Ex Parte Jaax et al

Patent Trial and Appeal Board

Oct 30, 2014

12575974 (P.T.A.B. Oct. 30, 2014)

UNITED STATES PATENT AND TRADEMARKOFFICE
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.
12/575,974 10/08/2009 Kristen N. Jaax 05-00691-05 1088
71422 7590 10/30/2014
VISTA IP LAW GROUP LLP/BSC - NEUROMODULATION
2040 MAIN STREET, Suite 710
IRVINE, CA 92614
EXAMINER
D ABREU, MICHAEL JOSEPH
ART UNIT PAPER NUMBER
3762
MAIL DATE DELIVERY MODE
10/30/2014 PAPER
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.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte KRISTEN N. JAAX, TODD K. WHITEHURST,
RAFAEL CARBUNARU, and ALLISON M. FOSTER
__________

Appeal 2012-006095
Application 12/575,974
Technology Center 3700
__________

Before DONALD E. ADAMS, 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 method
of treating a patient having autism. The Examiner rejected the claims on
obviousness grounds. We have jurisdiction under 35 U.S.C. § 6(b). We
affirm.

1 Appellants identify the Real Party in Interest as Boston Scientific
Neuromodulation Corporation. (See App. Br. 2).
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Application 12/575,974

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STATEMENT OF THE CASE
Background
“Various regions in the brain have been shown to demonstrate
structural or functional abnormalities in connection with a diagnosis of
autism” (Spec. ¶ 5).
Studies examining regional variations suggest significant
enlargements in the temporal, parietal, and occipital lobes.
Other areas of the brain including, but not limited to, the
fusiform gyrus, amygdala, cingulate gyrus, basal ganglia, and
corpus callosum have all been shown to be enlarged or to
demonstrate decreased or abnormally low activity in autistic
patients

(Id.). The Specification describes “[m]ethods of treating autism include
applying at least one stimulus to a stimulation site within the brain of a
patient with an implanted stimulator in accordance with one or more
stimulation parameters” (Id. ¶ 6).
The Claims
Claims 21–30 are on appeal. Independent claim 21, the sole
independent claim, is representative, and reads as follows:
21. A method of treating a patient having autism, said
method comprising:
applying at least one stimulus to a stimulation site within
a brain of said patient in accordance with one or more
stimulation parameters, thereby treating said autism;
wherein said stimulation site comprises at least one of a
ventricle, a corpus collosum, a stria terminalis, and a medial
septal nucleus.

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The Issue

The Examiner has rejected the claims under 35 U.S.C. § 103(a) as
being unpatentable over the combination of Morrell2 and Rezai.3 The issue
presented on appeal is whether the Examiner presented a prima facie
showing of obviousness to stimulate at least one of a ventricle, a corpus
collosum, a stria terminalis, and a medial septal nucleus region within the
brain in order to treat a patient having autism.
FINDINGS OF FACT
FF1. Morrell teaches that “[m]odulation of the function of the cingulate
cortex can alleviate symptoms associated with psychiatric
disorders believed to arise because of functional or structural
abnormalities of this structure” (Morrell, col. 3 ll. 46–49). Morrell
further teaches that “[d]ysfunction of the cingulate cortex is also
implicated in the social disability associated with autism and
pervasive developmental disorders” (id. at col. 3 ll. 54–56).
FF2. Morrell teaches that “[t]he precise region of the cingulate cortex
over which therapy is optimally applied may differ from individual
to individual and by the psychiatric or behavioral disorder” (id. at
col. 4 ll. 25–27). Morrell further teaches that “[d]irect cortical
stimulation of the cingulate cortex using a device according to the
invention provides advantages over resective and lesion-based
surgery and over deep-brain stimulation” (id. at col. 4 ll. 47–50).
FF3. Rezai generally teaches the electrical and/or chemical stimulation
of specific regions of the brain, including, inter alia, the thalamus

2 Morrell, US 7,353,065 B2, issued Apr. 1, 2008.
3 Rezai, US 2003/0181954 A1, published Sep. 25, 2003.
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and the cingulate cortex, in order to treat a variety of psychiatric
disorders, including autism (Rezai, ¶ 29).
FF4. Rezai teaches that
The architecture of the brain provides a substantial advantage in
the search for a general solution to undesirable neuronal activity.
This design advantage takes the form of a centralized signaling
nexus through which many of the brain’s disparate functions are
channeled in an organized and predictable manner. More
particularly, the thalamus is comprised of a large plurality (as
many as one hundred or more) of neuronal bundles or nuclei, as
well as white matter tracts (highways of information) which
receive and channel nerve activity from all areas of the nervous
system and interconnects various activities within the brain. The
thalamus is analogous to a centralized train station such as a
grand central station. Many different train tracks come together,
and many trains carrying many different cargoes enter and exit;
however, if one has a schedule and a map, it is easy to find all
the trains that carry coal because all coal carriers are routed
through the same tracks.

(Id. ¶ 77).
Rezai further teaches that
[I]n the thalamus, all the brain signals travel in an organized
fashion. The activities in the peripheral areas of the brain
which are associated with the same, or similar conditions, are
channeled through the same areas of the thalamus. In this way,
the thalamus acts as a train relay station, or as a post office, re-
routing disparate signals along similar paths when the
appropriate outcomes of the original signals are similar.

(Id. ¶78). Based on this observation, Rezai teaches “the treatment of
common neurological disorders, particularly psychiatric disorders, by brain
stimulation of one specific area, rather than having to customize the (gross)
placement of the stimulator and/or catheter for each patient” (id. ¶ 79).
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Rezai states that “although Direct stimulation in the regions described herein
is one aspect of the present invention, modulation of the thalamus and the
thalamic nuclei to effect another region of the brain is a preferred
embodiment of the present invention” (id.).
FF5. Figure 1B of the Specification is reproduced below (annotations
added):

FIG. 1B depicts, in perspective view, the structures of the
brain that make up the limbic system. The limbic system is
involved with emotion formation, learning, and memory. As
shown in Fig. 1B, the limbic system includes, but is not limited
to, several subcortical structures located around the thalamus
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(16). Exemplary structures of the limbic system include the
cingulate gyrus (14), corpus collosum (15), thalamus (16), stria
terminalis (17), caudate nucleus (18), basal ganglia (19),
hippocampus (20), entorhinal cortex (21), amygdala (22),
mammillary body (23), medial septal nucleus (24), prefrontal
cortex (25), and fornix (26).

(Spec. ¶ 22).
FF6. The Specification teaches:
Nearly every brain area has been implicated in autism.
However, studies have shown that structures of the temporal
lobe (11) (e.g., the fusiform gyrus (27)) and the limbic system
(e.g., the cingulate gyrus (14), corpus collosum (15), thalamus
(16), stria terminalis (17), caudate nucleus (18), basal ganglia
(19), hippocampus (20), entorhinal cortex (21), amygdala (22),
mammillary body (23), medial septal nucleus (24), prefrontal
cortex (25), and fornix (26)) are most likely to be primarily
responsible for the deficits of autism. These brain structures
normally mediate the processing of emotional and social
information, which are the primary characteristics that are
disordered in autism.

(Id. ¶ 26). The Specification further teaches “[i]t is believed that applying a
stimulus to one or more areas of the brain may be useful in treating autistic
patients” (id. ¶ 29). “The stimulation site referred to herein may include any
area within the brain” (id. ¶ 31).

PRINCIPLES OF LAW
“[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
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application is beyond his or her skill.” KSR Int’l Co. v. Teleflex Inc., 550
U.S. 398, 417 (2007). Furthermore,
[w]hen there is a design need or market pressure to solve a
problem and there are a finite number of identified, predictable
solutions, a person of ordinary skill has good reason to pursue
the known options within his or her technical grasp. If this
leads to the anticipated success, it is likely the product not of
innovation but of ordinary skill and common sense. In that
instance the fact that a combination was obvious to try might
show that it was obvious under § 103.

Id. at 421.
ANALYSIS
The Examiner finds that “Morrell indicates that the stimulating
electrodes may be placed in the subdural space or within the limbic system
of the patient, specifically the cingulate cortex (e.g. Col 3, line 64 - Col 4,
line 3)” and that “Rezai specifies the treatment of psychiatric disorders,
including autism, by electrically or chemically stimulating the thalamus (e.g.
¶ [0029-0030]) because the thalamus has a large plurality of nuclei, which
receive and channel nerve activity from all areas of the nervous system (e.g.
¶ [0077-0078])” (Ans. 5). Based on the finding that “the corpus callosum,
cerebral ventricle, stria terminalis, and medial septal nucleus are all in the

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central region of the brain and are effectively interconnected with one
another,” the Examiner asserts that
it would have been obvious to one of ordinary skill in the art to
try, choosing from a finite number of identified and predictable
solutions as exhibited by both Morrell and Rezai to yield the
predictable results of stimulating the brain at a central location
which is in communication with a variety of signals coming
from both the central and peripheral nervous system, with a
reasonable expectation of success.

(Id.).
Based on the cited teachings of the prior art (FF1–4) and the rationale
supplied by the Examiner, we determine that the Examiner has made a prima
facie showing of obviousness. We have considered Appellants’ contentions,
but are not persuaded otherwise.
Appellants argue that “the Examiner has failed to point to any
reference that the thalamus, cingulate cortex, and medial septal nucleus
communicate with each other, and that the stimulation of one of these brain
structures would create the same therapeutic effect as stimulating the other
brain structures” (App. Br. 4). Appellants further argue that “the Examiner
has still not shown that the thalamus is synaptically connected to these brain
structures, and further, that stimulation of the thalamus would indirectly
stimulate the other brain structures, or vice versa” (id. at 4–5). This
argument, however, is contradicted by Rezai’s teaching that the thalamus
“receive[s] and channel[s] nerve activity from all areas of the nervous
system and interconnects various activities within the brain,” and that “in the
thalamus, all the brain signals travel in an organized fashion,” thereby
allowing for “activities in the peripheral areas of the brain which are
associated with the same, or similar conditions, [to be] channeled through
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the same areas of the thalamus” (FF4). Based on this observation, Rezai
specifically teaches that the thalamus may be stimulated in order to affect
another region of the brain (id.). In view of this teaching, we find that one
skilled in the art would have found sufficient motivation to stimulate the
thalamus as taught by Rezai in order to modulate other nearby regions of the
brain that may be associated with autism.
Appellants further argue that an “obvious to try” rationale is not
applicable because “Morrell and Rezai make no mention of delivering a
stimulus to the claimed stimulation sites” and “provide no indication of
which other areas of the brain are critical for treating autism” (App. Br. 6).
Appellants assert that “one of ordinary skill in the art can appreciate that
there are hundreds, if not thousands, of possible stimulation sites in the
brain,” and “[t]his can hardly be considered as being ‘finite’ in the sense that
one of ordinary skill in the art would easily arrive at the claimed brain
stimulation site for treating autism” (id.).
We are not persuaded by this reasoning. The Examiner’s rejection is
not based on a rationale that it would have been obvious to try to stimulate
any of the hundreds (or thousands) of possible stimulation sites in the brain,
but rather based on the findings that 1) stimulation of the thalamus can be
used to treat psychiatric disorders associated with other regions of the brain
(FF4) and 2) the claimed regions (at least one of a ventricle, a corpus
collosum, a stria terminalis, and a medial septal nucleus) form part of the
limbic system of the brain, which also includes another proximal brain
region, the cingulate cortex, that has been implicated in autism (FF1, FF5).
Given the close proximity of the claimed stimulation sites to the cingulate
cortex, and the interconnectedness of those regions with the thalamus, we
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find that this is not a situation where what would have been “obvious to try”
would have been to “vary all parameters or try each of numerous possible
choices until one possibly arrived at a successful result, where the prior art
gave either no indication of which parameters were critical or no direction as
to which of many possible choices is likely to be successful.” In re
O'Farrell, 853 F.2d 894, 903 (Fed. Cir. 1988). Nor is this a situation where
“what was ‘obvious to try’ was to explore a new technology or general
approach that seemed to be a promising field of experimentation, where the
prior art gave only general guidance as to the particular form of the claimed
invention or how to achieve it.” Id.
Appellants acknowledge that “the claims do not require direct
stimulation of any sites,” but disagree that “merely because one brain
structure is adjacent to or communicates with another brain structure that
stimulation of one of the brain structures will indirectly stimulate the other
brain structure, at least not to the extent that it results in the treatment of a
specific disease” (Reply Br. 2). The Specification, however, states that
“[n]early every brain area has been implicated in autism,” and identifies the
regions within the limbic system as “most likely to be primarily responsible
for the deficits of autism” (FF6). Appellants have not identified any
particular criticality or unexpected results associated with stimulating the
specific brain regions recited in the claims compared to other regions within
the limbic system for the treatment of autism. Moreover, the claims are
directed to “[a] method of treating a patient having autism,” and do not
require any particular level of efficacy for treating autism. The prior art
cited by the Examiner adequately provides a reasonable expectation of
success that stimulating the thalamus may affect other regions within the
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limbic system that are implicated in autism. See O’Farrell, 853 F.3d at 903-
04 (“[o]bviousness does not require absolute predictability of success ... all
that is required is a reasonable expectation of success.”); see also Hoffmann-
La Roche Inc. v. Apotex Inc., 748 F.3d 1326, 1331 (Fed. Cir. 2014)
(“Conclusive proof of efficacy is not necessary to show obviousness.”).
As such, we conclude that it would have been obvious to stimulate at
least one of a cerebral ventricle, a corpus collosum, a stria terminalis, and a
medial septal nucleus in order to treat a patient having autism as recited in
claims 21 and 27–30. Appellants have not made separate arguments for the
limitations recited in dependent claims 22–26, and therefore those claims fall
with claim 21. 37 C.F.R. § 41.37(c)(1)(vii).

SUMMARY
We affirm the rejection under 35 U.S.C. § 103(a).

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

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