Trials@uspto.gov
`571.272.7822
`
` Paper No. 14
`
`
` Entered: March 23, 2017
`
`
`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 IPR2016-01847
`Patent 8,467,844 B2
`____________
`
`
`
`Before MEREDITH C. PETRAVICK, WILLIAM V. SAINDON, and
`RICHARD E. RICE, Administrative Patent Judges.
`
`PETRAVICK, Administrative Patent Judge.
`
`DECISION
`Institution of Inter Partes Review
`37 C.F.R. § 42.108
`
`
`
`
`
`I. INTRODUCTION
`A. Background
`Medtronic Xomed, Inc. (“Petitioner”) filed a Petition requesting inter
`partes review of claims 1–7 of U.S. Patent No. 8,467,844 B2 (Ex. 1001, “the
`’844 patent”) pursuant to 35 U.S.C. §§ 311–319. Paper 1 (“Pet.”).
`
`
`
`
`571.272.7822
`
` Paper No. 14
`
`
` Entered: March 23, 2017
`
`
`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 IPR2016-01847
`Patent 8,467,844 B2
`____________
`
`
`
`Before MEREDITH C. PETRAVICK, WILLIAM V. SAINDON, and
`RICHARD E. RICE, Administrative Patent Judges.
`
`PETRAVICK, Administrative Patent Judge.
`
`DECISION
`Institution of Inter Partes Review
`37 C.F.R. § 42.108
`
`
`
`
`
`I. INTRODUCTION
`A. Background
`Medtronic Xomed, Inc. (“Petitioner”) filed a Petition requesting inter
`partes review of claims 1–7 of U.S. Patent No. 8,467,844 B2 (Ex. 1001, “the
`’844 patent”) pursuant to 35 U.S.C. §§ 311–319. Paper 1 (“Pet.”).
`
`
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`IPR2016-01847
`Patent 8,467,844 B2
`Neurovision Medical Products, Inc. (“Patent Owner”) filed a Preliminary
`Response to the Petition. Paper 12 (“Prelim. Resp.”). Under 35 U.S.C.
`§ 314 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 the Petition shows that
`there is a reasonable likelihood that Petitioner would prevail with respect to
`at least one of the challenged claims. For the reasons discussed below, we
`institute an inter partes review as to claims 1–7 of the ’844 patent.
`
`
`B. Related Proceedings
`Both Petitioner and Patent Owner state that the ’844 patent is involved
`
`in Neurovision Med. Prods. v. Medtronic Pub. Ltd. Co., Case No. 2:16-cv-
`00127-JRG-RSP in the Eastern District of Texas. Pet. 1, Paper 6, 2.
`
`U.S. Patent No. 8,634,894 B2 (“the ’894 patent”) claims priority to
`the ’844 patent (Ex. 2024, [62]) and is the subject of pending inter partes
`reviews, IPR2016-01405, IPR2016-01406, and IPR2017-00456. Pet. 1,
`Paper 11, 1. Additionally, the ’894 patent was the subject of IPR2015-
`00502, which terminated due to settlement prior to the Board issuing a final
`written decision. Paper 11, 1.
`
`
`
`C. The ’844 patent
`The ’844 patent is titled “Electrode for Prolonged Monitoring of
`
`Laryngeal Electromyography” and issued on June 18, 2013, from U.S.
`Patent Application No. 12/887,427, filed on September 21, 2010. Ex. 1001,
`[54], [45], [21], [22]. U.S. Patent Application No. 12/887,427 claims
`
`2
`
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`IPR2016-01847
`Patent 8,467,844 B2
`priority to U.S. Provisional Application No. 61/244,402, filed on September
`21, 2009. Id. at [60], 1:5–6.
`
`The ’844 patent discloses a laryngeal electromyography tube having
`electrodes, electrical traces, and conductive pads directly imprinted on, and
`thus substantially flush with, the surface of the tube. See id. at 5:56–60. The
`electrodes, electrical traces, and conductive pads are imprinted 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 6:3–6. 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
`4:47–5:15.
`
`The ’844 patent discloses various embodiments, in which the number
`and placement of the electrodes vary. See id. at Figs. 1, 2, 4, 7. Figure 7
`depicts an embodiment in which two electrodes are placed on the tube such
`that an electrode is in contact with the vocal cords and another is in contact
`with the tongue when the tube is in use. Id. at 4:41–44. Figure 7 is
`reproduced below.
`
`
`
`
`3
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`IPR2016-01847
`Patent 8,467,844 B2
`Figure 7 depicts laryngeal electromyography tube 60 having an endotracheal
`tube 12 imprinted with two electrode plates 62 and 64. Id. at 4:41–44.
`Electrode plate 62 is positioned to contact the vocal cords, and electrode
`plate 64 is positioned to contact the tongue. Id. Conductive traces 20
`connect the electrode plates to conductive pads 22, which attach to lead
`wires of an external device. Id. at 4:4–7, 4:44–46. Tube 60 also has an
`endotracheal tube balloon 15, which, when inflated, holds tube 60 in a
`desired position when in use. See id. at 3:67–4:1, Fig. 8. Figure 8 depicts
`tube 60 in use and is reproduced below.
`
`
`
`Figure 8 depicts tube 60 placed within the trachea with one electrode
`
`plate adjacent the vocal cords and one electrode contacting the tongue. Id. at
`3:50–52.
`
`
`
`4
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`IPR2016-01847
`Patent 8,467,844 B2
`
`D. Illustrative Claim
`Claims 1 and 4 are independent. Claims 2 and 3 depend from claim 1.
`
`Claims 5–7 depend from claim 4. Claim 1, reproduced below, is illustrative
`of the claimed subject matter.
`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 one or more electrically conductive electrode plates
`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 electrode plates,
`
`said tube having on its surface electrically conductive
`traces connected to or integral with the electrode plates, the
`traces applied directly to the tube surface and running along the
`length of the endotracheal tube to a proximal end thereof,
`
`conductive pads connected to or integral with the
`conductive traces, the pads applied directly to the tube surface
`at the proximal end of the endotracheal tube, and
`
`electrical leads connected to the pads, said leads adapted
`to connect to monitoring equipment,
`
`the electrically conductive traces covered by an
`insulating material along their length from a point adjacent the
`electrode plates to a point adjacent the conductive pads[,]
`
`wherein a first of said electrode plates is located proximal
`of the balloon and positioned to contact the vocal cords when
`placed within the trachea and a second electrode plate is located
`further proximal thereof and positioned to contact the tongue
`when the first electrode plate is positioned to contact the vocal
`cords.
`Ex. 1001, 7:5–31.
`
`5
`
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`IPR2016-01847
`Patent 8,467,844 B2
`E. Asserted Grounds of Unpatentability
`Petitioner asserts the following grounds of unpatentability:
`No. Ground Claims Prior Art
`1
`§ 103
`1–7
`Kartush1, Topsakal2, Cook3, and Hon4
`2
`§ 103
`1–7
`Goldstone5, Teves6, Cook, and Hon
`
`Pet. 2.
`
`To support its Petition, Petitioner proffers a Declaration of Dr. Ralph
`
`P. Tufano (Ex. 1009) and a Declaration of Mr. Guy R. Lowery (Ex. 1012).7
`
`
`
`
`1 Kartush, U.S. Patent Application Publication No. 2010/0145178 A1
`(published June 10, 2010) (Ex. 1021)
`2 Cahide Topsakal, Ossama Al-Mefty, Ketan R. Bulsara, and Veronica S.
`Williford, Intraoperative Monitoring of Lower Cranial Nerves in Skull Base
`Surgery: Technical Report and Review of 123 Monitored Cases, 31
`NEUROSURG. REV. 45–53 (2008) (Ex. 1007).
`3 Cook et al., U.S. Patent No. 4,890,623 (issued Jan. 2, 1990) (Ex. 1004).
`4 K.K. B. Hon, L. Li, and I.M. Hutchings, Direct Writing Technology —
`Advances and Developments, 57 CIRP ANNALS– MANUFACTURING
`TECHNOLOGY 601–620 (2008) (Ex. 1005).
`5 Goldstone et al., U.S. Patent No. 5,024,228 (issued June 18, 1991)
`(Ex. 1003).
`6 Teves, U.S. Patent No. 5,365,940 (issued Nov. 22, 1994) (Ex. 1013).
`7 Patent Owner argues that we should afford the testimony of Dr. Tufano and
`Mr. Lowery no weight. Prelim. Resp. 55–61. For example, Patent Owner
`argues that we should give no weight to Mr. Lowery’s testimony because he
`does not rely on prior art to form his opinions but instead relies upon his
`own work. Id. at 57. At this point in the proceeding, Patent Owner’s
`argument is mere attorney argument unsupported by evidence, and we are
`not persuaded to give no weight to the testimony. We note that Patent
`Owner will have the opportunity to cross-examine Dr. Tufano and Mr.
`Lowery during the trial.
`
`6
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`IPR2016-01847
`Patent 8,467,844 B2
`
`II. ANALYSIS
`A. 35 U.S.C. § 325(d)
`Patent Owner requests that we deny the Petition and terminate the
`proceeding under 35 U.S.C. § 325(d) because Petitioner has filed multiple
`petitions challenging the ’894 patent, which is related to the ’844 patent.
`Prelim. Resp. 4, n. 1.
`Section 325(d) of the Statute states
`during the pendency of any post-grant review under this
`chapter, if another proceeding or matter involving the patent is
`before the Office, the Director may determine the manner in
`which the post-grant review or other proceeding or matter may
`proceed, including providing for the . . . termination of any
`such matter or proceeding.
`35 U.S.C. § 325(d) (emphasis added). The ’894 patent is not the subject of
`this proceeding. Patent Owner points to no other proceeding or matter
`before the Office involving the ’844 patent. We are not persuaded to deny
`the Petition under 35 U.S.C. § 325(d).
`
`
`
`B. Claim Construction
`In an inter partes review, the Board interprets claim terms in an
`unexpired patent according to the 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
`approach). Under that standard, and absent any special definitions, we give
`claim terms their ordinary and customary meaning, as they would be
`understood by one of ordinary skill in the art at the time of the invention.
`In re Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir. 2007).
`
`7
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`IPR2016-01847
`Patent 8,467,844 B2
`Petitioner proposes constructions for the terms “positioned to contact”
`and “electrode plate.” Pet. 3–4. Patent Owner disputes that Petitioner’s
`proposed constructions are the broadest reasonable construction and argues
`that no construction is necessary. Prelim. Resp. 9–11. For the purposes of
`this Decision, we determine that no explicit claim constructions are needed
`to resolve the issues before us. See, e.g., 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.’”) (citation
`omitted).
`
`
`C. Unpatentability Grounds
`Section 103(a) forbids issuance of a patent when “the
`differences between the subject matter sought to be patented
`and the prior art are such that the subject matter as a whole
`would have been obvious at the time the invention was made to
`a person having ordinary skill in the art to which said subject
`matter pertains.”
`KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 406 (2007). The ultimate
`determination of obviousness under § 103 is a question of law based on
`underlying factual findings. In re Baxter Int’l, Inc., 678 F.3d 1357, 1361
`(Fed. Cir. 2012) (citing Graham v. John Deere Co., 383 U.S. 1, 17–18
`(1966)). These underlying factual considerations consist of: (1) the “level
`of ordinary skill in the pertinent art,” (2) the “scope and content of the prior
`art,” (3) the “differences between the prior art and the claims at issue,” and
`(4) “secondary considerations” of non-obviousness such as “commercial
`
`8
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`IPR2016-01847
`Patent 8,467,844 B2
`success, long-felt but unsolved needs, failure of others, etc.”8 KSR, 550 U.S.
`at 406 (quoting Graham, 338 U.S. at 17–18).
`
`
`1. 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 (“POSA”)].” See Prelim. Resp. 25–27.
`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 declarations. Id. at 26–27.
`We are not persuaded by Patent Owner’s argument that setting forth
`the appropriate level of ordinary skill in the art in the declarations, rather
`than the Petition, is a basis to deny the Petition, or that this somehow renders
`the declarations “improper.” The cases relied upon by Patent Owner, which
`do not consider analysis in a declaration that was not included in the relevant
`portion of the Petition (see Prelim. Resp. 26), are based on very different
`facts and do not support Patent Owner’s arguments here.
`
`Moreover, although the Petition itself does not explicitly set forth the
`level of ordinary skill in the art, the declarations of Dr. Tufano (Ex. 1009)
`and Mr. Lowery (Ex. 1012), which were submitted with the Petition, define
`the level of ordinary skill in the art. Ex. 1009 ¶ 18; Ex. 1012 ¶ 29. In
`
`8 The record contains no arguments or evidence concerning secondary
`considerations.
`
`9
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`IPR2016-01847
`Patent 8,467,844 B2
`particular, Dr. Tufano and Mr. Lowery each testify that a POSA would have
`had “1) a degree in engineering, science or medicine, and 2) at least 3 years
`of experience in the product development and/or use of ET tubes with
`electrodes.” Ex. 1009 ¶ 18; see Ex. 1012 ¶ 29.
`
`
`2. Prior Art Status of Kartush and Hon
`
`Patent Owner argues that neither Kartush nor Hon are prior art to
`claims 1–7 because claims 1–7 were conceived prior to Hon’s October 2008
`publication date and Kartush’s June 10, 2010 publication date9 and Patent
`Owner was reasonably diligent in reducing the claims to practice from the
`time period just before Hon’s publication date. Prelim. Resp. 11–25.
`
`
`a. Effective Filing Date of the ’844 Patent
`Before turning to Patent Owner’s argument, we must first determine
`
`the effective filing date of the ’844 patent. The ’844 patent claims priority
`under 35 U.S.C. § 119(e) to U.S. Provisional Application No. 61/244,402
`(“the ’402 provisional application”), filed on September 21, 2009. Ex. 1001,
`[60], 1:5–6. Petitioner contends that the ’844 patent is not entitled to the
`claim of priority because the ’402 provisional application does not properly
`support the claims of the ’844 patent. Pet. 16. Petitioner argues that the
`’402 provisional application does not provide the required support for the
`electrode plates positioned to contact the tongue, recited by independent
`claims 1 and 4. Petitioner, thus, contends that the effective date of the ’844
`
`9 Kartush claims priority to a number of prior applications, including U.S.
`Provisional Application No. 60/886,119 filed on Jan. 23, 2007. Ex. 1021,
`[60], [63]. Petitioner, however, does not rely on 35 U.S.C. § 102(e) to argue
`a prior-art date earlier than June 10, 2010. See Pet. 18 (stating that Kartush
`is prior art under 35 U.S.C. § 102(a)).
`
`10
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`Patent 8,467,844 B2
`patent is September 21, 2010, the filing date of U.S. Patent Application No.
`12/887,427, from which the ’844 patent matured. Id.; see Ex. 1001, [21],
`[22]. Patent Owner does not explicitly address Petitioner’s contentions but
`implies that the effective filing date of the ’844 patent is September 21,
`2009, the filing date of the ’402 provisional application. See Prelim. Resp. 8
`(“claims priority to U.S. Provisional Application”), 13 (“constructive
`reduction to practice date based on the filing of Provisional Application No.
`61/244,402”).
`
`Pursuant to 35 U.S.C. § 119(e), to be entitled to priority to the filing
`date of a provisional patent application, the provisional patent application
`must disclose the invention in the matter provided in 35 U.S.C. § 112, first
`paragraph, which requires a written description of the invention. To satisfy
`the written description requirement, an applicant must convey with
`reasonable clarity to those skilled in the art that, as of the filing date sought,
`they were in possession of the invention, and that the invention, in that
`context, is whatever is now claimed. Vas-Cath, Inc. v. Mahurkar, 935 F.2d
`1555, 1563-64 (Fed. Cir. 1991). The test for sufficiency of support in a
`provisional patent application is whether the disclosure of the application
`relied upon “reasonably conveys to the artisan that the inventor had
`possession at that time of the later claimed subject matter.” Ralston Purina
`Co. v. Far-Mar-Co., Inc., 772 F.2d 1570, 1575 (Fed. Cir. 1985) (quoting In
`re Kaslow, 707 F.2d 1366, 1375 (Fed. Cir. 1983)).
`
`Petitioner argues that the ’402 provisional application does not
`provide the required written description support for electrode plates
`positioned to contact the tongue because the ’402 provisional application
`only describes electrodes positioned to contact the vocal cords and does not
`mention the tongue. Pet. 16 (citing Ex. 1011, 9–10). After review of the
`
`11
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`IPR2016-01847
`Patent 8,467,844 B2
`’402 provisional application and on this record, we determine that the ’402
`provisional application does not provide the required written description
`support for electrode plates positioned to contact the tongue and, thus, the
`’844 patent is not entitled to claim priority to the filing date of the ’402
`provisional application. Thus, on this record and for purposes of this
`Decision, the effective date of the ’844 patent is September 21, 2010.
`
`
`b. Prior Art Status of Hon
`Hon published in October 2008. Ex. 1005, 601; see also Pet. iii
`
`(Petitioner stating that Hon’s publication date is October 2008), Prelim.
`Resp. 11, 13 (Patent Owner agreeing with Petitioner that Hon’s publication
`date is October 2008). Hon is available as prior art under 35 U.S.C. § 102(b)
`because Hon was published more than one year prior to the effective filing
`date of the ’844 patent. See 35 U.S.C. § 102(b). Section 102(b) is a
`statutory bar, and a statutory bar cannot be overcome by evidence of prior
`invention.
`
`
`c. Prior Art Status of Kartush
`Patent Owner asserts that Kartush is not prior art to claims 1–7, that
`claims 1–7 were conceived prior to Kartush’s June 10, 2010 publication
`date, and that Patent Owner was reasonably diligent in reducing the claims
`to practice from a time period prior to Kartush’s publication. Prelim. Resp.
`13. To support this argument, Patent Owner submits U.S. Provisional
`Application No. 61/126,567, which was filed on May 6, 2008 (Ex. 2012,
`“the ’567 provisional application”), and asserts that the ’567 provisional
`application “discloses every limitation of claims 1–7.” Id. Patent Owner
`argues that “conception prior to Kartush . . . is supported by an earlier draft
`
`12
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`Patent 8,467,844 B2
`of the ’567 provisional 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.” Prelim
`Resp. 18–19 (citing: Ex. 2001, 135–40; Ex. 2003 ¶ 5; Ex. 2004 ¶ 5).
`Patent Owner’s argument is not persuasive, as Patent Owner has
`failed to establish that the evidence, namely the ’567 provisional application,
`discloses every limitation of any claim, let alone all of claims 1–7. As cited
`correctly by Patent Owner, to antedate Kartush, 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 12 (citing Coleman v.
`Dines, 754 F.2d 353, 359 (Fed. Cir. 1985)).
`Patent Owner’s evidence, however, fails to establish possession of
`every feature recited in the patented claims. For example, independent claim
`1 recites, inter alia, “a second electrode plate is located further proximal [of
`the balloon] and positioned to contact the tongue when the first electrode
`plate is positioned to contact the vocal cords.” Ex. 1001, 7:26–30.
`Independent claim 4 recites a similar limitation. Id. at 8:22–26. Patent
`Owner points to a number of passages of the ’567 provisional application as
`support for these limitations. Prelim Resp. 16 (citing Ex. 2012, 5–7).
`However, none of the passages discusses electrodes positioned to contact the
`tongue. See Ex. 2012, 5–7. Further, the sketch on page 8 of the ’567
`provisional application also does not show such. See id. at 8.
`Patent Owner also argues that claims 1–7 “were actually reduced to
`practice by at least November 2008.” Prelim Resp., 19. To support its
`argument, Patent Owner proffers alleged images of embodiments of the
`invention (Prelim. Resp. 19–20), a set of 158 documents (Ex. 2001), a
`
`13
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`Patent 8,467,844 B2
`Declaration of Stephen W. Blakely (Ex. 2003), a Declaration of James Lee
`Rea (Ex. 2004), and a Declaration of Ryan M. Rea (Ex. 2005). See Prelim.
`Resp. 19–25. To establish an actual reduction to practice, patentees must
`prove that they (1) constructed an embodiment or performed a process that
`meets all the claimed limitations of the invention, and (2) determined that
`the invention worked for its intended purpose. Easton v. Evans, 204 F.3d
`1094, 1097 (Fed. Cir. 2000). Patent Owner’s evidence, however, fails to
`establish that the inventors constructed an embodiment that meets all the
`claimed limitations of the invention. The testimony of inventors James Rea
`and Stephen Blakely and the testimony of Ryan Rea do not indicate that the
`embodiments included electrodes positioned to contact the tongue. See
`generally, Exs. 2003–2005. None of the cited portions of the 158 documents
`mention an electrode positioned to contact the tongue. See Prelim. Resp.
`22–24, Ex. 2016. The images of embodiments of the invention do not show
`an electrode positioned on an endotracheal tube to contact the tongue. See
`Prelim. Resp. 19–20.
`Accordingly, Patent Owner’s evidence is insufficient to show an
`invention date prior to Kartush’s June 10, 2010 publication date. On this
`record, we determine that Kartush is prior art, at least, under 35 U.S.C.
`§ 102(a).
`
`
`3. Ground 1 – Based on Kartush
`
`Petitioner contends that claims 1–7 are unpatentable over a
`combination of Kartush, Topsakal, Cook, and Hon. Pet. 18–39.
`
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`14
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`Patent 8,467,844 B2
`
`a. Overview of Prior Art
`i. Kartush
`Kartush is a U.S. patent application publication, titled “Nerve
`
`Monitoring Device” and published on June 10, 2010. Ex. 1021, [43], [54].
`Kartush discloses an embodiment of cannula 12 that is an endotracheal tube
`having a sensor 14 that contacts vocal cords 119. Id. ¶¶ 51, 54–56. Figure 4
`of Kartush is reproduced below.
`
`
`Figure 4 depicts an embodiment of cannula 12 that is an endotracheal tube
`positioned in a patient. Id. ¶ 34. The endotracheal tube has sensors 14 and
`an inflatable cuff (not shown). Id. ¶¶ 51, 58. Sensor 14 may be an electrode
`that detects electrical signals and is positioned to contact the vocal cords. Id.
`¶¶ 60, 65. Sensor 14 communicates with output element 40 via direct wire
`
`15
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`IPR2016-01847
`Patent 8,467,844 B2
`or wirelessly. Id. ¶ 76. Kartush suggest that additional sensors can be
`placed on the tube. Id. ¶¶ 56, 57, 65, 67.
`
`Kartush suggests that sensor 14 can be constructed in a variety of
`ways, including as exposed wires or plates. Id. ¶¶ 68, 71, 72, 75. Kartush
`states “[t]he sensor[] 14 can be joined directly to the exterior surface 13 of
`the cannula 12 via an adhesive, or can be embedded or molded within the
`cannula components, or can be joined to another structural element that is
`place about the ET tube.” Id. ¶ 72.
`
`
`ii. Topsakal
`
`Topsakal is a paper titled “Intraoperative Monitoring of Lower
`Cranial Nerves in Skull Base Surgery: Technical Report and Review of 123
`Monitored Cases” and published in 2008. Ex. 1007, 45; see also Pet. iii
`(Petitioner stating that Topsakal’s publication date is 2008). Topsakal
`discloses that during skull base surgery it is desirable to monitor multiple
`lower cranial nerves, CN9–12, including the hypoglossal nerve, CN12, in
`the tongue. Id. at 47, 50.
`
`
`iii. Cook
`Cook is a U.S. patent, which issued on January 2, 1990, and is titled
`
`“Biopotential Sensing Device and Method for Making.” Ex. 1004, [45],
`[54]. Cook discloses a biopotential sensing device utilizing printed circuit
`technology (id. at 1:6–8), which in one embodiment is a percutaneous
`catheter 10 (id. at 3:55–58). Figure 1 is reproduced below.
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`Figure 1 depicts Cook’s percutaneous catheter 10, including a distal
`end with plurality of ring electrodes 12, and a proximal end with molded
`bifurcated fitting 14 having connector pins 24. Id. at 3:55–68. Flexible
`member 16 is formed by tube 28 and substrate film 30—which has a printed
`circuit formed thereon, as shown in Figure 6—and helically wrapped around
`tube 28. Id. at 4:4–15. Figure 6 provides a side view of the proximal
`portion of catheter 10 and is also reproduced below. Id. at 3:35–37.
`
`
`Figure 6 depicts substrate film 30, with a printed circuit formed
`thereon, wrapped helically around tube 28. Id. at 4:13–15. As explained in
`Cook, the circuit pattern is printed utilizing known techniques, such as
`laminating a thin film copper foil onto the plastic film. Id. at 4:13–24.
`Figure 3 depicts Cook’s printed circuit and is reproduced below.
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`Figure 3 depicts a top view of a circuit printed on a substrate. Id. at 3:28–30.
`As described in Cook, the circuit includes printed electrode pads 12A–12H,
`printed circuit wires 32 separately connected to each electrode pad, and
`terminal pad 34 connected to each wire. Id. at 4:25–29.
`
`
`iv. Hon
`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. 11, 13 (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.” Id. 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.
`
`
`
`b. Analysis
`i. Independent Claims 1 and 4
`According to Petitioner, Kartush discloses electrodes positioned on an
`
`endotracheal tube to contact the vocal cords. Pet. 18 (citing Ex. 1021 ¶¶ 52–
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`57, ¶ 67, Figs. 4 and 5). Petitioner asserts that Kartush does not explicitly
`describe an electrode positioned to contact the tongue but does suggest that
`additional electrodes, which are connected to different channels of a
`monitoring device, may be provided to contact muscles other than the vocal
`cords. Pet. 18–19 (citing Ex. 1021 ¶¶ 22, 52, 56, 57, 66, 67, 86, 87).
`
`Petitioner relies upon Topsakal to teach that providing electrodes for
`contacting both the tongue and the vocal cords is preferred in skull base
`operations because it protects against injury during surgery. Pet. 19–21
`(citing Ex. 1007, 47, 50). Petitioner asserts providing a sensor for
`monitoring the tongue on Kartush’s endotracheal tube would have been
`obvious in order to simplify the surgical procedure by avoiding the need for
`separate devices. Pet. 21–22. According to Petitioner, the combination of
`Kartush and Topsakal would result in electrodes positioned to contact the
`vocal cords at a distal end of the endotracheal tube and electrodes positioned
`to contact the tongue at a proximal end of the endotracheal tube. Id. at 22–
`24.
`
`
`Further, Petitioner contends that Kartush describes that the sensors
`can be attached directly to the exterior surface of the tube using various
`techniques and can be connected to a monitoring device via a wire. Id. at
`24–25 (citing Ex. 1021 ¶¶ 68, 75, 76, 101). Kartush, however, does not
`explain in detail the circuitry extending along the tube or the transition to the
`external leads that connect to the monitoring equipment. Pet. 25.
`
`Petitioner relies upon Cook’s description of printed circuits including
`electrodes, traces, and connection points. Pet. 25 (citing Ex. 1004, Fig. 3,
`4:25–32). The cited portion of Cook discloses a circuit pattern that includes
`electro pads 12A–12H connected to terminal pads 34 by circuit wires 32.
`Ex. 1004, Fig. 3, 4:25–32. Petitioner reasons that “the incorporation of
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`Cook’s disclosure of printing electrodes on medical tubes with Kartush’s
`tube [having conductive electrodes] merely combines prior art elements to
`yield predictable results by using a known technique to improve a similar
`device.” Pet. 26 (quotation omitted). Petitioner further reasons that a POSA
`would have provided Cook’s terminal pads when using a printed circuit
`pattern to communicate with associated monitoring equipment. Pet. 26.
`Petitioner cites to Cook’s disclosed advantages of printed circuit technology,
`including by (i) permitting the size, shape, and orientation of each electrode
`to be individually controlled to provide a sensing device which is optimal for
`each application, and (ii) allowing for less expensive designs. See id. at 26
`(citing Ex. 1004, 6:17–65).
`In relying on Hon, Petitioner cites to Hon’s teaching of “directly
`applying electrodes (using metal paints/inks) on rounded substrates, without
`first forming the same on a carrier substrate.” Pet. 27 (citing Ex. 1005, 601;
`Ex. 1009 ¶¶ 69–70). In further combining Hon’s teachings with the
`previously discussed combination of Kartush, Topsakal, and Cook,
`Petitioner reasons that a POSA would have used “Hon’s techniques to apply
`traces and electrodes directly to the surface” to achieve (1) cost reduction;
`(2) process chain simplification; (3) greater design freedom; and (4) lower
`environmental footprint. Id. at 27–28 (citing Ex. 1005, 617).
`
`Notwithstanding Patent Owner’s arguments, discussed below, we are
`persuaded at this stage of the proceeding by Petitioner’s asserted reasons for
`combining Kartush, Topsakal, Cook, and Hon, as well as Petitioner’s
`showing that the proposed combination satisfies the limitations of claims 1
`and 4.
`
`In contesting the proposed ground, Patent Owner presents numerous
`arguments. Prelim. Resp. 29–37, 45–49. We have considered all of Patent
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`Owner’s arguments but find them unpersuasive. We address each argument
`in turn, below.
`
`First, Patent Owner argues that none of Kartush, Topsakal, Cook, or
`Hon individually disclose electrode plates, traces, and pads applied directly
`to the surface of the tube, without the inclusion of a carrier film between the
`tube surface and the electrode plates, traces, and pads. Id. at 29–37. For
`example, Patent Owner argues that Kartush does not teach electrodes, traces,
`and pads that are applied directly to the surface of the endotracheal tube
`because Kartush discloses manufacturing its sensors separately and then
`attaching the sensors to the tube. Id. at 29 (citing Ex. 1021 ¶ 75). As another
`example, Patent Owner argues that Cook also does not teach such because
`Cook discloses printing the circuit on a substrate film. Prelim. Resp. 30–31.
`Patent Owner’s argument is unpersuasive because it does not address the
`proposed ground of unpatentability. In particular, Petitioner’s proposed
`ground does not rely on Kartush or Cook alone for teaching or disclosing
`these claimed features. For example, Petitioner relies upon Hon to teach
`directly printing on the surface of the tube without a carrier film between the
`tube surface and electrodes. Pet. 27–28.
` Second, Patent Owner argues that Cook’s teachings are incompatible
`with Kartush because
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