Reply Declaration of Sylvia Hall-Ellis, Ph.D.
`Petition for Inter Partes Review of
`U.S. Patent No. 10,716,793 B2
`
`
`
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`
`LIQUIDIA TECHNOLOGIES, INC.,
`Petitioner
`
`v.
`
`UNITED THERAPEUTICS CORPORATION,
`Patent Owner
`
`
`
`
`IPR2021-00406
`U.S. Patent No. 10,716,793 B2
`
`
`
`REPLY DECLARATION OF SYLVIA HALL-ELLIS, PH.D.
`
`
`
`
`
`Liquidia's Exhibit 1112
`Page 1
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`

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`Reply Declaration of Sylvia Hall-Ellis, Ph.D.
`Petition for Inter Partes Review of
`U.S. Patent No. 10,716,793 B2
`
`
`Table of Contents
`
`Page
`
` 
`I. 
`
`II. 
`
`III. 
`
`INTRODUCTION .............................................................................................................. 3 
`
`MATERIALS CONSIDERED ........................................................................................... 4 
`
`LEGAL PRINCIPLES ........................................................................................................ 8 
`
`A.  Public Accessibility of a Printed Publication...................................................................... 8 
`B.  Persons of Ordinary Skill in the Art ................................................................................... 9 
`C.  Priority Date ........................................................................................................................ 9 
`D.  Summary of Opinions ....................................................................................................... 10 
`IV. 
`Library Cataloging Practices ............................................................................................. 10 
`
`V.  Wyman is not qualified to opine on the public accessibility of Voswinckel JAHA and
`Voswinckel JESC.............................................................................................................. 11 
`
`VI. 
`
`Voswinkcel JAHA qualifies as a publicly accessible printed publication ........................ 14 
`
`VII.  Voswinckel JESC qualifies as a publicly accessible printed publication ......................... 39 
`
`
` 
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`-i-
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`Liquidia's Exhibit 1112
`Page 2
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`Reply Declaration of Sylvia Hall-Ellis, Ph.D.
`Petition for Inter Partes Review of
`U.S. Patent No. 10,716,793 B2
`
`I, Sylvia D. Hall-Ellis, declare as follows:
`
`I.
`
`INTRODUCTION
`
`1.
`
`2.
`
`I am over the age of eighteen and otherwise competent to make this declaration.
`
`I have been retained by counsel for Petitioner Liquidia Technologies, Inc.
`
`(“Liquidia”) to offer my expert opinion regarding the public availability of certain publications,
`
`discussed below.
`
`3.
`
`I understand that the Patent Trial and Appeal Board (“the Board”) has instituted
`
`inter partes review of U.S. Patent No. 10,716,793 (“’793 Patent”) based on the petition submitted
`
`by Liquidia. Since institution, I understand that Patent Owner United Therapeutics Corporation
`
`(“UTC”) has filed a Patent Owner Response as well as a declaration from Ms. Pilar Wyman in
`
`support thereof.
`
`4.
`
`I originally submitted a declaration on January 7, 2021 in this proceeding. My
`
`background, qualifications, and experience relevant to the issues raised in this proceeding are
`
`summarized in Section I.A of my original declaration. Ex. 1036 at ¶¶ 7-10. A full description of
`
`my background and qualifications is set forth in my curriculum vitae, attached as Exhibit A to my
`
`original 2021 declaration. Id., Exhibit A.
`
`5.
`
`This declaration presents my additional opinions in response to the Declaration of
`
`Ms. Pilar Wyman (Ex. 2041) (the “Wyman Declaration”), dated November 10, 2021, as it relates
`
`to the public availability of the two printed publications referred to in the Wyman Declaration as
`
`Voswinckel JAHA and Voswinckel JESC before May 15, 2006.
`
`6.
`
`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.
`
`
`
`-3-
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`Liquidia's Exhibit 1112
`Page 3
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`

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`Reply Declaration of Sylvia Hall-Ellis, Ph.D.
`Petition for Inter Partes Review of
`U.S. Patent No. 10,716,793 B2
`
`
`7.
`
`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 Declaration, the substance of my
`
`opinions, or the outcome of this proceeding. I have no other interests in this proceeding or with
`
`any of the parties.
`
`II. MATERIALS CONSIDERED
`
`8.
`
`This Declaration is based on information known to me as of the date I signed this
`
`Declaration, and I reserve the right to amend or supplement this report in view of any additional
`
`discovery, documents, information, reports, and/or testimony that I receive after issuance of this
`
`report.
`
`9.
`
`The bases for my opinions herein and any testimony that I may be called upon to
`
`provide are as follows: (i) the materials identified throughout this Declaration, listed below; (ii) the
`
`independent research identified in this Declarations (iii) the materials identified in my 2021
`
`declaration (Ex. 1036); (iv) the materials identified in the Wyman Declaration; (iv) my knowledge,
`
`education, research skills and methodology, and experience; and (v) the materials listed in the table
`
`below. The foregoing are among the types of information reasonably relied upon by experts in my
`
`field for the purposes of forming opinions or inferences on the matters that are the subject of my
`
`work in this case. Throughout this report, I cite portions of these documents. These citations are
`
`intended only as examples, and I reserve the right to rely on all portions of these documents in
`
`addition to those cited in this report.
`
`Exhibit
`No.
`1007
`
`Description
`
`Voswinckel, R., et al., Abstract 218: “Inhaled treprostinil is a potent pulmonary
`vasodilator in severe pulmonary hypertension,” European Heart Journal 25:22
`(2004) (“Voswinckel JESC”)
`
`-4-
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`Liquidia's Exhibit 1112
`Page 4
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`

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`Reply Declaration of Sylvia Hall-Ellis, Ph.D.
`Petition for Inter Partes Review of
`U.S. Patent No. 10,716,793 B2
`
`
`1008
`
`1036
`1089
`1090
`1091
`1092
`1093
`1094
`1095
`1096
`1104
`
`1106
`
`1110
`
`1113
`1114
`
`1115
`1116
`1117
`1118
`
`1119
`1120
`1121
`1122
`1123
`
`Robert Voswinckel, Beate Enke, Andre Kreckel, Frank Reichenberger, Stefanie
`Krick, Henning Gall, Tobias Gessier, Thomas Schmehl, Markus G. Kohstall,
`Friedrich Grimminger, Hossein A. Ghofrani, Werner Seeger, and Horst
`Olschewski, Abstract 1414: “Inhaled Treprostinil Sodium (TRE) For the
`Treatment of Pulmonary Hypertension,” Abstracts from the 2004 Scientific
`Sessions of the American Heart Association, Circulation, 110(17 Suppl.):III-295
`(October 26, 2004) (“Voswinckel JAHA”)
`Declaration of Sylvia Hall-Ellis, Ph.D. (“Hall-Ellis Decl.”)
`Voswinckel JESC, UWash
`Voswinckel JESC, UWisc
`Voswinckel JESC, British Library
`Voswinckel JESC, Add’l Pages
`Voswinckel JAHA, British Library
`Voswinckel JAHA, Library of Congress
`Voswinckel JAHA, Stanford
`Voswinckel JAHA, UC Davis
`Sulica, R. and Poon, M., “Medical therapeutics for pulmonary arterial
`hypertension: from basic science and clinical trial design to evidence-based
`medicine,” Expert Rev. Cardiovasc. Ther. 3(2), (2005) (“Sulica 2005”)
`Reply Declaration of Nicholas Hill, M.D. (“Hill Reply Declaration”)
`*Note: I only reviewed the excerpts I cite herein, which were provided to me by
`Liquidia’s counsel
`Transcript from the December 29, 2021 Deposition of Lyndsey Pilar Wyman,
`Liquida Technologies, Inc. v. United Therapeutics Corp., IPR2021-00406
`JAHA Supplement Author Index
`American Heart Association 2004 Online Archive, pages available at
`https://web.archive.org/web/20041130084648/http://circ.ahajournals.org:80/;
`https://web.archive.org/web/20041206215947/http://aha.agora.com/abstractview
`er/;
`https://web.archive.org/web/20041128050933/http://circ.ahajournals.org/content
`s-by-date.0.shtml; and
`https://web.archive.org/web/20041204145419/http://circ.ahajournals.org/content
`/vol110/issue17/
`Affidavit of Duncan Hall, December 7, 2021
`Voswinckel JAHA British Library Declaration
`JAHA Supplement PubMed Search Results
`PubMed.gov search results for Sulica, R. and Poon, M., “Medical therapeutics
`for pulmonary arterial hypertension: from basic science and clinical trial design
`to evidence-based medicine,” Expert Rev. Cardiovasc. Ther. 3(2), (2005)
`Voswinckel JESC British Library Declaration
`Voswinckel JESC Web of Science Search Results
`Ghofrani 2005, British Library
`Ghofrani 2005 Search Results
`Circulation MARC record, British Library
`
`-5-
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`Liquidia's Exhibit 1112
`Page 5
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`

`

`Reply Declaration of Sylvia Hall-Ellis, Ph.D.
`Petition for Inter Partes Review of
`U.S. Patent No. 10,716,793 B2
`
`
`Circulation MARC record, Library of Congress
`Circulation MARC record, Stanford
`Circulation MARC record, UC Davis
`European Heart Journal bibliographic record, UWash
`European Heart Journal MARC record, UWisc
`European Heart Journal MARC record, British Library
`University of Wisconsin–Madison Library Catalog Search for holdings of
`Circulation: the journal of the American Heart Association
`Declaration of Ms. Pilar Wyman (“Wyman Declaration”)
`Deposition Transcript of Sylvia Hall-Ellis, Ph. D.
`American Heart Association Listing of Circulation Supplements
`Oxford Academic Listing of European Heart Journal Supplements
`
`1124
`1125
`1126
`1127
`1128
`1129
`2040
`
`2041
`2043
`2044
`2049
`
`
`10.
`
`In preparing this report, I used authoritative databases, such as the OCLC
`
`bibliographic database (also known as “WorldCat”), the Library of Congress Online Catalog, the
`
`Internet Archive (also known as the Wayback Machine), and the Web of Science. I also used the
`
`databases and sources relied on in the Wyman Declaration, such as PubMed, Ovid, Chemical
`
`Abstracts, the American Heart Association Online Archive, and the Oxford University Press
`
`Medicine Archive.
`
`11.
`
`Internet Archive. The Internet Archive, a 501(c)(3) non-profit, is an online digital
`
`archive of Internet web sites and web pages and other cultural artifacts in digital form.1 Like a
`
`paper library, the Internet Archive provides free access to researchers, historians, scholars, the
`
`print disabled, and the general public. The organization’s mission is to provide Universal Access
`
`to All Knowledge.
`
`12.
`
`Established in 1996 by archiving the Internet itself, the Internet Archive features
`
`20+ years of web history accessible through the Wayback Machine and more than 625 library and
`
`other partners through our Archive-It program to identify important web pages. As the Internet
`
`
`1 See https://archive.org/ (last visited Feb. 3, 2022).
`-6-
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`Liquidia's Exhibit 1112
`Page 6
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`

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`Reply Declaration of Sylvia Hall-Ellis, Ph.D.
`Petition for Inter Partes Review of
`U.S. Patent No. 10,716,793 B2
`
`Archive grew, so did its commitment to provide digital versions of other published works.
`
`Currently, the Internet Archive includes approximately 330 billion web pages, 20 million books
`
`and
`
`texts,
`
`4.5 million audio
`
`recordings (including
`
`180,000 live
`
`concerts),
`
`4
`
`million videos (including 1.6 million Television News programs), 3 million images, and
`
`200,000 software programs.
`
`13.
`
`The Internet Archive maintains an archive of webpages collected from the Internet
`
`using software called a crawler. Crawlers automatically create a snapshot of webpages as they
`
`existed at a certain point in time. The Wayback Machine is an application using a crawler created
`
`by the Internet Archive to search its archive of web page URLs and to represent, graphically, the
`
`date of each crawler capture. The Internet Archive captures data that is openly available to users
`
`of the Internet. Some sites are “not archived because they were password protected, blocked by
`
`robots.txt, or otherwise inaccessible to our automated systems. Site owners might have also
`
`requested that their sites be excluded from the Wayback Machine.”2
`
`14. Many Internet Archive captures made by the WayBack Machine have a banner at
`
`the top with the capture date prominently displayed. Other dates when captures of the same URL
`
`have been made are indicated to the right and left of the date provided in the banner. Some captures
`
`may lack this banner. In any case, the URL for the capture begins with the identification of the
`
`Internet Archive page (e.g., http://web.archive.org/web/) followed by information that dates and
`
`time stamps the capture as follows: year in yyyy, month in mm, day in dd, time code in hh:mm:ss
`
`(e.g., 20071120082013, or November 20, 2007 at 8:20:13 a.m.). These elements are then followed
`
`by the URL of the original capture site. When links are active, the Wayback Machine is
`
`
`2 https://help.archive.org/hc/en-us/articles/360004651732-Using-The-Wayback-Machine (last
`visited Feb. 3, 2022).
`
`-7-
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`Liquidia's Exhibit 1112
`Page 7
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`

`

`Reply Declaration of Sylvia Hall-Ellis, Ph.D.
`Petition for Inter Partes Review of
`U.S. Patent No. 10,716,793 B2
`
`programmed to produce the archived file with the closest available date (not the closest available
`
`prior date) to the page upon which the link appeared and was clicked. I and other professionals in
`
`the field of library and information resources are familiar with the Internet Archive and the
`
`Wayback Machine. As previously noted, the Internet Archive and the Wayback Machine are
`
`among the types of information reasonably relied upon by experts in my field for the purposes of
`
`forming opinions or inferences on matters that are the subject of their work.3
`
`III. LEGAL PRINCIPLES
`
`15.
`
`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.
`
`A.
`
`16.
`
`Public Accessibility of a Printed Publication
`
`Relevant to my response to the Wyman Declaration, I note below as part of my
`
`understanding of the legal standards for public accessibility of a printed publication, in addition to
`
`what I already set forth in my 2021 declaration. See Ex. 1036, ¶¶ 11-14.
`
`17.
`
`I understand that there is a presumption of public accessibility as of the printed
`
`publication’s publication date if it is published by an established publisher.
`
`18.
`
`I am informed by counsel that, even if a printed publication is not cataloged and
`
`indexed in a meaningful way, it may still qualify as publicly accessible if it is cited by a “research
`
`
`3 For more information about the Internet Archive see the Wayback Machine FAQ,
`https://help.archive.org/hc/en-us#The_Wayback_Machine (last visited Feb. 3, 2022).
`-8-
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`Page 8
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`

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`Reply Declaration of Sylvia Hall-Ellis, Ph.D.
`Petition for Inter Partes Review of
`U.S. Patent No. 10,716,793 B2
`
`aid,” a publicly available publication that can reasonably lead a person interested in the relevant
`
`subject matter to the non-cataloged and non-indexed printed publication.
`
`19.
`
`I am informed by counsel that cataloging and indexing are not the only factors to
`
`be considered in determining public accessibility of a printed publication and that a printed
`
`publication that has never been cataloged or indexed in any library or database can nevertheless
`
`be found publicly accessible. For example, I understand that printed publications presented to an
`
`audience of persons interested in the relevant subject matter at an academic conference, without
`
`any expectation of confidentiality, may still qualify as publicly accessible.
`
`B.
`
`20.
`
`Persons of Ordinary Skill in the Art
`
`I set forth a definition of a person of ordinary skill in the art (“POSA”) in my 2021
`
`declaration. Ex. 1036, ¶¶ 15-17. I understand from counsel that UTC has since set forth its own
`
`definition, reproduced below:
`
`A POSA, with respect to the ’793 patent, would have an M.D. or a graduate degree (Masters
`
`or Ph.D.) in a field relating to drug development and at least two years practical experience
`
`in either (i) the investigation or treatment of pulmonary hypertension; or (ii) in the
`
`development of potential drug candidates, specifically in the delivery of drugs by
`
`inhalation.
`
`My analysis applies equally to either definition of a POSA.
`
`C.
`
`21.
`
`Priority Date
`
`As noted in my 2021 declaration, I am informed by counsel that the priority date
`
`for the ’793 Patent at issue is May 15, 2006. Ex. 1036, ¶ 26.
`
`-9-
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`Liquidia's Exhibit 1112
`Page 9
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`

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`Reply Declaration of Sylvia Hall-Ellis, Ph.D.
`Petition for Inter Partes Review of
`U.S. Patent No. 10,716,793 B2
`
`
`D.
`
`Summary of Opinions
`
`22.
`
`It is my opinion that the Voswinckel JAHA (Ex. 1008) and Voswinckel JESC (Ex.
`
`1007) printed publications discussed in my 2021 declaration were publicly accessible before the
`
`May 15, 2006 priority date, and that Wyman’s analysis to the contrary is unqualified, flawed, and
`
`incorrect.
`
`IV.
`
`LIBRARY CATALOGING PRACTICES
`
`23.
`
`Relevant to my response to the Wyman Declaration, I note the following about
`
`library cataloging practices, in addition to what I already set forth in my 2021 declaration. See Ex.
`
`1036, ¶¶ 27-46.
`
`24.
`
`Cataloging is the transcription of bibliographic data to describe a resource;
`
`assignment of subject headings is the assignment of points of access including, but not limited to
`
`subjects, genres, and other terms. These two distinct processes take place at the time that a MARC
`
`record is prepared for addition to a library’s online catalog.
`
`25.
`
`Learning to transcribe bibliographic data and classify resources are fundamental
`
`skills and competencies that graduate library and information science students choosing a career
`
`path in the organization of information must complete as part of the Master of Library and
`
`Information Science (MLIS) degree, which I earned before getting my Ph.D. in Library and
`
`Information Science.
`
`26. My research has focused on the knowledge, technical skills, and competencies for
`
`catalogers and metadata specialists in the library and information profession and provided the
`
`foundation for the adoption of core competencies by the American Library Association.4
`
`
`4 See https://alair.ala.org/handle/11213/7853 (last visited Feb. 3, 2022).
`-10-
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`Liquidia's Exhibit 1112
`Page 10
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`

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`Reply Declaration of Sylvia Hall-Ellis, Ph.D.
`Petition for Inter Partes Review of
`U.S. Patent No. 10,716,793 B2
`
`
`27.
`
`I understand that under the legal principles, the cataloging and indexing of a work
`
`in a meaningful way that bears a relationship to the subject of the work at hand provides a key
`
`indicator that such work would have been accessible to the public. In almost all libraries, as part
`
`of their routine business practice, the assignment of points of access to a work by subject and/or
`
`genre, in accordance with the MARC standard, will result in that work being indexed in a way that
`
`bears a relationship to the subject of the work, as discussed in my opening declaration (Ex. 1036,
`
`¶¶ 27-43).
`
`V. WYMAN IS NOT QUALIFIED TO OPINE ON THE PUBLIC ACCESSIBILITY
`OF VOSWINCKEL JAHA AND VOSWINCKEL JESC
`
`28.
`
`It is my opinion that Wyman is not qualified to opine on the matters of public
`
`accessibility of printed publications given her educational background. Wyman has a Bachelor’s
`
`degree from St. John’s College (Santa Fe, New Mexico) in Liberal Arts and two-years-worth of
`
`postgraduate education in Mathematics at the University of California at Berkeley and at Mills
`
`College (Oakland, California). See Wyman Declaration at CV (Pilar Wyman’s CV). A general
`
`liberal arts degree and graduate work in mathematics do not prepare an individual such as Wyman
`
`for graduate studies at a program accredited by the American Library Association5 in the fields of
`
`library services, information science, cataloging practices, and library operations. Ms. Wyman
`
`does not hold a graduate degree from an American Library Association accredited program is by
`
`her own admission “not a trained librarian.” Ex. 1110 (Wyman Dep. Tr.) at 49:13-19 (“Q. And
`
`so you don’t hold a—a graduate degree from an American Library Association accredited
`
`
`5 See https://www.ala.org/educationcareers/accreditedprograms/directory (last visited Feb. 3,
`2022)
`
`-11-
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`Reply Declaration of Sylvia Hall-Ellis, Ph.D.
`Petition for Inter Partes Review of
`U.S. Patent No. 10,716,793 B2
`
`program? A. That’s right. I’m not a librarian. I have worked as a librarian, but I am not a trained
`
`librarian.”).
`
`29.
`
`Professional librarians hold a graduate degree from a program accredited by the
`
`American Library Association. The Master of Library and Information Science (MLIS) degree
`
`prepares students through education, internships, and supervised field experience so that they meet
`
`the knowledge, technical skills, and competencies articulated by formal statements from relevant
`
`professional organizations.6 The design, building, and maintenance of databases as part of the
`
`graduate education results in highly developed understanding of the information seeking process
`
`and searching strategies that surpass those of the clientele they serve. In addition, professional
`
`librarians who work in research and academic libraries and information centers typically hold a
`
`second graduate degree or doctorate in the discipline or field of study. For example, medical
`
`librarians have graduate degrees in biology or nursing; law librarians in academic law libraries
`
`have a juris doctor (J.D.). Professional librarians have sophisticated research skills that enable
`
`them to conduct formal studies and contribute to the scholarly knowledge of the library,
`
`information, and related fields.
`
`30.
`
`It is also my opinion that Wyman is not qualified to opine on the matters of public
`
`accessibility of printed publications given her professional experience. Outside of serving as an
`
`expert in this IPR and the previous IPR2017-01621, Ms. Wyman acknowledges that she’s never
`
`been asked to assess the public availability of a document. Ex. 1110 (Wyman Dep. Tr.) at 27:15-
`
`20. The vast majority of Wyman’s career was focused on pursuits outside the realm of library
`
`practices. See Wyman Declaration at CV (Pilar Wyman’s CV). For 19 years, Wyman worked in
`
`
`6 See https://www.ala.org/educationcareers/node/99/ (last visited Feb. 3, 2022)
`-12-
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`Reply Declaration of Sylvia Hall-Ellis, Ph.D.
`Petition for Inter Partes Review of
`U.S. Patent No. 10,716,793 B2
`
`various atypical positions such as a research assistant in the Middle East Bureau of the Washington
`
`Post, a computer supervisor in the U.S. and abroad, a mathematics teacher, and a computer teacher
`
`who provided technical support to students in a private school. See id. Wyman does not indicate
`
`that any of this experience related to matters of public accessibility of printed publications.
`
`31. Wyman is a member of a professional group that offers workshops and short
`
`courses.7 However, Wyman’s experience is not specific to indexing practices in the field of library
`
`science (she provided her indexing services to only one library client) nor does she explain the
`
`research methodology that she used to arrive at her conclusions. Wyman’s CV indicates that she
`
`does not have any serious expertise in library or information sciences practices. Wyman has never
`
`worked in a research library—her only identifiable work experience as a librarian was at a private
`
`K-12 school that did not generate MARC records, the international industry-wide standard for
`
`organizing library catalog information. See Ex. 1110 (Wyman Dep. Tr.) at 50:22-53:11. Further,
`
`Wyman provides some examples of her indexing projects on her professional website8 but they
`
`consist of matching the topics in books or journals to the pages on which they appear, which is not
`
`the type of indexing related to the issue of public availability. Ms. Wyman acknowledges that her
`
`“own intimate working experience is with closed indexes,” which she defines as “[w]hen you go
`
`to the back of the book for these book-style indexes, you see the index entire. You can—you can
`
`peruse it. You can read it. You can see all of what’s contained in the index. It’s called a ‘closed
`
`index.’” Ex. 1110 (Wyman Dep. Tr.) at 18:21-19:10, 29:20-30:2.
`
`
`7 See https://www.asindexing.org/become-an-indexer/indexing-courses-and-workshops/ (last
`visited Feb. 3, 2022).
`8 See https://wymanindexing.wordpress.com/titles-indexed-2020/ (last visited Feb. 3, 2022).
`-13-
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`Liquidia's Exhibit 1112
`Page 13
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`Reply Declaration of Sylvia Hall-Ellis, Ph.D.
`Petition for Inter Partes Review of
`U.S. Patent No. 10,716,793 B2
`
`
`32.
`
`All in all, Wyman’s CV and deposition testimony show that indexing for libraries
`
`was never the focus of her career. Her indexing experience falls substantially short of the rigorous
`
`information seeking and indexing practices observed by the colleagues and professional research
`
`librarians from which I have obtained copies of the Voswinckel JAHA and Voswinckel JESC
`
`abstracts.
`
`VI. VOSWINKCEL JAHA QUALIFIES AS A PUBLICLY ACCESSIBLE PRINTED
`PUBLICATION
`
`33.
`
`Voswinckel JAHA (Ex. 1008) refers to an abstract titled “Inhaled Treprostinil
`
`Sodium (TRE) For the Treatment of Pulmonary Hypertension” by Robert Voswinckel, Beate
`
`Enke, Andre Kreckel, Frank Reichenberger, Stefanie Krick, Henning Gall, Tobias Gessler,
`
`Thomas Schmehl, Markus G. Kohstall, Friedrich Grimminger, Hossein A. Ghofrani, Warner
`
`Seeger, and Horst Olschewski published in a supplement titled “Abstracts from Scientific Sessions
`
`2004” (the “JAHA Supplement”) to Volume 110, No. 17 of the journal “Circulation.” Voswinckel
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`JAHA was presented at the 2004 Scientific Sessions of the American Heart Association, which
`
`was held on November 7-10, 2004, in New Orleans, Louisiana.9 I have obtained date-stamped
`
`copies of Voswinckel JAHA from the British Library (stamped November 19, 2004), the Library
`
`of Congress (stamped October 2004), the Lane Medical Library at the Stanford University Medical
`
`Center (stamped November 11, 2004), and the University of California Davis Health Sciences
`
`Library (stamped November 17, 2004), which are attached as Exhibits 1093-1096, respectively.
`
`Voswinckel JAHA appears on page III-295 of the JAHA Supplement and can be easily found
`
`
`
`9
`See
`https://www.unboundmedicine.com/medline/citation/16082756/Abstracts_from_the_2004_Scien
`tific_Sessions_of_the_American_Heart_Association__November_7_10_2004_New_Orleans_Lo
`uisiana_USA_ (last visited Feb. 3, 2022).
`
`-14-
`
`
`Liquidia's Exhibit 1112
`Page 14
`
`

`

`Reply Declaration of Sylvia Hall-Ellis, Ph.D.
`Petition for Inter Partes Review of
`U.S. Patent No. 10,716,793 B2
`
`using the Author Index, beginning on page III-837. See Exs. 1093-1096, 1113. The presence of
`
`these date stamped copies establishes the public accessibility of Voswinckel JAHA.
`
`34.
`
`The Wyman Declaration takes issue about Liquidia not quoting the Voswinckel
`
`JAHA abstract title correctly. See Wyman Declaration at ¶¶7-8. Specifically, the Wyman
`
`Declaration points out that Liquidia cites a section heading in the JAHA Supplement “Pulmonary
`
`Arterial Hypertension: New Therapies,” instead of the abstract title “Inhaled Treprostinil Sodium
`
`for the Treatment of Pulmonary Hypertension.” See id. I am informed by counsel that, in this
`
`proceeding, Liquidia cited to the abstract’s proper title in its Petition. Nonetheless, this point in
`
`the Wyman Declaration does not change my opinion regarding the public accessibility of
`
`Voswinckel JAHA.
`
`35.
`
`It is my opinion that Voswinckel JAHA qualifies as a publicly available printed
`
`publication that was accessible prior to the May 15, 2006 priority date, based on its availability to
`
`the public in at least the British Library, the Library of Congress, the Lane Medical Library at the
`
`Stanford University Medical Center, and the University of California Davis Health Sciences
`
`Library prior to May 15, 2006. The Wyman Declaration argues that the JAHA Supplement and
`
`Voswinckel JAHA are difficult to find and “continue to be difficult to access even today.” Id. at
`
`¶¶9-15. In support of its argument, the Wyman Declaration asserts that the Voswinckel JAHA
`
`abstract is difficult to find in the JAHA Supplement (see id. at ¶10), that the JAHA Supplement is
`
`released irregularly and may have been released significantly after the Scientific Sessions 2004
`
`Conference in November 2004 (see id. at ¶¶10-12, 14), that the JAHA Supplement does not appear
`
`in the American Heart Association online archives (see id. at ¶12), and that the JAHA Supplement
`
`submitted in the ’793 IPR had no date-stamp evidencing date of receipt by a library (see id. at ¶13).
`
`Because each prong of the Wyman Declaration’s argument fails, as I explain in detail below, a
`
`-15-
`
`
`Liquidia's Exhibit 1112
`Page 15
`
`

`

`Reply Declaration of Sylvia Hall-Ellis, Ph.D.
`Petition for Inter Partes Review of
`U.S. Patent No. 10,716,793 B2
`
`person of ordinary skill in the art that was interested in the subject matter would have found
`
`Voswinckel JAHA, exercising no more than reasonable diligence.
`
`36.
`
`The Voswinckel JAHA abstract is not difficult to find by a person of ordinary skill
`
`in the art within the JAHA Supplement. To begin with, the JAHA Supplement was prepared in
`
`conjunction with the American Heart Association’s 2004 Scientific Sessions. Thus, a person of
`
`ordinary skill in the art attending the 2004 Scientific Sessions would have known to review the
`
`JAHA supplement prior to the conference and would have found Voswinckel JAHA. Dr. Nicholas
`
`Hill, another expert retained by Liquidia, agrees that:
`
`[A] POSA in 2004 would have attended the Scientific Sessions 2004
`
`Conference, as it is one of the principal conferences on the circulatory system
`
`and diseases and conditions affecting circulation, including pulmonary
`
`hypertension. . . . A person attending the meeting can thus use the meeting
`
`program to determine which researchers and clinicians are presenting at the
`
`meeting as well as the subject matter on which the clinicians or researchers are
`
`presenting. . . . A POSA attending the Scientific Sessions 2004 Conference
`
`would have been interested in presentations on treatments for pulmonary
`
`hypertension, including pulmonary arterial hypertension, and contrary to Ms.
`
`Wyman’s opinions, would have been able to identify the abstracts disclosing
`
`such treatments, including Voswinckel JAHA. See Ex. 2041 (Wyman Decl.) at
`
`¶ 25 (stating without evidence that “a POSA conducting diligent research would
`
`not sift through such voluminous results”). The meeting programs and
`
`supplements are provided for just this purpose, and I myself use such meeting
`
`programs and supplements to identify abstracts on subject matter of interest.
`
`-16-
`
`
`Liquidia's Exhibit 1112
`Page 16
`
`

`

`Reply Declaration of Sylvia Hall-Ellis, Ph.D.
`Petition for Inter Partes Review of
`U.S. Patent No. 10,716,793 B2
`
`Ex. 1106 (“Reply Declaration of Dr. Hill”) at ¶ 22. Further, Despite the JAHA Supplement being
`
`1,102-pages-long, the abstracts are indexed by author. See Ex. 1093 at 5; Ex. 1094 at 6; Ex. 1095
`
`at 9; Ex. 1096 at 4. Specifically, the Voswinckel JAHA abstract, numbered 1414, is indexed under
`
`the authors “Voswinckel, Robert” and “Seeger, Werner.” See Ex. 1095 at 16; Ex. 1113 at 5. Dr.
`
`Hill also “note[s] that at the time, and still today, the number of physicians and researchers working
`
`on treatments for pulmonary arterial hypertension was small. A POSA would have thus known
`
`the names of the other physicians and researchers in the field and would have sought out research,
`
`including abstracts and presentations, by these physicians and researchers. . . . Accordingly, and
`
`in direct contradiction to Ms. Wyman’s opinion, a POSA would have found Robert Voswinckel’s
`
`name in the Author Index (or the names of other authors from the Gies