DECLARATION OF MICHAEL MUMFORD
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`L-J U1
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`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`BEFORE THE BOARD OF PATENT APPEALS AND INTERFERBNCB5
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`Interference. No. 102.572
`
`Examiner-in-Chief
`Mzry F. Dewncy
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`) )
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`) )
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`)
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`Cabiily er.
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`:1
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`V-
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`Boss at :1
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`1.
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`1. Michael Mutnlore. declare and state tint I am a citizen of the United
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`residing in Beilevue. Wuhington. My curriculum vitae is attached as Cabiily
`State:
`Exhibit No. 16.
`'
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`From June. 1981 until November, 1987, I was to employee of Oenontech.
`2..
`(Gcnenteeh)
`located at 460 Point San Bruno Blvd" South San Prtneiseo. California _
`
`Inc.
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`94080. During the time spanning June. 1981 to April. 1985 I was responsible for
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`microbiei
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`fermentation optimization which was performed to eenfim. as well as
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`maximize exprselon of gene products.
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`I am presently employed by Immune: as Vice i
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`President of File: Pleat Operations.
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`in Semis. Washington.
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`3.
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`Cienenteeh Notebook No. 1246 (Cabiily Exhibit No. 17) contain:
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`handwritten records or samples
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`received by myself of other: under my supervision
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`in the Permentation Research and Procesx Development Deptnnacut.
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`These slmpiesv
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`were used to nuke DMSO etoeiu of microbial cultures for frozen swrifl 10 7->9 “iilind
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`it was my normal pnetiee to begin ferrnentxtien
`in fermentation runs.
`later
`research and optimization within a few weeks after
`I
`received it new recombinant‘
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`organism that 1 rescxreher wxnted to be grown.
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`4,
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`The procedure I need to make DMSO stock: was to purify the strain: that
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`lllquot of _me liquid
`I aeizievec purifleaxion by meeting a smell
`were received.
`culture: or a colony from a. plate. onto an agar plate containing selective media-
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`Ancr incubation.
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`I would pick a single colony to inoculate into teleetive liquid media.
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`This would be grown to an optical density of nppreximateiy 1.0 at a wavelength of
`500nm. The culture would then be diluted to n final concentration of 1093 DMSCI.
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`GNE-MED-02033
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`GNE—HGso0082o47
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`GNE—‘GSKO000'3436
`Mylan v. Genentech
`Mylan V. Genentech
`IPR2016-00710
`Genentech Exhibit 2031
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`IPR2016-00710
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`Genentech Exhibit 2031 G“E'”L”'B“"5°°°8°78°
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`GNE-REG00080780
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`DECLARATION OF MICHAEL MUMFORD
`
`37
`
`As
`tho fcrrnentntioiz progressed. eunpies would be taken hourly after
`inoculation.
`Product expression would be induced by the addition of MA (50 uxlm1)- The
`fcrxncnuttioo would continue for
`tour to slat hours zftor
`induction.
`The cuiiuto would
`be harvested by centrifttgatiort.
`the wet biomass
`scrapped from the centrifuge
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`container into A plnstic bag and frozen at approximately —60'C or below for at
`hours.
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`ices: ‘24
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`10.
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`On January 12, 1983.
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`I
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`recorded the fermentation of WSIIO/pGGhcevy
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`from DMSO stock No. 1246-22 (Cabiuy Exhibit No. 18. Enter Nos. 00697-D0698). This
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`fcrntentntion conducted December 21. 1982. was assigned idcntitictttion number
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`00-11.
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`The product
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`that was expected from the fermentation Hm Wins. the hem!
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`chain of the anti-CEA tntlbody.
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`This wzs the first
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`immunoglobniin gene we worked
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`with in the Fe:-naentstion Research and Process Deveiopment Depanrnont.
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`I
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`recorded
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`in my notebook tiut refrectilc bodies were seen. Rcfrnctile bodies are indicative of
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`recombinant protein over expression.
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`Aneiyeis by SD8-poiyecr-yiunide gel
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`electrophoresis (PAGE) shows 1 band in the 55i:D region which is the expected
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`molecuier weight of the heavy chain product.
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`“
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`11.
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`On January 12. 1983.
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`I
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`recorded fermentation: of W3110/pGGhczvy from
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`DMSO stool: No. 1246-22 (Cabiiiy Exhibit No. 18. Ba!» Nos. 00699-00701). These
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`torrnorttations were assigned identification numbers 00-2! and GO-33 and were
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`conducted January 3. 1983.
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`The product
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`that was expected from the fermentation run
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`was the heavy chain of an anti-CEA antibody. as in fermentation run 06-11.
`However.
`in then:
`fermentation run: more were verietioes of the fermentation
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`format such that
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`some fermentation nutrients were removed and product
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`induction
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`occurrcd at I later time point
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`in the process. Anelysit by SDS-PAGE show: a bend in
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`the 55itD region which is the expected molecular weight of the heavy chain product.
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`the fez-rnontation run GO-SJ was rm-vested and given to Dr. Ron Wctzol
`I recorded that
`for purification.
`8
`.
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`recorded in my notebook multiple fcrmcnteticrts
`I
`On January 20. 1983.
`12.
`of w3no1poaRt+t. tram omso stock No. 1246-20 (Clbiiiy Exhibit No. 18. Bates Nos.
`D0726-00729).
`These fermentation: were unigned identification numbers. GO-2!-i. G6-
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`31 and 60-41 end was conducted January 6. 1983. The product
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`that Wes expected from
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`those fermentation rum we:
`the light chain of In anti-CEA antibody.
`The
`fermontetion designated OG-31. producing the light citein anti-CBA antioody. wt!
`examined microscopically at
`the completion of
`the fennentsticfi
`run in Whifih
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`SDS-PAGE eztziysis
`signifying product expression.
`refrtctiie bodies were seen.
`(cahiiiy Exhibit No. 18. Beta: Nos. 00728-00729)
`indicated product expression at
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`the
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`GNE-MED-02035
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`...,,
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`GNE:GSKOO00'3438
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`GNE-HGS 00082049
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`GNE-LILLY-BMS 00080782
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`GNE-REG00080782
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`

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`DECLARATION OF MICHAEL MUMFORD
`
`38
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`23.: kt: maucum» wuight
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`range which was expected is: ugh: than ptmoin.
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`This
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`fcxmcnmion wu harvcslcd (486 gums) and given to Dr. Ron Wotzcl
`(Cabmy Exhibit No. 13. mm Nos. 00727).
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`for purmcmun
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`On February 14. 1983, I reeordod the fermentation: of thc co-
`13.
`mnsro:-xned mums. W311OIpl02 (GGLI-3.1) ‘mu «V3110/pea (GGLH-2) from the DMSO
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`flocks No. 1246-31 and 1245-32. rcspccuveky (Cabiny Exhibit No. 18. Buzz: Nos. 00730.
`00733 Ind OO734)-
`These fcnnenzazioni were assigned idcutiflcuion numbers OGLH-1
`and GGLI-I-2. Ind were zrown in biorencmrs No. 2 and 3 on February 8. 1983.. Th:
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`products
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`that were expected from than fermentation fun! WGTB 13013 111% 11th!
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`ind
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`SD8—P.-5.68 shows protein ¢1pre:s!on from the
`heavy chain of an gnu-CEA antibody.
`zinc course suuphs.
`I
`rcccrded that we fcrmcnzition run No. OGLH-1 WIS harvested
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`the so gum: at w: ‘oiolnass pm: was given ‘In Dr. Ron Wetzel.
`and cm:
`UGLH-1 demonstrated" retncziin bodies upon miamsaapi: analysis.
`14.
`I
`runner ficclarc um an sutcmcnts nude 65 1117 °*'3 ¥3°‘‘’l°d8° #3 '-31°
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`Pea-mcnuuon
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`sad um. nu smut-noau made on information and belief an boliaved 10 bu mac; and
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`zurzhcr mu mesa I-uzcmcnts was made with the knowledge lhlt willful
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`false
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`tn: punishable by fine Or
`smcmcnu and the like 5: mad:
`undcr Socticn 1001 of Title 18 or the Unite.-d States Code.
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`i!I1P‘-'iS0flm°l'lV-» 0? 170?-h‘
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`7.
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`fitcgcl Zumford 9‘:
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`GNE-MED-02036
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`C3NE—|(W3SK0O0O'3439
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`GNE-HGS 00082050
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`GNE-LILLY-BMS 00080783
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`GNE-REG00080783