Ex Parte van Oort et al

Patent Trial and Appeal Board

May 7, 2013

11669345 (P.T.A.B. May. 7, 2013)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte GEESKE VAN OORT,
WILLEM BOUTE, and GUSTAAF A.P. STOOP
__________

Appeal 2011-011933
Application 11/669,345
Technology Center 3700
__________

Before DEMETRA J. MILLS, LORA M. GREEN, and MELANIE L.
McCOLLUM, Administrative Patent Judges.

McCOLLUM, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to an
implantable medical device (IMD), a method for use in an IMD, and a
computer-readable medium. The Examiner has rejected the claims as
anticipated. We have jurisdiction under 35 U.S.C. § 6(b). We reverse.
STATEMENT OF THE CASE
Claims 1-39 are pending and on appeal (App. Br. 2). Claim 1 is
illustrative and reads as follows:
1. A method for use in an implantable medical device, comprising:
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storing a first threshold corresponding to detecting a first
physiological event;
sensing a first physiological signal corresponding to the first
physiological event;
detecting a plurality of the first physiological events in response to the
first physiological signal and the first threshold;
storing a second threshold different than the first threshold;
determining, in response to detecting at least one of the plurality of
the first physiological events, if the second threshold has been met; and
enabling detailed monitoring of next ones of the detected plurality of
the first physiological events in response to the second threshold being met.
Claims 1-12, 14-25, and 27-38 stand rejected under 35 U.S.C.
§ 102(e) as anticipated by Shen et al. (US 2008/0058651 A1, Mar. 6, 2008)
(Ans. 4).
Claims 13, 26, and 39 stand rejected under 35 U.S.C. § 103(a) as
obvious over Shen (Ans. 9).
ANTICIPATION
The Examiner finds that Shen teaches each and every feature of
independent claim 1 (Ans. 4-5). For the same reasons, the Examiner finds
that Shen teaches each and every feature of claims 14 and 27, which are also
independent (id.).
Appellants argue that Shen does not disclose the following limitations
of claim 1:
“determining, in response to detecting at least one of the plurality of
the first physiological events, if the second threshold has been met; and
enabling detailed monitoring of next ones of the detected plurality of
the first physiological events in response to the second threshold being met.”
(App. Br. 6.) Appellants traverse the rejection of claims 14 and 27 for the
same reasons (id. at 6-10).
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Findings of Fact
1. Shen discloses:
[A] method carried out by a therapeutic implantable medical
device includes detecting a plurality of physiologic episodes of
interest, recording a single set of diagnostic data indicative of
physiologic activity, determining that the single set of
diagnostic data corresponds in time with at least two
physiologic episodes, and associating the single set of
diagnostic data with the least two of the plurality of physiologic
episodes.
(Shen, ¶ [0006].)
2. Shen also discloses:
FIG. 5 depicts an illustrative scenario 500 in which a single set
of EGM data is recorded for each set of multiple concurrent
cardiac events. . . . Two events are considered to be concurrent
if one event occurs or is detected while diagnostic data is being
recorded in response to the occurrence or detection of the other
event.
(Id. at ¶ [0054].)
3. In addition, Shen discloses that, “[w]hen an episode is detected,
recording of diagnostic data is triggered” (id. at ¶ [0055]).
4. Shen also discloses:
A request to record EGM data is said to expire when the time
duration specified in the request is reached. If EGM data is
already being recorded when a request to record is issued, EGM
data will continue to be recorded in the set of EGM data
currently being recorded. EGM data will continue to be
recorded until expiration of the last request received while
recording the set of EGM data. After all requests for recording
EGM data have expired while recording a particular set of
EGM data, no more EGM data is recorded into that particular
set of EGM data. When another request for recording is issued,
recording will begin again to form another set of EGM data.
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All requests involve recording of onset (prior to the event) and
post (after the event) data.
(Id. at ¶ [0056].)
5. In addition, Shen discloses: “FIG. 10 is a flow chart illustrating
an algorithm 1000 that can be carried out by a therapeutic IMD to carry out
time-based diagnostic data management.” (Id. at ¶ [0077].)
6. Shen also discloses:
The algorithm 1000 generally determines when to record (e.g.,
save in a more permanent memory) diagnostic data based on
events that occur. Received diagnostic data is analyzed to
monitor for physiologic events of interest. A detecting
operation 1004 detects a physiologic event of interest. The
detecting operation 1004 triggers a process for gathering and
generating data related to the event. A query operation 1006
determines whether sufficient memory is available for storing
the event-related data. The query operation 1006 may test
memory to determine if there is available memory above a
certain sufficiency threshold. If the query operation determines
that insufficient memory is available, the algorithm 1000
branches “No” to a memory reallocation operation.
(Id. at ¶ [0079].)
7. In addition, Shen discloses: “If the query operation 1006
determines that sufficient memory is available, the algorithm 1000 branches
‘Yes’ to a creating/updating operation 1008,” which “creates one or more
data structures for the detected event,” and a “recording operation 1010
begins recording diagnostic data at the available memory location” (id. at
¶¶ [0080]-[0081]).
8. Shen also discloses: “FIG. 11 is a flowchart illustrating an
algorithm 1100 that can be carried out by a therapeutic IMD for allocating
diagnostic data memory based on an event prioritization schedule with
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specified minimum numbers of event types and maximum numbers of event
types.” (Id. at ¶ [0085].)
Analysis
The Examiner finds:
Shen discloses storing a first threshold corresponding to
detecting a first physiological event (“When an episode is
detected, recording of diagnostic data is triggered”, pg.
[0054], the threshold is considered to be the metric which
induces the triggering of data recordings) . . . [and]
determining, in response to the detecting, if a second threshold
has been met (pg. [0079]; the second threshold is considered to
be the threshold related to the particular event which causes it
to be stored, or considered for storage, into memory).
(Ans. 4-5.) The Examiner explains: “The initial threshold is considered to
be the recording threshold which enables recording due to the detection of
an event; the second threshold is considered to be associated with the
memory allocation.” (Id. at 5 (emphasis omitted).)
In paragraph 55, Shen discloses that, “[w]hen an episode is detected,
recording of diagnostic data is triggered” (Finding of Fact (FF) 3). In
paragraph 79, Shen discloses that the “algorithm 1000 generally determines
when to record . . . diagnostic data based on events that occur” (FF 6). We
understand that the Examiner is considering the metric that induces this data
recording to be the first threshold (Ans. 4).
In paragraph 79, Shen additionally discloses: “A query operation
1006 determines whether sufficient memory is available for storing the
event-related data. The query operation 1006 may test memory to determine
if there is available memory above a certain sufficiency threshold.” (FF 6
(emphasis added).) We understand that the Examiner is considering this
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threshold to be the second threshold (Ans. 5). In addition, we agree with the
Examiner that this threshold is different from the first threshold. However,
we agree with Appellants that the Examiner has not adequately explained
how Shen discloses enabling detailed monitoring of next ones of the
detected plurality of the first physiological events in response to this second
threshold being met (App. Br. 7).
Alternatively, the Examiner finds that “[e]ach priority has an
associated threshold as well as a maximum and minimum number of events
which are to be recorded related to that specific episode type, these can
broadly be interpreted to be thresholds as well” (Ans. 5 (emphasis omitted)).
We note that Shen discloses “an algorithm 1100 that can be carried
out by a therapeutic IMD for allocating diagnostic data memory based on an
event prioritization schedule with specified minimum numbers of event
types and maximum numbers of event types” (FF 8). However, as with
query operation 1006, which determines “if there is available memory above
a certain sufficiency threshold” (FF 6), the Examiner has not adequately
explained how Shen discloses enabling detailed monitoring of next ones of
the detected plurality of the first physiological events in response to any
priority thresholds, or the minimums or maximums, being met.
The Examiner also finds:
Shen further discloses in paragraph [0056] in relation to
figure 5, the first threshold is met, this is the episode being
detected (504 ATR Episode 1, Fig. 5). Once the episode is
detected recording of the EGM ensues for a specified time
duration. This time duration is interpreted to be a detail or
monitoring or detailed monitoring. If a second episode (510 AF
Episode 1 or 518 VF Episode 1, Fig. 5) is detected during that
time frame (i.e. a second threshold is met) the time frame is
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extended (time runs along the x-axis of Fig. 5), this is to say
that in response to the second threshold being met, detailed
monitoring (EMG 1, and the associated time that EMG 1 is
recorded) of that event is enabled.
(Ans. 5 (emphasis omitted).)
In paragraph 56, Shen discloses: “If EGM data is already being
recorded when a request to record is issued, EGM data will continue to be
recorded in the set of EGM data currently being recorded.” (FF 4.) We
understand that the Examiner is considering the metric that induces detection
of a second episode (510 AF Episode 1 or 518 VF Episode 1, Fig. 5) to be a
second threshold (Ans. 5). However, we again agree with Appellants that
the Examiner has not adequately explained how Shen discloses enabling
detailed monitoring of next ones of the detected plurality of the first
physiological events in response to this metric being met (App. Br. 9). In
particular, we do not agree with the findings of the Examiner concerning
Shen’s paragraph 63 (Ans. 12) for the reasons stated in the Reply Brief at
pages 5-6.
Conclusion
The Examiner has not set forth a prima facie case that Shen discloses
enabling detailed monitoring of next ones of the detected plurality of the
first physiological events in response to the second threshold being met. We
therefore reverse the anticipation rejection of claim 1 and of claims 14 and
27, which also recite this feature, as well as of claims 2-12, 15-25, and 28-
38, which depend from claims 1, 14, or 27.
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OBVIOUSNESS
In rejecting claims 13, 26, and 39, which depend from claims 1, 14,
and 27, respectively, the Examiner concludes that the additional features
recited in these claims would have been obvious in view of Shen (Ans. 9).
However, the Examiner does not explain why all of the features of claims 1,
14, or 27 would have been obvious. We therefore reverse the obviousness
rejection of claims 13, 26, and 39.

REVERSED

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