Ex Parte White

Patent Trial and Appeal Board

Dec 30, 2014

10206798 (P.T.A.B. Dec. 30, 2014)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte HARLEY WHITE
____________

Appeal 2012-006954
Application 10/206,7981
Technology Center 3700
____________

Before JEFFREY N. FREDMAN, ULRIKE W. JENKS, and
AMANDA F. WIEKER, Administrative Patent Judges.

WIEKER, Administrative Patent Judge.

DECISION ON APPEAL

This is an appeal under 35 U.S.C. § 134(a) involving claims directed
to methods for administering therapeutic shocks. The Examiner rejected the
claims as obvious. We have jurisdiction under 35 U.S.C. § 6(b).
We affirm.

1 According to Appellant, the real party in interest is Cardiac Pacemakers,
Inc. (App. Br. 2).

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STATEMENT OF THE CASE

Claims 1–18, 32–36, 41–47, and 49–52 are pending and on appeal.
Claim 1 is representative and reads as follows:
1. A method comprising:
receiving a plurality of cardiac complexes over a
plurality of heartbeats following therapeutic shock therapy and
before any subsequent shock therapy is delivered;
calculating similarity metrics indicative of the similarity
between the received cardiac complexes and a template,
wherein the template represents a cardiac complex with normal
atrio-ventricular conduction;
calculating a trend metric based on the calculated
similarity metrics;
if the trend metric indicates a trend toward the template,
inhibiting further delivery of therapeutic shock therapy; and,
if the trend metric does not indicate a trend toward the
template, continuing delivery of therapeutic shock therapy.
(App. Br. 24).

Independent claims 15, 32, and 41 recite similar limitations.
The following ground of rejection is before us for review:
Claims 1–18, 32–36, 41–47, and 49–52 under 35 U.S.C. § 103(a) as
obvious over Van Hofwegen2 and Street.3
CLAIMS 1, 4–10, 15–18, 32, 41, 44, AND 45

THE ISSUE

The Examiner finds that Van Hofwegen discloses a method
comprising the steps of applying a cardiac shock, conducting an arrhythmia

2 Van Hofwegen et al., US 5,179,945, issued Jan. 19, 1993.
3 Street, A., US 6,516,219 B1, issued Feb. 4, 2003.
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analysis to determine whether reversion has occurred, and either delivering
or inhibiting additional shock therapy based on the reversion determination
(Ans. 4–5). The Examiner finds that Van Hofwegen does not disclose
evaluating a template as part of the arrhythmia analysis (id.), but finds that
other types of arrhythmia analyses may be used (id.).
The Examiner finds that Street discloses an arrhythmia analysis
comprising the steps of comparing sensed cardiac waveforms against a
template, calculating similarity and trend metrics, and either delivering
shock therapy if the trend is decreasing or inhibiting therapy if the trend is
increasing (id. at 5). The Examiner concludes it would have been obvious to
modify Van Hofwegen with Street’s arrhythmia analysis “to provide the
predictable results of accurately predicting the arrhythmia on a continuous
basis to determine whether to deliver or inhibit therapy” (id. at 6).
The issue is: Does the evidence of record support the Examiner’s
conclusion that the combination of Van Hofwegen and Street render obvious
the claimed methods?
FINDINGS OF FACT

FF1. Van Hofwegen discloses a method to “evaluate [a] heart
condition before discharging [a] defibrillation capacitor” (Van Hofwegen
col. 1, ll. 52–58).
FF2. Van Hofwegen discloses that the method involves an arrhythmia
analysis in which “a check is made on the duration of the last R-R interval
detected . . . . [against] a programmable tachycardia primary rate cycle
length limit (PCLL)” (id. at col. 2, ll. 34–39; see also id. at col. 4, ll. 59–64).
FF3. Van Hofwegen discloses:
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If the last R-R interval is greater than PCLL, a second
delay is initiated . . . to monitor the cardiac activity further after
capacitor discharge but before making the decision to discharge
the capacitor . . . If no rapid interval is detected during this
time, the shock is not delivered and a post intervention (PI)
monitoring routine is entered . . . .
(Id. at col. 2, ll. 40–47, 51–54; see also id. at col. 4, l. 67–col. 5, l. 11; col. 5,
ll. 16–19).
FF4. Van Hofwegen discloses that, by contrast, “[i]f any R-R interval
detected during this interval is less than PCLL, this indicates that the
arrhythmia has not reverted and that the capacitor charge is to be delivered
to the patient immediately, but synchronously. . . . The PI routine is entered
also after the synchronous shock” (id. at col. 2, ll. 47–51, 54–55; see also id.
at col. 5, ll. 12–16, 21–23).
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FF5. Van Hofwegen’s Figure 3 is reproduced below:

FIG. 3 is a flow chart illustrating post-intervention (PI) monitoring (id. at
col. 3, ll. 23–25).
FF6. Van Hofwegen discloses that if, during the PI monitoring
routine (id. at FIG. 3, step 52), it is determined that an arrhythmia has not
reverted (id. at FIG. 3, step 53), that a shock was already delivered (id. at
FIG. 3, step 55A), but that the maximum number of shocks has not been
exceeded (id. at FIG. 3, step 55B), the algorithm begins again by charging
the capacitors (id. at FIG. 3, “to step 34;” id. at FIG. 2, step 34) and
comparing R-R intervals against PCLL (id. at col. 5, ll. 39–58; see also id. at
col. 2, ll. 56–65; col. 5, l. 24–col. 6, l. 7).
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FF7. Van Hofwegen discloses that the PI monitoring steps of
“monitor R-wave activity” (step 52) and determine if “arrhythmia reverted”
(step 53) “may involve many types of cardiac analysis not considered a part
of the present invention” (id. at col. 5, ll. 30–33).
FF8. Street discloses a “method and apparatus for forecasting
impending onset of arrhythmia based upon analysis of real-time intact . . .
intracardiac electrograms” (Street col. 1, ll. 56–59).
FF9. Street discloses that the method includes acquiring an “initial
normal sinus rhythm template” (id. at col. 2, ll. 51–54).
FF10. Street discloses that “an intact intracardiac electrogram
[complex] is acquired” (id. at 2, col. 55–56) and is “compared to the
template and is given a morphology score indicated as M,” reflecting a
correlation between the complex and the template (id. at col. 4, ll. 14–21).
FF11. Street discloses that:
The inventive method assembles a sliding window of
complexes, N in number . . . and considers each complex in
turn. The morphology score, M, is used to determine the count
of complexes [“S”] within the window that are considered to be
highly correlated to the template. Complexes that have a score
less than a lower threshold may be removed from the analysis
entirely . . . .
. . .
. . . A summation of the S values for the window is made
to generate a total ST.
As the sliding window advances, it considers a new set of
N complexes each iteration, changing its underlying
membership each time by one complex. The value of ST is
recalculated each time the window is advanced. This time-
varying value is a measure of how many of the total non-
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arrhythmic complexes considered are good matches or highly
correlated complexes.
(Id. at col. 4, ll. 22–30, 55–63).
FF12. Street discloses that if ST decreases “it indicates that the intact
electrocardiogram comprises a decreasing proportion of correlated
complexes,” which “provides a predictor of arrhythmia” (id. at col. 4, ll. 63–
65; see also col. 2, ll. 61–65).
FF13. If arrhythmia is predicted, Street discloses that “[t]here are
various alternative responses . . . [including] preventing arrhythmia (e.g.,
pacing . . .)” (id. at col. 3, ll. 48–55).
PRINCIPLES OF LAW

“The combination of familiar elements according to known methods
is likely to be obvious when it does no more than yield predictable results.”
KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007).
ANALYSIS

We agree with the Examiner’s findings regarding Van Hofwegen
(Ans. 4–9). We find that Van Hofwegen discloses delivering a therapeutic
shock to a patient (FF6), receiving a plurality of cardiac complexes over a
plurality of heartbeats before any subsequent shock therapy is delivered
(FF2, 5–6), conducting an arrhythmia analysis to determine whether
reversion has occurred (FF2), and either inhibiting (FF3) or delivering (FF4)
shock therapy based on the arrhythmia analysis. We also find that Van
Hofwegen teaches that alternate arrhythmia analyses can be applied (FF7).
We agree with the Examiner’s findings regarding Street (Ans. 4–9).
We find that Street discloses calculating similarity metrics (M) indicative of
the similarity between received cardiac complexes (FF10) and a normal
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template (FF9), calculating a trend metric (ST) based on the similarity
metrics (FF11), and, if the trend metric does not indicate a trend toward the
template (FF12), delivering therapeutic shock therapy (FF13).
Applying the KSR standard of obviousness to these findings of fact,
we agree with the Examiner’s conclusion that a person of ordinary skill in
the art would have found it obvious to modify the method disclosed by Van
Hofwegen with the arrhythmia analysis taught by Street “to provide the
predictable results of accurately predicting the arrhythmia on a continuous
basis to determine whether to deliver or inhibit therapy” (Ans. 6).
Van Hofwegen and Street both disclose arrhythmia analyses
undertaken to determine an appropriate therapeutic response (FF3–4; FF12–
13). Van Hofwegen discloses that if arrhythmia is detected, shock therapy
will be delivered (FF4); if arrhythmia is not detected, shock therapy will be
inhibited (FF3). Although Van Hofwegen does not utilize similarity and
trend metrics in this analysis, Van Hofwegen explicitly states that other
arrhythmia analyses could be used (FF7). In the same field of endeavor,
Street discloses an alternate arrhythmia analysis that involves determining
similarity and trend metrics (FF10–11). Combining Van Hofwegen and
Street is a simple substitution of Street’s known method of arrhythmia
analysis for Van Hofwegen’s analysis, and therefore, amounts to a
substitution of one analysis for another, which functions for the same
purpose and provides no unexpected results. See KSR, 550 U.S. at 416.
Appellant contends that Van Hofwegen “does not discuss anything
relating to inhibiting delivery of shocks based upon a morphology analysis”
(App. Br. 18) and that Street “does not deal in any way with the problem of
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distinguishing between a ventricular rhythm and a supraventricular rhythm
following delivery of a therapeutic shock” (id. at 19).
We are not persuaded. That Van Hofwegen may not discuss
morphology analyses, or that Street may not evaluate cardiac rhythms after
therapeutic shock, even if true, is not dispositive because neither reference is
alleged to be anticipatory. The relevant inquiry in an obviousness analysis is
what the combined teachings as a whole would have suggested to a person
of ordinary skill in the art. In re Keller, 642 F.2d 413, 425 (CCPA 1981).
And the Examiner has provided an articulated reasoning with some rational
underpinning to support the legal conclusion of obviousness, in light of the
combined teachings of Van Hofwegen and Street.
Appellant also argues that neither Van Hofwegen nor Street “teach[es]
anything relating to the problem of distinguishing between a
tachyarrhythmia with normal AV conduction and a tachyarrhythmia of
ventricular origin nor any awareness of the problem of post-shock distortion
of electrogram morphology in determining whether or not normal AV
conduction is present” (App. Br. 19).
We are not persuaded. Appellant’s arguments are not commensurate
with the claims. The claims do not recite “distinguishing between a
tachyarrhythmia with normal AV conduction and a tachyarrhythmia of
ventricular origin” (see Ans. 12). Appellant argues that, effectively, the
claims do recite a “distinguishing” step because they require administration
of shock therapy based on a claimed trend analysis, which correlates with
supraventricular or ventricular rhythms (Reply Br. 4). That the trend
analysis may correlate with other parameters, however, does not read those
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parameters into the claims. Furthermore, even if it did, the prior art satisfies
the claimed trend analysis, as discussed above.
Likewise, the claims do not recite a step of managing “post-shock
distortion of electrogram morphology” (see Ans. 12). Appellant admits as
much but argues that “post-shock distortion of electrogram morphology . . .
is the rationale for the recited steps” (Reply Br. 4). Again, that post-shock
distortion may be the rationale for the invention does not read such a
limitation into the claims. It is well established that limitations not
appearing in the claims cannot be relied upon for patentability. In re Self,
671 F.2d 1344, 1348 (CCPA 1982).
Appellant also argues that “nothing in prior art of record would
suggest to one of ordinary skill in the art either how to modify the Van
Hofwegen device to operate in the manner as presently claimed[ ]or the
desirability of doing so. . . . [The rejection] involve[s] the use of
impermissible hindsight” (App. Br. 19; Reply. Br. 4).
We disagree. The Examiner provides an articulated reasoning with a
rational underpinning to support the legal conclusion of obviousness. See
KSR, 550 U.S. at 418. In particular, the Examiner finds that the combination
of references “provide[s] the predictable results of accurately predicting the
arrhythmia on a continuous basis to determine whether to deliver or inhibit
therapy” (Ans. 6). The Examiner supports this reasoning with ample
citations to the references (id. at 4–9). We agree with the Examiner, and
conclude that the combination of Van Hofwegen and Street is no more than
the simple substitution of Street’s known method of arrhythmia analysis for
Van Hofwegen’s, for the same purpose and with no unexpected results.
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Appellant argues that, even if combined, Street determines whether
the complexes trend away from, not toward, a template (App. Br. 19–20).
We are not persuaded. Again, Appellant attacks the references
individually, when the rejection is based upon the combination. Van
Hofwegen and Street disclose arrhythmia analyses. Van Hofwegen
discloses that when arrhythmia is not detected, shock will be inhibited, and
when arrhythmia is detected, shock will be delivered (FF3–4). It would
have been obvious to one skilled in the art, therefore, that in the
combination, when arrhythmia is not detected, i.e., when Street’s trend
metric indicates a trend toward the template, additional shocks are inhibited,
as disclosed by Van Hofwegen.
Appellant also argues that the references do not disclose “receiving a
plurality of cardiac complexes . . . following therapeutic shock therapy and
before any subsequent shock therapy is delivered” (App. Br. 20).
We disagree. In the Reply Brief, Appellant admits that Van
Hofwegen does, “in certain instances[,] monitor a plurality of heartbeats
after delivering a shock before a subsequent shock is delivered” (Reply Br.
6). Appellant argues that, nonetheless, “Van Hofwegen does not teach
configuring its device to analyze a plurality of heartbeats in the manner
recited by the pending claims” (id.). Again, Appellant attacks the references
individually, when the rejection is based upon the combination. Van
Hofwegen and Street together satisfy the claimed analysis steps.
Finally, in the Reply Brief, Appellant presents a new claim
construction argument, contending that Van Hofwegen does not satisfy the
“inhibit” claim limitations, when properly interpreted (Reply Br. 2–3). A
new argument presented in the Reply Brief leaves the Examiner with no
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opportunity to respond and, therefore, will not be considered absent a
showing of good cause explaining why the argument could not have been
presented in the Appeal Brief. See Ex parte Borden, 93 USPQ2d 1473, 1477
(BPAI 2010) (informative). As Appellant offers no showing of good cause,
this argument is improper. We do not consider it, other than to note that
Appellant does not identify any portion of the Specification supporting the
proposed construction, and we find no intrinsic support.
We affirm the rejection of claims 1, 4–10, 15–18, 32, 41, 44, and 45.
CLAIMS 11–14, 42, AND 43

The Examiner finds that Van Hofwegen and Street disclose the
claimed invention, except that they do not specify using an average for the
moving window or discarding certain metrics from the analysis (Ans. 9).
The Examiner concludes that such limitations would have been obvious
because such techniques were known in the art to smooth data and to remove
any aberrant or uncharacteristic values from the analysis (id. at 9–10).
Appellant argues that the Examiner’s rejection of claims 11–14, 42,
and 43 presents “mere conclusory assertions regarding what would have
been obvious to one of ordinary skill in the art. Appellant finds no teaching
or suggestion in the cited references for the use of what is recited by those
claims in the context of the presently claimed subject matter” (App. Br. 21).
We are not persuaded. Appellant asserts that that the prior art does
not teach these features without presenting any substantive argument
pointing out with particularity how, based on the record, these limitations are
distinguishable. Appellant does not address the Examiner’s rejection, which
presents an articulated reasoning with some rational underpinning to support
the legal conclusion of obviousness. See In re Lovin, 652 F.3d 1349, 1357
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(Fed. Cir. 2011) (“[T]he Board reasonably interpreted Rule 41.37 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.”).
We affirm the rejection of claims 11–14, 42, and 43.
CLAIMS 2, 3, 33–36, 46, AND 47

The Examiner finds that Van Hofwegen and Street disclose the
claimed invention, except that they do not specify using certain metric
thresholds in the arrhythmia analysis (Ans. 10). The Examiner concludes
that such limitations would have been an obvious matter of design choice
because the specific thresholds are not used for a particular purpose or to
solve a stated problem, the invention would have performed equally well as
claimed, and such limitations provide predictable results (id. at 10–11).
Appellant argues that the Examiner’s rejection of claims 2, 3, 33–36,
46, and 47 presents “mere conclusory assertions regarding what would have
been obvious to one of ordinary skill in the art. Appellant finds no teaching
or suggestion in the cited references for the use of what is recited by those
claims in the context of the presently claimed subject matter” (App. Br. 21).
We are not persuaded. Again, Appellant does not address the
Examiner’s rejection, which presents an articulated reasoning with some
rational underpinning to support the legal conclusion of obviousness. See In
re Lovin, 652 F.3d 1349, 1357 (Fed. Cir. 2011) (“[T]he Board reasonably
interpreted Rule 41.37 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.”).
We affirm the rejection of claims 2, 3, 33–36, 46, and 47.
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CLAIMS 49–52

The Examiner finds that Van Hofwegen and Street disclose storing
data indicative of a patient’s cardiac rhythm, such as R-R intervals, in
memory, to be used in determining whether to deliver or inhibit therapeutic
shock (Ans. 11). The Examiner also states that the prior art “does not
specifically state the details of storing data in memory indicating the cardiac
rhythm is a SVT [supraventricular] or VT [ventricular]” but concludes that
such limitations would have been obvious to “provide the predictable results
of allowing a physician to review the data at a later date” (id.).
Appellant argues that “[n]either Van Hofwegen nor Street contain[s]
any teachings that relate to distinguishing between SVT and a ventricular
rhythm such as VT or VF” (App. Br. 22).
We agree with the Examiner that the claims do not recite a step of
“distinguishing between SVT and VT/VF,” as argued by Appellant (Ans.
15–16). Limitations not appearing in the claims cannot be relied upon for
patentability. In re Self, 671 F.2d at 1348. Nonetheless, the combination of
Van Hofwegen and Street teaches an arrhythmia analysis in which shock
therapy is inhibited or delivered based on the movement of trend metrics
toward or away from a template. Appellant recognizes that the “acts of
either inhibiting or continuing further shock therapy . . . necessarily
encompasses determining whether the rhythm represented by the cardiac
complexes is SVT or VT/VF” (Reply Br. 6). These references, therefore,
“distinguish” between supraventricular and ventricular rhythms.
Appellant also argues that the claimed limitation of “storing data in a
memory indicating that the cardiac rhythm represented by the received
cardiac complexes is a [supraventricular or ventricular] rhythm” in fact
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requires “storing a statement to that effect, not simply the storing any type of
cardiac data that may or may not be evidence of such” (Reply Br. 7).
We are not persuaded. We agree with the Examiner’s finding that
Van Hofwegen and Street store data indicating the type of cardiac rhythm,
specifically, “cardiac condition information such as R-R wave intervals”
(Van Hofwegen col. 3, ll. 59–61) or “intracardiac electrogram” information
(Street col. 5, ll. 53–56). This data inherently indicates the type of cardiac
rhythm, whether supraventricular or ventricular, as necessary to determine
whether to inhibit or deliver shock therapy. The plain language of claims
49–52 does not require “storing a statement to that effect,” as argued by
Appellant (Reply Br. 7). We conclude, therefore, that this data inherently
indicates the type of cardiac rhythm and satisfies claims 49–52.
We affirm the rejection of claims 49–52.
SUMMARY

We affirm the rejections of claims 1–18, 32–36, 41–47, and 49–52.
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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