STRYKER SP I NE, Plaintiff,

v. BI EDERMANN MOTE CH GMBH , et al. , Def endants. UNITED STAT ES DIS TRICT COURT

F OR THE DIS TRICT OF COLUM BIA

Civil Action No. 08–1827 (CKK)

MEMORAN DUM OP INION (Nove mber 15, 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 (the “ Boa rd”) pursuant to 35 U.S.C. § 146. I n a prior r uling issued on Fe bruar y 16, 2010, the Court denied Stry ker’ s motions for summary judgme nt and g rante d-inpart a nd denied- in-part De fenda nts’ motion for summary

judgme nt. See Stryker Spinev. Biedermann M

otech Gm bH

, 684 F. Supp. 2d 68 (D.D .C. 2010). The Court found that ther e we re g enuine issues of material fa ct re lating to whe ther the B oard e rre d by failing to rede fine the interfe renc e count to ac count for two a lleg ed pate ntably distinct inventions. According ly , the Court held a benc h trial to hear the par ties’ evidenc e re g ardingthis iss ue. This Memora ndum Opinion sets forth the Court’s finding s of fa ct and c onclusions of law. The be nch trial wa s held over two da y s on Aug ust 25 and 26, 2010. Stry ker c alled one witness, Dr. B ret A. F err ee, to testify as an e x pert in the fie lds of orthopedic sur g ery , spinalsurg ery , spinal bone fixation technology , and pedic le fixation assemblies. Defe ndants also ca lled

one witness, Dr . Erik K. Antonsson, to testify as an e x pert in the fie ld of mecha nical eng ineer ing and the a pplication of mec hanica l eng ineer ing pr inciples to orthopedic medic al device s. Prior to the trial, Stry

ker f iled a [66] Motion in Limine to Ex clude Expert Testimony of Dr. E rik K. Antonsson. The Court took Stry ker’ s motion in limine under a dvisement prior to and dur ing the bench tr ial and allowe d Dr. Antonsson to prese nt his testim ony on the re cord. F ollowing the bench tr ial, the par

ties submitt ed propose d finding s of fa ct and c onclusions of law with citations to the rec ord. Havingconsidere d the evidenc e pre sented duringthe benc h trial, the par ties’ proposed finding s of fa ct and c onclusions of law, the r eleva nt authorities, and the r ecor d as a whole, the Court concludes that the Boa rd prope rly

decla red a single interfe renc e count that doe s not encompa ss two patentably distinct inventions. According ly , Def endants a re e ntitled to judgment on Stry ker’ s claim that the B oard e rre d by failing to rede fine the inter fer ence count into two separ ate c ounts. Bec ause the rema inder of Stry ker’ s claims are conting ent upon a r edef ined interfe renc e count, the Court sha ll enter fina l judgment f or De fenda

nts and dismiss t his action. I. F INDING S OF F ACT 1 The followingfinding s of fa ct ar e base d on the administrative re cord, the evidenc e 2 Finding s of fa ct may

also be c ontained in the sec tion entitled “Conclusions of L aw,” and 1 vice ve rsa. The substance of the findingor conc lusion, rather tha n the cha rac terization by

the Court, controls. In a Minute Orde r date d Marc h 6, 2009, the Court g rante d Stry ker’ s unopposed motion 2 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 have the same e ffe ct as if or igina lly taken a nd produce d in this action. The administrative re cord w as also admitted as Joi nt Ex hibit 4 during the be nch trial. 2(testimony and exhibits ) submitted by the par ties during the benc h trial, the par ties’ stipulations of undisputed fa cts, and the r ecor d as a whole. A. Stryke r’s Patent ( the ’460 Patent) Plaintiff Stry

ker Spine (“ Stry

ker” ) is the assig nee of

U.S. Patent No. 6,974,460 (“the ’460 Patent”), which is titl ed “B iased Angulation Bone Fixation Assembly .” See J oint Ex . (“JX”) 1 3 (the ’460 Pate nt). J ohn Carbone, A aron Ma rkworth, Micha el Hora

n, and Yve s Crozet are named as the inventors of

the ’460 Patent. Id. ; Stip. Fact ¶ 4. The ’ 460 Patent was issued on De cembe r 4 13, 2005. J X 1 at 1. The invention desc ribed by the ’460 Patent re lates to spinal fix ation device s, more specific ally , pedicle f

ix ation assemblies. JX 1 at col. 1, lines 12-14. Spinal fix ation is a surg ical technique in whic h surg ical implants are used to fuse tog ether and/or mec hanica lly

immobil ize two or more ve rtebra l bodies of the spinal column. See id. at lines 41-44. One technique f or spinal fix ation involves immobi liz ing the spine using or thopedic stabilizi ng rods, or spine r ods, fastene d with bone scre ws into the pedicles of verte bral bodies. See id. at lines 55-60. Unde r prior pate nts identified in the ’460 Patent, the pe dicle scr ew ( or anc horing element) has a spherica lly

shaped he ad that fits within a rod c apturingassembly (which c apture s the spine rod) so as to permit movement of the a ssembly relative to the pedicle sc rew . See id. at col. 2, lines 29-40. Acc ordingto the inventors of the ’ 460 Patent, there was a need f or spinal fixation devices

The Court shall use the a bbrevia tions “J X,” “ PX,” and “ DX,” to r efe r to “Joint Ex hibit,” 3 “Plaintiff’s Exhibi t,” and “ Def endants’ E x hibit,” respec tively

. Citations t o “Stip. Fac t” re fer to the parties’ agree d stipulated fac ts as descr ibed in the 4 J oint Pretrial Statement, ECF No. 64. 3that provide a g reater de g ree of angulation betwee n the rod c apturingassemblies and the anchor ing e lements. Id. at lines 41-47. The ref ore, one stated g oal of the ’ 460 Patent is to provide for

a bone f ix ation assembly

that allows g reater a

ng ulation so that the rod ca pturing assembly can be manipulated to cove r a br oader rang e of a

ng les for c apturingan orthope dic stabiliz ing r od. Id. at lines 64-67. A f urther g oal of the ‘ 460 Patent is to provide for greater “biase d” angulation, meaningthat there is gr eate r angulation in one direc tion compare d to another

. See id. ; Tr. (8/25/10 AM) a t 86:22-87:5 (Testimony

of Dr. B ret F err ee)

. The ’460 Pate nt contains 39 claims, five of which ar e indepe ndent (c laims 1, 18, 24, 33, and 38). Stip. Fa ct ¶ 11. Independe nt claim 1 of the ’460 Pate nt rea ds as follows: 1. A bone f

ix ation assembly

comprising : a coupling element having a n inner surf

ace defininga first bore coaxial with a first longitudinal axis and a second bore coaxial w ith a second longitudinal axis , wher ein said first and s econd longitudinal axes intersec t and are in communication with one anothe r; said coupling element including a seat adjac en t s ai d lower end of said coupling element, said seat being define d by t h e inner surfa ce of said coupling element; and an anchor ing element assembled with said coupling element, said anchor ing element having a first end for insertion into bone and a head space d from the first end, said hea d beingin contact with seat of said couplingelement. J X 1 at col. 15, lines 42-55; Stip. Fac t ¶ 41. Claim 1 thus requires a c oupling e lement with two bores ha ving inter sectinglongitudinal axes. Independe nt claim 18 of the ’460 Pate nt rea ds as follows: 18. A bone f

ix ation assembly

comprising : a coupling element having an upper end defining a first plane, a lower end defining a sec ond plane, a

nd at least one bore e x tending from said upper end towar d said lower e nd, wher ein said first and se cond plane s intersec t one another ; an anchor ing element assembled with said coupling element, said anchor ing element beingadapte d for inser

tion into bone; and said coupling element having a U-shaped opening that extends from the upp er end

4of said coupling element toward the lower end of s aid coupling element, wher ein said U-sha

ped openingis adapted to re ceive a stabilizi ngrod. J X 1 at col. 16, lines 50-63; Stip. Fac t ¶ 43. Claim 18 thus requires end sur fac es def ining plane s, with the upper a

nd lower pla

nes interse cting . Claim 18 calls for “a t least one bore ” but does not require two bores. B. 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.” Stip. Fac t ¶ 9; J X 2 (the ’ 431 Application) at 1. Def endant De Puy

has bee n identified as the e x clusive license e of the ’431 Application. St ip. Fa ct ¶ 10. The ’431 Application was filed on January 22, 2004. Stip. Fact ¶ 22. The ’431 Application claimed to be a continuation of A pplication No. 10/037,698, filed Nove mber 9, 2001, which cla imed priority from Ge rman Application No. 10055888.7, filed Novembe r 10, 2000, and Ge rman Application No. 10065397.7, filed Dec ember 27, 2000. J X 2 at 1. The named inventor s for the ’ 431 Application ar e L utz Biederma

nn and Jurge n Har

ms. St ip. Fac t ¶ 8. 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 Applica

tion

rea ds as follows: A bone scre w having a scre w m em b er (1) possessing a threa ded section (2) and a head (3) and a rec eiving part (5) at the head end for rec eiving a rod to be connec ted to the bone scre w is provided. The rec eiving part (5) has on [si c] open first bore (6) an d a substantially U-shape d cross-se ction having two fre e leg s provided wit h a threa d. Fur

thermore , the rec eiving part has a second bore (7) on the end opposite to the first bore (6) whose diameter is g reater than that of the threa ded section (20 and smaller than that of the head (3). On the bottom of the first bore a seat for the head (3) is provided. I n order that the s cre w m ember can be pi voted t o at l east one side by an enlar g ed ang le, the edg e bounding the fre e end of the second bore (7) viewed relative to the axis of the fir st bore (6) is of asy mmetric construc tion.

5J X 2 at 1 (f igur es omitted). 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 a pplication for the ’ 460 Patent. See J X 3 (’431 Application File History ) at DPS00558-69. B ieder mann proposed two inter fer ence counts, one of which was dire cted to an “ assembly or couplingelement” as desc ribed by either c laims 1- 9, 11-13, 15-18, 20, 22- 31, 34-37, 41 and 42 of the ’460 Patent or c laims 6-35 and 40-42 of the ’431 Application, and the other of which wa s directe d to a “method” as def ined by either c laims 44-47 of the ’ 460 Patent or cla ims 36-39 of the ’431 Application. J X 3 at DPS000559. On J anuar y 10, 2006, Bie derma

nn filed a “ Sugg estion of Interfe renc e Unde r 37 CFR 41.202(a )” proposing only

a sing le count of inter fer ence direc ted towar d an asse mbly or couplingelement. J X 3 at DPS000471-85. On May 16, 2007, Bie derma

nn filed a “ Supplemental Sugg estion of Interfe renc e” w ith the PTO. See J X 3 at DPS000348-63. Bie derma nn proposed what it called a “Simplified McKelvey

Count,” defined a s “[t] he asse mbly or couplingelement of

Carbone claims 1, 18, 24, 33, or 38, or the assembly or couplingelement of

Bie derma

nn claims 6, 18, 28, 33 or 35.” JX 3 at DPS000351. Bieder mann explained that the simplified McKelve y count “ha s the adva ntag e of c ombining the pa rties’ indepe ndent claims, which a re not pa tentably distinct from one a

nother, 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 independe nt claims.” Id. C. The Interfere nce Procee ding On Octobe r 10, 2007, the B oard issued a notice dec laringPatent Interfe renc e No. 105,578

6involving the ’ 460 Patent and the ’ 431 Application. Stip. Fact ¶ 12; Admin. R. (“AR”) 2- 7. Administrative Patent J udg e (A PJ ) Jameson L ee w as assigned to manag e the inter fer ence proce eding . AR 3; St ip. Fac t ¶ 29. The inventor s of the ’431 A pplication (B ieder

mann and Har ms) wer e identified a s the senior pa rty , wher eas the inventors of the ’ 460 Patent (Carbone et al.) we re ide ntified as the junior pa rty . AR 4; St ip. Fac t ¶ 23. The inter fer ence was de clar ed on the basis of a

single count (“ Count 1”), def ined as c laim 1, 18, 24, 33, or 38 of the ’ 460 Patent or claim 6, 18, 28, 33, or 35 of the ’431 Application. St ip. Fac t ¶ 23; AR 5. All remainingclaims of the ’460 Pate nt and the ’431 A pplication wer e said to “c orre spond to” the sole interf ere nce count, such that they

would rise or f

all with the count itself. Stip. Fact ¶ 23. The interf

ere nce count was later re decla

red to substitute Biede rmann’s c laim 22 for B ieder mann’s cla im 18. See AR 153-54; Stip. Fact ¶ 30. Duringa motions confer ence held on Dec ember 5, 2007, Stry

ker e x plained its proposal to file a motion to rede fine the inter fer ence by repla cingCount 1 with t wo new c ounts, Count 2 and Count 3. S tip. Fac t ¶ 31; AR 156-61. In an orde r date d Dec ember 6, 2007, APJ L ee a

uthorized Stry ker to file a

motion to redefine the interfe renc e. Stip. Fac t ¶ 32; AR 160. On Fe bruar y 15, 2008, Stry

ker f iled its “Revised Substantive Motion 1” to redef ine the interf

ere nce. Stip. Fa ct ¶ 33; AR 307-59. Claims 1, 24, or 38 of the ’460 Pate nt and claims 6, 28, or 35 of the ’431 Application def

ine what Stry

ker c alled propose d Count 2. S tip. Fac t ¶ 37; AR 319. Claims 18 or 33 of the ’460 Pate nt and claims 22 or 33 of the ’431 Application define what Stry ker c alled proposed Count 3. Stip. Fact ¶ 38; AR 320. In its mot ion, Stry ker a rgued that Count 1 “includes two separ ate inventions which a re patentably

distinct from eac h other, a nd that it is t here fore inappropriate to include these two separ ate inventions in a sing le count.” A R 310. St ry ker

7explained that the first invention, expressed by Count 2, is represe nted by claim 1 of the ’ 460 Patent. AR 311. Stry

ker e x plained that the se cond invention, expressed by Count 3, is repr esente d by

claim 18 of the ’ 460 Patent. AR 312. Acc ording ly , Stry ker a rgued that cla ims 1 and 18 of the ’460 Patent exemplify “entire ly separ ate” inventions. AR 314. I n support of its “Revised Substantive Motion 1,” Stry ker f iled a dec lara

tion by Charles L . Bush, Jr. (“B ush Dec laration”). See AR 329-51. 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 which, inter alia , denied Stry ker’ s Revised Substantive Motion 1. Stip. Fact ¶ 34; AR 468-81. The Boa rd also ente red judgment ag ainst Stry ker in the Interfe renc e, ca

ncellingclaims 1-39 of the ’460 Patent. Stip. Fac t ¶ 34; AR 482-84. The B oard beg an its written opinion by discussing the qualifications of Mr. Charles B ush as an e x pert, a nd the B oard c oncluded that Mr. B ush was qualifie d to testify as to the knowledg e of one skilled in the ar t in the field of bone f

ix ation assemblies at the time of the invention(s). AR 471. Howe ver, the B oard c oncluded that Mr. B ush did not offer te stimony reg ardingwhat the knowle dg e of one skilled in the art was a

nd did not provide evidenc e that his ana ly sis of Count 1 and the two proposed Counts involved considera tion of the level of or dinary skill i n the ar

t. Id. There fore , the B oard c oncluded that Stry ker ha d failed to c onduct an a dequate leg al ana ly sis reg ardingthe obviousness of proposed Count 2 over proposed Count 3, and vice versa . See AR 471-79. The Boa rd explained:

When an interfe renc e involves more than one count, “ea ch count must descr ibe a patentably distinct invention.” 37 C

. F. R

. § 41.201. There fore , a party moving to re define the interfe ring subject matter by dividing an exis ting c ount into two separ ate counts must e stablish that the exis ting count embodies two patentably distinct inventions. Two inventions a re patentably distinct when the subject matter

8of one invention if prior art, would not have anticipated o r rendered obvious the

subject of the second invention. The party filing a m otion to rede fine the subject matter of a

n interfe renc e has the burden of proof. Establishing nonobviousness in a motion to rede fine an interfe renc e require s t h e same fac tual inquiries require d under a [si c] 35 U.S.C. § 103 to deter mine whether an invention is obvious, i.e., (1) the scope of and content of the prior art; (2) the differ ence s betwee n the claimed subject matter and the prior art; (3) the level of ordinary skill in the art; and (4) seconda ry co n s id e rations, such as unexpected results. See G raham v. J

ohn Dee re Co. , 383 U.S. 1, 17 (1966). There fore , to establish a prima fac ie case o f n o n o b v io u s n e s s, the movant must addre ss not only the differ ence s betwee n the proposed new 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 arr ive at any conclusion of n o n o b v iousness. Comparing the differ ence s betwee n the proposed new counts without adequa tely addre ssing the scope and content of the prior art and the level of ordinary skill in the art does not satisfy the burden of establishing prima fac ie nonobviousness. See Pec hiney Emballage Flexible Europe v. Cryovac, Inc. , 73 USPQ2d 1571 (Bd. Pat. App. & Int. 2004). Stip. Fact ¶ 39; AR 473. On May 30, 2008, Stry

ker soug ht rehe aring

of the judg ment and denia l of its moti on to rede fine the inter fer ence . Stip. Fact ¶ 35; AR 485-527. O n August 27, 2008, a pane l of the Boa rd (APJs S chaf

er, L ee, a nd Moore) issued a wr itten decision deny ing Stry ker’ s reque st for rehe aring

. See AR 528-38. D. Stryke r’s § 146 Proce eding Stry ker e lected to r eview the Boa rd’s de cision and conduc t further proce eding s befor e a district court pursua

nt to 35 U.S.C . § 146. In its First Amended Complaint, Stry ker de mands, inter alia , a dec laratory

judgme nt that the claims at issue in the interf ere nce a re dire cted to two separ ate a nd patentably

distinct inventions correspondingto proposed Counts 2 and 3. Stip. Fact ¶ 36; First Am. Compl. at 36-37. I n rulingon the par ties’ cr oss-motions for summary judgme nt, the Court deter

mined that there wer e g enuine issues of material fa ct with respe ct to this iss ue and

9order ed that the pa rties pre sent furthe r evide nce at a benc h trial. E. Evidenc e Prese nted During the Benc h Trial As Stry ker’ s counsel explained in his opening statement, the sole issue at trial was “whe ther the B oard of

Patent Appea ls and Interfe renc es of the Pate nt and Tra demar k Offic e

err oneously

decla red a nd adjudicate d an Interfe renc e . . . as be ing a ddresse d to a sing le count which wa s treate d as a sing le invention.” Tr. ( 8/25/10 AM) at 5:10-14. The inve ntion described by Stry ker’ s proposed Count 2 is also known as the “ intersec ting bor es” or “interse cting axes” invention. Tr. (8/25/10 AM) at 48:15-20. The invention desc ribed by Stry ker’ s proposed Count 3 is also known as the “ intersec ting plane s” invention. Id. at 48:21-24. Stry ker pr esente d one witness, Dr. B ret F err ee, in support of its contention that the Boa rd er red. B ieder

mann pre sented one witness, Dr . Erik Antonsson, to rebut Dr. F err ee’ s testimony

.

1. Dr. F err ee Dr. B ret A. F err ee is a

board- cer

tified orthopedic sur g eon spec ializi ng in spinal surg ery . Tr. (8/25/10 AM) at 20:2-4. Dr. F err ee attended colleg e at Case Western Reser ve Univer sity , wher e he r ece ived a de g ree in psy chology and natur al scienc es. Id. at 20:5-13. Dr. F err ee attended me dical school at the University of Cincinnati College of Medicine , g raduating with an M.D. deg ree in 1986. Id. at 21:8-16. He g raduated in the top five pe rce nt of his medical school class and w as ele cted into Alpha Ome g a Alpha, the national medica l honor society

. Id. at 21:21- 22:7. Dr. F err ee subse quently completed a

five-year residenc y

in orthopedic surg ery

at the University

of Cincinnati. Id. at 23:4-24:6. Duringhis residenc y , Dr. F err ee r ece ived trainingin spinal surg ery

and par ticipated in hundre ds of spinal surg erie s. Id. at 25:7-26:2, 27:5-11. Be tween 1991 a

nd 1992, Dr. F err ee c ompleted a f ellowship in the depar

tments of orthopedic

10surg ery

and neur osurg ery

at Tufts Univer sity

in Boston. Id. at 26:7-11. Duringhis fellowship y ear , Dr. F err ee f

ocused on c omplex spinal surg ery and par ticipated in about 350 spinal operations. Id. at 26:17-27:11. Fr om 1992 to 2000, Dr. Fe rre e joined a pr actice known as Wellington Orthopedic and Sports Medicine, pe rfor ming a lmost 400 spi nal surg erie s per year by the y ear 2000. Id. at 27:12-22. F rom 2000 to 2006, Dr. F err ee be came a solo prac titioner exclusively

perf orming spinal surg ery . Id. at 27:23-25. Since 2006, Dr . Fe rre e has de voted his time to the resea

rch a nd development of

spinal device s and tec hnologie s. Id. at 28:1-5. Dr. F err ee w as boar d cer

tified in 1995 by

the Amer ican B oard of

Orthopedic Surg eons and is licensed to pr actice medicine in the state of Ohio. Id. at 28:6-13. He has experienc e as a clinical instructor, a ssistant professor, a nd rese arc h lecture r, and he has made numerous prese ntations at profe ssional confe renc es re lating to spinal surg ery . Id. at 29:13-19, 30:5-19; PX 6 (Curriculum Vitae of B ret A. F err ee, M.D .) at 3-5. D r. F err ee ha s authored or coauthor ed many profe ssional publications, with a focus on spinal surg ery with emphasis on fix ation sy stems, including pe dicle fixation sy stems and complications re lated to the spinal surg erie s. Tr. (8/25/10 AM) at 30:20-31:7; PX 6 at 5-6. Dr . Fe rre e has a lso been involved in inventing or deve loping device s in the field of spinal fixation technolog y , and he is the na med inventor on a

pproxi mately 50 patents and 140 patent applications in the United States and inter nationally . Tr. (8/25/10 AM) at 31:23-32:5; PX at 6-7. Dr. F err ee ha s ext ensive e x perie nce w ith pedicle scr ew sy stems. He led a team of eng ineer s in designingand deve loping a device involving pedic le scre ws which ha s been use d on approximately

30,000 or more pa

tients in the United States and interna tionally . Tr. (8/25/10 AM) at 34:16-35:6. Dur ing his c are er a s a surg eon, Dr . Fe rre e inserte d over a thousand pedicle

11scre ws in hundreds of patients rang ing f rom teena g ers to patients in their e ighties. Id. at 35:7-25. Wit hout objection from De fenda nts, the Court qualified Dr. F err ee a s an expert in the fields of orthope dic surg ery , spinal surg ery , spinal bone fixation technology , and pedic le fixation assemblies. See Tr. (8/25/10 AM) a t 36:17-37:7. Dr. F err ee e x plained that a pe dicle scr ew is a me tal scre w g ener ally acc ompanied by

a coupling component of the scre w or within the asse mbly that is screw ed into the individual verte bra. Tr . (8/25/10 AM) at 37:20-25. Ty pically , two pedicle sc rew s are used in ea ch ver tebra , and these pedicle sc rew s are then conne cted tog ether by a rod, which is held in place by scre ws within the pedicle sc rew . Id. at 37:25-38:3. The pur pose of this sy stem is to align the spine a nd hold it in t he prope r alig nment duringthe fusion proc ess, i.e., whe n two or more ve rtebra e ar e fused tog ether

. Id. at 38:4-10. Dr. F err ee f

urther te stified that the first pedic le scre ws he used dur ing the 1980s were single components with a thre ad on one e nd, to be scre wed into the ver tebra , and a U -shape d seat on the other e nd, into which rods wer e inserte d. Tr. (8/25/10 AM) at 40:3-8. Dr. F err ee explained that the problem with these ty pes of de vices wa s that the spinal rods would nee d to be bent in order

to fit into a series of pe dicle scr ews, a nd bendingthe rods wa s difficult. Id. at 40:11-16. Dr. F err ee e x plained that beg inning a round appr ox imately

1992, the pedicle scre ws

wer e sepa rate d into two components, a couplingcomponent and a scre w component. Id. at 40:20-24. This enable d the couplingelement to swivel re lative to the scre w component, making it easier to a lign the r ods with the coupling element of the scre ws. Id. at 40:23-41:1. Dr. F err ee e x plained that the inventions in the ’460 Patent a nd the ‘431 Applica

tion improved upon these pr ior scre w sy stems by incre asing the angulation permitted betwe en the

12axis of the scr ew a nd the axis of the coupling e lement in at least one plane, makingit easier f or pedicle sc rew s to be inserted into ar eas of the spine with larg e cur

vature s or def

ormities, such as the nec k. Tr. (8/25/10 AM) at 41:2-24. Dr. F err ee opine d that as of Nove mber 2000, a person of ordinary skill i n the field of bone fixation relating to the spine and spinal proble ms would fall into one of two categ ories. See Tr. (8/25/10 AM) at 44:8-17. The first c ateg ory would be per sons with an eng ineer ing de g ree and seve ral y ear s’ experienc e desig ning me dical devic es. Id. at 44:17-19. Dr. F err ee later explained that a mecha

nical eng ineer ing de g ree would qualify and that “se vera l y ear s” mea ns three or four

or more year s. Id. at 106:3-9. The se cond categ ory would be surg eons who have used a va riety of these spina l devices a

nd who have been involved in de signing medical de vices and medica l technolog ies. Id. at 44:20-23. Dr. F err ee te stified that as of Nove mber 2000, he had worke d with many

individuals who fell into each of these c ateg ories, and he considere d himself to be a pe rson in the sec ond cate g ory as of Nove mber 2000. Id. at 44:24-45:14. Be fore trial, Dr. F err ee r eviewe d the ’460 Patent a nd its drawing s, written spec ification, and cla ims. Tr. (8/25/10 AM) at 46:12-17. Dr . Fe rre e testified that in his opinion, the ’460 Patent contains at lea st two inventions. Id. at 46:18-22. The f irst invention, described by claims 1, 24, and 38 of the ’460 Patent, ca lls for a c oupling e lement with two bores that ha ve longitudinal axes that intersec t. Id. at 46:23-47:18. Dr. F err ee e x plained that a “ bore” means a n “elong ate c ylindrical hollow are a within the couplingcomponent.” Id. at 47:11-14. The se cond invention, describe d by

claims 18 and 33 of the ’460 Patent, ca lls for a c oupling e lement having an upper and lower

end def ining plane s that intersec t. Id. at 47:19-48:14. Claim 18 does not make a ny ref ere nce to inter sectingaxes or intersec ting bor es. Id. at 48:5-7. Claim 1 does not

13make a

ny ref ere nce to inter sectingplanes. Id. at 48:8-10. Dr. F err ee te stified that Figure 2 of the ’460 Patent illustrates a de vice that incor porate s the intersec ting bor es invention but not the intersec ting plane s invention. Tr. (8/25/10 AM) at 49:2-50:2; J X 1 at F ig. 2. F igur e 2 is descr ibed as “ a simplified view of a pair of bone fix ation assemblies couple d with an orthopedic stabiliz ing r od, in acc ordanc e with ce rtain pre fer red embodiments of the pre sent invention.” JX 1 at col. 5, lines 52-56. Figure 2 doe s not purport to identify prior ar t. See Tr. (8/25/10 AM) at 50:4-51:7. I n the dra wing , it appear s that the upper and lower ends of the a ssemblies are para llel, i.e., not intersecting

. SeeJ X at F ig. 2. H oweve r, Figure 2 doe s not show the internal g eometry of the c oupling e lement. See id. ; Tr. (8/25/10 AM) at 51:14-16. Ac cordingto Dr. F err ee, a person of ordinary skill i n the ar

t of bone fixation relating to the spine a

nd spinal problems as of N ovember 2000 would conclude that the device shown in Figure 2 ha s two bores, one that enable s the insertion of a sc rewand one that holds the rod in place , and that those bore s intersec t one another . Tr. (8/25/10 AM) at 51:17-53:7. There fore , acc ordingto Dr. F err ee, a person of ordinary skill i n the ar

t of bone fixation relating to the spine and spinal pr oblems as of Nove mber 2000 would have re cog nized Fig ure 2 a s embodying only

the intersec ting bor es invention and not the interse cting planes invention. Id. at 80:2-9. Dr. F err ee opine d that the intersec ting bor es invention and the inter sectingplanes invention can be used sepa rate ly and indepe ndently , or they may be used tog ether . Tr. (8/25/10 AM) at 80:18-25. Dr. F err ee opine d that a per son of ordinar y skill i n the ar

t as of Nove mber 2000 would not have f

ound the intersec ting plane s claims obvious over the inter sectingbores c laims. Tr.

14(8/25/10 AM) at 82:22-83:1. Dr . Fe rre e explained that the basis for this opini on was the f

act that the intersec ting plane s claims, such as c laim 18 of the ’460 Patent, f ocus on the e x terna l g eometry of the c oupling e lement (i.e., the top, bottom, and sides of the couplingelement) and do not describe whether

the couplingelement ha s intersec ting bor es. Id. at 83:2-8, 18-21. Simi larly , the intersec ting bor es cla ims, such as claim 1 of the ’ 460 Patent, descr ibes only the internal g eometry

of the c oupling e lement (i.e., the bores a nd the seat) and make s no mention of intersec ting plane s. Id. at 83:9-17. F or the same rea sons, Dr. F err ee a lso opined that a per son of ordinary skill i n the ar

t as of Nove mber 2000 would not have found the interse cting bores c laims obvious in view of the interse cting planes c laims. Tr. (8/25/10 AM) at 83:22-84:15. Dr. F err ee e x plained that in his view, the interse cting bores invention is more advanta g eous than the inter sectingplanes invention bec ause it allows for g reater a ng ulation of the scre w without removingany portion of the sea

t, which could compr omise the stability of the

scre w. See Tr. (8/25/10 AM) at 84:19-85:22. The “se at” of the couplingelement is desig ned to captur e the he ad of the scre w so as to pre vent the scr ew f rom fallingor beingpulled out of the coupling element. See id. at 63:5-18. Dr. F err ee c ompare d the embodiment illustrated in Figure 7 of the ’460 Pate nt (and modele d three -dimensionally by PX 11 ), which shows inc rea sed

5 angulation without removal of the se at, with the embodiment illustrated in Figure 3 of the ’431 Application (a

nd modeled thre e-dimensionally by PX 13), which shows that incr ease d angulation is achieve d by

removingpart of the seat. Id. at 85:3-22. Dr. F err ee te stified that the ordinar y Prior to the trial, Dr. F err ee w orked w ith St ry ker to c reate three -dimensional models that 5 fairly depict, in Dr. F err ee’ s view, the important fe ature s of ce rtain figures dr awn in the ’ 460 Patent and the ’ 431 Application. Tr. ( 8/25/10 AM) at 55:13-58:13. The Court admitted these models as demonstrative e x hibits, designate d as Plaintiff’s Exhibi ts 10, 11, 12, and 13. Id. at 59:14-24. 15skilled artisan would have understood this advanta g e of the intersec ting bor es invention over the

intersec ting plane s invention. Id. at 94:24-95:2, 95:20-96:9. Dr. F err ee te stified that the ordinar y skilled artisan would under stand that the objec t of both the intersec ting bor es invention and the inter sectingplanes invention—as de scribed in claims 1 and 18 of the ’460 Patent—is to achieve a g reater a ngulation in at least one dire ction as compar ed to another , i.e., biased a ng ulation. Tr. (8/25/10 AM) at 86:22-87:5. Dr. F err ee te stified, and the Court agree s, that Figure 7 of the ’460 Patent is an embodiment of both claim 1 and c laim 18. Tr. (8/25/10 AM) at 96:10-14, 20-24. Dr. F err ee 6 also testified that F igur e 7 would have been a n obvious embodiment of claims 1 and 18 to an ordinary skilled artisan re adingthe ’460 Patent in Nove mber 2000. Id. at 96:16-19, 96:25-97:3. Dr. F err ee te stified that an ordina ry skilled artisan as of

November

2000 would have understood that the most common way to end a bor e is in a plane perpe ndicular to the ax is of the bore, a nd that this would have bee n obvious to the skill ed ar tisan. Tr. (8/25/10 AM) at 103:3-17. The bore s shown in Figure 7 e ach e nd in planes that ar e per pendicular

to their axes. See id. at 103:18-104:3; J X 1 at F ig. 7. Plaintiff’s Ex hibit 10 is a model cr eate d by Dr. F err ee r epre sentingthe embodiment descr ibed in Figure 2 of

the ’460 Patent. Id. at 60:2-6. The a ng le betwe en the f

irst bore a nd second bor e in Plaintiff’s Exhi bit 10 is l ess than the a ng le shown in Figure 2, how ever . Id. at 107:19-24. Dr. F err ee a lso testified that the U-sha ped openingin Plainti ff’ s Ex hibit 10 ex tends below the inter section of the bor es, which is lower than what is illustrated in Figure 2. Id. at

Ex cept whe re state d otherwise, a ll refe renc es to claims and f igur es ar e to the ’460 6 Patent. 16107:25-108:13. Dr. F err ee e x plained that he be lieved, base d on the written spec ification and

other e mbodiments in t he ’460 Pate nt, that the rod should g o low enoug h to articulate with the head of the scre w that g oes into the coupling device , to help immobil ize the screw

. Id. at 108:4- 109:19. Dr. F err ee a lso admitted that the other figures on whic h he re lied all had interse cting planes a nd not just i ntersec ting bor es. Id. at 109:12-19. Dr. F err ee te stified that in Plainti ff’ s Ex hibit 10, the screw doe s not substantially angulate more to the left than to the right, with any differ ence beinga matter

of a f ew de g ree s. Id. at 114:5-16. Dr. F err ee thus testified that it is possible that the embodiment in Figure 2 w ould not achieve the object of the invention in allowing g reater biase d angulation. Id. at 119:23-120:4. Plaintiff’s Ex hibit 13 is a model cr eate d by Dr. F err ee r epre sentingthe embodiment descr ibed in Figure 3 of

the ’431 Applica

tion. Tr. (8/25/10 AM) at 74:16-23. Plaintiff’s Exhibit 13 repr esents the inter sectingplanes invention but not the intersec ting bor es invention. Id. at 76:14-20; 114:22-25. Dr. F err ee te stified that the scre w in Plaintiff’s Ex hibit 13 clearly angulated more to the rig ht than to the left. Id. at 115:1-5. Dr. F err ee c oncede d that his model of the intersec ting plane s invention in P laintiff’s Exhibi t 13 allows g reater fa vored a ng ulation than his model of the bore s invention in P laintiff’s Exhibi t 10. Id. at 115:6-10. Dr. F err ee a g ree d that if the seat in the coupling e lement is sufficient to hold the scr ew in position, the intersec ting planes invention in Figure 3 of the ’431 Application would be better tha n the intersec ting bor es invention alone. Id. at 115:11-16. Dr. F err ee te stified that it would obvious t o the skilled artisan in Nove mber 2000 re ading claim 18 to make a

bone fixation assembly

comprising a couplingelement a nd an anc horing element, suc h as a sc rewwith a round he ad. Tr. ( 8/25/10 PM ) at 4:9-23. He further testified that

17it would obvious t hat the top end of the couplingelement de fines a f irst plane and the bottom end define s a sec ond plane, with one or more bore s g oing f

rom the top plane to the bottom plane. Id. at 5:8-13. Howe ver, D r. F err ee te stified that he wa s not convinced that it would be obvious to the skilled artisan in Nove mber 2000 to see k a solution that has two bores. Id. at 6:17-7:24. Dr. Fe rre e conf

irmed that duringhis deposition, he had testified that it would be obvious to use one bore a nd also obvious that two bores could be used. Id. at 9:15-24. Dr. F err ee a lso testified that in his opini on, the most obvious sol ution using two bore s would involve colinear bores of differ ent sizes, not bores with intersectingaxes. Id. at 10:4-20. Howe ver, he conce ded that such

an ar rang ement would ac tually constitute a sing le bore as def ined in the ’460 Patent, not multiple bores. Id. at 10:21-11:2. DuringDr. F err ee’ s cross-e x amination, counsel for Def endants dre w a diagram that wa s admitted into evidence as De fenda nts’ Ex hibit 10. See Tr. (8/25/10 PM) at 12:21-24. Dr . Fe rre e

conce ded that the diagram in De fenda nts’ Ex hibit 10 was drawn ba sed on the infor mation in claim 18. Id. at 13:20-22. Dr. F err ee te stified that Def endants’ E x hibit 10 depicts a coupling element that ha s a top end that de fines a pla ne and a bottom end that defines a plane, a nd those planes interse ct. Id. at 13:2-8. Dr. F err ee e x plained that the or dinary skilled artisan would understand that there ne eds to be a seat to hold the scr ew in plac e, and the ordinary way to form that seat would be with an axis perpendicular to the bottom surface of the c oupling e lement. Id. at 12:6-16. Dr. F err ee a lso testified that the ordinar y way to machine a

seat would have bee n to cut an a ng led bore into the bottom end. Id. at 12:17-19. Dr. F err ee te stified that the seat may be considere d to be a pa

rt of the bor e. See Tr. (8/25/10 AM) at 72:22-73:4, 92:1-93:21. Theref ore, Dr. F err ee a g ree d that Def endants’ E x hibit 10 shows two int erse cting bores, with interse cting

18axes. Tr. (8/25/10 PM) at 13:9-12. Dr. F err ee te stified that the diagram in De fenda nts’ Ex hibit 10 meets all the limitations of claim 1 of the ’460 Pate nt. Id. at 13:16-19. Def endants’ E x hibit 9 is a CAD dra wing that repr esente d one ver sion of Figure 2 of the ’460 Patent, with intersec ting bor es but para llel planes. Tr. ( 8/25/10 PM ) at 13:23-14:8. In Def endants’ E x hibit 9, the screw he ad is touchingthe seat of the couplingmember at a lower part on the left of the draw ing tha n on the rig ht. Id. at 14:17-22. Dr. F err ee te stified that the ordinar y skilled artisan would under stand, if he trie d to fabric ate F igur e 2 using phy sical or CAD mode ls, that there was e x cess meta l on the rig ht side that could be mac hined off w ithout having a ny impact on the scr ew. Id. at 14:25-15:15. In fac t, Dr. F err ee e x plained that ther e would be motivation to remove this ex cess mate rial bec ause it would allow for g reater a ng ulation of the

scre w, there by

achie ving the object of the invention. Id. at 15:25-16:14. Ther efor e, Dr . Fe rre e testified that it would be obvious for the or dinary skilled artisan doing work on a para llel planes embodiment with intersectingbores to re move excess mater ial from one side of the lowe r end of the couplingelement. Id. The re sult of removingthat materia l would be an e mbodiment that has both intersectingbores a

nd intersec ting plane s. 2. Dr. Antonsson Dr. Er ik K. Antonsson is the director of rese arc h for the N orthrop Gr umman Aer ospace Corporation and a

fac ulty associate at the California Institut e of Te chnology . Tr. (8/25/10 PM) at 33:16-24. Dr. Antonsson ea rned a Ph.D. from the Massa chusetts Institut e of Te chnolog y (“MI T”) in 1982 a

nd serve d on the fa culty

of the California

Institut e of Te chnolog y

for 25 year s as a pr ofessor of

mecha nical eng ineer ing. Id. at 33:4-16, 39:16-40:3. Duringhis gr aduate studies at MI T, Dr. Antonsson wor ked under the supervision of Profe ssor Robert W. Mann in the

19field of e ng ineer ing de sign a pplied to biomechanics. Id. at 34:17-23. Afte r re ceivinghis doctora l deg ree , Dr. Antonsson worke d as a r esea rche r at MI T and at Massachuse tts Genera l Hospital, focusingon biomechanc ial rese arc h. Id. at 36:23-37:10. During his aca demic ca

ree r and continuingto the prese nt, Dr. Antonsson consults as an e x pert witness in intellectua l proper ty case s, including some involvingorthopedic me dical devic es in which he was qua lified to testify about the desig n of spine devic es. Id. at 40:4-17. Dr. Antonsson could rec all at least three such ca ses within the last five y ear s, and a f ourth such ca se at some e arlier point in ti me. Id. at 56:9-57:1, 59:5-60:20. Def endants moved to qua lify Dr. Antonsson as a

n expert in the field of mec hanica l eng ineer ing a

nd the application of mecha nical eng ineer ing pr inciples to orthopedic medic al device s. Tr. (8/25/10 PM) at 42. Stry ker obje cted, a

nd the Court took the objection to his ex pert testimony under a dvisement. Id. at 62:23-25. The Court f inds that Dr. Antonsson is qualified to g ive expert testimony

reg ardingthe field of me chanic al eng ineer ing a nd the application of mecha nical eng ineer ing principles to orthopedic medic al device s. The Court ac knowledg es that 7 the most of Dr. Antonsson’s e x perie nce r elatingto biomechanics dates bac k to his early

aca demic ca

ree r, and the Court considers this fac t in weig hing his opinions. Dr. Antonsson testified that in pre paration for his testimony , he had r eviewe d the expert repor t and deposition testimony of Dr. F err ee, the ’460 Patent and the ’431 Application, and the administrative re cord in the inter fer ence proce eding . Tr. (8/25/10 PM) at 63:18-25. Dr

. Antonsson did not consider any other prior

art. Id. at 65:3-5.

For this reason, the Court DEN I ES St ry ker’ s [66] Motion in Limine to Ex clude Expert 7 Testimony

of Dr. E rik K. Antonsson. 20Dr. Antonsson opined that a person of ordinary skill i n the ar

t relatingto the inventions at issue in this case would be a person who, a s of Novembe r 2000, holds a four -y ear bache lor’s deg ree from an a ccr edited instituti on in mechanic al eng ineer ing or biomechanic s, or a surg eon with some experience in desig ning spina l implant devices. Id. at 66:18-22, 67:12-19. Dr

. Antonsson testified that he qualifie s as a pe rson of ordina ry skill i n the ar

t under his def

inition. Id. at 67:9-11. Dr. Antonsson testified that in his opinion, claim 18 would be obvious to a person of ordinary skill i n the ar

t as of Nove mber 2000 ba sed on cla im 1. Tr. (8/25/10 PM) at 68:10-16. Dr. Antonsson explained that althoug h claim 1 does not spec ifically addre ss the ends of the coupling element or

the planes de fined by

them, a per son of ordinar y skill i n the ar

t would understand that bores have ends, i.e., they are not of infinite leng th, and that those ends a re define d by

planes. Id. at 69:22-71:16. Dr. Antonsson fur ther testified that the conventional wa y to make a bor e is to cre ate a hole with an axis perpendicula r to the plane that bounds it, as this enable s the bore to be fabr icated in a prec ise and c ontrolled manner

. Id. at 75:12-76:5. Dr. Antonsson expl ained that it is harde r to fabr icate a n oblique bore ope ning be cause , in such a circ umstance, the cutting tool is only cutting material for

a portion of its revolution, produc ing a less prec ise cut and possibly damag ing tools or lea

ving tool mar

ks. Id. at 76:8-17. Dr. Antonsson opined that a per son of ordinar y skill i n the ar

t would understand that the sta ndard a nd most obvious configur ation of a bor e is for its axis t o be per pendicular

to the plane that e nds it. Id. at 76:19-77:3. Dr. Antonsson testified that F igur e 7 of the ’460 Patent is an example of this conventional c onfig uration. Id. at 77:18-78:23. Dr. Antonsson also testified that Fig ure 7 captur es eve ry

element of

claim 18. Id. at 80:4-6.

21Dr. Antonsson testified that in his opinion, a person of ordinary skill i n the ar

t would not, based on c laim 1, cre ate a device with the config

uration shown in Def

endants’ E x hibit 9. Tr. (8/25/10 PM) at 83:8-16. Dr. Antonsson explained that the conf igur ation is Defe ndants’ Exhibi t 9 is not an obvious config uration bec ause ( a) it deviates from the c onvention of havingbores with axes perpendicula

r to their end pla

nes and ( b) it has a se at with excess, i.e., unnec essar y materia l on one side that, if re moved, would fa cilitate g reater a ng ulation of the scr ew in

acc ordanc e with the objec t of the invention. Id. at 83:17-85:15. Dr. Antonsson also testified that in his opinion, claim 1 would be obvious to a per son of ordinary skill i n the ar

t based on c laim 18. Tr. (8/25/10 AM) at 86:21-87:6. Dr. Antonsson opined that it would be obvious to use two bores ba sed on the languag e “a t least one bore ” in claim 18. Id. at 87:13-24. Dr. Antonsson further opine d that it would be obvious to a skilled artisan to make a two-bor ed devic e such that the axes of the bore s intersec t. Id. at 87:25-88:11. Dr. Antonsson explained that the base s for this opinion are the conventional a rra ng ement of bores ha ving ax es per

pendicular

to the surfa ces f

rom which they

extend and the desire to achieve incre ased a

ng ulation. Id. at 90:15-91:3. F. Finding Regarding the Leve l of Skill in t he Re levant Art The Court finds that as of November

2000, a per son with the ordinary level of skill in the art of spina l bone fixation devices would be a person who unde rstands both the medica l need f or such devic es and the mecha nical oper ation of such de vices, de veloped through a combination of profe ssional training and experienc e. The Court finds that the definitions of an ordina ry skilled artisan pr offe red by

Drs. F err ee a

nd Antonsson and substantially the same. The ref

ore, the Court finds that both Dr. F err ee a nd Dr. Antonsson ar e per sons of at lea st ordinary skill i n the re levant

22art a s of Novembe r 2000. 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 section 146 is “desc ribed a s a hy brid of an a

ppeal a nd a trial 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.” Abbott GMBH & Co. KG v. Y

eda Re search &Dev . Co, Ltd., 576 F. Supp. 2d 44, 49 (D.D .C. 2008) (citing 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. § 145; 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.

23III. CONCLUSIONS OF LAW

The sole leg al issue to be dec ided by the Court is whether the PTO err ed by improperly decla ringand re fusing to rede fine the sing le interfe renc e count. Stry ker’ s position i s that the Boa rd er red by failingto rede fine the inter fer ence count as two sepa rate counts—one for

the “interse cting axes” invention as desc ribed by claims 1, 24, and 38 of the ’460 Patent and a nother for the “ intersec ting plane s” invention descr ibed by claims 18 and 33 of the ’460 Patent. Stry ker claims that these inventions ar e pate ntably distinct and that the Boa

rd er red a s a matter of

law by decla ringan interf

ere nce ba sed on a sing le count conta ining both inventions. Stry ker thus asks this Court t o reve rse the B oard’ s decision and e ither re mand for f urther pr ocee dings or

rule on Stry ker’ s conting ent motions for summary judgme nt as to unpatentability and lac k of written specific ation or ena

bling disclosure

. Def

endants c laim that, based on the r ecor d befor e the 8 Boa rd and be fore this Court, S try ker c annot establish that its two proposed interf ere nce c ounts

are patentably

distinct and theref

ore D efe ndants are entitled to judgment. A. The Interfere nce Count and the Test for Patentable Distinctness 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, St ry ker must show that the inventions in proposed Counts 2 and 3

are patentably

distinct from eac h other. Two inve ntive claims are patentably distinct when one of Stry ker f iled two such motions: [ 32] Mot ion for Summary J udg ment Reg arding 8 Def endants’ F ailure to Comply with 35 U.S.C. § 112 and [ 33] Mot ion for Summary J udg ment Reg ardingUnpatenta

bility of De fenda

nts’ Claims Under 35 U.S.C. §§ 102 and 103. B eca use succe ss on these motions is contingent upon the r edef inition of the interfer ence count, the Court previously

denied these motions as premature

. See 684 F. Supp. 2d at 102. 24the claims anticipates or re nders obvious the other claim when c onsidered a s prior ar t. See E li Lill y &Co. v. Bd. of Rege nts of the Univ. of W ash. , 334 F.3d 1264, 1268 ( Fe d. Cir. 2003) (“Invention ‘A’ is the same patentable inv ention as invention ‘B ’ whe n invention ‘A’ is the same as (35 U.S.C. 102) or is obvious (35 U.S.C. 103) in view of inve ntion ‘B’ assuming inve ntion ‘B’ is prior art with re spect to invention ‘A.’ ” (citation omitted)); Eli Li lly & Co. v. Barr Labs., Inc. , 251 F.3d 955, 986 ( Fe d. Cir. 2001) (“Alater patent claim is not patentably distinct from an

ear lier pate nt claim if the later claim is obvious over, or a nticipated by , the ea

rlier c laim.”). Acc ording ly , Stry

ker must establish that the invention in proposed Count 2 is patentable ove r the invention in Count 3 as prior a rt, and vice versa . Eli Li lly &Co. v. Bd. of Rege nts , 334 F.3d at 1268. Whether a c laim is patentably distinct from another is a question of law that is re viewed de novo. In re DB C , 545 F.3d 1373, 1377 ( Fe d. Cir. 2008). The only disputed issue reg ardingpatentable distinctness is obvious ness—whethe r the “interse cting axes” invention is obvious over the “inter sectingplanes” invention as prior a rt, and vice ve rsa. “A patent may not be obtained . . . if the differ ence s betwee n the subject matter 9 soug ht to be patented a

nd the prior a

rt are such that the subjec t matter as a whole would have been obvious at the time the invention was made to a per son having ordinary skill i n the ar

t to which said subjec t matter per tains.” 35 U.S.C. § 103(a). T here are sever al basic f actua l inquiries associate d with determining whether an invention is obvious: (1) the scope and conte nt of prior art; (2) the diffe renc es betwe en the c laimed subject matter and the pr ior art; and ( 3) the leve l of

The pa rties have not argued, and the Boa rd did not find, that either of Stry ker’ s 9 proposed c ounts were invalid for anticipation. Anticipation defea ts patentability

and occ urs when e ach a

nd ever y claim limitation i s disclosed in a prior a rt ref ere nce, e ither explicitl y

or implicitl y . Voda v. Cordis Corp. , 536 F.3d 1311, 1323- 24 (F ed. Cir. 2008); see 35 U.S.C. § 102. 25ordinary

skill i n the per

tinent art. Baye r Schering Pharma AG v. Barr Labs., Inc. , 575 F.3d 1341, 1347 (F ed. Cir. 2009) (citingGraham v. J ohn Dee re Co. , 383 U.S. 1, 17-18 (1966))

. Where a ppropriate , a cour

t should also look to s econda ry fac tors that may

be re levant to the obviousness analy sis, such as commer cial succ ess, long felt but unsolved nee ds, and fa ilure of others. Graham , 383 U.S. at 17-18; see also KSR Int’l Co. v. Teleflex Inc. , 550 U.S. 398, 406-07 (2007) ( rea ffirming Graham ). “Obviousness is deter

mined from the va

ntag e point of a hy

pothetical per son having ordinary skill i n the ar

t to which the patent pe rtains.” In re Rouffet , 149 F.3d 1350, 1357 ( Fe d. Cir. 1998). This person skilled in the ar t is akin to the “rea sonable pe rson” use d as a r efe renc e in neg lige nce de terminations, and the pe rson is presumed to have knowledg e of a ll releva nt prior ar t ref ere nces. Id. Most, if not all, inventions are combinations of e lements from prior art. Id. A court may not rely on hindsight in order

to show that an invention is obvious; rather, it must show “re asons why

the skilled artisan, c onfronted w ith the same problems a s the inventor and with no knowledg e of the claimed invention, would sele ct the ele ments from the c ited prior ar t ref ere nces f or combination in the manne r cla imed.” 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 per sons of ordinar

y 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” test—should be made f

lexi bly , with an appr eciation for the role that common sense may play in the inventive proc ess. See KSR I nt’l , 550 U.S. at 407, 415, 420 (2007). “ A per son of ordinar y skill i s also a per son of ordinar y cre ativity , not an automaton.” Id. at 421. “The ultimate deter mination of whether

an invention would have been obvious is a leg al conc lusion based on

26underlying f indings of f

act.” In re DB C , 545 F.3d at 1377. B. The Obviousness of Stryke r’s Proposed Counts In conductingan obviousness ana ly sis, the Court considers all of the r eleva nt fac tors descr ibed above . The Court has he ard te stimony from two experts whom it finds to possess at least an or dinary

level of skill in the rele vant ar t. Neither of

these e x perts conside red a ny prior art other than the alter

native propose d interfe renc e counts, a s the test for patentable distinctness require s eac h proposed c ount to be considere d prior ar t to the other. The pa

rties have also not 1 0 prese nted any

evidenc e of se condar

y fac tors that are rele vant to the obviousness ana ly sis. Acc ording ly , the Court focuse s primarily on the level of

ordinary skill i n the ar

t and the differ ence s betwee n the proposed inter fer ence counts, as def ined by claims 1 and 18 of the ’460 Patent. Stry

ker a sks the Court to ag ree with Dr. F err ee’ s opinion testim ony that the intersec ting bores invention as de scribed by claim 1 would not be obvious to a per son skilled in the art based on the intersec ting plane s invention as descr ibed by claim 18 as prior

art. This testimony eff ectively amounts to a leg al conc lusion that claims 1 and 18 repr esent patentably distinct inventions. Howeve r, for the re asons explained below, the Court does not find Dr . Fe rre e’s testimony on this point to be per suasive. When asked to explain why he did not think it would be obvious for the skilled artisan to intuit t hat the invention desc ribed in cla im 1 could have inter sectingplanes, Dr . Fe rre e simply

Def endants a rgue that Stry

ker’ s failure to present e vidence reg ardingany other prior

art 1 0 is fatal to its claim. Howeve r, the Court finds that it is unnecessa ry to addre ss this arg ument beca use it conclude s that Stry ker’ s proposed c ounts are not pa tentably distinct without consideringother prior

art. 27testified that claim 1 foc uses only on the “inter

nal g eometry” of the coupling element a nd there fore it does not say

any thing a bout intersectingplanes. How ever , that testimony mere ly establishes that cla im 1 does not anticipate c laim 18; it does not do any thing to explain how the ordinary skilled artisan would have constructe d the “e x terna l ge ometry” of the coupling element based on c laim 1. Dr. F err ee f ocused his testimony

on Figure 2 of

the ’460 Patent, the only embodiment of cla im 1 that has what appe ar to be para llel planes. B ut when Dr . Fe rre e cr eate d a three -dimensional workingmodel based on F igur e 2, he c reated a model that did not provide f or any meaning ful degree of fa

vored a ng ulation, one of the obje cts of the invention. Dr . Fe rre e also testified that the ordina

ry skilled artisan would under stand from a CAD draw ing ba sed on F igur e 2 that it would be advanta g eous to remove excess materia l from one side of the lower end, which would result in an invention with intersec ting plane s. Moreove r, Dr. F err ee did not testify that Figure 2 w as the only

obvious embodiment of claim 1. To the c ontrary , he agree d that Figure 7, which conta ins intersectingplanes a nd all of the other

limit ations of claim 18, wa s also an obvious embodiment of claim 1. And Dr . Fe rre e agree d that the ordinar y skilled artisan would have unde rstood that the most common way for a bore to e nd would be in a plane perpe ndicular to the axis of the bore . There fore , Dr. F err ee’ s testimony supports the conc lusion that the ordinary skilled artisan re adingclaim 1 would have found it obvious to create an invention with intersec ting plane s. Simi larly , when a sked to explain why it would not be obvious for the skilled artisan to intuit t hat the invention desc ribed in cla im 18 could have bor es with intersec ting ax es, Dr. Fe rre e’s a nswer w as that cla im 18 does not say any thing a bout the internal struc ture of the bores. As noted above , howeve r, this testimony mere ly establishes that cla im 18 does not anticipate

28claim 1; it does not ex plain how the ordina ry skilled artisan would g o about construc ting the invention in claim 18 without int erse cting bores. Dr . Fe rre e testified that he was not convinc ed that it would be obvious to the skill ed ar tisan rea ding c laim 18 to use two intersec ting bor es, despite havingpreviously testified at his deposition that it would be obvious and de spite the fac t that the languag e of c laim 18 calls for “ at least one ” bore . Dr. F err ee f urther opine d that if two bores we re use d, it would be most obvious t o use two colinea r bore s of diffe rent sizes, but he later c oncede d that such an a rra ng ement would ac tually

qualify as a sing le bore for pur

poses of the ’460 Patent. The ref

ore, the Court does not find this testim ony persua sive. Dr. F err ee a lso explained that the seat is par t of the bore and that the or dinary skilled artisan would under stand that the normal wa

y to arra ng e the se at would be to have its ax is perpendic ular to the plane that ends it. And Dr. F err ee te stified that Figure 7 is an obvious e mbodiment of both claim 1 and claim 18. Ther efor e, Dr . Fe rre e’s testimony supports the conc lusion that it would be obvious for the ordinar

y skilled artisan re adingclaim 18 to cre ate a n invention with two bores with intersec ting ax es. Ba sed on Dr. F err ee’ s testimony alone, then, the Court concludes that as of Nove mber 2000, it would have bee n obvious for a pe rson of ordina ry skill i n the ar

t rea ding c laim 1 to

cre ate a n invention with all of the limit ations of claim 18. Similarly , the Court conclude s that as of Nove mber 2000, it would have been obvious for a per son of ordinar

y skill i n the ar

t rea ding claim 18 to cre ate a

n invention with all of the limit ations of claim 1. The ref ore, the Court conclude s that claim 1 is obvious in vi ew of claim 18, and c laim 18 is obvious i n view of c laim 1. Acc ording ly , the Court conclude s that Stry ker’ s proposed interf

ere nce Counts 2 and 3 do not repr esent patentably

distinct inventions, and therefor e the B oard did not er r by decla ring a sing le

29interfe renc e count or ref using to re define the interfe renc e count. The Court is able to re ach the se conc lusions without rely ing on the expert testimony of Dr. Antonsson. Howe ver, in the a lternative, the Court finds that Dr. Antonsson’s testimony supports the conc lusion that claims 1 and 18 do not describe patentably distinct inventions. Dr. Antonsson testified that the “c onventional way” for a bore to be drilled is perpe ndicular to the fac e fr om which it ext ends and tha t the ordinary

skilled artisan would under stand to this to be the

case . There fore , an ordina ry skilled artisan re adingclaim 1 would under stand that the normal way to end ea ch of the intersec ting bor es would be to c reate intersec ting plane s. Sim ilarly , an ordinary skilled artisan re adingclaim 18 would under stand the bore s would ext end perpe ndicularly

from the inter sectingplanes to cr eate intersec ting ax es. Dr. A ntonsson also explained that the ordinary skilled artisan would under stand that the embodiment in Fig ure 2—the only

embodiment with intersectingbores but not intersec ting ax es—does not ac hieve the object of the invention beca use it contains excess mater ial on the lower end that inhibits gre ater angulation of the scr ew, mea ning that the artisan would have motivation to makes the end pla nes nonpara llel, i.e., intersec ting. And like D r. F err ee, D r. Antonsson also testified that F igur e 7 is an obvious embodiment of both claim 1 and c laim 18. There fore , the Court conclude s that Dr. Antonsson’s testimony

provides an a lternative ba sis for holding that claims 1 and 18 do not descr ibe patenta

bly distinct inventions. Stry ker r elies primar ily

on Figure 2 in a sserting that the intersec ting ax es invention and the intersec ting plane s invention are patentably distinct. However , the test for patentable distinctness is not whether there exis ts some embodiment of the fir st invention that does not

cover the sec ond invention. Rather, the test is whethe r there is an obvious embodiment of the

30first invention that also cover s the second inve ntion. See Comc ast Cable Commc’ns Corp. v.

Finistar Corp. , 571 F. Supp. 2d 1137, 1145 (N.D . Cal. 2008) (“ A sing le obvious embodiment of a cla im is sufficient to invalidate the entire claim eve n if the cla im would also cover not- soobvious embodiments.”). Her e, both experts testified that Figure 7 of the ’460 Patent wa s an 1 1 obvious embodiment of both the intersec ting ax es invention and the inter sectingplanes invention. Stry

ker a rgues that this an improper te st beca use the foc us must be on the claims and not on the embodiments of those cla ims. To ill ustrate its position, S try ker pr oposes two hy pothetical cla ims, one descr ibing “ [a] clock with a dig ital rea dout” and the othe r desc ribing “[a] radio which re ceive s AM and F M stations,” such that a dig ital AM-FM c lock ra dio would be an embodiment of both of the se cla ims. See Pl.’s Response to Defs.’ Propose d Finding s of Fa ct & Conc lusions of L aw at 3. Stry ker a rgues that under

the appr oach f

avore d by Def endants, the digital c lock and the r adio ar e not patenta bly distinct inventions because the re is a sing le embodiment that encompa sses both. See id. Howeve r, Stry ker misconstrue s Defe ndants’ argument beca

use it omits t he most critical e lement of the a naly sis: obvious ness. I f it would be obvious to the ordinary

skilled artisan to cre ate a digital c lock ra dio based solely on either a digital c lock or a

radio (a highly suspect proposition), then the two inve ntions would not be patentably

distinct. See M

uniauction, Inc. v . Thomson Corp. , 532 F.3d 1318, 1328 n.4 (“[C] laims which are broad e noug h to rea d on obvious subject matter a re unpatentable e ven though the y

also rea d on nonobvious subject matter.” (citation omitted)). The case of Gould v. Stry ker a rgues that Comcast Cable is inapplicable be cause it involved an infring ement 1 1 dispute in which the asse rted patent claim was a lleg ed to be invalid for obviousness under 35 U.S.C. § 103. However , this is t he same standard of obviousness that is applied when deter mining whe ther two inventions ar e pate ntably distinct. See E li Li lly & Co. v. Bd. of Rege nts , 334 F.3d at 1268. 31Mossinghoff , 711 F.2d 396 ( D.C. Cir. 1983), cited by Stry ker, is distinguishable beca use it focuse d on the issue of c ollatera l estoppel and did not involve questions of obviousness. Stry ker a lso argues that the Court’s c onclusion improperly relies on hindsig ht beca

use there is nothing in claim 1 that tea ches or sug g ests that there would be interse cting planes, a nd there is nothing in claim 18 that tea ches or sug g ests that there would be interse cting bores. Howeve r, Stry

ker’ s relianc e on the “ teac hing or sug g estion” test is overly mecha nical. Common sense dictates that the ordinar y skilled artisan would have had to make at least an e ducate d g uess about how to compose the exterior of the c oupling e lement base d only on claim 1 and the inter ior of the c oupling e lement base d only on claim 18; the ar

tisan would not have be en at a complete loss as to how to do these things. The testimony in the rec ord showed that it would have bee n obvious to the artisan to try to use intersec ting plane s and interse cting axes in the same invention and that he w ould have ha d motivation to do s o in order to a chieve the object of the invention. There fore , the Court’s deter mination that the inventions are not pate ntably distinct is not based on hindsight, but rathe r on the re cord e vidence reg arding the level of

ordinary skill i n the ar

t. C. Summary of Conclusions and Judgme nt As explained above, the Court concludes that based on the e vidence in the rec ord of this § 146 proce eding , the “inter sectingaxes” invention and the “ intersec ting plane s” invention descr ibed in Stry

ker’ s proposed Counts 2 and 3 ar e not patenta bly distinct. Theref

ore, the Boa

rd did not err by

decla ringa sing le interfe renc e count e ncompassingboth inventions or denying Stry ker’ s motion t o rede fine the inter fer ence as two sepa rate counts. Be cause all of Stry ker’ s

rema ining c laims in thi s action ar e conting ent upon a r edef ined interfe renc e, the Court shall ente r judgme nt for De fenda

nts and dismiss t his action. An appr opriate O rder acc ompanies this

32Memorandum Opinion.

Date: November

15, 2010 /s/ COL L EEN KOL L AR-KOTEL L Y United States District J udg e

33