Ex Parte Spokoyny

Board of Patent Appeals and Interferences

Nov 17, 2008

10460583 (B.P.A.I. Nov. 17, 2008)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte ELEONORA S. SPOKOYNY
__________

Appeal 2008-4610
Application 10/460,583
Technology Center 3700
__________

Decided: November 17, 2008
__________

Before DONALD E. ADAMS, LORA M. GREEN, and
FRANCISCO C. PRATS, Administrative Patent Judges.

PRATS, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a
neurological testing template. The Examiner has rejected the claims as
anticipated. We have jurisdiction under 35 U.S.C. § 6(b). We affirm.
STATEMENT OF THE CASE
“Certain diseases and/or injuries affecting peripheral nerves are
accompanied by a decrease in nerve conduction velocity across the involved
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segment of the nerve” (Spec. 1). Nerve conduction studies, which measure
the electrical conductivity of different segments of the damaged or
compromised nerve, can be used to locate the segment of the nerve involved
in the problem (id. at 1-3). One technique, termed “inching” or
“centimetering,” involves using electrodes to sequentially measure the
conductivity of adjacent segments along the course of the involved nerve (id.
at 4).
The Specification discloses “a template, carried on a flexible body
member, for use in diagnosing focal peripheral neuropathies when using the
‘inching technique’ to obtain a spaced array of conduction velocity readings
for precise localization of nerve entrapment” (id.). The Specification
discloses that the template has “locating means thereon which are used to
efficiently and accurately determine electrode placement for nerve velocity
measurements along the nerve being investigated” (id. at 5).
Claims 1, 2, and 5-11 stand finally rejected and are on appeal (App.
Br. 2).1 Claim 1 is representative and reads as follows:
1. A neurological testing template for assistance in
diagnosing focal peripheral neuropathy disorders when
using the “inching technique” to position an independent
anode and cathode assembly, of the type having a fixed
space between the anode and cathode of such assembly,
to obtain a spaced array of conduction velocity readings
for use in the localization of nerve entrapment,
comprising:

a flexible, generally non-conductive, body member
having a length, width and thickness and adapted to be in
constant relationship to an extremity having nerves being

1 Appeal Brief filed September 13, 2007.
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examined, in a manner that the axis of elongation of said
length of said body member extends generally in the
direction of elongation of such extremity and of the
selected nerve being examined;

said body member having a series of longitudinally
spaced openings extending through said thickness
thereof, which are cooperative with such anode and
cathode assembly such that, during an inching procedure,
such cathode and anode are in conductive contact with
the skin of such extremity through a longitudinally
spaced pair of said openings and are selectively moved
longitudinally along said body member and positioned to
be in conductive contact with such skin through other
pairs of said openings to obtain conductive readings
along such selected nerve being examined.

The Examiner cites the following documents as evidence of
unpatentability:
Lemmen US 5,327,902 Jul. 12, 1994
Fischer et al. US 5,511,316 Apr. 30, 1996
Cory et al. US 6,564,079 B1 May 13, 2003
Laufer et al. US 2003/0191511 A1 Oct. 9, 2003

The following rejections are before us for review:
Claims 1 and 5-11 stand rejected under 35 U.S.C. § 102(b) as being
anticipated by Fischer (Ans. 3-4).
Claims 1, 2, 5-8, and 11 stand rejected under 35 U.S.C. § 102(e) as
being anticipated by Cory (Ans. 4-5).
ANTICIPATION -- FISCHER
ISSUE
The Examiner cites Fischer as disclosing a template that has a
“flexible (Col. 1, lines 45 - 49), non-conductive body member (10) having a
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length, width and thickness; the body member includes a series of
longitudinally spaced openings (70, 71, 72) extending through the thickness
thereof. The openings extend arcuately across a portion of the width (Figure
1)” (Ans. 3).
The Examiner finds that “the use of the [claimed] template for
neurological testing with an anode and cathode assembly is merely intended
use,” and that because “the fixed space between the anode and cathode of an
assembly can be formed of any predetermined size based on a desired
procedure (Lemmen Col. 3, lines 58 - 63), the assembly disclosed by Fisher
et al. inherently possess the spacing between openings as claimed” (Ans. 4).
Appellant contends that the Examiner erred in finding that Fischer
anticipates the claims because Fischer does not explicitly disclose that its
template is flexible and non-conductive (App. Br. 5-6). Appellant also
contends that the Examiner erred in applying the Fischer reference to the
instant claims because it is non-analogous art to the claimed invention (id. at
6-7) (citing In re Oetiker, 977 F.2d 1443 (Fed. Cir. 1992)). Appellant
further contends that the Examiner erred by failing to give patentable weight
to the functional limitations directed to the template’s use in an inching
procedure (App. Br. 10-11).
The issues with respect to this rejection, then, are whether the
Examiner erred in finding that Fischer’s template meets the structural
limitations recited in the claims, including the flexibility and
non-conductivity limitations, and whether the Examiner erred in finding that
the claims’ functional limitations encompass Fischer’s template.
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FINDINGS OF FACT (“FF”)
1. Fischer discloses a “stencil for cutting sandpaper . . . preferably made
of a material such as polycarbonate plastic. The stencil itself would
normally be rectangular in shape and be formed of a sheet of plastic
material. The thickness of the sheet would be in the range of 1-5 mm”
(Fischer, col. 1, ll. 45-49). Fischer states that “[i]n its preferred form the
stencil would be 320 millimeters long and 270 millimeters wide” (Fischer,
col. 1, ll. 49-50).
2. Fischer’s stencil is essentially a plastic sheet with critically placed
slots in it that, when placed on a standard sheet of sandpaper, allow using a
knife to accurately cut the sandpaper into smaller sheets useful in different
applications (Fischer, col. 2, ll. 13-43).
3. Fischer discloses that, in order to secure sheets of sandpaper to the
stencil for cutting, the stencil has corner “lips [which] extend downwardly
from the bottom surface of the sheet of plastic material and they are
positioned at the respective corners of the stencil. Each of these corner lips
has a first and a second inner edge and they intersect each other at a
substantially 90 degree angle” (Fischer, col. 1, ll. 53-57). Fischer states that
“[t]he height of the corner lips is H1 and it would normally be in the range
of 1 to 4 mm. As an example, if the corner lip has a height of 2mm, 5
stacked sheets of 120 sandpaper could be received in the bottom recess of
the stencil” (id. at col. 1, ll. 64-67).
4. Figure 1 of Fischer, reproduced below, shows a top plan view of the
stencil:
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Figure 1 shows stencil 10, which is “normally formed of a sheet of
plastic material having a planar top surface 12 and a planar bottom surface
14” (Fischer, col. 2, ll. 62-64). Figure 1 also shows:
[A] series of slots 64 and 66 [which] allows the standard
sized sheet of sandpaper to be cut into 1/3 sheet sections. After
the primary cuts are made in the respective slots 64 and 66,
straight edge 28 is placed adjacent these cuts and a cut can be
made across the complete width of the sheet of sandpaper.

(Fischer, col. 3, ll. 39-44.)
5. As also shown in Figure 1 of Fischer, the stencil has a “series of
arcuate slots 70, 71 and 72 [which] allow 6 inch, 7 inch, and 8 inch circular
disks of sandpaper to be formed” (Fischer, col. 3, ll. 45-46).
6. Lemmen discloses “[a]n apparatus for use in nerve conduction studies
[which] includes a fixture for supporting a reference electrode, a recording
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electrode, a cathode and an anode with the distance between the cathode and
the recording electrode being preselected and fixed” (Lemmen, abstract).
7. Lemmen discloses that, while the distance between the cathode and
recording electrode is adjustable and is denoted by gradations or tick marks,
once the distance has been set, it is fixed by a set screw (see Lemmen, col. 3,
ll. 38-55). Lemmen elaborates that the electrodes “are mounted a
preselected distance . . . with respect to each other. The distance . . .
between recording electrode 12 and stimulating cathode or electrode 14 is
preselected and corresponds to that needed for the type of study being
conducted” (id. at col. 3, ll. 58-63).
8. Laufer discloses a device “that can deliver thermal energy to an area
of infarcted heart tissue” (Laufer [0001]). Laufer discloses that, in one
embodiment, the device’s “housing is injection molded using electrically
insulating polycarbonate” (id. at [0059]).
9. Appellant’s Figure 1 is reproduced below:

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Appellant’s Figure 1 shows the rectangular template 50 with two
circular openings and a series of evenly spaced arcuate openings all aligned
along a center line x-x.
10. Appellant’s Figure 4 is reproduced below:

Appellant’s Figure 4 shows the template 50 in use on a subject’s hand
and wrist, with the arcuate openings extending along the length of the
patient’s arm. The figure also shows an anode/cathode assembly placed on
the subject’s skin, with cathode 24 passing through an opening the template
and anode 22 passing through in a separate arcuate opening some distance
from the first opening.
PRINCIPLES OF LAW
It is well settled that, “[t]o anticipate a claim, a prior art reference
must disclose every limitation of the claimed invention, either explicitly or
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inherently.” In re Schreiber, 128 F.3d 1473, 1477 (Fed. Cir. 1997). During
examination, however, the PTO must interpret terms in a claim using “the
broadest reasonable meaning of the words in their ordinary usage as they
would be understood by one of ordinary skill in the art, taking into account
whatever enlightenment by way of definitions or otherwise that may be
afforded by the written description contained in the applicant’s
specification.” In re Morris, 127 F.3d 1048, 1054 (Fed. Cir. 1997).
It is also “well settled that the recitation of a new intended use for an
old product does not make a claim to that old product patentable.”
Schreiber, 128 F.3d at 1477. Thus, functional limitations directed to
intended uses in an apparatus claim do not serve to distinguish the claimed
apparatus from prior art apparatuses inherently capable of performing the
claimed function. See id. at 1478-79 (holding that a prior art apparatus
meeting all claimed structural limitations was anticipatory because it was
inherently capable of performing the claimed function).
“A patent applicant is free to recite features of an apparatus either
structurally or functionally.” Id. at 1478. However, “‘[f]unctional’
terminology may render a claim quite broad . . .[;] a claim employing such
language covers any and all embodiments which perform the recited
function.” In re Swinehart, 439 F.2d 210, 213 (CCPA 1971) (emphasis
added).
Moreover, as stated in In re Best, 562 F.2d 1252, 1254-55 (CCPA
1977) (quoting In re Swinehart, 439 F.2d at 212-13):
[W]here the Patent Office has reason to believe that a functional
limitation asserted to be critical for establishing novelty in the
claimed subject matter may, in fact, be an inherent
characteristic of the prior art, it possesses the authority to
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require the applicant to prove that the subject matter shown to
be in the prior art does not possess the characteristic relied on.

See also In re Spada, 911 F.2d 705, 708 (Fed. Cir. 1990) (“[W]hen the PTO
shows sound basis for believing that the products of the applicant and the
prior art are the same, the applicant has the burden of showing that they are
not.”).
ANALYSIS
Appellant’s arguments do not persuade us that the Examiner erred in
finding that Fischer’s template meets the structural limitations recited in the
claims, including the flexibility and non-conductivity limitations. Nor are
we persuaded that the Examiner erred in finding that the claims’ functional
limitations encompass Fischer’s template.
Appellant argues that the Examiner incorrectly found that Fischer’s
stencil meets the limitation requiring the template to be flexible because
polycarbonate plastic 1 to 5 millimeters thick “is not flexible as is required
by Applicant’s claim, which specifically requires that the body member be
flexible so that it may be adapted to ‘to be in constant contact with an
extremity’, which is impossible with a non-flexible or relatively rigid piece
of plastic with specifically defined corner lips” as disclosed by Fischer (App.
Br. 5). For example, Appellant argues, “the bodies of all I-Pods are made of
polycarbonate plastic ~ 1mm thick. It certainly is too rigid to follow the
curved surface of human skin” (Reply Br. 4-5).
We are not persuaded by these arguments. Appellant has provided no
evidence to support the assertions regarding the flexibility of polycarbonate
plastic. It is well settled that argument by counsel cannot take the place of
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evidence. In re Cole, 326 F.2d 769, 773 (CCPA 1964); In re Geisler, 116
F.3d 1465, 1471 (Fed. Cir. 1997).
Moreover, claim 1 merely recites that the template must be “flexible,”
without requiring any particular degree of flexibility other than the capacity
to “be in constant relationship to an extremity having nerves being
examined.” Thus, rather than requiring constant contact with the skin, claim
1 only requires the template to be capable of being in a constant relationship
with the examined extremity.
Given its relative thinness, 1 millimeter, compared to its overall
length, 320 millimeters (FF 1), and its construction of plastic, we agree with
the Examiner that it was reasonable to conclude that Fischer’s stencil has at
least some degree of flexibility. We therefore also agree that when claim 1
is given its broadest reasonable interpretation consistent with the
Specification, Fischer’s stencil meets the limitation requiring the template to
be flexible.
Appellant argues that the Examiner incorrectly found that Fischer’s
stencil meets the limitation requiring the template to be non-conductive,
because “[p]lastic may indeed have conductive characteristics” (App. Br. 5;
see also Reply Br. 5). In response, the Examiner contends that
polycarbonate is known to be non-conductive, as evidenced by Laufer’s use
of polycarbonate as an electrically simulating material on a medical device
(Ans. 5; see also FF 8).
Appellant’s arguments do not persuade us that the Examiner erred in
finding that Fischer meets the non-conductivity limitation. Specifically,
claim 1 requires the template to be “generally non-conductive.”
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As the Examiner points out, polycarbonate plastic can be used as an
electrically insulating material (FF 8). Given the absence of any disclosure
in Fischer suggesting that the polycarbonate was modified to conduct
electricity, we agree with the Examiner that it was reasonable to conclude
that Fischer’s plastic stencil was generally non-conductive. Therefore, even
assuming for argument’s sake that certain variants of polycarbonate are
conductive, a preponderance of the evidence supports the Examiner’s
finding that Fischer’s polycarbonate plastic stencil is non-conductive.
Thus, we agree with the Examiner that Fischer meets the
non-conductivity limitation in claim 1. Moreover, because Fischer’s stencil
also has longitudinally spaced openings (see Fischer Fig. 1, slots 64, 66, 71,
and 72 (FF 4)), we agree with the Examiner that Fischer’s stencil meets all
of the explicitly recited structural limitations in claim 1.
Appellant argues that Fischer is inapplicable to the instant claims
because it is not analogous art to the claimed invention (App. Br. 6-7). We
are not persuaded by this argument.
As stated in Schreiber, 128 F.3d at 1478 (citation omitted):
“[T]he question whether a reference is analogous art is
irrelevant to whether that reference anticipates. A reference
may be from an entirely different field of endeavor than that of
the claimed invention or may be directed to an entirely different
problem from the one addressed by the inventor, yet the
reference will still anticipate if it explicitly or inherently
discloses every limitation recited in the claims.”

Thus, in the instant case, the fact that Fischer’s stencil is used for an
entirely different purpose than Appellant’s template does not render Fischer
any less anticipatory.
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Appellant argues that it is acceptable to use functional language to
define a product, and that the Examiner’s finding of anticipation
inappropriately ignores that language (App. Br. 10-11). While we agree
with Appellant that functional language is a proper way to limit a claim, see
Schreiber, 128 F.3d at 1478, Appellant’s argument does not persuade us that
the Examiner erred in finding that Fischer meets the functional limitations of
claim 1.
As noted above, “‘[f]unctional’ terminology may render a claim quite
broad . . .[;] a claim employing such language covers any and all
embodiments which perform the recited function.” Swinehart, 439 F.2d at
213 (emphasis added). Thus, any apparatus capable of performing a claim
intended use will meet the functional limitation. See Schreiber, 128 F.3d. at
1478-79.
In the instant case, as discussed above, Fischer’s stencil meets all of
the structural limitations recited in claim 1. Fischer’s stencil therefore has
all of the structural attributes recited in claim 1 as being required to perform
the recited function.
The functional limitations in claim 1 require the template to be
capable of assisting an “inching technique” diagnosis of nerve disorders by
allowing the anode and cathode to be in conductive contact with the skin
through a longitudinally spaced pair of openings, after which the anode and
cathode are “selectively moved” to be in contact with the skin through other
pairs of openings.
Fischer’s stencil has at least three pair of longitudinally separated,
equally spaced openings (see Fischer, Fig. 1 (FF 4)). Thus, we agree with
the Examiner that Fischer’s stencil, when placed adjacent to the skin, would
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allow a cathode/anode pair having a fixed separation to be selectively moved
longitudinally along an extremity, which is all that claim 1 requires. We do
not agree with Appellant that the stencil’s 1 millimeter thick corner lips (see
FF 3) would have impaired placing the stencil adjacent to the skin.
Moreover, as the Examiner points out, different electrode separations
can be used to perform nerve conduction studies (see FF 6-7). Given the
capacity of anode/cathode pairs to be adjusted to accommodate differently
spaced openings, we therefore agree with the Examiner that it was
reasonable to conclude that Fischer’s stencil could be used in the manner
recited in claim 1.
Because the Examiner reasonably concluded that Fischer’s stencil
meets all of the structural limitations and functional limitations of claim 1,
the burden shifted to Appellant to show non-anticipation. See In re Best,
562 F.2d at 1255; In re Spada, 911 F.2d at 708. As discussed above, we
conclude that Appellant has not met that burden with respect to the argued
structural limitations.
Moreover, Appellant does not point to, and we do not see, any
evidence of record suggesting that Fischer’s stencil is incapable of
performing the recited functions. We therefore affirm the Examiner’s
rejection of claim 1 as anticipated by Fischer. Because they were not argued
separately, claims 5-7, 10, and 11 fall with claim 1. See 37 C.F.R.
§ 41.37(c)(1)(vii).
Appellant argues that Fischer does not inherently meet the limitation
in claim 8 requiring arcuate openings across at least a portion of the width of
the body member of claim 8, or the arcuate dimension criteria recited in
claim 9 (App. Br. 9). Thus, Appellant argues, “[t]o be functional, all arcuate
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openings should have the same radius equal to distance between the cathode
and anode in the assembly (Claim 9). This is not the case in the prior art
stencil where openings have various radii” (Reply Br. 6).
Claims 8 and 9 depend from claim 1 through claim 5. Claims 5, 8,
and 9 read as follows:
5. A neurological testing template as specified in Claim 1 wherein
the spacing between longitudinally spaced adjacent pairs of said
openings are a whole number fraction of such fixed space.

8. A neurological testing template as is specified in Claim 5
wherein at least some of said openings extend arcuately across a
portion of said width.

9. A neurological testing template as is specified in Claim 8
wherein the radius of the arcuate centerline of said arcuate
openings is equal to the center to center distance between such
anode and cathode.

Appellant’s argument does not persuade us that Fischer fails to meet
the limitations of claim 8. As seen in Figure 1 of Fischer, the stencil has a
number of arcuate openings that extend across a portion of the width of the
stencil (FF 4). We therefore affirm the Examiner’s rejection of claim 8 as
anticipated by Fischer.
With respect to claim 9, the Specification does not define “radius of
the arcuate centerline.” However, as seen in Appellant’s Figures 1 and 4,
the arcuate openings are evenly spaced, along a center line x-x, so as to
accommodate serial readings using a cathode/anode assembly having a fixed
distance between the two electrodes (FF 9, 10).
Therefore, when claim 9 is given its broadest reasonable interpretation
consistent with the Specification, we interpret it as encompassing templates
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that have a plurality of evenly spaced arcuate openings. Fischer’s stencil has
a plurality of evenly spaced arcuate openings (FF 4).
Thus, we agree with the Examiner that it was reasonable to conclude
that, given the proper electrode separation setting, the radii of the arcuate
centerline of the openings in Fischer’s stencil would equal the distance
between an anode and cathode used in the manner recited in claim 9. We
therefore also affirm the Examiner’s rejection of claim 9 as anticipated by
Fischer.
ANTICIPATION -- CORY
ISSUE
Claims 1, 2, 5-8, and 11 stand rejected under 35 U.S.C. § 102(e) as
being anticipated by Cory (Ans. 4-5).
The Examiner cites Cory as disclosing a template for use in an
electrode system, the template including
[A]n elongated flexible generally non-conductive body member
can be seen in figure 7C around element 308, that is capable of
being adapted to be in constant relationship to an extremity, the
body member has a series of longitudinally spaced arcuate
transversely extending openings extending through the
thickness of the body member, can be seen around element 702
in Figure 7C, that is capable of being used with a cathode and
anode assembly, and is capable of being moved along the body
member in conductive contact with the skin.

(Id. at 4.)
The Examiner further finds that “the use of the [claimed] template for
neurological testing with an anode and cathode assembly is merely intended
use,” and that because “the fixed space between the anode and cathode of an
assembly can be formed of any predetermined size based on a desired
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procedure (Lemmen: Col. 3, lines 58 - 63), the assembly disclosed by C[o]ry
et al. inherently possess the spacing between openings as claimed” (Ans. 5).
Appellant contends that Cory does not meet all of the claim
limitations because the configuration of Cory’s device “is not suitable for
nerve conduction velocity testing using a cathode/anode assembly and is not
at all applicable to an inching technique of such testing” (App. Br. 7).
Moreover, Appellant argues, Cory’s device differs from the rejected claims
because Cory’s electrode sensor is not movable (id. at 7-8), nor does it have
“‘arcuate transversely extending openings’” (id. at 8; see also Appellant’s
claim 8), or the “‘arcuate centerline of said arcuate openings’” recited in
claim 9 (Reply Br. 6).
Appellant further argues that a person using Cory’s device cannot
readily rotate the testing probe, due to the absence of the claimed arcuate
openings and the presence of adhesive on Cory’s skin attachment system
(App. Br. 8). Appellant further argues that “[f]illing individual holes with
electro conductive gel, as specified by Cory, is counterproductive for the
structure claimed by applicant, since gel in arcuate openings will create
artifacts with other nerves and will reduce the accuracy of measurements”
(id. at 9).
The Examiner has not rejected claim 9 as being anticipated by Cory
(see Ans. 4). The issues with respect to this rejection, then, are whether the
Examiner erred in finding that Cory’s template meets the functional
limitations in claim 1, and whether the Examiner erred in finding that Cory’s
template meets the structural limitations in claim 8.
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FINDINGS OF FACT
11. Cory discloses a “medical device for the noninvasive location and
imaging of peripheral nerves” (Cory, col. 1, ll. 7-8). Specifically, the device
“is a sensor system for use at the skin surface comprising an electrode array
assembly with multiple electrodes and a skin attachment system” (id. at col.
1, ll. 9-11).
12. Cory discloses that in one embodiment the individual electrodes
comprising the electrode array have an “edge-to-edge spacing of about 3
mm” (Cory, col. 4, l. 8).
13. The skin attachment system of Cory’s device “provides an interface
between the electrode array and the skin surface of a living being, preferably
a mammal, more preferably a human patient. The skin attachment system
comprises a plurality of layers” (Cory, col. 4, ll. 23-27).
14. The layers of Cory’s skin attachment system include “the support
layer, [which] contains a plurality of hydrogel islands arranged in a support .
. . [and] the skin marking guide layer, [which] is fenestrated (i.e. has holes)
so that the hydrogel islands protrude through the holes therein” allowing
electrical conductivity between the skin and the array’s individual electrodes
(Cory, col. 4, ll. 27-31).
15. Cory discloses that “[t]he support layer and the skin marking guide
layer are held together by an adhesive that is easily broken, so that after
imaging the peripheral nerves, the practi[ti]oner may then peel the support
layer away from the skin marking guide layer, leaving the latter attached to
the skin” (Cory, col. 4, ll. 31-36).
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16. Cory discloses that the hydrogel “may be any electrically conductive
hydrogel known in the medicinal, biofeedback or biological testing arts”
(Cory, col. 4, ll. 37-39).
17. Cory discloses that “[t]he skin marking guide layer may be made of
any polymeric material known in the medical arts. Particularly
advantageous are those polymeric materials that are clear or translucent.
The polymeric materials may be colored in order to enhance their visibility
against skin” (Cory, col. 4, ll. 44-48). Thus, in one embodiment, the skin
marking guide “is formed of a material such as 4 mil polyethylene, colored
so as to be easily visible on all skin types (e.g., blue or white)” (id. at col. 7,
ll. 63-65).
18. Cory discloses:
Once samples have been taken with the device, all but the
bottom (skin marking guide) layer of the skin attachment
system may be removed from the skin of the subject. This
bottom layer is fenestrated, with holes that correspond to the
location of the electrodes in the electrode array, and provides a
skin marking guide. Skin can be marked through this skin
marking guide to facilitate subsequent injection(s) at the site(s)
chosen by the practitioner based upon the readings obtained, or
the skin marking guide may be left in place on the skin to
provide a convenient template for guiding a nerve stimulation
needle or other needle.

(Cory, col. 5, ll. 1-12.)
19. Figure 7C of Cory is reproduced below:
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Figure 7C “depicts marking of skin 602 through a hole 702 in skin
marking guide 308 with a pen 710” (Cory, col. 8, ll. 61-62).
20. Appellant does not contest the Examiner’s finding that Cory’s skin
marking guide 308 is a flexible, generally non-conductive body member
having longitudinally spaced openings through its thickness.
21. Appellant’s Specification discloses that, when using the template,
“[a]s is normal, a conductive gel is applied intermediate the ends of
electrodes 22 and 24 and the adjacent skin areas to provide better electrical
conductivity therebetween” (Spec. 9-10).
ANALYSIS
Appellant’s arguments do not persuade us that the Examiner erred in
finding that Cory’s template meets the functional limitations in claim 1. Nor
are we persuaded that the Examiner erred in finding that Cory’s template
meets the structural limitations in claim 8.
The Examiner states that “[o]nly the skin marking guide (308) forms
the basis of the rejection” (Ans. 6; see also FF 18, 19). Appellant does not
contest (FF 20), and we do not detect any error in, the Examiner’s finding
that Cory’s skin marking guide 308 is a flexible, generally non-conductive
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body member having longitudinally spaced openings through its thickness.
We therefore agree with the Examiner that Cory’s skin marking guide meets
all of the structural limitations recited in claim 1 as being required to
perform the claimed function.
While claim 1 recites that the device has an intended use that employs
an anode/cathode assembly, claim 1 does not in fact recite the electrode
assembly as being part of the claimed template. Because claim 1 is directed
to a template, not a device that has an electrode, it is irrelevant whether
Cory’s electrode moves in relation to the skin marking guide when Cory
uses the device for nerve imaging. Appellant’s argument does not,
therefore, persuade us that Cory’s skin marking guide is distinguishable
from claim 1 on this basis.
Appellant argues that “Cory has adhesive on top of the skin
attachment system to insure fixed (not movable) contact with the electrode
array. This arrangement is contra to the structure claimed by applicant and
will prevent freely moving the electrode assembly” (App. Br. 8). Appellant
further argues that “when accumulated on electrodes [the adhesive] may
substantially distort electrical readings” (Reply Br. 6).
We are not persuaded by this argument. We note that Cory’s skin
marking guide might have residual adhesive on it after removal of the
electrode and supporting assembly (see FF 15). However, because the
template of claim 1 is recited in opening “comprising” language, we do not
agree with Appellant that claim 1 excludes the presence of any residual
adhesive that might be present. See Genentech, Inc. v. Chiron Corp., 112
F.3d 495, 501 (Fed. Cir. 1997) (“‘Comprising’ is a term of art used in claim
language which means that the named elements are essential, but other
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Application 10/460,583

elements may be added and still form a construct within the scope of the
claim.”).
Moreover, given that a marking pen can be inserted into and removed
from the openings to mark a patient’s skin (see FF 18-19), we are not
persuaded that the adhesive would inhibit motion of an electrode assembly.
Also, because claim 1 is a product claim, it does not exclude any unclaimed
process steps, such as cleaning the electrodes should adhesive actually
accumulate on them.
Appellant argues that “[f]illing individual holes with electro
conductive gel, as specified by Cory, is counterproductive for the structure
claimed by applicant, since gel in arcuate openings will create artifacts with
other nerves and will reduce the accuracy of measurements” (App. Br. 9; see
also Reply Br. 7). We are not persuaded by this argument.
As noted above, argument by counsel is no substitute for evidence.
See In re Cole, 326 F.2d at 773; In re Geisler, 116 F.3d at 1471. Appellant
has provided no evidence supporting the assertion that electrically
conductive gel would have the stated detrimental effects. To the contrary,
Appellant’s Specification discloses that electrically conductive gel is not
only suitable with the claimed device, but “provide[s] better electrical
conductivity” between the skin and the electrodes (Spec. 10 (FF 21)).
Appellant argues that Cory’s device cannot be put to the claimed
intended use because it has “no ‘arcuate transversely extending openings’”
(App. Br. 8). The Examiner responds that “[t]he numerous circular openings
(702) are ‘arcuate transversely extending openings’” (Ans. 6).
Claim 8 requires only that “at least some of said openings extend
arcuately across a portion of said width.”
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Application 10/460,583

Cory’s skin marking guide contains a number of longitudinally spaced
circular openings (FF 19). Because the edges of the circular openings are
curved, we agree with the Examiner that Cory’s openings can be considered
to extend arcuately across a portion of the template’s width, as required by
claim 8. Appellant’s argument therefore does not persuade us the Examiner
erred in finding that Cory meets that limitation.
In sum, Appellant’s arguments do not persuade us that the Examiner
erred in finding that Cory’s template meets the limitations in claim 1. We
therefore affirm the Examiner’s rejection of claim 1 as anticipated by Cory.
Because claims 2, 5-7, and 11 were not argued separately, they fall with
claim 1. See 37 C.F.R. § 41.37(c)(1)(vii).
Because Appellant’s arguments do not persuade us that the Examiner
erred in finding that Cory meets the limitations of claim 8, we also affirm the
Examiner’s rejection of that claim as anticipated by Cory.
SUMMARY
We affirm the Examiner’s rejection of claims 1 and 5-11 under 35
U.S.C. § 102(b) as being anticipated by Fischer.
We affirm the Examiner’s rejection of claims 1, 2, 5-8, and 11 under
35 U.S.C. § 102(e) as being anticipated by Cory.

AFFIRMED

cdc
HOWARD E. SANDLER
25901 RICH SPRINGS CIRCLE
LAGUNA HILLS CA 92653
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