Ex Parte Goetz

Patent Trial and Appeal Board

Aug 11, 2017

13750832 (P.T.A.B. Aug. 11, 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.
13/750,832 01/25/2013 Steven M. Goetz 1023-928US02/P0035986USC7 6961
71996 7590 08/15/2017
SHUMAKER & SIEFFERT , P.A
1625 RADIO DRIVE , SUITE 100
WOODBURY, MN 55125
EXAMINER
LEVICKY, WILLIAM J
ART UNIT PAPER NUMBER
3762
NOTIFICATION DATE DELIVERY MODE
08/15/2017 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):
pairdocketing @ ssiplaw.com
medtronic_neuro_docketing @ cardinal-ip.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte STEVEN M. GOETZ
(Applicant: MEDTRONIC, INC.)1
Appeal 2016-003704
Application 13/750,832
Technology Center 3700
Before ERIC B. GRIMES, JEFFREY N. FREDMAN, and DAVID COTTA,
Administrative Patent Judges.
GRIMES, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims relating
to modeling the effect of therapy delivered to one anatomical structure on a
second anatomical structure, which have been rejected as obvious. We have
jurisdiction under 35 U.S.C. § 6(b).
We reverse.
STATEMENT OF THE CASE
“Medical devices, such as electrical stimulators, may be used in
different therapeutic applications. . . . Electrical stimulation therapy may
1 Appellant identifies the Real Party in Interest as Medtronic, Inc. (Appeal
Br. 3.)
Appeal 2016-003704
Application 13/750,832
include stimulation of nerve, muscle, or brain tissue, or other tissue within a
patient.” (Spec. 13.)
Claims 1—22 are on appeal. Claim 1 is illustrative and reads as
follows (emphasis added):
Claim 1: A method comprising:
defining, using a processor, a model of a network of interconnected
anatomical structures of a patient, wherein the model of the network
includes at least one link indicating a functional relationship between at least
a first anatomical structure and a second anatomical structure, the model
further indicating at least one stimulation induced side effect associated with
therapy delivered to at least one of the first anatomical structure or the
second anatomical structure;
sensing activity in at least the first anatomical structure, the activity
occurring in response to therapy delivered to the second anatomical
structure;
adjusting, based on the sensed activity, at least one of: the functional
relationship between the first anatomical structure and the second anatomical
structure, or the therapy delivered to the second anatomical structure.
Claims 10 and 19, the only other independent claims, are directed to a
system for carrying out the method of claim 1. Both of claims 10 and 19
require a model “indicating at least one stimulation induced side effect
associated with therapy delivered to at least one of the first anatomical
structure or the second anatomical structure.” (Appeal Br. 19, 21.)
DISCUSSION
The Examiner has rejected claims 1—20 under 35 U.S.C. § 103(a) as
obvious based on John2 and Krystal3 (Final Action 3). The Examiner has
2 US 2006/0217781 Al; published Sept. 28, 2006
3 US 5,626,627; issued May 6, 1997
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Application 13/750,832
rejected claims 21 and 22 under 35 U.S.C. § 103(a) as obvious based on
John, Krystal, and Garg4 (Final Action 8). The same issue is dispositive for
both rejections.
The Examiner finds that John teaches a method and system meeting
all of the limitations of the independent claims on appeal except that “John
does not disclose the model further indicating at least one stimulation
induced side effect associated with therapy delivered to at least one of the
first anatomical structure or the second anatomical structure.” (Final Action
3—4.) The Examiner finds that Krystal “teaches that it is known to use a
model indicating stimulation induced side effects associated with therapy
delivered as set forth in Column 3 lines 36-41 to provide optimizing the
administration of therapy by performing a risk to benefit analysis.” (Id. at
4.)
The Examiner concludes that it would have been obvious “to modify
the method as taught by John, with a model indicating stimulation induced
side effects associated with therapy delivered as taught by Krystal et al.,
since such a modification would provide the predictable results of
optimizing the administration of therapy by performing a risk to benefit
analysis.” (Id.)
Appellant argues that “Krystal does not disclose indicating at least one
stimulation induced side effect associated with therapy delivered to at least
one of a first anatomical structure or a second anatomical structure,” but
rather “discloses electroconvulsive therapy (ECT), in which ‘two stimulus
4 US 2008/0270188 Al; published Oct. 30, 2008
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Application 13/750,832
electrodes are applied to the patient’s scalp’ and ‘an electric current is
applied between these electrodes.’” (Appeal Br. 7.)
Appellant also argues that “the Examiner has not established that one
having ordinary skill in the art at the time of Appellant’s disclosure would
have had an apparent reason to modify the model disclosed by John in view
of the model disclosed by Krystal.” {Id. at 8.) Specifically, Appellant
argues that
Krystal fails to disclose that these models indicate any interaction
between brain structures. Thus, one having ordinary skill in the
art would not have looked to the models disclosed by Krystal that
are used to predict “associated side-effects for a given seizure”
to modify the method disclosed by John, which uses information
about interactions between brain structures “to guide the
adjustment of neurostimulation parameters.”
{Id.)
Appellant argues that “[t]he problems addressed in Krystal are
inapplicable to the system of John” because “the stimulation in Krystal
presents a situation in which achieving the desired therapeutic result — a
seizure — also causes a side effect” whereas “[tjhere is no indication in John
that achieving the desired therapeutic effect, such as alleviating pain or
preventing or disrupting a seizure, is associated with or causes a concurrent
side-effect.” {Id. at 9.)
We agree with Appellant that the Examiner has not shown that the
method of claim 1 would have been obvious to a person of ordinary skill in
the art based on John and Krystal. John discloses that “neurostimulators are
used to treat a wide variety of medical conditions including movement
disorders, epilepsy, pain, depression, and other disorders of the central
nervous system.” (John 14.) John states that past studies showed that
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Application 13/750,832
“stimulation caused modulation of activity in several areas distal from the
site of stimulation.” {Id. 1 6.)
John states that its invention
recognizes, addresses, and utilizes the interactions and
connectivity that exists between different brain regions of a brain
network to provide improved treatment. ... For example,
linking rules can be used to increase inhibitory stimulation at a
first area when stimulation is provided at a second area, wherein
the stimulation at second area has [been] shown to produce
unwanted increase in the activity of the first area.
{Id. 1 8.) More specifically, John discloses that
[w]hen stimulating brain networks the stimulation protocols of
current invention can incorporate these interactions in order to
more accurately and efficiently provide treatment, by
differentially modulating different brain regions in an intended
fashion. For example, linking rules can be used during neuro­
stimulation treatment to adjust for one or more interactions
between brain structures.
{Id. 1128.)
John also discloses that
information about the brain networks can be created using
modeling methods . . . , where, for example, a relevant brain
network can be identified [] as the regions (reflected as imaged
voxels of a neural region) which show covariance with a
characteristic of the disorder. . . . Accordingly, a brain network
may be identified as a circuit which is established by imaging
methods as correlated with at least one characteristic of a mood,
anxiety, or other psychiatric or neurological disorder.
{Id. 1106.)
Thus, John discloses a method in which “linking rules” are used to
adjust the parameters of neurostimulation treatment of a particular patient,
during the treatment, depending on the effect of the neurostimulation of one
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Application 13/750,832
brain region on the activity of a second brain region. John discloses that
modeling methods can be used to identify regions of the brain that are
associated with “mood, anxiety, or other psychiatric or neurological
disorder.” {Id.)
Krystal discloses an “electroconvulsive therapy (ECT) treatment
including methodology for simultaneously and accurately predicting seizure
adequacy during treatment.” (Krystal 1:14—17.) “In ECT two stimulus
electrodes are applied to the patient’s scalp. An electric current is applied
between these electrodes, only a fraction of which reaches the brain, the rest
being deflected by the skin and skull.” {Id. at 1:39-42.)
“The goal of ECT therapy is the induction of an electrical response in
the neural tissue of the patient’s brain. This appears on an electro­
encephalograph (EEG) instrument... as a pattern similar to a typical
epileptic grand mal seizure pattern.” {Id. at 1:48—52.) Krystal states that
“there is a relationship between the beneficial effects and adverse effects
associated with ECT treatments and the degree to which the stimulus
intensity exceeds the seizure threshold (the amount of electrical charge
necessary just barely to cause a seizure). This is termed relative stimulus
intensity.” {id. at 2:36-41.)
Krystal states that its invention “uses the EEG data, which is routinely
recorded noninvasively from the scalp during ECT treatments, for the
prediction of ECT seizure adequacy in terms of relative stimulus intensity,
therapeutic outcome, and adverse cognitive effects.” {Id. at 3:5—9.) That is,
“models are developed using data where the treatment relative stimulus
intensity, therapeutic potency, and associated adverse effects are known and
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Application 13/750,832
these models are then used for the prediction of the relative stimulus
intensity, expected therapeutic response, and associated side-effects for a
given seizure.” (Id. at 3:36-41.)
Thus, Krystal discloses using data recorded during ECT treatments, in
which an electric current is applied via electrodes attached to the patient’s
scalp in order to induce a seizure, in order to predict the relative stimulus
intensity, expected therapeutic response, and associated side-effects caused
by a given seizure.
We agree with Appellant that “[t]he problems addressed in Krystal are
inapplicable to the system of John.” (Appeal Br. 9.) That is,
the adverse cognitive effects, such as memory loss, appears to be
due to the seizures themselves. Accordingly, the stimulation in
Krystal presents a situation in which achieving the desired
therapeutic result — a seizure — also causes a side effect. ... In
contrast, John discloses providing therapy with immediate
therapeutic effect. . . . There is no indication in John that
achieving the desired therapeutic effect... is associated with or
causes a concurrent side-effect.
(Id.)
John’s method, as discussed above, is directed to a method of
optimizing the efficacy of neurostimulation therapy by monitoring the effect
of the therapy at one brain region on a second brain region and adjusting the
therapeutic parameters accordingly. The Examiner has not pointed to any
disclosure in John of side effects caused by its neurostimulation treatment.
In view of the differences between the therapies applied in John and
Krystal, and in view of the different purposes of the modeling discussed in
each reference, the Examiner has not provided sufficient reasoning to
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Application 13/750,832
support the conclusion that a person of ordinary skill in the art would have
considered it obvious to combine the teachings of the cited references.
In response to Appellant’s argument, the Examiner reasoned that John
and Krystal are analogous art. (Ans. 4.) Even assuming that John and
Krystal are in the same field of endeavor, however, that fact would not be
enough to support a prima facie case of obviousness. Rather, the Examiner
must identify a reason that would have led a skilled artisan to combine the
teachings of the references in the way that the claimed invention does. See
KSRInt’l Co. v. Teleflex Inc., 550 U.S. 398, 418-19 (2007) (“[I]t can be
important to identify a reason that would have prompted a person of
ordinary skill in the relevant field to combine the elements in the way the
claimed new invention does.”); Unigene Labs., Inc. v. Apotex, Inc., 655 F.3d
1352, 1360 (Fed. Cir. 2011) (“[0]bviousness requires the additional showing
that a person of ordinary skill at the time of the invention would have
selected and combined those prior art elements in the normal course of
research and development to yield the claimed invention.”).
The rejection of claims 21 and 22 under 35 U.S.C. § 103(a) as obvious
based on John, Krystal, and Garg relies on John and Krystal would have
made obvious the method of claim 1 (Final Action 8), and is also reversed
for the reasons discussed above.
SUMMARY
We reverse both of the rejections on appeal.
REVERSED
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