Trials@uspto.gov
`571-272-7822
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` Paper 56
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`Date: January 5, 2021
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`OTICON MEDICAL AB; OTICON MEDICAL LLC;
`WILLIAM DEMANT HOLDING A/S,
`Petitioner,
`
`v.
`
`COCHLEAR BONE ANCHORED SOLUTIONS AB,
`Patent Owner.
`____________
`
`IPR2017-010181
`Patent 7,043,040 B2
`____________
`
`
`
`Before JAMES B. ARPIN, BARBARA A. PARVIS, and
`AMANDA F. WIEKER, Administrative Patent Judges.
`
`WIEKER, Administrative Patent Judge.
`
`
`
`
`JUDGMENT
`Final Written Decision on Remand
`Determining Challenged Claim Unpatentable
`35 U.S.C. §§ 144, 318(a)
`
`
`
`
`
`1 Case IPR2017-01019 has been consolidated with this proceeding.
`
`

`

`IPR2017-01018
`Patent 7,043,040 B2
`
`
`I.
`
`INTRODUCTION
`
`A. Background
`
`In IPR2017-01018 and IPR2017-01019, Oticon Medical AB, Oticon
`Medical LLC, and William Demant Holding A/S (“Petitioner”) filed
`Petitions requesting inter partes reviews of claims 1–13 of U.S. Patent
`No. 7,043,040 B2 (Ex. 1001, “the ’040 patent”), across the two petitions.
`Paper 1 (“Pet.”);2 IPR2017-01019, Paper 1. We partially instituted trial in
`both proceedings, and consolidated them. Paper 7 (instituting), 27;
`IPR2017-01019, Paper 7 (instituting), 20; Paper 9 (consolidating).
`After institution, Patent Owner filed a Response (Paper 23), as well as
`a statutory disclaimer of claims 1–3 and 13 (Paper 24). Petitioner filed a
`Reply (Paper 28). Moreover, as required by SAS Institute Inc. v. Iancu, 138
`S. Ct. 1348 (2018), we incorporated into this proceeding those grounds
`asserted by Petitioner for which institution previously had been denied, and
`authorized the parties to conduct supplemental briefing directed to the newly
`added grounds. Paper 33, 3–5. Specifically, Patent Owner filed a
`Supplemental Response (Paper 35, “Supp. Resp.”) and Petitioner filed a
`Supplemental Reply (Paper 40, “Supp. Reply”). An oral hearing was held
`on July 11, 2018. Paper 51.3
`On August 21, 2018, we entered a Final Written Decision addressing
`claims 4–12 (claims 1–3 and 13 having been disclaimed), pursuant to 35
`
`
`2 Unless noted by the prefix “–1019,” all citations to papers or exhibits
`herein refer to filings in IPR2017-01018.
`3 For a more complete recitation of the procedural background of this
`proceeding, please see pages 2–4 of the August, 21, 2018, Final Written
`Decision.
`
`
`
`2
`
`

`

`IPR2017-01018
`Patent 7,043,040 B2
`
`U.S.C. § 318(a) and 37 C.F.R. § 42.73. In that Decision, we determined that
`Petitioner had met its burden of demonstrating that challenged claims 4–6,
`11, and 12 are unpatentable by a preponderance of the evidence, and
`determined that Petitioner had not met its burden of demonstrating that
`challenged claims 7–10 are unpatentable by a preponderance of the
`evidence. Paper 52 (“Final Dec.”).
`Patent Owner appealed our Final Written Decision regarding
`claims 4–6, 11, and 12 to the U.S. Court of Appeals for the Federal Circuit
`(“the Federal Circuit”), and Petitioner cross-appealed our Final Written
`Decision regarding claims 7–10. Papers 53–54; Cochlear Bone Anchored
`Solutions AB v. Oticon Med. AB, 958 F.3d 1348, 1352 (Fed. Cir. 2020). The
`Federal Circuit affirmed the Final Written Decision as to claims 4–9 and 11–
`12, but vacated and remanded the Decision regarding claim 10. Cochlear,
`958 F.3d at 1361.
`Subsequently, we held a conference call with the parties to discuss the
`procedure on remand. During that call, we discussed the parties’ agreement
`that no additional briefing, submission of additional evidence, or oral
`argument was requested and, accordingly, none was authorized. Paper 55, 2.
`We further confirmed the parties’ agreement that the scope of the issues the
`Board will consider on remand is limited to:
`(1)
`“whether
`the directivity-dependent-microphone
`alternative [of claim 10] is outside the scope of § 112, ¶6, because
`it recites a structure (the directivity dependent microphone) that
`sufficiently corresponds to the claimed directivity means”; and
`(2) “whether any asserted prior-art challenges render the
`directivity-dependent-microphone alternative within claim 10
`unpatentable, if considered on its own, and whether, if so, claim
`10 as a whole is unpatentable on that ground.”
`
`
`
`3
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`IPR2017-01018
`Patent 7,043,040 B2
`
`Id. (formatting added); see also Cochlear, 958 F.3d at 1360. Accordingly,
`this Final Written Decision on Remand addresses claim 10, consistent with
`the Federal Circuit’s decision.
`
`B. Related Proceedings
`
`The parties represent that the ’040 patent is at issue in district court
`litigation, Cochlear Ltd. et al. v. Oticon Medical AB et al., No. 1:16-cv-
`01700 (D. Colo.), and in an arbitration proceeding under the Arbitration
`Rules of the Arbitration Institute of the Stockholm Chamber of Commerce
`(SCC Arbitration No V2016/181). Pet. 1–2; Paper 4, 2.
`
`C. The ’040 Patent
`
`The ’040 patent, entitled “Hearing Aid Apparatus,” issued on May 9,
`
`2006. Ex. 1001, codes (45), (54). The ’040 patent explains that prior art
`bone anchored hearing aids were useful in treating certain types of hearing
`loss. Id. at 1:45–50, 1:62–67. The ’040 patent describes operation of these
`devices as follows:
`In such a bone anchored hearing aid the sound information
`is mechanically transmitted by means of a vibrator via the skull
`bone to the inner ear of a patient. The hearing aid device is
`connected to an implanted titanium screw installed in the bone
`behind the poor, external ear[, i.e., the external portion of a deaf
`ear,] and the sound is transmitted via the skull bone to the cochlea
`(inner ear) of this poor ear.
`Id. at 1:52–58. According to the ’040 patent, however, these devices were
`not used for patients with “unilateral hearing loss, i.e.[,] individuals with []
`normal or [] slightly impaired hearing on one ear and a profound hearing
`loss in the inner ear on the other side of the head.” Id. at 1:8–11, 2:1–5.
`Consequently, the ’040 patent seeks to provide a hearing aid for
`
`
`
`4
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`

`IPR2017-01018
`Patent 7,043,040 B2
`
`rehabilitation of unilateral hearing loss based on this bone conducting
`principle. Id. at 2:5–12.
`Figure 1 of the ’040 patent is reproduced below.
`
`
`Figure 1 depicts a patient’s skull with a hearing aid located near the patient’s
`deaf ear. Id. at 2:33, 2:44–50 (also noting that the patient’s other ear is
`“normal or [has] only [] slightly impaired hearing”). Skin penetrating
`spacer 11 is anchored to skull bone 2 by fixture 3. Id. at 2:50–53.
`A housing at the opposite end of spacer 11 includes vibrator 1,
`microphone 5, and electronic circuitry 4. Id. at 2:50–55. Because high
`frequencies are attenuated during bone conduction across the skull, the
`frequency characteristics of the hearing aid are adapted such that “the
`amplification is higher in the treble . . . than in the bass.” Id. at 2:56–62.
`
`
`
`5
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`IPR2017-01018
`Patent 7,043,040 B2
`
`The ’040 patent also discloses alternative embodiments that avoid
`
`skin penetration, shown in Figures 2 and 3 below. Id. at 2:34–39.
`
`
`
`
`Figures 2 and 3 depict schematic views of a skull in which a hearing aid is
`partially implanted. Id. at 2:34–39, 3:9–11. As shown in Figure 2,
`implantable part 8 includes a vibrator, while external part 7 includes
`microphone 6 and battery 9. Id. at 3:9–12. “[P]ower is transmitted to the
`implanted part 8 of the hearing aid by means of induction.” Id. at 3:12–14.
`
`In the embodiment shown in Figure 3, implantable part 8 is arranged
`on the non-deaf side, and includes rechargeable battery 10, which is charged
`by induction from an external power supply. Id. at 3:15–20. External part 7,
`including microphone 6 and battery 9, is located on the deaf side of the
`skull, and the signal is transmitted from external part 7 to implantable part 8
`by radio signal. Id. at 3:20–24.
`
`D. Illustrative Claims
`
`As noted, claim 10 is before us on remand. Claim 10 depends from
`claim 6, which depends from independent claim 1. Each claim is
`reproduced below.
`1. A bone-conducting bone-anchored hearing aid apparatus
`for sound transmission from one side of a patient’s head to the
`6
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`IPR2017-01018
`Patent 7,043,040 B2
`
`
`patient’s cochlea on another side of the patient’s head for
`rehabilitation of unilateral hearing loss, the hearing aid apparatus
`comprising:
`a vibratory generating part arranged to generate vibrations
`that are mechanically transmitted through the skull bone
`from a deaf side to the inner ear on the other side of the
`patient; and
`an implantable part operative to mechanically anchor the
`vibratory generating part, the implantable part being
`osseointegrated in the patient’s skull bone behind an
`external ear at the deaf side of a patient.
`Ex. 1001, 3:29–41.
`6. The hearing aid apparatus according to claim 1, further
`comprising:
`electronic circuitry operative to convert a signal from a
`microphone of the hearing aid to the vibratory generating part
`from an analog signal to a digital signal.
`Id. at 4:1–5.
`10. The hearing aid apparatus according to claim 6, further
`comprising:
`least one directivity
`directivity means comprising at
`dependent microphone and/or signal processing means in the
`electronic circuitry.
`Id. at 4:20–24.
`
`
`
`7
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`IPR2017-01018
`Patent 7,043,040 B2
`
`
`E. Applied References
`
`With respect to claim 10, Petitioner relies upon the following
`references. Pet. 4–6.
`Name
`
`Reference
`
`Date
`
`Carlsson
`
`Vaneecloo F.M. Vaneecloo et al., Prosthetic Rehabilitation
`of Unilateral Anakusis: Study by stereo-
`audiometry, 117 ANN. OTOLARYNGOL. CHIR.
`CERVICOFAC. 410 (2000)
`Peder U. Carlsson, On Direct Bone Conduction
`Hearing Devices, Technical Report 195, Dept. of
`Applied Electronics, Chalmers University of
`Technology (1990)
`Leysieffer CA 2301437 A1
`
`Lesinski
`
`U.S. Patent No. 5,881,158
`
`Published
`Oct. 8, 2000
`Issued
`Mar. 9, 1999
`
`Exhibit
`No.
`Ex. 10034
`
`Ex. 1007
`
`Ex. 1009
`
`Ex. 1018
`
`With respect to claim 10, Petitioner relies upon the Declaration of
`Dr. Gerald R. Popelka (Ex. 1002), and the deposition testimony of
`Dr. Rubinstein. Ex. 1127 (June 20, 2018, deposition of Dr. Rubinstein).
`With respect to claim 10, Patent Owner relies upon the June 5, 2018,
`Declaration of Jay Rubinstein (Ex. 2031).
`
`
`4 Petitioner provides an original version of the Vaneecloo reference in
`French. See Ex. 1004. In this Decision, we cite to the English translation of
`Vaneecloo, which was submitted with a sworn statement attesting to its
`accuracy. Ex. 1003, 1.
`
`
`
`8
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`IPR2017-01018
`Patent 7,043,040 B2
`
`
`F. Asserted Ground of Unpatentability
`
`One asserted ground of unpatentability is before us on remand. Pet. 6.
`Claim(s)
`35 U.S.C. §
`References/Basis
`Challenged
`10
`
`§ 103(a) Vaneecloo, Carlsson, Leysieffer, and Lesinski
`
`II. DISCUSSION
`
`A. Claim Construction
`
`The Petition was filed March 3, 2017, prior to the effective date of the
`rule change that replaced the broadest reasonable interpretation standard.
`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 (Oct. 11, 2018) (amending 37 C.F.R. § 42.100(b) effective
`November 13, 2018) (now codified at 37 C.F.R. § 42.100(b) (2019)). We,
`therefore, apply the broadest reasonable interpretation standard in this
`proceeding. As such, the claim terms of the ’040 patent are given their
`broadest reasonable interpretation in light of the specification. 37 C.F.R.
`§ 42.100(b) (2016). Under that standard, we generally give claim terms their
`ordinary and customary meaning, as understood by a person of ordinary skill
`in the art in the context of the entire patent disclosure. In re Translogic
`Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir. 2007).
`In our Final Written Decision, we determined that claims 7–10
`contain means-plus-function limitations subject to 35 U.S.C. § 112 ¶ 6, and
`that the Specification lacks corresponding structure for those limitations.
`Final Dec. 12–28. Because we could not identify the corresponding
`structure, we determined that we could not compare the claims to the
`asserted prior art and, therefore, Petitioner had not met its burden of
`9
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`IPR2017-01018
`Patent 7,043,040 B2
`
`demonstrating the unpatentability of claims 7–10. Id. at 29–30. Petitioner
`challenged this determination on appeal, and the Federal Circuit affirmed, as
`to claims 7–9. Cochlear, 958 F.3d at 1359.
`As to claim 10, however, the Federal Circuit determined that we erred.
`Id. at 1359–60. Specifically, the Federal Circuit noted that claim 10, unlike
`claims 7–9, “does not contain a required claim element in means-plus-
`function form.” Id. at 1359. In other words, because claim 10 includes
`“and/or” language, it encompasses “three alternative subsets of claim
`coverage”: namely, “directivity means comprising” either (1) “a directivity
`dependent microphone only”; (2) “signal processing means only”; or
`(3) “a directivity dependent microphone together with signal processing
`means.” Id. The Federal Circuit agreed with our determination that the
`“signal processing means” recitation—which appears in alternatives (2) and
`(3)—invokes § 112 ¶ 6 and the Specification does not recite corresponding
`structure. Id. at 1360. The Court determined, however, that the at least one
`directivity dependent microphone recitation5 in alternative (1) is a “stand-
`alone alternative” and “is a clear structure for performing the claimed
`directivity means.” Id. at 1360. Thus, even if claim 10 is indefinite due to
`
`
`5 The claim recites “at least one directivity dependent microphone.”
`Ex. 1001, 4:20–24 (emphasis added). Neither the Federal Circuit’s decision
`nor the parties’ briefing addresses whether the phrase “at least one” applies
`to each of the alternative subsets or only to the first. Nevertheless, because
`the Federal Circuit determined that the Specification fails to recite
`corresponding structure for the second and third alternative subsets, we need
`not determine here whether the phrase was intended to apply beyond the first
`alternative subset. We interpret “at least one” to mean one or more.
`Ex. 1010, 134 (original claim 7 reciting “one or more directivity dependent
`microphones and/or signal processing means” (emphasis added)).
`10
`
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`

`IPR2017-01018
`Patent 7,043,040 B2
`
`the “signal processing means” recitation, the Court determined that the claim
`may not be incapable of being compared to the prior art to determine if the
`directivity dependent microphone alternative is rendered obvious by the
`asserted prior art. Id.
`Accordingly, the court vacated and remanded our determination as to
`claim 10, and instructed that, on remand, we consider “whether the
`directivity-dependent-microphone alternative is outside the scope of § 112,
`¶6, because it recites a structure (the directivity dependent microphone) that
`sufficiently corresponds to the claimed directivity means” and “whether any
`asserted prior-art challenges render the directivity-dependent-microphone
`alternative within claim 10 unpatentable, if considered on its own, and
`whether, if so, claim 10 as a whole is unpatentable on that ground.” Id.
`In light of these instructions, we have considered the recited
`“directivity means comprising at least one directivity dependent
`microphone” and determine that § 112 ¶ 6 is not invoked by this alternative
`recitation. Here, the claim recites “means” and also recites a function to be
`performed by the “means.” Namely, in the Final Written Decision, we
`determined that the claimed directivity means performs the function of
`“providing directivity of sound.” Final Dec. 26; see also Ex. 1001, 2:66–
`3:6; Ex. 2031 ¶ 76 (Dr. Rubinstein testifying that the prior art lacked a
`directivity dependent microphone used “for example, to provide directivity
`of sound”); Ex. 3002 (defining “directivity” as “the property of being
`directional”; defining “directional” as, inter alia, “suitable for detecting the
`direction from which radio signals come or for sending out radio signals in
`one direction only”). However, the claim “then goes on to elaborate
`sufficient structure . . . within the claim itself to perform entirely the recited
`
`
`
`11
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`

`IPR2017-01018
`Patent 7,043,040 B2
`
`function,” which dictates that “the claim is not in means-plus-function
`format.” Sage Prod., Inc. v. Devon Indus., Inc., 126 F.3d 1420, 1427–28
`(Fed. Cir. 1997) (emphases added); see also Cole v. Kimberly–Clark Corp.,
`102 F.3d 524, 531 (Fed. Cir. 1996) (“To invoke [§ 112 ¶ 6], the alleged
`means-plus-function claim element must not recite a definite structure which
`performs the described function.”) (emphasis added).
`Specifically, a directivity dependent microphone is recited in claim 10
`itself, and the record shows such a microphone to be a definite structure that
`performs the recited function. See Ex. 1010, 134 (original claim 7 reciting
`“one or more directivity dependent microphones” as structure for the recited
`“directivity means”); Ex. 1018, 7:19–39 (prior art disclosing “array 128 of
`individual implantable microphones 50,” which “provide[s] the subject 12
`with directivity which the subject 12 may use to enhance the sounds of
`interest while concurrently reducing noise”); Ex. 1002 ¶¶ 108, 181
`(Dr. Popelka testifying that an ordinarily skilled artisan “would have desired
`to use a hearing aid device that is better at catering towards individual needs,
`such as improved directivity of sound perception,” including through use of
`a directivity dependent microphone, as taught by Lesinski); Ex. 2031 ¶¶ 35
`(Dr. Rubinstein testifying that an ordinarily skilled artisan “would have
`understood the term ‘directivity dependent microphone’ to be synonymous
`with ‘directional microphone’”), 76 (Dr. Rubinstein testifying that the prior
`art lacked a directivity dependent microphone used “for example, to provide
`directivity of sound”); see also Cole, 102 F.3d at 530–531 (determining
`“perforation means . . . for tearing” is not a means-plus-function element
`under § 112 ¶ 6 “because it describes the structure supporting the tearing
`function (i.e., perforations)”).
`
`
`
`12
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`IPR2017-01018
`Patent 7,043,040 B2
`
`
`The Federal Circuit explains, “[s]ufficient structure exists when the
`claim language specifies the exact structure that performs the function in
`question without need to resort to other portions of the specification or
`extrinsic evidence for an adequate understanding of the structure.” TriMed,
`Inc. v. Stryker Corp., 514 F.3d 1256, 1259–60 (Fed. Cir. 2008). However,
`the Federal Circuit clarifies:
`While it is true that the claim language, in order to avoid the
`application of § 112, ¶ 6 when a claim recites the term “means,”
`must “specif[y] the exact structure that performs the functions in
`question,” TriMed does not preclude consideration of the written
`description, prosecution history, and extrinsic evidence to
`determine if a challenger has rebutted the presumption that a
`claim
`limitation
`that
`lacks
`the
`term “means” connotes
`sufficiently definite structure to those of skill in the art.
`Moreover, where the claims recite the term “means,” we have
`considered the written description to inform the analysis of
`whether the claim recites sufficiently definite structure to
`overcome the presumption that § 112, ¶ 6 governs the
`construction of the claim.
`Inventio AG v. ThyssenKrupp Elevator Americas Corp., 649 F.3d 1350,
`1357 (Fed. Cir. 2011) (emphasis added); but see Williamson v. Citrix Online,
`LLC, 792 F.3d 1339, 1349 (Fed. Cir. 2015) (overruling Inventio’s “strong”
`presumption that a term lacking the word “means” does not invoke 35
`U.S.C. § 112 ¶ 6, but leaving unchanged the presumption that the use of
`“means” invokes 35 U.S.C. § 112 ¶ 6).
`Patent Owner’s expert, Dr. Rubenstein, testified that, although the
`terms “directivity means” and “directivity dependent microphone” appear
`only in claim 10, the subject matter of claim 10 is supported in the
`Specification. See Ex. 1127, 41:14–43:18. In particular, the Specification
`discloses:
`
`
`
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`IPR2017-01018
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`
`
`As the vibrations from the vibrator 1 in this case must be
`transmitted from one side of the skull to the other it is, due to
`specific resonance and attenuation characteristics in the skull, an
`advantage if the electronic circuitry 4 comprises means for
`converting the signal from the microphone 5 from an analog to a
`digital signal for the necessary signal processing. Such signal
`processing means can then be used for adapting for instance the
`frequency characteristics to individual differences in the head
`shadow effect, the sound environment, the skull resonance,
`sound direction and the hearing capacity of the well-functioning
`ear. The signal processing means can also be used for actively
`counteracting acoustic feed-back problems.
`Ex. 1001, 2:63–3:8 (emphases added). Although “signal processing means”
`and a “directivity dependent microphone” can be related to each other and
`can operate together to determine directivity or “sound direction,” we
`understand that they are different alternatives and may operate separately to
`perform the recited function. Cochlear, 958 F.3d at 1359–60; see Ex. 1127,
`43:12–44:10. Moreover, despite the Specification’s failure to describe
`expressly the “directivity dependent microphone” (see Ex. 1127, 43:12–18,
`44:12–16), the parties’ experts agree that a person of ordinary skill in the
`relevant art would have understood a “directivity dependent microphone” to
`encompass known directional microphones (see, e.g., Ex. 1002 ¶¶ 175, 177–
`178; Ex. 2031 ¶ 35; Ex. 1127, 44:18–23). See also S3 Inc. v. Nvidia Corp.,
`259 F.3d 1364, 1370 (Fed. Cir. 2001) (“S3 presented evidence that a selector
`is a standard electronic component whose structure is well known in this art,
`and that such standard components are usually represented in the manner
`shown in the ’279 patent.”).
`Accordingly, because the “at least one directivity dependent
`microphone” claim alternative itself recites structure for performing the
`recited function, this alternative of claim 10 does not invoke § 112 ¶ 6. Sage
`
`
`
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`
`Prod., 126 F.3d at 1427–28. Therefore, we need not consider whether the
`Specification discloses structure for performing the “directivity” function for
`this alternative, as we would if § 112 ¶ 6 were invoked. Accordingly, we
`proceed to consider whether Petitioner has shown claim 10 to be
`unpatentable as obvious, over the ground presented in the Petition. See infra
`§ II.D.5.
`
`B. Principles of Law
`
`A claim is unpatentable under 35 U.S.C. § 103(a) if “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 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 skill in the art; and (4) when in evidence, objective evidence
`of nonobviousness. Graham v. John Deere Co., 383 U.S. 1, 17–18 (1966).
`When evaluating a combination of teachings, we must also “determine
`whether there was an apparent reason to combine the known elements in the
`fashion claimed by the patent at issue.” KSR, 550 U.S. at 418 (citing In re
`Kahn, 441, F.3d 977, 988 (Fed. Cir. 2006)). Whether a combination of
`elements produced a predictable result weighs in the ultimate determination
`of obviousness. Id. at 416–17.
`“In an [inter partes review], the petitioner has the burden from the
`onset to show with particularity why the patent it challenges is
`unpatentable.” Harmonic, Inc. v. Avid Tech., Inc., 815 F.3d 1356, 1363
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`(Fed. Cir. 2016). The burden of persuasion never shifts to Patent Owner.
`Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378
`(Fed. Cir. 2015). To prevail, Petitioner must support its challenge by a
`preponderance of the evidence. 35 U.S.C. § 316(e) (2018); 37 C.F.R.
`§ 42.1(d).
`We analyze the challenge presented in the Petition in accordance with
`the above-stated principles.
`
`C. Level of Ordinary Skill in the Art
`
`In determining whether an invention would have been obvious at the
`time it was made, we consider the level of ordinary skill in the pertinent art
`at the time of the invention. Graham, 383 U.S. at 17.
`As in our Final Written Decision, we adopt Petitioner’s assessment of
`the level of skill in the art. Final Dec. 47–48.
`
`D. Obviousness over the Combined Teachings of
`Vaneecloo, Carlsson, Leysieffer, and Lesinski
`
`Petitioner contends that claim 10 of the ’040 patent is unpatentable as
`obvious over the combined teachings of Vaneecloo, Carlsson, Leysieffer,
`and Lesinski. Pet. 55–58, Supp. Reply 6–7. Patent Owner disagrees. Supp.
`Resp. 10–12.
`
` Overview of Vaneecloo (Ex. 1003)
`
`Vaneecloo is an article entitled “Prosthetic Rehabilitation of
`Unilateral Anakusis: Study by stereo-audiometry,” which discusses clinical
`and stereo-audiometric results for two patients with unilateral hearing loss
`who were treated with a “semi-implantable bone-anchored hearing aid
`
`
`
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`(BAHA),” placed on the deaf side. Ex. 1003, 410.6 According to
`Vaneecloo, the BAHA devices were “anchored directly in the bone” with
`“titanium fixture[s]” and were “designed to capture and transmit
`transcranially to the remaining functional ear the information received from
`the side of the anakusis.” Id. at 410–12.7
`Vaneecloo explains that, although low-pitched sounds bypass the
`patient’s head with little attenuation, this is not the case on the deaf side,
`where “due to the diffraction effect, high-pitched sounds reach the ear
`opposite the source with an attenuation that increases proportionately with
`the frequency of the sound.” Id. at 410. In patients implanted with the
`BAHA device, however, Vaneecloo reports that:
`[D]ue to the multidirectional control tests of the prosthetic gain,
`we found that the amplification of the high-pitched sounds
`captured on the anakusis side and perceived by transcranial route
`by the contralateral ear allowed for a significant rise in sound
`perception thresholds of frequencies between 1,000 and 4,000
`Hz, when the source of the sound was located on the anakusis
`side of the auditory hemifield.
`Id. at 415. Vaneecloo states that the tests were “performed with a fixed
`loudspeaker and a swivel chair,” at 2000 Hz and 250 Hz. Id. at 414; see also
`id. at Figs. 11–12.
`
`
`6 We recognize that “BAHA” is a trademarked term. Reg. No. 2118182
`(Dec. 2, 1997) (live). However, Vaneecloo utilizes this term without
`indicating whether it refers to a device manufactured by registered
`trademark owner Cochlear Bone Anchored Solutions AB (Patent Owner in
`this proceeding). For consistency with Vaneecloo’s disclosure, we utilize
`the same term.
`7 The term “anakusic” or “anacusic” refers to a patient’s deaf ear, and
`“contralateral” refers to a patient’s non-deaf ear, in patients with unilateral
`hearing loss. Ex. 1002 ¶¶ 68, 70; Ex. 1003, 410, 415.
`17
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`

`IPR2017-01018
`Patent 7,043,040 B2
`
`
` Overview of Carlsson (Ex. 1007)
`
`Carlsson is an article entitled “On Direct Bone Conduction Hearing
`Devices,” which discusses BAHA devices. Ex. 1007, Abstract. Carlsson
`explains that such devices transmit sound information “by percutaneous
`direct bone conduction,” which transmits vibrations from the device to the
`skull. Id.; see also id. at 4, 10. According to Carlsson, “[a] skin-penetrating
`abutment is attached to an implanted titanium fixture situated behind the
`pinna. The abutment contains a bayonet coupling to which the BAHA is
`connected.” Id. at 4, Fig. 1. The attached BAHA component includes, inter
`alia, a microphone and transducer. Id. at 18–20, Fig. 10.
`According to Carlsson, BAHA devices present several advantages
`over the prior art, including superior technical performance, “increased
`speech intelligibility,” and “improved wearing comfort.” Id. at Abstract, 22.
`
` Overview of Leysieffer (Ex. 1009)
`
`Leysieffer is a Canadian Patent Publication entitled “Implantable
`System for Rehabilitation of a Hearing Disorder.” Ex. 1009, code (54).
`Leysieffer teaches a partially implantable hearing aid system including
`wireless telemetry means that transmit data from an external unit to an
`implantable component to permit an operating program or parameter to be
`modified or replaced while the component is implanted. Id. at code (57),
`9:27–30, Figs. 1, 3 (telemetry system 125). Leysieffer’s device also includes
`battery 60 within implant housing 56, wherein the battery may be recharged
`by induction. Id. at 10:20–22, 13:10–11, 14:10–11, 14:29–15:2, Fig. 3.
`
`
`
`18
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`

`

`IPR2017-01018
`Patent 7,043,040 B2
`
`
` Overview of Lesinski (Ex. 1018)
`
`Lesinski is a United States Patent entitled “Microphones for an
`Implantable Hearing Aid.” Ex. 1018, code (54). Lesinski discloses an
`implantable electronics module that includes an array of individual
`microphones, aligned in a row. Id. at 7:3–5, 7:19–23, Fig. 6. Each
`microphone generates an independent signal, which is summed by a signal-
`processing amplifier. Id. at 7:30–34. “In this way the hearing aid 10 can
`provide the subject 12 with directivity which the subject 12 may use to
`enhance the sounds of interest while concurrently reducing noise.” Id. at
`7:34–37.
`
` Analysis of Claim 10
`
`Petitioner contends that a person of ordinary skill in the art “would
`have found it obvious to modify the BAHA apparatus of the Vaneecloo-
`Carlsson-Leysieffer combination [of claim 6] . . . to include directional
`microphone functionality, such as taught by Lesinski.” Pet. 56. Petitioner
`contends this would have been a combination of known prior art elements in
`known ways, to attain predictable results. Id. at 56–57. Petitioner relies on
`Dr. Popelka’s testimony in contending that “the use of microphones for
`purposes of directivity of sound in hearing aids” was well known, and
`provided advantages such as improved signal-to-noise ratio and improved
`speech recognition in noisy environments. Id. at 57 (citing Ex. 1002 ¶¶ 177–
`180). Dr. Popelka cites two studies that evaluated directional microphone
`use during monaural listening (listening with one ear), which he contends
`are pertinent to unilateral hearing loss. Ex. 1002 ¶¶ 178–180 (citing
`Exs. 1022–23).
`
`
`
`19
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`

`IPR2017-01018
`Patent 7,043,040 B2
`
`
`Patent Owner argues that an ordinarily skilled artisan would not have
`found it obvious to include Lesinski’s directional microphone arrangement
`because it “would fundamentally change” a bone-anchored device and
`“would not be operational.” Supp. Resp. 11. Patent Owner relies on
`Dr. Rubinstein’s testimony that the proposed modification would require
`attaching multiple microphones at locations around a patient’s head, “which
`is not at all the device” of the challenged patent. Id. (citing Ex. 2031 ¶ 79).8
`Patent Owner also relies on Dr. Rubinstein’s testimony that such a change
`would “negate an acknowledged improvement of those [bone-anchored]
`devices”—“a simpler, slimmer profile.” Id. (citing Ex. 2031 ¶ 81).
`Patent Owner next contends that the monaural listening studies relied
`upon by Dr. Popelka “are in no way equivalent to SSD . . . and thus would
`not be looked to by a [person of ordinary skill in the art] concerned with
`unilateral deafness.” Id. at 12 (citing Ex. 2031 ¶ 88). Finally, Patent Owner
`alleges that, even after the critical date, manufacturers chose not to use
`directional microphones in CROS hearing aids,9 which Patent Owner
`
`
`8 This argument conflicts with Patent Owner’s additional argument that
`implanted microphones, like Lesinski’s, have a number of problems, such as
`the detection of body or muscle n