Ex Parte Fletcher et al

Patent Trial and Appeal Board

Sep 27, 2017

13722260 (P.T.A.B. Sep. 27, 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.
13/722,260 12/20/2012 Kellie Fletcher ATI-020906 US ORD 5253
26294 7590 09/29/2017
TAROLLI, SUNDHEIM, COVELL & TUMMINO L.L.P.
1300 EAST NINTH STREET, SUITE 1700
CLEVELAND, OH 44114
EXAMINER
FLORY, CHRISTOPHER A
ART UNIT PAPER NUMBER
3762
NOTIFICATION DATE DELIVERY MODE
09/29/2017 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):
rkline @ tarolli. com
docketing@tarolli.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte KELLIE FLETCHER, PATRICK HARD,
ANTHONY V. CAPARSO, and KAREN TSUEI1
Appeal 2016-008107
Application 13/722,260
Technology Center 3700
Before JOHN E. SCHNEIDER, RYAN H. FLAX, and
TIMOTHY G. MAJORS, Administrative Patent Judges.
FLAX, Administrative Patent Judge.
DECISION ON APPEAL
This is a decision on appeal under 35 U.S.C. § 134(a) involving
claims directed to a method for conducting a clinical trial with an
implantable neurostimulator. Claims 1, 4, 6—21, and 51 are on appeal as
rejected under 35 U.S.C. § 103(a).2 We have jurisdiction under 35 U.S.C.
§ 6(b).
We affirm.
1 Appellants identify the Real Party in Interest as “Autonomic Technologies,
Inc.” App. Br. 3.
2 Claims 22-49 stand withdrawn due to a restriction. App. Br. 5.
Appeal 2016-008107
Application 13/722,260
STATEMENT OF THE CASE
The Specification states:
The invention relates generally to systems, devices, and methods
for using an implantable medical device to deliver therapy to a
patient. More specifically, according to one aspect of the
invention, systems, devices, and methods according to the
invention are used to deliver electrical stimulation to a
peripheral, central or autonomic neural structure.
Spec. 12. The Specification further states:
Ongoing clinical studies evaluate the efficacy, safety, and
reliability of new devices and methods for treatment of such
headaches. A proposed new therapy requires approval from a
regulatory authority before being granted permission to be
marketed. . . . Such studies typically include a patient group
which receives a placebo treatment, as for example when the
study relates to a new pharmacological agent.
Id. 1 8. The Specification describes an exemplary clinical trial design
having “three therapy modes: full therapy mode, placebo therapy mode, and
sub-perception therapy mode.” Id. at 174. The Specification describes that,
in a full therapy mode, a full therapeutic stimulation is applied and the
patient can experience the sensation of the therapy (e.g., tingling or tickling
sensations) associated with neurostimulation. Id. 175. The Specification
describes that, in a placebo therapy mode, the system indicates to the patient
that stimulation is being applied, but no stimulation is applied to the patient.
Id. 176. The Specification describes that, in a sub-perception therapy mode
some, but less than full, stimulation is applied, but necessarily less than can
be sensed by the patient (e.g., no tickling, tingling, or pain) and the system
does not indicate to the patient that the stimulation is occurring, thus
blinding the patient to this mode. Id. ]f 77.
2
Appeal 2016-008107
Application 13/722,260
Claim 1 is representative and is reproduced below:
1. A method for conducting a clinical trial with an implantable
neurostimulator, the method comprising the steps of:
implanting a neurostimulator in a trial subject, the
neurostimulator being capable of providing an adjustable level of
therapy;
using the neurostimulator to apply therapy to the trial
subject; and controlling the application of therapy applied to the
trial subject according to a clinical trial design that selects a
therapy mode from a group of available therapy modes
comprising:
a full therapy mode in which stimulation is applied
at a level sufficient to both apply therapy to the trial
subject and to allow the trial subject to perceive that the
therapy is being applied,
a placebo therapy mode in which stimulation at a
level sufficient to apply therapy is not applied, and
a sub-perception therapy mode in which stimulation
is applied at a level sufficient to apply therapy to the trial
subject, but insufficient to allow the trial subject to
perceive that therapy is being applied, the sub-perception
therapy mode blinding the trial subject as to whether full
therapy or placebo therapy is being applied.
App. Br. 22 (Claims App’x).
The following rejections are on appeal:
Claims 1, 4, 6—10, and 51 stand rejected under 35 U.S.C. § 103(a)
over Harris3 and Bradley4 or Park.5 Final Action 3.
3 US 2008/0021341 A1 (published Jan. 24, 2008) (“Harris”).
4 US 2003/0139781 A1 (published July 24, 2003) (“Bradley”).
5 US 2007/0299476 A1 (published Dec. 27, 2007) (“Park”).
3
Appeal 2016-008107
Application 13/722,260
Claims 11—21 stand rejected under 35 U.S.C. § 103(a) over Harris and
Bradley or Park and also Burnett6 or Kehr.7 Final Action 3.
FINDINGS OF FACT
We adopt the Examiner’s findings of fact, reasoning on scope and
content of the claims and prior art, and conclusions set out in the Final
Action and Answer. The findings of fact set forth below are provided to
highlight certain evidence.
FF1. Harris discloses “[t]he present invention provides
methods and systems for improving clinical trials of experimental
therapies,” where “FIG. 12 illustrates a simplified method of
performing a clinical trial” and “FIG. 13 illustrates a more detailed
method of performing a clinical trial.” Harris Abstract, || 46-47,
Figs. 12, 13; see also Final Action 3—11, and Ans. 2—9 (discussing
Harris).
FF2. Further to the preceding finding of fact, Harris discloses
“the experimental therapy may comprise electrical stimulation. The
electrical stimulation may comprise cortical stimulation, deep brain
stimulation, cranial nerve stimulation, peripheral nerve stimulation
(e.g., vagus nerve), or the like.” Harris 115; see also Final Action 3—
11, and Ans. 2—9 (discussing Harris).
FF3. Further to the preceding findings of fact, Harris discloses
“[i]n some cases, it may be desirable to change at least one parameter
6 US 2003/0158583 A1 (published Aug. 21, 2003) (“Burnett”).
7 US 2003/0036683 A1 (published Feb. 20, 2003) (“Kehr”).
4
Appeal 2016-008107
Application 13/722,260
of the therapy after the second time period has finished,” and “[t]he
parameter change may be any desired parameter. ... For electrical
stimulation, the parameter change may include frequency, pulse
amplitude, pulse width, pulses per burst, burst frequency, burst/no­
burst, duty cycle, etc.” Harris 19—20; see also Final Action 3—11,
and Ans. 2—9 (discussing Harris).
FF4. Harris discloses:
In a further aspect, the present invention provides a
method of evaluating an experimental therapy for a patient
population in a clinical trial. The method comprises minimally
invasively implanting the patient population with one or more
devices (e.g., between the skull and at least one layer of the scalp)
that are configured to measure a physiological signals from a
patient and processing the physiological signal from the patient
population for a baseline period to obtain a first patient data. A
placebo therapy is commenced in a control group of the patient
population and the experimental therapy is commenced in an
intervention group of the patient population. The physiological
signal from the control group and the intervention group are
measured for a second time period after the patients’ have
commenced the placebo therapy and experimental therapy,
respectively. The physiological signals obtained during the
second time period are processed to obtain a second patient data.
The experimental therapy is evaluated by analyzing the first
patient data and the second patient for both the control group and
the intervention group.
Harris 125; see also Final Action 3—11, and Ans. 2—9 (discussing
Harris).
FF5. Harris discloses:
For patients suspected or known to have epilepsy, the
systems of the present invention may be used to provide data and
other metrics to the patients and physicians that heretofore have
5
Appeal 2016-008107
Application 13/722,260
not been accurately measurable. For example, the data may be
analyzed to . . . determine the effect of, and the adjustment to
parameters of, electrical stimulation (e.g., vagus nerve
stimulation (VNS), deep brain stimulation (DBS), cortical
stimulation, etc.).
Harris | 61; see also Final Action 3—11, and Ans. 2—9 (discussing
Harris).
FF6. Harris discloses:
such methods are equally applicable to assessing the
efficacy and optimizing patient-specific parameters of non-
pharmacological therapies. For example, the present invention
may also be used to evaluate and optimize parameters for the
electrical stimulation provided by the Vagus Nerve Stimulator
(sold by Cyberonics Corporation), Responsive Neurostimulator
(RNS) (manufactured by NeuroPace Corporation), Deep Brain
Stimulators (manufactured by Medtronic), and other commercial
and experimental neural and spinal cord stimulators.
Furthermore, the systems of the present invention will also
be able to provide metrics for the effectiveness of changes to
various electrical parameters (e.g., frequency, pulse amplitude,
pulse width, pulses per burst, burst frequency, burst/no-burst,
duty cycle, etc.) for the electrical stimulation treatments. Such
metrics will provide a reliable indication regarding the
effectiveness of such parameter changes, and could lead to
optimization of stimulation for parameters for individual patients
or the patient population as a whole.
Harris 158—59; see also Final Action 3—11, and Ans. 2—9
(discussing Harris).
FF7. Harris discloses:
It should be appreciated however, that the present
invention is not limited to clinical trials for epilepsy therapies,
and the present invention has equal applicability to other clinical
trials (e.g., cancer therapy, cardiac therapy, therapy for other
6
Appeal 2016-008107
Application 13/722,260
neurological disorders, therapy for psychiatric disorders, or the
like.)
FIGS. 12-13 illustrate some methods of performing
clinical trials that are encompassed by the present invention. The
present invention is applicable to any type of clinical trial,
including but not limited to a randomized clinical trial, e.g., an
open clinical trial, a single-blinded study, a double-blinded
study, a triple-blinded study, or the like.
Harris 162—63; see also Final Action 3—11, and Ans. 2—9
(discussing Harris).
FF8. Bradley discloses “current is delivered to each electrode
implanted in the patient’s body while the electric field potential is
measured on all other electrodes NOT involved in sinking/sourcing
current. The constant current may be set to a subperception level, or
to another suitable level that is comfortable for the patient” and “a
first step involves applying suitable stimuli, e.g., subperception
stimuli.” Bradley 61, 65; see also Final Action 3—5, 8—11, and
Ans. 2—6, 8—9 (discussing Bradley).
FF9. Park discloses “delivering electrical stimulation to a
sympathetic afferent nerve, acquiring information indicative of
autonomic tone and, based at least in part on the information,
determining if the delivering caused an increase in parasympathetic
nerve activity” and “[vjarious exemplary techniques may include
delivering nerve stimulation sub-threshold (to avoid muscle
contraction) and/or sub-perception stimulation (to avoid sensation,
pain, etc.).” Park Abstract, till; see also Final Action 3—5, 7—11,
and Ans. 2—6, 8—9 (discussing Park).
7
Appeal 2016-008107
Application 13/722,260
DISCUSSION
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). Because Appellants present
essentially the same arguments and evidence in support of the patentability
of the claims over each rejection, we address both rejections together.
“[Wjhen a patent claims [something] 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.”
KSRInt’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007), citing United States
v. Adams, 383 U.S. 39, 50—51 (1966). “The combination of familiar
elements according to known methods is likely to be obvious when it does
no more than yield predictable results.” Id. As to motivation to combine
separately disclosed subject matter, “the question is whether there is
something in the prior art as a whole to suggest the desirability, and thus the
obviousness, of making the combination, not whether there is something in
the prior art as a whole to suggest that the combination is the most desirable
combination available.” In re Fulton, 391 F.3d 1195, 1200 (Fed. Cir. 2004)
(citation omitted).
It is prima facie obvious to combine two [things] each of which
is taught by the prior art to be useful for the same purpose, in
order to form a third [thing] which is to be used for the very same
purpose. . . . [T]he idea of combining them flows logically from
their having been individually taught in the prior art.
In re Kerkhoven, 626 F.2d 846, 850 (CCPA 1980). Further,
an implicit motivation to combine exists not only when a
suggestion may be gleaned from the prior art as a whole, but
8
Appeal 2016-008107
Application 13/722,260
when the ‘improvement’ is technology-independent and the
combination of references results in a product or process that is
more desirable, for example because it is stronger, cheaper,
cleaner, faster, lighter, smaller, more durable, or more efficient.
Because the desire to enhance commercial opportunities by
improving a product or process is universal—and even common-
sensical— . . . there exists in these situations a motivation to
combine prior art references even absent any hint of suggestion
in the references themselves. In such situations, the proper
question is whether the ordinary artisan possesses knowledge
and skills rendering him capable of combining the prior art
references.
Dystar Textilfarben Gmbh & Co. Deutschland KG v. C.H. Patrick Co., 464
F.3d 1356, 1368 (Fed. Cir. 2006).
Finally, we note that “[n]on-obviousness cannot be established by
attacking references individually where the rejection is based upon the
teachings of a combination of references. . . . [The references] must be read,
not in isolation, but for what [they] fairly teach [] in combination with the
prior art as a whole.” In re Merck & Co., 800 F.2d 1091, 1097 (Fed. Cir.
1986).
Reviewing the Examiner’s rationale for the obviousness rejections and
the cited prior art combinations, we find that in view of the findings of fact
set forth above, and under the above-cited precedent, the Examiner has
established that Appellants’ claims would have been obvious. In agreement
with the Examiner, we find that the prior art combination teaches conducting
a clinical trial using electrical neurostimulation therapy where the therapy is
selected from a full therapy mode, a placebo therapy mode, and a sub­
perception therapy mode, including in a blind study. See, e.g., Final Action
3; FF1—FF9. Further, we find that the skilled artisan would have combined
9
Appeal 2016-008107
Application 13/722,260
Harris and Bradley or Park because, inter alia, Harris discloses using full
and placebo electrostimulation therapy, adjusting the stimulation between
the two, and monitoring the results thereof to optimize stimulation
parameters (FF2—FF6) and, further, because a sub-perception stimulation is
comfortable and/or allows the avoidance of sensation and/or pain, etc. (FF8,
FF9). Further, the skilled artisan would have reasonably expected such a
combination to succeed because Harris explains that full, placebo, and
intermediate stimulation therapy is within the scope of its invention and
because Park explains that sub-perception stimulation is suitable for nerve
stimulation therapy. FF6, FF9.
Appellants have not produced evidence showing, or persuasively
argued, that the Examiner’s determinations are incorrect. We address
Appellants’ arguments below.
Appellants assert, “[t]he Examiner admits that Harris does not
disclose sub-perception therapy,” and argue “[njeither Bradley nor Park,
however, teach this alleged sub-perception therapy mode in addition to a full
therapy and placebo therapy mode.” App. Br. 13. Appellants contend
Bradley and Park are not related to conducting a clinical trial or blinding a
trial subject to therapy application, so their disclosures of sub-perception
therapy cannot be combined with a clinical trial, as in Harris. Id. at 13—14;
see also id. at 18—19 (Appellants essentially reiterate these arguments).
This argument is not persuasive. Non-obviousness over a
combination of prior art cannot be established by attacking the references
individually. See In re Merck & Co., 800 F.2d at 1097. The Examiner has
based the rejection primarily upon the teachings of Harris, which teaches
10
Appeal 2016-008107
Application 13/722,260
and suggests all aspects of the invention of claim 1, but not that its disclosed
adjusted stimulation therapy is a sub-perception therapy. The Examiner
looked to Bradley and Park as teaching such a sub-perception mode and as
explaining why such a mode is advantageous. We find the Examiner’s
rationale for combining the references to include the sub-perception mode of
Park or Bradly in Harris’s clinical trial method to be reasonable.
Appellants argue there would have been no reason to combine Harris,
Bradley, and/or Park because avoiding pain to a patient, which Bradley (and
Park) identify as an advantage relating to sub-perception therapy, would
make no sense. According to Appellants, once the methods of Bradley or
Park are applied to Harris, “therapy is delivered without pain, discomfort,
etc.,” assumedly under a sub-perception therapy mode, and there would be
no reason for a full therapy mode. App. Br. 15—16; see also id. at 18—19
(Appellants essentially reiterate these arguments at this later point in the
Brief).
This argument is not persuasive. As identified by the Examiner, there
is no evidence that any of Harris’s stimulation modes necessarily causes pain
or discomfort. See, e.g., Ans. 3. However, eliminating any sensation
associated with electrical neurostimulation, as suggested by the combination
of Bradley or Park with Harris, would be desirable and advantageous and
there is no evidence that making such a combination would cause a full
stimulation therapy of Harris to be replaced in a clinical trial setting.
Appellants argue combining Harris, Bradley, and/or Park would
destroy the intent, purpose, and function of the later two’s systems because,
claim 1 requires a full therapy mode (that allegedly causes pain or
11
Appeal 2016-008107
Application 13/722,260
discomfort), which Bradley and Park are specifically designed to avoid.
App. Br. 16.
This argument is not persuasive. First, the Examiner is not proposing
to modify the systems or methods of Bradley or Park. And, in any event,
even if the combination with Harris ran counter to some of Bradley’s or
Park’s teachings, that is not dispositive. See also In re Urbanski, 809 F.3d
1237, 1243 (Fed. Cir. 2016) (holding that a combination of references may
be obvious even if the combination is at the expense of a benefit of one of
the references). Second, as noted above, Appellants’ argument presumes
that a full therapy mode necessarily causes pain, but that is not supported by
the evidence. And third, the Examiner has added Park’s or Bradley’s sub­
perception stimulation mode therapy to Harris as, in the Examiner
terminology, an “N-th mode,” in addition to a placebo mode and a full
therapy mode described by Harris. Doing so is within the scope of the
invention described by Harris and would not destroy the intent, purpose, or
function of Harris’s method, and the Examiner has provided reasoning with
a rational basis explaining why it would be advantageous to do so.
Appellants argue that the Examiner has mischaracterized the
disclosure of Harris, which, while acknowledging that full therapy and
placebo modes exist, and further acknowledging that “Harris teaches a
system and method for monitoring and evaluating a clinical trial,” does not
disclose administering stimulation therapy in a clinical trial setting. App.
Br. 17, 19. Rather, Appellants argue, Harris’s system is used for monitoring
(not stimulating) long-term, epileptic patients. Id.
12
Appeal 2016-008107
Application 13/722,260
Appellants’ argument is not persuasive. It could not be clearer that
Harris is directed to and discloses using electrical neurostimulation in a
clinical trial setting. See, e.g., FF1—FF7.
Appellants also separately indicate that claim 6 is allowable, but
merely identity limitations recited by the claim while arguing they are not
disclosed or suggested by the prior art. Statements in a brief that “merely
mention [a] claim . . . and lack any type of separate, substantive argument
concerning the claim” are not sufficient to constitute separate argument
regarding that claim under 37 C.F.R. § 41.37(c)(l)(vii). In re Kao, 639 F.3d
1057, 1065 (Fed. Cir. 2011). Thus, Appellants’ argument is not persuasive.
Appellants make no arguments specifically directed to the
patentability or rejection of claims 11—21 over Harris, Bradley or Park, and
Burnett or Kehr.
In view of the above, we affirm each obviousness rejection.
SUMMARY
The rejections of the claims as obvious are each affirmed.
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
13