UNITED STATES PATENT AND TRADEMARK OFFICE
`
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`_____________
`
`
`
`DECLARATION OF JAMES L. MULLINS, Ph.D.
`
`
`Mail Stop PATENT BOARD
`Patent Trial and Appeal Board
`U.S. Patent & Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`
`
`
`Declaration of James L. Mullins, Ph.D.
`
`1
`
`
`
`ALVOGEN, Exh. 1055, p. 0001
`
`

`

`TABLE OF CONTENTS
`
`Page
`INTRODUCTION ............................................................................................ 3
`
`I.
`
`II. BACKGROUND AND QUALIFICATIONS .................................................. 3
`
`III. PRELIMINARIES ............................................................................................ 5
`
`A. Materials considered.............................................................................. 6
`
`B.
`
`C.
`
`D.
`
`E.
`
`F.
`
`Persons of ordinary skill in the art ........................................................ 7
`
`Library catalog records .......................................................................... 8
`
`Periodical publications ........................................................................10
`
`Ownership and date stamp ..................................................................10
`
`Indexing ...............................................................................................11
`
`IV. OPINION REGARDING INDIVIDUAL DOCUMENTS ............................13
`
`A.
`
`Palumbo, A., et al., “Low-dose thalidomide plus dexamethasone is
`an effective salvage therapy for advanced myeloma,”
`Haemtologica, Volume 86, Number 4 (April 2001): 399-403.
`(Palumbo) ............................................................................................13
`
`B. Muller, G.W., et al., “Amino-substituted thalidomide analogs:
`potent inhibitors of TNF-alpha production,” Bioorganic and
`Medicinal Chemistry Letters. Volume 9, Number 11 (June 7,
`1999): 1625-30. (Muller) .....................................................................16
`
`C.
`
`D.
`
`E.
`
`Hideshima, T., et al., “Thalidomide and its analogs overcome drug
`resistance of human multiple myleloma cells to conventional
`therapy,” Blood, Volume 96, Number 9 (November 1, 2000): 2943-
`50. (Hideshima) ...................................................................................20
`
`Corral, L.G., et al., “Differential cytokine modulation and T cell
`activation by two distinct classes of thalidomide analogues that are
`potent inhibitors of TNF-alpha,” Journal of Immunology, Volume
`163, Number 1, (July 1, 1999): 380-386. (Corral I) ............................23
`
`Corral, L., and Kaplan, G., “Immunomodulation by thalidomide
`and thalidomide analogues,” Annals of the Rheumatic Diseases,
`Volume 58, Supplement, Number 1 (November 1999): 107-113.
`(Corral II) ............................................................................................26
`
`V. CONCLUSION ..............................................................................................29
`
`Declaration of James L. Mullins, Ph.D.
`
`2
`
`
`
`ALVOGEN, Exh. 1055, p. 0002
`
`

`

`I, James L. Mullins, hereby declare under penalty of perjury:
`
`I.
`
`INTRODUCTION
`
`1.
`
`I have personal knowledge of the facts and opinions set forth in this
`
`declaration, I believe them to be true, and if called upon to do so, I would testify
`
`competently to them. I have been warned that willful false statements and the like
`
`are punishable by fine or imprisonment, or both.
`
`2.
`
`I am a retired academic librarian working as the Founder and Owner of
`
`the firm Prior Art Documentation Librarian Services, LLC at 106 Berrow,
`
`Williamsburg, VA 23188. Attached as Appendix A is a true and correct copy of my
`
`Curriculum Vitae describing my background and experience. Further information
`
`about my firm, Prior Art Documentation Librarian Services, LLC (PADLS), is
`
`available at www.priorartdoclib.com.
`
`3.
`
`I have been retained by Baker Botts LLP to investigate the authenticity
`
`and dates of public accessibility of certain documents for use in one or more inter
`
`partes review proceedings. For this service, I am being paid my usual hourly fee of
`
`$185/hour. My compensation in no way depends on the substance of my testimony
`
`or the outcome of the proceeding.
`
`II. BACKGROUND AND QUALIFICATIONS
`
`4.
`
`I am presently Dean of Libraries Emeritus and Esther Ellis Norton
`
`Professor Emeritus, Purdue University, 2018 – present. Other experience includes:
`
`Declaration of James L. Mullins, Ph.D.
`
`3
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`ALVOGEN, Exh. 1055, p. 0003
`
`

`

`•
`
`•
`
`•
`
`•
`
`•
`
`•
`
`Dean of Libraries and Professor & Esther Ellis Norton Professor,
`Purdue University, West Lafayette, IN, 2004-2017.
`
`Assistant/Associate Director for Administration, Massachusetts
`Institute of Technology (MIT), Cambridge, MA, 2000-2004.
`
`University Librarian and Director, Falvey Memorial Library,
`Villanova University, Villanova, PA, 1996-2000
`
`Director of Library Services, Indiana University South Bend,
`South Bend, IN, 1978-1996. Part-time instructor, School of Library
`and Information Science, Indiana University, Bloomington, IN,
`1978 -1996.
`
`Associate Law Librarian, and associated titles, Indiana University
`School of Law, Bloomington, IN, 1974-1978
`
`Catalog Librarian, Assistant Professor, Georgia Southern College
`(now University), Statesboro, GA, 1973-1974.
`
`5.
`
`Over the course of my career as a librarian, instructor of library science,
`
`author of scholarly publications, and presenter at national and international
`
`conferences, I have had experience with catalog records and online library
`
`management systems built around Machine-Readable Cataloging (MARC)
`
`standards.
`
`6.
`
`In the course of more than forty-four years as an academic librarian and
`
`scholar, I have been an active researcher. In my years as a librarian, I have facilitated
`
`the research of faculty colleagues either directly or through the provision of and
`
`access to the requisite print and/or digital materials and services at the universities
`
`where I worked. I have kept current on the professional library science literature and
`
`Declaration of James L. Mullins, Ph.D.
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`4
`
`ALVOGEN, Exh. 1055, p. 0004
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`

`

`served on the editorial board of the most prominent library journal, College and
`
`Research Libraries. This followed service as the chair of the Research Committee
`
`of the Association of College and Research Libraries (ACRL), a division of the
`
`American Library Association (ALA). As an academic library administrator, I have
`
`had responsibility to ensure that students were educated to identify, locate, assess and
`
`integrate information garnered from library resources.
`
`III. PRELIMINARIES
`
`7.
`
`I am not a lawyer, and I am not rendering an opinion on the legal
`
`question of whether a particular document is, or is not, a “printed publication” under
`
`the law.
`
`8.
`
`I am, however, rendering my expert opinion on the authenticity of the
`
`documents referenced herein and on when and how these documents were
`
`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 by November 6, 2001.
`
`9.
`
`I am informed by counsel that an item is considered authentic if there is
`
`sufficient evidence to support a finding that the item is what it is claimed to be. I am
`
`also informed that authenticity can be established based on the contents of the
`
`documents themselves, such as the appearance, content, substance, internal patterns,
`
`Declaration of James L. Mullins, Ph.D.
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`5
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`ALVOGEN, Exh. 1055, p. 0005
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`

`

`or other distinctive characteristics of the item, taken together with all of the
`
`circumstances.
`
`10.
`
`I am informed by counsel that a reference qualifies as a “printed
`
`publication” if it was sufficiently accessible to the public interested in the art. I am
`
`also informed that dissemination and public accessibility are the keys in determining
`
`whether a reference was “published.” I understand that a given reference is publicly
`
`accessible upon a satisfactory showing that such a document has been disseminated
`
`or otherwise made available to the extent that persons interested and ordinarily skilled
`
`in the subject matter or art exercising reasonable diligence can locate it. I have also
`
`been informed by counsel that materials available in a library constitute printed
`
`publications if they are cataloged and indexed according to general library practices
`
`that make the references available to members of the interested public, and that
`
`evidence relevant to this inquiry includes the acquisition, indexing, cataloging,
`
`shelving, and circulation practices of the library.
`
`A. Materials considered
`
`11.
`
`In forming the opinions expressed in this declaration I have reviewed
`
`the documents and appendices referenced herein. These materials were records
`
`created in the ordinary course of business by publishers, libraries, indexing services,
`
`and others. From my years of experience, I am familiar with the process for creating
`
`many of these records, and I know that these records are created by people with
`
`Declaration of James L. Mullins, Ph.D.
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`ALVOGEN, Exh. 1055, p. 0006
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`

`

`knowledge of the information in the record. Further, these records are created with
`
`the expectation that researchers and other members of the public will use them. All
`
`materials cited in this declaration and its appendices are of a type that experts in my
`
`field would reasonably rely upon and refer to in forming their opinions.
`
`B.
`
`Persons of ordinary skill in the art
`
`12.
`
`I am told by counsel that the subject matter of this proceeding relates to
`
`methods of treating multiple myeloma by administering lenalidomide and
`
`dexamethasone on a 28-day cycle that includes a seven-day rest period.
`
`13.
`
`I have been informed by counsel that a “person of ordinary skill in the
`
`art at the time of the invention” is a hypothetical person who is presumed to be
`
`familiar with the relevant field and its literature at the time of the invention. This
`
`hypothetical person is also a person of ordinary creativity, capable of understanding
`
`the scientific principles applicable to the pertinent field.
`
`14.
`
`I am told by counsel that a person of ordinary skill in this subject matter
`
`or art would have had several years of experience as a practicing physician in the
`
`fields of oncology and hematology. Such a person also would have had experience
`
`with the administration of therapeutic agents and the development of drug regimens
`
`and dosing schedules. Typically, such a person would have an M.D. as well as
`
`experience in clinical oncology or pharmacology.
`
`Declaration of James L. Mullins, Ph.D.
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`7
`
`ALVOGEN, Exh. 1055, p. 0007
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`

`

`15.
`
`In the early 2000s such a person would have had access to a vast array
`
`of print resources in methods of treating multiple myeloma, access to reference
`
`librarians (e.g., at universities), and access to a fast-changing set of online resources.
`
`C. Library catalog records
`
`16. Some background on MARC formatted records, OCLC, and WorldCat
`
`is helpful to understand the library catalog records discussed in this declaration.
`
`MARC practices have been consistent since the MARC format was developed by the
`
`Library of Congress in the 1960s and, by the early 1970s, became the U.S. national
`
`standard for disseminating bibliographic data. By the mid-1970s, MARC format
`
`became the international standard and persists through the present. The MARC
`
`practices discussed below were in place during the late 1990s and early 2000s
`
`timeframe relevant to the documents referenced herein.
`
`17. Libraries world-wide have used
`
`the machine-readable MARC
`
`(Machine-Readable Cataloging) format for catalog records. MARC formatted
`
`records have provided a variety of subject access points based on the content of the
`
`document being cataloged. Subject headings may be found in the MARC fields 6XX.
`
`For example, MARC Field 600 identifies personal names used as subjects and the
`
`MARC Field 650 identifies topical terms. A researcher might discover material
`
`relevant to his or her topic by a search using the terms employed in the MARC Fields
`
`6XX.
`
`Declaration of James L. Mullins, Ph.D.
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`ALVOGEN, Exh. 1055, p. 0008
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`

`

`18. The MARC Field 040, subfield “a,” identifies the library or other entity
`
`that created the original catalog record for a given document and transcribed it into
`
`machine readable form. The MARC Field 008 identifies the date when this first
`
`catalog record was entered on the file. This date persists in subsequent uses of the
`
`first catalog record, although newly-created records for the same document, separate
`
`from the original record will show a new date. It is not unusual to find multiple
`
`catalog records for the same document
`
`19. WorldCat is the world’s largest public online catalog, maintained by the
`
`Online Computer Library Center, Inc., or OCLC, and built with the records created
`
`by the thousands of libraries that are members of OCLC. OCLC has provided
`
`bibliographic and abstract information to the public based on MARC records, and
`
`WorldCat has provided a user-friendly interface for the materials maintained by
`
`OCLC. WorldCat requires no knowledge of MARC tags and codes and does not
`
`require a log-in or password. WorldCat is easily accessible through the World Wide
`
`Web to all who wish to search it; there are no restrictions to be a member of a
`
`particular community, etc. The date a given catalog record was created
`
`(corresponding to the MARC Field 008) appears in some detailed WorldCat records
`
`as the Date of Entry but not necessarily all. Although WorldCat is a more modern
`
`system, libraries had access to the OCLC database since the mid-1980s, and well
`
`before 1999.
`
`Declaration of James L. Mullins, Ph.D.
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`ALVOGEN, Exh. 1055, p. 0009
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`

`

`20. Once the MARC record is created by a cataloger at an OCLC
`
`participating member institution, it becomes available to other OCLC participating
`
`members through OCLC databases such as WorldCat, where persons interested and
`
`ordinarily skilled in the subject matter or art, exercising reasonable diligence, can
`
`locate it.
`
`D.
`
`Periodical publications
`
`21. A library typically creates a catalog record for a periodical publication
`
`when the library receives its first issue. When the institution receives subsequent
`
`issues/volumes of the periodical, the issues/volumes are 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.
`
`22. The initial periodicals record will sometimes not reflect all subsequent
`
`changes in publication details (including minor variations in title, frequency, etc.,).
`
`E. Ownership and date stamp
`
`23. Every library has a different practice or policy on whether-or-not to date
`
`stamp, but all will have an ownership stamp somewhere in the book. The ownership
`
`stamp typically appears on the cover page, verso of the cover page, or a designated
`
`page within the book, sometimes even on the top, side, or bottom edge of the
`
`monograph or periodical. The ownership and date stamp can also vary from one
`
`Declaration of James L. Mullins, Ph.D.
`
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`
`ALVOGEN, Exh. 1055, p. 0010
`
`

`

`library to another when the stamp is entered on the monograph or periodical. It could
`
`occur when received in acquisitions after shipment to the library, or it could be at
`
`time of cataloging.
`
`F.
`
`Indexing
`
`24. A researcher may discover material relevant to his or her topic in a
`
`variety of ways. One common means of discovery is to search for relevant
`
`information in an index of periodical and other publications. Having found relevant
`
`material, the researcher will then normally obtain it online, look for it in libraries, or
`
`purchase it from the publisher, a bookstore, a document delivery service, or other
`
`provider. Sometimes, the date of a document’s public accessibility will involve both
`
`indexing and library date information. Date information for indexing entries is,
`
`however, often unavailable. This is especially true for online indices.
`
`25.
`
`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.
`
`26. Online indexing services 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
`
`Declaration of James L. Mullins, Ph.D.
`
`11
`
`ALVOGEN, Exh. 1055, p. 0011
`
`

`

`the document was publicly available and in use by researchers no later than the
`
`publication date of the citing document.
`
`27. Medline – This is a database of bibliographic information from the
`
`National Library of Medicine. The database provides access to publications in the
`
`life sciences and to biomedical information from all areas of medicine and health
`
`care. More than 26 million records are included in the database. These have been
`
`indexed from some 5,639 publications issued from 1950 to the present. The database
`
`is freely available via the PubMed interface. One of the most heavily used medical
`
`databases, Medline had over 1.5 billion users in 2011.
`
`28. Web of Science – As its print predecessors, Science Citation Index,
`
`Social Science Citation Index and Arts and Humanities Citation Index, this database
`
`is the starting point for researchers and librarians because of the very thorough
`
`coverage. The database includes the content of the print index with 100 years of back
`
`files and extremely broad coverage, including over 250 subject categories. Web of
`
`Science indexes 1,700 arts and humanities journals from 1975 to the present, 8,500
`
`scientific journals from 1900 to the present, and some 300 social science journals also
`
`covering 1900 to the present. It is used by more than 6,000 scholarly institutions
`
`worldwide.
`
`29. Google Scholar – This web search engine indexes full text or metadata
`
`of scholarly literature, covering numerous formats and disciplines. The size of the
`
`Declaration of James L. Mullins, Ph.D.
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`ALVOGEN, Exh. 1055, p. 0012
`
`

`

`database is not published by Google, but researchers have estimated that it contained
`
`approximately 160 million items in 2014. (see Oduna-Malea, Enrique, Ayllon, Juan
`
`Manuel, Martin-Martin, Alberto, Delgado Lopez-Cozar, Emilio “About the size of
`
`Google Scholar: playing the numbers”, Sep. 2015, Scientometrics, 104(3), pp. 931-
`
`949, https://arxiv.org/ftp/arxiv/papers/1407/1407.6239.pdf. The database is not
`
`limited by type of publication and includes dissertations, prepublication materials,
`
`technical reports, patents and more. Google Scholar is similar to many subscription
`
`databases, e.g., Scopus and Web of Science, in its broad subject coverage.
`
`IV. OPINION REGARDING INDIVIDUAL DOCUMENTS
`
`A.
`Palumbo, A., et al., “Low-dose thalidomide plus dexamethasone is
`an effective salvage therapy for advanced myeloma,” Haemtologica, Volume
`86, Number 4 (April 2001): 399-403. (Palumbo)
`
`1.
`
`Authentication
`
`30.
`
`“Palumbo” refers to a research paper by A. Palumbo, et al., published in
`
`the journal Haemtologica, volume 86, number 4 (April 2001), pages 399-403. I
`
`requested a copy of the Palumbo paper from the Wisconsin Tech Services (WTS)
`
`which provided scans from a print copy held in the National Library of Medicine
`
`located in Bethesda, Maryland.
`
`31. Exhibit A1 is a true and accurate copy of the cover, title page, publisher
`
`information, table of contents and the Palumbo paper from the print issue of
`
`Haemtologica, volume 86, number 4 (April 2001). On the cover of the issue is the
`
`Declaration of James L. Mullins, Ph.D.
`
`13
`
`ALVOGEN, Exh. 1055, p. 0013
`
`

`

`ownership and date label (upper left-hand corner) of the National Library of
`
`Medicine, that shows a check-in date of 2001-05-22 (May 22, 2001).
`
`32. Exhibit A1 is a true and accurate copy of the Palumbo paper from the
`
`print copy owned by the National Library of Medicine. The copy of the Palumbo
`
`paper in Exhibit A1 is not missing any intermediate pages of the article’s text, the
`
`text on each page appears to flow seamlessly from one page to the next, and there are
`
`no visible alterations to the document. Exhibit A1 was found within the custody of
`
`a library – a place where, if authentic, it would likely be housed and available.
`
`33. The Palumbo paper is also readily available online. Exhibit A2 is a true
`
`and accurate copy of the Palumbo paper that I downloaded at the Haemtologica
`
`website at: http://www.haematologica.org/content/86/4/399.full.pdf+html on August
`
`17, 2018 – a place where, if authentic, the Palumbo paper would likely be found and
`
`made available. Based on my review, the text and figures of Exhibit A2 are the same
`
`as Exhibit A1. Exhibit A2 was filed as Exhibit 1015 in this proceeding.
`
`34.
`
`I conclude, based on finding the Palumbo paper in print, in both a library
`
`and online through a reputable, disciplinary database, that the Palumbo paper is an
`
`authentic document and that Exhibit A1 and Exhibit A2 (Exhibit 1015) are authentic
`
`copies of the Palumbo paper.
`
`Declaration of James L. Mullins, Ph.D.
`
`14
`
`ALVOGEN, Exh. 1055, p. 0014
`
`

`

`2.
`
`Public Accessibility
`
`35. Exhibit A3 is a true and accurate copy of the record in OCLC WorldCat
`
`for Haematologica. The OCLC WorldCat record indicates that Haematologica was
`
`cataloged as a periodical in 1920. WorldCat shows 81 libraries world-wide holding
`
`the journal Haematologica among those 81 is the National Library of Medicine.
`
`Exhibit A3 indicates that Haematologica was cataloged and indexed in a meaningful
`
`way—including by title and by subject, including Hematology -- Periodicals; Blood
`
`-- Diseases -- Periodicals; and Blood -- Periodicals.
`
`36. Exhibit A4 is the OPAC (online catalog) and MARC records for
`
`Haematologica from the National Library of Medicine (NLM). The NLM OPAC
`
`record indicates that the library has held this title in print from its start in 1920.
`
`Frequency changed in 1998 when the journal became monthly and has continued with
`
`that frequency.
`
`37. Allowing for a week at the most between the date stamp, May 22, 2001,
`
`and the issue’s availability on the shelf, it would have been available no later than the
`
`end of May 2001.
`
`38. Exhibit A5 is further evidence that the Palumbo paper was publicly
`
`available no later than November 1, 2001. The Palumbo paper is cited as number 24
`
`in References on page 587 of the article by Bernard Combe, entitled “Thalidomide:
`
`new indications?” published in Joint Bone Spine, volume 68 (2001), pages 582-587
`
`Declaration of James L. Mullins, Ph.D.
`
`15
`
`ALVOGEN, Exh. 1055, p. 0015
`
`

`

`in December 2001. Because it takes at least six months for a manuscript such as this
`
`to reach the publication stage, the Palumbo paper would have had to have been
`
`publicly available by no later than November 1, 2001.
`
`3.
`
`Conclusion
`
`39. Based on the evidence presented here—publication in a widely held
`
`journal, online indexing and publication, and library processing—it is my opinion
`
`that the Palumbo paper (attached as Exhibit A1 and Exhibit A2 (Exhibit 1015)) is an
`
`authentic document. It is also my opinion that the Palumbo paper was publicly
`
`available to researchers no later than the end of May 2001. Thus, in my opinion, the
`
`Palumbo paper was sufficiently accessible to the public interested in the art, such that
`
`an ordinarily skilled researcher, exercising reasonable diligence, would have had no
`
`difficulty finding copies of the Palumbo paper in the journal Haematologica no later
`
`than the end of May 2001.
`
`B. Muller, G.W., et al., “Amino-substituted thalidomide analogs:
`potent inhibitors of TNF-alpha production,” Bioorganic and Medicinal
`Chemistry Letters. Volume 9, Number 11 (June 7, 1999): 1625-30. (Muller)
`
`1.
`
`Authentication
`
`40.
`
`“Muller” refers to a research paper by G.W. Muller, et. al., published in
`
`the journal Bioorganic and Medicinal Chemistry Letters, volume 9, number 11 (June
`
`7, 1999), pages 1625-30. I requested a copy of the Muller paper from the Wisconsin
`
`Declaration of James L. Mullins, Ph.D.
`
`16
`
`ALVOGEN, Exh. 1055, p. 0016
`
`

`

`Tech Services (WTS) which provided scans from a print copy held in the Linda Hall
`
`Library located in Kansas City, Missouri.
`
`41. Exhibit B1 is a true and accurate copy of the cover, title page, publisher
`
`information, title page, table of contents and the Muller paper from the print issue of
`
`Bioorganic and Medicinal Chemistry Letters, volume 9, number 11 (June 7, 1999),
`
`pages 1625-30. On the cover of the issue and the title page is the ownership and date
`
`stamp of the Linda Hall Library that shows a check-in date of June 16, 1999.
`
`42. Exhibit B1 is a true and accurate copy of the Muller paper from the print
`
`copy owned by the Linda Hall Library. The copy of the Muller paper in Exhibit B1
`
`is not missing any intermediate pages of the article’s text, the text on each page
`
`appears to flow seamlessly from one page to the next, and there are no visible
`
`alterations to the document. Exhibit B1 was found within the custody of a library –
`
`a place where, if authentic, it would likely be housed and available.
`
`43. The Muller paper is also readily available online. Exhibit B2 is a true
`
`and accurate copy of the Muller paper that I downloaded through the Science Direct
`
`database accessed by Purdue University Libraries: https://ac-els-cdn-com.ezproxy.
`
`lib.purdue.edu/S0960894X99002504/1-s2.0-S0960894X99002504-main.pdf?tid=f4
`
`32a813-e295-45c0-a0ac-caaf804e3d88&acdnat=15345289500a27ce19bb05b9d5f04
`
`970e260d102a7 on August 17, 2018 – a place where, if authentic, the Muller paper
`
`would likely be found and made available. Based on my review, the text and figures
`
`Declaration of James L. Mullins, Ph.D.
`
`17
`
`ALVOGEN, Exh. 1055, p. 0017
`
`

`

`of Exhibit B2 are the same as Exhibit B1. Exhibit B2 was filed as Exhibit 1008 in
`
`this proceeding.
`
`44.
`
`I conclude, based on finding the Muller paper in print, in both a library
`
`and online through a reputable, disciplinary database, that the Muller paper is an
`
`authentic document and that Exhibit B1 and Exhibit B2 (Exhibit 1008) are authentic
`
`copies of the Muller paper.
`
`2.
`
`Public Accessibility
`
`45. Exhibit B3 is a true and accurate copy of the record in OCLC WorldCat
`
`for Bioorganic and Medicinal Chemistry Letters. The OCLC WorldCat record
`
`indicates that Bioorganic and Medicinal Chemistry Letters was cataloged as a
`
`periodical in 1991. WorldCat shows 779 libraries world-wide holding the journal
`
`Bioorganic and Medicinal Chemistry Letters. Exhibit B3 indicates that Bioorganic
`
`and Medicinal Chemistry Letters was cataloged and indexed in a meaningful way—
`
`including by title and by subject, including Bioorganic chemistry -- Periodicals;
`
`Pharmacological chemistry -- Periodicals; Biochemistry -- Periodicals.
`
`46. Exhibit B4 is the OPAC (online catalog) and MARC records for
`
`Bioorganic and Medicinal Chemistry Letters from the Linda Hall Library. The Linda
`
`Hall Library OPAC record indicates that the library has held this title in print from
`
`its start in 1991, received as a monthly issue.
`
`Declaration of James L. Mullins, Ph.D.
`
`18
`
`ALVOGEN, Exh. 1055, p. 0018
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`

`

`47. Allowing for a week at the most between the date stamp, June 16, 1999,
`
`and the issue’s availability on the shelf, it would have been available no later than the
`
`end of June 1999.
`
`48. Exhibit B5 is further evidence that the Muller paper was publicly
`
`available in 1999. The Muller paper is cited as number 40 in References on page
`
`1112 of the article by Laura C. Corral and Gilla Kaplan, entitled “Immunomodulation
`
`by Thalidomide and Thalidomide Analogues?” published in Annals of Rheumatic
`
`Diseases, 1999:58 (Suppl), pages 1107-1113, received by the National Library of
`
`Medicine in December 1999, as discussed in Exhibit E1 below.
`
`3.
`
`Conclusion
`
`49. Based on the evidence presented here—publication in a widely held
`
`journal, online indexing and publication, and library processing—it is my opinion
`
`that the Muller paper (attached as Exhibit B1 and Exhibit B2 (Exhibit 1008)) is an
`
`authentic document. It is also my opinion that the Muller paper was publicly
`
`available to researchers at least by the end of June 1999. Thus, in my opinion, the
`
`Muller paper was sufficiently accessible to the public interested in the art, such that
`
`an ordinarily skilled researcher, exercising reasonable diligence, would have had no
`
`difficulty finding copies of the Muller article in the journal Bioorganic and Medicinal
`
`Chemistry Letters no later than the end of June 1999.
`
`Declaration of James L. Mullins, Ph.D.
`
`19
`
`ALVOGEN, Exh. 1055, p. 0019
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`

`

`C. Hideshima, T., et al., “Thalidomide and its analogs overcome drug
`resistance of human multiple myleloma cells to conventional therapy,” Blood,
`Volume 96, Number 9 (November 1, 2000): 2943-50. (Hideshima)
`
`1.
`
`Authentication
`
`50.
`
`“Hideshima” refers to a research paper by T. Hidshima, et al.,
`
`“Thalidomide and its Analogs Overcome Drug Resistance of Human Multiple
`
`Myleloma Cells to Conventional Therapy” in Blood, volume 96, number 9
`
`(November 1, 2000), pages 2943-2950. I requested a copy of the Hideshima paper
`
`from the Wisconsin Tech Services (WTS) which provided scans from a print copy
`
`held in the National Library of Medicine located in Bethesda, Maryland.
`
`51. Exhibit C1 is a true and accurate copy of the cover, title page, table of
`
`contents and the Hideshima paper from the print issue of the journal Blood, volume
`
`96, number 9 (November 1, 2000), pages 2943-2950. On the cover of the issue is the
`
`ownership label of the National Library of Medicine that shows that this issue of
`
`Blood was received and checked-in November 9, 2000.
`
`52. Exhibit C1 is a true and accurate copy of the Hideshima paper from the
`
`print copy owned by the National Library of Medicine. The copy of the Hideshima
`
`paper in Exhibit C1 is not missing any intermediate pages of the article’s text, the
`
`text on each page appears to flow seamlessly from one page to the next, and there are
`
`no visible alterations to the document. Exhibit C1 was found within the custody of a
`
`library – a place where, if authentic, it would likely be housed and available.
`
`Declaration of James L. Mullins, Ph.D.
`
`20
`
`ALVOGEN, Exh. 1055, p. 0020
`
`

`

`53. The Hideshima is also readily available online. Exhibit C2 is a true and
`
`accurate copy of the Hideshima paper that I downloaded through the journal Blood
`
`website: http://www.bloodjournal.org/content/bloodjournal/96/9/2943.full.pdf on
`
`August 28, 2018 – a place where, if authentic, the Hideshima paper would likely be
`
`found and made available. Based on my review, the text and figures of Exhibit C2
`
`are the same as Exhibit C1. Exhibit C2 was filed as Exhibit 1016 in this proceeding.
`
`54.
`
`I conclude, based on finding the Hideshima paper in print, in both a
`
`library and online through a reputable, disciplinary database, that the Hideshima
`
`paper is an authentic document and that Exhibit C1 and Exhibit C2 (Exhibit 1016)
`
`are authentic copies of the Hideshima paper.
`
`2.
`
`Public Accessibility
`
`55. Exhibit C3 is a true and accurate copy of the record in OCLC WorldCat
`
`for the journal Blood. The OCLC WorldCat record indicates that the journal Blood
`
`is held in 838 libraries world-wide including the National Library of Medicine.
`
`Exhibit C3 indicates that the journal Blood was cataloged and indexed in a
`
`meaningful way—including by title and by subject, including: Blood -- Periodicals;
`
`Hematology -- Periodicals; and Blood.
`
`56. Exhibit C4 is the OPAC (online catalog) and Exhibit C5 is the MARC
`
`records for the journal Blood from the National Library of Medicine. The National
`
`Library of Medicine OPAC record indicates that the library has held this title in print
`
`Declaration of James L. Mullins, Ph.D.
`
`21
`
`ALVOGEN, Exh. 1055, p. 0021
`
`

`

`from its start in 1946. Exhibits C4 and C5 indicate that the National Library of
`
`Medicine holds volume 96 in the section title