Cochlear Limited

Patent Trials and Appeals Board

Aug 4, 2020

2020001080 (P.T.A.B. Aug. 4, 2020)

UNITED STATES PATENT AND TRADEMARK OFFICE
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O. Box 1450
Alexandria, Virginia 22313-1450
www.uspto.gov
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
15/187,893 06/21/2016 John Michael Heasman 3065.0248C 9188
110239 7590 08/04/2020
Edell Shapiro & Finnan LLC
9801 Washingtonian Blvd., Suite 750
Gaithersburg, MD 20878
EXAMINER
EVANISKO, GEORGE ROBERT
ART UNIT PAPER NUMBER
3792
NOTIFICATION DATE DELIVERY MODE
08/04/2020 ELECTRONIC
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address(es):
epatent@usiplaw.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte JOHN MICHAEL HEASMAN, LUKE CAMPBELL,
STEPHEN O'LEARY, KERRIE PLANT, and
KRISTIEN JOHANNA MARIA VERHOEVEN
Appeal 2020-001080
Application 15/187,893
Technology Center 3700
Before CHARLES N. GREENHUT, MICHAEL J. FITZPATRICK, and
WILLIAM A. CAPP, Administrative Patent Judges.
GREENHUT, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the
Examiner’s decision to reject claims 1–6, 9, 20–23, and 26–31. See Final
Act. 1. We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.

1 We use the term “Appellant” to refer to “applicant” as defined in 37 C.F.R.
§ 1.42. Appellant identifies the real party in interest as Cochlear Limited.
Appeal Br. 3.
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Application 15/187,893
2
CLAIMED SUBJECT MATTER
The claims are directed to a cochlea health monitoring method. Claim
1, reproduced below, is illustrative of the claimed subject matter:
1. A method, comprising:
obtaining, at a hearing prosthesis, a plurality of biomarkers
each associated with a cochlea health of a recipient of the hearing
prosthesis, wherein one or more of the plurality of biomarkers
comprise in-vivo biomarkers obtained via an electrode array
configured to be implanted in the cochlea;
collectively analyzing, at the hearing prosthesis, the
plurality of biomarkers together in order to identify one or more
precursors of a potential future change to the cochlea health; and
in response to the identification of the one or more
precursors of a potential future change to the cochlea health,
initiating one or more remedial actions at the hearing prosthesis.
REFERENCE
The prior art relied upon by the Examiner is:
Name Reference Date
Litvak US 2015/0057714 A1 Feb. 26, 2015

REJECTIONS2
Claims 1–5, 9, and 28–31 are rejected under 35 U.S.C. § 102(a)(1) as
being anticipated by Litvak. Final Act. 4.
Claims 6, 20–23, 26, and 27 are rejected under 35 U.S.C. § 102(a) as
anticipated by or, in the alternative, under 35 U.S.C. § 103 as obvious over
Litvak. Final Act. 5–6.

2 The Examiner withdrew the rejection under 35 U.S.C. § 112(b). Adv. Act.
May 3, 2019.
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3
OPINION
Claim 1
With respect to the anticipation rejection of claim 1, Appellant argues:
“[t]he concept of any type of collective analysis, where a plurality of
biomarkers are analyzed together, is entirely missing from Litvak. Instead,
as detailed above, Litvak merely discloses the one-to-one comparison of an
evoked response to a baseline response.” Appeal Br. 12; see also Reply
Br. 3–4.
First, a careful reading of the claim reveals no prohibition on the
so-called “one-to-one comparison of an evoked response to a baseline
response” step allegedly practiced by Litvak. The claim requires a plurality
of biomarkers but that does not necessarily require a plurality of “responses”
as that term is used by Litvak. Litvak clearly discloses “an electrode
array 110 with a plurality of electrodes 112 disposed thereon” (Litvak
para. 21) which may be used to “monitor for and record the evoked
response” (Litvak para. 39 (cited at Final Act. 4)). Appellant does not
provide any analysis as to why the signal monitored and/or recorded from
each electrode reasonably constitutes a “biomarker” within the broadest
reasonable interpretation of that term. Although Appellant might disclose in
their preferred embodiment biomarkers of various types (see, e.g., Fig. 2
elements 256, 258, 260), as the Examiner points out (Ans. 3) such a
requirement is absent from claim 1. It is therefore inapposite that Litvak
characterizes the “evoked response” deduced from those electrodes in the
singular: the claim contains no language precluding collective analysis of
biomarkers so as to arrive at some singular quantity. In fact, the claim
actually requires, as Appellant points out, “collectively analyzing . . . the
plurality of biomarkers.” We are not apprised of any reasons why this
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4
limitation is not met as Litvak evaluates the response detected from the
plurality of electrodes 112. Ans. 3–4.
Second, in addition to the “plurality of biomarkers” limitation being
met by measurements taken at different points in space along Litvak’s
electrode array 110, as the Examiner points out, the “plurality of
biomarkers” limitation is alternatively satisfied by Litvak’s measurement of
electrode outputs at different points in time. Final Act. 4–5 (citing Litvak
paras. 54–55). This means even Litvak’s evoked responses are not actually
evaluated singularly or “one-to-one” as Appellant argues. Again, as the
Examiner correctly points out, “the claim does not state there are a plurality
of ‘different’ biomarkers obtained or analyzed, or a plurality of ‘different
sensors’ being used.” Ans. 3. Appellant does not apprise us of any reason
why monitoring or recording the output from an electrode at a first point in
time, and then monitoring or recording the output from that electrode at a
second point in time, and comparing those two outputs in order to determine
a trend does not reasonably constitute “obtaining” and “collectively
analyzing” “a plurality of biomarkers” according to claim 1. Ans. 3–4.
In the course of our analysis we understand the term “biomarker” to
include a physiological characteristic typically measured to indicate the
presence of a disease, abnormality or condition.3 Under either of the first or
second theories discussed above the signals monitored from the one or more
of Litvak’s electrodes constitute biomarkers within this definition. Appellant
argues the baseline response in Litvak is not reasonably regarded as a

3 biological marker. (2005). In R. M. Youngson, Collins Dictionary of
Medicine (4th ed.). Collins. Retrieved from Credo Reference:
https://search.credoreference.com/content/entry/collinsmed/biological_mark
er/0?institutionId=743 last accessed July 22, 2020 (copy attached).
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5
biomarker. Appeal Br. 13–15. Because Litvak’s baseline is a value for
comparing a physiological characteristic as opposed to being indicative of a
physiological characteristic itself, we agree with Appellant that Litvak’s
baseline does not satisfy the definition of a biomarker. The Examiner sets
forth a rebuttal to Appellant’s argument in this regard (Ans. 5) but it is not
clear that the Examiner advanced this position in the appealed action. In any
case, our disagreement with the Examiner on this point is not fatal to the
rejection because we agree with the Examiner that Litvak discloses a
“plurality of biomarkers” under either of the first or second theories
discussed above.
Appellant next argues
Litvak teaches a technique for determining a current “residual
hearing status” of a patient. However, determining the current
“residual hearing status” of a patient is not what is recited in
Appellant’s claim 1. Instead, Appellant’s claim 1 specifically
recites that the collective analysis of the plurality of biomarkers
is “to identify one or more precursors of a potential future
change to the cochlea health.”
Appeal Br. 16–20 (emphasis in original).
We disagree with Appellant that Litvak focuses exclusively on the
past or the current state of the patient. Litvak’s use of terms like
“deteriorating” and Litvak’s use of mitigation strategies is a persuasive
indication that Litvak, by detecting abnormalities in patient responses, is
“identify[ing] one or more precursors of a potential future change to the
cochlea health.” Ans. 7 (citing Litvak paras. 59, 73). Litvak need not use
these exact words to disclose a step falling within the subject matter they
define. A “potential future change” does not require absolute certainty that
cochlea health will change. We agree with the Examiner that one skilled in
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the art would understand the term “deteriorating” to involve a trend that
indicates not only what has happened and what is currently happening, but
what at least has the “potential” to continue to happen in the “future.”
Appellant does not apprise us of any alternate definitions for the term
“deteriorating.”
For the foregoing reasons we are not apprised of any error in the
Examiner’s determination that Litvak anticipates claim 1.

Claims 2 and 4
The additional specificity added to claim 2 is an analysis that requires
identification of a precursor of potential future residual hearing loss
specifically as opposed to just a change in cochlea health. Claim 4 requires
some adjustment to take place to remediate that potential future residual
hearing loss. Claims 2 and 4 are argued based on the “potential future”
language that we discussed above in connection with claim 1. Because
Appellant’s arguments are based on those proffered with respect to claim 1
(Appeal Br. 21–22, 23), Appellant’s arguments are unpersuasive for the
reasons discussed above in connection with claim 1.
Claim 3
Claim 3 depends from claim 2 and recites “adjusting one or more
attributes of the electrical or acoustic stimulation signals to remediate the
potential future residual hearing loss.” Appeal Br. 27. Appellant argues
“Litvak does not disclose, in any manner whatsoever, the use of ‘electro-
acoustic phenomena’ to identify either past or future residual hearing loss. . .
. [T]he term “electro-acoustic phenomena” does not appear anywhere in the
outstanding Office Action.” Appeal Br. 22–23. Appellant contends the
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7
Examiner is confusing the ability to deliver electrical and acoustic
stimulation with the ability to identify electrical and acoustic phenomena.
Reply Br. 5–7.
Appellant’s Specification expressly defines “electro-acoustic
phenomena”:
As used herein, “electro-acoustic phenomena” are interactions of
electrical and acoustic stimulation, or effects thereof, that can be
detected and correlated to patterns of behavior or established
patterns relating to known pathologies, pathophysiology or
physiology associated with residual hearing loss.
Spec. para. 32 (cited at Ans. 7–8).
In rejecting claim 3 (among other claims) the Examiner refers to
“electro-acoustic effects” and cites paragraph 67 of Litvak. Final Act. 4. It
is true that Litvak’s electro-acoustic stimulation (“EAS”) system has the
ability to deliver stimulation in the form of electrical or acoustic energy.
However, Litvak’s EAS system is a closed loop system that can also monitor
the evoked response of that stimulation in a patient. In the course of that
analysis Litvak considers the interplay between the electrical and acoustical
stimulation provided. Litvak para. 67. These “effects” of the electrical and
acoustic stimulation fall squarely within the “effects thereof” language used
in the definition quoted above. As Appellant expressly defines “electro-
acoustic phenomena” as including electro-acoustic “effects” we see no error
in the Examiner’s use of the term “effects” in place of “phenomena” in the
Final Rejection.
For the foregoing reasons, we are not apprised of error in the
Examiner’s rejection of claim 3.

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Claim 9
With regard to claim 9, Appellant, addressing the Examiner’s reliance
on paragraphs 57–60 (et seq.) of Litvak for the classifying aspect of the
claimed method (see Final Act. 4–5; Ans. 9), argues, “Appellant recognizes
that Litvak teaches different notifications and that residual hearing changes
may be due to different causes. However, nowhere does Litvak teach that the
EAS sound processor 104 can determine the ‘type’ or ‘cause’ of the residual
hearing changes.” Appeal Br. 24–25.
The paragraphs cited by the Examiner first describe making a
determination whether to notify the patient (para. 57) and a list of possible
causes that may affect residual hearing status (para. 57). “Type” is a very
broad term and is probably broad enough to encompass cochlea health
changes that are worthy of notification and those that are not. Under this
interpretation the claim language would seem to be satisfied by paragraph 57
alone. Nonetheless, we will focus on the specific examples that follow in
paragraphs 60 and 65 because they more clearly satisfy the language of
claim 9.
Paragraph 60 provides a specific example wherein the evoked
response trend is employed to detect “deterioration in the patient’s residual
hearing.” “[D]eterioration” is reasonably regarded as a “type” of “change to
the cochlea health.” Litvak goes on to say that the deterioration may be
attributable to an “infection,” which is reasonably regarded as a “cause.”
Paragraph 60 attributes a subsequent increase in the amplitude of the evoked
response to the infection going away—another “cause” of a cochlea health
change. Litvak’s indication that recovering from the infection would
decrease the necessary stimulation intensity implies that the increase in
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amplitude of the evoked response coincides with an improving “type” of
cochlea health.
Paragraph 65 contains a similar discussion, but in the context of nerve
regeneration where the exemplary physiological change is associated with
improvement, as opposed to deterioration, of the cochlea’s health. Here also,
the trend of evoked responses increasing in amplitude, the “precursor of the
change,” is implicitly “classif[ied]” as an improvement in cochlea health
because Litvak indicates it may warrant an adjustment to the stimulation
parameters.
In each of the examples discussed above, Litvak may not use the
precise word “classifying.” However, in order to know whether to increase
or decrease the stimulation based on the trend of evoked responses, one
would need to categorize at least the type of cochlea health change
potentially associated with the trend as being associated with improving or
deteriorating, which are “type[s]” of cochlea health changes. This action
satisfies the language of claim 9.

Claim 28
Appellant’s position with regard to claim 28 is:
Litvak does not disclose, in any manner whatsoever, the use of
“patterns” to determine whether a problem has occurred. Instead,
Litvak merely discloses a simplistic one-to-one comparison
between an evoked response and a baseline response to identify
a relative difference between the evoked response and the
baseline response. . . . Moreover, a text search of the Final Office
Action reveals that the terms “patterns of behavior” or
“established patterns relating to known pathologies,
pathophysiology, or physiology” that “correlate to potential
future changes in the cochlea health” do not appear anywhere in
the outstanding Office Action.
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Appeal Br. 25–26.
From the Final Action, it seems apparent that the Examiner is relying
on the baseline response in Litvak as the recited “patterns of behavior”
against which the patient’s biomarkers are compared according to claim 28.
Final Act. 4. It is not clear why Appellant’s text search did not reveal this.
Litvak uses the term “baseline response” to refer to “some type of
fixed evoked response that a clinician may consider to be normal,
acceptable, and/or desirable.” Litvak para. 54 (cited at Final Act. 4). As
Litvak’s baseline response 602 is a repeatable quantity measured over time
(see Litvak Fig. 6), we see no reason why this baseline response is not
reasonably regarded as either one of a “pattern of behavior” (e.g., of the
cochlea) or an “established pattern” according to claim 28. As it is
considered normal by a clinician, we see no reason why it is not “relating to
known . . . physiology” as require of the second type of possible pattern, the
“established pattern,” recited in claim 28.
As Appellant does not appear to have fully appreciated the
Examiner’s position, the Examiner’s position with regard to claim 28 stands
uncontroverted.
The remaining claims and the clarity of the Final Action
From the Appellant’s briefing there seems to have been instances
where Appellant did not fully appreciate the positions taken by the
Examiner. With regard to the dependent claims specifically, Appellant
argues:
Appellant notes that, in rejecting claims 2-5, 9, and 28-31, as well
as in rejecting dependent claims 6, 20-23, 26, and 27, the
Examiner failed to address the claim elements of each rejected
claim and has only provided an uninformative and improper
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omnibus rejection of these claims. It is well recognized that
omnibus rejections are to be avoided under the examination
guidelines provided in the MPEP. See, MPEP § 707.07(d),
explaining that a “plurality of claims should never be grouped
together in a common rejection, unless that rejection is equally
applicable to all claims in the group.”
Appeal Br. 20.
In response to the Examiner’s Answer, Appellant further argues:
In the Examiner’s Answer, the Examiner supplemented the
rejections of claims 2, 3, 4, 9, and 28 (i.e., only the claims
specifically argued by Appellant), while ignoring the remaining
dependent claims. In other words, the Examiner has still only
applied omnibus rejections to dependent claims 5, 6, 20-23, 26,
and 27. Accordingly, Appellant continues to request that the
Examiner's final rejection of at least these claims be overturned
for at least the reason that the Examiner has failed to properly
address each of claims 5, 6, 20-23, 26, and 27 and, as such, has
failed to comply with M.P.E.P. §707.07.
Reply Br. 5.
Our jurisdiction to review “adverse decisions of examiners” under 35
U.S.C. § 6(b)(1) does not extend to all decisions made by examiners that
could arguably be regarded as adverse to an applicant-appellant. “There are
a host of various kinds of decisions an examiner makes in the examination
proceeding — mostly matters of a discretionary, procedural or
nonsubstantive nature — which have not been and are not now appealable to
the board or to this court when they are not directly connected with the
merits of issues involving rejections of claims . . . .” In re Hengehold, 440
F.2d 1395, 1403 (CCPA 1971). The Board does not exercise any supervisory
authority over patent examiners. Our primary focus is on matters that
“require[] the exercise of technical skill and legal judgment in order to
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evaluate the facts presented, interpret the requirements of [United States
Code Title 35 and United States Code of Federal Regulations Title 37] and
weigh the facts against those requirements.” In re Searles, 422 F.2d 431,
434–435 (CCPA 1970). In other words, the primary purpose of the Board is
to address matters related to the merits of rejections. See MPEP § 1201; see
also Ex parte Frye, 94 USPQ2d 1072, 1075 (BPAI 2010) (precedential).
“It is well-established that the Board is free to affirm an examiner’s
rejection so long as ‘appellants have had a fair opportunity to react to the
thrust of the rejection.’” In re Jung, 637 F.3d 1356, 1365 (Fed. Cir. 2011)
(citations omitted). Although Appellant may not consider the appealed
action in this case to be a model of clarity, “all that is required of the office
to meet its prima facie burden of production is to set forth the statutory basis
of the rejection and the reference or references relied upon in a sufficiently
articulate and informative manner as to meet the notice requirement of
§ 132.” Jung, 637 F.3d at 1363. If there is a lack of clarity in the Examiner’s
rejection preventing an appellant from providing a substantive response it is
preferable to resolve any such uncertainties by petition under 37 C.F.R.
§§ 1.104, 1.181, or by an interview with the Examiner, or the Examiner’s
supervisor, prior to taking an appeal. Indeed, the Final Action expressly
states:
Any inquiry concerning this communication or earlier
communications from the examiner should be directed to George
Robert Evanisko whose telephone number is (571) 272-4945.
The examiner can normally be reached on M-F 8AM-5PM.
Examiner interviews are available via telephone, in-
person, and video conferencing using a USPTO supplied web-
based collaboration tool. To schedule an interview, applicant is
encouraged to use the USPTO Automated Interview Request
(AIR) at http://www.uspto.gov/interviewpractice.
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If attempts to reach the examiner by telephone are
unsuccessful, the examiner’s supervisor, Niketa Patel can be
reached on 571-272-4156. The fax phone number for the
organization where this application or proceeding is assigned is
571-273-8300.
Final Act. 7.
The Board will not, as a general matter, advocate for appellants by
scouring the record to see if the Board can identify some flaw in the
Examiner’s findings of fact, articulated reasoning, or legal conclusions. See,
e.g., Halliburton Energy Services, Inc. v. M-I LLC, 514 F.3d 1244, 1250 n.2
(Fed. Cir. 2008). 37 C.F.R. § 41.37(c)(1)(iv) requires “arguments [to]
explain why the examiner erred as to each ground of rejection contested by
appellant.” This rule also contains another provision with which Appellant
has not complied with regard to dependent claims 5, 6, 20–23, 26, and 27:
“any claim(s) argued separately or as a subgroup shall be argued under a
separate subheading that identifies the claim(s) by number.” Our reviewing
court has interpreted since-unchanged language in the predecessor of 37
C.F.R. § 41.37(c)(1)(iv) to require “more substantive arguments in an appeal
brief than a mere recitation of the claim elements and a naked assertion that
the corresponding elements were not found in the prior art.” In re Lovin, 652
F.3d 1349, 1357 (Fed. Cir. 2011). As a “ground of rejection” may be
considered “not merely the statutory requirement for patentability that a
claim fails to meet but also the precise reason why the claim fails that
requirement” (Hyatt v. Dudas, 551 F.3d 1307, 1312 (Fed. Cir. 2008)) the
language of 37 C.F.R. § 41.37(c)(1)(iv) requiring “arguments [to] explain
why the examiner erred as to each ground of rejection” is understood to
pertain to the merits of the rejection as opposed to its form. See App. Br. 20
(citing MPEP § 707.07(d)). We are mindful that it is difficult to address the
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merits of a rejection if appellant does not fully appreciate or understand the
position advanced by the Examiner. Here, however, there is no indication in
the record before us that Appellant has made an effort to resolve issues of
the appealed action’s clarity by exercising any of the available options
described above. Further, although the Examiner did not individually
address each claim by number in a format similar to that presented in the
listing of claims, because the language used by the Examiner and/or the cited
portions of Litvak is sufficiently indicative of the claims being addressed
and how Litvak meets them, we need not exercise significant speculation as
to the basis for the Examiner’s rejection. We therefore conclude that, insofar
as the claims separately argued, the Examiner’s action here met the
threshold requirement of “provid[ing] prior notice to the applicant of all
‘matters of fact and law asserted’ prior to an appeal hearing before the
Board.” In re Stepan Co., 660 F.3d 1341, 1345 (Fed. Cir. 2011) (citing 5
U.S.C. § 554(b)(3)). Thus, to the extent we might have discretion to do so,
we see no reason on the record before us why fairness would compel us to
waive the aforementioned requirement of 37 C.F.R. § 41.37(c)(1)(iv) to
explain “why the examiner erred as to each ground of rejection.” Nor are we
apprised of any good and sufficient reasons to waive the aforementioned
requirement to provide such arguments for claims for which Appellant seeks
review under separate subheadings. Accordingly, our reasoning above with
respect to the claims separately argued remains unchanged in light of
Appellant’s arguments pertaining to the clarity of the appealed action
(Appeal Br. 20–21; Reply Br. 4–5) and we do not consider dependent
claims 5, 6, 20–23, 26, and 27 to be before us for review.
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CONCLUSION
The Examiner’s rejections are AFFIRMED.
DECISION SUMMARY
Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
1–5, 9, 28–31 102(a)(1) Litvak 1–5, 9, 28–31
6, 20–23, 26,
27
102(a)(1) Litvak 6, 20–23, 26,
27

6, 20–23, 26,
27
103 Litvak 6, 20–23, 26,
27

Overall
Outcome
1–6, 9, 20–
23, 26–31

TIME PERIOD FOR RESPONSE
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R.
§ 1.136(a)(1)(iv).
AFFIRMED