Trials@uspto.gov
`571.272.7822
`
` Paper No. 12
`
`
`
` Entered: December 29, 2016
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`MEDTRONIC XOMED, INC.,
`Petitioner,
`
`v.
`
`NEUROVISION MEDICAL PRODUCTS, INC.,
`Patent Owner.
`____________
`
`Case IPR2016-01405
`Patent 8,634,894 B2
`____________
`
`
`
`Before WILLIAM V. SAINDON, RICHARD E. RICE, and
`MICHAEL L. WOODS, Administrative Patent Judges.
`
`WOODS, Administrative Patent Judge.
`
`DECISION
`Institution of Inter Partes Review
`37 C.F.R. § 42.108
`
`
`
`
`
`
`
`
`
`
`571.272.7822
`
` Paper No. 12
`
`
`
` Entered: December 29, 2016
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`MEDTRONIC XOMED, INC.,
`Petitioner,
`
`v.
`
`NEUROVISION MEDICAL PRODUCTS, INC.,
`Patent Owner.
`____________
`
`Case IPR2016-01405
`Patent 8,634,894 B2
`____________
`
`
`
`Before WILLIAM V. SAINDON, RICHARD E. RICE, and
`MICHAEL L. WOODS, Administrative Patent Judges.
`
`WOODS, Administrative Patent Judge.
`
`DECISION
`Institution of Inter Partes Review
`37 C.F.R. § 42.108
`
`
`
`
`
`
`
`
`
`
`
`IPR2016-01405
`Patent 8,634,894 B2
`
`I. INTRODUCTION
`A. Background
`Medtronic Xomed, Inc. (“Petitioner”) filed a Petition requesting inter
`partes review of claims 1–19 of U.S. Patent No. 8,634,894 B2 (Ex. 1001,
`“the ’894 patent”) pursuant to 35 U.S.C. §§ 311–319. Paper 2 (“Pet.”).
`Neurovision Medical Products, Inc. (“Patent Owner”) filed a Preliminary
`Response to the Petition. Paper 6 (“Prelim. Resp.”). We have jurisdiction
`under 35 U.S.C. § 314, which provides that an inter partes review may not
`be instituted “unless . . . the information presented in the petition . . . shows
`that there is a reasonable likelihood that the petitioner would prevail with
`respect to at least 1 of the claims challenged in the petition.”
`We conclude that Petitioner has demonstrated that there is a
`reasonable likelihood that it would prevail with respect to at least one of the
`challenged claims. For the reasons described below, we institute an inter
`partes review as to claims 1–19 of the ’894 patent.
`
`
`B. Related Proceedings
`Petitioner notifies us that it is a named defendant in a patent
`
`infringement litigation involving the ’894 patent. Pet. 1 (referencing case
`No. 2:16-CV-00127, pending in the U.S. District Court for the Eastern
`District of Texas). Petitioner also notifies us that it has filed concurrently
`with this Petition a second inter partes review petition of the ’894 patent,
`which we identify as IPR2016-01406, and further notifies us of the existence
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`of a third inter partes review of the ’894 patent, now terminated, filed by
`another petitioner. Id. (referencing IPR2015-00502).1
`
`C. The ’894 patent (Ex. 1001)
`The ’894 patent is titled “Electrode for Prolonged Monitoring of
`
`Laryngeal Electromyography” and issued on January 21, 2014. Ex. 1001, 1.
`The ’894 patent discloses a laryngeal electromyography tube having
`electrodes, electrical traces, and conductive pads directly imprinted on the
`surface of, and thus substantially flush with, the surface of the tube, which
`permit the tube to be used for prolonged monitoring, such as in excess of
`eight hours. See id. at col. 1, l. 45–col. 2, l. 2; col. 6, ll. 30–58. The
`electrodes, electrical traces, and conductive pads are formed with conductive
`ink or paint that comprises a mixture of conductive materials dissolved or
`suspended in a liquid carrier. See id. at col. 4, l. 49–col. 5, l. 16. The ink or
`paint can be applied on the surface of the tube by “painting, screen printing,
`transfer printing, gravure, flexographic or offset printing, as well as inkjet or
`electrostatic printing methods.” Id. at col. 6, ll. 5–7.
`
`The ’894 patent discloses various embodiments, in which the number
`and placement of the electrodes vary. See, e.g., id. at Figs. 1, 2, 4, 7. Figure
`7 depicts an embodiment in which two electrodes are placed on the tube
`such that one electrode is in contact with the vocal cords and a second
`electrode is in contact with the tongue when the tube is in use. Ex. 1001,
`col. 4, ll. 43–46. Figure 7 is reproduced below.
`
`
`1 On July 16, 2015, the Board instituted an inter partes review of claims 4,
`6–11, and 14–19, as unpatentable over Goldstone, Lowery, and Hon, but
`denied institution of claims 1–3, 5, 12, and 13 of the ’894 patent, in
`IPR2015-00502. Paper 15, 30.
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`Figure 7 depicts laryngeal electromyography tube 60 having
`endotracheal tube 12 imprinted with two electrodes 62 and 64. Id. at col. 4,
`ll. 43–46.
`Figure 8 depicts the embodiment of Figure 7 in use and is reproduced
`below. Id. at col. 4, l. 43.
`
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`As shown above in Figure 8, electrode 62 contacts the vocal cords
`while second electrode 64 “rests against the tongue.” Ex. 1001, col. 4, ll.
`43–46.
`As shown in the embodiment of Figures 7 and 8, conductive trace 20
`
`connects electrode 62 to conductive pad 22, which attaches to lead wires 24
`of an external device. See id. at col. 4, ll. 2–13, 46–48. Tube 60 also has an
`endotracheal tube balloon 15 for retaining, presumably, tube 60 in a desired
`position when in use. See id. at col. 4, ll. 2–3.
`
`
`D. Claims
`Claims 1, 4, 10, and 14 are independent, with claims 2 and 3
`depending from claim 1, claims 5–9 depending from claim 4, claims 11–13
`depending from claim 10, and with claims 15–19 depending from claim 14.
`Ex. 1001, col. 7, l. 7–col. 9, l. 32. Claim 1 is illustrative of the subject
`matter at issue and is reproduced below:
`1. A device for use in monitoring electrical signals during
`laryngeal electromyography comprising:
`
`an endotracheal tube having a retention balloon at or
`adjacent a distal end thereof, said tube having on its outer surface
`first and second electrically conductive electrodes applied
`proximal of the balloon directly to the surface of the tube,
`without the inclusion of a carrier film between the tube surface
`and the electrodes, said first and second electrodes electrically
`isolated from each other, at least one of said electrically
`conductive electrodes positioned to contact the vocal cords, the
`second electrode positioned to contact tissue, nerves and muscle
`in the trachea or the tongue when the tube is positioned in the
`trachea,
`
`said tube having on its surface first and second electrically
`conductive traces, said traces electrically isolated from each
`other, each trace connected to or integral with an electrode, the
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`Patent 8,634,894 B2
`traces applied directly to the tube surface and running along the
`length of the endotracheal tube to a proximal portion of the tube,
`
`a proximal connection point connected to or integral with
`each of the conductive traces, the connection points applied
`directly to the tube surface at a proximal end of the traces on the
`endotracheal tube, and
`
`electrical leads connected to the connection points, said
`leads adapted for connection to monitoring equipment,
`
`the electrically conductive traces covered by an insulating
`material along their length from a point adjacent the electrodes
`to a point adjacent the connection points.
`
`
`E. Asserted Ground of Unpatentability
`Petitioner asserts that claims 1–19 are obvious over Lowery,2
`Goldstone,3 and Hon.4 Pet. 2.
`To support its Petition, Petitioner submits the declarations of
`Dr. Andrew C. Goldstone (Ex. 1009, “Goldstone Decl.”) and Mr. Guy
`Lowery (Ex. 1012, “Lowery Decl.”). Dr. Goldstone is one of the inventors
`of the Goldstone patent (see Goldstone Decl. ¶ 1), and Mr. Lowery is a
`named inventor of the Lowery application (see Lowery Decl. ¶ 13).
`
`
`II. ANALYSIS
`A. 35 U.S.C. § 325(d)
`A threshold issue before us is whether we should exercise our
`discretion under 35 U.S.C. § 325(d) to deny the Petition.
`
`
`2 U.S. Patent App. Pub. No. 2009/0227885 A1 (published Sept. 10, 2009)
`(Ex. 1002) (also referred to herein as “the Lowery application”).
`3 U.S. Patent No. 5,024,228 (issued June 18, 1991) (Ex. 1003) (also referred
`to herein as “the Goldstone patent”).
`4 K.K. B. Hon, L. Li, and I.M. Hutchings, Direct Writing Technology —
`Advances and Developments, 57 CIRP Annuals – Manufacturing
`Technology 601–620 (2008) (Ex. 1005).
`
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`Institution of inter partes review is discretionary. See 35 U.S.C.
`§ 314(a); 37 C.F.R. § 42.108(a). Among the factors we consider in deciding
`whether to exercise discretion not to institute review are:
`(1) the resources of the Board;
`(2) the requirement under 35 U.S.C. § 316(a)(11) to issue a final
`determination not later than 1 year after the date on which the Director
`notices institution of review;
`(3) whether the same petitioner already previously filed a petition
`directed to the same claims of the same patent;
`(4) whether at the time of filing of the first petition the petitioner
`knew of the prior art asserted in the second petition or should have known
`about it;
`(5) whether at the time of filing of the second petition the petitioner
`already received patent owner’s preliminary response to the first petition or
`received the Board’s decision on whether to institute review in the first
`petition;
`(6) the length of time that elapsed between the time petitioner learned
`of the prior art asserted in the second petition and filing of the second
`petition; and
`(7) whether petitioner provides adequate explanation for the time
`elapsed between the filings of multiple petitions directed to the same claims
`of the same patent.
`See, e.g., NVIDIA Corp. v. Samsung Elec. Co., Ltd., Case IPR2016-00134,
`slip op. at 6–7 (PTAB May 4, 2016) (Paper 9).
`In short, we are concerned about fundamental fairness for both
`Petitioner and Patent Owner.
`
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`Patent Owner argues that we should deny the Petition because (1) the
`Petition relies upon prior art and arguments that are the same or substantially
`the same as considered during prior inter partes review IPR2015-00502 (the
`“’502 petition”), and (2) the Petition relies upon prior art and arguments that
`are the same or substantially the same as considered during the prosecution
`of the ’894 patent. Prelim. Resp. 15–21. We separately address each of
`these two arguments, below.
`First, and with respect to Patent Owner’s argument that we should
`deny the Petition due to the prior-filed ’502 petition (Prelim. Resp. 15–17),
`Patent Owner points out that Petitioner relies on the same combination of
`prior art references and the same declarations submitted with the ’502
`petition. Id. at 17. While acknowledging that a different petitioner filed the
`’502 petition, Patent Owner suggests that this fact should be given little
`weight, as “nothing in §325(d) limits its reach to the same petitioners[, and
`that, instead,] the determining factor is whether the ‘same or substantially
`the same prior art or arguments previously were presented to the Office.’”
`Id.
`
`Petitioner, on the other hand, argues that although the same prior art
`references are being applied as in the ’502 petition, “the prior petitioner did
`not rely on Lowery’s electrode positioning” and the prior petitioner relied
`upon an improper definition of trachea. Pet. 21, 2–4. We further note that
`the Board found error in the prior petitioner’s definition of “trachea” and
`denied institution of claims 1–3, 5, 12, and 13 as a result of that improper
`definition. Paper 15, 10, 15–16.
`Given the totality of facts noted above, we determine that it would be
`unfair to Petitioner to exercise our discretion under 35 U.S.C. § 325(d) to
`deny institution based on the prior-filed ’502 petition. Although the ’502
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`petition and the Petition before us each rely on the same prior art references,
`we agree with Petitioner that the arguments presented in the pending Petition
`are not the same as those presented in the prior petition, in that the pending
`Petition relies on a different interpretation of “trachea” and relies on
`different disclosures in the applied art. Additionally, the present Petitioner is
`different from the prior petitioner, and this fact also weighs against denying
`the Petition.
`Second, and with respect to Patent Owner’s argument that we should
`deny the Petition due to the prosecution history of the ’894 patent (Prelim.
`Resp. 17–21), Patent Owner acknowledges that Hon was not considered by
`the examiner during prosecution, but states that “Hon is cumulative of other
`prior art in the prosecution record.” Id. at 17. In support of the assertion
`that Hon is cumulative, Patent Owner references Petitioner’s statements that
`“Hon provides known techniques for manufacturing devices similar to
`Lowery and Goldstone” and that “[b]oth Lowery and Goldstone describe
`that the electrodes and other conductive elements . . . may be applied
`directly to the tube.” Id. (emphasis omitted) (citing Pet. 28, 26–27).
`Patent Owner’s second argument is not persuasive, as we disagree
`with Patent Owner’s assertion that Hon is cumulative simply because
`Petitioner makes statements as to the similarity among Hon, Goldstone, and
`Lowery. Rather, Patent Owner takes Petitioner’s statements out of context
`and ignores, selectively, the precise teachings of Hon that Petitioner relies
`upon, which are different from the teachings of Lowery and Goldstone. See,
`e.g., Pet. 28 (citing to Hon’s benefits of “cost reduction,” “process chain
`simplification,” “greater design freedom,” and “lower ‘environmental
`footprint’”).
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`We, thus, are not persuaded by Patent Owner’s argument that the
`same or substantially the same arguments were considered during
`prosecution of the ’894 patent. Prelim. Resp. 17.
`For the foregoing reasons, we decline to exercise our discretion under
`35 U.S.C. § 325(d) to deny the Petition.
`B. Claim Construction
`In an inter partes review, claim terms in an unexpired patent are given
`their broadest reasonable construction in light of the specification of the
`patent in which they appear. 37 C.F.R. § 42.100(b); Cuozzo Speed Techs.
`LLC v. Lee, 136 S. Ct. 2131, 2144–46 (2016) (upholding the use of the
`broadest reasonable interpretation standard). A presumption exists that a
`claim term should be construed in light of its ordinary and customary
`meaning. CCS Fitness, Inc. v. Brunswick Corp., 288 F.3d 1359, 1366 (Fed.
`Cir. 2002). Under the broadest reasonable construction standard, claim
`terms are generally given their ordinary and customary meaning, as would
`be understood by one of ordinary skill in the art in the context of the entire
`disclosure. In re Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir.
`2007).
`
`i. “trachea”
`Petitioner contends that “trachea” should be construed as “an
`anatomical structure that connects to the larynx below the vocal cords.” Pet.
`6 (citing Ex. 1009 ¶¶ 30–32). Petitioner asserts that this construction is
`consistent with the Board’s construction in IPR2015-00502. Id. (citing
`Paper 15, 10). We further note that in IPR2015-00502, the Board construed
`“trachea” as not including the vocal cords. Paper 15, 10 (“we agree with
`Patent Owner that the portions [of the Specification and prosecution history]
`do not define the trachea as including the vocal cords.”).
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`Patent Owner does not propose a different interpretation of “trachea.”
`At this time, we agree with and adopt Petitioner’s proposed
`construction that the trachea is an anatomical structure that connects to the
`larynx below the vocal cords, and does not include the vocal cords.
`
`
`ii. Remaining Claim Terms
`We determine that no other terms require express construction for the
`purposes of this Decision. See Wellman, Inc. v. Eastman Chem. Co., 642
`F.3d 1355, 1361 (Fed. Cir. 2011) (“[C]laim terms need only be construed ‘to
`the extent necessary to resolve the controversy.’”) (quoting Vivid Techs.,
`Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)).
`
`
`C. Overview of Prior Art
`i. Goldstone (Ex. 1003)
`Goldstone is a U.S. patent, which issued on June 18, 1991, and is
`titled “Electrode Endotracheal Tube.” Ex. 1003, 1. Goldstone discloses an
`endotracheal tube having electrodes for detecting electromyographic signals
`of the laryngeal muscles. Id. at Abstract. Figure 1 of Goldstone is
`reproduced below.
`
`11
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`
`Figure 1 depicts Goldstone’s electrode endotracheal tube 10 having
`fitting 14 on proximal end 11 and inflatable cuff 13 near distal end 12. Id. at
`col. 4, l. 64–col. 5, l. 13. Four electrode wires 16A, 16B, 16C, and 16D run
`between proximal end 11 and distal end 12. Id. at col. 5, ll. 14–18. Each
`electrode has first portion 42 that is insulated against electrical contact, and
`second portion 43 that is on outer surface 23 of the tube, is uninsulated, and
`is capable of forming electrical contact. Id. at col. 5, ll. 22–36. Electrical
`connecting plugs 19A, 19B, 19C, and 19D connect respective wires 16A,
`16B, 16C, and 16D to an electromyographic processing machine (not
`shown) and may be “ports, alligator clips or insulated wires with bared
`ends.” Id. at col. 5, ll. 58–63.
`Notably, Goldstone discloses that the insulated wires could be “any
`type of electrically conducting lead suitable for use as an electrode,
`including metal paint, metallic tape or metal strips.” Id. at col. 5, ll. 18–21
`(emphasis added).
`
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`In use, exposed second wire portion 43 is “positioned on the tube so
`that the uninsulated portion contacts a set of laryngeal muscles, particularly
`a vocal cord of that set, when the endotracheal tube is properly positioned.”
`Id. at col. 3, ll. 40–44; col. 5, l. 65–col. 6, l. 9; Fig. 6.
`
`
`ii. Lowery (Ex. 1002)
`
`Lowery is a U.S. patent application publication, which published on
`September 10, 2009, and is titled “Apparatus and Methods for the
`Measurement of Cardiac Output.” Ex. 1002, 1. Lowery discloses an
`endotracheal tube with an array of electrodes on an inflatable cuff that is
`used to measure cardiac parameters, such as cardiac output. Id. at Abstract.
`Figure 1 is reproduced below:
`
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`Figure 1 depicts Lowery’s apparatus 10 including tube 12 having
`proximal portion 14 and distal portion 16. Ex. 1002 ¶ 26. Proximal portion
`14 has coupler member 20 for coupling to medical equipment, such as a
`ventilator, and distal portion 16 has inflatable cuff 22, which when inflated,
`fixes tube 12 in the correct position. Id. Apparatus 10 also includes several
`electrodes 24 with electrode patches 26 (shown in Fig. 2) disposed on
`inflatable cuff 22. Id. ¶ 27. Tube 12 also has current electrode 42, which
`contacts the trachea and is connected to electrode runner 48. Id. ¶ 34.
`
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`14
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`Figure 2 of Lowery is reproduced below:
`
`
`Figure 2 depicts electrode patches 26 disposed on inflatable cuff 22.
`Ex. 1002 ¶ 27. Electrode patches 26 connect to electrode runners 28 and, in
`use, patches 26 contact the wall of the trachea. Id. ¶¶ 27, 31.
`
`
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`Figure 3A of Lowery is reproduced below:
`
`
`
`Figure 3A shows electrode runner 28 connected to external wires 30
`by traced conductive circuit material 70. Ex. 1002 ¶¶ 27, 28. Electrode
`runner 48 (shown in Figure 1) is also connected to external wires 30 by
`traced conductive circuit material 70 operably linked to flexible support
`material 72. See id. ¶ 28. Traced conductive circuit material 70 and flexible
`support material 72 contain holes 74, which are at least partially filled with
`conductive polymeric material 34 forming an electrical connection between
`electrode runner 28 and external wires 30. Id.
`In certain embodiments, electrodes 26, 42 and electrode runners 28,
`48 are printed onto the cuff and tube “using a novel printing methodology
`that uses a positive displacement dispensing system.” Id. ¶ 39. The
`methodology may include printing a polymeric underlayer on the cuff and
`tube, printing the conductive material on the underlayer, and printing a
`polymeric overlayer on top of the conductive material, except for over a
`portion of the electrodes. Id. ¶¶ 15, 40, 44, 48, 49. Lowery states,
`“Generally, the width of the line formed by the conductive material will be
`less than that of the polymeric underlayer, such that no conductive material
`directly contacts either the distal portion of the tube 16 or the inflatable cuff
`22.” Id. ¶ 48.
`
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`iii. Hon (Ex. 1005)
`
`Hon is an article titled “Direct Writing Technology — Advances and
`Developments” and published in October 2008. Ex. 1005, 601; Pet. iii
`(Petitioner stating that Hon’s publication date is October 2008); Prelim.
`Resp. 22, 4 (Patent Owner agreeing with Petitioner that Hon’s publication
`date is October 2008). Hon discloses that direct writing is “a group of
`processes which are used to precisely deposit functional and/or structural
`materials on to a substrate in digitally defined locations.” Ex. 1005, 601.
`The substrate is an integral part of the final product and may be curvilinear,
`round, or flexible. Id. Hon discloses that metallic particles suspended in a
`suitable fugitive liquid can be printed by inkjet processes, and are used for
`electrical applications. Id. at 613.
`
`
`D. Prior Art Status of Hon
`Patent Owner asserts that Hon is not prior art to the challenged claims,
`as the “challenged claims were conceived prior to Hon[’s October 2008
`publication date] and Patent Owner was reasonably diligent in reducing the
`claims to practice from the time period just before Hon’s” publication date.
`Prelim. Resp. 22. To support this argument, Patent Owner submits
`provisional patent application No. 61/126,567, which was filed on May 6,
`2008, (Ex. 2012, “the ’567 Application”), and asserts that the ’567
`Application “discloses every limitation of the challenged claims.”5 Id. at
`
`
`5 We note that the ’894 patent does not claim priority to the ’567
`Application. Ex. 1001, 1. Nevertheless, Patent Owner relies on the ’567
`Application and its May 6, 2008 filing date as evidence of conception prior
`to Hon’s publication date. Prelim. Resp. 22–23.
`
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`22–23. Patent Owner argues that “conception prior to Hon is supported by
`an earlier draft of the ’567 Application exchanged between the inventors on
`April 21, 2008[, and that the] draft is largely identical to the ’567
`Application in its disclosures as relevant to the challenged claims.” Id. at 28
`(citing Ex. 2012; Ex. 2001, 135–40; Ex. 2003 ¶ 5; Ex. 2004 ¶ 5).6
`Patent Owner’s argument is not persuasive, as Patent Owner has
`failed to establish that the evidence, namely the ’567 Application, discloses
`every limitation of any claim, let alone all of the challenged claims.
`As cited correctly by Patent Owner, to antedate Hon, Patent Owner
`must show, by corroborating evidence, possession of every feature recited in
`the patented claim, and that every limitation of the claim must have been
`known to the inventor at the time of the alleged conception. Id. at 21 (citing
`Coleman v. Dines, 754 F.2d 353 (Fed. Cir. 1985)). Patent Owner’s own
`evidence, however, fails to establish possession of every feature recited in
`the patented claims.
`For example, independent claim 1 recites, inter alia, “at least one of
`said electrically conductive electrodes positioned to contact the vocal cords
`[and] the second electrode positioned to contact tissue, nerves and muscle in
`the trachea or the tongue when the tube is positioned in the trachea.” Ex.
`1001, col. 7, ll. 17–21. Patent Owner does not point out, nor can we discern
`from our own reading of the ’567 Application, where support for this
`limitation exists.
`
`
`6 Patent Owner also submits declaration evidence of the inventors (id. at 28
`(citing Exs. 2003, 2004)) and 158 documents that were allegedly
`“exchanged/generated by the inventors, Neurovision personnel, potential
`suppliers, and others, evidencing diligence in the reduction to practice” (id.
`at 32 (citing Ex. 2001)). See also id. at 32–47 (providing in-part a chart to
`summarize communications with the inventors).
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`As another example, independent claim 4 recites, inter alia, that “the
`electrodes, traces and connection points [are] formed by applying a
`conductive ink or paint.” Ex. 1001, col. 7, ll. 56–58 (emphasis added).
`Notably, the claim requires that the (1) electrodes, (2) traces, and (3)
`connection points be “formed by applying a conductive ink or paint.” Patent
`Owner, however, does not identify where the ’567 Application discloses
`connection points formed by applying conductive ink or paint.
`Patent Owner relies on the “contact pads” described in the ’567
`Application as being the claimed “connection points.” Prelim. Resp. 23
`(associating the “first and second connection points as the ‘Contact Pad’”).
`Accordingly, for Patent Owner’s argument to be persuasive, the ’567
`Application should support a finding that its “Contact Pads” are “formed by
`applying a conductive ink or paint.”
`In its Preliminary Response, Patent Owner relies on the following
`disclosure (from the ’567 Application) for support of this limitation:
`What is described and claimed here is an otherwise standard ET
`tube but with a permanent surface coating of medically
`acceptable, electrically-conductive material, e.g., silver/silver
`chloride or other coating. This surface coating would embody
`both the electrode surfaces in contact with the vocal cords and
`also the “electrical leads” to carry the electrical signal to
`contact pads at the termination of the ET tube, such that
`appropriate electrical lead wires can be attached . . .
`Prelim. Resp. 24 (emphasis added) (citing Ex. 2012, 3). We note that the
`’567 Application describes that only the (1) electrode surfaces and (2)
`electrical leads (traces) would have a “surface coating,” and not the “contact
`pads,” which, as discussed above, Patent Owner itself identified as
`corresponding to the claimed “connection points.” In other words, the ’567
`
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`Application does not provide support for the asserted “connection points” as
`being “formed by applying a conductive ink or paint.”
`Similarly, independent claim 10 recites, inter alia, that the
`“conductive electrodes, traces and connection points comprise a conductive
`paint or printing ink.” Ex. 1001, col. 8, ll. 36–38 (emphasis added). We do
`not see, however, any support for the limitation that the “connection points”
`“comprise a conductive paint or printing ink.”
`As another example, independent claim 14 recites, inter alia, “at least
`one of the first or second electrodes positioned to contact the vocal cords, a
`wall of the trachea or the tongue when the tube is positioned for
`electromyography in the trachea with the retention balloon distal of the vocal
`cords.” Ex. 1001, col. 8, ll. 63–67. Patent Owner does not point out, nor
`can we discern from our own reading of the ’567 Application, however,
`where support for this limitation exists.
`Accordingly, Patent Owner’s evidence is insufficient to show an
`invention date prior to Hon’s October 2008 publication date. On this record,
`we determine that Hon is prior art to the challenged claims under 35 U.S.C.
`§ 102(a).
`
`
`E. Obvious Over Lowery, Goldstone, and Hon
`Petitioner contends that claims 1–19 are unpatentable over Lowery,
`Goldstone, and Hon. Pet. 20.
`According to Petitioner, “[b]oth Lowery and Goldstone are directed to
`endotracheal tubes with electrodes positioned on the exterior surfaces of the
`tubes” (id. at 22), with Goldstone disclosing electrodes positioned to contact
`the vocal cords and Lowery disclosing electrodes positioned to contact the
`trachea (id. at 21).
`
`20
`
`
`
`IPR2016-01405
`Patent 8,634,894 B2
`In relying on Goldstone, Petitioner asserts that Goldstone’s electrodes
`43 “contact the vocal cords when the tube is positioned in the trachea” (id. at
`24 (citing Ex. 1003, col. 3, ll. 40–46, Fig. 1)) to help “the surgeon locate or
`identify the nerve in the surgical field to help avoid nerve damage” during
`surgery (id. at 25 (citing Ex. 1009 ¶¶ 39–44)).
`In relying on Lowery, Petitioner asserts that Lowery’s electrode
`patches 44 “are provided at various positions on the tube to contact the
`patient’s trachea . . . [to] indicate changes in cardiac output” (id. at 22),
`which may “indicate a risk of hemodynamic failure resulting from sepsis,
`cardiac arrest, hemorrhage, etc.” (id. at 23 (citing Ex. 1009 ¶¶ 48–49; Ex.
`1025, col. 6, ll. 14–38)).
`To satisfy the claimed requirement that at least one of the electrodes
`be “positioned to contact the vocal cords” while the other electrode be
`“positioned to contact tissue, nerves, and muscle in the trachea or the
`tongue” when the tube is positioned in the trachea (Ex. 1001, col. 7, ll. 7–
`36), Petitioner proposes to combine certain teachings in Goldstone and
`Lowery (Pet. 25–26). In particular, Petitioner reasons that it would have
`been obvious to a person of ordinary skill in the art to use Goldstone’s
`electrodes along with Lowery’s electrodes to prevent the two types of
`injuries addressed in both Goldstone and Lowery. See id. at 25. Petitioner
`explains, “a [person of ordinary skill in the art] would have had reason to use
`both technologies on a single tube to mitigate both complications” (id. at 25–
`26) and doing so “would have saved manufacturing costs” (id. at 26
`(citations omitted)). Petitioner further explains that the “combination would
`simply have involved the relative positioning of . . . multiple electrodes
`called for in each reference to achieve the benefits of both stated goals in a
`predictable manner.” Id.
`
`21
`
`
`
`IPR2016-01405
`Patent 8,634,894 B2
`In relying on Hon, Petitioner asserts that “Hon teaches numerous
`printing techniques known in the medical field for directly printing
`electrodes (using metal paints/inks) on rounded substrates” including
`“techniques for printing on medical devices with inflatable balloons of the
`type used on endotracheal tubes.” Id. at 27–28 (citing Ex. 1005, 611, 617;
`Ex. 1009 ¶¶ 56–57)).
`To satisfy the claimed requirement that the first and second electrodes
`are applied “directly to the surface of the tube” and “without the inclusion of
`a carrier film between the tube surface and the electrodes” (Ex. 1001, col. 7,
`ll. 7–36), Petitioner proposes that it would have been obvious to a person of
`ordinary skill in the art to use Hon’s printing techniques and materials to
`print directly on the tube and without a carrier film, as doing so would
`provide numerous benefits. Id. at 28. In particular, Petitioner reasons that
`the use of Hon’s printing techniques on the tube would result in: (1) cost
`reduction; (2) process chain simplification; (3) greater design freedom; and
`(4) a lower environmental footprint. Id. (citing Ex. 1005, 617; Ex. 1009
`¶ 83).
`
`Notwithstanding Patent Owner’s arguments, discussed below, we are
`persuaded at this stage of the proceeding by Petitioner’s asserted reasons for
`combining Lowery, Goldstone, and Hon, as well as Petitioner’s showing that
`the proposed combination satisfies the claimed limitations.
`In contesting the proposed ground, and in addition to those arguments
`discussed supra (pertaining to 35 U.S.C. § 325(d) and Hon’s status as prior
`art), Patent Owner presents numerous other arguments, which we address
`separately, below. Several of Patent Owner’s arguments also are presented
`in the “Background” section of the Preliminary Response. See Prelim. Resp.
`
`22
`
`
`
`IPR2016-01405
`Patent 8,634,894 B2
`7–15. For completeness of record, we include these arguments in our below
`discussion.
`
`
`i. Level of Ordinary Skill in the Art
`Patent Owner acknowledges that Petitioner’s declarations set forth the
`level of ordinary skill in the art, but nonetheless argues that the Petition is
`fatally flawed as it “lacks any explanation of the appropriate level of skill for
`a [person of ordinary skill in the art].” See Prelim. Resp. 47. In support of
`this argument, Patent Owner asserts that “[a]nalysis in a declaration that is
`not included in the relevant portion of a petition need not be considered.”
`Id. (citing Epsilon Data Management, LLC v. RPost Communications, Ltd.,
`CBM2014-00017, slip op. at 9 (PTAB Apr. 22, 2014) (Paper 21)). Patent
`Owner also argues that it was improper for the Petition to rely on these two
`declarati
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