Ex Parte Patwardhan et al

Board of Patent Appeals and Interferences

Apr 26, 2010

09957566 (B.P.A.I. Apr. 26, 2010)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte RAVISH VINAY PATWARDHAN and
RICHARD SHANE TUBBS
__________

Appeal 2007-3315
Application 09/957,566
Technology Center 3700
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Decided: April 26, 2010
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Before DEMETRA J. MILLS, ERIC GRIMES, and RICHARD M.
LEBOVITZ, Administrative Patent Judges.

GRIMES, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a method
of treating epilepsy. The Examiner has rejected the claims as anticipated
and obvious. We have jurisdiction under 35 U.S.C. § 6(b). We affirm.
BACKGROUND
The Specification states that “[v]agal nerve stimulation (VNS) for
control of medically refractory epilepsy was introduced by Zabara (United
States Patent 5,540,734), and has recently received approval for use in
selected patients by the Food and Drug Administration” and that “[a]lthough
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helpful as a last resort in many of these patients, VNS has been shown to be
limited in efficacy, with accompanying undesirable side effects (e.g.
hoarseness, dysphagia, cough, and dysautonomia)” (Specification 4). The
Specification also states that “VNS is also limited to the left side, since
right-sided stimulation is associated with significant cardiac side effects” (id.
at 4-5).
The Specification also states that a “patient presently failing VNS
often has no other good treatment option available” and that a “more
desirable technique would offer minimal invasiveness as with VNS, with
improved efficacy and minimal side effects” (id. at 5). The Specification
also states that “the prior art is deficient in the lack of an effective technique
using carotid sinus nerve stimulation for epilepsy control” and that the
“present invention fulfills this long-standing need and desire in the art” and
“is directed to carotid sinus nerve stimulation” (id.).
DISCUSSION
1. CLAIMS
Claims 1-3 and 5-8 are pending and on appeal.
We will focus on claims 1 and 5-7, which are representative and read
as follows:
Claim 1. A method of treating, controlling or preventing
epilepsy, comprising:
attaching at least one electrode to afferents of at least one of a
patient's carotid sinus nerves;
applying modulating electric signals to at least one of the
patient’s carotid sinus nerves through the electrode(s) attached thereto
to [sic];
stimulating at least one of said carotid sinus nerves via said
applied modulating electric signals; and
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resolving epileptic seizure activity exhibited by said patient
thereby treating, controlling or preventing epilepsy in the patient.

Claim 5. The method of claim [1, wherein said modulating
electric signals applied to said carotid sinus nerve(s) have a frequency
of about 5 to about 300 cycles per second at a constant current of
about 0.5 to about 20 milliamperes and a pulse width of about 0.1 to 1
millisecond,]
wherein said modulating electric signals have a current of 10
mA, a frequency of 40 Hz, a pulsewidth of 1 ms, said modulating
electric signals applied to said carotid sinus nerve(s) for a time
duration of 10 seconds.

Claim 6. The method of claim 1, wherein the signal is applied
utilizing a plurality of electrodes attached to at least one of said
carotid nerves.

Claim 7. The method of claim 1, further comprising:
reapplying said modulating electric signals over a
period of time.

2. ANTICIPATION
Claims 1-3 and 8 stand rejected under 35 U.S.C. § 102(b) as being
anticipated by Zabara.1 Dependent claims 2, 3, and 8 have not been argued
separately and therefore stand or fall with claim 1. 37 C.F.R.
§ 41.37(c)(1)(vii).
The Examiner finds that “Zabara discloses a method of treating
epilepsy comprising attaching at least one electrode to the afferents of at
least one of the patient’s carotid sinus nerves . . . , and applying modulating
electric signals to at least one of the carotid sinus nerves through the

1 Zabara, US 5,540,734, Jul. 30, 1996.
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electrode” (Answer 3-4). The Examiner further states that claim 1’s
recitation of “resolving epileptic seizure activity exhibited by said patient
thereby treating, controlling or preventing epilepsy in the patient” is a
statement of desired result hinging on the performance of the claimed
attaching, applying and stimulating steps and that any prior art method
disclosing such steps would inherently resolve epileptic seizure activity (id.
at 4).
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.
“To anticipate a claim, a prior art reference must disclose every
limitation of the claimed invention, either explicitly or inherently.” In re
Schreiber, 128 F.3d 1473, 1477 (Fed. Cir. 1997).
We agree with the Examiner that Zabara discloses all of the
limitations in claim 1.
Specifically, Zabara discloses “methods of treating, controlling or
preventing medical, psychiatric or neurological disorders,” including
epileptic seizure, by “application of modulating electric signals directly to at
least one of a patient’s trigeminal and glossopharyngeal nerves” (Zabara,
col. 2, l. 66 to col. 3, l. 6). Zabara also discloses that the “carotid sinus nerve
is a branch of the glossopharyngeal nerve” (id. at col. 3, ll. 41-46).
Zabara also discloses that the “method acts to stimulate nerve
afferents which in turn stimulate the brain and cause/allow the brain to act in
the best interest of the host through use of the brain’s natural mechanisms”
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(id. at col. 3, ll. 47-50). Zabara also teaches that “one of the branches of the
glossopharyngeal nerve may receive the electrode, including the carotid
sinus nerve” and that the “surgeon will often find it convenient to first locate
the bifurcation of the carotid artery, and at that point identify the carotid
sinus nerve” (id. at col. 8, ll. 3-8). Thus, Zabora describes “stimulating at
least one . . . carotid sinus nerve” as recited in claim 1.
Thus, we agree with the Examiner that Zabara discloses all of the
limitations in claim 1. The Examiner has therefore established a prima facie
case of anticipation.
Appellants argue Zabara teaches a neurocybernetic prosthesis which
only theoretically may have applicability for epilepsy control and that,
although Zabara teaches that one of the branches of the glossopharyngeal
nerve, including the carotid sinus nerve, may receive the electrode, Zabara
does not demonstrate resolution of seizure activity (Appeal Br. 8-9).
Appellants also argue that, while Zabara discloses that the glossopharyngeal
and trigeminal nerves both have a large number of afferents which terminate
in the brain, thus increasing the likelihood that the proper afferent(s) will be
stimulated, it also discloses that the stimulation of both nerves increases the
likelihood of reaching non-target tissues and leading to possible undesirable
effect (id. at 9-10). Finally, Appellants argue that Zabara is unclear about
whether one or both of the cited nerves should receive stimulation or
whether stimulation of the carotid sinus nerve will lead to a desirable or
undesirable effect since right-sided vagus nerve stimulation was associated
with cardiac effects (id. at 10). Thus, Appellants argue that the instant
invention is materially different from the disclosure of Zabara (id. at 11).
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We are not persuaded by these arguments. Appellants’ argument, in
essence, is that Zabara does not enable a method of treating epilepsy by
stimulating the carotid sinus nerve because the experiments were not
actually conducted. However, “[p]roof of efficacy is not required for a prior
art reference to be enabling for purposes of anticipation. . . . [T]he proper
issue is whether the [prior art] is enabling in the sense that it describes the
claimed invention sufficiently to enable a person of ordinary skill in the art
to carry out the invention.” Impax Labs. v. Aventis Pharms., 468 F.3d 1366,
1383 (Fed. Cir. 2006). “Anticipation does not require the actual creation or
reduction to practice of the prior art subject matter; anticipation requires
only an enabling disclosure.” Schering Corp. v. Geneva Pharms., Inc., 339
F.3d 1373, 1380 (Fed. Cir. 2003) (citing In re Donohue, 766 F.2d 531, 533
(Fed. Cir. 1985)).
Appellants have not provided evidence that Zabara lacks any of the
method steps required to practice the claimed method; rather, Appellants
argue that Zabara provides “uncertainties” because the experiments were not
conducted. However, “[i]n patent prosecution, the examiner is entitled to
reject application claims as anticipated by a prior art patent without
conducting an inquiry into whether or not that patent is enabled. . . . The
applicant, however, can then overcome that rejection by proving that the
relevant disclosures of the prior art patent are not enabled.” Amgen, Inc. v.
Hoechst Marion Roussel, Inc., 314 F.3d 1313, 1355 (Fed. Cir. 2003). Thus,
“a presumption arises that both the claimed and unclaimed disclosures in a
prior art patent are enabled” (id.)
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The Zabara disclosure is presumed to be enabling. Appellants have
provided no evidence that Zabora’s method – which meets all the limitations
of claim 22 – would not work as described and that it would require undue
experimentation to practice Zabara’s method of treating epilepsy by
applying modulating electric signals directly to a patient’s carotid sinus
nerve. On this record, Appellants have not met their burden of rebutting the
presumption of enablement of the Zabara reference. We therefore affirm the
Examiner's anticipation rejection of claim 1. Claims 2, 3, and 8 fall with
claim 1 because separate arguments for their patentability were not provided.
3. OBVIOUSNESS I
Claims 5 and 7 stand rejected under 35 U.S.C § 103 as obvious over
Zabara.
The Examiner relies on Zabara for the teachings discussed above and,
with regard to claim 5, the Examiner further relies on Zabara for disclosing
that the exact stimulation parameters are a matter of obvious design
dependent upon the malady being treated and the condition of the patient,
and for disclosing a range of electrical parameters for the disclosed treatment
methods (Answer 5). The Examiner concludes that the parameters recited in
claim 5 would have been an obvious matter of design dictated by routine
experimentation to ascertain the most effective parameters (id.).
With regard to claim 7, the Examiner relies on Zabara for disclosing
that one may reapply signals, with the exact parameters of stimulation and
treatment times dependent upon the application at hand, and that repeated
stimulation of the glossopharyngeal nerve may be practiced (e.g., once a
week) (id.).
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We conclude that the Examiner has set forth a prima facie case that
the claims would have been obvious to the ordinary artisan. Zabara teaches
the method of claim 1, as set forth above. Zabara also teaches that “one can
vary the current, frequency, pulse width, period, duration and rate of the
electric signals,” that “the current . . . is typically about 1.0 to 10
milliamperes,” that “the frequency of the signal . . . is typically about 10 to
about 30 cycles per second,” and that “the pulses width . . . can vary between
about 0.1 and 1 millisecond” (Zabara, col. 8, ll. 10-22). Zabara also teaches
that “a stimulating signal might be given for a duration of 10 seconds or 30
seconds” (id. at col. 8, ll. 28-30). Finally, Zabara teaches optimizing
parameters: “the various parameters associated with the electric pulses are
increased in steps over several weekly intervals, and the patient’s response is
monitored” (id. at col. 8, ll. 39-43). Thus, Zabora provides evidence that
persons of skill in the art routinely adjust the frequency of the modulatory
electrical signals to achieve the desired effect; in this case, to resolve
epileptic activity. Accordingly, we find that optimizing the modulatory
electric signals to resolve epileptic activity would have been within the level
of ordinary skill in the art We agree with the Examiner that these teachings
would have made the methods defined by claims 5 and 7 prima facie
obvious.
Appellants argue that,
although it may be obvious to one of ordinary skill in the art to
determine the specific signal parameters and length of time in
which to apply the stimulating signals as recited in dependent
claim 5 and to reapply the stimulating signals as recited in
dependent claim 7, including these limitations into the instant
invention does not render the invention obvious because Zabara
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neither anticipates nor renders the invention obvious as recited
in independent claim 1.
(Br. 14.)
We are not persuaded by this argument. For the reasons discussed
above, we agree with the Examiner that Zabara discloses the method of
claim 1. Because the parameters recited in claim 5 are within the ranges
suggested by Zabara, and Zabara also teaches the reapplication of electrical
stimulation over a period of time, we also agree with the Examiner that
claims 5 and 7 would have been obvious based on Zabara.
4. OBVIOUSNESS II
Claim 6 stands rejected under 35 U.S.C § 103 as obvious in view of
Zabara and Bullara.2
The Examiner relies on Zabara for the teachings discussed above.
The Examiner relies on Bullara for disclosing a helical electrode that is
useful in wrapping around nerves and that such an assembly may contain
any number of electrodes, depending on the particular objective to be
achieved (Answer 6). The Examiner further reasons that using more than
one electrode to stimulate a nerve is old and well-known by those of
ordinary skill in the art to allow for targeted stimulation of nerves (id.).
We conclude that the Examiner has set forth a prima facie case that
claim 6 would have been obvious to the ordinary artisan. Zabara is
discussed above. Bullara teaches “[a]n implantable helical electrode
assembly configured to fit around a nerve for electrically triggering or
measuring an action potential …” (Bullara, abstract). Bullara also teaches

2 Bullara, US 4,573,481, Mar. 4, 1986.
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that the “number of individual electrodes in the assembly is dictated by the
specific form of neurostimulation to be achieved, but the assembly is useful
with either single or plural electrodes” (id. at col. 2, ll. 65-68). Thus, we find
support for and agree with the Examiner’s findings that persons of skill in
the art would have considered the use of a plurality of electrodes as recited
in claim 6 to be a conventional use of a known means of electrical
stimulation. If “a technique has been used to improve one device, and a
person of ordinary skill would recognize that it would improve similar
devices in the same way, using the technique is obvious unless its
application is beyond his or her skill.” KSR Int’l Co. v. Teleflex Inc., 127 S.
Ct. 1727, 1740 (2007).
Appellants argue that Zabara does not render independent claim 1
obvious and, therefore, incorporating the limitation of claim 6 in
independent claim l does not render the instant invention obvious (Br. 15).
We are not persuaded by this argument. As discussed above, Zabara
teaches all of the elements of claim 1 and anticipates the invention of claim
1. For the reasons discussed above, we also conclude that the combination
of Zabara and Bullara would have suggested the method of claim 6. The
rejection of claim 6 under 35 U.S.C. § 103 is affirmed.
SUMMARY
The Examiner’s position is supported by the preponderance of the
evidence of record. We therefore affirm the rejection of claims 1-3 and 8
under 35 U.S.C. § 102 and the rejection of claims 5-7 under 35 U.S.C.
§ 103.
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TIME PERIOD
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)(iv).

AFFIRMED

LP

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