UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________
`
`SANDOZ, INC.,
`Petitioner,
`
`v.
`
`ACERTA PHARMA B.V.,
`Patent Owner.
`_____________________
`
`Case IPR2023-00478
`Patent 10,272,083
`_____________________
`
`DECLARATION OF SYLVIA D. HALL-ELLIS, PH.D.
`
`SANDOZ INC.
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`IPR2023-00478
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`Ex. 1003, p. 1 of 119
`
`
`_____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________
`
`SANDOZ, INC.,
`Petitioner,
`
`v.
`
`ACERTA PHARMA B.V.,
`Patent Owner.
`_____________________
`
`Case IPR2023-00478
`Patent 10,272,083
`_____________________
`
`DECLARATION OF SYLVIA D. HALL-ELLIS, PH.D.
`
`SANDOZ INC.
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`IPR2023-00478
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`Ex. 1003, p. 1 of 119
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`
`
`I.
`
`INTRODUCTION
`1. My name is Sylvia D. Hall-Ellis. I have been retained as an expert by
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`Sandoz Inc. (hereafter “Petitioner”).
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`2.
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`I have written this report at the request of Petitioner to provide my
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`expert opinion regarding the authenticity and public availability of several
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`publications. My report sets forth my opinions in detail and provides the basis for
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`my opinions regarding the public availability of these publications.
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`3.
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`I reserve the right to supplement or amend my opinions, and bases for
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`them, in response any additional evidence, testimony, discovery, argument, and/or
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`other additional information that may be provided to me after the date of this
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`report.
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`4.
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`I am being compensated for my time spent working on this matter at
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`my normal consulting rate of $325 per hour, plus reimbursement for any additional
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`reasonable expenses. My compensation is not in any way tied to the content of this
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`report, the substance of my opinions, or the outcome of this proceeding. I have no
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`other interests in this proceeding or with any of the parties.
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`5.
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`All of the materials that I considered are discussed explicitly in this
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`declaration.
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`1
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`II. QUALIFICATIONS
`6.
`I am currently an Adjunct Professor in the School of Information at
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`San José State University. I obtained a Master of Library Science from the
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`University of North Texas in 1972 and a Ph.D. in Library Science from the
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`University of Pittsburgh in 1985. Over the last fifty years, I have held various
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`positions in the field of library and information resources. I was first employed as
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`a librarian in 1966 and have been involved in the field of library sciences since,
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`holding numerous positions.
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`7.
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`I am a member of the American Library Association (ALA) and its
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`Association for Library Collections & Technical Services (ALCTS) Division, and I
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`served on the Committee on Cataloging: Resource and Description (which wrote
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`the new cataloging rules) and as the chair of the Committee for Education and
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`Training of Catalogers and the Competencies and Education for a Career in
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`Cataloging Interest Group. I also served as the Chair of the ALCTS Division’s
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`Task Force on Competencies and Education for a Career in Cataloging.
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`Additionally, I have served as the Chair for the ALA Office of Diversity’s
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`Committee on Diversity, as a member of the national Board of Directors for
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`REFORMA, as a member of the Editorial Board for the ALCTS premier
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`cataloging journal, Library Resources and Technical Services, and a Co-Chair of
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`2
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`the Membership of the Library Research Round Table (LRRT) for ALA. Currently
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`I serve as a member of the LRRT Nominating Committee.
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`8.
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`I have also given over one hundred presentations in the field,
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`including several on library cataloging systems and Machine-Readable Cataloging
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`(“MARC”) standards. My current research interests include library cataloging
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`systems, metadata, and organization of electronic resources.
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`9. My full curriculum vitae is attached hereto as an Appendix to this
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`report.
`
`III. LIBRARY CATALOGING PRACTICES
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`10.
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`I am fully familiar with the library cataloging standard known as the
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`MARC standard, which is an industry-wide standard method of storing and
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`organizing library catalog information.1 MARC was first developed in the 1960s
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`by the Library of Congress. A MARC-compatible library is one that has a catalog
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`consisting of individual MARC records for each of its items. Today, MARC is the
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`primary communications protocol for the transfer and storage of bibliographic
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`metadata in libraries.2
`
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`1 The full text of the standard is available from the Library of Congress at
`http://www.loc.gov/marc/bibliographic/ (last visited January 31, 2023).
`2 Almost every major library in the world is MARC-compatible. See, e.g., MARC
`Frequently Asked Questions (FAQ), Library of Congress,
`https://www.loc.gov/marc/faq.html (last visited January 31, 2023) (“MARC is the
`3
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`11. A MARC record comprises several fields, each of which contains
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`specific data about the work. Each field is identified by a standardized, unique,
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`three-digit code corresponding to the type of data that follow. For example, a
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`work’s title is recorded in field 245, the primary author of the work is recorded in
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`field 100, an item’s International Standard Book Number (“ISBN”) is recorded in
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`field 020, an item’s International Standard Serial Number (“ISSN”) is recorded in
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`field 022, an item’s Library of Congress call number is recorded in field 050, and
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`the publication date is recorded in field 260 under the subfield “c.” If a work is a
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`periodical, then its publication frequency is recorded in field 310, and the
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`publication dates (e.g., the first and last publication) are recorded in field 362,
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`which is also referred to as the enumeration/chronology field.
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`12. The library that created the record is recorded in field 040 in subfield
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`“a” with a unique library code. When viewing the MARC record online via Online
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`Computer Library Center’s (“OCLC”) bibliographic database, hovering over this
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`code with the mouse reveals the full name of the library. I used this method of
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`
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`acronym for MAchine-Readable Cataloging. It defines a data format that emerged
`from a Library of Congress-led initiative that began nearly forty years ago. It
`provides the mechanism by which computers exchange, use, and interpret
`bibliographic information, and its data elements make up the foundation of most
`library catalogs used today.”). MARC is the ANSI/NISO Z39.2-1994 (reaffirmed
`2016) standard for Information Interchange Format.
`4
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`“mousing over” the library codes in the OCLC database to identify the originating
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`library for the MARC records discussed in this report. Where this “mouse over”
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`option was not available, I consulted the Directory of OCLC Libraries to identify
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`the institution that created the MARC record.3
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`13. MARC records also include several fields that include subject matter
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`classification information. An overview of MARC record fields is available
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`through the Library of Congress.4 For example, 6XX fields are termed “Subject
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`Access Fields.”5 Among these, for example, is the 650 field; this is the “Subject
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`Added Entry – Topical Term” field.6 The 650 field is a “[s]ubject added entry in
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`which the entry element is a topical term.” These entries “are assigned to a
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`bibliographic record to provide access according to generally accepted thesaurus-
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`building rules (e.g., Library of Congress Subject Headings (LCSH), Medical
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`Subject Headings (MeSH)).” Further, MARC records include call numbers, which
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`themselves include a classification number. For example, the 050 field is the
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`“Library of Congress Call Number.” 7 A defined portion of the Library of
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`Congress Call Number is the classification number, and “source of the
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`3 https://www.oclc.org/en/contacts/libraries.html.
`4 http://www.loc.gov/marc/bibliographic/.
`5 http://www.loc.gov/marc/bibliographic/bd6xx.html.
`6 http://www.loc.gov/marc/bibliographic/bd650.html.
`7 http://www.loc.gov/marc/bibliographic/bd050.html.
`5
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`classification number
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`is Library of Congress Classification and
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`the LC
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`Classification-Additions and Changes.” Thus, included in the 050 field is a subject
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`matter classification. Each item in a library has a single classification number. A
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`library selects a classification scheme (e.g., the Library of Congress Classification
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`scheme just described or a similar scheme such as the Dewey Decimal
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`Classification scheme) and uses it consistently. When the Library of Congress
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`assigns the classification number, it appears as part of the 050 field. If a local
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`library assigns the classification number, it appears in a 090 field. In either
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`scenario, the MARC record includes a classification number that represents a
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`subject matter classification.
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`14. The OCLC was created “to establish, maintain and operate a
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`computerized library network and to promote the evolution of library use, of
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`libraries themselves, and of librarianship, and to provide processes and products
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`for the benefit of library users and libraries, including such objectives as increasing
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`availability of library resources to individual library patrons and reducing the rate
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`of rise of library per-unit costs, all for the fundamental public purpose of furthering
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`ease of access to and use of the ever-expanding body of worldwide scientific,
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`6
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`literary and educational knowledge and information.” 8 Among other services,
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`OCLC and its members are responsible for maintaining the WorldCat database,9
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`used by independent and institutional libraries throughout the world.
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`15. OCLC also provides its members online access to MARC records
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`through its OCLC bibliographic database. When an OCLC member institution
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`acquires a work, it creates a MARC record for this work in its computer catalog
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`system in the ordinary course of its business. MARC records created at the Library
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`of Congress are directly uploaded or may be tape-loaded into the OCLC database
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`through a subscription to MARC Distribution Services daily or weekly. Once the
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`MARC record is created by a cataloger at an OCLC member institution or is tape-
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`loaded from a participating institution, the MARC record is then made available to
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`any other OCLC members online, and therefore made available to the public.
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`Accordingly, once the MARC record is created by a cataloger at an OCLC member
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`institution or is tape-loaded from the Library of Congress or another library
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`anywhere in the world, any publication corresponding to the MARC record has
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`been cataloged and indexed according to its subject matter such that a person
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`interested in that subject matter could, with reasonable diligence, locate and access
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`8 Third Article, Amended Articles of Incorporation of OCLC Online Computer
`Library Center, Incorporated (available at
`https://www.oclc.org/content/dam/oclc/membership/articles-of-incorporation.pdf).
`9 http://www.worldcat.org/.
`
`7
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`the publication through any library with access to the OCLC bibliographic
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`database or through the Library of Congress.
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`16. When an OCLC member institution creates a new MARC record,
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`OCLC automatically supplies the date of creation for that record. The date of
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`creation for the MARC record appears in the fixed field (008), characters 00
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`through 05. The MARC record creation date reflects the date on which, or shortly
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`after which, the item was first acquired or cataloged. Initially, field 005 of the
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`MARC record is automatically populated with the date the MARC record was
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`created in year, month, day format (YYYYMMDD) (some of the newer library
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`catalog systems also include hour, minute, second (HHMMSS)). Thereafter, the
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`library’s computer system may automatically update the date in field 005 every
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`time the library updates the MARC record (e.g., to reflect that an item has been
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`moved to a different shelving location within the library). Field 005 is visible
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`when viewing a MARC record via an appropriate computerized interface, but
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`when a MARC record is printed to hardcopy, no “005” label appears. The initial
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`field 005 date (i.e., the date the MARC record was created) does appear, however,
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`next to the label “Entered.”10 The date upon which the most recent update to field
`
`
`10 In this report, I sometimes refer to the “Entered” entry as Field 008, characters
`00-05. Field 005 is visible when viewing a MARC record via an appropriate
`computerized interface. But when a MARC record is printed directly to hardcopy
`8
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`005 occurred also appears, next to the label “Replaced.” Thus, when an item’s
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`MARC record has been printed to hardcopy—as is the case with the exhibits to this
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`report—the date reflected next to the label “Entered” is necessarily on or after the
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`date the library first cataloged and indexed the underlying item.
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`17. Once one library has cataloged and indexed a publication by creating
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`a MARC record for that publication, other libraries that receive the publication do
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`not create additional MARC records—the other libraries instead rely on the
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`original MARC record. They may update or revise the MARC record to ensure
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`accuracy, but they do not replace or duplicate it. This practice does more than save
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`libraries from duplicating labor. It also enhances the accuracy of MARC records.
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`Further, it allows librarians around the world to know that a particular MARC
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`record is authoritative (in contrast, a hypothetical system wherein duplicative
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`records were created would result in confusion as to which record is authoritative).
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`18. The date of creation of the MARC record by a cataloger at an OCLC
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`member institution reflects when the underlying item is accessible to the public.
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`Upwards of two-thirds to three-quarters of book sales to libraries come from a
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`jobber or wholesaler for online and print resources. These resellers make it their
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`business to provide books to their customers as fast as possible, often providing
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`from the OCLC database, the “005” label is not shown. The date in the 005 field
`instead appears next to the label “Replaced.”
`9
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`turnaround times of only a single day after publication. Libraries purchase a
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`significant portion of the balance of their books directly from publishers
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`themselves, which provide delivery on a similarly expedited schedule. In general,
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`libraries make these purchases throughout the year as the books are published and
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`shelve the books as soon thereafter as possible in order to make the books available
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`to their patrons. Thus, books are generally available at libraries across the country
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`within just a few days of publication.
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`19. Catalogers can create MARC records for all types of print, online, and
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`digital resources. For example, MARC records cover serial publications, including
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`both serially-published monographs and journals. OCLC hosts MARC records for
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`more than 320 million serial publications. Serial publications are those
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`publications that have the same collective title but are intended to be continued
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`indefinitely with enumeration such as a volume or issue number (e.g., magazines,
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`journals, etc.). In the OCLC bibliographic database, the first issue or volume of
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`the monographic serial is typically cataloged (i.e., a corresponding MARC record
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`is created), but the date is left open-ended with the use of a punctuation mark such
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`as a dash. MARC records for serial publications represent the entire run of the
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`title. With knowledge of the first issue or volume published, future issues or
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`volumes can be predicted based on the information provided in the MARC record,
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`for example in field 362. In my extensive professional experience, is it highly
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`10
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`unusual for a library to stop collecting and shelving a serial publication prior to the
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`time of its cessation. If a subscription to a serial publication ends or is cancelled,
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`the library will denote that it has stopped receiving new issues or volumes by
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`filling in the end date in the MARC record.
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`20. The handling of printed journal subscriptions is shown on the covers
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`of individual issues. As was the best practice among libraries, issues arrived at a
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`central facility and were immediately received, verified as part of a subscription,
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`checked in, and stamped with the institution’s name and date. Determining that the
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`issue was part of the library subscription ensured that the entire set of publications
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`for the year had been received so that they could be professionally bound and
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`retained. This process also verified that each of the published issues arrived so that
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`the library staff did not have to request or claim an issue that did not arrive as
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`expected. In large public libraries with branches and multi-campus libraries within
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`academic institutions, the journals were sorted and delivered to the subscribing
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`unit. The issues were frequently stamped again to acknowledge receipt. The new
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`issue was placed in the public area; the older issue was stored so that it remained
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`available.
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`21. The foregoing process has been standard library practice longer than I
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`have been working in the profession. I first learned the steps in the process in the
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`late 1970s and later supervised it. Although the checking in process has become
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`11
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`automated and now links electronically to holdings records for the MARC record
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`for each serial title, the manual stamping and placing the issue in a public area has
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`not changed for 50 years. Unless I note otherwise below in reference to a specific
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`serial publication, it is my expert opinion that this standard protocol was followed
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`for each of the serial publications discussed below.
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`22.
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`In preparing this report, I used authoritative databases, such as the
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`OCLC bibliographic database and the Library of Congress Online Catalog, to
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`confirm citation details of the various publications discussed.
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`23. A researcher may discover material relevant to his or her topic in a
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`variety of ways. One common means of discovery is to search for relevant
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`information in an index of periodical and other publications. Having found
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`relevant material, the researcher will then normally obtain it online, look for it in
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`libraries, or purchase it from the publisher, a bookstore, a document delivery
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`service, or other provider. Sometimes, the date of a document’s public
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`accessibility will involve both indexing and library date information. However,
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`date information for indexing entries is often unavailable. This is especially true
`
`for online indices.
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`24.
`
`Indexing services use a wide variety of controlled vocabularies to
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`provide subject access and other means of discovering the content of documents.
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`The formats in which these access terms are presented vary from service to service.
`
`12
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`25. Online
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`indexing
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`services
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`commonly provide bibliographic
`
`information, abstracts, and full-text copies of the indexed publications, along with
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`a list of the documents cited in the indexed publication. These services also often
`
`provide lists of publications that cite a given document. A citation of a document
`
`is evidence that the document was publicly available and in use by researchers no
`
`later than the publication date of the citing document.
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`26. Before the widespread development of online databases to index
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`articles in journals, magazines, conference papers, and technical reports, libraries
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`purchased printed volumes of indices. Graduate library school education mandated
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`that students learn about the bibliographic control of disciplines, the prominent
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`indexing volumes, and searching strategies required to use them effectively and
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`efficiently. Half of the courses that I studied in library school were focused on the
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`bibliography and resources in academic disciplines.
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`27. Librarians consulted with information seekers to verify citations,
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`check availability in union catalogs, printed books catalogs, the OCLC database,
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`and make formal requests for materials (e.g., books, conference proceedings,
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`journal articles). Requests were transmitted using Telex machines, rudimentary
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`email systems, and the United States Postal Service. During my career, I have
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`performed and supervised staff who handled these resource sharing tasks.
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`28. A major firm known for the breadth of subjects and comprehensive
`
`13
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`treatment in the preparation of index volumes, the H. W. Wilson Company offered
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`these reference resources since the firm was founded in 1898. The Reader’s Guide
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`to Periodical Literature is one of the best-known titles available from H. W.
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`Wilson. Each volume includes a comprehensive index for 300 of the most popular
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`and important periodicals published in the United States and Canada. Information
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`seekers have subject access expressed in plain language terminology, author
`
`access, and cross references to find the desired results from their searches. The
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`family of index titles included Science & Technology Index, Business Periodicals,
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`Applied Science & Technology Index, Humanities Index, Biological & Agricultural
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`Index, and Industrial Arts Index. These printed indices have been superseded by
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`digital database offerings available to information seekers through EBSCO.
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`29.
`
`Information seekers also used printed versions of Chemical Abstracts
`
`and Index Medicus to locate articles, scientific reports, and research papers.
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`Chemical Abstracts began publication in 1907 and by 2007 its databases
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`“contained more than 27 million records of journal and patent literature.”11 In
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`2010, Chemical Abstracts discontinued the print index. Access is now available
`
`
`11 Chemical Abstracts Service, “CAS History,” available at
`https://www.cas.org/about/cas-history (last accessed January 31, 2023); American
`Chemical Society, “Chemical Abstracts Service,” available at
`https://www.acs.org/content/acs/en/education/whatischemistry/landmarks/cas.html
`(last accessed January 31, 2023).
`
`14
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`through two electronic databases: CAplus and Registry. 12 Index Medicus is
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`a bibliographic index to medical science information, started in 1879.13 Currently,
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`PubMed includes the content that had been published as Index Medicus.14
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`30. Established in 1836 as part of the Surgeon General of the Army’s
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`Office, the National Library of Medicine (NLM) has been instrumental in the
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`development of access to medical books, journals, and research publications. In
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`the 1970s, NLM introduced MEDLINE, followed by “the establishment of the
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`National Center for Biotechnology Information in 1988, the introduction of free
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`MEDLINE in 1997, the creation of consumer-friendly MedlinePlus in 1998, and
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`the introduction of ClinicalTrials.gov and PubMed Central in 2000.”15
`
`
`12 American Chemical Society, “Chemical Abstracts Service,” available at
`https://www.acs.org/content/acs/en/education/whatischemistry/landmarks/cas.html
`(last accessed January 31, 2023).
`13 Stephen J. Greenberg and Patricia E. Gallagher, “The great contribution: Index
`Medicus, Index-Catalogue, and IndexCat,” Journal of Medical Library
`Association, April 2009, available at
`https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2670211/ (last accessed January
`31, 2023).
`14 U.S. National Library of Medicine, “List of All Journals Cited in PubMed®,”
`https://www.nlm.nih.gov/bsd/serfile_addedinfo.html (last accessed January 31,
`2023).
`15 U.S. National Library of Medicine, “A Brief History of NLM,” available at
`https://www.nlm.nih.gov/about/briefhistory.html (last accessed January 31, 2023).
`15
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`31. Online indexing services such as Google Scholar16 or ScienceDirect17
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`commonly provide bibliographic information, abstracts, and full-text copies of the
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`indexed publications, along with a list of the documents cited in the indexed
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`publication. These services also often provide lists of publications that cite a given
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`document.
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`32. A citation of a document by another is evidence that the document
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`was publicly available and in use no later than the publication date of the citing
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`document.
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`IV. PRELIMINARIES
`
`33.
`
`Scope of this declaration. I am not an attorney and will not offer
`
`opinions on the law. I am, however, rendering my expert opinion on the
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`authenticity of the documents referenced herein and when and how each of these
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`documents was disseminated or otherwise made available to the extent that persons
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`interested and ordinarily skilled in the subject matter or art, exercising reasonable
`
`diligence, could have located the documents before January 21, 2015.
`
`34.
`
`I am informed by counsel that a printed publication qualifies as
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`publicly accessible as of the date it was disseminated or otherwise made available
`
`such that a person interested in and ordinarily skilled in the relevant subject matter
`
`
`16 https://scholar.google.com/.
`17 https://www.sciencedirect.com/.
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`16
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`could locate it through the exercise of ordinary diligence.
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`35. While I understand that the determination of public accessibility under
`
`the foregoing standard rests on a case-by-case analysis of the facts particular to an
`
`individual publication, I also understand that a printed publication is rendered
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`“publicly accessible” if it is cataloged and indexed by a library such that a person
`
`interested in the relevant subject matter could locate it exercising reasonable
`
`diligence (i.e., I understand that cataloging and indexing by a library in a manner
`
`that permits a person of ordinary skill in the relevant subject matter to locate the
`
`publication is sufficient, though there are other ways that a printed publication may
`
`qualify as publicly accessible). One manner of sufficient indexing is indexing
`
`according to subject-matter category. I understand that the cataloging and
`
`indexing by a single library of a single instance of a particular printed publication
`
`is sufficient, even if the single library is in a foreign country. I understand that,
`
`even if access to a library is restricted, a printed publication that has been cataloged
`
`and indexed therein is publicly accessible so long as a presumption is raised that
`
`the portion of the public concerned with the relevant subject matter would know of
`
`the printed publication. I also understand that the cataloging and indexing of
`
`information that would guide a person interested in the relevant subject matter to
`
`the printed publication, such as the cataloging and indexing of an abstract for the
`
`printed publication, is sufficient to render the printed publication publicly
`
`17
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`SANDOZ INC.
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`IPR2023-00478
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`Ex. 1003, p. 18 of 119
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`
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`accessible.
`
`36.
`
`I understand that routine business practices, such as general library
`
`cataloging and indexing practices, can be used to establish an approximate date on
`
`which a printed publication became publicly accessible.
`
`37. Persons of ordinary skill in the art. I am told by counsel that the
`
`subject matter of this proceeding relates generally to the field of oncology.
`
`38.
`
`I have been informed by counsel that a “person of ordinary skill in the
`
`art at the time of the invention” (POSA) is a hypothetical person who is presumed
`
`to be familiar with the relevant field and its literature at the time of the inventions.
`
`This hypothetical person is also a person of ordinary creativity, capable of
`
`understanding the scientific principles applicable to the pertinent field.
`
`39.
`
`I am told by counsel that a person of ordinary skill in this subject
`
`matter would have been an oncologist with at least a medical degree (M.D.) and
`
`five years’ clinical experience treating lymphomas/leukemias and/or researching
`
`treatments for them. A POSA would have had experience with conducting, or
`
`participating in, clinical trials on oncology drugs and would have been familiar
`
`with the state of the art regarding the clinical development and use of Bruton’s
`
`Tyrosine Kinase (“BTK”) inhibitors.
`
`40.
`
`It is my opinion that such a person would have been engaged in
`
`research, learning through study and practice in the field and possibly through
`
`18
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`SANDOZ INC.
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`IPR2023-00478
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`Ex. 1003, p. 19 of 119
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`
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`formal instruction the bibliographic resources relevant to his or her research. By
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`the early 2010s such a person would have had access to a vast array of long-
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`established print resources in oncology as well as to a rich set of online resources
`
`providing indexing information, abstracts, and full text services for oncology
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`references.
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`41. Based on my experience working
`
`in research
`
`libraries with
`
`researchers having the qualifications described above, or even lesser qualifications,
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`it is my opinion that such researchers would have been able to locate the material
`
`discussed herein on their own or with the assistance of a research librarian with
`
`relative ease using the tools and resources described herein.
`
`V.
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`PUBLICATIONS
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`A. Document 1: Exhibit 1008 (“Cheson”)
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`42. Exhibit 1008 is a copy of Volume 11, Issue 9, Supplement 12 of the
`
`journal Clinical Advances in Hematology & Oncology found in the Mirand Library
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`at the Roswell Park Cancer Institute (Buffalo, New York). The supplement
`
`(hereafter Cheson) dated September 2013 contains four articles
`
`in
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`the
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`“Advancements in the Treatment of B-Cell Malignancies” at the International
`
`Conference on Malignant Lymphoma on June 18, 2013, in Lugano, Switzerland.
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`The papers are as follows: “B-Cell Receptor Pathway Inhibitors—Rationale and
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`Potential” by John G. Gribben (pages 3-4); “The Potential for Eliminating
`
`19
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`SANDOZ INC.
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`IPR2023-00478
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`Ex. 1003, p. 20 of 119
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`
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`Chemotherapy in Indolent Non-Hodgkin Lymphoma” by Bruce D. Cheson (pages
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`5-8); “The Changing Landscape in CLL” by Susan O’Brien (pages 9-11); and
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`“Mantle Cell Lymphoma: The Changing Landscape” by Andre Goy (pages 11-15).
`
`Exhibit 1008 is a true and correct copy of the supplement that I understand is being
`
`submitted as an exhibit in this proceeding. Exhibit 1008 is a true and correct copy
`
`of the issue cover, table of contents, and the four articles. I obtained this copy of
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`the supplement from the Mirand Library at the Roswell Park Cancer Institute.
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`Specifically, the text of the articles is complete; no pages are missing, and the text
`
`on each page appears to flow seamlessly from one page to the next; further, there
`
`are no visible alterations to the document. Exhibit 1008 was found within the
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`custody of a library—a place where, if authentic, a copy of this journal would
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`likely be. Exhibit 1008 is a true and correct copy in a condition that creates no
`
`suspicion about their authenticity.
`
`43. The cover of the September 2013 supplement 12 of the journal
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`Clinical Advances in Hematology & Oncology has a stamp affixed by or on behalf
`
`of the Mirand Library at the Roswell Park Cancer Institute which shows that it was
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`received, verified, and checked in on September 27, 2013. Therefore, in my
`
`experience, this issue of the supplement of the journal Clinical Advances in
`
`Hematology & Oncology would have been available to users on or shortly after the
`
`date indicated on the cover, September 27, 2013.
`
`20
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`SANDOZ INC.
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`IPR2023-00478
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`Ex. 1003, p. 21 of 119
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`44. Attached hereto as Attachment 1a is a true and correct copy of the
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`metadata record for the journal Clinical Advances in Hematology & Oncology in
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`the Mirand Library at the Roswell Park Cancer Institute. The library ownership is
`
`indicated by the presence of the library’s name at the top of each page of
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`Attachment 1a. I personally identified and retrieved the metadata record that is
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`Attachment 1a. Attachment 1a also shows that Exhibit 1008 was catalogued with
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`four descriptor terms reading “Hematology $v Periodicals” (see Attachment 1b,
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`Library of Congress sh2008121540), “Hematological oncology $v Periodicals”
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`(see Attachment 1c, Library of Congress subject heading sh92005211 and
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`Attachment 1d, Library of Congress subject heading sh8509989), “Oncology $v
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`Periodicals” (see Attachment 1e, Library of Congress sh85094724 and Attachment
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`1d, Library of Congress subject heading sh850
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