Ex Parte Moffitt et al

Patent Trial and Appeal Board

Oct 31, 2012

12204154 (P.T.A.B. Oct. 31, 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.
12/204,154 09/04/2008 Michael Moffitt 08-00265-01 4475
7590 11/01/2012
Michael J. Bolan
Vista IP Law Group LLP
9th Floor
2040 Main Street
Irvine, CA 92614
EXAMINER
HOLMES, REX R
ART UNIT PAPER NUMBER
3762
MAIL DATE DELIVERY MODE
11/01/2012 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 PATENT TRIAL AND APPEAL BOARD
__________

Ex parte MICHAEL MOFFITT, DONGCHUL LEE, KERRY BRADLEY,
and DAVID K.L. PETERSON
__________

Appeal 2011-010704
Application 12/204,154
Technology Center 3700
__________

Before TONI R. SCHEINER, DONALD E. ADAMS, and LORA M.
GREEN, Administrative Patent Judges.

GREEN, Administrative Patent Judge.

DECISION ON APPEAL
This is a decision on appeal under 35 U.S.C. § 134 from the
Examiner‟s rejection of claims 1-18. We have jurisdiction under 35 U.S.C.
§ 6(b).
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STATEMENT OF THE CASE
Claim 9 is representative of the claims on appeal, and reads as
follows:
9. A neurostimulation system for providing therapy to a patient,
comprising:
a neurostimulation paddle lead carrying a plurality of electrodes
comprising at least four electrodes extending in a direction transverse to a
longitudinal axis of the paddle lead, wherein the at least four electrodes has
two inner electrodes and two outer electrodes flanking the two inner
electrodes; and
a neurostimulator for configuring a first one of the inner electrodes as
a cathode, a second one of the inner electrodes as one of a cathode and an
anode, and the outer electrodes as anodes, conveying electrical energy
between the cathodes and the anodes to create an electrical field that
stimulates tissue of the patient, reconfiguring the second one of the inner
electrodes as the other of the cathode and the anode, and reconveying
electrical energy between the cathodes and the anodes to create an electrical
field that stimulates the tissue.

The following grounds of rejection are before us for review:
I. Claims 1-3, 5-11, and 13-18 stand rejected under 35 U.S.C.
§ 103(a) as being rendered obvious by Feler
1
(Ans. 3). As
Appellants only argue claims 17 and 18 separately (App. Br. 10).
As to the remaining claims, we focus our analysis on claim 9, and
claims 1-3, 5-8, 10, 11, and 13-16 stand or fall with that claim. 37
C.F.R. § 41.37(c)(1)(vii).

1
Feller et al., US 2007/0179579 A1, published Aug. 2, 2007.
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II. Claims 4 and 12 stand rejected under 35 U.S.C. § 103(a) as being
rendered obvious by the combination of Feler and Moffitt
2
(Ans.
4).

We affirm-in-part.

ISSUES
Whether the Examiner has established by a preponderance of the
evidence that claim 9 is rendered obvious by Feler?

FINDINGS OF FACT
FF1. The “invention relates to tissue stimulation systems… systems
[especially] for electrically stimulating spinal cord tissue” (Spec. 1, ¶ 0002).
FF2. Figure 3 of the Specification is reproduced below:

2
Moffitt, US 2008/0109048 A1, published May 8, 2008.
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Figure 3 “is a profile view of an implanatable pulse generator (IPG) and one
embodiment of a neurostimulation paddle” (id. at 19, ¶0048).
FF3. According to the Specification:
[T]he electrodes 26 are arranged in four columns along the
longitudinal axis of the stimulation lead 12. In particular, the
electrodes 26 are arranged in two inner columns of electrodes
26' that are immediately adjacent to each other, and two outer
columns of electrodes 26" that flank and are immediately
adjacent the respective inner electrode columns 26'. For the
purposes of this specification, two electrode columns are
immediately adjacent to each other if no electrode column is
disposed between the respective electrode columns. As will be
described in further detail below, the use of four or more
electrode columns allows the locus of stimulation energy to be
adjusted in the transverse direction, as well as provides the
option of electronically selecting wider or narrower cathode-
anode spacings.
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(Id. at 25, ¶0073.)
FF4. The Specification teaches that electrodes that are selected to transmit
or receive electrical energy are designated as “„activated,‟” and those that
are not are designated as “„non-activated‟” (id. at 23, ¶0069).
FF5. As to the rejection of claim 9 over Feler, the Examiner finds that
“Feler teaches that it is known to use at least four electrodes in a medial-
lateral arrangement wherein there are four electrodes in a row” (Ans. 3
(citing Feler, Fig. 6)).
FF6. The Examiner finds further that Feler teaches that an implantable
stimulator can selectively switch each of the electrodes from anodes to
cathodes, and vice versa, in order to directionally control the electric field
and target the desired area of the spine (id. (citing Feler, ¶0008)).
FF7. The Examiner thus finds that “Feler teaches the claimed invention but
fails to explicitly state the specific activation of selectively setting the
anodes and cathodes to direct the current” (id.).
FF8. The Examiner finds, however, that “Feler teaches that there are a
finite number of combinations of electrode polarity and that setting them
provides a predictable result and reasonable expectations for success in
directing the current” (id. at 4).
FF9. The Examiner concludes that it would have been obvious given the
teachings of Feler “to try the finite number of combinations of electrode
polarities at the time the invention was made to have modified Feler with a
inner electrode that changes from cathode to anode and vice versa in order to
provide the predictable result of various directional electric fields in order to
direct the current to the various targeted tissues” (id.).
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FF10. Feler teaches “an effective neuromodulation therapy for multiple pain
locations using a multi-column, multi-row paddle lead” (Feler, p. 1, ¶0002).
FF11. Figure 6 of Feler is reproduced below:

Figure 6 shows “a system for [an] implantable pulse generator with a multi-
column, multi-row paddle lead” (id. at 2, ¶0015).
FF12. According to Feler:
The multiple columns of electrodes also enable lateral
“steering” of the electrical field using a single channel pulse
generator. A single channel pulse generator refers to a pulse
generator that provides an equal magnitude pulse to each active
electrode at a given time. Specifically, each electrode is either
“active” (i.e., it is coupled to the pulse generator output during
pulse generation by a suitable gate or switch) or “inactive” (i.e.,
the gate or switch does not couple the electrode to the pulse
generator output). Each “active” electrode experiences the
same amplitude; only the polarity varies depending upon
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whether the electrodes are set as cathodes or anodes as defined
by the positions of the respective gates or switches.

(Id. at p. 4, ¶0045.)

ANALYSIS
Appellants argue that “claim 9 requires the neurostimulator that
configures „a first one of the inner electrodes as a cathode, a second one of
the inner electrodes as one of a cathode and an anode, and the outer
electrodes as anodes,‟ and that reconfigures „the second one of the inner
electrodes as the other of the cathode and the anode‟” (App. Br. 5).
Appellants assert that “Feler never discloses how the electrodes can be
switched between cathodes and anodes in order to vary the effective-anode
spacing” (id.). Appellants assert that the claims do not “merely require the
changing of an electrode between an anode and a cathode,” but require “a
specific series of electrode combinations, and in particular, configuring a
first one of the inner electrodes as a cathode, a second one of the inner
electrodes as one of a cathode and an anode, and the outer electrodes as
anodes, and then reconfiguring the second one of the inner electrodes as the
other of the cathode and the anode” (id. at 6).
Appellants argue further that the surgical paddle of Feler has twenty
electrodes, and thus
the number of electrode combinations is a function of twenty
electrodes-not four electrodes. Thus, while the number of
electrode combinations that can be made from the Feler
electrodes can be considered finite in the sense that there is less
than an infinite number of possibilities, the Feler surgical
paddle has twenty electrodes, so that there are 100‟s of
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thousands, if not millions, of electrode combinations that can be
made. This can hardly be considered as being “finite” in the
sense that one of ordinary skill in the art would easily arrive at
the claimed electrode combination.

(Id. at 6-7.) Appellants assert that the Feler does not teach that four
electrodes of the paddle lead in Fig. 6 can be placed in a medial lateral
arrangement (id. at 7).
Appellants‟ arguments have been carefully considered, but are not
deemed to be convincing. Claim 9 is drawn to an apparatus. Feler teaches
an apparatus that is very similar to the claimed apparatus (see FF2 and FF11;
see also Ans. 5 (comparing Figure 3 of the Specification to Figures 6 and 7
of Feler)). Moreover, as found by the Examiner, the electrodes of Feler are
capable of being independently activated, and thus may be either in an
activated, or non-activated state, and also may be used as an anode or
cathode (FF12). Thus, as found by the Examiner (FF7), Feler teaches an
apparatus that would be capable of performing the function of the claimed
apparatus.
Moreover, we also agree with the Examiner that it would have been
obvious to use the apparatus of Feler to determine which combination of
electrodes gives the best pain relief, to arrive at an inner electrode that
changes from cathode to anode and vice versa in order to provide the
predictable result of various directional electric fields in order to direct the
current to the various targeted tissues (FF9).
Appellants argue further that the Examiner‟s rejection is not a
permissible application of “obvious to try” (App. Br. 7-8). Appellants assert
that “Feler vaguely discloses that electrical field steering, isolation of an
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electrical field to specific fibers or neural structures, or hyperpolarization
can be accomplished by selection electrodes as cathodes or anodes (see
paragraphs [0043]-[0045]), but “makes no mention of any specific electrode
combinations, provides no indication of which electrode combinations are
critical, provides no direction as to which of many possible choices is likely
to be successful, and provides no guidance as to the claimed invention or
how to achieve it” (id. at 8). According to Appellants, “[i]t appears . . . that
the Examiner would conclude that, no matter how beneficial and
unpredictable a particular electrode combination or series of electrode
combinations is, it would still be obvious in view of Feler, because one of
ordinary skill in the art, in the process of steering current around the
electrode array, would run through the thousands and thousands of possible
electrode combinations using the Feler surgical paddle to happen upon the
specific series of electrode combinations required by the claimed
invention” (id.).
We have considered Appellants‟ arguments as to obvious-to-try, but
as discussed above, conclude that the apparatus of Feler renders the claimed
apparatus obvious. While Appellants assert that it would take “thousands
and thousands of possible electrode combinations,” (id.) Appellants do not
point to any evidence to support that assertion, and arguments of counsel
cannot take the place of evidence in the record. See Estee Lauder Inc. v.
L’Oreal, S.A., 129 F.3d 588, 595 (Fed. Cir. 1997). We further note that the
instant Specification discloses that the “locus and size of the medial-lateral
electrical field generated by the electrodes . . . can be fine-tuned through the
use of current steering,” (Spec. 40, ¶ 00105) which is the same method
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disclosed by Feler. And while Appellants appear to argue unexpected
results, they point to no evidence of record to support that argument. See In
re DeBlauwe, 736 F.2d 699, 705, 222 USPQ 191, 196 (Fed. Cir. 1984)
(noting that unexpected results must be established by factual evidence).
Appellants also argue that “the Examiner is not one of ordinary skill
in the art, and therefore, cannot make a determination that it would be
obvious to modify the disclosure of a prior art reference without pointing to
support in a supplement prior art reference suggesting such modification”
(App. Br. 9). Appellants assert further that “the Examiner provided no
rationale as to why it would have been obvious to one of ordinary skill in the
art to utilize the specific electrode combinations recited in the claims” (id. at
10).
As discussed above, we conclude that the Examiner has set forth a
prima facie case of obviousness, including setting rationale as to why the
apparatus of Feler renders obvious the apparatus of claim 9 (see, e.g., FF8
and 9). As to Appellants‟ argument that the Examiner necessarily needed a
supplemental prior art reference, we note that while holding that some
rationale must be supplied for a conclusion of obviousness, the Supreme
Court nonetheless rejected a “rigid approach” to the obviousness question,
and instead emphasized that “[t]hroughout this Court‟s engagement with the
question of obviousness, our cases have set forth an expansive and flexible
approach . . . .” KSR Int' l Co. v. Teleflex Inc., 550 U.S. 398, 415 (2007).
The Court also rejected the use of “rigid and mandatory formulas” as being
“incompatible with our precedents.” Id. at 419; see also id. at 421 (“Rigid
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preventative rules that deny factfinders recourse to common sense, however,
are neither necessary under our case law nor consistent with it.”).
The Court thus reasoned that the analysis under 35 U.S.C. § 103 “need
not seek out precise teachings directed to the specific subject matter of the
challenged claim, for a court can take account of the inferences and creative
steps that a person of ordinary skill in the art would employ.” Id. at 418; see
also id. at 421. Thus, there is no requirement that the Examiner provide a
supplemental reference to support the prima facie obviousness rejection.
As to claims 17 and 18, Appellants argue that the Examiner provided
no rationale as to why the additionally recited limitations would have been
rendered obvious by Feler (App. Br. 10). We agree that the Examiner did
not address the limitations in claims 17 and 18, nor did the Examiner
respond to Appellants‟ argument in the Examiner‟s Answer. As the
Examiner has thus not met his burden as to claims 17 and 18, we reverse the
rejection as to those claims.
As to the rejection of claims 4 and 12 over the combination of Feler
and Moffitt, Appellants argue that Feler does not render independent claims
1 and 9 obvious, and Moffitt does not remedy that deficiency (App. Br. 11).
As Appellants do not present separate, additional argument as to claims 4
and 12, we affirm their rejection for the reasons set forth above as to claim 9.

CONCLUSION OF LAW
We conclude that the Examiner has established by a preponderance of
the evidence that claim 9 is rendered obvious by Feler.

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SUMMARY
We affirm the rejection of claims 1-3, 5-11, and 13-18 as being
rendered obvious by Feler as to claims 1-3, 5-11, and 13-16, but reverse as
to claims 17 and 18.
We also affirm the rejection of claims 4 and 12 as being rendered
obvious by the combination of Feler and Moffitt.

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-IN-PART

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