CYTOL OGI C, I NC., and COL ORADO STATE UN I VERSI TY RESEARC H FO UNDAT I ON, Pla int if fs , v. BI OPHERESI S GMBH, and BI OPHERESI S TECHNOL OGI ES, I NC., De fe nd ants
. UNITED STAT ES DIS TRICT COURT

F OR THE D ISTRIC T OF CO LU M BIA

Civil Action No. 08-978 ( CKK)

M EM OR

AN DU M OP IN ION (January 15, 2010) Plaintiffs, Cy

tologic, I nc. and Colora do State University Resear ch F oundation (collec tively , “Cy

tologic” ), filed the a

bove-c aptioned ac tion challeng ing the actions and de cision of the B oard of

Patent Appea ls and Interfe renc es of the United States Patent and Tra demar k Offic e pursua

nt to 35 U.S.C . § 146. Cy tologic na med as De fenda

nts Biopher esis GMBH , and B iop he re sis Te c hn olo g ie s, Inc . ( c oll e c tiv e ly , “ B iop he re sis ” ). Pr e se ntl y be fo re the Court

is Cy tologic’ s [20] Motion for Summary J udg ment to Vacate Interfe renc e Pursuant to 35 U.S.C. § 135(b)( 1) and Reque st for Ora l Hear ing. A fter a sear chingrevie w of the pa rties’ brie fing , the administrative re cord, the rele vant ca se law, a nd the entire rec ord her ein, the Court shall DENY Cy tologic’ s [20] Motion for Summary J udg ment to Vacate Interfe renc e Pursuant to 35 U.S.C. §2

135(b)( 1) and Reque st for Ora l Hear ing, f or the re asons set for

th below. Specific ally , the Court finds that the B oard of

Patent Appea ls and Interfe renc es (the “ Boa rd”) corr ectly

allocate d the burden of proof with re spect to Cy

tologic’ s preliminary

Section 135(b)( 1) Motion and that Cy tologic is pre cluded f

rom raisingnew a

rguments reg ardingmateria lity befor e this Court that
wer e not pre sented to the B oard be low. I. BACKG ROUND As is expl ained in more detail below, Cy tologic’ s now-pendingmotion for summary judgme nt is narrow in foc us and ra ises only two discrete challeng es to the B oard’ s decision below. Consequently , much of the pr ocee dings be fore the B oard a re not dire ctly

rele vant to the instant Memorandum Opinion. Indeed, g iven the Court’s ultimate re solution of Cy tologic’ s motion, the Court does not herein re ach the substantive merits of any of the B oard’ s findings of fac t in the interfer ence proce eding s. Nonethele ss, in order to better understand Cy

tologic’ s pendingmotion and the arguments raised the rein, it is nece ssary to provide a br ief re view of the rele vant patent a

nd interfe renc e law a s well as the g ener al fa ctual bac kg round of this ca se so that Cy tologic’ s curr ent ar g uments may be plac ed in the prope r conte x t. A. Patent and Interfere nce B ackground 1. Patent Prosecution The proc ess of obtaininga pate nt is known as “prose cution”and be g ins with the filing of an application with the Patent and Trade mark Of fice (“PTO” ). See I

nterve t, Inc. v . Merial Ltd. , 64 3 F . Su pp . 2 d 9 7, 99 (D .D .C. 20 09 ); see ge nerally 37 C.F.R. § 1.51. A patent a pplication consists of a spec ification of the pr oposed pate nt, including a claim or c laims, an oath or decla ration, dra

wing s as may

be nec essar

y , and the a

ppropriate filing f

ee. 37 C.F .R. § 1.51(b).A claim may be either independe nt or depe ndent. An indepe ndent claim stands alone 1 and does not re fer

to another c laim, while a depe ndent claim make s express refe renc e to one or more pre vious claims and includes a ll of the limit ations of the ea rlier c laims, as well as the ne w limit ation(s) found only

in the depende nt claim. See35 U.S.C. § 112.

3 Foc using on the specific ation in particular , as Judge He nry H. Kenne dy , J r. aptly

explained in a
rec ent dec ision, [a] specific ation must include both a written desc ription of the i n v en t i o n and an enable ment for a claimed invention that expl ains the “ma nner a nd proce ss of making and us ing [ the inv e nti on ], in

su c h f ull , c le ar, c on c ise , a

nd e xac t te rm s a s to e na

ble any person skilled in the art to which it pe rtains
. . . to make and use the same.” At the e nd of the wr itt e n d e sc ri pti on

and e na ble me nt, a

pr op e r sp eci fi c a tio n s ho uld c on c lud e wi th a lis t of “c la ims ,” wh ic h id e nti fy the sp e c if ic inn ov a tio ns , c omp on e nts or su bp art s o f t

he inven ti on , the a

pp lic ant r e g ard s a s h e rs . Ac la im i s a sin g le sentenc e desc ription of what the a ppl i ca n t believes to be her inve ntion, setting the bo un da ri e s of the inv e nti on the a

pp lic ant w ish e s th e PTO to e xami ne . Asin g le c la im can be composed of multiple eleme nts and/or limitation s . E l ements are the 1 previous l y

known phy sical compone nts that make up the c laimed invention. L imitations , o n the other ha nd, usually

descr ibe the cla im’s restrictions. An applicat i o n may

contain seve ral c laims, and ea ch cla im usually contains seve ral restric tions. I t is these claims that define the scope of pate nt protection. Interve t , 643 F. Supp. 2d at 99 (inter nal citations omitted). A p ate nt e xami ne r t

he n r e vie ws the a

pp lic a tio n to de te rm ine wh e the r a pate nt s ho uld i s s u e. “O nt ak i n g u

p an ap p l i ca t i o nfo r e x am i n at i o no r ap at en ti na r ee x am i n at i o np ro ce ed i n g, the examiner shall make a thoroug h study

there of and sha ll make a thorough investigation of the available prior ar

t relatingto the subject matter of the claimed inve ntion.” 37 C.F.R. § 1.104(a) (1). I f the patent examiner deter mines that the applica

nt is entitl ed to a patent under the law, a “Notice of

Allowance ” is issued. Id. § 1.311(a) . I f, howe ver, the patent examiner deter mines that there a

re de ficienc ies or proble ms with the application, the examiner will issue an “O ffice Action” a dvising the a pplicant as to the “ rea sons for any adver se ac tion or any objection or re quirement.” Id. § 1.104(a) (2). Upon r ece ipt of an Off ice Ac tion, an applicant may4

amend the c laims, argue as to the me rits of the examiner’s f indings, or both. See id. § 1.111. Th is b a c k a

nd fo rt h b e tw e e n th e a

pp lic ant a nd the pate nt e xami ne r c on tin ue s unti l a

pate nt i s issued or a f

inal reje ction occur s. 2. Patent Interfe renc e Prac tice United States patent law , unlike much of the r est of the wor ld, is premised on the principle that the f

irst to invent — rather tha n the first to file a patent application — is g rante d the patent r ight. R OB E R T L. H AR MON , P AT ENTS AND TH E F ED ER A L C IR C U IT , 1 15 1 ( 20 09 ). As a conseque nce of

this rule, there must be a mec hanism for de termining who amongmultipl e pate nt applicants, or, a s in this case, amongan applica nt and a patentee, w as the fir st to invent the
c la im e d s u b je c t m att e r . T h at m e c h an is m i s kn o w na s aninte r f e r e n c e , w h ic his a

“ p r o c e e d in g [] principally

decla red to pe rmit a deter

mination of priority .” Minnesota Mining and Mfg. Co. v. Norton Co. , 9 29 F .2 d 6 70 , 6 74 (F e d. Cir . 1 99 1) . A s is of t- re pe a te d, “ [i]nte rf

e re nc e pr a c tic e is highly arc ane a nd specia liz ed,” Conservolite, Inc. v . W idmayer , 21 F.3d 1098, 1100 ( Fe d. Cir. 1994), and c an be “ virtually incomprehe nsible to the uniniti ated,” P AT ENTS AND TH E F ED ER AL C IR C U IT , supra p. 3, at 1152.

“ An int e rf e re nc e e xists if

the su bje c t matte r o f a

c la im o f o ne pa

rt y wo uld , if pr ior art , have a nticipated or r ender ed obvious the subject matter of a c laim of the opposing party and vice
versa .” 37 C.F.R. § 41.203. Either the patent applica nt or the pate nt examiner may sug g est an interfe renc e. See id. § 41.202. I f the Dire ctor of the PTO ag ree s that an interf ere nce is wa

rra nted

— i.e. , that “an a

pplication is made for

a pate nt which would interfe re w ith any pending application, or w ith any

unexpired patent” — he may decla re a n interfe renc e and pr ovide notice of such de clar ation to the applicants, or a pplicant and patentee, a s the ca se may be. 35 U.S.C. §Pursuant to the implementing r egulations, an administrative pate nt judge decla res the 2 patent interf

ere nce on the Direc tor’s beha lf. 37 C.F.R. § 41.203(b). 5 13 5( a ); see also 37 C.F.R. § 41.203. The B oard de termines questions of prior ity of the 2 inventions and may

deter mine questions of patenta bility as we ll. 35 U.S.C . § 135(a)
. As is releva

nt to the case at hand, onc e an inter fer ence is determined to be w arr anted a nd notice has be en provide d to the parties, a period is then set for

the filing of pre liminary statements and pr eliminary motions wit h the B oard. Gen. I nstrument Corp., Inc. v. Sc ientificAtlantic, Inc. , 9 9 5 F
. 2 d

2 0 9 , 2 1 1 ( F e d
. C i r . 1 9 9 3 )
. “ T h e ‘ p r e l i m i n ar y’ m o t i o n s ar e u s u a l l y a critica l part of a

n interfe renc e.” Id. at 212. In particula r, as is of import in this case, a party may file a pr eliminary

motion under 35 U.S.C. § 135(b)(1). Se c tio n 1 35 (b )( 1) mot ion s a re thr e sh old motions t hat should be re solved befor e issues of pr iority and/or patentability

are addre ssed, as resolution in favor of

the movant would end the inter fer ence proce eding s. See B erman v . Housey , 2 91 F .3 d 1 34 5, 13 52 (F e d. Cir . 2 00 2) ; see also 37 C.F.R. § 41.201. “[S] ection 135(b) was e nforc ed to codify a leg al principle a

kin to laches, imposing ‘ a statut e of lim itatio ns , s o to sp e ak, on int e rf e re nc e s so that th e pate nte e mig ht b e mor e se c ur e in his property

rig ht.’” In re Be rger , 2 7 9 F. 3 d 9 7 5 , 9 8 2 (F ed
. C i r. 2 0 0 2 ) ( qu o t i n g Corbett v. Chi sh olm , 5 68 F .2 d 7 59 , 7 64 -6 5 ( C.C .P. A. 19 77 )) . It pr ov ide s th a t: [a] claim which is the same as, or f or the same or subst an tially the same subjec t matter a s, a cla im of an issued patent may not be made in any application unless such a cla im is m ade pr ior to one y ear from the date on which the patent was g rante d. 35 U.S.C. § 135(b)(1). A s the Fe dera l Circuit has expl ained, “ [t ]hi s provision require s an
a pp lic ant w ish ingto p ro vo ke an inte rf e re nc e wi th a

n is su e d p a te nt t o d o s o b y fi lin g a c la im wh ic h is ‘f

or the same or

su bs tanti a lly

the same su

bje c t ma tte r’ a s a c la im o f t

he iss ue d p a te nt,The pa rties do not dispute any

of the spec ific fa ctual finding s made by the B oard in the 3 ba c kg ro un d s e c tio n o f i ts Janu ary 25 , 2 00 7 d e c isi on , a s r e g ard ingthe pr oc e dura l hi sto ry of thi s claim. Acc ording ly , the Court has re lied on and cites pr imarily to the Boa

rd dec ision below, as supported by

the Administrative Recor d, in rec iting the f actua l background of this ca se. 6 prior to one year

from the issue da

te of the patent.” In re Be rger , 279 F.3d at 981. To furthe r its purpose of imposing a statute of limitations-like bar on inter fer ence proce eding s, “[a]m ended or supplemental cla ims added to a pe nding a pplication afte r the one y ear anniver sary

of the issuanc e of a

patent may

benef it from the timely

filings of orig inal patent claims so long a s the ‘the late r filed c laim does not differ from an e arlier

claim in any

‘mater ial limit ation.’” Se ar

s Ec ologic al A

pp lic ati on s Co ., LLC v . M LI As so cs. , LLC , 652 F. Supp. 2d 244, 2 6 9 (N
. D. N. Y. S ep t
. 1 , 2 0 0 9 ) ( q u o t i n g In re Be rger , 2 79 F .3 d at 98 1) ; see also In reBerger , 279 F .3 d at 98 2 ( “ To fu

rt he r t hat pu rp os e , a c op ie d c la im m ay

be e nti tle d to the e arl ie r e ff e c tiv e date of pr ior c la ims in a

n a pp lic atio n o nly

if the c op ie d c la im d oe s n ot d if fe r f ro m th e pr ior

c la ims in
any mate ri a l li mit atio n. ” ). “ Th e ana ly sis fo c us e s o n th e c op ie d c la im t o d e te rm ine wh e the r a ll materia l limi tations of the copied c laim nece ssarily occur in the prior cla ims.” In re Be rger , 279 F .3 d at 98 2. “ I f a ll m ate ri a l li mit atio ns of the c op ie d c la im a

re pr e se nt i n, or

ne c e ssa ri ly re su lt from, the limitations of the prior cla ims, then the copied c laim is entitl ed to the ea rlier e ffe ctive filing date of those pr ior claims for pur poses of satisfy

ing 35 U .S.C. § 135(b).” Id. B. Factual Back

ground

3 1. Cy

tologic Pate nt Cy tologic w as g rante d the patent at issue on April 30, 2002, which issued fr om a patent application filed on N ovember 20, 1999. J oint Appendix , Docke t No. [25] (her einaf ter “ J A-1” ), Ex. P1 0 ( B oa

rd ’s De c isi on

on Mo tio ns , d a te d Jan . 2 5, 20 07 ) ( he re ina ft e r, “ B d. De c .” ), a t 4; seeGi ve n th e pa rt ie s’ fo c us on

c la ims 17 -2 2, the Court

lim its its dis c us sio n o f B iop he re sis ’ 4 patent application to these claims only and does not a ddress the patent prosec ution hist ory of the re m ai n i n g cl ai m s , wh i ch ar e n o tre l ev an tt o th e p art i es ’ a rgu m en t s as p re s en t edi nth ei r b ri ef i n g. 7 als o id. , E x. P1 ( U. S. Pate nt 6 ,3 79 ,7 08 B 1) (h e re ina ft e r “ Cy tol og ic pate nt” ). Th e Cy

tol og ic Patent is directed to a

method for e nhancingan immune re sponse by selec tively

removing immune sy stem inhibit ors pre sent in the blood. See Cy tol og ic Pate nt at c ols . 1 1- 4. Th is i s
acc omplished by

bring ing the blood into contact with a binding partne r ( e.g. , antibodies or fra g ment of antibodies) c apable of selec tively binding to tar g eted immune sy stem inhibit ors. Id. at. col. 5, lines 26-34. This method is believe d to be ef fec tive in the treatment of some ty pes of
canc er. See id. at col. 6, lines 15-34. In discussing Cy tologic’ s patent, the c ritical date for purposes of 35 U .S.C. § 135(b)(1) — i.e., one y ear from the date on which the patent was g rante d — is April 30, 2003 . For convenie nce, the Court shall refe r to this date as the “ critica l date.” 2. Biophe resis’ Patent Application Given the importanc e of c lear ly demar catingwhich re levant eve nts occurr ed bef ore the
c ri tic a l date and

wh ic h e ve nts oc c ur

re d a ft e r, the Court

div ide s th e dis c us sio n o f B iop he re sis ’ patent application and related eve nts acc ording ly
.

i. Pr e -c ri tic a l da

te e ve nts
. Biophe resis filed the patent application now at issue on November 10, 2000, Patent Application 09/709,045. Bd. D ec. at 5. As orig inally filed, B iophere sis’ application conta ined 16 claims. Id. at 12 . O n Jan ua ry 22 , 2 00 3, the a

pp lic a tio n w a s ame nd e d to inc lud e ne w c la ims 17-22, which the application stated “ essentially corr espond to” the c laims of Cy tologic’ s patent. Id. at 12 ; see also J A-1, Ex. P3 (Biophere sis Amendment and Response to Of fice Action, dated Jan. 22 , 2 00 3) (h e re ina ft e r “ B iop he re sis Jan. 22 , 2 00 3 Ame nd .” ), a t 6. In p art ic ula r, the pa rt ie s’ 4The pa rties foc us exclusively

on post-critica l date eve nts beg inning in Jul y 2004 and 5 continuing the rea fter, a

nd the Court there fore focuse s its dis cussion of the re levant fa ctual background on these e vents as we ll. The Court notes, howeve r, that the re cord r efle cts that betwee n the post-cr itical date ( i.e. , April 30, 2003) and the J uly 21, 2004 Offic e Ac tion dis c us sio n a

bo ve , B iop he re sis and

the pate nt e xami ne r d id t ake c e rt a in a c tio ns re g ard ingc la ims 17-22. Specific ally , on J uly 29, 2003, the patent e x aminer issued a n Offic e Ac tion rejec ting claims 17-22 under

35 U.S.C. § 103(a) a s unpatentable . Bd. D ec. at 13. Biopher esis replied on October 29, 2003, but did not make any amendments to cla ims 17-22. Id. The patent examiner ag ain re jected c laims 17-22 on Fe bruar y 25, 2004 as unpate ntable. Id. On April 16, 2004, Biophe resis re plied and made minor g rammatica l amendments to claims 17-22, whic h are not rele vant to the pendingdispute. Id. at 13 ; se e als o D e f s . ’ O p p ’ na t1 8 , n . 6
. M o r e s p e c i f i c a l l y, Biophe resis re place d “antibody” with “a ntibodies” and re place d “fr ag ment” with “f rag ments.” B d. De c . at 13 . T he se va ri ou s c omm

un ic a tio ns and

ame ndme nts , h ow e ve r, are no t mate ri a l to th e p art i es ’ a rgu m en t s as p re s en t edi nth ei r b ri ef i n g. 8 dis pute fo c us e s o n c la ims 17 and 22 , whic h r e a d a s f

oll ow s: 1 7
. A m et h o d

o f e n h an ci n g an i m mun e r es p o n s e t o a p at i en tco mp ri s i n g: a . ob ta ini ngwh ole blo od fr om t he patie nt; b. se pa

ratin g out th e pla sm; c. contac ting the pla sma with antibody specific ally binding to a ta

rg eted immune sy stem inhibit or; d. removingthe inhibitor bound to the antibody from the plasma ; and e . re tur

nin g the anti bo dy -c oll e c te d p la sma to t he patie nt. * * * 22
. Th e me tho d o f c la im 1 7 w he re in t he targ e te d immun e sy st em in hib ito r i s se le c te d f ro m th e g ro up con si st ingof so lub le re c e pto rs fo r t

umo r n e c ro sis fac tors alpha a

nd beta. Bd. D ec. at 12-13; Biopher esis J an. 23, 2003 Amend. at 3-4.

ii. Pos t- c ri tic a l da

te e ve nts
. 5 July 21, 2004 Of

fi ce A ction . On J uly

12, 2004, the patent e x aminer issued a n Offic e Action re jectingBiophe resis’ c laims 17-22. In so doing, the patent examiner ra ised two g rounds for r ejec tion that are of

particula r importance to Cy

tologic’ s prese nt motion. To understand the pate nt e xami ne r’ s r e

je c tio n o f c la ims 17 -2 2 a nd Cy tol og ic ’s re late d a

rgume nt, the Court

mus t9

make a brief dive rsion once a g ain into substantive patent law — spe cifica lly , 35 U.S.C. § 112. Th e fi rs t tw o p ara g ra

ph s o f s e c tio n 1 12 pr ov ide , in re le va nt p art , a s f

oll ow s: The spec ification shall contain a written desc ri ption of the invention, and of the manner and proc ess of makingand usingit, in such fu l l , cl ear , concise , and exact te rm s as to en a

ble any pe rs on sk ill e d in th e art to whic h it

pe rt a ins , o r w ithwh ic h it is most nearly

connec ted, to make and use the same, and shall set forth the be st mode contemplated by

the inventor of c arr

ying out his invention. The spec ification shall conc lude with one or more claims particula rly pointing out and dis tin c tly

c la imi ngthe su

bje c t matte r which t

he a pp lic ant r e g ard s a s h is invention. Perhaps somewhat unimag inatively , these pa ragraphs a

re r efe rre d to as “sec tion 112, para. 1” and “ sec tion112, para. 2,” respe ctively . The for mer looks into the adequa cy of the c laim’s written de sc ri pti on

wh ile the latte r c on sid e rs the ind e fi nit e ne ss o f t he c la im l angua g e , e a c h o f whic h is a “distinct question[ ].” Applic. of Cormany , 476 F.2d 998, 999- 1000 (C.C.PA. 1973) (“We re g ard indefiniteness of c laim lang uag e and ina dequate support for it in the spec ification to be distinct questions, and we sha ll therefor e conside r them sepa rate ly , the forme r beinga question of compliance with the second pa ragraph of

§ 112 and the latter

a question of c ompliance with the first para g raph.” ) (inter

nal citations omitted). In this case, the patent examiner raise d objections under both the f irst and sec ond para g raph of

section 112 in reje cting Biophe resis’ c laims 17-22. Fi rst , the patent e x aminer reje cted c laims 17-21 (but not claim 22) for failure to comply

with the written desc ription require ment pursuant to sec tion 112, para. 1. JA-1, Ex. P 4 (Patent Examiner’s Off ice Ac tion, dated July

12, 2004) (he reina fter “ J uly 12, 2004 Offic e Ac tion”), at 5. The patent examiner based his re

jection on the fa ct that the “spe cification does not use the term ‘ta rg eted immune sy stem inhibit or,’ nor

can sa id term be said to flow f rom the spec ification as or igina lly filed.” Id.10

Rathe r, the sp e c if

ic atio n w a s li mit e d to me tho ds of re mov ingimmun e inh ibi tor s produced by tum or s . Id. Th e pate nt e xami ne r t he re fo re c on c lud e d th a t c la ims 17 -2 1, wh ic h d id n ot c on ta in this li mitation ( i.e. , only

immune inhibit ors produc ed by tumors as opposed to all targ eted immune sy stem inhibit ors), should be r ejec ted under 35 U.S.C. § 112, para. 1. Id. Im p o rt an t l y, as the B oard obse rved in its decision, “the examiner did not rejec t claim 22, which limited the targ eted immune sy stem inhibit or to soluble rec eptors for tumor necr osis factors a lpha and be ta, on this ground.” Bd. D ec. at 14. Second, the patent e x aminer r ejec ted claims 17-22 unde r 35 U.S.C. § 112, para . 2, as indefinite. Jul y

12, 2004 Offic e Ac tion at 6. The e x aminer r easone d that while claim 17 “r ecites ‘conta ctingthe plasma with antibodies spec ifically binding to a ta

rg eted immune sy stem inhibitor,” the “spec ification does not use nor define the term ‘immune sy stem inhibit or,’ he nce the metes a

nd bounds of the cla im cannot be de termined.’” Id. at 7. Bio phe r e sis ’ O c to be r 6, 20 04 Am e ndm e nt . B iop he re sis su bs e qu e ntl y

ame nd e d c la ims 17 -2 2 o n O c tob e r 6 , 2 00 4. B d. De c . at 15 ; JA- 1, P5 ( B iop he re sis Am e ndme nt a nd Re sp on se to Offic e Ac tion of J uly

12, 2004, dated Oc t. 6, 2004) (her einaf ter “ Biophe resis Oc t. 6, 2004 Amend.”) . Specifica lly , with respec t to claim 17, Biopher esis amende d step (c) by revising “conta ctingthe plasma with antibodies spec ifically binding to a ta

rg eted immune sy stem inh ibi tor ” to r e a d “ c on ta c tin g the pla sma wi th a nti bo die s o r a

nti bo dy fr a g me nts sp e c if

ic a lly binding to soluble cy

tokine rec eptor molec ules which func tion as cy tokine inhibitors.” Bd. De c.
at 15 ; se e als o Biophe resis Oc t. 6, 2004 Amend. at 4. In other wor ds, the amende d claim 17 re ad as follows (with adde d languag e under lined and dele ted languag e struck out) :11

1 7
. A m et h o d

o f e n h an ci n g an i m mun e r es p o n s e t o a p at i en tco mp ri s i n g: a . ob ta ini ngwh ole blo od fr om t he patie nt; b. se pa

ratin g out th e pla sm; c. contacting the pla sma with antibody or antibody fra g ments specific ally

binding to a ta

rg eted immune sy stem inhibitor soluble cy tokine rec eptor molec ules wh ic h f un c tio n a s c y

tok ine inh ibi tor s; d. removing the inhibitor bound to the antibody from the plasma; and e . re tur

nin gthe anti bo dy -c oll e c te d pla sma to t he patie nt. Biophe resis Oc t. 6, 2004 Amend. at 4. Claim 22, which is depende nt on claim 17, was
corr esponding ly

revised to r efle ct the cha ng es in claim 17, as f

ollows (deleted la

ng uag e struck out): 22
. Th e me tho d o f cla im 17 whe rei n th e targ e te d immun e sy ste m inh ibi tor is

se le c te d f ro m th e g ro up con si sti ngof so lub le re c e pto rs fo r t

umo r n e c ro sis fac tors alpha a

nd beta. Id. at 5; se e als o Bd. D ec. at 15. January 6, 2005 Of

fi ce A ction . In the next Office A ction, dated January 6, 2005, the pate nt e xami ne r i nd ic ate d th at ame nd e d c la ims 17 -2 2 w e re a llo wa ble . B d. De c . at 15 ; se e als o J A-1, Ex. P6 (P atent Examiner’s Of fice Action mailed Jan. 6, 2005). Bio phe r e sis ’ M ay6, 20 05 Am e ndm e nt . There afte r, on May 6, 2005, Biophe resis filed another amendment with the PTO, c ance lling cla ims 1-22 and addingclaims 23-41. Claims 23- 41 are patterne d afte r the c laims in Cy tologic’ s patent in order

to provoke a

n interfe renc e. B d. De c . at 15 ; se e als o J A-1, Ex. P7 (Biophere sis Amendment under C.F .R. § 1.116 to Office Action of January

6, 2005, dated Ma

y 6, 2005) (he reina fter, “ Biophe resis May 6, 2005 Amend.”) , at 8. To that e nd , B iop he re sis su bmi tte d a “ Sug g e sti on

of Inte rf e re nc e ,” ind ic a tin g that “ it be lie ve s th a t it s c la ims 23 -4 1 inte rf e re wi th c la ims 1- 44 of

the [Cy tol og ic ] pa

te nt. ” JA- 1, Ex. P812

(B iophere sis Sugg estion of an Interfe renc e under 37 C.F.R. 41.202, dated Ma y 6, 2005) (her einaf ter “ Sugg estion of Interfe renc e”)
. Cla ims 23 -4 1 h ave no t be e n ame nd e d. B d. De c . at 15 . A s is of re le va nc e to t he pa rt ie s’ dis pute , c la im 2 3 r e a ds a s f oll ow s: 23
. A m e tho d o f e nh anc ingan immun e re sp on se in a patie nt h avin g solu ble cy tokine rec eptor molec ules in the blood which inhibit the imm une re sponse, the method comprisingof: a . ob ta ini ngwh ole blo od fr om t he patie nt; b. separ ating plasma fr om the blood; c. contac ting the p l asma with at lea st one cy tokine rec eptor inhibitor selec ted fr o m the g roup consisting of antibodies or a ntibody fr agments binding to soluble cy tokine rec eptor molec ules, and cy tokine molecules a

nd epitopes there of binding to soluble cy tokine re c e pto r m ole c ule s; d. removingsoluble cy tokine rec eptor molecules bound to the c y tokine rec eptor inhibitor from the plasma ; and e . re tu

r n in g th e p la s ma

f r o m wh ic hth e s o lu

b le c y to k in e r e ceptor mol e c ule s h ave be e n r e mov e d to the patie nt. Id. at 16; Biophe resis May 6, 2005 Amend. at 2. 3. J anuar

y 12, 2006 Interfe renc e On J anuar

y 12, 2006, the B oard de clar ed an inter fer ence betwee n the Cy tologic pa tent
and the B iop he re sis pate nt a

pp lic atio n. B d. De c . at 4; se e als o J A-1, Ex. P2 (Declar ation of Interfe renc e No. 105,413) (her einaf ter, “ Dec l. of Interfe renc e”) . The sole c ount was def ined as claim 1 of the Cy

tologic patent and cla im 23 of the Biophe resis pate nt application. Id. a t4
. In addition, claims 1-44 of the Cy tologic patent and cla ims 23-41 of the B iophere sis patent wer e identified as c orre sponding to the c ount, which means that all of these c laims are a ffe cted by the ultimate judgment on the inter fer ence . See id. As is releva

nt to the instant Memorandum Opinion, Cy tologic f iled a pre liminary

motionAt oral a rgument, counsel for

Biophe resis empha siz ed that it declined to f ile an 6 op po sit ion

to C y tol og ic ’s Se c tio n 1 35 (b )( 1) “ no t [a s] a c on c e ssi on

of the me ri ts, ” but “ rathe r t o simpli fy and strea mline the proce eding s” throug h amendment of its claims that “would rende r un n e c e s s ar

y g e tt in g into ma

n y o f th e is s u e s th o s e o r ig in a l m o ti o n s s o u g h t t o r a is e . ” JA
- 2 , E x. D1 (Tr anscr ipt of November 9, 2006 Ora l Arguments) at 8:6-17.

13 arguing that Biopher esis claims 23-41 ar e bar red unde r sec tion 135(b)(1). SeeJA- 1, Ex. P9 (Cy tologic Sec tion 135(b)(1) motion, titled “Howe ll Subs tantive Motion 1,” dated F eb. 21, 2006) (h e re ina ft e r “ Se c tio n 1 35 (b )( 1) Mo tio n” ); se e als o Bd. D ec. at 10. Biopher esis did not file an opposition; instead, B iophere sis filed a motion requestingthat, in the event Cy tologic’ s Section 135(b)( 1) Motion was g rante d, Biophe resis be pe rmitted to substi tute proposed c laims 42-46 for claims 23-41. Bd. D ec. at 3, 10. The B oard he ard or al ar g uments on Cy tologic’ s Section 6 135(b)( 1) Motion on November 9, 2006. Id. at 4. On J anuar

y 25, 2007, the B oard issued a decision that, in rele vant par t, denied Cy tologic’ s Section 135(b)(1) Motion. As set forth there in, the Boa rd held, inte r a lia , that Cy tologic, a s the moving pa rty , bore the burden of

provingthat Biophe resis’ involved c laims 23- 41 are barr ed under

35 U.S.C. § 135(b)(1) a

nd that Cy

tologic ha d “not satisf[ied] its burden of provingthat there is a materia l differ ence betwee n the subject matter now claimed a

nd that claimed pr ior to the § 135(b) c ritical date .” Id. at 17. In so doing, the Boa rd re jected Cy tologic’ s argument that “the r eplac ement of ‘ targ eted immune sy stem inhibit or’ in cla im 17 (a pre -cr itical date c laim) with ‘soluble cy tokine rec eptor molec ules, and c y tokine molecules a

nd epitopes there of binding to soluble rece ptor molecules’ in claim 23 (a post-c ritical date claim) re nders the latter re citation a mater ial limit ation.” Id. at 16. Cy tologic ha d argued that the limitation was materia l beca

use the amended languag e “w as nec essar y to overc ome the examiner’s [J uly 12, 2004] rejection, which wa s based on the notion that the ter m ‘targ eted sy stem inhibit or’ lac ks14

written desc ription in the specification, as orig inally filed, in violation of 35 U.S.C. § 112, para. 1.” Id. Th e B oa

rd did no t a g re e , c on c lud ingthat: [C y tologic]’s arg ument would have some forc e if claim 17 wer e the only pre- critica l date c laim. But that is not the case . Her e, we deter mine that claim 22 is also a pre critica l date cla im. Cl aim 22 was never r ejec ted as be ing in violation of the written descr iption of 3 5 U.S.C. § 112, para. 1. . . . In this reg ard, c laim 22 limi ted the targ eted immune sy stem inhibit or to soluble rec eptors for t u m o r n ecr osis factors alpha a nd beta. [Cy

tologic] failed to addre ss how and why the diffe renc es betwe en any of the post-critica l da

te claims 23-41, on one ha nd, and pre -cr itical date c laim 22, on the oth e r h and , c on sti tut e mate ri a l di ff e re nc e s.
*** At issue is whether [Biophere sis] ’s pos t-critica l date c laims, which interfe re w ith the claims of [Cy

tologic]’s pate nt, are no t enti t l ed to the filing date of [Biopher esis]’s pre- critica l date cla ims. I f a later filed claim involved in interfer ence does not diffe r fr om a n e arl ie r fi le d cla im in any mate ri a l limitatio n, the n a re je c tio n und e r 3 5 U .S. C. § 135(b)( 1) of that c laim is not appropriate. H ere , [C y t o l o gi c] has not established that the diffe renc es betwe en the post-c ritical date involved c laims and all pre- critica l d at e c l a i m s , i np art i c u l ar

c l a i m2 2 , w e r e i n

f a c tn e c e s s ar

y f o r p a t e n t a b i l i ty. Id. at 17-18. The Boa

rd there fore conclude d that Cy tologic ha d failed to show that c laims 23-41
wer e bar red unde r sec tion 135(b)(1). Cy tologic now

challeng es that dec ision. 4. Th e Ins tant L aws uit On J une 6, 2008, Cy

tologic f iled the above -ca

ptioned lawsuit seekingrevie w of the Boa rd’s de cisions in the interfer ence pursuant to 35 U.S.C. § 146. Se e ge ne ra lly Compl., Docket No. [1] . At the Court’s re quest, the par ties filed a joint status report pr oposing a schedule for pr oc e e din gin t

his matte r. Jt. Status . Re po rt , D oc ke t N o. [17]. Cy tol og ic ind ic a te d it s inte nt t o fi le a summa ry jud g me nt m oti on

un de r 3 5 U .S. C. § 13 5( b) (1 ), wh ic h, if g ra nte d, wo uld

re su lt i n a voiding of the B oard’ s decision. See id. at 2. Cy tologic the ref

ore pr oposed that the pa

rties brief, a nd the Court resolve, the section 135(b) (1) issue be fore proce edingwith discovery
. Id. at15

2. B iop he re sis ind ic ate d th at w hil e it “ [did ] not ob je c t to e arl y

pr e se ntatio n o f P la int if

fs ’ pr op os e d d isp os iti ve mot ion ba se d o n § 13 5( b) ,” it t oo k th e po sit ion that th e pa

rt ie s sh ou ld proce ed to brief

disputes as to the scope of discovery

in this case. Id. at 3-4. The Court ult imate ly

a g re e d w ithCy

tol og ic ’s pr op os e d s c he du le and se t a sc he du le fo r p ro c e e din g wi th Cy tologic’ s motion for summary judgme nt on the threshold sec tion 135(b)(1) que stion, defer ring consideration of discovery issues until after the motion is resolved. See11/13/08 Order, D ocket No. [18]
. Pursuant to that schedule, Cy tologic f iled the now-pe nding Motion for Summary J udg ment to Vacate Interfe renc e Pursuant to 35 U.S.C. § 135(b)(1) and Reque st for Ora l Hea ring
. SeePls.’ MS J , Docke t No. [20] . Biophe resis filed a n opposition, seeDef

s.’Opp’n, Docke t No. [21] , and Cy

tologic ha s since filed its re ply , seeP l s . ’ R e p l y , D o c k e tN o . [ 2 3 ]
. In addition, the parties jointly moved for a

n order enter ing the entire a dminist rative r ecor d of the int e rf e re nc e pr oc e e din g be low

a s p art of the re c or d in

thi s c a se , seeDocke t No. [22] , which the Court gr anted, see12/31/08 Min. Order. The parties have also filed the ir J oint Appendix of the Administrative Record. SeeDocke t Nos. [25] & [26]. In addition, after principal brie finghad been c ompleted, the Court issued a minute orde r direc ting Cy tologic to f

ile a supplementa l notice, see12/16/09 Min. Order, whic h notice Cy tologic ha s timely

filed, seePls.’ Notice, Docke t No. [28] . The Court provided B iophere sis an opportunity to respond to Cy

tologic’ s supplemental notice a

nd also invited Biopher esis to file a sur- reply addre ssing a

particula r argument that Cy

tologic ha d raised f

or the fir st tim e in its reply , see12/22/09 Min. Order, whic h it has now done, seeDef

s.’ Sur-Reply . Cy

tologic subse quently

filed an unoppose d motion for leave to file a tar g eted r esponse to B iophere sis’ sur-re ply , which the Court g rante d. See 1/15/10As the Court conc ludes that the issues pre sented in Cy tologic’ s pendingmotion may be 7 resolved on the extensive briefingfiled by the par ties, an ora l hear ing is unne cessa ry and the Court sh a ll the re fo re DENYCy tol og ic ’s re qu e st t

hat th e Court

ho ld o ra l argume nts on

its motion. 16 Min. Order . Acc ording ly , the par ties’ brief ing is c omplete, and the matter is there fore ripe for
re vie w a nd re so lut ion

by the Court
. 7

II. LEGAL STANDARD A. Summary J

udgment Pursuant to Fede ral Rule of Civil Procedure 56, a par ty is entitled to summ ary

judgme nt “if the ple ading s, the discover y and disclosure materia ls on file, and any aff idavits show that the re is n o g e nu ine iss ue a s to any mate ri a l f

a c t and that th e mov ant i s e nti tle d to jud g me nt a s a
matte r o f l aw. ” F e d. R. C iv. P. 5 6( c ); see also Tao v. Free h , 27 F.3d 635, 638 ( D.C. Cir. 1994). Under the summary

judgme nt standard, the movingparty bear s the “initial responsibility of informing the district court of the basis for [its] motion, and identifying those portions of the pleading s, depositions, answers to interr og atories, a nd admissions on file, toge ther with the aff idavits which [it ] believe[s] demonstrate the absenc e of a g enuine issue of

materia l fac t.” Ce lote xCor p. v . Ca tre tt , 4 7 7 U. S
. 3 1 7 , 3 2 3 (1 9 8 6 ). Inre s p o n s e, th e n o n -m o v i n g p arty mu s t“go beyond the pleading s and by [i ts] own af

fidavits, or depositions, answer s to interrog atories, a nd admissions on file, ‘desig nate’ specific fac ts showing that ther e is a g enuine issue f or trial.” Id. at 324 (interna l citations omit ted). Although a

court should dra

w all infer ence s from the supportingrec ords submitted by the nonmoving pa

rty , the mere exis tence of a f actua l dispute, by

itself, is insufficient to bar summar y judgme nt. See Anderson v. Liberty Lobby, I nc. , 477 U.S. 242, 248 (1986). To be materia l, the17

fac tual asser

tion mustbe ca

pable of aff ectingthe substantive outcome of the litigation; to be g enuine, the issue must be suppor ted by sufficie nt admissible evidence that a re asonable trier- offac t could find for the nonmoving pa rty
. Laningham v. U.S. Navy , 8 13 F .2 d 1 23 6, 12 42 -4 3 ( D. C. Cir . 1 98 7) ; Liberty Lobby , 477 U.S. at 251 (the c ourt must determine “ whether the evidenc e prese nts a sufficie nt disag ree ment to require submissi on to a jury or whe ther it is so one-sided that one par

ty must prevail as a

matter of la

w”) . “I f the e vidence is merely colora ble, or is not sufficie ntly

probative, summar

y judgme nt may

be g rante d.” Liberty Lobby , 477 U.S. at 249-50 (interna l citations omit ted). “ Mere alleg ations or denials in the a dverse party ’s pleading s are insufficient to def

eat a n otherwise pr oper motion for summar y judgme nt.” W

illiams v. Callaghan , 9 38 F . Su

pp . 4 6, 49 (D .D .C. 19 96 ). Th e a dv e rs e pa rt y mus t do mor e tha

n s imp ly “show that ther e is some metaphy sical doubt as to the mater ial fac ts.” Ma tsu sh ita El e c . I nd us . Co. v . Ze nit

h R ad io C or p ., 475 U.S. 574, 586 (1986). Instead, while the movant bear s the initial responsibility

of identifying those portions of the re cord that demonstrate the a bsence of a g e nu ine iss ue of

mate ri a l f

a c t, t he burd e n s hif

ts t o th e no n- mov ant t o “ c ome fo rw ard wi th ‘s pe c if ic fa c ts s ho wi ngthat th e re is a genuine issue for trial .’” Id. a t 58 7 ( c iti ngF e d. R. C iv. P. 56(e) ) (e mphasis in origina l). B. Standard of Review Unde r 35 U.S.C. § 146 Cy tologic se eks re view of the Boa rd’s de cision in the interfe renc e proc eedingbelow pursuant to 35 U.S.C. § 146, seeCompl. ¶ 1, which provides that “[a]ny party to an interfe renc e dis satis fi e d w iththe de c isi on of the B oa rd
. . . o n th e int e rf

e re nc e , ma

y have re me dy

by c ivi l
a c tio n, ” 35 U. S.C. § 1 46 . A n a c tio n und e r s e c tio n 1 46 “ may be ins tit ute d a g a ins t th e pa

rt y in interest as shown by

the re cords of

the Patent and Tr adema

rk Off ice at the time of the dec ision18

complained of

” — in this case, B iophere sis. Id. Mo re ov e r, wh e re , a s h e re , th e re is “ an a dv e rs e pa rt y re sid ingin a

fo re ig n c ountr

y , th e Un ite d St a te s D istri c t Co ur t f or the Di str ic t of

Col umb ia shall have jurisdiction and ma y issue summons aga inst the adverse parties.” Id. Judic ia l r e vie w und e r s e c tio n 1 46 is “ de sc ri be d a s a hy br id o f a n a pp e a l and a tr ia l de
novo .” Estee Lauder Inc . v. L’Oreal, S.A. , 1 29 F .3 d 5 88 , 5 92 (F e d. Cir . 1 99 7) . In s uc h a c tio ns , the re cord be low may

be admitted by

either pa rty , but the parties may

“take further

testimony .” See35 U. S.C. § 1 45 ; see also Agilent Tech., I nc. v. A ffymetrix, Inc

. , 567 F.3d 1366, 1379 ( Fe d. Cir. 2009). “Que stions of law are revie wed de novo , but the underly ing f actua l determinations made by the B oard a

re r eviewe d for c lear

err or.” Abbott GMBH &Co. KG v. Y eda Re search & Dev . Co, Ltd., 5 7 6 F. S u

p p . 2 d 4 4 , 4 9 (D
. D. C
. 2 0 0 8 ) ( ci t i n g W inner Int’l Royalty Corp. v. W ang , 202 F.3d 1340, 1348 ( Fe d. Cir. 2000)). I f, howe ver, the district court ac cepts ne w evidenc e not previously

befor e the B oard, the Court must m ake de novo fac tual finding s for issues on which the cour t acc epts new e vidence
. Id. The Court notes that for purposes of Cy

tologic’ s pending motion, the parties have relied solely on the administrative re cord a nd have not submitted new evidenc e. III . D ISC USS ION As indicated a

bove, Cy tologic’ s pendingmotion for summary judgme nt focuses solely

on the B oard’ s decision to deny Cy tologic’ s preliminary

Section 135(b)( 1) Motion. The Court
e mph a size s at th e outse t th at, i n c ha lle ng ingthe B oa rd ’s de c isi on , Cy

tol og ic ha s c ho se n n ot t o dis pute the ma

jor ity of the B oa rd ’s un de rl yingfi nd ing s o f f a c t and c on c lus ion s o f l aw a s se t f or th in the Boa

rd’s leng thy

discussion of Cy

tologic’ s Section 135(b)(1) Motion. See Bd. D ec. at 10- 23 (p or tio n o f t he B oa rd De c isi on dis c us sin g Cy

tol og ic ’s Se c tio n 1 35 (b )( 1) Mo tio n) . Cy tol og ic19

h a s i n s t e a d

p r e s e n t e d

a v e r y n ar r o wan d t ar g e t e d c h a l l e n g e t o th e B o ar d ’ s d e c i s i o n . S p e c i f i c a l l y, Cy tologic a rgues that the B oard’ s decision is in error for only two discrete rea sons, as outlined below, either

of which Cy

tologic a sserts re quire re versa l of the B oard’ s decision and f inal judgme nt in favor of

Cy tologic. T he Court’s discussion is theref ore similarly

limit ed in scope , addre ssing only

the two spec ific B oard r

ulings that Cy

tologic now

claims are in error
. Fi rst , Cy tol og ic argue s th at th e B oa rd e rr on e ou sly

a llo c a te d th e burd e n o f p ro of wi th respe ct to the question of mater iality under se ction 135(b)( 1). Ac cordingto Cy tologic, in or der to succe ed on its Section 135(b)(1) Motion, it neede d to show only that Biophe resis cla ims 23-41 — which for

med the basis of the interfe renc e proc eeding s — were filed more tha n one y ear

afte r Cy tologic’ s patent wa s issued. Once this showing wa s made, Cy tologic ha d demonstrated that the c la ims we re ba

rr e d und e r s e c tio n 1 35 (b )( 1) a bs e nt p ro of

by B iop he re sis tha

t c la ims 23 -4 1 d id
no t di ff e r i n a ny mate ri a l li mit atio n f

ro m it s p re -c ri tic a l da

te c la ims 17 -2 2, su c h th a t th e c la ims
c ou ld b e ne fi t f

ro m th e e arl ie r f

ili ngdate . B e c a

us e B iop he re sis did

no t f ile an o pp os iti on

to Cy tol og ic ’s Se c tio n 1 35 (b )( 1) Mo tio n, Cy tol og ic c on te nd s th a t B iop he re sis fa ile d to me e t it s burden of proof with re spect to mater iality and the B oard should have found that cla ims 23-41
wer e ther efor e bar

red unde r sec tion 135(b)(1). F or the re asons set for th below, the Court ult imate ly

fi nd s th at Cy

tol og ic ’s argume nt l a c ks me ri t and c on c lud e s th a t th e B oa

rd c or re c tly he ld t hat Cy tol og ic — a

nd no t B iop he re sis — b or e the bu rd e n o f d e mon str a tin g that B iop he re sis claims 23-41 diffe red in a materia l limi tation from claims 17-22. Second, Cy

tologic a rgues that eve n if the B oard pr operly allocate d the burde n of proof , the B oard none theless er

red when it held that Cy

tologic ha d not demonstrated that c laims 23-41 dif fe re d in a mate ri a l li mit atio n f

ro m c la ims 17 -2 2 b e c a

us e it i g no re d a

ke y fa c t in re a c hin g thi s20

deter mination — namely , that the patent e x aminer r ejec ted claims 17-22 unde r sec tion 112, para. 2. Cy tologic c ontends that the pate nt examiner’s reje ction of the c laims under sec tion 112, para. 2 conclusively

demonstrates that the claims diffe r in a mate rial limitation, and the Boa rd the re fo re a c te d in

e rr or wh e n it fa ile d to c on sid e r t

he e ff e c t of the se c tio n 1 12 , p ara . 2 re je c tio n in de nyingCy

tol og ic ’s Pr e lim ina

ry Se c tio n 1 35 (b )( 1) Mo tio n. As is d isc us se d in mor e de ta il be low , th e Court

fi nd s th at Cy

tol og ic did

no t pr e se nt t

his sp e c if ic argume nt t o th e B oa

rd and is there fore prec luded from doingso now. A. Burden of Proof First, Cy tologic a rgues that the B oard e rre d when it re quired Cy tologic to be ar the burden of pr ov ingtha

t B iop he re sis ’ i nv olv e d c la ims (2 3- 41 ) m a te ri a lly dif fe re d f ro m it s p re -c ri tic a l date claims (17-22) . Acc ordingto Cy tologic, it should have been r equire d to show only that Biophe resis cla ims 23-41 had bee n filed af ter the c ritical date — i.e. , more than one y ear afte r Cy tologic’ s patent had be en issued — and that once this showing was made , the burde n then shifted to Biophe resis to show that these c laims do no t dif fe r m a te ri a lly

fr om t he e arl ie r c la ims (17-22) , such that they

may benef it from the ea

rlier f iling date pursuant to sec tion 135(b)(1). Pls.’ MS J at 7-8. B eca

use B iophere sis chose not to file an opposition to Cy tologic’ s motion, but instead filed a

motion seeking leave to file furthe r ame ndments to the claims, Cy tologic a rgues that Biophe resis cle arly

failed to mee t its burden, and the B oard the ref ore should have g rante d Cy tologic’ s section 135(b) motion. Id. at 8. As the Court understa

nds Cy tologic’ s argument, it does not dispute the Boa rd’s holding pursuant to 37 C.F.R. § 41-121(b) that Cy tologic, “ [a] s the moving pa rty , [] bear s the burden of provingthat [Biophere sis] ’s involved claims 23-41 a re ba rre d under U .S.C. § 135(b)(1).” Bd.Whil e sec tion 41.121(b) explicitl y applies only

to “conteste d case s,” the re g ulations 8 make c lear

that “[a] patent interfer ence is a contested c ase” and is there fore subject to the g ener al proce dures g overningcontested c ases, includingthe proc edure s set forth in 37 C.F.R. § 41.121(b). 37. U.S.C. § 41.200(a)
. 21 De c . at 10 . N or

c ou ld i t, a s th e re g ulatio ns make c le ar t hat Cy tol og ic , a s th e mov ant, pr op e rl y bore the burden of

proof to show that it was e ntitled to the remedy reque sted. Specifica lly , 37 C.F .R. § 4 1. 12 1( b) pr ov ide s th at “ [t]he pa rt y fi lin g the mot ion

ha s th e burd e n o f p ro of

to establish that it is entit led to the re quested re lief.” In addition, although not c ited by the B oard, 8 37 C.F.R.§ 41.208(b) — whic h g overns the r equire ments for substantive motions filed in patent interfe renc es (a s opposed to contested c ases in g ener al) a nd serve s to supplement the g ener al require ments for motions filed in contested c ases a s set forth in 37 C.F.R. § 41.121 — furthe r sp e c if ie s th a t, “ [t]o b e su ff

ic ie nt, a mot ion mus t pr ov ide a

sh ow ing , s up po rt e d w itha pp ro pr iate evidenc e, such that, if unrebutted, it would justify the re lief soug ht. The burde n of proof is on the movant.” 37 C.F .R. § 41.208(b). Rathe r, it a

pp e ars that Cy

tol og ic dis a g re e s o nly

a s to wh a t sh ow ingit w a s r e qu ir e d to make in orde r to meet that burde n of proof . Specifica lly , the B oard he ld that Cy tologic, a s the movant, had the bur den to show not only that the involved claims (23- 41) we re f iled afte r the post-critica l date — a f

act that is undisputed — but also that those claims mater ially differ ed from the pr e-c ritical date claims 17-22. SeeBd. D ec. at 17 (“[Cy tologic’ s] assertion does not
satis fy its burd e n o f p ro vin g that th e re is a mate ri a l di ff

e re nc e be tw e e n th e su

bje c t matte r c la ims
no w a nd that c la ime d p ri or

to t he § 1 35 (b ) c ri tic a l date .” ). Cy tol og ic dis a g re e s, arguin g that it should have be en re quired to prove only that Biophe resis’ involved c laims (23-41) we re f iled
a ft e r t he po st- c ri tic a l date . A c c or din g to C y tol og ic , o nc e it m a de that sh ow ing , it satis fi e d it s22

burden of proof unde r sec tion 135(b)(1), a nd it was then up to Biophe resis, as the patent applicant, to show that its post-critica l date cla ims are none theless per missibl e bec ause the y

do not materially

differ from pre -cr itical date c laims. Pl s.’ MSJ at 7-8. The Court, however , does not ag ree . As explained below, the Court finds that the B oard c orre ctly held that Cy

tologic, a s the movant, was r equire d to prove that B iophere sis’ post-critical date claims we re ba rre d by section 135(b) (1) — whic h nece ssarily included demonstrating that the c laims contained a materia l limi tation not found in the pre- critica l date cla ims, such that they could not benef

it from th e e ar l i er cl ai m s ’ p re -c ri t i ca l d at e f i l i n g. As an initial matter, ther e is no dispute that a pate nt applicant who se eks dec laration of an interfe renc e base d on claims filed af ter the r eleva

nt critical date — i.e., more than a y ear afte r the iss ua nc e of the pate nt at is su e — b e ars the burd e n in the fi rs t in sta

nc e of de mon str a tin g that it s late -f ile d c la ims are no t ba

rr e d b y se c tio n 1 35 (b )( 1) . A s B iop he re sis argue s, and a s Cy tol og ic does not dispute, the par

ty initially reque sting the inter fer ence must demonstrate that it is entitled to priority of cla ims, and the patent e x aminer must be satisfied that the conditions for a n interfe renc e have been me t. SeeDe fs .’ Op p’ n at 10 -1 1. Ac c or din g ly , in thi s c a se , it

is
un dis pute d th at B iop he re sis ini tia lly bo re the burd e n o f p ro vin g to t he pate nt e xami ne r t

hat it s late filed c laims (23-41) do not diffe r in any materia l limi tation from its tim ely claims (17-22) , su c h th at se c tio n 1 35 (b )( 1) did no t ba r t he e xami ne r f

ro m de c lari ngan inte rf

e re nc e in t

he fi rs t instance ba sed on B iophere sis claims 23-41. Once an interf

ere nce ha s been de clar ed, howe ver, the parties disagree as to who bea rs the burd e n o f s ho wi ngmate ri a lity (o r i mmate ri a lity

) whe n a pr e lim ina

ry se c tio n 1 35 (b )( 1) mot ion is filed duringinterfe renc e proc eeding s. Cy tologic a rgues that the patent applicant at all times23

reta ins the burden of

showing an abse nce of

materia lity , while B iophere sis takes the position th at , o n ce an i n t er fe re n ce h as b ee nd ec l ar ed , th e p arty s ee k i n g t o ch al l en ge t h atd ec i s i o nth ro u gh
a sec tion 135(b)(1) motion bea rs the burde n of provingmateria lity . Neither party has provided the Court with any

case law dire ctly

addre ssing the que stion of the burden of proof unde r 37 C.F.R. § 41.121(b) whe n a par ty files a se ction 135(b)( 1) motion during a n interfe renc e proce eding , nor is the Court awa re of any such authority . Although Cy tologic c ites to the decision in Rege nts of the University of Califor nia v. Unive rsity of Iowa Research Foundation , 455 F.3d 1371 ( Fe d. Cir. 2006), that opinion does not specifica lly discuss or addr ess a pa

rty ’s burden of proof on a

preliminary

section 135(b) (1) motion afte r an inter fer ence has bee n decla red. Similarly , Cy

tologic r elies hea

vily on Parks v. Fine , 773 F.2d 1577 ( Fe d. Cir. 1985), but that decision makes no r efe renc e to the cur rent re g ulatory

scheme specific ally

allocatingthe burden of proof on the pa

rty proponent a

nd indeed wa s decide d well bef ore the rele vant regulations reg ardingthe burde n of proof took effe ct. The pa

rticular que stion at hand thus appea rs to be an issue of

first impression. No ne the le ss, Cy

tol og ic ma int a ins tha

t Pa rk s g overns the outc ome of this Court’s decision — notwithstanding that Cy tologic c oncede s the dec ision was issued well bef ore the curr ent regulations were promulg ated. Citing to the w ell established princ iple that the PTO lacks substantive rulemakingauthority to overturn leg al pre cede nt, Cy tologic a rgues that the PTO wa s without authority

to issue regulations contradictingthe holding in Parks and ther efor e, to the extent the holding in Parks differ s from the c urre nt regulations, the decision in Parks controls. See P l s . ’ S ur- S urr ep l y

at1 -2 (c i t i n g Koniklijke Philips Elec. N.V. v. Cardiac Sci. Ope rating Co. ,

__ F .3 d _ _, Civ . A c t. N o. 20 09 -1 24 1, 20 10 WL10 91 3 ( F e d. Cir . Jan . 5 , 2 01 0) ; Agilent Tech.,24

Inc. v . Affymetrix, I

nc. , 5 67 F .3 d 1 36 6 ( F e d. Cir . 2 00 9) ; W yeth v . Kappos , _

_ F .3 d _ _, Civ . A c t. No. 2009-1120, 2010 WL27184 (F ed. Cir. J an. 7, 2010)) . This argument is without m erit. As the ca ses cited by

Cy tologic ma

ke cle ar, a lthough the PTO doe s not have a uthority to issue substantive rules, it does have the authority to issue “ procedural

regulations reg ardingthe conduct of

proce eding s befor e the a g ency .” W y e th , 2010 WL27184, at *3 (interna l quotations
mark s o mitte d) (e mph a sis a dd e d) ; see also Me rck &Co., Inc. v. Ke ssler , 80 F.3d 1543, 1549- 50 (F e d. Cir . 1 99 6) (P TO Commis sio ne r i s a uth or ize d “ to p ro mul g a te re g ulatio ns dir e c te d o nly to ‘t he c on du c t of

pr oc e e din g s in

the [PTO ];’ it d oe s N OT g ra nt t he Commis sio n th e a

uth or ity to issue substantive rules”) (quoting Animal Legal Defense F und v. Quigg , 932 F.2d 920, 930 ( Fe d. Cir. 1991)). As re g ulations gove rningthe burde n of proof duringinterfe renc e proc eeding s are proce dural — not substantive — the PTO wa s theref ore w ell within its authority to issue the regulations at issue. Cf. Mahurkar v . C.R. Bard, Inc. , 79 F.3d 1572, 1576 ( Fe d. Cir. 1996) (d e sc ri bin gru le s r e g ard ingburd e n o f p ro of in t he int e rf e re nc e pr oc e e din g a s p ro c e dura l in
natur e ); Kubota v. Shibuya , 999 F.2d 517, 521 ( Fe d. Cir. 1993) (discountingprec edent de cided under the old interfer ence rules and upholdingPTO’s issuance of newregulations that chang ed burden of proof in interf

ere nce pr ocee dings) . The Court there fore reje cts Cy tologic’ s position that the holding in Parks g overns the spe cific que stion at issue in thi s case . The issue pre sented by

the par ties thus appear s to be one of f irst impression and neither party has direc ted the Court to any binding pr ece dent that g overns r esolution of this question. The Court, howe ver, is not without guida nce. Ca ref ul reviewof the re levant ca se law a nd the prese nt regulatory

scheme persua de the Court that B iophere sis has the better a rgument, for the
rea sons set forth below.25

As discussed above , the re g ulations make cle ar that “[t] he par ty filing the motion has the burden of proof to esta

blish that itis entitled to the requeste d relief ,” 37 C.F.R. § 41.121(b) , and that, “[t] o be suff

icient, a motion must provide a showing , supported with appr opriate e vidence , such that, if unre butted, it would just ify the re lief sought,” id. § 41.208(b). In this case, Cy tologic’ s preliminary

Section 135(b)( 1) Motion sought to prove that Biophe resis’ late r filed claims wer e time bar

red pur suant to that section, such that the inter fer ence should be dissolved. Where, a s here , the claims at issue a re suppleme ntal or ame nded cla ims filed more than one y ear afte r the c halleng ed pate nt was g rante d, section 135(b) (1) a s construed by the re levant ca se law bars suc h claims unless they are “entitled to the ea

rlier e ffe ctive date of prior c laims in an application.” In re Be rger , 2 79 F . 3 d at 98 2. Whe the r a po st- c ri tic a l date c la im m ay be ne fi t from the e arlier

filing date in turn depe nds upon showing that the later f iled claim does not diffe r from an e arlier

claim in any

“mater ial limit ation.” Id. “I f all mater ial limit ations of the copie d claim ar e pre sent in, or nec essar ily result from, the limitations of the prior c laims, then the copied claim is entitled to the ear lier ef fec tive filing date of those pr ior claims for pur poses of satisfy

ing 35 U.S.C. § 135(b).” Id. In other wor ds, post-critical date claims ar e entitled to the ea rlier f iling date of pre- critica l date cla ims and are not barre d by section 135(b) if they

“do[] not differ

from the prior c laims in any

materia l limi tation.” Id. F ro m th is f low s th e e min e ntl y

re a so na ble conclusion that in order

to show that it was entitled to the relief soug ht — i.e. , th a t B iop he re sis ’ po st- c ri tic a l da

te c la ims (2 3- 41 ) a

re ba rr e d und e r s e c tio n 1 35 (b )( 1) — Cy tol og ic wa s r e qu ir e d to p r o v e th atth o s e c l a i m s c o u l d n o tb e n e f

i tf r o mth e e ar l i e r

f i l i n g d a t e o f

th e p r e - c r i t i c a l c l a i m s . In order to do so, Cy

tologic ha d to show that the post-critica l date cla ims differe d from the e arlier filed cla ims (17-22) in a mate rial limitation. I t was not enoug h to simpl y point the Boa

rd to the26

undisputed fac t that Biopher esis’ post-cr itical date c laims were filed more tha n one y ear

afte r Cy tologic’ s patent wa s g rante d. Case law makes cle ar that such claims may nonetheless se rve a s the ba sis fo r a

n inte rf e re nc e if the y do no t di ff

e r i n a mate ri a l li mit a tio n f

ro m B iop he re sis ’ t ime ly pr e -c ri tic a l date c la ims
. Cy tologic’ s argument to the contra ry appea rs to be base d on the pre mise that beca use the statute itself “doe s not contain any languag e re g ardingmateria l differ ence s betwee n post- and pre- critica l date cla ims,” Cy tologic ne eded to pr ove only that the B iophere sis’ claims wer e filed
a ft e r t he c ri tic a l date a s se t f

or th i n s e c tio n 1 35 (b )( 1) in o rd e r t o s ho w that th e c la ims are tim e barr ed under

the statute. Pls.’ MSJ at 7-8. B ut this l ine of re asoningignor es we ll established
case law construingsection 135(b) (1) to bar only those amende d or supplemental c laims that dif fe r f ro m pr e vio us , ti me ly

c la ims in a

mate ri a l li mit a tio n. Just a s a pr op on e nt s e e kin g to pr ov ok e an inte rf

e re nc e be ars the burd e n o f p ro vin g tha t a late r f ile d c la im d oe s n ot m a te ri a lly differ from an e arlier

filed cla im, a proponent see king to dissolve an inter fer ence based on
se c tio n 1 35 (b )( 1) be ars the burd e n o f p ro vin g that a late r f ile d c la im does materia lly differ from
an ea rlier f iled claim. Indeed, Cy

tologic’ s position t hat the movant see king to dissolve an int e rf e re nc e pr oc e e din g purs ua nt t o s e c tio n 1 35 (b )( 1) ne e d o nly sh owtha t th e inv olv e d c la ims
wer e filed a fter the one y ear critica l date make s litt le sense. A s discussed above , the patent examiner must be satisfied that the c onditions for an interf ere nce ha ve bee n met befor e an interfe renc e is dec lare d. This in turn require s that the party reque sting the inter fer ence
su ff ic ie ntl y de mon str ate that any

c la ims fi le d a ft e r t

he on e y e ar c ri tic a l date are a ble to b e ne fi t f r o mth e e ar l i e r

f i l i n g d at e o f

p r i o r c l a i m s , s u c hth a tth e y

ar e n o tb ar

r e d b y s e c t i o n1 3 5 ( b ) ( 1 )
. It would be fa

r fr om effic ient or log ical if the inter fer ence could then be dissolved simply upon a27

sh ow ingthat th e inv olv e d c la ims we re fi le d a ft e r t he on e y e ar c ri tic a l da

te — a fa c t of wh ic h a ll parties a nd the B oard a

re sur ely awa re. A re view of r ece nt case law supports this conclusion. Althoug h, as discussed a bove, neither the parties nor

the Court has identified a case in which the par

ties directly

litigated the specific question at hand, at least one c ourt has proc eede d on the under standing — acc epted by all parties — that the pa

rty moving f or dissolution of an interfe renc e pursua nt to section 13 5( b) (1 ) b e ars the burd e n o f p ro vin g “ that th e pr e -c ri tic a l date c la ims did no t in c lud e the same materia l limi tations stated within the post-critical date claims.” Sears Ecological Applications , 652 F. Supp. 2d at 270. More over, r ece nt decisions by the Fe dera l Circuit confirm the g ener al trend unde r the ne w PTO regulatory scheme to require the par ty seekingto dissolve an interfe renc e to bea

r the burde n of showingthat it is entit led to the re quested re lief. See, e .g., Conservolite, Inc. v . W

idmayer , 21 F.3d 1098, 1101 ( Fe d. Cir. 1994) (“onc e an inter fer ence has been de clar ed, the bur den is on a pa rty who see ks to chang e the nature of the interfe renc e to take
a c tio n b y me ans of a su ita ble mot ion

to p e rs ua de the e xami ne r- in- c hie f o r t he B oa rd of the me ri ts of his or he r p os iti on ” ); Kub ota , 9 99 F .2 d at 52 2 ( “ I t se e ms t o u s th a t, whil e the burd e n in iti a lly
may be on a pa rt y se e kin g to p ro vid e an inte rf e re nc e , o r s e e kin g to o bta in e nti tle me nt t o a pr ior ity date, onc e an inter fer ence has bee n decla red a nd a par ty seeks to cha

ng e the status of the parties by mot ion , th e burd e n is the n o n th e mov ant u nd e r t he ne w r ule s, rathe r t

ha n o n th e pa

rt y
or ig ina lly pr ov ok ingthe int e rf

e re nc e or ob ta ini nge nti tle me nt. ” ); Bilstad v. W akalopulos , 386 F.3d 1116, 1121 ( Fe d. Cir. 2004) (“T hus, once [the par ty seekingto provoke a

n interfe renc e] convince d the examiner he w as entitled to an interf ere nce, that decision was pr esumed to be
corr ect, a nd [t he par

ty seekingto dissolve the interfer ence ] bore the burde n of provingthat it was28

incorre ct by

a pre pondera

nce of the evidenc e.”) . Although, a s Cy tologic note s, these ca ses involve differ ent pre liminary substantive motions and do not directly addre ss the burden of

proof in filing a preliminary

section 135(b) (1) motion, the log ic behind these decisions is persua sive and fur ther supports findingthat Cy tologic bor e the bur den of showingthat the interfe renc e wa s wrong ly invoked in the first instance . In order to do so, Cy

tologic w as re quired to show that Biophe resis’ late r filed c laims did not i n fac t benef it from the timely

filing date of its ear lier claims. Acc ording ly , the Court finds that the B oard c orre ctly held that Cy

tologic — a

nd not Biophe resis — bore the burde n of demonstrating that B iophere sis claims 23-41 differ ed in a
mate ri a l li mit atio n f

ro m c la ims 17 -2 2. Cy

tol og ic ’s mot ion

is t he re fo re DENI ED to t

he e xtent it argues that the B oard inc orre ctly allocate d the burde n of proof with respec t to Cy

tologic’ s preliminary

Section 135(b)( 1) Motion. B. Materiality Under Se ction 135( b) ( 1) Second, Cy

tologic c ontends that eve n if the B oard pr operly held that it bore the bur den of proof on mate riality , Cy

tologic none theless demonstrate d that Biophe resis cla ims 23-41 differ ed in a mater ial limit ation from cla ims 17-22, and the B oard the ref ore e rre d when it found to the contra ry . Cy tologic’ s argument on this point is a narr ow one. Spec ifically , Cy tologic a rgues that the B oard e rrone ously

“neg lected to c onsider” that claim 22 had bee n reje cted by the patent examiner for be ing inde finite under 35 U .S.C. § 112, para. 2. Pls.’ MSJ at 9. Unfor tunately for C y t o l o gi c, i td i d

n o tp re s en tth i s s p ec i fi c a rgu m en tt o th e B o ar d i nth e i n t er fe re n ce p ro ce ed i n gs below and is ther efor e for eclose d from doingso now. Wit h respe ct to the issue of mate riality , Cy tologic a rgued in its preliminary

Section 135(b)( 1) Motion that Biopher esis claim 17 diffe red f rom Biophe resis cla im 23 in a material29

limit ation beca

use the for

mer c ontained the phr ase “ targ eted immune sy stem inhibit or” while the latter ha d been a

mended to re place that languag e with the phra se “soluble c y tokine rec eptor molecules, a

nd cy tokine molecules a

nd epitopes there of binding to soluble rece ptor molecules.” Section 135(b)( 1) Mot. at 11. Acc ordingto Cy tologic, be cause Biophe resis ame nded the languag e in claim 23 in orde r to addre ss the patent examiner’s r ejec tion of claim 17 “a s not supported by

the spec ification” unde r sec tion 112, para. 1, the amendment wa s “nec essar y for patentability ” and the ref

ore material unde r F eder al Circuit case law. Id. at 11. Cy tologic’ s
mate ri a lity

argume nt t

hu s f oc us e d o n th e fa c t th a t B iop he re sis ha d a dd e d th e phra se “ so lub le
c y tok ine re c e pto r m ole c ule s” to c la im 2 3 in re sp on se to t

he pate nt e xami ne r’ s r e

je c tio n o f c la im 17 under to sec tion 112, para. 1 ( written desc ription). See id. Cy tologic’ s materiality

argument was thus base d solely on the patent e x aminer’ s section 11 2, pa ra . 1 (wri tte n d e sc ri pti on ) r e je c tio n. Cy

tol og ic did

no t r a ise a

sim ila r m a te ri a lity argument based on the patent examiner’s r ejec tion under sec tion 112, para. 2 ( indefiniteness). See id. When asked to provide the Court with recor d citations to any discussion of section 112, para . 2 in its briefing below, Cy tologic r esponded that it had “ra ised that argument at pag e 11, lines 11-20 of the [] S ection § 135(b) (1) Motion befor e the B oard.” Pls.’ Not. at 1. The cited po rt ion of Cy tol og ic ’s Se c tio n 1 35 (b )( 1) Mo tio n, ho we ve r, do e s not contain any

discussion of section 112, par a. 2 or of

the patent e x aminer’ s rejec tion of claims 17-22 as indef inite — but ins te a d r e fe rs onl

y to section 112, para . 1 and the patent examiner’s re jection of c laim 17 as “not supported by

the spec ification.” SeeSection 135(b)( 1) Mot. at 11. The r eleva nt provision of Cy tol og ic ’s br ie f b e low

state s in fu ll: The Examiner of [Bio p here sis] Claim 17 required r emoval of the rec itation of30

“tar g eted immune sy stem inhibitor” from the claim, because it was not supported by the spec ification. (Ma

terial F act 39). In Claim 23, [ Biophe resis] replac ed the re c itatio n o f “t arg e te d immun e sy ste m inhib ito r” us e d in Cla im 1 7 w ith“ so lub le cy tokine rec eptor molec ules, an d cy tokine molecules a

nd epitopes there of binding to soluble r ece ptor molecules.” (Mater ial Fa ct 40). The phra se adde d to Claim 23 of “soluble r ece ptor molecules” is a materia l limi t at i o n compar ed to “tar g eted immun e sy ste m inhib ito r” wh ic h wa s re c ite d in [ B iop he re sis ] Cla im 1 7, be c a us e it was a n amendment necessa

ry for patentability
. Only upon addingClaims 23-41 and canc eling Claims 17-22 over the c laims found to be re liable. (See also Mater ial Fa ct 41). See id. at 11 (l ine s 1 1- 20 ). As c are fu l r e vie w o f t his pa ssa g e c on fi rm s, Cy

tol og ic ’s argume nt i n its briefingbelow wa s based solely on the patent e x aminer’ s rejec tion of claim 17 as “not supported by

the spec ification” — a

section 112, par a. 1 wr itten description ar g ument. The briefingmakes no mention of, nor includes any

argument based on, the patent examiner’s reje ction of cla ims 17-22 under sec tion 112, para. 2 f or indefinitene ss. See id. Simi larly , the specific statements of mate rial fa ct cited to in the quoted pa ssag e foc us solely on the patent
e xami ne r’ s r e

je c tio n o f c la im 1 7 a s “ no t su pp or te d b y the sp e c if

ic a tio n, ” and

c on ta in n o f

a c ts relating to the patent examiner’s sec tion 112, para. 2 r ejec tion for indefinitene ss. See id. , Ap p. B, ¶¶ 39- 41. Cy tol og ic ’s on ly

argume nt t o th e B oa

rd , th e n, wa s it s c on te nti on that B iop he re sis ’ p os tand pre -cr itical date c laims differe d in a mater ial limit ation beca use the phra se “soluble c y tokine
rec eptor molec ules” wa s added to c laim 23 in order to over come the patent examiner’s re jection of c la im 1 7 und e r s e c tio n 1 12 , p ara . 1 re je c tio n. Th e B oa

rd ult imate ly

re je c te d th is a

rgume nt, finding that claim 22 was a lso a pre- critica l date cla im and that it, unlike claim 17, had not been
re je c te d b y the pate nt e xami ne r u

nd e r s e c tio n 1 12 , p ara . 1 . B e c a us e Cy tol og ic ’s argume nt w ith respe ct to the patent e x aminer’ s section 112, par a. 1 re jection did not apply

to claim 22 and31

Cy tologic ha d not presente d any alternative argument addre ssing c laim 22 in particular, the Boa rd held that Cy

tologic ha d failed to prove that Biophe resis’ post-c ritical date claims are not entitled to claim 22’s ea

rlier f iling date
. See Bd. D ec. at 17-18. Given that Cy tologic pr esente d the B oard w ith an argument based on the patent examiner’s r ejec tion of claim 22 under se ction 11 2, pa ra . 2 , it is d if fi c ult to u nd e rs tand ho w the B oa

rd e rr e d, a s Cy

tol og ic c on te nd s, wh e n it

“ ne g le c te d to c on sid e r” that ve ry argume nt —

an a rgume nt t hat w a s n e ve r b e fo re it. Re g ard le ss, Cy tol og ic ’s fa ilure to r a ise any su c h a rgume nt i n th e int e rf

e re nc e pr oc e e din g s is fata l to its e ff or ts to do so now. Ca se law m ake s c le ar t

hat a pa rt y may no t r a ise ne w i ssu e s o n a pp e a l th a t w e re no t f

ull y prese nted at the B oard le vel. Con se rv oli te , 2 1 F .3 d at 11 02 ; se e als o I n r e W att s , 354 F.3d 1362, 13 67 -6 8 ( F e d. Cir . 2 00 4) . “ In a pr oc e e din g be fo re the B oa rd the a pp lic ant i s g ive n a

fu ll ‘opportunity

to bring forth the f

acts thoug ht nece ssary

to support his or her position.’” In re W att s , 3 5 4 F. 3 d

at1 3 6 7 (qu o t i n g In re Gartside , 203 F.3d 1305, 1314 ( Fe d. Cir. 2000)). “[T]he parties to an inter fer ence must make complete pr esentation of the issues at the B oard le vel so that the interfe renc e is eff

icient and not wa steful of a dminist rative a nd judicial resour ces.” Con se rv oli te , 21 F.3d at 1102. Thus, while “Section 146 author izes the district court on revie w to acc ept new te stimony ,” such te stimony must relate to “issues r aised by the par ties during the proce eding s below or by

the B oard’ s decision.” Id. “ In o rd e r f or an is su e to b e ra ise d a de qu a te ly in an interfe renc e proc eedingso that it qualifies for e videntiary revie w in a sec tion 146 proce eding , more is re quired than pa ssing r efe renc e to the subjec t during the cour se of the int e rf e re nc e pr oc e e din g . F or

the mos t pa

rt , p art ie s sh ou ld r a ise iss ue s in the mann e r c le arl y sp e c if ie d in the PTO ’s int e rf

e re nc e re g ulatio ns , th a t is thr ou g h p re lim ina ry mot ion s, mot ion s to32

corr ect inventor ship, belated motions delay ed for g ood cause or opposition to these motions.” Gen. I nstrument Corp., Inc. v. Sc ientific-Atlanta, Inc. , 995 F.2d 209, 214 ( Fe d. Cir. 1993). Her e, Cy tologic did not ra ise any

materia lity

argument reg ardingthe patent e x aminer’ s
re je c tio n o f c la ims 17 -2 2 und e r s e c tio n 1 12 , p ara . 2 a t B oa rd le ve l. A lth ou g h Cy

tol og ic g ener ally argued that B iophere sis’ post-critical date claims ar e bar red unde r sec tion 135(b)(1) be c a us e the y c on ta in m ate ri a l li mit atio ns no t pr e se nt i n B iop he re sis ’ p re -c ri tic a l da te c la ims , it s fa ilure to r a ise the sp e c if

ic argume nt n owa t is su e pr e c lud e s c on sid e ratio n o f t hat argume nt i n this section 146 action. See Se ars Ecological Applications , 6 5 2 F. S u p p . 2 d at2 7 1 (“ Al th o u gh the over arc hing issue of

whether [defendant]’s post-critica l date cla ims relate ba ck to its precritica l date cla ims was prese nted bef ore the Boa

rd, [plaintiff] ’s fa ilure to raise an ar g ument at the Interfe renc e with re spect to [a particula r] lim itation issue bars pre sent consider ation of that
argume nt i n th is § 14 6 a c tio n. ” ). Ac c or din g ly , Cy tol og ic ’s mot ion

is D EN I ED to t

he e xtent it
argue s th at th e B oa

rd e rr e d w he n it

fa ile d to c on sid e r t

he pate nt e xami ne r’ s in de fi nit e ne ss reje ction of cla im 22 under 35 U.S.C. § 112, para . 2 (indefinitene ss). IV . C ON CL USI ON F or the re a so ns se t f

or th a bo ve , Cy tol og ic ’s [20] M oti on

fo r S umm ary

Judg me nt t o Vac ate Interfe renc e Pursuant to 35 U.S.C. § 135(b)(1) and Reque st for Ora l Hear ing is DEN I ED. An appr opriate O rder

acc ompanies this Memorandum Opinion. Date: January

15, 2010 / s / CO LLEEN K OLLA R- K OTEL LY Un i t edS t at es Di s tri ctJ u d ge