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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`_________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_________________
`
`
`BLUEBIRD BIO, INC.
`Petitioner
`
`v.
`
`SLOAN KETTERING INSTITUTE FOR CANCER RESEARCH,
`Patent Owner
`
`_________________
`
`Patent No. 8,058,061
`_________________
`
`DECLARATION OF INGRID HSIEH-YEE, PH.D.
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`Page 1 of 171
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`BLUEBIRD EXHIBIT 1036
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`I.
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`TABLE OF CONTENTS
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`Introduction ...................................................................................................... 1
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`A. Qualifications and Professional Experience .......................................... 1
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`B.
`
`C.
`
`Scope of This Declaration ..................................................................... 8
`
`Evidence Considered in Forming My Opinions.................................... 9
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`II.
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`Authenticity and Public Availability of the May Thesis (Ex 1004) .............. 12
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`A. Authentication ..................................................................................... 12
`
`B.
`
`C.
`
`D.
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`ProQuest Affidavit .............................................................................. 14
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`ProQuest Database Record for the May Thesis ................................... 16
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`Summary of My Opinion on the May Thesis ...................................... 18
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`III. Authenticity and Public Availability of the May Article (Ex 1005) ............. 18
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`A. Authentication ..................................................................................... 18
`
`B.
`
`C.
`
`Records of the University of Wisconsin-Madison Library System .... 21
`
`PubMed Record for the May Article ................................................... 26
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`D. Usage Record ...................................................................................... 28
`
`E.
`
`Summary of My Opinion on the May Article ..................................... 29
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`IV. Authenticity and Public Availability of the May Abstract (Ex 1006) ........... 30
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`A. Authentication ..................................................................................... 30
`
`B.
`
`C.
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`Publisher Webpage .............................................................................. 31
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`Summary of My Opinion on the May Abstract ................................... 33
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`V. Authenticity and Public Availability of Himanen (Ex 1047) ........................ 33
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`i
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`Page 2 of 171
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`A. Authentication ..................................................................................... 33
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`B.
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`C.
`
`D.
`
`Records of the University of Wisconsin-Madison Library System .... 37
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`PubMed Record for Himanen ............................................................. 41
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`Summary of My Opinion on Himanen ................................................ 44
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`VI. Conclusion ..................................................................................................... 44
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`
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`
`
`ii
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`Page 3 of 171
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`I.
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`Introduction
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`I, Ingrid Hsieh-Yee, Ph.D., do hereby declare as follows:
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`1.
`
`I have been retained as an independent expert witness on behalf of
`
`bluebird bio, Inc. (“BLUEBIRD”) for proceedings before the United States Patent
`
`and Trademark Office (“PTO”) regarding the authenticity and public availability of
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`certain prior art references in relation to US Patent No. 8,058,061.
`
`2.
`
`I am being compensated for my work in this matter at my customary
`
`hourly rate. I am also being reimbursed for any reasonable expenses associated with
`
`my work and testimony in this investigation. My compensation is not contingent on
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`the results of my study, the substance of my opinions, or the outcome of this matter.
`
`A. Qualifications and Professional Experience
`
`3. My complete qualifications and professional experience are described
`
`in my academic curriculum vitae (Appendix A). The following is a brief summary
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`of my relevant qualifications and professional experience.
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`4.
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`I was a Professor in the Department of Library and Information Science
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`at the Catholic University of America for 32 years and retired at the end of August
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`2022. I have experience working in an academic library, a medical library, and a
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`legislative library. I hold a Ph.D. in Library and Information Studies from the
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`University of Wisconsin-Madison and a Masters in Library and Information Studies
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`from the University of Wisconsin-Madison.
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`1
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`5.
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`I am an expert on library cataloging and classification and have
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`published two editions on this subject, Organizing Audiovisual and Electronic
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`Resources for Access: A Cataloging Guide (2000 and 2006). I taught a variety of
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`courses, including Cataloging and Classification, Advanced Cataloging and
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`Classification, Organization of Internet Resources, Organization of Information,
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`Digital Content Creation and Management, Internet Searches and Web Design,
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`Information Literacy Instruction, Advanced Information Retrieval and Analysis
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`Strategies, and The Information Professions in Society. I am familiar with metadata
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`schema design and implementation. In my teaching, I covered the design and
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`implementation of metadata in databases, search engines, digital repositories, digital
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`libraries, and digital archives. I also covered how information organization affects
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`the discovery and access to digital resources on the Internet. My research interests
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`cover cataloging and classification, information organization, metadata, information
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`retrieval, information architecture, digital collections, scholarly communication,
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`user interaction with information systems, and others.
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`6.
`
`I am very familiar with a library cataloging encoding standard known
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`as the “Machine-Readable Cataloging” standard, also known as “MARC,” which
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`became the national standard for sharing bibliographic data in the United States by
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`1971 and the international standard by 1973. MARC is the primary communications
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`2
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`protocol for the transfer and storage of bibliographic metadata in libraries. Experts
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`in my field reasonably rely upon MARC records when forming their opinions.
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`7.
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`A MARC record consists of 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 follows. Appendix B is a true
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`and correct copy of Parts VII to X of “Understanding MARC Bibliographic:
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`Machine-Readable Cataloging”
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`(http://www.loc.gov/marc/umb/um07to10.html)
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`from the Library of Congress that explains commonly used MARC fields. For
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`example, the personal author of the work is recorded in Field 100, the title is recorded
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`in Field 245, publisher information is recorded in Field 260, the physical volume and
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`characteristics of a publication are recorded in Field 300, and topical subjects are
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`recorded in the 650 fields.
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`8.
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`The Online Computer Library Center (OCLC)
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`is
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`the
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`largest
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`bibliographic network of the world, with more than 534 million records and
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`thousands of member institutions (many of which are libraries of some type) in more
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`than 100 countries. OCLC was founded in 1967 to promote and support library
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`cooperation. According to the “Third Article, Amended Articles of Incorporation of
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`OCLC Online Computer Library Center, Inc.,” OCLC was created “to establish,
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`maintain and operate a computerized library network and to promote the evolution
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`of library use, of libraries themselves, and of librarianship, and to provide processes
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`3
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`and products for the benefit of library users and libraries, including such objectives
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`as increasing availability of library resources to individual library patrons and
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`reducing the rate of rise of library per-unit costs, all for the fundamental public
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`purpose of furthering ease of access to and use of the ever-expanding body of
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`worldwide scientific, literary and educational knowledge and information” (source:
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`https://www.oclc.org/content/dam/oclc/membership/articles-of-incorporation.pdf).
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`9.
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`OCLC members can contribute original cataloging records in MARC
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`to the system or derive cataloging records from existing records, an activity referred
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`to as “copy cataloging.” When an OCLC participating institution acquires a work,
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`it can create an original MARC record for the work in OCLC’s Connexion system
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`(a system for catalogers to create and share MARC records), and the system will
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`automatically generate a code for the date of record creation in the yymmdd format,
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`and the creating library’s OCLC symbol is recorded in subfield “a” of the 040 field.
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`Once the MARC record is in Connexion, it becomes available to other OCLC
`
`members for adoption to their local online catalogs (i.e., copy cataloging).
`
`10. After a MARC record is created in Connexion, it also becomes
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`searchable and viewable on WorldCat, which is a free web portal for users to explore
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`more than 10,000 libraries worldwide. The record in WorldCat, however, is not
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`presented in MARC fields. Instead, the data elements are labeled to help users
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`4
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`interpret the record. Thus, the information stored in MARC records in Connexion
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`is available to the interested public through the user-friendly WorldCat web portal.
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`11. Library online catalogs gained acceptance in the early 1980s and many
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`libraries migrated their systems to the World Wide Web in the mid-1990s. Library
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`online catalogs are based on MARC records that represent their collections in order
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`to help the public understand what materials are publicly accessible in those
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`libraries. Most libraries with online catalogs have made their catalogs freely
`
`available on the Web. These online catalogs offer user-friendly search interfaces.
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`Strong user interest in keyword searches and the popularity of Google have led to
`
`the “googlization” of library search systems. As a result, many library catalogs now
`
`provide a single search box for users to conduct keyword searches, with additional
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`support for searches by author, title, subject terms, and other data elements such as
`
`ISBN (International Standard Book Number). Library catalogs these days also offer
`
`features for users to narrow their search results by language, year, format, and other
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`elements. Many libraries display MARC records on their online catalogs with labels
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`for the data elements to help the public interpret MARC records. Many libraries also
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`offer the option to display MARC records in MARC fields.
`
`12. Libraries create MARC records for works they acquire, including
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`books, serials, motion pictures, and publications in other formats. Monograph
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`cataloging is fairly common in libraries, and most libraries make a newly cataloged
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`5
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`monograph available to the public soon after the cataloging work is completed,
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`usually within a week. Libraries can create original cataloging records or use an
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`existing record in OCLC to create a copy cataloging record. As soon as the
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`cataloging record is completed, it is added to the library’s online catalog for users.
`
`If the record is an original record, it is also entered into OCLC WorldCat. If it is a
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`copy cataloging record, the library’s holding symbol is attached to the existing
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`original record in OCLC WorldCat to facilitate searching and interlibrary loan.
`
`13. The cataloging of serials and the serial check-in process are discussed
`
`here to show how libraries usually provide access to newly received serial issues.
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`According to the glossary of the RDA: Resource Description and Access cataloging
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`standard, a serial is “a mode of issuance of a manifestation issued in successive parts,
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`usually bearing numbering, that has no predetermined conclusion. A serial includes
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`a periodical, monographic series, newspaper, etc.” Because the publisher of a serial
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`makes new issues of the serial available successively, a customary cataloging
`
`practice is to create one bibliographic record for the serial, and the serial record
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`(encoded in MARC) typically provides information on the beginning date and
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`frequency of the serial, not the dates of individual issues. In other words, libraries
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`typically do not create MARC records for individual issues of a serial. Instead, they
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`rely on a serial check-in system to track the receipt of new issues. A common
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`check-in practice is to date stamp a new issue when it arrives. This practice has
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`become automated since the late 1990s, and libraries now vary in how they share the
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`receipt date of a new serial issue with the public. Some libraries use a date stamp,
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`some affix a label to indicate the receipt date, some pencil in the receipt date, and
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`some do not provide the information to the public.
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`14. The serial check-in process usually takes less than an hour, and one of
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`the steps involves placing a date stamp on the new issue to document the date the
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`issue is checked in. After that, the holdings information of the serial is updated in
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`the library’s catalog so that users know which issues are available for request or
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`access. After serial check-in is completed, the new issue is placed on the shelf with
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`the previous issues of the serial. Libraries with a public periodical room typically
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`place new issues in the periodical room for easy user access. Because information
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`presented in serials often reflects latest discovery, a general practice of libraries is to
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`make new issues of serials available for user access soon after they are checked in,
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`usually within a week.
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`15.
`
`I am personally familiar with many online catalogs, databases, and
`
`search engines. In preparing for this declaration, I used the following authoritative
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`information systems to search for records:
`
` Google Scholar (https://scholar.google.com)
`
` Online catalog of the University of Wisconsin-Madison General Library
`
`System (https://search.library.wisc.edu/search/system)
`
`
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`7
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` ProQuest Dissertations & Theses Global
`
`(https://about.proquest.com/en/dissertations/)
`
` PubMed (https://pubmed.ncbi.nlm.nih.gov/)
`
` WorldCat (https://www.worldcat.org)
`
`B.
`
`16.
`
`Scope of This Declaration
`
`I have been asked to offer my expert opinion on the authenticity and
`
`public availability date of the following documents:
`
`May, C. M.
`
`(2001). Therapeutic hemoglobin
`
`synthesis
`
`in
`
`beta-thalassemic mice
`
`expressing
`
`lentivirus-encoded
`
`human
`
`beta-globin
`
`(Order No. 3020182), available
`
`from ProQuest
`
`Dissertations & Theses Global (304774780), obtained from ProQuest
`
`on September 21, 2022, Ex 1004 (“the May Thesis”);
`
`
`
`May, C., Rivella, S., Callegari, J., Heller, G., Gaensler, K. M. L.,
`
`Luzzatto, L., & Sadelain, M. (2000). Therapeutic haemoglobin
`
`synthesis in β-thalassaemic mice expressing lentivirus-encoded human
`
`β-globin, Nature, vol. 406, no. 6791, pp. 82-86, obtained by counsel
`
`from the University of Wisconsin-Madison Memorial Library on
`
`September 28, 2022, Ex 1005 (“the May Article”);
`
`
`
`
`
`8
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`Page 11 of 171
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`
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`May, C., Rivella, S., Callegari, J., Gaensler, K., & Sadelain, M., (May
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`1, 2000). 683. Lentiviral-mediated Transfer of the Human β-Globin
`
`Gene and Large Locus Control Region Elements Permit Sustained
`
`Production of Therapeutic Levels of β-Globin in Long-term Bone
`
`Marrow Chimeras, in “Stem Cell and Blood—Preclinical and Clinical
`
`Applications,” Molecular Therapy, vol. 1, Issue 5, P. S248-249,
`
`obtained by counsel, Ex 1006 (“the May Abstract”);
`
`
`
`Himanen, J. P., Mirza, U. A., Chait, B. T., Bookchin, R. M., &
`
`Manning, J. M. (1996). A recombinant sickle hemoglobin triple mutant
`
`with independent inhibitory effects on polymerization, Journal of
`
`Biological Chemistry, vol. 271, no. 41, pp. 25152-25156, obtained by
`
`counsel
`
`from
`
`the Steenbock Library of
`
`the University of
`
`Wisconsin-Madison, Ex 1047 (“Himanen”).
`
`C. Evidence Considered in Forming My Opinions
`
`17.
`
`In the preparation of this declaration, I have reviewed the documents
`
`referenced below and any other documents I reference herein, and each of these is a
`
`type of material that experts in my field would reasonably rely upon when forming
`
`their opinions:
`
`(1) The document referenced above in Section I.B;
`
`
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`9
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`Page 12 of 171
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`
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`(2)
`
`ProQuest affidavit on the public availability of the May Thesis,
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`obtained from ProQuest on September 21, 2022, Appendix 1004A;
`
`(3)
`
`ProQuest database record for the May Thesis, available from the
`
`ProQuest Dissertations & Theses Global database (PQDT) at
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`https://www.proquest.com/docview/304774780?pq-
`
`origsite=gscholar&fromopenview=true, accessed and obtained on
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`September 19, 2022, Appendix 1004B;
`
`(4)
`
`Publisher copy of the May Article, obtained from counsel on
`
`October 6, 2022, Appendix 1005A;
`
`(5) Bibliographic and MARC records for Nature that contains the May
`
`Article,
`
`available
`
`at
`
`https://search.library.wisc.edu/serial/999481760902121 from the
`
`online catalog of the University of Wisconsin-Madison Library
`
`System, accessed and obtained on October 6, 2022, Appendix
`
`1005B;
`
`(6)
`
`Pubmed metadata record for the May Article, available at
`
`https://pubmed.ncbi.nlm.nih.gov/10894546/, accessed and obtained
`
`on October 3, 2022, Appendix 1005C;
`
`
`
`10
`
`Page 13 of 171
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`
`
`(7) Citations to the May Article, obtained from Google Scholar,
`
`Appendix 1005D;
`
`(8) Publisher’s copy of “Stem Cell and Blood—Preclinical and Clinical
`
`Applications”
`
`that contains
`
`the May Abstract, available at
`
`https://www.cell.com/action/showPdf?pii=S1525-
`
`0016%2800%2990176-X, accessed and obtained on October 3,
`
`Appendix 1006A;
`
`(9)
`
`Publisher webpage for “Stem Cell and Blood—Preclinical and
`
`Clinical Applications” that contains the May Abstract, available at
`
`https://www.cell.com/molecular-therapy-family/molecular-
`
`therapy/fulltext/S1525-0016(00)90176-
`
`X?_returnURL=https%3A%2F%2Flinkinghub.elsevier.com%2Fre
`
`trieve%2Fpii%2FS152500160090176X%3Fshowall%3Dtrue,
`
`accessed and obtained on October 3, 2022, Appendix 1006B;
`
`(10) Publisher
`
`copy
`
`of
`
`Himanen,
`
`available
`
`at
`
`https://www.jbc.org/action/showPdf?pii=S0021-
`
`9258%2819%2978269-6
`
`from
`
`the publisher’s webpage
`
`for
`
`Himanen, accessed and obtained on October 6, 2022, Appendix
`
`1047A;
`
`
`
`11
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`Page 14 of 171
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`
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`(11) Bibliographic and MARC records for Journal of Biological
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`Chemistry
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`that
`
`contains
`
`Himanen,
`
`available
`
`at
`
`https://search.library.wisc.edu/serial/999483131502121 from the
`
`online catalog of the University of Wisconsin-Madison Library
`
`System, accessed and obtained on October 6, 2022, Appendix
`
`1047B;
`
`(12) PubMed metadata
`
`record
`
`for Himanen,
`
`available
`
`at
`
`https://pubmed.ncbi.nlm.nih.gov/8810271/, accessed and obtained
`
`on October 6, 2022, Appendix 1047C.
`
`These records are identified and discussed in this declaration. Experts in the field
`
`would reasonably rely on the data described herein to form their opinions.
`
`II. Authenticity and Public Availability of the May Thesis (Ex 1004)
`A. Authentication
`
`18. Ex 1004 is a true and correct copy of “Therapeutic hemoglobin
`
`synthesis
`
`in beta-thalassemic mice expressing
`
`lentivirus-encoded human
`
`beta-globin,” (“the May Thesis”), a dissertation completed by Chad M. May in 2001
`
`at the Weill Medical College of Cornell University, that I obtained from ProQuest,
`
`the publisher of the ProQuest Dissertations & Theses (PQDT) database, which is the
`
`most comprehensive collection of dissertations and theses in the world. When I
`
`began preparing this declaration I searched Google Scholar for records for the May
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`
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`12
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`Page 15 of 171
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`
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`Thesis, and retrieved a record that led me to a ProQuest database that contains the
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`May Thesis. I then requested an affidavit from ProQuest on the date when the May
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`Thesis was added to PQDT and became publicly accessible. The affidavit I received
`
`from ProQuest includes a copy of the May Thesis, which is presented as Ex 1004 in
`
`this declaration.
`
`19.
`
` Page 1 of Ex 1004 is the “Information to Users” page that states that
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`“[t]his manuscript has been reproduced from the microfilm master. UMI films the
`
`text directly from the original or copy submitted.” This page also shows that UMI
`
`of ProQuest Information and Learning of Ann Arbor, MI is the publisher. Page 3 is
`
`the title page that shows “Therapeutic hemoglobin synthesis in beta-thalassemic
`
`mice expressing lentivirus-encoded human beta-globin“ is the title of a doctoral
`
`thesis by Chad M. May submitted to “the Faculty of the Graduate School of Cornell
`
`University” in “May 2001.” Page 4 is the copyright page for the UMI copy of the
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`May Thesis that shows the UMI Number for the May Thesis is “3020182” and that
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`“UMI Microform 3020182” has a “2001” copyright date, with Bell & Howell
`
`Information and Learning Company as the copyright holder. Page 5 shows the
`
`original thesis has a “2001” copyright date with the author as the copyright holder.
`
`Pages 6 and 7 are the abstract, page 8 (internal page iii) is a “Biographical Sketch”
`
`of the author, followed by the dedication page and the acknowledgement page, and
`
`pages 11 to 14 (internal pages vi to ix) are the table of contents. Ex 1004 shows the
`
`
`
`13
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`Page 16 of 171
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`
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`May Thesis has a front matter that ends on internal page xv, the main text has seven
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`chapters, including an appendix in Chapter 6 and a list of 155 references in Chapter
`
`7, tables and figures, and the last numbered page of the May Thesis is page 130.
`
`20. The PQDT copy of the May Thesis (Ex 1004) is in a condition that
`
`creates no suspicion about its authenticity. Specifically, the front matter and the
`
`body of the text are not missing any intermediate pages, the text on each page
`
`appears to flow seamlessly from one page to the next, and there are no visible
`
`alterations to the document. Moreover, Ex 1004 was provided by ProQuest, the
`
`publisher of a database known as the most comprehensive dissertations and theses
`
`database, a place where, if authentic, this thesis would likely be found. I therefore
`
`see no reason to question the authenticity of this copy of the May Thesis (Ex 1004).
`
`B.
`
`ProQuest Affidavit
`
`21. Appendix 1004A is a true and correct copy of a ProQuest affidavit by
`
`Ms. LaTonya Morris on the public availability of the May Thesis. I personally
`
`requested this affidavit from ProQuest and received it on September 21, 2022. This
`
`is the type of material experts in my field would reasonably rely upon when forming
`
`their opinions.
`
`22. Ms. Morris states in the affidavit that “ProQuest is an information
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`company that collects, organizes publishes and distributes for sale content from a
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`wide range of sources, including dissertations and master’s theses.” (¶ 2) She also
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`14
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`indicates that the sales and publication practices of ProQuest are that “ProQuest
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`receives dissertations and master’s theses from participating degree granting
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`institutions. Shortly after these works are received, ProQuest makes them available
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`for sale to the public … Prior to 2013, a ‘Record’ of each dissertation and each
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`master’s thesis submitted to ProQuest was published in ProQuest’s print publication
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`Dissertation Abstracts International or Master’s Abstracts International” and such a
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`record typically includes “an abstract, index record, and citation information
`
`including title, author name, degree granting institution and degree date.” (¶ 3) She
`
`further describes how, prior to 1985, ProQuest disseminated records of dissertations
`
`and master’s theses through print publications, then created the Abstract Database
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`in 1985 to provide access to those records. An important change in 1997 was that
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`“ProQuest made available the contents of the Abstract Databases in its ProQuest
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`Digital Dissertations and Theses database (‘PQDT’), which is accessible via the
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`world wide web to authenticated subscribers” (¶ 4) and “PQDT allows for text
`
`searching of the Records as well as full text where the full PDF is properly
`
`formatted.” (¶ 5) She also clarifies that “[o]nce a Record is published on the
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`Abstract Database, the Record is available to the students, faculty, staff and /or
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`patrons of any institutions that subscribe to the Abstract Database.” (¶ 6) After
`
`reviewing ProQuest’s records on the May Thesis, which is Dissertation No. 3020182
`
`in PQDT, Ms. Morris states that ProQuest first made the May Thesis available for
`
`
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`15
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`Page 18 of 171
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`sale in PDF format and placed in PQDT on November 26, 2001 (¶ 8) and that “[a]t
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`the time of the Dissertation’s publication, the Record of the Dissertation was made
`
`available directly from ProQuest in electronic format and online via third party
`
`vendors, including Dialog, as part of the Abstract Database which was made
`
`available via such vendors in the ordinary course of business.” (¶ 9) This affidavit
`
`confirms my prior knowledge about Dissertation Abstracts International, the
`
`Abstracts Database, and the relationship between the Abstracts Database and PQDT.
`
`It is therefore my opinion that the May Thesis became publicly discoverable and
`
`accessible via PQDT on November 26, 2001.
`
`C.
`
`ProQuest Database Record for the May Thesis
`
`23. The ProQuest Dissertations & Theses Global database (“PQDT”) is the
`
`most comprehensive collection of dissertations and thesis in the world that is
`
`“updated weekly and features 24 indexed and searchable fields, including full text
`
`searchability
`
`for
`
`the
`
`entire
`
`text of
`
`full-text dissertations”
`
`(source:
`
`https://proquest.libguides.com/pqdt/content). Graduate students typically consult
`
`this database to determine if their proposed thesis or dissertation topics have not
`
`already been written about; and students, faculty and other researchers search this
`
`database for titles related to their research interests. Researchers can access this
`
`database online as well as print reference products such as Dissertation Abstracts
`
`International (“DAI”). This information about PQDT and DAI is supported by a
`
`
`
`16
`
`Page 19 of 171
`
`
`
`ProQuest webpage “Finding the dissertation or thesis you need” archived by the
`
`Internet
`
`Archive
`
`on
`
`October
`
`21,
`
`2008,
`
`and
`
`available
`
`at
`
`https://web.archive.org/web/20081021040200/http://www.umi.com/en-
`
`US/products/dissertations/individuals.shtml.
`
`24. Appendix 1004B is a database record for the May Thesis that I
`
`personally located, identified, and obtained from PQDT. This is the type of record
`
`experts in my field would reasonably rely upon when forming their opinions.
`
`25. This PQDT database record shows that it represents Therapeutic
`
`hemoglobin synthesis in beta-thalassemic mice expressing lentivirus-encoded
`
`human beta-globin by “May, Chad Michael” of the Weill Medical College of
`
`Cornell University, the dissertation was published by ProQuest Dissertations
`
`Publishing with a 2001 publication date, and the ProQuest dissertation number for
`
`this thesis is “3020182.” The database record shows that users can obtain the full
`
`text in PDF, preview PDF, and view abstract/details. It also shows an abstract that
`
`is identical to the abstract in the May Thesis. The record details area shows the
`
`subjects of the May Thesis are “Molecular biology” and “Immunology” and seven
`
`keywords are provided
`
`to represent
`
`the subjects,
`
`including “Health and
`
`environmental sciences; Biological sciences; Globin; Hemoglobin; Lentivirus-
`
`encoded; Thalassemic; Therapeutic.” The record also shows the May Thesis has a
`
`total of 130 pages, the degree date is “2001,” its ISBN is ”978-0-493-32698-6,”
`
`
`
`17
`
`Page 20 of 171
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`
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`Weill Medical College of Cornell University is the degree granting institution, the
`
`dissertation number is “3020182” and the ProQuest document ID is “304774780.”
`
`In addition, the database record shows the source of these details is “DAI-B 62/07,
`
`Dissertation Abstracts International,” meaning the May Thesis was indexed in vol.
`
`62, no. 7 of Dissertation Abstracts International. B, The sciences and engineering.
`
`This PQDT record has made the May Thesis discoverable by author, title, subjects,
`
`keywords, abstracts and full text. After users discover this record, they would have
`
`been able to access the May Thesis from an institution that subscribes to PQDT or
`
`purchase a copy of the dissertation from ProQuest.
`
`D.
`
`Summary of My Opinion on the May Thesis
`
`26. Based on the ProQuest copy of the May Thesis (Ex 1004), the ProQuest
`
`affidavit (Appendix 1004A), and the PQDT database record (Appendix 1004B), it
`
`is my opinion that the May Thesis was published by the Weill Medical College of
`
`Cornell University in 2001, and ProQuest made this dissertation discoverable and
`
`accessible in PDF no later than November 26, 2001.
`
`III. Authenticity and Public Availability of the May Article (Ex 1005)
`
`A. Authentication
`
`27. Ex 1005 is a true and correct copy of Therapeutic haemoglobin
`
`synthesis in β-thalassaemic mice expressing lentivirus-encoded human β-globin,
`
`(“May Article”), by May et al., Nature, vol. 406, no. 6791, pp. 82-86, obtained by
`
`
`
`18
`
`Page 21 of 171
`
`
`
`counsel from the library system of the University of Wisconsin-Madison. When I
`
`began preparing this declaration I searched WorldCat by the title of the May
`
`Article for
`
`records
`
`and
`
`retrieved
`
`a
`
`WorldCat
`
`record
`
`(https://worldcat.org/en/title/4654005982)
`
`that
`
`showed
`
`the University of
`
`Wisconsin-Madison General Library System held the journal containing the May
`
`Article, so I searched their online catalog for records for this journal, and the search
`
`results confirmed the holdings information. I then obtained a copy of the May Article
`
`from this library system through counsel, who obtained the copy from Wisconsin
`
`TechSearch (WTS), a document delivery service based at the University of
`
`Wisconsin-Madison. This copy is presented as Ex 1005 in this declaration.
`
`28. The first page of Ex 1005 is the cover of Nature that shows this journal
`
`is an international weekly journal of science that is also available online at
`
`www.nature.com, and this print issue has a “6 July 2000” issue date. The cover
`
`highlights four articles in this issue, including “-Thalassaemia: Prospects for gene
`
`therapy.” It carries an address label of the Memorial Library of the University of
`
`Wisconsin-Madison, a date stamp of “Received JUL 18 2000 University Library”
`
`and a label stating “Do Not Remove From Current Periodicals Room.” Page 2 is the
`
`table of content that identifies this issue as “Volume 406, issue no. 6791” and shows
`
`an article “-Thalassaemia: Prospects for gene therapy” that begins on page 82. The
`
`bottom of page 2 shows the ISSN of Nature is “0028-0836” and the journal “is
`
`
`
`19
`
`Page 22 of 171
`
`
`
`published weekly on Thursday, except the last week in December,” by the Nature
`
`Publishing Group of London. Pages 3 to 7 (internal pages 82 to 86) are the May
`
`Article, and internal page 82 shows the title, authors, and abstract, and also shows
`
`the May Article is placed in the “Letters to nature” section of this issue. Ex 1005
`
`has a total of five pages, including six figures (some color) and 30 references. The
`
`publication history is shown on internal page 86 indicating the article was
`
`“[r]eceived 10 February; accepted 17 May 2000.” A note after the references
`
`indicates “[s]upplementary information is available on Nature’s World-Wide Web
`
`site (http://www.nature.com) or as paper copy from the London editorial office of
`
`Nature.”
`
`29. Appendix 1005A is a true and correct copy of the May Article obtained
`
`by counsel from the publisher. Because the May Article is about gene therapy, I
`
`searched PubMed to determine if it was indexed. I found a PubMed record
`
`(https://pubmed.ncbi.nlm.nih.gov/10894546/ ) for the May Article that showed a full
`
`text link to “Nature Publishing Group” that led me to the publisher’s webpage for
`
`the May Article at https://www.nature.com/articles/35017565. It informed users that
`
`they could obtain the May Article from an institution with a subscription to the
`
`journal or purchase the article from the publisher, so I obtained a copy of the May
`
`Article through counsel. This publisher copy is presented as Appendix 1005A in
`
`this declaration. I personally located and identified this article, and obtained this
`
`
`
`20
`
`Page 23 of 171
`
`
`
`copy through counsel. This is the type of material experts in my field would
`
`reasonably r
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