Ex Parte Ferek-Petric

Patent Trial and Appeal Board

Oct 30, 2012

10418856 (P.T.A.B. Oct. 30, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE
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BEFORE THE PATENT TRIAL AND APPEAL BOARD
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Ex parte BOZIDAR FEREK-PETRIC
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Appeal 2010-000676
Application 10/418,856
Technology Center 3700
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Before STEVEN D.A. McCARTHY, BRETT C. MARTIN and
ANNETTE R. REIMERS, Administrative Patent Judges.

McCARTHY, Administrative Patent Judge.

DECISION ON APPEAL

STATEMENT OF THE CASE 1
The Appellant1 appeals under 35 U.S.C. § 134 from the Examiner’s 2
final decision rejecting claims 1-16 and 47-54. Claims 17-46 and 55-58 are 3
cancelled. We have jurisdiction under 35 U.S.C. § 6(b). 4
We sustain the rejection of claims 14 and 16 under 35 U.S.C. § 103(a) 5
as being unpatentable over Hess (US 5,861,007, issued Jan. 19, 1999)6

1 The Appellant identifies the real party in interest as Medtronic, Inc. of
Minneapolis, Minnesota.
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Thacker (US 5,024,222, issued Jun. 18, 1991); and as being unpatentable 1
over Carlson (US 6,678,547 B2, issued Jan. 13, 2004) and Hess. We do not 2
sustain the rejection of claim 15 under § 103(a) as being unpatentable over 3
Hess and Thacker or the rejection of claims 1-13, 15 and 47-54 as being 4
unpatentable over Carlson and Hess. 5
Claims 1, 14 and 47 are independent . Claim 14 is illustrative: 6
14. A method comprising: 7
sensing a physiological condition of a 8
patient used as an indicator of autonomic nervous 9
system activity; 10
determining autonomic nervous system 11
activity of a patient based upon the sensed 12
physiological condition indicator of such activity; 13
and 14
selecting a number of atrioventricular (AV) 15
conduction sequences in a search for an AV delay 16
that promotes intrinsic ventricular conduction and 17
that supplies ventricular paces when needed, the 18
search being invoked in response to a 19
determination of the presence of autonomic 20
nervous system activity of a patient, wherein the 21
search includes monitoring intrinsic ventricular 22
activations to determine a time of occurrence 23
before scheduled ventricular paces and includes 24
adjusting an applied AV delay. 25
Claim 1 recites a method including the step of “selecting a set of 26
search criteria based upon the measurement of the autonomic nervous 27
system activity.” Claim 47 recites an implantable medical device including 28
a processor, “wherein . . . the processor selects and applies a set of search 29
criteria based upon the determined activity.” 30
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ISSUES 1
The Appellant argues claims 14 and 16 as a group for purposes of 2
both grounds of rejection under § 103(a). (App. Br. 6-9 and 15-16; Reply 3
Br. 2-4). Claim 14 is representative. The Appellant argues both grounds of 4
rejection of claim 15 separately. (App. Br. 9-11 and 19; Reply Br. 2-4). 5
Only issues and findings of fact contested by the Appellant have been 6
considered. See Ex parte Frye, 94 USPQ2d 1072, 1075-76 (BPAI 2010). 7
This appeal turns on four issues: 8
First, does the reasoning articulated by the Examiner in support of the 9
conclusion that the subject matter of representative claim 14 would have 10
been obvious from the combined teachings of Hess and Thacker lack some 11
rational underpinning because the proposed combination of the teachings 12
would undermine the principle of operation taught by Hess? (See App. Br. 13
6-9). 14
Second, do the evidence and technical reasoning underlying the 15
rejection of representative claim 14 as unpatentable over Carlson and Hess 16
adequately support the conclusion that one of ordinary skill in the art would 17
have had reason to invoke a search for an AV delay that promotes intrinsic 18
ventricular conduction “in response to a determination of the presence of 19
autonomic nervous system activity of a patient” as recited in claim 14? (See 20
App. Br. 15-16). 21
Third, do the evidence and technical reasoning underlying the 22
rejection of claim 15 adequately support the conclusion that a method 23
including the step of selecting a number of AV conduction sequences based 24
on sympathetic nervous system activity and parasympathetic nervous system 25
activity would have been obvious? (See App. Br. 9-11 and 19). 26
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Fourth, does Carlson disclose “selecting a set of search criteria based 1
upon the measurement of the autonomic nervous system activity” as recited 2
in independent claims 1 and 47. (See App. Br. 12-15; Reply Br. 2-3). 3
4
FINDINGS OF FACT 5
The record supports the following findings of fact (“FF”) by a 6
preponderance of the evidence. 7
8
Introduction 9
1. The human heart includes four chambers, two atria and two 10
ventricles. “[T]he atria act as primer pumps for the ventricles and the 11
ventricles provide the major source of power for moving blood throughout 12
the vascular system.” (Thacker, col. 4, ll. 50-53). The atria and ventricles 13
act in response to waves of electric voltage which periodically propagate 14
across the heart from the atria, through an artrioventricular (“AV”) node to 15
the ventricles. (See Thacker, col. 4, ll. 40-50). 16
2. Each propagation of a wave of electric potential from the atria 17
to the ventricles may be referred to as an atrioventricular (“AV”) conduction 18
sequence. “The propagation of the action potential through A-V node is 19
delayed by approximately 1/10 of a second to allow the atria to contract 20
ahead of the ventricles thereby pumping blood into the ventricles prior to the 21
very strong ventricular contraction.” (Hess, col. 4, ll. 45-50). 22
3. The heart responds to the physiological demand of the body for 23
blood. Among these responses is the raising or lowering of the heart rate, 24
that is, the time frequency of the waves of electric voltage across the heart. 25
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The autonomic nervous system itself has two 1
components: sympathetic and parasympathetic (or 2
vagal). The sympathetic component of the 3
autonomic nervous system is relatively slow 4
acting, and is associated with a tendency to raise 5
heart rate, blood pressure and/or cardiac output. 6
The parasympathetic/vagal component of the 7
autonomic nervous system, which provides a 8
relatively faster response than the sympathetic 9
component, is associated with a tendency to reduce 10
heart rate, blood pressure and/or cardiac output. 11
(Carlson, col. 2, ll. 19-27). 12
4. In some patients, the propagation of the voltage waves from the 13
atria to one or both ventricles is fully or intermittently blocked. One 14
method of treating such patients is to use a pacemaker or pacer to apply 15
artificial pacing pulses to the patient’s ventricle. An atrioventricular (“AV”) 16
delay is used to maintain the proper delay between the atrial conduction and 17
the ventricular pulse so as to promote efficient pumping of blood to the 18
body. (See Hess, col. 1, ll. 45-49). 19
5. “Rate adaptive pacers” are pacers which follow a patient’s 20
physiological demand. (Hess, col. 1, ll. 23-24). In other words, a rate 21
adaptive pacer “should vary cardiac rate and, consequently, cardiac output in 22
response to the body’s physiological needs.” (Thacker, col. 1, ll. 15-17). 23
24
Hess 25
6. Hess teaches that rate adaptive pacers were available as of the 26
filing date of the application underlying this appeal. (Hess, col. 1, ll. 23-24). 27
7. Hess teaches that a change in the heart rate induced by a rate 28
adaptive pacer may indicate a need to also change the length of the AV 29
delay. (Hess, col. 1, ll. 21-22). Hess describes an algorithm which 30
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“generally adapts the AV interval [that is, the AV delay] to lengthen where 1
the patient is capable of AV conduction and to shorten otherwise.” (Hess, 2
col. 4, ll. 44-46). 3
8. Hess teaches that: 4
A particularly problematic situation exists in 5
intermittent AV block patients, since the 6
opportunity for natural conduction will be 7
prevented by having an AV interval that is shorter 8
than the natural one. This problem manifests in 9
rate adaptive pacing because the length of the AV 10
interval should be (and is) adjusted shorter as the 11
rate increases in order to promote efficient cardiac 12
hemodynamics. 13
(Hess, col. 1, ll. 49-56). 14
9. Hess’ algorithm assumes initial values for the AV interval; runs 15
a pacemaker on the initial values; and collects data or runs for a number of 16
AV even sequences until a sufficient number of AV event sequences 17
yielding meaningful data are counted. (Hess, col. 4, ll. 60-66 and fig. 3, refs. 18
12 and 13). The algorithm then lengthens the AV interval, shortens the AV 19
interval or leaves the AV interval unchanged based on the collected data. 20
(E.g., Hess, col. 5, l. 27 – col. 6, l. 18). 21
10. In other words, Hess’ algorithm searches for an AV delay. The 22
search includes monitoring intrinsic ventricular activations (that is, instances 23
of natural ventricular conduction) to determine a time of occurrence before 24
scheduled ventricular paces. The search also includes adjusting an applied 25
AV delay. 26
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Thacker 1
11. Thacker describes a rate-responsive pacing system. (Thacker, 2
col. 6, ll. 54-56). Thacker describes the preferred pacing system as capable 3
of adjusting “both the pacing rate and the A-V interval in accordance with a 4
physiological sensor to optimize the cardiac output of the patient’s heart.” 5
(Thacker, col. 2, ll. 17-21). 6
12. The Examiner finds that Thacker’s “physiological sensor” 7
senses a physiological condition of a patient indicative of autonomic nervous 8
system activity. (Ans. 3). The Appellant does not appear to contest this 9
finding. (See generally App. Br. 6-9; Reply Br. 2). 10
13. Thacker teaches adjusting both the pacing rate and AV delay in 11
order to optimize the cardiac output as measured by the physiological 12
sensor. (Thacker, col. 2, ll. 17-21). Thacker teaches first adjusting the 13
pacing rate to optimize the output from the physiological sensor. Thacker 14
teaches then reducing the pacing rate and adjusting the AV delay to optimize 15
the output from the physiological sensor. The process of reducing the 16
pacing rate and adjusting the AV delay to optimize the output from the 17
physiological sensor is repeated until the optimum combination of pacing 18
rate and AV delay is determined. (Thacker, col. 3, ll. 24-38). 19
20
Carlson 21
14. Carlson describes a cardiac rhythm management system 100 22
including a cardiac rhythm management device 105 and a time-domain heart 23
rate variability (“HRV”) signal processing module 160. (Carlson, col. 5, ll. 24
21-27; col. 7, ll. 54-61; and fig. 1). Processing a heart rate interval signal 25
215, the module 160 generates an indicator of sympathetic/parasympathetic 26
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nervous system balance. This indicator consists of the ratio between the 1
variance of a low frequency component of the processed heart rate interval 2
signal to the variance of a high frequency component of the processed heart 3
rate interval signal. Carlson refers to this indicator as the “LF/HF ratio.” 4
(Carlson, col. 7, l. 54 – col. 8, l. 39). 5
15. The Appellant does not appear to contest the Examiner’s 6
finding that the LF/HF ratio is a physiological condition of a patient used as 7
an indicator of autonomic nervous system activity. (See Ans. 6). 8
16. Carlson teaches that: 9
FIG. 7 is a schematic/block diagram illustrating 10
generally, by way of example, and not by way of 11
limitation, one embodiment of portions of device 105 12
including a controller 700 and a therapy module 705. 13
Therapy module 705 provides cardiac rhythm 14
management therapy to heart 115 via electrodes that 15
are communicatively associated therewith. Examples 16
of such therapy include, without limitation, atrial or 17
ventricular pacing therapy, antitachyarrhythmia 18
therapy, multi-site coordination therapy such as 19
biventricular pacing, drug delivery. In one such 20
embodiment, the parameters of such therapy are 21
adjusted and/or optimized by controller 700 based at 22
least in part on one or more indications of 23
sympathetic/parasympathetic balance obtained from 24
time-domain HRV signal processing module 160. 25
For example, such parameters for providing dual 26
chamber pacing therapy are well known in the art 27
(e.g., rate, amplitude, pulsewidth, AV-delay, etc.); 28
such parameters are adjusted, either individually or in 29
combination, to increase or decrease a particular 30
indicator of autonomic balance (e.g., to decrease the 31
lowest local minima of the smoothed LF/HF signal). 32
(Carlson, col. 9, ll. 18-37). 33
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ANALYSIS 1
First Issue 2
The Examiner’s findings regarding the teachings of Hess and Thacker 3
are summarized in tabular form on pages 3-4 of the Answer. The Examiner 4
finds that “Hess does not explicitly disclose that the physiological sensor 5
that controls the rate responsive mode is a sensor that detects autonomic 6
nervous system activity.” (Ans. 5). The Examiner concludes that it would 7
have been obvious: 8
to provide Hess’ invention with a rate-responsive 9
pacemaker that is responsive to sympathetic 10
nervous system activity to maximize cardiac 11
performance based on an accurate measure of the 12
physiological demand of the body; and to search 13
for an appropriate AV delay based on autonomic 14
nervous system activity to provide an optimal 15
delay based on the specific physiological demand 16
of the patient at a given time. 17
(Id.) 18
The Appellant argues that: 19
There is no rational reason why one having 20
ordinary skill in the art would have looked to 21
Thacker to modify Hess. The AV search 22
techniques disclosed by Hess and Thacker differ, 23
such that modification to Hess in view of Thacker 24
in the manner proposed by the Examiner would 25
have changed and undermined the principle of 26
operation of the Hess technique. 27
(App. Br. 8). The Appellant explains that: 28
Hess is concerned with maintaining intrinsic 29
ventricular conduction and adjusting an AV delay 30
in order to help maintain the intrinsic ventricular 31
conduction. While Thacker states that AV 32
synchrony is important to maintaining efficient 33
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performance of the heart, Thacker does not 1
disclose or suggest that adjusting AV delay in 2
accordance with the techniques described by 3
Thacker maintains intrinsic ventricular conduction. 4
Indeed, neither Hess not Thacker provides any 5
indication that adjusting AV delay to optimize 6
cardiac output of a patient’s heart, as disclosed by 7
Thacker, would result in the maintenance of 8
intrinsic ventricular conduction, as required by 9
Hess. 10
(Id.) 11
The Examiner’s reasoning has a rational underpinning in the teachings 12
of Hess and Thacker. Hess teaches that rate adaptive pacers were available 13
as of the filing date of the application underlying this appeal. (FF 6). 14
Thacker teaches combining a rate adaptive pacer with a physiological sensor 15
for sensing a physiological condition indicative of autonomic nervous 16
system activity. (FF 12). Thacker teaches adjusting pacing rate in response 17
to the physiological sensor in order to optimize the cardiac output. (See FF 5 18
and 13). Both Hess and Thacker suggest adjusting AV delay in a rate 19
adaptive pacer along with adjustments in pacing rate, in Thacker’s case as a 20
means to further optimize cardiac output. (See FF 7 and 13). 21
Therefore, one of ordinary skill in the art familiar with the teachings 22
of Hess and Thacker would have had reason to combine a rate adaptive 23
pacer with a physiological sensor and to program the pacer to adjust pacing 24
rate and AV delay in response to changes in a physiological condition 25
indicative of autonomic nervous system activity. At this point however, 26
Hess would have suggested to one of ordinary skill in the art a problem with 27
the combination: Where the physiological demand is high, the pacer might 28
adjust the length of the AV delay in response to physiological demand until 29
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the AV delay is shorter than the intrinsic AV interval. (See FF 8). Hess also 1
would have suggested a solution to this problem, namely, altering the 2
algorithm used to adjust the pacing rate and the AV delay to optimize 3
cardiac output as measured by the physiological sensor subject to the 4
constraint that the pacing rate and the AV delay must be sufficiently long to 5
promote natural ventricular conduction. (See FF 7, 9 and 10). 6
Given these parameters, the acquisition of an appropriate algorithm 7
would be a matter of implementation rather than invention. The Appellant 8
suggests no reason why this implementation would have been beyond the 9
level of ordinary skill in the art. Neither does the Appellant suggest any 10
reason why the results of implementing such an algorithm would have been 11
so unpredictable that the implementation would require more than ordinary 12
skill in the art. Therefore, the combination proposed by the Examiner would 13
not have undermined the principle of operation of Hess. Instead, the 14
principle of operation of Hess would have led one of ordinary skill in the art 15
to implement the combination in the fashion claimed in claim 14. 16
We sustain the rejection of claims 14 and 16 under § 103(a) as being 17
unpatentable over Hess and Thacker. 18
19
Second Issue 20
With respect to the rejection of representative claim 14 as being 21
unpatentable over Carlson and Hess, the Appellant argues that “Carlson fails 22
to disclose or suggest invoking a search for an AV delay in response to a 23
determination of the presence of [autonomic nervous system] activity of a 24
patient. Hess fails to cure this fundamental deficiency of Carlson.” (App. 25
Br. 15-16). The Appellant does not identify any formal definition or clear 26
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disclaimer in the Specification which might narrow the meaning of the term 1
“in response to” as used in claim 14 as opposed to the ordinary meaning of 2
the term. The broadest reasonable interpretation of the term “in response to” 3
encompasses either a sequence of causation or a sequence in time. 4
Here, Carlson suggests that “the parameters of such therapy,” which 5
may include the AV delay, “are adjusted and/or optimized by controller 700 6
based at least in part on one or more indications of sympathetic 7
/parasympathetic balance obtained from time-domain HRV signal 8
processing module 160,” a physiological condition of a patient used as an 9
indicator of autonomic nervous system activity. (FF 15 and 16). In other 10
words, Carlson teaches that a change in a physiological condition of a 11
patient used as an indicator of autonomic nervous system activity may cause 12
the system to adjust or optimize a parameter such as the AV delay. Hess 13
teaches a technique for adjusting or optimizing the AV delay, namely, by 14
means of a search. Therefore, the combined teachings of Carlson and Hess 15
would have provided one of ordinary skill in the art reason to invoke a 16
search for an AV delay that promotes intrinsic ventricular conduction in 17
response to a determination of the presence of autonomic nervous system 18
activity of a patient as recited in claim 14. Since the Appellant has not 19
identified an error in the rejection of representative claim 14, we sustain the 20
rejection of claims 14 and 16 under § 103(a) as being unpatentable over 21
Carlson and Hess. 22
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Third Issue 1
Claim 15 recites the “method of claim 14, further comprising: 2
selecting a first number of atrioventricular conduction sequences; selecting a 3
second number of atrioventricular sequences when the determination 4
indicates an increase in sympathetic nervous system activity relative to 5
parasympathetic nervous system activity, wherein the second number is 6
smaller than the first number.” The Examiner concludes that, “in regards to 7
[claim 15], because the optimization routine is converging on an optimal 8
value, each iteration will result in a decreased available potential conduction 9
sequences.” (Ans. 5). Claim 15 recites the selection of different numbers 10
“of atrioventricular (AV) conduction sequences in a search for an AV 11
delay.” The Examiner’s reasoning does not imply that one of ordinary skill 12
in the art would have had reason to select different such numbers depending 13
on whether there is an increase in sympathetic nervous system activity 14
relative to parasympathetic nervous system activity. The Examiner’s 15
reasoning on page 11 appears to confuse the determination of an AV delay 16
with the selection of a number of AV conduction sequences for use in a 17
search to determine that AV delay. 18
The Examiner has not articulated reasoning with some rational 19
underpinning sufficient to support the conclusion that the subject matter of 20
claim 15 would have been obvious from the combined teachings of Hess and 21
Thacker; or from the combined teachings of Carlson and Hess. Therefore, 22
we do not sustain the rejection of claim 15 under § 103(a) as being 23
unpatentable over Hess and Thacker; or the rejection of claim 15 under 24
§ 103(a) as being unpatentable over Carlson and Hess. 25
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Fourth Issue 1
Independent claim 1 recites a method including the step of “selecting 2
a set of search criteria based upon the measurement of the autonomic 3
nervous system activity.” Independent claim 47 recites an implantable 4
medical device including a processor capable of selecting and applying “a 5
set of search criteria based upon the determined activity.” The Examiner 6
finds that Carlson discloses selecting a set of search criteria at column 9, 7
lines 27-30. (Ans. 6). Column 9, lines 27-30 of Carlson teach that, in “one 8
such embodiment, the parameters of such therapy are adjusted and/or 9
optimized by controller 700 based at least in part on one or more indications 10
of sympathetic/parasympathetic balance obtained from time-domain HRV 11
signal processing module 160.” (FF 16). More specifically, the Examiner 12
finds that the “‘search criteria’ is the change that must be made to the AV 13
delay to achieve the desired autonomic balance response.” (Ans. 13). 14
The Examiner’s finding appears to confuse search criteria with the 15
result of the search. The Appellant does not identify any formal definition 16
or clear disclaimer in the Specification which might narrow the meaning of 17
the term “search criteria” as used in claim 14 beyond the ordinary usage of 18
the term. Nevertheless, the ordinary usage of the term “criteria” is limited to 19
standards “on which a decision or judgment may be based.” (WEBSTER’S 20
THIRD NEW INT’L DICTIONARY (G&C Merriam Co. 1971)(“criterion,” def. 21
2)). The Examiner identifies nothing in the Specification which suggests 22
that a broader interpretation might be reasonable. Therefore, a “set of search 23
criteria” refers to standards or parameters which might be used in the search 24
to determine the change required to the AV delay and not to the change 25
itself. 26
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The Examiner has not provided adequate reasoning to support the 1
finding that Carlson discloses “selecting a set of search criteria based upon 2
the measurement of the autonomic nervous system activity.” The Examiner 3
provides no reason to explain how Hess might remedy this deficiency. We 4
do not sustain the rejection of claims 1-13 and 47-54 as being unpatentable 5
over Carlson and Hess. 6
7
DECISION 8
We AFFIRM the Examiner’s decision rejecting claims 14 and 16. 9
We REVERSE the Examiner’s decision rejecting claims 1-13, 15 and 10
47-54. 11
12
AFFIRMED-IN-PART 13
14
15
16
Klh 17