`
`
`
`
`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. 10,716,793 B2
`
`Issue Date: July 21, 2020
`
`
`Title: Treprostinil Administration By Inhalation
`
`
`
`
`DECLARATION OF SYLVIA HALL-ELLIS, PH.D.
`
`
`
`
`
`
`
`
`
`Liquidia's Exhibit 1036
`Page 1
`
`

`

`Table of Contents
`
`
`Page
`
`
`
` I.
`
`II.
`III.
`
`INTRODUCTION .......................................................................................... 1
`QUALIFICATIONS ....................................................................................... 2
`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
`D.
`Summary of Opinions .......................................................................... 9
`IV. LIBRARY CATALOGING PRACTICES ..................................................... 9
`A. MARC Records and OCLC .................................................................. 9
`B.
`Journals ............................................................................................... 21
`PUBLICATIONS IN THIS PROCEEDING ................................................ 23
`A. Ghofrani [Exhibit B] .......................................................................... 23
`B.
`Remodulin® label [Exhibit C] ............................................................ 28
`C.
`Voswinckel 2004a (a.k.a. Voswinckel JAHA) [Exhibit D] ............... 30
`D. Voswinckel 2004b (a.k.a. Voswinckel JESC) [Exhibit E] ................ 36
`E.
`Voswinckel 2006 [Exhibit F] ............................................................. 41
`VI. CONCLUSION ............................................................................................. 46
`
`
`V.
`
`
`
`
`
`
`
`
`
`Liquidia's Exhibit 1036
`Page 2
`
`

`

`
`
`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.
`
`As of the preparation and signing of this declaration, many libraries
`
`across the nation are closed or permit only limited access due to the COVID-19 virus.
`
`However, were the libraries open, I would expect to be able to obtain paper copies
`
`of at least some of the documents in this declaration. Additionally, it is my typical
`
`practice to obtain a paper copy of each publication to further confirm my opinions
`
`that the documents were available prior to the alleged priority date of the patent at
`
`issue. I reserve the right to supplement my declaration when the libraries reopen to
`
`1
`
`
`Liquidia's Exhibit 1036
`Page 3
`
`

`

`
`
`provide such information.
`
`5.
`
`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.
`
`6.
`
`All of the materials that I considered and relied upon are discussed
`
`explicitly in this declaration.
`
`II. QUALIFICATIONS
`I am currently an Adjunct Professor in the School of Information at San
`7.
`
`José State University in San José, California. I obtained a Master 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.
`
`8.
`
`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
`
`2
`
`
`Liquidia's Exhibit 1036
`Page 4
`
`

`

`
`
`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
`
`Services. Currently I serve as a Co-Chair for the Library Research Round Table of
`
`the American Library Association.
`
`9.
`
`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.
`
`10. My full curriculum vitae is attached hereto as Exhibit A.
`
`III. PRELIMINARIES
`Scope of Declaration and Legal Standards
`A.
`11.
`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
`
`3
`
`
`Liquidia's Exhibit 1036
`Page 5
`
`

`

`
`
`located the documents before the dates discussed below with respect to the specific
`
`documents.
`
`12.
`
`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.
`
`13. 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
`
`4
`
`
`Liquidia's Exhibit 1036
`Page 6
`
`

`

`
`
`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.
`
`14.
`
`I understand that routine business practices, such as general library
`
`cataloging and indexing practices, can be used to establish an approximate date on
`
`which a printed publication became publicly accessible.
`
`B.
`15.
`
`Persons of Ordinary Skill in the Art
`I am told by counsel that the subject matter of this proceeding generally
`
`relates to inhalation therapies, particularly involving the compound treprostinil, to
`
`treat patients with pulmonary hypertension.
`
`16.
`
`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.
`
`17.
`
`I am told by counsel that the subject matter covers two multiple
`
`disciplines. I understand that, with respect to the method of treating pulmonary
`
`hypertension, a person of ordinary skill in this subject matter or art would typically
`
`be someone with a medical degree with a specialty in pulmonology or cardiology,
`
`5
`
`
`Liquidia's Exhibit 1036
`Page 7
`
`

`

`
`
`plus at least two years of experience treating patients with pulmonary hypertension
`
`as an attending, including with inhaled therapies, or equivalent. I also understand
`
`that, with respect to inhaled formulations used in the method to treat pulmonary
`
`hypertension, a person of ordinary skill in this subject matter or art would typically
`
`be someone with a Ph.D. in pharmaceutical science or a related discipline like
`
`chemistry or medicinal chemistry, plus two years of experience in pharmaceutical
`
`formulations, including inhaled products, or equivalent (e.g., a masters degree in the
`
`same fields, plus 5 years of 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 declaration.
`
`C. Use of Authoritative Databases
`In preparing this report, I used authoritative databases, such as the
`18.
`
`OCLC bibliographic database,
`
`the Library of Congress Online Catalog,
`
`ResearchGate, and Semantic Scholar, to confirm citation details of the publication
`
`discussed.
`
`19.
`
`Indexing. 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
`
`6
`
`
`Liquidia's Exhibit 1036
`Page 8
`
`

`

`
`
`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.
`
`20.
`
`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.
`
`21. 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
`
`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.
`
`22. ResearchGate.1 A social networking site for scientists and researchers
`
`to share papers, ask and answer questions, and find collaborators, ReseachGate is
`
`the largest academic social network in terms of active users, although other services
`
`have more registered users, and a 2015–2016 survey suggests that almost as many
`
`academics have Google Scholar profiles. Features available to ResearchGate
`
`members include following a research interest and the work of other individual
`
`participants, a blogging feature for users to write short reviews on peer-reviewed
`
`1 www.researchgate.net
`
`
`
`7
`
`
`Liquidia's Exhibit 1036
`Page 9
`
`

`

`
`
`articles, private chat rooms for sharing data, editing documents, or discussing
`
`confidential topics, and a research-focused job board. ResearchGate indexes self-
`
`published information on user profiles and suggests members to connect with others
`
`who have similar interests. Member questions are fielded to others who have
`
`identified relevant expertise on their profiles.
`
`23. ResearchGate restricts its user accounts to people at recognized
`
`institutions and published researchers. As of 2018, ResearchGate had more than 15
`
`million users, with its largest user-bases coming from Europe and North America.
`
`Most of ResearchGate’s users are involved in medicine, biology, engineering,
`
`computer science, agricultural sciences, and psychology. ResearchGate publishes a
`
`citation impact measurement in the form of an “RG Score,” which is reported to be
`
`correlated with existing citation impact measures. ResearchGate does not charge
`
`fees for putting content on the site and does not require peer review.
`
`24.
`
`Semantic Scholar.2 Developed at the Allen Institute for Artificial
`
`Intelligence and released in November 2015, Semantic Scholar is designed to be an
`
`AI-backed search engine for scientific journal articles which uses a combination of
`
`machine learning, natural language processing, and machine vision to add a layer of
`
`semantic analysis to the traditional methods of citation analysis, and to extract
`
`relevant figures, entities, and venues from papers. Semantic Scholar is designed to
`
`
`2 www.semanticscholar.org
`
`8
`
`
`Liquidia's Exhibit 1036
`Page 10
`
`

`

`
`
`highlight important, influential papers, and to identify the connections between
`
`them.
`
`25. As of January 2018, following a 2017 project that added biomedical
`
`papers and topic summaries, the Semantic Scholar corpus included more than 40
`
`million papers from computer science and biomedicine. As of August 2019, the
`
`number of included papers had grown to more than 173 million after the addition of
`
`the Microsoft Academic Graph records, already used by Lens.org.
`
`D.
`26.
`
`Summary of Opinions
`I am informed by counsel that the priority date for the patent at issue is
`
`May 15, 2006. As I will explain below, it is my opinion that the printed publications
`
`discussed in my Declaration were publicly accessible before the May 15, 2006
`
`priority date.
`
`IV. LIBRARY CATALOGING PRACTICES
`A. MARC Records and OCLC
`I am fully familiar with the library cataloging standard known as the
`27.
`
`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.
`
`28. 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
`9
`
`
`Liquidia's Exhibit 1036
`Page 11
`
`

`

`
`
`bibliographic metadata in libraries.3 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 the assurance that their
`data will still be compatible.
`a MARC Record Necessary? LIBRARY OF CONGRESS,
`Is
`
`Why
`
`http://www.loc.gov/marc/umb/um01to06.html#part2 (last visited December 7,
`
`2020).
`
`
`3 A complete history of the development of MARC can be found in MARC: Its
`History and Implications by Henriette 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 December 7, 2020).
`
`10
`
`
`Liquidia's Exhibit 1036
`Page 12
`
`

`

`
`
`29. 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 December 7, 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 forty years ago. It
`
`provides the mechanism by which computers exchange, use, and interpret
`
`bibliographic information, and its data elements make up the foundation of most
`
`library catalogs used today.”). MARC is the ANSI/NISO Z39.2-1994 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 December 7, 2020).
`
`30. 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 December 7, 2020);
`
`http://www.loc.gov/marc/bibliographic/ (last visited December 7, 2020). For
`
`example, 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
`
`11
`
`
`Liquidia's Exhibit 1036
`Page 13
`
`

`

`
`
`subfield “c.” Id.4 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 December 7,
`
`2020).5
`
`31. 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 December 7, 2020);
`
`http://www.loc.gov/marc/bibliographic/ (last visited December 7, 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
`
`
`4 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
`December 7, 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”).
`5 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.
`
`12
`
`
`Liquidia's Exhibit 1036
`Page 14
`
`

`

`
`
`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 December 7, 2020).
`
`32.
`
`I
`
`consulted
`
`the
`
`Directory
`
`of
`
`OCLC
`
`Libraries
`
`(http://www.oclc.org/contacts/libraries.en.html; last visited December 7, 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.
`
`33. 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
`
`13
`
`
`Liquidia's Exhibit 1036
`Page 15
`
`

`

`
`
`http://www.loc.gov/marc/bibliographic/bd650.html (last visited December 7, 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.
`
`34. 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 December 7, 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.
`
`35. Each item in a library has a single classification number. A library
`
`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
`
`14
`
`
`Liquidia's Exhibit 1036
`Page 16
`
`

`

`
`
`a 09X (e.g., 090) field. See http://www.loc.gov/marc/bibliographic/bd09x.html (last
`
`visited December 7, 2020).
`
`36. 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,6 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
`
`=25&bibId=2579985 (last visited December 7, 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.
`
`37. The OCLC was created “to establish, maintain, and operate a
`
`
`6 The Unlikely Spy is a 1996 novel written by Daniel Silva, who happens to be one
`of my favorite authors.
`
`15
`
`
`Liquidia's Exhibit 1036
`Page 17
`
`

`

`
`
`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.”7 Among other services,
`
`OCLC and its members are responsible for maintaining the WorldCat database
`
`(http://www.worldcat.org/; last visited December 7, 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 December 7, 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 December 7, 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
`
`
`7 Third Article, Amended Articles of Incorporation of OCLC Online Computer
`Library
`Center,
`Inc.
`(available
`at
`https://www.oclc.org/content/dam/oclc/membership/articles-of-incorporation.pdf;
`last visited December 7, 2020).
`
`16
`
`
`Liquidia's Exhibit 1036
`Page 18
`
`

`

`
`
`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.”).
`
`38. 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
`
`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
`
`access to the OCLC bibliographic database or through the Library of Congress.
`
`39. Fields 008, 005, and 955 in MARC Records as Indicators of Public
`
`Accessibility. 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,
`
`17
`
`
`Liquidia's Exhibit 1036
`Page 19
`
`

`

`
`
`characters 00 through 05, in the ordinary course of its business.
`
` See
`
`http://www.loc.gov/marc/bibliographic/bd008a.html (last visited December 7,
`
`2020). For OCLC member institutions that use OCLC software to create original
`
`MARC 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.
`
`40. When other MARC-compatible libraries subsequently acquire their
`
`own copies of the same work, as mentioned, they create MARC records in their own
`
`computer catalog systems for their copies in the ordinary course of business.8 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.9 The previously created MARC record used by subsequently-acquiring
`
`libraries to create MARC records for their own copies may be obtained through the
`
`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
`
`
`8 Initial contributions to the bibliographic database for a work are called “master
`records.”
`9 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.
`
`18
`
`
`Liquidia's Exhibit 1036
`Page 20
`
`

`

`
`
`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.10 But the library that
`
`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
`
`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.
`
`41. 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
`
`
`10 This practice is not required by, but is nevertheless co