Ex Parte Bradley

Patent Trial and Appeal Board

Jul 21, 2014

12173169 (P.T.A.B. Jul. 21, 2014)

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.
12/173,169 07/15/2008 Kerry Bradley 05-01631-02 6374
71422 7590 07/21/2014
VISTA IP LAW GROUP LLP/BSC - NEUROMODULATION
2040 MAIN STREET, Suite 710
IRVINE, CA 92614
EXAMINER
PORTER, JR, GARY A
ART UNIT PAPER NUMBER
3766
MAIL DATE DELIVERY MODE
07/21/2014 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 KERRY BRADLEY

__________

Appeal 2011-011845
Application 12/173,169
Technology Center 3700
__________

Before LORA M. GREEN, JEFFREY N. FREDMAN, and
ULRIKE W. JENKS, Administrative Patent Judges.

FREDMAN, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal1 under 35 U.S.C. § 134 involving claims to
neurostimulation systems. The Examiner rejected the claims as anticipated
and as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We affirm.

1 Appellant identifies the Real Party in Interest as Boston Scientific
Neuromodulation Corporation (see App. Br. 2).
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Statement of the Case
Background
“Neurostimulation systems . . . include at least one electrode
positioned to enable stimulation of neural elements that are the target tissue
(i.e. the tissue that, when sufficiently stimulated, will create the desired
therapeutic effect)” (Spec. 1, ll. 5-10). The Specification teaches that “there
are instances where the target tissue is not directly adjacent to an electrode
and, because electrical field strength decreases exponentially with distance
from the electrode, a relatively strong electric field must be created to
generate APs [action potentials] in the target neural fibers” (Spec. 2, ll. 5-8).
According to the Specification, the “electric field may, however, result in the
generation of APs in the non-target fiber bundles between the electrode and
the target fibers. The generation of APs in the non-target tissue may, in turn,
lead to undesirable outcomes (e.g., discomfort) for the patient” (Spec. 2, ll.
8-12).
The Specification teaches that “it may also be desirable in, for
example, the context of leads that are oriented transverse to the target neural
fibers, to selectively control the shape of the AP generating region in order
to prevent the generation of APs in non-target fibers” (Spec. 2, ll. 12-15).
The Claims
Claims 1-4 and 21-27 are on appeal. Claim 1 is representative and
reads as follows:
1. A method, comprising the steps of:
sinking a first portion of current sourced from one or
more electrodes at a first electrode that is a first distance
from a first neural fiber bundle and is a second distance from
a second neural fiber bundle different from the first distance,
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wherein the first portion of the current sunk at the first
electrode has a magnitude sufficient to generate action
potentials in neural fibers in the first and second neural fiber
bundles; and
sinking a second portion of the current sourced from
the one or more electrodes to a remote electrode separate
from the first electrode, wherein the current sourced by the
one or more electrodes has a magnitude sufficient to block at
least some of the action potentials in the first neural fiber
bundle.

The issues
A. The Examiner rejected claims 1-4 and 22-27 under 35 U.S.C. § 102(b)
as anticipated by Meadows2 (Ans. 4-7).
B. The Examiner rejected claims 1-4 under 35 U.S.C. § 103(a) as
obvious over Cohen3 and Meadows (Ans. 7-9).
C. The Examiner rejected claim 21 under 35 U.S.C. § 103(a) as obvious
over Meadows (Ans. 9-10).
A. 35 U.S.C. § 102(b) over Meadows
The Examiner finds that “Meadows discloses sourcing current into
neural tissue with a first electrode E8, sinking a portion of the current from
the first electrode E8 at a second electrode E7 and sinking another portion of
the current from the first electrode E8 at a remote electrode E6” (Ans. 4-5).
The Examiner finds that “electrode E6 is considered remote since it is
spaced apart from electrode E8” (Ans. 5).
The Examiner finds that “Appellant’s specification indicates that
sinking 2 milliamps of current at an electrode is sufficient to generate action

2 Meadows et al., US 6,516,227 B1, issued Feb. 4, 2003.
3 Cohen et al., US 2003/0045914 A1, published Mar. 6, 2003.
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potentials” (Ans. 5). The Examiner finds that “Appellant’s specification
also indicates that the hyperpolarization threshold is 2-8 times greater than
the depolarization threshold” (Ans. 5).
The Examiner finds that
Meadows discloses sourcing 6 mA from E8, sinking 4 mA at
E6 and 2 mA at E7. These values lie within the ranges
disclosed by Appellant. Therefore, the Examiner concluded
that the stimulation applied by Meadows accomplishes the
same result claimed by Appellant since the spatial
relationship of the electrodes to the neural fiber bundles are
the same as those claimed and the current amplitudes are
within the ranges Appellant states are sufficient to generate
and block action potentials.

(Ans. 13-14.)
The issue with respect to this rejection is: Does the evidence of record
support the Examiner’s conclusion that Meadows inherently anticipates the
claims?
Findings of Fact
1. The Specification teaches that “[e]lectrodes E1 and E3 are each
sourcing 50% of the total current (e.g., 1 mA each) and 100% of the total
current (e.g., 2 mA) is being sunk at electrode E2. As such, there is local
current balance at the stimulation site” (Spec. 12, ll. 4-6).
2. The Specification teaches that the “depolarizing electric field
generated by electrode E2 is sufficient to create APs in some of the neural
fibers in the first fiber bundle FB1. In other words, the depolarization
threshold DPT has been met for the first fiber bundle FB1 in the tissue
adjacent electrode E2” (Spec. 12, ll. 6-10).
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3. The Specification teaches that when “the electric field is at or
above the hyperpolarization threshold HPT, the neural fibers within the
electric field will block APs that were fired at other points along the fibers”
(Spec. 12, ll. 17-19).
4. The Specification teaches that it “should be noted here that the
magnitude of the hyperpolarization threshold HPT has been estimated to be
about 2 to 8 times the magnitude of the depolarization threshold DPT”
(Spec. 12, ll. 19-22).
5. The Specification teaches that “a ‘remote’ electrode is an
electrode that, when sourcing or sinking stimulation current, will not have a
clinically significant neuromodulatory effect on the target tissue other than
reducing the amount of current sourced or sunk at the target tissue” (Spec. 9,
ll. 16-19).
6. Meadows teaches a “Spinal Cord Stimulation System. A spinal
cord stimulation system is a programmable implantable pulse generating
system used to treat chronic pain by providing electrical stimulation pulses
from an electrode array placed epidurally near a patient’s spine” (Meadows,
col. 1, ll. 9-13).
7. Meadows teaches that the “pulse generator generates electrical
pulses that are delivered to the dorsal column fibers within the spinal cord
through the electrodes which are implanted along the dura of the spinal
cord” (Meadows, col. 1, ll. 23-26).
8. Meadows teaches that “FIG. 3A assumes the use of an electrode
array 110 having sixteen electrodes connected to the implantable pulse
generator (IPG) 100. In addition to these sixteen electrodes, which are
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numbered E1 through E16, a case electrode (or return electrode) is also
available” (Meadows, col. 12, ll. 15-19).
9. Figure 3A of Meadows is reproduced, in part, below:

“The operation of multiple channels used to provide a stimulus pattern
through multiple electrodes is illustrated in FIG. 3A” (Meadows, col. 12, ll.
13-14).
10. Meadows teaches that “channel 2 of the IPG 100 is set to
generate and apply a 6 mA pulse, having a repetition rate of 50 pps and a
width of 300 µs, between electrode E8 (+6 mA) and electrodes E6 and E7 (-
4 mA and -2 mA, respectively)” (Meadows, col. 12, ll. 32-35).
11. Meadows teaches that:
When more than two electrodes are used with a given
channel, the sum of the current sourced from the positive
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electrodes should be equal to the sum of the current sunk
(returned) through the negative electrodes, as is the case
with channel 2 in the example of FIG. 3A (+6 mA sourced
from electrode E8, and a total of -6 mA sunk to electrodes
E6 [-4 mA] and E7 [-2 mA]).

(Meadows, col. 12, ll. 58-65.)
12. Figure 2A of Meadows is reproduced below:

The paddle lead shown at (E) in FIG. 2A similarly has two
columns of eight electrode contacts 115 in each row, with
the electrode contacts in one column being offset from the
electrode contacts in the other column, and with each
electrode contact being connected to one or more wires
carried in the flexible cable or carrier 116

(Meadows, col. 9, ll. 61-66).
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Principles of Law
“A single prior art reference that discloses, either expressly or
inherently, each limitation of a claim invalidates that claim by anticipation.”
Perricone v. Medicis Pharm. Corp., 432 F.3d 1368, 1375 (Fed. Cir. 2005).
“[D]uring examination proceedings, claims are given their broadest
reasonable interpretation consistent with the specification.” In re Hyatt, 211
F.3d 1367, 1372 (Fed. Cir. 2000).
Analysis
Claim 1
Meadows teaches a method where multiple electrodes are placed into
the spinal cord (FF 6) where the electrodes adjacent the dorsal column fibers
in the spinal cord are necessarily a “distance” from neural fiber bundles (FF
7; see, e.g., Ans. 12). Meadows teaches an example where source electrode
E8 provides 6 mA of current, a first 4 mA portion of which is sunk or
returned to electrode E6, and a second 2mA portion of which is sunk or
returned to electrode E7 (FF 9-11).
Meadows does not specifically address whether the 2 mA of current
sunk at electrode E7 is of a magnitude sufficient to generate action potentials
in a neural fiber, nor does Meadows address whether the 4 mA of current
sunk at electrode E6 is of a magnitude sufficient to block action potentials in
a neural fiber.
The Examiner relies upon Appellant’s Specification to evidence that
“sinking 2 milliamps of current at an electrode is sufficient to generate
action potentials” (Ans. 5; cf. FF 1-2). The Examiner further relies upon
Appellant’s Specification to evidence that “the hyperpolarization threshold
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is 2-8 times greater than the depolarization threshold . . . . Therefore, if
2mA is sufficient to depolarize a fiber bundle and cause an action potential,
then 4mA is sufficient to hyperpolarize a fiber bundle and block an action
potential” (Ans. 5; cf. FF 3-4).
Appellant contends that “the Examiner cannot assume the magnitude
values of depolarization/hyperpolarization current sourced and sunk at an
arbitrary combination of electrode based on a
depolarization/hyperpolarization threshold of a nerve fiber bundle” (App.
Br. 7). Appellant contends that “the current values used in the embodiment
illustrated in the Appellant’s specification are hypothetical and are set forth
for purposes of illustrating the operation of the embodiment” (App. Br. 8).
Appellant contends that it “does not follow that if these hypothetical current
values are applied to another embodiment, it would provide the same results
as that of the hypothetical embodiment” (App. Br. 8).
We find that the Examiner has the better position. We appreciate
Appellant’s point that an inherency rejection requires that the result must not
simply be probable but must necessarily occur. See MEHL/Biophile Int’l
Corp. v. Milgraum, 192 F.3d 1362, 1365 (Fed. Cir. 1999). However, as
noted in Best,
Where, as here, the claimed and prior art products are
identical or substantially identical, or are produced by
identical or substantially identical processes, the PTO can
require an applicant to prove that the prior art products do
not necessarily or inherently possess the characteristics of
his claimed product. . . . Whether the rejection is based on
“inherency” under 35 U.S.C. § 102, on “prima facie
obviousness” under 35 U.S.C. § 103, jointly or alternatively,
the burden of proof is the same, and its fairness is evidenced
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by the PTO’s inability to manufacture products or to obtain
and compare prior art products

In re Best, 562 F.2d 1252, 1255 (CCPA 1977).
In this situation, we conclude that the balance of the evidence supports
the Examiner. In particular, the Examiner does not simply state, without
support, that the electrode current levels of Meadows would inherently have
the required magnitudes sufficient to generate action potentials and block
action potentials as required by claim 1. Instead, the Examiner carefully
compares Meadows disclosure with the evidence of the Specification, which
teaches that 2 mA current of electrode E7 is of sufficient magnitude to create
action potentials (Ans. 5; FF 1-2, 9-11). The Examiner also reasons, based
on evidence directly sourced from the Specification, that the 4 mA current of
electrode E6 of Meadows is two times the depolarization threshold, the
magnitude identified by the Specification itself as the level necessary to
induce hyperpolarization (Ans. 5-6; FF 3-4, 9-11).
Thus, the Examiner has established, with evidentiary support, that
Meadows teaches all of the specific elements required by claim 1. In
response, Appellant solely provides attorney argument, not evidence. See In
re Pearson, 494 F.2d 1399, 1405 (CCPA 1974) (“Attorney’s argument in a
brief cannot take the place of evidence.”).
Appellant’s argument that the Specification is “hypothetical” is also
not persuasive, since the Examiner may reasonably rely upon the teachings
of the Specification as accurate. See, e.g., In re Marzocchi, 439 F.2d 220,
223 (CCPA 1971). (A “specification disclosure which contains a teaching of
the manner and process of making and using the invention in terms which
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correspond in scope to those used in describing and defining the subject
matter sought to be patented must be taken as in compliance with the
enabling requirement of the first paragraph of § 112 unless there is reason to
doubt the objective truth of the statements contained therein.”)
Appellant contends that to assume “that sunk electrical current having
a magnitude of three times the sunk electrical current necessary to depolarize
a nerve fiber bundle will, in fact, always hyperpolarize the nerve fiber
bundle is a mischaracterization of Appellant’s specification. Again, this is
why a range for the hyperpolarization/depolarization threshold ratio is
provided” (App. Br. 9).
We remain unpersuaded. This argument is not supported by evidence,
but simply represents attorney argument. Pearson, 494 F.2d at 1405.
Further, this argument fails to address the specific issue, which is not
whether any set of electrodes with the proper arrangement will satisfy the
claim requirements, but whether the specific example disclosed by Meadows
inherently anticipates. The Examiner has provided evidence to support the
inherency position (Ans. 5-6; FF 1-4, 6-11), while Appellant has provided
no rebuttal evidence, only argument.
Appellant contends that
It makes no sense to conclude that the language “a remote
electrode separate from the first electrode” only requires the
remote electrode to be separate from the first electrode. If
this were the case, why would one use the term “remote” to
qualify the electrode, when according to the Examiner, the
limitation would have the same meaning without the term
“remote”?

(App. Br. 13).
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We are not persuaded. Claim 1 provides no guidance on the distances
required for the electrodes to function, nor does claim 1 provide any
guidance on the distance required for a “remote” electrode. Turning to the
Specification, the Specification teaches that “a ‘remote’ electrode is an
electrode that, when sourcing or sinking stimulation current, will not have a
clinically significant neuromodulatory effect on the target tissue other than
reducing the amount of current sourced or sunk at the target tissue” (Spec. 9,
ll. 16-19; FF 5). Thus, no specific distance is required by the Specification
for an electrode to be identified as “remote.” We therefore agree with the
Examiner that, absent evidence to the contrary, the electrode of Meadows is
reasonably interpreted as “remote,” since electrodes E6 and E7 of Meadows
function as current sinks and no “significant neuromodulatory effect” is
taught, so that each electrode is “remote” from the other (FF 9-11).
Claim 2
Appellant contends that:
There is no disclosure in Meadows, explicit or implicit, that
sourcing current at electrode E8 and sinking current at
electrodes E6, E7 would block action potentials in a neural
fiber bundle that is closer to electrode E8 than another
neural fiber bundle. The fact that each electrode in the
Meadows system will be a separate distance from a neural
fiber bundle does not necessarily result in this claimed step.

(App. Br. 17-18.)
We are not persuaded. Meadows discloses that “FIG. 3A assumes the
use of an electrode array 110 having sixteen electrodes connected to the
implantable pulse generator (IPG) 100. In addition to these sixteen
electrodes, which are numbered E1 through E16, a case electrode (or return
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electrode) is also available” (Meadows, col. 12, ll. 15-19; FF 8). In Figure
2A, Meadows discloses seven different electrode configurations, but only
configuration (E) shows sixteen electrodes as required by Figure 3A (FF 12).
Configuration (E) of Figure 2A of Meadows shows electrodes which are
offset from one another such that, no matter whether the electrodes are
numbered E1 to E8 sequentially or alternatively, the distance between
electrodes E6 and E8 will be greater than the distance between electrodes E6
and E7 in Figure 3A, consistent with the requirement of claim 2 and the
Examiner’s position (see Ans. 5-6; 22).
Claim 22
Appellant contends that “if the case electrode is considered to be the
claimed remote electrode, there is no disclosure in Meadow[s] that current
be sunk in both the case electrode and a lead electrode” (App. Br. 20).
We are not persuaded for the reasons given above. We find that the
electrode of Meadows is reasonably interpreted as “remote,” since electrodes
E6 and E7 of Meadows function as current sinks and no “significant
neuromodulatory effect” is taught, so that each electrode is “remote” from
the other (FF 9-11).
Conclusion of Law
The evidence of record supports the Examiner’s conclusion that
Meadows inherently anticipates the claims.
B. 35 U.S.C. § 103(a) over Cohen and Meadows
Appellant does not separately argue the claims in this obviousness
rejection. Instead, Appellant argues that Meadows does not anticipate
claims as discussed above. Having affirmed the anticipation rejection of the
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claims over Meadows, we also find that the further combination with Cohen
render the claims obvious for the reasons given by the Examiner (see Ans. 7-
9). See In re McDaniel, 293 F.3d 1379, 1385 (Fed. Cir. 2002) (“It is well
settled that ‘anticipation is the epitome of obviousness.’”)

C. 35 U.S.C. § 103(a) over Meadows
Appellant contends that “if the case electrode, which has a greater
surface area than a lead electrode, is considered to be the claimed remote
electrode, there is no disclosure in Meadow[s] that current be sunk in both
the case electrode and a lead electrode” (App. Br. 21).
The Examiner finds that “it would have been an obvious matter of
design choice to make the case electrode larger than the lead electrodes,
since such a modification would have involved a mere change in the size of
a component. A change in size is generally recognized as being within the
level of ordinary skill in the art” (Ans. 10).
We find that the Examiner has the better position. The size of the
electrode is reasonably interpreted as a results effective variable based upon
Meadows’ disclosure of multiple different size and shape electrodes in
Figure 2A (FF 12). Therefore, in the absence of any evidence of a
secondary consideration, “[W]here the general conditions of a claim are
disclosed in the prior art, it is not inventive to discover the optimum or
workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456
(CCPA 1955).

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SUMMARY
In summary, we affirm the rejection of claims 1, 2, and 22 under
35 U.S.C. § 102(b) as anticipated by Meadows. Pursuant to 37 C.F.R.
§ 41.37(c)(1), we also affirm the rejection of claims 3, 4, and 23-27, as these
claims were not argued separately.
We affirm the rejection of claims 1-4 under 35 U.S.C. § 103(a) as
obvious over Cohen and Meadows.
We affirm the rejection of claim 21 under 35 U.S.C. § 103(a) as
obvious over Meadows.

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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