IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`HOPEWELL PHARMA VENTURES,INC.,
`Petitioner,
`
`Vv.
`
`MERCK SERONOS.A.,
`Patent Owner.
`
`Case IPR2023-00480
`U.S. Patent No. 7,713,947
`
`DECLARATION OF NANCYE. ADAMSEd.D.
`IN SUPPORT OF PETITION FOR INTER PARTES REVIEW OFU.S.
`PATENTNO.7,713,947
`
`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,
`
`Vv.
`
`MERCK SERONOS.A.,
`Patent Owner.
`
`Case IPR2023-00480
`U.S. Patent No. 7,713,947
`
`DECLARATION OF NANCYE. ADAMSEd.D.
`IN SUPPORT OF PETITION FOR INTER PARTES REVIEW OFU.S.
`PATENTNO.7,713,947
`
`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. 7,713,947
`Declaration ofNancy E. Adams Ed.D.
`TABLE OF CONTENTS
`
`Introdtiction siscaissassancssvicsnsiannnceorseesacenvessecenssuseveeoesnemenearensnenannangnenilesaitnnne seb eve) 2
`
`A.
`
`B.
`
`C.
`
`Qualifications and Professional Experience ...........::::scecceeeeeseeetrerreenes 2
`
`Scope of This Declaration ...........cccssseseeseeteeseeneeneneeeseeeenessnensecsaesnanes 4
`
`Evidence Considered in Forming My Opinions...........:.::sssseeeeereeeeees 5
`
`Il.
`
`Authenticity and Public Availability of Stelmasiak (EX1013)......:sseeesee 5
`
`A.
`
` AUthentication...............srcorscceesenrennsnnessersnensensensiasnannanpacnteenesasteneens a
`
`B.. Usame Rewordd ssssccssccscssciaisssssasionseepgeenncccesnsuncsssovsee prone smmenececmennnemens 6
`
`C.
`
`Summary of My Opinion on Stelmasiak (EX1013) .....:csecceeeeseeeeeerens 7
`
`Listof Documents Considered ....::1ssccss<csosurersmneoranananennvsnamseverenssaseeess 7
`
`COREBOT one ccicinmensnsnennenensn nescnmeeen ie monieenoomnrm mERoRSTap nen Mr meRN Ree nce ie 8
`
`Ii.
`
`IV.
`
`
`
`Inter Partes Review of U.S. Patent No. 7,713,947
`Declaration ofNancy E. Adams Ed.D.
`
`1.
`
`INTRODUCTION
`
`I, Nancy E. Adams Ed.D., do hereby declare as follows:
`
`1.
`
`[have beenretained as an independentexpert 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 U.S. Patent No. 7,713,947.
`
`Z.
`
`I am being compensated for my work in this matter at my customary
`
`hourly rate, which is $250/hour. I am also reimbursed for any reasonable expenses
`
`associated with my work on this matter. My compensation is not contingent onthe
`
`results of my study, the substance of myopinions, or the outcomeofthis matter.
`
`Bs
`
`I understand that this Declaration accompaniesa petition for an Inter
`
`Partes Review (IPR) involving U.S. Patent No. 7,713,947 (“the °947 patent”)
`
`(EX1001), which resulted from U.S. Patent Application No. 11/722,018 (“the ’018
`
`application”), filed on June 18, 2007. I understand that the ’947 patent alleges a
`
`priority date of December 22, 2004.I refer to this date throughout this declaration.
`
`A.
`
`Qualifications and Professional Experience
`
`4.|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. 7,713,947
`Declaration ofNancy E. Adams Ed.D.
`I am the Assistant Dean of Foundational Sciences at Penn State College
`
`s
`
`of Medicine and Librarian for Education andInstruction 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 positions at the University level, such
`
`as Harrisburg University of Science and Technology, The University of Maine, and
`
`WayneState 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 of college 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 as the search specialist on a systematic review team in which myrole
`
`was to formulate, execute, and document an exhaustive search of the literature
`
`answering a specific research question.
`
`
`
`Inter Partes Review of U.S. Patent No. 7,713,947
`Declaration ofNancy E. Adams Ed.D.
`I am familiar with metadata schema design and implementation. As a
`
`t
`
`librarian, I routinely use the metadata associated with publications to answer
`
`reference questionsor track downitemsthat researchers need. I have used online
`
`cataloging systemsto create new catalog recordsfor items held by libraries.
`
`8.
`
`I am personally familiar with manyonlinecatalogs, databases, and
`
`search engines,includingall of the particular catalogs, databases, and search
`
`engines that I relied upon in forming myopinions.In preparingforthis
`
`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 askedto offer an opinion on the 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, “Ste/masiak’).
`
`
`
`Inter Partes Review of U.S. Patent No. 7,713,947
`Declaration ofNancy E. Adams Ed.D.
`Evidence Considered in Forming My Opinions
`
`C.
`
`10.
`
`In preparing this Declaration, I have reviewed the documents|
`
`referenceherein, and eachoftheseis a type of material that experts in myfield of
`
`library cataloging and referenceclassification would reasonably rely upon when
`
`forming their opinions.
`
`Il.
`
`AUTHENTICITY AND PUBLIC AVAILABILITY OF STELMASIAK
`(EX1013)
`
`A.
`
`Authentication
`
`11.
`
`EX1013 is 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 publisherof the journal. I began my research by searching Google
`
`Scholar bythetitle of Stelmasiak for records, and a retrieved record led meto the
`
`publisher’s webpage for Ste/masiakat
`
`https://medscimonit.com/abstract/index/idArt/502798 (EX1039) that shows the
`
`publisher provides “open access” to Stelmasiak, meaning there is norestriction on
`
`user access. I then followed the PDF link to downloadthe full text of Stelmasiak.
`
`This publisher copy is presented as EX1013 in this Declaration.
`
`12.
`
`In EX1013, page 1 showsthetitle, authors, abstract, key words, and a
`
`note at the bottom of page|title showing Ste/masiak was received “97.08.30”
`
`
`
`Inter Partes Review of U.S. Patent No. 7,713,947
`Declaration ofNancy E. Adams Ed.D.
`(1997, August 30), and accepted “98.01.03”(1998, January 3). EX1013 shows
`
`Stelmasiak hasa total of 5 pages, including 21 references.
`
`13.
`
`The publisher’s copy of Stelmasiak (EX1013)is in a condition that
`
`does not create suspicion aboutits authenticity. Specifically, this copy is not
`
`missing any intermediate pages, the text on each page appears to flow seamlessly
`
`from one pageto the next, and there are novisible alterations to the document.
`
`Moreover, EX1013 is in the custody of the publisher, a place where, if authentic,it
`
`would likely be found. Accordingly, I see no reason to question the authenticity of
`
`this copy of Stelmasiak (EX1013).
`
`B.
`
`Usage Record
`
`14. Actual usage ofan article is reflected by otherarticles that make
`
`referenceto 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 December22,
`
`2004. Stelmasiak wascited in the ’018 application specification when it was
`
`originally filed (EX1004, page 170, lines 22-23). I understand that the ’018
`
`application later issued as the ’947 patent, which also cites Stelmasiak (EX1001,
`
`col. 3, lines 20-21).
`
`
`
`Inter Partes Review of U.S. Patent No. 7,713,947
`Declaration ofNancy E. Adams Ed.D.
`Summary of My Opinion on Stelmasiak (EX1013)
`
`C.
`
`15.
`
`The publisher’s copy of Ste/masiak (EX1013) and my knowledge of
`
`digital archives in particular inform my opinion that Stelmasiak 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.
`
`Hil. LIST OF DOCUMENTS CONSIDERED
`
`
`
`
`
`
` 1001
`DeLuca,G., “Cladribine Regimen for Treating Multiple
`
`
`Sclerosis,” U.S. Patent No. 7,713,947 B2 (filed June 18, 2007;
`issued May
`11, 2010)
`
`
`
`
`File History
`for U.S. Patent No. 7,713,947,pages 167-194
`
`
`
`Stelmasiak, Z., et al., “A pilot trial of cladribine (2-
`1013
`
`
`
`chlorodeoxyadenosine) in remitting-relapsing multiple sclerosis,”
`
`
`
`MedSci Monit 4(1):4-8 (1998
`
`Langtry, H.D. and Lamb, H.M., “Cladribine, A Review of its Use
`
`
`in Multiple Sclerosis” BioDrugs 9(5):419-433 (1998
`1039
`Stelmasiak,Z., et al., “A silat trial of sladvibine (2-
`
`chiorodaoxyadenssine) in remitting-relapsing multiple sclerosis,”
`
`MedSci Monit 4(1):4-8 (1998), available
`
`athttps://medscimonit.com/abstract/index/idArt/502798
`
`
`
`
`
`
`
`
`
`
`
`
`Declaration ofNancy E. Adams Ed.D.
`
`Iv. CONCLUSION
`
`16.
`
`I declare that all statements made herein of my own knowledgeare
`
`true andthatall statements made on information andbelief are believed to be true;
`
`and further, that these statements were madewith the knowledge that willful false
`
`statements and thelike so made are punishable byfine or imprisonment, or both,
`
`under Section 1001 of Title 18 of United States Code.
`
`Respectfully submitted,
`
`—arty C (Moroes
`
`Nancy E. Adanis, Ed.D.
`
`Date: Vary a3
`
`
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