DECLARATION OF MICHAEL MUMFORD
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`LJ 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-Chiof
`Mary F. Downey
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`) )
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`) )
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`)
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`Cabiliy ct I1
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`V-
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`Boss at :1
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` mm
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`i.
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`1. Michael Mumlord. declare and state that I am a citizen of the Unitca
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`residinz in Benet-ue. Washington. My curriculum vitae is attached as Czbiily
`State:
`Exhibit No. 16.
`’
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`From June. 1981 and! November, 1987, I was no cmpioyoo of Gcnnntech.
`2.
`(Gcncmceh) located at 460 Point San Bruno Blvd.. South sari Pm-tcisco. Caiitornin
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`Inc.
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`94080. During the time spanning June. 1981 to April. 1985 I was responsible for
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`microbial
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`tcmenution optimization which was performed to confirm. as well as
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`maximize exproseion of gene products.
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`I am presently employed by Immune: as Vice 0
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`President of File: mm Opentiona.
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`its Semis. Washington.
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`3.
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`Ooaemech Notebook No. 1246 (Cabiily Exhibit No. 17) contain:
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`handwritten record: or sunpies received by myself of other: under my supervision
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`in the Fermentation Research and Ptocesl Development Dcpminent.
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`These simple:
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`were used to make DMSO stocks of microbial cultures for frozen storzfl 10 5° “¥i1i==d
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`it wls my normal practice to begin fcritientxtion
`in fermentation runs.
`later
`research and optimization within a few wocks after
`I
`received a. new recombinlni
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`organism {hit a researcher V/tl'l1¢d to be grown.
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`4,
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`The procedure I used to make DMSO stock: was to purify the strain:
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`that
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`i Achieved purification by tweaking a smsu lliquot of _me liquid
`were received.
`cultures or
`an onion from a. pine. onto an :33: pint: containing selective media-
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`Aftcr incubation.
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`I would pick a single colony to inoculate into selective liquid media.
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`This would be grown to an optical dersity of npproxinmciy 1.0 at a wavelength of
`500nm.
`The cuinxrc would then be diluted to a final eoncenarstion of 10% DMSO.
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`GNE-MED-02033
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`MERCK v. GENENTECH
`IPR2016-01373
`GENENTECH 2027
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`GNE-LILLY-BMS 00080780
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`DECLARATION OF MICHAEL MUMFORD
`
`37
`
`At
`the fet-tncntuioa progressed. eunpies would be token hourly after
`inoculation.
`Product expression would be induced by the addition of MA (50 u$!n‘11)- The
`fermentation wouid continue for
`tour to Six hours after
`induction.
`The cuiiuro would
`be harvested by oentrifugation.
`the wet biomass
`scrapped from the centrifuge
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`container into A plastic bag and frozen It 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 W3110/pGGhcevy
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`from DMSO stock No. 1266-22 (Cabiuy Exhibit No. 15. Bate: Nos. 00697-D0698). This
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`fct-ntcntetion conducted December 21. 1982. was assigned idcntitietttion number
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`GG-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 Intlbody.
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`This wzs the first
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`immunoglobuiin gene we worked
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`with in the Pct-muntetion Research and Process Deveiopment Department.
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`I
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`recorded
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`in my notebook tint
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`refrnctiie bodies were seen. Rcfreetiie bodies are indicative of
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`recombinant protein over expression.
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`Atreiycis by SD8-poiyecr-yiunide goi
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`electrophoresis (PAGE) shows 1 band in the 55i:D region which is the expected
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`moiecuier weight of
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`the heavy chain product.
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`“
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`11.
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`on Jmunry 12. 1983.
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`I
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`recorded fermentation: of W31i0/pGGhczvy from
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`DMSO stock No. 1246-22 (Cabiiiy Exhibit No. 18. Bates Nos. 00699-00701). These
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`fermentation; were essizned identification numbers 05-2! and GO-31 and were
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`conducted January 3. 1983.
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`The product
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`that we: expected from the fermentation run
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`in fermentation run 06-11.
`was the holvy chain of an anti-CEA antibody. 3.:
`However.
`in these fermentation run: more were verieticn: 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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`occurred et a into:
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`time point
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`in the process. Aneiyeie by SD8-PAGE snow: 8 band in
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`the 55th region which it
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`the expected molecular weight of the heavy chain product.
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`the fermentation run GO-SJ was harvested and given to Dr. Ron Wetzci
`recorded that
`I
`for purification.
`8
`.
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`recorded in my notebook multiple fermentation:
`I
`On Jentury 20. 1983.
`12.
`of W3110/pGGRi+i. from DMSO stock No. 1246-20 (Cebiiiy Exhibit No. 18. Bates Noe
`D0726-00729).
`These fermentation: were urigncd identification number: 00-23. 66-
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`31 and G041 end was conducted January 6. 1983. The product that Wes expected from
`
`those fermentation rum we:
`the light chain of In anti-CEA antibody.
`The
`fcrmentetion designated OG-31. producing the light citein anti-CBA antibody. wee
`examined microscopically at
`the completion of
`the fertnentaticfi
`run in which
`
`SDS-PAGE enziysis
`signifying product expression.
`rcfrectiio bodies were seen.
`(ceiaiiiy Exhibit No.
`1%. Butte: Nos. 00728-00729)
`indicated product expression at
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`the
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`GNE-MED-02035
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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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`23.5 kn melacular weight
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`range which was expected for light than pzotc-in.
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`This
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`fermentation was harvested (486 gums) and given to Dr. Ron Wetzel
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`for purification
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`(Cabmy Exhibit No. 1%. mm Nes. 00727).
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`13.
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`On. February 14. 1983,
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`I rceordod the iermenmions of the co-
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`mnsioz-med smma. W311OIpl0g (ecu-3.1) ‘and wsno/pea (GGLH-2) from the DMSO
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`stocks No. 1246-31 and 1246-32. rcspectlvely (Cabiny Exhibit No. 18. Base: Hos. 00730.
`00733 tnd 00734).
`Tues:
`fcnnenzazlom were assigned ldeutlflcnlon numbers OCILH-1
`and GGLH-2. and were zrown in bioretcxors No. 2 and 3 on February 8. 1983.. The
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`products
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`11111. were expected from then fermentation run! WGIB 13013 T-11¢ 11th!
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`I114
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`SD8—PAGE shows pratein expression from the
`heavy chain of an um-CEA antibody.
`time course samples.
`I
`reecrdcd that we fermenzitlun run No. OGLH-1 we:
`lurvested
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`‘biomass pm: was given ‘In D:. Ron Wetzel.
`the so gram: 0: wet
`and that
`GGLI-I~1 demonstrated" retnczila bodies upon mic:-cseopic analysis.
`14.
`I
`runner eeelare thtt all statements made of R17 0“ ¥3°“’l=d¢¢ 39¢ W10
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`Fcrmcnuunn
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`3nd um. all smeznoau made on information and belle! are believed to be true; and
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`runner um mesa I-cuemcnts w¢:e made with the knowledge that willful
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`false
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`smcmem: and the like so made tn: punishable by fine or imprisonment. or both.
`under Section 1001 of Title 18 er the United States Code.
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`7.
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`fitcfiel zumtord %
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`GNE-MED-02036
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`GNE—t3sKoooo'3439
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`GNE-HGS 00082050
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`GNE-LILLY-BMS 00080783
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`GNE-REG00080783