`
`David L. Cavanaugh (Reg. No. 36,476)
`Owen K. Allen (Reg. No. 71,118)
`Robert J. Gunther, Jr. (Pro Hac Vice to be filed)
`Lisa J. Pirozzolo (Pro Hac Vice to be filed)
`Kevin S. Prussia (Pro Hac Vice to be filed)
`Andrew J. Danford (Pro Hac Vice to be filed)
`WILMER CUTLER PICKERING
` HALE AND DORR LLP
`1875 Pennsylvania Ave., NW
`Washington, DC 20006
`
`Adam R. Brausa (Reg. No.
`60,287)
`Daralyn J. Durie (Pro Hac Vice
`to be filed)
`DURIE TANGRI LLP
`217 Leidesdorff Street
`San Francisco, CA 94111
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`____________________________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`____________________________________________
`
`PFIZER, INC.,
`Petitioner,
`
`v.
`
`GENENTECH, INC.,
`Patent Owner.
`____________________________________________
`
`Case IPR2017-01488
`Patent 6,407,213
`____________________________________________
`
`DECLARATION OF IRENE LOEFFLER
`
`Pfizer v. Genentech
`IPR2017-01488
`Genentech Exhibit 2019
`
`
`
`IPR2017-01488
`Declaration of Irene Loeffler
`
`I, Irene Loeffler, declare as follows:
`
`1.
`
`I am the Associate Director of Records and Image Management in
`
`Genentech’s Corporate Records Management Program Group. I have personal
`
`knowledge of the facts set forth herein.
`
`2.
`
`I have worked at Genentech since 1987 holding various records
`
`positions, including: Central Records Administrator; Manager, Biomedical
`
`Records; Manager, Records and Image Management; Senior Manager, Records
`
`and Image Management; and my current role as Associate Director, Records and
`
`Image Management.
`
`3.
`
`In connection with my duties and responsibilities at Genentech, I
`
`oversee the ordering, assigning, tracking, recalling, scanning (previously
`
`microfilming), indexing, storing, and retrieving of laboratory notebooks.
`
`4.
`
`The exhibits listed below are true and authentic copies of several
`
`Genentech laboratory notebooks. Each laboratory notebook receives a unique
`
`numerical identifier when it is issued, which allows Genentech to accurately track
`
`those records. The notebook numbers and scientists to whom they were issued are
`
`as follows:
`
`a. Exhibit 2001: Notebook 10098 (Leonard Presta)
`
`b. Exhibit 2002: Notebook 10823 (Leonard Presta)
`
`c. Exhibit 2003: Notebook 11268 (Paul Carter)
`
`1
`
`
`
`
`
`
`
`
`
`IPR2017-01488
`Declaration of Irene Loeffler
`
`
`d. Exhibit 2004: Notebook 11643 (Paul Carter)
`
`e. Exhibit 2005: Notebook 10840 (John Brady)1
`
`f. Exhibit 2006: Notebook 11162 (John Brady)
`
`g. Exhibit 2007: Notebook 11008 (Ann Rowland)
`
`h. Exhibit 2008: Notebook 11297 (Tim Hotaling)
`
`i. Exhibit 2009: Notebook 11568 (Monique Carver).
`
`5.
`
`At the time that these notebooks were issued, Genentech scientists
`
`were instructed to record all work in their assigned notebooks and to sign and date
`
`each entry on a daily basis; no data was to be held back for later entry. Any
`
`attachments, such as computer data, were to be permanently affixed to the
`
`notebooks without covering any other entries. These instructions are included
`
`behind the front cover of Genentech’s laboratory notebooks to remind Genentech’s
`
`scientists of their responsibility to maintain timely and accurate records of their
`
`research.
`
`6.
`
`I am familiar with Genentech’s practices regarding the creation,
`
`modification, and keeping of its laboratory notebooks through my employment
`
`with Genentech. Each of the laboratory notebooks listed above was created by
`
`
`1 At the time that Notebooks 10840 and 11162 were issued, Mr. Brady’s name was
`
`John Ridgway. He subsequently changed his name to John Ridgway Brady.
`
`2
`
`
`
`
`
`
`
`
`
`IPR2017-01488
`Declaration of Irene Loeffler
`
`
`Genentech personnel during the regular course of business. It was the regular
`
`practice of Genentech’s personnel to create such records at or near the time the
`
`recorded act, event, condition, or opinion occurred. It was the general practice of
`
`Genentech’s personnel to date such documents as of the date the record was
`
`created or modified. Such records would only be made by someone with
`
`knowledge or from information transmitted by someone with knowledge.
`
`7.
`
`It was Genentech’s general practice to recall for imaging laboratory
`
`notebooks one year after they were issued or as soon as they were completed.
`
`Genentech microfilmed the notebooks until November 2007 at which time
`
`Genentech began scanning the notebooks. Exhibits 2001-2009 were initially
`
`microfilmed approximately one year after they were issued and then scanned in
`
`high-resolution color in or around November 2016.
`
`
`
`
`
`
`
`3
`
`
`
`[PR2017-01488
`
`Declaration of Irene Loeffler
`
`I declare under penalty of perjury of the laws of the United States of
`
`America that the foregoing is true and correct.
`
`Executed on: August i, 2017
`
`
`(/1 t1
`.
`
`
`Irene Loeffler
`
`
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