Paper No. __
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`Filed: November 24, 2015
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`
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`___________________
`
`
`NEPTUNE GENERICS, LLC
`
`PETITIONER
`
`V.
`
`ELI LILLY & COMPANY
`
`PATENT OWNER
`
`___________________
`
`CASE NO.: UNASSIGNED
`PATENT NO. 7,772,209
`FILED: JULY 11, 2007
`ISSUED: AUGUST 10, 2010
`INVENTOR: CLET NIYIKIZA
`
`TITLE: ANTIFOLATE COMBINATION THERAPIES
`___________________
`
`DECLARATION OF SCOTT BENNETT, Ph.D.
`
`Teva – Fresenius
`Exhibit 1029-00001
`
`
`
`Filed: November 24, 2015
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`___________________
`
`
`NEPTUNE GENERICS, LLC
`
`PETITIONER
`
`V.
`
`ELI LILLY & COMPANY
`
`PATENT OWNER
`
`___________________
`
`CASE NO.: UNASSIGNED
`PATENT NO. 7,772,209
`FILED: JULY 11, 2007
`ISSUED: AUGUST 10, 2010
`INVENTOR: CLET NIYIKIZA
`
`TITLE: ANTIFOLATE COMBINATION THERAPIES
`___________________
`
`DECLARATION OF SCOTT BENNETT, Ph.D.
`
`Teva – Fresenius
`Exhibit 1029-00001
`
`
`
`I, Scott Bennett, hereby declare as follows:
`
`I.
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`PROFESSIONAL BACKGROUND AND QUALIFICATIONS
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`1.
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`I make this declaration based on my personal knowledge,
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`consideration of the materials I discuss herein, and my expert opinions.
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`2.
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`I am a retired academic librarian working as a Managing Partner in
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`Prior Art Documentation Services LLP, at 711 South Race Street, Urbana, IL,
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`61801-4132. I have over 27 years of research librarian experience.
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`3.
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`From 1974-1981, I was employed as an Instructor, Assistant, and
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`Associate Professor of Library Administration at the University of Illinois at
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`Urbana-Champaign, Urbana, IL.
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`4.
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`From 1981-1989, I was employed as the Assistant University
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`Librarian for Collection Management at Northwestern University, Evanston, IL.
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`5.
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`From 1989-1994, I was employed as the Director of the Milton S.
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`Eisenhower Library at the Johns Hopkins University, Baltimore, MD.
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`6.
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`From 1994-2001, I was employed as the University Librarian at Yale
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`University, New Haven, CT.
`
`7.
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`I received an A.B. in English from Oberlin College (1960), a Ph.D. in
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`English from Indiana University (1967), and an M.A. in Library Science from the
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`University of Illinois (1976)
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`
`
`1
`
`Teva – Fresenius
`Exhibit 1029-00002
`
`
`
`8.
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`Additional details of my education and experience are set forth in my
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`curriculum vitae, a copy of which is attached as Exhibit 1029. Information about
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`my company is available at http://www.priorartdocumentation.com.
`
`II.
`
`SCOPE OF THIS REPORT
`
`9.
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`I have been asked to authenticate the following documents and
`
`establish their availability prior to the earliest priority date of June 30, 1999, and
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`prior to June 30, 2000 (the filing date of the Provisional Application for the U. S.
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`Patent No. 7,772,209):
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`a. Niyikiza, C, et al. MTA (LY231514): Relationship of vitamin
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`metabolite profile, drug exposure, and other patient characteristics
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`to toxicity. Annals of Oncology, Vol. 9, Suppl. 4, (1998): 126-127,
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`Abstract 609P (hereinafter “Niyikiza”).
`
`b. Carrasco, M., et al. Acute megaloblastic anemia: homocysteine
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`levels are useful for diagnosis and follow-up. Haematologica, 84.8
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`(August 1999): 767-768 (hereinafter “Carrasco”).
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`10.
`
`I reserve the right to supplement my opinion and/or this declaration in
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`the future to respond to any arguments that the Patent Owner raises and to take into
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`account new information as it becomes available.
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`
`
`2
`
`Teva – Fresenius
`Exhibit 1029-00003
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`
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`III. FEES
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`11. My compensation for time spent working on this matter is based on a
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`rate of $85 per hour. This compensation is not contingent on my opinions, my
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`performance or the outcome of the inter partes review, or any issues in or related
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`to this inter partes review.
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`IV.
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` INTRODUCTORY INFORMATION
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`12. Conference papers. Niyikiza is an abstract of a paper presented at a
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`conference. Conference papers enter the realm of public discourse at the time they
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`are presented at the conference. The circumstances of such presentation vary
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`substantially, especially as regards the prominence of the conference, the number
`
`of conference participants, and the organization of the conference. Formal
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`publication of papers presented at conferences also varies widely. Sometimes, the
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`papers are published before the conference so as to be available to conference
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`participants. Sometimes, papers are published only after the conference, and in
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`some cases only abstracts of the papers are published.
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`13. Library catalog records. Libraries world-wide use the MARC format
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`for catalog records; this format was developed at the Library of Congress in the
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`1960s. WorldCat is the world’s largest public online catalog (see
`
`https://en.wikipedia.org/wiki/OCLC ). Its records appear in many different
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`catalogs, including the Statewide Illinois Library Catalog.
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`
`
`3
`
`Teva – Fresenius
`Exhibit 1029-00004
`
`
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`14. Library management of periodicals. For periodical publications, a
`
`library will typically create a catalog record for the periodical when the library
`
`orders or 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 holdings records, and made publicly
`
`accessible very soon thereafter—normally within a few days of receipt or (at most)
`
`within a few weeks of receipt.
`
`15.
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`Indexing. An ordinarily skilled researcher will typically begin his or
`
`her search for relevant information in an index of periodical and other publications.
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`Having found relevant material, the researcher will then obtain it online, look for it
`
`in libraries, or purchase it from the publisher, a bookstore, or other provider.
`
`V. DOCUMENTS REPRESENTED AS PRIOR ART
`
`A. Niyikiza
`
`1.
`
`Authentication
`
`16. Niyikiza is an abstract of a research paper presented at a conference
`
`and published in the Annals of Oncology; a copy of Niyikiza is available online
`
`from Oxford University Press Journals (Ex. 1031 at 2). Ex. 1032 is the relevant
`
`entry from University of Illinois at Urbana-Champaign Library directory to
`
`electronic journals.
`
`
`
`4
`
`Teva – Fresenius
`Exhibit 1029-00005
`
`
`
`2.
`
`17.
`
`Public accessibility
`
` Niyikiza was presented as a poster in a session on novel therapeutics
`
`and pharmacology at the 23rd Congress of the European Society for Medical
`
`Oncology, on 6-10 November 1998, in Athens, Greece. Niyikiza therefore entered
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`the public realm of discourse early in November 1998.
`
`18. Abstracts of Congress proceedings were published in the Annals of
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`Oncology, which is held by 197 libraries world-wide, as indicated in the Statewide
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`Illinois Library Catalog record for this journal (Ex. 1033). Ex. 1034 is a copy of
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`the publication cover and table of contents of the Congress proceedings, and a
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`copy of Niyikiza from the University of Wisconsin Health Sciences Library. A
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`date stamp (Ex. 1034 at 3) shows that Niyikiza was processed at that library on 2
`
`December 1998 and was therefore publicly accessible soon thereafter.
`
`19. Based on the evidence presented here—online availability of the
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`document, the prominence of the annual ESMO congress at which it was
`
`presented, wide spread availability of the journal title, and a library
`
`processing date stamp—it is my opinion that Niyikiza is an authentic
`
`document that was publicly accessible to ordinarily skilled researchers no
`
`later than January 1999.
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`B.
`
`Carrasco
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`
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`5
`
`Teva – Fresenius
`Exhibit 1029-00006
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`
`
`1.
`
`Authentication
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`20. Carrasco is a research paper, an online copy of which is available
`
`from the Highwire Press (Ex. 1035). Ex. 1036 is the relevant entry from
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`University of Illinois at Urbana-Champaign Library directory to electronic
`
`journals.
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`2.
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`Public accessibility
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`21. Carrasco was published in Haematologica, a journal that is held by
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`118 libraries world-wide, as indicated in the Statewide Illinois Library Catalog
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`record for this journal (Ex. 1037). Ex. 1038 is a copy of Carrasco, and of the
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`cover and relevant table of contents for the Haematologica, from the University of
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`Michigan Taubman Medical Library. A date stamp (Ex. 1038 at 6) shows that
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`Carrasco was processed at that library on 27 October 1999 and was therefore
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`publicly accessible soon thereafter.
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`22. Carrasco was indexed in the widely used Web of Science abstracting
`
`and indexing service (Ex. 1039).
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`23. Based on the evidence presented here—online availability of the
`
`document, the indexing record for it, and wide spread availability of the
`
`journal title, and a library processing date stamp —it is my opinion that
`
`Carrasco is an authentic document that was publicly accessible to ordinarily
`
`skilled researchers no later than November 1999.
`
`
`
`6
`
`Teva – Fresenius
`Exhibit 1029-00007
`
`
`
`VI.
`
` SUMMARY
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`24. The evidence described above and supported by the attachments to
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`this declaration conclusively indicates that Niyikiza was available to diligent
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`researchers ordinarily skilled in the relevant art substantially before June 30, 1999,
`
`and Carrasco was available to diligent researchers ordinarily skilled in the relevant
`
`art substantially before June 30, 2000.
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`VII. CERTIFICATION:
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`25.
`
`I declare that all statements made herein of my own knowledge are
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`true and that all statements made on information and belief are believed to be true;
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`and further that these statements were made with the knowledge that willful false
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`statements and the like so made are punishable by fine or imprisonment, or both,
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`under Section 1001 of Title 18 of the United States Code.
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`Executed on this 23rd day of November, 2015.
`
` Respectfully submitted,
`
`___________________________
`Scott Bennett
`Managing Partner
`Prior Art Documentation Services LLC
`
`
`
`7
`
`
`
`
`
`
`
`Teva – Fresenius
`Exhibit 1029-00008
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`
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`ATTACHMENTS
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`The following attachments are true and accurate representations of library material
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`and online documents and records, as they are identified above. All attachments
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`were created on 17-23 November 2015, and all URLs referenced in this declaration
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`were available on 18 November 2015.
`
`Exhibit No.
`1031
`1032
`
`1033
`1034
`1035
`1036
`
`1037
`1038
`
`1039
`
`
`DESCRIPTION:
`Copy of Niyikiza from Oxford University Press Journals
`University of Illinois at Urbana-Champaign Library directory
`entry for Annals of Oncology
`Statewide Illinois Library Catalog record for Annals of Oncology
`Copy of Niyikiza from the University of Wisconsin Library
`Online copy of Carrasco from the Highwire Press
`University of Illinois at Urbana-Champaign Library directory
`entry for Haematologica
`Statewide Illinois Library Catalog record for Haematologica
`Copy of Carrasco from the University of Michigan Taubman
`Medical Library
`Web of Science entry for Carrasco
`
`
`
`
`
`8
`
`Teva – Fresenius
`Exhibit 1029-00009
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