UNITED STATES PATENT AND TRADEMARK OFFICE
`_________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_________________________
`
`FORESIGHT DIAGNOSTICS INC.
`Petitioner
`
`vs.
`
`PERSONALIS, INC.
`Patent Owner
`
`_________________________
`
`DECLARATION OF INGRID HSIEH-YEE, PH.D.
`
`Foresight EX1021
`Foresight v Personalis
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`
`_________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_________________________
`
`FORESIGHT DIAGNOSTICS INC.
`Petitioner
`
`vs.
`
`PERSONALIS, INC.
`Patent Owner
`
`_________________________
`
`DECLARATION OF INGRID HSIEH-YEE, PH.D.
`
`Foresight EX1021
`Foresight v Personalis
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`TABLE OF CONTENTS
`
`I.
`
`Introduction .................................................................................................... 3
`
`A.
`
`B.
`
`C.
`
`Qualifications and Professional Experience ........................................ 3
`
`Scope of This Declaration .................................................................... 5
`
`Evidence Considered in Forming My Opinions .................................. 6
`
`II.
`
`Authenticity and Public Availability of Leary (Ex.1002) .............................. 7
`
`A.
`
`B.
`
`C.
`
`D.
`
`E.
`
`Authentication ...................................................................................... 7
`
`PubMed Record for Leary ................................................................... 9
`
`Internet Archive Access ..................................................................... 12
`
`Usage Record ..................................................................................... 14
`
`Summary of My Opinion on Leary .................................................... 14
`
`III. Authenticity and Public Availability of Chan (Ex.1008) ............................. 15
`
`A.
`
`B.
`
`C.
`
`D.
`
`E.
`
`Authentication .................................................................................... 15
`
`PubMed Record for Chan .................................................................. 16
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`Swanton Commentary on Chan ......................................................... 20
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`Copyright registration record ............................................................. 23
`
`Summary of My Opinion on Chan .................................................... 24
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`IV. Conclusion .................................................................................................... 24
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`2
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`I.
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`Introduction
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`I, Ingrid Hsieh-Yee, Ph.D., do hereby declare as follows:
`
`1.
`
`I have personal knowledge of all of the matters about which I discuss
`
`in this declaration.
`
`2.
`
`I have been retained as an independent expert witness on behalf of
`
`Foresight Diagnostics, Inc. (“FORESIGHT”) for proceedings before the United
`
`States Patent and Trademark Office (“PTO”) regarding the authenticity and public
`
`availability of certain prior art references in relation to US Patent No. 11,384,394.
`
`3.
`
`I am being compensated for my work in this matter at my customary
`
`hourly rate. I am also being reimbursed for any reasonable expenses associated with
`
`my work and testimony in this investigation. My compensation is not contingent on
`
`the results of my study, the substance of my opinions, or the outcome of this matter.
`
`A.
`
`4.
`
`Qualifications and Professional Experience
`
`My complete qualifications and professional experience are described
`
`in my academic curriculum vitae (Appendix A). The following is a brief summary
`
`of my relevant qualifications and professional experience.
`
`5.
`
`I was a professor in the Department of Library and Information Science
`
`at the Catholic University of America for 32 years and retired at the end of August
`
`2022. I have experience working in an academic library, a medical library, and a
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`legislative library. I hold a Ph.D. in Library and Information Studies from the
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`University of Wisconsin-Madison and a Masters in Library and Information Studies
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`from the University of Wisconsin-Madison.
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`6.
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`I am an expert on library cataloging and classification and have
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`published two editions on this subject, Organizing Audiovisual and Electronic
`
`Resources for Access: A Cataloging Guide (2000 and 2006). I taught a variety of
`
`courses, including Cataloging and Classification, Advanced Cataloging and
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`Classification, Organization of Internet Resources, Organization of Information,
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`Digital Content Creation and Management, Internet Searches and Web Design,
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`Information Literacy Instruction, Advanced Information Retrieval and Analysis
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`Strategies, and The Information Professions in Society. I am familiar with metadata
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`schema design and implementation. In my teaching I covered the design and
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`implementation of metadata in databases, search engines, digital repositories, digital
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`libraries, and digital archives. I also covered database design and how information
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`organization affects the discovery and access to digital resources on the Internet. My
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`research interests cover cataloging and classification, information organization,
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`metadata, information retrieval, information architecture, digital collections,
`
`scholarly communication, user interaction with information systems, and others.
`
`7.
`
`I am personally familiar with many online catalogs, databases, search
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`engines, digital libraries and digital archives. In preparing for this declaration, I used
`
`the following authoritative information systems to search for records:
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`• Google Scholar (https://scholar.google.com/)
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`• Internet Archive (https://archive.org/)
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`• Public catalog of the U.S. Copyright Office
`
`(https://cocatalog.loc.gov/)
`
`• PubMed (https://pubmed.ncbi.nlm.nih.gov/)
`
`• PubMed Central (https://www.ncbi.nlm.nih.gov/pmc/)
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`Scope of This Declaration
`
`I have been asked to offer an opinion on the authenticity and public
`
`B.
`
`8.
`
`availability date of the following documents:
`
`• Leary, R. J., Kinde, I., Diehl, F., Schmidt, K., Clouser, C., Duncan, C.,
`
`... & Velculescu, V. E., (2010, Feb. 24), Development of personalized
`
`tumor biomarkers using massively parallel sequencing, Science
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`Translational Medicine, vol. 2, no. 20, page 20ra14, Ex.1002
`
`(“Leary”);
`
`• Chan, K. A., Jiang, P., Zheng, Y. W., Liao, G. J., Sun, H., Wong, J., ...
`
`& Lo, Y. M. D., (2013, January 1), Cancer genome scanning in plasma:
`
`detection of tumor-associated copy number aberrations, single-
`
`nucleotide variants, and tumoral heterogeneity by massively parallel
`
`sequencing, Clinical Chemistry, vol. 59, no. 1, pp. 211-224, Ex.1008
`
`(“Chan”).
`
`
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`C. Evidence Considered in Forming My Opinions
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`9.
`
`In the preparation of this declaration, I have reviewed the documents
`
`referenced below and any other documents I reference herein, and each of these is a
`
`type of material that experts in my field would reasonably rely upon when forming
`
`their opinions:
`
`(1) The documents referenced above in Section I.B;
`
`(2)
`
`PubMed metadata
`
`record
`
`for
`
`Leary,
`
`available
`
`at
`
`https://pubmed.ncbi.nlm.nih.gov/20371490/, accessed and obtained
`
`on October 17, 2022, Appendix 1002A;
`
`(3) Website of Science Translational Medicine, archived by the Internet
`
`Archive on February 25, 2010, accessed and obtained on October
`
`17, 2022, Appendix 1002B;
`
`(4) Citations to Leary, obtained from Google Scholar, Appendix
`
`1002C;
`
`(5)
`
`PubMed metadata
`
`record
`
`for
`
`Chan,
`
`available
`
`at
`
`https://pubmed.ncbi.nlm.nih.gov/23065472/, accessed and obtained
`
`on October 10, 2022, Appendix 1008A;
`
`(6)
`
`Swanton, C., (2013), Plasma-derived tumor DNA analysis at whole-
`
`genome resolution, Clinical Chemistry, vol. 59, no. 1, pp. 6-8
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`
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`(previously published online on October 31, 2012), available at the
`
`publisher
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`website
`
`at
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`https://academic.oup.com/clinchem/article/59/1/6/5622134,
`
`accessed and obtained on October 10, 2022, Appendix 1008B;
`
`(7)
`
`PubMed metadata
`
`record
`
`for
`
`Swanton,
`
`available
`
`at
`
`https://pubmed.ncbi.nlm.nih.gov/23115052/, accessed and obtained
`
`on October 10, 2022, Appendix 1008C;
`
`(8) Copyright registration record for the print issue of vol. 59, no. 1 of
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`Clinical Chemistry, available at https://cocatalog.loc.gov/cgi-
`
`bin/Pwebrecon.cgi?v1=92&ti=76,92&Search%5FArg=clinical%20
`
`chemistry&Search%5FCode=TALL&CNT=25&PID=RnVcF4wz
`
`REI3T2XU7XOyP4XtD9Rk&SEQ=20221010200253&SID=1
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`from the public catalog of the U.S. Copyright Office, accessed and
`
`obtained on October 10, 2022, Appendix 1008D.
`
`II. Authenticity and Public Availability of Leary (Ex.1002)
`
`A. Authentication
`
`10. Ex.1002 is a true and correct copy of Development of personalized
`
`tumor biomarkers using massively parallel sequencing, (“Leary”), Science
`
`Translational Medicine, vol. 2, no. 20, pp. 20ra14-20ra14, that I obtained from the
`
`publisher. I began my research on Google Scholar by searching by the title of Leary
`
`
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`for records, and a retrieved record led me to the publisher’s website for Leary at
`
`https://www.science.org/doi/abs/10.1126/scitranslmed.3000702.
`
`The
`
`“check
`
`access” link on this website brought up a page that informed users that the article
`
`was free to AAAS members, and “[a]s a service to the community, this article is
`
`available for free. Login or register for free to read this article.” As a member of
`
`AAAS I then logged into the system to download the full text of Leary. This AAAS
`
`copy is presented as Ex.1002 in this declaration.
`
`11. Ex.1002 is a true and correct copy of Leary obtained from the publisher
`
`AAAS. Page 1 shows the title, authors, abstract and a note showing Leary was
`
`published on “24 February 2010; Volume 2 Issue 20 20ra14” and is available on
`
`www.ScienceTranslationalMedicineorg. Page 6 shows supplementary materials of
`
`this article include three tables and two figures that are available online. Page 7
`
`shows the manuscript was submitted on “7 December 2009, accepted 4 February
`
`2010, published 24 February 2010” with “10.1126/scitranslmed.3000702” as its
`
`digital object identifier. Ex.1002 shows Leary has a total of seven pages, two tables,
`
`four figures and 30 references. The AAAS website for Leary includes a download
`
`link for the supplementary materials. I downloaded these tables and figures and
`
`included them as pages 9 to 15 of Ex.1002.
`
`12. The publisher’s copy of Leary (Ex.1002) is in a condition that creates
`
`no suspicion about its authenticity. Specifically, this copy is not missing any
`
`
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`intermediate pages, the text on each page appears to flow seamlessly from one page
`
`to the next, and there are no visible alterations to the document. Moreover, Ex.1002
`
`is in the custody of the publisher, a place where, if authentic, it would likely be
`
`found. Accordingly, I see no reason to question the authenticity of this copy of Leary
`
`(Ex.1002).
`
`B.
`
`PubMed Record for Leary
`
`13. To determine whether Leary was indexed, I searched PubMed by the
`
`article
`
`title
`
`for
`
`records
`
`and
`
`located
`
`a
`
`record
`
`at
`
`https://pubmed.ncbi.nlm.nih.gov/20371490/. This PubMed record is presented as
`
`Appendix 1002A in this declaration. PubMed is an authoritative system that
`
`contains “more than 34 million citations for biomedical literature from MEDLINE,
`
`life science journals, and online books” and PubMed records may include links to
`
`“full text content from PubMed Central and publisher web sites” (source:
`
`https://pubmed.ncbi.nlm.nih.gov). I personally located, identified and obtained the
`
`PubMed metadata record for Leary (Appendix 1002A). I saved the metadata record
`
`in PDF and also saved the record in PubMed format to show the record details in
`
`data fields.
`
`14. Appendix 1002A is a true and correct copy of the PubMed metadata
`
`record for Leary. The top of page 1 shows a full text link to “Science Translational
`
`Medicine AAAS” that takes users to the publisher’s website for Leary. Page 1 also
`
`
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`shows the title, authors, and an abstract. The area above the title shows a note of “Sci
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`Transl Med. 2010 Feb 24; 2(20):20ra14. Doi: 10.1126/scitranslmed.3000702” that
`
`indicates Leary was published on February 24, 2010, in vol. 2, no. 20, pages 20ra14
`
`of Science Translational Medicine, with a doi (digital object identifier) of
`
`“10.1126/scitranslmed.3000702.” The authors, title, journal title, issue numbering,
`
`page numbers and doi match the information presented in the publisher’s copy of
`
`Leary (Ex.1002), confirming this record represents Leary. Page 1 also shows the
`
`PMID (PubMed Identifier) of this metadata record is “20371490” and a copy of
`
`Leary is freely available at PMC, the PubMed Central digital archive. The PMC
`
`record’s identifier is 2858564.
`
`15.
`
`I
`
`obtained
`
`PMC2858564
`
`from
`
`https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2858564/ and included a screen
`
`capture of the top this record as page 3 of Appendix 1002A. This record shows the
`
`PMC copy is an author manuscript that became available for public access in PMC
`
`on “2010 Aug 24.” The archived copy is available as a webpage, a PDF, and a
`
`PubReader file.
`
`16. Pages 4 to 5 of Appendix 1002A are the PubMed record in PubMed
`
`format to show data in specific fields. I use the “MEDLINE/PubMed Data Element
`
`(Field) Descriptions” (https://www.nlm.nih.gov/bsd/mms/medlineelements.html) to
`
`interpret the record. The “PMID” field shows “20371490” as the PubMed identifier
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`for the record for Leary. The “STAT” field shows the status of the record is
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`“MEDLINE” (meaning Medical subject headings were assigned to the article), and
`
`the DCOM field shows this index record was completed on “20100615” (i.e., June
`
`15, 2010). The first IS field shows the ISSN (International Standard Serial Number)
`
`for the electronic version of this journal is “1946-6242” and the ISSN for the print
`
`journal is “1946-6234.” Fields VI (volume), IP (issue), DP (date of publication), Ti
`
`(title), PG (pages) and JT (journal title) show Leary was published in vol. 2, no. 20
`
`(2010 Feb 24) of Science Translational Medicine as page 20ra14. The first FAU (full
`
`author) field shows “Leary, Rebecca J” as the first author. Field CRDT (creation
`
`date) and Field EDAT (entrez date) show the metadata record was added to PubMed
`
`on “2010/04/08” (i.e., April 8, 2010), and Field MHDT (MeSH date) shows medical
`
`subject headings were added to the record on “2010/06/16”” (i.e., June 16, 2010) to
`
`elevate this record into MEDLINE (source: https://pubmed.ncbi.nlm.nih.gov/help/).
`
`The PubMed record shows 11 medical subject headings were assigned to indicate
`
`the subjects of the Leary article. Field “AID” (Article identifier) shows the doi of
`
`Leary.
`
`17. This PubMed metadata record (Appendix 1002A) made Leary
`
`discoverable in PubMed on April 8, 2010, when it was entered into PubMed.
`
`Interested users would have been able to search for Leary in PubMed by the authors,
`
`title, journal title, ISSN, and abstract. After medical subject headings were added to
`
`
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`enrich the PubMed record on June 16, 2010, interested users would have been able
`
`to conduct subject searches to discover Leary.
`
`C.
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`Internet Archive Access
`
`18. To determine the availability of Leary on the Internet I searched
`
`Internet Archive for records. Internet Archive is a digital library that provides access
`
`to websites, webpages, and other web resources, and provides free access to its
`
`contents for researchers, scholars, and the general public. Appendix 1002B is a true
`
`and correct copy of the website of Science Translational Medicine archived by the
`
`Internet Archive on February 25, 2010. I personally located, identified and obtained
`
`this record. This is the type of record experts in my field would reasonably rely upon
`
`when forming their opinions.
`
`19. Page 1 of Appendix 1002B is a Wayback Machine calendar that shows
`
`the original URL of this website was http://stm.sciencemag.org/ and the website was
`
`captured 2,318 times from “13 Oct 2009” to “8 Oct 2022.” The calendar shows this
`
`archived copy was captured on “Feb 25 2010” and
`
`is available at
`
`web.archive.org/web/20100225013602/http://stm.sciencemag.org/. I have used
`
`Internet Archive in the past and am familiar with the Internet Archives’ practice of
`
`assigning an extended URL
`
`to an archived
`
`file
`
`in
`
`the
`
`format of
`
`http://www.archive.org/web/[Year in yyyy][Month in mm][Day in dd][Time code
`
`in hh:mm:ss]/[Archived URL] to show the point of time an archived file was
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`captured. The URL of the archived website means this website was archived on
`
`“20100225013602” (i.e., February 25, 2010, 1 a.m., 36 minutes and 2 seconds).
`
`Because Internet Archive does not capture web resources as soon as they appear on
`
`the Internet, the archive date means the archived resource would have been available
`
`for public access no later than the archive date. The archive date of Appendix 1002B
`
`therefore means that this website would have been available for public access no
`
`later than February 25, 2010.
`
`20. Appendix 1002B shows “Development of Personalized Tumor
`
`Biomarkers Using Massively Parallel Sequencing” was a research article highlighted
`
`on the website by February 25, 2010. Pages 2 and 3 show the website saved in PDF
`
`and page 3 shows this archived website has a “2010” copyright date, with the
`
`American Association for the Advancement of Science as the copyright holder. The
`
`link of this research article retrieves an archived copy of the webpage for this article.
`
`Page 4 of Appendix 1002B is a screen capture of this webpage with a Wayback
`
`Machine calendar that shows this archived copy was captured on “Jun 09 2012.”
`
`Pages 5 and 6 are the archived webpage saved in PDF. The title, authors, abstract
`
`and publication history on this page matches the information presented in the AAAS
`
`copy of Leary (Ex.1002). The “Read the Full Text” link on page 5 leads to the
`
`webpage for the full article (page 7 of Appendix 1002B) that informs visitors that
`
`they need to “Register for Free or Subscribe/Join AAAS to View Full Text.” These
`
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`archived records from the Internet Archive inform my opinion that Leary was
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`available on the Internet no later than February 25, 2010, to registered users and
`
`AAAS members.
`
`D. Usage Record
`
`21. Actual usage of an article is reflected by other articles that makes
`
`reference to it. The citation history of Google Scholar shows Leary has been cited
`
`629 times, including 24 times in 2010. Appendix 1002C presents seven citations
`
`published in 2010 to demonstrate early usage. The earliest citation appeared in
`
`March 2010. Page 2 is a screen capture of Google Scholar showing 629 citations
`
`made reference to Leary, and page 3 is a screen capture showing 24 citations
`
`appeared in 2010.
`
`E.
`
`Summary of My Opinion on Leary
`
`22. Taken together, the AAAS copy of Leary (Ex.1002), the PubMed
`
`records for Leary (Appendix 1002A), and the Science Translational Medicine
`
`website archived by the Internet Archive (Appendix 1002B) inform my opinion that
`
`Leary was published online on February 24, 2010, highlighted as a research article
`
`on the journal website on February 25, 2010, indexed by PubMed and became
`
`discoverable in PubMed by June 16, 2010. Based on my knowledge and experience
`
`with online databases, it is my opinion that Leary would have been publicly
`
`accessible by February 25, 2010, on the Internet, and no later than June 16, 2010,
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`when it became discoverable in PubMed. Citation history shows the earliest citation
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`appeared in March 2010.
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`III. Authenticity and Public Availability of Chan (Ex.1008)
`
`A. Authentication
`
`23. Ex.1008 is a true and correct copy of Cancer genome scanning in
`
`plasma: detection of tumor-associated copy number aberrations, single-nucleotide
`
`variants, and tumoral heterogeneity by massively parallel sequencing, (“Chan”), by
`
`Chan et al., Clinical Chemistry, vol. 59, no. 1, pp. 211-224, that I obtained from the
`
`publisher. I began my research on Google Scholar by searching by the title of Chan
`
`for records, and a retrieved record led me to the publisher’s website for Chan at
`
`https://academic.oup.com/clinchem/article/59/1/211/5622098. I then followed the
`
`PDF link to acquire a copy. This copy from Elsevier is presented as Ex.1008 in this
`
`declaration.
`
`24. Ex.1008 is a true and correct copy of Chan obtained from the publisher.
`
`Page 1 (internal page 211) shows the title, authors, and a “2012” copyright date for
`
`Chan, with the American Association for Clinical Chemistry as the copyright holder.
`
`The top of the page shows Chan appears in Clinical Chemistry “59:1, 211-244
`
`(2013).” The bottom of the page shows the manuscript was received on September
`
`6, 2012 and accepted on September 27, 2012, and this article was “[p]reviously
`
`published online at DOI: 10.1373/clinchem.2012.196014.” Ex.1008 shows Chan
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`has a total of 14 pages, including four color figures, three tables, and 35 references.
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`25. The publisher’s copy of Chan (Ex.1008) is in a condition that creates
`
`no suspicion about its authenticity. Specifically, this copy is not missing any
`
`intermediate pages, the text on each page appears to flow seamlessly from one page
`
`to the next, and there are no visible alterations to the document. Moreover, Ex.1008
`
`is in the custody of the publisher, a place where, if authentic, it would likely be
`
`found. Accordingly, I see no reason to question the authenticity of this copy of Chan
`
`(Ex.1008).
`
`B.
`
`PubMed Record for Chan
`
`26. To determine whether Chan was indexed, I searched PubMed by the
`
`article
`
`title
`
`for
`
`records
`
`and
`
`located
`
`a
`
`record
`
`at
`
`https://pubmed.ncbi.nlm.nih.gov/23065472/. This PubMed record is presented as
`
`Appendix 1008A in this declaration. PubMed is an authoritative system that
`
`contains “more than 34 million citations for biomedical literature from MEDLINE,
`
`life science journals, and online books” and PubMed records may include links to
`
`“full text content from PubMed Central and publisher web sites” (source:
`
`https://pubmed.ncbi.nlm.nih.gov). I personally located, identified and obtained the
`
`PubMed metadata record for Chan. I saved the metadata record in PDF and also
`
`saved the record in PubMed format to show the record details in data fields.
`
`27. Appendix 1008A is a true and correct copy of the PubMed metadata
`
`
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`record for Chan. The top of page 1 shows a full text link to “Oxford Academic” that
`
`takes users to the publisher’s website for Chan. Page 1 also shows the title, authors,
`
`and an abstract that covers the background, methods, results, and conclusions of this
`
`study. A note after the abstract shows Chan has a “2012” copyright date, with the
`
`American Association for Clinical Chemistry as the copyright holder. The area
`
`above the title shows a note of “Clin Chem. 2013 Jan; 59(1):211-24. Doi:
`
`10.1373/clinchem.2012.196014. Epub 2012 Oct 11” that indicates Chan was first
`
`published online in Clinical Chemistry on October 11, 2012, with a doi (digital
`
`object identifier) of “10.1373/clinchem.2012.196014.” This note is consistent with
`
`the note on page 1 of Ex.1008 that Chan was previously “published online at DOI:
`
`10.1373/clinchem.2012.196014.” This note also indicates that Chan was later
`
`published in the print version of Clinical Chemistry, vol. 59, no. 1, pages 211 to 244,
`
`and this print issue has a “January 2013” issue date. The PMID (PubMed Identifier)
`
`for this metadata record is “23065472.” The authors, title, copyright date, copyright
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`holder, journal title, issue numbering, page numbers and doi match the information
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`presented in the publisher’s copy of Chan (Ex.1008), confirming this record
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`represents Chan.
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`28. The “Comment in” note area following the abstract shows C. Swanton
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`commented on Chan in an article entitled “Plasma-derived tumor DNA analysis at
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`whole-genome resolution”, which was published online on October 31, 2012, and
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`later appeared in the print issue of Clinical Chemistry, vol. 51, issue 1, pages 6 to 8,
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`and the print issue has a “January 2013” issue date. The PubMed metadata record
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`for Chan (Appendix 1008A) informs my opinion that Chan was published online
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`on October 11, 2012, and Swanton’s commentary on Chan was published online on
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`October 31, 2012. Both articles were later published in the print version of Clinical
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`Chemistry vol. 59, no. 1.
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`29. Pages 3 to 4 of Appendix 1008A are the PubMed record in PubMed
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`format to show data in specific fields. I use the “MEDLINE/PubMed Data Element
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`(Field) Descriptions” (https://www.nlm.nih.gov/bsd/mms/medlineelements.html) to
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`interpret the record. The “PMID” field shows “23065472” as the PubMed identifier
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`for the record for Chan. The “STAT” field shows the status of the record is
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`“MEDLINE” (meaning Medical subject headings were assigned to the article), and
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`the DCOM field shows this index record was completed on “20130429” (i.e., April
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`29, 2013). The first IS field shows the ISSN (International Standard Serial Number)
`
`for the electronic version of this journal is “1530-8561” and the ISSN for the print
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`journal is “0009-9147.” Fields VI (volume), IP (issue), DP (date of publication), Ti
`
`(title), PG (pages) and JT (journal title) show Chan was published in vol. 59, no. 1
`
`(January 2013) of Clinical Chemistry from pages 211 to 224. The first FAU (full
`
`author) field shows “Chan, K C Allen” as the first author. Field “DEP” (date of
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`electronic publication) on page 4 of Appendix 1008A shows Chan was published
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`electronically on “20121011” (i.e., October 11, 2012). Field CRDT (creation date)
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`and Field EDAT (entrez date) show the metadata record was added to PubMed on
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`“2012/10/16” (i.e., October 16, 2012), and Field MHDT (MeSH date) shows medical
`
`subject headings were added to the record on “2013/04/30” (i.e., April 30, 2013) and
`
`the
`
`record
`
`was
`
`elevated
`
`to
`
`MEDLINE
`
`(source:
`
`https://pubmed.ncbi.nlm.nih.gov/help/). The PubMed record shows nine medical
`
`subject headings were assigned to indicate the subjects of the Chan article. Field
`
`“AID” (Article identifier) shows the doi of Chan. Field “CIN” (Comment in) shows
`
`an article containing a commentary on Chan appears in “Clin Chem. 2013 Jan; 59
`
`(1): 6-8. PMID: 23115052.” The PMID (PubMed Identifier) refers to the Swanton
`
`commentary (see page 1 of Appendix 1008A) that was first published electronically
`
`on October 31, 2012.
`
`30. This PubMed metadata record (Appendix 1008A) made Chan
`
`discoverable in PubMed on October 16, 2012, after Chan was published
`
`electronically on October 11, 2012. Interested users would have been able to search
`
`for Chan in PubMed by the authors, title, journal title, ISSN, and abstract. Medical
`
`subject headings were added to enrich the PubMed record on April 30, 2013. From
`
`that date on, interested users would have been able to conduct subject searches to
`
`discover Chan.
`
`
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`19
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`C.
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`Swanton Commentary on Chan
`
`31. The PubMed metadata record for Chan shows Swanton commented on
`
`Chan and the Swanton commentary was published electronically on October 31,
`
`2012, and indexed by PubMed metadata record 23115052. I retrieved this PubMed
`
`metadata record and followed the full text link to obtain a copy of Swanton from the
`
`publisher. This publisher copy of Swanton is presented as Appendix 1008B.
`
`32. Appendix 1008B is a true and correct copy of Plasma-derived tumor
`
`DNA analysis at whole-genome resolution, (“Swanton”), by Charles Swanton that I
`
`obtained from the publisher. Page 1 shows the title and author and indicates this
`
`article is an editorial. The top of this page shows Swanton appears in “Clinical
`
`Chemistry 59:1, 6-8 (2013)” meaning vol. 59, no. 1 (2013), pages 6 to 8. The
`
`publication history at the bottom of page 1 shows the manuscript was received on
`
`“October 2, 2012; accepted October 4, 2012” and Swanton was “[p]reviously
`
`published online at DOI: 10.1373/clinchem.2012.197053.” Appendix 1008B shows
`
`Swanton has a total of three pages, including 16 references, and reference 16 is the
`
`Chan article.
`
`33.
`
`Swanton was also indexed by PubMed (PMID 23115052). Appendix
`
`1008C is a true and correct copy of the PubMed metadata record for Swanton. I
`
`personally located, identified and obtained this record from PubMed. This is the type
`
`of record experts in my field would reasonably rely upon when forming their
`
`
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`opinions.
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`34. The top of the PubMed Metadata record (Appendix 1008C) shows a
`
`full text link to “Oxford Academic” that takes users to the publisher’s webpage for
`
`Swanton at https://academic.oup.com/clinchem/article/59/1/6/5622134?login=false.
`
`The metadata record shows the title and author of Swanton, the PMID (PubMed
`
`identifier) for this record as “23115052” and the DOI (digital object identifier) of
`
`Swanton as “10.1373/clinchem.2012.197053.” The area above the title shows a note
`
`of
`
`“Editorial
`
`>
`
`Clin
`
`Chem.
`
`2013
`
`Jan;
`
`59(1):
`
`6-8.
`
`doi:
`
`10.1373/clinchem.2012.197053. Epub 2012 Oct 31” that indicates Swanton is an
`
`editorial that was first published online in Clinical Chemistry on October 31, 2012,
`
`and later appeared in the print version of Clinical Chemistry, vol. 59, no. 1, pages 6
`
`to 8, and the print issue has an issue date of January 2013. The “Comment on” area
`
`shows Swanton contains a commentary on Chan, which was published
`
`electronically on October 11, 2012.
`
`35. Page 2 of Appendix 1008C is the PubMed record saved in PubMed
`
`format to show data in specific fields. I use the “MEDLINE/PubMed Data Element
`
`(Field) Descriptions” (https://www.nlm.nih.gov/bsd/mms/medlineelements.html) to
`
`interpret the record. The “PMID” field shows “23115052” as the PubMed identifier,
`
`and the DCOM field shows this index record was completed on “20130429” (i.e.,
`
`April 29, 2013). The first IS field shows the ISSN (International Standard Serial
`
`
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`21
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`Number) for the electronic version of this journal is “1530-8561” and the ISSN for
`
`the print journal is “0009-9147.” Fields VI (volume), IP (issue), DP (date of
`
`publication), Ti (title), PG (pages) and JT (journal title) show Swanton was published
`
`in vol. 59 no. 1 (January 2013) of Clinical Chemistry from pages 6 to 8. The FAU
`
`(full author) field shows “Swanton, Charles” as the author. Field “DEP” (Date of
`
`electronic publication) shows Swanton was published electronically on “20121031”
`
`(i.e., October 31, 2012). Field CRDT (Creation date) and Field EDAT (Entrez date)
`
`show the metadata record was added to PubMed on “2012/11/02” (i.e., November
`
`2, 2012) and Field MHDT (MeSH date) shows medical subject headings were added
`
`to the record on “2013/04/30” (i.e., April 30, 2013) to elevate this record into
`
`MEDLINE (source: https://pubmed.ncbi.nlm.nih.gov/help/). Six medical subject
`
`headings were assigned to the record to indicate the subjects of Swanton. Field
`
`“AID” (Article identifier) shows the doi of Swanton. Field “CON” (Comment on)
`
`shows the work commented on by Swanton appears in “Clin Chem. 2013 Jan; 59(1)
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`: 211-24. PMID: 23065472.” This PMID refers to Chan (see page 1), which was first
`
`published electronically on October 11, 2012.
`
`36. This PubMed metadata record (Appendix 1008C) clarifies the
`
`relationship between Swanton and Chan and shows that Swanton became
`
`discoverable in PubMed on November 2, 2012, after it was published on October
`
`31, 2012. As of November 2, 2012, interested users would have been able to search
`
`
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`22
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`for Swanton in PubMed by title, author, journal title, and ISSNs. They would also
`
`have been able to use the note in the “Common on” note area to discover Chan. Six
`
`medical subject headings were added to enrich the PubMed record for Swanton on
`
`April 29, 2013, enabling users to conduct subject searches to locate Swanton.
`
`D. Copyright registration record
`
`37. Appendix 1008D is a true and correct copy of the copyright registration
`
`record for vol. 59, no.1 of Clinical Chemistry that contains Chan and Swanton. I
`
`obtain
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