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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`REGENERON PHARMACEUTICALS, INC.,
`Petitioner,
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`v.
`
`NOVARTIS PHARMA AG,
`NOVARTIS TECHNOLOGY LLC,
`NOVARTIS PHARMACEUTICALS CORPORATION,
`Patent Owners.
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`
`
`Case IPR2021-00816
`Patent 9,220,631
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`SECOND DECLARATION OF JAMES L. MULLINS, PH.D.
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`Regeneron Exhibit 1103.001
`Regeneron v. Novartis
`IPR2021-00816
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`

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`TABLE OF CONTENTS
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`Page
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`I.
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`INTRODUCTION ........................................................................................... 1
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`II. QUALIFICATIONS ........................................................................................ 2
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`III. BACKGROUND ON PUBLIC ACCESSIBILITY ........................................ 2
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`A.
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`Scope of this Declaration ...................................................................... 2
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`B.
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`Person of Ordinary Skill in the Art ....................................................... 4
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`C.
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`Library Catalog Records and Other Resources ..................................... 6
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`D. Monograph Publications ..................................................................... 11
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`E.
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`F.
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`Ownership and Date Stamp ................................................................. 12
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`Indexing/Cataloging ............................................................................ 13
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`H.
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`Periodical Publications ........................................................................ 15
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`IV. OPINION REGARDING AUTHENTICITY AND PUBLIC
`ACCESSIBILITY .......................................................................................... 16
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`A. Document A: Ex. 1015 & Ex. 1016: Sandeep Nema and John
`D. Ludwig, editors, Pharmaceutical Dosage Forms: Parenteral
`Medications, 3rd edition ...................................................................... 16
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`1.
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`2.
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`3.
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`Authentication ........................................................................... 16
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`Public Accessibility .................................................................. 19
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`Conclusion ................................................................................ 23
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`B. Document B: Ex. 1214: Shawn Kinney, et al., “A Rational
`Approach to Determining the Maximum Product Sterility”,
`Drug Delivery Technology, Volume 9, Number 2 ............................. 23
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`1.
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`2.
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`Authentication ........................................................................... 23
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`Public Accessibility .................................................................. 27
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`i
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`Regeneron Exhibit 1103.002
`Regeneron v. Novartis
`IPR2021-00816
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`3.
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`Conclusion ................................................................................ 32
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`V. AVAILABILITY FOR CROSS-EXAMINATION ...................................... 32
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`VI. RIGHT TO SUPPLEMENT .......................................................................... 33
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`VII. JURAT ........................................................................................................... 33
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`ii
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`Regeneron Exhibit 1103.003
`Regeneron v. Novartis
`IPR2021-00816
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`

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`
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`I.
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`I, Dr. James L. Mullins, declare as follows:
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`INTRODUCTION
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`1. My name is Dr. James L. Mullins. I have been retained by petitioner
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`Regeneron Pharmaceutical, Inc. (“Regeneron”) to provide opinions on various
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`documents.
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`2.
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`I am presently Dean Emeritus of Libraries and Esther Ellis Norton
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`Professor Emeritus at Purdue University. My career as a professional and academic/
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`research librarian spanned more than 44 years including library positions at Indiana
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`University, Villanova University, Massachusetts Institute of Technology, and
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`Purdue University. Appendix A is a true and correct copy of my curriculum vitae
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`my background and experience.
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`3.
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`In 2018, I founded the firm Prior Art Documentation Librarian
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`Services, LLC, located at 106 Berrow, Williamsburg, VA 23188 after purchasing
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`the intellectual property of and as a successor to Prior Art Documentation, LLC
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`located at 711 South Race Street, Urbana, IL 61801. Further information about my
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`firm, Prior Art Documentation Librarian Services, LLC (PADLS), is available at
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`www.priorartdoclib.com.
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`4.
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`I have been retained by Regeneron to offer my opinion on the
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`authenticity and dates of public accessibility of various documents. For this service,
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`I am being paid my usual hourly fee of $275.00. I have no stake in the outcome of
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`
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`1
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`Regeneron Exhibit 1103.004
`Regeneron v. Novartis
`IPR2021-00816
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`this proceeding or any related litigation or administrative proceedings, and my
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`compensation in no way depends on the substance of my testimony or the outcome
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`of this proceeding.
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`II. QUALIFICATIONS
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`5. My qualifications are laid out in my first declaration (Ex. 1033) and in
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`my CV (Appendix A).
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`III. BACKGROUND ON PUBLIC ACCESSIBILITY
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`A.
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`6.
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`Scope of this Declaration
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`I am not a lawyer, and I am not rendering an opinion on the legal
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`question of whether a particular document is, or is not, a “printed publication” under
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`the law. I am, however, rendering my expert opinion on the authenticity of the
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`document referenced herein and when and how this document was disseminated or
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`otherwise made available to the extent that persons interested and ordinarily skilled
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`in the subject matter or art, exercising reasonable diligence, could have located the
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`document.
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`7.
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`I am informed by counsel that an item is considered authentic if there
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`is sufficient evidence to support a finding that the item is what it is claimed to be. I
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`am also informed that authenticity can be established based on the contents of the
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`document itself, such as the appearance, content, substance, internal patterns, or
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`other distinctive characteristics of the item.
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`
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`2
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`Regeneron Exhibit 1103.005
`Regeneron v. Novartis
`IPR2021-00816
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`

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`8.
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`I am informed by counsel that a given reference qualifies as “publicly
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`accessible” if it was disseminated or otherwise made available such that a person
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`interested in and ordinarily skilled in the relevant subject matter could locate it
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`through the exercise of ordinary diligence.
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`9. While I understand that the determination of public accessibility under
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`the foregoing standard rests on a case-by-case analysis of the facts particular to an
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`individual publication, I also understand that a printed publication is rendered
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`“publicly accessible” if it is cataloged and indexed by a library such that a person
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`interested in the relevant subject matter could locate it (i.e., I understand that
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`cataloging and indexing by a library is sufficient, though there are other ways that a
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`printed publication may qualify as “publicly accessible”). One manner of sufficient
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`indexing is indexing according to subject matter. I understand that it is not necessary
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`to prove someone actually looked at the printed publication in order to show it was
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`publicly accessible by virtue of a library’s cataloging and indexing thereof. I
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`understand that cataloging and indexing by a single library of a single instance of a
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`particular printed publication is sufficient. I understand that, even if access to a
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`library is restricted, a printed publication that has been cataloged and indexed therein
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`is publicly accessible so long as a presumption is raised that the portion of the public
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`concerned with the relevant subject matter would know of the printed publication. I
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`also understand that the cataloging and indexing of information that would guide a
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`3
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`Regeneron Exhibit 1103.006
`Regeneron v. Novartis
`IPR2021-00816
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`

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`person interested in the relevant subject matter to the printed publication, such as the
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`cataloging and indexing of an abstract for the printed publication, is sufficient to
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`render the printed publication publicly accessible.
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`10.
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`I understand that evidence showing the specific date when a printed
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`publication became publicly accessible is not necessary. Rather, routine business
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`practices, such as general library cataloging and indexing practices, can be used to
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`establish an approximate date on which a printed publication became publicly
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`accessible.
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`B.
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`11.
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`Person of Ordinary Skill in the Art
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`In forming the opinions expressed in this declaration, I have reviewed
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`the documents and appendices referenced herein. These materials are records created
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`in the ordinary course of business by publishers, libraries, indexing services, and
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`others. From my years of experience, I am familiar with the process for creating many
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`of these records, and I know that these records are created by people with knowledge
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`of the information contained within the record. Further, these records are created
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`with the expectation that researchers and other members of the public will use them.
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`All materials cited in this declaration and its appendices are of a type that experts in
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`my field would reasonably rely upon and refer to in forming their opinions.
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`4
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`Regeneron Exhibit 1103.007
`Regeneron v. Novartis
`IPR2021-00816
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`12.
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`I have been informed by counsel that the subject matter of this
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`proceeding relates to a terminally sterilized pre-filled syringe for intravitreal
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`injection that includes a VEGF-antagonist solution.
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`13.
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`I have been informed by counsel that, with respect to claims 1-23 of the
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`’631 Patent, a person of ordinary skill would have had at least an advanced degree
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`(Dipl.Ing, M.S., or Ph.D.), with research experience in mechanical engineering,
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`biomedical engineering, materials science, chemistry, or a related field, or at least 2-
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`3 years of professional experience in one or more of those fields. Furthermore, I
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`understand that a POSITA would have had experience with (i) the design of pre-
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`filled syringes; and (ii) sterilization of drug delivery devices, including those
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`containing sterilization sensitive therapeutics. Such sterilization experience would
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`include experience with microbiology. I have further been informed by counsel that,
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`with respect to claims 24-26 of the ’631 Patent, a person of ordinary skill would be
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`an ophthalmologist with experience administering VEGF-antagonist drugs to
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`patients via the intravitreal route.
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`14.
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`I further understand that Novartis has proposed a different definition of
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`POSITA, under which a POSITA would have had an advanced degree (i.e., an M.S.,
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`a Ph.D., or equivalent), and at least 2-3 years of professional experience, in
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`mechanical engineering, biomedical engineering, materials science, chemistry,
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`chemical engineering, or a related field, including experience with the design of a
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`5
`
`Regeneron Exhibit 1103.008
`Regeneron v. Novartis
`IPR2021-00816
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`PFS and/or the development of ophthalmologic drug products or drug delivery
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`devices. Such a person would have been a member of a product development team
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`and would have drawn upon not only his or her own skills, but also the specialized
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`skills of team members in complementary fields including ophthalmology,
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`microbiology and toxicology. My opinions do not change and are equally valid
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`under either definition of POSITA.
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`15.
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`It is my opinion that such a person would have been actively engaged
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`in academic research and learning through study and practice in the field, and
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`possibly through formal instruction through the bibliographic resources relevant to
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`his or her research. By the 2000s, such a person would have had access to a vast
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`array of print resources, including at least the documents referenced below, as well
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`as to a fast-changing set of online resources.
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`C. Library Catalog Records and Other Resources
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`16. Although I have previously provided background on library catalog
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`records (see Ex. 1033), some additional background on MARC (Machine-Readable
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`Cataloging) formatted records, OCLC, and WorldCat is helpful to understand the
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`library catalog records discussed in this declaration. I am fully familiar with the
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`library cataloging standard known as the MARC standard, which is an industry-wide
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`6
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`Regeneron Exhibit 1103.009
`Regeneron v. Novartis
`IPR2021-00816
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`standard method of storing and organizing library catalog information.1 MARC
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`practices have been consistent since the MARC format was developed by the Library
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`of Congress in the 1960s, and by the early 1970s became the U.S. national standard
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`for disseminating bibliographic data. By the mid-1970s, MARC format became the
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`international standard, and persists through the present. A MARC-compatible library
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`is one that has a catalog consisting of individual MARC records for each of its items.
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`The underlying MARC format (computer program) underpins the online public
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`access catalog (OPAC) that is available to library users to locate a particular holding
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`of a library. Today, MARC is the primary communications protocol for the transfer
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`and storage of bibliographic metadata in libraries.2 The MARC practices discussed
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`below were in place during the late 1990s period relevant to the documents
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`referenced herein.
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`17. Online Computer Library Center (OCLC) is a not-for-profit worldwide
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`consortium of libraries. Similar to MARC standards, OCLC’s practices have been
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`1 The full text of the standard is available from the Library of Congress at
`http://www.loc.gov/marc/bibliographic/.
`2 Almost every major library in the world uses a catalog that is MARC-compatible.
`See, e.g., Library of Congress, MARC Frequently Asked Questions (FAQ),
`https://www.loc.gov/marc/faq.html (last visited Jan. 24, 2018) (“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 (reaffirmed
`2009) standard for Information Interchange Format.
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`
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`7
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`Regeneron Exhibit 1103.010
`Regeneron v. Novartis
`IPR2021-00816
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`consistent since the 1970s through the present. Accordingly, the OCLC practices
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`discussed below were in place during the period discussed in my opinions section.
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`OCLC was created “to establish, maintain and operate a computerized library
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`network and to promote the evolution of library use, of libraries themselves, and of
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`librarianship, and to provide processes and products for the benefit of library users
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`and libraries, including such objectives as increasing availability of library resources
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`to individual library patrons and reducing the rate of rise of library per-unit costs, all
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`for the fundamental public purpose of furthering ease of access to and use of the
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`ever-expanding body of worldwide scientific, literary and educational knowledge
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`and information.”3 Among other services, OCLC and its members are responsible
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`for maintaining the WorldCat database (http://www.worldcat.org/), used by libraries
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`throughout the world.
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`18. Libraries worldwide use the machine-readable MARC format for
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`catalog records. MARC-formatted records include a variety of subject access points
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`based on the content of the document being cataloged. A MARC record for a
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`particular work comprises several fields, each of which contains specific data about
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`the work. Each field is identified by a standardized, unique, three-digit code
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`3 OCLC Online Computer Library Center, Inc., Amended Articles of Incorporation
`of OCLC Online Computer Library Center, Inc., Third Article (OCLC, Dublin,
`Ohio) Revised November 30, 2016, https://www.oclc.org/content/dam/oclc/
`membership/articles-of-incorporation.pdf.
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`
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`8
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`Regeneron Exhibit 1103.011
`Regeneron v. Novartis
`IPR2021-00816
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`corresponding to the type of data that follows. For example, a work’s title is recorded
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`in field 245, the primary author of the work is recorded in field 100, a work’s
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`International Standard Book Number (“ISBN”) is recorded in field 020, and the
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`work’s Library of Congress call number (assigned by Library of Congress) is
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`recorded in field 050. Some fields can contain subfields, which are indicated by
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`letters. For example, a work’s publication date is recorded in field 260 under the
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`subfield “c.”
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`19. The MARC Field 040, subfield “a,” identifies the library or other entity
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`that created the catalog record in the MARC format. The MARC Field 008 identifies
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`the date when this first MARC record was created.
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`20. MARC records also include several fields that include subject matter
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`classification information. An overview of MARC record fields is available through
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`the Library of Congress at http://www.loc.gov/marc/bibliographic/. For example,
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`6XX fields are termed “Subject Access Fields.”4 Among these, for example, is the
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`650 field; this is the “Subject Added Entry – Topical Term” field. See
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`http://www.loc.gov/marc/bibliographic/bd650.html. The 650 field is a “[s]ubject
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`added entry in which the entry element is a topical term.” Id. The 650 field entries
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`“are assigned to a bibliographic record to provide access according to generally
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`accepted thesaurus-building rules (e.g., Library of Congress Subject Headings
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`4 See http://www.loc.gov/marc/bibliographic/bd6xx.html.
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`9
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`Regeneron Exhibit 1103.012
`Regeneron v. Novartis
`IPR2021-00816
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`(LCSH), Medical Subject Headings (MeSH)).” Id. Thus, a researcher can easily
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`discover material relevant to a topic of interest with a search using the terms
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`employed in the MARC Fields 6XX.
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`21. Further, MARC records include call numbers, which themselves
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`include a classification number. For example, the 050 field is dedicated as the
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`“Library of Congress Call Number”5 as assigned by the Library of Congress. A
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`defined portion of the Library of Congress Call Number is the classification number,
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`and “source of the classification number is Library of Congress Classification and
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`the LC Classification-Additions and Changes.” Id. Thus, included in the 050 field is
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`a subject matter classification. As an example: TK5105.59 indicates books on
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`computer networks – security measures. When a local library assigns a classification
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`number, most often a Library of Congress derived classification number created
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`by a local library cataloger or it could be a Dewey Decimal classification number
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`for example, 005.8, computer networks – security measures, it appears in the 090
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`field. In either scenario, the MARC record includes a classification number in the
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`call number field that represents a subject matter classification.
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`22. The 9XX fields, which are not part of the standard MARC 21 format,6
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`were defined by OCLC for use by the Library of Congress, processing or holding
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`5 See http://www.loc.gov/marc/bibliographic/bd050.html.
`6 See https://www.oclc.org/bibformats/en/9xx.html.
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`
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`10
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`Regeneron Exhibit 1103.013
`Regeneron v. Novartis
`IPR2021-00816
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`notes for a local library, and for internal OCLC use. For example, the 955 field is
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`reserved for use by the Library of Congress to track the progress of a new acquisition
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`from the time it is submitted for Cataloging in Publication (CIP) review until it is
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`published and fully cataloged and publicly available for use within the Library of
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`Congress. Fields 901- 907, 910, and 945-949 have been defined by OCLC for local
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`use and will pass OCLC validation. Fields 905 or 910 are often used by an individual
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`library for internal processing purposes, for example the date of cataloging and/or
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`the initials of the cataloger.
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`D. Monograph Publications
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`23. Monograph publications are written on a single topic, presented at
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`length, and distinguished from an article and include books, dissertations,
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`proceedings of a conference, and technical reports. A library typically creates a
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`catalog record when the monograph is acquired by the library. First, it will search
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`OCLC to determine if a record has already been created by the Library of Congress
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`or another OCLC institution. If a record is found in OCLC, the record is downloaded
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`into the library’s LMS. The library’s LMS typically includes the OPAC (online
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`public access catalog by which researchers locate a particular library holding in a
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`user-friendly format), acquisitions, cataloging, and circulation integrated functions.
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`Once the item is downloaded into the library’s LMS, the library adds its identifier to
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`the OCLC database so when a search is completed on WorldCat, the library will be
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`
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`11
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`Regeneron Exhibit 1103.014
`Regeneron v. Novartis
`IPR2021-00816
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`indicated as an owner of the title. Once a record is created in a library’s LMS, it is
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`searchable and viewable through the library’s OPAC. The record is typically
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`searchable by author, title, and subject heading, at that library and from anywhere in
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`the world through the internet by accessing that library’s OPAC. The OPAC also
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`connects with the circulation function of the library which typically indicates
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`whether the record is available, in circulation, etc., with its call number and location
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`in a specific departmental/disciplinary library, if applicable. The OPAC not only
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`provides immediate bibliographic access on site, it also facilitates the interlibrary
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`loan process, which involves loaning a publication from one library to another.
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`E. Ownership and Date Stamp
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`24. Every library sets its own practice or policy on whether-or-not to date
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`stamp, but all will have an ownership stamp somewhere in the publication—
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`typically on the cover page, verso of the cover page, or a designated page within the
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`publication, sometimes even on the top, side, or bottom edge of the monograph or
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`periodical. The ownership and date stamp can also vary from one library to another
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`when the stamp is entered on the monograph. It can occur when received in
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`acquisitions after shipment to the library, or it can be at time of cataloging.
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`Therefore, there could be instances when the date of receipt precedes the cataloging
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`date or vice versa.
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`
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`12
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`Regeneron Exhibit 1103.015
`Regeneron v. Novartis
`IPR2021-00816
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`

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`F.
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`Indexing/Cataloging
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`25. A researcher may discover material relevant to his or her topic in a
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`variety of ways. One common means of discovery is to search for relevant
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`information in an index of periodical and other publications. Having found relevant
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`material, the researcher will then normally obtain it online, look for it in libraries, or
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`purchase it from the publisher, a bookstore, a document delivery service, or other
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`provider. Sometimes, the date of a document’s public accessibility will involve both
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`indexing and library date information. Date information for indexing entries is,
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`however, often unavailable. This is especially true for online indices, including
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`Wiley Online Library and WorldCat.
`
`26. WorldCat is the world’s largest public online catalog, maintained by the
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`OCLC, Inc., a not-for-profit international library consortium, and built with the
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`records created by thousands of libraries that are members of OCLC. Prior to
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`WorldCat, the OCLC database base was accessible since 1991 through a search
`
`engine called FirstSearch. FirstSearch required access from an OCLC, Inc. member
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`library, therefore, not open access. In 2006, OCLC’s WorldCat was separated from
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`FirstSearch and was made accessible as an open access data base, freely available
`
`to anyone in the world.
`
`27. WorldCat requires no knowledge of MARC tags and code and does not
`
`require a login or password. WorldCat is easily accessible through the World Wide
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`
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`13
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`Regeneron Exhibit 1103.016
`Regeneron v. Novartis
`IPR2021-00816
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`Web to all who wish to search it; there are no restrictions to be a member of a
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`particular community, etc. The date a given catalog record was created
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`(corresponding to the MARC Field 008) appears in some detailed WorldCat records
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`as the Date of Entry but not necessarily all. WorldCat does not provide a view of the
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`underlying MARC format for a specific WorldCat record. In order to see the
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`underlying MARC format the researcher must locate the book in a holding library
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`listed among those shown in WorldCat, and search the online public catalog (OPAC)
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`of a holding library. Whereas WorldCat records are widely available, the availability
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`of library specific MARC formatted records varies from library to library. When a
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`specific library wishes to make the underlying MARC format available there will be
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`a link from the library’s OPAC display, often identified as a MARC record or
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`librarian/staff view.
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`28. When a MARC record is created by the Library of Congress or an
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`OCLC member institution, the date of creation for that record is automatically
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`populated in the fixed field (008), with characters 00 through 05 in year, month, day
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`format (YYMMDD).7 Therefore, the MARC record creation date reflects the date
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`on which the publication associated with the record was first cataloged. Thereafter,
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`the local library’s computer system may automatically update the date in field 005
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`7 Some of the newer library catalog systems also include hour, minute, second
`(HHMMSS).
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`
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`14
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`Regeneron Exhibit 1103.017
`Regeneron v. Novartis
`IPR2021-00816
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`every time the library updates the MARC record (e.g., to reflect that an item has been
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`moved to a different shelving location within the library, or a reload of the
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`bibliographic data with the introduction of a new library management system that
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`creates and manages the OPAC).
`
`G.
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`Periodical Publications.
`
`29. A library typically creates a catalog record for a periodical publication
`
`when the library receives its first issue. When the institution receives subsequent
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`issues/volumes of the periodical, the issues/volumes are generally checked in (often
`
`using a date stamp), added to the institution’s holding records, and made available
`
`very soon thereafter – normally within a few days of receipt or (at most) within a
`
`few weeks of receipt.
`
`30. ProQuest – ProQuest’s collections span six centuries, all disciplines
`
`and the diverse content types needed by researchers, providing the world’s largest
`
`collection of dissertations and theses; three centuries of newspapers; more than
`
`450,000 academic eBooks; collections of important scholarly journals and other
`
`content researchers need such as data; and unique digital vaults of primary source
`
`materials . ProQuest’s renowned abstracting and indexing enables researchers to find
`
`sources in their area of study. See https://about.proquest.com/libraries/academic/.
`
`31. Wisconsin TechSearch (WTS) – WTS offers an array of article
`
`delivery and research services to individuals and organizations not affiliated with
`
`
`
`15
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`IPR2021-00816
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`the University of Wisconsin or who need the specialized skills of WTS staff in
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`locating and retrieving information. See https://wts.wisc.edu/.
`
`IV. OPINION REGARDING AUTHENTICITY AND PUBLIC
`ACCESSIBILITY
`
`A. Document A: Ex. 1015 & Ex. 1016: Sandeep Nema and John D.
`Ludwig, editors, Pharmaceutical Dosage Forms: Parenteral
`Medications, 3rd edition. Volume 1: Formulation and Packaging;
`Volume 2: Facility Design, Sterilization and Processing. Informa
`Healthcare, 2010. (“Nema”)
`
`32.
`
`I have been asked to opine on a book titled: Pharmaceutical Dosage
`
`Forms: Parenteral Medications, 3rd edition, edited by Sandeep Nema and John D.
`
`Ludwig, published in three volumes, for this declaration, Volume 1 - Formulation
`
`and Packaging; and Volume 2 - Facility Design, Sterilization and Processing have
`
`been included in this declaration to authenticate and document public access.
`
`1.
`
`Authentication
`
`33.
`
`I have evaluated the Nema reference several ways: (1) by assessing
`
`scans of a copy provided to me by counsel, Ex. 1015 and Ex. 1016; (2) by assessing
`
`scans of a print copy held by the National Library of Medicine (NLM), Attachment
`
`A-1 (3) by assessing downloads of Nema available to me as an emeritus faculty
`
`member of Purdue University through the Purdue University Libraries, from the
`
`ProQuest
`
`Ebook
`
`Central,
`
`at
`
`
`
`this
`
`URL:
`
`https://ebookcentral.proquest.com/lib/purdue/detail.action?pq-
`
`origsite=primo&docID=584343.
`
`
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`16
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`34.
`
`It is available for a fee through ProQuest Ebook Central at this URL:
`
`https://www.taylorfrancis.com/books/edit/10.1201/b17733/pharmaceutical-dosage-
`
`forms-sandeep-nema-john-ludwig.
`
`35. Attachment A-1, obtained by me at my request by Wisconsin
`
`TechSearch (WTS) was made from the print copy owned by the National Library of
`
`Medicine (NLM). I received Attachment A-1 on March 9, 2022, and it contains scans
`
`of Volume 1 of Nema that include: partial back cover with a barcode label that reads
`
`“National Library of Medicine” (shown below); spine of the book with a label that reads
`
`“2010 L-841 v.1 (shown below); cover of volume 1; front flyleaf with ownership stamp
`
`that reads “Property of the National Library of Medicine” (shown below); title page
`
`of volume 1; verso of the title page (copyright); Contents [volume 1].
`
`
`
`
`
`
`
`Selected Scans of Volume 1 of Nema (Ex. 1015)
`
`36. Attachment A-1 also contains scans of Volume 2 of Nema that includes:
`
`partial back cover with a barcode label that reads “National Library of Medicine” (shown
`
`below); spine of the book with a label that reads “2010 L-841 v.2; cover of volume 2
`
`(shown below); front flyleaf with ownership stamp that reads “Property of the
`
`
`
`17
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`National Library of Medicine” (shown below); title page of volume 2; verso of the
`
`title page (copyright); and Contents [volume 2].
`
`
`
`
`
`Selected Scans of Volume 2 of Nema (Ex. 1016)
`
`37. All identifying characteristics, such as stamps and notations, on
`
`Attachment A- 1 are consistent with library practice and procedure that I have
`
`observed during my career as a professional librarian, specifically with those items
`
`held by the National Library of Medicine (NLM). I have no cause for concern about
`
`the authenticity or accuracy of these identifying attributes. In addition, Nema was
`
`found within the collection of a library, the National Library of Medicine, one of the
`
`most likely locations for an authentic publication to be located.
`
`38. Attachment A-2 is a download of Nema from the ProQuest Ebook
`
`Central database. I completed this download through Purdue University Libraries
`
`on March 26, 2022, as an emeritus faculty member at Purdue at this URL:
`
`https://ebookcentral.proquest.com/lib/purdue/detail.action?pq-
`
`origsite=primo&docID=584343.
`
`
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`18
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`39.
`
`It is also available for a fee through ProQuest Ebook Central at this
`
`URL: https://www.taylorfrancis.com/books/edit/10.1201/b17733/pharmaceutical-
`
`dosage-forms-sandeep-nema-john-ludwig.
`
`40. After comparing Attachment A-1 and A-2, with the corresponding
`
`pages of Ex. 1015 and Ex. 1016, I found no difference between Attachment A-1 and
`
`Attachment A-2 with Ex. 1015 or Ex.1016.
`
`41. Therefore, upon finding Nema in the National Library of Medicine, and
`
`as a download provided through a research library, Purdue University, from the
`
`publisher database, ProQuest Ebook Central, I have determined that Ex. 1015 and
`
`Ex. 1016, Nema, are authentic documents.
`
`42.
`
`I conclude and affirm that Nema, Ex. 1015 and Ex. 1016 are authentic
`
`documents.
`
`2.
`
`Public Accessibility
`
`43. Attachment A-3 is a true and correct copy of the WorldCat entry for
`
`Nema. I obtained Attachment A-3 by completing a search on WorldCat on March
`
`27, 2022, by searching using Maryland (National Library of Medicine) as the
`
`geographical location. The National Library of Medicine was second on the list
`
`among the 67 libraries that held Nema worldwide.
`
`44. Attachment A-3 shows that Nema is the document associated with this
`
`WorldCat entry, as verified by authors: Sandeep Nema and John D. Ludwig; title:
`
`
`
`19
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`Pharmace