UNITED STATES PATENT AND TRADEMARK OFFICE
`__________________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________________________________
`
`FORESIGHT DIAGNOSTICS INC.,
`Petitioner,
`
`v.
`
`PERSONALIS, INC.,
`Patent Owner.
`
`Case Nos. IPR2023-00224 and IPR2023-00317
`U.S. Patent Nos. 11,384,394 and 11,408,033
`
`DECLARATION OF DAN NORTON
`
`Personalis EX2035
`
`
`__________________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________________________________
`
`FORESIGHT DIAGNOSTICS INC.,
`Petitioner,
`
`v.
`
`PERSONALIS, INC.,
`Patent Owner.
`
`Case Nos. IPR2023-00224 and IPR2023-00317
`U.S. Patent Nos. 11,384,394 and 11,408,033
`
`DECLARATION OF DAN NORTON
`
`Personalis EX2035
`
`
`
`TABLE OF CONTENTS
`
`
`Page No.
`
`
`
`
`
`I. BACKGROUND AND QUALIFICATIONS ........................................................ 1
`II. INDUSTRY PRAISE FOR PERSONALIS’ NEXT PERSONAL® ASSAY ....... 2
`A.
`The Scientist Magazine praise for NeXT Personal® ............................. 2
`B.
`TRACERx praise for NeXT Personal® ................................................. 5
`C.
`AstraZeneca’s trust and recognition for NeXT Personal® .................... 6
`III. CERTIFICATION ............................................................................................... 7
`
`
`Table of Contents, Page 1
`
`Personalis EX2035
`
`
`
`
`
`Exhibit No.
`
`2001
`
`2153
`
`2154
`
`2156
`
`LIST OF EXHIBITS CITED
`
`
`Description
`
`The Scientist Staff, “2022 Top 10 Innovations,” Dec. 12, 2022,
`available at https://www.the-scientist.com/features/2022-top-10-
`innovations-70792
`
`“Personalis MRD Assays to Support UK’s TRACERx ctDNA
`Monitoring Study,” Precision Medicine Online, April 5, 2023
`
`“Personalis, AstraZeneca Extend Collaboration Around Residual
`Cancer Detection Test,” GenomeWeb, March 7, 2023
`
`Labrousse, “MATRIX plasma-in-plasma contrived samples
`assessment and detection of MRD using the Personalis NeXT
`Personal assay,” American Society of Clinical Oncology, e15056,
`2023
`
`
`
`Exhibit List, Page 1
`
`Personalis EX2035
`
`
`
`Foresight Diagnostics v. Personalis
`IPR2023-00224 and IPR2023-00317
`1.
`I, Dan Norton, make this Declaration in connection with inter partes
`
`review proceedings at the U.S. Patent & Trademark Office concerning U.S. Patent
`
`No. 11,384,394 (“the ’394 patent”) and U.S. Patent No. 11,408,033 (“the ’033
`
`patent”).
`
`2.
`
`This declaration discusses examples of industry praise for Personalis’
`
`NeXT Personal® assay that have been provided by The Scientist Magazine, Precision
`
`Medicine Online, and GenomeWeb.
`
`I. BACKGROUND AND QUALIFICATIONS
`3.
`I am Director of Product Management at Personalis, Inc. I have held
`
`this position from August 2023 to present. I was previously the Associate Director
`
`of Product Management for Liquid Biopsies at Personalis from January 2022 until
`
`August 2023. Before that, I was the Senior Product Manager of Immuno-Oncology
`
`at Personalis from November 2018 until January 2022.
`
`4.
`
`I was a Senior Product Manager of Droplet Digital Sequencing at Bio-
`
`Rad Laboratories from March 2017 until November 2018.
`
`5.
`
`I was a Product Manager of DNA Applications at Illumina, Inc. from
`
`September 2014 until March 2017. I was a Senior Program Manager of Genomic
`
`Solutions at Illumina from October 2012 until September 2014.
`
`-1-
`
`Personalis EX2035
`
`
`
`Foresight Diagnostics v. Personalis
`IPR2023-00224 and IPR2023-00317
`6.
`I was a Business Development Manager at Althea Technologies from
`
`December 2011 until October 2012. I was a Project Manager at Althea from 2008
`
`until December 2011.
`
`7.
`
`I was a Senior Production Specialist / Project Lead at Bayer Health Care
`
`from 2006-2008. I was a Production Specialist at Bayer from 2004-2006.
`
`8.
`
`I earned a Masters of Business Administration from the University of
`
`California, San Diego in 2011.
`
`9.
`
`I earned a Bachelors of Science in Microbiology, Immunology &
`
`Molecular Genetics and Neuroscience from the University of California, Los
`
`Angeles in 2004.
`
`II. INDUSTRY PRAISE FOR PERSONALIS’ NEXT PERSONAL® ASSAY
`10. Personalis’ NeXT Personal® assay has received widespread attention
`
`and praise. Below, I discuss three examples of industry praise for Personalis’ NeXT
`
`Personal® assay.
`
`A. The Scientist Magazine praise for NeXT Personal®
`
`11. The Scientist Magazine ranked Personalis’ NeXT Personal® assay as
`
`the top innovation of 2022. See Exhibit 2001 at 1-2. This recognition is evidence
`
`of industry attention and praise that Personalis has received for its NeXT Personal®
`
`assay.
`
`-2-
`
`Personalis EX2035
`
`
`
`Foresight Diagnostics v. Personalis
`IPR2023-00224 and IPR2023-00317
`12.
`I was interviewed by The Scientist Magazine in connection with their
`
`“2022 Top 10 Innovations” article that published in the December 2022, Issue 2 of
`
`that magazine. The article includes the following paragraph:
`
`Using 1 mm3 of tumor tissue sampled from a patient, Personalis’s lab
`performs whole genome sequencing to identify up to 1,800 single-
`nucleotide variants. These patient-specific mutations are used to design
`a panel of primers targeting those regions for sequencing in future blood
`biopsies. The assay also includes primers for other known cancer-
`related genes, says Dan Norton, associate director for product
`management at Personalis. “We can see if there are other variants
`emerging that have a precision therapy associated that may be more
`effective for that patient.”
`
`When The Scientist Magazine interviewed me, I remember being pressed for time
`
`such that I didn’t have a chance to confer with members of the Personalis scientific
`
`team regarding details of the NeXT Personal assay. I have since been informed by
`
`members of the Personalis scientific team that the sentence in the article stating that
`
`Personalis’ NeXT Personal® assay involves “patient-specific mutations [that] are
`
`used to design a panel of primers targeting those regions for sequencing in future
`
`blood biopsies” is incorrect. I have been informed that the NeXT Personal® assay
`
`involves patient-specific mutations that are used to design a panel of capture probes
`
`targeting regions for sequencing in future blood biopsies. I have been informed that
`
`capture probes are nucleic acid sequences that hybridizes to target DNA, either in
`
`-3-
`
`Personalis EX2035
`
`
`
`Foresight Diagnostics v. Personalis
`IPR2023-00224 and IPR2023-00317
`solution or on a solid support, so that one can physically capture and isolate the
`
`targeted DNA.
`
`13.
`
`I understand that the Board has determined that a person of ordinary
`
`skill in the art related to the ‘394 and ‘033 patents would have had the following
`
`credentials at the time of invention in the 2012-2013 timeframe:
`
`(1) an advanced degree (such as an M.D. or the equivalent of a Ph.D.
`in a life or physical sciences, engineering, or mathematics discipline),
`(2) an understanding of various sequencing and next generation
`sequencing methods, sample preparation methods, targeted enrichment
`methods, bioinformatics methods for interpreting sequencing data, and
`methods for identifying genetic variants in a sample,
`(3) an understanding of clinical applications of sequencing technology
`to conditions associated with nucleic acid variation, such as cancer,
`non-invasive prenatal testing, and transplant rejection, and
`(4) an understanding of cancer biology as it relates to mutations
`associated with tumor diagnosis, progression, and treatment, as well as
`awareness of the various types of mutations that can occur in and
`influence the course of a patient’s cancer.
`
`I am not a person of ordinary skill in the art. For example, I do not have an advanced
`
`degree such as an M.D. or the equivalent of a Ph.D. in a life or physical sciences,
`
`engineering, or mathematics discipline.
`
`-4-
`
`Personalis EX2035
`
`
`
`Foresight Diagnostics v. Personalis
`IPR2023-00224 and IPR2023-00317
`B.
`TRACERx praise for NeXT Personal®
`
`14. Another example of industry praise and attention is contained in the
`
`article entitled “Personalis MRD Assays to Support UK’s TRACERx ctDNA
`
`Monitoring Study” that was published by Precision Medicine Online on April 5,
`
`2023. Exhibit 2153 is a true and correct copy of this article.
`
`15. This article reports that three institutions (Cancer Research UK,
`
`University College London, and the Francis Crick Institute) “have adopted
`
`Personalis’ NeXT Personal, a personalized residual disease detection platform in
`
`their TRACERx study.” The “TRAcking Cancer Evolution through therapy (RX)”
`
`or “TRACERx” study is a large, United Kingdom-based research initiative that aims
`
`to transform the understanding of non-small cell lung cancer and to make precision
`
`medicine for lung cancer patients a reality using cutting-edge methods to collect and
`
`analyze genomic data. As the flagship lung cancer study of Cancer Research UK,
`
`the on-going TRACERx study has been conducted for over nine years and resulted
`
`in numerous peer-reviewed publications in top-tier journals such as Nature and the
`
`New England Journal of Medicine; those published results have included data from
`
`two prior generations of MRD assays.
`
`16. This article also includes a quote from Dr. Charles Swanton, the
`
`principal investigator of the TRACERx study, that “Personalis’ highly sensitive test
`
`will allow us to achieve a rich understanding of the complex tumor ecosystem,
`
`-5-
`
`Personalis EX2035
`
`
`
`Foresight Diagnostics v. Personalis
`IPR2023-00224 and IPR2023-00317
`including by tracking clinically relevant ctDNA variants at recurrence, and
`
`ultimately allowing us to make more informed decisions about patient care.”
`
`17. The adoption of Personalis’ NeXT Personal® assay by these three UK
`
`institutions, as well as the praise from Dr. Swanton regarding the assay’s high
`
`sensitivity, provides significant evidence of industry recognition and attention
`
`received by Personalis’ NeXT Personal® assay.
`
`C. AstraZeneca’s trust and recognition for NeXT Personal®
`
`18. Another example of industry praise and attention is contained in the
`
`article entitled “Personalis, AstraZeneca Extend Collaboration Around Residual
`
`Cancer Detection Test” that was published by GenomeWeb on March 7, 2023.
`
`Exhibit 2154 is a true and correct copy of this article.
`
`19. This article reports that AstraZeneca and Personalis have decided to
`
`continue its ongoing collaboration “to explore the cancer sequencing firm’s NeXT
`
`Personal® molecular residual disease (MRD) test in clinical research and drug
`
`development.” AstraZeneca’s ongoing collaboration with Personalis to use the
`
`NeXT Personal® assay for clinical research and drug development provides evidence
`
`of industry trust and recognition for the high sensitivity and specificity provided by
`
`Personalis’ NeXT Personal® assay.
`
`20.
`
`In reaching its decision, AstraZeneca evaluated the performance of the
`
`NeXT Personal® assay using a plasma-in-plasma contrived sample study design that
`
`-6-
`
`Personalis EX2035
`
`
`
`Foresight Diagnostics v. Personalis
`IPR2023-00224 and IPR2023-00317
`was developed to enable AstraZeneca to robustly assess the analytical performance
`
`(e.g., sensitivity, specificity) of emerging MRD assays for use with clinical samples.
`
`AstraZeneca submitted an abstract describing the successful results of this
`
`evaluation to the 2023 American Society of Clinical Oncology Annual Meeting.
`
`Exhibit 2156 is a true and correct copy of this abstract. In it, AstraZeneca reports
`
`that “[t]he Personalis NeXT Personal® assay shows ultra-high sensitivity with
`
`reproducible data down to the 1-3 PPM range, and expansion of the personalized
`
`panel fixed clinical content allows tracking of more driver and resistance mutations
`
`with no impact to the MRD sensitivity.”
`
`III. CERTIFICATION
`21.
`I declare that all statements made herein of my own knowledge are true
`
`and that all statements made on information and belief are believed to be true; and
`
`further that these statements were made with the knowledge that willful false
`
`statements and the like so made are punishable by fine or imprisonment, or both,
`
`under Section 1001 of Title 18 of the United States Code.
`
`
`Dated:
`
`
`
`
`
`By:
`
`Dan Norton
`
`
`
`
`
`-7-
`
`October 3, 2023
`
`Personalis EX2035
`
`
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