STRYKER SP I NE, Plaintiff,
v. BI EDERMANN MOTE CH GMBH , e t al

. , De fe nd ants
. UNITED STAT ES DIS TRICT COURT F OR THE D ISTRIC T OF CO LU M BIA

Civil Action No. 08–1827 (CKK)

M EM OR

AN DU M OP IN ION (F ebrua ry 16, 2010) This case involves a dispute betwe en Plaintiff Stry ker Spine (“ Stry

ker” ), a F renc h corpor ation, and De fenda nts Biede rmann Motec h GmbH (“ Bie derma nn”) a nd DePuy Spine, I nc. (“D ePuy ”), ove r a patent interfe renc e proc eedingat the United States Patent a nd Trade mark Offic e (“ PTO”). Stry

ker se eks judicial re view of de cisions made by the PTO’s B oard of

Patent Appea ls and Interfe renc es pursua nt to 35 U.S.C . § 146. Pending be fore the Court are a ser ies of dispositi ve motions. St ry ker ha s filed a [31] M otion for Summary J udg ment reg ardingthe PTO’s ref usal to rede fine the inter fer ence count (“ Redefinition Motion”); a [32] Motion for Summary J udg ment reg ardingDef

endants’ f ailure to a dequate ly

support their pate nt claims under 35 U.S.C. § 112 (“§ 112 Motion”); a [33] M otion for Summary J udg ment reg ardingthe unpatentability

of De fenda

nts’ claims over pr ior art ( “Unpatentability Motion”); and a [35] Motion for Summary

J udg ment reg ardingthe unconstitutionality of the a ppointment of an Administrative Patent J udg e (“ Unconstitutionality Motion”). Def

endants oppose the se motions and have separ ately

filed a sing le [36] Motion for Summary J udg ment. The United States ha s also intervene d and filed a n opposition t o Stry

ker’ s Unconstitutionality

Motion. Brief

ing on2

these motions is now complete. For the re asons explained below, the Court shall DENYeac h of Stry ker’ s motions for summary judgme nt and GRANT- I N-PART and DEN Y-I

N-PART Def

endants’ motion for summary judgme nt. Wi th respec t to St ry ker’ s Unconstitutionality

Motion, the Court finds that
any c on sti tut ion a l de fe c t in

the a dmi nis tr a tiv e pate nt j ud g e ’s a pp ointme nt w a s c ur e d b y his
rea ppointment prior to the PTO’s issuance of a f inal decision on re hear ing. T here fore , the Court shall awa rd judg ment to Defe ndants on this claim. Wi th respec t to St ry ker’ s Redefinition Motion, the Court finds that there ar e g enuine issues of material fa ct that pre clude the a war d of summary judgme nt to either par

ty . Be cause the issues raise d in the § 112 Motion and Unpatenta

bility Motion are both conting ent on Stry ker’ s succe ss on the Redefinition Motion, the Court sh a ll a lso de ny

the pa rt ie s’ mot ion s w ithre sp e c t to the se iss ue s.

I. BACKG ROUND A. ThePa te nt Pro c ess a nd In te rfe re nc e Proc e e dings Ge ne ra lly 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 PTO. See I nterve t, Inc. v . Merial Ltd. , 6 43 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 proposed patent as pre scribed by 35 U.S.C. § 112, including a c laim or claims, 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). The spec ification re quired by 35 U.S.C. § 112 includes both a “wr itten description of the invention” (de scription) and a written explanation of “the ma nner a nd proce ss of makingand
us ingit, in s uc 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 pe rs on sk ill e d in the art toA 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 which it perta ins, or with which it is most near ly connec ted, to make a

nd use” it (e nablement)
. 35 U.S.C. § 112, para. 1. As Judge Henr y H. Kenne dy , J r., aptly

explained in a rec ent dec ision, At the e nd of the wr itt e n de sc ri pti on and e na ble me nt, a pr op e r s pe c if

ic 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 subpar ts of the invention, the applica nt reg ards a s hers. 35 U.S.C. § 112, para . 2. A claim is a sing le sentenc e desc ription of what the a pplicant believe s t o be her i n v e n t i o n , s e t t i n g th e b o un d ar i e s o f th e i n v e n t i o n th e a p p l i c an t w i s h e s th e P T O t o e xami ne . Asin g le c la im c an b e c omp os e d o f m ult ipl e e le me nts and

/or lim itatio ns . [1] Elements ar e the previously known phy sical compone nts that make up the c laimed inv e nti on . L imi tatio ns , on the oth e r hand , usu a lly de sc ri be the c la im’ s r e str ic tio ns . An application may

contain seve ral c laims, and eac h claim 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. A p a te 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 may 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 s4

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 rig ht. 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 , su

pra , 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. § 4 1. 20 2. I f t he Di re c tor

of the PTO a g re e s th a t an inte rf e re nc e is
war rante d— i.e. , that “an a

pplication is made for

a pate nt which would interfe re w ith any pendingapplication, or w ith any unexpired patent”—he may decla re a n interfe renc e and pr ovide notice of suc h decla

ration to the applica

nts, or applicant a

nd patentee , as the c ase ma y be. 35Pursuant 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). The B oard is compr ised of the PTO Dire ctor, the D eputy PTO Direc tor, the 3 Commi ssioner for

Patents, the Commis sioner for Trade marks, and the administrative patent judge s. See 37 C.F.R. § 41.2. In contested c ases, suc h as interf ere nce pr ocee dings, f

inal Boa rd actions must be taken by

a pane l of at lea st three B oard me mbers, but non-fina l actions may be taken by a sing le B oard me mber. Id. 5 U. S.C. § 1 35 (a ); see also 37 C.F.R. § 41.203. The notice decla ringan interf

ere nce ide ntifies the 2 interfe ringsubject matter; the involved a pplications, patents, and c laims; the acc orded be nefit for
eac h count; and the c laims corre sponding to e ach c ount. 37 C.F.R. § 41.203(b). An administrative patent judg e (A PJ ) may chang e the de clar ation of interf ere nce, a nd a par ty may sug g est an a dditional interfer ence . Id. § 41.203(c) -(d) . The B oard of Patent Appea ls and Interfe renc es (the “ Boa

rd”) deter mines questions of priority of the inventions and may deter mine questions of patenta

bility as we ll. 35 U.S.C . § 135(a)
. 3 Interfe renc e proc eeding s are g overne d by the PTO’s re g ulations for conte sted ca ses. See 37 C.F .R. § 4 1. 20 0( a ). An int e rf e re nc e pr oc e e din g may

inv olv e on e or

mor e c ounts ; a

c ount i s the B oard’ s descr iption of the interfe ringsubject matter that sets the scope of admissible proofs on priority
. Id. § 41.201. Eac h count must describe a pate ntably distinct invention. Id. Parties
are pr e sume d to have inv e nte d inte rf e ri ngsu bje c t matte r i n th e or de r o f t he date s o f t

he ir
acc orded be nefit for

eac h count. Id. § 207(a) (1). The “ac corde d benef it” is the Boa

rd’s
rec og nition that a patent application provides a prope r written de scription and ena blement. Id. § 41.201. The pa

rty with the ear lier ac corde d benef it is deemed the senior

party , while the other party is the junior party
. Id. Priority may be prove d by

a pre pondera

nce of the evidenc e. Id. § 41.207(a) (2). The parties may file substantive and r esponsive motions. Subst antive motionsIn a Minute Orde r date d Marc h 6, 2009, the Court g rante d Stry ker’ s unopposed motion 4 to admit into evidence the a dminist rative r ecor d of the proc eeding s in I nterfe renc e No. 105,578. Pursuant to 35 U.S.C. § 146, t he testimony and exhibits of the a dminist rative r ecor d shall have the same e ffe ct as if or igina lly taken a nd produce d in this action.

6 mus t ( 1) ra ise a

thr e sh old iss ue (i .e ., an is su e that, i f r e so lve d in fa vo r o f t he mov ant, wo uld deprive the opponent of standingin the interfe renc e); (2) seek to c hang e the sc ope of the definition of the interf

eringsubject matter or

the cor responde nce of

claims to the count; (3) se ek to chang e the be nefit ac corde d for the c ount; or (4) see k judgme nt on derivation or on pr iority
. See 37 C.F.R. §§ 41.208, 41.200. “To be sufficie nt, a motion must provide a showing , supported wi th a pp ro pr iate e vid e nc e , s uc h th a t, i f u nr e butte d, it w ou ld j us tif

y the re lie f s ou g ht. ” 37 C.F .R. § 41.208(b). B. Str

y k e r S pin e ’s Pa te nt Str y ke r S pin e is the a ssi g ne e of U. S. Pate nt N o. 6, 97 4, 46 0 ( “ the ’4 60 Pate nt” ), wh ic h is titled “Bia sed Angulation Bone Fixation Assembly .” See Ad min . Re c or d ( “ AR ” ) 4; D e fs .’ Mo t. 4 for Summ. J ., Shaw Dec l. Ex . 7 (the ’460 Pate nt) at 1. The ’ 460 Patent was issued on De cembe r 13, 2005, and wa s based on U.S. Patent Application No. 10/091,068 (“the ’068 A pplication”), which wa s filed on Marc h 5, 2002. AR 4. The ’068 A pplication claimed the be nefit of Pr ov isi on a l App lic a tio n N o. 60 /32 2, 04 2, fi le d o n Se pte mbe r 1 4, 20 01 . F ir st A m. C omp l. (“F AC”) ¶

19; Answer ¶

19. The named inventors of the ’460 Patent ar e John C arbone , Aar on Markwor th, Michael Hor an, and Y ves Crozet. AR 4. T h e d ev i ce d es cr i b edb y

th e ’ 4 6 0 P at en ti s i n t en d edfo r s p i n al fi x at i o n , i
. e. , s ec uri n g a sp ina l r od to t he bo ne s o f t

he ve rt e br a e . T he a

bs tr a c t of the ’4 60 Pate nt r e a ds a s f oll ow s: A bone fix ation assembly including a coupling element having an inner surfa ce defininga first bore coaxial with a first longitudinal ax is, and a se cond bore coaxial7

with a sec ond longitudinal axis, wher eby the s econd longitudinal ax is intersec ts the first longitudinal ax is. The couplingelement ha s a sea t adjace nt the lower e nd of the c ou pli nge le me nt, the se a t be ingde fi ne d b y the inn e r s ur fa c e of the c ou pli nge le me nt. Th e a sse mbl y

inc lud e s an a

nc ho ri nge le me nt a sse mbl e d w iththe c ou pli nge le me nt, the anc horingelem ent having a f irst end for inse rtion into bone and a he ad spac ed from th e fi rs t e nd , th e he a d b e ingin c on ta c t w iththe se a t of the c ou pli nge le me nt. Th e a sse mbl y

pr ov ide s su ff

ic ie nt a ngulatio n b e tw e e n a dja c e nt a nc ho ri nge le me nts secur ing a common orthopedic r od, and is particula rly useful for assemblies mounted in spines having abnorma l curvatures and in the c erivicothora cic r eg ion of the spine. ’460 Patent at 1. The ’460 Pate nt contains 39 claims, five of which ar e indepe ndent (c laims 1, 18, 24, 33, and 38). F AC ¶ 20; ’460 Patent cols. 15-18. A ccor ding to Stry ker, c laims 1 and 18 repr esent tw o d ist inc tly

pate nta ble inv e nti on s. Cla im 1 , w hic h Stry ke r c a lls the “ int e rs e c tin g a xes” inv e nti on , is de sc ri be d in the ’4 60 Pate nt a s f

oll ow s: 1. A bone f

ix ation assembly

comprising : a coupling element having an inner surf ace defininga first bore coaxial with a first long itudinal ax is and a second bore c oaxial with a sec ond longitudinal axis , wher ein first said first and sec ond longitudinal axes intersec t and ar e in communication with one another ; said coupling element including a s e a t a d

ja c e n t s a id

lo w e r e n d o f s a id c o u p li n g e le me n t, s a id

s e a t b e ing define d by

the inner sur fac e of sa id coupl i n g element; and a n anchor ing e lement assembled with said coupling element, said anchoring e lement havinga first e nd for insertion into bone and a he ad spac ed fr om the first end, said head being in contact wi th s e a t of

sa id c ou pli nge le me nt. ’460 Patent col. 15:42-55. Claim 18, which Stry

ker c alls the “interse cting planes” invention, is described in the ’ 460 Pate nt a s f

oll ow s: 18. A bone f

ix ation assembly comprising : a coupling element having an upper end defininga first plane , a lower end def ining a second plan e, an d at l east one bore extending fr om said upper e nd toward sa id lower end, wher ein said first and sec ond planes interse ct one a

nother; an a

n ch o ringelement a ssembled with said coupling e le m e n t , s a i d an c h o r i n g e l e m e n t b e i n g a d a p t e d f o r i n s e rt i o n i n t o b o n e ; an d s a id c ou pli nge le me nt havin g a U- sh a pe d ope nin g that exte nd s fr om the up pe r e nd of sa id cou p li n g e le me n t to w ar d th e lo w e r e n d o f s a id c o u p li n g e le me n t, w h e r e in said U-8

shaped ope ning is a dapted to re ceive a stabilizi ng rod. ’460 Patent col. 16:50-63. C. Defendants’ Patent Application & Suggestion of Interferenc e Def endant B ieder

mann is the assig nee of

U.S. Patent Application No. 10/763,431 (“the ’431 Application”), which is titled “B one Scre w.” F AC ¶ 16; Answer ¶ 16. De fenda

nt DePuy has bee n identified as the e x clusive license e of the ’431 Application. Answer ¶ 18. The ’431 Application was f

iled on J anuar

y 22, 2004. FAC ¶ 23; Answ er ¶ 23. The ’431 A

pplication claimed to be a

continuation of Application No. 10/037,698, filed November 9, 2001, which claimed pr iority

from Ge rman Application No. 10055888.7, filed Novembe r 10, 2000, and Ger man Application No. 10065397.7, f iled Dec ember

27, 2000. FAC ¶ 23; Answ er ¶ 23. The
name d inve nto rs of

the ’4 31 Ap pli c a tio n a

re Lutz B ie de rm ann

and Jurg e n H arm s. De fs .’ Mo t. for Summ. J ., Shaw Dec l. Ex . 6 (the ‘431 A pplication) at 1. L ike the ’460 Pate nt, the ’431 Application describes a device that connec ts a bone scr ew to a couplingelement f

or the re ceipt of a

n anchor ing r od. The a

bstract of the ’431 Application
re a ds a s f oll ow s: A bone sc rewhavinga scr ew membe r (1) possessing a threa ded sec t i o n (2) a

nd a head ( 3) and a

rec eiving part (5) at t he head end for rece iving a rod t o be conne cted to the bone screw is provided. The rece iving part (5) has on [si c] open first bore (6) and a substantially

U-shape d cross-se ct i o n h av ing two f ree leg s provided with a thr e a d. F ur

the rm or e , the re c e ivi ng pa rt ha s a sec on d bor e (7 ) on t he e nd op po sit e to the first bore (6) whose diameter is g reater than that of the thre aded se ction (20 and smaller than that of

the hea d (3). On the bottom of the first bore a seat for the hea d ( 3 ) is p r o v id e d
. Ino r d e r

th a t t h e s c r e wme mb e r

c anb e p iv o te d

to at l e a s t o n e side by an enla rg ed ang le, the edg e boundingthe fre e end of the sec ond bore ( 7) viewe d relative to the axis of the fir st bore (6) is of asy mmetric construc tion. ’431 Application at 1 (figure omitted).The Court strictly adher es to the text of L ocal Civil Rule 7(h) (for merly Rule 56.1 when 5 resolvingmotions for summary judgme nt). Se e Bu rk

e v . G ou ld , 286 F.3d 513, 519 ( D.C. Cir. 2002) (f inding district cour

ts must i nvoke the loca l rule bef ore a pplying it to the ca se). The Court has advised the pa

rties that it strictly

adher es to Rule 7(h) a

nd has stated that it “a ssumes fac ts identified by

the moving pa

rty in its st atement of

materia l fac ts are a dmitted, unless such a fac t is controverte d in the statement of g enuine issues filed in opposition to the motion.” [ 3] Orde r at 1 (O ct. 29, 2008). Thus, in most instances the Court shall cite only to one par

ty ’s State me nt o f M a te ri a l F a c ts ( “ Stmt .” ) u nle ss a state me nt i s c on tr a dic te d b y the op po sin g pa

rt y , in which ca se the Court may cite a pa rty ’s Response to the Statement of Material F acts (“ Resp. Stmt .”). Stry

ker f iled a sepa

rate Statement for e ach motion, so the Court shall ref er pa re nth e tic a lly

to s ub sta nti ve mot ion

to whic h e a c h c or

re sp on ds . T he Court

sh a ll a lso c ite direc tly to evidence in the rec ord, whe re a ppropriate
. 9 On J uly 9, 2004, Be idermann f

iled a “Re quest for D ecla ration of Interfe renc e Unde r 37 CFR 1.604(a) ” betwe en the ’ 431 Application and the ’ 460 Patent. See Pl.’s Redefinition Mot., Ex. B . B ie de rm ann

pr op os e d tw o inte rf

e re nc e c ounts , o ne of

wh ic h w a s d ir e c te d to an “ a sse mbl y or couplingelement” as addr essed in 33 cla ims in t he ’460 Pate nt (which we re c opied by B ie de rm ann ), and

the oth e r o f whic h w a s d ir e c te d to a “ me tho d” a s d e fi ne d in

fo ur oth e r c la ims in the ’460 Patent (a lso copied by Bie derma

nn). Pl.’s Stm t. (Redef

inition) ¶ 4. On J anuar

y 10, 5 2 0 0 6 , B i e d e r

m an nf i l e d a “ S u g g e s t i o no f

In t e r f e r e n c e U n d e r

3 7 C F R 4 1
. 2 0 2 ( a ) ” p r o p o s i n g o n l y a sin g le c ount o f i nte rf

e re nc e dir e c te d to wa

rd an a sse mbl y

or c ou pli nge le me nt. De fs .’ Re sp . Stmt. (Redef inition) ¶ 4; Pl .’s § 112 Mot., Ex s. U-V. On A pril 13, 2007, the examiner in char g e of the ’431 Application issued an action ac knowledg ing B ieder mann’s sug g estion of interfe renc e. Pl.’s Stmt . (Redef

inition) ¶ 5; Pl .’s Redef

inition M ot., Ex . C (“4/13/07 PTO Commc’n”). Among other thing s, the PTO indicated that B ieder mann had “ list[ ed] a varie ty of cla ims as being the proposed c ount” and infor med B ieder

mann that “[r]espectfully , a count c annot consist of more tha n o ne c la im. ” 4/1 3/0 7 PT O C omm c ’n a t 2. Th e PTO state d th a t B ie de rm ann ha d o ne month to corre ct any

defic iencies. Id.An interfe renc e count that use s the alternative to describe the interfe ringsubject matter, 6 i.e., “Par ty A’s cla im X or

Part y B ’s c la im Y ,” is k

no wn a s a “ Mc Ke lve y

c ount” a ft e r t

he APJ who first used it. See Pl. ’s Re de fi nit ion Mo t., Ex. E (H e rb e rt

D. Ha rt I I I , “ An Inte rf e re nc e : What, When, and How Muc h Does It Cost? ”) at 4. 10 On May 16 , 2 00 7, B ie de rm ann

fi le d a “ Sup ple me nta l Su g g e sti on of Inte rf e re nc e ” wi th th e P T O. De fs
. ’ R es p . S t m t
. (R ed ef i n i t i o n ) ¶6 ; P l
. ’s R ed ef

i n i t i o nM o t
. , E x . D ( “S u

p p . S u gg. Inte rf .” ). B ie de rm ann

e xpla ine d th a t in

its vie w, the PTO ’s state me nt t hat a c ount c ann ot c on sis t of more tha

n one cla im is i ncorr ect. See Sup p. Sug g . Inte rf . at 2. B ie de rm ann

e xpla ine d th a t it s proposed c ount was known a s a “Mc Kelvey count” a nd that such counts have been pr oposed by the B oard in many

interfe renc es and a

re the ref ore a cce ptable. Id. at 2-3. B ieder mann then 6 proposed what it called a “ Simpl ified McKe lvey Count,” defined a s “[t] he asse mbly or coupling element of

Carbone c laims 1, 18, 24, 33, or 38, or the a ssembly or couplingelement of Bie derma nn claims 6, 18, 28, 33 or 35.” Id. at 4. B ieder mann explained that the simplified McKe lvey

count “ha s the adva

ntag e of c ombining the pa rties’ indepe ndent claims, which a re not patentably

distinct from one anothe r, while swe epingin the rema ining de pendent c laims, which do not add fe ature s that rende r their subjec t matter as a whole ea ch sepa

rate ly patentable over the parties’ combined indepe ndent claims.” Id. D. The Interfere nce Procee ding On Octobe r 10, 2007, Patent Interfe renc e No. 105,578 wa s decla red involvingthe ’460 Patent and the ’ 431 Application. Def s.’ Stmt. ¶ 1. Admini strative Patent Judge ( APJ ) Jameson L ee w as assig ned to manag e the inter fer ence proce eding
. Id. ¶ 3. B ieder mann and Ha

rms, the inventors of the ’ 431 Application, wer e identified a s the senior pa rty , wher eas the inventors ofBie derma nn was a ccor ded the be nefit of the G erma n application filed on N ovember 10, 7 2000, making its claim senior to that of Carbone et al., who we re a ccor ded the be nefit of a provisional application datingback to Septembe r 14, 2001. The interf

ere nce c ount was later

rede clar ed to substitute Biede rmann’s c laim 22 for 8 Bie derma nn’s claim 18. SeeAR 153-54. Although the Boa

rd often r efe rre d to the inventors as the pa rties bef ore it, the Court 9 sh a ll p ri mari ly

uti lize the name s o f t

he pa rt ie s to thi s a c tio n ( i.e ., Str y ke r a nd B ie de rm ann ), wi th the under standing that actions we re taken on their be half in the proc eeding s below. 11 th e ’ 4 6 0 P a t e n t( C ar

b o n e e ta l
. ) w e r e i d e n t i f

i e d a s th e j un i o r

p arty. Id. The interf

ere nce w as 7 decla red on the basis of a sing le count, which r ead “ Carbone’ s patent cla im 1, 18, 24, 33, or 38 or Bie derma nn’s claim 6, 18, 28, 33, or 35.” AR 5. The de clar ation of interf ere nce sc heduled a

n 8 initial confere nce c all for De cembe r 5, 2007. Id. ¶ 5. Unde r the B oard’ s Standing Or der g overningproce dures in interf ere nce pr ocee dings, e ach pa rty must file a list of the substantive motions i t intends to file prior to this ini tial confe renc e ca ll. AR 29 (Standing Or der ¶ 104.2.1), 71 (Standing Orde r ¶ 204)
. Stry ker did not seek to contest the pr iority of invention pe r sein the interfe renc e 9 proce eding . Pl.’s Unpatentability Br . at 3-4. Rather , Stry

ker vie wed the sing le interfe renc e count
as enc ompassing two distinct inventions: the first based on c laims 1, 24, and 38 of the ’ 460 Patent (the “ intersec ting ax es” inve ntion) and the sec ond based on c laims 18 and 33 of the ’ 460 Pate nt ( the “ int e rs e c tin g pla ne s” inv e nti on ). Str

y ke r a lso tho ug ht t

hat B ie de rm ann ’s c la ims lacke d support and we re unpatentable ba sed on prior a rt. Acc ording ly , Stry

ker f iled the following list of moti ons on November 29, 2007: 1. Carbone Misce llaneous Motion 1 (No Interfe renc e in Fa ct) ba sed on B ie de rm ann ’s la c k o f s up po rt fo r t he inv e nti on

of the c ount; 2. Carbone Misce llaneous Motion 2 (to rede fine the inter fer ing subje ct matter)In li g ht o f S tr y ke r’ s c on c e ssi on

of pr ior ity , B ie de rm ann ’s pr op os e d mo tio ns we re a ll 10 moot. See AR 160. 12 pr op os inga

su bs tit ute c ount; 3. Carbone Misce llaneous Motion 3 (for judg ment based on pr ior art) based on the un pate nta bil ity of the c ount; 4. Carbone Misce llaneous Motion 4 (to desig nate Car bone cla ims not c or re sp on din g to t

he pr op os e d n e w s ub sti tut e c ou nt) Def s.’ Stmt. ¶ 7. On November 30, 2007, A PJ L ee issued a n Orde r dismissing Stry

ker’ s motions as being“so vague as to be not useful for r easona ble pre paration of the schedule d telephone confe renc e ca ll on Dece mber 5, 2007.” Id. ¶ 8; AR 148-49. APJ L ee g ave Stry ker until the end of the da y to file a re vised motions li st to ex plain more spec ifically (1) why there is no interfe renc e in fa ct; (2) why a substitute count is neede d and what substit ute count is proposed; (3) whic h of B ieder

mann’s cla ims are unpatentable a nd on what g rounds; and (4) which of Bie derma nn’s claims do not corr espond to Stry ker’ s proposed substitute count and why . AR 148-49. Stry

ker f iled a re vised list of moti ons. AR 150-52. Bie derma nn also filed a list of motions pertaining to pr iority . AR 144-45. Duringthe motions confer ence call held on De cembe r 5, 2007, Stry ker’ s counsel d i s cu s s edi t s re v i s edm o t i o n s l i s tan d i n fo rm edAP J L ee th atS try k er wo u l d n o tb e f i l i n g a priority motion in t he interf

ere nce. Def

s.’ Stmt. ¶¶ 11-12. On De cembe r 6, 2007, APJ L ee 10 iss ue d a n O rd e r a uth or izin g su

bs tanti ve mot ion s. AR

15 6- 61 . T he Or de r a

uth or ize d Stry

ke r t o fi le a mot ion to r e de fi ne the Inte rf

e re nc e by re pla c ingthe c ur

re nt c ount w ith

tw o n e w c ounts : Count 2 (consisting of Stry ker’ s claim 1 or 24 or 38 or Bie derma

nn’s claim 6 or 28 or

35) and Count 3 (consisting of Stry ker’ s claim 18 or 33 or B ieder mann’s cla im 22 or 33). AR 160. The13

Orde r also author ized St ry ker to file a

conting ent motion (i.e., conting ent upon g rantingof the motion to redefine the Interfe renc e) f or judg ment ag ainst Biede rmann’s c laims in proposed Count 2, for lack of

written desc ription in the specification. AR 161. However , the Orde r denie d authorization for Stry

ker to file a

motion attacking Bie derma nn’s claims in proposed Count 2 for lack of enablingdisclosure. AR 157-58. The Orde r also denie d authorization for Stry ker to file a motion attacking Bie derma nn’s claims in proposed Count 3 as unpatentable ove r prior a rt. AR 159, 161. On Dec ember

20, 2007, Stry

ker f iled a re quest for r ehea

ringof APJ L ee’ s ruling that Stry ker w as not authorized to file a motion based on la ck of e nabling disclosure. AR 169-187. Str y ke r a lso fi le d a

re qu e st f or re he ari ngof

APJ L e e ’s ru lin g that Str y ke r w a s n ot a

uth or ize d to file a motion based on unpatentability . AR 188-96. On January 22, 2008, a thre e-judg e pane l of the B oard ( APJ s Schafe r, L ee, a nd Moore) issued a dec ision denying r ehea ringand af

firming APJ L e e ’s ru lin g s. AR

20 2- 17 . T he B oa

rd no te d th a t Inte rf

e re nc e pr oc e e din g s a

re a c tiv e ly manag ed by

the APJ , and the APJ has discretion to disallow moti ons that will not serve the interests of a chievinga spee dy , just, and inex pensive re solution of the I nterfe renc e. AR 204-06. The B oard e x plained that Stry ker’ s basis for its proposed motion as to lack of enablingdisclosure
wa s th e purp or

te d la c k o f wri tte n d e sc ri pti on , a nd the B oa rd re je c te d th is the or

y a s n ot v ia

ble beca use the e nablement r equire ment is disti nct from the written descr iption requirement ( i.e., an invention may

be ena bled eve n if it is not described). See AR 208-13. The B oard a lso ex plained that a lth ou g h th e B oa

rd may de te rm ine iss ue s o f u

np a te nta bil ity in i nte rf e re nc e pr oc e e din g s, it i s not require d to do so. AR 213-16. On Fe bruar

y 15, 2008, Stry

ker f iled a “Re vised Substantive Motion 1” to redef ine the14

interfe renc e. See AR 307-59. Four day s later, APJ L ee he ld a telephone confe renc e with counse l fo r b oth pa rt ie s. AR 36 0. APJ L e e or de re d Stry ke r t o f ile a re vis e d Su

bs tanti ve Mo tio n 2 to f

ix
cer tain err ors in its original f iling. AR 364. On F ebrua ry 21, 2008, Stry

ker f iled its “Revised Substantive Motion 2,” continge nt upon the g rantingof Substantive Motion 1, for judg ment that Bie derma nn’s claims per

taining to pr oposed Count 2 are unpatentable for f ailing to mee t the “wr itten description” r equire ment of 35 U.S.C. § 112. See AR 365-465. On April 30, 2008, a pa

nel of the B oard ( APJ s Schafe r, L ee, a nd Moore) issued a Memorandum Opinion and O rder
. See AR 468-81. The B oard de nied Stry ker’ s Revised Substantive Motion 1 t o rede fine the inter fer ence count. AR 469. Be cause Stry ker’ s Revised Substantive Motion 2 was continge nt on the g rantingof Motion 1, the Boa rd dismissed the conting ent motion. AR 479. The Boa rd then e ntere d judgme nt ag ainst Stry ker in the Interfe renc e, ca

ncellingclaims 1-39 of the ’460 Patent. AR 482-84. On Ma y 30, 2008, Stry

ker filed a “ Request for Re hear ing of J udg ment Ba sed on De nial of Carbone Revised Substantive Motion 1.” AR 485-527. On August 27, 2008, a pane l of the B oard ( APJ s Schafe r, L ee, a nd Moore) issued a wr itten decision on Stry ker’ s reque st for re hear ing. See AR 528-38. II. LEGAL STANDARD This action is broug ht pursuant to 35 U.S.C. § 146, which states in pertinent par t that “[a]ny party to an interfe renc e dissatisfied with the dec ision of the Boa rd of Patent Appe als and Interfe renc es on the interf ere nce, ma

y have r emedy

by civil action . . . .” Judicial review unde r
se 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. , 129 F.3d 588, 592 ( Fe d. Cir. 1997). “Que stions of law are revie wed de novo , but the under lying f

actua l determinations made by the B oard a

re r eviewe d for c lear

err or.” Ab bo tt15

GMBH & Co. KG v. Y

eda Re search &Dev . Co, Lt d., 576 F. Supp. 2d 44, 49 (D.D .C. 2008) (c i t i n g W inner Int’l Royalty Corp. v. W ang , 202 F.3d 1340, 1348 ( Fe d. Cir. 2000)). An a ction broug ht under § 146 is essentially a proc eedingto reviewthe ac tion of the Boa rd. Conservolite, Inc. v . W idmayer , 21 F.3d 1098, 1102 ( Fe d. Cir. 1994). “A pa rty may not . . . advanc e new

leg al theories at the trial court leve l, even if the overa rchingleg al issue was pr esente d below.” Boston Sci. Scime d, Inc. v . Medtronic Vasc ular, Inc. , 497 F.3d 1293, 1298 ( Fe d. Cir. 2007). The r ecor d below may

be admitted by

either pa rty , but the parties may

also “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). Howe ver, the parties’ rig ht to offer new e vidence is lim ited to issues raised by the par ties duringthe proc eeding s below or by the B oard’ s decision. W idmayer , 21 F.3d at 1102. I f the district court ac cepts ne w evidenc e not pre viously befor e the B oard, the Court must m ake de
novo fac tual finding s for issues on which the court a cce pts new evide nce. Y eda Re search & Dev

. , 576 F. Supp. 2d at 49. In addition to the administrative rec ord, which ha s been a cce pted int o e vid e nc e , th e pa

rt ie s h ave su

bmi tte d a se ri e s o f d e c lara

tio ns and e xhibi ts i n s up po rt

of the ir motions for summary

judgme nt. The Court shall consider this evide nce where appropr iate in the context of a summary

judgme nt motion. “A motion for summary

judgme nt in an action see king judicia l reviewof an inter fer ence p ro ce ed i n g p urs u an tt o 3 5 U. S
. C
. § 1 4 6 i s s u b j ec tt o th e s am e l ega l s t an d ar d as o th er p ro ce ed i n gs unrelated to patent law issues.” Se ar s Ec ologic al A

pp lic ati on s Co . v . M

LI As so cs. , LLC , 6 52 F. Supp. 2d 244, 256 (N.D.N.Y. 2009) . Summary judgme nt is proper whe n “the plea dings, the discovery [i f any] and disclosure mater ials on file, and a ny aff idavits show that there is no g enuine issue a s to any

materia l fac t and that the movant is entitled to judgme nt as a matter of16

law.” F ed. R. Civ. P. 56(c). Under the summary

judgme nt standard, the movingparty bear s the “initial responsibility

of informingthe district court of the basis for its motion, and identifying those portions of the plea dings, de positions, answers to interrog atories, a nd admissions on file, toge ther with the a ffidavits, if any , which it believes de monstrate the a bsence of a g enuine issue of mater ial fac t.” Ce lote

xCor p. v . Ca tre tt , 477 U.S. 317, 323 (1986) (inter nal quotation marks omitted). I n response , the non-movingparty must “g o beyond the pleading s and by [i ts] own
a ff ida vit s, or by the de po sit ion s, ans we rs to i nte rr og a tor ie s, and a dmi ssi on s o n f

ile , d e signate specific fac ts showing that ther e is a g enuine issue f or trial.” Id. at 324 (interna l quotation marks omitted). All underlying f acts a nd infere nces a

re a naly zed in the light most favorable to the nonmoving pa

rty
. Anderson v. Liberty Lobby, I nc. , 477 U.S. 242, 247 (1986). III . D ISC USS ION There are at least four

separ ate issues ra ised by the par ties’ cr oss-motions for summary jud g me nt. In n o p art ic ula r o rd e r, tho se iss ue s a

re : w he the r t

he PTO e rr e d b y

imp ro pe rl y decla ringand re fusing to rede fine the sing le interfe renc e count; whe ther the PTO e rre d by failing to conclude that Biede rmann’s patent application lac ked ade quate wr itten specification and enable ment; whether

the PTO err ed by

failingto conclude that Biede rmann’s c laims are unpatentable ; and whethe r the a lleg edly unconstitutional appointment of one of the
a dmi nis tr a tiv e pate nt j ud g e s th a t r ule d o n th e int e rf

e re nc e re nd e rs the de c isi on s ma de by that A PJ
nu ll a nd vo id. B e c a

us e a fi nd ingthat on e of

the APJs w a s unc on sti tut ion a lly a pp ointe d w ou ld require a re mand to the B oard f or re consideration of the merits of the inter fer ence proce eding , the Court c on sid e rs that is su e fi rs t. T he Court ne xt ad dr e sse s th e Re de fi nit ion Mo tio n b e c a

us e Str y ke r’ s o the r c la ims are c on tin g e nt u po n th e re de fi nit ion

of the int e rf e re nc e c ount.Def endants a lso argued that Stry ker ha d failed to c omply

with Rule 5.1, which requir es 11 a lit ig ant c ha lle ng ingthe c on sti tut ion a lity of a fe de ra l st a tut e to n oti fy

the Un ite d St a te s so that it may intervene . [39] Def

s.’ Opp’n at 8-9. Howe ver, Stry ker ultimately

did provide a Rule 5.1 17 A. Unconstitutional Appointment of the Administrative Patent Judge Stry ker c ontends that the dec isions of the Boa rd that ar e under

revie w in this action are invalid and void beca

use Administrative Patent Judge James T. Moore, who was a member of

the thr e e -j ud g e pa

ne l r e vie wi ngthe me ri ts o f t he un de rl yingint e rf

e re nc e pr oc e e din g , r e c e ive d h is
c o m m i s s i o ni nv i o l a t i o no f th e Ap p o i n t m e n t s C l a

u s e o f th e U n i t e d

S t a t e s C o n s t i tu t i o n , A rt i c l e II, Section 2, cl. 2. B oth Defe ndants and the United States as Interve nor conte nd that the B oard’ s de c isi on s b e low

are va lid be c a us e , amon g oth e r t

hin g s, APJ Mo or e wa s c on sti tut ion a lly
re a pp ointe d b e fo re the B oa

rd iss ue d it s f

ina l de c isi on

on re he ari ng . B e fo re a dd

re ssi ngthe me ri ts of the c on sti tut ion a l qu e sti on , h ow e ve r, the Court mus t de te rm ine wh e the r S tr y ke r h a s p ro pe rl y pr e se nte d it

to t his Court
. 1. Procedur al Def

enses De fe nd ants argue that Str y ke r h a s n ot p ro pe rl y

pr e se nte d a

c on sti tut ion a l c ha lle ng e to t his Court beca

use it did not include a re quest for de clar atory relief in its First Amended Complaint. See [39] D e fs .’ Op p’ n at 9. Whil e that is te c hn ic a lly tr ue , it c ann ot b e sa id t

hat Str y ke r f a ile d to plead a constitutional challeng e. The First Amende d Complaint contains severa l alleg ations relating to the unc onstitut ional appointment of the a dminist rative patent judge s, see F ir st A m. Compl. ¶¶ 72, 115, 130, 146, and it specific ally reque sts relief in the f

orm of a r emand to the PTO and an o rd e r d ir e c tin g the PTO to “ re a ssi g n th e Inte rf e re nc e to a

ne w A PJ an d a

lawf ull y constituted panel of A PJ s.” Id. , Demand f or Relief ¶

3(a) . These a lleg ations are sufficie nt under the notice plea ding r equire ments of Rule 8. 11notice, see [42] Rule 5.1 Notice of Constitutional Question, and the United States did interve ne. 18 Ad dit ion a lly , D e fe nd ants c on te nd that Str y ke r w a ive d th is a

rgume nt b y

fa ili ngto r a ise it with the Boa

rd until its final May

30, 2008, reque st for re hear ing be fore the B oard. See [39] Def s.’ Opp’n at 9-11. Bie derma nn relies on In re DB C , 545 F.3d 1373 ( Fe d. Cir. 2008), for the proposition that an argument may be wa ived in fede ral c ourt if it is not t imely prese nted to the Boa rd. The DB C court he ld that the appellant ha d waived his Appointments Clause cha lleng e by failingto raise the issue be fore the B oard a nd prese nting f

or the fir st tim e on appe al in fede ral court. Id. at 1377-78. Althoug h there is some lang uag e in DB C su g g e sti ngthat a lit ig ant m

us t pr e se nt a “ tim e ly” c la im t o th e B oa rd in o rd e r t o p re se rv e re vie w i n f e de ra l c ourt , th e ra

tio na le fo r t hat r ule is t o p ro vid e the a g e nc y an o pp or tun ity to c or re c t any e rr or s “ be fo re it i s h a le d into fede ral c ourt.” DBC , 5 4 5 F. 3 d at1 3 7 9 (qu o t i n g W

oodford v. Ngo , 548 U.S. 81, 89 (2006)). That objective is satisfied whe re, a s in this case, the litiga nt raises the issue in a

motion for rehe aring
. Indeed, the DBC

court a pproved suc h an appr oach: [N]ot hin g pr e ve nte d D B C f

ro m takin g ste ps wh ile thi s c a se wa s b e fo re the B oa rd to a sc e rt a in the a

pp ointme nt s tatus of

the a dmi nis tr a tiv e pate nt j ud g e s a ssi g ne d to its cas e. Eve n if DB C did not l ear n of the judg es assig ned to its panel until oral argument or until a decision was issued, it sti ll had an opportunity to challeng e the composit i o n o f the pa

nel in a post-ar g ument submissi on or in a motion for rec onside r a ti o n . I f D B C h a d ti me ly r a is e d th is is s u e b e f o r e th e B o ar d , th e Board could have evaluated and corr ecte d the alleg ed constitutional infirmity by providing DB C with a panel of a dminist rative patent judge s appoi n t ed by the Secr etar

y . Of course , th e B o ar d

ma y n o t h av e c o r

r e c te d th e p r o b le m, o r

e v e na c kn o w le d g e d

th at the problem e x isted. But in that ca se, DB C would have pre serve d its rig ht to appeal the issue. 545 F.3d at 1379. Not only did Stry ker r aise this issue in its request for r ehea ring , AR 495-96, the B oa rd a c tua lly a dd re sse d th e me ri ts o f t

his argume nt a

nd re je c te d it , A R 53 5. Th e Court is the re fo re no t pe rs ua de d th a t Str y ke r w a ive d it s App ointme nts Cla us e c ha lle ng e by

wa iti ngun til19

its request for

rehe aringto raise it with the B oard. 2. Th e Ap po intme nts Cla us e Th e Ap po intme nts Cla

us e of the Un ite d St a te s Co ns tit uti on state s: [The President] shall nom inate, and by and with the Advice and Consent of the Senate, sha ll appoint Ambassadors, other public Ministers and Consuls, Ju d g e s o f the Supreme Court, and all other Office rs of the United States, whose Appointments are not here in otherwise pr ovided for, a nd which shall be e stablished b y L aw ; but the Congr ess may by L aw vest the Appointment of such infe rior Of fice rs, as they

think pr op e r, in t

he Pr e sid e nt a lon e , in

the Court s o f L aw, or in the He a ds of De pa rtme nts
. U. S. C O N ST ., art. I I , § 2, cl. 2. “[A]ny appointee e x erc ising sig nificant a uthority pursuant to the laws of the Un ite d St a te s is an ‘ Of fi c e r o f t he Un ite d St a te s, ’ a

nd mus t, t he re fo re , b e a

pp ointe d in the manner

presc ribed by

[t he Appointments Clause].” Buck ley v . Valeo , 424 U.S. 1, 126 (1976); see also Offic ers of

the United States within the Meaningof the Appointments Clause, 37 Op. Off. L eg al Counsel __, 2007 OL C L EXI S 3, at *11 (2007) (de scribingoffice rs as those who possess deleg ated sove reig n authority from the f

eder al g overnme nt). The Supre me Court has held that postmasters, district cour t clerks, F eder al Elec tion Com missioners, and spec ial trial judge s in Tax C ourt are all “infe rior Of fice rs.” See F

reytag v . Comm’r , 501 U.S. 868, 880-82 (1 99 1) ; Buck

ley , 424 U.S. at 126 (citingcase s). The diff ere nce be tween a

n “Of fice r of the United States” who must be a ppointed and an “ employ ee” who may be hire d is that employ ees
are “lesser

functionar ies subordinate to off icer s of the United States.” Buck ley , 424 U.S. at 126 n.162. In explaining why a spec ial trial judg e in Tax Court is an inferior off icer subject to the Appointments Clause, the Supreme Court noted that the of fice of spec ial trial judg e is established by law, with the duties, salar y , and mea

ns of appointment spec ified by statute. Freytag , 5 01 U. S. at 881. Moreove r, the Court noted, they perf orm more than me rely

minist eria l tasks, such as20

takin g te sti mony , c on du c tin g tr ia ls, and ru lin g on the a dmi ssi bil ity

of e vid e nc e , a

nd the y e xer c ise signific ant discre tion. Id. The Appointments Clause re stricts Congr ess’s powe r to vest the appointment of infe rior of fi c e rs to t he Pr e sid e nt, the “ Court s o f L aw, ” or the “ He a ds of

De pa rtme nts .” Th e Sup re me Court has held that “the term ‘De partment’ r efe rs only to a par t or division of the executive g ov e rnme nt, a s th e De pa

rtme nt o f S tate , o r o f t

he Tr e a su ry , e xpre ssl y

c re a te d a nd g ive n th e name of a de partment by

Congr ess.” Freytag , 501 U.S. at 868 (interna l quotation marks and alter ations omi tte d) ; see also Burnap v. U nited States , 252 U.S. 512, 515 (1920) (“ The ter m ‘hea d of a depar tment’ means . . . the Sec reta ry in char g e of a

g reat divisi on of the e x ecutive br anch of the g overnme nt, like the State, Trea sury , and War, who is a me mber of the Cabinet.”) T he ter m does not include infer ior commissioners and bure au off icer s. Id. (c i t i n g United States v. Ge rmaine , 99 U
. S
. 5 0 8 , 5 1 1 ( 1 8 7 8 ) )
. T h e t e r m“ C o urt s o f

Law ” h a s b e e ni n t e r

p r e t e d t o i n c l u d e b o thA rt i c l e III courts and le g islative courts cr eate d pursuant to Article Iof the Constituti on. Freytag , 5 01 U. S. at 890. 3. Administrative Patent J udg e Moore ’s Appointment The lawreg ardingthe appointment of a dminist rative patent judge s has cha ng ed seve ral times within t he last dozen y ear s. Prior to March 29, 2000, a dminist rative patent judge s were appointed by

the Secr etar

y of Commerce
. See 35 U.S.C.A. § 3(a) ( West 1999) (“The Secre tary of Comme rc e , u

po n th e no min a tio n o f t

he Commis sio ne r [o f P a te nts and Tr a de mark s], i n
acc ordanc e with law, sha ll appoint all other offic ers a nd employ ees.” ). Howe ver, e ffe ctive Marc h 29, 2000, the law pr ovided that administrative pate nt judge s should be appointed by the Direc tor of the PTO. See 35 U.S.C.A. § 6(a) ( West 2000) (“The administrative patent judg esThis is the curre nt lang uag e of 35 U .S.C. § 6, as of the date of this opini on. 12 21 shall be per sons of compete nt leg al knowledg e and sc ientific ability who ar e appointed by

the Direc tor.”) I

n 2008, the law wa s chang ed ag ain. See Act of Aug ust 12, 2008, Pub. L . No. 110- 313, 122 Stat. 3014 (2008). The la w now provide s that administrative patent judg es shall be “appointed by

the Secr etar

y of Commerce , in consultation with the Director .” 35 U.S.C.A. § 6(a) (We st 2 00 9) . T he 20 08 Ac t a lso a dd e d tw o a dd iti on a l su bs e c tio ns re latin g to a

pp ointme nts previously

made by the PTO Direc tor: (c) Authority

of the Sec reta

ry .—The Sec reta

ry o f C o m m er ce ma

y , in his or her discretion, dee m the appointm ent of an administrative patent judg e who, be fore the date of the ena ctment of this subsection, held off ice pur suant to an appointment by the Dire ctor to take eff

ect on the date on which the Direc tor initially appointed the administrative patent judg e. (d) De fense to challeng e of appointment.—I t shall be a defe nse to a c halleng e to the appointment of an administrative patent judge on the basis of the judg e’s having be en orig inally appointed by

the Director that the administ rative patent judge so appointed was a cting as a de fac to office r. 35 U.S.C.A. § 6 (West 2009). 12 Th e pa rt ie s a g re e that A dmi nis tr a tiv e Pate nt Jud g e Jame s T . M oo re wa s a pp ointe d to his position on November 5, 2001. See Stmt . (Unc onstitut ionality) ¶ 13; [47] Def s.’ Corre cted Resp. Stmt . (Unc onstitut ionality) Mot. ¶ 13. This falls within the statutory time period duringwhich APJ appointments were beingmade by the PTO Direc tor. Althoug h Def endants do not conc ede that APJ Moore wa s appointed by the PTO Direc tor, they

do conce de that Moore was not appointed by

the Secr etar

y of Commerce
. See [47] D e fs .’ Cor re c te d Re sp . Stmt. (Unc onstitut ionality) ¶ 13. Stry ker w as unable to obtain discovery from the PTO to conf

irm thatStr y ke r d id o bta in f

ro m D e fe nd ants a

le tte r f ro m th e PTO re sp on din g to a F OIA r e qu e st 13 in an unre lated matter

that listed the APJ appointments occur ringbetwee n Marc h 29, 2000 and May 10, 2008, which included the name of APJ Moore. See Pl
. ’ s U n c o n s ti tuti o n a li ty M o t. , E x. DD. It appea

rs that the PTO did not produce any documents in response to Stry ker’ s subpoena duces te cum . Stry ker sug g ests in a footnote in one of its brief that the e x hibits produced by the 14 Gover nment lack “ authentication or expl anation.” See [55] Pl.’s Reply Mem. Resp. to United States’ Mem. at 3 n.4. How ever , Stry ker doe s not actually

contest the fa ct that APJ Moore wa s rea ppointed by

the Secr etar

y on August 12, 2008. Neither Def endants nor the United States disputes that administrative patent judg es ar e 15 “infe rior off

icer s” subject to the Appointments Clause. L ike the spec ial trial judg es of the T ax Court, which wer e dee med infer ior offic ers in Freytag , 501 U.S. at 880-82, the off ice of administrative patent judg e is define d by statute and is endowe d with significa nt discretion. 22 Moore wa s appointed in this manner, but exhi bits provided by the United States provide c lear 13 evidenc e that APJ Moore wa s in fact a ppointed by

the PTO Direc tor on Novembe r 5, 2001. See [53] Interve nor United States’ Me m. Supp. C onstitut ionality of APJ Moore, Ex. 1 (Mem. Re: Ratification of the D irec tor’s Administrative Patent and Tr adema rk Judge Appointments) at 2-3. On August 12, 2008—the day that the law wa s chang ed—the Sec reta ry of Commerce
rea ppointed APJ Moore a

nd deeme d the appointment to take e ffe ct on the date that the Dire ctor initially appointed him. Id. , E x. 1 at 6; id. , Ex . 2, at 1. 14 4. Constit utionality

of APJ Moore’ s Initial Appointment The Appointments Clause provide s that administrative patent judg es, as infe rior off icer s of the United States, may only be appointed by

either the President, a “ Court of L aw,” or a 15 “He ad of D epar

tment.” B eca

use APJ Moore wa s appointed by the PTO Direc tor, his initi al appointment would have be en unconstitutional unless the Direc tor of the PTO c an be c onsidered either a “Court of L aw” or a “ Hea d of De partment.” Def endants a dvance theories a s to why the PTO Di re c tor

may be lon g to e ith e r o f t

he se c a te g or ie s. Th e Un ite d St a te s, a s Inte rv e no r, wh ile23

not expl icitly

conce ding the point, does not argue that APJ Moore wa s constitutionally appointed by the PTO Di re c tor . Rathe r, bo th D e fe nd ants and the Un ite d St a te s a

rgue that e ve n if

APJ Moore wa s unconstitutionally appointed in the first instance , his reappointment on August 12, 2008, cure s any

constitutional defec t beca use (1) the B oard issued its final de cision on rehe aring afte r the re appointment; (2) APJ Moore’ s appointment was dee med re troac tive by the Secr etar

y of Commerce ; and/or (3) APJ Moore’ s prior ac tions were le g itimate under the de facto officer doctrine. I t is well settled that courts should avoid dec iding c onstitut ional questions where it is not
nece ssary to do so. See ge nerally Ashwander v. Tenn. Valley Auth. , 297 U.S. 288, 347 (1935) (B rande is, J ., concur

ring ). Ac cording ly , the Court shall not decide whether APJ Moore’ s appointment by

the PTO Direc tor was unc onstitut ional unless none of the three theories a bove
c ur e s th e a lle g e d c on sti tut ion a l de fe c t. F or purp os e s o f t

he ana ly sis be low , th e Court sh a ll
assume arguendo that A PJ Moo re ’s ini tia l a pp ointme nt w a s unc on sti tut ion a l. 5. The B oard’ s Dec ision on RehearingAfter APJ Moore’ s Reappointment Def endants a nd Interve nor United States ar g ue that APJ Moore’ s rea ppointment by

the Secre tary of Commerce on August 12, 2008, cured a ny constitutional defec t in the prior B oard actions bec ause the Boa

rd did not issue its final decision denying Stry ker’ s motion for rehe aring
un til Au g us t 27 , 2 00 8. Ho we ve r, Str y ke r c on te nd s th a t th e B oa rd ’s de c isi on

on re he ari ngc ou ld not ratify the prior r

ulings made by

an unlawf

ully -constituted pane l beca use the B oard’ s standard of re vie w o n r e he ari ngis n arr owin s c op e . B e fo re e xami nin g the sc op e of the B oa rd ’s re vie w i n the context of a motion for re hear ing, the Court shall ex amine the leg al authorities cited by eac h p arty.24

In support of their a

rgument that a lawf

ully appointed off

icer can r atify

the dec isions of an unlawf ully appointed off

icer , Def endants a nd Interve nor cite An drad e v . R e gn e ry , 824 F.2d 1253 (D.C. Cir. 1987). In Andrade , f e de ra l e mpl oy e e s c ha lle ng e d th e a c ts o f a g e nc y of fi c ia ls who wer e implementing a re duction in force prog ram (RI F) on the g rounds that the off icials had not been c onstitut ionally

appointed to their positions. See 824 F.2d at 1255. Howeve r, the c ourt reje cted the e mploy ees’ challeng e bec ause the officia l responsible for hiring ag ency

employ ees
was c onstitut ionally

appointed thre e day s befor e the RI F f ormally went into eff

ect. Id. at 1256- 57. The c ourt reje cted the e mploy ees’ argument that the ac tions should be set aside bec ause the RI F wa s planned a

nd conce ived bef

ore the office r wa s appointed, re asoningthat the har m was not leg ally

cog nizable until i t was for mally implemented, which oc curr ed only afte r an of

ficial was duly appointed. Id. at 1257. Def endants a nalog ize the Boa

rd’s August 2008 decision on rehe aringto the Andrade of fi c e r’ s r a tif

ic a tio n o f t

he e arl ie r d e c isi on s. Th e Un ite d St a te s a lso
c ite s Olympic F

ederal Sav ings & Loan Association v. Director, Office of Thrift Supervision , No. 90-482, 1990 WL134841 (D.D.C. Sept. 6, 1990). In Ol y mp ic , the cour

t held that the plaintiff’s Appointments Clause challeng e wa s moot because the plaintiff: (a ) did not oppose the g overnme nt’s mootness argument, (b) did not identify any actions it sought to have invalidated, (c) did not contest the g overnme nt’s repr esentation that the properly appointed succ essor ha d ratified the prior dire ctor’s a cts, and (d) did not argue that the defac to office r doctrine was inapplicable. Id. at *3. In support of its view that a r uling on r ehea

ringis not equivalent to ratification, St ry ker
c ite s Ryde r v. United States , 515 U.S. 177 (1995). In Ryde r , the Supreme Court re viewed a n Appointments Clause challeng e brought by a Coast Guar d enlistee c onvicted by a cour t-martialThe Ryde r Court did not reac h the closely rela ted question of whe ther the Court of 16 Mil ita ry Ap pe a ls a

pp lie d s ome so rt

of ha rm le ss- e rr or

re vie w b a se d o n th e pe tit ion e r’ s f a ilure to identify any adver se conse quence s from the unc onstitut ional composition of the Coast Guard Court of Military

Review. 515 U.S. at 186. 25 whose c onviction was upheld on a ppeal, f irst by the Coast Guar d Court of Military Review a nd then by the Court of Military

Appea ls. 515 U.S. at 179-80. Two judg es on the for mer c ourt had been unc onstitut ionally

appointed, but the Court of Military Appea ls—despite rea liz ing the
c on sti tut ion a l vi olatio n— a ff ir me d th e jud g me nt o n th e g ro un d th a t th e jud g e s’ a c tio ns we re va lid defac to . Id. at 180. The Supre me Court reje cted this application of the de facto office r doctrine , id. at 183-84, a

nd went on to consider

the g overnme nt’s argument that any constitutional defec t in the first court’ s composition was eff ectively cure d by the re view ava ilable in the Court of Milit ary Appea ls, id. at 186. The Court found that after “[e]x amining the differ ence in function and author ity

betwee n the Coast Guar d Court of Military Review a nd the Court of Military Ap pe a ls, it i s q

uit e c le ar t

hat th e fo rm e r h a d b ro a de r d isc re tio n to re vie w c la ims of e rr or , r e vis e fac tual deter

minations, and revise se ntence s than did the latter.” Id. a t 18 7. Th us , th e Court

he ld that th e Court

of Mil ita ry Ap pe a ls’ re vie w d id n ot c ur e the c on sti tut ion a l de fe c t be c a us e it d id
no t “ g [i]ve pe tit ion e r a ll the po ssi bil ity fo r r e lie f t

hat r e vie w b y

a pr op e rl y c on sti tut e d Co a st Guar d Court of Military

Review would have g iven him.” Id. at 187-88. Stry ker a nalog izes the 16 Boa rd sitting in August 2008 to the Court of Mili tary Appea ls in Ryde r

—proper ly

appointed but limit ed by

a nar row standa

rd of r eview. W h e th e r th i s c a s e i s g o v e r

n e d b y Andrade or Ry de r depends upon the scope of the Boa rd’s a uthority in the context of a motion for rehe aring . I f the B oard ha d only limit ed authority on rehe aring , then the prope rly constituted Boa

rd could not fully

ratify its earlierThe B oard’ s rules of pr ocedur e ar e conta ined in part 41 of T itle 37 of the Code of 17 Fe dera l Reg ulations. I n proce eding s befor e the B oard, a party may cite “37 C.F .R. § 41.x ” as
“ B oa rd Rul e x.” AR

2; R ule s o f P ra c tic e B e fo re the B oa rd of Pate nt A pp e a ls a nd Inte rf e re nc e s, 69 Fe d. Reg . 49960, 49961 (Aug . 12, 2004). 26 decisions, eve n if they

wer e not final for

purposes of judicia l reviewuntil a decision had be en iss ue d o n r e he ari ng . Re qu e sts fo r a re he ari ngare g ov e rn e d b y B oa rd Rul e 12 5( c ), wh ic h s tate s in pe rt ine nt p art : (3) Burden on rehe aring. The burde n of showinga dec ision should be modified lies w i thth e p arty a t t a c k i n g th e d e c i s i o n . T h e r e qu e s tmu s ts p e c i f i c a l l y i d e n t i f

y: (i) All matters the pa

rty believes to have bee n misapprehe nded or ove rlooked, a nd (ii) The pla ce where the m atter was pre viously addre ssed in a motion, oppositi on, or r e p l y. 37 C.F.R. § 125(c) (3). The B oard’ s Standing Or der a lso has a provision re lating to r equests for 17
re he ari ng s: A reque st f

or rehe aringis, in form, a miscellane ous motion, but no prior conf ere nce c a ll i s r e qu ir e d. Th e argume nt r e sp on si ve to th e de c isi on mus t be ma de wi th particula rity in the following manner : On pa g e _, lin e s _ -_ , the op ini on state s _. Th e op ini on is b e lie ve d to have ov e rl oo ke d [or mis a pp re he nd e d] _. Th is poi nt wa s set fo rt h in _ Motion [ or Opposition or Reply ] _ at pag e _, lines _-_. Th e re qu e st mus t in c lud e a s an a pp e nd ix an

e viden ce li st se tti ngfo rt h a lis t ( in numerica l order by

exhi b i t n u m b er) of ea ch exhibit t hat the par ty believes w as overlooke d or misappre hended. AR 53 (S tand ingOr de r ¶

12 5. 2) . A s a

mis c e lla ne ou s mo tio n, a

re qu e st f or re he ari ngis l imi te d to 10 pag es in leng th (excluding table s and appe ndices). A R 30 (Standing Or der ¶ 121.2). The Standing Or der f

urther states that “[e]vidence not alre ady of re cord at the time of the dec ision will not be admitted absent a showingof excusable ne g lect for the belate d submissi on.” AR 53Stry ker a lso asked the B oard to rule on the merits of Revised Substantive Motion 2. 18 AR 488. The B oard ha d dismiss ed Motion 2 beca use it was conting ent on the g rantingof Motion 1, see AR 479, but St ry

ker soug ht a rulingon Motion 2 in t he eve nt the Boa rd’s de cision to deny Motion 1 was reve rsed on a ppeal. See AR 494-95. The B oard de clined and de nied Stry ker’ s reque st for re hear ing on Motion 2. AR 536. 27 (Standing Orde r ¶ 125.4) . Stry ker a rgues that these pr ovisions authoriz e only a nar row standa

rd of re view on re hear ing, limiting the B oard to c onsideration of matters that have been “misappre hended or

overlooke d.” Stry

ker f urther c laims, albeit without factual support, that the Boa rd’s re view on re hear ing is akin to a district court’s re view on a motion for r econside ration. See [55] Pl.’s Reply

Mem. Resp. to United States’ Mem. at 4- 5. Def endants a nd Interve nor dispute this int erpr etation of the B oard’ s regulations, construing the phra se “misappr ehende d or overlooke d” as pe rmitting the B oard to c onsider on re hear ing the substance of any issues that
wer e pre viously

befor e the B oard. There is admittedly

some ambig uity

in the Boa

rd’s re g ulations reg ardingthe meaningof “misunderstood or ove rlooked.” Howeve r, the proc edura l limi tations on briefingand the
e vid e nc e in t

he re c or d a

pp e ar t o b e a ime d at pr e ve nti ngan uns uc c e ssf ul c la ima nt f ro m si mpl y taking a sec ond bite at the apple . And nothing in the r egulations prohibits t he B oard f rom
rec onsideringthe merits of the B oard’ s orig inal decision, as longas the pa rty proper ly includes the issues in its request. Her e, the r ecor d shows that Stry ker e x plicitly

soug ht a full revie w on the merits in its May

30, 2008, reque st for re hear ing of the B oard’ s denial of its Revised Substantive Motion 1. See AR 488 (“[Stry ker] respe ctfully

reque sts that the Boa

rd . . . re hear

and 18
rec onsider the B oard’ s denial of Car bone Revised Substantive Motion 1 to Redefine the Interfe renc e by

dividing Count 1 into two separate counts . . . .”) Although limited to ten pag es by the rules, Stry

ker’ s reque st discusses the arguments and fa cts raise d in its R evised Substantive28

Motion, ex plaining why , in Stry ker’ s view, the inventions in proposed c ounts 2 and 3 are distinguishable f

rom ea ch other

in view of prior

art, discussingthe level of ordinary skill i n the art, a nd revie wing the leg al authority cited by the B oard in its April 30, 1998, opinion. See AR 48 8- 94 . Stry

ke r a lso re a tta c he d th e de c lara tio n o f C ha

rl e s L . B us h, Jr., wh ic h it ha d in c lud e d in support of its Revised Substantive Motion 1. See AR 497-520. The re cord indicates that the B oard, sitting on r ehea ringas a c onstitut ionally

appointed panel, did addr ess the mer its of Stry ker’ s reque st for re hear ing. T he B oard’ s opinion on rehe aringdemonstrates that its analy sis was detailed a nd thoroug h. See A R

5 3 2 ( “ S u b s t an t i v e l y, we ha ve re viewed Ca

rbone Revise d Motion 1 anew on a pag e-by -pag e basis for

a discussion of the spec ific ele ments of ea ch count a s compare d to those of the other and how the dif

fer ence s are such that the subjec t matter of one count would not have be en obvious over the subject matter of the oth e r. ” ) T he de c isi on a lso re ve a ls that it

sp e c if ic a lly re c on sid e re d th e me ri ts o f t he ana ly sis it previously

conducte d. See AR

53 2- 33 (“ Th e B oa

rd re c og nize s n owand

re c og nize d w he n it wrote the initial decision that Carbone may have a theory on why these ‘inve ntions’ are
c on c e ptu a lly

dif fe re nt.
. . . T he pr ob le m w a s a nd is that Ca

rb on e ha s f

a ile d to make the fi na l, vital analy sis—given the subject matter of one count why

the subject matter

of the other

count would not have be en obvious to one of or dinary skill i n the ar

t.”) In doing so, the Boa

rd
rea ffirme d its April 30, 2008, decision that Stry ker ha d not established that the sing le count of the Interfe renc e embodied two patentably distinct inventions. See AR 46 9; A R 53 0- 34 . Wh ile the B oard did not have occa sion to revisit the J anuar y 22, 2008, decision re g ardingpreliminary ruling s by APJ L ee, those ruling s involved motions t hat wer e conting ent upon the succ ess of theStry ker’ s reque sts for re hear ing of APJ L ee’ s rulings indicate that Stry ker’ s proposed 19 mot ion s atta c kin g B ie de rm ann ’s c la ims ba se d o n la c k o f e na bli ngdis c los ur e and

un pate nta bil ity wer e g rounded on Propose d Counts 2 and 3, respec tively
. See AR 176 (discussing lack of disclosures with re spect to “c laim 1,” the basis for Proposed Count 2); AR 196 (“[St ry ker] re qu e sts a uth or izatio n to br ingthe Pr op os e d M oti on a tta c kin g the c la ims of

B ie de rm ann

se t f or th in Proposed Count 3.”) As De fenda nts point out , Stry

ker ha s conce ded the c ontinge nt nature of these motions, which it has essentially rene wed be fore this Court on sum mary judgme nt. See Stmt . P. & A. Supp. Pl.’s § 112 Mot. at 1-2; Stm t. P. &. A. Supp. Pl.’s Unpatentability Mot. 2. 29 motion to redefine the Interfe renc e. There fore , the denial of Revised Substantive Motion 1, 19 up he ld o n r e he ari ng , r e nd e rs any c on sti tut ion a l de fe c t in

the Janu ary

pa ne l ir re le va nt. Be cause the B oard c onducted the sa me ana ly sis and rea ched the same c onclusion on rehe aringas it did in it s initi al dec ision on S try ker’ s Revised Substantive Motion 1 (to redefine the Inte rf e re nc e ), Str

y ke r c ann ot c re dib ly

argue that it

wa s d e nie d th e op po rt

un ity to h ave its substantive claims consider ed by a prope rly

constituted panel. Unlike in Ryde r , the
c on sti tut ion a lly -a

pp ointe d r e he ari ngpa

ne l g ave Str

y ke r a ll the po ssi bil ity

of re lie f t hat a pr op e rl y
c on sti tut e d p ane l w ou ld h ave g ive n it ini tia lly . T he re fo re , a

ny c on sti tut ion a l de fe c t in

APJ Moore’ s initi al appointment was c ured in this particula r instance by

the substantive dec ision on the me ri ts o n r e he ari ngby a pr op e rl y c on sti tut e d p ane l. In light of the substantive nature of the B oard’ s review on rehe aring , a re mand to the Boa rd for de novo considera

tion is unnecessar

y . Although Stry

ker se eks a r emand to a completely

new pa nel of APJs , it has not provided the Court with any rea son—other than administrative inertia—f

or orde ringthe B oard to a ppoint a differ ent pane l of judg es to rehe ar Stry ker’ s claims. SeePl.’s Unconstituti onality Br . at 16-17. That is inconsist ent with the principle that a

new judg e should only

be assig ned on re mand wher e ther e is some alleg ation of bias or impropriety

by the prior judg e. See, e .g. , 2 8 U. S
. C
. § 1 4 4 (r equ i ri n g re cu s al wh er e j u d ge30

ha s p e rs on a l bi a s o r p re

jud ic e a g a ins t a

pa rt y ); Armco, I

nc. v. U nited Steelworkers of Am. , 280 F.3d 669, 683 ( 6th Cir. 2002) (holding that fac tors to be consider ed bef ore r eassig ning a

differ ent j u d g e ar e ( 1 ) w h e th e r

th e o r i g i n a l j u d g e l i k e l y w o u l d h av e d i f f i c u l ty s e t t i n g a s i d e p r e v i o u s l yexpressed views on r emand, ( 2) whe ther re assig nment is advisable to pre serve the appe ara nce of justice, and (3) whether

rea ssignment would be excessively wastef ul and duplicative) . Stry

ker fea rs that the same panel on r emand mig ht simpl y issue the same r

ulings that it did befor e. B ut such a r esult would not be unconstitutional. See A ndrade, 824 F.2d at 1256-57 (holding that Appointments Clause is satisfied when c onstitut ionally -appointed of fice r implements and ratifies the a c ts o f p ri or , una

pp ointe d o ff

ic e rs ). Mo re ov e r, Str

y ke r h a s n ot i de nti fi e d a

ny re a so n to believe that a diffe rent pa nel would re ach a

differ ent conc lusion. Acc ording ly , the Court shall deny Stry ker’ s Unconstitutionality

Motion and g rant-in- part Def endants’s motion for summar y judgme nt with respec t to the alleg edly unconstitutional appointment of APJ Moore. B eca use the Court finds that the B oard’ s decision on re hear ing
cure s the constitutional defec t in its ear lier dec isions, it does not rea ch the pa rties’ a lternative arguments reg ardingthe 2008 statutory provisions permitting re troac tive appointment and a de facto officer

defe nse. B. Rede

fining the Interferenc e Count The Court shall now addr ess the par ties’ cr oss-motions for summary judgme nt on the iss ue of wh e the r t he B oa rd e rr e d b y fa ili ngto r e de fi ne the int e rf e re nc e c ount a s tw o s e pa

ra te
c ounts —o ne fo r t

he “ int e rs e c tin g a xes” inv e nti on and ano the r f or the “ int e rs e c tin g pla

ne s” invention. Stry

ker c laims that these inventions are distinctly patentable and that the B oard e rre d
a s a matte r o f l aw b y

de c lari ngan inte rf

e re nc e ba se d o n a

sin g le c ount c on ta ini ngbo th31

inventions. St ry

ker nowasks this Court to reverse the B oard’ s decision and e ither re mand for fu rt he r p ro c e e din g s o r r

ule on Str y ke r’ s c on tin g e nt m oti on s f or summa ry jud g me nt a s to unpatentability

and lac k of written spe cification or enablingdisclosure. See Pl.’s Redefinition B r. a t 43 -4 4. De fe nd ants c la im that, b a se d o n th e re c or d b e fo re the B oa rd and be fo re thi s Co ur

t, Stry ker c annot establish that its two proposed interf ere nce c ounts are distinctly patentable and there fore Def

endants a re e ntitled to judgment as a matter of la

w. Stry ker r aises thre e primar

y claims of er

ror by the B oard in its motion for summary jud g me nt. F ir st, Str

y ke r c la ims that th e B oa

rd e rr e d a s a

matte r o f l aw b y

de c lari nga

sin g le interfe renc e count c onsisting of multiple independe nt claims. Second, Stry ker c laims that the Boa rd’s de clar ation of interf

ere nce w as ar

bitrary and ca pricious bec ause the Boa

rd did not provide a ny rational e x planation for de clar ing only a sing le claim. And third, Stry ker c laims that the B oard e rre d by

failingto rede fine the inter fer ence as havingtwo separ ate c ounts, one for e ach of Stry ker’ s patentably

distinct inventions. After re viewingthe evidenc e pre sented to the B oard
and the re le va

nt s tand ard s th a t a

pp ly , th e Court

sh a ll a dd re ss e a c h o f t

he pa rt ie s’ c on te nti on s. 1. Th e Sig nif

ic anc e of the Inte rf e re nc e “ Cou

nt” Acc ordingto PTO regulations, a “c ount” is “the B oard’ s descr iption of the interfe ring subject matter that sets the scope of admissible proofs on priority .” 37 C.F.R. § 41.201. “Wher e there is more than one c ount, eac h count must describe a pate ntably distinct invention.” Id. The parties a g ree that to preva il on its motion to redefine the interfe renc e count to include two
se pa rate c ounts , Stry

ke r m us t sh owthat th e inv e nti on s in pr op os e d Co un ts 2 and

3 a re pate nta bly distinct from eac h other. See [41] Def s.’ Redef inition Opp’n at 15; [ 31] P l.’s Redefinition Br . at 28. In proce eding s befor e the B oard, a party filing a motion to redefine the interfe renc e has the32

burden of proof to esta

blish it is entitled to the relief r equeste d. 37 C.F.R. § 41.121(b). For one cla im to be patentably distinct from another, the first claim must not be obvious based on the subject matter of the sec ond claim. “A patent may not be obtained . . . if the differ ence s betwee n the subject matter soug ht to be patented a

nd the prior a

rt are such that the subject matter a s a whole w ould have be en obvious at the time the invention wa s made to a person ha ving or dinary

skill i n the ar

t to which said subject matter perta ins.” 35 U.S.C. § 103(a). Th e re are se ve ra l ba sic fa c tua l in qu ir ie s a sso c iate d w ithde te rm ini ngwh e the r a n inve nti on

is obvious: (1) the scope and conte nt of prior a rt; (2) the diff

ere nces be tween the claimed subjec t matter a nd the prior a

rt; and (3) the level of

ordinary skill i n the per

tinent art. Graham v. J

ohn De e reCo. of K

an sa s Ci ty , 3 83 U. S. 1 , 1 7 ( 19 66 ). Whe re a pp ro pr iate , a

c ourt sh ou ld a lso loo k to
se c on da ry fa c tor s th a t ma

y be re le va nt t o th e ob vio us ne ss a

na ly sis , s uc h a s c omm e rc ia l su c c e ss, long f elt but unsolved needs, a

nd failure of others. Id. a t 17 -1 8; see also KSR Int’l Co. v. Teleflex Inc. , 5 5 0 U. S
. 3 9 8 , 4 0 6 -0 7 (2 0 0 7 ) ( re af fi rm i n g Graham ). Whether a claim is patentably

distinct from anothe r is a question of law that is reviewe d de novo. In re DB C , 545 F.3d 1373, 1377 (F ed. Cir. 2008).

2. Stry

ker’ s Motion to R edef

ine the Interfe renc e In Stry ker’ s Revised Substantive Motion 1 (“Motion 1”), Stry ker sought to persuade the Boa rd that Count 1 of the interf ere nce a ctually

contained two patentably distinct inventions and sh ou ld t he re fo re be re de fi ne d into t wo c ounts : Co un t 2 ( pe rt a ini ngto t he “ int e rs e c tin g a xes” inv e nti on ) a

nd Count 3 (p e rt a ini ngto t

he “ int e rs e c tin g pla

ne s” inv e nti on ). Str

y ke r e xpla ine d in Motion 1 that the ’460 Patent is directed to spinal fixation devices for alteringthe alig nment of adjac ent ver

tebra l bodies relative to e ach othe r, known a s “pedic le scre w sy stems.” AR 312-13.For simpli city , Stry

ker limited its analy sis of the two inventions to claims 1 and 18 of 20 the ’460 Patent. See Pl.’s Redefinition Br. at 24 n.10. Howeve r, the invention in proposed Count 2 actua lly includes cla ims 1, 24, and 38, while proposed Count 3 includes c laims 18 and 13. Stry ker a sserts that “[a] sim ilar ana ly sis could be provided be tween a ny pair of c laims from the two proposed c ounts.” Id. 33 Stry ker f urther e x plained that the pr ior art f or these sy stems (including U.S. Patent No. 6,537,276, the “Me tz P atent”) captur ed a spine rod but did not work when the rod ca pturing
a sse mbl ie s n e e de d to be ro tate d to e xtre me ang le s. AR 31 3. Str y ke r a rgue d th a t to so lve thi s pr ob le m, t

he ’4 60 Pate nt e nc omp a sse d tw o d ist inc t bo ne fi xati on a sse mbl y inv e nti on s, exemplified by

claims 1 and 18 of the ’460 Patent. The f irst invention, described by claim 1, 20
cre ates g reater a

ng ulation by

havinga pair

of bore s with longitudinal axes that intersect e ach other, thus biasingthe hea d of a f astene r to one side. AR 314. This “inter sectingaxes” invention
a lso ha s a se a t at th e low e r e nd

of the c ou pli nge le me nt a

nd an a nc ho ri nge le me nt w itha

he a d in contac t with that seat. Id. Stry ker e x plained that the a dvantag e of c laim 1 over prior art is the much g reater a

ng ulation of the fa stener w ith respec t to the coupling e lement, allowingthe spinal rod to be situated c loser to the bone. A R 315. St ry ker use s the “interse cting axes” invention in a
commerc ial product c alled the OA SYS im plant sy stem. AR 314. By contra st, St ry

ker e x plained in Motion 1 that claim 18 of the ’460 Pate nt was direc ted to a bone f

ix ation assembly

“in which the c oupling e lement has only a sing le bore extending from the uppe r end to the lowe r end,” but with the upper a nd lower e nds definingfirst and sec ond planes whic h intersec t eac h other. AR 316. This “inter sectingplanes” invention also has an anchor ing e lement and a

coupling element with a U -shape d openingto rec eive a stabiliz ing r od. Id. Stry ker a rgued that the “ intersec ting plane s” invention was e x emplified by all of the embodiments in Biede rmann’s ’ 431 Application and is also used in a commerc ial product sold byThe pa rties have used numerous illustrations to expl ain and c larify their positions 21 be fo re the B oa

rd and thi s Co ur t. A lth ou g h th e Court

do e s n ot i nc lud e any

te c hn ic a l di a g ra

ms i n this opini on to aid a lay

person’ s understanding , the Court can of fer an over simpli fied ve rsion of Stry ker’ s basic position reg ardingthe diffe renc e betwe en the two inventions. Imag ine a c ylinder wi th p ara lle l e nd s, su c h a s a ty pic a l c an o f s ou

p. Ac c or din g to S tr

y ke r, the “ int e rs e c tin g pla

ne s” invention is created by

cutting one end of the cylinder at a n ang led edg e, such that the ends ar e no longe r par allel. B y

contra st, the “interse cting axes” invention would be cr eate d by joining two cylinders at an a

ng le. 34 Def endant De Puy

as the MOUN TAI

NEER OCT spinal sy stem. Id. S try k er ar gu edth atal th o u gh the “ int e rs e c tin g pla

ne s” inv e nti on

a lso re su lts in gre a te r a

ngulatio n c omp are d to the pr ior art , it does so in a “ve ry

differ ent manner ” fr om the “interse cting axes” invention. AR 317. Stry ker analy zed the products shown in the ‘431 A pplication and the c ommercia l MOUNTAI NEER OC T s y ste m and

de te rm ine d th a t th e y

do no t c re a te angulatio n b y us ingtw o b or e s w ith intersec ting ax es, but rathe r “a re the result of simply

removingan ang led portion of the lowe r end of the sing le bore coupling element.” AR 318. As Stry ker wrote in its Motion: 21 I t is thus clear that the c laims in both the C arbone ’460 Patent and the Bie derma nn [’431] application enc ompass two differ ent inven t i ons which do not overla p eac h other, one of which r equire s two separ ate bor es havingintersec ting long itudinal ax es in the c ou pli ng e le me nt, and the oth e r of wh ic h r e qu ir e s o nly

a sin g le bo re but f

ir st and sec ond ends of the c oupling e lement which are containe d in planes which int e rs e c t e a c h o the r; i.e. , which ar e not par allel to eac h other. AR 31 8. Str y ke r t he re fo re pr op os e d it s tw o s ub sti tut e int e rf e re nc e c ounts , w ithCount 2 consisting of

the claims per

taining to the “ intersec ting ax es” inve ntion and Count 3 consisti ngof the claims per

taining to the “ intersec ting plane s” invention. AR 319-20. Stry ker a ppended to Motion 1 a de clar ation by Charles L . Bush, Jr., an eng ineer ing manag er at Stry

ker’ s Cervica l Division. See AR 32 9- 35 1 ( “ B us h D e c l.” ), ¶ 1 . M r. B us h decla red that he had be en a de sign e ng ineer in the field of biomedica l eng ineer ing f or six teen y ear s and that he w as listed as a na med inventor on seve ral patents and pate nt applications forAs explained below, the Eli Li lly court’s a pplication of a two- way

test is based on PTO 22 regulations that have since been a mended. See Rules of Practice Be fore the B oard of Patent Appea ls and Interfe renc es, 69 F ed. Reg . 49960 (Aug . 12, 2004). In Motion 1, S try

ker r efe rre d to the invention in Count 3 as “I nvention (1)” and the 23 invention in Count 2 as “Invention (2).” See AR 322-26. 35 medical de vices, includingdevice s for spinal use. B ush Dec l., ¶¶ 3-4 ( AR 330). Mr. B ush stated that “[h] avingworke d with many biomedical eng ineer s and orthopedic and neur o [si c] surg eons prior to and up to 2001, I am familiar with the level [sic] a per son of ordinar y skill had in the field of medic al device s in 2000 and 2001.” Id. , ¶ 4 (AR 330-31) . Stry ker r elied hea

vily on the Bush de clar ation in Motion 1. In th e l e g a l ar g u m e n ts e c t i o no f M o t i o n1 , S tr

yk e r ar g u e d th a tth e B o ar d

s h o u l d a p p l y a

“ tw o- wa y te st” to d e te rm ine that Co un t 2 a nd Count 3 c on ta in p a te nta

bly dis tin c t inve nti on s, ci t i n g Eli Li lly &Co. v. Board of Regents of the Univ ersity of W ashington , 334 F.3d 1264 ( Fe d. Cir. 2003). AR 321. Under the two-wa

y test, the invention in Count 2 m ust be patenta ble over the invention in Count 3 as prior art, a nd vice ve rsa. El i Lil ly , 334 F.3d at 1268. Stry ker the n 22 explained why , in its vi ew, the “ intersec ting ax es” inve ntion (Count 2) was nonobvious over the “interse cting planes” invention (Count 3) as prior a rt. See AR 323-24. Stry ker c laimed that 23 with separate bore s of intersec ting ax es, one c ould achieve g reater a ng ulation of the scr ew vis-a

vis the coupling element a nd obtain a lower

profile, whe ther or not the e nds of the devic e ar e para llel to each othe r. AR 323. Stry ker a lso emphasized that the invention in Count 2 allows for g re a te r s tr e ng th t

ha n th e inv e nti on

in C ount 3 be c a

us e the fa ste ne r i s c oaxial (i .e ., a lig ne d) wi th the lower bore a nd thus is not s ubjected to torsion whe n forc es pull the faste ner a way from the
c ou pli nge le me nt. AR

32 4. Str y ke r a lso e xpla ine d w hy , in its vie w, the “ int e rs e c tin g pla ne s”36

invention was nonobvious over the “interse cting axes” invention as prior a rt. AR 324-26. Str y ke r e xpla ine d th a t by

re mov ingmate ri a l to c re a te an a ng le d e nd , th e inv e nti on

in C ount 3 is easie r to manufa cture . AR 325. Howeve r, the de sign e x poses more of the scre w, wea

keningthe device and subjec ting the f astene r to torsional forc es whe n the fa stener is plac ed in an a ng ulated position. AR 325-26. S try ker thus ar g ued that these Counts contain completely distinct inv e nti on s. 3. The B oard’ s Rejection of Stry ker’ s Motion to R edef

ine the Interfe renc e In its April 30, 2008, Memorandum Opinion and Or der, the Boa rd denie d Stry

ker’ s motion to redefine the interfe renc e. The Boa rd beg an its written opinion by discussing the qualifications of Mr. Bush, a nd the B oard c oncluded that Mr. B ush is qualified to testify as to the knowledg e of one skilled in the art in the field of bone fix ation assemblies at the time of the invention(s). AR 471. Howe ver, the Boa rd conc luded that Mr. B ush did not offer te stimony
re g ard ingwh a t th e kn ow le dg e of on e sk ill e d in

the art wa s a nd did no t pr ov ide e vid e nc e that hi s analy sis of Count 1 and the two proposed Counts involved consideration of the level of or dinary skill i n the ar

t. Id. Thus, the B oard r

uled that Mr. B ush’s testimony was insuffic ient to prove that Count 1 encompasses two patentably distinct inventions. Id. The B oard be g an its leg al ana ly sis with a refe renc e to the standa rd for patentability

under 35 U.S.C. § 103 as elaborated in Graham . A R 47 3. Th e B oa rd the n e xpla ine d th a t, “ to e sta bli sh a prima f acie case of nonobviousness, [S try ker] must address not only the diffe renc es betwe en the proposed ne w counts, but also the scope and conte nt of the prior a rt and the le vel of ordina

ry skill i n the ar

t, to arrive at any

conclusion of nonobviousness.” Id. The B oard c ited Pec hiney Emballage Flex ible Europe v. Cryov ac Inc

. , 73 U.S.P.Q.2d 1571 (B.P.A.I . 2004), in support of37

this propositi on. Id. The B oard note d that althoug h Stry ker discusse d prior ar

t cited in the ’460 Patent, it “did not discuss prior art re lating to c oupling a rt in g ener al, eve n though the focus of the proposed c ounts relates to the ‘ couplingelement’ rec ited in the corr espondingclaims.” AR 475. Thus, the B oard a sked: “Was the leve l of ordinar y skill i n the ar

t and the scope and conte nt of the prior

art such that one of ordina ry skill would not have known that either the body of the coupling element or

mere ly the entra nce or exit ang le at an e nd of the c oupling e lement ca n be responsible for

the couplingelement’ s fac ing dif fer ent direc tions at opposing ends? ” AR 475. Th e B oa rd we nt o n to no te that Str

y ke r d id n ot e ve n d isc us s th e le ve l of or din ary sk ill in the ar t in its motion, ins tead statingleg al conc lusions in i ts statement of mater ial fac ts (the second a ppendix t o the motion) based on state ments in the Bush De clar ation. AR 476. As for the c on te nts of

the B us h d e c laratio n, the B oa rd ru le d th a t Mr . B us h’ s st a te me nts a s to obviousness were conclusory and base d only

on a brie f discussion of the diff ere nces be tween the two inventions. AR 476-77. “He [Mr. Bush] does not discuss the art relating to this interfe renc e beyond a fe w produc ts manufac tured by his company

and an a ffiliated c ompany . He doe s not discuss or mention the knowledg e that a skilled a rtisan did or did not have dur ing the rele vant tim e -f ra me .” AR 47 7. With out th a t di sc us sio n a nd ana ly sis , th e B oa

rd he ld, Str y ke r f a ile d to satisfy the burde n of provingprima fa cie nonobviousness. Id. Moreove r, the B oard he ld that Stry ker ha d failed to suff

iciently consider a

nother of the Graham fac tors: the differ ence s betwee n the claimed subje ct matter a nd the prior a

rt. Id. In addition to holding that Stry ker ha d failed to c onduct the pate ntability analy sis required b y Graham , the B oard state d that Stry ker ha d not even pe rsuasively distinguished the c laims of the two proposed c ounts, i.e., claims 1 and 18 of the ’460 Patent. AR 477. Althoug h Stry ker38

char acte rized the “interse cting planes” invention in Moti on 1 as having“a sing le bore ,” the languag e of c laim 18 in the ’460 Patent ac tually ref ers to a c oupling e lement with “at lea st one bo re .” AR

47 7- 78 . T he B oa

rd de e me d th is l ang

ua g e signif

ic ant b e c a us e it s ug g e sts mul tip le bores, a nd there fore claims 1 and 18 a re not distinguisha

ble by the number of

bores involved. AR 478. I n addition, the Boa rd noted that c laim 1 does not prec lude the upper and lower

ends from havingintersec ting plane s, as re cited in claim 18. Id. The B oard a lso found that claim 18 descr ibes a “ U-shape d” openingto rec eive the sta biliz ing r od, but this could also be a fe ature of
c la im 1 . A R 47 8- 79 . T he B oa rd sa id t hat Str y ke r h a d n ot s ho wn

that th e va

ri anc e s in the c la ims would not have be en obvious to one of or dinary skill i n the ar

t. Id. Acc ording ly , the B oard denied Motion 1. In its request for

rehe aring , Stry

ker a rgued that the B oard ha d err ed in deny ing Motion 1. First, Stry ker a rgued that the B oard misappr ehende d Mr. B ush’s testimony reg ardingthe kn ow le dg e of

on e sk ill e d in

the art . A R 48 9. Str

y ke r c la ime d th a t Mr . B us h te sti fi e d in de ta il
re g ard ingthe dif

fe re nc e s b e tw e e n th e inv e nti on s a nd the Me tz Pate nt, wh ic h w a s th e mos t rele vant prior a

rt. AR 490-91. Second, Stry ker a rgued that the B oard should not have relied on the Pec hiney

case for the e videntiary

standard, a

nd that Stry

ker satisfied that standard in a ny
e v e n t. A R 4 9 1
- 9 2
. T h ir d , Str y k e r ar g u e d th a t c o n tr ar

y to th e B o ar d ’ s r

u li n g , it d id e mp h a s iz e the dif fe re nc e s b e tw e e n th e tw o inve nti on s a nd the pr ior art . A R 49 3- 94 . Stry

ke r n ote d th a t it ha d r e pe a te dly

sh ow n h owthe “ int e rs e c tin g a xes” inv e nti on and the “ int e rs e c tin g pla

ne s” invention were distinct from and not sug g ested by the Metz Patent. Id. In its decision on rehe aring , the B oard r ejec ted Stry ker’ s arguments. The B oard be g an by reiter ating that when a

naly zing whethe r propose d interfe renc e counts a re patentably

distinct, eachAntic ipatio n d e fe a ts p a te nta bil ity and oc c ur s w he n e a c h a

nd e ve ry c la im l imi tatio n is 24 disclosed in a prior a

rt ref ere nce, e ither explicitl y

or implicitly
. Voda v. Cordis Corp. , 536 F.3d 13 11 , 1 32 3- 24 (F e d. Cir . 2 00 8) ; see 35 U.S.C. § 102. The parties have not ar g ued, and the Boa rd did not find, that either of Stry ker’ s proposed c ounts were invalid for anticipation.

39 proposed c ount is presumed to be prior art to the other s, and the re maining c ounts are e valuated in light of that c ount for nonobviousness and la ck of a nticipation. AR 530-31. The B oard

24 noted that althoug h Stry

ker a naly zed whether

eac h proposed c ount was pate ntably distinct from the Metz Patent as prior ar t, it did not adequately

analy ze whether

the proposed c ounts were pate nta bly dis tin c t f ro m each othe r . AR 531-32. Althoug h Stry ker f ocused g ener ically

on the differ ent inventions descr ibed by eac h proposed c ount, the Boa rd stated that “ [t ]he problem was and is that [S try

ker] has fa iled to make the f inal, vital analy sis—given the subject matter of one count why

the subject matter

of the other

count would not have be en obvious to one of or dinary skill i n the ar

t.” AR 533. The B oard f ound that Stry

ker ha d not considere d and discussed the prior ar t relatingto the features that distinguished the two proposed c ounts, i.e., the coupling element. AR 533. The Boa rd also discussed Mr . Bush’ s decla ration, noting that it was defic ient be c a us e it d id n ot d isc us s th e le ve l of sk ill in t he art a s r e qu ir e d f

or a fu ll o bv iou sn e ss a

na ly sis under Graham , and it did not focus on the close st prior art that c an potentially make up the dif fe re nc e s b e tw e e n th e tw o p ro po se d c ounts . A R 53 4. F ina lly , th e B oa rd e xpla ine d th a t it s relianc e on Pec hiney Em ballage as an e x ample of the require d patentability analy sis is not improper a

nd that Stry

ker ha d failed to show how disc ussion of that case was e rror . AR 534-35. Ac co rd i n gl y , th e B o ar d

re j ec t edS try

k er ’s ar gu m en t s an d

d en i edre h ea ri n g. 4. The F orm of the Sing le Interfe renc e Count Stry ker’ s first objection in this § 146 procee ding is to the for m of the interf

ere nce c ountTo a c e rt a in e xtent, S tr

y ke r’ s o bje c tio n to the fo rm of the int e rf e re nc e c ount i s 25 intertwined with its argument that the B oard e rre d by decla ringa sing le interfe renc e count containingtwo distinctly

patentable inventions. The Court addre sses this substantive objection below under

subheading6. Str y k e r a ls o d is p u te s th a t i t i s f

o r e c lo s e d f r o m r a is in g n e wle g a l t

h e o r ie s in th e c o n te xt 26 of its oppositi on to Defe ndants’ motion for summary judgme nt with respec t to the Boa rd’s fa ilure to consider Stry

ker’ s arg uments reg ardingthe unpatenta bility of Proposed Count 3 over pr ior art. See Pl. ’s Op p’ n to De fs .’ Mo t. f or Sum m. J. at 13 -2 2. Rathe r t ha n r e br ie f t he iss ue in i ts r e ply brief suppor

ting its Redef

inition M otion, St ry

ker inc orporated the ar g uments from its ear lier opposition. See Pl.’s Redefinition Reply at 2. 40 decla red by the B oard. See Pl.’s Redefinition Br. at 16-20. Stry ker c ontends that the B oard 25
err ed by including multiple independe nt claims from both the ’460 Patent a nd the ’431 Application in a sing le interfe renc e count. Stry ker c laims that a proper

interfe renc e count c an
c on ta in at mo st one ind e pe nd e nt c la im f ro m e a c h p art

y , w ithe a c h c la im d e fi nin g the same patentable subject matter. See Pl.’s Redefinition Br. at 18. Defe ndants counter that Stry ker’ s objection to the form of

the count is a ne w leg al theory that was ne ver pr esente d to the Boa rd and th er ef o re ca n n o tb e r ai s edh er e. De fs
. ’ R ed ef i n i t i o nOp p ’n at1 2 (c i t i n g Bo sto n S c ie nti fic , 497 F.3d at 1298 (“A pa

rty may not . . . advanc e new

leg al theorie s at the trial cour t level, eve n if the
overa rchingleg al issue was pr esente d below.”) ) Rather than identify

in the rec ord whe re it had raised this issue with the B oard, how ever , Stry ker disputes that it is forec losed from ra ising ne w leg al theorie s befor e this Court. See Pl.’s Redefinition Reply at 2. 26 “It is well-established that a pa rty g ener ally may not challeng e an a g ency

decision on a basis that was not pre sented to the a g ency .” In re DB C , 5 4 5 F. 3 d at1 3 7 8 (c i t i n g W

oodford v. Ngo , 5 48 U. S. 8 1, 90 (2 00 6) ). In th e sp e c if ic c on te xt of

§ 1 46 pr oc e e din g s in

the dis tr ic t c ourt , the Fe dera l Circuit has expl ained that a party may prese nt new evide nce to the tr ial court whe n appea ling a

board de cision in an interfe renc e proc eedingbut it may not “adva

nce ne w leg al41

theories at the trial court leve l, even if the overa rchingleg al issue was pr esente d below.” Boston Scientific Scime d, Inc. v . Medtronic Vasc ular, Inc. , 497 F.3d 1293, 1298 ( Fe d. Cir. 2007). Str y ke r a sse rt s th a t Boston Scientific is disti ng uishable bec ause the parties ha d stipulated that the
on ly iss ue to b e de c ide d w a s p ri or ity and on e pa rt y so ug ht t o r a ise the or ie s o f c on str uc tiv e tr us t and equitable assig nment. See id. The Court does not agree that the par ties’ stipulation was the
rea son the Fe dera l Circuit sanctioned exclusion of evidenc e re lated to new le g al theorie s; rather , it w a s th e pa

rt y ’s fa ilure to p re se nt i ts t

he or ie s to the B oa

rd that ju sti fi e d d e nyingthe ir consideration in the dist rict cour t. See id. This principle wa s thoroug hly explained in Conservolite v. W idmayer , 21 F.3d 1098 ( Fe d. Cir. 1994). The Con se rv oli tecourt e x plained that “[w]hile the expression ‘ de novo ’ is often used to describe a § 146 ac tion, the statute does not use this lang uag e or state that new issues c an fr e e ly be ra ise d. ” 21 F .3 d at 11 02 . “ [T]he pa rt ie s to an inte rf

e re nc e mus t make a

c omp le te prese ntation of the issues at the B oard le vel so that the interf ere nce is e fficie nt and not wastef ul of administrative a

nd judicial resour ces.” Id. In o rd e r t o a de qu a te ly ra ise an is su e so that it qualifies for

considera

tion in a § 146 proce eding , “the issue should have been r aised a s specifie d in the PTO’s interfe renc e rule s, for e x ample, throug h preliminary motions, m otions to correc t inv e nto rs hip , mi sc e lla

ne ou s mo tio ns , b e late d mo tio ns de lay e d f or g oo d c a us e , o r o pp os iti on

to these motions.” Id. The Con se rv oli tecourt a lso said that under a ppropriate circ umstances, a district court may

exercise its discre tion and admit testimony on issues that were not raised befor e the B oard. Id. Appropriate circ umstances may include an inter

veningchang e in the law, the pre sence of a ne w issue, or the a dmission of other evidenc e dese rvingof a r esponse or furtherStr y ke r c on te nd s in

its op po sit ion

br ie f t ha t Con se rv oli teactua lly

supports the 27 admission of evidenc e re lating to the K atz refe renc es as pr ior art. See Pl. ’s Op p’ n to De fs .’ Mo t. for Summ. J . at 15-16. B ut Stry ker did not make a similar ar g ument with respec t to its argument reg ardingthe form of

the dec laration of interfe renc e. 42 elabor ation. Id. Str

y ke r d oe s n ot d isp ute the se pr inc ipl e s. 27 Stry ker ha s failed to ar

ticulate whe re in the r ecor d it presented a rguments to the Boa

rd reg ardingthe alleg edly

improper f

orm of the inter fer ence count, and it is not appare nt from the
re c or d th a t th e B oa

rd ha d o c c a sio n to a dd

re ss i t. T he re c or d d e mon str a te s th a t Str y ke r c ou ld have pr esente d this argument to the Boa rd, but did not. Moreover , Stry ker f ailed to ar g ue that this case pr esents an a

ppropriate circ umstance f or the Court to exercise its discre tion to consider
a new leg al issue. Acc ording ly , the Court declines to e x erc ise its discretion to hear this new issue, and it is not proper for Stry ker to pre sent that issue to this C ourt for a djudication in a § 146 proce eding . Stry

ker’ s motion for summary judgme nt will not be gr anted on the ba sis that the form of the interfe renc e count wa s improper.

5. The L ack of

Ag ency Ex planation Acc ompanying the Dec laration of Interfe renc e Stry ker ne x t claims that the PTO acte d arbitra rily and ca priciously by failingto provide an explanation to acc ompany the dec laration of interfe renc e as a single count. See Pl.’s Redefinition Br . 20-23. Citing numer ous prec edents fr om the field of a dminist rative la w, Stry ker contends that the B oard should have provided a detailed e x planation for why it defined the interfe renc e as a

single count so as to per

mit effec tive judicial revie w of its decision-making proce ss. Howeve r, the Court is not persuade d that the APJ ’s dec laration of interfe renc e wa s an
arb itr ary and c a pr ic iou s a g e nc y

a c tio n. Th e PTO ’s re g ulatio ns state that “ [a]n int e rf e re nc e e xists if the subject matter

of a c laim of one pa

rty would, if prior a

rt, have anticipated or

rende redThis describe s a “two- way unpatentability

test.” See Rules of Practice Be fore the 28 Boa rd of Patent Appe als and Interfe renc es, 69 F ed. Reg . 49960, 49969 (Aug . 12, 2004). The Con se rv oli tecourt re lied on a prior ve rsion of the PTO re g ulations which 29 explained that one invention (invention A) is the “ same patentable invention” a s another invention (invention B) when invention A is the same as (35 U.S.C. § 102) or is obvious (35 U.S.C. § 103) in view of invention B a ssuming invention B is prior art with re spect to invention A. 21 F.3d at 1101 n.3 (citing 37 C.F.R. § 1.601(n) ( 1994)). Althoug h this langua g e is no long er in t he re g ulatio ns , th e sta

nd ard is s ub sta nti ve ly e mbo die d in

the c ur re nt l angua g e of

37 C.F .R. § 41.203(a)
. 43 ob vio us the su

bje c t matte r o f a

c la im o f t

he op po sin g pa

rt y and vic e ve rs a .” 37 C.F .R. § 41.203(a)
. By

decla ringan interf

ere nce of a sing le count, the APJ defined the scope of the 28 interfe ringsubject matter in a ccor dance with the regulations. See id. § 4 1
. 2 0 3 (b ) ( re qu i ri n g a de c laratio n to ide nti fy

(1 ) t he int e rf e ri ngsu bje c t matte r; (2 ) t

he inv olv e d a

pp lic a tio ns , p a te nts , and cla ims; (3) the ac corde d benef it for ea ch count; and ( 4) the c laims corre sponding to e ach count). “ As a pre requisite to the dec laration of an interf ere nce be tween a

n application and a

n issued patent, the PTO must deter mine that the subject matter of the a pplication claim, whethe r or not the languag e of the claim is identical to that of the patent claim, is patentable , and whe ther the claims ar e dra

wn to the same inve ntion.” Con se rv oli te , 21 F.3d at 1101. Thus, the 29 decla ration of inter fer ence repr esente d the PTO’s conc lusion that the claims contained ther ein ar e drawn to the same invention. Whil e it is true that the notice of decla ration does not ela

borate on the re asons why an interfe renc e wa s decla

red, the actua l declar ation is just one of a ser ies of eve nts that shed light on the ag ency ’s dec ision-making pr ocess. As Stry ker itself ide ntified in its brief, an inter fer ence was fir st sugg ested by

Bie derma

nn in its prosecution of the ‘431 A pplication. After

the B oard sug g ested a

defic iency , Bie derma

nn filed a suppleme ntal sug g estion of interfe renc e proposingStry ker c ontends the fa cts support separ ate patentability based on a

“two-w ay

test” as 30 descr ibed above
. See Pl.’s Redefinition Br . at 29. The B oard e x plained the pr oper te st as “the inverse of a two-w ay

obviousness test”: “I f a f irst proposed count is shown or de monstrated as no n- ob vio us in l ig ht o f a

nd no t anti c ipate d b y

a se c on d p ro po se d c ount, the te st o f p a te nta ble distinction i s met for those two c ounts.” AR 531. This is consistent with a prior Boa rd regulation that defined the standard f or pate ntable distinctness: “Invention ‘A’ is the same patentable invention a s inve nti on ‘B ’ whe n inve nti on

‘A ’ i s th e same a s ( 35 U. S.C. 10 2) or is obvious (35 U.S.C. 103) in view of invention ‘B ’ assuminginvention ‘B’ is prior art with re spect to invention ‘A.’” Se e El i Lil ly , 334 F.3d at 1268 (quoting 37 C.F .R. § 1.601(n) (2003) ). 44 what it called a

“Simplified McKelvey

Count,” which included e ach of the independe nt claims of the ‘4 60 Pate nt a

nd the ‘4 31 Ap pli c a tio n. Th e B oa rd a do pte d B ie de rm ann ’s su g g e sti on wh e n it decla red the interfe renc e. Thus, the B oard did not ac t arbitrar ily in declar ing the interfe renc e count as it did; its decision was based on the sug g estion of interfe renc e duringBie derma nn’s prosec ution of the ’431 Application. St ry ker ha s not cited, and this Court has not found, any
case s in which a de clar ation of interf ere nce w as held to be a

rbitrar y or ca pricious in violation of the Administrative Proce dure A ct, see 5 U.S.C. § 706. I n light of the rec ord on which the Boa rd appar ently

based its dec ision, the Court shall deny Stry ker’ s motion for summary judgme nt on that ba sis
. 6. The Patenta ble Distinctness of Stry

ker’ s Two Proposed Interfe renc e Counts Th e Court

no w t ur ns to S tr y ke r’ s c or e argume nt—

that th e inv e nti on s d e sc ri be d b y its p ro p o s edC o un t s 2 an d

3 ar e p at en t ab l y

d i s t i n ct
. I f t h ey

ar e, th en th e B o ar d

erre d b y d ec l ar i n g a single interfe renc e count a nd reje cting Stry

ker’ s motion t o rede fine the inter fer ence as two counts. See 37 C.F.R. 41.201 (“[E]ach count must descr ibe a patentably distinct invention.”) The only d issue reg ardingpatentable distinctness is obvious ness—whethe r the “ intersec ting axes” invention is obvious over the “inter sectingplanes” invention as prior a rt, and vice versa . 30Obviousness is a leg al conc lusion based on under lying f indings of f

act, a nd the B oard’ s 31 fac tual finding s are revie wed f or substantial evidenc e. In re DB C , 5 45 F .3 d at 13 77 . H ow e ve r, it does not appe ar that the Boa rd eve r made fac tual finding s reg ardingthe patenta ble distinctness of claims 1 and 18 of the ‘460 Patent bec ause, pur suant to its regulations, the Boa rd pre sumed the single interfe renc e count to be pr oper a nd place d the burde n on Stry ker to e stablish otherwise. See 37 C.F.R. § 41.121(b). Ac cording ly , the Court must make its own fac tual finding s based on the e vid e nc e pr e se nte d in thi s § 14 6 p ro c e e din g to s up po rt its c on c lus ion

wi th r e sp e c t to ob vio us ne ss. 45 Obviousness is a leg al conc lusion that is reviewed de novo by this Court. In re DB C , 545 F.3d at 13 77
. Ac c or din g ly , th e Court sh a ll r e vie w the e vid e nc e that Str y ke r p re se nte d to the B oa

rd in 31 addition to the evidence it has prese nted in this § 146 procee ding a nd deter mine whether

Stry ker ha s sh ow n th a t it s p ro po se d Co un ts 2 and 3 c on ta in p a te nta

bly dis tin c t inve nti on s.
a . Ob vio us ne ss. An obviousness ana ly sis is based on sever al fa ctual inquiries, and a court must examine the scope and conte nt of the prior a rt, the diffe renc es betwe en the pr ior art a nd the claims at issue, and the leve l of ordinar y skill i n the per

tinent art. Ba

y e r S c he ring Pha rm a A G v . B arr Laboratori es, Inc

. , 5 7 5 F. 3 d 1 3 4 1 , 1 3 4 7 (F ed
. C i r. 2 0 0 9 ) ( ci t i n g Graham , 383 U.S. 1 at 17-18). The c ourt may

also consider

seconda ry objective e vidence of nonobviousness, such a s
commerc ial succe ss, long f elt but unsolved need, f

ailure of others, and the like. Id.

“ Ob vio us ne ss i s d e te rm ine d f ro m th e va

nta g e po int

of a hy po the tic a l pe rs on

havin g or din ary

sk ill in the art to which the patent per tains.” In re Rouffet , 149 F.3d 1350, 1357 ( Fe d. Cir. 1998). This person skilled in the art is akin to the “ rea sonable pe rson” use d as a r efe renc e in neg lige nce deter minations, and the person is pre sumed to have know ledg e of a ll releva nt prior ar t refe renc es. Id. Most, if not all, inventions are combinations of e lements from prior art. Id. A cour

t may not rely on hindsight in order

to show that an invention is obvious; rather, it must show “rea sons whyStry ker is cor rec t in that prior art’s f

ailure to pre clude a

claimed invention does not 32 rende r a c laim obvious. See Pl.’s Redefinition Br. at 31-32. This does not mean, howe ver, that the B oard “ demonstrated a distressing la ck of unde rstandingof basic patent law princ iples” whe n it ex plained that althoug h claim 1 of the ’ 460 Patent does not expli citly call for intersec ting planes, it does not pre clude them. See id. a t 31 . T he B oa rd wa s me re ly

e xpla ini ngwhy , in

its view, Stry

ker ha d failed to mee t its burden of proof with respec t to nonobviousness. See AR 477-78. Once a prima f

acie case of obviousness is established with respe ct to an invention, the 33 burd e n s hif

ts t o th e inv e nti on ’s pr op on e nt t o c ome fo rw ard wi th e vid e nc e and

/or argume nt t o establish patentability
. See I n re Sullivan , 498 F.3d 1345, 1351 ( Fe d. Cir. 2007). The B oard never indicated that a

prima fa cie c ase of

obviousness had bee n established with re spect to the two proposed c ounts, although its pre sumption t hat the sing le interfe renc e count wa s corr ect appea rs to have ha d a similar ef fec t. See AR

47 3 ( e xpla ini ngStr

y ke r’ s o bli g a tio n to e sta

bli sh no no bv iou sn e ss) . B e c a

us e thi s Co ur

t r e vie ws the de te rm inatio n o f o bv iou sn e ss de novo , the B oa rd ’s po sit ion

re g ard ingany

pr ima fa c ie c a se of

ob vio us ne ss i s immate ri a l. 46 the skilled artisan, c onfronted w ith the same problems a s the inventor and w ith no knowledg e of the claimed inve ntion, would select the e lements from the c ited prior ar t refe renc es for combination in the manner claimed.” Id. There are at least thre e possible source s for a motivation to combine prior art re fer ence s: (1) the tea ching s of prior a rt; (2) the know ledg e of persons of or dinary

skill i n the ar

t; and (3) the nature of the problem to be solved. Id. The Supreme Court has state d that this inqui ry —known as the “ teac hing, sug g estion, or motivation” te st— sh ou ld b e ma de fl e xibly , w ithan a pp re c iatio n f

or the ro le that c omm on

se ns e may

pla y in the inventive proc ess. See KSR I nt’l Co. v. Teleflex I

nc. , 550 U.S. 398, 407, 415, 420 (2007). 32 Def endants c laim that there is an “ overla p” in subject matter

betwee n the two proposed counts and that this overla p establishes a pr ima fac ie ca se of obviousness that Stry ker ha s failed to r e but. See Def

s.’ Redef inition Opp’n at 17. Specifica lly , Def endants c laim that there is an 33
ov e rl a p b e c a us e pr op os e d Co un t 2 ( c la im 1 ) c a lls fo r a “ pa ir of bo re s” and

pr op os e d Co un t 3 (cla im 18) calls for “ at least one bore,” which ca n include two bore s. Thus, Defe ndants argue,In a footnote, D efe ndants also cite Aelony v . Arni , 547 F.2d 566 ( C.C.P .A. 1977), 34 appar ently

for the pr oposition t hat, wher e a pla intiff has “f ailed to proff

er a ny evidenc e which would support their mere alleg ation of pate ntable distinction,” id. at 571, judg ment should be enter ed for

the def endant. See Def

s.’ Reply Supp. Mot. for Summ . J . at 2. 47 the intersec ting plane s invention overlaps with the interse cting axes invention, render ing the latter obvious. Def

endants c ite two case s for the pr oposition t hat this overlap in subjec t matter establishes a pr ima fac ie ca se of obviousness. In In re Pe terson , 315 F.3d 1325 ( Fe d. Cir. 2003), the Fe dera l Circuit affirme d the B oard’ s conclusion that a patent claim for a metal alloy

was ob vio us ba se d o n p ri or

art that di sc los e d r ang e s f

or e le me nta l c omp os iti on

that ov e rl a

pp e d w ith the ra ng es for the claimed patent. The Peterson court he ld that in cases involving overla pping rang es, eve n a slig ht overlap in ra ng e esta blishes a prima fa cie c ase of obviousness. 315 F.3d at 1329. The sec ond case cited by Def endants, In reMa lag

ar i , 499 F.2d 1297 ( C.C.P .A. 1974), also aff irmed a f inding of prima fa cie obviousness ba sed on prior a rt that disclosed the ra

ng e of
c arb on that sh ou ld b e us e d in

a c e rt a in s te e lmakin g pr oc e ss. 34 Th e Court

a g re e s w ithStr

y ke r t hat th e se “ ra

ng e ” c a se s a

re ina pp lic a ble . T he ra

ng e c a se s, which involve cla ims for specif ic compositions of materials, provide a poor a nalog y for the
e le me nts of

the c la ims a t is su e in t

his c a se . E ve n th ou g h c la ims 1 a nd 18 “ ov e rl a

p” in t he se ns e that th e y may bo th i nv olv e tw o b or e s, thi s o ve rl a p d oe s n ot c re a te pr ima

fa c ie ob vio us ne ss beca use the number

of bore s—unlike elementa l composition i n a metal a lloy —is not the critical fe a tur e of e ith e r c la im. Th e c ri tic a l f e a tur e of c la im 1 is that it

c a lls fo r t

wo bo re s w ith int e rs e c tin g a xes, and

the c ri tic a l f

e a tur e of c la im 1 8 is that it

c a lls fo r u

pp e r a nd low e r e nd s w ith intersec ting plane s. I t may be that cla im 18’s sugg estion of two bore s makes it obvious to a person skilled in the ar

t that those bores should have intersec ting ax es, but that is a conc lusion48

that must be drawn ba sed on a pr oper Graham analy sis, not on flim sy compar isons to cases involving complete ly

differ ent patenta

ble subject matter
. Th e Court

a g re e s w iththe B oa

rd that Str y ke r f a ile d to c on du c t an a

pp ro pr iate obviousness analy sis util izi ng the three fac tors identified in Graham : (1) the sc ope and c ontent of prior ar t; (2) the diffe renc es betwe en the c laimed subject matter and the pr ior art; and ( 3) the level of or dinary

skill i n the per

tinent art. Graham , 3 83 U. S. at 17 . A lth ou g h Stry ke r t ho ro ug hly dis c us se d th e dif

fe re nc e s b e tw e e n e a c h o f t he tw o inve nti on s a

nd wh a t it vie we d a s th e “ c los e st prior ar t (the Metz Patent),” AR 490, Stry ker should have explained in more detail why eac h invention was not obvious over the othe r as pr ior art. Rely ing on c onclusory

statements of nonobviousness by

one expert who is skilled in the art does not mee t the standard r equire d by Graham . Mr. B ush’s dec laration did not ex plain what the leve l of ordinar y skill i n the ar

t was (beyond stating that he possessed it) or e x plain in any detail why

he thoug ht, in light of the prior art a nd the level of

skill, t hat one invention would not have been obvious ove r the other
. See Bush De cl., ¶¶ 4, 28- 29. Stry ker a rgues that a “ full-blown Graham analy sis” is inappropriate when de ciding whether two claims from the same patent a re patentably

distinct from eac h other. See Pl.’s Op p’ n to De fs .’ Mo t. f

or Sum m. J. at 6- 7. Ye t Str y ke r f a ils to e xpla in why

the B oa rd sh ou ld apply a diffe rent test to deter

mine the patenta

ble distinctness of sepa

rate interfe renc e counts than it does when de termining whether there is an interfe renc e in the first plac e. See 37 C.F.R. § 41 .2 03 (a ) ( “ 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
ve rs a .” ) S tr

y ke r’ s o nly c itatio ns in s up po rt

of a dif fe re nt t e st a

re to a pa rt of the PTO ’s Manual49

of Patent Examining Proce dure reg ardingrestric tion and double patentingand to a F eder al Circuit case involving “obviousne ss”-ty pe double patenting. See Pl.’s Opp’n to Defs.’ Mot. for Summ. J . at 7. Those c ontext s are quite differ ent from inter fer ence proce eding s, where the B oard has pre viously

require d a Graham obviousness analy sis to be applied when de termining patentable distinctness. See P echine y Emballage , 73 U.S.P.Q.2d at 1573. The PTO’s interpre tation of its own regulations is entitl ed to substantial defe renc e, se e El i Lil ly , 334 F.3d at 1266, and Stry

ker ha s not shown that the PTO’s adoption of the Graham ana ly sis is p la inl y
err oneous or inconsistent with 37 C.F.R. § 41.201. Acc ording ly , the Court shall apply the Graham analy sis for obviousness that has bee n rea ffirme d by the Supreme Court. See Tele flex , 550 U.S. at 406-07. In attempt to cure the def ects in Mr. B ush’s dec laration, St ry ker pr offe rs the testimony of Dr. B ret F err ee, a

n expert in spinal fix ation technolog y . See Pl.’s Redefinition Br., De cl. of Dr
. B re t F e rr e e (“ F e rr e e De c l.” ). Dr . F e rr e e de c lare s th a t he is a n o rt ho pe dic surg e on

sp e c ia lizin g in sp ina l surg e ry

and that he ha s a

uth or e d r e se arc h p a

pe rs on sp ina l f ixat ion te c hn olo g y , s pe c if

ic a lly pedicle sc rewfix ation. Fe rre e De cl. ¶ 1. Dr . Fe rre e states that in his opinion, as of Nove mber 2000, a per son of ordinar y skill i n the field of spina l bone fixation t echnology would have be en ei th er a p er s o nwi thanen gi n ee ri n g d egr ee an d atl ea s ts ev er al y ea rs o f e x p er i en ce i nth e d es i gn of medica l devices or

a surg eon who ha d perf

ormed surg ery

on spinal disorders usinga var iety of exis ting de vices a

nd who had de sign e x perie nce. F err ee D ecl. ¶ 5. Dr. F err ee f

urther de clar es that no thi ngin c la ims 1, 24 , a nd 38 of the ‘4 60 Pate nt ( de fi nin g the “ int e rs e c tin g a xes” invention) would sug g est to a per son of ordinar y skill i n the ar

t that the upper a

nd lower pla

nes of the c oupling e lement should intersec t. Id. ¶ 1 9. Simi larl y , D r. F e rr e e op ine s th a t no thi ngin50

c la ims 18 and

33 of the ‘4 60 Pate nt ( de fi nin g the “ int e rs e c tin g pla ne s” inv e nti on ) w ou ld s ug g e st to a pe rs on of or din ary sk ill in t he art that a c ou pli nge le me nt s ho uld

have tw o inte rn a l bo re s w ith intersec ting ax es. Id. ¶ 20. Dr. F err ee’ s testimony

is rebutted by

Def endants’ e x pert, Er ik K. Antonsson, Ph.D., P.E. Dr . A nto ns so n is the Di re c tor of Re se arc h at N or

thr op Gr umm an A e ro sp a c e Sy ste ms, and he is a Boa rd Certified Re g istered Profe ssional Eng ineer with experience in biomechanics. See Def s.’ Redefinition Opp’n, Ex. A (Expert Report of Erik K. Antonnson, Ph.D., P.E.) (“ Antonsson Report”) at 1. Dr. A ntonsson opines that, as of Nove mber 2000, the le vel of skill in the art of spinal fix ation device s was a pe rson with a B ache lor of Scienc e degree in mechanic al eng ineer ing ( or equiva lent) fr om a four- y ear acc redited unive rsity , with a y ear or two of experience in orthopedic biomec hanics, or e quivalent experienc e, or a surg eon who ha d perf ormed surg ery

on spinal disorders usinga var iety of existi ng device s and treatment reg imens and havingexperience desig ning spina l implants. Id. at 3. Dr. A ntonsson s Dr. Fe rre e’s conclusions re g ardingthe obviousness of the “ intersec ting ax es” inve ntion with respect to the “interse cting planes” invention, and vice ve rsa. Id. a t 7- 14 . D r. Anton sso n e xpla ins that, i n h is vie w, a sk ill e d a rt isa n w ou ld u nd e rs tand that it wo uld be c onve nti on a l f

or the a xis of

a bo re to extend perpendic ularly

from the plane define d by the end f rom which the bor e extends. Id. at 7. There fore , a skilled artisan w ould understand that c laim 1, with its pair of bor es with intersec ting axes, would include ends with intersec ting plane s. Id. Simi larl y , th e sk ill e d a rt isa n w ou ld
un de rs tand

that c la im 1 8, wi th at le a st o ne bo re and e nd s h avin g int e rs e c tin g pla ne s, wo uld include a c oupling e lement with bores of intersec ting plane s. Id. Thus, Dr. Antonsson disag ree s with Dr. F err ee’ s opinion that claims 1 and 18 repr esent patentably distinct inventions. Id. at 8.51

Th e pa rt ie s h ave thu s p ro du c e d c on fl ic tin ge xpe rt te sti mony

re g ard ingthe fa c ts t

hat mu st be conside red in the obviousness a naly sis. Specifically , the par ties’ experts disag ree about the level of know ledg e of one skilled in the art and whe ther it would have been obvious to one skilled in the art that, g iven a c oupling e lement with ends def ining plane s that intersec t, there should be a pa ir of bore s with intersectingaxes. Howeve r, in order to cre ate a

g enuine issue of
mate ri a l f a c t th a t pr e c lud e s summa ry jud g me nt, the pa

rt ie s’ e xpe rt

te sti mony

mus t be a dmi ssi ble under the principles in Fe dera l Rules of Evidence
. See Fe d. R. Civ. P . 56(e) (1) ( holding that
su pp or tin g a ff ida vit s mu st s e t out f

a c ts that w ou ld b e a dmi ssi ble in e vid e nc e ); Merit Motors, Inc. v. Chrysler Corp. , 569 F.2d 666, 673 ( D.C. Cir. 1977) (“To hold that [Fe dera l Rule of Evidence ] 703 preve nts a court f

rom g rantingsummary

judgme nt ag ainst a par

ty who re lies solely

on an expert’s opinion that has no more ba sis in or out of the rec ord than [the expert’s] theoretical speculations would seriously undermine the principles of Rule 56.” ) Unsurpr isingly , the par ties object to ea ch other ’s expert testimony as inadmissible. The Court shall there fore consider whether either D r. F err ee’ s or Dr. A ntonsson’s testimony must be excluded under the F eder al Rules of Evidence
. b
. E x p e rtt e s t i m o n y. F e de ra l Ru le of

Ev ide nc e 70 2 g ov e rn s th e us e of e xpe rt te sti mony

in f e de ra l c ourt s. Rul e 702 provides: “[i] f scientific , technica l, or other spe cialized knowledg e will assist the trier of f act to understand the e vidence or to deter mine a fa ct in issue, a witness qualifie d as an e x pert by knowledg e, skill, ex perie nce, tr aining , or educ ation, may testify there to in the form of a

n opinion or otherw ise, if (1) the testimony is based on suff

icient fa cts or data , (2) the te stimony is the product of r eliable pr inciples and methods, and ( 3) the witness ha s applied the princ iples andThe c oncer ns underlying the court’s r ole as g ateke eper under Da ub e rt

are of lesser 35 import in a bench tria l, where no scre eningof the fa ctfinder can take plac e, but the standa rds of rele vance and re liability

must sti ll be met. Seaboard Lumber Co. v. United States , 308 F.3d 1283 (F ed. Cir. 2002). Stry

ker did not dema

nd a jury trial for c ontested issues of fa ct, and it not clea r in any event that it is entitled to a jury deter mination in a proce edingunder 35 U .S.C. § 146. 52 methods reliably

to the fac ts of the ca se.” The Supreme Court’s de cision in Da ub e rt v . M e rre ll Dow Pharmace uticals, Inc. , 509 U.S. 579 (1993), esta blished a g ateke epingrole for trial court judge s in determining the admissibilit y of expert testimony

on scientific e vidence
. Se e als o Kumho Tire Co. v. Carmichael , 5 26 U. S. 1 37 (1 99 9) (e xten din g g a te ke e pin g re qu ir e me nts to non-scientific expert testimony). The judg e must make “ a pre liminary assessment of whether

the
rea soning or

methodology

underlying the testimony is scientifically

valid and of whether

that
rea soning or

methodology

proper ly can be applied to the fa cts in issue.” 509 U.S. at 592-93. The Da ub e rt

Court established a list of fa ctors a c ourt should consider whe n assessingthe reliability of expert testimony : (1) whe ther a theory or tec hnique ca

n be (a nd has bee n) tested; (2) whether it has been subjec ted to peer revie w and publication; (3) the known or pote ntial rate of
err or and the exis tence of control standa rds; and (4) the level of

g ener al ac cepta

nce in the rele vant scientific c ommunity
. Id. a t 59 3- 94 . In c a se s invo lvi ngte c hn ic a l r a the r t ha n s c ie nti fi c expertise, a cour

t may apply any of these f actor s to the ext ent they

are rele vant. Kum ho Tire , 526 U.S. at 150. “The inquiry envisioned by

Rule 702 is . . . a flexibl e one.” Da ub e rt , 509 U.S. at 594. 35 i. Dr. F err ee. Def endants c ontend that Dr. F err ee’ s opinions do not m eet the minimum standards for reliability under Rule 702. De fenda nts note that Dr. F err ee did not conside r seve ral re levant
mate ri a ls, su c h a s th e pa

pe rs in t he Inte rf e re nc e pr oc e e din g s, the pr ior art re fe rr e d to by

Mr . B us h53

in his report, and the file histories of the ‘ 460 Patent and the ‘ 431 Application. See Pl.’s Resp. Stmt . ¶ 62 . D e fe nd ants a lso c on te nd that D r. F e rr e e ’s de po sit ion te sti mon y ind ic a te d th a t hi s conclusions re g ardingthe patenta ble distinctness of claims 1 and 18 a re unsuppor

ted. For example, Dr. F err ee sa id he had he ard of the Grah am v . J

oh n D e e rete st f

or ob vio us ne ss b ut d id
no t kn owwh a t th e e le me nts of the te st w e re . D e fs .’ Stmt . ¶ 65 . D r. F e rr e e a lso state d th a t in decidingthat claims 1 and 18 we re patentably distinct, he did not consider the prior art. Pl.’s Resp. Stmt . ¶ 66. He also did not consider what the ‘460 Patent or the ‘ 431 Application disclosed. Pl.’s Stm t. ¶¶ 67-68. H e also a g ree d that the phra se “at least one” bore sug g ested that a per son skilled in the art could use more than one bor e. Pl.’s Stmt . ¶ 69. Def endants c ontend that the above statements show that Dr. F err ee’ s opinions are too conclusory

to be re liable. Howe ver, the Court finds that these objec tions go to the we ight of Dr. F e rr e e ’s te sti mony

rathe r t ha n it s a dmi ssi bil ity . D r. F e rr e e ’s fa ilure to u nd e rs tand the pure ly leg al ana ly sis of Graham or re view the e ntire re cord of the Interfe renc e proc eedingdoes not rende r his opinion unreliable. Dr . Fe rre e’s opinion re g ardingthe level of skill i n the ar

t and the teac hings of

claims 1 and 18 a

re ba sed on his expertise in the rele vant field a nd there fore may

be
c on sid e re d b y

thi s Co ur t at tr ia l. ii. Dr. Antonsson. Stry ker c ontends that Dr. Antonsson is not qualified to g ive expert testimony reg arding the kn ow le dg e of

on e sk ill e d in

the art of bo ne fi xati on

a sse mbl ie s b e c a

us e his e xpe ri e nc e is i n g ener al mecha

nical eng ineer ing w ith lit tle or no expertise in orthopedic biomec hanics, a specie s of biomedica l eng ineer ing. See Pl.’s Redefinition Reply at 10-20. Stry

ker a rgues that Dr. Antonsson’s only

work re lated to biomedical e ng ineer ing oc curr ed longbefor e Nove mber 2000,54

the re levant time in question for this patent . Indeed, D r. Antonsson’s primar y experience
re latin g to b iom e c ha

nic s a pp e ars to d a te ba c k to his tim e a s a n und e rgra du a te and

g ra du a te student, when he worke d on hip prosthetics. See Antonsson Report at 1-2. In 1984, Dr. Antonsson also held the position of Assistant Professor of Or thopedics (B ioeng ineer ing) at the Har vard University

Medica l School. Id. at 2. Howe ver, D r. Antonsson’s more r ece nt work has not involved biomechanics a nd has foc used on other a spects of me chanic al eng ineer ing. See id. at 2. He ha s, howeve r, re cently g iven expert testimony

perta ining to biomecha

nics and orthopedic spine implants spec ifically
. See id. at 15. Str y ke r c ite s se ve ra l c a se s in

su pp or t of its argume nt t

hat D r. Anton sso n’ s e xpe rt ise is insufficiently

specific to be re liable in this case. In Shrevev. Sears, Roe buck & Co. , 166 F. Supp. 2d 378 (D. Md. 2001), that court explained that “a n expert who is a mecha

nical eng ineer

is not
nece ssarily

qualified to testify

as an e x pert on a

ny issue within the vast field of mec hanica l eng ineer ing. Unless he is to testify only to ge nera l eng ineer ing pr inciples that any mecha nical eng ineer would know, the eng ineer must possess ‘some special skill, knowledg e, or e x perie nce’
conce rningthe par

ticular issue be fore the Court.” Id. at 392 (interna l citation omitt ed). The Shreve court e x cluded the te stimony of a me chanic al eng ineer ing e x pert on the ground that he had no prof

essional experienc e re lating to the sa fe de sign a nd operation of “snow throwe rs,” wh ic h w e re a t is su e in t

ha t c a se . Stry

ke r a lso c ite s Oglesby v . Gene ral Motors Corp. , 190 F.3d 244 (4th Cir. 1999), in which the c ourt similarly held that testimony

by a mec hanica l eng ineer could be e x cluded be cause the eng ineer lacke d specia liz ed knowledg e of the manufa cturing proce ss to which his testimony was dire cted. Id. at 247. Unlike the experts whose te stimony was re jected in these and other

case s cited by

Stry ker,55

ho we ve r, Dr . A nto ns so n d oe s h ave so me e xpe ri e nc e in o rt ho pe dic bio me c ha

nic s— it i s ju st that it
wa s v e ry e arl y in h is c are e r. Hi s r e c e nt e xpe rt te sti mony

re g ard ingor

tho pe dic sp ine imp lants , while not adequate on its own to establish specialized knowledg e, strong ly sug g ests that Dr. Antonsson has continuing expertise in the specific field. In addition, the case s cited by Stry ker
m o s t l y i n v o l v e e x p ertt es t i m o n y o nd es i gnd ef

ec t s , i nwh i ch th e n ee d

fo r s p ec i al i z edkn o wl ed ge is paramount. B y

contra st, Dr. Antonsson explains i n his ex pert report that “the te chnolog y at iss ue c on c e rn s th e a

pp lic a tio n o f p ri nc ipl e s o f m e c ha nic a l e ng ine e ri ngto t

he de sign o f o rt

ho pe dic device s.” Antonsson Report at 3. Thus, the le vel of spec ialized ex pertise to which D r. Anton sso n is te sti fy

ingis c los e r t o th a t of

a g e ne ra lize d me c ha

nic a l e ng ine e r t

ha n to an e xpe rt

in sp ina l f ixat ion . T he Court

the re fo re fi nd s th a t hi s te sti mony is s uf fi c ie ntl y re lia ble un de r R

ule 70 2 n ot t o b e e xclu de d. Str y ke r’ s o bje c tio ns to t

he ba se s f or Dr . A nto ns so n’ s c on c lus ion s g o to th e i r w e i g h tr a th e r

th anth e i r

a dm i s s i b i l i ty. There fore , based on the prese nt rec ord, the Court finds that neither party has shown that the re are no g e nu ine iss ue s o f m a te ri a l f a c t and that e ith e r p art

y is e nti tle d to jud g me nt a s a matter of la

w with respe ct to the re definition of the interf ere nce c ount. The Court shall proce ed toward a hear ing of

the experts and any

other fa ctual issues to be re solved. C. The Parties’ Rem aining Motions The Court shall now addr ess the re maining issues r aised by the par ties’ dispositive motions. The relief sought by Stry ker in its Unpatenta

bility Motion and § 112 Motion are conting ent upon the Court’s g rantingits Redefinition Moti on. There fore , beca use the Court denies Stry

ker’ s Redefinition Motion, it shall also deny Stry ker’ s Unpatenta

bility Motion and § 112 Motion. S imilarly , Def endants see k summary

judgme nt with respec t to the Boa rd’s56

reje ction of Stry

ker’ s conting ent motions or its failure to permit Stry ker to file a dditional conting ent motions. However , the deter mination of these issues depe nds on whether the B oard pr op e rl y de c lare d a

sin g le int e rf

e re nc e c ount, and

the y may be c ome moo t if

the Court

we re to order a re mand for c onsideration of a two-count interf

ere nce. T here fore , except as explained
a bo ve , th e Court

sh a ll d e ny

De fe nd ants ’ m oti on

fo r s umm ary

jud g me nt. IV . C ON CL USI ON Th e Court

ha s a dd re sse d th e me ri ts o f t

wo of the fo ur iss ue s p re se nte d b y

the pa rt ie s’ dispositi ve motions. W ith respec t to the purportedly unconstitutional appointment of the administrative patent judg e who pa rticipated in the inter fer ence proce edingbelow, the Court fi n d s th atan y

co n s t i tu t i o n al d ef

ec twa s cu re d

b y th e c o n s t i tu t i o n al re ap p o i n t m en to f t h e j u d ge prior to the issuance of a f inal decision on re hear ing. With respec t to St ry ker’ s claim that the B oa rd imp ro pe rl y

de c lare d a

n inte rf e re nc e c ount c on ta ini ngtw o p a te nta bly dis tin c t inve nti on s, the Court finds there are g enuine issues of material fa ct that pre clude summary judgme nt for either pa rty . Be cause the re maining issues r aised by the par ties are conting ent in some way on the re definition of the interf ere nce c ount, the Court shall not address them at this time. Acc ording ly , the Court shall DENY Stry ker’ s motions for summary judgme nt and GRANT-I

N-PART and DEN Y-I

N-PART Def

endants’ motions for summar y judgme nt. The Court shall schedule a

status confe renc e with the par ties to discuss resolution of the d issues of materia l fac t. An appropr iate Or der a ccompa nies this Memorandum Opinion.
Date: Fe bruar

y 16, 2010 /s/ C O LLE E N K O LLA R
- K O T E LLY Un i t edS t at es Di s tri ctJ u d ge