Ex Parte Kwok et al

Board of Patent Appeals and Interferences

Jan 26, 2012

11222384 (B.P.A.I. Jan. 26, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte JONATHAN KWOK and KENT LEE
__________

Appeal 2010-008170
Application 11/222,384
Technology Center 3700
__________

Before DEMETRA J. MILLS, ERIC GRIMES, and
FRANCISCO C. PRATS, Administrative Patent Judges.

PRATS, Administrative Patent Judge.

DECISION ON APPEAL
This appeal under 35 U.S.C. § 134 involves claims to methods and an
apparatus for evaluating sleep disorders. The Examiner entered rejections
for obviousness.
We have jurisdiction under 35 U.S.C. § 6(b). We affirm.

STATEMENT OF THE CASE
Claims 1-23 stand finally rejected and appealed (App. Br. 3). Claim 1
is representative and reads as follows:
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1. A method, comprising:
implantably sensing one or more conditions associated with a
sleep disorder;
computing a sleep disorder detection value based on the sensed
one or more conditions, the sleep disorder detection value
characterizing the sleep disorder;
receiving manually-reported patient data having relevance to
the sleep disorder or patient condition, the manually-reported patient
data comprising answers to questions associated with one or more
sleep disorder indicators;
computing a patient data score using the received patient data,
the data score characterizing the sleep disorder; and
producing a sleep disorder diagnostic value for the sleep
disorder using the sleep disorder detection value and the patient data
score, the sleep disorder diagnostic value indicative of one or both of
presence and level of severity of the sleep disorder.

The following rejections are before us for review:
(1) Claims 1, 3-5, 7, 9, 10, 13-15, and 19-21, under 35 U.S.C. § 103(a)
as obvious over Bardy
1
and Cho
2
(Ans. 4-6);
(2) Claims 2, 8, 16, 17, and 23, under 35 U.S.C. § 103(a) as obvious
over Bardy, Cho, and Westbrook
3
(Ans. 6-7);
(3) Claims 6, 11, and 22, under 35 U.S.C. § 103(a) as obvious over
Bardy, Cho, and Gottesman
4
(Ans. 7-8);
(4) Claim 12, under U.S.C. § 103(a) as obvious over Bardy, Cho,
Westbrook, and ARES (“the Apnea Risk Evaluation System”) (Ans. 8); and

1
U.S. Patent App. Pub. No. 2002/0029002 A1 (published March 7, 2002).
2
U.S. Patent App. Pub. No. 2002/0193697 A1 (published December 19,
2002).
3
U.S. Patent App. Pub. No. 2002/0165462 A1 (published November 7,
2002).
4
U.S. Patent App. Pub. No. 2006/0122864 A1 (published June 8, 2006).
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(5) Claim 18, under U.S.C. § 103(a) as obvious over Bardy, Cho, and
Drew
5
(Ans. 8).
OBVIOUSNESS – BARDY AND CHO
The Examiner found that Bardy taught a process having the same
basic steps as recited in claim 1, except that Bardy did not “pertain primarily
to the detection of sleep disorders, but of atrial fibrillation. However, Bardy
teaches that in a further embodiment, multiple near-simultaneous disorders,
such as sleep-apnea are considered in addition to primary atrial fibrillation”
(Ans. 4). The Examiner found, moreover, that Cho taught that, “in the
detection of sleep apnea, the parameters used to monitor sleep disorders can
be used to monitor congestive heart failure” (id. (citing Cho [0044])).
From the references’ combined teachings, the Examiner reasoned that
an ordinary artisan would have considered it obvious “to modify the method
of Bardy, pertaining to the primary detection of atrial fibrillation, to
primarily detect sleep disorders, as taught by Cho for the primary monitoring
and treatment of sleep disorders” (id. at 4-5).
Appellants contend that none of the sections of Bardy cited by the
Examiner in either the Final Rejection or the Examiner’s Answer “appear to
contain a step analogous to the claimed step of producing a quantitative
diagnostic value for a disorder using detected conditions and patient
questionnaire data, in the manner claimed” (App. Br. 11; see also Reply Br.
8). Thus, Appellants urge:
It is simply not enough that Bardy’s paragraph [0045] describes
recording multiple types of data, as the independent claims
concern collecting data about a detected patient condition

5
U.S. Patent App. Pub. No. 2006/0094971 A1 (published May 4, 2006).
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associated with a sleep disorder, collecting questionnaire data
concerning the sleep disorder, and then using both of these to
produce a sleep disorder diagnostic value, the sleep disorder
diagnostic value indicative of one or both of presence and level
of severity of a sleep disorder.

(App. Br. 11-12; see also Reply Br. 8 (“Simultaneous storage of different
types of data is not equivalent to producing a disorder quantitative diagnostic
value from a disorder detection value associated with a disorder and a
computed patient questionnaire data score characterizing the disorder, in the
manner of the claims.”).) Further, Appellants contend, “Cho being generally
directed to detection of sleep apnea does not constitute a teaching of
particular use of detected episodes of sleep disordered breathing and
questionnaire data in producing a sleep disorder quantitative diagnostic
value” (App. Br. 12).
As stated in In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992):
[T]he examiner bears the initial burden . . . of presenting a
prima facie case of unpatentability. . . .
After evidence or argument is submitted by the applicant
in response, patentability is determined on the totality of the
record, by a preponderance of evidence with due consideration
to persuasiveness of argument.

Appellants’ arguments do not persuade us that a preponderance of
evidence fails to support the Examiner’s conclusion that a person of ordinary
skill in this art viewing the cited references would have considered claim 1
prima facie obvious.
In KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007), the
Supreme Court reaffirmed that the obviousness analysis “need not seek out
precise teachings directed to the specific subject matter of the challenged
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claim, for a court can take account of the inferences and creative steps that a
person of ordinary skill in the art would employ.”); id. at 421 (“A person of
ordinary skill is . . . a person of ordinary creativity, not an automaton.”).
Here, claim 1 recites a process in which (a) a sleep disorder detection
value, computed from one or more implant-sensed sleep disorder-related
conditions, and (b) a patient data score, computed from data generated from
responses to questions regarding the sleep disorder, are used to “produc[e] a
sleep disorder diagnostic value for the sleep disorder . . . the sleep disorder
diagnostic value indicative of one or both of presence and level of severity
of the sleep disorder.” Thus, because the “diagnostic value” can simply
indicate the presence of the sleep disorder, claim 1 encompasses processes in
which implant-sensed data and questionnaire-generated data are used in
combination to simply determine, yes or no, whether the patient has a sleep
disorder.
Cho undisputedly discloses implantably monitoring patients to detect
sleep apnea, based on a number of physical conditions (see Cho [0014],
[0044]). It may be true that Cho does not describe using questionnaire-
generated data to verify a diagnosis of sleep apnea.
However, as the Examiner points out, in a system directed to
managing atrial fibrillation patients, Bardy shows that it was known in the
art of implant-sensed disease diagnosis that combining implant-detected
physical condition values with questionnaire-generated data was useful in
forming an overall diagnosis of the disorder:
Each [patient] record 40 stores patient information which
includes a snapshot of telemetered signals data which were
recorded by the implantable medical device 12 or the external
medical device 26, for instance, on per heartbeat, binned
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average or derived bases; measures derived from the recorded
device measures; and manually collected information, such as
obtained through a patient medical history interview or
questionnaire.

(Bardy [0045] (emphasis added).) Moreover, Bardy fairly suggests using
both types of data in a patient’s diagnosis:
[T]he quality of life module 132 compares quality of life and
symptom measures set 25a, 25b from the reference baseline 26
and monitoring sets 27, the results of which are incorporated
into the comparisons performed by the analysis module 131, in
part, to either refute or support the findings based on
physiological “hard” data. . . . [T]he patient query engines
134, found in interactive expert systems for diagnosing medical
conditions, can interactively query the patient. Using the
personal computer 18 (shown in FIG. 1), the patient can have
an interactive dialogue with the automated server system 16, as
well as human experts as necessary, to self assess his or her
medical condition. Such expert systems are well known in the
art . . . .

(Id. at [0056] (emphasis added).)
We recognize that Bardy is directed to managing an atrial fibrillation
patient. However, we find that an ordinary artisan detecting sleep apnea
conditions according to Cho would have reasonably inferred from Bardy’s
teachings that it would be useful to include apnea-relevant questionnaire-
generated data in making an actual apnea diagnosis. As noted above, prior
art must be considered not only for what it explicitly states, but also for what
an ordinarily creative person would infer from those teachings. KSR, 550
U.S. at 418.
Thus, while Appellants urge that merely storing both types of data
does not meet the requirements of claim 1, we are not persuaded that the
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cited references fail to suggest producing a diagnostic value as required by
claim 1. In particular, as noted above, claim 1 encompasses producing a
diagnostic value that simply indicates the presence or absence of the
disorder.
In sum, as Appellants’ arguments do not persuade us that the
Examiner failed to make a prima facie case of obviousness as to claim 1, we
affirm the Examiner’s rejection of that claim over Bardy and Cho. Claims
3-5, 7, 9, 10, 13-15, and 19-21 fall with claim 1, as they were not argued
separately. See 37 C.F.R. § 41.37(c)(1)(vii).
OBVIOUSNESS – BARDY, CHO, AND WESTBROOK
The Examiner rejected claims 2, 8, 16, 17, and 23 as obvious over
Bardy, Cho, and Westbrook (Ans. 6-7). The Examiner concluded that,
based on Westbrook’s teachings, an ordinary artisan would have considered
it obvious “to modify the method of Bardy incorporating the sleep apnea
detection taught by Cho with Westbrook to account for patient-specific risk
factors in determining the risk and severity of sleep apnea as accurately as
possible for each individual patient” (id.).
Appellants argue that the Examiner erred in concluding that claims 2
and 16 would have been obvious over the cited references because the
Examiner failed to adequately explain how the cited references teach or
suggest using patient-specific sleep disorder risk factor data “to weight at
least one of the sleep disorder detection value and the patient data score
relative to [each] other” (App. Br. 14). Thus, Appellants urge:
[It] is not inherent that combining two parameters must
necessarily require an affirmative procedure of weighting one
of the parameters relative to the other - instead two parameters
could be mathematically aggregated without weighting one
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relative to the other. For example, in the equation 2x2=4, there
is no weighting. Weighting is not inherent, as contended in the
rejection.

(Id.) Moreover, Appellants argue, the Examiner’s implied claim
interpretation, that the claims encompass a sleep disorder detection value
and patient data score as having a one-to-one weighting, is unreasonable,
since “the entire use of the patient-specific sleep disorder risk factor data
(upon which the weighting is based) is rendered superfluous in a 1:1 ratio, as
no risk factor data is needed to arrive at a default 1:1 ratio” (Reply Br. 9).
Appellants’ arguments do not persuade us that the Examiner erred in
concluding that the cited references would have rendered claim 2 obvious to
an ordinary artisan. Claim 2 recites:
2. The method of claim 1, further comprising:
receiving patient-specific sleep disorder risk factor data
indicative of one or more sleep disorder risk factors; and
weighting at least one of the sleep disorder detection value and
the patient data score relative to the other based on the patient-specific
sleep disorder risk factor data; wherein the sleep disorder diagnostic
value is produced based on the sleep disorder detection value and the
patient data score for which at least one is weighted relative to the
other.

Thus, while claim 2 requires giving the sleep disorder detection value
and patient data score relative weights to each other, the claim does not
require assigning any particular relative weight to those factors. We are
therefore not persuaded that claim 2 excludes equal weighting values for the
sleep disorder detection value and patient data score.
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Moreover, as the Examiner points out, Westbrook discloses that
questionnaire-obtainable risk factors, as well as implantably sensed risk
factors, for sleep apnea were well known in the art:
The analysis of pre-existing risk factors for SA [sleep
apnea] includes, but is not limited to, responses to
demographic, life-style and quality of life questions, including
age, gender, body mass index (BMI), neck circumference,
frequency and manifestation of excessive daytime sleepiness,
frequency and magnitude of snoring, observed apneas, history
of hypertension and use of alcohol. One hundred and twenty-
eight questions were extracted from a clinical questionnaire
applied in interviews with over 10,000 patients tested at major
U.S. sleep laboratories.

(Westbrook [0150].)

We are not persuaded that an ordinary artisan, being a person of
ordinary creativity, and being prompted by Cho and Bardy to include both
implant-sensed data as well as questionnaire-generated data in assessing
sleep apnea, and being further aware of the well-known risk factors for sleep
apnea as described by Westbrook, would have lacked impetus for assigning
an appropriate relative weight to either the implant-sensed data or
questionnaire-generated data when evaluating a particular subject, as claim 2
requires. We therefore affirm the Examiner’s rejection of claim 2 over Cho,
Bardy, and Westbrook.
As they were not argued separately, claims 16, 17, and 23 fall with
claim 2. See 37 C.F.R. § 41.37(c)(1)(vii).
Appellants’ arguments also do not persuade us that the Examiner
erred in maintaining this rejection over claim 8. Claim 8 reads as follows:
8. The method of claim 1, wherein receiving the patient data
comprises receiving the patient data in the form of a
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questionnaire, the questionnaire comprising a plurality of
questions each of which is assigned a value, and computing the
patient data score comprises operating on the values to compute
the patient data score.

Westbrook describes a preferred embodiment of its apnea
evaluation system thusly:
[T]he preferred embodiment includes an Apnea Risk Evaluation
System (ARES) questionnaire that is filled out by a sleep study
patient. Those skilled in the art will be familiar with the
questions that are posed to patients being evaluated for sleep
apnea, and will be able to construct such a questionnaire
without further explanation. The questionnaire thereby
provides information that can be submitted to discriminant
function or other type of analysis that can be used to assign risk
categories based on questionnaire responses. In addition to
patient responses elicited by the questionnaire, overnight
recordings are employed to collect patient physiological data
during a session of the patient’s sleep. The patient
physiological data collection and recording occurs
automatically through a physiological monitoring system.

(Westbrook [0053].)
Thus, Westbrook discloses not only that both questionnaire-generated
data as well as data obtainable through implanted sensors should be
considered in evaluating sleep apnea, but also that an ordinary artisan would
have readily understood the types of questions to be asked and how those
questions discriminate between apnea risk categories. Given these
teachings, we are not persuaded that an ordinary artisan viewing the
references’ combined teachings would have failed to take into account the
relative weight of the questions asked in an apnea questionnaire, when
combining the data generated by the questionnaire with implant-sensed data.
As Appellants’ arguments therefore do not persuade us that the Examiner
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erred in concluding that claim 8 would have been obvious to an ordinary
artisan, we affirm the Examiner’s rejection of that claim over the cited
references.
OBVIOUSNESS – BARDY, CHO, AND GOTTESMAN
The Examiner rejected claims 6, 11, and 22 over Bardy, Cho, and
Gottesman (Ans. 7). The Examiner found, as to claims 6, 11, and 22, that
Bardy and Cho failed to teach using “binary diagnoses for the sleep disorder
detection value and the patient data score and logically combining the two
values to produce a sleep disorder diagnostic value” (id.).
However, given Gottesman’s teaching of using a binary determination
to define a patient condition in a patient management network, the Examiner
concluded that an ordinary artisan would have considered it obvious “to
modify the method of Bardy incorporating the sleep apnea detection taught
by Cho with Gottesman to allow for the use of the simplest type of indicator
methods for diagnosis of a patient condition” (id.).
Appellants argue that the section of Gottesman cited by the Examiner
to support the prima facie case only concerns “one binary diagnosis, and
does not teach or suggest combining two binary diagnoses to produce a
disorder diagnostic value, such as by logical combination. As such, the use
of Bardy, Cho, and Gottesman in the Office Action does not account for all
elements of claims 6, 11, and 22” (App. Br. 16). Moreover, Appellants
argue, “[i]n specific regard to claim 11, it is noted that paragraph [0125] [of
Gottesman] does not discuss multiple thresholds” (Reply Br. 11).
Claim 11 states:
11. The method of claim 1, further comprising comparing each of the
sleep disorder detection value and the patient data score to respective
thresholds, wherein the sleep disorder diagnostic value is a binary
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diagnosis as to whether the sleep disorder is present and the binary
diagnosis is determined based on the comparison of each of the sleep
disorder detection value and the patient data score to the respective
thresholds.

As the Examiner points out, and Appellants do not dispute, Gottesman
provides evidence that it was known in the art that evaluating whether or not
a patient has a particular disorder, such as obesity, can be considered a
binary determination, from a logical standpoint (see Gottesman [0125]).
Moreover, as discussed above, Bardy teaches that it was known in the art to
compare specific observed results to threshold values to determine whether
in fact the patient actually has the disorder of interest:
[T]he analysis module 131 analyzes the results from the
comparison module 130, which are stored as a combined
measures set 95 (not shown), to a set of indicator thresholds . . .
. Similarly, the quality of life module 132 compares quality of
life and symptom measures set 25a, 25b from the reference
baseline 26 and monitoring sets 27, the results of which are
incorporated into the comparisons performed by the analysis
module 131, in part, to either refute or support the findings
based on physiological “hard” data. . . .

(Bardy [0056].)
While Appellants urge that none of the cited references discusses
binary diagnostic analyses, making a diagnosis of a disorder based on a
threshold value, as taught by Bardy and recited in claim 11, claim 11
essentially requires a practitioner to decide, yes or no (in a binary manner),
whether the patient has the disorder, based on comparing the observed data
to the threshold values. In the instant case, given that Bardy suggests
diagnosing a disorder based on just such a threshold analysis, using both
questionnaire-generated and implant-sensed data, we are not persuaded that
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the cited references would have failed to suggest diagnosing sleep apnea
using the same analysis.
Therefore, as Appellants’ arguments do not persuade us that the
Examiner erred in concluding that claim 11 would have been obvious to an
ordinary artisan in view of Bardy, Cho, and Gottesman, we affirm the
Examiner’s rejection of that claim over those references. As they were not
argued separately, claims 6 and 22 fall with claim 11. See 37 C.F.R. §
41.37(c)(1)(vii).
OBVIOUSNESS –
BARDY, CHO, WESTBROOK, AND ARES
The Examiner also rejected claim 12 as obvious over Bardy, Cho,
Westbrook, and ARES (“the Apnea Risk Evaluation System”) (Ans. 8). The
Examiner found that Bardy and Cho failed to teach the use of questions
characterizing patient daytime sleepiness, and to meet that deficiency cited
Westbrook as teaching “the use of the Apnea Risk Evaluation System
(ARES) in determining the risk of sleep apnea, which comprises questions
concerning patient daytime sleepiness” (id.).
Based on these teachings, the Examiner concluded that an ordinary
artisan would have considered it obvious “to modify the method of Bardy
incorporating the sleep apnea detection taught by Cho with Westbrook to
utilize questionnaires which determine the patient’s daytime sleepiness, as it
is a parameter known to be affected by various sleep disorders” (id.).
As Appellants direct no specific argument to this ground of rejection,
and we detect no deficiency in the Examiner’s prima facie case, we affirm
this rejection as well.

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OBVIOUSNESS – BARDY, CHO, AND DREW
The Examiner rejected claim 18 as obvious over Bardy, Cho, and
Drew (Ans. 8). The Examiner found that Bardy and Cho differed from
claim 18 in failing to “teach the diagnostic value is a Boolean value,” and to
meet that feature cited Drew as disclosing, “in a system for medical data
processing, including the study of sleep disorders ([0046]), . . . the use of
Boolean values for data classification ([0101])” (id.).
Based on the references’ teachings, the Examiner concluded that an
ordinary artisan would have considered it obvious to “modify the method of
Bardy incorporating the sleep apnea detection taught by Cho to employ
Boolean values similar to those of Drew to allow for a logic based
diagnostics indicator” (id.).
Appellants argue that the sections of Drew cited by the Examiner fail
to teach or suggest the claimed subject matter, because counting up results as
taught by Drew “does not constitute a Boolean value (e.g., the sleep disorder
diagnostic value) developed from a Boolean operation performed on the two
Boolean values respectively associated with the patient data and data
indicative of the sensed one or more conditions associated with the
disordered breathing sleep disorder” (App. Br. 17).
The Examiner responds that, “[w]ith the addition of Boolean values
(each valued as 1 as taught by Drew) compared with the threshold ([0012]),
the result is a true/false determination depending on whether or not the sum
meets the threshold (i.e. meets threshold = true, does not meet threshold =
false)” (Ans. 11-12). Thus, the Examiner reasons, “[w]hile using the
summed counter may also allow the user [to] see how close to the threshold
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the resulting combined data was, the true/false result based on the threshold
is still a Boolean operation” (id. at 12).
Appellants reply that paragraph [0012] of Drew cited by the Examiner
does not appear to address Boolean values (Reply Br. 11), and reiterate that
the analysis explicitly applied in paragraph [0101] of Drew does not yield a
Boolean value (id. at 12).
We find that the Examiner has the better position.
Claim 18 recites:
18. The method of claim 15, further comprising comparing each of the
one or more detected conditions and the questionnaire data to
respective thresholds to generate two respective Boolean values,
wherein the sleep disorder diagnostic value comprises a Boolean
value developed from a Boolean operation performed on the two
Boolean values respectively associated with the patient data and data
indicative of the sensed one or more conditions associated with the
disordered breathing sleep disorder.

As the Examiner points out, in methods involving implantably sensing
data in patients suffering from a variety of conditions (Drew [0046]), Drew
teaches that it was known in the art to use Boolean logic in assessing the
collected data (id. at [0101]). As the Examiner also points out (Ans. 11-12),
and Appellants do not dispute, the use of Boolean values as claimed
encompasses applying a threshold analysis to determine, in a simple
true/false sense, whether a patient has a sleep disorder.
Thus, claim 18 encompasses a process in which the practitioner
determines, true or false, whether a patient has a sleep disorder based on
comparing a patient’s observed questionnaire-generated and implant-sensed
data to threshold values, and then based on a combination of those true/false
determinations, makes an ultimate true/false determination as to the patient’s
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diagnosis. Here, Bardy suggests determining, through a threshold analysis
using both questionnaire-generated and implant-sensed data, whether it was
true or false that a patient had a particular disorder (see Bardy [0056]).
Given Bardy’s teaching of the usefulness of combining threshold
analyses using both questionnaire-generated and implant-sensed data to
diagnose whether or not a patient had a particular disorder, and given the
known use of Boolean logic in this type of assessment, as taught by Drew,
we agree with the Examiner that an ordinary artisan evaluating sleep apnea
patients as taught by Cho, would have been prompted to apply those known
analytical techniques to make the ultimate apnea diagnosis. Thus, as
Appellants’ arguments do not persuade us that the Examiner erred in
concluding that claim 18 would have been obvious to an ordinary artisan in
view of Bardy, Cho, and Drew, we affirm the Examiner’s rejection of that
claim over those references.

SUMMARY
We affirm the Examiner’s obviousness rejection of claims 1, 3-5, 7, 9,
10, 13-15, and 19-21 over Bardy and Cho.
We affirm the Examiner’s obviousness rejection of claims 2, 8, 16,
17, and 23 over Bardy, Cho, and Westbrook.
We affirm the Examiner’s obviousness rejection of claims 6, 11, and
22 over Bardy, Cho, and Gottesman.
We affirm the Examiner’s obviousness rejection of claim 12 over
Bardy, Cho, Westbrook, and ARES.
We affirm the Examiner’s obviousness rejection of claim 18 over
Bardy, Cho, and Drew.
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TIME PERIOD
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).

AFFIRMED

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