Ex Parte Ghanem et al

Patent Trial and Appeal Board

Oct 11, 2012

11380842 (P.T.A.B. Oct. 11, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte RAJA N. GHANEM, ROBERT W. STADLER, and
XUSHENG ZHANG
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Appeal 2010-010148
Application 11/380,842
Technology Center 3700
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Before LINDA E. HORNER, PATRICK R. SCANLON, and
BRADFORD E. KILE, Administrative Patent Judges.

HORNER, Administrative Patent Judge.

DECISION ON APPEAL

STATEMENT OF THE CASE
Raja N. Ghanem et al. (Appellants) seek our review under 35 U.S.C.
§ 134 of the Examiner’s decision rejecting claims 1-4 and 6-22. We have
jurisdiction under 35 U.S.C. § 6(b).
We REVERSE.
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Application 11/380,842

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THE INVENTION
Appellants’ claimed invention relates to “a method and apparatus for
detecting arrhythmias in a subcutaneous medical device.” Spec.,
para. [0003]. Claims 1, 21, and 22 are independent. Claim 1, reproduced
below, is representative of the subject matter on appeal.
1. A method of detecting a cardiac event by a medical
device, comprising:
sensing cardiac signals from a plurality of
electrodes, the plurality of electrodes forming a first
sensing vector and a second sensing vector;
separately identifying the first sensing vector and
the second sensing vector as being corrupted by noise in
response to determining a signal energy content metric
of corresponding sensed cardiac signals not being
within predetermined limits;
separately identifying the first sensing vector and
the second sensing vector as being corrupted by noise in
response to determining a noise to signal ratio of
corresponding sensed cardiac signals not being less than
a signal to noise threshold;
separately identifying the first sensing vector and
the second sensing vector as being corrupted by noise in
response to determining corresponding sensed cardiac
signals being associated with muscle noise;
separately identifying the first sensing vector and
the second sensing vector as being corrupted by noise in
response to determining a mean frequency of
corresponding sensed cardiac signals not being less than
a mean frequency threshold;
otherwise, separately identifying the first sensing
vector and the second sensing vector as not being
corrupted by noise; and
delivering therapy via the device in response to
the identifying.

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Application 11/380,842

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THE EVIDENCE
The Examiner relies upon the following evidence:
Hartley US 5,957,857 Sep. 28, 1999
Kohler US 2002/0058878 A1 May 16, 2002
Stratbucker US 6,532,379 B2 Mar. 11, 2003
Ostroff US 2004/0254613 A1 Dec. 16, 2004
THE REJECTIONS
Appellants seek review of the following rejections:1
1. Claims 1-4, 6-8, 10, 11, and 13-22 are rejected under
35 U.S.C. § 103(a) as being unpatentable over Kohler and Ostroff.
2. Claim 9 is rejected under 35 U.S.C. § 103(a) as being unpatentable
over Kohler, Ostroff, and Hartley.
3. Claim 12 is rejected under 35 U.S.C. § 103(a) as being unpatentable
over Kohler, Ostroff, and Stratbucker.
ISSUE
The Examiner determined that Kohler discloses a method of detecting
a cardiac event that includes determining whether a mean frequency
corresponding to the sensed cardiac signals is less than a mean frequency
threshold. Ans. 5 (citing Kohler, paras. [0014], [0016]). See also Ans. 17-
18 (citing Kohler, para. [0030]).
Appellants argue that “[a] mean frequency is a precise term and
definition, i.e., the average frequency of the signal, and Kohler et al ‘878

1 The Examiner withdrew the following provisional rejections based on non-
statutory, obviousness-type double patenting: claims 1-15 over claims 1-18
of Application 11/380,815; claims 16-18 over claims 1-5 of Application
11/380,815; and claims 1-4 and 6-22 over claims 1-26 of Application
11/380,823. Ans. 3, 16; Final Office Action 2-3.
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Application 11/380,842

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does not show, disclose or suggest ever determining such a value.” App.
Br. 17.
The issue presented by this appeal is:
Does Kohler disclose a method of detecting a cardiac event that
includes determining whether a mean frequency corresponding to the sensed
cardiac signals is not less than a mean frequency threshold?
ANALYSIS
Independent claim 1 calls for a method of detecting a cardiac event by
a medical device comprising “separately identifying the first sensing vector
and the second sensing vector as being corrupted by noise in response to
determining a mean frequency of corresponding sensed cardiac signals not
being less than a mean frequency threshold.” Independent claim 21 is
directed to a computer readable medium having computer executable
instructions for performing a method comprising the same step as set forth
above in claim 1. Claim 22 is directed to a medical device comprising
means for performing the substantially same step as set forth above in
claim 1.
The Specification describes that “[t]he mean frequency of the signal
during the 3 second segment for each channel ECG1 and ECG2 is generated,
for example, by calculating the ratio of the mean absolute amplitude of the
first derivative of the 3 second segment to the mean absolute amplitude of
the 3 second segment, multiplied by a constant scaling factor.” Spec., para.
[0095]. The Specification explains that “[i]f the mean frequency is
determined to be greater than or equal to the predetermined mean frequency
threshold, . . ., the three second segment for that channel is identified as
being likely corrupted with noise.” Id. As such, the description of the
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calculation of mean frequency provided in the Specification is consistent
with Appellants’ proffered definition of mean frequency as “the average
frequency of the signal.” App. Br. 17.
Appellants argue that Kohler’s disclosure of comparing a number of
zero-crossings with a threshold is not the same as determining a mean
frequency of a signal. App. Br. 18. We agree with Appellants.
Kohler’s method uses the morphology of the QRS complex, which is
characterized by a relative high-amplitude oscillation that markedly guides
the signal curve away from the zero line of the electrocardiogram, as
compared to other signal segments, to identify the QRS complex based on a
zero crossing count. Kohler, para. [0015]. Kohler describes that “[t]he
differentiation between a QRS complex and the other signal segments can
thus be detected with a frequency measurement that can be described
representatively, based on the discussed signal characteristics, by the number
of zero crossings per defined evaluated segment.” Kohler, para. [0016].
Kohler states that “[t]he zero crossing count produces a number that is
nearly proportional to the given dominant frequency of the signal.” Id.
As disclosed in Kohler, the use of the zero crossing count merely
serves as a surrogate for the dominant frequency of the signal, and thus
Kohler’s system does not determine a mean frequency of sensed cardiac
signals and compare this frequency to a mean frequency threshold. As such,
the Examiner erred in the finding as to the scope and content of Kohler on
which the determination of obviousness of claims 1, 21, and 22 was based.
Accordingly, we do not sustain the rejection of independent claims 1, 21,
and 22, or dependent claims 2-4, 6-8, 10, 11, and 13-20, under
35 U.S.C. § 103(a) as being unpatentable over Kohler and Ostroff.
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The rejection of claim 9 based on Kohler, Ostroff, and Hartley and the
rejection of claim 12 based on Kohler, Ostroff, and Stratbucker both suffer
from the same erroneous finding as to the scope and content of Kohler as set
forth supra. The Examiner did not rely on Hartley or Stratbucker to disclose
determining the mean frequency of sensed cardiac signals and comparing
that mean frequency to a threshold. Ans. 14-15. As such, we do not sustain
the rejections of dependent claims 9 and 12 for the same reasons set forth
supra in our analysis of independent claim 1.
CONCLUSION
Kohler does not disclose a method of detecting a cardiac event that
includes determining whether a mean frequency corresponding to the sensed
cardiac signals is not less than a mean frequency threshold.
DECISION
We REVERSE the decision of the Examiner to reject claims 1-4 and
6-22.

REVERSED

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