Trials@uspto.gov
`Tel: 571-272-7822
`
`Paper 75
`Date: July 8, 2020
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`CARDIOVASCULAR SYSTEMS, INC.,
`Petitioner,
`v.
`SHOCKWAVE MEDICAL, INC.,
`Patent Owner.
`
`
`IPR2019-00409
`Patent 8,728,091 B2
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`
`Before MITCHELL G. WEATHERLY, RICHARD H. MARSCHALL, and
`AVELYN M. ROSS, Administrative Patent Judges.
`
`ROSS, Administrative Patent Judge.
`
`JUDGMENT
`Final Written Decision
`Determining All Challenged Claims Unpatentable
`Denying Petitioner’s Motion to Exclude
`Denying Patent Owner’s Motion to Exclude
`35 U.S.C. § 318(a); 37 C.F.R. § 42.64
`
`
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`
`
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`Tel: 571-272-7822
`
`Paper 75
`Date: July 8, 2020
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`CARDIOVASCULAR SYSTEMS, INC.,
`Petitioner,
`v.
`SHOCKWAVE MEDICAL, INC.,
`Patent Owner.
`
`
`IPR2019-00409
`Patent 8,728,091 B2
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`
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`
`
`
`
`
`
`Before MITCHELL G. WEATHERLY, RICHARD H. MARSCHALL, and
`AVELYN M. ROSS, Administrative Patent Judges.
`
`ROSS, Administrative Patent Judge.
`
`JUDGMENT
`Final Written Decision
`Determining All Challenged Claims Unpatentable
`Denying Petitioner’s Motion to Exclude
`Denying Patent Owner’s Motion to Exclude
`35 U.S.C. § 318(a); 37 C.F.R. § 42.64
`
`
`
`
`
`
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`IPR2019-00409
`Patent 8,728,091 B2
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`I. INTRODUCTION
`We have jurisdiction to hear this inter partes review under 35 U.S.C.
`§ 6. This Final Written Decision is issued pursuant to 35 U.S.C. § 318(a)
`and 37 C.F.R. § 42.73. For the reasons discussed herein, we determine that
`Cardiovascular Systems, Inc., (“Petitioner”) has shown, by a preponderance
`of the evidence, that claims 1–14 (“the challenged claims”) of U.S. Patent
`No. 8,728,091 B2 (Ex. 1001, “the ’091 patent”) are unpatentable.
`
`A. Procedural History
`Petitioner filed a Petition (Paper 1, “Pet.”) requesting an inter partes
`review of claims 1–14 of the ’091 patent. Petitioner relies on the declaration
`testimony of Dr. Morten Olgaard Jensen (Ex. 1002) to support its positions.
`Shockwave Medical, Inc., (“Patent Owner”) filed a Preliminary Response to
`the Petition (Paper 11, “Prelim. Resp.”). Pursuant to 35 U.S.C. § 314(a), on
`July 11, 2019, inter partes review was instituted on the following grounds:
`Claim(s) Challenged
`35 U.S.C. § Reference(s)/Basis
`1–14
`103
`Hawkins1 and Li2
`
`1–3, 10
`
`1–14
`
`1–14
`
`103
`
`103
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`103
`
`Hawkins and Chernenko3
`
`Hawkins, Chernenko and Li
`
`Hawkins and Heeren4
`
`
`
`
`1 Hawkins, et al., US 2009/0312768 A1, published December 17, 2009
`(Ex. 1003).
`2 US 2006/0221528 A1, published October 5, 2006 (Ex. 1004).
`3 US 2003/0176873 A1, published September 18, 2003 (Ex. 1005).
`4 US 2013/0041355 A1, published February 14, 2013 (Ex. 1006).
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`See Paper 14 (“Inst. Dec.”).
`Subsequent to institution, Patent Owner filed a Patent Owner
`Response (Paper 34, “PO Resp.”), along with a Declaration of Daniel W.
`van der Weide, Ph.D. (Ex. 2100) to support its positions. Petitioner filed a
`Reply (Paper 48, “Pet. Reply”) to the Patent Owner Response, along with a
`Supplemental Declaration of Dr. Jensen (Ex. 1200), and Patent Owner filed
`a Sur-Reply (Paper 55, “Sur-Reply”).
`Petitioner filed a Motion to Exclude certain exhibits. Paper 62 (“Pet.
`MTE”). Thereafter, Patent Owner filed an Opposition to Petitioner’s Motion
`to Exclude (Paper 65, “PO MTE Opp.”).
`Patent Owner also filed a Motion to Exclude certain exhibits.
`Paper 61 (“PO MTE”). Petitioner filed an Opposition to Patent Owner’s
`Motion to Exclude (Paper 63, “Pet. MTE Opp.”).
`An oral hearing was held on April 16, 2020. A transcript of the
`hearing is included in the record. Paper 74 (“Tr.”).
`
`B. Related Proceedings
`Petitioner states that it “is not aware of any judicial or administrative
`matter that would affect, or be affected by, a decision in the proceeding.”
`Pet. 64. Patent Owner identifies concurrently filed petitions for inter partes
`review, IPR2019-00405 and IPR2019-00408, as related proceedings.
`Paper 3, 2. In addition, Patent Owner identifies several issued U.S. patents
`and applications as related matters. Id. at 2–3.
`
`C. The ’091 Patent
`The ’091 patent “relates to a treatment system for percutaneous
`coronary angioplasty or peripheral angioplasty in which a dilation catheter is
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`used to cross a lesion in order to dilate the lesion and restore normal blood
`flow in the artery.” Ex. 1001, 1:15–18. Figure 1 below illustrates a
`simplified view of an angioplasty balloon catheter.
`
`
`
`Figure 1 shows an angioplasty balloon catheter 20 including hollow
`sheath 21, dilating balloon 26, and guidewire 28. Id. at 7:34–40. The
`catheter includes shock wave generator 25, i.e., at least one pair of
`electrodes 22 and 24, within balloon 26 to generate a high voltage arc across
`the electrodes. Id. at 1:45–51. “The arc in turn causes a steam bubble to
`form” and “[e]ach steam bubble has the potential of producing two shock
`waves, a leading edge shock wave as a result of bubble expansion and a
`trailing edge wave as a result of bubble collapse.” Id. at 1:56–62. Through
`use of repeated shockwaves, the calcified lesions can be broken up without
`damaging the surrounding tissue. Id. at 1:53–54. Because the trailing edge
`shock waves exhibit highly variable and greater energy levels, the
`’091 patent describes using the leading edge shock waves to create the steam
`bubble. Id. at 2:8–10. Even though the leading edge shock waves exhibit
`lower energy levels, these shock waves are a more consistent energy level.
`Id.
`
`The ’091 patent explains that “it has been learned that to sustain a
`leading edge shock wave, it is not necessary to sustain the high voltage
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`throughout the shock wave” because it does not produce a shock wave of
`greater intensity and the heat produced by the steam bubbles may damage
`tissue. Id. at 2:21–29. Therefore, “there is a need to control the applied
`energy to assure appropriate bubble and shock wave formation while at the
`same time conserving electrode material and assuring tissue safety.” Id.
`at 2:49–52. The ’091 patent explains that problems may be avoided and
`certain advantages are achieved by including a power source with a current
`sensor that sends signals to terminate the high voltage supply when current
`flow reaches a predetermined limit. Id. at 3:1–10, 8:20–40.
`
`D. Illustrative Claims
`Petitioner challenges claims 1–14 of the ’091 patent. Independent
`claims 1 and 10 are illustrative of the challenged claims and are reproduced
`below:
`
`A balloon catheter for delivering shockwaves to a
`1.
`calcified lesion comprising:
`an elongated carrier;
`a flexible balloon mounted on the elongate carrier,
`said balloon being fillable with a conductive fluid;
`a pair of electrodes on the elongated carrier within the
`balloon; and
`a power source coupled to the electrodes for supplying
`voltage pulses to the electrodes, each voltage pulse generating an
`arc in the fluid within the balloon and causing current to flow
`between the electrodes and producing a shockwave;
`wherein the power source includes a current sensor for
`detecting the current flow between the electrodes during each
`voltage pulse, and wherein when the current reaches a
`predetermined value during each voltage pulse, the sensor
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`generates a signal that causes the power source to terminate the
`voltage supplied to the electrodes for that pulse.
`Ex. 1001, 11:28–46.
`
`
`10. A method for delivering shockwaves to a calcified
`lesion comprising:
`advancing a balloon catheter to a calcified lesion wherein
`the balloon catheter includes an elongated carrier, a flexible
`balloon, and a pair of electrodes on the elongated carrier within
`the balloon, wherein the electrodes are connected to a power
`source;
`activating the power source to supply one or more voltage
`pulses to the electrodes such that during each pulse, an arc is
`generated in the balloon and a current flows between the
`electrodes producing a shockwave;
`detecting when the current reaches a predetermined value
`during each pulse; and
`terminating the voltage supplied to the electrodes after the
`current reaches the predetermined value for that pulse.
`Id. at 12:19–33. The remaining independent claims, claims 6 and 14, differ
`primarily in that each additionally requires termination of the voltage supply
`at a predetermined time after the current has reached a predetermined
`threshold. Id. at 11:59–12:12, 12:41–61 (claim 14 requiring a “delay timer”
`to trigger the timer in response to the current sensor signal).
`
`II. ANALYSIS
`
`A. Applicable Law
`To prevail in its challenges to the patentability of the claims,
`Petitioner must demonstrate by a preponderance of the evidence that the
`challenged claims are unpatentable. 35 U.S.C. § 316(e) (2018). “In an
`[inter partes review], the petitioner has the burden from the onset to show
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`with particularity why the patent it challenges is unpatentable.” Harmonic
`Inc. v. Avid Tech., Inc., 815 F.3d 1356, 1363 (Fed. Cir. 2016) (citing
`35 U.S.C. § 312(a)(3) (requiring inter partes review petitions to identify
`“with particularity . . . the evidence that supports the grounds for the
`challenge to each claim”)). This burden of persuasion never shifts to the
`patent owner. See Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800
`F.3d 1375, 1378 (Fed. Cir. 2015) (discussing the burden of proof in inter
`partes review). Furthermore, a petitioner cannot satisfy its burden of
`proving obviousness by employing “mere conclusory statements.” In re
`Magnum Oil Tools Int’l, Ltd., 829 F.3d 1364, 1380 (Fed. Cir. 2016).
`A claim is unpatentable under 35 U.S.C. § 103 if the differences
`between the claimed subject matter and the prior art are such that the subject
`matter, as a whole, would have been obvious at the time of the invention to a
`person having ordinary skill in the art. KSR Int’l Co. v. Teleflex Inc., 550
`U.S. 398, 406 (2007). The question of obviousness is resolved on the basis
`of underlying factual determinations including: (1) the scope and content of
`the prior art; (2) any differences between the claimed subject matter and the
`prior art; (3) the level of ordinary skill in the art; and (4) objective evidence
`of nonobviousness. Graham v. John Deere Co., 383 U.S. 1, 17–18 (1966).
`Consideration of the Graham factors “helps inform the ultimate obviousness
`determination.” Apple Inc. v. Samsung Elecs. Co., 839 F.3d 1034, 1048
`(Fed. Cir. 2016) (en banc), cert. denied, 138 S. Ct. 420 (2017).
`To prevail in an inter partes review, Petitioner must explain how the
`proposed combinations of prior art would have rendered the challenged
`claims unpatentable. An obviousness analysis “need not seek out precise
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`teachings directed to the specific subject matter of the challenged claim, for
`a court can take account of the inferences and creative steps that a person of
`ordinary skill in the art would employ.” KSR, 550 U.S. at 418; accord In re
`Translogic Tech., Inc., 504 F.3d 1249, 1259 (Fed. Cir. 2007). However,
`Petitioner cannot satisfy its burden of proving obviousness by employing
`“mere conclusory statements,” but “must instead articulate specific
`reasoning, based on evidence of record” to support an obviousness
`determination. In re Magnum Oil Tools Int’l, Ltd., 829 F.3d 1364, 1380–81
`(Fed. Cir. 2016). Petitioner also must articulate a reason why a person of
`ordinary skill in the art would have combined the prior art references. In re
`NuVasive, 842 F.3d 1376, 1382 (Fed. Cir. 2016).
`At this final stage, we determine whether a preponderance of the
`evidence of record shows that the challenged claims would have been
`rendered obvious in view of the asserted prior art. We analyze the asserted
`grounds of unpatentability in accordance with these principles.
`
`B. Level of Ordinary Skill in the Art and Dr. Jensen’s testimony
`1. Level of Ordinary Skill in the Art
`We review the grounds of unpatentability in view of the
`understanding of a person of ordinary skill in the art at the time of the
`invention. Graham, 383 U.S. at 17. Petitioner submits that the ordinarily
`skilled artisan would have
`knowledge roughly equivalent to the knowledge and/or training
`of a person holding the degree of Bachelor of Science in
`Mechanical Engineering, Electrical Engineering, Biomedical
`Engineering, or equivalent, and between three and five years of
`practical experience, including familiarity with the various
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`medical devices and techniques for angioplasty lithotripsy,
`and/or familiarity with electro-pulsed surgical devices generally.
`Pet. 7; see Ex. 1002 ¶¶ 36–37.
`Patent Owner disagrees and contends that the level of ordinary skill in
`the art requires:
`(1) a masters or doctorate degree in electrical engineering or
`related field of study or an equivalent understanding of the
`relevant aspects of the generation and management of electrical
`arcs; and (2) at least two years’ experience in electrohydraulic
`shockwave devices or an equivalent understanding of the
`relevant aspects of generation and management of shockwaves
`and pulsed signals.
`PO Resp. 16 (quoting Ex. 2100 ¶ 71).
`
`The parties’ positions primarily differ in that Patent Owner suggests
`an advanced degree, i.e., “a masters or doctorate degree in electrical
`engineering” and two years of experience in electrohydraulic shockwave
`devices is required. Id. Petitioner, instead, explains that a bachelor’s degree
`in mechanical engineering, electrical engineering, or biomedical
`engineering, with at least three years of experience in angioplasty lithotripsy
`or electro-pulsed surgical devices, is required though “[s]pecific study
`and/or experience conditions may be met by equivalent experience,
`education, or training.” Pet. 7; Ex. 1002 ¶¶ 34–38.
`On this record, the parties’ positions are similar. On education,
`Petitioner includes other engineering disciplines in addition to electrical
`engineering and does not require an advanced degree as a basis for attaining
`ordinary skill. However, Petitioner contends that more experience in the
`field is needed to attain ordinary skill. Id. Based on the record, we adopt
`Patent Owner’s definition of the ordinarily skilled artisan as consistent with
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`the level of skill necessary to address the problems encountered in this
`field.5 Further, we find that the prior art of record reflects the level of skill
`in the art at the time of the invention. See Okajima v. Bourdeau, 261 F.3d
`1350, 1355 (Fed. Cir. 2001).
`
`2. Dr. Jensen’s Testimony
`Patent Owner asserts that Dr. Jensen’s testimony should be afforded
`little, if any weight. PO Resp. 14. Patent Owner contends that “Dr. Jensen
`… does not have this [requisite] level of skill even today.” Id. at 16.
`Specifically, Patent Owner contends that Dr. Jensen did not understand the
`concepts of inductance and negative resistance nor did he understand certain
`figures from the prior art. Id. at 16–17. As a result, Patent Owner contends
`that “Dr. Jensen is not skilled in the relevant art [and] his opinions are
`entitled to little, if any, weight.” Id. at 18.
`Petitioner argues that the concept of negative resistance is not relevant
`to the case (Pet. Reply 6–10) and that “Chernenko purposefully did not
`disclose the details of various components in Fig. 4b” (id. at 18). Petitioner
`further asserts that “Dr. Jensen is qualified as an expert under either party’s
`definition of a [person of ordinary skill in the art] [as] established in the
`Petition.” Id. at 6.
`We agree with Petitioner that Dr. Jensen’s background and experience
`meets the level of skill in the art that we adopt in this case. See Ex. 1002
`
`
`
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`5 Though we adopt Patent Owner’s definition of the level of skill in the art,
`the outcome of our Decision would remain the same under Petitioner’s
`proposed definition.
`
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`¶¶ 8–13 (statement of qualifications), Appendix A (curriculum vitae) (listing
`a bachelor’s degree in electrical engineering, master’s degree in biomedical
`engineering, and doctoral degrees in medical science). Furthermore, a
`declarant’s expertise and experience need not match perfectly the experience
`and education of a person of ordinary skill in the art in order to provide
`testimony so long as there is an adequate relationship between the
`declarant’s education and experience when compared to the claimed
`invention. SEB S.A. v. Montgomery Ward & Co., Inc., 594 F.3d 1360, 1373
`(Fed. Cir. 2010). Accordingly, we find that Dr. Jensen is qualified to testify
`about the perspective of one of ordinary skill in the art at the time of the
`invention.
`
`C. Claim Construction
`In an inter partes review filed after November 13, 2018, we construe
`claims “using the same claim construction standard that would be used to
`construe the claim in a civil action under 35 U.S.C. 282(b), including
`construing the claim in accordance with the ordinary and customary
`meaning of such claim as understood by one of ordinary skill in the art and
`the prosecution history pertaining to the patent.” See Changes to the Claim
`Construction Standard for Interpreting Claims in Trial Proceedings Before
`the Patent Trial and Appeal Board, 83 Fed. Reg. 51,340, 51,340, 51,358
`(Oct. 11, 2018) (now codified at 37 C.F.R. pt. 42);6 see also Phillips v. AWH
`Corp., 415 F.3d 1303 (Fed. Cir. 2005) (en banc).
`
`
`
`6 On October 11, 2018, the USPTO revised its rules to harmonize the
`Board’s claim construction standard with that used in federal district court.
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`1. “predetermined value” and “predetermined delay time”
`Petitioner provides proposed constructions for the terms
`“predetermined value” (Pet. 8) and “predetermined delay time” (id. at 9).
`Petitioner asserts “predetermined value” means “a value set in advance” and
`“predetermined delay time” means “an amount of delay time set in
`advance.” Id. at 9– 10. Patent Owner does not propose any express
`construction for any claim language. See generally PO Resp. Neither party
`argues that the construction of either term is dispositive of any issue
`presented in this inter partes review. Accordingly, we need not resolve the
`meaning of terms “predetermined value” or “predetermined delay time.”
`See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d
`1013, 1017 (Fed. Cir. 2017) (citing Vivid Techs., Inc. v. Am. Sci. & Eng’g,
`Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (“[O]nly those terms need be
`construed that are in controversy, and only to the extent necessary to resolve
`the controversy.”)).
`
`2. “terminate the voltage supplied to the electrodes for that pulse”
`The relevant claim language is reproduced below:
`wherein the power source includes a current sensor for detecting
`the current flow between the electrodes during each voltage
`pulse, and wherein when the current reaches a predetermined
`value during each voltage pulse, the sensor generates a signal that
`causes the power source to terminate the voltage supplied to the
`electrodes for that pulse.
`
`
`
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`This rule change applies to petitions filed on or after November 13, 2018.
`Id.
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`Ex. 1001, 11:40–46 (emphasis added). Though neither party requested in
`their briefing that we construe the phrase “terminate the voltage supplied to
`the electrode for that pulse” (see generally Pet., PO Resp.; Tr. 71:17–72:4),
`the issue arises in Petitioner’s reply brief where it addresses the relevance of
`“inductance and negative resistance” raised by Patent Owner in its Patent
`Owner Response.
`
`According to Patent Owner, “[a] phenomenon known as ‘negative
`resistance’ is inherent in electric arc generation [and] . . . provides that at
`ambient pressure or above, when extinguishing a pulse the voltage must
`increase before current may decrease.” PO Resp. 10 (citing Ex. 2100
`¶¶ 38–50, 151). Patent Owner explains that the “negative resistance
`phenomenon (and the associated delay) poses a significant hurdle in arc
`termination in the context of the device claimed in the ’091 patent.” Id.
`at 13 (citing Ex. 2100 ¶¶ 43, 45). Inductance similarly results in a delay that
`“prohibit[s] rapid and reliable termination of a voltage pulse,” which “would
`also generally defeat any attempt to prematurely terminate a pulse that is
`generally 3 s or less.” Id. at 15 (citing Ex. 2100 ¶¶ 37, 45, 50, 52). Patent
`Owner alleges that the delay caused by inductance together with negative
`resistance “pose[s] a significant challenge with respect to early termination
`of an arc-generating high voltage pulse in the context of the device claimed
`in the ‘091 patent.” Id. (citing Ex. 2100 ¶ 50).
`
`It its Reply, Petitioner explained that both inductance and negative
`resistance are not relevant because “element 1[e] states that the ‘power
`source terminates the voltage supplied to the electrodes for that pulse,’ not
`the voltage ‘at’ the electrodes (i.e., not the voltage pulse, the current, or the
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`resulting arc).” Pet. Reply 6–7. According to Petitioner, its understanding
`of the claim language is supported by the Specification. Id. at 7 (citing
`Ex. 1001, 7:50–51, 9:11–18, Figs. 2, 6). Petitioner asserts that the
`’091 patent Specification fails to discuss negative resistance or inductance or
`offer any solution for its effects. Id. at 8.
`Patent Owner in its Sur-Reply contends that Petitioner “contrive[s] a
`new Reply claim construction under which the ‘voltage pulse’ need not be
`terminated” and is in conflict with positions taken in the Petition. Sur-
`Reply 2. According to Patent Owner, Petitioner originally took the position
`that the “claims are obvious because the prior art allegedly taught
`termination of voltage pulses,” but now asserts that “the ‘voltage pulse’ need
`not be terminated” because “the claim requires terminating the ‘voltage
`supplied to the electrodes.’” Id. at 2–3. Patent Owner contends that
`Petitioner’s new argument “runs counter to the claim language,
`specification, file history, expert testimony, and the immutable scientific
`principles underlying the operation of the devices in question.” Id. at 3.
`Patent Owner explains that according to the claims and the Specification,
`“[t]here is no difference between the ‘voltage pulse supplied to the
`electrodes’ and the ‘voltage supplied to the electrodes for that pulse.’ In
`other words, the ‘voltage supplied to the electrodes for that pulse’ is the
`voltage pulse.” Id. at 4. Patent Owner further asserts that claim
`amendments during prosecution confirm this understanding. Claim 1 was
`amended as follows:
`a power source coupled to the electrodes for supplying [[a]]
`voltage pulses to the electrodes, to generate each voltage pulse
`generating an arc . . .
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`wherein the power sources includes a current sensor for detecting
`the current flow between the electrodes during each voltage
`pulse, and wherein the current reaches a predetermined value
`during each voltage pulse, the sensor generates a signal that
`causes the power source to terminate the voltage supply supplied
`to the electrodes for that pulse.
`Ex. 1010A, 32. Therefore, Patent Owner contends that it is the voltage pulse
`itself that is terminated. Sur-Reply 5.
`
`Any claim construction analysis must begin with the words of the
`claim as the claim defines the scope of the invention. See Vitronics Corp. v.
`Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996). The claim,
`however, is not read in isolation but rather in view of the specification.
`Phillips, 415 F.3d 1315; Vitronics, 90 F.3d at 1582 (characterizing the
`specification as “the single best guide to the meaning of a disputed claim”).
`In addition, the prosecution history should be examined because it “provides
`evidence of how the PTO and the inventor understood the patent.” Phillips,
`415 F.3d at 1317. Applying these principles, we agree with Petitioner that a
`current sensor that “generates a signal that causes the power source to
`terminate the voltage supplied to the electrodes for that pulse” means that
`the power source terminates the voltage supplied to the electrodes and not,
`as Patent Owner suggests, a signal that instantaneously terminates the
`voltage pulse across or at the electrode. Sur-Reply 5–6. The plain language
`of the claim is consistent with the Specification, which repeatedly describes
`application and termination of the voltage supplied to the electrodes. See,
`e.g., Ex. 1001, 2:47–49; 2:67–3:4, 6:5–9, 9:18–23, 10:47–49. The
`prosecution history does not compel a different reading.
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`Patent Owner does not propose any express construction but
`
`nevertheless invites us to construe “terminate the voltage supplied to the
`electrodes for that pulse” as terminating the voltage pulse across (or at) the
`electrodes for that pulse. According to Patent Owner, such an understanding
`is the only way to achieve the intended purpose of the ’091 patent, i.e.,
`“termination of the voltage pulse during that pulse and that allows the
`benefits of electrode there and heat reduction to be controlled – to be
`achieved.” Tr. 77:20–78:7; Sur-Reply 4 (“That benefit occurs only if the
`voltage pulse across the electrodes is actually shortened which is
`synonymous with terminating the voltage pulse.” (emphasis added)). While
`claims are generally interpreted in light of the purpose of the invention, the
`purpose of the invention cannot be used to rewrite the claims or displace the
`plain, unambiguous meaning of the words. Innova/Pure Water, Inc. v.
`Safari Water Filtration Sys., Inc., 381 F.3d 1111, 1117 (Fed. Cir. 2004)
`(explaining that claims are interpreted in light of the specification but
`caution must be taken to avoid reading limitations into the claims); Teleflex
`Inc. v. Ficosa N. Am. Corp., 299 F.3d 1313, 1326 (Fed. Cir. 2002) (“[T]he
`claims must be read in view of the specification, but limitations from the
`specification are not read into the claims.” (citation omitted)). Despite the
`opportunity to amend, Patent Owner did not amend its claim to state that the
`voltage pulse itself was terminated.7 Innova/Pure Water, 381 F.3d at 1119
`
`
`
`
`7 Patent Owner amended claim 1 to add “pulse” or “voltage pulse” five times
`(see Ex. 1010A, 32) yet did not amend the language to state that the “voltage
`pulse” was terminated.
`
`16
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`IPR2019-00409
`Patent 8,728,091 B2
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`(“[W]hen an applicant uses different terms in a claim it is permissible to
`infer that he intended his choice of different terms to reflect a differentiation
`in the meaning of those terms.”). As written, the signal causes the power
`source to terminate the voltage supplied to the electrodes—without express
`limitations on the timing or effect on the voltage pulse across the electrodes;
`we will not discount the differences in Patent Owner’s choice of words. In
`re Hiniker Co., 150 F.3d 1362, 1368–69 (Fed. Cir. 1998) (“The invention
`disclosed in . . . [the] written description may be outstanding in its field, but
`the name of the game is the claim.”).
`
`D. Obviousness in view of Hawkins and Li
`Petitioner contends the subject matter of claims 1–14 would have been
`obvious over the combined disclosures of Hawkins and Li. Pet. 12–35.
`
`1. Hawkins
`Hawkins discloses a treatment system for the dilation of calcified
`lesions or plaque in an artery wall. Ex. 1003 ¶ 2. According to Hawkins,
`the invention includes a catheter comprising an elongated carrier, a dilating
`balloon, and an arc generator comprising at least one electrode pair within
`the balloon. Id. ¶ 3. The arc generator is connected to a power source and
`arcs across the electrodes to form shockwaves within the balloon that are
`used to break up the calcified lesion. Id. ¶¶ 10, 51. One exemplary
`embodiment is shown below in Figure 15.
`
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`17
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`IPR2019-00409
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`Figure 15 illustrates a dilation catheter 110 with a balloon 116. Id. ¶ 64.
`The catheter includes a parabolic reflector 114, which acts as an electrode,
`and electrode 112 between which an arc is formed that generates a
`shockwave focused on the calcified lesion. Id. The catheter may be
`equipped with a sensor, located on the distal end on one electrode, to sense
`reflected energy. Id. ¶¶ 6, 58.
`
`2. Li
`Li discloses a system and method for “providing over-current
`protection in a switching power supply.” Ex. 1004 ¶ 2. According to Li, the
`switching power supply may include a current sense circuit and a shut-off
`circuit. Id. ¶ 5. For example, when the over-current protection circuit
`receives a measured current value from the current sense circuit, the “over-
`current detector 50 determines that the measured current is between a first
`predetermined over-current threshold and a second predetermined over-
`current threshold, then the level 1 over-current detector 50 activates the
`level 1 cycle pulse adjust circuit 54.” Id. ¶ 24. The gate logic controller
`then begins “narrowing pulses or deactivating pulses.” Id. The cycle pulse
`18
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`IPR2019-00409
`Patent 8,728,091 B2
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`adjust circuit may also be connected to a shut-off circuit where “[t]he level 1
`shut-off circuit 58 monitors the activity of the level 1 cycle pulse adjust
`circuit 54 and issues a shut-off command . . . upon the occurrence of a
`level 1 predetermined threshold condition.” Id. ¶ 25. The shut-off circuit
`may include a timer where “[u]pon the timer reaching a predetermined time,
`the level 1 shut-off circuit 58 could issue the shut-off command.” Id.
`
`3. Analysis of Claim 1
`Petitioner argues that “Hawkins discloses all the features of claim 1,
`except it may not expressly disclose directly sensing current to control
`voltage pulses.” Pet. 12. Petitioner asserts that Hawkins describes a balloon
`catheter that includes an elongated carrier, a flexible balloon, a pair of
`electrodes within the balloon, and a power source to generate current arcs
`within the fluid to produce shockwaves. Id. at 12–14 (citing Ex. 1003 ¶¶ 2,
`3, 10, 14, 19, 38, 42, 45, 46, 49–55, 56–62, 64 and Figs. 2–15; Ex. 1002
`¶¶ 79–83). Relevant to the claimed current sensor, Petitioner argues that
`Hawkins describes a sensor located on the distal end of one electrode to
`detect reflected energy signals. Id. at 15 (citing Ex. 1003 ¶¶ 6, 15, 22, 37,
`57–58, Fig. 9; Ex. 1002 ¶ 85). In particular, Dr. Jensen testifies that,
`because the reflected energy indicates effectiveness of the shockwave
`resultant from the current flow, it is analogous to current sensing. Id.; see
`also Ex. 1002 ¶ 84 (same).
`Additionally, Petitioner asserts that Li describes a current sense circuit
`that detects current levels and provides the measured current to the over-
`current protection circuit. Pet. 16. “When the sensor detects the threshold
`current level, Li narrows (terminates) the voltage pulse to limit the amount
`19
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`IPR2019-00409
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`of current applied” for each pulse. Id. at 16–17 (citing Ex. 1004 ¶¶ 24).
`Petitioner reasons that the person of ordinary skill in the art would have
`reason to combine Hawkins and Li to “reduce the risk of shock to the user
`and the subject, as well as the device itself.” Id. at 17–18 (citing Ex. 1002
`¶¶ 95–96). Dr. Jensen testifies that, in addition to the practical advantage of
`avoiding electric shock, reducing shock risk provides advantages such as
`enhanced device lifetime, enhanced device reliability, and reduced warranty
`issues. Ex. 1002 ¶¶ 95–98; see also Pet. 18–19 (same).
`
`Petitioner also argues that Li’s level 1 shut-off circuit independently
`meets the current sensing requirements of claim 1 alone or together with Li’s
`current sense circuit. Pet. 20. Petitioner explains that the shut-off circuit
`initiates a delay timer once a threshold current is sensed. Id. When the
`delay timer reaches a predetermined time, the shut-off circuit issues a shut-
`off command to terminate the pulse. Id. Petitioner reasons that when
`applied individually, the shut-off circuit “reduce[s] processing requirements,
`avoid[s] response lag-time, and provide[s] reliably-timed voltage
`termination.” Id. at 20–21; see Ex. 1002 ¶¶ 103–104. When applied in
`combination with the current sense circuit, Petitioner asserts “Li’s overriding
`protection provides an additional layer of reliability in current protection.”
`Pet. 21 (citing Ex. 1002 ¶¶ 103–105).
`
`Petitioner asserts that “Li is from the same field of contr
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