` #:14457
`UNITED STATES DISTRICT COURT
`CENTRAL DISTRICT OF CALIFORNIA
`
`CIVIL MINUTES - GENERAL
`Case No. SACV 12-00327-JVS (MLGx)
`Medtronic Inc. v. Edwards Lifesciences Corp., et al.
`Title
`
`Date September 17, 2013
`
`James V. Selna
`
`Present: The
`Honorable
`Not Present
`Ellen Matheson for Karla J. Tunis
`Court Reporter
`Deputy Clerk
`Attorneys Present for Defendants:
`Attorneys Present for Plaintiffs:
`Not Present
`Not Present
`(IN CHAMBERS) Order re Motions for Summary Judgment
`
`Proceedings:
`
`Plaintiff/Counterclaim-Defendant Medtronic, Inc. (“Medtronic”) alleges that
`Defendants/Counterclaim-Plaintiffs Edwards Lifesciences Corporation et al.
`(collectively, “Edwards”) indirectly infringe two patents assigned to Medtronic: U.S.
`Patent No. 7,184,829 (“the ‘829 Patent”), titled “Method and System for Nerve
`Stimulation Prior to and During a Medical Procedure”; and U.S. Patent No. 8,036,741
`(“the ‘741 Patent”), titled “Method and System for Nerve Stimulation and Cardiac
`Sensing Prior to and During a Medical Procedure” (collectively, the “patents-in-suit”).
`(Complaint, Docket No. 1.) Medtronic alleges that Edwards induces infringement of
`Claim 43 of the ‘829 Patent, and Claims 10–13, 15–18, 20–21, and 28 of the ‘741 Patent
`(collectively, the “Asserted Claims”).
`
`Medtronic and Edwards move for summary judgment pursuant to Federal Rule of
`Civil Procedure 56 on the following infringement and invalidity issues1:
`
`(1) Edwards’s Motion for Summary Judgment of Noninfringement, Docket No. 214:
`Noninfringement Brief, Docket No. 283; Noninfringement Opposition, Docket No. 336;
`Noninfringement Reply, Docket No. 400.
`
`(2) Medtronic’s Motion for Partial Summary Judgment on Edwards’ Derivation Claim (35
`U.S.C. § 102(f)), Docket No. 211: Derivation Brief, Docket No. 230; Derivation Opposition,
`Docket No. 339; Derivation Reply, Docket No. 381.
`
`(3) Edwards’s Motion for Summary Judgment of Invalidity of the ‘741 Patent Under 35
`
`1 The Court applies the pre-America Invents Act version of Title 35 of the U.S. Code.
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`Edwards Lifesciences v. Boston Scientific Scimed
`IPR2017-00060 U.S. Patent 8,992,608
`Exhibit 2007
`
`
`
`Case 8:12-cv-00327-JVS-JPR Document 414 Filed 09/17/13 Page 1 of 58 Page ID
` #:14457
`UNITED STATES DISTRICT COURT
`CENTRAL DISTRICT OF CALIFORNIA
`
`CIVIL MINUTES - GENERAL
`Case No. SACV 12-00327-JVS (MLGx)
`Medtronic Inc. v. Edwards Lifesciences Corp., et al.
`Title
`
`Date September 17, 2013
`
`James V. Selna
`
`Present: The
`Honorable
`Not Present
`Ellen Matheson for Karla J. Tunis
`Court Reporter
`Deputy Clerk
`Attorneys Present for Defendants:
`Attorneys Present for Plaintiffs:
`Not Present
`Not Present
`(IN CHAMBERS) Order re Motions for Summary Judgment
`
`Proceedings:
`
`Plaintiff/Counterclaim-Defendant Medtronic, Inc. (“Medtronic”) alleges that
`Defendants/Counterclaim-Plaintiffs Edwards Lifesciences Corporation et al.
`(collectively, “Edwards”) indirectly infringe two patents assigned to Medtronic: U.S.
`Patent No. 7,184,829 (“the ‘829 Patent”), titled “Method and System for Nerve
`Stimulation Prior to and During a Medical Procedure”; and U.S. Patent No. 8,036,741
`(“the ‘741 Patent”), titled “Method and System for Nerve Stimulation and Cardiac
`Sensing Prior to and During a Medical Procedure” (collectively, the “patents-in-suit”).
`(Complaint, Docket No. 1.) Medtronic alleges that Edwards induces infringement of
`Claim 43 of the ‘829 Patent, and Claims 10–13, 15–18, 20–21, and 28 of the ‘741 Patent
`(collectively, the “Asserted Claims”).
`
`Medtronic and Edwards move for summary judgment pursuant to Federal Rule of
`Civil Procedure 56 on the following infringement and invalidity issues1:
`
`(1) Edwards’s Motion for Summary Judgment of Noninfringement, Docket No. 214:
`Noninfringement Brief, Docket No. 283; Noninfringement Opposition, Docket No. 336;
`Noninfringement Reply, Docket No. 400.
`
`(2) Medtronic’s Motion for Partial Summary Judgment on Edwards’ Derivation Claim (35
`U.S.C. § 102(f)), Docket No. 211: Derivation Brief, Docket No. 230; Derivation Opposition,
`Docket No. 339; Derivation Reply, Docket No. 381.
`
`(3) Edwards’s Motion for Summary Judgment of Invalidity of the ‘741 Patent Under 35
`
`1 The Court applies the pre-America Invents Act version of Title 35 of the U.S. Code.
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` #:14458
`UNITED STATES DISTRICT COURT
`CENTRAL DISTRICT OF CALIFORNIA
`
`CIVIL MINUTES - GENERAL
`Case No. SACV 12-00327-JVS (MLGx)
`Medtronic Inc. v. Edwards Lifesciences Corp., et al.
`Title
`
`Date September 17, 2013
`
`U.S.C. §§ 102(f) and 112, Docket No. 216: ‘741 Invalidity Brief, Docket No. 285; ‘741
`Invalidity Opposition, Docket No. 338; ‘741 Invalidity Reply, Docket No. 402.
`
`(4) Medtronic’s Motion for Partial Summary Judgment on Edwards’ Public Use and On Sale
`Bar Claims (35 U.S.C. § 102(b)), Docket No. 213: Public Use/On-Sale Brief, Docket No.
`231; Public Use/On-Sale Opposition, Docket No. 340; Public Use/On-Sale Reply, Docket
`No. 490.
`
`(5) Edwards’s Motion for Summary Judgment of Invalidity Under 35 U.S.C. §§ 102 and 103,
`Docket No. 215: Invalidity Brief, Docket No. 284; Invalidity Opposition, Docket No. 337;
`Invalidity Reply, Docket No. 401.
`
`For the following reasons, the Noninfringement Motion is DENIED, the
`Derivation Motion is GRANTED, the ‘741 Invalidity Motion is DENIED, the Public
`Use/On-Sale Bar Motion is GRANTED in part and DENIED in part, and the Invalidity
`Motion is DENIED.
`
`I.
`
`FACTUAL BACKGROUND2
`
`Medtronic accuses Edwards of indirectly infringing the Asserted Claims when
`physicians use transfemoral and transapical procedures to implant Edwards’s SAPIEN
`Transcatheter Heart Valve (“THV”) (the “SAPIEN”). (Noninfringement SUF ¶ 1, Docket
`No. 28-1.) The Court construed disputed terms in the Asserted Claims on March 7, 2013.
`(Claim Construction Order, Docket No. 86.) The Court presumes familiarity with the
`procedural history of this matter.
`
`Medtronic contends that the Asserted Claims cover “critical steps that Edwards
`instructs physicians to take in order to safely and effectively deploy the SAPIEN,” which
`Medtronic considers a “stent device,” “at the site of the native aortic valve” through rapid
`pacing. (Noninfringement SUF ¶¶ 2, 23.) The SAPIEN is used to replace damaged
`(stenotic) native aortic heart valves, which lie between the left ventricle of the heart and
`the aorta and allow blood to exit the left ventricle and flow through to the body. (Id. ¶
`
`2 Unless otherwise noted, the facts set forth throughout the Court’s analysis are uncontroverted.
`The Court resolves objections to material challenged evidence as stated herein. The Court does not rely
`on legal conclusions presented as facts.
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`
`CIVIL MINUTES - GENERAL
`Case No. SACV 12-00327-JVS (MLGx)
`Medtronic Inc. v. Edwards Lifesciences Corp., et al.
`Title
`
`Date September 17, 2013
`
`28.) Rapid pacing increases the heart rate to affect stroke volume and cardiac output and
`ensure the SAPIEN can be deployed safely. (E.g., Buller Opening Report ¶¶ 61–62
`(“Pacing to achieve an increased rate will obviously increase the frequency of the heart
`beat, but when there is a fall in stroke volume the amplitude of cardiac movement will
`also fall.”), Buller Decl. Ex. 1, Docket No. 287; Ing Dep. at 29:2–23, Raman Decl. Ex.
`18, Docket No. 217.) A typical rapid pacing range is between 160 and 220 beats per
`minute. (Noninfringement SUF ¶ 10.) When the heart is paced to within that range, it is
`in a state referred to as ventricular tachycardia. (Id. ¶ 11.) After pacing ends, the heart
`typically regains its normal function.
`
`II.
`
`LEGAL STANDARD
`
`Summary judgment is appropriate only where the record, read in the light most
`favorable to the nonmoving party, indicates “that there is no genuine issue as to any
`material fact and . . . the moving party is entitled to a judgment as a matter of law.” Fed.
`R. Civ. P. 56(c)(2); see also Celotex Corp. v. Catrett, 477 U.S. 317, 323-24 (1986);
`PowerOasis, Inc. v. T-Mobile USA, Inc., 522 F.3d 1299, 1303 (Fed. Cir. 2008).
`Summary adjudication, or partial summary judgment “upon all or any part of [a] claim,”
`is appropriate where there is no genuine issue of material fact as to that portion of the
`claim. Fed. R. Civ. P. 56(a), (b); see also Lies v. Farrell Lines, Inc., 641 F.2d 765, 769 n.3
`(9th Cir. 1981) (“Rule 56 authorizes a summary adjudication that will often fall short of a
`final determination, even of a single claim.” (internal quotation marks omitted)).
`
`Material facts are those necessary to the proof or defense of a claim, and are
`determined by reference to substantive law. Anderson v. Liberty Lobby, Inc., 477 U.S.
`242, 248 (1986). “[A] complete failure of proof concerning an essential element of the
`nonmoving party’s case necessarily renders all other facts immaterial.” Celotex, 477 U.S.
`at 322. A fact issue is genuine “if the evidence is such that a reasonable jury could return
`a verdict for the nonmoving party.” Anderson, 477 U.S. at 248. To demonstrate a genuine
`issue, the opposing party “must do more than simply show that there is some
`metaphysical doubt as to the material facts. . . . [T]he nonmoving party must come
`forward with specific facts showing that there is a genuine issue for trial.” Matsushita
`Elec. Indus. Co. v. Zenith Radio Corp., 475 U.S. 574, 586–87 (1986) (citations and
`internal quotation marks omitted). In deciding a motion for summary judgment, “[t]he
`evidence of the nonmovant is to be believed, and all justifiable inferences are to be drawn
`in his favor.” Anderson, 477 U.S. at 255. Nevertheless, inferences are not drawn out of
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`UNITED STATES DISTRICT COURT
`CENTRAL DISTRICT OF CALIFORNIA
`
`CIVIL MINUTES - GENERAL
`Case No. SACV 12-00327-JVS (MLGx)
`Medtronic Inc. v. Edwards Lifesciences Corp., et al.
`Title
`
`Date September 17, 2013
`
`the air, and the opposing party must produce a factual predicate from which the inference
`may be drawn. See Richards v. Nielsen Freight Lines, 602 F. Supp. 1224, 1244-45 (E.D.
`Cal. 1985), aff’d, 810 F.2d 898, 902 (9th Cir. 1987).
`
`The burden initially is on the moving party to demonstrate an absence of a genuine
`issue of material fact. Celotex, 477 U.S. at 323. If the moving party meets its burden, then
`the nonmoving party must produce enough evidence to rebut the moving party’s claim
`and create a genuine issue of material fact. See id. at 322–23. If the nonmoving party
`meets this burden, then the motion will be denied. Nissan Fire & Marine Ins. Co. v. Fritz
`Co., 210 F.3d 1099, 1103 (9th Cir. 2000).
`
`Where the parties have made cross-motions for summary judgment, the court must
`consider each motion on its own merits. Fair Hous. Council of Riverside Cnty., Inc. v.
`Riverside Two, 249 F.3d 1132, 1136 (9th Cir. 2001). The court should consider each
`party’s evidentiary showing, regardless of which motion the evidence was tendered
`under. See id. at 1137.
`
`III. REQUEST FOR JUDICIAL NOTICE
`
`Edwards requests that the Court take judicial notice of several documents pursuant
`to Federal Rule of Evidence 201. (Request for Judicial Notice (“RJN”), Docket No. 218.)
`Medtronic opposes because (1) Edwards has not substantiated its request and (2) the
`parties dispute the meaning and relevance of the documents. (Objections to RJN, Docket
`No. 312.) Edwards did not substantiate its request, but the Court will take judicial notice
`of the documents and the facts stated therein. Medtronic does not argue that Edwards
`altered the documents or dispute that the contents Edwards relies upon are in these
`documents. Thus, in that regard, the facts themselves are not subject to material dispute.
`Lee v. City of L.A., 250 F.3d 668, 689–90 (9th Cir. 2001). The interpretation of the facts
`is a different matter. Under Medtronic’s position, courts could never take judicial notice
`of alleged prior art at the summary judgment stage if the parties disagree over its meaning
`and import. The Court does not take Edwards’s contentions about the documents’
`meaning and import as true simply because the Court takes judicial notice. Accordingly,
`the Court GRANTS Edwards’s Request for Judicial Notice.
`
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`UNITED STATES DISTRICT COURT
`CENTRAL DISTRICT OF CALIFORNIA
`
`CIVIL MINUTES - GENERAL
`Case No. SACV 12-00327-JVS (MLGx)
`Medtronic Inc. v. Edwards Lifesciences Corp., et al.
`Title
`
`Date September 17, 2013
`
`IV. DISCUSSION
`
`The Court considers the motions separately, except where issues overlap. The
`parties frame the issues in a variety of ways and cite a substantial amount of evidence.
`The Court attempts to address the most significant and principal issues, including all that
`are dispositive.
`
`A.
`
`Noninfringement of the Patents-in-Suit
`
`Edwards moves for summary judgment of noninfringement based on the
`requirements of the three Asserted Independent Claims: (1) Claim 43 of the ‘829 Patent’s
`requirement, as construed by the Court, that “the stimulation [of the Purkinje fibers] stops
`or slows cardiac rhythm”; and (2) Claims 10 and 28 of the ‘741 Patent’s “stent device”
`requirement, where a “stent device” is a “device providing support within the space of a
`tubular structure in the body.”
`
`1.
`
`Legal Standard
`
`35 U.S.C. § 271(b) provides that “[w]hoever actively induces infringement of a
`patent shall be liable as an infringer.” The threshold requirement, which Edwards argues
`cannot be met here, is direct infringement by an actor. Dynacore Holdings Corp. v. U.S.
`Phillips Corp., 363 F.3d 1263, 1272 (Fed. Cir. 2004). An actor is liable for direct
`infringement under 35 U.S.C. § 271(a) when she commits all the elements of
`infringement, such as the making, using, or selling of a patented invention. Akamai
`Techs., Inc. v. Limelight Networks, Inc., 692 F.3d 1301, 1305, 1307 (Fed. Cir. 2012) (per
`curiam); see also Joy Techs., Inc. v. Flakt, Inc., 6 F.3d 770, 773 (Fed. Cir. 1993). The
`inquiry has two steps: first, the court must determine the scope and meaning of the patent
`claims asserted—a question of law. Cybor Corp. v. FAS Techs., Inc., 138 F.3d 1448,
`1454 (Fed. Cir. 1998) (en banc) (citation omitted). Second, the court must determine
`“whether the claims, as properly interpreted, cover the accused device or process”—a
`question of fact. SmithKline Diagnostics, Inc. v. Helena Labs. Corp., 859 F.2d 878, 889
`(Fed. Cir. 1998). The actor must perform each and every step or element of a claimed
`method or product; if any claim limitation is absent from the accused device, there is no
`literal infringement as a matter of law. Cephalon, Inc. v. Watson Pharm., Inc., 769 F.
`Supp. 2d 729, 746 (D. Del. 2011) (citations omitted); see also Akamai Techs., 692 F.3d at
`1307. The patent owner has the burden of proving infringement by a preponderance of
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`CENTRAL DISTRICT OF CALIFORNIA
`
`CIVIL MINUTES - GENERAL
`Case No. SACV 12-00327-JVS (MLGx)
`Medtronic Inc. v. Edwards Lifesciences Corp., et al.
`Title
`
`Date September 17, 2013
`
`the evidence. SmithKline, 859 F.2d at 889. Direct infringement may be shown through
`direct and circumstantial evidence. Moleculon Research Corp. v. CBS, Inc., 793 F.2d
`1261, 1272 (Fed. Cir. 1986).
`
`Induced infringement has two additional elements. First, “a patent holder must
`prove that once the defendant[] knew of the patent, [it] actively and knowingly aid[ed]
`and abett[ed] another’s direct infringement.” DSU Med. Corp. v. JMS Co., 471 F.3d
`1293, 1306 (Fed. Cir. 2006) (internal quotation marks and citation omitted). Second, the
`patent holder must prove that the defendant intended to cause direct infringement, that is,
`a defendant must induce acts by another that the defendant knows constitute patent
`infringement. Id. (citation omitted); Global-Tech Appliances, Inc. v. SEB S.A., 131 S. Ct.
`2060, 2068 (2011).
`
`2.
`
`Induced Infringement of Claim 43 of the ‘829 Patent
`
`Claim 43 of the ‘829 Patent recites:
`
`A method of electrically manipulating cardiac rhythm during a
`medical procedure, comprising: providing a stimulator, the
`stimulator comprising a stimulation electrode; positioning the
`stimulation electrode in a position suitable for stimulating
`Purkinje fibers to stop or slow cardiac rhythm; [and] intermittently
`starting and stopping stimulation of the Purkinje fibers multiple
`times in order to manipulate cardiac rhythm during a medical
`procedure.
`
`(‘829 Patent at 20:47–56, Raman Decl. Ex. 4.) The Court construed the final phrase as
`“intermittently starting and stopping stimulation of the Purkinje fibers to adjust the
`beating of the heart multiple times, where the stimulation stops or slows cardiac rhythm
`during a series of one or more medical procedures.” (Claim Construction Order, at 26.)
`
`a.
`
`Analysis Under the Current Claim Construction
`
`Edwards argues that Medtronic cannot show by a preponderance of the evidence
`that physicians directly infringe Claim 43, because it is undisputed that a person of
`ordinary skill in the art (“POSITA”) would understand that the rapid pacing used to
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`UNITED STATES DISTRICT COURT
`CENTRAL DISTRICT OF CALIFORNIA
`
`CIVIL MINUTES - GENERAL
`Case No. SACV 12-00327-JVS (MLGx)
`Medtronic Inc. v. Edwards Lifesciences Corp., et al.
`Title
`
`Date September 17, 2013
`
`implant the SAPIEN only increases cardiac rhythm. Edwards cites the opinion of its
`expert, Dr. Nigel Buller (“Buller”); literature associating ventricular tachycardia with a
`fast heart rhythm; and statements by Medtronic’s expert, Dr. David Benditt (“Benditt”).
`(See Noninfringement SUF ¶¶ 8–17.) Edwards argues that the Court must disregard
`Benditt’s written report because (1) he does not define “cardiac rhythm” in accordance
`with the Claim Construction Order; and (2) his deposition testimony reveals
`inconsistencies that lessen the report’s probative value. (See, e.g., Noninfringement
`Reply, at 1–9).
`
`According to Buller, who extensively cites outside literature, cardiac rhythm “is
`the pattern in time of the heart beating, looked at by either the mechanical activity or
`electrical activity, or both.” (Buller Rebuttal Report ¶ 72, Buller Decl. Ex. 2.) To a
`POSITA, “whether a cardiac rhythm is slow or fast is purely a measure of the rate of
`beating of the heart, i.e., how many times it beats in a given period of time.” (Id.)
`Therefore, a POSITA “would understand ‘stop or slow cardiac rhythm’ to only cover
`situations where the heart rate is stopped or slowed, and not where the heart is beating at
`a higher rate, such as is the case with rapid pacing induced ventricular tachycardia.” (Id. ¶
`71.) Buller knows of no instances “where tachycardia is described as a slow or stopped
`cardiac rhythm.” (Id. ¶ 72.) He rejects using cardiac output as a measure heart rate or
`regularity. (Id. ¶ 73.)
`
`Benditt, an electrophysiologist and cardiologist, agrees that cardiac rhythm consists
`of related electrical and mechanical components. (Benditt Opening Report ¶ 234, Hedden
`Decl. Ex. 30, Docket No. 311.) Benditt, who does not cite outside literature, opines that
`the electrical component “relates to the electrical conduction system and the electrical
`impulses that cause the heart to beat.” (Id.) He refers to it “in terms of heart rate and/or
`regularity.” (Id.) The mechanical component “relates to cardiac output (i.e., the amount of
`blood pumped per unit of time), including the mechanical movement of the heart, blood
`flow, and blood pressure.” (Id.) Mechanical rhythm changes depending on the rate and
`regularity of the electrical conduction. (Id. ¶ 235.) “When the electrical cardiac rhythm is
`very fast, such as in ventricular tachycardia, the mechanical cardiac rhythm, i.e., heart
`movement and cardiac outflow, is significantly reduced.” (Id. ¶ 237.)
`
`To establish infringement, Benditt concludes:
`
`Rapid pacing takes advantage of this mechanical reduction in cardiac
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`UNITED STATES DISTRICT COURT
`CENTRAL DISTRICT OF CALIFORNIA
`
`CIVIL MINUTES - GENERAL
`Case No. SACV 12-00327-JVS (MLGx)
`Medtronic Inc. v. Edwards Lifesciences Corp., et al.
`Title
`
`Date September 17, 2013
`
`rhythm by inducing a very fast heart rate . . . similar to the rates
`exhibited by a heart in tachycardia. As a result, slowed or stopped
`cardiac rhythm may be characterized by a decreased heart rate (i.e., a
`very slow rhythm), or by an increased heart rate (e.g., rapid pacing)
`depending on the circumstances. The result would be a stopping or
`marked reduction of cardiac output.
`
`(Id.)
`
`The Court finds that Benditt’s opinion is not an “unsupported conclusion on the
`ultimate issue of infringement.” Arthur A. Collins, Inc. v. N. Telecom Ltd., 216 F.3d
`1042, 1046 (Fed. Cir. 2000) (“[C]onclusory expert declarations devoid of facts upon
`which the conclusions were reached do not raise a genuine issue of material fact.”
`(citing Zelinski v. Brunswick Corp., 185 F.3d 1311, 1317 (Fed. Cir. 1999))). In
`isolation, because a reasonable factfinder could credit Benditt’s definition of cardiac
`rhythm, the conflicting opinions create a triable issue of fact as to whether the rapid
`pacing used to implant the SAPIEN reads on Claim 43. See SunTiger, Inc. v.
`Scientific Research Funding Grp., 189 F.3d 1327, 1336–37 (Fed. Cir. 1999). But even
`viewing the facts and drawing inferences in the light most favorable to Medtronic, the
`Court finds that Medtronic cannot carry its burden of persuasion under the current
`claim construction.
`
`First, the Court previously explained that although to “manipulate cardiac
`rhythm” includes “adjustments to the beating of the heart,” cardiac rhythm “is not
`used interchangeably with ‘heart beat.’” (Claim Construction Order, at 21). The Court
`cited extrinsic evidence defining “cardiac” as “relating to” or “pertaining to” the heart;
`“rhythm” as, inter alia, “the pattern of recurrence of the cardiac cycle”; and “sinus
`rhythm” as “the rhythm of the heart produced by impulses from the sinoatrial node.
`(Id.) The Court concluded that “it is preferable to give the general term ‘cardiac
`rhythm’ its full meaning, let the claim speak for itself, and not restrict it to the beating
`of the heart or the rhythm of the beating of the heart.” (Id.)
`
`In light of that reasoning, the Court finds that Benditt does not address cardiac
`rhythm in view of the meaning of “rhythm”—something akin to “the pattern of
`recurrence of the cardiac cycle.” Although he defines cardiac output as “the amount of
`blood pumped per unit of time” (Benditt Opening Report ¶ 234), Benditt does not
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`CIVIL MINUTES - GENERAL
`Case No. SACV 12-00327-JVS (MLGx)
`Medtronic Inc. v. Edwards Lifesciences Corp., et al.
`Title
`
`Date September 17, 2013
`
`explain how the mechanical movement of the heart, blood flow, and blood pressure
`relate to rhythm and not simply movement.3 (See id. ¶ 66 (“In [ventricular
`tachycardia], the heart does not have sufficient time to fill with blood between beats,
`resulting in decreased output and decreased blood pressure. As a result, rapid pacing
`stabilizes the heart from a mechanical perspective . . . .”), ¶ 237 (“The result would be
`a stopping or marked reduction of cardiac output.”).) Further, Benditt’s fine
`distinction between electrical and mechanical activity divorces the “rhythm of the
`beating of the heart” from any infringement analysis of rapid pacing by implying that
`it is irrelevant so long as mechanical rhythm slows or stops. Yet, the Court never
`excluded “rhythm of the beating of the heart” from the definition of “cardiac rhythm.”
`Because a reasonable factfinder therefore cannot rely on Benditt’s written opinion,
`these shortcomings are fatal to Medtronic’ ability to show infringement by rapid
`pacing.4
`
`Second, Benditt’s testimony reveals inconsistencies in his opinion that weaken
`its probative value. In his report, Benditt explains that rapid pacing induces a
`condition like natural ventricular tachycardia—a marked decrease in cardiac output.
`(Id. ¶ 56.) Benditt testified that ventricular tachycardia could mean “a specific heart
`
`3 Extrinsic evidence indicates rhythm and movement are not synonymous, and a better
`understanding of the mechanical component may involve “the rate of contraction of the cardiac muscle.”
`See Merriam-Webster Dictionary, http://www.merriam-webster.com/dictionary/rhythm (last visited
`September 10, 2013) (defining “rhythm” as “a movement, fluctuation, or variation marked by the
`regular recurrence or natural flow of related elements”; or “a regularly recurrent quantitative change in a
`variable biological process”). Medtronic itself cites to a report distinguishing cardiac output and motion.
`(Noninfringement Opposition, at 9; Webb et al., Rapid Pacing to Facilitate Transcatheter Prosthetic
`Heart Valve Implantation, at EDWARDS00008197 (“We describe the technique of rapid ventricular
`pacing to produce a transient reduction in cardiac and catheter motion, transvalvular flow, and cardiac
`output . . . .”), Hedden Decl. Ex. 33.)
`
`4 To some extent, Buller’s opinion—“whether a cardiac rhythm is slow or fast is purely a
`measure of beating of the heart” (Buller Rebuttal Report ¶ 72)—also is inconsistent with the Court’s
`decision not to restrict cardiac rhythm to the “rhythm of the beating of the heart.” Edwards argues that
`Buller “considered ‘the measure of the rate of beating of the heart,’ both electrical and mechanical . . . in
`concluding that the condition of ventricular tachycardia induced by rapid pacing did not constitute a
`stopped or slowed ‘cardiac rhythm.’” (Noninfringement Reply, at 8.) Buller, however, did not elaborate
`on his distinction between mechanical and electrical activity. Regardless, Medtronic bears the burden of
`persuasion, not Edwards.
`CV-90 (06/04)
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`Case 8:12-cv-00327-JVS-JPR Document 414 Filed 09/17/13 Page 10 of 58 Page ID
` #:14466
`UNITED STATES DISTRICT COURT
`CENTRAL DISTRICT OF CALIFORNIA
`
`CIVIL MINUTES - GENERAL
`Case No. SACV 12-00327-JVS (MLGx)
`Medtronic Inc. v. Edwards Lifesciences Corp., et al.
`Title
`
`Date September 17, 2013
`
`rhythm disorder . . . It’s a spontaneous rhythm. . . . The term ventricular tachycardia
`may also be used to simply mean a rapid ventricular rate.” (Benditt Dep. at 59:3–15,
`Raman Decl. Ex. 12.) Either case would “[m]ore or less” result in reduced cardiac
`output. (Id. at 59:18–24; see id. at 60:19–22 (“Whether it’s a spontaneous ventricular
`tachycardia or a pacing rapid heart rate, it always depends in part on the rate and in
`part, large part, on the heart function.”).) During a colloquy about ventricular
`tachycardia, Benditt conceded he had never “heard of a paced ventricular tachycardia
`being classified as a slow cardiac rhythm.” (Id. at 63:3–6.) Benditt “think[s] it would
`“be wrong” to refer to it in that way. (Id. at 63:19–11.) During questioning as to
`whether he would refer to spontaneous ventricular tachycardia as a “slow heart
`rhythm,” Benditt clarified, however, that “rhythm also implies cardiac output.” (Id. at
`64:13–15.) Thus, although a reasonable factfinder could question the value of
`Benditt’s opinion because of his inconsistent language, the Court disagrees that
`Benditt “unequivocally admitted” that ventricular tachycardia such as achieved by
`rapid pacing is not a stopped or slowed cardiac rhythm. (See Noninfringement Brief,
`at 7.) Benditt never negated his distinction between electrical and mechanical activity.
`
`Therefore, under the current claim construction, the Court finds that there is no
`genuine dispute that rapid pacing does not “stop[] or slow[] cardiac rhythm.”5
`Nevertheless, the Court must deny the Noninfringement Motion as to Claim 43
`because this construction of Claim 43 is incorrect.
`
`b.
`
`Modification of the Construction of Claim 43
`
`Claim construction is matter of law and may be addressed on summary
`judgment. See Markman v. W. Instruments, Inc., 517 U.S. 370, 388 (1996). The Court
`finds that it improperly construed “in order to manipulate cardiac rhythm” by limiting
`it to “where the stimulation stops or slows cardiac rhythm.” The Court formulated this
`construction, which was not in the Tentative Claim Construction Order, after the
`Markman hearing on February 25, 2013.
`
`5 The Court previously stated that “the patentee chose when to differentiate between methods
`directed only to slowing or stopping the heart rate and those that encompass increasing the heart rate,
`both of which may stop or slow cardiac rhythm.” (Claim Construction Order, at 24.) The evidence
`shows this conclusion was scientifically incorrect as to increased heart rates.
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`UNITED STATES DISTRICT COURT
`CENTRAL DISTRICT OF CALIFORNIA
`
`CIVIL MINUTES - GENERAL
`Case No. SACV 12-00327-JVS (MLGx)
`Medtronic Inc. v. Edwards Lifesciences Corp., et al.
`Title
`
`Date September 17, 2013
`
`While addressing the preceding limitation, “suitable for,” the Court found that
`“nothing in the claim language or specification justifies excluding any placement of
`the stimulation that could either stop, slow, or quicken cardiac rhythm when the
`Purkinje fibers are stimulated.” (Claim Construction Order, at 20.) Claim 43 only
`requires that the stimulation electrode be “in a position capable of and appropriate for
`stimulating the Purkinje fibers to stop or slow cardiac rhythm.” (Id. at 22.) Upon
`turning to the final disputed term, however, the Court relied on attorney argument
`rather than on the claim language and the specification when it reasoned that the
`language of Claim 43 “is broad enough to encompass slowing, stopping, or speeding
`up the heart beat, assuming it includes stopping or slowing cardiac rhythm.” (Id. at 23
`(relying on Medtronic’s Markman Brief).) The Court then limited the claim to
`stimulation that “stops or slows cardiac rhythm.”
`
`Upon further consideration, the Court finds that nothing in the plain language of
`the claim or the specification supports a conclusion that stimulation of the Purkinje
`fibers must only stop or slow cardiac rhythm. The patentee distinguished between the
`phrase “to manipulate” and the phrase “to stop or slow.” (Compare ‘829 Patent at
`20:51–53 (“to stop or slow cardiac rhythm”) with id. at 20:54–56 (“to manipulate
`cardiac rhythm”).) Given the earlier use of “suitable for,” Claim 43 is broad enough to
`encompass slowing, stopping, or increasing cardiac rhythm. The Court should have let
`the straightforward claim language speak for itself, because construction cannot
`meaningfully add to the term “to manipulate cardiac rhythm.” Phillips v. AWH Corp.,
`415 F.3d 1303, 1314 (Fed. Cir. 2005). Therefore, the Court modifies the construction
`of “intermittently starting and stopping stimulation of the Purkinje fibers multiple
`times in order to manipulate cardiac rhythm during a medical procedure.” The proper
`construction is “intermittently starting and stopping stimulation of the Purkinje fibers
`to adjust the beating of the heart multiple times in order to manipulate cardiac rhythm
`during a series of one or more medical procedures.”
`
`The foregoing analysis establishes that the parties and experts agree that rapid
`pacing manipulates cardiac rhythm. Accordingly, the Court DENIES the
`Noninfringement Motion as to Claim 43 of the ‘829 Patent.
`
`2.
`
`Induced Infringement of the ‘741 Patent
`
`Claim 10 of the ‘741 Patent recites:
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`Case 8:12-cv-00327-JVS-JPR Document 414 Filed 09/17/13 Page 12 of 58 Page ID
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`UNITED STATES DISTRICT COURT
`CENTRAL DISTRICT OF CALIFORNIA
`
`CIVIL MINUTES - GENERAL
`Case No. SACV 12-00327-JVS (MLGx)
`Medtronic Inc. v. Edwards Lifescien