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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`SANDOZ INC.,
`Petitioner
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`v .
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`PHARMACYCLICS LLC,
`Patent Owner.
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`U.S. Patent No. 9,795,604 to Byrd et al.
`Issue Date: October 24, 2017
`Title: Methods of Treating and Preventing Graft Versus Host Disease
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`
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`Inter Partes Review No.: IPR2019–00865
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`DECLARATION OF SYLVIA D. HALL-ELLIS, Ph.D.
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`SAN EX 1008, Page 1
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`I.
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`INTRODUCTION
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`1. My name is Sylvia D. Hall-Ellis. I have been retained as an expert by
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`Petitioner, Sandoz Inc. (“Sandoz”). I have written this report at the request of Sandoz
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`to provide my expert opinion regarding the authenticity and public availability of
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`several journal publications. My report sets forth my opinions in detail and provides
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`the basis for my opinions regarding the public availability of these publications.
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`2.
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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 report.
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`3.
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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 $300 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 litigation. I have no
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`other interests in this proceeding or with any of the parties.
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`4.
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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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`II. QUALIFICATIONS
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`5.
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`I am currently an Adjunct Professor in the School of Information at San
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`José State University. I obtained a Masters of Library Science from the University
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`of North Texas in 1972 and a Ph.D. in Library Science from the University of
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`SAN EX 1008, Page 2
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`Pittsburgh in 1985. Over the last forty-five years, I have held various positions in
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`the field of library and information resources. I was first employed as a librarian in
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`1966, and have been involved in the field of library sciences since, holding numerous
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`positions.
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`6.
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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 the
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`current 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 Task
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`Force on Competencies and Education for a Career in Cataloging. Additionally, I
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`have served as the Chair for the ALA Office of Diversity’s Committee on Diversity.
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`Currently, I serve as a member of the Editorial Board for the ALCTS premier
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`cataloging journal, Library Resources and Technical Services.
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`7.
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`I have also given over one hundred presentations in the field, including
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`several on library cataloging systems and Machine-Readable Cataloging (“MARC”)
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`standards. My current research interests include library cataloging systems,
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`metadata, and organization of electronic resources.
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`8. My full curriculum vitae is attached hereto as Attachment 1.
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`SAN EX 1008, Page 3
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`III. SUMMARY OF OPINIONS
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`9.
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`In view of the foregoing, it is my opinion that the publications described
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`above were publicly available on or about the corresponding date listed in the table
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`below:
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`Exhibit
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`Publication
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`Exhibit 1003
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`Shimabukuro-Vornhagen, Alexander,
`Michael J. Hallek, Rainer F. Storb, and
`Michael S. von Bergwelt-Baildon. “The
`Role of B cells in the Pathogenesis of
`Graft-versus-host Disease.” Blood, vol.
`114, number 24 (3 December 2009): 4919-
`4927.
`Exhibit 1004 Herman, Sarah E. M., Amber L. Gordon,
`Erin Hertlein, Asha Ramanunni, Xiaoli
`Zhang, Samantha Jaglowski, Joseph Flynn,
`Jeffrey Jones, Kristie A. Blum, Joseph J.
`Buggy, Ahmed Hamdy, Amy J. Johnson,
`and John C. Byrd. “Bruton Tyrosine
`Kinase Represents a Promising Therapeutic
`Target for Treatment of Chronic
`Lymphocytic Leukemia and is Effectively
`Targeted by PCI-32765.” Blood, vol. 117,
`number 23 (9 June 2011): 6287-6296.
`Exhibit 1005 Uckun, Faith M., and Sanjive Qazi.
`“Bruton’s Tyrosine Kinase as a Molecular
`Target in Treatment of Leukemias and
`Lymphomas as well as Inflammatory
`Disorders and Autoimmunity.” Expert
`Opinion on Therapeutic Patents, vol. 20,
`issue 11 (November 2010): 1457-1470.
`
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`IV. LIBRARY CATALOGING PRACTICES
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`Publicly Available
`on or About
`January 12, 2010
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`July 8, 2011
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`December 6, 2010
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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 by
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`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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`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 work’s
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`title is recorded in Field 245, the primary author of the work is recorded in Field 100,
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`an item’s International Standard Serial Number (“ISSN”) is recorded in Field 022,
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`an item’s Library of Congress call number is recorded in Field 050, and the
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`publication date is recorded in Field 260 under the subfield “c.” If a work is a
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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/.
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`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 March 15, 2019) (“MARC is the
`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.
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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, which
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`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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`“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. To the extent this “mouse
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`over” option was not available, I consulted the Directory of OCLC Libraries in order
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`to identify 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 through
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`the Library of Congress at http://www.loc.gov/marc/bibliographic/. For example,
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`6XX
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`fields
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`are
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`termed
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`“Subject
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`Access
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`Fields.”
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`
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`See
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`http://www.loc.gov/marc/bibliographic/bd6xx.html. Among these, for example, is
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`the 650 field; this is the “Subject Added Entry – Topical Term” field. See
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`http://www.loc.gov/marc/bibliographic/bd650.html. The 650 field is a “[s]ubject
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`added entry in which the entry element is a topical term.” Id. These entries “are
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`3 https://www.oclc.org/en/contacts/libraries.html.
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`assigned to a bibliographic record to provide access according to generally accepted
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`thesaurus-building rules (e.g., Library of Congress Subject Headings (LCSH),
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`Medical Subject Headings (MeSH)).” Id. Further, MARC records include call
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`numbers, which themselves include a classification number. For example, the 050
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`field
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`is
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`the
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`“Library
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`of
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`Congress
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`Call Number.”
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`
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`See
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`http://www.loc.gov/marc/bibliographic/bd050.html. A defined portion of the
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`Library of Congress Call Number is the classification number, and “source of the
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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.” Id. Thus, included in the 050 field is a
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`subject matter classification. Each item in a library has a single classification
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`number. A library selects a classification scheme (e.g., the Library of Congress
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`Classification 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 library
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`assigns the classification number, it appears in a 090 field. In either scenario, the
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`MARC record includes a classification number that represents a subject matter
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`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 libraries
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`themselves, and of librarianship, and to provide processes and products for the
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`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 of
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`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, literary
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`and educational knowledge and information.”4 Among other services, OCLC and
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`its members are
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`responsible
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`for maintaining
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`the WorldCat database
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`(http://www.worldcat.org/), used by
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`independent and
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`institutional
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`libraries
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`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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`4 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).
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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 been
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`cataloged and indexed according to its subject matter such that a person interested
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`in that subject matter could, with reasonable diligence, locate and access the
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`publication through any library with access to the OCLC bibliographic database or
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`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 through
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`05. The MARC record creation date reflects the date on which, or shortly after
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`which, the item was first acquired or cataloged. Initially, Field 005 of the MARC
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`record is automatically populated with the date the MARC record was created in
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`year, month, day format (YYYYMMDD) (some of the newer library catalog systems
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`also include hour, minute, second (HHMMSS)). Thereafter, the library’s computer
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`system may automatically update the date in Field 005 every time the library updates
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`the MARC record (e.g., to reflect that an item has been moved to a different shelving
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`location within the library). Field 005 is visible when viewing a MARC record via
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`an appropriate computerized interface, but when a MARC record is printed to
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`hardcopy, no “005” label appears. The initial Field 005 date (i.e., the date the MARC
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`record was created) does appear, however, next to the label “Entered.”5 The date
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`upon which the most recent update to Field 005 occurred also appears, next to the
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`label “Replaced.” Thus, when an item’s MARC record has been printed to
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`hardcopy—as is the case with the exhibits to this report—the date reflected next to
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`the label “Entered” is necessarily on or after the date the library first cataloged and
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`indexed the underlying item.
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`17. Once one library has cataloged and indexed a publication by creating a
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`MARC record for that publication, other libraries that receive the publication do not
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`create additional MARC records—the other libraries instead rely on the original
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`MARC record. They may update or revise the MARC record to ensure accuracy,
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`but they do not replace or duplicate it. This practice does more than save libraries
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`from duplicating labor. It also enhances the accuracy of MARC records. Further, it
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`allows librarians around the world to know that a particular MARC record is
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`authoritative (in contrast, a hypothetical system wherein duplicative records were
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`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 journal sales to libraries come from a
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`5
`In this report, I sometimes refer to the “Entered” entry as Field 008, characters
`00-05.
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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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`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 themselves,
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`which provide delivery on a similarly expedited schedule. In general, libraries make
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`these purchases throughout the year as the books are published and shelve the books
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`as soon thereafter as possible in order to make the books available to their patrons.
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`Thus, books are generally available at libraries across the country within just a few
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`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 publications
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`that have the same collective title but are intended to be continued indefinitely with
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`enumeration such as a volume or issue number (e.g., magazines, journals, etc.). In
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`the OCLC bibliographic database, the first issue or volume of the monographic serial
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`is typically cataloged (i.e., a corresponding MARC record is created), but the date is
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`left open-ended with the use of a punctuation mark such as a dash. MARC records
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`for serial publications represent the entire run of the title. With knowledge of the
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`first issue or volume published, future issues or volumes can be predicted based on
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`the information provided in the MARC record, for example in Field 362. In my
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`extensive professional experience, is it highly unusual for a library to stop collecting
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`and shelving a serial publication prior to the time it ceases publication. If a
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`subscription to a serial publication ends or is cancelled, the library will denote that
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`it has stopped receiving new issues or volumes by filling in the end date in the
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`MARC record.
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`20. The handling of printed journal subscriptions is shown on the covers of
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`individual issues. As was the best practice among libraries, issues arrived at a central
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`facility and were immediately received, verified as part of a subscription, checked
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`in, and stamped with the institution’s name and date. Determining that the issue was
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`part of the library subscription ensured that the entire set of publications for the year
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`had been received so that they could be professionally bound and retained. This
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`process also verified that each of the published issues arrived so that the library staff
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`did not have to request or claim an issue that did not arrive as expected. In large
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`public libraries with branches and multi-campus libraries within academic
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`institutions, the journals were sorted and delivered to the subscribing unit. The
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`issues were frequently stamped again to acknowledge receipt. The new issue was
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`placed in the public area; the older issue was stored so that it remained 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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`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. Unless I note
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`otherwise below in reference to a specific serial publication, it is my expert opinion
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`that this standard protocol was followed for each of the serial publications discussed
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`below.
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`23.
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`Indexing. A researcher may discover material relevant to his or her
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`topic in a 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 relevant
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`material, the researcher will then normally obtain it online, look for it in libraries, or
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`purchase it from the publisher, a bookstore, a document delivery service, or other
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`provider. Sometimes, the date of a document’s public accessibility will involve both
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`indexing and library date information. However, date information for indexing
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`entries is often unavailable. This is especially true for online indices.
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`24.
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`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.
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`25. Online indexing services commonly provide bibliographic information,
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`abstracts, and full-text copies of the indexed publications, along with a list of the
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`documents cited in the indexed publication. These services also often provide lists
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`of publications that cite a given document. A citation of a document is evidence that
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`the document was publicly available and in use by persons interested and ordinarily
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`skilled in the subject matter or art no later than the publication date of the citing
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`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 consult with information seekers to verify citations, check
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`availability in union catalogs, printed books catalogs, the OCLC database, and make
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`formal requests for materials (e.g., books, conference proceedings, journal articles).
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`Requests were transmitted using Telex machines, rudimentary email systems, and
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`the United States Postal Service. During my career, I have performed and supervised
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`staff who handled these resource sharing tasks.
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`28.
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`Information seekers also use printed versions of Chemical Abstracts
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`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 “contained
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`more than 27 million records of journal and patent literature.”6 In 2010, Chemical
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`Abstracts discontinued the print index. Access is now available through two
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`electronic databases: CAplus and Registry.7 Index Medicus is a bibliographic
`
`index to medical science information, started in 1879.8 Currently, PubMed includes
`
`the content that had been published as Index Medicus.9
`
`
`6
`at
`available
`“CAS History,”
`Chemical Abstracts
`Service,
`https://www.cas.org/about/cas-history (last accessed March 15, 2019); American
`available
`at
`Chemical
`Society,
`“Chemical Abstracts
`Service,”
`https://www.acs.org/content/acs/en/education/whatischemistry/landmarks/cas.html
`(last accessed March 15 2019).
`7 American Chemical Society, “Chemical Abstracts Service,” available at
`https://www.acs.org/content/acs/en/education/whatischemistry/landmarks/cas.html
`(last accessed March 15, 2019).
`8 Stephen Greenberg and Patricia Gallagher, “The great contribution: Index
`Medicus, Index-Catalogue, and IndexCast,” Journal of Medical Library
`Association,
`at
`April
`2009,
`available
`https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2670211/ (last accessed March 15,
`2019).
`9 U.S. National Library of Medicine, “List of All Journals Cited in PubMed®,”
`https://www.nlm.nih.gov/bsd/serfile_addedinfo.html (last accessed February 19,
`2019).
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`29. 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 the
`
`1970s, NLM introduced MEDLINE, followed by “the establishment of the National
`
`Center for Biotechnology Information in 1988, the introduction of free MEDLINE
`
`in 1997, the creation of consumer-friendly MedlinePlus in 1998, and the introduction
`
`of ClinicalTrials.gov in 2000.”10
`
`30. Online
`
`indexing
`
`services
`
`such
`
`as Google
`
`Scholar
`
`(https://scholar.google.com/) or ScienceDirect (https://www.sciencedirect.com/)
`
`commonly provide bibliographic information, abstracts, and full-text copies of the
`
`indexed publications, along with a list of the documents cited in the indexed
`
`publication. These services also often provide lists of publications that cite a given
`
`document.
`
`31. A citation of a document by another is evidence that the document was
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`publicly available and in use no later than the publication date of the citing
`
`document.
`
`V.
`
`PRELIMINARIES
`
`32.
`
`Scope of this declaration. I am not an attorney and will not offer
`
`
`10 U.S. National Library of Medicine, “A Brief History of NLM,” available at
`https://www.nlm.nih.gov/about/briefhistory.html (last accessed February 19, 2019).
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`opinions on the law. I am, however, rendering my expert opinion on the public
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`availability 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 October 25, 2013, a date which
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`I have been informed is relevant for the purposes of Sandoz’s petition for inter partes
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`review.
`
`33.
`
`I am informed by counsel that a printed publication qualifies as publicly
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`accessible as of the date it was disseminated or otherwise made available such that
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`a person interested in and ordinarily skilled in the relevant subject matter could
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`locate it through the exercise of ordinary diligence.
`
`34. 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
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`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
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`interested and ordinarily skilled in the subject matter or art could locate it exercising
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`reasonable diligence (i.e., I understand that cataloging and indexing by a library in a
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`manner that such a person 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
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`16
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`SAN EX 1008, Page 17
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`
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`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
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`publication that has been cataloged and indexed therein is publicly accessible so long
`
`as a presumption is raised that a person interested and ordinarily skilled in the subject
`
`matter or art would know of the printed publication. I also understand that the
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`cataloging and indexing of information that would guide such a person to the printed
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`publication, such as the cataloging and indexing of an abstract for the printed
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`publication, is sufficient to render the printed publication publicly accessible.
`
`35.
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`I understand that routine business practices, such as general library
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`cataloging and indexing practices, can be used to establish an approximate date on
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`which a printed publication became publicly accessible.
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`36. Persons of ordinary skill in the art. I am informed by counsel that the
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`subject matter of this proceeding relates generally to the field of medicine and
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`particularly to the treatment of graft versus host disease (“GVHD”).
`
`37.
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`I have been informed by counsel that a person of ordinary skill in the
`
`art as of October 25, 2013 (“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.
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`17
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`SAN EX 1008, Page 18
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`38.
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`I am told by counsel that in October 25, 2013 a POSA would have
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`possessed a high level of skill, such as having an advanced degree in the field of
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`medicine with additional, specialized training, such as a fellowship, in hematology
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`or oncology as well as several years’ experience specializing in transplantation. A
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`POSA would as of the relevant time also preferably have had some experience
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`investigating pharmaceutical compositions for treating GVHD or related conditions.
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`39.
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` It is my opinion that such a person would have been engaged in
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`research, learning through study and practice in the field and possibly through formal
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`instruction the bibliographic resources relevant to his or her research. On or around
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`October 25, 2013 such a person would have had access to a vast array of long-
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`established print resources in medicine as well as to a rich set of online resources
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`providing indexing information, abstracts, and full text services for medicinal
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`references.
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`40. Based on my experience working in research libraries with researchers
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`having the qualifications described above, or even lesser qualifications, it is my
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`opinion that a person interested and ordinarily skilled in the subject matter or art,
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`including a POSA, would have been able to locate the material discussed herein on
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`their own or with the assistance of a research librarian with relative ease using the
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`tools and resources described herein.
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`18
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`SAN EX 1008, Page 19
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`VI. EXHIBIT 1003 (“SHIMABUKURO-VORNHAGEN”)
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`41. Exhibit 1003, submitted with Sandoz’s petition for inter partes review,
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`is a true and correct copy of portions of December 3, 2009 issue of the journal Blood
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`(Volume 114, Issue 24) found in the National Library of Medicine. Exhibit 1003
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`comprises the issue cover, table of contents, and the article “The Role of B cells in
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`the Pathogenesis of Graft-versus-host Disease” by Alexander Shimabukuro-
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`Vornhagen, Michael J. Hallek, Rainer F. Storb, and Michael S. von Bergwelt-
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`Baildon (hereafter “Shimabukuro-Vornhagen”), which appears on pages 4919–4927
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`of the issue. I obtained this copy of Exhibit 1003 from the National Library of
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`Medicine. The text of the Shimabukuro-Vornhagen article is complete; no pages are
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`missing, and the text on each page appears to flow seamlessly from one page to the
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`next; further, there are no visible alterations to the document. The document from
`
`which Exhibit 1003 was copied was found within the custody of a library and was
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`in a condition that creates no suspicion about its authenticity.
`
`42. The cover of Exhibit 1003 has an ownership stamp affixed by or on
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`behalf of the National Library of Medicine which shows that it was received,
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`verified, and checked in on or near January 12, 2010. Therefore, in my experience,
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`this issue of the journal Blood would have been available to users at the National
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`Library of Medicine on or shortly after that date.
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`19
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`SAN EX 1008, Page 20
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`43.
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`I also reviewed MARC records that corroborate that the National
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`Library of Medicine received the issue of Blood from which Exhibit 1003 was
`
`copied. Attached hereto as Attachment 2a is a true and correct copy of the MARC
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`record for the journal Blood at the National Library of Medicine. The library
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`ownership is indicated by the presence of the library’s code (DNLM) in the 040 field.
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`I personally identified and retrieved the MARC record that is Attachment 2a.
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`Attachment 2a also shows that Exhibit 1003 was catalogued with descriptor term
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`“Hematology” in the 650 field.
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`44. Based on finding a print copy of Exhibit 1003 in the National Library
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`of Medicine and MARC record in its online library catalog attached as Attachment
`
`2a, it is my opinion that Exhibit 1003 including the article “The Role of B cells in
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`the Pathogenesis of Graft-versus-host Disease” by Shimabukuro-Vornhagen, et al.
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`published in the journal Blood would have been available at the National Library of
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`Medicine on or shortly after January 12, 2010.
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`45. As noted in the holdings information (field 362), the National Library
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`of Medicine has received the journal Blood since January 1946 and continues to
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`receive the publication. In view of the MARC record for Exhibit 1003, the
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`Shimabukuro-Vornhagen article would have been publicly available on or shortly
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`after January 12, 2010, because the serial title had been received, cataloged, and
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`20
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`SAN EX 1008, Page 21
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`indexed at the National Library of Medicine and made part of its online catalog
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`database.
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`46.
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`I also reviewed other MARC records that corroborate
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