Declaration of Sylvia Hall-Ellis, Ph.D.
`Petition for Inter Partes Review of
`U.S. Patent No. 9,593,066
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`LIQUIDIA TECHNOLOGIES, INC.,
`
`Petitioner
`
`v.
`
`UNITED THERAPEUTICS CORPORATION,
`
`Patent Owner
`
`U.S. Patent No. 9,593,066
`
`Issue Date: March 14, 2017
`
`Title: Process to Prepare Treprostinil, the Active Ingredient in Remodulin®
`
`DECLARATION OF SYLVIA HALL-ELLIS, PH.D.
`
`Liquidia - Exhibit 1015 - Page 1
`
`

`

`Declaration of Sylvia Hall-Ellis, Ph.D.
`Petition for Inter Partes Review of
`U.S. Patent No. 7,266,175
`
`Table of Contents
`
`Page
`
`INTRODUCTION .......................................................................................... 1
`I.
`II. QUALIFICATIONS ....................................................................................... 2
`III. PRELIMINARIES .......................................................................................... 3
`A.
`Scope of Declaration and Legal Standards .......................................... 3
`B.
`Persons of Ordinary Skill in the Art ..................................................... 5
`C. Use of Authoritative Databases ............................................................ 6
`1.
`Indexing ..................................................................................... 6
`Summary of Opinions .......................................................................... 7
`D.
`IV. LIBRARY CATALOGING PRACTICES ..................................................... 7
`A. MARC Records and OCLC .................................................................. 7
`1.
`OCLC Online Union Catalog................................................... 14
`2.
`Fields 008, 005, and 955 in MARC Records as Indicators
`of Public Accessibility ............................................................. 16
`Journals ............................................................................................... 20
`B.
`PUBLICATIONS IN THIS PROCEEDING ................................................ 22
`A. Moriarty [Exhibit B] ........................................................................... 22
`B. Wiberg [Exhibit C] ............................................................................. 28
`C.
`Schoffstall [Exhibit D] ....................................................................... 32
`D.
`Ege [Exhibit E] ................................................................................... 36
`VI. CONCLUSION ............................................................................................. 39
`
`V.
`
`
`
`-i-
`
`Liquidia - Exhibit 1015 - Page 2
`
`

`

`Declaration of Sylvia Hall-Ellis, Ph.D.
`Petition for Inter Partes Review of
`U.S. Patent No. 9,593,066
`
`I, Sylvia D. Hall-Ellis, Ph.D., declare as follows:
`
`I.
`
`INTRODUCTION
`1.
`My name is Sylvia D. Hall-Ellis. I have been retained as an expert by
`
`Liquidia Technologies, Inc., who I am informed is a petitioner to this IPR proceeding
`
`(“the Petitioner”).
`
`2.
`
`I have written this declaration at the request of the Petitioner to provide
`
`my expert opinion regarding the public availability of a number of publications,
`
`identified below. My Declaration sets forth my opinions in detail and provides the
`
`basis for my opinions regarding the public availability of these publications.
`
`3.
`
`I reserve the right to supplement or amend my opinions, and bases for
`
`them, in response to any additional evidence, testimony, discovery, argument, and/or
`
`other additional information that may be provided to me after the date of this
`
`Declaration.
`
`4.
`
`I am being compensated for my time spent working on this matter at
`
`my normal consulting rate of $300 per hour, plus reimbursement for any additional
`
`reasonable expenses. My compensation is not in any way tied to the content of this
`
`report, the substance of my opinions, or the outcome of this litigation. I have no
`
`other interests in this proceeding or with any of the parties.
`
`5.
`
`All of the materials that I considered and relied upon are discussed
`
`1
`
`Liquidia - Exhibit 1015 - Page 3
`
`

`

`Declaration of Sylvia Hall-Ellis, Ph.D.
`Petition for Inter Partes Review of
`U.S. Patent No. 9,593,066
`
`explicitly in this declaration.
`
`II. QUALIFICATIONS
`6.
`I am currently an Adjunct Professor in the School of Information at San
`
`José State University in San José, California. I obtained a Masters of Library
`
`Science from the University of North Texas in 1972 and a Ph.D. in Library Science
`
`from the University of Pittsburgh in 1985. Over the last fifty years, I have held
`
`various positions in the field of library and information resources. I was first
`
`employed as a librarian in 1966 and have been involved in the field of library
`
`sciences since, holding numerous positions.
`
`7.
`
`I am a member of the American Library Association (ALA) and its
`
`Association for Library Collections & Technical Services (ALCTS) Division, and I
`
`served on the Committee on Cataloging: Resource and Description (which wrote the
`
`new cataloging rules) and as the chair of the Committee for Education and Training
`
`of Catalogers and the Competencies and Education for a Career in Cataloging
`
`Interest Group. I also served as the Chair of the ALCTS Division’s Task Force on
`
`Competencies and Education for a Career in Cataloging. Additionally, I have served
`
`as the Chair for the ALA Office of Diversity’s Committee on Diversity, as a member
`
`of the REFORMA National Board of Directors, and as a member of the Editorial
`
`Board for the ALCTS premier cataloging journal, Library Resources and Technical
`
`2
`
`Liquidia - Exhibit 1015 - Page 4
`
`

`

`Declaration of Sylvia Hall-Ellis, Ph.D.
`Petition for Inter Partes Review of
`U.S. Patent No. 9,593,066
`
`Services.
`
`8.
`
`I have also given over one hundred presentations in the field, including
`
`several on library cataloging systems and Machine-Readable Cataloging (“MARC”)
`
`standards. My current research interests include library cataloging systems,
`
`metadata, and organization of electronic resources.
`
`9.
`
`My full curriculum vitae is attached hereto as Exhibit A.
`
`III. PRELIMINARIES
`A.
`Scope of Declaration and Legal Standards
`10.
`I am not an attorney and will not offer opinions on the law. I am,
`
`however, rendering my expert opinion on the authenticity of the documents
`
`referenced herein and on when and how each of these documents was disseminated
`
`or otherwise made available to the extent that persons interested and ordinarily
`
`skilled in the subject matter or art, exercising reasonable diligence, could have
`
`located the documents before the dates discussed below with respect to the specific
`
`documents.
`
`11.
`
`I am informed by counsel that a printed publication qualifies as publicly
`
`accessible as of the date it was disseminated or otherwise made available such that
`
`a person interested in and ordinarily skilled in the relevant subject matter could
`
`locate it through the exercise of ordinary diligence.
`
`3
`
`Liquidia - Exhibit 1015 - Page 5
`
`

`

`Declaration of Sylvia Hall-Ellis, Ph.D.
`Petition for Inter Partes Review of
`U.S. Patent No. 9,593,066
`
`12. While I understand that the determination of public accessibility under
`
`the foregoing standard rests on a case-by-case analysis of the facts particular to an
`
`individual publication, I also understand that a printed publication is rendered
`
`“publicly accessible” if it is cataloged and indexed by a library such that a person
`
`interested in the relevant subject matter could locate it (i.e., I understand that
`
`cataloging and indexing by a library is sufficient, though there are other ways that a
`
`printed publication may qualify as publicly accessible). One manner of sufficient
`
`indexing is indexing according to subject matter category. I understand that the
`
`cataloging and indexing by a single library of a single instance of a particular printed
`
`publication is sufficient, even if the single library is in a foreign country. I
`
`understand that, even if access to a library is restricted, a printed publication that has
`
`been cataloged and indexed therein is publicly accessible so long as a presumption
`
`is raised that the portion of the public concerned with the relevant subject matter
`
`would know of the printed publication. I also understand that the cataloging and
`
`indexing of information that would guide a person interested in the relevant subject
`
`matter to the printed publication, such as the cataloging and indexing of an abstract
`
`for the printed publication, is sufficient to render the printed publication publicly
`
`accessible.
`
`13.
`
`I understand that routine business practices, such as general library
`
`4
`
`Liquidia - Exhibit 1015 - Page 6
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`

`

`Declaration of Sylvia Hall-Ellis, Ph.D.
`Petition for Inter Partes Review of
`U.S. Patent No. 9,593,066
`
`cataloging and indexing practices, can be used to establish an approximate date on
`
`which a printed publication became publicly accessible.
`
`B.
`14.
`
`Persons of Ordinary Skill in the Art
`I am told by counsel that the subject matter of this proceeding generally
`
`relates to a searchable content repository.
`
`15.
`
`I have been informed by counsel that a “person of ordinary skill in the
`
`art at the time of the inventions” 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.
`
`16.
`
`I am told by counsel that a person of ordinary skill in this subject matter
`
`or art would typically be someone who is a medical physicist with a Ph.D. (or similar
`
`advanced degree) in physics, medical physics, or a related field, and two or more
`
`years of experience in radiation oncology physics, treatment planning, treatment
`
`plan optimization related to radiation oncology applications, and computer
`
`programming associated with treatment plan optimization (or equivalent degree or
`
`experience). I have been further informed by counsel that a person of ordinary skill
`
`in the art would have been familiar with and able to understand the information
`
`known in the art relating to these fields, including the publications discussed in this
`
`5
`
`Liquidia - Exhibit 1015 - Page 7
`
`

`

`Declaration of Sylvia Hall-Ellis, Ph.D.
`Petition for Inter Partes Review of
`U.S. Patent No. 9,593,066
`
`declaration.
`
`C.
`17.
`
`Use of Authoritative Databases
`In preparing this report, I used authoritative databases, such as the
`
`OCLC bibliographic database and the Library of Congress Online Catalog, to
`
`confirm citation details of the publication discussed.
`
`Indexing
`1.
`18. A researcher may discover material relevant to his or her topic in a
`
`variety of ways. One common means of discovery is to search for relevant
`
`information in an index of periodical and other publications. Having found relevant
`
`material, the researcher will then normally obtain it online, look for it in libraries, or
`
`purchase it from the publisher, a bookstore, a document delivery service, or other
`
`provider. Sometimes, the date of a document’s public accessibility will involve both
`
`indexing and library date information.
`
`19.
`
`Indexing services use a wide variety of controlled vocabularies to
`
`provide subject access and other means of discovering the content of documents.
`
`The formats in which these access terms are presented vary from service to service.
`
`20. Online indexing services and digital repositories 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
`
`6
`
`Liquidia - Exhibit 1015 - Page 8
`
`

`

`Declaration of Sylvia Hall-Ellis, Ph.D.
`Petition for Inter Partes Review of
`U.S. Patent No. 9,593,066
`
`also often provide lists of publications that cite a given document. A citation of a
`
`document is evidence that the document was publicly available and in use by
`
`researchers no later than the publication date of the citing document.
`
`D.
`21.
`
`Summary of Opinions
`I am informed by counsel that the priority date for the patent at issue is
`
`December 17, 2007. As I will explain below, it is my opinion that the printed
`
`publications discussed in my Declaration were publicly accessible more than one
`
`year before the December 17, 2007 priority date.
`
`IV. LIBRARY CATALOGING PRACTICES
`A. MARC Records and OCLC
`22.
`I am fully familiar with the library cataloging standard known as the
`
`MARC standard, which is an industry-wide standard method of storing and
`
`organizing library catalog information. MARC was first developed in the 1960’s by
`
`the Library of Congress. A MARC-compatible library is one that has a catalog
`
`consisting of individual MARC records for works made available at that library.
`
`23.
`
`Since at least the early 1970s and continuing to the present day, MARC
`
`has been the primary communications protocol for the transfer and storage of
`
`7
`
`Liquidia - Exhibit 1015 - Page 9
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`

`

`Declaration of Sylvia Hall-Ellis, Ph.D.
`Petition for Inter Partes Review of
`U.S. Patent No. 9,593,066
`
`bibliographic metadata in libraries.1 As explained by the Library of Congress:
`
`You could devise your own method of organizing the bibliographic
`
`information, but you would be isolating your library, limiting its options, and
`
`creating much more work for yourself. Using the MARC standard prevents
`
`duplication of work and allows libraries to better share bibliographic
`
`resources. Choosing to use MARC enables libraries to acquire cataloging data
`
`that is predictable and reliable. If a library were to develop a “home-grown”
`
`system that did not use MARC records, it would not be taking advantage of
`
`an industry-wide standard whose primary purpose is to foster communication
`
`of information.
`
`Using the MARC standard also enables libraries to make use of commercially
`
`available library automation systems to manage library operations. Many
`
`systems are available for libraries of all sizes and are designed to work with
`
`the MARC format. Systems are maintained and improved by the vendor so
`
`that libraries can benefit from the latest advances in computer technology. The
`
`MARC standard also allows libraries to replace one system with another with
`
`
`1 A complete history of the development of MARC can be found in MARC: Its
`History and Implications by Henrietta D. Avram (Washington, DC: Library of
`Congress,
`1975)
`and
`available
`online
`from
`the Hathi
`Trust
`(https://babel.hathitrust.org/cgi/pt?id=mdp.39015034388556;view=1up;seq=1; last
`visited March 24, 2020).
`
`8
`
`Liquidia - Exhibit 1015 - Page 10
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`

`

`Declaration of Sylvia Hall-Ellis, Ph.D.
`Petition for Inter Partes Review of
`U.S. Patent No. 9,593,066
`
`the assurance that their data will still be compatible.
`
`Why
`
`Is
`
`a MARC Record Necessary? LIBRARY
`
`OF CONGRESS,
`
`http://www.loc.gov/marc/umb/um01to06.html#part2 (last visited March 24, 2020).
`
`24.
`
`Thus, 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 24, 2020) (“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 fifty 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 standard
`
`(reaffirmed in 2016) for Information Interchange Format. The full text of the
`
`standard
`
`is
`
`available
`
`from
`
`the
`
`Library
`
`of
`
`Congress
`
`at
`
`http://www.loc.gov/marc/bibliographic/ (last visited March 24, 2020).
`
`25. A MARC record comprises 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 follow. See, e.g.,
`
`http://www.loc.gov/marc/umb/um07to10.html (last visited March 24, 2020);
`
`http://www.loc.gov/marc/bibliographic/ (last visited March 24, 2020). For example,
`
`9
`
`Liquidia - Exhibit 1015 - Page 11
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`

`

`Declaration of Sylvia Hall-Ellis, Ph.D.
`Petition for Inter Partes Review of
`U.S. Patent No. 9,593,066
`
`a work’s title is recorded in field 245, the primary author of the work is recorded in
`
`field 100, a work’s International Standard Book Number (“ISBN”) is recorded in
`
`field 020, a work’s International Standard Serial Number (“ISSN”) is recorded in
`
`field 022, and the publication date is recorded in field 260 under the subfield “c.”
`
`Id.2 If a work is a periodical, then its publication frequency is recorded in field 310,
`
`and the publication dates (e.g., the first and last publication) are recorded in field
`
`362, which is also referred to as the enumeration/chronology field. See
`
`http://www.loc.gov/marc/bibliographic/bd3xx.html (last visited March 24, 2020).3
`
`26.
`
`The library that initially created the MARC record is reflected in field
`
`040 in subfield “a” with that library’s unique library code.
`
`See, e.g.,
`
`http://www.loc.gov/marc/umb/um07to10.html (last visited March 24, 2020);
`
`
`2 In some MARC records, field 264 is used rather than field 260 to record publication
`information. See http://www.loc.gov/marc/bibliographic/bd264.html (last visited
`March 24, 2020) (“Information in field 264 is similar to information in field 260
`(Publication, Distribution, etc. (Imprint)). Field 264 is useful for cases where the
`content standard or institutional policies make a distinction between functions”).
`3 Upwards of two-thirds to three-quarters of book sales to libraries come from a
`jobber or wholesaler for online and print resources. These resellers make it their
`business to provide books to their customers as fast as possible, often providing
`turnaround times of only a single day after publication. Libraries purchase a
`significant portion of the balance of their books directly from publishers themselves,
`which provide delivery on a similarly expedited schedule. In general, libraries make
`these purchases throughout the year as the books are published and shelve the books
`as soon thereafter as possible in order to make the books available to their patrons.
`Thus, books are generally available at libraries across the country within just a few
`days of publication.
`
`10
`
`Liquidia - Exhibit 1015 - Page 12
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`

`

`Declaration of Sylvia Hall-Ellis, Ph.D.
`Petition for Inter Partes Review of
`U.S. Patent No. 9,593,066
`
`http://www.loc.gov/marc/bibliographic/ (last visited March 24, 2020). Once a
`
`MARC record for a particular work is originally created by one library, other
`
`libraries can use that original MARC record to then create their own MARC records
`
`for their own copies of the same work. These other libraries may modify or add to
`
`the original MARC record as necessary to reflect data specific to their own copies
`
`of the work. However, the library that created the original MARC record would still
`
`be reflected in these modified MARC records (corresponding to other copies of the
`
`same work at other libraries) in field 040, subfield “a”. The modifying library (or
`
`libraries)
`
`is
`
`reflected
`
`in
`
`field
`
`040,
`
`subfield
`
`“d”.
`
`See
`
`http://www.loc.gov/marc/bibliographic/bd040.html (last visited March 24, 2020).
`
`27.
`
`I
`
`consulted
`
`the
`
`Directory
`
`of
`
`OCLC
`
`Libraries
`
`(http://www.oclc.org/contacts/libraries.en.html; last visited March 24, 2020) in
`
`order to identify the institution that created or modified the MARC record.
`
`Moreover, when viewing the MARC record online via Online Computer Library
`
`Center’s (“OCLC”) bibliographic database, which I discuss further below, hovering
`
`over a library code in field 040 with the mouse reveals the full name of the library.
`
`I also used this method of “mousing over” the library codes in the OCLC database
`
`to identify the originating and modifying libraries for the MARC records discussed
`
`in this report.
`
`11
`
`Liquidia - Exhibit 1015 - Page 13
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`

`

`Declaration of Sylvia Hall-Ellis, Ph.D.
`Petition for Inter Partes Review of
`U.S. Patent No. 9,593,066
`
`28. MARC records also include one or more fields that show information
`
`regarding subject matter classification. For example, 6XX fields are termed
`
`“Subject Access Fields.” See http://www.loc.gov/marc/bibliographic/bd6xx.html
`
`(last visited March 24, 2020). Among these, for example, is the 650 field; this is the
`
`“Subject
`
`Added
`
`Entry
`
`–
`
`Topical
`
`Term”
`
`field.
`
`See
`
`http://www.loc.gov/marc/bibliographic/bd650.html (last visited March 24, 2020).
`
`The 650 field is a “[s]ubject added entry in which the entry element is a topical
`
`term.” Id. These entries “are assigned to a bibliographic record to provide access
`
`according to generally accepted thesaurus-building rules (e.g., Library of Congress
`
`Subject Headings (LCSH), Medical Subject Headings (MeSH)).” Id.
`
`29.
`
`Further, MARC records can include call numbers, which themselves
`
`contain a classification number. For example, a MARC record may identify a 050
`
`field, which
`
`is
`
`the
`
`“Library of Congress Call Number.”
`
` See
`
`http://www.loc.gov/marc/bibliographic/bd050.html (last visited March 24, 2020). A
`
`defined portion of the Library of Congress Call Number is the classification number,
`
`and “source of the classification number is Library of Congress Classification and
`
`the LC Classification-Additions and Changes.” Id. Thus, the 050 field may be used
`
`to show information regarding subject matter classification.
`
`30.
`
`Each item in a library has a single classification number. A library
`
`12
`
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`

`

`Declaration of Sylvia Hall-Ellis, Ph.D.
`Petition for Inter Partes Review of
`U.S. Patent No. 9,593,066
`
`selects a classification scheme (e.g., the Library of Congress Classification scheme
`
`just described or a similar scheme such as the Dewey Decimal Classification
`
`scheme) and uses it consistently. When the Library of Congress assigns the
`
`classification number, it appears as part of the 050 field, as discussed above. For
`
`MARC records created by libraries other than the Library of Congress (e.g., a
`
`university library or a local public library), the classification number may appear in
`
`a 09X (e.g., 090) field. See http://www.loc.gov/marc/bibliographic/bd09x.html (last
`
`visited March 24, 2020).
`
`31. When a MARC-compatible library acquires a work, it creates a MARC
`
`record for its copy of the work in its computer catalog system in the ordinary course
`
`of its business. This MARC record (for the copy of a work available at the particular
`
`library) may be later accessed by researchers in a number of ways. For example,
`
`many libraries, including the Library of Congress, make their MARC records
`
`available through their website. As an example, the MARC record for the copy of
`
`The Unlikely Spy, by Daniel Silva,4 available at the Library of Congress can be
`
`viewed
`
`through
`
`the
`
`Library
`
`of
`
`Congress
`
`website,
`
`at
`
`https://catalog.loc.gov/vwebv/staffView?searchId=20265&recPointer=1&recCount
`
`
`4 The Unlikely Spy is a 1996 novel written by Daniel Silva, who happens to be one
`of my favorite authors.
`
`13
`
`Liquidia - Exhibit 1015 - Page 15
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`

`

`Declaration of Sylvia Hall-Ellis, Ph.D.
`Petition for Inter Partes Review of
`U.S. Patent No. 9,593,066
`
`=25&bibId=2579985 (last visited March 24, 2020). One could, of course, always
`
`physically visit the library at which the work is available, and request to see that
`
`library’s MARC record for the work. Moreover, members of the Online Computer
`
`Library Center (“OCLC”) can access the MARC records of other member
`
`institutions through OCLC’s online bibliographic database, as I explain further
`
`below.
`
` OCLC Online Union Catalog
`1.
`The OCLC was created “to establish, maintain and operate a
`
`32.
`
`computerized library network and to promote the evolution of library use, of libraries
`
`themselves, and of librarianship, and to provide processes 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.”5 Among other services, OCLC and
`
`its members are
`
`responsible
`
`for maintaining
`
`the WorldCat database
`
`
`5 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;
`last visited March 24, 2020).
`
`14
`
`Liquidia - Exhibit 1015 - Page 16
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`

`

`Declaration of Sylvia Hall-Ellis, Ph.D.
`Petition for Inter Partes Review of
`U.S. Patent No. 9,593,066
`
`(http://www.worldcat.org/; last visited March 24, 2020), used by independent and
`
`institutional libraries throughout the world. All libraries that are members of OCLC
`
`are MARC-compatible. See, e.g., https://help.oclc.org/Metadata_Services/OCLC-
`
`MARC_records/About_OCLC-MARC_records (last visited March 24, 2020)
`
`(“OCLC-MARC records describes records produced since November 1993.”);
`
`https://www.oclc.org/support/services/worldcat/documentation/cataloging/electron
`
`icresources.en.html (last visited March 24, 2020) (“Like the two superseded OCLC
`
`documents, this revised set of guidelines is intended to assist catalogers in creating
`
`records for electronic resources in WorldCat, the OCLC Online Union Catalog.
`
`These guidelines pertain to OCLC-MARC tagging (that is, content designation).
`
`Cataloging rules and manuals (such as AACR2) govern the content of records. You
`
`should implement these guidelines immediately.”).
`
`33. When an OCLC member institution acquires a publication, like the
`
`other MARC-compatible libraries discussed above, it creates a MARC record for
`
`this publication in its computer catalog system in the ordinary course of its business.
`
`MARC records created at the Library of Congress are tape-loaded into the OCLC
`
`database through a subscription to MARC Distribution Services daily or weekly.
`
`Once the MARC record is created by a cataloger at an OCLC member library or is
`
`tape-loaded from the Library of Congress, the MARC record is then made available
`
`15
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`Liquidia - Exhibit 1015 - Page 17
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`

`

`Declaration of Sylvia Hall-Ellis, Ph.D.
`Petition for Inter Partes Review of
`U.S. Patent No. 9,593,066
`
`to any other OCLC members online, and thereby made available to the public.
`
`Accordingly, once the MARC record is created by a cataloger at an OCLC member
`
`library or is tape-loaded from the Library of Congress, any publication
`
`corresponding to the MARC record has been cataloged and indexed according to its
`
`subject matter such that a person interested in that subject matter could, with
`
`reasonable diligence, locate and access the publication through any library with
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`access to the OCLC bibliographic database or through the Library of Congress.
`
`2.
`
`Fields 008, 005, and 955 in MARC Records as Indicators of
`Public Accessibility
`34. When a MARC-compatible library creates an original MARC record
`
`for a work, the library records the date of creation of that MARC record in field 008,
`
`characters 00 through 05, in the ordinary course of its business.
`
` See
`
`http://www.loc.gov/marc/bibliographic/bd008a.html (last visited March 24, 2020).
`
`For OCLC member institutions that use OCLC software to create original MARC
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`records, the date of creation in field 008 is automatically supplied by the OCLC
`
`software. The MARC record creation date in field 008 thus reflects the date on
`
`which, or shortly after which, a work was first acquired and cataloged by the library
`
`that created the original MARC record.
`
`35. When other MARC-compatible libraries subsequently acquire their
`
`own copies of the same work, as mentioned, they create MARC records in their own
`
`16
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`Liquidia - Exhibit 1015 - Page 18
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`

`

`Declaration of Sylvia Hall-Ellis, Ph.D.
`Petition for Inter Partes Review of
`U.S. Patent No. 9,593,066
`
`computer catalog systems for their copies in the ordinary course of business.6 They
`
`may use a MARC record previously created for that work (by another MARC-
`
`compatible library) to create their own MARC records for their own copies of that
`
`same work.7 The previously created MARC record used by subsequently-acquiring
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`libraries to create MARC records for their own copies may be obtained through the
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`OCLC bibliographic database, as described above. If, when creating a MARC
`
`record to represent its own copy of the work, the subsequently-acquiring library uses
`
`the master MARC record in its original form, the subsequently-acquiring library
`
`cannot reenter data into the 008 field; therefore, the date in the 008 field will continue
`
`to reflect the date the MARC record was initially created by the originating library.
`
`On the other hand, if the subsequently-acquiring library modifies the previously
`
`created MARC record when creating its own MARC record for its own copy of the
`
`work, the subsequently-acquiring library may enter into the 008 field of its own
`
`MARC record the date its own MARC record was created.8 But the library that
`
`
`6 Initial contributions to the bibliographic database for a work are called “master
`records.”
`7 When a local library uses a master record in OCLC and produces (or downloads)
`it to the in-house system, the three-character symbol for the subsequent library is
`added to the holdings for the work.
`8 This practice is not required by, but is nevertheless consistent with, the MARC
`standard. Many MARC records exist today whose 008 fields indicate when the first
`original MARC record for a work was created, rather than when a derivative record
`
`17
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`Liquidia - Exhibit 1015 - Page 19
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`

`

`Declaration of Sylvia Hall-Ellis, Ph.D.
`Petition for Inter Partes Review of
`U.S. Patent No. 9,593,066
`
`created the original MARC record used by the subsequently-acquiring library would
`
`still be reflected in the MARC record of the subsequently-acquiring library in field
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`040, subfield “a”. Thus, the work identified by any MARC record possessed by any
`
`MARC-compatible library would have been accessible to the public at least as of the
`
`date shown in the 008 field, or shortly thereafter, either from the library that
`
`possesses the MARC record itself, or from the originating library indicated in field
`
`040, subfield “a”. As discussed, a MARC-compatible library in the ordinary course
`
`of its business creates a MARC record in its own catalog system for a work when it
`
`acquires a copy of that work.
`
`36. Moreover, when a MARC record is created by a library for its own copy
`
`of a work, field 005 is automatically populated with the date that MARC record was
`
`created
`
`in
`
`year, month,
`
`day
`
`format
`
`(YYYYMMDD).
`
`
`
`See
`
`http://www.loc.gov/marc/bibliographic/bd005.html (last visited March 24, 2020).9
`
`Thereafter, the library’s computer system may automatically update the date in field
`
`005 every time the library updates the MARC record (e.g., to reflect that an item has
`
`
`was created based on the original MARC record by a subsequently-acquiring library
`for its own computer catalog system.
`9 Some of the newer library catalog systems also include hour, minute, second
`(HHMMSS).
`
`18
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`Liquidia - Exhibit 1015 - Page 20
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`

`

`Declaration of Sylvia Hall-Ellis, Ph.D.
`Petition for Inter Partes Review of
`U.S. Patent No. 9,593,066
`
`been moved to a different shelving location within the library). Id.10 Thus, the work
`
`identified by any MARC record possessed by any MARC-compatible library would
`
`have been accessible to the public at least as of the date shown in the 005 field, or
`
`shortly thereafter, from the library that possesses the MARC record itself. As noted,
`
`because the 005 field may be updated each time the library updates its MARC record,
`
`the work identified by the MARC record may, in fact, have been accessible to the
`
`public from that library much earlier than the date indicated in the 005 field.
`
`37. Moreover, MARC records