Ex Parte Scott

Patent Trial and Appeal Board

Jul 31, 2017

12359104 (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.
12/359,104 01/23/2009 Timothy L. Scott 104292-1255 3778
137985 7590 08/02/2017
FOT FY Rr T ARDNFR T T P
EXAMINER
3000 K STREET N.W. ALTER MORSCHAUSER, ALYSSA MARGO
SUITE 600
WASHINGTON, DC 20007-5109 ART UNIT PAPER NUMBER
3762
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):
ipdocketing @ foley. com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte TIMOTHY L. SCOTT
Appeal 2016-006391
Application 12/3 59,1041
Technology Center 3700
Before TAWEN CHANG, TIMOTHY G. MAJORS, and
DAVID COTTA, Administrative Patent Judges.
COTTA, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a method
of treating a medical condition in a patient using an implantable medical
device. The Examiner rejected the claims on appeal under 35 U.S.C.
§ 102(b) as anticipated.
We AFFIRM.
1 According to Appellant, the real party in interest is Cyberonics, Inc. App.
Br. 2.
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Application 12/359,104
STATEMENT OF THE CASE
The Specification teaches that “[tjherapies using electrical signals . . .
have been found to effective” in “treating diseases such as depression and
epilepsy.” Spec. 2. “Implantable medical devices [IMDs] have been
effectively used to deliver therapeutic stimulation to various portions of the
human body (e.g., the vagus nerve) for treating these diseases.” Id.
“Generally, IMDs for vagus nerve stimulation (VNS) provide a
conventional-type electrical signal, which may include pulse trains that are
approximately 30-60 seconds in length at 10-30 Hz, with off-times of from
about 7-300 seconds.” Id. at 6. The Specification explains:
conventional open-loop VNS consists of a single type of
stimulation signal that is provided based upon predetermined
parameters. Typically, a physician programs a first type of
stimulation signal to be delivered by the IMD for a period of
time. After this period of time, further evaluation of the
patient’s condition may prompt the physician to alter and
reprogram the IMD to provide a second stimulation signal
different, but largely similar to the first stimulation signal.
Regardless of the magnitude of the change, however, the
implementation of the second signal is done manually by the
physician, and a return to the first signal must likewise be
manually implemented by the physician. In this manner, the
conventional IMDs for VNS essentially provide just one type of
open-loop therapy at a time.
Id. at 6.
The Specification discloses that the present invention relates to
“medical device systems for applying electrical signals to a cranial nerve for
the treatment of various medical conditions, and for providing a chronic
condition therapy and an acute condition therapy using a microburst
electrical signal and a non-microburst electrical signal.” Id. at 1 (emphasis
added).
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Application 12/359,104
Claims 1—4, 6—11, 23—26 and 28—33 are on appeal. Claim 1 is
illustrative and reads as follows:
1. A method of treating a medical condition in a patient using
an implantable medical device, comprising: applying to a cranial
nerve a first electrical signal including at least one microburst of
a plurality of pulses during a first time period to treat the medical
condition, the first time period being a time period during which
there is no indication that an acute condition has occurred; and
applying a second electrical signal to the cranial nerve to treat
the medical condition in response to an indication of an acute
event associated with the medical condition for treating the acute
event, the second electrical signal including at least one burst of
a second plurality of pulses during a second time period that is a
non-micro burst, wherein the first time period occurs prior to the
second time period;
wherein applying the first electrical signal further
comprises applying the microburst signal in a predetermined
timing pattern;
wherein applying the second electrical signal in an acute
therapy mode is triggered by the indication of the acute event
where the acute therapy mode is implemented in a course that
has a predetermined duration, the predetermined duration being
independent of a change in an initiation signal for the second
electrical signal.
App. Br. 16.
The Examiner rejected claims 1—4, 6—11, 23—26 and 28—33 under 35
U.S.C. § 102(b) as anticipated by Craig.2
FINDINGS OF FACT
1. Craig discloses: “This invention relates generally to medical
device systems and, more particularly, to medical device systems for
applying electrical signals to a cranial nerve for the treatment of various
2 Craig, US Patent Publication No. 2007/0233193 Al, published Oct. 4,
2007 (“Craig”).
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Application 12/359,104
medical conditions, and for improved electrical signals in such systems.”
Craig 1 5.
2. Craig discloses:
While feedback stimulation schemes have been proposed,
conventional vagus nerve stimulation (VNS) usually involves
non-feedback stimulation characterized by a number of
parameters. Specifically, conventional vagus nerve stimulation
usually involves a series of electrical pulses in bursts defined by
an “on-time” and an “off-time.” During the on-time, electrical
pulses of a defined electrical current (e.g., 0.5—2.0 milliamps)
and pulse width (e.g., 0.25—1.0 milliseconds) are delivered at a
defined frequency (e.g., 20—30 Hz) for the on-time duration,
usually a specific number of seconds, e.g., 10—60 seconds. The
pulse bursts are separated from one another by the off-time, (e.g.,
30 seconds—5 minutes) in which no electrical signal is applied to
the nerve. The on-time and off-time parameters together define
a duty cycle, which is the ratio of the on-time to the combination
of the on-time and off-time, and which describes the percentage
of time that the electrical signal is applied to the nerve.
Id. at 111.
3. Craig discloses:
Applicant has discovered that it is possible to provide improved
therapeutic neurostimulation treatments for a variety of medical
conditions by a new type of electrical stimulation of the cranial
nerves capable of providing enhanced evoked potentials in the
brain. . . . The electrical signal for this improved therapy is
substantially different from the electrical signals in conventional
VNS. In particular, electrical signals in [Craig’s] invention are
characterized by very short bursts of a limited number of
electrical pulses. These short[] bursts of less than 1 second are
referred to hereinafter as “microbursts,” and electrical
stimulation applying microbursts to a cranial nerve is referred to
as “microburst stimulation.”
Id. at 115.
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4. Craig discloses:
In one embodiment, [Craig’s] invention provides a computer
readable program storage device encoded with instructions that,
when executed by a computer, perform a method, comprising
generating an electrical signal comprising a series of micro bursts
separated by interburst periods, with each microburst comprising
a number of pulses per microburst, an interpulse interval, and a
micro burst duration, wherein at least one of the interburst period,
the number of pulses per microburst, the microburst duration, or
the interpulse period is selected to enhance cranial nerve evoked
potentials, and applying the electrical signal to a cranial nerve of
the patient to treat the medical condition.
Id. at |20.
5. Craig discloses:
In a further embodiment, during the off-time of the microburst
stimulation, an alternative stimulation technique, such as
conventional cranial nerve stimulation, can be performed.
Conventional cranial nerve stimulation generally also involves
an on-time and an off-time, and the on-time of the micro burst
stimulation may be during the off-time of the conventional
cranial nerve stimulation.
If both microburst stimulation and an alternative stimulation
technique are performed, the on-times, the off times, or both of
the two stimulation regimes may partially or wholly overlap.
Id. at || 64—65.
6. Craig discloses:
[Stimulation may be provided in at least two different
modalities. Where cranial nerve stimulation is provided based
solely on programmed off-times and on-times, the stimulation
may be referred to as passive, inactive, or non-feedback
stimulation. In contrast, stimulation may be triggered by one or
more feedback loops according to changes in the body or mind
of the patient. This stimulation may be referred to as active or
feedback-loop stimulation. In one embodiment, feedback-loop
stimulation may be manually-triggered stimulation, in which the
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Application 12/359,104
patient manually causes the activation of a pulse burst outside of
the programmed on-time/off-time cycle. The patient may
manually activate the IMD 100 to stimulate the cranial nerve,
such as vagus nerve 127, to treat an acute episode of a medical
condition.
Id. at | 81
7. Craig discloses:
In one embodiment, the sensor may sense a body parameter that
corresponds to a symptom of a medical condition. If the sensor
is to be used to detect a symptom of the medical condition, a
signal analysis circuit may be incorporated into the IMD 100 for
processing and analyzing signals from the sensor. Upon
detection of the symptom of the medical condition, the processed
digital signal may be supplied to a microprocessor in the IMD
100 to trigger application of the electrical signal to the cranial
nerve, such as vagus nerve 127. In another embodiment, the
detection of a symptom of interest may trigger a stimulation
program including different stimulation parameters from a
passive stimulation program. This may entail providing a higher
current stimulation signal or providing a higher ratio of on-time
to off-time.
Id. at | 84.
8. Craig discloses:
The electrodes may be operatively coupled to at least one of a
main trunk of the right or left vagus nerve, or any branch thereof.
The IMD 100 may then generate a controlled electrical signal
characterized by an interburst period, a number of pulses per
microburst, an interpulse interval, and a microburst duration,
wherein at least one of the interburst period, the number of pulses
per microburst, the interpulse interval, or the microburst duration
is selected to enhance cranial nerve evoked potentials (block
720). This may include a predetermined electrical signal that is
preprogrammed based upon a particular condition of a patient.
Id. at | 85.
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ANALYSIS
Appellant argues the claims in three groups with Group I comprising
claims 1—4, and 6—11 (directed to methods of treating a medical condition),
Group 2 comprising claims 23—26 (directed to an implantable medical
device), and Group 3 comprising claims 28—33 (directed to a system for
treating a medical condition). Appellant’s arguments are substantially the
same for each group, focusing on claim language common to claims in all
three groups. Accordingly we address all three groups together.
Craig discloses a method of treating a medical condition by applying a
microburst of pulses to a cranial nerve during a time period when no acute
condition has occurred. See e.g., FF1, FF3, and FF6. A second non­
microburst signal may be applied in response to an acute event. See e.g.,
FF2, FF5, FF7. The first signal, the microburst signal, may be applied in a
predetermined timing pattern. See e.g., FF4, FF8. The second signal may be
triggered by an acute event and may have a predetermined duration that is
independent of any changes in the triggering signal. See e.g., FF6, FF7.
The Examiner found that Craig teaches all of the limitations of and
anticipates claims 1—4, 6—11, 23—26 and 28—33. We adopt the Examiner’s
findings of fact and reasoning regarding the scope and content of the prior
art (Ans. 3—9; Final Act. 2—8) and agree that the claims are anticipated by
Craig. We address Appellant’s arguments below.
Appellant argues that Craig does not disclose applying the microburst
signal in a “predetermined time pattern.” App. Br. 9. We are not persuaded.
Craig discloses that its medical device may be controlled by a
computer that is programmed to cause the device to generate microbursts in
which the number or pulses, duration, or interpulse period is selected to
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“enhance cranial nerve evoked potentials.” FF4. In executing this program,
and absent persuasive argument or evidence to the contrary, Craig’s
computer would apply the miocroburst signal in a “predetermined timing
pattern.” In addition, after disclosing that its device can generate signals
characterized by interburst period, number of pulses per microburst, an
interpulse interval, and a microburst duration, Craig states that its device
may generate “a predetermined electrical signal that is preprogrammed
based upon a particular condition of a patient.” FF8. This also conveys that
the programmed signal would include a “predetermined timing pattern.”
Appellant argues that Craig does not disclose that applying the second
electrical signal in an “acute therapy mode which is triggered by the
indication of the acute event where the acute therapy mode is implemented
in a course that has a predetermined duration where the predetermined
duration fis] independent of a change in an initiation signal for the second
electrical signal.” App. Br. 9; Reply Br. 3.
Appellant concedes that Craig discloses both feedback and non­
feedback based stimulation, but contends that “Craig does not disclose that
one treatment ‘is triggered by the indication of an acute event.’” Reply Br.
4. Appellant argues that in contrast to a treatment triggered by an acute
event, as claimed, Craig discloses a treatment that is “manually triggered.”
Id. We are not persuaded.
Craig discloses that a patient “may manually activate the IMD 100 to
stimulate the cranial nerve, such as vagus nerve 127, to treat an acute
episode of a medical condition.” FF6. While this passage does describe a
manually triggered treatment, the manual trigger is employed to treat an
“acute medical condition.” The fact that the acute medical condition is
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Application 12/359,104
sensed by the patient rather than by a medical sensor is immaterial. Nothing
in the claim requires that the therapy mode be triggered independent of
patient input.
In addition, Craig also discloses that a “sensor may sense a body
parameter that corresponds to a symptom of a medical condition” and that
“detection of the symptom of the medical condition” may “trigger
application of the electrical signal to the cranial nerve.” FF7. While this
disclosure does not track the “acute event” language of the claim verbatim, it
nonetheless contemplates a signal triggered by an acute event. See In re
Schaumann, 572 F.2d 312, 317 (CCPA 1978) “([Although appellants would
have us hold that Hildebrandt fails as an anticipation because it does not
contain a description of the subject matter of the appealed claims, ipsissimis
verbis, we cannot countenance a result which so obviously exhalts [sic] form
over substance.”).
Appellant argues that Craig’s second electrical signal is not disclosed
to be implemented in a course that has a “predetermined duration” that is
“independent of a change in the initiation signal for the second electrical
signal.” Reply. Br. 4. We are not persuaded.
Craig discloses that “the detection of a symptom of interest may
trigger a stimulation program including different stimulation parameters
from a passive stimulation program.” FF7. As “passive stimulation” is
expressly defined to be “non-feedback” stimulation (FF6), the stimulation
provided would be independent of any changes in the signal that initiated the
stimulation. In addition, Craig discloses simultaneously employing
microburst and conventional stimulation. FF5. Conventional stimulation
“usually involves non-feedback stimulation.” FF2.
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Accordingly, we find that a preponderance of the evidence supported
the Examiner’s determination that Craig anticipates claims 1—4, 6—11, 23—26
and 28—33.
SUMMARY
For the reasons provided herein, and those set forth in the Examiner’s
Answer and Final Office Action, we affirm the Examiner’s rejection of
claims 1—4, 6—11, 23—26 and 28—33 under 35 U.S.C. § 102(b) as anticipated
by Craig.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(1).
AFFIRMED
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