Ex Parte Charlton et al

Patent Trial and Appeal Board

Jul 31, 2017

13829792 (P.T.A.B. Jul. 31, 2017)

United States Patent and Trademark Office
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O.Box 1450
Alexandria, Virginia 22313-1450
www.uspto.gov
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
13/829,792 03/14/2013 Sandra Beck Charlton C00003221.USU1 3713
27581 7590
Medtronic, Inc. (CRDM)
710 MEDTRONIC PARKWAY NE
MS: LC340 Legal Patents
MINNEAPOLIS, MN 55432-9924
EXAMINER
STICE, PAULA J
ART UNIT PAPER NUMBER
3766
NOTIFICATION DATE DELIVERY MODE
08/02/2017 ELECTRONIC
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address(es):
medtronic_crdm_docketing @ c ardinal-ip .com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte SANDRA BECK CHARLTON, JAMES JASON SIMS, and
MARK RICHARD SWANOVICH
Appeal 2016-001329
Application 13/829,7921
Technology Center 3700
Before TAWEN CHANG, JOHN E. SCHNEIDER, and
DEVON ZASTROW NEWMAN, Administrative Patent Judges.
NEWMAN, Administrative Patent Judge.
DECISION ON APPEAL
This appeal under 35 U.S.C. § 134 involves claims to an implantable
medical device for providing electrical stimulation to a patient. The
Examiner entered final rejections that the claims are anticipated and obvious.
We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM.
STATEMENT OF THE CASE
Background
The Specification discloses:
1 Appellants identify the real party in interest as Medtronic, Incorporated.
App. Br. 3.
Appeal 2016-001329
Application 13/829,792
Implantable medical devices such as pacemakers are commonly
configured to treat cardiac arrhythmias by delivering pacing
pulses to cardiac tissue. . . .
Pacemakers commonly incorporate a power source, such as a
battery, which provides operational power to the componentry of
the pacemaker, including electronics which manage the function
of the device, monitor the condition of the patient in which the
device is implanted and deliver therapy to the patient. Many or
most device functions operate effectively continually, such as
sensing the cardiac condition of the patient, or frequently, such
as cardiac pacing therapy delivery in certain patients[.]
Because pacemakers often provide life-sustaining therapy to the
patients in which they are implanted and because pacemakers
generally have a finite, limited energy resource, e.g., a battery, it
is desirable to extend operation of the pacemaker by minimizing
the energy used by the implantable medical device.
Spec. 2-A.
The Specification discloses “implantable medical devices and systems
and related methods and, more particularly, to implantable medical devices
and systems providing therapeutic stimulation to a patient.” Id. 11.
“Capture is produced by pacing pulses having sufficient energy to
produce a propagating wavefront of electrical depolarization that results in
contraction of the heart tissue.” App. Br. 8.
The Claims
Claims 1—9, 12—21, and 24 are pending and on appeal. Claims 1, 6,
and 13 are illustrative and read as follows, with emphasis on the terms at
issue for clarity:
1. A medical system, comprising:
an implantable medical device for providing electrical
stimulation to a patient, said implantable medical device having:
2
Appeal 2016-001329
Application 13/829,792
a plurality of electrodes; and
electrical circuitry, operatively coupled to each of said
plurality of electrodes, being configured to provide a stimulating
signal establishing a plurality of stimulation vectors with said
plurality of electrodes within said patient; and
said electrical circuitry being configured to calculate an
energy consumption for each of said plurality of stimulation
vectors;
said medical system being configured to take an action
based, at least in part, on said energy consumption calculated for
each of said plurality of stimulation vectors;
wherein said electrical circuitry is configured to calculate
said energy consumption for each of said plurality of stimulation
vectors by (I) ramping up a magnitude of one of said plurality of
stimulation vectors until capture occurs; and
wherein said electrical circuitry is further configured to
calculate said energy consumption for each of said plurality of
stimulation vectors by (2) reducing said amplitude of said one of
said plurality of stimulation vectors until loss of capture occurs,
and (3) returning said amplitude to said amplitude at which
capture previously occurred.
App. Br. 13 (Claims App.) (emphasis added).
6. The medical system of claim [1 further comprising a
plurality of leads wherein each of said plurality of leads are
operatively coupled to said plurality of electrodes, wherein at
least one of said plurality of electrodes comprises a left
ventricular pacing electrode and wherein said energy
consumption calculated by said electrical circuitry comprises a
left ventricular energy consumption, wherein said electrical
circuitry is configured with action comprising displaying, by
each of said plurality of stimulation vectors, to a user said energy
consumption calculated by said electrical circuitry] wherein said
electrical circuitry is configured wherein energy consumption is
displayed only for ones of said plurality of stimulation vectors
achieving a predetermined efficacy.
3
Appeal 2016-001329
Application 13/829,792
Id. at 14 ( with dependent claim limitations imported in brackets for
clarity).
13. A device-implemented method using an implantable
medical device having a plurality of electrodes, comprising the
steps of:
delivering a plurality of stimulating signals establishing a
plurality of stimulation vectors with said plurality of electrodes
to a heart of a patient;
calculating an energy consumption for each of said
plurality of stimulation vectors; and
taking an action based, at least in part, on said energy
consumption calculated for each of said plurality of stimulation
vectors;
wherein said calculating step comprises calculating said
energy consumption for each of said plurality of stimulation
vectors by (1) ramping up an amplitude of one of said plurality
of stimulation vectors until capture occurs; and
wherein said calculating step comprises calculating said
energy consumption for each of said plurality of stimulation
vectors by (2) reducing said amplitude of said one of said
plurality of stimulation vectors until loss of capture occurs, and
(3) returning said amplitude to said amplitude at which capture
previously occurred.
Id. at 15.
4
Appeal 2016-001329
Application 13/829,792
The Issues
The following rejections are before us to review:
Claims 1—5, 8, 9, 12—17, 20—21, and 24 are rejected under pre-
AIA 35 U.S.C. § 102(b) as anticipated by Sathaye.2 Final Act. 3.3
Claims 6—7 and 18—19 are rejected under pre-AIA 35 U.S.C. §
103(a) as obvious over Sathaye. Final Act. 3.
ANTICIPATION
The issue with respect to this rejection is: Does the preponderance of
evidence on this record support the Examiner’s finding that Sathaye
describes Appellants’ claimed invention?
Findings of Fact
FF1. Sathaye discloses:
A pace pulse must exceed a minimum energy value, or
capture threshold, to “capture” the heart tissue, generating an
evoked response that generates a propagating depolarization
wave that results in a contraction of the heart chamber. It is
desirable for a pace pulse to have sufficient energy to stimulate
capture of the heart chamber without expending energy
significantly in excess of the capture threshold. Pacing in excess
of a capture threshold can cause excessive energy consumption,
require premature battery replacement, and can unintentionally
stimulate nerves or muscles. However, if a pace pulse energy is
too low, the pace pulses may not reliably produce a contractile
response in the heart chamber and may result in ineffective
pacing that does not improve cardiac function or cardiac output.
Sathaye 1 6.
2 Sathaye, et al. (US 2009/0043351 Al, pub. Feb. 12, 2009) (“Sathaye”).
3 Examiner’s Final Office Action, mailed December 15, 2014.
5
Appeal 2016-001329
Application 13/829,792
FF2. Sathaye discloses an implantable medical device having
multiple electrodes as shown in Figure 6 reproduced below:
Figure 6, reproduced above, shows “a therapy device incorporating circuitry
capable of implementing electrode combination selection techniques in
accordance with [the] embodiments of the invention.” Sathaye 124.
FF3. Sathaye discloses “[t]he CRM [(cardiac rhythm management)]
device 200 also includes a memory 245 for storing program instructions
and/or data, accessed by and through the control processor 240. In various
configurations, the memory 245 may be used to store information related to
activation thresholds, parameters, orders, measured values, program
instructions, and the like.” Id. 1 56.
FF4. Sathaye discloses that the electrodes are operatively coupled to
an electrical circuit and the circuit is configured to determine a plurality of
stimulation vectors. Sathaye, Figures 2, 6; Figure 7.
FF5. Sathaye discloses that “selecting an appropriate electrode
combination, such as one electrode combination of a plurality of electrode
combinations made possible by a multi-electrode lead that affects the desired
6
Appeal 2016-001329
Application 13/829,792
cardiac response with the least amount of energy consumption and that does
not unintentionally stimulate tissue, can be many-factored and complicated.”
Id. 139. Sathaye discloses the claimed method of selection shown in Figure
4 reproduced below:
400
At implant, measure or estimate capture
threshold and phrenic nerve activation
threshold for each electrode combination
-410
Compare capture threshold and phrenic nerve
activation of one electrode combination to at
Isast one other electrode combination
—-420
| Select combiantion based on the comparison
| (performed by human or system)
- 430
i Deliver therapy using the selected electrode
I combtantion
.......440
..-450
no
Electrode combination update?
i yes
________________________i.............................................. .
System automatically updates combination i
'v~- 460
Figure 4
Figure 10 is “a flowchart illustrating a method of evaluating a plurality of
electrode combinations, and further exemplifying how capture thresholds for
a plurality of electrode combinations can be determined. Sathaye 128.
Sathaye discloses that “selecting 430 can be done according to criteria. For
example, the results of the comparison can be reviewed and the electrode
combination(s) matching a predetermined criterion can be selected.” Id. |
70. “[Selecting 430 can include selecting according to the criteria that the
selected electrode combination be the combination with the lowest capture
7
Appeal 2016-001329
Application 13/829,792
threshold that was not associated with phrenic nerve activation” (e.g., a
capture event). Id. 171. The Examiner concludes that, through these
disclosures, Sathaye discloses calculating an energy consumption for the
vectors. Final Act. 3.
FF6. Sathaye discloses:
1. A method comprising:
evaluating, for each electrode combination of a plurality
of electrode combinations, one or more first parameters produced
by electrical stimulation delivered using the electrode
combination, the first parameters supportive of cardiac function
consistent with a prescribed therapy;
evaluating, for each electrode combination of the plurality
of electrode combinations, one or more second parameters
produced by the electrical stimulation delivered using the
electrode combination, the second parameters not supportive of
cardiac function consistent with the prescribed therapy;
determining an order for at least some of the electrode
combinations of the plurality of electrode combinations based on
the evaluations of the first parameters and the second parameters;
selecting one or more electrode combinations based on the
order; and
delivering an electrical stimulation therapy using the
selected one or more electrode combinations, wherein at least
one of evaluating the first and second parameters, ordering the
electrode combinations, and selecting the electrode combinations
for therapy delivery is performed automatically by a cardiac
rhythm management (CRM) system.
8. The method of claim 1, wherein determining the order of
at least some electrode combinations comprises ranking at least
some electrode combinations based on one or more of capture
threshold, therapy energy consumption, undesirable activation of
nerve or muscle tissue, anodal cardiac stimulation, degree of
responsiveness to resynchronization therapy, impedance, cardiac
8
Appeal 2016-001329
Application 13/829,792
contractility, electrode combination activation timing, cardiac
output, stroke volume, dP/dt, hemodynamics, and historical
success of therapy using the electrode combinations.
Sathaye 12—13.
FF7. Sathaye discloses that the “pacing energy required to capture the
heart is dependent on the electrode combination used for pacing” and that
“different electrode combinations can have different energy requirements for
capture.” Id. 135. Sathaye discloses an iterative method by which the
capture threshold value for a particular set of electrode combinations is
determined:
step down capoa* tlnei-ho-ld test, -set
mitiai pacing Energy
Deliver pac mg otibe ;<( p;udng energy usi:t;
Lo:-s cii capture detector' Slctffi rnpltitv i&ntftjokl vxHie for
skeij-nik cumbiriatkc! |
Dskrrnipc other teneficial i
store !
Determiw. nors-behttlsias |
parajOKtcrx, store i
Most: cSt'VtMdc-
coir.binetioas Ki let-:?
PeUjViws pacing energy
$v.itc-K K' r>u*t eJcctrodt:
ijjrtibireiCtiir!
Figure 10
Sathaye Figure 10, reproduced above, is a flowchart illustrating how capture
thresholds for a plurality of electrode combinations can be determined. See
also Sathaye ^fl[ 136-42 (describing the method in detail).
9
Appeal 2016-001329
Application 13/829,792
FF8. Based on the above disclosures, the Examiner concludes that
Sathaye’s disclosed medical device is configured to calculate energy
consumption and to “to take an action based at least in part on the energy
consumption. . . Ans. 3 (further citing Sathaye Figures 4, 5, 8, and 11, and
1135, 71, and 140).
FF9. Sathaye discloses that “[t]he energy of the pacing pulse is a
product of two energy parameters-the amplitude of the pacing pulse and the
duration of the pulse. Thus, the capture threshold voltage over a range of
pulse widths may be expressed in a strength-duration plot 910 as illustrated
in FIG. 9. ” Id. 1128. Figure 9 is shown below:
FT; Pulse Width
Figure 9
Figure 9 is “a graph illustrating various aspects of a strength-duration plot
for a parameter that supports cardiac function and a strength-duration plot
for a parameter that does not support cardiac function that may be used to
select an electrode combination for a therapeutic electrical stimulation. . . .”
Id. 127. The Examiner concludes that the above figure and Sathaye 1131
10
Appeal 2016-001329
Application 13/829,792
disclose “ramping the voltage until capture occurs [and] reducing the voltage
until loss of capture and returning to the previous value prior to loss of
capture for stimulation. . . Final Act. 4.
FF10. Sathaye discloses:
FIG. 9 provides graphs illustrating a strength-duration plot
910 associated with capture and a strength-duration plot 920
associated with an undesirable activation. A pacing pulse having
a pulse width of Wi requires a pulse amplitude of Vci to produce
capture. A pacing pulse having pulse width Wi and pulse
amplitude Vci exceeds the voltage threshold, Vui, for an
undesirable activation. If the pulse width is increased to W2, the
voltage required for capture, VC2, is less than the voltage required
for undesirable activation, Vc2. Therefore, pacing pulses can be
delivered at the pacing energy associated with W2, Vc2 to provide
capture of the heart without causing the undesirable activation.
The shaded area 950 between the plots 910, 920 indicates the
energy parameter values that may be used to produce capture and
avoid undesirable activation.
If multiple-point strength duration plots are known for
capture and undesirable activation, the energy parameters for a
particular electrode combination may be determined based on
these two plots. For example, returning to FIG. 9, the area 950 to
the right of the intersection 951 of the strength-duration plots
910, 920 defines the set of energy parameter values that produce
capture while avoiding undesirable stimulation. Energy
parameter values that fall within this region 950, or within a
modified region 960 that includes appropriate safety margins for
pacing 961 and undesirable activation 962, may be selected.
Sathaye ^fl[ 131, 132.
FF11. Sathaye discloses: “Although the process 1000 of FIG. 10 used
a step down capture threshold test, in other implementations, the capture
threshold test may involve a step-up capture threshold test, a binary search
11
Appeal 2016-001329
Application 13/829,792
test, or may involve other capture threshold testing methods as are known in
the art.” Id. 1141.
FF12. Sathaye discloses that the system can include “a graphics
display screen 320 . . . that is capable of displaying graphics, alphanumeric
symbols, and/or other information [including] one or more of the parameters
downloaded from the CRM on the screen 320.” Id. | 59.
FF13. Sathaye discloses that:
selecting 430 can include selecting according to the criteria that
the selected electrode combination be the combination with the
lowest capture threshold that was not associated with phrenic
nerve activation. Other criteria that can be used additionally or
alternatively include responsiveness to CRT, low energy
consumption, extra-cardiac activation, dP/dt, among others
indicative of beneficial parameters consistent with a prescribed
therapy or non-beneficial parameters inconsistent with the
prescribed therapy. The electrode combination fitting such
criteria can be identified for selection based on the comparison
430.
Id. 171. The Examiner further finds Figure 10 of Sathaye discloses
“achieving a predetermined efficacy (capture).”
FF14. Sathaye discloses that “[t]he electrode combination information
can be displayed as organized according to a rank, one or more groups, one
or more categories, or other information organization scheme.” Id. | 89.
Analysis
The Examiner finds that Sathaye anticipates the subject matter of
claims 1—5, 8, 9, 12—17, 20—21, and 24. Final Act. 3^4. In this regard, the
Examiner finds that Sathaye and Appellants both disclose “an implantable
medical device [system] having a plurality of electrodes . . . operatively
coupled to an electrical circuit...[,] the circuit configured to determine a
12
Appeal 2016-001329
Application 13/829,792
plurality of stimulation vectors ...[,] calculate an energy consumption for
the vectors [and] configured to take an action based at least in part on the
energy consumption. ...” Id. at 3; FF1—8. The Examiner further finds
Sathaye discloses circuitry performing calculation of energy consumption,
determination of capture by amplitude and pulse duration, and determining a
capture threshold voltage. Id. at 3^4; FF5, FF9. The Examiner finds that
Sathaye discloses “the ramping up of voltages ... on the Y-axis” of Figure 9
and that “Sathaye further discloses ramping the voltage until capture occurs
[and] reducing the voltage until loss of capture and returning to the previous
value prior to loss of capture for stimulation.” Id.', FF9.
We adopt the Examiner’s findings of fact, reasoning on scope and
content of the prior art, and conclusions set out in the Final Office Action
and Answer. We conclude that the Examiner has established a prima facie
case that the rejected claims would have been anticipated by Sathaye. FF1—
11. Appellants have not produced evidence showing, or persuasively
argued, that the Examiner’s determinations are incorrect. Only those
arguments made by Appellants in the Briefs have been considered in this
Decision. Arguments not presented in the Briefs are waived. See 37 C.F.R.
§ 41.37(c)(l)(iv) (2015).
Appellants argue that Sathaye does not teach the claimed invention
because Figure 9 of Sathaye, cited by the Examiner, “does not disclose
increasing the amplitude during the test nor the manner in which stimulation
parameters are varied,” but rather teaches “testing each electrode
combination starting with a relatively high combination energy level and
then decreasing the energy level until loss of capture and storing the
13
Appeal 2016-001329
Application 13/829,792
effective energy level and then, without more testing of that electrode
combination, switching to a new electrode combination.” App. Br. 8.
According to Appellants, “Figure 9 illustrates only established strength-
duration relationships of electrodes and does not disclose the manner in
which either voltage or pulse is modified.” Reply Br. 4.
Appellants argue Sathaye discloses that “the combination energy
delivered may be increased by increasing the pulse width. There is no
discussion or suggestion ... of increasing the combination energy by
increasing the amplitude.” Id. at 9. Instead, Appellants argue, in the
disclosed testing process “the combination energy delivered is
systematically decreased until capture is lost, the parameters are stored and
the process switches to a different electrode combination.” Id.
Appellants acknowledge that Sathaye discloses “the capture threshold
test may involve a step-up capture [method]” but argue this mention is made
“tangentially . . . without disclosing how the combination energy may be
increased [and that Sathaye] does not disclose any manner in how the
amplitude would be increased.” Id.
Appellants further argue that Sathaye’s step down capture test process
does not disclose an increase in amplitude, as claimed by the Examiner, but
“just the energy which, of course, can be accomplished by increasing pulse
duration” as Sathaye discloses. Id. at 10. Appellants further argue that even
if Sathaye’s disclosure were found to teach increasing amplitude, this would
not anticipate claims 1 and 13, which require the further steps of “reducing
said amplitude of said one of said plurality of stimulation vectors until loss
14
Appeal 2016-001329
Application 13/829,792
of capture occurs, and then returning said amplitude to said amplitude at
which capture previously occurred.” Id.
The Examiner responds that “[i]t is known in the art that magnitude
and amplitude are interchangeable terms with the same meaning” and notes
that for this reason, the Examiner and the skilled artisan would both
recognize that Appellants’ own interchangeable use of these terms in the
claims is consistent with knowledge in the art. Ans. 2.
The Examiner explains that, with respect to Figure 9, “[t]he y-axis
demonstrates voltage, which is voltage amplitude and would certainly satisfy
the claim language of an amplitude and/or the amplitude. The x-axis is
pulse width [and the] strength duration plot is clearly voltage vs. pulse
width.” Id. at 3. The Examiner finds that “the voltage amplitude is clearly
being modified and/or adjusted in order to create each plot for each electrode
combination.” Id. As a result, the Examiner argues “figure 9 is clear
confirmation that the voltage amplitude is increased and/or decreased in
order to produce the strength-duration plot for each electrode combination”
and that Sathaye discloses that as an alternative, “a step-up capture threshold
test can be used to determine the threshold parameters.” Id. at 3^4. The
Examiner concludes that because the “claim in question is a device/system
claim, the circuit can most certainly function to perform step-down and/or
step-up threshold testing.” Id. at 4.
We are not persuaded that Appellants have shown error in the
Examiner’s findings. As the Examiner states, Sathaye discloses an
implanted medical device and method for evaluating a plurality of electrode
combinations to determine the capture threshold of a plurality of stimulation
15
Appeal 2016-001329
Application 13/829,792
vectors. FF1—11. Sathaye teaches calculation of the pacing energy to
determine the capture threshold, and storing the values of the capture
threshold in the device. Sathaye discloses Figure 9 as an example of the
relationship between amplitude voltage and pulse width, which makes clear
to the skilled artisan 1) that varying one parameter directly affects the other
parameter; and 2) how to determine the capture threshold with a margin of
error for use in programming. FF9. Sathaye discloses that a step-up capture
threshold test may be used. FF11. Given these disclosures, including that
an exemplary relationship of amplitude voltage and pulse width is plotted in
Figure 9, and the understanding in the art that magnitude and amplitude are
interchangeable, which Appellants do not contest, we agree with the
Examiner that Sathaye discloses a medical device capable of use in
performing the enumerated steps of claim 1. Final Act. 3^4; FF1—11. It is
not necessary that the medical device perform the step-up method in every
instance for a finding of anticipation; rather, if the system disclosed by
Sathaye is capable of performing the comparison, a finding of anticipation is
appropriate.
The law of anticipation does not require that the reference
“teach” what the subject [application] teaches. Assuming that a
reference is properly “prior art,” it is only necessary that the
claims under attack . . . “read on’ something disclosed in the
reference, i.e., all limitations of the claim are found in the
reference.
Kalman v. Kimberly-Clark Corp., 713 F.2d 760, 772, (Fed. Cir. 1983). .
Appellants next argue that the Examiner’s cited reference paragraphs
126 through 128 disclose “estimating” rather than measuring the capture
threshold, but are “silent as to how energy parameters are modified in order
16
Appeal 2016-001329
Application 13/829,792
to achieve capture.” App. Br. 9. Appellants argue Sathaye “does not show,
disclose nor suggest (1) first ramping up the magnitude, (2) reducing the
amplitude and (3) again increasing the amplitude as claims 1 and 13
explicitly require.” Id.
The Examiner responds:
The ramping up of the magnitude is clearly established in figure
9. Reduction of the amplitude until loss of capture occurs is
clearly demonstrated in figures 4 and 8 when the initial capture
threshold is determined, paragraph 0062 explicitly states: “For
example, the capture threshold test may step down the pacing
energy for successive pacing cycles until loss of capture is
detected. ” Further Sathaye is clearly demonstrating returning
the amplitude where capture occurred at step 1020 of figure 10
in that the pacing energy is delivered. This step is also
demonstrated in figure 12 at 1270 in that the electrode
combination would certainly be used at the established capture
threshold.
Ans. 4. The Examiner concludes “Sathaye discloses all of the claimed
physical hardware of the system claimed and also discloses the software
aspect (i.e. circuitry configuration).” Id. at 4—5. The Examiner further notes
that the language of method claim 13 “in no way limits how the method type
language is performed” and concludes that because the Sathaye system
performs each claimed tasks and contains the system hardware to do so, the
device also anticipates the method. Id. at 5.
In reply, Appellants state that step 1020 of Figure 10 is described in
Sathaye as
“delivering a pacing pulse at pacing energy to an electrode
combination” and “after delivery] of the pacing pulse, the
process monitors to determine whether loss of capture is
detected’.” This is part of the “step down” threshold test [and
does not disclose] “returning the amplitude to the amplitude at
17
Appeal 2016-001329
Application 13/829,792
which capture previously occurred” as explicitly required by
claims 1 and 13.”
Reply Br. 5. According to Appellants, Sathaye’s purpose is to “achiev[e]
capture and decreasing amplitude until loss of capture occurs in order to
determine efficacy of each successive electrode combination” rather than
“effective electrical stimulation while lowering the amount of energy
consumed and preserving energy, e.g., battery, resources.” Id.
We begin by construing “configured to calculate said energy
consumption.” Because the Specification does not define the term, we apply
the broadest reasonable interpretation in light of the Specification. See In re
Am. Acad. ofSci. Tech Ctr., 367 F.3d 1359, 1364 (Fed. Cir. 2004) (“The
Patent and Trademark Office (‘PTO’) determines the scope of claims in
patent applications not solely on the basis of the claim language, but upon
giving claims their broadest reasonable construction ‘in light of the
specification as it would be interpreted by one of ordinary skill in the art’”).
The Specification explains that:
In an embodiment, the energy consumption for each of the
plurality of stimulation vectors is calculated by (1) ramping up
an amplitude of one of the plurality of stimulation vectors until
capture occurs.
In an embodiment, the energy consumption for each of the
plurality of stimulation vectors is calculated by (2) reducing the
amplitude of the one of the plurality of stimulation vectors until
loss of capture occurs, and (3) returning the amplitude the
amplitude to the amplitude at which capture previously occurred.
Spec. H28, 29. Based on these disclosures, we construe the broadest
reasonable scope of circuitry “configured to calculate said energy
consumption” to comprise circuitry capable of varying the amplitude of one
18
Appeal 2016-001329
Application 13/829,792
of the plurality of stimulation vectors through either a step-up or a step-
down application of magnitude/amplitude until capture occurs, and applying
the amplitude of capture. As this is precisely what Sathaye discloses, as
discussed above, we are not persuaded that Sathaye fails to anticipate the
claimed device and method. Furthermore, as the Examiner has identified,
Sathaye discloses that stimulating the heart in excess of the capture threshold
can require premature battery replacement. Sathaye 1 6. Accordingly, we
are not persuaded that the skilled artisan would not recognize Sathaye’s
disclosures as anticipating the claimed method’s use for preserving battery
life of the claimed medical device. We affirm the Examiner’s rejection of
anticipation of claims 1 and 13.
Conclusion of Law
We affirm the rejection of claims 1 and 13. Claims 2—5, 8, 9, 12, 14—
17, 20-21, and 24 have not been argued separately and, therefore, fall with
claims 1 and 13. 37 C.F.R. § 41.37(c)(l)(iv).
OBVIOUSNESS
Claims 6 and 18 depend indirectly from claims 1 and 13, respectively,
and further require that energy consumption be displayed or be configured to
display “only for ones of . . . plurality of stimulation vectors achieving a
predetermined efficacy.” App. Br. 14, 16 (Claims App.). Claims 7 and 19
depend from claims 6 and 18, respectively, and further require circuitry
configured to display or a step of displaying “energy consumption for each
of said plurality of stimulation vectors based, at least in part, on a value of
said energy consumption.” (Id.) The Examiner finds that Sathaye renders
19
Appeal 2016-001329
Application 13/829,792
obvious the subject matter of claims 6—7 and 18—19. In this regard, the
Examiner relies on the Examiner’s fact finding regarding claims 1, 2, 3, and
5, on which claim 6 depends. Final Act. 3^4. The Examiner further finds
that Sathaye “discloses displaying the parameters [downloaded from the
cardiac rhythm management device] and that one of the parameters is energy
consumption ...[,] and [further discloses] achieving a predetermined
efficacy (capture), as shown in fig. 10. Sathaye further discloses ranking the
parameters.” Id. at 5.
The Examiner concludes that although it is unclear whether Sathaye’s
parameters are displayed, “it would have been obvious to one of ordinary
skill in the art at the time the invention was made to modify Sathaye to
include the display of these parameters in order to allow for an acting
physician to choose the appropriate electrode pair.” Id.
The issue with regard to this rejection is whether a preponderance of
the evidence supports a conclusion that Sathaye suggests the subject matter
of claims 6—7 and 18—19.
Appellants rely on their arguments made in relation to the anticipation
rejection and do not separately argue claims 6—7 and 18—19. App. Br. 11.
For the reasons discussed above, as well as our own factual findings, we are
not persuaded by Appellants’ arguments. See FF12—14. Accordingly, we
affirm the rejection of claims 6—7 and 18—19.
Conclusion of Law
We affirm the rejection of claims 6—7 and 18—19 under 35 U.S.C. §
103(a) as obvious over Sathaye.
20
Appeal 2016-001329
Application 13/829,792
SUMMARY
We affirm the rejection of claims 1—5, 8, 9, 12—17, 20-21, and
24 under pre-AIA 35 U.S.C. § 102(b) as anticipated by Sathaye.
We affirm the rejection of claims 6—7 and 18—19 under pre-AIA
35 U.S.C. § 103(a) as obvious over Sathaye.
TIME PERIOD FOR RESPONSE
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
21