Ex Parte Younker et al

Patent Trial and Appeal Board

Oct 23, 2017

13835905 (P.T.A.B. Oct. 23, 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.
13/835,905 03/15/2013 Gregory A. Younker C0002236.USU1/LG10126.L33 8479
27581 7590 10/25/2017
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
10/25/2017 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 GREGORY A. YOUNKER and IDARA D. UKO
Appeal 2016-007270
Application 13/835,905
Technology Center 3700
Before JEFFREY N. FREDMAN, ULRIKE W. JENKS, and
DAVID COTTA, Administrative Patent Judges.
FREDMAN, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal1 under 35 U.S.C. § 134(a) involving claims to a
medical system. The Examiner rejected the claims as obvious. We have
jurisdiction under 35 U.S.C. § 6(b). We affirm.
Statement of the Case
Background
“The present invention relates generally to power source monitors
and, more particularly, to power source monitors for implantable medical
devices having an energy source having a voltage which declines over its
useful life” (Spec. 11).
1 Appellants identify the Real Party in Interest as Medtronic Inc. (see App.
Br. 3).
Appeal 2016-007270
Application 13/835,905
The Claims
Claims 1, 3—8, 10-13, 19, 21—26, and 28—31 are on appeal.
Independent claim 1 is representative and reads as follows:
1. A medical system, comprising:
an implantable medical device having:
an energy source having a longevity characterized
by a depth of discharge representative of a first
stage of discharge representative of beginning of
service, a second stage of discharge representative
of recommended replacement time and a third
stage of discharge representative of end of service;
and
electrical circuitry operatively coupled to and
being powered by said energy source, said
electrical circuitry being configured to calculate a
remaining longevity of said energy source; and
a display, operatively coupled to said electrical circuitry,
configured to display in graphical form using a scale length
representative of a time between said first stage of discharge
and said third stage of discharge;
a first portion of said graphical form of said display
between said second stage of discharge and said third stage of
discharge being indicated in a first color;
a second portion of said graphical form of said display
between said remaining longevity and said second stage of
discharge being indicated in a second color;
a third portion of said graphical form of said display
between said first stage of discharge and said remaining
longevity being indicated in a third color;
wherein said implantable medical is capable of being
configured to deliver a plurality of electrical activities;
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Application 13/835,905
wherein said electrical circuitry is further configured to
calculate a remaining longevity of said energy source separately
for each of said plurality of electrical activities;
wherein said energy source has a predetermined expected
longevity for each of said plurality of electrical activities;
wherein said display is configured to display,
simultaneously for each of said plurality of electrical activities,
in graphical form an indication representative of said remaining
longevity compared with said expected longevity.
The Issues
A. The Examiner rejected claims 1, 10, 11, 13, 19, 28, 29, and 31 under
35 U.S.C. § 103(a) as obvious over Gandhi,2 Bland,3 and Ryu4 (Final Act.
3-5).
B. The Examiner rejected claims 3—6 and 21—24 under 35 U.S.C.
§ 103(a) as obvious over Gandhi, Bland, Ryu, and Heinze5 (Final Act. 5—6).
C. The Examiner rejected claims 7, 8, 25, and 26 under 35 U.S.C.
§ 103(a) as obvious over Gandhi, Bland, Ryu, and Rogers6 (Final Act. 6).
D. The Examiner rejected claims 12 and 30 under 35 U.S.C. § 103(a) as
obvious over Gandhi, Bland, Ryu, and Colbom7 (Final Act. 7).
2 Gandhi et al., US 7,469,161 Bl, issued Dec. 23, 2008.
3 Bland et al., US 2009/0062682 Al, published Mar. 5, 2009.
4 Ryu et al., US 2011/0196441 Al, published Aug. 11, 2011.
5 Heinze et al., US 2006/0176177 Al, published Aug. 10, 2006
6 Rogers et al., US 6,901,293 B2, issued May 31, 2005.
7 Colbom, J., US 2012/0265266 Al, published Oct. 18, 2012.
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Application 13/835,905
A. 35 U.S.C. § 103(a) over Gandhi, Bland, and Ryu
The Examiner finds Gandhi teaches a battery powered implantable
medical device where “processor 202 (figure 2) is configured to calculate
remaining longevity of the energy source . . . and a display 900 (figure 9). . .
[is] configured to display in a graphical form using a scale length
representative of time between the first stage of discharge and the third stage
of discharge” (Final Act. 3). The Examiner finds Gandhi teaches “the
graphs used in the device and method can be color coded” (Final Act. at 4).
The Examiner acknowledges that Gandhi does not expressly teach
that a “gauge[, as opposed to the graph,] associated with the battery life is or
can be color coded” (Final Act. 4). The Examiner finds Bland teaches “a
battery fuel gauge 13/36 (figure 2B) which is disclosed as having different
colors for the battery bar, green indicative of a full battery, yellow indicative
of 1/3 full and red indicative of critically low battery levels” (Id.).
The Examiner acknowledges that Gandhi and Bland do not teach “to
calculate a remaining longevity separately for a plurality of electrical
activities, and a display configured to display for each activity, in graphical
form, an indication representative of the remaining longevity” (Final Act. 4).
The Examiner finds Ryu teaches an implantable medical device that
is capable of testing all possible configurations which would
necessarily include the current pacing configuration along with
the longevity factor (pgs. 0057-0058) and then displaying, in
graphical form, simultaneously for each pacing configuration
remaining longevity (considered to be the current pacing
configuration) along with expected longevity for each of the
other pacing configurations.
(Id.).
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The Examiner finds it obvious to incorporate Ryu’s configuration into
the device of Gandhi and Bland in “order for a physician to choose the most
appropriate [treatment] configuration based on several factors including
longevity” (Final Act. 5).
The issue with respect to these rejections is: Does the evidence of
record support the Examiner’s conclusion that Gandhi, Bland, and Ryu
render claim 1 obvious?
Findings of Fact
1. Gandhi teaches “systems and methods for monitoring and
managing power consumption of the implantable medical devices” (Gandhi
4:2426).
2. Figure 2 of Gandhi is reproduced below:
Figure 2 depicts “IMD 102 comprises a processor 202, a battery 204,
communication circuitry 206, therapy circuitry 208, and a memory 210. . . .
battery parameters can be used to determine battery longevity and other
battery statistics” (Gandhi 5:28-42).
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Application 13/835,905
3. Figures 8a-c of Gandhi are reproduced below:
Figure 8 depicts “power consumption of an IMD is displayed on a graphical
visual display as a semi-circular dial... As power consumption increases,
the needle or line will move and the color can change to indicate, for
example, low, medium, and/or high power consumption rates” (Gandhi
8:48-54).
4. Gandhi teaches that an implantable medical device may
comprise multiple components that consume power, teaching “therapy
circuitry 208 can include circuitry for providing heart pacing therapy,
cardiac defibrillation therapy, and/or cardiac resynchronization therapy, drug
delivery therapy, or any other therapy associated with a suitable IMD”
(Gandhi 6:46-A9).
5. Gandi also teaches “examples of sensors that may affect the
power consumption include an XL (excellerometer) sensor, a MV (minute
ventilator) sensor, pressure sensors, temperature sensors, etc.” (Gandhi
10:53-56).
6. Gandhi teaches the “invention can calculate the power
consumption rate and display this rate to a user, for example, via a graphical
visual indicator” with the result that “the physician or health care
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professional can easily observe conditions that may lead to a high power
consumption rates, and can be given an opportunity to make changes to IMD
parameters that might improve the power consumption rate, and thus, the
longevity of the IMD battery” (Gandhi 4:59 to 5:6).
7. Gandhi teaches “battery power consumption or throttle
indicator 914 can display power consumption rate using one or more
different graph and/or color configurations” (Gandhi 11:19-21).
8. Bland teaches the
battery icon may also be colored to indicate the remaining
battery power. A green color can show the battery is charging,
fully charged, and 2/3 full. A yellow color can indicate the
battery is 1/3 full or act as a reminder to recharge the battery. A
red color can be used to indicate the battery life is critically
low.
(Bland 1122).
9. Ryu teaches a method of “controlling the delivering stimulation
therapy for use with an implantable cardiac stimulation device equipped to
delivery pacing or other stimulation therapy in accordance with a selectable
set of stimulation control parameters” (Ryu 1 5).
10. Ryu teaches “device longevity expected to be achieved using
each of the plurality of sets of stimulation control parameters is [] assessed.
A particular set of stimulation control parameters is then selected or
determined based on the degree of hemodynamic benefit and the degree of
longevity” (Ryu 1 5).
11. Ryu teaches the implantable device system
calculates a comparison value or “score” representative of the
relative degree of hemodynamic benefit vs. device longevity for
the candidate MSLV pacing configuration for comparison
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Application 13/835,905
against the input bias value. Assuming there are more pacing
configurations to be tested, as determined at step 210, the
system returns to step 202 to select a different pacing
configuration and the assessment procedure is repeated.
(Ryu 1 57).
12. Ryu teaches “the system displays the rankings for clinician
review” (Ryu 158).
13. Figure 5 of Ryu is reproduced below:
QusckSb'm
MORE CONTROL LESS RISK.
OPTIMIZE
FOR —
DEVICE LONGEVITY
UPDATE
\ 316
U
OPTIMIZE
FOR
HEMODYNAMICS
REBUTS:
CONFIGURATION (TOUCH FOR DETAILS) SCORE (0ATL/HEMO.) SET DEVICE
TIP - R1 ~ SMS ~ R-2 COIL ~ 35MS ~ RV 96 (87/99) PROGRAM
TIP - COIL « 4MS ~ R-1 COIL « 8MS R-2C0... 92 (80/96) PROGRAM
\ TIP - Rl ~ 42MS ~ RV 85 (92/80) PROGRAM j
FIG. 5
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Figure 5 depicts “a graphical input display 304 generated and displayed by
the device programmer. The clinician, using a mouse controller, touch
screen, or other suitable input device, slides or repositions the slide bar to a
desired point between the opposing ends points of ‘optimize for device
longevity’ and ‘optimize for hemodynamics’” (Ryu | 59).
Principles of Law
“If a person of ordinary skill can implement a predictable variation, §
103 likely bars its patentability.” KSRInt’l Co. v. Teleflex Inc., 550 U.S.
398, 417 (2007).
Analysis
We adopt the Examiner’s findings of fact and reasoning regarding the
scope and content of the prior art (Final Act. 3—5; FF 1—13) and agree that
the claims are rendered obvious by Gandhi, Bland, and Ryu. We address
Appellants’ arguments below.
Appellants contend
neither Gandhi et al ‘161 nor Bland et al ‘682 show, disclose or
suggest a device which is configured to calculate a remaining
longevity of an energy source separately for each of a plurality
of electrical activities and in which a display is configured to
display, in graphical form, an indication representative of the
remaining longevity compared with the expected longevity
separately for each of the plurality of electrical activities.
(App. Br. 7). Appellants acknowledge Ryu teaches a system that “estimates
the degree of device longevity expected to be achieved based on
predetermined models of current drain on a power supply” and “compares
the values or scores for the various candidate configurations against the
input bias value and ranks the values based on the degree of match” (App.
Br. 8-9).
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Appellants contend, however, that Ryu “does not show, disclose or
suggest a display in graphical form an indication representative of the
remaining longevity with the expected longevity as explicitly claimed”
(App. Br. 9). Appellants further contend Ryu’s teaching of a “degree of
match with an arbitrary input bias is certainly not equivalent to and does not
suggest an indication representative of remaining longevity compared with
expect longevity” (Id.).
We do not find these arguments persuasive. Gandhi teaches an
implantable medical device (FF 1) with an battery energy source and
electrical circuitry coupled to configure the longevity of that energy source
(FF 2), and a display to show three stages of discharge (FF 3), with Bland
evidencing that discharge can be shown with a green color for a first stage of
discharge, a yellow color for a second stage of discharge, and a red color for
a third stage of discharge (FF 8; cf. FF 7).
Gandhi teaches that the implantable medical device may be
configured to deliver a plurality of electrical activities (FF 4—5).
While we agree with Appellants that Gandhi and Bland do not suggest
separate analysis of longevity of a plurality of electrical activities, Ryu
expressly teaches to calculate “a comparison value or ‘score’ representative
of the relative degree of hemodynamic benefit vs. device longevity for the
candidate MSLV pacing configuration for comparison against the input bias
value” (FF 11). Ryu’s device is therefore configured to calculate separate
scores for different configurations of the electrical activities to guide the
physician in identifying the longevity (i.e. battery life) of the device
depending upon the chosen electrical activity (FF 11—13). This calculation
is reasonably understood as a “predetermined expected longevity” because
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the value or score given by Ryu is a determined value that is directly
associated with device longevity that represents, at least in part, expectations
regarding the longevity of the device under particular conditions (FF 11).
Finally, while Ryu displays the results in tabular form, with figure 5
showing a score that shows battery values of 87, 80, and 92 relative to
hemodynamic benefits of 99, 96, and 80 (FF 13), we agree with the
Examiner that it would have been obvious to visualize Ryu using the
graphical display formats suggested by Gandhi and Bland (see Ans. 4—5)
because graphical displays allow “the physician or health care professional
can easily observe conditions that may lead to a high power consumption
rates, and can be given an opportunity to make changes to IMD parameters
that might improve the power consumption rate, and thus, the longevity of
the IMD battery” (FF 6).
Thus, the person of ordinary skill in the art would have had good
reason to model battery longevity impacts of the different electrical activities
performed by the Gandhi or Ryu implantable medical devices (FF 4, 5, 9—
11) and display these results graphically as taught by Gandhi and Bland (FF
3, 8) to allow physicians to easily adjust implantable medical device
parameters to improve battery longevity (FF 6).
We are not persuaded by Appellants’ argument that Ryu alone does
not teach calculation of a “remaining longevity” because the rejection relies
upon the combination of Ryu with Gandhi and Bland, not Ryu alone. Both
Gandhi and Bland teach the importance of displaying remaining longevity of
a battery relative to expected longevity in graphical form with green, yellow,
and red colors indicating the level of battery life remaining and the complete
dial showing expected longevity (FF 3, 8). “Non-obviousness cannot be
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Application 13/835,905
established by attacking references individually where the rejection is based
upon the teachings of a combination of references.” In re Merck & Co., 800
F.2d 1091, 1097 (Fed. Cir. 1986). In determining obviousness, furthermore,
a reference “must be read, not in isolation, but for what it fairly teaches in
combination with the prior art as a whole.” Id.
We recognize, but find unpersuasive, Appellants’ argument that Ryu’s
“scores, and certainly the rankings, are not representative of longevity
(calculated vs. expected) since such scores are calculated using an arbitrary
input bias with hemodynamic benefit which cannot be predicted and
prevents such scores from being representative of longevity” (App. Br. 9; cf.
Reply Br. 4). As we noted above, Gandhi and Bland suggest showing
graphs with remaining longevity compared to originally expected longevity
(FF 3, 8) satisfying this claim limitation. However, Ryu’s calculations
necessarily provide predictions of a relative expected longevity based on the
particular parameters chosen and therefore may also be reasonably
considered to satisfy at least calculations of the remaining longevities that
depend upon selected options by the physician (FF 13). In either case, we
agree with the Examiner that the combination of Gandhi, Bland, and Ryu
reasonably renders obvious an implanted medical device with a display
configured to show a plurality of electrical activities with remaining
longevity shown compared to the original, expected longevity (see Ans. 3—
5).
Conclusion of Law
The evidence of record supports the Examiner’s conclusion that
Gandhi, Bland, and Ryu render claim 1 obvious.
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B.-D. 35 U.S.C. § 103(a)
Appellants do not separately argue these rejections. The Examiner
provides sound fact-based reasoning explaining why the further
combinations of Heinze, Rogers, and Colbom with Gandhi, Bland, and Ryu
renders the rejected claims obvious (see Final Act. 5—7). Having affirmed
the rejection of claim 1 over Gandhi, Bland, and Ryu for the reasons above,
we affirm these further rejections for the Examiner’s reasons.
SUMMARY
In summary, we affirm the rejection of claim 1, under 35 U.S.C.
§ 103(a) as obvious over Gandhi, Bland, and Ryu. Claims 10, 11, 13, 19,
28, 29, and 31 fall with claim 1.
We affirm the rejection of claims 3—6 and 21—24 under 35 U.S.C.
§ 103(a) as obvious over Gandhi, Bland, Ryu, and Heinze.
We affirm the rejection of claims 7, 8, 25, and 26 under 35 U.S.C.
§ 103(a) as obvious over Gandhi, Bland, Ryu, and Rogers.
We affirm the rejection of claims 12 and 30 under 35 U.S.C. § 103(a)
as obvious over Gandhi, Bland, Ryu, and Colbom.
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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