Ex Parte Heruth et al

Board of Patent Appeals and Interferences

Mar 7, 2012

11374793 (B.P.A.I. Mar. 7, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte KENNETH T. HERUTH, MARK S. LENT,
RUCHIKA SINGHAL, and MICHAEL J. SCHENDEL
__________

Appeal 2010-009170
Application 11/374,793
Technology Center 3700
__________

Before RICHARD E. SCHAFER, RICHARD TORCZON, and
LORA M. GREEN, Administrative Patent Judges.

GREEN, Administrative Patent Judge.

DECISION ON APPEAL
This is a decision on appeal under 35 U.S.C. § 134 from the
Examiner’s rejection of claims 1-19, 26, and 27.1 We have jurisdiction
under 35 U.S.C. § 6(b).

1 The Examiner withdrew the rejection of claims 20-25 (Ans. 3; see also
Reply Br. 3).
Appeal 2010-009170
Application 11/374,793

2
STATEMENT OF THE CASE
According to the Specification, the invention relates “to implantable
medical devices, systems and methods for coordinating therapy delivery
between a pulse generator and an infusion device” (Spec. 5).
The Specification teaches that a stimulation system that is capable of
providing electrical signals to one or more regions in proximity to the source
of pain may be used, wherein the system employs an implantable pulse
generator that can produce a number of independent stimulation pulses that
are sent to the region being treated using insulated leads that are connected
to electrodes (id. at 13). The Specification teaches further that various
stimulation parameters may be applied to a stimulation signal delivered by
an electrode, such as frequency and amplitude (current or voltage), pulse
width, etc. (id. at 15).
The Specification also teaches that pain treating agents may be
administered alone or in combination, as well as in combination with
stimulation (id. at 26). The Specification provides examples wherein one
pain agent may be administered during a period of low frequency
stimulation, and another agent may be administered in periods of high
frequency stimulation (id. at 26-28).
A system for such therapy may include a stimulation module and an
infusion module (id. at 33). As taught by the Specification:
[A] determination may be made as to whether a switch from
generation of a first electrical signal (e.g., low frequency) to a
second electrical signal (e.g., high frequency) has occurred . . . .
If such a switch has occurred a change in infusion parameter for
delivering a first therapeutic agent may be made at a
predetermined time relative to the switch . . . . If no such
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Application 11/374,793

3
switch has occurred, the infusion parameters associated with the
first therapeutic agent may remain unchanged, which may mean
that no agent is delivered . . . . Such a change in infusion rate
relative to a switch in stimulation parameters may occur one
time (e.g., as with a patient programmer request for additional
pain therapy) or may occur in a continuous manner . . .
indefinitely or for a defined period of time.

(Id. at 33.)
Claims 1, 26, and 27 are the independent claims on appeal, and are
drawn to an infusion system (claims 1 and 26), and a method of instructing
an infusion device (claim 27). Claims 1 and 27 are representative, and read
as follows:
1. A system comprising:
a pulse generator configured to alternate between generation of a first
electrical signal and generation of a second electrical signal;
a first infusion device configured to deliver a first therapeutic agent at a
first rate at a first predetermined time that is a first predetermined time
interval before or after a time when the pulse generator switches from
generation of the first signal to generation of the second signal; and
a control unit configured to coordinate the delivery of the first therapeutic
agent at the first rate from the first infusion device with the switch from the
generation of the first signal to the generation of the second signal.

27. A method comprising:
identifying whether a first predetermined electrical signal is being
generated by an implantable pulse generator via a control unit; and
instructing an infusion device to deliver a therapeutic agent at a rate if
the predetermined electrical signal is being generated via the control unit,
wherein the control unit is separate from the implantable pulse generator and
the infusion device.

Appeal 2010-009170
Application 11/374,793

4
The following grounds of rejection are before us for review:
I. Claims 1-3, 7-19, 26, and 27 stand rejected under 35 U.S.C.
§ 102(b) as being anticipated by Rise.2
II. Claims 4-6 stand rejected under 35 U.S.C. § 102(b), or in the
alternative, under § 103(a), as being anticipated or rendered
obvious by Rise.
We reverse
ANALYSIS
The Examiner finds that Rise teaches all of the components of the
system of claim 1 (Ans. 4). The Examiner relies on Figure 16C of Rise as
teaching the limitations of (1) a pulse generator configured to alternate
between generation of a first electrical signal and generation of a second
electrical signal; and (2) a first infusion device configured to deliver a first
therapeutic agent at a first rate at a first predetermined time that is a first
predetermined time interval before or after a time when the pulse generator
switches from generation of the first signal to generation of the second
signal (id.). The Examiner also cites Rise, column 8, lines 6-24, as
disclosing a signal generator that alternates between a first and second
electrical signal (id.).
Specifically, the Examiner finds:
Rise discloses the drug infusion device delivering the
therapeutic agent at a predetermined time in relation to
switching from generation of a first signal to generation of the
second signal as seen in Fig. 16c. Rise illustrates a square wave
signal for electrical stimulation and at the end of the first signal

2 Rise, US 6,128,537, issued Oct. 3, 2000.
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Appeal 2010-009170
Application 11/374,793

6
automatically determines the level of drug delivery required to alleviate the
symptoms of the neurological disorder (id. at col. 10, ll. 35-41). Rise also
teaches that treatment efficacy may be enhanced by stimulating the neural
tissue while the drugs are being administered (id. at col. 10, ll. 42-44). To
accomplish that stimulation, Rise teaches that the sensor output is input into
the pulse generator (id. at col. 10, ll. 44-67).

Claims 1-3, 7-19, and 26
Appellants argue that while “Rise describes delivering both
stimulation and drug therapy, Rise does not disclose or suggest a first
infusion device configured to deliver a first therapeutic agent at a first rate at
a first predetermined time that is a first predetermined time interval before or
after a time when the pulse generator switches from generation of the first
signal to generation of the second signal” (App. Br. 9). Appellants further
assert that the Examiner’s reasoning that changing from full-on electrical
stimulation to full-off electrical stimulation, which the Examiner finds reads
on changing from a first signal to a second, null signal, is incorrect, as claim
1 requires a pulse generator that is configured to alternate between
generation of a first electrical signal and a second electrical signal (id.).
Thus, as to Figure 16C of Rise, relied upon by the Examiner, Appellants
assert that the ordinary artisan would understand the pulses in Figure 16C to
be single periodic signal, not two different electrical signals (Reply. Br. 5).
As to Figure 16C, we agree with Appellants that the ordinary artisan
would understand the pulses produced by the signal generator to stimulate
the desired neuronal tissue to be a single periodic signal, and not two
Appeal 2010-009170
Application 11/374,793

7
different signals. First, as taught by Rise, Figure 16C demonstrates
alternating infusion of a drug substance with stimulation of the neuronal
tissue, and thus the ordinary artisan would understand that the pulse
generator is producing a single, periodic signal. Second, in light of the
Specification, the ordinary artisan would interpret “first signal” and “second
signal” as required by claim 1 as referring to signals that differ in stimulation
parameters such as frequency and amplitude (current or voltage), pulse
width, etc. (See Spec. 15.)
Moreover, Rise does not teach that the infusion device is “configured
to deliver a first therapeutic agent at a first rate at a first predetermined time
that is a first predetermined time interval before or after a time when the
pulse generator switches from generation of the first signal to generation of
the second signal,” as required by independent claim 1, or that the infusion
device is “configured to deliver a first therapeutic agent at a predetermined
time that is a predetermined time interval before or after a time when the
pulse generator switches from generation of the first signal to generation of
the second signal” as required by independent claim 26. Rather, at best,
Rise discloses that a dosing schedule may be programmed into the infusion
device, or be controlled by a sensor within a closed loop feedback system
(Rise, col. 10, ll. 35-41). We thus reverse the anticipation rejection over
Rise as to claims 1-3, 7-19, and 26.

Claim 27
Appellants argue that while Rise “describes that the implanted device
may be programmed via telemetry,” Rise does not disclose “that a device
Appeal 2010-009170
Application 11/374,793

8
separate from the pulse generator and infusion device identifies whether the
pulse generator is generating a first electrical signal and controls the infusion
device to deliver a therapeutic agent based on the identification” (App. Br.
13).
For the reasons set forth above with respect to claims 1 and 26, we
agree with Appellants that the Examiner has not provided evidence that Rise
meets the method limitation of “identifying whether a first predetermined
signal is being generated by an implantable pulse generator via a control
unit,” such that the infusion device is instructed to deliver a therapeutic
agent based on whether the predetermined signal was generated.” as required
by the method of claim 27. That is, Figure 16C of Rise, relied upon by the
Examiner, only shows that the infusion of an agent may be alternated with
application of electrical stimulation (Rise, col. 14, ll. 33-36). Figure 16C, in
and of itself, does not demonstrate whether the control unit has identified
whether a not a predetermined signal is being generated by the pulse
generator. Rise, as discussed above, teaches that dosages and corresponding
time increments for the therapeutic agent may be programmed into a
microprocessor for delivery of the active agent (id. at col. 6, ll. 13-25; col.
10, ll. 35-37), or that a sensor may be used with a closed feedback system to
automatically determine the amount of drug delivery. Thus, as the
microprocessor of Rise is executing a program to control delivery of the
therapeutic agent by the infusion device, there would be no reason for the
control unit to “identify[ ] whether a first predetermined electrical signal is
being generated by an implantable pulse generator via a control unit,” as the
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Application 11/374,793

9
microprocessor would control whether or not there is a signal. We thus
reverse the anticipation rejection over Rise as to claim 27 as well.

Claims 4-6
As to claims 4-6, Appellants reiterate the arguments made with
respect to claim 1 (App. Br. 13). Claims 4-6 depend from claim 1. We
reverse the obviousness rejection as well. The Examiner did not explain
how the above-noted differences between the subject matter of claim 1 and
Rise are rendered obvious.

SUMMARY
The rejections of:
I. Claims 1-3, 7-19, 26, and 27 under 35 U.S.C. § 102(b) as being
anticipated by Rise; and
II. Claims 4-6 under 35 U.S.C. § 102(b), or in the alternative, under
§ 103(a) as being anticipated or rendered obvious by Rise;
are reversed.

REVERSED

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