulman, G.I. Regulation of hepatic glucose metabolism in health and disease

Pound, P. and Ritskes-Hoitinga, M. Is it possible to overcome issues of external validity in preclinical animal research? Why most animal models are bound to fail

Hackam, D.G. and Redelmeier, D.A. Translation of research evidence from animals to humans

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Richter, S.H., Garner, J.P. and Wurbel, H. Environmental standardization: cure or cause of poor reproducibility in animal experiments?

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Begley, C. G. and Ellis, L. M. Drug development: Raise standards for preclinical cancer research

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Curriculum Vitae of Dr. Thomas Hartung, M.D., Ph.D.

Curriculum Vitae of Dr. Qiang Tong, Ph.D.

Cheng Z, Chen AF, Wu F, Sheng L, Zhang HK, Gu M, Li YY, Zhang LN, Hu LH, Li JY, Li J. 8,8-Dimethyldihydroberberine with improved bioavailability and oral efficacy on obese and diabetic mouse models

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Yang F, Gao R, Luo X, Liu R, Xiong D. Berberine influences multiple diseases by modifying gut microbiota

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Yu Y, Liu L, Wang X, Liu X, Liu X, Xie L, Wang G. Modulation of glucagon-like peptide-1 release by berberine: in vivo and in vitro studies

Yao Y, Chen H, Yan L, Wang W, Wang D. Berberine alleviates type 2 diabetic symptoms by altering gut microbiota and reducing aromatic amino acids

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Zhang Y, Gu Y, Ren H, Wang S, Zhong H, Zhao X, Ma J, Gu X, Xue Y, Huang S, Yang J, Chen L, Chen G, Qu S, Liang J, Qin L, Huang Q, Peng Y, Li Q, Wang X, Kong P, Hou G, Gao M, Shi Z, Li X, Qiu Y, Zou Y, Yang H, Wang J, Xu G, Lai S, Li J, Ning G, Wang W. Gut microbiome-related effects of berberine and probiotics on type 2 diabetes (the PREMOTE study)

Kun Wang, Xinchi Feng, Liwei Chai, Shijie Cao & Feng Qiu The metabolism of berberine and its contribution to the pharmacological effects

Curriculum Vitae of Dr. Chad M. Kerksick

Bertorello, S. The Future Exploring of Gut Microbiome-Immunity Interactions: From In Vivo Vitro Models to In Silico Innovations

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Nguyen TLA, et al. How informative is the mouse for human gut microbiota research?

DeSesso JM and Jacobson CF. Anatomical and physiological parameters affecting gastrointestinal absorption in humans and rats

Cabrera O, Berman DM, Kenyon NS, Ricordi C, Berggren P-O, Caicedo A. The unique cytoarchitecture of human pancreatic islets has implications for islet cell function

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Martic-Kehl MI, et al. Can animals data predict human outcome? Problems and pitfalls of translational animal research

Shoyaib AAI, Archie SR, Karamyan VT. Intraperitoneal Route of Drug Administration: Should it Be Used in Experimental Animal Studies?

Kowalski GM and Bruce CR. The regulation of glucose metabolism: implications and considerations for the assessment of glucose homeostasis in rodents

Ye J, Iglesias MA, Watson DG, Ellis B, Wood L, et al. PPARα/γ ragaglitazar eliminates fatty liver and enhances insulin action in fat-fed rats in the absence of hematomegaly

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Molero JC, Turner N, Thien CBF, Langdon WY, James DE, Cooney GJ. Genetic ablation of the c-Cbl uniquitin ligase domain results in increased energy expenditure and improved insulin action

Declaration of Mark D. Nielsen in support of Patent Owner’s Preliminary Response

Declaration of Dr. Thomas Hartung, M.D., Ph.D.

Declaration of Chad M. Kerksick, Ph.D.

Declaration of Qiang Tong, Ph.D.

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

Declaration of Hua Chen

Patent Assignment Record of U.S. Patent No. 10,278,961

Longitude Licensing Ltd., v. Amazon.com, Inc. & Western Digital Tech. Inc., No. 23cv0039 (C. D. Cal. Feb. 26, 2024)

Polaris PowerLED Technologies, LLC v. VIZIO, Inc., et al, No. 23cv3478 (C. D. Cal. April 8, 2024)

Notice: Patent Owner Power of Attorney

Patent Owner Discretionary Denial Brief

2001 - Text Only of Complaint in Nanjing Nutrabuilding Bio-Tech Co., Ltd. v. Bonerge Lifescience (Hunan) Co., Ltd.

2002 - Exhibit 11 to Complaint

2003 - Excerpt of Petitioner's Responses to Requests for Admissions in Parallel Litigation

2004 - Exhibit 12 to Complaint

2005 - Petitioner's Amended Answer to Complaint in Parallel Litigation

2006 - Exhibit 13 to Complaint

2007 - Exhibit 14 to Complaint

2008 - Return of Service of Summons and Complaint in Parallel Litigation

2009 - Joint Rule 26(f) Report in Parallel Litigation

2010 - Scheduling Order in Parallel Litigation

2011 - Amended Scheduling Order in Parallel Litigation

2012 - Patent Owner's Preliminary Infringement Contentions in Parallel Litigation

2013 - Declaration of Mark D. Nielsen

2014 - Petitioner's Motion to Stay Brief in Parallel Litigation

2015 - Court Order Denying without prejudice Petitioner's Motion to Stay in Parallel Litigation

2016 - Petitioner's Invalidity Contentions in Parallel Litigation

2017 - Interim Processes for PTAB Workload Management March 26, 2025

2018 - Pound and Bracken - Is animal research sufficiently evidence based to be a cornerstone of biomedical research?

2019 - Small, L. et al, Modeling insulin resistance in rodents by alterations in diet: what have high-fat and high-calorie diets revealed?

2020 - Lai, M. et al - You are what you eat, or are you? The challenges of translating high-fat-fed rodents to human obesity and diabetes

Petitioner's stipulation

Notice: Mandatory Notice

Notice: Notice filing date accorded

Notice: Power of Attorney

U.S. Patent No. 10,278,961

Excerpts of Prosecution File History of U.S. Patent No. 10,278,961

Nigel Turner et al., Berberine and Its More Biologically Available Derivati

Shannon Reagan-Shaw et al., Dose translation from animal to human studies r

Yifei Zhang et al., Treatment of Type 2 Diabetes and Dyslipidemia with the

Ru Feng et al., Transforming berberine into its intestine-absorbable form b

Guidance for Industry Estimating the Maximum Safe Starting Dose in Initial

Chunqiu Chen et al., A randomized clinical trial of berberine hydrochloride

Li Liu et al., Berberine suppresses intestinal disaccharidases with benefic

Aillen JF King, The use of animal models in diabetes research, British Jour

U.S. Application 12/443,401, published on May 6, 2010 as US 2010/0113494. (

Expert Declaration of Dr. Ronald J. Shebuski, Sr.

Petition for Inter Partes Review of U.S. Patent 10,278,961