UNITED STATES PATENT AND TRADEMARK OFFICE
`
`________________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`________________________________
`
`RIGEL PHARMACEUTICALS, INC.,
`
`Petitioner,
`
`v.
`
`SERVIER PHARMACEUTICALS LLC
`
`Patent Owner.
`____________________________
`
`Case IPR2022-01423
`U.S. Patent No. 10,610,125
`________________________________
`
`DECLARATION OF DAVID H. SHERMAN
`IN SUPPORT OF PETITION FOR INTER PARTES REVIEW
`U.S. PATENT NO. 10,610,125
`
`Rigel Exhibit 1003
`Page 1 of 98
`
`

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`Declaration of Prof. David H. Sherman
`U.S. Patent No. 10,610,125
`
`TABLE OF CONTENTS
`
`LIST OF EXHIBITS REFERENCED IN DECLARATION .................................. iv
`INTRODUCTION ............................................................................................... 1
`I.
`II. BACKGROUND AND QUALIFICATIONS .................................................... 2
`III. MATERIALS CONSIDERED ........................................................................... 8
`IV. MY UNDERSTANDING OF CERTAIN LEGAL STANDARDS ................... 9
`A. Ordinary Skill in the Art ........................................................................... 10
`B. Claim Construction ................................................................................... 10
`C. Anticipation (35 U.S.C. §102) .................................................................. 11
`D. Obviousness (35 U.S.C. §103) ................................................................. 12
`E. Prior Art and Priority ................................................................................ 15
`V. BACKGROUND ............................................................................................... 17
`A. Overview of Technology .......................................................................... 17
`B. The ’125 Patent ......................................................................................... 18
`C. Technical Background and Prior Art ........................................................ 25
`1. Parsons .................................................................................................. 25
`2. Bleeker .................................................................................................. 26
`3. Kang ...................................................................................................... 27
`4. Yan ........................................................................................................ 28
`5. Zhao ...................................................................................................... 29
`6. Mardis ................................................................................................... 30
`7. Vogelstein ............................................................................................. 32
`8. Dang 2009............................................................................................. 34
`9. Dang’243 .............................................................................................. 37
`10. PM’678 ............................................................................................... 37
`i
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`Rigel Exhibit 1003
`Page 2 of 98
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`

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`Declaration of Prof. David H. Sherman
`U.S. Patent No. 10,610,125
`
`11. PM 2012 ............................................................................................. 39
`VI. A PERSON OF ORDINARY SKILL IN THE RELEVANT FIELD IN THE
`RELEVANT TIMEFRAME .................................................................................... 44
`VII. CLAIM CONSTRUCTION .............................................................................. 46
`VIII. SUMMARY OF MY OPINIONS ................................................................... 46
`IX. THE CHALLENGED CLAIMS ARE INVALID ............................................ 47
`A. There can be no valid priority claim before July 13, 2013 ...................... 47
`1.The state of the art as of March 2010 .................................................... 48
`2. The scope of the Challenged Claims is broad ...................................... 51
`3. The disclosure of the 2010 Application does not provide sufficient
`information to demonstrate possession of methods for treating IDH1-
`mutant AML ............................................................................................. 53
`4.The scope of claims with respect to the small molecule inhibitor
`compounds is not supported by the 2010 application .............................. 61
`5. Neither do the provisional applications support the Challenged
`Claims ....................................................................................................... 72
`6. There can be no valid priority datebefore July 11, 2013 ...................... 72
`B. Ground 1: PM’678 anticipates the Challenged Claims ............................ 73
`1. Claim 1 ................................................................................................. 73
`2. Claims 2-5............................................................................................. 75
`3. Claim 9-12 ............................................................................................ 76
`C. Ground 2: PM 2012 in view of PM’678 renders obvious the Challenged
`Claims ....................................................................................................... 78
`1. Claim 1 ................................................................................................. 78
`2. Claims 2-5............................................................................................. 80
`3. Claim 9-12 ............................................................................................ 81
`D. Ground 3: PM’678 (optionally together with PM 2012) in view of
`Dang’243 renders Challenged Claim 12 .................................................. 83
`ii
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`Rigel Exhibit 1003
`Page 3 of 98
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`Declaration of Prof. David H. Sherman
`U.S. Patent No. 10,610,125
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`E. Ground 4: Dang’243 Anticipates Claims 1-5 and 9-12 ........................... 84
`
`1. Claim 1 ................................................................................................. 84
`
`2. Claims 2-5............................................................................................. 86
`
`3. Claim 9-12 ............................................................................................ 87
`X. NO SECONDARY CONSIDERATIONS ........................................................ 89
`XI. CONCLUSION ................................................................................................. 89
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`iii
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`Rigel Exhibit 1003
`Page 4 of 98
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`

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`Declaration of Prof. David H. Sherman
`U.S. Patent No. 10,610,125
`
`LIST OF EXHIBITS REFERENCED IN DECLARATION
`
`Exhibit
`
`Description
`
`1001
`1002
`1004
`1007
`
`1008
`
`1009
`
`1010
`
`1011
`
`1012
`
`1013
`
`1014
`
`1015
`
`1016
`
`U.S. Patent No. 10,610,125 (“’125 Patent”)
`Excerpted Prosecution History of U.S. Patent No. 10,610,125
`Curriculum Vitae of Professor David J. Sherman
`Mardis et al., Recurring Mutations Found by Sequencing an Acute
`Myeloid Leukemia Genome, 361 N. ENGL. J. MED. 1058 (2009).
`(“Mardis”)
`Vogelstein et al., U.S. Pat. App. Pub. No. 2011/0229479
`(“Vogelstein”)
`Dang et al., Int’l Pat. App. Pub. No. 2010/105243
`(“Dang ’243” or “2010 Application”)
`Popovici-Muller et al., Pat. App. Pub. No. 2012/009678
`(“PM ’678”)
`Popovici-Muller et al., Discovery of the First Potent Inhibitors of
`Mutant IDH1 That Lower Tumor 2-HG in Vivo, 3 ACS MED. CHEM.
`LETT. 850 (2012).
`(“PM 2012”)
`Zhao et al. Glioma-Derived Mutations in IDH1 Dominantly Inhibit
`IDH1 Catalytic Activity and Induce HIF-1α, 324 SCIENCE 261
`(2009).
`Tostmann et al., Protecting Chemistry Inventions: The Double-
`Edged Sword of Being an Unpredictable Art, 6 ACS MED. CHEM.
`LETT. 364-6 (2015).
`Golub et al., Mutant Isocitrate Dehydrogenase Inhibitors as
`Targeted Cancer Therapeutics, 9 FRONT. ONCOL. 417 (2019).
`(“Golub”)
`Parsons et al., An Integrated Genomic Analysis of Human
`Glioblastoma Multiform, SCIENCEXPRESS (2008). (“Parsons”)
`Yan et al., IDH1 and IDH2 Mutations in Gliomas, 360 N. ENGL. J.
`MED. 765 (2009).
`(“Yan”)
`
`iv
`
`
`
`Rigel Exhibit 1003
`Page 5 of 98
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`

`

`Declaration of Prof. David H. Sherman
`U.S. Patent No. 10,610,125
`
`Exhibit
`
`Description
`
`1017
`
`1019
`
`1022
`
`1023
`1024
`
`1025
`
`1026
`
`1027
`
`1028
`
`1029
`
`1030
`
`Bleeker et al., IDH1 Mutations at Residue p.R132 (IDH1R132) Occur
`Frequently in High-Grade Gliomas But Not in Other Solid Tumors,
`30 HUMAN MUTATION 7 (2009).
`(“Bleeker”)
`Kang et al., Mutational Analysis of IDH1 Codon 132 in
`Glioblastomas and Other Common Cancers, 125 INT. J. CANCER
`353 (2009).
`(“Kang”)
`Gross et al., Cancer-associated Metabolite 2-hydroxyglutarate
`Accumulates in Acute Myelogenous Leukemia With Isocitrate
`Dehydrogenase 1 and 2 Mutations, 207 J. EXP. MED. 339 (2010).
`(“Gross”)
`Salituro et al., Int’l Pat. App. Pub. No. 2011/072174
`Dang et al., Cancer-associated IDH1 Mutations Produce 2-
`hydroxyglutarate, 462 NATURE 739 (2009).
`(“Dang 2009”)
`U.S. Provisional Pat. App. No. 61/229,689, filed July 29, 2009
`(“July 29, 2009 Provisional”)
`Gottlieb et al., Int’l Pat. App. Pub. no. 2006/016143
`(“Gottlieb”)
`Shin et al., Catechin Gallates are NADP+-competitive Inhibitors of
`Glucose-6-phosphate Dehydrogenase and Other Enzymes that
`Employ NADP+ as a Coenzyme, 16 Bioorganic & Medicinal
`Chemistry (2008), 16, 3580-86
`Lee & Park, Oxalomalate Regulates Ionizing Radiation-Induced
`Apoptosis in Mice, 42 FREE RADICAL BIO. & MED. 44-51 (2007).
`(“Lee & Park”)
`Korean Pat. App. Pub. no. 10-2005-0036293 A, provided with
`English-language abstract and translation
`Brock, Generation and Phenotypic Characterization of Aspergillus
`nidulans Methylisocitrate Lyase Deletion Mutants: Methylisocitrate
`Inhibits Growth and Conididation, 71 APPLIED & ENV’TAL
`MICROBIO. 5465-75 (2015).
`
`v
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`Rigel Exhibit 1003
`Page 6 of 98
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`

`

`Declaration of Prof. David H. Sherman
`U.S. Patent No. 10,610,125
`
`Exhibit
`
`Description
`
`1031
`
`1032
`1033
`1034
`
`1035
`
`1036
`
`1037
`
`1038
`
`1039
`
`1040
`
`1041
`
`1042
`
`Korean Pat. App. Pub. no. 10-2002-0095553 A, provided with
`English-language abstract and translation
`Einat et al., U.S. Pat. App. Pub. No. 2004/0067234
`Koh et al., Int’l Pub. No. WO 02/33063
`Pirrung et al., O-Alkyl Hydroxamates as Metaphors of Enzyme-
`Bound Enolate Intermediates in Hydroxy Acid Dehydrogenases.
`Inhibitors of Isopropylmalate Dehydrogenase, Isocitrate
`Dehydrogenase, and Tartrate Dehydrogenase, 61 J. ORG. CHEM.
`4527-4531 (1996).
`Ingebretsen, Mechanism of the Inhibitory Effect of Glyoxylate Plus
`Oxaloacetate and Oxalomalate on the NADP-Specific Isocitrate
`Dehydrogenase, 452 BIOCHIMICA ET BIOPHYSICA ACTA 302-9
`Enzymology (1976).
`Plaut et al., α-Methylisocitrate: A Selective Inhibitor of TPN-Linked
`Isocitrate Dehydrogenase From Bovine Heart and Rat Liver, 250 J.
`BIOL. CHEM. 6351-4 (1975).
`Marr & Weber, Feedback Inhibition of an Allosteric
`Triphosphopyridine Nucleotide-specific Isocitrate Dehydrogenase,
`244 J. BIOL. CHEM. 5709-12 (1969).
`Duan et al., Discovery of DC_H31 as Potential Mutant IDH1
`Inhibitor Through NADPH-based High Throughput Screening, 27
`BIOORGANIC. & MEDICINAL CHEM. 3229-36 (2019).
`Pelosi et al., Isocitrate Dehydrogenase Mutations in Human
`Cancers: Physiopathological Mechanisms and Therapeutic
`Targeting, 1 J. EXPL. RSCH. PHARMACOLOGY 20-34 (2016).
`Chaturvedi et al., In Vivo Efficacy of Mutant IDH1 Inhibitor HMS-
`101 and Structural Resolution of Distinct Binding Site, 34 Leukemia
`416-26 (2020).
`Heuser et al., Safety and Efficacy of BAY1436032 in IDH1-mutant
`AML: Phase 1 Study Results, 34 LEUKEMIA 2903-13 (2020).
`NAT’L CANCER INST., Pan-mutant-IDH1 Inhibitor BAY1436032,
`https://www.cancer.gov/publications/dictionaries/cancer-
`drug/def/pan-mutant-idh1-inhibitor-bay-1436032 (last visited Aug.
`15, 2022).
`
`vi
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`Rigel Exhibit 1003
`Page 7 of 98
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`

`

`Declaration of Prof. David H. Sherman
`U.S. Patent No. 10,610,125
`
`Exhibit
`
`Description
`
`1051
`
`1052
`
`1058
`
`Matteo et al., Molecular Mechanisms of Isocitrate Dehydrogenase 1
`(IDH1) Mutations Identified in Tumors: The Role of Size and
`Hydrophobicity at Residue 132 on Catalytic Efficiency, 292 J. BIOL.
`CHEM. 7971-83 (2017).
`(“Matteo”)
`Frezza et al. IDH1 Mutations in Gliomas: When an Enzyme Loses
`its Grip, 17 Cancer Cell 7-9 (2010).
`(“Frezza”)
`Popvici-Muller et al., Discovery of AG-120 (Ivosidenib): A First-in-
`Class Mutant IDH1 Inhibitor for the Treatment of IDH1 Mutant
`Cancers, 9 ACS MED. CHEM. LETT. 300-5 (2018).
`(“PM 2018”)
`
`vii
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`Rigel Exhibit 1003
`Page 8 of 98
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`

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`Declaration of Prof. David H. Sherman
`U.S. Patent No. 10,610,125
`
`I, Professor David H. Sherman, declare as follows:
`
`I.
`
`INTRODUCTION
`
`1.
`
`I have been retained by Petitioner Rigel Pharmaceuticals, Inc.
`
`(“Rigel”) as a technical expert witness to provide my independent opinions in
`
`connection with a petition for inter partes review (“IPR”) of U.S. Patent No.
`
`10,610,125 (“the ’125 Patent,” EX1001) before the Patent Trial and Appeal Board
`
`(“Board”). I understand that the ’125 Patent is currently assigned to Servier
`
`Pharmaceuticals LLC (“Patent Owner”).
`
`2.
`
`I have been asked by Rigel to offer opinions on the ’125 Patent,
`
`including whether Claims 1-5 and 9-12 are entitled to their 2009 and 2010 Priority
`
`Dates, and the unpatentability of Claims 1-5 and 9-12 (to which I may refer
`
`subsequently as the “Challenged Claims”) in view of certain prior art. This
`
`Declaration sets forth the opinions I have reached to date regarding these matters.
`
`3.
`
`I am being compensated at my standard hourly consulting rate of $700
`
`for my time spent in this matter. My compensation is not contingent on the
`
`outcome of the IPR or on the substance of my opinions.
`
`4.
`
`I have no financial interest in Rigel or Patent Owner.
`
`5. My opinions and the bases for my opinions are set forth below.
`
`1
`
`
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`Rigel Exhibit 1003
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`Declaration of Prof. David H. Sherman
`U.S. Patent No. 10,610,125
`
`II.
`
`BACKGROUND AND QUALIFICATIONS
`
`6.
`
`I am currently the Hans W. Vahlteich Professor of Medicinal
`
`Chemistry at the University of Michigan (UM) and hold appointments as Professor
`
`in the Department of Chemistry (College of Literature, Science, and the Arts), the
`
`Department of Medicinal Chemistry (College of Pharmacy), and the Department of
`
`Microbiology & Immunology (Medical School). I was founding Director of the
`
`Center for Chemical Genomics (2004-2011; 2013-2014), which is an academic
`
`drug discovery center, and am a Research Professor in the Life Sciences Institute at
`
`UM. I currently serve as Principal Investigator for the UM Natural Products
`
`Biosciences Initiative and the Natural Products Discovery Core. I am also a
`
`member of the Michigan Drug Discovery (MDD) executive board that oversees all
`
`academic drug discovery programs at UM. My duties for MDD include reviewing
`
`grant proposals to fund drug discovery and development efforts, including efforts
`
`to synthesize new drug leads and derivatives.
`
`7.
`
`I specialize in the fields of synthetic and medicinal chemistry, and
`
`drug discovery, all of which are directly relevant to the technology involved in this
`
`case, including the biological mechanisms of action of small molecule
`
`pharmaceuticals.
`
`2
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`Declaration of Prof. David H. Sherman
`U.S. Patent No. 10,610,125
`
`8.
`
`During my 30-year academic career, I have published over 300 peer-
`
`reviewed research publications in the fields of synthetic organic and medicinal
`
`chemistry, microbial genetics, genomics and biochemistry, bioorganic chemistry,
`
`molecular microbiology, microbial pathogenesis, enzymology, metabolic
`
`engineering, structural biology, molecular immunology, and immunochemistry.
`
`Thus, my background includes research experience that spans the multi-
`
`disciplinary fields of synthetic medicinal chemistry, microbial genetics and
`
`biochemistry, microbiology, and immunology, particularly relating to the
`
`synthesis, biosynthesis, and characterization of small biologically active molecules.
`
`9.
`
`I received a B.A. in Chemistry, with Honors, from the University of
`
`California, Santa Cruz, in 1978 and a Ph.D. in Synthetic Organic Chemistry from
`
`Columbia University in 1981.
`
`10. My dissertation research focused on development of organic
`
`chemistry reaction methodology and applications toward natural product total
`
`synthesis. This involved developing synthetic schemes and processes for several
`
`small molecules, including steroids and prostaglandins. From 1981 through 1984, I
`
`was a Postdoctoral Researcher in molecular immunology at Yale University (1981-
`
`1982) and in immunochemistry at the Massachusetts Institute of Technology
`
`(1982-1984).
`
`3
`
`
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`Declaration of Prof. David H. Sherman
`U.S. Patent No. 10,610,125
`
`11. From 1984 through 1990, I was a Research Scientist in the
`
`Department of Molecular Immunology at Biogen Research Corporation (1984-
`
`1987) and the Department of Genetics at the John Innes Institute in Norwich, U.K.
`
`(1987-1990).
`
`12. From 1990 through 2000, I progressed from Assistant Professor to
`
`Associate Professor, to Professor in the BioTechnology Institute, and Department
`
`of Microbiology at the University of Minnesota. From 1996 through 1998, I
`
`served as Director of the Center for Microbial Physiology and Metabolic
`
`Engineering at the University of Minnesota. In 1997 (while on iniversity
`
`sabbatical leave), I served as Senior Director of ChromaXome Corporation, a
`
`young biotechnology company in San Diego, California. From 1998 through
`
`2001, I was Director of the Microbiology, Immunology and Cancer Biology
`
`Graduate Program at the University of Minnesota.
`
`13.
`
`In 2003, I was awarded the John Gideon Searle Professorship and
`
`appointed Professor in the Departments of Medicinal Chemistry (College of
`
`Pharmacy), Chemistry (College of Literature, Science and the Arts), and
`
`Microbiology & Immunology (Medical School) at the University of Michigan. In
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`2007, I was awarded the Hans W. Vahlteich Professorship at UM College of
`
`Pharmacy.
`
`4
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`Rigel Exhibit 1003
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`Declaration of Prof. David H. Sherman
`U.S. Patent No. 10,610,125
`
`14.
`
`In 2011, following eight years as Director of the Center for Chemical
`
`Genomics at the University of Michigan Life Sciences Institute, I was appointed
`
`Associate Dean for Research and Graduate Education in the College of Pharmacy
`
`at the University of Michigan (2011-2016).
`
`15.
`
`I have been a member of the American Chemical Society since 1978,
`
`the American Association for the Advancement of Science since 1982, the
`
`American Society for Microbiology since 1987, and the Society for Industrial
`
`Microbiology and Biotechnology since 2000. More recently, I have become a
`
`member of the American Society for Pharmaceutical Sciences (2011), and the
`
`American Society for Pharmacognosy (2011).
`
`16.
`
`I currently serve as a referee of research articles submitted to the
`
`following scientific journals: ACS Chemical Biology; ACS Catalysis, ACS
`
`Synthetic Biology, Angewandte Chemie International Edition, Antimicrobial
`
`Agents and Chemotherapy; Applied Microbiology and Biotechnology; Canadian
`
`Journal of Microbiology; ChemBioChem; Gene; Journal of Applied and
`
`Environmental Microbiology; Journal of Bacteriology; Journal of Immunology;
`
`Microbiology; Molecular Microbiology; Proceedings of the National Academy of
`
`Sciences USA; Tetrahedron; Science; Nature; Journal of the American Chemical
`
`Society; Journal of Medicinal Chemistry; Journal of Organic Chemistry; Organic
`5
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`Rigel Exhibit 1003
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`Declaration of Prof. David H. Sherman
`U.S. Patent No. 10,610,125
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`Letters; Cell Chemical Biology; Biotechnology Progress; Journal of Natural
`
`Products; Nature Biotechnology; Nature Chemistry; and Nature Chemical Biology.
`
`17.
`
`In 2016, I was appointed to the Microbiology Spectrum Advisory
`
`Board at the American Society for Microbiology Press. In 2017, I was appointed
`
`to the editorial board of the Journal of Biological Chemistry at the American
`
`Society for Biochemistry and Molecular Biology.
`
`18.
`
`I currently serve as a Grant Reviewer for: The Wellcome Trust;
`
`United States Department of Agriculture; National Science Foundation; American
`
`Cancer Society; National Institutes of Health Small Business Innovation Research
`
`Review Panel; National Research Initiative Competitive Grants Program; Canadian
`
`NSERC; National Institutes of Health Natural Products and Bioorganic Chemistry
`
`Study Section (Ad hoc reviewer, 1997, 2002, 2003, 2004); and National Institutes
`
`of Health Special Emphasis Review Panel (March 2000, April 2000, December
`
`2001, March 2005, June 2008, September 2013, June 2018). I also served in 2018,
`
`2019 and 2020 as a special reviewer for the NIH Director’s Pioneer Award.
`
`19.
`
`I have served as a Permanent Member of the National Institutes of
`
`Health (NIH) Synthetic Biological Chemistry B Study Section (2005-2009). In
`
`2010-2012, I was appointed to the College of NIH Reviewers by the NIH Center
`
`for Scientific Review. In 2014, I served as an expert reviewer at the Center for
`6
`
`
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`Rigel Exhibit 1003
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`Declaration of Prof. David H. Sherman
`U.S. Patent No. 10,610,125
`
`Advancing Natural Products Innovation and Technology. In 2016, I served on an
`
`expert panel to review grants at the National Science Foundation relating to
`
`microbial biochemistry and biotechnology. In 2019 and 2020, I served as an
`
`expert reviewer to evaluate grant applications at the National Center for Advancing
`
`Translational Research (NIH), and for the National Oceanographic and
`
`Atmospheric Administration (genomics of harmful algal blooms).
`
`20.
`
`In 2008, I was elected Fellow of the American Association for the
`
`Advancement of Science, and I received both the A. C. Cope Scholar Award by the
`
`American Chemical Society and the Charles Thom Award from the Society of
`
`Industrial Microbiology and Biotechnology in 2009. In 2015, the American
`
`Society for Microbiology named me a Distinguished Lecturer.
`
`
`
`21. Additionally, in 2008, I co-founded Alluvium Biosciences in Ann
`
`Arbor Michigan. Alluvium Biosciences is a biotechnology company that focuses
`
`on various types of drug discovery and development programs, as well as other
`
`biological and chemical research projects, including chemical synthesis. I am
`
`currently Chief Technical Consultant to Alluvium Biosciences.
`
`22. Over the past forty years, I have conducted research in the fields of
`
`synthetic chemistry and medicinal chemistry, microbial genetics and biochemistry,
`
`molecular immunology, immunochemistry, protein biochemistry, genomics,
`7
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`
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`Rigel Exhibit 1003
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`Declaration of Prof. David H. Sherman
`U.S. Patent No. 10,610,125
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`metabolomics, and proteomics to understand the complex interplay of small
`
`molecules and proteins, and biomolecules involved in the assembly of biologically
`
`active molecules and their interactions with target receptors in cells and tissues.
`
`23.
`
`I am a named inventor on over a dozen issued U.S. patents relating to
`
`synthetic and medicinal chemistry, nucleic acids, metabolic and genetic
`
`engineering, and enzymology. A list of my complete publications, patents and
`
`patent applications and additional information regarding my background,
`
`qualifications are included as part of my curriculum vitae (“CV”), which is
`
`included in EX1004.
`
`24.
`
`I have served as an expert witness in district court patent infringement
`
`cases, and International Trade Commission (“ITC”) investigations in the field of
`
`medicinal chemistry, and drug discovery/development as shown in my CV.
`
`25. Based on my experiences described above, and as indicated in my
`
`CV, I am qualified to provide the following opinions regarding the ’125 Patent.
`
`III. MATERIALS CONSIDERED
`
`26.
`
`In forming my opinions, in addition to my education, knowledge, and
`
`experience, I have reviewed and considered the ’125 Patent and each of the
`
`documents and items listed in the List of Exhibits above and the other documents
`
`cited in my Declaration.
`
`8
`
`
`
`Rigel Exhibit 1003
`Page 16 of 98
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`

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`Declaration of Prof. David H. Sherman
`U.S. Patent No. 10,610,125
`
`27.
`
`The opinions I have set forth in this Declaration are not exhaustive of
`
`my opinions regarding the unpatentability of the Challenged Claims of the ’125
`
`Patent. Thus, the fact that I do not address a particular point should not be
`
`understood to indicate that any issued claim of the ’125 Patent is patentable and/or
`
`complies with the requirements of any applicable patent law, patent rule, or any
`
`other applicable statute, case law, or rule.
`
`28.
`
`I reserve the right to amend and supplement this Declaration based on
`
`consideration of additional evidence, arguments, or testimony presented during this
`
`IPR or during any other proceedings related to the ’125 Patent.
`
`IV. MY UNDERSTANDING OF CERTAIN LEGAL STANDARDS
`
`29.
`
`I am not a legal expert and offer no opinions on the law. However, I
`
`have been informed by counsel of the various legal standards that apply, some of
`
`which I have set forth my understanding below, and I have applied these standards
`
`in arriving at my conclusions.
`
`30.
`
`I understand that for a claim to be found unpatentable in this
`
`proceeding, Petitioner must prove that the claim is unpatentable by a
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`preponderance of the evidence. Put another way, Petitioner must show the claim is
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`more likely than not anticipated or obvious in light of prior art.
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`Declaration of Prof. David H. Sherman
`U.S. Patent No. 10,610,125
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`A. Ordinary Skill in the Art
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`31. My opinions in this Declaration are based on, and applied from the
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`perspective of, an understanding of a person of ordinary skill in the art, which I
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`understand is typically referred to by the acronym “POSA.”
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`32.
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`I understand that a POSA is a hypothetical person who is presumed to
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`be aware of the relevant information that is considered prior art at the time of
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`invention. By “relevant,” I mean relevant to the Challenged Claims of the ’125
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`Patent.
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`33.
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`I understand that, in assessing the level of skill of a POSA, one should
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`consider the type of problems encountered in the art, the solutions to those
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`problems, the pace of innovation in the field, the sophistication of the technology,
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`the level of education of active workers in the field, and my own experience
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`working with those of skill in the art at the time of the invention.
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`B. Claim Construction
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`34.
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`I understand that claims, including the Challenged Claims, are
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`generally interpreted according to their ordinary and customary meaning taking
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`into consideration the so-called “intrinsic evidence” of the patent consisting of (1)
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`the claim language; (2) the specification and drawings; and (3) the prosecution
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`history. I understand that the Board has discretion to take into consideration so-
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`Page 18 of 98
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`Declaration of Prof. David H. Sherman
`U.S. Patent No. 10,610,125
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`called “extrinsic evidence” including references (prior art and non-prior art) as well
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`as definitions from dictionaries and treatises.
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`35.
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`I understand that claim terms may be explicitly defined in the patent
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`specification, or they may be implicitly defined through consistent usage in the
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`specification. I also understand that the scope of claim terms may be limited by
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`statements in the specification or prosecution history where the application clearly
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`disavows or disclaims subject matter in a clear and unmistakable manner.
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`36.
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`I understand that antecedent basis in a claim is a recitation of words or
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`phrases that makes clear (e.g., introduces) a limitation in the claim. For example, I
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`understand “a lever” recited at the beginning of the claim provides antecedent basis
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`for “the lever” recited later in the claim.
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`37.
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`I understand that for purposes of this IPR, the standards for claim
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`construction are the same as the standards used in the federal district courts.
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`C. Anticipation (35 U.S.C. §102)
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`38.
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`I understand that a claim is unpatentable as anticipated if all
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`limitations of that claim are (1) present in a single prior art device, system, or
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`method or (2) described in a single prior art reference.
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`Declaration of Prof. David H. Sherman
`U.S. Patent No. 10,610,125
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`39. To anticipate the claim, the prior art does not have to use the same
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`words as the claim, but all the limitations of the claim must have been present or
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`described, either expressly or inherently, as arranged in the claim.
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`40.
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`I understand that for prior art to inherently have or disclose a
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`limitation of the claim, the prior art must necessarily include the claim limitation
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`that is not expressly present or disclosed. I understand that inherency may not be
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`established by probabilities or possibilities.
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`D. Obviousness (35 U.S.C. §103)
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`41.
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`I understand that a claim is unpatentable as obvious if the claimed
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`subject matter as a whole would have been obvious to a POSA at the time the
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`invention was made in light of the teachings of a single prior art device, system,
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`method, or reference, or in light of a combination of prior art.
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`42.
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`I understand that obviousness is a question of law based on underlying
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`factual issues including the level of ordinary skill in the art at the time of the
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`patent’s alleged invention, the scope and content of the prior art, any differences
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`between the prior art and the claimed invention, and any objective indicia of non-
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`obviousness (if available), also known as “secondary considerations.”
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`43.
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`I understand that the scope and content of prior art for deciding
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`whether the invention was obvious includes at least prior art in the same field as
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`Page 20 of 98
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`Declaration of Prof. David H. Sherman
`U.S. Patent No. 10,610,125
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`the claimed invention. The prior art can also come from different fields that a
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`POSA would have considered when trying to solve the problem that is addressed
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`by the invention.
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`44.
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`I understand that the existence of each and every limitation of the
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`claimed invention in the prior art does not necessarily prove obviousness. Most, if
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`not all, inventions rely on building blocks of prior art. But, in considering whether
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`a claimed invention is obvious, I understand that one may find obviousness if, at
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`the time of the patent’s alleged invention, there was a reason that would have
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`prompted a POSA to combine the known elements in a way the claimed invention
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`does, taking into account such factors as (1) whether the claimed invention was
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`merely the predictable result of using prior art elements according to their known
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`function(s); (2) whether the claimed invention provides an obvious solution to a
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`known problem in the relevant field; (3) whether the prior art teaches or suggests
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`the desirability of combining elements claimed in the invention; (4) whether the
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`prior art teaches away from combining elements in the claimed invention; (5)
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`whether it would have been obvious to try the combinations of elements, such as
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`when there is a design need or market pressure to solve a problem and there are a
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`13
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`Declaration of Prof. David H. Sherman
`U.S. Patent No. 10,610,125
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`finite number of identified, predictable solutions; and (6) whether the change
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`resulted more from design incentives or other market forces.
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`45.
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`I understand that in order for a claim to be rendered obvious by a
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`combination or modification of prior art, it must be shown that a POSA would
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`have had a motivation to combine or modify the prior art with a reasonable
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`expectation of success that the combination of prior art would result in the claimed
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`invention.
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`46.
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`In assessing obviousness, I have been instructed to consider both the
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`ordinary creativity and common sense of a POSA. However, I also understand that
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`it is impermissible to find obviousness based on hindsight reasoning, i.e.,
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`combining prior art using the claimed invention as a template, without establishing
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`that, as of the date of the invention, there exists a motivation to combine or
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`apparent reason to combine and/or modify the prior art.
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`47.
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`I understand secondary considerations include comme