throbber
Attmney Becket N 9.
`
`T33 PN—i}03/'001} S 3} 3€§(§3—2€}§ 5 (AKBM-321'7~'-i}
`
`?ATTENT
`
`EN
`
`UNTTEIB STATES PATENT ANT} T"RABTIMART{ GF T'<‘l?CTI
`
`in Re Patent ef:
`
`SAMPALIS, Fotini
`
`Confniiiatieii Ne;
`
`ii 897
`
`Control No:
`
`95./'00 1 , 774
`
`Group Art Unit:
`
`3991
`
`Filed:
`
`FOR:
`
`Oetehei i9fi 2011
`
`Exeniiner:
`
`CAMPELL Bruce R.
`
`TNTER PARTES REEXART 917 US. PATENT 8,030,348: NATURITTL MARINE
`SOURCTE T’E§0S§’Ti0T.fET’iE}§§ CGM§’RTSENG T’C’LYUNSATURATEE)
` F,i\'T'i”Y
`
`ACTBS AND THEIR AP ?T..TCATT{)NS
`
`Mai} Step Qeeieretien
`C()1'1’itIliSSi0Ii€1' fer Patents
`
`PO. Box M50
`
`Ai6X8.1ld,1'ia, VA 223 i 3-1450
`
`
`
`E, Bari L. White, declare as tbiiews:
`
`1.
`
`i am at
`
`Citizen.
`
`2.
`
`1 ant etmrentiy the President and CEO of MD); Biefxnaiytieai Labeietoiy,
`
`inc. in College
`
`S'tEt't'.i{_‘.iIi, TX, which offers, ahmitg other things, expert zttiztiytieai services for the identification
`
`of hiesuhstances.
`
`[N
`
`I have 61 PhD. in analytical eheinistry specializing in mass speetroiiietry from the Uiiiversity
`
`of Nerth Careiina. at Chapel i-iiii. Since i985, i have wei‘i<:ed prefessieneiiye in the area ef
`
`eiiaiytieai chemistry and mass speetmiiietry (amend 27 years).
`
`I was appointed aiici served
`
`as ,A£iju11£‘.i. Professor ef Ch,f:D'1iSi1'_‘y’,, Wake Forest University, Depertinent of Ci’i€i(}'tiiSt1”§/ and
`
`have published niere than 27
`
`reviewed jeurnai articles.
`
`I eurrentiy seive as 21 Peer
`
`Reviewer fer J. {7.i1mmaiog2i‘(1pi1ic Sciemre and J. C7i1r0nizar0gm<zpizy.
`
`I am a metnber (if the
`
`Aineriean Cheniicai Seciety (CN€I3S~Seetien Ciiairrnaii
`
`‘E33, ChainiiEeet/i’1regi'ain Chair “[92,
`
`«'eei'etary ‘9i and TI'€:’<!.§u1"t31‘
`
`‘$50), Mississippi Aeadteniy of Science, Society of Aiiaiytieai
`
`000001
`
`Petition for Inter Partes Review
`Of U.S. Patent 8,278,351
`Exhibit
`
`ENZYMOTEC - 1055
`
`000001
`
`

`
`U.S.S.N. 95./tllll ,7?‘
`Declaration of Dr. Earl l_.. White
`
`LI:
`
`6.
`
`Cheniists of Pittsburgh, Applied Spectiescopy Society, Phi Lambda Upsilon Honorary
`
`Chemical Society, America Society for M ass Spectrornetry, National Technical Association
`
`and Alpha Phi Alpha Fraternity, lne., Triangle Area Mass Spectronietry Discussion Group,
`
`National Organizatiori of Blacl: Chemists and Chemical Eirigirieers (N()l3»CliClE3), Bay Ai'ea
`
`l\/lass Spectrornetry Discussion group (BAl‘vlS) and the SF Bay Area Proteorne Society. My
`
`Curriculum Vitae is attached Appentlix A.
`
`l am consiclered an expert in the area of ideiititication of hiornolecules using, analytical
`
`techniques in general, and mass spectroine.try, specifically.
`
`l ant being cornpensated at my customary hourly rate fill‘ my time spent on developing,
`
`forrniiig, and expressing the facts and opinions in this cleclaration.
`
`l have no personal interest
`
`in the ultirnate outeonie of the reexaniination proeeediiigs involving US. patent 8,{}3ll,3r-l8
`
`(“the “"348 patent”).
`
`ln Ztlll, MDX Bioztinalytical Laboratory, lnc. was contracted. hy Neptune Tecliiiologies and
`
`Bioressources,
`
`lnc. of Quebec, Canada to analy;2:e certain phospholipid samples {the
`
`“Beaudoin Qil Fractions”) and report which fatty acid phospholipitls are present.
`
`Furthermore, l was asherl to opiiie on whether certain fatty acid phospliolipids were present
`
`or absent in the Beaudoin Gil Fractioiis, Within the levels of detection ofa conventional mass
`
`spectrometry experiment. The results of this analysis were suhiiiittetl in a Declaration <la.terl
`
`May 3l. 2(3ll in
`
`l(l.«"4-85,094 (now the ‘348 patent). There, l stated that “it my
`
`opinion that the Beaucloin Oil
`
`l9‘ractiohs received and testecl by me do not contain l’Ls
`
`[phospholipiclsj which have attachecl to them Dl~lA and DHA, EPA and EPA, l3‘l::lA and EPA,
`
`or EPA and DHA, at the detection limits d.esei‘il*>e(l ahove in paragraph 7 [outlining liquid
`
`chromatography/niass speetrorrietry (LC/l\/lS) and tandeni niass spectrornetry (l\/lS,/MS)
`
`techniques].” White Declaration ofivlay 3l, Zill l, fit l3.
`
`l have heen informed that Al{€:l' Biol\/larine filed a Request for Reexamination {U.S.S.N.
`
`95./{ltll ,774) which questions the accuracy of the data that l presented in the Declaration of
`
`May 3 l , 201 l. Al<:er also filed. a Corrected Request for Reexarnination, which I have read.
`
`I specifically note that Al<er’s Corrected. Request for Reexarriination states, at pages Zllwll
`
`(ernph asis add.eal.):
`
`OOQD02
`
`000002
`
`

`
`U.S.S.N. 95./Gill ,7?‘
`Declaration of Dr. Earl L. White
`
`“Requestors further note that the analysis hy Dr. White was incomplete hecause Dr. Wliite
`apparently did not utilize any reference standards or positive controls in his analysis. This raises
`the questions of whether: 1) the conditions used by Dr. White were sufficient to detect the claimed
`phospholipid species; and 2) the assuniptions by Dr. White in the interpretation of the MS data
`were correct.
`dl:
`t
`'
`'
`‘"
`
`tndpoin
`tion 1 Chin ties. From an analytir
`Validate the det.
`_
`, iefere ce
`‘
`
`
`
`
`
`standarcts and ‘(iSlilV€
`controls to ‘verify’ that the analytical procedures are Worsuig and W ill
`perform their intended purpose.
`it
`is especially important
`to optimize mass specti'onietri(:
`
`paran
`is using re ference compounds. See the Declaration by Dr. Thoinas Gundersen in Support
`oflteogtiest for inter Parties Reexamination ofU.S. l’at.ent No. ?5.0'30,348.”
`
`9.
`
`I clarify herein that, as is standard in the industry, I eonteniporaneeusly ran adequate controls
`
`when l eondticted the experiments that were reported in the Declaration of May Bl , 201 1.
`
`10.1 suhniit herewith controls, which were analyzed at the sanie tiine the experiments were
`
`a.naly;3.ed, that were reported in the Deela.rati.on of May Ell,
`
`'20l l. Specifically, i ran the
`
`tellovvting eontrols that are St1TYlt.‘(12tl'i2‘.€Cl
`
`in detail helow:
`
`a.
`
`a series ofposirive controls in the form of a coniniereial phospholipid standard set
`
`which contains four pliospholipids of various weiglits; and
`
`h.
`
`a selvent—only rzegative control of 20% acetonitrile, which was run at the beginning of
`
`the experiinent and hetween each run that involved a species that differed frorn the
`
`previous.
`
`As discussed helow, such a contrel
`
`is crucial
`
`to correct
`
`for
`
`the
`
`eontaniination of data froin other samples (the somcalled “nieniory effect” or “carry~
`
`over effect”).
`
`ll. it is necessary to run positive centrcls to demonstrate expeiiinental sensitivity and validity of
`
`data generated.
`
`it is well known in the field that such controls inust he run, and therefore I,
`
`having over 25 years in the field, ran adequate positive controls in generating the data
`
`reported in my Declaration of May 3 l, Ztll i.
`
`12. Specitica.lly, I ran a series of positive controls in the forrn of a cornniercial pliesphoiipid
`
`standard.
`
`l?’igure l). This standard. set is cornrnereially available trorn Sigrna-Altlrich
`
`(Catalog No. P3Sl7-IVL). This standard set includes four different cornnion phospholipid
`
`species of dittereiit
`
`rnolecular masses,
`
`such
`
`as
`
` l_.~(i..—lysophosphatidylcholine,
`
`L-"fie
`
`phosphatidylcholine, L-onphospliatidylethanoiarnine, and L—d-pliosphatidylinositol sodium
`
`salt.
`
`13. llurther, a sound and experiinentally viahle mass speetroineti'y experiment i'equires solvent
`
`“hlanle” or “negative centrol”" sainples at the beginning of a series of runs and between
`
`OOQD03
`
`000003
`
`

`
`U,S.S.N. 95./Gt)? ,3774
`Declaration of Dr. Earl L. White
`
`different experiinentai runs, specifically when the chemical species to be studied are different
`
`between runs. Such standards correct for the ‘Tnernery effect,” ale, contarnination froin the
`
`cheniieal earryoVe.i* from prior sainpies. Blank controls in the form of 29% acetonitriie were
`
`run first thing each day, between every sarnpie set (which wonhi wash out carry over
`
`species}, and at the end at a day as a eohnnn-cleaning technique. A representative soiVent~
`
`eiiiy run is irieiuded as Figure 2. Note that the signal inteiisity is at least one order of
`
`magnitude lower than in the positive centre} {6.{)t’iX104 in Figure ii Versus 1.5x} G3 in Figure
`
`2}. The small peak at 22.22 minutes is a, eontarniiiant in the seivent hiank. The noise level is
`
`indicative of the iew ievei ef this contaminant. The haseiine rise at 26 minutes is due to high
`
`eeneentration of acetonitriie used to clean the column.
`
`It is weii known in the tieid that
`
`megtztive centreis tntist he run and therefoi'e I, having over 25 years in the field, ran adequate
`
`negative eentrels in generating the data reported in the Declaration of May 31,, 2011.
`
`14. A,CC01‘:‘.‘ii1lgify',
`
`5 eeiiternperaneousiy ran adequtate controls (lieu, positive and negatixze eeiitreis)
`
`when I conducted the experiments that were reported in the Deeiaration of May 31, 20} 1.
`
`[rest of page intemioiwdly left blank]
`
`OOOIDO4
`
`000004
`
`

`
`n
`
`.
`
`-.
`
`3?’ _£1’5.£
`<;3fj£§§;',. }i'$a:;ii L. W'§1:‘ce
`
`?11l‘fi‘§§f3' dis ‘.3021:-;~': that afii sta:*;eIm::1ts
`
`EG}2ax§fie£§g§$
`
`{mm ?.11ۤ
`
`ti‘.-.21‘:
`
`S€a.i"t‘»§’.1‘}i;’..‘:‘:t$
`
`«:33:
`
`i‘§’i.E‘c), am fi:.z"i';‘nerr,_ "i.§';‘-.31‘
`
`iiqesvz
`
`hemzsa oi my azzwu
`s
`. ,
`K
`’m‘£‘“<:3‘:‘;:?~.::ai.i<>;1 arzzé beiiaé‘ are beisevec. N: 02::
`
`{N
`:3.
`
`:::iz3.it<::ras;2:1a$:=. ‘Wm’-e 1-'z1..z‘:_<‘§.0:+*.. ‘wiifi =;’m2 5
`in
`§312:3is}.:e,§>;e °‘=.§j«' fine "C3,!" §n'2§3:~iser;;':1e::::i, er ‘m>=;%,1, =.1n,<i2‘::s Sie=;:‘:Li0::
`
`ii§§=:>3— 5‘{} m&ua::
`atzzments
`‘
`
`‘E.
`
`of L
`
`f
`
`"
`
`0'
`
`'
`
`Cixfie, Eznsi ‘-fhafi: 515:1 wiiifui 1°
`
`
`
`?C§2s.i‘¢>:§;
`
`9
`
`000005
`
`000005
`
`

`
`U,S.S.N. 95./O03 ,7?‘
`Declaration of Dr. Earl L. White
`
`Phosphoiioid std
`Hlvlaw.
`L
`.
`.
`‘
`I
`
`Figure 1. Total ion Chiomatograms for phosphoiipid staiidard soiutioii. This standard was
`analyzed with fu}E~:9ca.o eiecti‘ospray ionization during the anaiysis of o‘L}'ier phosphoiipido
`samples.
`
`000906
`
`000006
`
`

`
`U,S.S.N. 95/06)”? ,3774
`Declaration of Dr. Earl L. White
`
`c
`
`;.
`
`
`
`
`
` +-..........-...-2.....-...........-..........-a.-.......-4....-......-...........-.-........-...........-...........-
`
`‘
`5.00
`
`.
`
`‘
`
`.
`WCIJICI
`
`‘
`
`‘
`‘V’: CID
`
`.
`
`1
`21'} DD
`
`-1
`
`-1
`25 UC-
`
`1
`
`
`
`Ffigméb 2. Totai ion chmmatcgram far 2: 26)‘?/is EiC13tO1'}iU.”i}6IH2O blank. Seivent biaiiks are ofierz
`so1Vent—pmgrammed at 21 faster 1':»1te fur the Sofie purpuse of sin/ing tinwe as is the case hrtreg
`
`93791 V1/EN
`
`OOODO7
`
`000007
`
`

`
`Suppltzrnentai Declaration of Dr. Earl L. ‘White
`
`U,S.S.N. 95./'00”? J74
`
`A§§$EE§§X A
`
`Cumcuium Vitas sf D1: Earl L. Whfis
`
`000008
`
`000008
`
`

`
`ATTACHMENT A
`
`EARL L Vs/’HE'E‘ E — Currieuium Vitae
`
`MDX Bifi./~XI‘iaiy”[iCai Laberatery, Erie.
`R0. Be); 236
`
`Weiibein, TX 77881
`
`Oftiee: (979) Sir-$7368
`Ceii:
`(520‘s981~629€i
`
`
`
`
`Etiiieatieii:
`
`University of North Carolina
`at Chapel Hill
`Chapel Hill, North Carolina
`Majer: Chemistry (Ariaiytiizai)
`Graduated: June £987
`
`University ef Pittsburgh
`iPisttsburgh, Penrisyivarii a
`M aj oi‘: Ciieinist1”y (Anaiyticaii)
`
`Degree: PhD.
`
`1983 1987
`
`Spectrometry
`
`1975 ~ 1 977
`
`1975
`
`1973 ~ 1 974 (pamtinie)
`
`Degree: MS.
`
`Jaeksen State University
`;Eaekseri, Mississippi
`Majer: Chemistry (Organie~Ari-aiytieai)
`Graduated: August 1975
`University ef Mississippi Fvtedieavi
`Center, Jaei<sen, Wississisppis
`
`Degree: BgSg
`
`1967-197}.
`
`Umlergrarluate Seheei:
`Jackson State Ceilege
`;Eaekseri, Mississippi
`Majer: Chemistry
`Graduated: December 73 971
`
`Prefessienal Experience:
`
`
`
`
`
`
`
`ii/G8—preserit President :3; CEQ
`Established MD); in 2008 and ineerperated in 2009, inanage business eenipenent and
`directs teehniseai ftirietiens. Maiiages but get, prepares quotes, prepesais, pi'eteceis and
`repeits for services peifermeci.
`
`lnterated Biemeleeuie Ceremtien Tues
`
`
`
`J "
`
`373:3
`
`Vice President, Anaiytieal & Fiiarmaeeiitieai Sciences
`G7/07m 11/GS
`Manage Advance Anaiytieai and Quality Ceritrei funsetiens at the Cer'pera,te ievei. Assist
`seiii0i'manageir1erit with the staff estimates and budgetary i‘equii'emerits.
`
`000009
`
`000009
`
`

`
`(CV Coritkl)
`
`l?.A.Rli lg. ‘Wlll'"l”l?.
`
`
`G9/02- 04,/l-,/2‘;ll{l7 Vice Presldeiit, Advanced Analytical Sciences & Blreettir, Quality
`Control
`
`to
`lunctiorls at the corporate level
`Manage Advance Analytical and Quality Control
`include QC operations in tilwensboro, KY and Gerniantown,
`ls/ll). Assist senior
`management with the staff estimates and budgetary requirements,
`research and
`development focuses.
`
`llllreetor, Advance Analytical Resources & Quality Control
`ll)/99439/’(l2
`Establislierl and directed tlie Advanced Analytical Resources Division including Assay
`Development Group. Directed Quality Control Group for production of pharmaceutical
`products under eGMP guidelines (proteins expressed in ]\7icorz‘a:zna beztzzizazmtzna plants)
`including Pliase l Clinical
`trials of at non—l*lodgl<in’s lymphoma vaccine. Release
`vaccines to Quality Assurance for patients use and maintained stability studies. Directed
`proteomics functions Within the Advance Analytical Resources Division.
`
`Large Scale Blolofi 7 Cor oration lformerl Blosouree Teelinolo ties lne. . Vaeaville CA
`
`l,€l,"98~lG/99
`
`Sr. Scientist
`
`included staffing with
`(Ilroup wliicli
`Developed Advance Analytical Resources
`approximately l0 scientist and purchasing of mass spectrometric equipment to include
`GC/'l\/lS, l‘vlALDl—TOF, LC/Q—TGF t‘vlS/l‘vlS and LCQwl\/lS/'l‘vl-S.
`
`Roll. Revnolds Tobacco Corn an ’ W/lll§‘i(3nv§?t3l£?EFl NC
`
`
`
`
`
`Sr. Staff R&l3 Clieniist, W ass Spectrometry Group lgeader
`l2/’88~(l9./98
`'l"eclinical responsibilities include; analytical methods
`development and analyses,
`operation and maintenance of gas clnoinatograplt/mass spectrometer/data systems, report
`writing and teclinical publication/presentations.
`Supervisory and managerial responsibilities included; learlersliip of mass specti‘onietr_v
`group, project management, budget proposal, capital equipment purchase, supervision of
`personnel, personnel evaluation and directed postdoctoral fellow research, etc.
`
`l2/85—l 2/88
`
`nan Clieiriist
`
`Responsibilities include; analytical methods development and analyses, operation and
`maintenance of gas cln‘omatograpl1/niass spectrometer/data systems, report writing and
`teclinical publication/presentations.
`
`Natlitnal lnstltute ofllinviromnental llealtli Sciences Nll?. llS‘ Research "lrlaiivle Purl»; NC
`
`
`Clieniist/Graduate Student Q-A}}§M}lEt’tiYl§3EHf
`(39/’83—l2,"85
`Graduate Student, Teacliing Assistant, Rt3S€E1l‘Cll Assistant, Chemist on "P Appointment”
`with NlEHS performing ion—molecule reaction studies using triple quadrupole mass
`spectrometry (M S/MS}.
`
`
`Clieniical lndustrv lnstitute e
`
`l98 l—l983
`Associate Scientist, Head, Analytical Services L-nit,
`Performed duties consistent with those of a department head to include budget and
`project management, proposal writing, equipment purcliasing, writing reports, and
`2
`0000010
`
`0000010
`
`

`
`EARL L. VVHETE
`(CV Cont'ti)
`chronratograpli./'rnass
`operation
`and inaintenance of gas
`supervision,
`personnel
`speetromecter/'d.aita system, pnarniacoltinetics research, scientific writing presentations and
`publications.
`
`19774 981
`
`Senior Research Associate
`
`Performed toxicological research on environmental chemicals in small animal studies.
`Also, published the first peer—r‘eViewed niarruscript for CHT.
`
`‘Westing honse R&i1=, Pi3fiT§i)‘£1¥'§ii3 PA
`
`Sinnrner— l 977 Anaiytieai Chenii:-it
`Summer employment during gratlnate school.
`
`Universitv of Pittshnrgii. Pittsburgh: PA.
`()9/754 2/77
`Teaching/Research Assistant and firatinate Student
`'l'-aiight nritlergraduate clrernistry laboratory and performed r‘esearch.
`
`Mississi
`
`rm Crime Lahorator’/Universitv of Mississi :2 Medieai Center. Jaelisoii MS
`
`instrumentation Specialist/Section Chief, Toxieoiogy
`12/7r-l~8./'75
`Same as below with adtlitionali l,'8-S}30TlSli’)l,ill‘.y of mass spectrornete (l‘v’lS) purchase and
`Supervision of M S operator‘.
`
`Gl/73-12/'74 Toxicoltigist i/Section Chief, Toxieoiogy Section
`As Section Chief, Toxicology Section, coorclinated personnel, analysis of suspectecl drug
`overtlosage samples, operation and rnaintenance of
`eliromatographs/cliron’iatographic
`data
`systeni,
`€‘7V'£ll1.EEtl§l0Ii,
`specification writing,
`and
`purchasing
`of
`scientific
`instrumentation and performed hlootl alcohol analyses.
`
`G7/72~Gl/73 Toxieoioiiist i
`iPerformed anaiysiis of suspected drug overdosage biological sarnplest operation and
`maintenance of
`chrornatograplrs.
`
`Arniy Metiieai Hospital, Fort Qiaciésong South Caroiina
`G2/’72«-G6./'72 L/ai3or*atory'i"eehnieian
`
`ilriiversity of Mississippi Metiieal Center, Jackson, MS
`€36/’7l)~(P2.«"72
`LaboratoryTeehiiieian
`
`Appointments:
`Atljunct Professor of Chemistry, Wake Forest University, Dept. of Chernistry
`Liaison, R.lR_—Corpoi'ation Associate, American Cliernical Society
`Co—AdVisor, graclnate student program with North Carolina A&'l‘ State University
`Visiting Professor, National Urban League Black Executives Exchange Program (BEEP)
`Adjunct Visitirig Prtifessor, SeiWorl:<s ofWinston-Salem
`
`Anditionai iélxperieiieesz
`Proficient in the o aeration and maintenance of these Analvtical instruments:
`*7
`“.9
`ooobo11
`
`0000011
`
`

`
`EARL iii. is/iiii'"i”E
`{CV Coritki)
`Gas ehroinatograph/inass spectronieter/tlata systein, ultra—Violet Visible—, infrarecl—, atoinie
`ahsorption/'eniission
`spectrophcitonietei"s,
`pH meter,
`specti'oliuororneters,
`high
`perlcr'ii'iar1ce liquid clircrnatogra.ph,s, EMIT arialyzer system, liquid scintilliation counters,
`electi'ospray/'Al’Cl—MS, capillary electroplioi‘esis~MS aiitl l\/ES/"IVES.
`
`Gtiiersz
`
`Peer Reviewer:
`
`,lournal — J. Chroincztograpizic. Scz"enr:e
`Journal — J. Cizrrinzaiogmpizy
`Site Visitor/Grrant proposal reviei rer---NSF Grant l’roposal—lncarnate Worcl College (1994)
`
`Military:
`
`Lieutenant Colonel — Retired (April 30, 2009 w,/34.66 years of service)
`
`United States Army National Guard, December l 97 1 — l 977
`ll2lh l\«iP Battalion, H HID, Jacksoni, MS ~ Clerk Typist — 4 Years
`
`l07fl“ Field Artillery, HHC, l?’ittsl3urgli, l’A, Battery Aitlrnan ~ 2 years
`Discharge: Honorable
`
`United States Anny Reserve, August l98(l to Septernber i988
`80:3”; Ml’ Company (CS), Nuclear‘ Biological
`Clieiriical (i\‘=BC) i\lC() — Noveinber 1984
`Direct Coniniission as Chemical Officer, November l 984
`
`Tours ofDu ty (three weeks, each)
`Suhic Bay, PhlllI)1')il1€-S (l987)
`Suhic Bay, Philippines (3988)
`United States Army Reserve, Septeniber P988 to present
`Direct Coniinission, Chernical Corp, i984 (ZLT)
`Direct Cornrnissiion as Meclical, Service Officer, Septernber i988, Current Rani: (l,‘s/lager‘)
`Previotuslyz li\/EA, Defeiise intelligence Agency (DEA), Washington, D.C., AFl‘viiC, Ft.
`Derrick, Fredrick, MD, William Beaumont Army Medical Center, Ft. Bliss, TX
`Sr. Observer/Trainer, 91“ Division, lst Btlfi, C-SS—Tasl{ Force, Canip P§i1'l{S, Dublin, CA
`Currently: LTC, l\/ES; Envirorirnientali Science Ol’licer/’liistr1ictor — 2ND Medical Brigade./'
`
`WMD l-"liograin
`
`Membership:
`American Chemical Society (CNCS~Sectioii Cha,ir'inan "93, Cliair~ Elect/'Prograrn t'_3liair '92,
`Secretary ’9l and Treasurer '90), Mississippi Acadeniy of Science, Society of Aiialytical
`Chemists of l’ittsl>urgh, Applied Spectroscopy Society, Phi Lainbcla Upsilon Honorary
`Cheniical Society, America Society for Mass Spectrornetry, Natioiial Technical Association
`arid Alplia Phi Alpha Fraternity, inc, Triangle Area Mass Spectrornelry Discussion Group,
`National {)i'gani;:-ation of Black Clieniists and Chemical Engineers (i\l{)BChCE), Bay Area
`Mass Spectrometry Discussion group (BAMS) and the SF Bay Area Froteonie Society.
`
`Civic Activities:
`
`Visiting Pi'ofessor', Natioiial Uihan l..eag1.ie’s Black Execiitives Exchange Prograin (fl§iE3lEil’),
`(l 986- l 997).
`
`Sciworiss of ‘\Viiiston~Saleni ature Science Center), Adjunct Professor, (1993-1998).
`
`4
`0000012
`
`0000012
`
`

`
`{CV Coritki)
`Co~coor(:linator, '1‘utorial Prograin, Unitecl 1\/letropolitan Missionary Baptist Church, (11992-
`1998).
`
`EARL 1;. V1/H1‘"l"E
`
`lvtediation Services of Forsyth County, Member
`Boa.rd~of-Directors,
`President — (1994), Presitleiit and Chairman of the Boarrl (19954 998).
`Advisory Board Council, Forsyth Center for the Deaf and Hard of Hearing (111)113-1998)
`Paniicipant/Denionstrator, Local e1enientary, iniddie, high sehoo1s anti coileges.
`
`—
`
`(1993), Vice
`
`Certificates aru1Awari1s:
`48%
`
`lnterpietatioii ot‘li1l’rai'ed Spectra, Mississippi Section of The Arnerican Cheinicai Society,
`ACS Filrn Short Course, January 22,1971.
`
`Retention Data in Gas C1ii‘oniatogr‘aphy, Wasliiiigtoii University School of Continuing
`Education, October 16, 1973.
`
`CNTA Mei‘itorious Service Awarcl, 1982.
`E1ectecl Who’s—Who in the South and Southwest in 1983.
`
`Recipient of the NSF Fellovvsliip, 1984~85
`
`Gas Clironiatography Troub1eshooting course, Hevvlett—Pac1§ard, Atianta, GA, September 27,
`1987.
`
`lntrocluction to CALS Course, R.;1. Reynolds Toibacco Company, Winston—Salein, NC,
`February 14, 1986.
`
`Aquarius '1‘i‘aining Course, 1—iew1ett~1’ac1<ai'c1, New Orleans, 1.../~\, September‘ 11, 1987.
`
`RJR Manageinent Developnieznt Prograin Course, RJ. Reyno1t.1s Tobacco Cornpany,
`Winston~Sa1ern, NC, .1une 27, 1988.
`
`VG lnstruinents, 70s and 7OSE. Basic Operation, Savannah, GA, October, i198S.
`
`Vi} htstrurnents, Quantitative Trace Analysis, Sa.vannali,
`
`(SA, November, 1988.
`
`Beckinan 1’ea1<—1’ro for Experienced Users, V\"11’1StOl1-38.16111, NC, Novernher, 1988.
`
`Wl'1o's—Who in Scieriee and Erigirieer in 1992.
`
`National Urban League°'s Biack Executives Exchange Prograin (BEEP) 5 Year Service
`A.VVI>t1‘t1, 1995.
`
`RJR Project Leader '1‘raining Prograin, 1’ehi‘uai‘y, 1992.
`
`Central North Carolina. Section, ACS Presitlent"'s Avvarct, 1994.
`
`G. Robert 1)i1\/laico R&1) Team Award for Results '1'hrough Diversity Facilitatiori, 1995.
`
`Central North Carolina Section, ACS, Outstanding Service Avvarct, 1995.
`
`1\/lerliation Services of Foi‘syth County, Past~C1iair AWt?t1‘rf1, 1998
`
`Winston—Sa1ern Stacie University/RJR Partners Prograin Mentor—ol’—the—year Award, 1998.
`
`WQQQ
`
`& W
`
`
`
`fiflfififififitfivfifi
`
`Enstitutes, ‘wnrlrshops anti Corwentions Attended:
`8%
`
`Mississippi Section of The Anierican Chemical Society, 1971 ACS Filrn Short Course,
`llattiesburg, MS.
`
`Toxicology Worksliop, Houston TX, 1972
`
`Pittsburgh Corrference, Cleveland, 011, Atlantic City, NJ, 1973, 1977, 1979, 1981}.
`
`Gas Chroinatography Short Course, Wasliington University School of Continuing Etlucation,
`St. Louis, MO, 1973.
`
`1-lewlett~1’acl<ard Gas Chi'oinatography'1‘i'ouhleshooting course, Atlanta, (SA, 1974.
`
`Liquid Chroniatography Worlrsliop, Waters Associates, 1‘viti1foi"t1, MA, 1975.
`
`‘K
`
`0000013
`
`0000013
`
`

`
`{CV Corit'd)
`48%
`
`EARL L. VVTTCTTTE
`
`Southern Association o1’17orensic Scientist Meeting, Aiburn, AL, 1975
`
`Mississippi AcaC1err1j~,IofScieiice Convention, ,1ac1t:son, MS, 1975
`
`Mass Spectrai 1111'f31‘p1’f3t’<11'10:11 Course (Fred 1\/1cLafferty), Raieigir, NC, 1978.
`
`North Carolina Academy of Science, Greensboro, NC, 1979.
`
`Arnerican Society for Mass Spectronietry, 1\/1inneapo1is, MN, Hono1u1u, H1, San Antonio,
`TX, San Diego, CA, Cincinnati, 011, Denver, CC’, San Francisco, CA, 1\’1i£t1'1’11 Beaxcii, 17L,
`Tucson, AZ, Washington, DC, Atlanta, GA; 1981, 1982, 19S4, 1985, 1986, 1987, 1988,
`1989, 1990, 1992, 1995.
`
`Nationai Teciinicat Association Nationai Convention, 1<.issirninee, 171..., C1eve1a.nd, 011, 1983,
`1984.
`
`Tntroduction to CALS Course, R1. Reynoids Tobacco Coinpany, W111S'1,G11-S’<1.1f.’.111, NC, 1986.
`
`1<,epnei‘—'1‘i‘egoe Ratioriai
`Winston—Sa1ern, NC, 1986.
`
`Processing
`
`course, R1. Reynoids Tobacco Company,
`
`1'1evv1ett—Pac1<ard Aquarius Training Course, Nevv Qrieans, LA, 1987.
`
`VG instruments 70S Basic Operation Training Course, Savannah, GA, 1988.
`
`Vi} Tnstrnrn ents Quantitative Ariaiysis Course, Savannah, GA, 1988.
`
`internationai Wor1<shop on Hybrid Mass Spectrornetry, Lake Louise, Canada, 1988.
`
`Arnericari C1ien'iica1 Society 1\1ation,a,1 Meeting, Washington,, DC, New Yor'1<, NY, Denver,
`CO, Chicago, 11..., San Diego, CA, San Francisco, CA, Oriaiitio, FL, Las Vegas, NV, Daiias,
`T'X, San Francisco, CA; 1990, 1991, 1992, 1993, 1994, 1995, 1996, 1997, 1998 and 1999.
`
`Sever-a1 Statistics Courses (1989, 90} and severai others.
`
`United States Army Reserve Annual Training, Medicai Service Corp, Oft1cer’s Basic and
`Advance Courses, Ft Sam Houston, TX, 1989 and 2003.
`
`United States Army Reserve Annuai Training, Medicai Service Corp, Wiiiiani Beaumont
`Arrny 1‘v1edica1 Center (Chief, Chemistry Lab Training), E1 Paso, TX, 1990, 1991, 1992, 1993
`and 1994.
`
`United States Army Reserve Annuai Training, ivietiicai Service Corp, Arnied Forces Medicai
`inte11igence Center (Anaiyst, NBC), Ft. Detrick, MD) 1995 & 1996.
`
`United States Army Reserve Annu-a1 Tmiriing, Meiiicai Service Corp, Detenise 1rite11igence
`Agency (fD1A} (Sr. Anaiyst, NBC),
`iiioiiing AF1E3, Washington, DC, 1997, 1998, 1999 &
`20110.
`
`innovation Week Training, R.1R.11RDepartnierit, Wi,nstori~Sa1eni, , (1993).
`
`Creative Leadership Trairiing, Center for Creative Leadersiiip, Greensboro, “NC, (1993).
`
`United States ,Arniy Reserve Anriuai Training, Medicai, Service Corp, Armed Forces 1‘v1ei1ica1
`inteiiigence Center (Senior Anaiyst Training}, 1’t. Detrick, MD, 1995 and 1996.
`
`United States Anny Reserve Annuai Training, Defeiise 1nte11igence Agency, DTA (Senior
`,Ana1yst Training}, Wasiiirigtori, DC. 1997.
`
`Tobacco Chemist Research Conference, Greensboro, NC, Winston—Sa.1ein, NC, (19911, 1997).
`
`fifififi
`
`Q Q
`
`éfifififi
`
`Q
`
`6
`0000014
`
`0000014
`
`

`
`{CV Cotitki)
`Piiiilicatinns:
`
`EARL L. ‘WH l’"l"E
`
`l.
`
`5»:
`
`DJ
`
`L, Development of Gas Chroinatograpliic Techniques for the Analysis of
`‘White,
`Toxapltene, Cltloroforni and HGXa.Cl1iG1‘0Gll1€tflC".
`l\/l.S. Thesis, (i975).
`IRCS
`Hume, A. 8., Douglas, B. H. and White, E. L, Placental transfer of ethyl alcohol.
`El/Zed. Sci: Drug ll/feiczb. and Taxical. Phi:irrm:zc0i., P!zysioi.,‘ Repi“0::z’., Biostretic rims’ Gym, 4:
`203 (l 976).
`M. and Plaiultey, F. W. Flarne
`‘White,
`L, Zielinslii, C. A., Former‘, R,l‘°~/'l., lleitliinar,
`emission studies of several metal ehloritles with vapor phase sampling.
`/lztzai. Cizim. /lam,
`ltll: 89-97, (l 978’).
`White, E. L, Bus, 3. S. and l‘l€t3l{,
`
`l-E.
`
`ii'A.
`
`Simultaneous rleterinination of n~l—lexane,
`
`tissues by gas
`in biological
`antl 2,5—lieXanecti0ne
`2—hexanone
`speetroinetry. Biomed. M52155 Specz‘re;>i:rz., 6:
`il69-l72, (E979).
`Bus, J. S., (White,
`L, Tyl, R. W. and Barrow, C. S. Perinatal toxicity and metabolism of
`n—liexane in Fiseliei‘—3=-‘V-i rats after inhalation C){pOSlll‘C during gestation.
`Toxicroi.
`/lppi.
`P.izarmac0f., 51: 295-302, G979).
`
`eliromatograpliy—niass
`
`Gillies, P. J, Norton, R. lvl, ‘White, E. L. and Bus, 1. S. Studies on the inhibition of
`
`sterologensis in it6X3.CEtt“i)Gl'1—lti(.ltlC§3(l distal axoriopa,tliy in sciatic nerve of the rat. Togricoi.
`/lppi. _P!zarn'za(:0i., 54: 2l7~22'2, (l 980).
`irons, R. D9,, Gross,
`A. and ‘White, E. L. Atlliillti-.2 Eyidertee for an euterogastrie cycle in
`the rat. Food C0.s'1m2z. Toxi(:(ii., iii: 393~39'7, (l.98(l‘).
`Bus, 3. S,, White,
`L, Gillies, P. J. and Barrow, C.
`
`Tissue distribution ot‘i1—liexane,
`
`nietliyl n—butyE l<etone and 2,5~liexanedione in rats after single or repeated inhalation
`exposure to n—hexane. Dmg Metczi). Z3lisp0s., $3‘: 3S6~38'7, (l98l).
`l-leek, l-E. d‘A., ‘White, E. It... and Selirnitz, M. C. Determination olfornialcleliyde in biological
`5
`tissue by
`ehi'oi'natography~mass speetronietry. Birzined.
`1‘/2F’ic2,s'.s‘ Specz‘r0m.,
`$3‘: 347-353
`(1982).
`An
`.lr., T.
`L, Cheplen, J. M., Sherrill, J. M. and Hanan,
`‘White,
`Raynor, T.
`evaluation of a water puritieation systein for use in animal facilities. La:zl70rat0.ry Am'mais.,
`18: 4561, (l9Sr-i).
`
`10.
`
`ll.
`
`l2,
`
`Cheplen, J. M, Barrow, C. S. and ‘White, E. L, Deteiniination of airborne tree elilorine in
`the presence of aniinonia by capillary gas ehr‘oniat0gra,plty. Anai’. Chem., ‘S6:
`il9/l—ll96,
`(l,984‘).
`ll»/l., Reaction of aninionia with
`l3ursey, M,
`liass, J, R. amt
`.l~t'_3.,
`‘White, E. in, Tabet,
`accelerated benzoyl ions using triple qi.iaclri.ipole mass speeti‘onietry. Org. M'ass S[.?E3(T'i7’()i?’l.
`22, l32—l39 (il987).
`ions:
`.White, E. L, "Reaction of arnnionia with g-as~pliase plienyl benzo-ate and benzoyl
`lon—moleeule reaction study using triple quadrupole niass speetroinetiy". Phi}. tlissertation,
`G987).
`
`l4.
`
`7
`
`l7., Chung, H. l.,., Coletrtaii, W. M., ill, Elder, J. F., Giles, J.
`(Bordon, M., Boigerding, l\/l.
`A., l‘~/loore, D.
`Rix, C.
`Uhrig, M.
`anti ‘White,
`E... Analysis of tlue—eurecl tobacco
`essential oil by l'1§/1‘)l,18l'1?ll(;‘(i analytical teeliniques, J. Chrmnc:z.i. Sci, 25, (1988).
`,‘White,
`E... and l3ursey, M.
`l\/l.,
`Distinguisliirig positional
`isomers of l'lf3X?lClll0l‘ll’la.l,§3d.
`hiplienyls by ion—moleeule reactions in a trig:tle~o,uacli'upoEe instrument. Bioazed. Erzvirrm.
`11/;!’a5:.s‘ Specfrmn.
`ltl, 4l 3-415, (l 989).
`
`P1
`I
`0000015
`
`0000015
`
`

`
`EARL L. Vi/'H1‘"1"E
`
`{CV Ceritki)
`16.
`Robertson, .111, 13., ‘White, 13. E1. and Bus, .1. S. Effects of niethyi etnyi ketone on hepatic
`niixed-tiinction oxidase activity and on in viva inetaboiisni of I’l~i16X£tI’l6. Xz2I2()i)i(3lic:'a,. 19,
`721-729, (19891).
`. ‘White,
`14., Unrig, M. S., Johnson, '1'. 1., Gordon, B. M., Hicks, R. D, Borgerding, M. 1?},
`Coleman, 111, W. M. and Elder, Jr., .1. F. Quantitative determination 01’ seieeteti eninpnnnds
`in a K,eritueky iR4F cigarette S)”,1’10i,{€ by inultidiniensional
`ehrornategrapiiy and selected
`ion rnnnit0ring—mass speetrnrnetry.
`.1. Clzronzaragzi‘. S<::i., 28, 393-399, (1990).
`Chu, 1., Bndnar, .1. A., Bownian, R. N. and ‘White,
`L. Deter'n'iin21tieri 01’ vincristine and
`
`17
`
`18.
`
`19.
`
`vinbiastine in C::zihz;n"c2nl‘izu.<: rosem plants by high perforrnance iiquid cnrornatography/i
`eieetrospray ionization mass spectri'>n'1etry.
`.1’. Liz}. (.71r()n'zair)gr. (ii: Rel. Teeiznoi. Et1{8) 1 1:39-
`1174 (1997).
`Cnu, 1., Botinar, .1. A, Bowman, R. N, aiid‘«1/Elite, E. L. Quantification ofyineristine and
`yinbiastine in C'z:zt.h»;:zraz'zzi2us roseus plants by capillary zonal eieetrepheresis. J. of
`Cfiroznafogz". A. 755 281-288 (1996).
`. Che, 1-H. and ’W1ii§‘.e, E. L, On—1ine Focusing CE~1‘v'1-S Deterinina.tinn of vinbiastine and
`\7111,C1‘iSEi11f3, 1n preparation, (1 998).
`.Chu, 1~i*1., Munze, .1.
`and ‘wiiite, E. 1...,
`
`A capillary eieetropnmesis/niass speetrernetry
`niethed for the deterrnination of tobacco specific nitiesaniines with eieetrespray ionization
`detection, 1n preparation, (1998).
`. VVBHQ, E. L and Brooks, C. 0., Development of an on-eoinrnn cryogenic trapping method
`for the d.eterniina.tion of Vinyl chloride in fresh niainstreain Vapor phase cigarette smoke, 111
`pr'eparation , ( 1998).
`.. 1-1aniey, K., Nguyen, E_.., Khan, 13., Pegue, (3., Vojdaiii, 13., Panda, 5)., Pinot, E9}, Oriedo, V.,
`Rasecinwa, 1..., Siibraniaiiian, S., Miiier, B. and ‘WS’iite., 131. 1... Development of a piant Vi1”Eii-
`Vect0r—based gene
`expression assay for
`the
`screening of yeast cyteehrenie P450
`inonenxygenases. Assay amt? Drug deveiopznent Tecr’2r20i0g‘ies.
`1(1—;?;) 147~1€S€)
`(20031).
`Du, 11., Cameron, '1‘. L, Garger,
`1., Pegne, G. 1)., Hannn, 1;. A., ‘White,
`Haniey, K M.
`and Grab0ws1<i, G. A., Woinian disease/eheiesteryi ester stnrage disease: effieaey o1’p1ant—
`produced hunian iyseseniai acid lipase. in mice. J. Lipid Res. 49, 16464657 (2008).
`i\) ‘J:
`.. MeCer'n’iici<., A. A., Rei‘id;v',S., Rein}, S. 1., Cameron, D. 1., C;e:ervvinks1~;i, D. K, Vejdani,
`Haniey, K 1i/1., Garger, S. 1., ‘White,
`1..., Nevak, 1,, Barrett, 1,, Holtz, R. 8., Tuse', D. and
`Levy, R. Plain.’-producer} idiotype Vaccines for the treatnient of i'1on~1*1or1gE<in’s iympi'}01’l'}.?t2
`Safetyt and ininninogenicity in a phase 1 clinical st1.idy.
`’]‘v’/£5 ‘£1111-(29) 101 3}»-111136 (20118).
`Zoi.ii<:nri, D., Rawe, 1., Singh, EVE}, Kubiin, C., Dawson, K., 1-1-addori, W. 17., ‘White, E. 11.,
`Haniey, K M., Tuse, D, Maiyj, W. and Papas, A. Discovery of Putative Salivary Bieinarkers
`for S_i'dgi'en’s Syndronie Using High Resointien Mass Speetrenietry and Bioinforrnaties,
`Subniitted, (21109).
`. Pogne, G.1’., Voj dani, F, Painier, i{.i§i., Hiatt, 131., Hume, S., Phelps, 1., Long, 1_.oi'i, Bohoroya,
`N, Kim, D0,, Pauly, M., Veiasco,
`.31., Wnaiey, K, Zeitiin, 1..., Garger, S.
`.31., ‘White,
`14).,
`Hayden, H. and Bratcher, 3., Protinction of Piiarinacentieai—grat’ie reconibinant apretinin and
`a monoclonal antibedy preduet using piant—based transient expressien systems.
`Pirmt
`BiozecknozioggryJournal. 8, 1-17, (2010).
`
`26.
`
`8
`0000016
`
`0000016
`
`

`
`{CV Coritkl)
`Abstracts aiitl./or l‘*“resentations:
`
`EA.RL 1;. ‘WHITE
`
`l.
`
`is
`
`'u.)
`
`L, 1’articipating Lecturer, Pre-suninrer lnstitute on lnstrurnental Methods,
`‘White,
`Jackson State College, Jaclrson, MS (May 1975).
`Plftllliffy, F. W. and ‘Willie, E. L, A niicroconiputer controlled atoniic ernission systein.
`l?.asterri Anal. Syri'ipos., (1977).
`Bus, .1. S., ‘White,
`14., 1%lecl<, ll. d’A. and Gibsori, .1. 13., The distribution and ri'ieta‘oolisni
`
`ot"n-liexane in pregnant Fiselier~344 rats. Temz't)i0gj.r, 17:42/X, (1978).
`Bus, ,1. 8., VVlllill.€:,
`1.. and Barrow, C.
`Disposition of n,-liexane in rats after single and
`repeated inlnaiaticon exposure. Taxicoi. Aflo

This document is available on Docket Alarm but you must sign up to view it.


Or .

Accessing this document will incur an additional charge of $.

After purchase, you can access this document again without charge.

Accept $ Charge
throbber

Still Working On It

This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.

Give it another minute or two to complete, and then try the refresh button.

throbber

A few More Minutes ... Still Working

It can take up to 5 minutes for us to download a document if the court servers are running slowly.

Thank you for your continued patience.

This document could not be displayed.

We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.

Your account does not support viewing this document.

You need a Paid Account to view this document. Click here to change your account type.

Your account does not support viewing this document.

Set your membership status to view this document.

With a Docket Alarm membership, you'll get a whole lot more, including:

  • Up-to-date information for this case.
  • Email alerts whenever there is an update.
  • Full text search for other cases.
  • Get email alerts whenever a new case matches your search.

Become a Member

One Moment Please

The filing “” is large (MB) and is being downloaded.

Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.

Your document is on its way!

If you do not receive the document in five minutes, contact support at support@docketalarm.com.

Sealed Document

We are unable to display this document, it may be under a court ordered seal.

If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.


Access Government Site

We are redirecting you
to a mobile optimized page.





Document Unreadable or Corrupt

Refresh this Document
Go to the Docket

We are unable to display this document.

Refresh this Document
Go to the Docket