Ex Parte Strother et al

Patent Trial and Appeal Board

Sep 11, 2014

11517170 (P.T.A.B. Sep. 11, 2014)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte ROBERT B. STROTHER and GEOFFREY B. THROPE
__________

Appeal 2012-005326
Application 11/517,170
Technology Center 3700
__________

Before ERIC B. GRIMES, ULRIKE W. JENKS, and
CHRISTOPHER G. PAULRAJ, Administrative Patent Judges.

PAULRAJ, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal1 under 35 U.S.C. § 134 involving claims to a pulse
generator and related method. The Examiner rejected the claims on
anticipation and obviousness grounds. We have jurisdiction under 35 U.S.C.
§ 6(b). We affirm-in-part.

STATEMENT OF THE CASE
Background
“The invention relates to systems and methods for providing
stimulation of central nervous system tissue, muscles, or nerves, or
combinations thereof.” (Spec. 2 ll. 24–26.) “[I]mplantable pulse generators

1 Appellants identify the Real Party in Interest as Medtronic, Inc. (see App.
Br. 3).
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can provide therapeutic and functional restoration outcomes in the field of
urology, such as for the treatment of (i) urinary and fecal incontinence; (ii)
micturition/retention; (iii) restoration of sexual function; (iv)
defecation/constipation; (v) pelvic floor muscle activity; and/or (vi) pelvic
pain” (id. at 3 ll. 10–16). “These implantable devices are . . . limited in their
ability to provide sufficient power which limits their use in a wide range of
stimulation applications, requires surgical replacement of the device when
the batteries fail, and limits their acceptance by patients. Rechargeable
batteries have been used but are limited by the need to recharge a power
supply frequently (e.g., daily), and the inconvenience of special recharge
methods” (id. at 4 ll. 15–22).
The Claims
Claims 1–7, 10–12, 15–19, and 22–37 are on appeal. Independent
claim 1 is representative, and reads as follows:
1. A pulse generator adapted to be coupled to an electrode to provide
electrical stimulation comprising:
a housing configured for implantation in tissue of a patient;
a rechargeable battery carried within the housing;
circuitry carried within the housing and coupled to the rechargeable
battery, the circuitry comprising first circuitry for generating electrical
stimulation pulses and second circuitry for recharging the rechargeable
battery; and
a power receiving coil coupled to the second circuitry,
wherein the circuitry is configured to suspend the generation of
electrical stimulation pulses when a capacity of the rechargeable battery
decreases below a first remaining capacity and the circuitry is configured to
cause the pulse generator to enter a dormant mode when the capacity of the
rechargeable battery decreases below a second remaining capacity,
wherein the first and second circuitry are electrically isolated from the
rechargeable battery when the pulse generator is in the dormant mode,
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wherein the pulse generator is configured to exit the dormant mode
upon receipt of power by the power receiving coil from a transcutaneously
applied radio frequency magnetic field, and
wherein the pulse generator exits the dormant mode by at least
electrically reconnecting the second circuitry to the rechargeable battery.

The Issues

The Examiner rejected the claims as follows:
I. Claims 1, 2, 4–7, 10, 11, 15–19, and 23–37 under 35 U.S.C.
§ 102(b) as being anticipated by Meadows.2
II. Claim 3 under 35 U.S.C. § 103(a) as being unpatentable over
Meadows.
III. Claims 12 and 22 under 35 U.S.C. § 103(a) as being
unpatentable over the combination of Meadows and
McDonald.3

FINDINGS OF FACT
FF1. Meadows teaches a rechargeable spinal cord stimulation (SCS)
system wherein “[w]hen the system’s replenishable power source
is fully charged, the user may operate the SCS system independent
of external controllers or power sources” (Meadows, Abstract).
“[T]he SCS system includes an implantable pulse generator (IPG)
that is powered by a rechargeable internal battery, e.g., a
rechargeable Lithium Ion battery providing an output voltage that
varies from about 4.1 volts, when fully charged, to about 3.5 volts,
when ready to be recharged” (id. at col. 3 ll. 28–33).

2 Meadows et al., US 6,516,227 B1, issued Feb. 4, 2003.
3 McDonald et al., US 4,257,423, issued Mar. 24, 1981.
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FF2. Fig. 4E-1 and Fig. 4E-2 of Meadows are reproduced below:

“FIG. 4E is a flow chart illustrating a representative low battery
shutdown and recovery sequence” (id. at col. 7 ll. 36–37).

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FF6. Meadows teaches:
The IPG 100' has three main modes that can initiate
either a reset sequence or a hibernation state. The first
mode is a hard power up reset that occurs at initial turn
on. The second mode is a state where a fully functional
IPG experiences battery depletion that may result in
erroneous communication between the modules, thereby
necessitating that the system power down in order to
protect the patient. The third mode is a re-awake mode
triggered from the depletion or hibernation state, which
re-awake mode requires that the system perform self
check and validation states.

(Id. at col. 24 ll. 24–33.)
FF7. With reference to Fig. 4E, Meadows teaches:
If the battery voltage falls below a first prescribed level,
designated as VBAT (3.0±0.1 V), and if HEXTRESET is
asserted, then all systems in the IPG are halted (block
4E08). Should the battery voltage fall below a second
prescribed level, designated as the battery protection
cutoff (2.5 V) (block 4E09), then the battery protection
circuitry disconnects the battery from the main circuit
(block 4E10). . . . When the battery voltage rises above
2.6 V, the protection circuitry reconnects the battery, and
HEXTRESET is asserted (block 4E14). When the
battery voltage rises above the VBAT threshold (3.0±0.1
V) (block 4E15), then HEXTRESET is released, and the
process goes through the power-on-reset process (block
4E16).

(Id. at col. 25 ll. 34–54.)
FF8. With reference to Fig. 9A, Meadows teaches:
The battery protection IC 686, with its FET switch 688,
is in series with the charge controller 684, and keeps the
battery within safe operating limits. Should an
overvoltage, undervoltage, or short-circuit condition be
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detected, the battery 180 is disconnected from the fault.
. . . Should the battery voltage fall below 2.5 V, the
battery is trickle[ ] charged at 10mA. . . . Should the
battery voltage drop below a safe minimum voltage . . . ,
the battery protection IC 686 prevents further discharge
of the battery by turning off the charge-enabling FET
switch 688.

(Id. at col. 42 l. 12–col. 43 l. 1.)
FF9. Meadows teaches: “An undervoltage state 714 exists when the
battery voltage is less than 2.5 volts. The undervoltage state 714
continues until the battery voltage is greater than 2.5 volts while
charging at a prescribed trickle charge current, e.g., 10 mA” (id. at
col. 43 ll. 12–16).
FF10. McDonald teaches a cardiac pacemaker pulse generator, wherein
“[a] magnetic field actuated reed relay switch 46 is connected
between the positive side of battery 44 and each of digital and
analog circuits 40 and 42 respectively” (McDonald, col. 6 ll. 51–
54).
PRINCIPLES OF LAW

“Anticipation requires that all of the claim elements and their
limitations are shown in a single prior art reference.” In re Skvorecz, 580
F.3d 1262, 1266 (Fed. Cir. 2009). “An anticipatory reference . . . need not
duplicate word for word what is in the claims. Anticipation can occur when
a claimed limitation is ‘inherent’ or otherwise implicit in the relevant
reference.” Standard Havens Prods., Inc. v. Gencor Indus. Inc., 953 F.2d
1360, 1369 (Fed. Cir. 1991) (citing Tyler Refrigeration v. Kysor Indus.
Corp., 777 F.2d 687, 689 (Fed. Cir. 1985)). “Description for the purposes of
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anticipation can be by drawings alone as well as by words.” In re Bager, 47
F.2d 951, 953 (CCPA 1931).
“Section 103(a) forbids issuance of a patent when ‘the differences
between the subject matter sought to be patented and the prior art are such
that the subject matter as a whole would have been obvious at the time the
invention was made to a person having ordinary skill in the art to which said
subject matter pertains.”’ KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 406
(2007) (quoting 35 U.S.C. § 103(a)). “[W]hen a patent claims a structure
already known in the prior art that is altered by the mere substitution of one
element for another known in the field, the combination must do more than
yield a predictable result.” Id. at 416. “[I]f a technique has been used to
improve one device, and a person of ordinary skill in the art would recognize
that it would improve similar devices in the same way, using the technique is
obvious unless its actual application is beyond his or her skill.” Id. at 417.

ANALYSIS
I. Rejection Under 35 U.S.C. § 102(b)
Claims 1, 2, 5, 7, 10, 11, 15–17, 19, 23, 25–27, and 29–37
With respect to independent claims 1, 15, 32, and 35, the Examiner
finds that
Meadows discloses a method for operating a pulse generator
and a pulse generator adapted to be coupled to an electrode to
provide electrical stimulation comprising a housing configured
for implantation in tissue of a patient; a rechargeable battery,
180, carried within the housing; circuitry carried within the
housing and coupled to the rechargeable battery, the circuitry
comprising first circuitry for generating electrical stimulation
pulses, 186', and second circuitry for recharging the
rechargeable battery, 100 (Abstract; Figs. 4A – 4C–3, 9A); and
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a power receiving coil coupled to the secondary circuitry, and
wherein the circuitry is configured to suspend the generation of
electrical stimulation pulses when a capacity of the
rechargeable battery decreases below a first remaining capacity,
4E03 – 4E05 (Fig. 4E–1), and the circuitry is configured to
cause the pulse generator to enter a dormant mode, hibernation
state, when the capacity of the rechargeable battery decreases
below a second remaining capacity, wherein the first and
second circuitry are electrically isolated from the rechargeable
battery when the pulse generator is in the dormant mode, via
FET 688, wherein the pulse generator is configured to exit the
dormant mode upon receipt of power by the power receiving
coil from a transcutaneously applied radio frequency magnetic
field, along the path described by element numbers 4E14 –
4E16, and wherein the pulse generator exits the dormant
mode by at least electrically reconnecting the second charge
circuitry to the rechargeable battery (Fig. 4E-2 & 9A; Col. 24,
ll. 24 – 33).

(Ans. 4–5; FF1–9.) We determine that a prima facie case of anticipation has
been made based on the cited teachings of Meadows. We have considered
Appellants’ arguments, but are not persuaded otherwise.
Appellants argue that “the Examiner failed to identify a particular
capacity at which the IPG 100 of Meadows enters the hibernation state,
characterized by the Examiner as the dormant mode of claim 1” (App. Br.
8). Appellants further assert that “Meadows fails to disclose that the IPG
100 enters the hibernation state at any particular capacity” (id.). We
disagree. The Examiner notes that the claimed “second remaining capacity”
at which the IPG enters the dormant mode can be the 3.0V in 4E08 or the
2.5V in 4E09 in Fig. 4E-1 of Meadows (Ans. 5). The Specification states
that in the dormant mode, the IPG is “temporarily inoperable and inert,” and
that “VBAT is not delivered to the remainder of the [IPG] circuitry” (Spec.
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at 27 ll. 30–32, 47 ll. 9–11). Similarly, Meadows teaches that the IPG enters
a “hibernation state,” which we consider equivalent to the claimed “dormant
mode,” when the IPG experiences battery depletion, and more specifically
that “all systems in the IPG are halted” when the battery voltage drops below
3.0V, and furthermore the battery is disconnected from the main circuit
when the voltage falls below the battery protection cutoff (2.5V) (FF2; FF6–
7).
Appellants further argue with respect to claim 1 that “Meadows fails
to explicitly describe the feature of the first circuitry for generating electrical
stimulation pulses and second circuitry for recharging the rechargeable
battery of the IPG 100 being electrically isolated from the rechargeable
battery when the IPG 100 is in the hibernation state” (App. Br. 9). However,
Meadows specifically teaches that “the battery protection circuitry
disconnects the battery from the main circuit” when the voltage drops below
2.5V (FF7). Meadows further teaches that “the battery protection IC 686
prevents further discharge of the battery by turning off the charge-enabling
FET switch 688” when the battery voltage drops below a safe minimum
voltage (FF8). A battery voltage of less than 2.5V is considered to be an
“undervoltage” state (FF9), and as discussed above will cause the IPG to
enter a hibernation state (FF6). We find this teaching satisfies the
requirement that “the first and second circuitry are electrically isolated from
the rechargeable battery when the pulse generator is in the dormant mode”
(Cl. 1).4

4 Appellants raise an argument concerning Meadows’ teaching of a “trickle
charge current” for the first time in their Reply Brief (Reply Br. 7). As a
result, the Examiner was not provided with an opportunity to respond to that
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Additionally, with respect to claim 1, Appellants argue that
“Meadows fails in any manner to disclose or suggest that the IPG 100 is
configured to exit the hibernation state upon receipt of power by a power
receiving coil from a transcutaneously applied radio frequency magnetic
field by electrically reconnecting the second circuitry to the rechargeable
battery” (App. Br. 9). We find no basis for that position since Meadows
specifically teaches “a re-awake mode triggered from the depletion or
hibernation state” (FF6). As noted by the Examiner, the steps for exiting the
hibernation state are depicted in 4E14 – 4E16 of Fig. 4E-2 (Ans. 5; FF2).
Nonetheless, Appellants point to block 4E17 to argue that “Meadows
discloses that the protection FET switches cannot be re-activated” (App. Br.
10). However, it is clear from Meadows that block 4E17, wherein the
battery is permanently disabled, only occurs if the battery voltage falls
below the battery protection circuit minimum (1.2V) and does not
necessarily occur whenever the voltage drops below 3.0V or 2.5V to cause
the IPG to enter into the hibernation state (FF2).
We therefore affirm the anticipation rejection of independent claim 1.
Appellants only refer back to their arguments for claim 1 when asserting the
patentability of independent claims 15, 32, and 35 (App. Br. 16–18), and we

position in the Answer. We therefore consider that argument waived since
Appellants have not explained why it could not have been previously raised.
See Ex parte Nakashima, 93 USPQ2d 1834 (BPAI 2010) (informative)
(explaining that arguments and evidence not timely presented in the
principal Brief will not be considered when filed in a Reply Brief, absent a
showing of good cause explaining why the argument could not have been
presented in the Principal Brief); Ex parte Borden, 93 USPQ2d 1473, 1477
(BPAI 2010) (informative) (“Properly interpreted, the Rules do not require
the Board to take up a belated argument that has not been addressed by the
Examiner, absent a showing of good cause.”).
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accordingly affirm the rejection of those claims for the same reasons we find
claim 1 to be anticipated. Furthermore, as Appellants have not separately
argued dependent claims 2, 5, 7, 10, 11, 16, 17, 19, 23, 25–27, 29–31, 33,
34, 36, and 37, those claims fall with their respective independent claims.
37 C.F.R. § 41.37(c)(1)(vii).
Claims 4 and 18
Dependent claims 4 and 18 recite that “the second remaining capacity
comprises a safety margin capacity between approximately 5% and
approximately 20% of a total capacity of the battery” (Cls. 4, 18). The
Examiner finds these claims anticipated on the basis that “Meadows
discloses a 17% drop from peak voltage, a drop from 3.0 volts to 2.5 volts,
in Col. 25, ll. 34 – 40” (Ans. 12). Appellants argue that “the cited portion of
Meadows fail to disclose that the battery of Meadows has a total capacity of
which 2.5V is between approximately 5% and 20% of the total capacity of
the battery” (Reply Br. 11). We find that Appellants have the better position
with respect to these claims. The Examiner merely calculates the percentage
difference between 3.0V and 2.5V, which Meadows teaches are the points at
which the battery enters the depletion/hibernation state, i.e., when all
systems in the IPG are halted (4E08) and when the battery protection
circuitry disconnects the battery from the main circuit (4E09) (FF2). The
Examiner does not identify the total capacity of the battery in making this
calculation.
We therefore reverse the anticipation rejection of claims 4 and 20.
Claim 6
Dependent claim 6 recites “wherein the capacity of the rechargeable
battery is at least 30 mA-hr when the rechargeable battery is fully charged,
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and wherein recharging of the rechargeable battery is required less than
weekly” (Cl. 6). The Examiner finds that “Meadows does disclose the
voltage of the implanted battery being 3.8 volts (Col. 25 ll. 51-59) and that
the implanted battery has a capacity of 720 mWHrs (milliwatt hours) (Col.
24, ll. 12 – 15),” and using the relationship between power and voltage
(P=I*V), calculates the current to be 189 mA-hr (Ans. 13). Appellants do
not dispute the Examiner’s calculation, but instead argue that “the cited
portion of Meadows fails to disclose that 3.8 volts is the capacity of the
rechargeable battery when the rechargeable battery is fully charged” (Reply
Br. 11). We disagree with Appellants as we find that one of ordinary skill in
the art would understand from reading Meadows that the battery is “fully
charged” when its output voltage is 3.8 volts. In particular, Meadows
teaches that “[w]hen the system’s replenishable power source is fully
charged, the user may operate the SCS system independent of external
controllers or power sources” (FF1). Meadows teaches that, at 3.8V,
“stimulation is re-enabled” and “normal operation resumes” (FF2), which
we consider to be a fully charged state for the battery. Appellants’
Specification does not define “fully charged” in any other manner.5
We therefore affirm the anticipation rejection of claim 6.

5 We recognize that Meadows elsewhere states that the battery has “an
output voltage that varies from about 4.1 volts, when fully charged, to about
3.5 volts, when ready to be recharged” (FF1). However, we do not find that
statement to suggest that the battery is considered fully charged only at 4.1
volts. Regardless, even using 4.1 volts as the maximum output voltage in
the Examiner’s calculation would result in a current capacity of
approximately 175 mA-hr, which still satisfies the claim requirements.
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Claims 24 and 28
Claim 24 depends from claim 23, which depends from independent
claim 1. Claim 23 specifies that
[T]he pulse generator is configured to enter an active and
charging mode upon the receipt of the power by the power
receiving coil from the transcutaneously applied radio
frequency magnetic field, wherein the rechargeable battery
provides battery power to the first circuitry of the implantable
pulse generator and receives recharge current from the second
circuitry when the pulse generator is in the active and charging
mode

(Cl. 23). Claim 24 further specifies that “the pulse generator is configured to
exit the dormant mode and enter an active and charging mode upon receipt
of power by the power receiving coil from a transcutaneously applied radio
frequency magnetic field when the rechargeable battery is at or less than the
first remaining capacity” (Cl. 24). Claim 28, which depends from claim 27,
which in turn depends from claim 15, recites a similar limitation.
With respect to claims 24 and 28, Appellants argue that “Meadows
fails to disclose that the IPG 100' is configured to exit a dormant mode and
enter an active and charging mode when the battery voltage rises above 3.0
volts,” that “[i]nstead, Meadows discloses that the battery monitor circuit
releases the HEXTRESET signal,” and that “[t]he Examiner failed to cite to
any portion of Meadows that discloses that releasing the HEXTRESET
signal results in the IPG 100' exiting a dormant mode” (App. Br. 15–16).
We are not convinced as we find that blocks 4E14 – 4E16 illustrate that,
when the battery voltage rises above the VBAT reset threshold, the
HEXTRESET is released and the processor goes through a “power-on-reset
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process” (FF2). We find this satisfies the claim requirements for “exit[ing]
the dormant mode and enter[ing] an active and charging mode” (Cls. 24, 28).
We therefore affirm the anticipation rejection of claims 24 and 28.

II. Rejections Under 35 U.S.C. § 103(b)
The Examiner rejected dependent claim 3 as obvious in view of the
teachings of Meadows alone. Appellants do not raise any separate
arguments for this rejection other than referring to their arguments with
respect to independent claim 1 (App. Br. 19). Because we find claim 1 to be
unpatentable as discussed above, we also accordingly affirm the obviousness
rejection of claim 3 based on Meadows.
The Examiner rejected dependent claims 12 and 22 as obvious over
the combination of Meadows and McDonald. Claim 12 requires that “the
implantable pulse generator is configured to enter the dormant mode based
on at least one of a wireless telemetry command from an external controller
or a static magnetic field transcutaneously applied to the pulse generator at
any capacity of the rechargeable battery” (Cl. 12). Claim 22 requires “at
least one of a wireless telemetry command from an external controller or a
static magnetic field transcutaneously applied to the pulse generator is
configured to cause the pulse generator to enter the dormant mode at any
capacity of the rechargeable battery” (Cl. 22). The Examiner relies upon
McDonald’s teaching of “a static magnetic field switch, commonly known
as a reed switch,” and asserts that it would have been obvious “to modify the
pulse generator taught by Meadows, with a static magnetic field switch since
it is well known in the art that such static switches are used to provide
activation and deactivation commands to an implant” (Ans. 9–10; FF10).
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Appellants argue that “the cited portion of McDonald fails to disclose or
suggest that the status [sic, static] switches are configured to cause an
implantable pulse generator to enter a dormant mode” (App. Br. 20). As
noted by the Examiner, “[a]ctivation of the reed switch will either connect or
disconnect the battery,” and “[i]n the situation where the switch disconnects
the battery, the implant is rendered inoperative, thus fulfilling the definition
of dormant” (Ans. 15). We find that the incorporation of a static magnetic
field switch, such as that taught by McDonald, in the IPG taught by
Meadows in order to trigger the hibernation state would have been the
obvious “combination of familiar elements according to known methods”
that “does no more than yield predictable results.” See KSR, 550 U.S. at
416.
We therefore affirm the obviousness rejection of claims 12 and 22
based on the combination of Meadows and McDonald.

SUMMARY
We affirm the rejection of claims 1, 2, 5–7, 10, 11, 15–17, 19, and 23–
37 under 35 U.S.C. § 102(b).
We reverse the rejection of claims 4 and 18 under 35 U.S.C. § 102(b).
We affirm the rejection of claim 3 under 35 U.S.C. § 103(a) based on
Meadows.
We affirm the rejection of claims 12 and 22 under 35 U.S.C. § 103(a)
based on Meadows and McDonald.

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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-IN-PART

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