Ex Parte Werder et al

Board of Patent Appeals and Interferences

Apr 27, 2012

11414153 (B.P.A.I. Apr. 27, 2012)

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.
11/414,153 04/28/2006 Jonathan Werder 151P20629US01 9538
54228 7590 04/30/2012
IPLM GROUP, P.A.
POST OFFICE BOX 18455
MINNEAPOLIS, MN 55418
EXAMINER
ALTER, ALYSSA MARGO
ART UNIT PAPER NUMBER
3762
MAIL DATE DELIVERY MODE
04/30/2012 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 BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte JONATHAN WERDER, LESLIE A. LEMIRE,
NINA M. GRAVES, and DAVID C. ULLESTAD
__________

Appeal 2010-008578
Application 11/414,153
Technology Center 3700
__________

Before DONALD E. ADAMS, FRANCISCO C. PRATS, and
ERICA A. FRANKLIN, Administrative Patent Judges.

PRATS, Administrative Patent Judge.

DECISION ON APPEAL
This appeal under 35 U.S.C. § 134 involves claims to an implantable
device for treating neurological disorders. The Examiner entered rejections
for anticipation and obviousness.
We have jurisdiction under 35 U.S.C. § 6(b). We reverse.

STATEMENT OF THE CASE
Claims 1-21 stand rejected and appealed (App. Br. 5). Claim 1 is
representative and reads as follows:
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1. An implantable medical device adapted to be implanted in
a patient having a plurality of neurological disorders,
comprising:

a first therapy module providing a first output to said patient for
the treatment of a first one of said plurality of disorders; and

a second therapy module providing a second output to said
patient for the treatment of a second one of said plurality of
disorders;

wherein said first therapy module and said second therapy
module provide concurrent treatment of said plurality of
neurological disorders.

The following rejections are before us for review:
(1) Claims 1-21, under 35 U.S.C. § 102(b) as anticipated by
Whitehurst,
1
or, in the alternative, under 35 U.S.C. § 103(a) as obvious over
Whitehurst (Ans. 4-6); and
(2) Claims 1-21, under 35 U.S.C. 103(a) as obvious over Whitehurst
and Scheiner
2
(Ans. 3-4).
DISCUSSION
Appellants contend that the Examiner erred in finding that Whitehurst
anticipates claim 1 because Whitehurst “does not show, disclose or suggest
one system control unit having a first therapy module providing an output
for treating a first of a plurality of disorders and a second therapy module
providing an output for treating a second of a plurality of disorders” (App.
Br. 11-12). Thus, Appellants argue, Whitehurst “cannot show, disclose or
suggest treating the first and second disorders concurrently” (id. at 12).

1
U.S. Patent No. 6,782,292 B2 (issued August 24, 2004).
2
U.S. Patent No. 6,415,183 B1 (issued July 2, 2002).
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The Examiner contends that Whitehurst discloses treating a “„mood
disorder comorbid with an anxiety disorder‟ [which] would be two different
disorders coexisting and being treated concurrently” (Ans. 5 (citing
Whitehurst col. 15, ll. 62-67)). Moreover, the Examiner argues,
Whitehurst‟s preferred systems “„include one or more sensors for sensing
symptoms or other conditions that may indicate a need for treatment‟” (Ans.
5-6 (citing Whitehurst, col. 5, ll. 41-43)).
Appellants respond that the portions of Whitehurst advanced by the
Examiner do not support the Examiner‟s finding that Whitehurst describes
concurrent treatment of distinct neurological disorders with a single device
(Reply Br. 16-17). In particular, Appellants argue that when column 15 of
Whitehurst is viewed in context, it is evident that Whitehurst describes using
more than one device when concurrently treating two disorders, contrary to
the claimed invention (see id. at 16).
As stated in In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992):
[T]he examiner bears the initial burden . . . of presenting a
prima facie case of unpatentability. . . .
After evidence or argument is submitted by the applicant
in response, patentability is determined on the totality of the
record, by a preponderance of evidence with due consideration
to persuasiveness of argument.

As to the rejection at issue, it is well settled that for a reference to
anticipate a claim, “[e]very element of the claimed invention must be
literally present, arranged as in the claim.” Richardson v. Suzuki Motor Co.,
Ltd., 868 F.2d 1226, 1236 (Fed. Cir. 1989) (emphasis added).
Here, claim 1 recites a medical device adapted to be implanted in a
patient having a plurality of neurological disorders. The device has a first
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therapy module configured to provide a first output to the patient to treat a
first neurological disorder. The device has a second therapy module
configured to provide a second output to the patient to treat a second
neurological disorder.
As seen in claim 1‟s dependent, claim 6, the first output can include
delivery of a medicament (see App. Br. 18). As seen in dependent claim 7,
the second output can be an electric stimulus signal (see id. at 19).
Claim 1 also requires that “said first therapy module and said second
therapy module provide concurrent treatment of said plurality of
neurological disorders.” Thus, the device must be configured so that
treatment of the first disorder by the first therapy module, and treatment of
the second disorder by the second module, can be provided concurrently.
We agree with Appellants that a preponderance of the evidence does
not support the Examiner‟s finding that Whitehurst describes a single
implantable device configured to treat a first neurological disorder with a
first therapy module, while concurrently treating a second neurological
disorder with a second therapy module, as required by claim 1.
Specifically, Whitehurst discloses “systems and methods for
introducing one or more stimulating drugs and/or applying electrical
stimulation to one or more areas of the brain via a „skull-mounted‟ device.
The stimulation may be used to treat mood and/or anxiety disorders”
(Whitehurst, col. 4, ll. 62-66). Whitehurst discloses that a “preferred form of
the invention uses one or more stimulating drugs and/or electrical
stimulation to treat depression. . . . Additional uses of the present invention
include the application to panic disorder, obsessive-compulsive disorder, and
other mood and/or anxiety disorders” (id. at col. 5, ll. 52-67).
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Whitehurst refers to its treatment device as a “system control unit
(SCU) . . . [which] preferably provides both electrical stimulation and one
or more stimulating drugs when necessary and desired. . . . Preferred
systems also include one or more sensors for sensing symptoms or other
conditions that may indicate a need for treatment” (id. at col. 5, ll. 25-43; see
also Figure 5 (showing preferred location of SCU 130 on patient‟s skull)).
As Whitehurst explains, “[e]lectrical and drug stimulation may be controlled
independently; alternatively, electrical and drug stimulation may be coupled,
e.g., electrical stimulation may be programmed to occur only during drug
infusion” (id. at col. 5, ll. 48-51).
Whitehurst discloses that, in one embodiment of its invention, “an
SCU operates independently. According to another embodiment of the
invention, an SCU operates in a coordinated manner with other implanted
SCUs, other implanted devices, or with devices external to the patient‟s
body” (id. at col. 6, ll. 60-64).
Thus, as to the concurrent treatment of distinct neurological disorders,
Whitehurst discloses using multiple SCUs, that is, multiple implanted
devices:
For the treatment of any of the various types and levels of
mood and/or anxiety disorders, it may be desirable to modify or
adjust the algorithmic functions performed by the implanted
and/or external components, as well as the surgical approaches,
in ways that would be obvious to skilled practitioners of these
arts. For example, it may be desirable to employ more than one
SCU 130, each of which could be separately controlled by
means of a digital address. Multiple channels and/or multiple
patterns of electrical and/or drug stimulation might thereby be
programmed by the clinician and controlled by the patient in
order to deal with complex or multiple symptoms or
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dysfunctions, such as a mood disorder comorbid with an
anxiety disorder.

(Id. at col. 15, ll. 55-67 (emphasis added).)
Thus, given that Whitehurst‟s only explicit description of concurrently
treating comorbid disorders states that the treatment is accomplished using
more than one separately controlled SCU, that is, more than one separately
controlled device, we agree with Appellants that a preponderance of the
evidence does not support a finding that Whitehurst describes a single device
configured to treat a first neurological disorder with a first therapy module,
while concurrently treating a second neurological disorder with a second
therapy module, as required by claim 1.
We therefore reverse the Examiner‟s anticipation rejection of claim 1
and its dependents. As claim 10 recites a method in which such concurrent
therapy is performed using a single device, we also reverse the Examiner‟s
anticipation rejection of claim 10 and its dependents.
The Examiner alternatively rejected claims 1-21 as obvious over
Whitehurst, reasoning that even if Whitehurst did not positively describe its
device as being configured to treat a first neurological disorder with a first
therapy module while concurrently treating a second neurological disorder
with a second module, an ordinary artisan would nonetheless have
considered it obvious “to treat two different disorders concurrently in order
to provide the predictable results of providing th[o]rough and expedited
treatment to the patient” (Ans. 6).
We reverse this rejection as well.
While the Supreme Court in KSR emphasized the importance of “an
expansive and flexible approach” to the obviousness question, KSR Int’l Co.
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v. Teleflex Inc., 550 U.S. 398, 415 (2007), it also reaffirmed the importance
of determining “whether there was an apparent reason to combine the
known elements in the fashion claimed by the patent at issue.” Id. at 418
(emphasis added).
Ultimately, therefore, “[i]n determining whether obviousness is
established by combining the teachings of the prior art, the test is what the
combined teachings of the references would have suggested to those of
ordinary skill in the art.” In re GPAC Inc., 57 F.3d 1573, 1581 (Fed. Cir.
1995) (internal quotations omitted).
Here, we are not persuaded that the Examiner has advanced a
sufficiently specific evidence-based rationale as to how or why Whitehurst‟s
teachings would have suggested that its device could or should be
reconfigured so that one of the therapy modules treats one disorder, while
the other therapy module concurrently treats a distinct disorder, as required
by claims 1 and 10. To the contrary, as noted above, Whitehurst teaches that
concurrent treatment of comorbid disorders is accomplished using more than
one separately controlled SCU, that is, more than one separately controlled
device (see Whitehurst, col. 15, ll. 55-67).
Thus, we agree with Appellants that a preponderance of the actual
evidence of record does not support the Examiner‟s finding that Whitehurst
would have suggested to an ordinary artisan that its SCU device should
somehow be reconfigured so as to treat one neurological disorder using one
therapy module, and concurrently treat a distinct neurological disorder using
a second. We therefore also reverse the Examiner‟s obviousness rejection of
claims 1 and 10 and their dependents over Whitehurst.
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The Examiner also rejected claims 1-21 as obvious over Whitehurst
and Scheiner (Ans. 3-4).
Although the Examiner maintained that Whitehurst by itself described
or at least suggested configuring its device so as to treat a first neurological
disorder with one therapy module, while concurrently treating a distinct
neurological disorder with a second module, the Examiner nonetheless
alternatively cited Scheiner as describing a device that “„provides concurrent
heart pacing and diaphragm pacing using one implanted system instead of
two‟ (col. 2, lines 25-26) and thus discloses treatment of two disorders
concurrently” (Ans. 3-4).
Based on the references‟ teachings, the Examiner reasoned that an
ordinary artisan would have considered it obvious “to modify the treatment
in Whitehurst with the concurrent treatment of Scheiner et al. in order to
provide the predictable results of providing comprehensive and expedited
treatment of multiple disorders without the need of multiple devices” (id. at
4).
We reverse this rejection as well.
We acknowledge Scheiner‟s disclosure of “a system for pacing both
the patient‟s diaphragm [respiration] and their heart. This system includes
inserting a lead into the patient‟s body so that an electrode is situated to
stimulate both the heart and the phrenic nerve” (Scheiner, col. 2, ll. 10-14).
As Scheiner explains “[s]ome of the advantages of the present system
are that it provides diaphragmatic pacing using the advanced, developed
technology provided by modern cardiac pacing lead technology. It also
provides phrenic pacing without the invasive surgery associated with
attaching nerve cuffs” (id. at col. 2, ll. 20-24). Furthermore, as the Examiner
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points out, Scheiner teaches that its system “provides concurrent heart
pacing and diaphragm pacing using one implanted system instead of two”
(id. at ll. 25-26).
As noted above, however, Whitehurst discloses that its SCU is
configured such that concurrent treatment of comorbid neurological
disorders can be achieved using a system composed of multiple devices
(Whitehurst, col. 15, ll. 55-67). Thus, given the significant differences in
purpose and result between the devices described in Whitehurst and
Scheiner, we are not persuaded that the Examiner has adequately explained
why an ordinary artisan treating neurological disorders with Whitehurst‟s
skull implanted devices would have been prompted to modify those devices
by Scheiner‟s teaching of the advantages of using a single implanted device
to pace both a patient‟s heart and respiration.
As we are not persuaded that Scheiner would have prompted an
ordinary artisan to modify Whitehurst‟s individual SCU devices so as to
treat a first neurological disorder with one therapy module, while
concurrently treating a second neurological disorder with a second therapy
module, we reverse the Examiner‟s rejection of claims 1-21 over Whitehurst
and Scheiner.

SUMMARY
We reverse the Examiner‟s rejection of claims 1-21 as anticipated by
Whitehurst, as well as the Examiner‟s alternative rejection of claims 1-21 as
being obvious over Whitehurst.
We also reverse the Examiner‟s obviousness rejection of claims 1-21
over Whitehurst and Scheiner.
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REVERSED
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