W.L. Gore & Associates, Inc. v. Medtronic, Inc. et al, No. 2:2010cv00441 - Document 189 (E.D. Va. 2012)

Court Description: OPINION AND ORDER - that the oral Rule 52(c) motions are DENIED. The Court finds in favor of Defendants and HOLDS that the accused manufacturing processes do not infringe claims 12, 16 or 19 of the '870 patent. Additionally, Medtronic's invalidity and unenforceability counterclaims are DISMISSED as moot. Signed by District Judge Mark S. Davis and filed on 6/18/12. (jcow, )

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FILED UNITED STATES DISTRICT EASTERN DISTRICT JUM 1 8 2012 COURT OF VIRGINIA CLERK U S. DISTRICT COUHT Norfolk Division W.L. GORE & ASSOCIATES, NORFOLK. VA INC., Plaintiff, Civil Action No. v. MEDTRONIC, INC., INC., 2:10cv441 MEDTRONIC USA, and MEDTRONIC VASCULAR, INC. , Defendants. OPINION AND I. INTRODUCTION The by patent Plaintiffs infringement W.L. Holdings, Medtronic, Gore Inc.,1 Inc., On Gore all January of its result parties of this agreed Complaint 2012, in to and in Motion longer a Complaint was shoes in this filed substitution. ECF to Third Plaintiff s 2012. ECF No. on Nos. the Gore for of case & 170. transferred Gore & a Associates, 15, Third 2012, Holdings, Holdings, and Amended is Complaint on no Amended reflecting filed be Inc. Inc." Inc., Supplemental 2012 a the will Holdings, Supplemental Medtronic As Supplemental Inc. Enterprise Amended dissolve infringement. of 15, Vascular to February Third defendants decision Enterprise a brought Enterprise Medtronic W.L. Enterprise and Gore Associates, Third was Holdings past on Gore February 124-1, a entry Gore Supplemental 182. to for rights, Gore and and of Court against Enterprise patent of Entry Thus, result sue to plaintiff for 169. party of "W.L. the ECF. to which the Consent A870 stipulate as Compl., the Inc., Inc., Gore right transfer to substituted stand the the "Gore"), USA as Holdings, the before Associates, Medtronic rights including & action (collectively 30, Enterprise Inc., 28, ORDER an this Answer February Inc., (collectively method of making a A five-day Opinion and of and merits Fact tubular bench Order The intraluminal trial was addresses determinations and Conclusions Procedure II. "Medtronic"). stent held and patent-in-suit in all 2012. motions Court's Findings constitutes the Law pursuant Federal Rule this suit to This remaining and of a graft. February resolves claims of Civil 52(a). BACKGROUND A. Procedural Background. On September Medtronic, No. 1995) The of alleging 5,810,870 Graft." (issued a tubular covering of than Talent graft. a *870 infringe to 1998), patent 12, Stent Joint stent Graft, 16, of and making Abstract. Graft, and 19 a the of the (filed tubular on graft 7, 1. a which Gore AUI June in having Stent ("JX") Exhibit Talent the Patent "Intraluminal intraluminal at against States polytetrafluoroethylene Stent methods United 5,810,870 adjustable Abdominal claims Gore's entitled No. 22, filed of "tubular expanded Abdominal directed Patent diametrically 0.10mm thick." Graft are claims Talent Gore patent"), September porus Medtronic's the A870 States on patent 2010, infringement ("the United *870 3, the form tubular is less alleges that components to Thoracic Stent patent, which intraluminal stent '870 Medtronic 2010, and on Medtronic's the moved April conducted a Inc., on hearing December See W.L. 2011 16, Gore U.S. February Gore's 3, v. the dismiss No. 372 the On to (1996), LEXIS v. issued granting October Markman and construing Assocs., Complaint Court and 40. pursuant 2011, 2012, Motion Assocs., v. issued the eight Medtronic Inc., on an Va. 2011). Court issued an Opinion Dismiss pursuant to Medtronic Medtronic's Rule Inc., U.S. Court and claim Supp. and Order See Dist. Order terms. 2d 667, Subsequently, inequitable 12(b)(6). 2012 amend Instruments, disputed F. denying to Opinion 778 19, this 2011, an (E.D. to leave Westview 143585 this opinion Gore 25, November on denying conduct W.L. Gore LEXIS 13611 on February & (E.D. 2012). The 2012. bench On concluded, advisement proceedings the & Dist. counterclaim Va. 370, dismiss 2011 to ECF U.S. 517 20, motion Complaint. to case. trial in February the and so Court ordered that it this 17, case 2012, took all preparation could commenced after final outstanding of carefully a arguments issues transcript consider the of 13, had under trial merits of B. Witnesses During the the at Trial five-day opportunity to against Lewis, Bench Trial Myers, Tr. are listed Joel grafts ¢ on the methods helped design Greenan Richard testified Tr. Mr. Park Gene to On ECF House, Tr. was offered the 175, at as number of James of J. whom called expert stent of David all also an manufacturing Dr. Dr. 226, Gore provided claim called No. patent. a the - the Thomas about product. as 98, were in Dr. stent grafts. The witnesses through with Medical testimony: who ¢ at who of parties first *870 submitted Treavor Mr. Gore Wayne the 288, Mr. ¢ Mr. at also deposition and Tr. and Plaintiff Transcript 146, all evidence.2 Medtronic, inventors Berry, trial, present infringement at bench former Talent - the at a a engineer stent graft. former design and World Tr. at Medtronic 283. employee development of the who Talent 284. - a Talent former Medtronic product's design employee and who testified development. Tr. at 285. ¢ Mr. Mark about ¢ Mr. the Spreeman the Pedro - FDA process Vargas - manufacturing a a Medtronic for the Medtronic of the import/export for also Gore process Dr. testified as relationship Last, Dr. to the between Jeffery Ace Stec, Tr. at market Gore Tr. Tr. and at 505, who device the device. competitive W.L. who device. employee Talent Baty, offered employee Talent Tr. 432, of as at offered The trial transcript is docketed at ECF Nos. 179, are in the format 181. "Tr." All references to followed by the page 4 the as the employee grafts Enterprise 178, and well about 286. Gore 2 180 286. testified stent Gore was a testified at by 175, trial number. who and the Holdings. Gore 176, as an 177, transcript expert later on the called expert in issue Dr. of Frank vascular damages. Veith, As Tr. surgery, at a rebuttal 1040, and endovascular witness, offered Gore him and procedures as an stent grafts. In Dr. response Gary to Loomis, devices and stents, Tr. grafts, Loomis fact on Talent Vice of stent damages has Last, Flores, a Dr. Kweli 1077, Vince and Medtronic for to as an as also Thomas was Tr. two Mexico for 930, the the endovascular market for Dr. the clinical use treatment of offered as aortic Medtronic's 1004. opportunity process his called in the Dr. as Medtronic competitive expert devices, offered Medtronic for medical well Medtronic's grafts the of grafts. Thompson, the offered intraluminal stents Additionally, Dr. area import/export testified vascular the the Tr. had of witnesses certain determinations to Medtronic non-infringement Roberto and Tr. and making Marketing who Zarins, testimony made as device. expert, Having Mr. in devices, of of case, expert obviousness. 906, of grafts aneurysms. the Tr. business Christopher of an such opinion testified Talent as for through President infringement methods issue device, therapies the the who and his witnesses employee 630, materials offered opinion Gore's to testifying credibility relating to observe the live the at demeanor trial, determinations, appropriate weight as to and the hear Court well as accord the testimony. Such determinations are set forth below where relevant. III. FINDINGS OF FACT The this Court's section, other findings but also determinations Fact of include documentary citations that appear are not or a meant Some of the inferences from the record set forth herein A. The As 1998 and fact and noted determinations are or of the based not Findings testimony thereof; are which in to exhaustive findings the David however, authority on the cited. law patent was issued D. Lewis, such the record inconsistent of or for All of Facts, ECF No. 150 Patent Application was filed was a on divisional Myers, as at inventors.3 10, No. June x870 J. Schwarz or proposed with those 7, f James 8. The 479,931 1995. application '870 at from f patent '931 of D. The Patent 22, House, Undisputed issued from application") 9. U.S. September Wayne Stipulation ("the Id. on '931 U.S. which application Application No. "931 application was assigned from the inventors to W.L. Gore on Gore assigned the be those rejected. above, names Karl August Many to '870 patent and claims and The limited citations conclusions are E. 3 below. combination to finding. not credibility with evidence of are any substantiated are findings fact December 25, '870 1, the 1999. patent to 1993. '870 PX W.L. Plaintiff's patent 608. Gore to Gore on Exhibit Gore Enterprise January {"PX") Enterprise 30, Holdings 2012. 607. Holdings W.L on reassigned 109,214 1993 ("the and patent" "the and of the from No. in U.S. parent the specification. The application") resulted or patent '214 Direct, independent 177. The in ECF. claim No 150 15. asserted No. f 10. at SI are August are 1. ("the Both contain ECF No. action on 5,735,892 at 635, Loomis claims filed patent Tr. this was Id_;_ parent asserted claims '870 patent. patent patent"). '892 Loomis which Claims methods '892 the the same 12, 16 16 and Tr. of and 645:13-17, making 12. A method a making a tubular adjustable at stent surface and openings having through a wall, stent, of a intraluminal having diametrically surface, a a luminal multiplicity of of the stent; being covering tubular, exterior covering tubular, covering tubular an tubular the said one and the wall b)affixing surface least the diametrically less having seam to luminal surface and a surface through to the an luminal of than making 0.10 adjustable exterior extending from surface exterior mm thick surface, the of and a exterior the tubular covering. 15. graft A method a tubular intraluminal comprising: a) selecting adjustable stent surface and openings through adjustable a stent at least having wall, the an and wall, having a one tubular, exterior having said diametrically surface, a tubular, collapsed a luminal multiplicity of diametrically diameter and an enlarged diameter wherein said enlarged diameter is at least 1.5 times the collapsed diameter, wherein said tubular, diametrically adjustable stent has been diametrically adjusted to the enlarged diameter; b)affixing a tubular covering to the tubular, diametrically adjustable stent; and ECF tubular comprising: a)selecting said of 19 19 depend intraluminal graft and are set out below: graft '870 177. claims Direct, 18, c) collapsing adjustable wherein stent the the to tubular exterior surface adjustable 16. diametrically collapsed covering A method 17. the according covering A of is method less is diameter affixed covering is of Patent, col. JX tubular, to claim than according tubular to the about to diametrically 15 wherein 0.10 claim following 10, the definitions "stent" cylindrical "wall" means applied means of to wherein said "a "multiplicity the disputed terms: forming a substantially cylindrical plane defined by stent;" of "opening" concluded structure;" substantially the PTFE. Court the eight "elongated members and rigid structure the 16 expanded hearing, Markman porous said mm thick. 1. After the the stent. tubular x870 tubular, about openings": more" and plain "covering" needed no ordinary meaning Court expressly to refused construction construction one to no means of skill limit the and and was in the was "two given or and ordinary meaning; and requires "multiplicity" given art. its its plain However, covering material the only to ePTFE; "affixing" needed and ordinary meaning. term "affixing" to luminal surface given of its Court expressly by construction and was the Court given refused to its plain limit the any particular method; "seam extending and was no However, from the plain exterior tubular surface covering" needed no and ordinary meaning. "has needed no meaning; been to limit diametrically construction and this through to construction However, adjusted was given phrase to to enlarged its the plain a the and seam the overlap; an refused the created diameter" ordinary "luminal Markman Inc. , Va. Opinion, 778 F. Supp. uses, an stent including occluded aneurysmal col both a W.L. 667, 2011 vessels, four of not vessel stent Gore & U.S. Assocs., Dist. v. LEXIS Medtronic 143585 (E.D. x870 described limited has to been 1. The embodiments at least patent has explains a number aortic of the one and of invention, covering with after "repair[ing] *870 each patent '870 the the the potential patency arteries." specification that of "maintain[ing] re-opened" particularly JX and the patent of which stent. has Id. at 4-8. In Example "tubular, surface, of 92, graft but 1:33-41, describes of 2d specification intraluminal col No. surface." Specification The at ECF "interior 2011). B. The a surface" means a openings covering exterior 1, patent in Example nitinol diametrically luminal surface through of shows 1 the ePTFE surfaces the a is of a and the wire stent, adjustable and wall a of wall, the subsequently stent. side-view Figure 4 of meeting stent and at the nitinol shows is affixed Id. a col having having stent" the to a limitations an multiplicity selected both 4:51-54. wire exterior and then luminal Figure stent cross-sectional and 1 of described view of Example and 1 where luminal a covering surfaces of has the been affixed to both the exterior stent. 49 45 FIG. I x870 patent, In meeting stent and the affixed is surface of a 4. nitinol wire an surface, exterior multiplicity selected the Figure & of a to example 2, 1 limitations having stent" an Example having 19. Figure 5 luminal of of the and the the "tubular, covering of only. patent with stent: Figure 5. 10 shows a ePTFE '870 a the and only a wall, of the subsequently at col. cross-sectional covering above), wall is patent 1 adjustable surface a FIG. 5 patent, luminal through surface invention Figure diametrically openings 51 '870 a (see of then *870 stent on the 6:15- view of luminal Example 3 commercially the an having a of exterior has an This exterior A ePTFE of the number in Example 3 Figure 6; at patent, through affixed to seam the commercially in the is depicted bottom also Def. is the stent and wall a of corner stent wall, the Figure available left meeting exterior in and stent" surface. 6 of Palmaz of a the the stent image) depicted below: Demonstrative Exhibit 1, ECF No. 186 14. Last, stent a openings selecting adjustable surface the 1 described luminal and of Palmaz diametrically a covering covering picture describes balloon-expandable surface, {showing '870 specification "tubular, multiplicity that patent. the available limitations having of (a Example wire stent) meeting adjustable and wall a wall, of exterior is the 4 describes first the given having an and having a surface of which the braided coating limitations stent stent" a a of exterior and a stent then only. 11 then given is "tubular, surface, multiplicity is stainless of a a wire braided into diametrically luminal openings ePTFE steel surface through covering on the the Thus, that the can be used requirements "having an having a specification of with the being exterior describes invention "tubular," surface, multiplicity various a of and types that would "diametrically luminal openings surface through of meet the adjustable," and the stents a wall, wall and of the stent."4 C. The Accused Products Gore the accuses Talent the methods Abdominal Stent of making Graft and two the Medtronic Talent products: Thoracic Stent Graft. The Talent endovascular Talent treatment Abdominal alleges that components (1) Abdominal or for treating 4 For type as wire 4,544,771," No. taught AUI can PCT serve two 19 stent of as the the graft stent *870 patent: (2) Talent graft. No. U.S. and Abdominal and primary The Either the graft used stent aneurysms. Pat. taught of the specifically Talent by formed US and Gore discloses: as 4,580,568," by 16 for aneurysms. specification taught "stents 12, aortic the made making ("AUI") approved sizes; of Iliac is aortic various Bifurcated abdominal example, braided as the has claims Aorto-Uni Graft abdominal method Abdominal Bifurcated Patent the Stent of Stent infringes Talent Palmaz Abdominal by wire "stents 92/03481." 3:49-55. 12 4,776,337," Wallsten as taught formed See "stents of x870 the "stents U.S. by of of Pat. No. Gianturco, U.S. Nitinol Patent at wire made 2:43-55; The Talent Thoracic thoracic aortic aneurysms. consists of Extension, The Distal the Talent the 4) Distal grafts Main for the Main, 2) process is the stent Proximal Distal for Main, having making all primary Gore and the 3) Proximal the Proximal offered Distal graft of the the treat various as serve to stent Either graft. Main approved Thoracic each same. can are Talent Extension; components Thoracic grafts The Proximal manufacturing stent the analysis 1) and accused Thoracic as a: stent sizes. Talent Main or component of an infringement Main collectively "Thoracic Main Component." Thus, in summary, Gore accuses three Talent manufacturing processes5: 1) Process for making the Talent Bifurcated 2) for making the Talent AUI below were Process The images demonstrative of the Court actual depicted slides displayed devices admitted at as relies. 13 Component Component trial taken and evidence from are and Plaintiff's representative upon which the 3) Process for making the Thoracic Main Component D. Accused Product Manufacturing Process The is manufacturing undisputed, Medtronic's Food and see manufacturing for stipulation Premarket Drug processes ECF Approval No. ("PMA") Administration process the involves accused 173, and Talent is submissions ("FDA"). eight products set to out the U.S. JX4-JX11. steps as set in The out in the protocols. 1) Talent Stent Graft Kitting The MI first 143, entitled process having Talent then takes the provides listed on at material, in operator is to the The the followed Talent place device MED0063877. Id. protocol Stent built. operator of is cut on Id. with then from a kitting 10. process This bill and of the to build include inspected, the by which software materials. necessary is This starts MED0063877. at components 14 JX program, required roll process computer gathers The manufacturing Kitting. a a materials MED0063878-79. which The "select," be the Graft Mexico. operator bill in Id. at components the the device. graft nitinol Z- shaped rings, components, and an the referred the support marker bands. appropriately will then be to as spring Id. labeled assigned to "springs," material, These bag The process described in MI stent graft components. 2) Graft Sizing, The is MI this second 135, the the (internal operator which operator cuts machine, into is tubular together the with edges of graft and inspected, as well other placed into container line. Id. same at which MED0063878- for all Talent as manufacturing in the material, the the areas chart on for hollow material sewn for the folds tube at and The using be a built. the graft material edges with together. following or to and location MED0063887. device In Id. sizing manually appropriate been JX 4. components determines then have process bag. either shape the of zip-lock spring a graft the then the sews the inventory forming material the all material, Cutting and Seaming. The operator sutures, of in from appropriate shape integrity tube. of provided the the takes operator at MED006388-97. into a followed material external) seaming, Id. protocol The or are stent Cutting and Seaming graft MED00638885. suture is the 145 the at MED0063874. entitled Graft Sizing, step, inspects Id. the or production 80. comprise components zip-lock a that this of material a seam where Id. process The is the diameter and length of the constructed Id^ 15 3) External The 137, Spring Suture - Talent Abdominal next only protocol applies entitled the MI 137 Thoracic graft protocol, into shaped to at graft any from the all Graft the first places material and rings bar"), spring," connected onto using connecting locking end of at MED0063912. The proper graft material spring placement. are exterior the the stent external operator then connecting bar integrity, Id. at bar graft of graft 16 Talent a to the component of at sewn tube, the tube. to the sews proceeding end. attached. external stitch graft wire then distal is Z- MED00637909. operator the two graft then orientation, diameter, a the sewing nitinol is spring to spring of graft inspects MED0063914-15. the comprised The the bare in Id. Id. for follow internal surface is not straight stiches. sewn. process positions is a The the Last, by exterior to MED0063911. which the springs springs then and MI does springs operator "double proximal ensure Stent process, Graft The located at to 5. graft double single Thoracic JX Stent are MED00637907-08. the Abdominal components a material Next, manufacturing The nitinol ("connecting the Suture. because Graft the as in Talent Talent covering. referred the Spring the Stent mandrel Id. to External manufacturing followed Stent Graft Id. Id. springs density, length, and 4) Internal Spring Suture The the next Talent entitled sewing Id. inside the graft the the is Id. The spring The of the first. Id. is then of and For the springs of to be are the then double sewn. Bifurcated material sewn and of tapered into is the placed the the double MED0063923-24. descending spring sewn component material, at in tube. springs spring Id. 138, graft inserted spring of involves which graft proximal material. of the the MI step straight and process is the upon Once within of number compressed graft This depending Id. is Grafts 6. and MED0063923. spring graft leg the graft will be order. the last Id. grafts, a tapered first, then sewn. spring Id. at is placed MED0063925. (the smaller spring of the tapered spring) is sewn The larger spring of the tapered spring is sewn Id. material to Stent interior type varies manufacturing JX the position single the the stub next. at released distal For inside Id. sewn remaining The spring appropriate is to assembling. material. the Suture. material is in Thoracic springs double compression The Spring internal the spring and MED0063923-29. grafts, in Internal operator graft followed Abdominal the at protocol After the placed of the double the tapered Bifurcated inside spring the is spring component graft then is placed and material. sewn. 17 Id. sewn, Id. within the the double The bare graft spring spring Below are images utilized in devices; these findings of what discussed was the of the different manufacturing images fact, are ECF No. process taken 186 for from at 14, springs the and and displayed during the three and accused Defendants are the discussed proposed representative of trial. WO Single Springs Double Spring Tapered Spring Double Spring 5) Stent Graft Edge The Talent next stent finishing. graft step 7. material called "end finished, ensure the and is The so the accused MI 140, operator that they operator end cuts can inspects IcL_ at is and form Id. of manufacturing the heats the at the configuration, label. method which configuration." proper length, in grafts JX Finish stent the edges material the shape, MED0063934-37. stent edge of appropriate constructed graft graft the When graft integrity, to graft MED0063938-39. 6) Marker Band Forming and Attachment The next protocol the Talent stent and Attachment. followed grafts is JX The 8. MI in the manufacturing 140, entitled operator cuts 18 Marker and process Band shapes of Forming radiopaque wires into figure-eight material. Id. inspects the stitching, Id. at at graft for material Talent next step stent Spring. nitinol wire the into proximal support at JX support finished, proper to finished, band and the position, knot the graft operator marker suture band integrity. the is 9. 143, The method entitled operator referred springs of accused MI to the operator spring Support Springs the springs end manufacturing Cutting cuts and and as "support of the Id. inspects the Z-shaped springs," graft at and material MED0063961. stent the Attaching shapes edge the graft of to device. integrity, When for proper integrity, and label. process material graft at the Talent MED0063965-66. 8) Talent Test The stent in grafts Support Id. When them MED0063955-56. The the sews integrity, 7) Cutting and Attaching sews and MED0063945-54. stent graft shapes final grafts Plan step is QI Grafts. JX procedures performed loading into 226, manufacturing entitled This on stent delivery the Talent protocol grafts in Mexico system and 19 for Stent inspection stent grafts. Id. QI shipped to Plan the the are Test of outlines completed completing facilities a Stent Grafts the After Talent manufacturing in 11. MED0170367-81. completed for a 226 from separate packaging. protocol, at the Medtronic's location for E. Import / Export Process In as submissions the to manufacturer, Minneapolis, MN. at having MED0058611; its "Manufacturing Medtronic listed locations in its PMA until Tr. at stent-grafts this in suit. 1. not Talent place ("PMA") at and in of 2006 CA, and Tijuana, in Submission, In Specification with Inc." business MED0019723. Vascular," Windsor present, by The what stent the listing Developer," manufacturing "Medtronic Mexico. Talent Medtronic Mexico," PMA 2006 during changed grafts are grafts PX at of the relevant time were 7 65, location the has stent Mexico. manufacturing changed However, completed PX70 "Medtronic at MED0019723. Mexico has Approval location PMA 2007 From and lists principal 2007, Rosa MED0058611-12; Vargas a "Medtronic manufacturing 2004 Medtronic Facilities both Santa manufactured FDA, Premarket PX69 with the is the into Talent periods location assembled Depo. where a in the delivery system. From 2004 until grafts were device delivery R. Flores shipped shipped to the system. PX Direct, via California. a R. April Tr. local 2008, United 134; PX 916-917. freight Flores completed States 765, for Depo. Specifically, company Direct, the Tr. 20 from insertion Vargas the Tijuana 916-917. Talent Once stent into Tr. at products to San the a 1; were Diego, product arrived in product next that same the for June remained shipped out 6 to into into States Talent Id. During delivery systems system, were sale grafts shipped and were use not in approved location Galway, graft sale for stent to had with and grafts Santa However, grafts for Talent States, system. stent delivery the United stent countries the the eventual 2008, the States the to December Talent United facility. into stent delivery the 2009, for UPS would send the States. into a CA delivery Talent United foreign January inserted the some the the States shipped so and Rosa, insertion with until period, United after the 2008 being in In the in insertion approval, were as FDA approval6, Santa United use time same period, the still for the stent-grafts or From CA, to countries sale were day of foreign Diego and had time Talent outside Rosa, during that received FDA delivery others systems were still sale. where system Ireland. the Talent began PX to 7 65, stent grafts transition Depo. from Vargas Tr. The entry codes that were used to ship these products for FDA purposes or San from Temporary 915. IFE Mexico is an sent to the will be entry shipped United that These Id. States. Id. that was IFE at 915. for Direct, for extra products is for Flores created TIB a Export product processing cannot be (IFE) Tr. 914- that but sold is then in the an entry used for products without first clearing customs. shipped with products at Import R. U.S. the be were (TIB). again; must the Bond only into that California States out shipped products warranty United United States. are to Importation will 916. 21 soon a be bond that shipped acts out as of a the at 1. Starting in Ireland inserts all systems in and use. through were Galway, PX the shipped date eventually Tr. at The 2; are the Kentucky the product is F. Contentions Medtronic's requirements of flown are flown to in the Medtronic components '870 to to to UPS in States before Depo. Vargas ECF No. products drives them Direct, Cologne, 179. from to the 908. Next, from Kentucky. Germany, Ireland the Tr. Louisville, Galway, grafts and Ireland. where Shannon, Id. Infringement proof theory with of respect the to case three patent: contends for given California. (non-invalidity-related) Gore's 2009 765, Flores Dublin, arriving PX and Ontario, related to Direct undermining are the R. January UPS. 908, up sale stent United Tr. Tijuana to moved eventually the delivery eventual Talent Ireland. are products then into Medtronic into From products MED0481742; flown 1. Ireland via picks in products the Ireland before on then at at Direct, truck DX091 the present, products' completed Galway, facility Airport. From (1) UPS Tr. routed to the Galway, once Flores Mexico California, 2009, until stent-grafts to all to and Talent prior trial, flown a 2009 Vargas first R. products focuses of are Specifically, Tijuana Depo. since being Medtronic Ireland from Mexico, they of completed 765, However, Mexico, August the that Talent 22 its process stent into of a bagging "kitting the bag," does not constitute Step A of (2) claims Medtronic steps as and contends of claims required the 12 by "selecting" 15 characteristics Medtronic steps contends are the required a. The construction b. The Talent extending luminal Additionally, claims the must named under defendants by if that sequentially "stent" A the is with not all formed step takes place; the Court finds in products the Talent's do not meet because: does "stent", the not meet the Court's and does exterior not contain a surface through portion of "seam to the surface." Medtronic fail a Step Talent's product from by even product of required shown sequentially process, Talent as performed "affixing" that claim language not because performed manufacturing has are patent and selected before the (3) Gore and the stent 15; that 12 a argues 35 did that U.S.C. not § a 271 (g) actually based "import" on the Plaintiff's the fact that product into the United States. G. Person of Ordinary Gore's person with of expert, ordinary respect to Skill Dr. skill the in the Art Berry, in the technical proposed art at field 23 the of that time the a of hypothetical the invention intraluminal stent graft '870 patent biomedical both engineering developing physician at making least making have three Berry also of physicians who experience of experience in Dr. and OR grafts 2) both in Tr. person scientists stents may and and a the Direct, this using be in and Berry that other making or experience noted with mechanical grafts; stent Dr. collaboration or stent Id. Medtronic's hypothetical intraluminal material to and stents. Court of Dr. 3) methods of a Dr. Berry's standard Dr. Loomis' and patent to ordinary both because 2) skill Court 24 1) a engineering, of in time of the devices, is finds a bit the proposed The more in intravascular ECF No. art. the vascular at Berry's of polymer suitable 639:2-9, a degree intravascular the it the materials Tr. in that field have: experience Dr. because the would and adopt at technical making Direct, art knowledge years' of proposed the chemical stents Loomis chooses for 3-5 in the science; and knowledge person skill or mammals; including The respect '870 or Loomis, ordinary graft design covering Dr. mechanical, chemistry device of with stent biomedical, of expert, person invention system stent years or in years grafts. in the or stent work grafts. 5 of 176. have degree least stents placement a stents No. also ECF AND at and endovascular 1) and with developing 298-97, would: Court 177. standard chooses rigorous required for than experience to be more directly patent. particular and on However, legal conclusions definition of relatively minor Gore and Medtronic in During judgment Rule 52(c) Dr. no the Court's the material issues factual the same were Loomis in graft adopted. effect on this findings even definitions of if the Thus, the propounded the analysis oral motions 52{c). Tr. by or this matter. Issues the on of stent remain differences conclusions the all and have Evidentiary with would Medtronic ultimate IV. point bench partial trial, both findings parties pursuant to made Rule for 1035. reads: If a party has been fully heard on an issue during a nonjury trial and the court finds against the party on that issue, the court may enter judgment against the party on a controlling with a close of Fed. R. law, the Pro. party has fully under Rule been 52(c), a or defeated issue. any the The judgment only court may, until the of heard a Inc., on district 231 partial 52 (a). Thus, matter credibility." on that render 52 (c). as judgment to required by Rule judgment Pharmacal, maintained on under evidence. A judgment on partial findings by findings of fact and conclusions enter resolve be that, supported law as Civ. defense finding decline of be or can favorable however, must claim Rule law 52 (c) on partial an issue." judge must Yamanouchi F.3d 1339, findings is 25 Id. "To weigh (Fed. after a judge findings the Pharm. 1343 made permits to once "a grant evidence Co. v. Cir. 2000). the JMOL court and Danbury has "A heard all the Civ. evidence Pro 52(c), bearing during with its Fed. to R. render evidence."). action is the crucial The to Civ. any render and motions reserve Pro. now a 52 (c), judgment ("The until concludes on court the that based V. law. fact." Fed. R. the may, best all INFRINGEMENT DISCUSSION AND A. Burden of Proof and Legal The step infringement is proper second step product or method. 1288 (Fed. Scientific the Court asserted, the each method Corp., however, the course the Abbott and and then 658 the the claim a of evidence, Rule 52 (c) OF LAW two-step the of v. 1347, properly (Fed. meaning construed to Inc., Cordis of the claims, claims Sandoz, 1354 and process relevant those also, scope Corp. the accused F.3d 1282, the v. Boston 2011) Cir. claims and the 566 first ("First patent are claims compared to device."). infringement, device. of see F.3d infringing every is Labs, 2009); the of Standards comparison determines prove or a Cir. allegedly To of is CONCLUSIONS analysis construction Accordingly, Court motions close the on the DENIED. are applicable Rule 52(c) judgment of 1991. of judgment Court testimony, to issue Notes terms discretion trial. decline the Advisory Committee Consistent exercised on a plaintiff element Uniloc USA, or its Inc. v. 26 must prove equivalent Microsoft in the the Corp., presence accused 632 F.3d 1292, 1301 Cir. 2011). a person must have claimed method." Lucent Techs, v. method 1317 of (Fed. claim, (Fed. fact Corp. and the F.3d Med. 1293, that v. Inc. this Scimed of 2005); 15 a but more likely v. Teva Pharms. (citing Inc., 261 Touch not USA, 1329, Cir. any such e.g., 424 v. Electro 1993). need Inc., Finisar Inc., must not have 418 1336 offer demonstrate occurred." F.3d Cardiovascular F.3d question Cir. (Fed. to 1301, See Inc. a the (Fed. Danek, instead Advanced a proving owner than is evidence. 1578 patent F.3d 1332 of Sofamor 1573, was Sys., the Carroll F.3d 580 of (citing 1323, the burden infringement, 2005) Life F.3d Id. infringe steps infringement Medtronic Cir. Inc., of Co. Cir. v. standard, "infringement (Fed. 523 owner bears (Fed. proof Inc., all Inc., evidence, preponderance Systems, Warner-Lambert 1341 a 1310 satisfy "definite" patent Prods, Mechanical To Group, by Gateway, substantial "[t]o practiced Furthermore, for DirecTV infringement Cross 2009). reviewed v. 2008), Cir. Specifically, 1326, Sys., Inc. (Fed. Cir. 2001)) . 1. Literal Literal asserted See S. 1384, Ct. infringement claims process. infringement Infringement covers Markman 134 v. L. requires exists the that any alleged Westview Ed. if 2d the 27 of infringer's Instr., 577 one 517 (1996). accused U.S. a product 370, However, method patent's 374, or 116 literal contain each limitation claim of will Sys. Inc. 1998); a based 1998). on Biosciences 2009) analysis Proof such may probative evidence quotes 1449, Inc., Inc., prove of may be fact of Cir. 1206, 1211 infringement F.3d 1363, by . . . may be See Martek 1372 any (Fed. method infringement sufficient Litton {Fed. evidence. 579 the F.3d infringement the from 1454 156 literal circumstantial Nutrinova, deviation infringement. F.3d LaGard, any any literal 140 v. is circumstantial internal of patentee ("A that v. of or Corp. exactly; Inc., Group direct claim finding Honeywell, Mas-Hamilton Cir. and asserted preclude v. (Fed. Cir. the . .") . . of and (citations omitted). 2. Doctrine of Equivalents Under that does patent the not claim ^equivalence' process doctrine and literally may the 339 that (quoting U.S. 605, "the Co. v. Graver product or or method substantially the the be Tank & Mfg. Such was way of of Davis between performs same found elements Hilton method upon elements (1950)). difference product infringe claimed 609 accused equivalents, nonetheless between Warner-Jenkinson (1997) of the to express infringe the Chem. v. terms if of is product or invention." U.S. Linde Air Prods. requires claimed a invention or the that same the a there 520 substantially 28 process Co., finding substantially or accused patented insubstantial with product the the Co. a "a 17, Co., showing and the the accused function same 21 result in as each claim AquaTex (Fed. limitation Indus., Cir. the infringer has Ltd., other which 234 (Fed. does Co. not of v. Cir. to as Calcar, Inc. under the 722, 1320, S. 1326 grant Consolidated Cir. Ct. 1831, of detail into a Indus., Kabushiki overruled 152 a L. Ed. patented would be the essential Kogyo 2000), its from differences Kinzoku accused where invention's imitation literal an infringement the (Fed. 122 permit patent two as the of an function (Fed. for Shoketsu 564 every tests doctrine result' 1338 the are element same F.3d method." to 2d on 944 invention convert hollow and useless Inc., 266 F.3d the thing." 1367, 1370 2001). the referred 479 or prevents insubstantial v. 558, "to equivalents retains Corp. U.S. copy White There under 535 or but F.3d Otherwise, protection Toro product Solutions, liability minor Festo grounds, (2002). an only See of avoiding invention identity. Co., patented Techniche doctrine from claimed v. the 2007). Thus, product Inc. of in an v. Cir. of commonly used equivalents. to The first "function-way-result" accused product substantially element American 2011) . doctrine of of the Honda The the test same way Motor second equivalents Co., way is infringement test and ^performs patented 29 analyze is "asks whether substantially to obtain invention." Inc., to often 651 prove to the the same American F.3d 1318, infringement show that the differences between infringing element Bioscience, Inc. (Fed. Cir. Corp., F.3d Proof experts or including of of the 1139 others and (Fed. 339 U.S. at the made F.3d Abraxis 1370, Hamilton "through technology; of course, Davis, a e.g., 467 v. corresponding 1382 Sundstrand 2004). 62 609). support the See Inc., be and Hilton to and Inc. Cir. in treatises; Tank, that Intern. versed art." explained (USA) equivalency may prior Graver Pharma Honeywell such element "insubstantial." Mayne 1131, texts claimed are v. 2006); 370 the The finding documents, the disclosures at 1520 Federal under of by by F.3d testimony (quoting Circuit the has doctrine of equivalents: [A] patentee testimony must and . . . linking 'insubstantiality of invention and the or respect with such evidence infringement evidence to is accused function, the be as differences' presented under must the particularized argument the claimed provide device way, to presented of on or result support doctrine to the between a the process, test when finding equivalents. of Such a limitation-by- Semiconductor Corp., limitation basis. Texas Instruments, 1558, 1567 1318, limited (Fed. not be Cir. 1338-39. It copyists applied v. Cypress 1996); see However, doctrine. unscrupulous Inc. so was and broadly the also American doctrine "designed to unanticipated that it 30 of Calcar, F.3d 651 F.3d equivalents protect "the is inventors equivalents" becomes 90 and second a from should prong of every infringement protection Deere & Co., doctrine the is on F.2d the basis, 383, be competitors Inc., patent to §§ has the U.S.C. direct 271 (a) covers In contrast, 7 However, 271(a) in submitted under the their to Court the Proposed of at Court of a or Fact or in its 1, ECF No. Third general Gore of 90 Gore 35 the not and U.S.C. 31 A. the 1567. 128, both infringement § 271{a). address of law infringement "Gore accuses 271(g)." 185. Thus, to this See or Section conclusions § 35 governing importation argued Complaint. Exhibit under U.S.C. stated: ECF No. the of F.3d at direct to only burden of statutes 35 did fact The Section 271(a) U.S. specific Amended 124, Hoffinger satisfaction the Court whether Gore intends argument under Section 271(a) since 1 language v. 2000). Inc., invention." 155, Inc. infringement instead at the evidence the two the under because limitation-by-limitation that and term on for findings infringement asserted Complaint notes the Cir. the is v. Further, upon Care, Instrs. Specifically, Findings unclear to infringement 271(g) Kinzenbaw claim rely extend (Fed. action patented proposed a Infringement under 271 (a), Section 271(g). Medtronic still "any Pool Texas 271(g), infringement.7 statute, to differences this and able 1416 to 1984). vitiate provide, test. brought Cir. testimony 3. Direct Gore to available claims[.]" (Fed. be 1408, particularized function-way-result the Zodiac F.3d of 389 should owner insubstantiality of used claims. 206 regularly scope never patent Indus., the 741 should potential of beyond charge, Gore it is waive its Section is Third Amend. sale of a "product United States." A U.S. others which U.S.C. 35 is § patent grants from making, made by a process offering "whoever without authority makes, sells any patented invention, "the right sale, for invention throughout the United States." Thus, in the 271(g). to the patentee using, patented or selling 35 U.S.C. uses, within the to exclude the § 154 (a) (1). offers to sell, or United or States imports into the United States any patented invention during the term of the patent therefor, infringes the patent." 35 U.S.C. § 271(a) . A claim for direct patent infringement under Section 271(a) requires, as an element of the claim, proof that the infringing activity took place in the United States. In Motion, added). Ltd., The 418 F.3d 1282, Patent Act of United States of America, U.S.C. § 100(c). 1952 sale, States. or defines Medtronic argues sell the Specifically, (Fed. Inc. v. Research Cir. 2005) United States as that not make or use the "the as they did not make, claimed methods Defendants patented States." 32 35 they did not directly argue "within" that methods use, the they directly infringe under the "make" or "use" prongs, did (emphasis its territories and possessions." infringe Gore's method claims, for 1313 NTP, "within offer United did not because they the United In analyzing the Defendant's contention, the first prong to consider is the "make" or "use" prong of 271 (a). "use" of a patented method or process from the use F.3d 1326, of a patented 1332 (Fed. system or Cir. 2002) between a claim to a product, are a tangible series of something, The items, acts and and or Federal Circuit Because a actions of in it by be section Inc. {emphasis the v. "make" fact that Mexico the and performed thus "within" However, under Section the the 271 (a) of of doing performed."). the hold United each sequence of performing used a each a of process of system the as a collectively, that States a as of the Ltd., 418 process required steps is country. in a Motion, finding of United must pursuant of Section products step Court the use are unless prong each or therefore this accused than the components Thus, "use" more of We Research or or of which consists consists out use 271 (a) added). carried 286 distinction all which [A process] unlike "within" performed within NTP, is the used process, comprised, doing This individually. cannot "the or apparatus, a be nothing is involves which to re Kollar, noted: is which recited. whole, not has to In (recognizing .... has fundamentally different device. device, claim steps process necessarily steps a therefore is The concept of of 271(a) are the direct at 1318 infringement under is largely patented F.3d precluded by the manufactured in process is not States. also to 33 consider the "sells" direct or infringement "offers to sell" prong. The question Federal Circuit's of method and "sells" whether "offers to commenting in indicated dicta Congress's directly infringed NTP, 418 open the question, but be infringed sell for the sale 271(a). 1335 to (Fed. method the to to does the found a prong of the unclear or Id. In claim 271 (a), despite the whether of to a a since "the a of summary, though the it noted difference and 34 § 271(a) could § again method the itself in under 550 F.3d 1325, sells or offers perform the patented 271 (a)). However, method of or offer sale sequence Federal "sells" never exists selling refers of sale of actions Circuit has never to sell" or "offers directly Therefore, between a must order infringement § above. claim seller or has left that to a be 271(a)." "process" a the infringe dicta a a though Inc., party under concept out method" direct patent that if then Computer that of process instructions the events, as Quanta (holding carrying Section "performance method the of Circuit that prong, v. agreed method issue Ltd. court ambiguous." clear under claims prong Federal the 271(a), history 'use' the infringe actual make open infringed method "sell" containing of that the left Section the not sequence be of the Ricoh, did opinion legislative actionable 2008) software "the In of be Co., Cir. Ricoch a to Ricoh sell 1320. performance the prongs under under could F.3d at can understanding only NTP claims sell" that 2005 final is addressed it remains selling the product that encompasses Computer, (" [A] Inc. or Apr. 25, forth the Medtronic in Last, patented 271(a) is in unclear in Section infringer (emphasis whether claims. The possibility "imports" prong of in L.L.C. Tex. put "offering to "selling evidence prong parties were IOM {S.D. *17 v. defendant no the other in to the products would during appear sold states have trial than agree, United infringement into term The "imports" to the intended Circuit method claim 271(a): 35 of the the similar a an the this "imports Congress that had as ^embodied' may be way non-infringement forth also during Federal (2008) actually only both 2117 same 57927, not for Quanta to the that States 2008. added). ways the 271(a), was products 271(a) invention many which of LEXIS was analyzing upon Talent put in e.g., 2109, WesternGeco under but See, Ct. nonetheless Dist. that, S. sold ."); U.S. Gore 128 be judgment December accused . claim, product. Inc., plaintiff method fact, that not . that Court conclusory beginning . summary the may 2012 appropriate). assist Elecs., {noting evidence making but methods Corp., themselves" the LG method 2012) perform" of product Geophysical the v. device, [final] been method patented article a a the this in prong of prong prong NTS could United patent." "sells" to again be can occur States 35 that apply left infringed any U.S.C. Section in if to § 271 (a) it is method open the under the Like the supra, sell the and infringed by to indicates prong The the that of However, the Federal left open NTP. of states that States or States a United product added). The while States, it the Zoltek a does NOT United claim.8 8 Zoltek States The appears example, Circuit to be in in dicta a by against is outside Corp. 271(a) of the as other v. the to United 36 the 2012) only does in 271(a) an States, by not in the Corp. clear through the of that a United product a process appear to or offer and method claims Circuit opinions. Corp., infringing a United (emphasis make importation Federal "if United infringement Saint-Gobain 271(a) 271(g) Zoltek patented the § patented to that the into Cir. seems patented statement but infringer.'" (Fed. issue against within process apparatus while under a an imports against or protect uses statement with that or 1322 court's line not the this stated patented process, as in Gemtron stated manufactured However, Earlier court 1309, that claims. the protect protect method issue. added). authority liable product "import" deciding made court's provisions the to sells, is F.3d may of method be 672 271(a) importation into shall States, without which to with closer by sell, sell broad does be one cited much 271 (a) made to apply that can difficult consider (emphasis came Section to a discussed claim history not to Zoltek, x[w]hoever offers United In products States v. at Circuit U.S.C. importation 271 (a) method offer did 1321 year, provisions a is and F.3d 418 35 sell decide Inc., "[t]itle sell Congress need not NTP, in to whether legislative section we of importation conceptually. respect offer question person the For Federal product is infringes if importation clearly protection does. infringement 271(a), is importation Thus, within have and the only is since final product "sale" or course law this is "performance" is for this Since a Court the only argued same to left open for sale" the does not States method to Federal unclear United of 271(g) has Court "offer prong the the avenue currently within Gore claims, relief also as consider 271(a). or States. that the under "sale" process provides for remaining the United concluded which unnecessary the or because 271(g), infringement infringement method Moreover, under it to to would claim, consider of 271 (a) the Circuit apply as under to it products appears method whether even infringement to claims, selling qualify appears for the as a the proper only under 271(g).9 4. Direct The under he the Court Section imports United frames and sold apparatus It since left 271(g). parties within consider uses, Mexico not United clear claim and not a 1371, did Section 271(g) issue to 1380 went infringe that sell, conclusions directed made of no law towards mention and put satisfying or to claim. of the forth the no 37 of Cir. Section at used, However, was claim under in that 271(a) claim 1380. their the an 271(a) proposed evidence or 271 (a) trial. at in 2009) imported, statute elements it conclude were Id. clear sells under they States. Id. at 1381. that the patented process infringement (Fed. on also appears Gore may have abandoned a they of reads: court dispute the offers F.3d Gemtron in did made or 572 The the court to Section 271(g) States." added). manufactured the Gemtron 9 now the product, (emphasis since is Infringement under argument Whoever States United without authority imports into the or offers to sell, sells, or uses within the States a product which is made by a process patented in the United States shall be liable infringer, if the importation, offer to sell, use of the product occurs during the term process patent. process retail sale remedy a will, (1) it (2) 35 U.S.C. be there which purposes of be is is materially is the patented infringed becomes a in 271(g) whether and (emphasis Medtronic or United States the U.S.C. 271(g) patentee must to United 35 Cir. of a § a of sale patented not be after by subsequent nonessential component can have a added). be said offered product States" Thus, to to have sell, which is thus and of infringement v. requires in that a can the two can an separate accused patent. Genentech, Thus, "271(g) patented be the relevant imported sold, made be by into or a used process found to have 271(g). establish claim Inc. 1996). product or title, inquiries. infringer or used a product made by a method or process America, or made changed trivial States Section scope use account by a for adequate sell, made this no on to so of granted noncommercial offer an or it § United "within infringement infringement use, as sale, or of such another product. question the is the for A product for for may unless other to processes; of title or considered of product this product. process action remedy account of importation that an no on under of In patent, infringement the United See Inc., 77 Nordisk 1364, requires importation process practiced established 38 . . . ." imported, a sold falling within the Novo F.3d First, of North 1367-68 (Fed. or sale abroad, Cardiac of the before Pacemakers, Inc. v. St. Jude Med., Inc., 576 F.3d 1348, 1369 (Fed. the process Cir. 2009). Second, infringes if the "materially U.S.C. § the patent, ("A will, for made after (1) by product is if the or (b) processes, 82 of F.3d the another 1568, Court between the the United not becomes "made (Fed. and the applies, between is the the being whether court must product of imported."). only a Lilly & offered Co. products the look the a Eli to the patent However, 39 82 no facts later Cyanamid requires or used in patented Inc., F.3d of Co., difference the changed' substantiality process required non-essential sold by place by Genetech, Lilly, "materially as "real sale, v. in exception produced Corp. 1996); This is is changed Am. so nonessential process v. be subsequent and or 35 process to by trivial the applies. exception for whether patented materially General Cir. a literally considered patented there 1560 determine be 1996). F.3d (Fed. a Cir. imported, by changed whether consider 271(g) trivial (a) Eli Bio-Technology ("To not "This is determine made a by" was product. process." 1553, title, the product States is materially product product then Section product"). 1571-73 to this it another of which is (2) of 271 (g) part of that must exception it or proves Court product purposes processes; because the changed" 271(g) component patentee at 80 1573 provision the and the are currently change product that before the Court that could support applying this "exception" to 271 (g) and no argument was made by Medtronic exception should be applied. the first Therefore, inquiry - whether Gore imported, sold or used a that has product they believed the Court must this focus on established that Medtronic made by a method or process falling within the scope of a claim in the patent. B. Step One - Term Construction Before under 271(g), devices scope the Court are of made one conducting the terms significant claim Court by the a bench take disputed issue first method or at trial, it process resolution on side terms trip before the have Court and if legal of that in to make construe the terms the process Court several could it key have appears factual findings, analyzing meaning a such the legal of that during its the of Talent within the to Although occurred specifically falls meaning these and sale Medtronic's clear infringement. could for the importation However, became and that to of decide issue. as order a the disagreed impact in at will claims construction hearing, must of the parties claim the looks Markman of Medtronic's it these method of manufacturing the three accused Talent products.10 10 With remaining Markman the exception disputed stage. It terms is of the could unclear to term have the not seek to have these term disputes earlier claim construction. 40 "rigid," been Court it appears addressed why the resolved during at parties the the the did Court's Under made to this the language first intrinsic of the and 979. in Words skill Phillips v. 2005) . a claim evidence the meaning ordinary of claim itself specification, accustomed step of in and other will of the art at Corp., 415 F.3d reference which includes issued claims, history. be view in AWH record, prosecution claim construction, given the the time 1303, of 52 F.3d ordinary specification to the 1316-1317 the the patent Markman, their is one or of invention. {Fed. Cir. "The inquiry into how a person of ordinary skill in the art understands a claim term provides an objective baseline from which to begin claim interpretation." Id_^ "Importantly, the person of ordinary skill in the art is deemed to read the claim term not the only in disputed patent, term any time for the import but 1225, (Fed. Cir. in context, limitations ColleqeNet, Am. Corp., of the particular the specification." proper claims." 1231 context appears, including specification at the Inc. 2005) 299 F.3d 1313, context Id^ however, from the v. this the entire examining the court will not specification ApplyYourself, (Fed. Cir. of "In (citing Teleflex, 1326 claim in which Inc., Inc. v. into the 418 F.3d Ficosa N. 2002)). 1. Comprising The first issue the Court addresses pertains to the meaning of the term "comprising" and whether the recited steps in claims 12 and 15 must be performed in sequential order. 41 Claims 12 and 15 both begin intraluminal with the graft phrase, comprising:", list the required steps. It is well "comprising" means that may be is the claim." Genentech, (Fed. Cir. L.P., 1997); 327 F.3d ^comprising' ended and method a are ApplyYourself, Inc., also Exerqen (Fed. is Cir. well are 2009) while by to Power both parties that 1409 agreed F.3d v. that steps."). 1225, Stores, ("The the including permits "does Cir. context, not but 2004). consistent the term the term or v. 2005); see 1312, 1319 'comprising' limited to.'"). elements not limitations that L.L.C. v. During trial, with open- Inc. F.3d not Mfq., elements additional remove Techs., 42 the 501 is of Cir. 575 the transition claim use (Fed. Inc., of Biocrest The 1235 which 495, CollegeNet, patent that, 112 2003) term elements scope unrecited F.3d Mosfet (Fed. the to JX 1. other excluded. mean it but Corp. indicates on language additional "comprising" present." 1396, claim tubular goes & 15, claim within Cir. a transitional Corp., (Fed. the claim, F.3d Chiron Wal-Mart ("In claim essential, Invitrogen 418 a in construct v. not v. understood However, required Corp. are additional suggests steps used 1368 for making the the also method allows "comprising" see that art form a Inc. 1364, in of elements still of "870 patent at claim 12 "term named method before established a added and "a this Siemens it case AG, 378 appeared law, the comprising claims allow the recited steps. additional Dr. steps Loomis Cross, to Tr. be added not limited unless the order." 1338, to performance claim Baldwin 1345 Inc. v. a Cir. (emphasis also method look to the claim the Altiris, Inc. 2003) (noting language to steps] must second the Though meaning patented of v. that determine be performed court Dr. the if, looks Berry term the as Id. Thus to "the never of or 1363, Cir. Court logic of the the the support for order. to or must and See 1369 look offered on is specific written" rest actually "comprising," a must order this there F.3d matter the (Fed. specification to 318 in 1342-43 Express, construction court a Gift F.3d order-specific whether first 512 prosecution decide Corp., specific or the Symantec of recited, a Inc./ specification steps order requires 1323, cases." method the Siebert, language, to In the steps rule the claim is Interactive F.3d narrower, some v. {citing 256 a steps Inc. "The require history limiting 2008) a general implicitly Sys., Inc., in the or added). claim prosecution 11 Graphic (Fed. history may of explicitly CompuServe 2001)) of as between at 818:25-819:7.u "[A]lthough a method claim necessarily recites the method in a particular order, in (Fed. "the Cir. claim grammar, and if not, [the then specification an opinion preamble on phrasing to the of the claim language, Gore's closing argument made clear that they did not dispute Dr. Loomis' opinion that "comprising" allowed additional steps to be performed in a method claim. 43 determine narrow this 12 case and performed the it the claim before covering "to patent, claim 12 see also, F.3d to implicitly & tubular, 15 requires nature of the claim suggests Step be of C performed tubular, covering also was claim such a added); Dr. Loomis the "antecedent basis" has maker stent to stent", in Step Envtl. in Direct, the plain written that plain Step "collapsing the the stent on requires "the the about 644 Tr. Servs., the to Tr. '870 that from implies *870 A. Direct, (holding states B. be adjustable nothing C to "affix" apparent Step of to Hudson similarly Step that A Additionally, referring (emphasis same is and C. in v. language Loomis 1998) steps 15 Step affixed the Dr. Corp. adjustable clearly just added); Cir. claim before Step "selected" otherwise"). diametrically diameter," just language in plain that instructs Envtl. (Fed. the language B the diametrically stent Mantech that implies (emphasis 1376 of finds Step the description must or clearly B. 1368, sequential meaning 15 the referring 642-643; Court Step clearly 152 directly construction"). In claim whether patent, (noting Step B the collapsed which claim Step C occur claim 12 C the 15 has after Step A and Step B). Thus, use the the term performed, Court finds "comprising," the steps that that although which allows are recited 44 both additional must still steps be and 15 to be performed sequentially, in the order claim 16 and 19 depend steps applies to those in which from they claim claims as 15, are claimed. the well. same Dr. Because sequencing Loomis Direct, of Tr. 645:6-17. 2. Step one of tubular, surface, of A a claims stage of the the process the Talent requirement Gore's term expert, the products in to 25. Dr. process intended took Talent "selecting" was at was enough Berry, claim of 12 stent, goes it method a "selected." on when to Dr. opine the through Medtronic a 45 the to the whether to make after list for the the program him to Talent devices in appropriate Tr. actual operator the specific final Direct, the computer the "selecting" important with that at was since, making Berry (emphasis necessary on of stent 15 15. was of multiplicity trial that characteristics the at and a least exterior construed satisfy explained language a to at an 12, not components whether device '870 the to went place ." bagging the analyze Berry . having dispute Dr. was . and having key physical characteristics . "selecting stent wall, Step A of claims addition read: a characteristics at order wall term of in both and a devices "selecting," physical look found 15 adjustable litigation, Medtronic's various and surface through Although Markman 12 diametrically luminal openings added). Selecting at 310:2- "selecting" "selects" and then the bags all at the components 324:20. Dr. Berry supported his opinion which instructs the operator required device" related work Protocol, Berry says stent of 10. in the the A870 literally Berry under doctrine selecting and particular device fully that formed the product inside kit is the following specific selected, stent or the various it 329:3-5; finds kit. at has those the of the at the same thing as the Medtronic instructions, at will into 335: 46 a if the a 15 does claim still met opinion, the you for select Berry a finished work order eventually particular, 1-19. Dr. and process Dr. as have DX88-DX90. components 333-34. components Id. Berry's Id. to bags, 12 is function Kitting that claim kitting Talent same in the "selected" to Dr. the into time has the of components limitation In the go according the equivalents. "select MI145 this Kitting that that device. device. is "selecting" according kit, bag all at to that a listed functionally because items id. Medtronic's progression characteristics argues kit the with process collecting stent in bag, Court of all the manufacturing constitute Dr. follow once Id^ this language, the them kitting patent. if to collect Thus, various Alternatively, not and Medtronic's with the then placing JX placed and order product, been the device. Protocol Kitting final necessary to actually build be a a stated stent placed built, specifically In contrast, Medtronic's Medtronic's kitting satisfy "selecting" '870 the patent. Dr. process this requires "physical covering opinion from to series parts of described agree Dr. in that performed Id. at to the A in any Dr. meet Id. and way, Loomis the at Id. is the and described in the Step is Loomis' formed Talent they B are such only a of a during the are ever connected stent as the manufacturing "stent" as used on cross, 47 Dr. in is formed. the Loomis described each graft of However, met of individual to method in be the process the attached by as Step A. Medtronic's never A covering is Because Step never a parties opinion occurring before a stent both is "stent" opinion, contains requires claim the However, formed Loomis's products. springs 15 because before Dr. requirements 662:3-12. process spring double argues and Loomis which merely earlier, the language Id. fully Dr. never the 12 In Thus to bag a B. double in stent" not of Dr. claim mentioned claims 15 the that does and affixed. contain As of be 12 650:10. that kitting not manufacturing manufacturing springs A. at opined products claims [the] to the does as 660:13-16. Step going Step Furthermore, in is language step Medtronic's affixed and before "selecting" B of Tr. of Loomis, Talent stating Loomis, Step the by Dr. its Direct, selection Step according for requirement Loomis supports expert, other material, could '870 never patent. conceded that Medtronic's manufacturing process begins computer and the and listing of process." Dr. agreed that they know going to how stent" step user limitations met the because is In at the Redirect, Markman the Medtronic functional limit it to a at make a specific Tr. these product] an his step affixing a is agreed the of the Id. language. at selecting all step stent word "making step. meets that before claim at that opinion arguments, the litigation, at ECF the in is is Id. No. an must 92 first construing the never formed, at 822; notes that the term argument from be "commercially (declining definition available 48 Court rejected stent 12, into commercially added happens chosen limitation Loomis since stent the Dr. that it for exactly how then, the also computer, size and specifically Op. Last, the what instructions a by and Loomis that 854:5-9. of the look explained in step at to before and Dr. selection on steps, "select allowed the 13-18. 832-833. Loomis A," 832: stent inserted stage Markman at actual additional Court that available." a not [to going the affixing considering "stent," Id. Dr. Step simply Loomis is user has must of Dr. be However, the which device allows Tr. user makes "select" could 819-822. Cross, parts. could process to the the components necessary to practice the the the "comprising" the Loomis to be and the one "the all before assemble that selects when a user goes device). of to "stent" This import or to in many ways relates to meaning of or fully the arguments "selecting" formed examines Phillips, provide claim 415 the claim 1314 guidance Vitronics, is Court must analysis. single guide to this and to F.3d "select" Usually, '870 patent for guidance, claims meaning 1582 (stating to is Technologies, premade of a disputed in the themselves particular that it "the claim is the term."). *870 patent, The in Step the Court found it helpful to consider Boston, Mass.) luminal of expanded PTFE film." See Looking to the specification of the "A Nitinol provided with both a the Court the dispositive; the four embodiments described in the patent. that, of relevant it meaning A of claim 12 and claim 15. states a the specification. "the the highly the the at word "selecting" only appears twice patent regarding disputed term, (noting as 90 always construction best the one language at substantial specification whether the meaning of F.3d terms"); and before stent. In determining first now wire stent In example 1, 10 the (Nitinol Medical of the type described by FIG. 1 was covering and an exterior covering *870 Patent col 4:51-54, JX1. Example 1 then explains that "This 3cm long stent was formed from 0.25mm diameter Nitinol hexagons." the word wire *870 at "formed" Nitinol wire is into 4:54-56. a tubular shape of The Court finds that the use of in conjunction with a description interlocking of how the shaped is essentially informing the reader that 49 either: 1) this particular Nitinol inventor himself in Example "pre-made" to "form" Nitinol stent, the stent tubular shape of Example 2 "Nitinol of at 6:15-16. to "form" 2. stent simply stent Johnson from its collapsed or that "0.07mm provided wire. the with fed into 8:10-13. a "make" the and of the the patent from wire scratch. 50 1 the N.J.) . . 4 heat into clear that stent of "A and 3 Palmaz & adjusted ." '870 at actually first states wire" is adhered to shorter lengths a stent. need not could the *870 specification one how Johnson steel into the a *870 Example was . of Example inventor wire of into PS30, stainless cut available 1." Example then language use stent: the is is the no. a Similarly, patent, 8.0mm that into description Warren, of choose Example the {part strand make Id. Example describes braids plain commercially stent type covering that "Nitinol for of himself. wire could available diameter single patent the in 2 Inc., again This machine Thus, or found 1 stent ePTFE 7-8. embodiments pre-made the diameter an at 4 used the inventor used a references incorporates Systems, outside forming ^870 type commercially Example making at a the the merely stent made/formed by hexagons." balloon-expandable Last, a 2 of shaping same Examples Interventional 7:6-9. and the wire unlike the by was even if the reader patent Example references of of Nitinol However, the himself *870 Thus, a or 2) interlocking the wire 1, stent and use a instead The question meaning to of in Examples it truly is a user as Loomis' 4, if until formed. the chooses a to user "selecting" scratch of the adjustable, multiplicity of openings, at prosecution trial, the indicates formed. open Court that The two history, the finds attributes listed premade, in Step A the art has the qualities addition dictionaries assist chooses the and court to the the in in the of the in claim are and Berry's a premade occur all once of the diametrically specification the claim to make treatises the must of with expert stent One listed stent also (tubular, nothing and 1) as can it is etc.). be opinions pre-made language skill available claims, from or scratch a in One already to leave of the art with stent 2) evidence or seem and offered intrinsic ordinary commercially in In that a Dr. that it making and the According "selecting" language, well "selected" possibilities: a that as specification "selects" skill claim 15. on from scratch, step claim required the of has simply means to Gore option from the and finished according the this this has make reviewed 12 is made qualities Having any, claims stent the to stent, in if definition, However, addition formed effect, used and 2 in what Dr. "selected" fully fully and 1, definition, or is "selecting" Medtronic not now the ordinary particular stent Step A. language "among determining 51 the and the the many meaning specification, tools of that can particular terminology Phillips, to to 415 or of F.3d at "carefully choose those 1318. choose pick Oxford as out skill the the best preference Dictionaries to another Pro Dictionary, Online Version definitions appear to "selecting" in "choice," on and whether of is the of "choice 12 with particular and 15 all of the qualities parts or satisfy the remains to "stent," with "selecting" necessary listed process or in method a stent of seen the a an See 2010), English These that is the term represents a not dependent the with as well as making that A step whether required of necessary formed" bag" particular that stent 12 items could and selected characteristics listed with the detailing the be 15. stent contains stent directions claims the already "kitting a Step to use create "selecting" be to others." simply requirement "to characteristics. choosing choice or www.oed.com. conclusion to make" or suitable" Oxford 2012), this characteristics Thus, "the invention." {April the claim satisfaction it the or and (March support A of or most www.english.oxforddictionaries.com, Step art The ordinary meaning of "select" is being in in enough to However, it constitute a in Step A. 3. Rigid In must determining consider construction of whether whether the term the infringement accused "stent." 52 As has devices occurred, meet mentioned the the above, Court Court's the Court defined stent cylindrical 92. At as and trial views as to noted that rigid it the became 582 F.3d correct construction derivative also a a non-claim term {Fed. claim in Techs. (Fed. Cir. still Trust has not LLC However, the in which a may J&L the derivative perform the Fiber the established do Cook elucidate v. differing v. necessitates to No. that cases court ECF Circuit words those 2012)(noting follows had 2009). a order 16, Lifesciences "in term, at Federal construe term substantially parties Cir. that a Op. The not Fiber 1373-74 the Edwards non-claim Advanced 1365, do noted of Markman "rigid." 1334 construction meaning." F.3d of has forming that claims. 1322, Circuit of courts the Federal construction clear meaning in members structure." ordinarily actually appear Inc., "elongated the claim's Servs., 674 construction claim of construction principles). Gore's art, expert, opined that construction, hold the which by it is Medtronic's definition used by the having open being in even implanted." expert, of Berry, "rigid" means device function Dr. rigid, Medtronic Dr. a as as one used "enough rigid Dr. shape that the Talent devices the and the not single are "the skill in Court's that Direct, though opined 53 in than Berry Loomis, ordinary rigidity cylindrical more of [the also blood Tr. and claim stent] can perform its vessel at giving the into 314:17-20. a specific double opposite of springs rigid, which is flexible." However, meaning on to be of rigid must state small Cross, Tr. consider whether at the Tr. Id. 669: agreed for state to 18-19. that the a delivery device." his and admit the any device collapsed Dr. Loomis the not of of the any the Dr. final of the and "stent" alone. Talent rigid. of Dr. spring the Loomis did springs Berry and the they must stent not devices Dr. in Talent that before that formed double rigid combination definition fully just covering 401:9-15. admitted Additionally, that own were Berry not to rigidity rigidity Dr. 396:19-24. at to Loomis would give and be did an not determine Cross, Tr. 844:2-7. Court finds that properly comports with skill the as in the art word cylindrical of the at enough extended at through, they met The of "flexible covering, their the the Tr. Loomis considered or to, on into on rigid. opinion be fully he seemed springs connected Dr. cross-examination, Cross, expert) become fit "rigidity" Berry single on including (Gore's to its Direct, 841:19-25. However, Dr. still from enough at analyzing Loomis cross-examination, collapsed device, Dr. ordinary and the well when in Berry's plain as it rigid." skill Dr. with defined As the Dr. art and a that Court's of "rigid" meaning ordinary the Berry 54 definition to intention stent as stated, it the stent more one and of use "substantially is clear graft to must one have enough flexibility to device while at the stent] be compressed down into more implanted." same time having "enough rigidity that rigid Dr. than the blood Berry Direct, Tr. construction a vessel into at 314:17-20. under the Court's . rigid," the Court does not agree with . delivery can hold the device open in a cylindrical shape and [remain] . the "stent" must be Dr. . which Thus, [the . it is although "substantially Loomis that this means the device must have little to no flexibility. 4. Another both .", 12 claim disputed 12 and although to that claim once first the Affixing the 15. the As spring Then, JX6 at a "locking stitch" 12 to single below are Plaintiff protocol; of the stitch spring on the taken a tubular differs placed essentially Dr. Berry shown in apex. the is essentially MI 55 138, at JX6 at trial is area"12 of in 343-344. from with images exhibits to . it attached representative refers . claim testimony graphic in the at of spring the and also The are from "apex Tr. B to covering holds demonstrative and springs. the trial and Id. the Direct, at covering undisputed into on Step slightly appeared "apex area" appears "Apex" zigzag it "affixing." stitch" comes from trial An image of the Suture is animation at corners language "locking MED0063923; experts, appear a was "affixing spring this according trial background, double and at begins: following attached with place. by 15 term a that displayed of the Internal Spring the vertex MED0063924. or manufacturing process described in the protocols "locking stitches" admitted as evidence. graft material double spring-> ;onnecting bar T single spring It is that only the body securely single spring is is of should initial, the to single the brought in before the Gore's and expert, when distinguish these later, more the spring to thorough the single the the of Berry, affixing that attach Specifically, Dr. the that are second is inserted; in place. that for begins, the stitches" from stage the or spring is opined "locking complete thoroughly spring springs initial 56 then body Dr. stitches covering. the all is are Subsequently, third determining the spring covering. repeated until trial, purposes Court of sutured process At these stitched thoroughly this after " stitch entire Berry body argued of that these initial covering, to hold the springs Dr. Berry, all Berry with the the are not really the "affixing" but rather they are just stitches begins. after stiches place Direct, respect first in to single Tr. the at listed in the true affixing According device, it in, comes after Step and A the that are "thrown on" 343-344. Talent spring characteristics until of has is stage to only a Dr. later, with formed, been stent that the true affixing stage begins as the body of each single spring is then thoroughly "affixed" to the covering. In these full the contrast, "initial body stiches, have Dr. a stitches" spring covering is the parties Medtronic's to the Direct, Dr. of Tr. Loomis has is openings, at was ever disagrees stitches that the of determining the offered do in by fact springs are opined spring there a from that with happened not disagrees and be as the later soon and no as initial because "stent" can the that both does not infringement. 660:13-21. should be distinguished from the for purposes Loomis, distinguished double spring double Dr. Loomis, the step multiplicity Though be Dr. "affixing" agree Loomis should stitches. sutured expert, l^ at 345:15-17. later first these full "affixing" Medtronic occur. that disputing Thus, secured 57 the "initial body spring element, that Court with stitches" an stitches no testimony these factually initial initial accepts stitch or "locking" stitch thoroughly In stitched to stage, Court its method plain No. 92. and finds at the time the Gore of and Dr. as the end the the stent secure of the covering. is suturing, "locking used in a The manufacturing spring is that at the limit "affixing" to any gave the 34, ECF stage, such use in a and a that never meaning be by_ adhered to it in and is will clear thoroughly the covering this case end. removing of that covering of art also agrees with will not process, the as stage begins But do mention in the lumen. beginning skill contemplates covering alone opinion "affixing" ordinary language, a at Loomis' "affixing" The Court way Op. Dr. ordinary the the a instead constitute "affixing" such protocols of plain claim actual has and Markman do Thus, stitches" process; itself single notes etc.), one the the affixing "locking the first to stitches." that for the not stitches invention. suitable initial Court heat, construed by in the stent be structure and of with Medtronic and initial Berry "affixing," the choose agrees the initial body ordinary meaning.13 The Court that term (suturing, and term would with 13 the full the covering. this particular that the construing Markman term before that secure to the through Because these be the initial The Court notes that at the Markman stage of litigation no arguments instead, process were the must made parties occur as to disputed (suturing, when the only by heat 58 affixing what adhesion, stage method glue, the etc.). began; affixing stitches after "locking stitches," used to that secure Gore's body hold the the the Court the springs single finds that the Court question of whether affixing stage has initial a begins addressed the or later is "locking must this the act the thoroughly held place, were not initial now before in does affixing "stent" they Thus, stage the in ultimately stent. spring the beginning of the be the the are whether place, affixing with will in sutures of that first Although begins regardless to instead constitute affixing covering argument of true initially as stitches Court begin rejects until the and the sutured, "locking stitches" stage. that the affixing stitches," be these the fully-formed affixing stage stage ultimate before is the complete opinion. 5. Seam Claim 12 (Step b) reads: affixing surface stent, B) of a the said tubular covering tubular, covering being to the diametrically less than exterior adjustable 0.10mm thick and said tubular covering having an exterior surface, a luminal surface and a seam extending from the exterior surface through to the luminal surface of the tubular covering. '870 patent contain Court the ruled through claim above the 12 "seam" phrase to the overlapping seam (emphasis Claim In Markman language. "seam luminal and added). gave extending surface" the 59 term its from was its the not 15 does not opinion, the exterior limited plain and surface to an ordinary meaning. At devices (depicted language. shown Gore's extending surface the the that the of forms extend luminal from the a from to surface. seam used by the defendants the by the proposed displayed accused the accused depicting was by contemplated created what the Berry tubular and Dr. at - the on claim process seam. and is These findings this on the of fact discussed the - Direct, as a micro surface 353:18-24. 60 of the at the The "seam luminal to see exterior at surface of level, device graphic of Dr. material that through image the surface 351:17-19. interface particle a the (interior) Tr. an to of ability on luminal seam meaning through as seam the Berry describe exterior surface covering" material Id. described exterior "passageway," the seam drawing the Dr. covering on a a the 80-81. covering. went the with at from stent stent Berry seam expert, of interface of is represent ECF No. whether of taken accurately is below) along were trial. now A photo below images and issue would to the below was taken from the demonstrative trial and depicts In Dr. Berry's overlapping the claim extends of the a one Id^ at because that the luminal from a 354: seam the patent they meet the ends creates demonstrative Dr. a the the 355. The Seam, but I through to V not exterior Interior V \ V 61 a at are an is no images displayed seam. to by of described of surface graphic surface folded according that example and type an would meet luminal gave there and passageway the this exterior exhibits Folds back on Itself | tube end; trial and depict a dead-end or "cuffed" ! «' - Plaintiff seam, language reason dead to Berry claim of device create language, from at by embodiments), through The claim Id. both the 18-21. the Talent 356:1-7. passageway surface. the not the surface at where meet the creates taken would not in because Id. as does used displayed "passageway" definition. both exterior covering. itself. is {as language seam seam seam which Berry's opinion, from the seam that Dr. exhibits back on "cuffed" Dr. Berry, interface through to below were Plaintiff at According used in faces or the away the claim the on from the tubular the demonstrative this of exterior Gore, is the and The that forms seam of The exhibits the of graphic the lumen of of or to by covering is the through the the interior forms luminal below was Plaintiff at the of covering, luminal the surface tip seam, as that which the image displayed surface, arterial Berry, part through the surface Dr. material, surface covering. side surface" is exterior touches to "exterior the the luminal according interface way depicts the the fold this and flow space. Thus, interior Therefore, blood surface seam is Berry language, from the flows. Talent the Dr. aneurysmal surface; blood to the while surface. a passage surface taken of from trial and description. y exterior surface Luminal surface is the interior surface, i.e., the part that forms the lumen through which blood flows Exterior surface is the part that faces away from the blood flow and touches the arterial surface or the aneurysmal space Dr. as it Berry would differentiate also have the explained been commonly his definition important used "dead 62 for end" of seam makes the or sense inventors "cuffed" seam to from a seam In that order make or to clear other time extends get the that a However, this a through sufficiently patent because extruded from (explaining tubes get a is the film, in the flat it from was '870 sheet they using a to a skill interface dissimilar inventors in between then feature sufficiently premade or two material." to thin extracted art, Dr. stated the the ^870 intact when 122-123, out of Thus, started so to or described with tube "seam" a graft thin with language necessitated of thin sheet a as 125 the is result material as of material. Dr. that either 63 for and the sheet tube. extruder" a the ePTFE real create a the extrude tube as tube Loomis a to expert, surfaces, the at produce Tr. to Gore, flat not to grafts seamless remain instead much vascular required seam") . wrap as Medtronic's the make a a Direct, exit needed extract did not surface. techniques to "trying have According design contrast, ordinary to was Lewis "to inventors creates they and could thinness. a In the as interior common would with split inevitable that the inventors Dr. thinness patent, really opposed to the technique the problem the commercial that tube machine. tend use of material a necessary necessary not the that they One covering the not machine seamless to thinness, graft-covering a thin exterior could tubes. creating material the desired user extracted for from of Direct, Loomis, "a seam the same Tr. at as one of just an material or is 665: 1-2; Dr. Berry Cross, Tr. interfacing of at 409:13-15 surfaces). (agreeing In Dr. that Loomis's a seam view, is the an claim language is not describing a "passageway" from the exterior side to the interior interface the of Id. not meet this that at that overlapping seam. examples seams overlapping In keep in mind the exterior the Court Court to nothing an testimony the an in the phrase language history surface that through his Cross, seam, that seam." the mandates to the overlap."). 64 a offer the and "seam an seam is an other than an Court must extending from surface." ordinary phrase the Op. meaning, was at Although not 39 extending surface' be the limited ("There specification, *seam luminal a any other experts, Markman claims, of is 19-25. of this it Loomis, 849: luminal plain Dr. not at both the example definition Tr. of to its hold of an exterior because to did construction through "overlapping the the An according meet the original creating opinion Id. Loomis would specifically prosecution exterior Dr. Loomis surface gave did solely its in describing touching, Loomis' Dr. evaluating or surfaces. Id. seam. Dr. definition, that that is seam used by the Talent products does in interior would meet language interfaced The definition the requiring be 667. two of and surface surface. of rather, surfaces interior interface side; or from created is the the by The Court of a first "seam," as finds agreed that the plain to by both experts "an interface between two surfaces, or dissimilar material." Dr. Berry Direct, an "interface" "seam," the of material). what through to the means and The Court phrase "passageway," most a surface surface, art 354:2-5. The micro of the the seam history '931 of the x870 Dr. to an Court examiner being anticipated by During the 65 patent for the claim a 39 piece inventors one at definition supported forming that from the to that explaining extends to tubular meet material Id. and the opinion meaning at the Markman also of would that "overlap," Khosravi, 1-2; from the through the Loomis' rejected rejection of invention. application initially the is 665: "extending Berry's level, with the patent. (the patent to of definition application responding this Dr. covering comports at defining seam interface device rejects already rejected by Berry's an an after surface Talent that is same material Tr. even phrase luminal the case, (also describing the seam as the particle time Court limits Dr. the properly at finds describes on exterior whether this Direct, However, is this effect 353:18-24 dispute definition. the at in either of the Loomis real covering" in Dr. surface exterior that Tr. and ordinary meaning a the luminal of skill 353:18-24, because it argument in was stage. by the prosecution litigation for '870 patent), (now claim of prior argued that 12) art. the the as In Khosravi was different because it used "tubes [that] do not have a seam extending through between their outer and inner surfaces." application added). prosecution Additionally, characterized their covering a luminal also "has JA-83 a through describes stent with extending added). the a patent the A '214 art of examiner's "New claims be (the claims but 72-88 delete Prosecution submitted all reference to surface through JX the a 72-88 "seam luminal and in 66 see "a applicants claim has JA-83 clearly a the history responding submitted . (emphasis the from . to new on . ." added). applicants the tubular a seam (sequentially) show extending of (emphasis limitation JA-181 [claim surface prosecution based seam surfaces"). the applicants of added); has In stent and which the the exterior exterior seamline surface 174-176. the "This patent). are inventors luminal material." History, claims deleted the the (emphasis material the {emphasis covering the parent 66 saying rejection, found rejections, of to of covering application the providing can by explaining: covering the Id. 39's by No. between exterior claim prior support again through that ECF response, seam its to tubular Application review stating method stating: allowed '214 a Further the claims the same covering." between through for the response differentiated 39] of JA-65, the invention's (again second in seam extending surfaces extending In history, '931 exterior covering." Thus, seam the the prosecution language inventors the to in require the a and applicants prior kind art of seam way for material that surfaces used is the in inventors a "through" surfaces going and the or Court the with finds that the and a or The argument not and was tube what and any that described exterior Talent from without seamless the patent differentiate was the "through inner" themselves the that for extended "passageway" seam between" way material that type a Berry's a applicants "in to of implies conclusion covering. Dr. explain The "outer tube dead-end claiming. seam 12 to cuffed, invention was as line claim the that language a the simply one of this This in was between disclosed language or claim only seam. the in luminal" themselves supports "seamline," covering material", "exterior history a of the the luminal seam does just the Court will that. C. Step Two Using now the analyze infringe - Infringemeni: Analysis terms and phrases whether the three claims 12, considering all Court it is finds the 16 and elements helpful just construed, separate 19 and to chart 67 of accused the limitations Talent 870' of devices patent. the the requirements: claims In the 68 1. Talent Thoracic Main Stent Graft Literal Infringement The Court elements: whether component as Court the at "elongated used language the above, a stent. "double Markman 12 and and then multiple and 16, and have an being the in as has exterior and a through thoracic also this stent covering wall with attached, attached. Gore's stent device expert, has Dr. a Berry "stent" opined as 69 inserted be section begins and the luminal the process as rigid "stent" surface, Medtronic are by defined the manufacturing springs "stent" Additionally, openings the a cylindrical 92. into important defined been requires of most have the inserted single No. 15 multiplicity of and "stent" ECF the devices language A of substantially discussed structure spring" a a at adjustable, As claim forming one Talent stage. Op. wall, the the claim diametrically of in considering accused Markman of a by the members structure." surface, begins that defined by the the individually Talent thoracic Court's claim construction claim and satisfies language. Dr. the Berry characteristics looked at the final listed stent in device determining whether a "stent" existed and admitted he was the covering advantage Cross, Tr. products of at the 397:8-10. had "elongated structures that the length of Dr. Berry also springs, also Id. the 313:5-7. a form 21. Dr. a and substantially the device is more at tubular, surface, looking stent holds rigid than at Tr. at the devices structure" the device the blood 315:20-22, at 318, final had had and a device, "two or vessel also an more" a "stacked found Tr. at the and thus form portion shape and implanted. device and a 318:21-24. that 313:19- members its surface found openings at metallic that trace lengthwise Id. which members they cylindrical into Berry 70 since was device." elongated the single bar"), the elongated exterior wall, Dr. the along 312:21-23. zigzag of because in at the structure." open Berry Tr. length these Talent "metallic "cross are Berry circumference (or that springs stated Dr. 314:9-20. Tr. single a Dr. of in "using final form to bar the structure" cylindrical rigid out the opined Berry the Direct, connecting "traversing stent." that addition cylindrical the Dr. Berry in Berry "substantially "substantially Id. member Additionally, of that spring in tracing Dr. the opined members" stent." double create Berry elongated, stated circumference to a are elongated at formed a the an Dr. to the all the the was luminal Last, Talent stent has a "multiplicity of openings" as Idof at 320-321 openings "two or analyzed, more" Dr. Medtronic's final whether Tr. fully to look consider and was selected spring, Court's a by the best were the single Id. at tapered claims. or two springs Dr. spring, had none), or the when and asked single that 1) correct the in 2) on a each language, Loomis (the double springs) met the characteristics Tr. his at 651:18-20. opinion elongated the to Dr. parts but multiplicity whether analysis order claim the Cross, definition double these members (at not and of cross-examination, springs, 71 in begin, elongated member Significantly, Loomis had determine Court's To Direct, limitations: one in single Loomis lacking had also Loomis process metal none explained spring the step. the and Dr. was to Dr. the listed Loomis 652:1-11. agreed with meeting individual "stent" not never analyzed devices "stent." affixing spring, of graft Dr. double the stent the though stent in contrast, manufacturing the of tapered Specifically, parts to this opinion, characteristics definition required Loomis' ever, none the Dr. if prior that of the the Loomis, stent to containing opined In Last, at 321. Talent only when, agreed definition the 850:1-4. Id. Dr. formed they met at was expert, openings). Berry "diametrically adjustable." the claim language. (noting the Court's construction of multiplicity was specifically required by the two openings. Dr. Berry spring, individually, the could meet Dr. the definition Berry Cross, explain that spring the by in itself the spring satisfied was a the spring Dr. the comes no other Loomis, the material words, in is fact a true required. Id. springs as to were form physical wired a Id. Thus, at single device Loomis 72 the been initial "affixing" once the single Dr. 662:8. Loomis the single of that by springs that the if double covering was to to Dr. the language; the are connected According connected to the the components agrees attached before if physically of had have constitute 662:10-16. connection or even claim and once then addition the double 10-16. at are to required the would formed not satisfy together that not if claim, 660: on the double definition there not. formed before that the springs Dr. not Id. are to the individual and the argued at went agree not with just way. enough did sutured. in" that Tr. could sequentially spring still formed is is in opined is "they're any not is is sutured double spring parties Court's listed Loomis and the they Loomis "stent" Loomis Direct, stent stent individually each a a under the double in because spring Dr. stated Dr. which Dr. Loomis claim, explained begins, to he since both stent, "stent" affixed of a language. Furthermore, under not and 387:13-15. characteristics infringement. suturing at opinion, is been the "stent" process claim had covering Tr. his "affixing" under of graft in other would the be single spring so affixed to that device, infringe 18. the it claim However, different would according process" were statement "The from Talent serpentine connected form not the added); Tr. as of at photos well to acknowledge to the to of as that the the the connecting bar." in a Thoracic actual the tubular also, by device individual Loomis showing a showing images pressed were Tr. in On the him which of a said: series of and structures (emphasis Dr. Loomis with arrows Dr. Loomis fact 828:14-15. s 73 "totally that MED0089269 itself, Cross, 663:7- Id. These (see springs a would configuration bar. at by FDA composed Device be opinion spring PX344A Gore at Medtronic. to connecting Id. would Loomis' double is process patent. by Dr. Graft the this submission stent." Dr. "870 used the length 827-828. and Loomis, questioned stacked the the one Stent full frame enlarged below) a Dr. Medtronic springs "stent" of the connected Thoracic by to than Gore a a language cross-examination, springs be "sutured However, Dr. Loomis disagreed and stated that instructions never discuss connecting bar to connecting bar" and connecting bar spring." In Court's the definition formed formed. the If to see truly be fully or whether the around spring is the with the and the sutured, passing held the would the formed it must be at whether underneath ever, see to a that if stent the a should stent is though the begins only ever the that to truly Court the thoroughly implanted the now determine before "affixing" fully formed before the final, is sutured the initial whether process the step in must steps Additionally, Court must the the is formed, with of look "affixing" are when one the to the manufacturing sequentially. secure least it under analyze determined components be exists, look only earlier "stent" should whether to a language Court or chooses was of claim performed step Thus, the if until covering stitches." begins. be device, it earlier "affixing" be to process that complete must "spring whether when, must also the is the Court mind claims the suture the the analysis Talent Court that connect only and manufacturing in way happens Court's fully keep that just questions process some the Id^ at 829:18-25. first the in "wrapping the manufacturing of the not such lumen, "locking a is "affixing" "stent" complete process First, assessing must the the a method consider final the fully Paymentech, ("Direct Court must agree of making an accused formed L.P., infringement F.3d requires Techs., ("A Inc. method [all Dr. the only a ever the whether of the the Tr. at 6 1378-79 party F.3d to On that although stent formed 387:16-17. stent Because Court cannot agree that final fully formed stent when before the the The component notes came process together process that in element Inc, considers components manufacturing or BMC Res., "affixing" Court individual Court begins although his form 498 whether protocols to v. Cir. or 2007) use the 75 or Dr. hand, and final Cir. one was in the the Next, Inc. each opining process, his claimed is he had F.3d at must before the never did understood device. method" to only method of 1378-79. "stent" Berry a Dr. determine proper analyzing to had products.14 must it as he hand; the he 1993) practicing Court of Joy cross-examination, graft infringed, stent graft. Res., by he components step making a not (Fed. manufacturing every the 775 only and to Court and perform 770, "each look the in itself (Fed. infringed accused fully graft, BMC method."). testify individual held Cross, Inc., patented to See that claimed method or product."); directly the appeared held Berry 14 of] is infringement never is Flakt, claim steps Berry v. Loomis process alone. 1373, and every step or element of a Dr. intralvmlnal manufacturing product 498 with be formed "affixing" held analyze how the the each process is of claim the complete. Specifically, exterior . . . clearly before ^870 the the accepts metal Step reads: the that (the are alone claims 12 and is not a & stage 15. such a tubular Because is to even begins. that spring, "stents" with Thus, since with be claim be of no infringement However, even if can the or formed Court single required by agree characteristics "the individual spring, the affixing stage begins before a "stent" therefore the the the stent to fully Furthermore, parties to language affixed characteristics both the sequentially. adjustable must none language covering the tapered the plain performed "stent" assertion "stent" the diametrically covering double 15. spring 12 that uncontested be "Affixing the finds earlier, step tubular, at "affixing" springs Step A, each patent Court the springs) B of implies stent," discussed requires surface ." As the double required by is formed and occur. Court had agreed with Gore and found that the "affixing" process does not begin until after the first single spring comes in, not formed with the construed definition substantially of the Court still finds that a "stent" is addition "stent" cylindrical and of is the spring. "elongated members rigid 15 single structure."15 The forming First, a the As background, in construing "stent" at the Markman stage, this Court made clear that because the claim language, the specification and the prosecution history made no mention of one particular function of a stent, the Court would not import a 76 Court agrees single spring "locking Dr. Gore is and inserted stitch," Berry were with the Direct, "metallic Dr. Tr. at the springs, single and spring structure or, traverse the "a the the length the fails Court Court for term members" find bar at and implies way to that into 14. the The "interconnected better encompassed embodiments. shown perforations the Id. is of all the and 15. from suitable (quoting metal and the wire, shape, size '870 a patent: quantity be Court term. proposed the perforated and of "elongated "stent" in again must the a here use The that form is the rejected found that member). It of the bar, members device.16 possible specification at made also of members construction wires" all {opining that elongated single Court of in a are allegation finds a double connecting structure." the out bar elongated Court springs The elongated infringement the zigzag 312-313 a satisfied. circumference an the rigid the form at the by tracing spring's also whether that the stent"). the Id. was First, limitation referenced stent stent. cylindrical some Op. definition double assess "structure" functional of the reasons. in trace cross must must two connected Markman of is connecting either point covering element the the the the (noting of and the at "elongated, length case spring's substantially that the the double Next, in that members" 312:21-23 structures" structures to "elongated across metallic that secured and circumference the Berry examples preferred "while sleeve may the having also be used"). 16 use This conclusion is of pieces "stent" must in connect further supported by the claim language's the to singular form a form, single 77 implying structure. any metallic Additionally, disagrees between from with the suture Loomis double looking connected Dr. at to that spring the the However, stage, thoroughly sutured initial double the locking be of performed performance 1368, cannot plain performed in of of the any Cir. claim "multiplicity of claim 15. 12 & multiplicity members are of that the through way 78 are agree the to the "structure" and the the See Mantech 152 F.3d because that the apparent steps steps simultaneous Services, [was] As from the not "be could they had to be added). have a that that a the springs finds (finding through such until springs requirement. stent Logically, the requires simultaneously," (emphasis openings" connected in Court language," or openings claims steps single simultaneously. Environmental claim claim order, requires that is to parties stent a them single the clear spring formed single formed is through the the 1998) the not Both the it single bar the of ever connects happen of and Hudson performed sequentially) the formation covering v. is connect language (Fed. nature meaning not each and of is springs; connecting members satisfy Corp. 1375-76 "sequential do the the that covering. sequentially, Environmental device bodies the the earlier, single connection the to Thus, affixing mentioned when connection the both this stiches spring. no spring's around "affixing" and Thoracic double loops covering. that single wall. stent the as to wall x870 can only if create "wall" the these with a patent, have a elongated openings. A second cylindrical Court reason and cannot rigid agree inserted and "rigid." As means device the the device that, earlier has in rigid than Berry Direct, cannot meet device have been asks the a are connected portion single springs have spring to over with single and it . is . . not the touching the yet into one "hold [remain] more The come it is the device rigid than Thoracic Dr. Talent double only the device a initial the the the the the accused device 79 becomes the middle single covering elongated cylindrical shape vessel which into eventually "rigid;" it is not until the affixing stage is complete.17 if the cause and to and the (since blood is the by clearly in Gore satisfies device) Thus, springs point could connected open the spring device the Thoracic single device collapse only place). more the covering to (since in to simply [remain] . At the is hold covering. the is can the covering yet implanted." Even the stitch cannot however, 17 fall of both stent] all whether "stent," Merely the until device "rigid" . is However, the implanted." . it that spring the [the and is single opinion, which definition to found the that shape into analyze middle members rigidity substantially stitch," this 314:17-20. Court for in "a be when "locking vessel this to point construed at finds cannot cylindrical blood stiches. a a affixed spring locking by the thoroughly requirements single at "enough a Tr. the Court structure" secured open the "rigid" at some Thus, point because "stent," as construed by the before a covering is "affixed," even definition of when the affixing the earlier "selecting," Court held Talent's satisfaction finding "stent" that before satisfying the the requires the this manufacturing process definition 15, selection on which of a was no although the contingent chosen the formed Since before on no the a stent affixing can also not be met. claim "stent," literal could constitute process formed formed alternative begins, begins. is not Gore's process element "selecting" element claim the of is Additionally, kitting bag affixing Court's process begins, Because the under process infringement of claim 12 can occur.18 Court Court, 16 and 19 depend, infringement of also claims 16 and 19 can also not be found.19 before the become rigid reasons the affixing before explained sequential formed before to preclude In looking acknowledges the Talent has an Direct, The the at that devices exterior Tr. Court at of complete, process Since the affixing the stage the the other concluded stent even begins, covering finds a on of is and the this the claim, less Talent devices are that fully be Court surface" than Tr. not same would the surface. MED0062966; be too "exterior is luminal PX314A at the the has that surface does (for the elements the clearly Court covering and it begins requires claim infringement. 347:18-22; also is affixing above). nature enough 18 process the of 0.10mm and Dr. at Berry 349:2-20. diametrically adjustable. Additionally, as construed earlier in the opinion, the Court finds the seam used on the Talent devices is a "seam extending from surface the 19 of the exterior tubular surface through The Court acknowledges collapsed the luminal that Medtronic did not contest the Talent device had "a collapsed diameter diameter wherein said enlarged diameter is at the to covering." diameter" and that 80 the that and an enlarged least 1.5 times device "ha[d] been Doctrine of Equivalents The Talent Court must equivalents. equivalents elements assess stent Thoracic now may still The is essential whether identical or the whether be found accused invention. Warner-Jenkinson U.S. the under the doctrine of the doctrine of product to each v. Hilton or process element of 40 The the that the element steps plain ever the initial process and "stent." begin or there application not of are multiple the even the the language; before was agreed assuming to claimed the of claim a first construction the double and single single "structure," since diametrically adjusted to the Direct, Transcript 361:10-16; Court acknowledges the was no no "stent" was the spring "affixing" revealed that there required begin double device was affixing was single the spring did not connection was First, process to by affixed. conclusion. to the 520 as covering this Co., above lacking meaning found the addition Court's found Chem. sequentially, layers stitch" parties after of claim existence "locking both ultimately performed the in Second, until Court were meaning selected However, the Davis contains (1997). 17, Co. of underlying inquiry equivalent infringement not did a not spring, accused form a between the enlarged diameter." Dr. Berry 364: 15-20. Additionally, the manufacturing protocol "collapsing the" Talent device "to about its when loading the Talent products into the 316B. 81 also provides for collapsed diameter" loading device. PX elongated members of not the Court's "rigid" until claim all thoroughly stitched. covering affixing "stent," before in with the (steps the all method groundwater must referred to *55 (N.D. written the the is Inc. 111. Jan. relies result of on a for to it in Androphy, 2000) step, 2000 {"If a already then the in B Step is 152 of at the a physically existence exist each LEXIS step Depuy 661, at claim as existence or method in of never 1375-76 step); Dist. a contaminated because in A, simply F.3d prior step and that order U.S. and necessitates region in inserted sequential Corp., performed was the Step in written device formation listed remediating device another "stent" application the been that Environmental 19, that had the language performed v. Third, simultaneously, affixed claim be revealed characteristics activity Orthopaedics, since claim stage. springs happen See Mantech in the Thus, covering satisfied. affixing construction until requirement the those physical constraints act as a condition precedent on that method step."). The between the Court must now ask whether the elements of Medtronic's claimed elements of the relies missing on existence element Step A is result the not test," in the of accused performed before the result Court must 82 process. in Step manufacturing Step B. is "equivalence" manufacturing patented the there Under consider process Since A, the process the whether and Step B essential is that "function-waythe accused process of creating simultaneously, substantially selecting covering. same making American Inc., 651 F.3d Court can and Pharma formed stent Inc. (Fed. whether v. the See e.g., the Court must keep in that limited by doctrine doctrine the "the would Techs., Inc. v. of Emtrack, an Inc., the the Co., that Inc. claimed v. Cir. the does not claim F.3d claim 12 and surface "of Mayne 2006). rule," 402 are doctrine elements entire the element (Fed. equivalents vitiate Motor between in first Alternatively, 1382 "all as affixing Honda Bioscience, mind the result" infringing Abraxis covering function before differences 1370, is same 2011). corresponding the same American Cir. F.3d applying of which apply if limitation." 1188, 1195 (Fed. 2005). As discussed covering is existence disputed Thus, in "selecting" Step the before this to A. B conclusion. through its B in exterior stent," "stent" Step Step the adjustable "selected" added) . earlier, affixed diametrically just fully 467 provides Cir. the Inc., equivalents the obtain (USA) However, Asyst affixing to 1338 the "insubstantial." way a 1318, and substantially Calcar, consider element stent "performs the and the clearly claim referred can occur; Even if "kitting 83 to in at bag 15 A has trial, process," to 12, Step Medtronic states the referring patent, "870 15 tubular, the Gore stent (emphasis to neither satisfied the be in party Step A's acknowledged that an additional step of "making that occur before Step B could be completed. of the steps claim is where a broken stent down, is in it stent" Thus, must be existence would have to when the language limited before to the sequential covering is affixed. The '870 patent's process, contains at least two separate product, and under the language as must occur in manufacturing affixing This of B - covering theory of element, 20 a in is "the to stent" equivalents is stent patent infringement of Step process accused stent occur process and the simultaneously. is not merely one requirements A entirely be of the fully formed eliminated. entirely be the the final Rather, which can a claim this in Court, elements. by would of this produce contrast, the by which patent formation '870 - the manufacturing method affixed no the the the new that of By covering of essentially Step the difference combination elements sequence. process, construed vitiate found.20 it before Because a of the a claim Warner-Jenkinson Co., Dr. Loomis agreed with this conclusion and opined that the doctrine reasons. of equivalents First, equivalent." does according lack a "stent" as language, and "if Dr. to defined by an element Loomis not work Dr. in this Loomis, the the Court and as is missing, then Direct, Tr. at case Talent for doctrine of equivalents. cross-examination, Dr. Berry Id. at agreed 672:7-9. 84 671:24. that two devices used in the claim you can't have an Second, Loomis opined that Medtronic's method of making the stent not done "substantially the same way" as would be required the is such particular a Additionally, choosing a Dr. was for on premade 520 U.S. of the allowed at 29 ("It doctrine, is important even as to such broad play as to an ensure that individual to effectively the application element, is eliminate that not element in its entirety."). In Circuit and Wooster affirmed held meet (Fed. Co. a where single June "[c]learly, 9, one sequentially, applications in infringing." Id.; that equivalent to of patent of called for bonding test. material, of 2000 U.S. of see the accused LEXIS The adhesive of process renders "finding a Calcar, signal from a from Medtronic's sequential occur them F.3d source of non- at sources' 1339 to be would it meaningless."). manufacturing requirement that sequential one plurality Talent 651 *12 noted two Inc, not 14132, cannot absence Am. device could court the also Federal distinct, material App. vitiate that claim limitation by rendering eliminates two accused the the non-infringement an bonding (unpublished) . thus, 'signals ¢Similarly, Co., finding the 2000) Operating court's application and (agreeing Newell application equivalents Cir. v. district applications only the a that sequential using Brush entirely and process cannot be stent and wrapping it with a covering was a "different way" of creating a stent graft than taking a series of springs and suturing Berry them Cross, frame Tr. at by frame under 407:13-15. 85 an already seamed cover. Dr. found to infringe under the equivalents test.21 Environmental which were Corp., 152 "performed not satisfy the F.3d in at any 1375-76 order, sequential nature of the The AUI component component in that Additionally, external some on the 21 as . to . burden that . invention respect to the presented doctrine of and and the and in that the added). stent, whether Medtronic's 22 no been fully Such Corp., AUI component and thus analysis. was the Dr. here, effect Dr. F.3d findings equivalence process or the patentee linking when must be 1558, 1567 made and such Court Berry part also of (Fed. were to ever stent equivalent to the covering does Direct, Berry's not Tr. 86 at consider on a v. Cir. 1996) Dr. Berry of law selecting made and as a to affixing performing the after a stent size of the infringement 301:21-23. the Inc. conclusions equivalent Dr. evidence under through the Court notes that the smallest not with presented the the the or Instruments, were forming argument between process, arguments of accused "[A] infringement fact of was and test of Texas arguments particularized differences' evidence 90 by formed. Additionally, no and considered.22 between result' the covering simultaneously was the steps sequentially, i.e., affixing has internal has process. device finding bag process" premade the basis." Though proposed "kitting be Main springs. infringement protocol testimony of accused a equivalents. Gore's of existed patented way, support Semiconductor (emphasis both demonstrating the 'function, to Thoracic double have spring" particularized limitation-by-limitation Cypress of 'insubstantiality claimed the "tapered" and need not "equivalence" process provide the analysis Stent Graft from purposes "external could ("AUI") components for steps the Court finds that Gore has failed to meet evidentiary must AUI However, infringement testimony the two (finding claim language). slightly has agreed the manufacturing is of Additionally, its it springs. both parties differs that simultaneously," or 2. Talent Abdominal Aorto-Uni See also Mantech that size analysis in its Loomis 2. Like double secured at Direct, the spring with Berry Tr. into "locking stiches." Dr. Berry Thoracic stent, a initial unlike inserted graphic image below by and is 23 Id. were Plaintiff device the next stitches. the AUI Direct, inserted locking displayed Dr. being However, is 670:14-16; stent, initial the AUI at Thoracic spring 368. Tr. taken during construction a seamed secured at to the trial and begins covering the 369:4-5. from at with and second Tr. double covering The a then Direct, with photo demonstrative are 330:1- and exhibits representative of and manufacturing process. graft material 23 At trial it was clarified that some Medtronic AUIs have only one interior Dr. Berry one double effect on component double Redirect, spring his has springs does spring Tr. or at not not (noting whether infringement one and 418 interior affect they two had opinion). double the Court's 87 interior that two double However, spring double whether or analysis. two the springs. AUIs springs whether interior had the had no AUI double Again, Gore's stated for double spring "a stent stent is with the is with only a expert, Berry Thoracic is and meeting locking that device does device. expert, not Dr. Loomis technically gave two double springs Loomis Cross, The AUI of Court process No of as could meet at for AUI Id. at stitch," construction at in of 369:9-12. and double opined reasons 671:1-2. to whether the second is a It secured springs are at 369:15-20. again same reasons the "locking Id. the same that as the However, the the Thoracic Dr. Loomis combination limitations of the AUI of claim. the Dr. 850:1-4. the not accused infringe the same substantial the Thoracic opinion does equivalents the Tr. finds component component. the Tr. for a comes of Loomis, Direct, no point claim spring the bodies Dr. infringe the openings [.]" thoroughly stitched to the covering. Medtronic's the with court's second double stitch that for at secured the multiplicity of after the opines, stent, inserted formed a Dr. literally reasons difference component component manufacturing and exists the that or process under the for the doctrine given for the between the manufacturing manufacturing would change Thoracic process the of Court's prior analysis. 3. Talent Abdominal Bifurcated Stent Graft The Main and Bifurcated AUI component components in differs that 88 the slightly graft from the splits and Thoracic has two legs, a longer Bifurcated However, agreed again, the Direct, Tr. and exhibits and components for a graphic displayed representative of not Dr. were be Berry by the protocol below image and infringement need 670:14-16; Additionally, internal of spring" and leg. both purposes analysis at shorter have "external infringement photo leg no taken Tr. from the during Bifurcated effect at device the parties on Dr. the Loomis 330:1-2. The demonstrative trial and of springs. both considered. Direct, Plaintiff external here, has some and are manufacturing process. graft material Like component the Thoracic construction inserted into "locking stiches." like AUI the a seamed Dr. component, and also the begins covering Berry a AUI with and Direct, second 89 stents, a then Tr. double the double secured at Bifurcated spring with 372:14-22. spring is being initial Next, inserted and is secured at 373:21-22. the to this for point a 373:2-6. is It secured the double Id. at patent. Dr. infringe the the The two opposed, with an springs double 180 are then Thus, infringed again opined same Loomis of that Dr. and the Court's component doctrine of Thoracic component. the does equivalents No at are at in and bodies of the covering. Medtronic's 19 of the for no double the substantial 90 Tr. springs Tr. manufacturing same with at opinion Loomis Cross, infringe device above Direct, gave accused not Bifurcated explained technically Dr. finds claim Ld_;_ the that and that bars other. that Dr. Id. spring comes opined 16 leg of Thoracic, stitched to 12, the Loomis limitations of the claim. Bifurcated Gore Id. ^870 374:22-23. two Court short the each stitch" Berry reasons device. from claims the The the connecting second double Dr. Loomis combination for springs' thoroughly 372:23-25; Dr. stitches. Again, meeting "locking Id_;_ at the stated degrees initial process for forms 13-17. formed is only after the Thoracic However, is spring at reasons locking stent with a multiplicity of openings. 373:20-22. bifurcated Id. same stent a initial second double the 374:2. diametrically with component. construction of 372-373; covering This Bifurcated Berry opine, at the as to to whether meet the 852:1-4. for the under the for the between the or given difference not 671:14-16. process literally reasons respect could at does manufacturing process manufacturing of process the of Bifurcated the Thoracic component component and exists the that would change the Court's prior analysis. 4. "Importation" under 35 U.S.C. In addition infringement, finds that based on at the argued as by least the "import" to portion that fact explained the Mexico. Medtronic Inc. control divisions the named since However, the is Section bringing 271(g) the Bristol-Myers Del. 1989); (S.D.N.Y. the 1994). also claims would fail did not actually as the Erbamont In of not the in the Tijuana, is of company and argued by whether "importer" or were subsidiary either one of under 271(g) Gore whether "importation" United v. a Court Mexico terms into Inc. be was the devices should specifically. their v. to that qualify have Pfizer Court located structure before Medtronic found Co. the Talent Mexico, exact "to goods accused appears have named Medtronic Mexico have the something can controlled Courts non- defendants Medtronic question defendants they by Mexico Medtronic, Thus, for trial, Plaintiff's named earlier, manufactured party. of at above into the United States. actually of given Medtronic a the product As reasons § 271(g) plain States Inc., Aceto Pfizer, the 91 723 Corp., "import" in ordinary and and meaning of from F. another Supp. 853 district F. court country." 1038, 1043 (D. Supp 104, 106 found that a foreign manufacturer was because sold it knowingly Inc., 853 court granted played Hong a not be See, e.g., not LEXIS 1081, *9 271 (g) to apply The Section 24 The v. at a the F. that an shipments behest 271(g). 130 Pfizer California holding the merely "importer." an 271(g) of entity of a 2d second 1152, which goods Cybiotronics, Supp. district from entity Ltd. 1174 v. (CD. the manufacturer "importer" Nippondenso Jan. to the of Mfg. 28, patented process. U.S.A., 1997) entity the patented the of 1997 U.S. (interpreting that actually Dist. Section imports the into the United States). Circuit 271(g) in Cybiotronics Smoothline may products to the Ltd., 111. only Federal of dismiss under the (N.D. patented product to Similarly, necessarily Air Section courts have agreed that the primary target rather Tec to under product 106. liable Elecs., but the "coordinating" Thus, is liable United States held 2001). 24 process, in the Source 271(g) at motion role to Golden of Supp some Kong could Cal. F. not has looked construing court its to the legislative meaning. The explained that history legislative "whatever role have played in the handling of shipments of United States, it did so at all times under the aegis of NAFT's supervision, and the products were at that time the 'property' of NAFT" and thus Smoothline could not be said to be the legal Cybiotronic/ s "Smoothline "importer" court went did in this under 271(g). on to state case could be Id^ at 1175. that even if said 'spirit' of the patent statute" and that "liability only by maintaining the 'fiction' (NAFT) acting as the 'importer' of record," that under actually 271 (g) imports liability into the may only attach United States. 92 Id. to violate The what the it was avoiding of another entity the fact remained to the at 1176. entity that history of the liability to a foreign statute makes specifically reach manufacturer's history of 271(g) The the the L. that 271 (g) the product. of 35 new was to injunction in Federal authorization, States, or made imports their 27 (1987). the district for § 271 (g) to for the was legislative district or the courts to of court of on in the remedy S. adjudicate based the the was a No. was an product 100-83 at to authorize impose and liability United practice States, those available seek in Rep. of "patent and overseas products of 1988, explained States 271 (g) of when someone, the United sells United § part provide damages uses into patented Previously, U.S.C. sue purpose infringement importation intended importer or seller of analyzing patented process." The processes In intended right without by the actual Congress Trade and Competitiveness Act 100-418, 102 Stat. 1107. It was No. § owners that Federal Circuit stated: enactment Omnibus Pub. clear only of upon processes. by exclusion action under the Tariff Act. Kinik Co. 25 The v. ITC, Pfizer history and district The the House commentary United has sale up no courts a or 2004)." the legislative H.R. Rep. . term in Senator may patent against not in the to on S. 100th . . Cong., only product of a within 1st if occurs the in the such process patent." on floor Lautenberg the a foreign United 93 of or its New Jersey "While the patent seller of Patent Before bill in the that would the U.S. foreign Amendments the of thus: manufacturer States, Process 568 the legislation enforce importer product." Hearing the 60, use sale is made of the the act of reach owner offending through the replete remarks Frank purpose are subsequent No. the 1987 "the made exists accompanying of its during presence 1987: product of manufacturer's of to that use the courts allow looked reports or Senate, U.S. Cir. Act Moreover, 13. summed a patent "Liability States at of States." 6. United Senate Amendments process importation, the (Fed. also specifying importation Sess. Id. and Patents protected the court 1362 stated: Process with 362 F.3d 1359, Subcomm. Act on Since the Medtronic question be Mexico or Medtronic claims, the 1373, is patented Mexico. indeed liability."26 one perform one To show Patents, on Pfizer 71 853 F. v. Supp and at such the an steps 498 cannot out F.3d avoid steps cases, or patent the L.P., of the a party It would be situations actions of method. 532 agency Qwest 1st F.3d to escape Id. the Sess. 21 to at 1379; (Fed. 1318 steps Communs. of another Cir. relationship the Trademarks 100th Cong., all infringement. perform LLC Copyrights the found to method party those the Corp., to the Judiciary, Inc., of "control," Sys., case, vicarious liability can arise directs such Data In in Thus, Thomas or Pavmentech, "A for direct steps patent contracting mastermind more v. v. entity. or they party performs by obligation contractual Centillion simply controls Inc. a 2007). at 1381. or process Cir. the Id. party Muiauction, 2008). for because Inc. liable this that "controlled" another in control would be in clear liable Res., however, to importer makes can be occurs when (Fed. Court the named defendants "For BMC process the actual jointly process." infringement, when the infringement 1378-79 unfair before is whether one of vicariously owned of evidence must Int'l, Senate or other exist. 631 F.3d Comm. (1987). 106. Under 271(b) and (c), a party can be held liable for indirect infringement by contributing to a third party's infringement or by actively inducing a third party to infringe. However, Gore's complaint does not assert claims of indirect infringement against Medtronic. 94 1279, 1287 (Fed. Cir. "'control or step attributable is direction' mastermind."' that 2011) . over to Furthermore, the the Muniauction, entire one process controlling Inc., 532 must F.3d such party, at that each i.e., 'the (noting 1329 "mere arms-length cooperation" will not give exercise also rise to direct infringement by any party).27 Thus, the admitted at (Medtronic be said Inc., have that that no the in law to step vicarious witnesses, of named every made assist consider, one by of the in their proposed in attributing or of Inc.) be said The and to Court arguments closing, fact can Medtronic claims. "control" findings USA can evidence defendants directed themselves opening the named or asserted or on Medtronic controlled liability the Court the or defendants Gore based of Vascular, sufficiently specifically or now whether Medtronic to performed notes must trial, such Mexico have Court were through conclusions liability to the named defendants. 27 The Court notes that the Federal Circuit has not yet analyzed joint infringement or vicarious liability in connection with infringement under 271(g). However, some courts have implied that the "direct or control" standard is inappropriate in a Section 271(g) case as the statue focuses on the importer of the products and not on the manufacturer of the products. See e.g., Flexsys Am. LP v. Kumho Tire U.S.A., Inc., 726 F. Supp. 2d 778, 799 (N.D. Ohio 2010) (noting that it is irrelevant under 271(g) who manufactured the goods so long as they were manufactured using a patented process). 95 The Court admitted First, at the is left trial Court to can support notes that documents have "Medtronic corner each page. also of begin devices by MED0063919; JX4 JX7 each by at of at the evidence theory. in most the of protocol bottom the to all Mexico at Tijuana, JX 5 JX9 at at left protocols applies Medtronic MED0063931; the liability stamped document of manufacturing However, MED0063883; any vicarious Vascular" "This manufactured whether a JX4-JX11. stating Facilities." decide Talent MED0063903; MED0063959; graft Mexico JX 6 JX10 at at MED0063875. Second, submitted that the main in to B.C.. MED0019723. listed as Medtronic of the the and PMA the 2006, PX69 actual Mexico ColiTrac Delivery PMA 2007 at in products Vascular Medtronic at the PMA listed as PMA 2006 moved System the at MED0019780. 96 is takes while FL, PMA Medtronic to two Santa in PX70 Medtronic Vascular and PMA 2007 Mexico Stent at have Graft Mexico Santa at Inc. Facility Medtronic FL, at in 2007, Thoracic Sunrise, clear facility Medtronic to made place MED0058611-12; Talent documents facility submission, and Sunrise, from it "Manufacturing Vascular from {"PMA") Mexico MED0058703; "Manufacturer" are Vascular facility Talent the Approval Vascular, Medtronic 2) Medtronic "Medtronic in 2002." Medtronic Developers."28 manufacturing the 1) Premarket by Specifically, MED0019723. 28 FDA California Specific Modular manufacturing Tijuana, and the facilities: Rosa, is the Rosa, and CA separate "Establishment in "Production the Flow" Medtronic makes clear Medtronic and being a Inc." division Medtronic approved to the PMA maintained defines goes between the endovascular at Medtronic stent of stent specifications to raw from to the specifications been grafts 2) are "All qualified material state Mexico Medtronic of also MED0058703. facility Stent that graft" and is and product in this Mexico FDA Vascular 97 made Changes Id. Vascular and through the design instructions for by the .... without by grafts changes prior initiated or Medtronic stent No and Any processes approved Medtronic be also controls manufacturing and see manufacturing. by 3) of submission detailed suppliers will that Medtronic for is Vascular added); Vascular contract manufacturing the material and at Medtronic raw Vascular;" Mexico quality between reviewed specifications "a (emphasis graft first 2006 "a and provides stent division Medtronic as for Id. Medtronic a manufacturing that "Medtronic and is submission, at MED0058704. described 1) However, PMA Abdominal graft relationship is statements: have to grafts." The Mexico Vascular;" Id. Medtronic various changes on of described stent the PMA Talent Id. Vascular Inc. responsibilities MED0058706. the is the "all of mention Medtronic are performed." The section no Mexico where Numbers." "Medtronic makes manufacture facility processes that of Instead, Registration to approval Medtronic Mexico that affect Medtronic Vascular Medtronic Vascular and vice-versa, that affect Medtronic Medtronic Mexico.29 MED0058712 (making Mexico control process and for the Occluder System" operates under (Brooklyn Park, under states that 114911 contracted 124, made 29 is with UPS Vascular clear for types by id. at manufacturing of "Medtronic Cardiac Medtronic Program" the stent Stent graft is the Mexico Surgery Inc." section, Grafts, Inter-Company under Id. the PMA subassembly qualified Facility." per Id. at added). to was 2004 an that Medtronic division Talent also Mexico's states of Mexico, see approval Significantly, Management Mexico ship not Additionally, from a considered Medtronic DX626. The facility (emphasis Third, Medtronic "Supplier "Medtronic and MED0058725 management Minnesota), the manufacturing DOP the Graft). PMA by about Medtronic Vascular's Medtronic the approved require MED0058705; Stent section, also statements over be changes by Medtronic Vascular may at similar oversight "Quality Last, IdL_ must until was the the products listed on these testimony April of changes where 2008, this described actual to entity Medtronic contracts. from witnesses Medtronic "approval" Ireland; DX103, at Mexico is that DX trial shipped required are in document DOP 113316 (DCR Procedure - Santa Rosa Requirements). This document was attached as Appendix 30 to the 2006 Modular PMA, however, it does not appear to have been admitted as evidence before this Court. PMA 2006, PX 69 at MED0058705. 98 the completed insertion Tr. at that Talent into 1; time R. a stent delivery Flores period, system. Direct, the company from Direct, Tr. Tr. products Tijuana 916-917. specifically grafts to San that PX summary, evidence that that subassembly products. the Court earlier importer is Section evidence to 271(g) that defendants, of or is a controlled The simply a local freight R. Flores nothing that "controlled preponderance support or directed" is the or Medtronic Talent not the statue. or of one actual finds to if the liability also other importing that insufficient manufacturer must the graft precedent Thus, vicarious it Court stent Circuit appears the the conclusion the it of the Federal under it via and of that Vascular Mexico. trial by infringement infringement, during found submissions liable joint directed at is Vargas Vascular "controlled Medtronic Medtronic submitted who apply finds clear Depo. Specifically, has controlling makes 765, for shipping/importing process. manufacturing However, discussed but Vascular States California. Court PMA United PX shipped Medtronic Court Medtronic's Medtronic Mexico's the 134; Diego, directed" Medtronic Mexico in this In the 916-917. were The evidences to the to find named activity evidence support such a conclusion. Medtronic contracts Mexico admitted is during the entity trial. 99 If listed the Court on all were shipping to draw a contrary conclusion "directed would or be actual a {or for different. However, against they the a the have named Medtronic such of to to the Gore's are actual vicariously because that products to the upon the might be the Court. also fail "importers" or for or any of any of that the claim because demonstrates directed the between infringement must it detailed States 271(g) liable they the before defendants it which conclusion is Section before contract) United evidence defendants activity, had the ship Court's the named Mexico evidence are Mexico Court about produce defendants defendants in Medtronic failed named the portion the Mexico this no the importing/shipping If facility completion, of Medtronic Medtronic products' one testimony and delivery Thus, this even Vascular instructions that assumption. contract insertion find controlled" mere Medtronic and actions controlled of the importation activity.30 30 The found the the The United before further product would address these under 271(g) do "offered "within products However, products infringement beginning issue 2008. infringement accused that defendants Talent States importation *870 notes named infringing 271 (g). the Court if not the were in it to United is for the infringe patent. 100 the for remaining Court claims also or 35 sale claims unnecessary potential since can sold, States." Thus, foreclose 271 (g) sell, approved 2008. only under U.S.C. and § in 271(g) everything the Court avenues earlier found 12, and 16 sold Section on be used" 19 to for that the of the VI. COUNTERCLAIMS The Federal discretion no to Circuit dismiss infringement. 1351 Nystrom Liquid 355 F.3d 1361, 1371 was found, DISMISSES unenforceability that Court district invalidity it finds 1347, Vaughan 2004). Thus, its Medtronic's has F.3d 339 v. exercises court where Inc., Corp. Cir. moot a Company Dynamics (Fed. the as of TREX 2003); hereby Company, since discretion invalidity no and and counterclaims. CONCLUSION For do v. Cir. infringement VII. held counterclaims (Fed. Inc., of has the reasons defendants not and set HOLDS infringe forth that claims Medtronic's counterclaims are DISMISSED The Order Clerk is to counsel It is REQUESTED of the 12, Additionally, above, the accused 16 or Court manufacturing 19 of invalidity the and to send record for the a copy 1$ favor processes '870 patent. unenforceability of this Opinion and parties. SO ORDERED. Mark June in as moot. UNITED Norfolk, finds Virginia 2012 101 S. STATES Davis DISTRICT JUDGE

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