`
`
` UNITED STATES PATENT AND TRADEMARK OFFICE
`
`_________________
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`_________________
`
`
`EVERGREEN THERAGNOSTICS, INC.
`
`Petitioner
`
`– vs. –
`
`ADVANCED ACCELERATOR APPLICATIONS SA
`
`Patent Owner
`
`_________________
`
`DECLARATION OF INGRID HSIEH-YEE, PH.D.
`IN SUPPORT OF PETITION FOR POST GRANT REVIEW
`OF U.S. PATENT NO. 10,596,276
`
`
`
`
`
`
`Evergeen Ex. 1008
`1 of 279
`
`

`

`
`
`Table of Contents
`
`I.
`
`INTRODUCTION ............................................................................................. 3
`A. Qualifications and Professional Experience .................................................... 3
`B. Scope of This Declaration ............................................................................. 11
`C. Evidence Considered in Forming My Opinions ............................................ 12
`II. Authentication and Public Availability of Strosberg (Exs. 1011 and 1012) ... 18
`A. Authentication ................................................................................................ 18
`B. PubMed Record ............................................................................................. 21
`C. New England Journal of Medicine Listing from Internet Archive ............... 24
`D. WorldCat Record ........................................................................................... 24
`E. Library of Congress Record .......................................................................... 25
`F. Actual Usage Record ..................................................................................... 28
`G. Summary of My Opinion on Strosberg ......................................................... 28
`III. AUTHENTICATION AND PUBLIC AVAILABILITY OF DE LEÓN
`RODRÍGUEZ (EX. 1014) ........................................................................................ 31
`A. PubMed Record ............................................................................................. 32
`B. Copyright Registration Record ...................................................................... 35
`C. Library of Congress Record .......................................................................... 35
`D. Linda Hall Library Record ............................................................................ 38
`E. Actual Usage Record ..................................................................................... 40
`F. Summary of My Opinions on De León-Rodríguez ....................................... 40
`IV. AUTHENTICATION AND PUBLIC AVAILABILITY OF SCOTT (EX.
`1015) ........................................................................................................................ 42
`A. PubMed Record ............................................................................................. 43
`B. PubMed Central Copy ................................................................................... 46
`C. Library of Congress Record .......................................................................... 46
`D. British Library MARC Record ...................................................................... 49
`
`
`
`i
`
`Evergeen Ex. 1008
`2 of 279
`
`

`

`
`
`E. Actual Usage Record ..................................................................................... 51
`F. Summary of My Opinions on Scott ............................................................... 51
`V. AUTHENTICATION AND PUBLIC AVAILABILITY OF FILICE (EX.
`1028) ........................................................................................................................ 54
`A. PubMed Record ............................................................................................. 55
`B. PubMed Central Archive of Journal of Oncology ........................................ 57
`C. National Library of Medicine Record ........................................................... 59
`D. Library of Congress Electronic Resources MARC Record........................... 61
`E. Actual Usage Records.................................................................................... 63
`F. Summary of My Opinions on Filice .............................................................. 64
`VI. AUTHENTICATION AND PUBLIC AVAILABILITY OF LUMARK®
`(EX. 1024) ................................................................................................................ 65
`A. LuMark® Product Webpage from Internet Archive ..................................... 65
`VII. CONCLUSION ................................................................................................ 68
`
`
`
`
`
`ii
`
`Evergeen Ex. 1008
`3 of 279
`
`

`

`
`
`I, Ingrid Hsieh-Yee, Ph.D., do hereby declare as follows:
`
`1.
`
`I have been retained as an independent expert witness on behalf of
`
`Evergreen Theragnostics, Inc. (“Evergreen”) for Post Grant Review (“PGR”)
`
`proceedings before the United States Patent and Trademark Office (“PTO”)
`
`regarding U.S. Patent Nos. 10,596,278 and 10,596,276.
`
`2.
`
`I am being compensated for my work in this matter at my customary
`
`hourly rate of $250/hour. I am also being reimbursed for any reasonable expenses
`
`associated with my work and testimony in this investigation. My compensation is
`
`not contingent on the results of my study, the substance of my opinions, or the
`
`outcome of this matter.
`
`I.
`
`INTRODUCTION
`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
`
`of my relevant qualifications and professional experience.
`
`4.
`
`I am currently a Professor in the Department of Library and Information
`
`Science at the Catholic University of America. I have experience working in an
`
`academic library, a medical library, and a legislative library and have been a
`
`professor for more than 25 years. I hold a Ph.D. in Library and Information Studies
`
`from the University of Wisconsin-Madison and a Masters in Library and Information
`3
`
`
`
`Evergeen Ex. 1008
`4 of 279
`
`

`

`
`
`Studies from the University of Wisconsin-Madison.
`
`5.
`
`I am an expert on library cataloging and classification and have
`
`published two editions on this subject, Organizing Audiovisual and Electronic
`
`Resources for Access: A Cataloging Guide (2000 and 2006). I teach a variety of
`
`courses, including Cataloging and Classification, Advanced Cataloging and
`
`Classification, Organization of Internet Resources, Organization of Information,
`
`Digital Content Creation and Management, Internet Searches and Web Design,
`
`Information Literacy Instruction, Advanced Information Retrieval and Analysis
`
`Strategies, and The Information Professions in Society. I am familiar with metadata
`
`schema design and implementation. In my teaching I have covered the design and
`
`implementation of metadata in databases, search engines, digital repositories, digital
`
`libraries, and digital archives. I have also covered how information organization
`
`affects the discovery of and access to digital resources on the Internet. My research
`
`interests cover cataloging and classification, information organization, metadata,
`
`information retrieval, information architecture, digital collections, scholarly
`
`communication, user interaction with information systems, and others.
`
`6.
`
`I am very familiar with a library cataloging encoding standard known
`
`as the “Machine-Readable Cataloging” standard, also known as “MARC,” which
`
`became the national standard for sharing bibliographic data in the United States by
`
`1971 and the international standard by 1973. MARC is the primary communications
`
`
`
`4
`
`Evergeen Ex. 1008
`5 of 279
`
`

`

`
`
`protocol for the transfer and storage of bibliographic metadata in libraries. Experts
`
`in my field reasonably rely upon MARC records when forming their opinions.
`
`7.
`
`A MARC record consists of several fields, each of which contains
`
`specific data about the work. Each field is identified by a standardized, unique, three-
`
`digit code corresponding to the type of data that follows. Appendix B is a true and
`
`correct copy of Parts 7 to 10 of “Understanding MARC Bibliographic: Machine-
`
`Readable Cataloging” (https://www.loc.gov/marc/umb/um07to10.html) from the
`
`Library of Congress that explains commonly used MARC fields. For example, the
`
`personal author of the work is recorded in Field 100, the title is recorded in Field
`
`245, the publisher information is recorded in Field 260, the physical volume and
`
`characteristics of a publication are recorded in Field 300, and topical subjects are
`
`recorded in the 650 fields.
`
`8.
`
`The Online Computer Library Center (OCLC)
`
`is
`
`the
`
`largest
`
`bibliographic network of the world, with more than 473 million records and
`
`thousands of member institutions (many of which are libraries of some type) in more
`
`than 100 countries. OCLC was founded in 1967 to promote and support library
`
`cooperation. According to the “Third Article, Amended Articles of Incorporation of
`
`OCLC Online Computer Library Center, Inc.,” OCLC was created “to establish,
`
`maintain and operate a computerized library network and to promote the evolution
`
`of library use, of libraries themselves, and of librarianship, and to provide processes
`
`
`
`5
`
`Evergeen Ex. 1008
`6 of 279
`
`

`

`
`
`and products for the benefit of library users and libraries, including such objectives
`
`as increasing availability of library resources to individual library patrons and
`
`reducing the rate of rise of library per-unit costs, all for the fundamental public
`
`purpose of furthering ease of access to and use of the ever-expanding body of
`
`worldwide scientific, literary and educational knowledge and information” (source:
`
`https://www.oclc.org/content/dam/oclc/membership/articles-ofincorporation.pdf).
`
`9.
`
`OCLC members can contribute original cataloging records in MARC
`
`to the system or derive cataloging records from existing records, an activity referred
`
`to as “copy cataloging.” When an OCLC-participating institution acquires a work, it
`
`can create an original MARC record for the work in OCLC’s Connexion system (a
`
`system for catalogers to create and share MARC records), and the system will
`
`automatically generate a code for the date of record creation in the yymmdd format,
`
`and the creating library’s OCLC symbol is recorded in subfield “a” of the 040 Field.
`
`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
`
`searchable and viewable on WorldCat, which is a free web portal for users to explore
`
`more than 10,000 libraries worldwide. The record in WorldCat, however, is not
`
`presented in MARC fields. Instead, the data elements are labeled to help users
`
`interpret the record. Thus, the information stored in MARC records in Connexion is
`
`
`
`6
`
`Evergeen Ex. 1008
`7 of 279
`
`

`

`
`
`available to the interested public through the user-friendly WorldCat web portal.
`
`11. WorldCat (http://www.worldcat.org) is “the world’s largest network of
`
`library content and services” and its features are summarized in “What is WorldCat”
`
`(http://www.worldcat.org/whatis/default.jsp). WorldCat began operation in January
`
`1998 as a free web portal to more than 10,000 library collections worldwide.
`
`Through WorldCat, users can search for information in their local libraries and
`
`libraries around the world. WorldCat allows users to search for books, CDs, videos,
`
`and many new types of digital content, such as audiobooks, in many languages.
`
`Users can also retrieve research materials and article citations with links to their full
`
`text. After an item is retrieved, WorldCat helps users identify a library nearby that
`
`holds the item or all the libraries that hold the item. WorldCat is an efficient way to
`
`explore the content held by more than 10,000 libraries around the world. WorldCat
`
`is publicly accessible, and there is no fee to perform a search on WorldCat.
`
`12. Library online catalogs gained acceptance in the early 1980s and many
`
`libraries migrated their systems to the World Wide Web in the mid-1990s. Library
`
`online catalogs are based on MARC records that represent their collections in order
`
`to help the public understand what materials are publicly accessible in those
`
`libraries. Most libraries with online catalogs have made their catalogs freely
`
`available on the Web. These online catalogs offer user-friendly search interfaces.
`
`Strong user interest in keyword searches and the popularity of Google have led to
`
`
`
`7
`
`Evergeen Ex. 1008
`8 of 279
`
`

`

`
`
`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
`
`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
`
`elements. Many libraries display MARC records on their online catalogs with labels
`
`for the data elements to help the public interpret MARC records. Many libraries also
`
`offer the option to display MARC records in MARC fields.
`
`13. Libraries create MARC records for works they acquire, including
`
`books, serials, motion pictures, and publications in other formats. Monograph
`
`cataloging is fairly common in libraries, and most libraries make a newly-cataloged
`
`monograph available to the public soon after the cataloging work is completed,
`
`usually within a week. Libraries can create original cataloging records or use an
`
`existing record in OCLC to create a copy cataloging record. As soon as the
`
`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
`
`copy cataloging record, the library’s holding symbol is attached to the existing
`
`original record in OCLC WorldCat to facilitate searching and interlibrary loan.
`
`14. 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.
`
`
`
`8
`
`Evergeen Ex. 1008
`9 of 279
`
`

`

`
`
`According to the glossary of the RDA: Resource Description and Access cataloging
`
`standard, a serial is “a mode of issuance of a manifestation issued in successive parts,
`
`usually bearing numbering, that has no predetermined conclusion. A serial includes
`
`a periodical, monographic series, newspaper, etc.” Because the publisher of a serial
`
`makes new issues of the serial available successively, a customary cataloging
`
`practice is to create one bibliographic record for the serial, and the MARC serial
`
`record typically provides information on the beginning date and frequency of the
`
`serial, not the dates of individual issues. In other words, libraries typically do not
`
`create MARC records for individual issues of a serial. Instead, they rely on a serial
`
`check-in system to track the receipt of new issues. A common check-in practice is
`
`to date stamp a new issue when it arrives. This practice has become automated since
`
`the late 1990s, and libraries now vary in how they share the receipt date of a new
`
`serial issue with the public. Some libraries use a date stamp, some affix a label to
`
`indicate the receipt date, some pencil in the receipt date, and some do not provide
`
`the information to the public.
`
`15. The serial check-in process usually takes less than an hour, and one of
`
`the steps involves placing a date stamp on the new issue to document the date the
`
`issue is checked in. After that, the holdings information of the serial is updated in
`
`the library’s catalog so that users know which issues are available for request or
`
`access. After serial check-in is completed, the new issue is placed on the shelf with
`
`
`
`9
`
`Evergeen Ex. 1008
`10 of 279
`
`

`

`
`
`the previous issues of the serial. Libraries with a public periodical room typically
`
`place new issues in the periodical room for easy user access. Because information
`
`presented in serials often reflects latest discovery, a general practice of libraries is to
`
`make new issues of serials available for user access soon after they are checked in,
`
`usually within a week.
`
`16.
`
`I am personally familiar with many online catalogs, databases, and
`
`search engines. In preparing for this declaration I used the following authoritative
`
`information systems to search for records:
`
`• Google Scholar (https://scholar.google.com)
`
`• Internet Archive (https://archive.org/)
`
`• Library of Congress E-Resources Online Catalog
`
`(https://eresources.loc.gov)
`
`• Online catalog of the Library of Congress (https://catalog.loc.gov/)
`
`• Online catalog of the Linda Hall Library (https://catalog.lindahall.org/)
`
`• Online catalog of the National Library of Medicine
`
`(https://locatorplus.gov/cgi-bin/Pwebrecon.cgi?DB=local&PAGE=First
`
`• Public catalog of the U.S. Copyright Office (https://cocatalog.loc.gov/)
`
`• PubMed (https://pubmed.ncbi.nlm.nih.gov/)
`
`
`
`10
`
`Evergeen Ex. 1008
`11 of 279
`
`

`

`
`
`• PubMed Central (https://www.ncbi.nlm.nih.gov/pmc/)
`
`• WorldCat (free for public access on the Web) (https://www.worldcat.org/)
`
`These records are identified and discussed in this declaration. Experts in the field
`
`reasonably rely on the data described herein to form their opinions.
`
`B.
`17.
`
`Scope of This Declaration
`
`I have been asked to offer an opinion on the authenticity and public
`
`availability date of the following documents:
`
`(1)
`
`Strosberg J. et al., “Phase 3 Trial of 177Lu-Dotatate for Midgut
`
`Neuroendocrine Tumors,” New England Journal of Medicine,
`
`376(2), pp. 125-135 (2017), including the Supplemental material
`
`available online, obtained from the journal website, Exs. 1011 and
`
`1012 (“Strosberg”);
`
`(2) De León-Rodríguez, L.M., & Kovacs, Z., “The Synthesis and
`
`Chelation Chemistry of DOTA-Peptide Conjugates,” Bioconjugate
`
`Chemistry, 19(2), pp. 391–402 (2008), obtained from Linda Hall
`
`Library, Ex. 1014 (“De León-Rodríguez”);
`
`(3)
`
`Scott P. et al., “Studies into radiolytic decomposition of fluorine-18
`
`labeled radiopharmaceuticals for positron emission tomography,”
`
`
`
`11
`
`Evergeen Ex. 1008
`12 of 279
`
`

`

`
`
`Applied Radiation and Isotopes, 67(1) (2009), pp. 88-94, Ex. 1015
`
`(“Scott”);
`
`(4)
`
`Filice A. et al., “Radiolabeled Somatostatin Analogues Therapy in
`
`Advanced Neuroendocrine Tumors: A Single Centre Experience,”
`
`Journal of Oncology (2012), obtained from publisher’s webpage for
`
`Filice at https://www.hindawi.com/journals/jo/2012/320198/, on
`
`September 21, 2020, Ex. 1028 (“Filice”); and
`
`(5)
`
`“Lutetium 177 – LuMark® Lu-177 Chloride“ product page
`
`available
`
`from
`
`IDB
`
`at
`
`https://www.idb-holland.com/our-
`
`products/lutetium-177-lumark/,
`
`accessed
`
`and
`
`obtained
`
`on
`
`September 24, 2020, Ex. 1024 (“LuMark®”).
`
`C. Evidence Considered in Forming My Opinions
`18.
`
`In the preparation of this declaration, I have reviewed the documents
`
`referenced below and any other documents I reference herein, and each of these is a
`
`type of material that experts in my field would reasonably rely upon when forming
`
`their opinions:
`
`(1) The documents referenced above in Section I.B;
`
`(2)
`
`PubMed record for Strosberg, available from PubMed at
`
`https://pubmed.ncbi.nlm.nih.gov/28076709/, accessed and obtained
`
`
`
`12
`
`Evergeen Ex. 1008
`13 of 279
`
`

`

`
`
`on July 29, 2020, Appendix 0001-A;
`
`(3) New England Journal of Medicine listing of Strosberg, archived by
`
`Internet
`
`Archive
`
`at
`
`https://web.archive.org/web/20170112054115/http://www.nejm.or
`
`g/, accessed and obtained on July 15, 2020, Appendix 0001-B;
`
`(4) WorldCat record for Strosberg, available from WorldCat at
`
`http://www.worldcat.org/oclc/6927136071, accessed and obtained
`
`on July 29, 2020, Appendix 0001-C;
`
`(5) MARC record for New England Journal of Medicine that contains
`
`Strosberg, available from the electronic resource online catalog of
`
`the
`
`Library
`
`of
`
`Congress
`
`at
`
`https://eresources.loc.gov/record=b1127757~S2,
`
`accessed
`
`and
`
`obtained on July 15, 2020, Appendix 0001-D;
`
`(6) Early citations to Strosberg, obtained from Google Scholar,
`
`Appendix 0001-E;
`
`(7)
`
`PubMed record for De León-Rodríguez, available from PubMed at
`
`https://pubmed.ncbi.nlm.nih.gov/18072717/, accessed and obtained
`
`on July 29, 2020, Appendix 0002-A;
`
`(8) Copyright registration record for Bioconjugate Chemistry whose
`
`
`
`13
`
`Evergeen Ex. 1008
`14 of 279
`
`

`

`
`
`vol. 19, no. 2 contains De León-Rodríguez, available from the public
`
`catalog
`
`of
`
`the
`
`U.S.
`
`Copyright
`
`Office
`
`at
`
`https://cocatalog.loc.gov/cgi-
`
`bin/Pwebrecon.cgi?v1=2&ti=1,2&Search%5FArg=Bioconjugate%
`
`20Chemistry&Search%5FCode=TALL&CNT=25&PID=zQyTB7
`
`gPYQB2KgwpY3ImuKYgCQ3i4&SEQ=20200715001127&SID=
`
`1, accessed and obtained on July 15, 2020, Appendix 0002-B;
`
`(9) MARC record for Bioconjugate Chemistry whose vol. 19, no. 2
`
`contains De León-Rodríguez, available from the online catalog of
`
`the
`
`Library
`
`of
`
`Congress
`
`at
`
`https://catalog.loc.gov/vwebv/staffView?searchId=19712&recPoin
`
`ter=0&recCount=25&searchType=2&bibId=11374297,
`
`accessed
`
`and obtained on July 15, 2020, Appendix 0002-C;
`
`(10) Bibliographic and MARC records for Bioconjugate Chemistry
`
`whose vol. 19, no. 2 contains De León-Rodríguez, available from
`
`the
`
`online
`
`catalog
`
`of
`
`the Linda Hall Library
`
`at
`
`https://catalog.lindahall.org/permalink/01LINDAHALL_INST/19l
`
`da7s/alma992891723405961, accessed and obtained on July 15,
`
`2020, Appendix 0002-D;
`
`(11) Early citations to De León-Rodríguez, obtained from Google
`14
`
`
`
`Evergeen Ex. 1008
`15 of 279
`
`

`

`
`
`Scholar, Appendix 0002-E;
`
`(12) PubMed
`
`record
`
`for Scott, available
`
`from PubMed at
`
`https://pubmed.ncbi.nlm.nih.gov/18951032/, accessed and obtained
`
`on September 9, 2020, Appendix 0003-A;
`
`(13) A physical copy of Scott archived by PubMed Central, available
`
`from
`
`PubMed
`
`Central
`
`at
`
`https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5938091/,
`
`accessed and obtained on September 9, 2020, Appendix 0003-B;
`
`(14) MARC record for Applied Radiation and Isotopes whose vol. 67,
`
`no. 1 contains Scott, available from the online catalog of the Library
`
`of
`
`Congress
`
`at
`
`https://catalog.loc.gov/vwebv/staffView?searchId=106896&recPoi
`
`nter=0&recCount=25&searchType=2&bibId=11422993, accessed
`
`and obtained on September 9, 2020, Appendix 0003-C;
`
`(15) MARC record for Applied Radiation and Isotopes whose vol. 67,
`
`no. 1 contains Scott, available from the online catalog of the British
`
`Library
`
`at
`
`http://explore.bl.uk/BLVU1:LSCOP-
`
`ALL:BLL01010821264 (see MARC display for the MARC record),
`
`accessed and obtained on September 9, 2020, Appendix 0003-D;
`
`
`
`15
`
`Evergeen Ex. 1008
`16 of 279
`
`

`

`
`
`(16) Citations to Scott, obtained from Google Scholar, Appendix 0003-
`
`E;
`
`(17) Journal of Oncology record for Filice, obtained from publisher’s
`
`webpage
`
`for
`
`Filice
`
`at
`
`https://www.hindawi.com/journals/jo/2012/320198/, obtained on
`
`September 21, 2020, Ex. 1028;
`
`(18) PubMed
`
`record
`
`for Filice,
`
`available on PubMed
`
`at
`
`https://pubmed.ncbi.nlm.nih.gov/22934111/, accessed and obtained
`
`on September 21, 2020, Appendix 0004-A;
`
`(19) PubMed Central archive of Journal of Oncology, available at
`
`PubMed
`
`Central
`
`at
`
`https://www.ncbi.nlm.nih.gov/pmc/journals/859/,
`
`and PubMed
`
`Central Journal List archived by Internet Archive, accessed and
`
`obtained on September 30, 2020, Appendix 0004-B;
`
`(20) MARC record for Journal of Oncology, whose 2012 issue contains
`
`Filice, available at the online catalog of the National Library of
`
`Medicine,
`
`at
`
`https://locatorplus.gov/cgi-
`
`bin/Pwebrecon.cgi?v4=2&ti=1,2&SEQ=20200923140023&Search
`
`%5FArg=Journal%20of%20Oncology&Search%5FCode=JALL&
`
`
`
`16
`
`Evergeen Ex. 1008
`17 of 279
`
`

`

`
`
`
`
`CNT=25&PID=fPcJetjBPUeM3k7GGTNrIVYU&SID=1,
`
`accessed and obtained on September 23, 2020, Appendix 0004-C;
`
`(21) MARC record for Journal of Oncology, whose 2012 issue contains
`
`Filice, available at the Library of Congress Electronic Resources
`
`Catalog
`
`at
`
`https://eresources.loc.gov/search~S2?/.b1106819/.b1106819/1%2C
`
`1%2C1%2CB/marc~b1106819, Appendix 0004-D;
`
`(22) Selected citations to Filice, obtained from Google Scholar,
`
`Appendix 0004-E;
`
`(23) Archived page of “Lutetium 177 – LuMark® Lu-177 Chloride“
`
`product
`
`page,
`
`available
`
`from
`
`Internet Archive
`
`at
`
`https://web.archive.org/web/20170419045255/https://www.idb-
`
`holland.com/our-products/lutetium-177-lumark/,
`
`accessed
`
`and
`
`obtained on September 24, 2020, Appendix 0005-A.
`
`
`
`
`
`17
`
`Evergeen Ex. 1008
`18 of 279
`
`

`

`
`
`II. AUTHENTICATION AND
`PUBLIC AVAILABILITY OF
`STROSBERG (EXS. 1011 AND 1012)
`A. Authentication
`19. Ex. 1011 is a true and correct copy of “Phase 3 Trial of 177Lu-Dotatate
`
`for Midgut Neuroendocrine Tumors,” (“Strosberg”), by Strosberg et al., in New
`
`England Journal of Medicine, vol. 376, no. 2, pp. 125-135, that I obtained from the
`
`journal website. When I was asked to prepare this declaration, I searched PubMed
`
`by the title of Strosberg for records. PubMed is an information system of the
`
`National Library of Medicine that contains more than 30 million citations for
`
`biomedical literature from MEDLINE, life science journals, and online books; and
`
`citations may include links to full-text content from PubMed Central and publisher
`
`web sites. The search results informed me that the full text of Strosberg is available
`
`from the New England Journal of Medicine website. I followed the link in the
`
`PubMed record for Strosberg to the webpage of Strosberg and found a Web version
`
`and a PDF link for article download. I was able to obtain the article for free because
`
`the journal offers free access to a small number of articles for new visitors. The Web
`
`version, the PDF version, and a reprint obtained from the publisher are presented as
`
`Ex. 1011 in this declaration. The project protocol associated with Strosberg is
`
`presented as Ex. 1012 in this declaration.
`
`20. The first page of Ex. 1011A is the Web version of Strosberg that shows
`
`“Phase 3 Trial of 177Lu-Dotatate for Midgut Neuroendocrine Tumors” is the title and
`18
`
`
`
`Evergeen Ex. 1008
`19 of 279
`
`

`

`
`
`Strosberg and others are the authors. The first page also shows Strosberg is an
`
`“Original Article” published on “January 12, 2017” in New England Journal of
`
`Medicine (2017; 376:125-135” and
`
`its DOI (digital object
`
`identifier)
`
`is
`
`“10.1056/NEJMoa1607427.” It also shows Strosberg has 30 references and 701
`
`citing articles, and provides links to letters about this article and related articles. The
`
`letters to the editor include comments from Hofman et al., Matuchansky, Ozdemir
`
`et al. and a reply from Strosberg and Krenning, two of the authors of Strosberg. The
`
`Abstract section shows the background, methods, results, and conclusions, followed
`
`by the full text. Strosberg includes one figure, four tables and 30 references. Page
`
`13 of Ex. 1011A shows a “Supplementary Material” section that lists protocol,
`
`supplementary appendix, and disclosure form in PDF for download. After the list
`
`of references, the first few letters are listed, including comments from Hofman et al.,
`
`Matuchansky, Ozdemir et al. and a reply from Strosberg and Krenning, two of the
`
`authors of Strosberg.
`
`21. Ex. 1011B is the PDF of Strosberg I obtained from the PDF download
`
`link in the Web version. Page 1 shows the same title, author, abstract, publication
`
`source and DOI as the Web version. The footer of each page shows Strosberg
`
`appears in “N ENG J MED 376:2 NEJM.org JANUARY 12, 2017” and also shows
`
`a “2017” copyright date with the “Massachusetts Medical Society” as the copyright
`
`holder. A side note on page 1 (internal page 125) shows “[a] complete list of
`
`
`
`19
`
`Evergeen Ex. 1008
`20 of 279
`
`

`

`
`
`investigators in the Neuroendocrine Tumors Therapy (NETTER-1) trial is provided
`
`in the Supplementary Appendix, available at NEJM.org.” The Trial Oversight
`
`section on page 3 (internal page 127) explains that “[t]he protocol and statistical
`
`analysis plan are available with the full text of this article at NEJM.org.” Thus, those
`
`in the field interested in the protocol would have been able to obtain a copy from the
`
`New England Journal of Medicine website. The end of the article on page 11 shows
`
`a “2016” copyright date with the Massachusetts Medical Society as the copyright
`
`holder. I have closely compared the Web version and the PDF version and found
`
`them to contain the same content, except that the former includes a Supplementary
`
`Material section (including the protocol and other materials) and links to citing
`
`articles, letters and related articles.
`
`22. Ex. 1011C is a reprint of Strosberg obtained from the journal to
`
`compare the online version with the print version. Page 1 is the cover that shows
`
`“The New England Journal of Medicine” is the title and the issue is “Vol. 376, No.
`
`2” published on “JANUARY 12, 2017.” The journal website www.nejm.org is
`
`printed on the cover. The table of contents on this page shows three original articles,
`
`including Strosberg. Page 3 (internal page 125) is the first page of Strosberg that
`
`shows the same title, authors, side notes, and copyright information as the PDF
`
`version (Ex. 1011B), and the bottom of this page includes a notes indicating this
`
`copy was “reprinted from THE NEW ENGLAND JOURNAL OF MEDICINE
`
`
`
`20
`
`Evergeen Ex. 1008
`21 of 279
`
`

`

`
`
`(ISSN 0028-4793) Vol. 376:125-135 (January 12, 2017).” I have closely compared
`
`this reprint with the PDF version and found them to have the same content.
`
`23. Ex. 1012 is the protocol I downloaded from the Web version of
`
`Strosberg. Page 1 is the cover page that shows “[t]his trial protocol has been
`
`provided by the authors to give readers additional information about their work” and
`
`the protocol is for “Strosberg J, El-Haddad G, Wolin E, et al. Phase 3 trial of 177Lu-
`
`Dotatate for midgut neuroendocrine tumors. N Engl J Med 2017;376:125-35. DOI:
`
`10.1056/NEJMoa1607427.” Page 2 explains the protocol file includes “1. Original
`
`protocol, final protocol, summary of changes” and “2. Original statistical analysis
`
`plan, final statistical analysis plan, summary of changes.” Page 3 (internal page 1) is
`
`the protocol cover page that identifies it as “Protocol No AAA-III-01/FINAL version
`
`1.0 November 14th, 2011.” This page shows the title of the study, indicates the
`
`protocol is for “Phase III” of the study, the “EudraCT No” is “2011-005049-11” and
`
`the sponsor of the study is “Advanced Accelerator Applications SA.” The bottom of
`
`the page shows notice indicating the protocol is “Property of Advanced Accelerator
`
`Applications SA.”
`
`B.
`PubMed Record
`24. Appendix 0001-A is a true and correct copy of the PubMed record for
`
`Strosberg. When I began preparing this declaration, I searched PubMed by the title
`
`of Strosberg for records because the Strosberg study is a medical research project.
`
`
`
`21
`
`Evergeen Ex. 1008
`22 of 279
`
`

`

`
`
`PubMed is an authoritative system that contains “more than 30 million citations for
`
`biomedical literature from MEDLINE, life science journals, and online books” and
`
`PubMed records may include links to “full-text center from PubMed Central and
`
`publisher web sites” (source: PubMed.gov). The top of page 1 shows the full text
`
`links to “NEJM” followed by “Clinical Trial N Engl J Med. 2017 Jan 12;376(2):125-
`
`135. doi: 10.1056/NEJMoa1607427” that shows the study as a clinical trial and
`
`where the article was published. The PubMed record includes the title, authors and
`
`three identifiers of Strosberg: 28076709 as the PubMed ID number; PMC5895095
`
`as the ID number for PubMed Central (an archive of PubMed articles); and
`
`“10.1056/NEJMoa1607427” as the digital object identifier. It also shows Strosberg
`
`is a “Free PMC article” meaning the archived copy at PMC is free for public access.
`
`The record shows the Abstract section of Strosberg and provides links to letters that
`
`commented on Strosberg. The letters appeared on March 15, April 6, June, and
`
`August of 2017. Page 4 is a screen capture of the top of the PubMed record to show
`
`full text links to the New England Journal of Medicine and PubMed Central that
`
`provide free full text access to Strosberg. Pages 5 to 38 are the PubMed record saved
`
`in MEDLINE format that shows data in specific fie