Ex Parte Heruth et al

Board of Patent Appeals and Interferences

Jan 5, 2012

10825964 (B.P.A.I. Jan. 5, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte KENNETH T. HERUTH and KEITH A. MIESEL
__________

Appeal 2010-008689
Application 10/825,964
Technology Center 3700
__________

Before TONI R. SCHEINER, DONALD E. ADAMS and
STEPHEN WALSH, Administrative Patent Judges.

WALSH, Administrative Patent Judge.

DECISION ON APPEAL
This is a decision on appeal under 35 U.S.C. § 134(a) from the
rejection of claims directed to a medical system. We have jurisdiction under
35 U.S.C. § 6(b). We affirm.
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STATEMENT OF THE CASE
Claims 20-23, 26-33, 35-38, 40, 43-45, 53, 55, 57-62, 72, and 73 are
on appeal. Claim 53 reads:
53. A medical system comprising:
a plurality of sensors, each of the sensors generating a signal as a
function of at least one physiological parameter of a patient; and
an implantable medical device that includes a processor to:
monitor a plurality of physiological parameters based on the
signals output by the sensors, wherein the plurality of physiological
parameters comprise at least one of blood pressure, muscular activity,
arterial blood flow, or galvanic skin response,
for each of the plurality of physiological parameters, determine
a respective one of a plurality of sleep metric values, each of the sleep
metric values indicating a non-binary probability of the patient being
asleep based on the respective physiological parameter, and
mathematically combine the plurality of sleep metric values that
each indicate that probability of the patient being asleep based on the
respective one of the plurality physiological parameters to determine
an overall sleep metric value that indicates an overall non-binary
probability of the patient being asleep. (Emphasis added.)

The text italicized in claim 53 as reproduced above highlights
Appellants’ issue on appeal. The same disputed text appears in the
independent claims 53, 72 and 73, and we select claim 53 as representative.
The Examiner rejected the claims under 35 U.S.C. § 103(a) as
unpatentable over Hatlestad1 and Koh.2

1 John D. Hatlestad et al., US 2005/0042589 A1, filed Aug. 18, 2003,
published Feb. 24, 2005.
2 Steve Koh et al., US 7,207,947 B2, filed Jan. 10, 2003, issued April 24,
2007.
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OBVIOUSNESS
The Issue
The Examiner’s position is that Hatlestad described a sleep quality
data and evaluation device which detected physiological and non-
physiological patient conditions. (Ans. 3-5.) Hatlestad, however, “does not
specifically disclose how the sleep metric values indicate a non-binary
probability of the sleep state of the patient.” (Id. at 5.) According to the
Examiner, Koh disclosed “a system and method for detecting circadian
states using an implantable medical device,” and “gaining a metric through a
mathematical analysis which combines the data to determine the sleep stage
of the patient.” (Id.) The Examiner concluded:
[i]t would have been obvious to one having ordinary skill in the art at
the time the Applicants' invention was made to modify a sleep quality
data collection and evaluation device which assess sleep quality based
on detected physiological or non-physiological patient conditions,
similar to that disclosed by Hatlestad et al., to include a device which
delivers a sleep metric value which indicates a non-binary probability
of the sleep state of the patient, similar to that disclosed by Koh et al.,
to provide a method which includes several parameters to assist with
determining the sleep state of a patient.

(Id. at 5-6.)
Appellants contend that “contrary to the Examiner’s argument, Koh
also fails to teach or suggest determining a non-binary probability of sleep in
a subject. Accordingly, even if Hatlestad were modified in view of Koh, the
resulting combination would not disclose or suggest each and every element
of independent claims 53, 72 and 73.” (App. Br. 6.) Appellants read Koh as
making a binary determination of whether a patient is asleep or awake. (Id.
at 7.) Appellants further contend that “[a]lthough each of [Koh’s] circadian
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parameters may be normalized or averaged together, none of the individual
parameters indicates a non-binary probability of the patient being asleep
and the combined metric does not indicate an overall non-binary probability
of the patient being asleep. The Koh values are raw or normalized
physiological parameter values, rather than probabilities.” (Id. at 7-8,
footnote omitted.) Appellants also disagree with the rejection’s
characterization of Hatlestad’s paragraphs [0090]-[0103] and [0135]-[0162].
(Id. at 8-10.)
The issue is whether a Hatlestad or Koh sleep metric value indicates a
non-binary probability of a patient being asleep.
Analysis
It is undisputed that each of Hatlestad and Koh described a medical
system comprising (1) a plurality of sensors generating a signal as a function
of at least one physiological parameter of a patient, and (2) an implantable
medical device including a processor to (i) monitor a plurality of
physiological parameters, (ii) determine a respective one of a plurality of
sleep metric values, and (iii) mathematically combine the plurality of sleep
metric values to determine an overall sleep metric value.
Appellants contend that the sleep metric values determined by
Hatlestad or Koh do not indicate a non-binary probability of the patient
being asleep. Appellants have not directed us to any disclosed definition of
“sleep metric value” that objectively distinguishes the claimed “sleep metric
value” from a sleep metric value determined by Hatlestad or Koh.
The Specification confirms that the claimed sleep metric value is not
required to be a probability value, and is only required to indicate a
probability. The point of distinction is explicitly set out in Appellants’
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Specification. Paragraph 36 states the possibility that “[a] sleep metric value
may be a numeric value that indicates the probability that patient 12 is
asleep.” (Spec. 9.) There is no reason that a raw number such as measured
by Hatlestad or Koh would not so indicate that probability. Paragraph 36
goes on to disclose an alternative more limited meaning: “[i]n some
embodiments, the sleep metric value may be a probability value, e.g., a
number within the range from 0 to 1.” (Id.) Claim 53 does not require the
sleep metric value to be the latter, more narrowly defined probability value.
Appellants’ contention that the prior art fails to determine probability
is misdirected and unpersuasive because the system defined in claim 53 does
not determine probability. Instead, its output is a sleep metric value that
“indicates” a probability; the output is not required to be a probability. (See
Spec. 9, [0036].) In the absence of a disclosed definition objectively
defining “indicate,” the claim is open to the ordinary meaning3 of “indicate.”

3 Ordinary meanings for “indicate” include:
Definition of 'indicate' Random House Webster's College Dictionary
1. (v.t.) to be a sign of; betoken: Snow indicates winter.

Definition of 'indicate' Princeton's WordNet
1. (verb) bespeak, betoken, indicate, point, signal, be a signal for or a
symptom of - "These symptoms indicate a serious illness"; "Her behavior
points to a severe neurosis"; "The economic indicators signal that the euro is
undervalued"

Definition of 'indicate' Webster Dictionary
1. (verb) indicate
to point out; to discover; to direct to a knowledge of; to show; to make
known
2. (verb) indicate
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The person to whom the value indicates a probability is a person of ordinary
skill in the art. It is evident that the prior art understood that sleep
measurements indicate probability, not binary certainty. Koh recognized,
for example, that “[p]osture detection does not properly distinguish between
simply lying down rather than sleeping.” (Koh, col. 1, ll. 39-40.) As
Appellants point out, Hatlestad described readjusting threshold values to
improve sleep detection. When sleep detection is described in terms of
readjusting threshold values and fine tuning, it seems evident that a person
of ordinary skill in the art would view all the numeric measurements as
indicating not binary certainties but probabilities. While there is nothing
intrinsically wrong with defining something by what it does, as claim 53
does, the prior art sleep metric values indicated (and still indicate) non-
binary probability to the practitioner of ordinary skill. What the prior art
metric indicated, and still indicates, was (and is) a subjective interpretation
by the person of ordinary skill in the art. A new description of the same
sleep metric value output from the prior art system does not make an old or
obvious system newly patentable to Appellants.
Claims 20-23, 26-33, 35-38, 40, 43-45, 55, 57-62, 72, and 73 have not
been argued separately and therefore fall with claim 53. 37 C.F.R.
§ 41.37(c)(1)(vii).

to show or manifest by symptoms; to point to as the proper remedies; as,
great prostration of strength indicates the use of stimulants

source: www.definitions.net/definition/indicate, accessed Jan. 3, 2012.
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SUMMARY
We affirm the rejection of claims 20-23, 26-33, 35-38, 40, 43-45, 53,
55, 57-62, 72, and 73 under 35 U.S.C. § 103(a) as unpatentable over
Hatlestad and Koh.
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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