# United States **Court of Appeals**  **for the Federal Circuit**

______________________
COCHLEAR BONE ANCHOR ED SOLUTIONS AB, Appellant

v.

OTICON MEDICAL AB, O TICON MEDICAL LLC, WILLIAM DEMANT HOLDI NG A/S, Cross

- Appellants

______________________

2019

- 1105, 2019

- 1106

______________________ Appeals from the United States Patent and Trademark Office, Patent Trial and Appeal Board in No s . IPR2017

- 01018, IPR2017

- 01019.

______________________
Decided: May 15, 2020

____________ __________
L AURA B URSON , Sheppard, Mullin, Richter & Hampton LLP, Los Angeles, CA, argued for appellant. Also represented by B RUCE G. C HAPMAN ; M ARK P ATRICK , Washington, DC

.

D AVID R. A NDERSON , Birch Stewart Kolasch & Birch, LLP, Falls Church, V A, argued for cross

- appellants. Also represented by E UGENE P EREZ

.

______________________
Before N EWMAN , O’M ALLEY , and T ARANTO , Circuit Judges. Case: 19-1105 Document: 53 Page: 1 Filed: 05/15/2020COCHLEAR BONE ANCHORED v. OTICON MEDICAL AB 2

Opinion for the court filed by Circuit Judge T ARANTO

. Opinion concurring in part and dissenting in part filed by Circuit Judge N EWMAN

. T ARANTO , Circuit Judge

.Cochlear Bone Anchored Solutions AB owns U.S. Patent No. 7,043,040, which describes and claims a bone

- anchored hearing aid that transmits sound waves tr anscranially from a patient’s deaf side to th e patient’s

non

- deaf ear. Oticon Medical AB , Oticon Medical LLC, and William Demant Holding A/S ( together , Oticon) successfully sought from the Patent and Trademark Office (PTO) two inter partes review s of, col lectively, all claims of the ’040 patent under 35 U.S.C. §§ 311

– 319. In those reviews, the PTO’s Patent Trial and Appeal Board concluded that Oticon proved claims 4

– 6 and 11

– 12 unpatentable, but did not prove claims 7

– 10 unpatentable. (Cochlear disclaime d claims 1

– 3 and 13.) Cochlear appeals the ruling on claims 4

– 6 and 11

– 12, while Oticon cross

- appeals the ruling on claims 7

– 10. We affirm the Board’s conclusion s as to all claims except claim 10, as to which we vacate and remand

. I

A
The ’040 patent describes a hearing aid with several parts. One part is a vibrat ion

- producing component implanted and mechanically anchored into a patient’s skull

on the patient’s deaf side . ’040 patent, col. 2, lines 16

– 22, 48

– 55. An external part of t he hearing aid, which includ es

a microphone

, picks up sound on the patient’s deaf side, processes the sound

, and generates vibrations in the implanted part. Id. , col. 2, line 4 4
, through col. 3, line 8

. Those vibrations are transmitted through the patien t’s skull to the patient’s non

- deaf ear , so that the patient’s

non

- deaf ear perceive s sound originating from the deaf

- ear side. Id. Case: 19-1105 Document: 53 Page: 2 Filed: 05/15/2020COCHLEAR BONE ANCHOR ED v. OTICON MEDICAL AB 3

Several additional details discussed in the specification are relevant to the issues before us. T he ’040 patent notes that high

- frequency soundwaves , as they traverse the skull, weaken in strength m ore than do l ow

- frequency soundwaves ; that is, transcranial attenuation is greater for treble than for bass f r equencies

. Id. , col. 2, lines 56

– 62. T he patent suggests t hat this differential attenuation may be addressed by selectively amplifying treble frequencies relative to bass frequencies. Id. In addition, t he patent describes the following alternative embodiments of the hearing aid: one with a battery in the extern al part that powers the internal part through induction , an other with a battery in the internal part that is re charged through induction. Id. , col. 3, lines 11

– 24

. Claim 1 of the ’040 patent is the independent claim on which all claims now at issue depe nd , directly or indirectly

. It recites :
1. A bone

- conducting bone

- anchored hearing aid apparatus for sound transmission from one side of a patient’s head to the patient’s cochleaon another side of the patient’s head for rehabilitation of unilateral heari ng loss, the hearing aid apparatus comprising:
a vibratory generating part arranged togenerate 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 generatingpart, the implantable part being osseointegrated in the patient’s skull bone behind an external ear at the deaf side of a patient. Case: 19-1105 Document: 53 Page: 3 Filed: 05/15/2020COCHLEAR BONE ANCHORED v. OTICON MEDICAL AB 4

Id. , col. 3, lines 29

– 41. Cochlear statutorily disclaimed independ ent claim s 1 and 13 and dependent claims 2

– 3 during the inter partes review s

. The claims addressed by the Board and now before us are d ependent claims 4

– 12 , all of which are apparatus claims.

C laims 4 and 5 require that the frequency characteristics of the hearing aid are “specifically adapted to transmit vibrations in the skull bone from one side of the skull to the other side” (by incorporation of claim 3) and require that treble frequencies are amplified more than bass frequencies. Id. , col. 3, lines 44

– 53. C laim 6 , dependent on claim 1, require s electronic circuitry “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. , col. 4, lines 1

– 5. Claim s 7

– 9 , dependent on claim 6, all require certain “digital signal processing means” or “signal processing means.” Id. , col. 4, lines 7

– 19

. Claim 10, dependent on claim 6, requires “directivity means comprising at least one directivity dependent microphone and/or signal processing means.” Id. , col. 4, lines 20

– 24. Cl aim 11 , dependent on claim 1, specif ies that the implant ed part and the vibrat ion

- producing part are include d in the internal part and that power is transmitted from the external part of the he aring aid to the internal part by induction

. Id. , col. 4, lines 26

– 32. C laim 12 , dependent on claim 11, adds that the internal part includes a rechargeable battery to be charged by induction from an external power supply

. Id.

, col. 4, lines 33

– 36.

B Oticon filed two petitions for inter partes reviews

, challenging all claims of the ’040 patent. The Board, acting as delegee of the PTO’s D irector, 37 C.F.R. §§ 42.4, 42.108, initially instituted a review only of claims 1

– 6 and 11

– 13 . It declin ed to institute a review of claims 7

– 10 on the ground that those claims likely are means

- plus

- function claim s Case: 19-1105 Document: 53 Page: 4 Filed: 05/15/2020COCHLEAR BONE ANCHOR ED v. OTICON MEDICAL AB 5

subject to 35 U.S.C. § 112, ¶ 6 (2006)

, 1 but there i s no identified correspo nding structure in the specification , without which “the differences between the claimed invention and the asserted prior art cannot be ascertained.” J.A. 295

. The Board consolidated the two IPR proceedings.

After the Supreme Court issued its decision in SAS Institute Inc. v. Iancu , 138 S. Ct. 1348 (2018)

, the Board added claims 7

– 10 to the proceedings. It authorized the filing of supplemental brief s on those claims. In the supplemental briefing, the parties agreed to broad constructions for the means

- plus

- function limitations, namely that the “digital signal processing means” and “signal processing means” limitations include a “digital signal process or” and the “directivity means” limitation include s “adirectivity dependent microphone (or directional microphone) and/or a digital signal processor.” J.A. 461

– 63, 476

. The Board proceeded to trial on the following invalidity grounds: claims 4

– 5 as obvio us over Vaneecloo 2 and Carlsson; 3 claims 6, 7, and 9 as obvious over Vaneecloo, Carlsson, and Leysieffer; 4 claim 8 as obvious over Vaneecloo,

1 Because of the filing date of the application that issued as the ’040 patent, the means

- plus

- function provision applicable in this case is 35 U.S.C. § 112, ¶ 6 , which is now codified, without change material to this case, as 35 U.S.C. § 112(f). See Zeroclick, LLC v. Apple Inc. , 891 F.3d 1003, 1006 n.2 (Fed. Cir. 2018).

2 F.M. Vaneecloo et al., P rosthetic Rehabilitation of Unilateral Anakusis: Study by Stereo

- Audiometry

, 117 Ann. Otolaryngol. Chir. Cervicofac. 410 (2000).

3 Peder U. Carlsson, Dep ’ t of Applied Electronics, Chalmers Univ. of Tech., Tech. Report No. 195

, On Direct Bone Conduction Hearing Devices: Advances in Transducer Technology and Measurement Methods (1990).

4 C an. Pat ent Pub. No. 2301437 A1. Case: 19-1105 Document: 53 Page: 5 Filed: 05/15/2020COCHLEAR BONE ANCHORED v. OTICON MEDICAL AB 6

Carlsson, Leysieffer, and Schaefer; 5 claim 10 as obvious over Vaneecloo, Carlsson, L e ysieffer, and Lesinski; 6 clai m 11 as anticipated by Hough; 7 and claim 12 as obvious over Hough and Leysieffer.

Vaneecloo describes a clinical study o f the “possibilities of prosthetic rehabilitation by semi

- implantable bone

- anchored hearing aid (BAHA) in two patients with unilateral

a nakusis

. ” 8 J. A

. 783. The study involved surgically implanting a bone

- anchored hearing device on a patient’s deaf side that transcranially transmit s sound received on the deaf side to the patient’s non

- deaf ear. J. A

. 784. The investigators concluded 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 .” J.A. 788.

Carlsson discloses the use of a bone

- anchored hearing device for the treatment of patients with conductive or sensorineural hearing loss. J. A

. 840

. Carlsson also discloses

a hearing aid fitting process in which the user manipulates the bass and treble frequency controls independently to optimize the device’s frequency characteristics for that user

. J. A

. 819

– 22. Leysieffer describes a partially or fully implantable hearing aid system capable of process ing or generat ing signals according to set parameters and convert ing acoustic signals into electrical signals. J. A

. 916
, 926. Leysieffer discloses transmitting signals , through inductive coupling,

5 U.S. Pat ent No. 4,729,366.

6 U.S. Pat ent No. 5,881,158.

7 J.V.D. Hough et al., Long

- Term Results for the Xomed Audiant Bone Conductor , 28 Otolaryngol. Clinics of N. America 43 (1995).

8 “Anakusis” refers to hearing loss or deafness. Case: 19-1105 Document: 53 Page: 6 Filed: 05/15/2020COCHLEAR BONE ANCHOR ED v. OTICON MEDICAL AB 7

from an external unit to an implant ed part. J. A

. 917. Leysieffer also describes charging

, by inductive coupling

, a rechargeable battery cell located in the hearing aid ’s implanted part. J. A

. 925. Hough describes the Xomed Audiant Bone Conductor device, which uses an alternating electrical current generated by an e xternal processor to electromagnetically vibrat e an implanted osseointegrated magnet. J. A

. 1097

– 98

. The external processor includes a microphone to pick up sounds on a patient’s deaf side

, an amplifier, and an electromagnetic coil to vibrate the implante d magnet , which sends vibrations transcranially to a patient’s non

- deaf ear when activated

. J. A

. 1098. In its final written decision, the Board concluded that claims 4

– 6 and 11

– 12 are unpatentable on the grounds raised in Oticon’s petitions

. J.A. 48

– 86 , 89 . The Board also concluded that Oticon had not proven claims 7

– 10 unpatentable , reasoning that the means

- plus

- function limitations of those claims have no corresponding structure disclosed in the specification, so that the Board could not “ascertain the differences between the claimed invention and the asserted prior art” for those claims. J .A. 16

– 30 , 89

. The Board decided several claim

- construction disputes relevant to the issues now before us , relying on the broadest

- reasonable

- interpr etation standard, whose applicability to this case is not in dispute

. It ruled that claim 1’s preamble phrase “for rehabilitation of unilateral hearing loss,” applicable to all claims currently at issue, did not limit the scope of the claims. J

. A

. 33

– 35

. The Board also considered claim 3’s phrase “the frequency characteristicsof the apparatus are specifically adapted to transmit vibrations in the skull bone from one side of the skull to the other side

, ” applicable to claims 4 and 5, and determined that frequency characteristic adaptations need not “account for the mechanics of the skull.” J.A. 38

– 41. The Board construed claim 6’s “electronic circuitry” limitation, applicable Case: 19-1105 Document: 53 Page: 7 Filed: 05/15/2020COCHLEAR BONE ANCHORED v. OTICON MEDICAL AB 8

to claims 6

– 10, to mean “an analog

- to

- digital converter.” J .A. 31. The Board construed “induction

, ” in claims 11 and 12, to mean “electromagnetic induction,” but held that the term did not require the generation of voltage or current in the implanted part. J .A. 4 1

– 45.

C
Cochlear timely appealed the Board’s de termination that claims 4

– 6 and 11

– 12 have been proved unpatentable, and Oticon timely cross

- appealed the Board’s decision that claims 7

– 10 have not been proved unpatentable. We have jurisdiction under 28 U.S.C. § 1295(a)(4)(A).

We review t he Board’s comp liance with legal standards de novo, Pride Mobility Products Corp. v. Permobil, Inc.

, 818 F.3d 1307, 131 3

– 1 4 (Fed. Cir. 2016), and its underlying factual determinations for substantial evidence, Personal Web Tech nologies , LLC v. Apple, Inc. , 848 F.3d 987, 991 (Fed. Cir. 2017). Among the f actual determinations in an obviousness analysis are “findings as to the scope and content of the prior art

. . . [and] the presence or absence of a motivation to combine or modify with a reasonable expectation of success. ” Ariosa Diagnostics v. Verinata Health, Inc. , 805 F.3d 1359, 1364 (Fed. Cir. 2015). A determination of a nticipation is a factual finding reviewed for substantial

evidence support

. Dell Inc . v. Acceleron, LLC , 818 F.3d 1293, 1298 (Fed. Cir. 2016). “ We review the Board’s claim construction de novo and any underlying factual findings for substantial evidence.” Kaken Pharm

. Co. v. Iancu

, 952 F.3d 1346, 1350 (Fed. Cir. 2020).

II Cochlear challenges several aspe cts of the Board’s unpatentability determination s for claims 4

– 6 and 11

– 12. We do not find these challenges persuasive. Case: 19-1105 Document: 53 Page: 8 Filed: 05/15/2020COCHLEAR BONE ANCHOR ED v. OTICON MEDICAL AB 9

A

Cochlear challenges the Board ’s conclusion that claim 1’s preamble phrase “for rehabilitation of unilateral hearing loss” does not li mit the scope of the claim s and also the Board’s rejection of Cochlear’s narrowing construction of that phrase as limited to certain profound hearing loss

. We reject this challenge at the first step, agreeing with the Board that the phrase is not limiting for the apparatus claims at issue

. “We have treated the effect of preamble language as a claim

- construction issue.” Arctic Cat Inc. v. GEP Power Prods., Inc. , 919 F.3d 1320, 1327 (Fed. Cir. 2019). We have stated that “ as a general rule preamble language is not treated as limiting

, ” Aspex Eyewear, Inc. v. Marchon Eyewear, Inc. , 672 F.3d 1335, 1347 (Fed. Cir. 2012)

, but “[w] hether to treat a preamble as a limitation is determined on the facts of each case in light of the overall form of the claim [] and the invention as described in the specification and illuminated in the prosecution history

, ” Deere & Co. v. Bush Hog, LLC , 703 F.3d 1349, 1357 (Fed. Cir. 2012) (quotation marks omitted). We have also explained that “[t] hose general formulations have for decades beenimplemented through a number of more concrete and objective rules. ” Arctic Cat , 919 F.3d at 1327.

“ I n general, a preamble limits the invention if it recites essential structure or steps, or if it is necessary to give life, meaning, and vitality to the claim.” Catalina Mktg. Int’l

, Inc. v. Coolsavings.com, Inc. , 289 F.3d 801, 808 (Fed. Cir. 2002) (quotation marks omitted). The preamble may be limiting to the extent it is “necessary to provide antecedent basis for the body o f the claim.” Symantec Corp. v. Computer Assoc. Int’l, Inc. , 522 F.3d 1279, 1288 (Fed. Cir. 2008); see TomTom, Inc. v. Adolph , 790 F.3d 1315, 1323 (Fed. Cir. 2015). But “ p reamble language merely extolling benefits or features of the claimed invention doe s not limit the claim scope without clear reliance on those benefits or features Case: 19-1105 Document: 53 Page: 9 Filed: 05/15/2020COCHLEAR BONE ANCHORED v. OTICON MEDICAL AB 10

as patentably significant.” Catalina , 289 F.3d at 809. Further, “[w] e have long ruled that a preamble is not limiting where a patentee defines a structurally complete invent ion in the claim body and uses the preamble only to state a purpose or intended use for the invention. ” Arctic Cat , 919 F.3d at 1328 (quotation marks omitted); see Georgetown Rail Equip. Co. v. Holland L.P. , 867 F.3d 1229, 1236 (Fed. Cir. 2017) ; Catalina , 289 F.3d at 808; Rowe v. Dror , 112 F.3d 473, 478 (Fed. Cir. 1997).

The Board in this case correctly held that the preamble phrase “for rehabilitation of unilateral hearing loss” is not a limitation on the scope of the se apparatus claims. J.A. 3 1

– 3 5

. T he preamble’s recitation of “for rehabilitation of unilateral hearing loss” is merely a statement of intended

use of the claimed hearing aid

. It identifies no structure for the apparatus claimed. Moreover, th is use itself is not

an inventive or p atentably distinct aspect of the claimed invention , as “ rehabilitation of unilateral hearing loss” was a conventional use of prior art bone

- anchored hearing aids. See ’040 patent, col. 1, lines 44

– 61; Arctic Cat , 919 F.3d at 1329

– 30 (preamble phrase “[a] personal recreational vehicle” was not limiting because it merely described conventional, rather than inventive aspects of the claimed invention).

The bod ies of the claims contain the only descriptions of the structure for the hearing aid , with no additional structure furnished by the preamble phrase at issue

. For example, the body of independent claim 1 identif ies the orientation and implantation of the device relative to the patient’s head. See ’040 patent, col. 3, lines 36

– 37 (“from a deaf side to the inner ear on the other side of the patient”); id. , col. 3, lines 39

– 41 (“the implantable part being osseointegrated in the patient’s skull bone behind an external ear at the deaf side of a patient”). The body of the claim also recite s the function and position of the implanted “vibratory generating part.” See i d. , col. 3, lines 34

– 39 (“generate vibrations that are mechanically transmitted through the Case: 19-1105 Document: 53 Page: 10 Filed: 05/15/2020COCHLEAR BONE ANCHOR ED v. OTICON MEDICAL AB 11

skull” and “an implantable part operative to mechanically anchor the vibratory generating part”)

. These descriptions offer a complete structure such that “for rehabilitation of unilateral hearing loss” adds nothing to the configuration of the claimed device

. The phrase “for rehabilitation of unilateral hearing loss” also is not necessary to provide antecedent basis for the body of the claim s

. Although the preamble term “ a patient” may provide antecedent basis for claim 1’s later recitation of “the patient

, ” that is not the preamble languageCochlear argues is limiting. A conclusion that some preamb le language is limiting does not imply that other preamble language, or the entire preamble

, is limiting. See TomTom , 790 F.3d at 1322

– 23. The language at issue here , which states only an intended use, adds no structural element, and provides no antecede nt basis for the body of the claim s , is not limiting.

B
Claims 4 and 5, which depend directly or indirectly on disclaimed claim 3, require that “ the frequency characteristics of the [ bone

- anchored hearing aid ] are specifically adapted to transmit vibrations in the skull bone from one side of the skull to the other side.” Claim 4 further requires that the hearing aid amplif ies treble frequencies more than bass frequencies . C laim 5 additionally requires that the amplified “treble frequencies have a frequency greater than 1 kHz.”
Cochlear challenges the Board’s obviousness determinations for claims 4 and 5 on three grounds. The first argument

— that Carlsson teaches away from use in patients with profound hearing loss

— is premised on an incorrect assum ption that the intended

- use language of the preamble is limiting , an assumption we have rejected above. The second argument

— that the “specifically adapted to” limitation requires that the frequency characteristics “account for the mechanics of the skull”

— and third argument

— that Case: 19-1105 Document: 53 Page: 11 Filed: 05/15/2020COCHLEAR BONE ANCHORED v. OTICON MEDICAL AB 12

the Board lacked substantial evidence to find that Vaneecloo teaches amplifying treble frequencies more than bass frequencies

— are not persuasive for the reasons we now discuss

. Cochlear has not persuasively identified an error in th e Board ’s conclusion that the “specifically adapted to” limitation has its ordinary meaning , with no additional requirement that adaptions be made to frequency characteristic s to “account for the mechanics of the skull.” J.A. 39

– 41

. In fact, Cochlear has not concretely identified why the Board’s ordinary

- meaning construction is not the broadest reasonable interpretation.

To the extent that Cochlear is suggesting that the language requires a particular intent or objective of a hearing

aid designer or manufacturer, we reject the suggestion

. We have previously held that the claim term “adapted to” generally means “made to,” “designed to,” or “configured to” perform the stated function , and we have not introduce d a subjective element into the construction of the phrase. See In re Man Machine Interface Techs. LLC , 822 F.3d 1282, 1286 (Fed. Cir. 2016); In re Giannelli , 739 F.3d 1375, 1379 (Fed. Cir. 2014); Aspex Eyewear , 672 F.3d at 1349. To the extent that Cochl ear is suggesting an objective characteristic of the configuration , it has not shown overbreadth of the Board’s ordinary

- meaning construction. The claim phrase at issue, in its broadest reasonable interpretation, covers any frequency

- characteristic adapti on “to transmit vibrations in the skull bone from one side of the skull to the other side.” Either Cochlear’s proposal is redundant of that language or it is unduly limiting. In neither case is there error in the Board’s claim construction.

Cochlear’s fi nal challenge to the Board’s conclusion about claim s 4 and 5 addresses the additional differential

amplification limitations of those claims. This challenge turns specifically on whether there is substantial evidence in the record from which the Board cou ld have determined Case: 19-1105 Document: 53 Page: 12 Filed: 05/15/2020COCHLEAR BONE ANCHOR ED v. OTICON MEDICAL AB 13

that Vaneecloo discloses amplifying treble frequencies more than bass frequencies. We conclude that the Board did have such evidence.

The Board relied on Vaneecloo’s disclosure that “the amplification of the high

- pitched sounds captured on the anakusis side and perceived by transcranial route by thecontralateral ear allowed for a significant rise in sound perception thresholds of frequencies between 1,000 Hz and 4,000 Hz.” J. A

. 59 (citing J.A

. 788 )

. Based on th at statement, the Board found that Vaneecloo discloses amplifying treble frequencies more than bass frequencies. See J.A. 59

– 62. Vaneecloo’s disclosure explicitly states that the study involved amplification of treble frequencies. J.A. 788. Vaneecloo als o notes that “high

- pitched sounds reachthe ear opposite the source with an attenuation that increases proportionately with the frequency of the sound,” indicating that high

- pitched sounds must be amplified more than low

- pitched sounds. J.A. 783 ; see J. A

. 59

. Other record evidence further supports the notion that Vaneecloo discloses amplif ying treble frequenc ies more than bass frequencies. T he BAHA Classic 300 device available at the time of the Vaneecloo study 9 was capable of adjusting treble and bass f requencies relative to each other. J. A

. 1414 (“The low frequency response can be adjusted using the tone control

. . . . Turn the tone control [ counterclockwise ] to decrease the low frequency sound.”) ; J. A

. 1443 (“ [T] he low

- frequency response can be adju sted in order to increase

. . . the treble sound relative to the bass.”). The Board, therefore, had substantial evidence to conclude that Vaneecloo discloses amplif ying treble frequencies more than bass frequencies

.

9 Cochlear agrees that the BAHA Classic 300 was the bone

- anchored hearing aid in existence at the time of the Vaneecloo study. J.A. 58 ; J.A. 385. Case: 19-1105 Document: 53 Page: 13 Filed: 05/15/2020COCHLEAR BONE ANCHORED v. OTICON MEDICAL AB 14

C

Claim 6 requires electronic circuitry that converts an analog signal to a digital signal, which the Board construed as requiring “an analog

- to

- digital converter.” Cochlear does not dispute that the combination of Vaneecloo, Carlsson, and Leysieffer discloses all limitations of claim 6. But Cochlear challenges the Board’s finding that a relevant artisan would have been motivated to combine the signal processor disclosed in Leysieffer with the hearing aid disclosed by the combination of Vaneecloo and Carlsson.

W e reject that challenge, concluding that t he Board’s finding is supported by substantial evidence

. Oticon’s expert, Dr. Popelka , asserted that a relevant artisan wouldhave been motivated to modify the Vaneecloo/Carlsson device to include an analog

- to

- dig ital converter in order to obtain the advantages associated with digital processing ( e.g. , real

- time and multi

- channel audio signal processing ; feedback reduction ; more closely matching the needs of the individual patient). J. A

. 737

– 38. Leysieffer itself discusses the benefits of digital signal processing in bone

- anchored hearing aids, including adapting for patient

- specific circumstances and updating processing software without removing the implanted part of the hearing aid. J. A

. 921
, 931

. I n light of that evidence, and the absence of persuasive contrary evidence that the Board had to credit, the Board reasonably found a motivation to combine Leysieffer with Vaneecloo and Carlsson. 10

10 Cochlear additionally argues that the Board did not analyz e the motivation to combine references in light of the claim preamble. As discussed above, however, the preamble is not limiting. Case: 19-1105 Document: 53 Page: 14 Filed: 05/15/2020COCHLEAR BONE ANCHOR ED v. OTICON MEDICAL AB 15

D

Claim 11 requires the external part of the hearing aid
to transmit power to the internal part by induction. TheBoard found that Hough’s disclosure of an external electromagnetic coil that generates an alternating current, thereby causing the implanted magnet to vibrate, meets the induction limitation. J. A

. 78

– 81 (citing J.A. 1097

– 98 ); see also J.A. 1098 (“When the current is passed through the external coil

. . . alternating electromagnetic fields cause the magnet implanted in the temporal bone to vibrate.” )

. Cochlear challenges the Board’s finding that Hough anticipates claim 11, arguing that because there is no voltage or current generated in the internal part of Hough

, it is not powered by induction. We reject this challenge. Cochlear does not challenge the Board’s construction of “induction” to mean

, witho ut further qualification, “electromagnetic induction

. ” Appellant’s Br. 29. Although Cochlear earlier dispute d the Board’s construction of “power”

— which the Board declined to limit to electric power

— Cochlear’s argument on appeal focuses only on the constr uction of “induction

. ” Appellant’s Br. 29

– 30; J. A

. 41

– 45. Cochlear does not challenge the Board’s understanding of Hough. Instead, Cochlear argues that “electromagnetic induction” necessarily requires the generation of voltage or current in the internal part, a limitation that the Board specifically excluded from its construction of “induction.” J. A

. 44

– 45. We are not persuaded. Cochlear has not established a plain meaning of “electromagnetic induction” (or “power” ) as requiring a voltage or current on the receiving end. Nor does the ’040 patent specification require a particular
structure or the generation of voltage or current in the internal part. See, e.g. , ’040 patent, col. 3, lines 11

– 14. Particularly for th e vibrator, t he ’040 patent describes the element in only general terms. Id.

, col. 3, lines 9

– 11; see also id.

, col. 2, lines 50

– 53; id.

, Fig. 2. We therefore affirm the Board’s finding that Hough anticipates claim 11. Case: 19-1105 Document: 53 Page: 15 Filed: 05/15/2020COCHLEAR BONE ANCHORED v. OTICON MEDICAL AB 16

E

Claim 12 , which depends on claim 11, further requires the external part of the hearing aid to charge, by induction, a rechargeable battery in the internal part. Cochlear does
not dispute that the combination of Hough and Leysieffer teaches every limitation of claim 12. Cochlear argues o nly that the Board did not have substantial evidence to find a motivation to combine Hough with Leysieffer because the internal part in Hough

— a magnet

— is not powered by a battery.
We disagree. The Board had substantial evidence to find that moving the bat tery to an internal part of the hearing aid would allow for a smaller and more aesthetically pleasing external part, a benefit that would have motivated a relevant artisan to combine the two references. J. A

. 82

– 85. T he prior art specifically notes a pati ent preference for hearing aids with smaller, more discrete external parts

, which can be achieved by moving external elements of the device to the internal part

. J.A. 83 (citing J. A

. 918

– 19, 1343 ); see also J. A

. 918

– 19 (visible external parts “stigmatize the wearer and therefore are not willingly worn,” and for these devices, “it now seems to be a good idea to design the systems such that they can be completely implanted”)

. Moving the battery to an internal part reduce s the size of the external part even if the internal part itself do es not require power, as is the case for Hough. Cochlear lastly argues that Hough teaches away from

us ing its disclosed device in patients with profound hearing loss. See J.A. 1099

. Becau se the preamble is not limiting, and there is therefore no limitation on the type of hearing loss to be treated by the claimed hearing aid , this argument is not persuasive

. III

On cross

- appeal, Oticon argues that the Board erred in determining that it coul d not conduct a prior

- art analysis Case: 19-1105 Document: 53 Page: 16 Filed: 05/15/2020COCHLEAR BONE ANCHOR ED v. OTICON MEDICAL AB 17

for claims 7

– 10 and, on that sole basis, ruling that those claims had not been proved unpatentable

. T he Board concluded that because these claims contain means

- plus

- function limitations, without a corresponding structure disclosed in the specification

, it could not construe the claims in order to compare the claim requirements with the prior art. We hold that t he Board did not err as to claims 7

– 9, but did err as to claim 10.

A

Where a c laim contains a requirement that must be met by any device or process within its scope, and the meaning of that requirement is entirely unknown, the claim cannot be compared to the prior art for purposes of an invalidity analysis , and so that analysis cann ot be conducted

. See Samsung Elecs

. America, Inc. v. Prisua Eng ’ g Corp. , 948 F.3d 1342, 1353 (Fed. Cir. 2020). One such situation can occur w hen a multi

- element claim recites as one required element a means for performing a function but does not recite a structure for performing that function . If the claim is in that format, 35 U.S.C. § 112, ¶ 6, states that the claim scope is defined based on what the specification
sets out as corresponding structure s for performing the claimed function. 35 U.S.C. § 11 2, ¶ 6 (claim element defined to mean those structures and equivalents). If the specification fails to recite a corresponding structure, then there is a wholly undefined claim element : the claim has what amounts to an inkblot as a require d element of the claim. Such a claim logically cannot be compared to prior art, because an essential claim element has no discern i ble meaning.

Such a claim is indefinite

, Williamson v. Citrix Online, LLC , 792 F.3d 1339, 135 1

– 5 2 (Fed. Cir. 2015) , but that is not the inquir y in an inter partes review, in which theBoard may not hold a challenged claim of a patent indefinite. See 35 U.S.C. § 311(b); Cuozzo Speed Techs., LLC v. Lee , 136 S. Ct. 2131, 2141

– 43 (2016); Samsung , 948 F.3d Case: 19-1105 Document: 53 Page: 17 Filed: 05/15/2020COCHLEAR BONE ANCHORED v. OTICON MEDICAL AB 18

at 1350

– 53. The crucial point for purposes of an inter partes review of issued claims is that, in the situation just described, it is impossible to conduct a prior

- art analysisbecause there is a required claim element without meaning . In this situation, the Board should “ conclude that it could not reach a decision on the merits with respect to whether petitioner had established the unpatentability of those claims under sections 102 or 103. ” Samsung , 948 F.3d at 1353. The Board here properly did just that for claims 7

– 9. Each of those claims plainly contains at least one required

means

- plus

- function claim element for which the specification provides no corresponding structure. In this circumstance, the Board’s necessa ry course of action was to conclude that unpatentability of claims 7

– 9 could not be shown. We therefore affirm the Board’s ruling as to claims 7

– 9.

Such a necessary rejection of the petitioner’s prior

- art challenge rests on a deficiency of the patentee’s making, not the petitioner’s. We have accordingly held, and here reiterate, that “in cases in which the Board cannot reach afinal decision as to the patentability of certain claims because it cannot ascertain the scope of those claims with reasonable cer tainty, the petitioner would not be estopped by35 U.S.C. § 315(e) from challenging those claims under sections 102 or 103 in other proceedings.” Samsung , 948 F.3d at 1353 n.3.

B Claim 10 is different in a crucial respect. It does not contain a require d claim element in means

- plus

- function form. Claim 10 recites a “directivity means comprising at least one directivity dependent microphone and/ or signal processing means in the electronic circuitry.” ’040 patent, col. 4, lines 20

– 24 ( e mphasis added). T he use of the disjunctive creates three alternative subsets of claim coverage

— a directivity dependent microphone only; signal Case: 19-1105 Document: 53 Page: 18 Filed: 05/15/2020COCHLEAR BONE ANCHOR ED v. OTICON MEDICAL AB 19

processing means only; and a directivity dependent microphone together with signal processing means. The first alternative is ind ependent of the other s, and it has a discern i ble meaning and can be compared to prior art.
The Board correctly held that claim 10 invokes means

plus

- function claiming in part, i.e. , insofar as it claims a “signal processing means

. ” The Board also correctl y heldthat the specification does not recite a corresponding structure for performing the signal processing function. J. A

. 25

– 27. Oticon does not challenge these holdings. But claim 10, unlike the other means

- plus

- function claims, also describes a stand

- alone alternative to the signal processing means: a directivity dependent microphone, which is a clear structure for performing t he claimed directivity means. The Board did not conclude that this alternative (which recites structure in the claim) i s even subject to 35 U.S.C. § 112, ¶ 6, let alone that it flunk s the requirement of that provision

. Rather, it relied entirely on the p resence of the signal

- processing

- means alternative s in the claim to deem a prior

- art analysis impossible. J.A. 26

– 29. That was

error. For present purposes, w e may assume that claim 10 is indefinite because it includes what is tantamount to an inkblot as an alternative way of coming within its boundaries. But Samsung establishes that indefiniteness of a claim does not always imply inability to conduct a prior

- art analysis needed for an inter partes review. See Samsung

, 948 F.3d at 1352

– 53, 1355 (remandin g for the Board to proceed despite one kind of indefiniteness, based on mixing product and process elements in a claim). The questions are different. Here, even if claim 10 is indefinite, such a conclusion would not imply that it is in capable of being

co mpared to prior art to determine if one of its alternatives is anticipated or would have been obvious on the grounds asserted. Case: 19-1105 Document: 53 Page: 19 Filed: 05/15/2020COCHLEAR BONE ANCHORED v. OTICON MEDICAL AB 20

We vacate the Board’s ruling as to claim 10 and remand. The Board should consider on remand whether the directivity

- dependent

- mi crophone alternative is outside the scope of § 112, ¶6, because it recites a structure (thedirectivity dependent microphone) that sufficiently corresponds to the claimed directivity means. Sage Prods., Inc. v. Devon Indus., Inc. , 126 F.3d 1420, 1427

– 28 ( Fed. Cir. 1997) (even if a claim uses the term “means,” “ where aclaim recites a function, but then goes on to elaborate sufficient structure, material, or acts within the claim itself to perform entirely the recited function, the claim is not in

means

- plu s

- function format ”); see also Williamson , 792 F.3d at 1349 ; cf. Media Rights Techs., Inc. v. Capital One Fin. Corp. , 800 F.3d 1366, 1372 (Fed. Cir. 2015) . The Board also should consider whether any asserted prior

- art challenges render the directivity

- depe ndent

- 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

. See In re Cuozzo Speed Techs.

, LLC, 793 F.3d 1268, 1281 (Fed. Cir. 2015) ; see also In re Klein

, 987 F.2d 1569, 1570 (Fed. Cir. 1993). We emphasize that we go no farther in vacating and remanding with respect to claim 10 than to hold that a prior

- art analysis is not made impossible, in the c ontext of the “and/or” claim at issue, by the impossibility of such an analysis as to other alternatives in such a disjunctive formulation.

IV

We affirm the Board’s decision that claims 4

– 6 and 11

– 12 are unpatentable and that claims 7

– 9 have not been

prove n unpatentable . We vacate the Board’s decision that claim 10 has not been proven unpatentable, and we remand for further proceedings on th at claim.
Each party shall bear its own costs. Case: 19-1105 Document: 53 Page: 20 Filed: 05/15/2020COCHLEAR BONE ANCHOR ED v. OTICON MEDICAL AB 21

AFFIRMED IN PART, VACATED IN PART, AND REMANDED Case: 19-1105 Document: 53 Page: 21 Filed: 05/15/2020

# United States **Court of Appeals**  **for the Federal Circuit**

______________________
COCHLEAR BONE ANCHOR ED SOLUTIONS AB, Appellant

v.

OTICON MEDICAL AB, O TICON MEDICAL LLC, WILLIAM DEMANT HOLDI NG A/S, Cross

- Appellants

______________________

2019

- 1105, 2019

- 1106

______________________ Appeals from the United States Patent and Trademark Office, Patent Trial and Appeal Board in No s . IPR2017

- 01018, IPR2017

- 01019.

______________________
N EWMAN , Circuit Judge , concurring i n part, dissenting in part.

I concur in the court’s decision concerning claims 7

– 10. However, t he Board erred in its invalidation of claims 4

– 6, 11, and 12, 1 and my colleagues err in sustaining that ruling.

The invention in U nited S tates Patent No. 7,043,040 (“ the ’ 040 patent ”) is a hearing aid for use in single

- side

1 Cochlear Bone Anchored Sols. AB v. Oticon Medical AB , IPR2017

- 01018, Paper No. 52, at 48

– 86 (P.T.A.B. Aug. 21, 2018) (“Board Op.”). Case: 19-1105 Document: 53 Page: 22 Filed: 05/15/2020COCHLEAR BONE ANCHOR ED v. OTICON MEDICAL AB 2

deafness , or “unilateral hearing loss

. ” Cochlear Bone Anchored Solutions AB (“ Cochlear ”) explains that single

- side deafness is usually due to damage to one ear such that the ear cannot perceive sound

, and is not remediable by simply increasing amplification to that ear

. The experts agreedthat there was an unmet need for effective remedy. However, my colleagues find the system in the ’ 040 patent to be obvious, although the system escaped the many persons studying the problem and seeking solution, as seen in the prior art. In finding the ’ 040 patent’s system obvious, the court employs an improper analytic technique. The court first removes major limitations from the claims, and then applies selected pieces of prior art to the residue. This is achieved by holding that the opening clause of all the claims is “not limiting

, ” whereby the claims are freed of critical limitations and are then held to embrace prior art that is excl uded from the ’ 040 system by the introductory
statement

. My colleagues dispose of these limitations by designating the introductory clause as a mere “preamble” that does not limit the claims

— although the clause states limitations fundamental to the ’ 040 i nvention. It is incorrect to remove such claim limitations when they describe substantive aspects of the invention, and the error is compounded when, as here, the court then broadens the residue of the claim into obviousness over prior art that is disavow ed by the preamble.

T

he claim is viewed as a whole

Claims 4

– 6, 11, and 12 all depend from claim 1, and start with the following clause:

1. A bone

- conducting bone

- anchored hearing aid apparatus for sound transmission from one side of a patient’s head to the patient’s cochlea on anotherside of the patient’s head for rehabilitation of unilateral hearing loss,

. . . . Case: 19-1105 Document: 53 Page: 23 Filed: 05/15/2020COCHLEAR BONE ANCHOR ED v. OTICON MEDICAL AB 3

The court rules that this entire clause is “not limiting,” and thereby opens the claims to prior art that is distinct from the ’ 040 invention, pr ior art that is distinguished by the limitations in this clause. As stated in In re Bulloch , 604F.2d 1362, 1365 (CCPA 1979), the “introductory claim language

. . . is more than a mere statement of purpose; and that language is essential to particularly p oint out the invention defined by the claims.”

Th is introductory claim language provides the “understanding of what the inventors actually invented and intended to encompass by the claim.” Corning Glass Works v. Sumitomo Elec. U.S.A., Inc. , 868 F.2d 1251, 1257 (Fed. Cir. 1989). The proper analytic method is to determine obviousness of the invention as a whole and the claims as a whole in light of the prior art as a whole

. See In re Gorman

, 933 F.2d 982, 986 (Fed. Cir. 1991) (“[T]he test is whether the te achings of the prior art, taken as a whole, would have made obvious the claimed invention.”)

. It is a distortion to hold that the obviousness determination does not include consider ation of the introductory words of the claim.

C laims cannot enlarge what is described in the specification, but neither can the claims be redacted to provide a broader focus for prior art. Determination of obviousness (and anticipation) is of the invention that is claimed, with claims that are viewed in light of the specification. See United States v. Adams , 383 U.S. 39, 48

– 49 (1966) (“Whilethe claims of a patent limit the invention, and specifications cannot be utilized to expand the patent monopoly, it is fundamental that claims are to be construed in the light of the specifications and both are to be read with a view to ascertaining the invention.”) (internal citation s omitted).
The court’s analysis produces major changes in the relation of the claimed invention to the prior art; as illustrated in the majority opinion at page 1 4 n. 10, where the court disposes of the obviousness analysis by stating that there is no need to “analyze the motivation to combine Case: 19-1105 Document: 53 Page: 24 Filed: 05/15/2020COCHLEAR BONE ANCHOR ED v. OTICON MEDICAL AB 4

references in light of the claim preamble” because “the preamble is not limiting

. ”

The opinion distorts the ’040 patent’s invention by stating: “Because the preamble is not limiting, [] there is therefore no limitation on the type of hearing loss to be treated by the claimed hearing aid

. ” Maj. Op. at 1 6 . It is, however, stated throughout the pate nt documents that the ’ 040 invention is directed to unilateral hearing loss. See

, e.g. , ’040 patent, Abstract (“ A hearing aid apparatus is intended for

. . . rehabilitation of patients with unilateral hearing loss.”); ’040 patent, col. 1, ll. 5

– 11 (“The p resent invention relates to a hearing aid

. . . for rehabilitation of patients with unilateral hearing loss.”)

. This is the invention for which patentability is determined. See Jansen v. Rexall Sundown, Inc.

, 342 F.3d 1329, 1333

– 34 (Fed. Cir. 2003)(the preamble is a statement of the purpose of the invention).

Here

, the “specification makes clear that the inventors were working on the particular problem ” of an effective treatment for unilateral hearing loss, n ot on “ general improvements ” in hearing aids

. Corning Glass , 868 F.2d at 1257; s ee ’ 040 patent, col. 1, ll. 5

– 11. The court’s exclusion of the “preamble” from the description of the claimed invention underlies the court’s entire analysis, and leads to th e court’s erroneous ruling of invalidity.

The invention described and claimed in the

’ 040 patent is not obvious from the prior art
The Board recognized that the ’ 040 patent’s hearing device is not simply a combination of known elements

, and stated: “ w e do not disagree with Patent Owner’s contention that the proposed modification would require ‘ substantially modifying the device. ’ ” Board Op. at 85. However, the Board then itself modified the device by removing the preamble’s limitations from the claim s. Case: 19-1105 Document: 53 Page: 25 Filed: 05/15/2020COCHLEAR BONE ANCHOR ED v. OTICON MEDICAL AB 5

Recourse to “broadest reasonable interpretation” does not permit an interpretation that is broader than that which is described and c laimed. See Organik Kimya AS v. Rohm & Haas Co. , 873 F.3d 887, 892 (Fed. Cir. 2017) (“E ven under the broadest reasonabl e interpretation, the Board ’ s construction cannot be divorced from the specification and the record evidence .”) (internal quotation marks omitted) . That interpretation must be consistent with the specification and the prosecution history, and must be the reasonable interpretation that would b e reached by a person of skill in the field of the invention.
For example, there is dispute about the meaning of “induction” in claims 11 and 12. Oticon argues that “induction” should be broadly construed to encompass Hough’s magnet, although the experts agree d that induction requires generation of current or voltage in the receiver. The Board, and now this court, hold that claim 11 is anticipated by the H o ugh device , a lthough the Board recognized that “Hough does not include an internal receiving conductor

. ” Board Op. at 84 . T he Board held that H o ugh anticipates claim 11 even though the experts for both sides agreed that H o ugh’s magnet does not serve as a conductor. The court errs in holding that Hough’s different system “anticipates” the ’ 040 patent claims. See MEHL/Biophile Int ’ l Corp. v. Milgraum , 192 F.3d 1362, 1365 (Fed. Cir. 1999) (“anticipation” requires that the invention is described in a single reference disclosing every limitation of the claims )

. The question of obviousness includes determining whether the prior art suggests producing the claimed combination and with a reasonable expectation of success. Here, no prior art suggests the combination that i s described and claimed in the ’ 040 patent

. It appears undisputed that at the time of this invention, transcranial attenuation was not even considered in bone

- anchored hearing devices

. Reply Br. 21

– 22 ( citing J.A. 464

– 65 ( “[A]t the critical date, [hearin g devices] were primarily used to treat conductive hearing loss (CHL), where sound Case: 19-1105 Document: 53 Page: 26 Filed: 05/15/2020COCHLEAR BONE ANCHOR ED v. OTICON MEDICAL AB 6

vibrations are sent to the normal functioning cochlea, not an injured cochlea.

. . . TA [transcranial attenuation] was not a consideration. When treating CHL, sound vibrati ons are not being transmitted to the opposite side of the head (and thus do not need to travel very far within the skull), and therefore TA is not a concern.” ) ; J.A. 2352

– 53
, ¶ 21 ( “[S]ince sound waves are not needed to travel across the skull to the cochl ea on the other side of the head (in thetreatment of conductive hearing loss), transcranial attenuation is not an important consideration.” ).
In sum, the analysis by the Board, and now by my colleagues, is contrary to the law s of obviousness and anticipat ion. T here is no suggestion in the prior art of this new and useful device. See Interconnect Planning Corp. v. Feil

, 774 F.2d 1132, 1143 (Fed. Cir. 198 5 ) (“[T]here must be some reason for the combination other than the hindsight gleaned from the invention itself.”). Nonetheless, the court here uses the ’ 040 patent’s teachings to select various aspects from the prior art, a nd then combin es these selection s with the template of the ’ 040 patent , having removed the limitations of the claims’ introductory clause. From this flawed analysis, and its flawed conclusion, I respectfully dissent. Case: 19-1105 Document: 53 Page: 27 Filed: 05/15/2020