UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`___________________
`
`FORESIGHT DIAGNOSTICS INC.,
`Petitioner,
`
`v.
`
`PERSONALIS, INC.,
`Patent Owner.
`
`____________________
`
`IPR2023-00317
`U.S. Patent No. 11,408,033
`____________________
`
`DECLARATION OF JOHN QUACKENBUSH, PH.D. IN SUPPORT OF
`PETITIONER FOR INTER PARTES REVIEW
`
`Mail Stop: PATENT BOARD
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`11166836
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`Foresight EX1020
`Foresight v Personalis
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`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`___________________
`
`FORESIGHT DIAGNOSTICS INC.,
`Petitioner,
`
`v.
`
`PERSONALIS, INC.,
`Patent Owner.
`
`____________________
`
`IPR2023-00317
`U.S. Patent No. 11,408,033
`____________________
`
`DECLARATION OF JOHN QUACKENBUSH, PH.D. IN SUPPORT OF
`PETITIONER FOR INTER PARTES REVIEW
`
`Mail Stop: PATENT BOARD
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
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`11166836
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`IPR2023-00317
`U.S. Patent No. 11,408,033
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`TABLE OF CONTENTS
`
`I.
`II.
`
`Page
`Introduction ............................................................................................ 1
`Legal Standards ...................................................................................... 7
`A.
`Claim Construction ...................................................................... 7
`B.
`Anticipation .................................................................................. 8
`C.
`Obviousness ................................................................................. 8
`III. The ’033 Patent ..................................................................................... 12
`IV. Person of Ordinary Skill in the Art ...................................................... 13
`V. Overview of a Person of Ordinary Skill in the Art’s Knowledge ........ 14
`A. Overview of Molecular Biology and Genetics .......................... 14
`1.
`The Central Dogma of Molecular Biology ...................... 14
`2.
`Genetics............................................................................ 18
`Genetic Mutations ...................................................................... 20
`Nucleic Acid Sequencing Technologies .................................... 23
`1.
`Sequencing Techniques ................................................... 23
`2. Whole-Genome Sequencing ............................................ 28
`3.
`Amplification and Enrichment ........................................ 30
`a)
`PCR ........................................................................ 34
`b)
`Solution-Based Hybrid Capture ............................ 36
`Personalized Cancer Testing and Monitoring ............................ 39
`Related Applications of Next-Generation Sequencing .............. 43
`
`B.
`C.
`
`D.
`E.
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`TABLE OF CONTENTS
`Cont'd
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`Page
`
`F.
`
`Providing Actionable Information to Healthcare
`Providers..................................................................................... 46
`VI. Prior Art References of the Grounds .................................................... 49
`A.
`Forshew (Ex. 1030) .................................................................... 49
`B. Wagle (Ex. 1033) ....................................................................... 50
`C.
`Chan (Ex. 1008) ......................................................................... 50
`VII. Claim Construction ............................................................................... 51
`A.
`“capture probe” .......................................................................... 52
`B.
`“polymorphism” ......................................................................... 56
`C.
`“biomedical report” .................................................................... 57
`VIII. Prior Art Anticipated or Would Have Rendered Obvious the
`Claims of the ’033 Patent ..................................................................... 58
`A. Ground 1: Forshew Anticipates Claims 1-7, 10-23 ................... 58
`1.
`Claim 1 ............................................................................. 63
`a)
`“producing, with the aid of a computer
`processor, a plurality of capture probes, wherein
`said plurality of capture probes hybridize to a
`plurality of polymorphisms, wherein said plurality
`of polymorphisms are in sequences encoding genes
`with known biomedically interpretable variants,
`and wherein said plurality of polymorphisms are
`based on or extracted from one or more databases
`of polymorphisms and are observed in a
`population of one or more samples” ................................ 64
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`TABLE OF CONTENTS
`Cont'd
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`Page
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`“contacting said nucleic acid sample with
`b)
`said plurality of capture probes produced in (a)” ............ 68
`c)
`“conducting a sequencing assay on a subset
`of nucleic acid molecules generated from said
`nucleic acid sample in step (b) to yield a result
`comprising a nucleic acid sequence, thereby
`analyzing said nucleic acid sample” ................................ 69
`d)
`“repeating steps (b)-(c) on a subsequently
`obtained biological sample from said individual” ........... 72
`Claim 2 ............................................................................. 73
`2.
`Claim 3 ............................................................................. 74
`3.
`Claim 4 ............................................................................. 74
`4.
`Claim 5 ............................................................................. 75
`5.
`Claim 6 ............................................................................. 75
`6.
`Claim 7 ............................................................................. 76
`7.
`Claim 10 ........................................................................... 76
`8.
`Claim 11 ........................................................................... 77
`9.
`10. Claim 12 ........................................................................... 77
`11. Claim 13 ........................................................................... 77
`12. Claim 14 ........................................................................... 78
`13. Claim 15 ........................................................................... 79
`14. Claim 16 ........................................................................... 79
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`TABLE OF CONTENTS
`Cont'd
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`Page
`15. Claim 17 ........................................................................... 79
`16. Claim 18 ........................................................................... 80
`17. Claim 19 ........................................................................... 80
`18. Claim 20 ........................................................................... 80
`19. Claim 21 ........................................................................... 81
`20. Claim 22 ........................................................................... 81
`21. Claim 23 ........................................................................... 82
`Ground 2: Claims 1-23 Would Have Been Obvious Over
`Forshew in view of Wagle ......................................................... 82
`1.
`Claims 1-23—Hybridization probes as “capture
`probes” ............................................................................. 84
`Claims 1-7, 10-23 ............................................................ 85
`2.
`Claim 8 ............................................................................. 88
`3.
`Claim 9 ............................................................................. 89
`4.
`Ground 3: Claims 1-9 and 11-23 Would Have Been
`Obvious Over Wagle in view of Chan ....................................... 90
`1.
`Claim 1 ............................................................................. 92
`a)
`“producing, with the aid of a computer
`processor, a plurality of capture probes, wherein
`said plurality of capture probes hybridize to a
`plurality of polymorphisms, wherein said plurality
`of polymorphisms are in sequences encoding genes
`with known biomedically interpretable variants,
`and wherein said plurality of polymorphisms are
`
`B.
`
`C.
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`TABLE OF CONTENTS
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`Page
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`based on or extracted from one or more databases
`of polymorphisms and are observed in a
`population of one or more samples” ................................ 94
`b)
`“contacting said nucleic acid sample with
`said plurality of capture probes produced in (a)” .......... 100
`c)
`conducting a sequencing assay on a subset
`of nucleic acid molecules generated from said
`nucleic acid sample in step (b) to yield a result
`comprising a nucleic acid sequence, thereby
`analyzing said nucleic acid sample” .............................. 104
`d)
`“repeating steps (b)-(c) on a subsequently
`obtained biological sample from said individual” ......... 106
`Claim 2 ........................................................................... 108
`2.
`Claim 3 ........................................................................... 109
`3.
`Claim 4 ........................................................................... 110
`4.
`Claim 5 ........................................................................... 111
`5.
`Claim 6 ........................................................................... 111
`6.
`Claim 7 ........................................................................... 112
`7.
`Claim 8 ........................................................................... 113
`8.
`Claim 9 ........................................................................... 114
`9.
`10. Claim 11 ......................................................................... 114
`11. Claim 12 ......................................................................... 115
`12. Claim 13 ......................................................................... 115
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`TABLE OF CONTENTS
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`Page
`13. Claim 14 ......................................................................... 116
`14. Claim 15 ......................................................................... 117
`15. Claim 16 ......................................................................... 117
`16. Claim 17 ......................................................................... 117
`17. Claim 18 ......................................................................... 118
`18. Claim 19 ......................................................................... 118
`19. Claim 20 ......................................................................... 118
`20. Claim 21 ......................................................................... 119
`21. Claim 22 ......................................................................... 119
`22. Claim 23 ......................................................................... 119
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`
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`Exhibits Cited
`
`Ex. 1001 U.S. Patent No. 11,408,033 issued to Bartha et al.
`
`Ex. 1002 Rebecca J. Leary et al., “Development of Personalized Tumor
`Biomarkers Using Massively Parallel Sequencing,” Science
`Translational Medicine (2010) (Leary)
`
`Ex. 1003 Quake et al., WO 2011/057061 (Quake)
`
`Ex. 1004 Matthew W. Anderson & Iris Schrijver, “Next Generation DNA
`Sequencing and the Future of Genomic Medicine,” Genes
`(2010) (Anderson)
`
`Ex. 1005 Andreas Gnirke et al., “Solution hybrid selection with ultra-long
`oligonucleotides for massively parallel targeted sequencing,”
`Nature Biotechnology (2009) (Gnirke)
`
`Ex. 1006
`
`Florian Mertes et al., “Targeted enrichment of genomic DNA
`regions for next-generation sequencing, Briefings in Functional
`Genomics,” Briefings in Functional Genomics (2011) (Mertes)
`
`Ex. 1007 Lira Mamanova et al., “Target-enrichment strategies for next-
`generation sequencing,” Nature (2010) (Mamanova)
`
`Ex. 1008 K.C. Allen Chan et al., “Cancer Genome Scanning in Plasma:
`Detection of Tumor-Associated Copy Number Aberrations,
`Single-Nucleotide Variants, and Tumoral Heterogeneity by
`Massively Parallel Sequencing,” Clinical Chemistry (2013)
`(Chan)
`
`Ex. 1010 Personalis v. Foresight, First Amended Complaint, D. Colo.,
`Case No. 1:22-v-01913, Dkt. 9, filed August, 17, 2022 (“FAC”)
`
`Ex. 1012 Timothy J. Ley et al., “DNA sequencing of a cytogenetically
`normal acute myeloid leukaemia genome,” Nature (2008) (Ley)
`
`Ex. 1013
`
`Jay Shendure & Hanlee Ji, “Next-generation DNA sequencing,”
`Nature Biotechnology (2008) (Shendure)
`
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`Ex. 1014
`
`Jeffrey S. Ross and Maureen Cronin, “Whole Cancer Genome
`Sequencing by Next-Generation Methods,” American Journal of
`Clinical Pathology (2011) (Ross)
`
`Ex. 1015 David J. McBride, et al., “Use of Cancer-Specific Genomic
`Rearrangements to Quantify Disease Burden in Plasma from
`Patients with Solid Tumors,” Genes, Chromosomes & Cancer
`(2010) (McBride)
`
`Ex. 1016 David M. Kurtz, et al., “Enhanced detection of minimal residual
`disease by targeted sequencing of phased variants in circulating
`tumor DNA,” Nature Biotechnology (2021) (Kurtz) (Ex. J to
`FAC)
`
`Ex. 1019
`
`https://www.genome.gov/about-genomics/fact-sheets/DNA-
`Sequencing-Costs-Data
`
`Ex. 1020 Declaration of John Quackenbush, Ph.D.
`
`Ex. 1021 Declaration of Ingrid Hsieh-Yee, Ph.D.
`
`Ex. 1023 Curriculum Vitae of John Quackenbush
`
`Ex. 1024
`
`https://www.garvan.org.au/research/kinghorn-centre-for-
`clinical-genomics/learn-about-genomics/for-gp/genetics-
`refresher-1/types-of-variants
`
`Ex. 1026 Leary Supplemental Information
`
`Ex. 1027
`
`Illumina, Technical Note: Sequencing
`
`Ex. 1028
`
`Illumina, Specification Sheet: Illumina Sequencing
`
`Ex. 1029 Hugo Lam, et al., “Performance comparison of whole-genome
`sequencing platforms,” Nature Biotechnology (2012) (Lam)
`
`Ex. 1030 Tim Forshew, et al., “Noninvasive Identification and Monitoring
`of Cancer Mutations by Targeted Deep Sequencing of Plasma
`DNA,” Science Translational Medicine (2012) (Forshew)
`
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`Ex. 1031 Matthew Meyerson, et al., “Advances in understanding cancer
`genomes through second-generation sequencing,” Nature
`Reviews (2010) (Meyerson)
`
`Ex. 1032
`
`Forshew Supplemental Information
`
`Ex. 1033 Nikhil Wagle et al., “High-Throughput Detection of Actionable
`Genomic Alterations in Clinical Tumor Samples by Targeted,
`Massively Parallel Sequencing,” Cancer Discovery (2012)
`(Wagle)
`
`Ex. 1034 Andreas Untergasser et al., “Primer3—new capabilities and
`interfaces,” Nucleic Acids Res. (2012) (Untergasser)
`
`Ex. 1035
`
`Simon Forbes et al., “COSMIC: mining complete cancer
`genomes in the Catalogue of Somatic Mutations in Cancer,”
`Nucleic Acids Res. (2011) (Forbes)
`
`Ex. 1036 Y. Kohara, “DNA probes on beads arrayed in a capillary, 'Bead-
`array', exhibited high hybridization performance,” Nucleic
`Acids Res. (2002) (Kohara)
`
`Ex. 1037
`
`Infringement Claim Chart for U.S. Patent No. 11,408,033; Ex. O
`to Patent Owner’s FAC
`
`Ex. 1038 C. Vale et al., “Does anti-EGFR therapy improve outcome in
`advanced colorectal cancer? A systematic review and meta-
`analysis.” Cancer Treat Rev. (2012) (Vale)
`
`Ex. 1039 Wagle Supplementary Tables
`
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`I.
`
`Introduction
`1. My name is John Quackenbush. I have been retained by Foresight
`
`Diagnostics Inc. (“Petitioner”) to provide my independent evaluation and opinions
`
`regarding U.S Patent No. 11,408,033 and related prior art.
`
`2.
`
`For this service, I am paid my standard hourly consulting fee, and I am
`
`reimbursed for actual expenses. My compensation in no way depends on the
`
`outcome of this matter or the substance of this declaration.
`
`3.
`
`In my testimony, I have relied upon my technical background, skills,
`
`knowledge, training, education and experience in the relevant art, and my
`
`examination of the materials utilized in preparing this declaration.
`
`4.
`
`In providing this testimony, I have relied on the materials cited herein,
`
`as well as my knowledge and experience working in the field before the priority date
`
`of the ’033 patent, from the perspective of a person of ordinary skill in the art as of
`
`the priority date.
`
`5.
`
`I am a Henry Pickering Walcott Professor of Computational Biology
`
`and Bioinformatics and Chair of the Department of Biostatistics at the Harvard T.H.
`
`Chan School of Public Health. I am also Founding Director and co-Director of the
`
`MS Program in Computational Biology and Quantitative Genetics and Director of
`
`the Big Data to Knowledge Training Program, co-Director of the Cancer Genomics
`
`Training Program, and the Faculty Director for the Harvard Quantitative Biomedical
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`Research Center. In addition, I hold appointments as Professor of Biostatistics and
`
`Computational Biology at the Dana-Farber Cancer Institute and at the Channing
`
`Division of Network Medicine of Brigham and Women’s Hospital.
`
`6.
`
`In addition to my academic appointments, I co-founded Genospace
`
`LLC in 2012. Genospace produces software solutions to operationalize precision
`
`medicine through the integration of clinical and genomic data and its presentation to
`
`clinical and research users in an intuitive format. Genospace was purchased by
`
`Hospital Corporation of America in January of 2017.
`
`7.
`
`In addition to my academic and research responsibilities, over the years
`
`I have taken significant regional and national research leadership responsibilities. I
`
`have served on the Scientific Advisory Board of the St. Jude’s Children’s Research
`
`Hospital and the Board of Scientific Counselors of the Environmental Protection
`
`Agency. I have also served on numerous scientific review panels for the National
`
`Institutes of Health, the National Science Foundation, the Department of Energy, the
`
`National Aeronautics and Space Administration, the Wellcome Trust, Genome
`
`British Columbia, Genome Canada, the National Sciences and Engineering Council
`
`of Canada, and the European Union. And I have served on numerous study panels
`
`for the National Research Council, the National Academy of Sciences, and the
`
`Institute of Medicine.
`
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`8.
`
`I have presented more than 350 talks, courses, and workshops since
`
`joining the Harvard School of Public Health and Dana-Farber in 2005. I have also
`
`taught numerous courses and workshops on the analysis of genomic data and served
`
`as an organizer of the EMBO course on DNA microarray analysis for more than 5
`
`years.
`
`9.
`
`Prior to joining the faculty at Dana-Farber and Harvard, I was a
`
`Professor of Chemical Engineering at the University of Maryland from 2003 – 2005;
`
`an Investigator with The Institute for Genomic Research from 2002 – 2006; a
`
`Professor in the Department of Biochemistry at The George Washington University
`
`from 2000 – 2005; a Lecturer in The Department of Biostatistics at The Johns
`
`Hopkins University from 1998 – 2005; an Associate Investigator at The Institute for
`
`Genomic Research from 1997 – 2001; and an Assistant Investigator at The Institute
`
`for Genomic Research in 1997.
`
`10.
`
`I received my Ph.D. in Theoretical Particle Physics at the University of
`
`California, Los Angeles in 1990. I also hold a Master of Science in Physics from
`
`University of California, Los Angeles and a Bachelor of Science in Physics from the
`
`California Institute of Technology.
`
`11.
`
`I have studied, taught, practiced, and conducted research involving the
`
`use of genomic technologies, including DNA sequencing and DNA microarrays, and
`
`involving computational analysis of data related to genomic technologies. I have
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`expertise in genomic technologies, computational analysis, and modeling of a plant,
`
`animal, and microbial systems with an emphasis on the study of human diseases,
`
`such as cancer.
`
`12.
`
`In describing my work, I often use terms to refer to techniques and
`
`technologies, as well as specific application areas. During the course of my career, I
`
`have worked in genomics, functional genomics, epigenomics, bioinformatics,
`
`biostatistics, computational biology, systems biology, network biology, and network
`
`medicine. Although the boundaries between these various fields are often not well
`
`defined, one possible distinction is that some are directed toward data generation
`
`while others are directed toward developing and applying methods for data analysis
`
`and interpretation. For example, genomics, functional genomics, and epigenomics
`
`are generally associated with the design and conduct of experiments for generation
`
`of large-scale data on hundreds, thousands, or tens of thousands of genes, RNA
`
`transcripts, or epigenetic sites within the genome (or other alterations such as
`
`identifying regulatory interactions or structural changes in the genome). Fields
`
`including bioinformatics, biostatistics, computational biology, systems biology,
`
`network biology, and network medicine generally involve the development of new
`
`methods for data analysis and application of those methods to the biological and
`
`biomedical data sets, including those generated using techniques such as genomics,
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`functional genomics, and epigenomics. The beauty of all of these techniques is that
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`their development and use is, largely although not entirely, independent of their
`
`application area. So methods developed on one area are often used in other areas.
`
`13.
`
`I have worked in the analysis of genes in hundreds of animal, plant,
`
`unicellular, and parasitic species, including human, mouse, rat, cattle, sheep, brown
`
`bear, salmon, corn, tomato, rice, yeast, the causative agent of malaria, and countless
`
`bacteria and viruses. Despite this diversity of applications, my primary research
`
`emphasis has been in the study of human diseases, with the greatest body of my
`
`recent work in the analysis of human cancers and pulmonary diseases. However, I
`
`have also explored a wide range of other issues in health and disease, including
`
`Alzheimer’s disease, Parkinson’s disease, Huntington’s disease, neonatal sepsis, and
`
`Down syndrome. My work has involved analysis of data generated from bulk tissue
`
`samples, small numbers of cells, single cells, and cell-free DNA.
`
`14.
`
`I have also done work relevant to reproductive health, an area that
`
`became personally important to me as my wife and I, then in our forties, became
`
`enmeshed in the use of assisted reproductive technology. This gave me first-hand
`
`exposure to a wide range of techniques, including pre-implantation prenatal
`
`screening and the use and limitations of technologies directed toward prenatal
`
`detection of genetic abnormalities including aneuploidies. Following the birth of my
`
`son in 2006 at Brigham and Women’s Hospital in Boston, I also worked with, and
`
`mentored, physician scientists at Harvard, published a genomic analysis of
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`diminished ovarian reserve, and presented the President’s plenary lecture at the 63rd
`
`American Society for Reproductive Medicine Annual Meeting in 2007 in which I
`
`described the use of genomic technology in reproductive, prenatal, and neonatal
`
`health.
`
`15.
`
`I have received numerous awards and honors including being
`
`recognized as a White House Open Science Champion of Change, an Australia
`
`Fellow, and a Distinguished International Advisor for the International Conference
`
`of BioInformatics and BioEngineering sponsored by the Institute of Electrical and
`
`Electronics Engineers. In 2022 I was elected to the National Academy of Medicine,
`
`one of three academies that make up the National Academies of Sciences,
`
`Engineering, and Medicine (the National Academies) in the United States.
`
`16.
`
`I have published more than 300 peer reviewed scientific papers that
`
`have been cited more than 88,000 times. I have had continuous grant support for my
`
`research from the National Institutes of Health and other organizations for nearly
`
`thirty years. In 2018, I received an NCI Outstanding Investigator Career Award, a
`
`seven-year research grant recognizing a lifetime record of substantial contributions
`
`to the field.
`
`17. A copy of my Curriculum Vitae, attached as Exhibit 1023, contains
`
`further details on my education, experience, publications, and other qualifications to
`
`render an expert opinion in this matter.
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`II. Legal Standards
`18.
` I am not a lawyer. However, I have been informed by counsel of
`
`general principles concerning patent law and the analysis of whether a patent claim
`
`is valid. I have followed these principles in arriving at my conclusions in this
`
`declaration. The sections below set forth my understanding of the legal principles
`
`that are relevant to my opinions in this declaration.
`
`A. Claim Construction
`
`19.
`
`I understand that the claims of a patent define the scope of the
`
`inventions that are protected by the patent. I understand that the language of the
`
`claims is construed as it would be understood by a hypothetical person having
`
`ordinary skill in the art (a “POSA”) at the time of the invention. Accordingly, where
`
`I refer below to a POSA—for example, where I discuss how such a person would
`
`have understood the specification or the claims, or what a POSA might have known,
`
`among other things—I am referring to such a person working at the time of the
`
`invention, even if for the sake of brevity I omit that specific timeframe from my
`
`statements.
`
`20.
`
`I understand words in a claim will be given their ordinary or customary
`
`meaning unless it appears that the inventor used them differently.
`
`21.
`
`I also understand that, in construing patent claims, courts seek to
`
`determine what a person skilled in the art would have understood the claims to mean
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`
`
`
`IPR2023-00317
`U.S. Patent No. 11,408,033
`
`primarily in light of the intrinsic evidence of record, which includes the language of
`
`the claim itself and other issued claims, the specification, the art cited during
`
`prosecution, and the prosecution history.
`
`22. As discussed below in Section VII (“Claim Construction”), where
`
`relevant, I have applied the implicit interpretation of the claim language that Patent
`
`Owner applied in its complaint for infringement against Petitioner. Exs. 1010, 1037.
`
`B. Anticipation
`
`23.
`
`I understand that, for an invention claimed in a patent to be found
`
`patentable, or to be valid, it must be, among other things, new in light of what came
`
`before it. That which came before is generally referred to as “prior art.” I understand
`
`anticipation requires that each and every element of a challenged claim is present in
`
`or otherwise taught by a single prior art reference.
`
`C. Obviousness
`
`24. Also, I understand that, for an invention claimed in a patent to be found
`
`patentable, or to be valid, it must be, among other things, not obvious in light of what
`
`came before it, i.e., prior art.
`
`25.
`
`I understand that a patent claim is unpatentable or may be found invalid
`
`as obvious if, at the time when the invention was made, the subject matter of the
`
`claim, considered as a whole, would have been obvious to a person having ordinary
`
`
`
`
`- 8 -
`
`Foresight EX1020
`Foresight v Personalis
`
`
`
`IPR2023-00317
`U.S. Patent No. 11,408,033
`
`skill in the field of the technology (the “art”) to which the claimed subject matter
`
`belongs.
`
`26.
`
`I understand that the obviousness standard is defined in the patent
`
`statute as follows:
`
`A patent may not be obtained though the invention is not identically
`disclosed or described as set forth in section 102 [in a single prior art
`reference], if the differences between the subject matter sought to be
`patented and the prior art are such that the subject matter as a whole
`would have been obvious at the time the invention was made to a person
`having ordinary skill in the art to which said subject matter pertains.
`Patentability shall not be negatived by the manner in which the
`invention was made.
`
`35 U.S.C. § 103(a).
`
`27.
`
`I understand that a claim in a patent is obvious when the differences
`
`between the subject matter sought to be patented and the prior art are such that the
`
`subject matter as a whole would have been obvious at the time the invention was
`
`made to a person having ordinary skill in the art to which the subject matter pertains.
`
`28.
`
`I understand that obviousness may be shown by considering more than
`
`one item of prior art, and that the following factors should be considered in analyzing
`
`obviousness: (1) the scope and content of the prior art; (2) the differences between
`
`the prior art and the claims; and (3) the level of ordinary skill in the pertinent art.
`
`
`
`
`- 9 -
`
`Foresight EX1020
`Foresight v Personalis
`
`
`
`IPR2023-00317
`U.S. Patent No. 11,408,033
`
`
`29.
`
`I understand that a person of ordinary skill in the art is assumed to have
`
`knowledge of all relevant prior art. I understand that one skilled in the art can
`
`combine the teachings of various prior art references based on the teachings of the
`
`individual prior art references, the general knowledge present in the art, or common
`
`sense. I understand that a teaching, motivation or suggestion appearing in the prior
`
`art may provide a basis for combining two (or more) prior art references or
`
`modifying a given prior art reference. A motivation to combine references may also
`
`be implicit in the prior art, and there is no requirement that there be an actual or
`
`explicit teaching to combine two references. Thus, one may take into account the
`
`inferences and creative steps that a person of ordinary skill in the art would employ
`
`to combine the known steps in the prior art in the manner claimed by the patent at
`
`issue.
`
`30.
`
`I understand that the combination of familiar steps according to known
`
`methods is likely to be obvious when it does no more than yield predictable results.
`
`I understand that when a work is available in one field of endeavor, design incentives
`
`and other market forces can prompt variations of that work, either in the same field
`
`or a different one. Likewise, if a technique has been used to improve one device, and
`
`a person of ordinary skill in the art would recognize that it would improve similar
`
`devices in the same way, using that technique to improve the other device in a
`
`predictable manner would normally be obvious.
`
`
`
`
`- 10 -
`
`Foresight EX1020
`Foresight v Personalis
`
`
`
`IPR2023-00317
`U.S. Patent No. 11,408,033
`
`
`31.
`
`I understand that a person of ordinary skill is also a person of ordinary
`
`creativity in the field. A person of ordinary skill attempting to solve a problem will
`
`not be restricted only to those steps of prior art designed to solve the same problem.
`
`Rather, in exercising common sense and ordinary creativity, a person of ordinary
`
`skill can draw upon prior art directed to any need or problem known in the field of
`
`endeavor at the time of the invention. In other words, the prior art does not need to
`
`be directed towards solving the same problem that is addressed in the patent. Further,
`
`the individual prior art references themselves need not all be directed towards
`
`solving the same problem.
`
`32.
`
`I further understand that in many fields, it may be that there is little
`
`discussion of obvious techniques or combination, and it often may be the case that
`
`market demand, rather than scientific literature or knowledge, will drive design
`
`trends. When there is such a design need or market pressure to solve a problem and
`
`there are a finite number of identified, predictable solutions, a person of ordinary
`
`skill has good reason to pursue the known options within their technical grasp. If
`
`this leads to the anticipated success, it is likely the result not of innovation but of
`
`ordin
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