`
`39
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`BEFORE THE BOARD OF PATENT APPEALS AND INTERFERENCES
`
`.
`
`‘
`
`Interference No.
`
`102.572
`
`Examiner-in-Chief
`Mary F- Downcy
`
`)
`)
`
`) )
`
`>
`
`Cabilly et al
`
`v.
`
`Boss ct
`
`3.1
`
` E
`
`1.
`
`1. William Holmes. declare and state that
`
`I am a citizen of the United
`
`States residing in Pacific.-t. California. My Curriculum Vitae is attached as Cabilly
`Exhibit No. 10.
`I am a co-inventor of United States Patent 4.816.561 cntitlbd
`
`Irnrnunoglobulin Preparations".
`"Recombinant
`Inc... which is 10°39‘! 3* 450 PL 535
`I have been ‘employed at Genentech.
`2.
`Bruno Blvd.. South San Francisco. California 94080 from August 2. 1979 to January 4.
`
`1985 and from June 1. 1987 to the present. My present position is that of Scientist.
`
`3.
`
`I was approached by Herb Heyneker to participate in a project.
`
`to
`
`express antibodies directed against human carcinoembryonic antigen (CEA)
`
`in E.coli.
`
`'
`
`I started working on this project on July 12. 1982 (Cabilly Exhibit No. 11. 38165 NO-
`00941).
`
`4.
`
`I received a sample of polyA mRNA from The City of Hope which had
`
`been isolated from the hybridoma cell
`
`line CEA.66-E3.
`
`This cell
`
`line produces an anti-
`
`From this rnRNA sample I prepared a cDNA which was then
`CEA antibody.
`incorporated into plasmids to make an E.coli colony library (Cabilly Exhibit
`Bates No. 00941, and Cabilly Exhibit No. 20. Estes No. 00989).
`
`lxlo. 11.
`
`inoculated colonies from the CEA.66-E6 CDNA into mierotiter plates
`l
`5.
`containing media (Cabilly Exhibit No. 11. Bates No. 00941).
`These cultures ivere
`
`stamped onto agar plates and allowed to grow.
`
`The colonies were then transferred to
`
`duplicate sets of nitrocellulose filters by Michael Rey (a laboratory technician in Dr.
`
`Hcynekcrs lab)
`
`transferred to agar plates and allowed to rcgrow (Cabi1ly Exhibit No.
`
`15. Bates No. 0050:). Mr. Rey also lysed the colonies on each of these filters and
`
`GNE-MED-02027
`
`GNEJGsKoood343o
`Mylan v. Genentech
`Mylan V. Genentech
`IPR2016-00710
`Genentech Exhibit 2029
`Genentech Exhibit 2029 GNE'L""'Y'BMs°°°8°m
`
`IPR2016-00710
`
`GNBHGS 00082041
`
`GNE-REG00080774
`
`
`
`
`
`
`
`DECLARATION OF WILLIAM HOLMES
`
`LA) VJ
`
`subsequent PAGE purification.
`
`I
`
`then ligated these fragments.
`
`transformed the
`
`ligation reaction into E.::oli. and analyzed the resultant colonies by restriction
`analysis to confix-tn pGammnC’EAtrp20'7-1* (Cabilly Exhibit No. 13. Bates Nos. 00881.
`00882 and 00876).
`'
`
`20.
`
`Shmuel Cabilly carried 01.11
`
`reactions to construct
`
`the FAB expression
`
`plasmid pGammaCEAFABt1p207-1* (Cabilly Exhibit. No. 20. Bates No. 00975-00976. and
`
`00982-00985). Michael Rey, Shmuel Cabilly and I analyzed several
`
`tetracycline
`
`resistant
`
`transformants from the pGammaCEAFABtrp207~1“'
`
`ligation by restriciion
`
`cleavage analysis and sequencing (Cabilly Exhibit No. 13. Bates Nos.VOO885-00887. and
`00889; Cabilly Exhibit No. 15, Bates Nos. 00541. 00543‘. and 00544. and Cahilly Exhibit No.
`
`20. Bates Nos. 00986-00987).
`
`further declare that all Statements made of my own knowledge are true
`I
`21.
`and Ihal all statements made on information and belief are believed to be true; and
`
`funher
`
`that
`
`these statements were made with the knowledge that willful
`
`false
`
`statements and the like so made are punishable by fine or imprisonment. or both.
`under Section 1001 of Title 18 of the United States Code.
`
`
`
`GNE-MED-02030
`
`A GNE-'GSKoo0o‘3433
`
`GNE-HGS 00082044
`
`GNE-LILLY-BMS 00080777
`
`GNE—REG00080777
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