“Preamble language merely extolling benefits or features of the claimed invention does not limit the claim scope without clear reliance on those benefits or features as patentably significant.” – CAFC opinion
Cochlear Bone Anchored Solutions AB (“Cochlear”) owns U.S. Patent No. 7,043,040 (“the ‘040 patent”), directed to a hearing aid for use in those with unilateral hearing loss. Oticon Medical AB, etc. (“Oticon”) successfully petitioned for inter partes review (IPR) of all claims of the ‘040 patent, and in those reviews the USPTO Patent and Trial Appeal Board (“PTAB” or “Board”) held claims 4-6 and 11-12 unpatentable, but maintained the validity of claims 7-10. Cochlear appealed the PTAB’s decision with respect to claims 4-6 and 11-12, while Oticon cross-appealed the PTAB’s determination in connection with claims 7-10. The Federal Circuit (Newman, O’Malley and Taranto) affirmed, but for claim 10, on which they vacated and remanded to the PTAB for further action.
Claim 1 is the only independent claim of the ‘040 patent, and the claims at issue all depend therefrom, in one form or another.
Claim 1 recites:
- 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 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.
The Board initially declined to institute a review of claims 7-10, after determining that they were means-plus-function claims with no corresponding structure taught in the specification. After the Supreme Court’s decision in SAS Institute Inc. v. Iancu, 138 S. Ct 1348 (2018), the Board added claims 7-10 to the proceedings and continued to trial of the invalidity of claim 11 as anticipated by a single reference and claims 4-10 and 12 as obvious over various combinations of five others. Ultimately, the Board adopted Oticon’s position in connection with claims 4-6 and 11-12, but held that they could reach no conclusion with respect to claims 7-10, within the bounds of their abilities in IPR proceedings. Specifically, the Board held that since these claims were means plus function claims without corresponding structure disclosed, they could not ascertain the differences between the claimed invention and the asserted prior art.
A critical part of the Board’s decision was its determination that the phrase “for rehabilitation of unilateral hearing loss” was not limiting.
Cochlear’s Challenge(s) to the PTAB Decision
Cochlear challenged the Board’s determination that the phrase “for rehabilitation of unilateral hearing loss” was non-limiting to the claim, as well as the determination that the phrase itself is not self-limiting to certain profound hearing loss. While acknowledging precedent in Deere & Co. v. Bush Hog, LLC, 703 F.3d 1349, 1357 (Fed. Cir. 2012) that such a determination is fact-based, the Federal Circuit agreed with the Board that the preamble “phrase is not limiting for the apparatus claims at issue.”
The Court continued, further acknowledging precedent that held that the preamble may be held as limiting to the extent “necessary to provide antecedent basis for the body of the claim” (Symantec Corp. v. Computer Assoc. Int’l, Inc., 522 F.3d 1279, 1288 (Fed. Cir. 2008)), but noting “preamble language merely extolling benefits or features of the claimed invention does not limit the claim scope without clear reliance on those benefits or features as patentably significant.” Catalina Mktg. Int’l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 808 (Fed. Cir. 2002). Using Cochlear’s ‘040 patent itself to support their position, the Court concluded:
The 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, this use itself is not an inventive or patentably 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
(Slip opinion, page 10, emphasis added).
Since Cochlear’s arguments that the prior art contained teachings against the use of implanted hearing aids in patients with profound hearing loss and certain of their arguments directed to a lack of motivation to combine were based upon a claim construction wherein the disputed preamble phrase was limiting, the Court affirmed the Board’s holdings of invalidity. To the extent that Cochlear’s arguments did not rely on the preamble as limiting, the Federal Circuit held that the Board’s decision was supported by substantial evidence. Cochlear’s challenge to the Board’s construction of claim 11 was similarly rejected by the Court.
The only win for Cochlear was that the Federal Circuit agreed with their argument that claim 10, reciting a “directivity means comprising at least one directivity dependent microphone and/or signal processing means in the electronic circuitry”, recited sufficient structure to allow comparison with the prior art. Slip Opinion, page 19. The Court thus vacated the Board’s ruling as to claim 10 and remanded for consideration of whether the claim escaped treatment under §112, ¶6 for its recitation of the directivity dependent microphone alternative and whether any asserted prior art renders the microphone alternative unpatentable.
The Newman Dissent
Judge Newman concurred in the decision regarding claims 7-10, but dissented regarding the Court’s affirmance of the Board’s holding in connection with claims 4-6, 11 and 12. Interestingly, and contrary to the majority’s assertion, Judge Newman’s dissent asserts that the record showed that there was an unmet need in the art for a treatment for unilateral hearing loss, and that transcranial attenuation had not been considered a possibility in bone anchored hearing devices:
It appears undisputed that at the time of this invention, transcranial attenuation was not even considered in bone-anchored hearing devices. (“[A]t the critical date, [hearing devices] were primarily used to treat conductive hearing loss (CHL), where sound vibrations are sent to the normal functioning cochlea, not an injured cochlea…TA [transcranial attenuation] was not a consideration. When treating CHL, sound vibrations 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.”)
(Dissenting opinion, pages 5-6, citations omitted).
When taken in context, the portion of the ‘040 specification the majority alleges concedes that bone-anchored hearing aids were conventionally used for rehabilitation of unilateral hearing loss, actually seems to support Judge Newman’s position. That portion states:
Unfortunately, these types of hearing aids for rehabilitation of patients with single sided deafness have significant drawbacks…For persons with other types of impaired hearing, for instance, a misfunction in the auditory canal or a chronic ear inflammation, there are bone conducting hearing aids on the market today, i.e., bone anchored hearing aids which mechanically transmit the sound information to a person’s inner ear via the skull bone.
(‘040 patent, lines 32-51).
Judge Newman thus took particular issue with the majority’s view that the preamble was non-limiting:
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 applied 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 excluded from the ‘040 system by the introductory statement.
(Dissenting opinion, page 2).
Judge Newman continues:
It is a distortion to hold that the obviousness determination does not include consideration of the introductory words of a claim…Claims cannot enlarge what is described in the specification, but neither can the claims be redacted to provide a broader focus for prior art.
(Dissenting opinion, page 3).
Nonetheless, the court here uses the ‘040 patent’s teachings to select various aspects from the prior art, and then combines these selections with the templated of the ‘040 patent, having removed the limitations of the claims introductory clause. From this flawed analysis, and its flawed conclusion, I respectfully dissent.