UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PA TENT TRIAL AND APPEAL BOARD
`
`BRECKENRIDGE PHARMACEUTICAL, INC.
`
`Petitioner
`
`v.
`
`NOV ARTIS PHARMACEUTICALS CORPORATION
`
`Patent Owner
`
`Case IPR2017-01592
`
`U.S. Patent No. 8,410,131
`
`DECLARATION OF DANIEL R. EVANS
`
`
`
`BEFORE THE PA TENT TRIAL AND APPEAL BOARD
`
`BRECKENRIDGE PHARMACEUTICAL, INC.
`
`Petitioner
`
`v.
`
`NOV ARTIS PHARMACEUTICALS CORPORATION
`
`Patent Owner
`
`Case IPR2017-01592
`
`U.S. Patent No. 8,410,131
`
`DECLARATION OF DANIEL R. EVANS
`
`
`
`I, Daniel R. Evans, declare as follows:
`
`1.
`
`I am a partner at Merchant & Gould, P.C.
`
`I am lead counsel for
`
`Breckenridge Pharmaceutical, Inc.
`
`in the above-styled Inter Partes Review
`
`(IPR2017-01592).
`
`2.
`
`As part of the preparation of the petition for inter partes review, I
`
`researched and located certain prior art references identified in the petition, including
`
`an abstract entitled "Sirolimus Prevents Tumor Progression: mTOR Targeting For
`
`The Inhibition Of Neoplastic Progression," which was authored by Fulung Luan and
`
`other authors (the "Luan Abstract").
`
`3.
`
`I identified the Luan Abstract and its date of publication from a review
`
`of other prior art references. One of those references was an article entitled
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`"Inhibitors of mTOR and FTY 720" by D. Morel (hereinafter referred to as "Morel").
`
`Morel, which was originally published in French in the September 1, 2001 issue of
`
`La Press Medicale. I commissioned an English translation of Morel as part of my
`
`prior art search in preparation of Breckenridge's IPR petition. A copy of both the
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`French version and English translation of Morel is attached hereto as Exhibit 1113.
`
`Therein, Morel includes reports of a meeting referred as "Transplant 2001" that took
`
`place in Chicago, Illinois on May 11-16, 2001. It can be seen that Morel was publicly
`
`available at least as early as October 29, 2001. (See Ex. 1113, p. 9.)
`
`4.
`
`I noticed that Morel summarizes several sessions of the Transplant
`
`2001 meeting with citations to the Supplement 1 issue of the 2001 American Journal
`
`1
`
`
`
`of Transplantation ("AJT") publication. (See Ex. 1113, p. 2.) As explained below,
`
`the AJT publication is the official journal of the American Society of Transplantation
`
`("AST") and the American Society of Transplant Surgeons ("ASTS"). I also noticed
`
`that Morel summarizes an "exciting abstract" that relates to "the ability of sirolimus
`
`to inhibit tumor proliferation and metastatic diffusion of a renal adenocarcinoma in
`
`the mouse, as compared to a control, unlike the highly stimulative effect of
`
`cyclosporine on tumor diffusion." (See Ex. 1113, p. 2.) I considered the "exciting
`
`abstract" relevant to Breckenridge's petition.
`
`5.
`
`I decided to research the materials that were presented at Transplant
`
`2001. From online research, I located a "Program Book" for the Transplant 2001
`
`conference. My experience attending conferences such as these is that these Program
`
`Books are compilations of information to be presented at conferences such as
`
`Transplant 2001. The Program Books are provided to conference attendees at the
`
`conference. A copy of the "Transplant 2001 Program Book" available online is
`
`attached as Exhibit 1114 to this declaration.
`
`6.
`
`The Transplant 2001 Program Book states that the Transplant 2001
`
`conference was organized by the AST and the ASTS, and was held in Chicago,
`
`Illinois on May 11-16, 2001. (See Ex. 1114, pp. 6, 15.) The Transplant 2001 Program
`
`Book included, among other things, copies of abstracts presented in "plenary,
`
`concurrent and poster sessions" that took place at Transplant 2001. (See Ex. 1114,
`
`2
`
`
`
`p. 7.) As pages 6-7 of the Transplant 2001 Program Book state under the heading
`
`Abstracts:
`
`All oral abstract presentations listed in the program section have
`
`been assigned a chronological program number. This number
`
`corresponds with the number of the abstract printed in this
`
`supplement. Poster presentations will be held in the River
`
`Exhibition Hall. All poster presentations have been assigned a
`
`chronological program number for reference when locating your
`
`printed abstract. Board numbers for poster presentations are
`
`identified with a P before the number. Please refer to the program
`
`for the appropriate board number when locating a poster for
`
`v1ewmg.
`
`* * *
`
`All accepted abstracts
`
`are published m
`
`this official
`
`TRANSPLANT 2001 program book, a supplement to the new
`
`joint AST/ASTS journal, American Journal of Transplantation
`
`(AJT). All abstracts selected for presentation and the final
`
`program are available on-line through the TRANSPLANT 2001
`
`website, www.transplant200 l .org.
`
`(See Ex. 1114, pp. 6, 7.)
`
`3
`
`
`
`7.
`
`I reviewed the Transplant 2001 Program Book after I located it. As part
`
`of that review, I discovered the Luan Abstract (Abstract# 428) on page 243 of the
`
`Transplant 2001 Program Book. (See Ex. 1114, p. 243.) It is this copy of the Luan
`
`Abstract from the Transplant 2001 Program Book that was submitted as page 001 in
`
`Ex. 1005 to Breckenridge's IPR petition. I also discovered that pages 75-77 of the
`
`Transplant 2001 Program Book show the schedule for the presentations at a plenary
`
`session of Transplant 2001 on Monday, May 14, 2001. (See Ex. 1114, pp. 75-77.)
`
`Page 77 of the Transplant 2001 Program Book states that the Luan Abstract was
`
`presented at a Joint Plenary Session in the Sheraton Chicago Ballroom at 10:30am
`
`on May 14, 2001. (See Ex. 1114, p. 071; see also Ex. 1010, p. 96 (i1190).) Copies of
`
`pages 7 5-77 of the Transplant 2001 Program Book were submitted as pages 007-009
`
`in Ex. 1005 to Breckenridge's IPR petition.
`
`8.
`
`After it was determined that Luan would be submitted as part of the
`
`grounds in Breckenridge's IPR petition, I contacted Mr. Terrence L. Stokke ofE.L.F.
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`Research Services LLC ("ELF") in St. Paul, Minnesota. ELF provides document
`
`research services. I asked Mr. Stokke to help confirm that the Transplant 2001
`
`Program Book was a publication that was publicly available in May 2001.
`
`9.
`
`Mr. Stokke originally provided me with a copy of the Luan Abstract
`
`with a date stamp ofNovember 7, 2001. (See Ex. 1115.) Therein, it can be seen that
`
`the AJT publication is the official journal of the AST and ASTS. (See Ex. 1115, p.
`
`1.) Subsequently, I conducted an online search to determine if the Luan Abstract had
`
`4
`
`
`
`been published earlier than November 2001. I reviewed the online library of
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`publications maintained by John Wiley & Sons, Inc. (the "Wiley Online Library")
`
`for the AJT publication. The Wiley Online Library indicated that the Transplant
`
`2001 Program Book, which included the Luan Abstract, was published in May 2001.
`
`A copy of the results from my search of the Wiley Online Library are included as
`
`pages 002-004 in Exhibit 1005 to Breckenridge's IPR petition.
`
`10.
`
`I note that the search results from the Wiley Online Library show that
`
`the Transplant 2001 Program Book was assigned a Digital Object Indicator ("DOI")
`
`of 10.ll 11/j.1600-6143.2001.tb00014.x. I am familiar with the use of DOis and
`
`have attached hereto the International Organization for Standardization ("ISO")
`
`publication (ISO 263 24: 12, attached as Exhibit 1116) that provides additional details
`
`concerning DOis. In essence, a DOI is a unique alphanumeric string assigned by the
`
`International DOI Foundation to identify a publication and provide its location on
`
`the Internet. A DOI number typed into a web browser obtains the appropriate
`
`webpage that hosts the electronic content. (See Ex. 1116 at 11, 1 Sect. 4.2.2 URI
`
`presentation.) For example, a search conducted on the website of the International
`
`DOI Foundation using the DOI number assigned to the Transplant 2001 Program
`
`Book directs a user to the Wiley Online Library that states the Transplant 2001
`
`Program Book was published in May 2001. (See Exhibit 1117 attached hereto, p. 1;
`
`1 The citation of page 11 is to the added page number-the native number is page 5.
`
`5
`
`
`
`cf Ex. 1005 at 002-004.) Inclusion of the above-mentioned DOI for the Transplant
`
`2001 Program Book into a web browser produces the above-mentioned Wiley
`
`Online Library webpage.
`
`11. After reviewing the results from the Wiley Online Library, I asked Mr.
`
`Stokke to contact Wiley to see if they could confirm the publication date for the
`
`Luan Abstract. Mr. Stol<l<.e and I worked together through a couple revisions of an
`
`email to be sent to Wiley. Mr. Stokke ultimately sent the "final revision" of the email
`
`to Wiley on June 5, 2017. The email from Mr. Stokke to the Journal Customer
`
`Services department of Wiley was attached as page 006 in Exhibit 1005.
`
`12. On June 6, 2017, Christine Goff of Wiley's Journal Customer Services
`
`responded by email to Mr. Stold<.e. Ms. Goff stated that the Transplant 2001 Program
`
`Book was published as the American Journal of Transplantation, Supplement 1,
`
`Volume 1 (2001) in May 2001. Ms. Goffs email response is shown on page 005 of
`
`Ex. 1005.
`
`I declare under penalty of perjury under the laws of the United States of
`
`America that the foregoing is true and correct.
`
`Dated: January 18, 2018
`
`6
`
`
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