IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`HOPEWELL PHARMA VENTURES, INC.,
`Petitioner,
`
`V.
`
`MERCK SERONOS.A.,
`Patent Owner.
`
`Case IPR2023-00481
`U.S. Patent No. 8,377,903
`
`DECLARATION OF NANCYE. ADAMS Ed.D.
`IN SUPPORT OF PETITION FOR INTER PARTES REVIEW OFU.S.
`PATENTNO.8,377,903
`
`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`Hopewell EX1040
`
`Hopewell EX1040
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`HOPEWELL PHARMA VENTURES, INC.,
`Petitioner,
`
`V.
`
`MERCK SERONOS.A.,
`Patent Owner.
`
`Case IPR2023-00481
`U.S. Patent No. 8,377,903
`
`DECLARATION OF NANCYE. ADAMS Ed.D.
`IN SUPPORT OF PETITION FOR INTER PARTES REVIEW OFU.S.
`PATENTNO.8,377,903
`
`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`Hopewell EX1040
`
`Hopewell EX1040
`
`
`
`Inter Partes Review of U.S. Patent No. 8,377,903
`Declaration ofNancy E. Adams Ed.D.
`TABLE OF CONTENTS
`
`IMtrOdUCtION........csceseessssssesesesesessesssnssescevesesesuenesesuesssessssuescacaceveseneaesveneseaeevees 2
`
`A.
`
`Qualifications and Professional Experience .............:.scs:ssseceseseeeeeeneeeees 2
`
`B.—Scope of This Declaration .....c.cccccccccsssssessscscessssscsssscscseescsesseessceeseseseces 4
`
`C.
`
`Evidence Considered in Forming My Opinions............:sessesssseeseeeeees 5
`
`Il.
`
`Authenticity and Public Availability of Stelmasiak (EX1013)....sssseeeee 5
`
`A.—Authentication... .cceccccccssssssesssseseecevesesssessessscscsssescscacscacacascseacseseecseass 5
`
`Bi.* LYRB6 ROCreas cccssnccecanccanscaneseizaparivandssciansinsiinansnnsansdndaranstcmnisniniandiccssie 6
`
`C.
`
`Summary of My Opinion on Stelmasiak ..cccccccccccccccsecsescssssescssesveesscsees 7
`
`II.
`
`DAS OEascene eedeononemensaneasiosaavamunadaniamseasonstin 7
`
`ES ONNG LISLOI se sicaxxaxsean crear enaanmenmnennasanay sSuucavaewwineael san ret encenmnrnamnennrnenmasiiocennantanee 8
`
`
`
`Inter Partes Review ofU.S. Patent No. 8,377,903
`Declaration ofNancy E. Adams Ed.D.
`
`I
`
`INTRODUCTION
`
`I, Nancy E. Adams Ed.D., do hereby declareas follows:
`
`1.
`
`[have been retained as an independent expert witness on behalf of
`
`Hopewell Pharma Ventures, Inc. for proceedings before the United States Patent
`
`and Trademark Office (“PTO”) regarding the authenticity and public availability of
`
`certain prior-art references in relation to US Patent No. 8,377,903.
`
`2.
`
`[am being compensated for my work in this matter at my customary
`
`hourly rate, which is $250/hour.I amalso reimbursed for any reasonable expenses
`
`associated with my workon this matter. My compensation is not contingent on the
`
`results of my study, the substance of my opinions, or the outcome of this matter.
`
`3.
`
`I understand thatthis Declaration accompanies a petition for anInter
`
`Partes Review (IPR) involving U.S. Patent No. 8,377,903 (“the °903 patent”)
`
`(EX1001), which resulted from U.S. Patent Application No. 12/766,173 (“the ?173
`
`application”), filed on April 23, 2010. I understand that the ’903 patentalleges a
`
`priority date of December 22, 2004. J refer to this date throughoutthis declaration.
`
`A.
`
`4.
`
`Qualifications and Professional Experience
`
`My complete qualifications and professional experience are described
`
`in my curriculum vitae (EX1030). The following is a brief summary of my
`
`relevant qualifications and professional experience.
`
`
`
`Inter Partes Review of U.S. Patent No. 8,377,903
`Declaration ofNancy E. Adams Ed.D.
`[am the Assistant Dean ofFoundational Sciences at Penn State College
`
`5.
`
`of Medicine and Librarian for Education and Instruction at Harrell Health Sciences
`
`Library. I have held this combined position since July of 2017; before that, I held
`
`the position Associate Director of the Harrell Health Sciences Library, which began
`
`2010. Before that, I held numerousLibrarian positionsat the University level, such
`
`as Harrisburg University of Science and Technology, The University of Maine, and
`
`Wayne State University.
`
`I have accumulated a total of 26 years of experience
`
`working in an academic library and medical
`
`library. I hold an Ed.D.
`
`in Adult
`
`Education from Pennsylvania State University and a Masters in Library and
`
`Information Science from WayneState University.
`
`6.
`
`I am an expert on library cataloging, classification, and searching. I
`
`have published contributed chapters to editions on this subject, Curriculum
`
`Mapping: A Match Made for Librarian Skill, and Making it better: library and
`
`student services collaboration at a new university (2020 and 2012).
`
`I have taught
`
`workshopsonliterature searching to a myriad ofcollege students, physicians, and
`
`medical students for decades.
`
`I have given presentations, such as “Searching
`
`PubMedlike an Expert: The Evolution, a PubMed Searching Discussion Forum.”I
`
`have served asthe search specialist on a systematic review team in which myrole
`
`was to formulate, execute, and document an exhaustive search ofthe literature
`
`answering a specific research question.
`
`
`
`Inter Partes Review of U.S. Patent No. 8,377,903
`Declaration ofNancy E. Adams Ed.D.
`Tam familiar with metadata schema design and implementation. As a
`
`7.
`
`librarian, I routinely use the metadata associated with publications to answer
`
`reference questions or track down itemsthat researchers need. I have used online
`
`cataloging systems to create new catalog records for items heldbylibraries.
`
`8.
`
`I am personally familiar with many online catalogs, databases, and
`
`search engines,including all of the particular catalogs, databases, and search
`
`enginesthatI relied upon in forming myopinions. In preparing for this
`
`Declaration,I used the following authoritative information system to search for
`
`records:
`
`e Google Scholar (http://scholar.google.com)
`
`B.
`
`9.
`
`Scope of This Declaration
`
`I have been asked to offer an opinion onthe authenticity and public-
`
`availability date of the following document:
`
`e Stelmasiak, Z., Solski, J., Nowicki, J., Porebska-Piwowarcyzk,E.,
`
`Jakubowksa, B., Ryba, M., and Grieb,P., (1998, Jan 1), “A pilottrial
`
`of cladribine (2-chlorodeoxyadenosine) in remitting-relapsing
`
`multiple sclerosis,” Medical Science Monitor, vol. 4, no. 1, pp. 4-8
`
`(EX1013, “Stelmasiak”).
`
`
`
`Inter Partes Review of U.S. Patent No. 8,377,903
`Declaration ofNaney E. Adams Ed.D.
`Evidence Considered in Forming My Opinions
`
`C.
`
`10.
`
`In preparing this Declaration, I have reviewed the documents|
`
`reference herein, and each of theseis a type of material that experts in my field of
`
`library cataloging and reference classification would reasonably rely upon when
`
`forming their opinions.
`
`I.
`
`AUTHENTICITY AND PUBLIC AVAILABILITY OF STELMASIAK
`(EX1013)
`
`A.
`
`Authentication
`
`ll.
`
`EX1013is a true and correct copy of “A pilottrial of cladribine(2-
`
`chlorodeoxyadenosine) in remitting-relapsing multiple sclerosis,”
`
`(“Stelmasiak”), Medical Science Monitor, vol. 4, no. 1, pp. 4-8, that I obtained
`
`from the publisher of the journal. I began my research by searching Google
`
`Scholarbythetitle ofStelmasiak for records, and a retrieved record led meto the
`
`publisher’s webpage for Stelmasiak at
`
`https://medscimonit.com/abstract/index/idArt/502798 (EX) that showsthe
`
`publisher provides “open access” to Stelmasiak, meaning there is norestriction on
`
`user access. I then followed the PDF link to download thefull text of Ste/masiak.
`
`This publisher copy is presented as EX1013 in this Declaration.
`
`12.
`
`In EX1013, page | showsthetitle, authors, abstract, key words, and a
`
`note at the bottom of page | title showing Stelmasiak was received “97.08.30”
`
`
`
`Inter Partes Review of U.S. Patent No. 8,377,903
`Declaration ofNancy E. Adams Ed.D.
`(1997, August 30), and accepted “98.01.03” (1998, January 3). EX1013 shows
`
`Stelmasiak has a total of 5pages,including 21 references.
`
`13.
`
`The publisher’s copy ofStelmasiak (EX1013) is in a condition that
`
`does not create suspicion aboutits authenticity. Specifically, this copyis not
`
`missing any intermediate pages, the text on each page appears to flow seamlessly
`
`from one page to thenext, and there are no visible alterations to the document.
`
`Moreover, EX1013 is in the custody ofthe publisher, a place where,ifauthentic,it
`
`wouldlikely be found. Accordingly, I see no reason to question the authenticity of
`
`this copy of Stelmasiak (EX1013).
`
`B.
`
`Usage Record
`
`14. Actual usage of an article is reflected by other articles thatmake
`
`reference to it. Langtry, H.D., and Lamb, H.M.., “Cladribine, A Review of its Use
`
`in Multiple Sclerosis,” Biodrugs 9(5):419-433,vol. 9, no. 5, pp. 419-433 “Langtry”
`
`(EX1016) cites Stelmasiak, which showsthat as of Langtry’s publication date,
`
`Stelmasiak would have been publically available, which was before December 22,
`
`2004. Stelmasiak wascited in the ’173 application specification when it was
`
`originally filed (EX1004, page 28, lines 13-14). I understand that the ’173
`
`application later issued as the °903 patent, whichalso cites Stelmasiak (EX1001,
`
`col. 3, lines 20-21).
`
`
`
`Inter Partes Review of U.S. Patent No. 8,377,903
`Declaration ofNancy E. Adams Ed.D.
`Summary of My Opinion on Stelmasiak
`
`C.
`
`15.
`
`The publisher’s copy of Stel/masiak (EX1013) and my knowledge of
`
`digital archives in particular inform my opinion that Ste/masiak was published on
`
`January 3, 1998. Because Medical Science Monitor has been available as a journal,
`
`Stelmasiak would have becomepublicly accessible when it was published on
`
`January 3, 1998 (EX1013), before December 22, 2004.
`
`Il. LISTOF DOCUMENTS CONSIDERED
`
`
`
`
`
`
`
`
`
`
`Description
`De Luca, G., “Cladribine Regimen for Treating Multiple
`Sclerosis,” U.S. Patent No. 8,377,903 B2 (filed Apr. 23, 2010;
`issued Feb. 19, 2013)|
`
` 1004 File History for U.S. Patent No. 8,377,903, pages 25-49
`
`
`
`1013
`Stelmasiak,Z., et al., “A pilot trial of cladribine (2-
`
`
` chlorodeoxyadenosine)in remitting-relapsing multiple sclerosis,”
`
`MedSci Monit 4(1):4-8 (1998
`
`
`
`
`
`Langtry, H.D. and Lamb, H.M., “Cladribine, A Review ofits Use
`
`in Multiple Sclerosis” BioDrugs 9(5):419-433 (1998
`
`
`Curriculum Vitae of Nancy E. Adams, Ed.D.
`
`Stelmasiak, Z., et al., “A pilot trial of cladribine (2-
`
`chlorodeoxyadenosine) in remitting-relapsing multiple sclerosis,”
`
`MedSci Monit 4(1):4-8 (1998), available
`
`athttps://medscimonit.com/abstract/index/idArt/502798
`
`
`
`
`
`
`1039
`
`
`
`
`
`
`
`IV. CONCLUSION
`
`Inter Partes Review of U.S. Patent No. 8,377,903
`Declaration ofNancy E. Adams Ed.D.
`
`16.
`
`1 declare that all statements made herein of my own knowledgeare
`
`true and that all statements made on information and belief are believed to betrue;
`
`and further, that these statements were made with the knowledgethat willful false
`
`statements and the like so madeare punishable by fine or imprisonment, or both,
`
`under Section 1001 of Title 18 of United States Code.
`
`Respectfully submitted,
`
`Nancy E. Adanis, Ed.D.
`
`Date: Va2/e3
`
`
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